Document xjyBBM2OQx3k0ba89o56bw226
UNITED STATES DISTRICT COURT DISTRICT OF NEVADA
NEVADA POWER COMPANY, Nevada corporation,
Plaintiff,
a
VS .
MONSANTO COMPANY, a foreign corporation; GENERAL ELECTRIC COMPANY, a foreign corporation; WESTINGHOUSE ELECTRIC CORPORATION; a foreign corporation; and DOES I XXV, inclusive,
Defendants.
CV-S-89-555-LDG-LRL
READING COPY
DEPOSITION OF ROBERT EMMET KELLY, VOLUME I
TAKEN ON FEBRUARY 15, 1994
M.D.
MARTIN & ASSOCIATES CERTIFIED COURT REPORTERS
2200 MARKET STREET, SUITE 412 GALVESTON/TEXAS 77550
(409) 762-2222 * FAX (409) 762-8040
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INDEX
2
THE WITNESS:
ROBERT EMMET KELLY, M.D. VOLUME I
EXAMINATION: By Mr. Bauer ..................................................................................
PAGE 11
KELLY EXHIBITS:
Exhibit No . 1 ............................................................................... "An Acneform Dermatergosis," by Jack W. Jones, M.D., and Herbert S. Alden, M.D.
9
Exhibit No. 2 ............................................................................... Program Symposium on Certain Chlorinated Hydrocarbons, Harvard School of Public Health, Boston, Massachusetts, June 30, 1937, and Attached Article from September, 1937, The Journal of Industrial Hygiene and Toxicology, "The Problem of Possible Systemic Effects from Certain Chlorinated Hydrocarbons," Drinker, et al
9
Exhibit No. 3 ............................................................................... Article from The Journal of Industrial Hygiene and Toxicology, February, 1938,"Morphological Changes in the Livers of Rats Resulting from Exposure to Certain Chlorinated Hydrocarbons," Bennett, et a1
9
Exhibit No. 4 ............................................................................... Report to the Monsanto Chemical Company by Cecil K. Drinker, M.D., September 15, 1938
9
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INDEX (Continued)
KELLY EXHIBITS:
PAGE
Exhibit No . 5 ............................................................................... Report to the Monsanto Chemical Company by Cecil K. Drinker, M.D., September 15, 1938
9
Exhibit No . 6 ............................................................................... Article from The Journal of Industrial Hygiene and Toxicology, May, 1939 ,"Further Observations on the Possible Systemic Toxicity of Certain of the Chlorinated Hydrocarbons with Suggestions for Permissible Concentrations in the Air of Workrooms," Cecil K. Drinker
9
Exhibit No . 7 ............................................................................... Article from the Journal of the American Medical Association, April 24, 1954, "Chloracne from an Unusual Exposure to Arochlor," Meigs, et al
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Exhibit No . 8 ............................................................................... Monsanto Chemical Company Letter Dated April 28, 1954, to Dr. J. Wister Meigs from R. Emmet Kelly, M.D.
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Exhibit No . 9 ............................................................................... Yale University School of Medicine Letter Dated May 7, 1954, to R. Emmet Kelly, M.D., from J. Wister Meigs, M.D.
9
Exhibit No. 10 ............................................................................
9
Scientific Associates Certificate
of Analysis Dated November 10,
1953, Re: "The Acute Oral
Toxicity (LD ) of Aroclor 1254 for
Rats," for the Monsanto Chemical Company
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INDEX (Continued)
KELLY EXHIBITS;
PAGE
Exhibit No . 11 ........................................................................... Scientific Associates Certificate of Analysis Dated December 11, 1953, Re: "The Acute Oral Toxicity of Aroclor 1242 for Rats," for the Monsanto Chemical Company
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Exhibit No . 12 ........................................................................... The Kettering Laboratory, University of Cincinnati, Report Dated June 22, 1955, "The Toxicity of the Vapor of Aroclor 1242 and Aroclor 1254," Treon, et al
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Exhibit No . 13 ........................................................................... The Kettering Laboratory, University of Cincinnati, Report Dated June 28, 1955, "The Toxicity of the Vapor of Aroclor 1242 and Aroclor 1254," Treon, et al
9
Exhibit No. 14 .......................................................................... Article from Industrial Hygiene Quarterly, June, 1956, "The Toxicity of the Vapors of Aroclor 1242 and Aroclor 1254," Treon, et al
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Exhibit No . 15 ........................................................................... Younger Laboratories Certificate of Analysis Dated March 4, 1963, RE: "Toxicological Investigation of Inerteen PPO," for Monsanto Chemical Company
9
Exhibit No. 16 ........................................................................... Younger Laboratories Certificate of Analysis Dated March 4, 1963, RE: "Toxicological Investigation of Pyranol 1470," for Monsanto Chemical Company
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INDEX (Continued)
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KELLY EXHIBITS:
PAGE
Exhibit No. 17 ........................................................................... Industrial Bio-Test Laboratories, Inc., Report Dated March 29, 1963, RE: "Subacute Dermal Toxicity of Aroclor 1254," for Monsanto Chemical Company
9
Exhibit No . 18 ........................................................................... Typewritten Note Dated October 11, 1937, from L. A. Watt
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Exhibit No . 19 ........................................................................... Single Page Entitled "Aroclor 1260"
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Exhibit No. 20 ........................................................................... Single Page Entitled "Transformer Pyranol* A-13-B 3B (Replaces Pyranol 1467 and Pyranol 1470)"
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Exhibit No. 21 ........................................................................... Single Page Entitled "Inerteen PPO"
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Exhibit No . 22 ........................................................................... "The Proper Handling of Aroclors and their Mixtures in the Electrical Industry," Revised January, 1960, Monsanto Chemical Co., P. G. Benignus
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Exhibit No. 2 3 ........................................................................... Monsanto ASKAREL Inspection and Maintenance Guide
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Exhibit No . 2 4 ........................................................................... Letter Dated March 8, 1961, to Mr. J. G. Sullivan from R. Emmet Kelly, M.D.
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Exhibit No . 2 5 ........................................................................... Monsanto Chemical Company Letter Dated July 2 5 , 19 5 6 , to H. W. Speicher from Elmer P. Wheeler
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INDEX (Continued)
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KELLY EXHIBITS:
PAGE
Exhibit No. 26 ........................................................................... Letter Dated October 23, 1959, to H. Wilbur Speicher from Elmer P. Wheeler
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Exhibit No. 2 7 ........................................................................... Letter Dated April 26, 1966, to Alvin W. Crow from R. Emmet Kelly
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Exhibit No. 2 8 ........................................................................... Hygienic Guide Series, Chlorodiphenyls
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Exhibit No. 29 ............................................................................ Monsanto, "Toxicity and Safe Handling of Askarel," Dated March 4, 1971, from R. Emmet Kelly
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Exhibit No. 30 ............................................................................ Monsanto Europe S.A. Memorandum Dated February 22, 1967, to Dr. R. Emmet Kelly from D. Wood
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Exhibit No. 31 ............................................................................ Monsanto Memorandum Dated September 11, 1968, to Dr. W. R. Richard from Elmer P. Wheeler
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Exhibit No. 3 2 ............................................................................ Letter Dated December 20, 1968, to Dr. Joseph C. Calandra from Elmer P. Wheeler
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Exhibit No. 3 3 ............................................................................ Letter Dated April 8, 1970, to Herbert Blumenthal, Ph.D., from R. Emmet Kelly, M.D.
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INDEX (Continued)
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KELLY EXHIBITS;
PAGE
Exhibit No . 34 ........................................................................... Monsanto Report Dated September 4, 1970, "Three-Generation Reproduction Study in Albino Rats With Aroclor 1242, Aroclor 1254, Aroclor 1260; Results of the First Generation," Submitted by R. Emmet Kelly, M.D.
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Exhibit No. 35 ........................................................................... Industrial Bio-Test Laboratories, Inc., Letter Dated November 12,, 1971, to Elmer P. Wheeler from J. C. Calandra, Submitting Report Entitled, "Two-Year Chronic Oral Toxicity Study with Aroclor 1260 in Albino Rats," IBT No. B7298
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Exhibit No. 36 ........................................................................... Memorandum Dated October 21, 1968, to W. R. Richard from Elmer P. Wheeler, RE: "Polychlorinated Biphenyls in the Environment"
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Exhibit No . 37 ........................................................................... Minutes of Meeting of the Corporate Development Committee Dated November 17, 1969, RE: "Report on Polychlorinated Biphenyls"
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APPEARANCES:
FOR THE PLAINTIFF:
Mr. Michael T. Gallagher Mr. John H. Kim Fisher, Gallagher & Lewis, L.L.P. First Interstate Bank Plaza 1000 Louisiana, 70th Floor Houston, Texas 77002
FOR THE DEFENDANT MONSANTO COMPANY:
Mr. Scott R. Bauer Mr. Bruce A. Featherstone Kirkland & Ellis 1999 Broadway Denver, Colorado 80202
FOR THE DEFENDANT GENERAL ELECTRIC COMPANY:
Mr. Evan J. Roth Williams & Connolly 7 2 5 Twe1fth Street, N.W. Washington, D.C. 20005
FOR THE DEFENDANT WESTINGHOUSE ELECTRIC CORPORATION:
Mr. Arvin Maskin Mr. Konrad L. Cailteaux Weil, Gotshal & Manges 767 Fifth Avenue New York, New York 10153
THE VIDEOGRAPHER:
Mr. Lou Getz Legal Media Systems, Inc. 550 Westcott, Suite 400 Houston, Texas 77007
ALSO PRESENT:
Ms. Lynette Weldon
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The oral videotaped deposition of ROBERT EMMET KELLY, M.D., was taken on February 15, 1994, beginning at 9:14 a.m., in the offices of Husch & Eppenberger, 100 N. Broadway, Suite 1300, St. Louis, Missouri, before Irma L. Reyes, a Certified Court Reporter and Notary Public in and for the State of Texas, pursuant to Notice and Agreement, the Federal Rules of Civil Procedure, and the following stipulation and waiver of counsel:
IT WAS STIPULATED AND/OR AGREED that the deposition is to be signed by the witness before any Notary Public or officer authorized to administer oaths.
IT WAS FURTHER STIPULATED AND/OR AGREED that the court reporter could swear the witness with the same force and effect as if she were a Notary Public in and for the State of Missouri.
(Instruments were marked Kelly Exhibit Nos. 1 through 37 for identification.)
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MR. ROTH: Scott, are we going to do this thing about the objections?
MR. BAUER: Sure. Do you want to agree that an objection from one party is good for everybody? MR. KIM: Yeah. MR. BAUER: We're going to stipulate that if one party objects, other parties can rely on that objection. MR. KIM: We'll stipulate to that. MR. BAUER: If one defendant objects -- if one defendant objects, the other defendants can rely on the objections. If plaintiff wants to object, I assume that plaintiff is going to make his objection. MR. GALLAGHER: Yes. MR. BAUER: Right. So that they don't have to both talk, in other words. Or when you're asking questions, all three of us don't have to make the same objections.
MR. KIM: That's fine. Agree that a Texas notary and Texas court reporter can swear the witness in? MR. BAUER: Sure.
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THE VIDEOGRAPHER: Today is the 15th of February, 1994. It's 14 minutes after 9:00 a.m., and we're on the record.
ROBERT EMMET KELLY, M.D., was called as a witness and, having been first duly sworn, testified as follows:
EXAMINATION BY MR. BAUER: Q. Good morning. A. Good morning. Q. Would you please state your name. A. Robert Emmet Kelly, M.D. Q. Dr. Kelly, as you know, my name is Scott Bauer. I'm with the law firm of Kirkland & Ellis representing Monsanto Company. Do you understand that you're here today to give a deposition in a case entitled Nevada Power Company vs Monsanto, General Electric
Company, and Westinqhouse Electric Company? A. Yes, I do. Q. Where do you live? A. 665 South Skinker, S-k-i-n-k-e-r, St. Louis,
Missouri 63105.
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Q. A. Q. A. Q. A.
Q. A. Q. A.
Q.
A. Q.
00
Are you a medical director -- excuse me. you a medical doctor? Yes, I am. And how old are you. Dr. Kelly?
Are
Do you -- could you describe your health condition, please? Well, I think it's pretty good for 84. I have an irregular heartbeat. I have some hypertension. A few other minor things. Are you currently under the care of a physician? Yes, I am. Has your doctor placed you under any restrictions ? Yes. He said I should not get in any prolonged -- which is a -- stressful situations, prolonged by -- that means four or five hours. Four hours, I believe is what
he specified. Has the doctor approved your going forward with testimony subject to those time restrictions? Yes, he has. Have you ever been employed by Monsanto?
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1 A. Yes, I have.
2 Q. For what period of time?
3 A. I was employedfrom 1938 --January of 1938
4 until November the 30th, 1974, with the
5 exception of 44 months in the Service. And I
6 was -- after 1974 I was engaged as a
7 consultant with -- two days a week with the
8 company.
9 Q. What was the period of time of your -- of
10 your military service?
11 A.
Forty -- from 1942 to 1946.
12 Q. Were you ever Monsanto's medical director?
13 A. Yes, I was.
14 Q. For what period of time were you
15 Monsanto's --
16 A. Well, I was the first one. Was from March or
17 April of 1942 until November the 30th, 1974.
18 Q.
When and where did you obtain your college
19 degree?
20 A.
I received a Bachelor's Degree in Science
2 1 from St. Louis University in 1930. It was a
22 combined course with the medical degree, and
23 I received the medical degree in 1932.
24 Q.
I'm sorry. Did you say where you received
25 your medical degree?
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1 A. 2 Q. 3 4 A. 5 6 7 8 9 Q. 10 11 12 A. 13 14 15 16 17 18 19 20 . Q. 21 22 A . 23 24 Q. 25
St. Louis University. The same institution. Dr. Kelly, are you board certified in any areas of medicine? Yes. I'm board certified in internal medicine, recertified in internal medicine, and also board certified in preventative medicine under the specialty of occupational medicine. What were your job responsibilities when you first started working for Monsanto in the mid-1930's. My job responsibilities was plant physician at the Queny, Q-u-e-n-y, plant in St. Louis. That consisted of taking care of the injuries
and occupational conditions that might have resulted from the -- their work, as well as carry out a preventative medical program for the employees to detect and prevent any occupational diseases. When did you formally receive the title "medical director"? When I returned from the Service in March or April of 1942 -- '46. Were you carrying out certain responsibilities of the medical director
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A.
Q. A.
Q.
A. Q. A. Q. A. Q. A. Q. A. Q.
position prior to that time? Well, I was sort of a medical director without portfolio because if any problem came up in any other plants, I was the only doctor around the headquarters building. So they'd say, "Well, we got a doctor over at the Queny plant. Let's ask him. II And during what period of time was that? That was roughly from, oh, the end of '36 until the beginning of the -- my service in '42. Okay. Dr. Kelly, I believe a little while ago you said that you started working in Monsanto in 1938. And now you just said -- Oh .
-- that you started -Did I say '38? -- in 1936. ' 36 . Which is it? It's ' 36 . 1936? That's right. Okay. What were your duties as Monsanto's medical director , starting in 1946 ?
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1 A.
2 3 4 5 6 7 8 9 10
11 12 13 Q.
14 15 16 A . 17 18
19 Q
20 21 A 22 Q 23 24 25 A
Well, I had responsibility to see that there was adequate medical installations in all our plants, laboratories, sales offices, et cetera. I was responsible for development -- developing an industrial hygiene program which monitored the environment of the workplace. I was responsible -- responsible for obtaining the toxicological information on our products, and I was responsible for disseminating that to our customers and to anybody who asked for it . You mentioned in that answer toxicological properties. Would you define the term
"toxic" or "toxicity"? "Toxicity" is an inherent quality of a product of a compound to cause injury to people. Or lack of it. And the toxic property of the -- of a chemical would be what? Harmful property. Do you differentiate between the toxicity of a substance and the hazard associated with the substance? Oh, yes.
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1 Q. And what's the difference?
2 A. Well, no matter how toxic a product is, if
3 you don't get the chance of absorbing it, it
4 isn't going to hurt you. In other words, if
5 something is inside a kettle or inside a
6 pipe, no matter how toxic it is, it isn't --
7 there's no particular hazard there.
8 Q. Dr. Kelly, you testified a minute ago that
9 one of your responsibilities as medical
10 director was to gather information about
11 toxicological properties. In carrying out
12 that function, did you have a practice of
13 reviewing medical and scientific articles?
14 A. A what?
15 Q. A practice of -
16 A . Oh .
17 Q. -- reading medical and scientific articles.
18 A. Yes, I did.
19 Q. When did you start that?
20 A.
I would say as soon as I started with
2 1 Monsanto.
22 Q. So 1936?
23 A. '36 .
24 Q. Okay. And for how long did you have such a
25 practice?
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1 A. Up till now. 2 Q. Okay. Did it continue throughout the period 3 of time of your employment - 4 A . Oh, yes. 5 Q. -- through 1974? 6 A. Yes. We subscribed to all the journals, 7 which weren't too many in the early days, in 8 the English language that related to 9 toxicity. 10 Q. Was there a library in the medical department 11 at Monsanto that subscribed to those 12 magazines - 13 A. Well, we had -14 Q. -- and periodicals? 15 A. Yes, we did. We had a librarian. And I 16 don't know what -- she was a sort of -- not 17 a -- she was not a degreed librarian, but she 18 was -- functioned as a librarian. And we 19 engaged her probably sometime after I came 20 back from the Service. But up till that 2 1 time, we did not. There weren't too many 22 journals in the 1930's and Forties. 23 Q. Do you recall some of the names of the 24 prominent journals in the early days? 25 A. There were two in the United States. One was
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Q.
A. Q. A. Q. A. Q.
American Journal of Toxicology. "Industrial hygiene and toxicology," I believe the term was. The other was a Journal of the Industrial Medical Association. And there was one in the United Kingdom that was published, the American Journal of -- I mean, the new -- the Journal of Industrial Toxico -- of Industrial Hygiene. That was an English journal. There was also Lancet. L-a-n-c-e-t, which was a general medical journal; but it had from time to time information about workers' health in it. Well, over the years, as the numbers of publications that were related to industrial hygiene and occupational medicine expanded, did Monsanto acquire additional
subscriptions? Yes, we did. Dr. Kelly, are you aware that the Nevada Power case involves polychlorinated biphenyl? Yes, I am. Do you also recognize the acronym "PCB" as being polychlorinated biphenyl? Yes, I do. Can you tell us what "chlorinated diphenyl"
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2 A. 3 4 5 6 Q. 7 8 9 10 A. 11 Q. 12 13 14 A. 15 Q. 16 17 A. 18 19 20 21 22 23 24 25
is?
Chlorinated diphenyl is the same as chlorinated biphenyl. It just changed the name sometime along about the Fifties from "di" to "bi." Okay. So during this deposition, if I say "chlorinated diphenyl" or "PCB" or "polychlorinated biphenyl," you understand we're talking about the same substance? Yes, I do. Did you review the available literature on the toxicity of PCBs from the 1930's to the 1970 ' s? Yes, I did. In the English language. Did others in the medical department also review some or all of that literature? Yes. You have to remember that the medical
department grew. When we started out, there was myself and a secretary. Then I don't - I engaged a part-time professor at Washington University as an associate medical director. It was a Dr. George Saunders who came onboard probably -- oh, I think he was after the - after 1946. We engaged an Elmer Wheeler, who was an industrial hygienist, in 1946 or '47.
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When we ended up -- when I left the company, we had four industrial hygienists. We engaged a toxicologist sometime in the early Fifties, I believe. When we left, we had four toxicologists. What was the name of the first toxicologist that you retained? William Hunt. Dr. William Hunt. He's a Ph . D . You mentioned an industrial hygienist, a Mr. Elmer Wheeler. Was -- do you know whether he was reading toxicological
literature concerning PCBs? Yes, he was. And after he came onboard, what about Dr. Hunt, the toxicologist? Well, yes, he was also. But he was -- PCBs was a small part of his job. I'd like to focus on electrical equipment now for a minute. Dr. Kelly. Were there any reports in the scientific literature from the
1930's until you retired at the end of 1974, reports in the scientific literature of adverse health effects from people exposed to PCBs that was in electrical equipment?
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1 It all depends what you mean by "electrical
2 equipment." If by electrical equipment you
3 mean wire, cable -
4Q
I'm focusing on for the moment now -- we'll
5 get to the cable coating items in a minute.
6 I'm talking about in -- electrical fluid in
7 electrical equipment, like transformers and
8 capacitors.
9 A . What was the question again?
10 Q. Sure. From the 1930's to the 1970's, do you
11 recall reading anything in the scientific
12 literature about adverse health effects to
13 people who received exposure to PCBs that was
14 in electrical equipment and transformers or
15 capacitors ?
16 A . No, I do not.
17 Q. Did you read any articles during that period
18 of time in which the authors of those
19 articles asserted that PCBs could not be used
20 safely in electrical equipment?
2 1 A . No, I did not.
22 Q. Did you form an opinion as of the 1930's
23 about whether PCBs could be used safely in
24 electrical equipment?
25 A .
Yes .
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A. Q.
A.
Q. A.
Q.
MR. KIM: Object. Improper predicate.
Go ahead. Yes, I do. It's the same as I have today, that they could be used safely in electrical equipment such as transformers and capacitors . (By Mr. Bauer) Was it your opinion in the 1930's that certain precautions were prudent with respect to PCBs in electrical equipment? Yes .
MR. KIM: Same objection. (By Mr. Bauer) And what was your opinion about precautions? You should avoid absorption through the skin. You avoid that by not having prolonged or repeated skin contact. You will avoid breathing the material at elevated temperatures. At room temperature there is no -- not enough vapor pressure to bother you; but if at elevated temperatures or in confined spaces, it could be harmful. Did you acquire more information about the toxicological properties of PCBs over the years after the 1930's?
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1 A.
2 3 4 5 6 7 8 9 10 11 12 13 14 A. 15 16 Q. 17 18 19 20
2 1 A.
22 23 24 25
Yes. I -- we acquired a great deal of lab -- o f animal work, information from animal work. We acquired a great deal of work from the negative history of all our -- of our workers and those of our customers' workers.
THE COURT REPORTER: "And those of our" what?
THE WITNESS: Beg pardon? THE COURT REPORTER: "Those of our " ? THE WITNESS: -- customers and people exposed to -- or people who used the electrical equipment. We had a lot of negative inform -- negative clinical information. (By Mr. Bauer) Based upon all the information you had after the 1930's up through 1974, did you ever, as Monsanto's medical director, form the opinion that PCBs were unreasonably dangerous? On the contrary. In the use that they were put to, they were quite safe. I would say that material has -- all industrial chemicals have some toxicity. In fact, not only industrial chemicals, chemicals we come in -
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1 use, whether it's a detergent or condiment.
2 Salt could be dangerous.
3 But I had -- I considered PCBs to
4 be of a mild to moderate toxicity, as far as
5 an industrial chemical was concerned. It
6 wasn't supposed to be taken internally. No
7 industrial chemical is supposed to be taken
8 internally.
9 Q. Did there come a time in the late 1960's or
10 early 1970's where you formed the opinion
11 that precautions other than the workers'
12 safety precautions were prudent with respect
13 to PCB electrical fluids?
14 A.
In the which? Which years?
15 Q. The late 1960's to early 1970's. You've
16 talked already about the workers' safety
17 precautions. Were there others that came
18 into play at that time?
19 A.
In the late Sixties the environmental aspect
20 of discarding PCBs became quite prominent due
2 1 to some work that originated in Europe and
22 was eventually cooperate -- confirmed in the
23 United States. And it showed that it could
24 be an environmental hazard to avian species,
25 a-v-i-a-n, avian species. Birds, especially
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1 predatory birds.
2 Q. And --
3 A.
That it might be.
4 Q.
-- what -- what additional precautions did
5 you -- did you have the opinion were prudent
6 after that period of time? Let's say around
7 19 7 0 .
8 A. To disposable -- to dispose of used PCBs and
9 discarded equipment in a safe manner, which
10 that varied with the type of material and the
11 type of equipment, whether it was a landfill,
12 whether it was deep injection or
13 incineration. It could be any one of them.
14 Q. Let's go back to the beginning in the 1930's
15 again and talk a little bit about the
16 toxicological properties of PCBs that you
17 did -- that you did have an understanding and
18 opinion about.
19 You've already testified that there
20 were some precautions that were prudent. Was
2 1 that because, in your opinion, there were
22 certain toxic properties of PCBs?
2 3 A.
Yes.
24 Q.
Okay. And would you generally describe what
25 those were and your understanding in the
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A.
A. Q.
1930's. In the Nineteen -- the early 19 3 0's -- I have to start with 1936 -- '37 probably, when they first came to my attention.
I knew that if individuals who were working with PCBs -- well, not -- it turned out it was not PCBs. It was -- it was a polychlorinated diphenyl benzene rather than polychlorinated diphenyl, per se. There was an episode, several episodes, of wire coating where a compound called chlorinated naphthalene, N-a-p-h-t-h-a-1-e-n-e - chlorinated naphthalene was manufactured by the Halowax, H-a-1-o-w-a-x, Corporation. They used to -- used this to impregnate wire coating for insulating properties. In one of
their formulations, a 10 percent solution, or 10 percent mixture, of chlorinated diphenyl benzene --
THE COURT REPORTER: What? THE WITNESS: Chlorinated diphenyl benzene, B-e-n-z-e-n-e. -- was used. That was these workers. (By Mr. Bauer) Let me stop you there for a second, Dr. Kelly. Was there a Monsanto
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product in any of those mixtures that you were talking about? The chlorinated diphenyl -Yes, uh-huh. -- benzene was a manufactured -- was a Monsanto product.
MR. KIM: Objection. (By Mr. Bauer) Okay. Do you recall the number designation for that product? Yes. It was 4465. Okay. And were you saying that 4465 was a mixture of -- of chlorinated diphenyl and chlorinate diphenyl benzene? That's correct. Okay. All right. I'm sorry. And in very general terms, what was the result of information that you received in the,1930's? Oh, it was pretty disastrous in some cases. These individuals absorbed a great deal of the Halowax mixture; and the majority of cases, by far the majority of cases, were
Halowax alone without any chlorinated diphenyl benzene in it. And they developed chloracne, which is a situation similar to teenage acne but much more generalized. It's
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1 a more serious type. It lasts longer, and
2 it's associated with black pigmentation
3 around the face. And in some cases, after
4 sufficient absorption, chemical hepatitis
5 occurred; and several of the people who were
6 exposed to this over prolonged periods of
7 time died.
8 Q.
Was it your opinion in the 1930's that
9 chlorinated diphenyl alone in sufficient dose
10 could cause chloracne?
11 A . Yes .
12 Q. Was it your opinion in the 1930's that
13 chlorinated diphenyl alone in sufficient dose
14 caused liver damage to experimental animals?
15 A .
In sufficient dose at elevated temperatures,
16 yes .
17 Q- Was it your opinion, therefore, that it was
18 prudent to limit exposure to humans?
19 A . Yes .
20 Q.
21
I'd like to switch now to -- for a moment to the topic of the responsibility for toxicity
22 and safe handling instructions.
23 During the time that you were
24 medical director of Monsanto, what department
25 had the responsibility for approving toxicity
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and safe handling instructions that were given to customers? The medical department. Was that practice implemented at your request ? Yes . Why did you request that that practice be implemented? Well, because the medical department knew more about the toxic properties of Monsanto products than anybody -- any other group in the company. Were there a number of different methods by which information about toxicity and safe handling was disseminated to Monsanto's
customers ? Oh, yes. Could you generally describe the various means ? Yes. It all depends on the level of worker we were talking with. In other words, you start off with the labels. The label eventually is this thing that goes down to the worker on the factory floor. On that - on the label we would put what was a safe
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handling data -- safe handling procedures to avoid injury. Okay. And - That was universal on our products. Then we had development bulletins. A development bulletin would be, "We've got product 'X.' These are the characteristics of it," the physical characteristics, the suggested uses. They would be sent to any prospective user of a product, even though we were not exactly sure what he wanted it for.
There we put more information. We put what toxicological information we had with our own experience with our employees, as far as lack of illness was concerned, and whatever animal toxicity information we possessed.
Then there was a marketing bulletin which with a compound was used, was already for the market we had a definite sales target for it. It was going to be used in a particular manner. We expend -- we expanded that information with relation to the proposed use.
Then, of course, we had direct
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communication with doctors, industrial hygienists, customers, purchasing agents who would call the medical department or write and ask for information; and we were -- these were usually technical people or scientific people. And we would expand what information we had in a letter -- in an individual letter to him with regard to his particular question.
So the information we sent out really depended on what particular group we were trying to, should I use the word, "educate . " Q. Do you recall whether information about the toxicity and the safe handling of PCBs was disseminated to Monsanto's customers through one or more of those methods? A. Yes. Through all of them. One or more, certainly. Q. What was Monsanto's policy regarding who
responded to inquiries from customers about the potential adverse health effects of Monsanto product? A. The medical department. Supposed somebody came into the -- or salesperson from the
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Detroit sales office goes into Ford Motor. He's got Product X. Says it's PCB. And he's saying to the customer, "What about this product? What do we know about it?"
He'd say, "Well, I'll have the medical department call you or write you." And then we do that.
Of course, this didn't mean that if the man at Ford Motor said, "Has this thing been used safely?" he wouldn't say, "Well, ask the medical department." He'd say, "Yes. I've sold this to General Motors, Chrysler. They've been using it for five years. They've had no problems."
But he would not give the definitive toxic -- toxicological information. Q. That came from who? A. That came from us. Q. Okay. And over what period -- A. The medical department. Q. The medical department? A. Right. Q. Over what period of time was that the practice?
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Well, it was definitely established from the time I was formally the medical director. But prior to that, say from '38 on, when the people of the company knew me better, they would be happy to buck these things down to the medical department. I mean, to the -- to me at the Queny plant, as a sort of in a sense, I was a medical director without a portfolio on that particular aspect of the position. During the -- after 1946, in that time period, when you testified earlier that you were essentially -- you were essentially were the medical department -- with a secretary, I
believe you said -- were you personally responding to inquiries from customers? Oh, yes. I had telephone conversations. I had letters. Not too many on PCB, but we made a bunch of products. As the medical department expanded, did others working for you also respond to customer inquiries? Yes. We were -- when we expanded, we were still a pretty small department. We were in a -- and we all saw each other's
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correspondence. We had lunch every day. We had some formal meetings once a week. We had contact during the day dozens of times. So we all knew what everybody was doing. And if I were out of town or if something had particular industrial hygiene overtones, Elmer Wheeler or one of the other industrial hygienists would do the -- would answer the letter. Sometime they went out over his signature, sometime over mine. And when it went out over my signature that I signed, I certainly reviewed and I saw the correspondence -- I mean, I certainly reviewed it before it went out. And the ones
that he signed, I would see the carbons of it; and we were both on the same wavelength as far as dispensing the information was concerned. Q. Were there -- were there times when he prepared initial drafts of letters that you signed? A . Yes. Q. Were there times that he prepared letters and signed them but asked you to review them before they went out?
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Yes. This being Elmer Wheeler? Yes. Well, it was not only Elmer Wheeler. Sometime Jack Garrett. If there was a particular -- this wasn't universal. It didn't happen all the time. It was strictly a question of industrial hygiene material which he knew -- information which he knew more than I did about industrial hygiene, he would answer it himself. We've already talked a little bit about Mr. Wheeler. When do you recall he joined Monsanto as an industrial hygienist?
I came back from the Service in '46. He joined, I believe, in '46 or '47. He had been an ihdustrial hygienist at the Army Laboratory of Industrial Hygiene. He had been an industrial hygienist for one of the New England states. I think it was either Vermont or New Hampshire or something like one of those. He was quite experienced in industrial hygiene. In the early Forties there weren't too many industrial hygienists. I guess we probably started the
industrial hygiene department when there were
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only a half a dozen companies had them. And you also now mentioned a second name Jack Garrett. When did he join Monsanto, approximately? Approximately early Fifties -- around that, I believe -- he joined the medical department. Then he was a research chemist at the Texas City operations. Was Mr. Wheeler involved in the American Industrial Hygiene Association? Yes. He was a member. First I got to say what the American Industrial Hygiene Association was. It's a group of industrial
hygienists. Just like the AMA is a group of physicians, it's a group of industrial hygienists. He was engaged in, he had many offices. He ended up being president of it for one particular year. Do you recall approximately when Mr. Wheeler was president of that association? Sixties, I guess. Sometime late Sixties. All right. Was there another organization that medical directors frequently belonged
to, of medical directors of different companies ?
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1 A. There's American Academy of Occupational 2 Medicine. There was a Medical Directors 3 Forum, which was sort of a group of 35 or 40 4 people of medical directors of multi-plant 5 operations. I think those are the only two. 6 Q. Was that a forum for medical directors to 7 share information about issues of common 8 concern? 9 A. Yes. There's also an Industrial Medical 10 Association, which anybody who was interested 11 in industrial medicine can join, and 12 eventually changed its name to the American 13 Occupational Medical Association. But the 14 criteria for joining it was not particularly 15 strict, whereas the criteria for joining the 16 Medical Directors Forum was quite strict, as 17 well as for the American Academy of 18 Occupational Medicine. You had to be a 19 full-time physician in the industry. 20 Q. Was the American Industrial Hygiene 2 1 Association a forum for industrial hygienists 22 to share information about issues? 23 A. Yes . 24 Q. All right. Let's move back now to Monsanto's 25 production and uses of polychlorinated
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1 biphenyls and move back to the 1930's again.
2 Do you recall when Monsanto started
3 producing polychlorinated biphenyls known
4 then as chlorinated diphenyl?
5 A.
Not exactly. I came, as I said, in March
6 of '36. They were manufacturing it then, and
7 the information I received or that I gathered
8 at that time was that a company called a
9 Swann Chemical Company, S-w-a-n-n, had
10 manufactured chlorinated PCBs starting
11 sometime around the early Thirties, 1931
12 or '32. Monsanto took over Swann in either
13 1936 or 1935, and we continued the
14 manufacture and sale of the product then.
15 Q. Okay. For how long did Monsanto manufacture
16 and sell PCBs?
17 A. Till after I left. I think it was 1977
18 they -- or '76 or '77 they discontinued it.
19 Q. There's some additional terms that we'll be
20 using during the day today that I'd like to
2 1 get out on the table now.
22 What was Monsanto's trade name for
23 the chlorinated biphenyl -- chlorinated
24 diphenyl?
25 A.
It was Aroclor, but it -- also, Aroclor was
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used as a trade name for chlorinated diphenyl benzene or chlorinated terphenyl. Okay. And how do you spell Aroclor? A-r-a-c-l-o-r [sic]. Do you know what "Pyranol" is? Yes. I know generally. I don't know all the constituents. Pyranol is a trademark name for a dielectric patented by General Electric. It's their product. And it contains PCBs, and it also contains in some formulations trichlorobenzene. And of course, there's scavengers and some other things that I don't know about that are in
there. Do you know what Inerteen is? That's I-n-e-e-r-t -- no. -- e-e-n . I-n-e-r-t-e-e-n -- t-e-e-n.
MR. KIM: Spell that again. MR. BAUER: I-n-e-r-t-e-e-n. That's Westinghouse's copyright name for chlorinated diphenyl benzene for a dielectric fluid, which contains -- in some cases contains trichlorobenzene along with the PCBs. Whether they use the term "Inerteen"
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1 in capacitor filling, I just don't know.
2 Q.
(By Mr. Bauer) Okay. So both Pyranol and
3 Inerteen would contain chlorinated diphenyl,
4 or what we call "PCB" today?
5 A. Correct.
6 Q. And some Aroclors were PCB?
7 A. Say that over.
8 Q.
Some Aroclors, some substances sold by
9 Monsanto as Aroclor, contained chlorinated
10 diphenyl, or what we call "PCB" today?
11 A. Well, they were, yes. Some of the Aroclors
12 were PCBs, some of them were still called
13 Aroclor but they were chlorinated diphenyl
14 benzene, which is a different property.
15 Q. You -- strike that.
16 Do you know when, approximately,
17 the electrical fluid use of PCBs was
18 developed?
19 A. No, I don't. I know it was developed by GE
20 and it was patented by GE, but I don't know
2 1 when .
22 Q. Was Monsanto making PCBs for use in
23 electrical equipment at the time you started
24 working with the company in the mid to late
25 1930's?
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Yes , they were. Did you understand at that time that there were benefits to using PCBs in electrical fluid to be used in transformers and capacitors? Oh, yes .
MR. KIM: Objection. Improper predicate. Improper foundation. They were relatively nonflammable. The substitute -- the other compound was mineral oil, which burns a little sort of like gasoline. And PCBs did not have that particular product -- property. (By Mr. Bauer) Would you briefly describe, please, other uses of PCBs that developed over the years, other than the electrical
fluid that we've been talking about. Yes. There were -- other uses were heat transfer agencies. In other words, if you were heating a particular compound inside your building and you didn't want a heating element in there, you would have the heating element outside the building; and that would -- that heating element would contain PCBs, which at that was called Therminol,
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T-h-e-r-m-i-n-o-1, in that application so that you'd heat it out here and it would go through the pipes into the particular area that you wanted heated. That was the heat transfer use.
There was also a hydraulic use. There it was called Pidraul, P-i-d-r-a-u-1 . In other words, if you're using a die-casting machine or something like that. Now we're getting outside of my field a little bit.
MR. KIM: Then I'll object to speculation.
THE WITNESS: Beg pardon? I couldn't hear you.
MR. KIM: I said I'm going to object to speculation and improper foundation. You can go ahead and answer. It's just something that we've got to do -
THE WITNESS: Okay. MR. KIM: -- to protect our record. Doctor. Q. (By Mr. Bauer) Just -- if you can just briefly describe what Pidraul was for. A. Pidraul was used as a hydraulic fluid, just like hydraulic fluids in your brake. I'm not
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Q.
A.
Q.
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saying in your automobile. I don't say that Pidraul was used in that, but it was used as a hydraulic fluid to transmit pressure from one area to the other.
It's also used as a plasticizer. It's use started expanding. Whenever you wanted a product that was not inflammable and had some characteristics of a plasticizer. Now, you mentioned earlier that Pyranol and Inerteen were General Electric and -- General Electric's and Westinghouse's trade names for electrical fluids? Yes. Did Monsanto make the PCBs that went into General Electric's Pyranol and Westinghouse's Inerteen? Yes. Monsanto was a sole producer of PCBs in the United States, as far as I know. Okay. Do you know who manufactured the other
constituents of Pyranol and Inerteen? No, I don't. You mentioned, for example, trichlorobenzene was sometimes in some formulations. Do you know what company manufactured trichloro - No, I do not .
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Q. A. Q. A. Q.
A. Q.
A.
Q.
Okay. Do you know over the years whether Monsanto was doing all of the blending of the various constituents of Pyranol and Inerteen? I do -As opposed to some other company doing blending. I do know they did blending. I'm not sure what years they did it or how much they did it. They did do it. I'd like to move now to questions about the human experience with PCBs.
Were there any PCB related health problems in any of Monsanto's PCB workers during all of the years that you worked for Monsanto? No, sir, there were not. To your knowledge, has Monsanto ever had a personal injury or workers' compensation claim filed against it in relation to PCBs by any of its employees? No. And I would have occasion to see all the compensation cases or injury cases that were
considered occupational in nature, and I have no recollection of any of them. And you would have seen those up through
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December of 1974? That's correct. Did the fact that Monsanto's PCB workers did not report adverse health effects to you play a role in your opinion about the relative toxicity of PCBs? Yes. Why is that? Well, here's an industrial chemical that we've been using for 40 years, manufacturing for 40 years; and we had no trouble with our workers. Dr. Kelly, during the decades of your
employment at Monsanto, do you recall how many times you received outside reports of adverse health effects from people exposed to PCBs? Probably less than half a dozen, I think. Want me to list them if I could remember them? We'll try to go through them - Okay.
-- generally here in a minute. But let me ask you another question before you do that.
Do any of those reports that you
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received from 1936 to 1974 from outside of Monsanto, from exposure to PCBs causing adverse health effects, were any of them related to PCBs in transformers or capacitors ? No, sir, they were not.
MR. FEATHERSTONE: Scott, can we take a break?
MR. BAUER: Let's take a break. THE VIDEOGRAPHER: We're going off the record. It's 57 minutes after 9:00 o'clock.
(A recess was taken.)
THE VIDEOGRAPHER: It's 13 minutes after 10:00 o'clock. We're back on the record. (By Mr. Bauer) Dr. Kelly, you testified earlier today that you reviewed scientific literature from the 1930's about chlorinated diphenyl, now known as "PCBs." Would you please look at what's been marked Deposition Exhibit 1 and tell us whether that's one of the articles that you read.
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1 A. 2 3 4 5 6 7 8 Q. 9 A. 10 Q. 11 A. 12 Q. 13 14 15 A. 16 Q. 17 18 19 20 A. 21 22 23 24 25
This is an article by Jones and Alden called,
"An Acneform," A-c-n-e-f-o -- pardon me --
f-o-r-m, "Dermatergosis." I'll have to spell
it. I can't even pronounce it.
D-e-r-m-a-t-e-r--g-o-s-i-s. That's one of
them. It was published in -- probably
around --
Do you recall -
Yes. I recall.
-- approximately when it was published?
Yes. 1935 or '36. When you say, "This was one of them," did you
mean this was one of the articles that you
read?
Yes.
.
All right. What does Jones and article -
excuse me. Strike that.
What is the Jones and Alden article
reporting about?
It's reporting about an outbreak of chloracne
in employees at a plant manufacturing PCB in
Anniston, Alabama. The plant was a Swann
Chemical Company. It was not -- this was a
plant that was taken over by Monsanto
sometime after this article was published.
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1 Q. So the -
2 A. Around that time.
3 Q. So the workers who were involved in the Jones
4 and Alden reports eventually became Monsanto
5 employees ?
6 A. That's correct.
7 Q. Dr. Kelly, do you recall approximately when
8 you first read the Jones and Alden paper?
9 A. Probably late '36. Probably. Or early '37.
10 I'm not sure.
11 Q. Do you recall whether you attended the
12 symposium put on by Dr. Drinker in June of
13 1937?
14 A.
'37 ?
15 Q . Yes.
16 A. Yes, I did.
17 Q. And is it your recollection that you read the
18 Jones and Alden article -
19 A. I'd read this before then. That's correct.
20 Q. Before going to the symposium?
2 1 A. That's correct.
22 Q. Do you recall whether -- how long before you
23 went to the symposium you read it?
24 A. No, I don't.
25 Q. All right. Do you recall whether the
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chloracne outbreak at the Anniston plant occurred several years before you read the article? Yes, it did. Okay. After you became a doctor for Monsanto, did you go to visit the workers at Monsanto's Anniston plant? Yes, I did. Did you see and speak with any of the specific workers who were in the PCB unit? Yes. I certainly don't remember their names; but I spoke with some of them, yes, and looked at their faces. And approximately when was that? Gosh. '36 or '37. I'm not sure when.
Did those workers have chloracne at that time? They did not. They had some residue. They had some small scarring around their face where the pustules had been opened. But there was no active chloracne and no other symptoms. Was there a plant physician at the Anniston plant when you went to visit it in the mid-1930's?
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Yes, there was. A Dr. Martin. Did you discuss the workers in the PCB unit with Dr. Martin? Yes, I did. And what was -- what were his conclusions about the health of those workers? Well, he said whatever testing he would do on them -- first of all, they had no clinical symptoms outside of the -- outside of the chloracne. Some of them complained of fatigue, but his clinical examination was negative. And what laboratory work was available to check out liver functions, he did; and he said they were -- turned out to
be negative. Now, you testified in Anniston that there was no -- there were no clinical symptoms. What do you mean - With the exception of fatigue. What do you mean by that? Well, "Do you feel sick?" In other words, "Do you have any particular complaints? Do you have any pains? Do you have any nausea? Do you have any headaches? Do you have" -
there's a difference between "symptoms" and
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Q.
A. Q. A.
"signs." "Symptom" is not an objective
finding. A "sign" is chloracne. It's a
pigmentation or pustules or swelling of the glands in the skin, whereas a "symptom" - as I said, headache, nausea, diarrhea, et cetera. Did you have discussions in the 1930's with Dr. Martin or others about the cause of the chloracne problem that occurred earlier at the Anniston plant? Yes, I did. And what did you learn? Well, I learned that it was the belief that the chloracne episode was caused when Swann Chemical changed their benzene supplier. They ended up with a product that was a
different color than their usual one and ended up with some different dielectric constants, properties, and also ended up with giving the people, the workers, chloracne. So they decided to get smart and change back to the original benzene supplier and the color came back to normal and the dielectric
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Q. A. Q.
A. Q.
A. Q.
A. Q. A. Q.
A.
constants came back to normal and they - were no more development of chloracne. So -- Did that change-back in the benzene supply occur before you visited the Anniston plant? Yes, it had. Was that conclusion, that there was a problem with the benzene supply, reported by Drs . Jones and Alden in the -- their article which we've marked as Exhibit 1? Yes, it was. Did Monsanto manufacture PCBs at the Anniston plant from whenever it purchased the plant
in '35 or so up through the time you retired? Yes, it did.
Was there ever any chloracne problem during that entire period of time? There was none. None with the workers in the PCB unit there? That's correct. All right. And did Monsanto later make PCBs in another plant? Yes. We made one in -- we made some PCBs in our East St. Louis plant, also called the Krummerich, K-r-u-m-m-e-r-i-c-h, plant. We also made it in one of the United Kingdom. I
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1 think it was in Wales or someplace in 2 England. 3 Q . Is there -4 MR. KIM: Can I ask him just real 5 quickly? Is the East St. Louis plant, the 6 Krummerich plant, also the Sauget plant? 7 THE WITNESS: Yes. 8 MR. KIM: Okay. 9 THE WITNESS: S-a-u-g-e-t. Also 10 called Plant B when I started. 11 12 (Discussion off the record.) 13 14 Q. (By Mr. Bauer) Did you receive any reports 15 of chloracne among the workers that 16 manufactured PCB at the Krummerich plant 17 during the entire time that you were medical 18 director? 19 A . I did not. 20 Q. Separate and apart from the work by 2 1 Drs. Jones and Alden, do you know whether 22 Swann did any other investigation into the 23 source of the chloracne problem? 24 A. Yes. I have seen reports from a Dr. Flinn -25 F-l-i-n-n, I believe -- at Columbia
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1 2 3 4 5 Q. 6 7 A. 8 9 10 11 12 13 14 Q. 15 16 17 18 19 A. 20 21 22 23 24 25
University in New York. I believe they engaged him to do some patch testing. I don't know if he did any animal testing on them, on the particular product. Do you recall what Dr. Flinn's conclusion was ? Yes. He thought there was some impurity in the -- in the product that -- in the PCBs . And he came out with -- he was never definite about it. But I don't think he ever -- he talked about something with a styrene compound. Or I don't know which, but it was -- it certainly wasn't very definite. Do you recall that Doctors -- strike that.
Let me back up and ask you: Do you know how Drs. Jones and Alden got involved in the -- in the chloracne issue with respect to Anniston? No, I don't. I have to assume that Dr. Martin sent them to them. These people were dermatologists in Atlanta, I believe. And Anniston is about -- I don't know how far it is from -- I think it was Atlanta. Either Atlanta or Birmingham. I don't know where they were.
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2 3 4 5 6 A. 7 Q. 8 9 10 11 12 13 A. 14 Q, 15 16 17 18 19 20 A 21 22 23 24 25
Well, I'm -- I wasn't asking you to assume whether Dr. Martin did it or not. What I was asking you was: Were they -- were they involved clinically in treating the workers who were exposed? Oh, yes. Okay. And -- strike that.
Do you recall whether Drs. Jones and Alden reported in the paper that we've marked as Exhibit 1 that an impurity that they thought was chlorinated styrene was the source of the chloracne problem? Yes . Was that your understanding as to the source of the chloracne problem when you were working at Monsanto in the late 1930's, that the earlier problem at the Anniston plant had been the result of chlorinated styrene in the benzene? Well, I wasn't an authority of what the
impurity was; and I wasn't sure that everybody was saying Jones and Alden were right on the impurity. I recognized the fact there was an impurity in that particular batches -- those particular batches that were
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made . And - I don't know what it was, and I don't think anybody else knew what it was in those days. And the problem was resolved how? By changing back to getting something that didn't have that contaminant, whatever it was, in it. Everybody believed it was the benzene, but it was a contaminant of benzene that carried through and was chlorinated along with the benzene. All right. Let's switch now to the Harvard symposium in 1937.
You testified a little earlier about wire coating problems and Halowax and chlorinated naphthalene. And you also mentioned a symposium in 1937. Let's first back up and ask you to tell us what your understanding is of what is -- what is Halowax? Halowax is a product -- was. I don't know if it's still around -- of the Halowax Corporation, H-a-1-o-w-a-x, which was a subsidiary of Union Carbon and Carbide. I don't know what they called it, if that was
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
Q. A.
Q. A. Q.
the same name they use today. That was a whole series of compounds that had quite a few uses. The one we're talking about is a -- use of it as an insulating -- insulating agent in cotton or covering of wires. The -You mentioned electrical wires earlier. It was -- it was used how with respect to electrical wires? It impregnated the coating. And I don't know what the coating was. The coating was a
fabric. If you're -- you're not young enough to realize it. When you used to have electrical wire and you pulled on it, you'd get some brown stuff on your hands. It wasn't a vinyl or a rubber compound. It was a -- sort of a sticky covering that you got your hands brown. That was chlorinated naphthalene. And -So is this something different than electrical fluids that were used in transformers and capacitors? Oh, yes.
Now, you earlier mentioned that one of the constituents of HaIowax was chlorinated naphthalene; is that correct?
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1 A. That's correct. 2 Q. All right. 3 A. That was a major constituent. 4 Q. All right. Is that something different than 5 PCBs ? 6 A. It's chlorinated naphthalene. 100 percent 7 different. It's a different horse entirely. 8 Q. All right. And did Monsanto manufacture 9 chlorinated naphthalene that went into 10 Halowax compounds? 11 A. No, it did not. 12 Q. All right. Now, you also mentioned a 13 constituent of Halowax that was chlorinated 14 diphenyl benzene. Is that something 15 different than what we call PCBs today? 16 A. Yes. It has another benzene ring on it. 17 It's a different compound. 18 Q. All right. Was chlorinated diphenyl benzene 19 part of a Monsanto product that went into 20 some of the Halowax compounds? 2 1 A. Yes, it was. 22 Q. All right. Were some of the Halowax 23 compounds straight chlorinated naphthalene? 24 A . Yes. 25 Q. All right. And do you recall what percentage
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A.
Q. A. Q. A. Q.
of a Monsanto product was in any of the Halowax compounds? Yes. The impression I gathered was there was 10 percent in one formulation. They had 90 percent chlorinated naphthalene and 10 percent chlorinated diphenyl benzene, which was a Monsanto product. Now, a mixture of chlorinate diphenyl benzene and PCBs. So it was really 5 percent PCB in the mixture, 5 percent or less than 5 -- somewhat less than 5 percent PCB. Around 6 percent or so of chlorinated diphenyl benzene and 90 percent Halowax Okay.
-- in this one formulation. Now, the mixture of chlorinated diphenyl and chlorinated diphenyl benzene, the two Monsanto products, is that what you earlier referred to as "4465"? Yes. I don't know if I talked about that today, but that's what it's -- that was the Monsanto designation for it. All right. Now, you mentioned earlier that there were some people who were exposed to the wire coating product, the Halowax
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1 compounds, that suffered health problems.
2 And there were even several deaths?
3 A . That's correct.
4 Q. All right. Now, how were they exposed to the
5 Halowax compounds?
6 A . They were exposed -- well, I don't know.
7 I've never been in a wire coating factory.
8 Q. All right. Was there discussions of that at 9 the symposium?
10 A . Yes. The impression was that it was mostly
11 skin absorption, although I'm not sure
12 whether they talked about the inhalation
13 avenue of exposure. I don't know.
14 But they -- they probably -- the
15 impression I gathered was they had to heat
16 this wire -- heat the stuff what they put on
17 the wire. But these people were grossly
18 contaminated as far as their skin was
19 concerned.
20 Q. 21
And they were grossly contaminated with chlorinated naphthalene, chlorinated diphenyl
22 benzene, and chlorinated diphenyl in the case
2 3 of one of the Halowax products?
24 A . That's correct.
25 Q. All right. And do you recall whether any of
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1 the people that suffered serious injuries
2 received those injuries as a result of
3 exposure to the Halowax compound that was
4 just chlorinated naphthalene?
5 A. Yes. Some of the reports I read, some of the
6 deaths were -- I do not recall any of the
7 deaths being associated with the Halowax
8 compound that contained the chlorinated
9 diphenyl benzene.
10 Q. And what about the chlorinated diphenyl?
11 A. Well, no. The only -- no. That's the same
12 thing. I mean, they had the same -- if
13 they --
14 Q. The mixture product, the 4465 that we talked
15 about ?
16 A. That's what I'm talking about, yes.
17 Q. All right. Who requested that Dr. Drinker
18 start some animal studies with respect to
19 these -- the three compounds that we've
20 talked about?
2 1 A.
Somebody at Halowax.
22 Q. Okay. Did -- and they were a Monsanto
23 customer at the time?
24 A. That's correct.
25 Q. And did they talk to you about that?
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16 17 18 A . 19
20 Q.
21 22 23 24 A 25
Yes, they talked to me. Not about who to pick or what to do, but how much to get some money to pay for this. Some money to pay for what? The work. And what was your response? Well, "I'll look. I'll check it out." So I talked to the people in charge of the marketing and said, "Do you want to go along with Halowax on this?" And so they did. I don't know what the percentage we paid; or at the present time, I don't know how much it was. Toxicological expenses were much cheaper in those days than they are now. Do you recall whether Halowax Corporation or
Monsanto paid for the majority of the expense for the Drinker work? Oh, yes, I think so. They -- but Halowax paid for the majority of the expense. Do you know whether any other company, other than Halowax and Monsanto, contributed to the Drinker -- the funding for the Drinker work?
MR. KIM: I'll object - I don't know.
MR. KIM: -- to the -- excuse me,
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1 Doctor.
2 I'll object to your question.
3 There's a mischaracterization in that I think
4 he only testified that Halowax funded it. I
5 don't believe he indicated Monsanto did.
6 But - -
7 MR. BAUER: Well, I thought he just
8 said that when you turned around. But let's
9 just ask him right now.
10 Q. 11
(By Mr. Bauer) What was your recollection about whether Monsanto contributed to the
12 funding for Dr. Drinker's work?
13 A. We did. I don't know what percentage or I
14 don't know the amount now but I thought it
15 was under 25,000. I don't know. That's the
16 impression I got.
17 Q. And you don't recall the total cost, so you
18 don't recall the percentage?
19 A.
I don't know. I don't know. When you talk
20 about the Drinker work, there was some work
2 1 after that first symposium that Monsanto
22 defrayed completely itself.
23 Q. All right. So the shared funding arrangement
24 with Halowax related to work done prior to
25 the symposium?
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1 A.
That's correct.
2 Q. And then Monsanto hired Dr. Drinker on its
3 own after the symposium?
4 A.
Yes .
5 Q. All right.
6 A.
I don't like the word "hired," but engaged
7 him.
8 Q. Engaged his services?
9 A. Yes.
10
Q.
All right.
And Dr. Drinker was with what
11 organization?
12
A.
Harvard University.
Whether it was the
13 Harvard School of Public Health -- he was a
14 well-recognized -- there were two Drinker
15 people, Phillip and Cecil; and one of them
16 invented the iron lung, which -- but he was a
17
well-known paramedical.
He was a Ph.D.
He
18 was not an M.D.
19 Q. Did Dr. Drinker present the summary results
20 of his work at the symposium at Harvard in
2 1 June of 1937?
22
A.
Yes.
The work that he had done obviously up
23 till then.
24 Q.
Right.
And were you present for that?
25 A .
Yes, I was.
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1 Q. Were you present during discussions
2 afterwards among the people that were at the
3 symposium?
4 A. Yes, I was.
5 Q. Do you recall anyone else who was present?
6 A. Well, there were about 40 or 50 people.
7 There was a state office -- health offices
8
from the New England states.
There was
9
people from industry.
There was Dr. Vosburgh
10
from GE was there.
There was Dr. von
11 Oettingen, who was a toxicologist from
12
DuPont.
There was quite a collection of
13 authorities of one sort or other there.
14 Q. You mentioned Dr. Vosburgh from General
15
Electric.
Did you know Dr. Vosburgh at that
16 time?
17 A.
I met him then.
I don't believe I knew him
18 before then.
19
Q.
All right.
What can you tell me about
20 Dr. Vosburgh?
2 1 A. Well, he was in the business before I
22
started.
He was -- I don't know when he
23
started with GE, but he was a well-known
24 occupational physician --
25 Q. Well, what --
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1 A. 2 Q. 3 4 A. 5 Q. 6 7 A. 8 Q. 9
10 11 12 A.
13 14 Q. 15 A. 16 17 Q. 18 19
20
21
22
23 A. 24 25
-- at that --
Sorry.
What was his position with General
Electric?
Medical director.
All right.
Do you recall how long he was
medical director after 1937?
No, I don't.
Did anyone at the symposium discuss any
experience that any of the General Electric
operations had with respect to Halowax
compounds ?
Yes.
I don't know if Vosburgh did it, but I
think some of the manufacturing people did.
And what do you recall about that?
Well, I can recall it if I look at that
paper.
They said we had problems.
All right.
Well, you -- we can look at the
paper in a minute.
But let me just get your
general recollection as to whether it was
related to a wire coating operation that
General Electric had or a transformer and
capacitor operation.
Oh.
It was all wire coating.
There was
nothing -- no mention of transformers or
capacitors at this time.
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21
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23 24 25
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After the symposium did you have discussions
with Dr. Vosburgh about the experience with
the transformer and capacitor workers that
were putting PCBs fluids in transformers and
capacitors at General Electric?
Yes, although I can't recall how specific I
was.
But I -- at that particular time, there
weren't too many people who were -- or too
many medical directors who were around to --
there just weren't too many medical
directors, period.
And there was only this
one big meeting where industrial hygienists
and occupational physicians went.
And I
would see Vosburgh there, and I would -- knew
him from the Drinker business.
And I talked
to him.
But at that particular time, PCBs
were still a popular topic.
GE was a big
customer of ours, and Vosburgh and I had
mutual interests in PCBs.
So I would talk
and say, "Are you having any problems?"
And
he'd say, "No."
And I don't specifically
know whether I said, "Do you have any
problems with the capacitor workers," or
not.
But he would ask me, "How are you
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1 getting along? How are your people doing?"
2 I would say, "We haven't seen anything."
3 And that's about the -- when you
4 say "discussion," it wasn't a formal thing.
5 We didn't sit down and say, "Let's talk about
6
PCBs . "
But it was brought up in our
7 conversations .
8 Q.
All right.
Do you recall Dr. Vosburgh ever
9 reporting to you that there were health
10 problems among the transformer and capacitor 11 workers that were putting PCB electrical 12 fluids -
13 A.
No.
His reports were always negative.
He
14 had no reports of any ill effect of
15
transformer workers.
In fact, I don't know
16 if they still kept on using Halowax or not or
17 if he had any of his cable workers after
18 that.
19 Q.
20
More broadly, do you recall whether anyone from General Electric's medical department
2 1 ever reported to you health problems from
22 workers that were using PCBs in the
23 manufacture of transformers or capacitors?
24 A.
No.
But I don't recall talking to anybody
25
outside of Vosburgh.
But the answer to your
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1 question is "no."
2 Q. Did Mr. Wheeler or Mr. Garrett or anyone else
3 in the Monsanto medical department tell you
4 that they'd been informed by General Electric
5 that General Electric's transformer and
6 capacitor workers were experiencing any
7 health problems from exposure to PCBs?
8 A.
No, they did not.
9
Q.
Let's go back to the Drinker symposium.
Did
10 Dr. Drinker publish an article about his
11 tests in the symposium in a periodical?
12 A.
Yes, he did.
13 Q. Would you turn to what's marked as Exhibit 2
14 and tell us -- well, identify Exhibit 2 for
15 us .
16 A.
Exhibit 2 is a "Symposium on Certain
17 Chlorinated Hydrocarbons" under the auspices
18 of the Harvard School of Public Health,
19
June 30th, 1937.
He lists three papers.
20
Q.
All right.
Is Exhibit 2 -- well, first of
2 1 all, is Exhibit 2 a document that was the
22 same -- the same paper was summarized or
23 discussed at the symposium?
24 A.
Yes, it was.
It is.
25 Q.
And then it was subsequently published in the
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1 2 A. 3 Q. 4 5 A. 6 7 8 Q. 9 10 A . 11 Q. 12 13 A . 14 15 16 17 18 19 20 21 22 23 24 25
Journal of Industrial Hygiene and Toxicology?
That's correct.
September, 1937.
All right.
Was that one of the periodicals
that you had a subscription of at Monsanto?
Yes.
It also disbanded.
I don't know what
happened to it, but it isn't published
anymore.
But it was one of the ones we had.
All right.
And did you receive a copy of
Exhibit 2 in 1937?
Yes, I did. Can you generally describe the types of tests
that Dr. Drinker performed?
Yes.
He did inhalation studies of which he
exposed rats to measured amounts of various
compounds.
He did some -- I think he did
some feeding, also; but I'm trying to find
that.
Yes.
He did feeding tests on
chlorinated naphthalenes and also on
chlorinated diphenyl, which he called
"chlorinated diphenyl."
So he did a -- he
also did a few subcutaneous injections.
So
he did a pretty thorough series of tests,
certainly from 1937.
It was pretty good
work.
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1 Q. And he reported that the products that he did
2 these studies on were chlorinated
3 naphthalenes?
4 A. Yes.
5 Q. And he also reported that he did work on a
6 Monsanto product?
7 A. That's correct.
8 Q. And what did he report in the 1937 paper the
9 product was?
10 A. He said it was chlorinated diphenyl.
11
Q.
All right.
Now, turn to what's marked
12 Exhibit 3 and identify that for us, please.
13 A.
This is a second of three papers read at the
14 symposium by Dr. Bennett, a pathologist.
15 This -- the title was, "Morphological,"
16 M-o-r-p-h-o-l-o-g-i-c-a-1, "Changes in the
17 Livers of Rats Resulting from Exposure to
18
Certain Chlorinated Hydrocarbons."
In other
19 words, this is a pathology that he found
20 out - -
2 1 Q. Was --
22 A.
-- after their experiments.
23 Q. Was Exhibit 3 also a paper presented at the
24 1937 symposium?
25 A. Yes, it was.
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1 Q. And was it subsequently published in the 2 Journal of Industrial Hygiene and Toxicology
3 in 1938?
4
A.
Yes, it was.
February, '38.
5 Q. And did you receive and review a copy of this 6 article in 1938?
7 A . Yes, I did.
8 Q. Was the Journal of Industrial Hygiene and 9 Toxicology a widely read journal in the
10 industrial -- strike that -- in the
11 occupational medicine field?
12
A.
Yes, I think so.
It was the only one that
13 was around, also. 14 Q. Do you recall the conclusion of Dr. Drinker 15 and Dr. Bennett with respect to the relative
16 toxicity of chlorinated naphthalene and what
17 they reported in Exhibit 2 and Exhibit 3 were
18 chlorinated diphenyl?
19 A .
Yes .
20 Q
What do you recall their conclusion was?
21 A.
Well, he found that -- he said that
22 chlorinated diphenyl and chlorinated
23
naphthalene were both quite toxic.
And he
24 stated that chlorinated di -- what he called
25 chlorinated diphenyl was as toxic as
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1 2 Q. 3 4 5 6 7 8 A. 9 Q. 10 11 A . 12 13 14 15 16 17 Q 18 19 20 A 21 22 Q 23 24 25 A
chlorinated naphthalene.
Would you turn to Page 123 of Exhibit 3 and
look at the paragraph labeled "4" on the
second column.
The last sentence of that
paragraph says:
"Chlorinated diphenyl
appears to be the most injurious compound of
all those tested."
That's right.
That's what he said.
Do you recall hearing that at the symposium
and reading it in Exhibit 2 and Exhibit 3?
I got two questions there.
I read -- I
recall reading it.
I don't know how to
characterize chlorinated diphenyl at the -
if he used that term as the most injurious
compound of the whole batch we tested.
I
don't know that.
You don't recall whether he said that at the
symposium, but he did put that in the
articles that you read?
That's correct.
He may have said it at the
symposium, but I don't recall it.
All right.
Now, you've testified a couple of
times that it's what he reported, was
chlorinated diphenyl?
That's correct.
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Did you later come to the conclusion that he
had misidentified his -- the substance that
he was testing and calling chlorinated
diphenyl in these papers?
Did I come -
Yes .
Yes.
I had the -- came to the conclusion
when I got back to St. Louis at that time,
over all this, in fact.
So I called up
Professor Drinker and said, "Look, we don't
have" -- "our chlorinated diphenyl, we don't
have the clinical experience that shows that
this is as bad as you have painted it to be.
Where did you get the chlorinated diphenyl?
You said it was a chlorinated diphenyl
chlorinated to 65 percent.
We don't make a
chlorinated diphenyl at 65 percent.
We make
a 62 and a 68.
Where did you get it?"
He said, "We got it from Halowax."
I said, "Well, I don't know how
they came to that conclusion, that this is
chlorinated diphenyl, because we don't sell
them chlorinated diphenyl.
We sell them what
we" -- "what is chlorinated diphenyl
benzene.
Why don't you retest this thing,
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1 and I'll send you some material right off our
2 production line as close to a 62 percent
3 chlorination as we've got."
4 So I thought. I'll send him the
5 most highly chlorinated one, which is 1268,
6 because the thinking at that day, those days
7 and even today, was that the more chlorine
8 you get in, the more toxic it is.
9 Q. All right.
10 A. So I sent him 1268.
11 Q. Let me stop you there for a minute.
12 Did Dr. Drinker report to you that
13 the Halowax Company identified the sample
14 that he tested in the 1937 work as
15 chlorinated diphenyl?
16 A.
I don't know what you mean by "identified."
17 He -- they called it that.
18 Q.
Okay.
The Halowax Company was the one that
19 called it chlorinated diphenyl -
20 A.
Yes.
2 1 Q.
-- when they gave the sample to Dr. Drinker?
22 A.
That's correct.
23 Q.
And was this the product that we talked
24 earlier about as being 4465?
25 A.
Yes .
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1 Q. And what is the "65" in "4465" mean?
2 A.
65 percent chlorination of a whole compound.
3
Q.
All right.
We've talked before -- you've
4 talked before about 1268 and 1262 and various
5
things like that.
Was there a -- was there a
6 naming practice at Monsanto where
7 Aroclor 1254 meant a particular thing?
8 A.
Yes.
It meant chlorinated biphenyl
9 chlorinated to 54 percent average.
10 Q.
Okay.
So --
11 A.
In other words, there was some 1248 in there,
12
rtiaybe some 1252 in there.
But the average of
13 the diphenyl was chlorinated to 54 percent.
14 Q.
So the last two digits of Aroclor 1254 means
15 54 percent chlorine?
16 A. 17 Q.
That's correct. What do the -- do the first two digits
18 designate something?
19 A.
It was an Aroclor.
20 Q. Did the first two digits mean that it was a
2 1 chlorinated diphenyl?
22 A. Yes .
23 Q.
What about the -- was there also a 5,000
24 series of Aroclors?
25 A.
Yes.
I don't know how extensive that was.
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1 There was a -- the one I remember was 5460.
2
Q.
All right.
And Aroclor 5460 was what
3 compound?
4 A . It was a chlorinated diphenyl benzene
5 chlorinated to 60 percent.
6 Q. All right. 7 A . Diphenyl benzene could also be called
8 chlorinate terphenyl, which means there's
9 another phenyl ring in it.
10
Q.
All right.
Was there a 4,000 series, Aroclor
11 4465?
12 A .
I don't know about the series.
I know there
13 was one compound called 4465.
14 Q. And was a mixture of what?
15 A .
Of chlorinated -- chlorinated diphenyl plus
16 5460, which is chlorinated diphenyl benzene.
17
Q.
All right.
And what did you do after having
1 8 a conversation with Dr. Drinker about his
19
source of chlorinated diphenyl?
Or what he
20 labeled as "chlorinated diphenyl"?
21 A.
I said, "I don't know what you tested.
I can
22 send you some honest to goodness chlorinated
23
diphenyl, and test that."
So -
24 Q. 25 A .
And did you do that?
So I called Anniston and said, "Send him a
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1 2 3 Q. 4 5 A. 6 7 8 9 Q. 10 11 12 13 14 15 16 A . 17 Q. 18 A . 19 Q. 20 A . 21 22 Q. 23 24 25 A .
couple of quarts of 1268."
So we sent it
up -- we sent it up to him.
Did you also send Dr. Drinker samples of
5460?
Yes, I did.
(A recess was taken.)
(By Mr. Bauer)
With respect to the substance
that Dr. Drinker labeled 4465 at the
symposium and his first two papers, would the
conclusion that he reached about the relative
toxicity of that compound at that time, did
he ever suggest that it was too dangerous to
use an electrical fluid?
No, he did not.
Did he -
In the electrical fluid?
Right.
He wasn't talking about the fluids.
He was
talking about wire impregnation.
I understand that.
The -- I understand that
what caused his concern was the wire
coating.
But he never did, no.
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1 Q.
Did he ever -- did he ever -- did Dr. Drinker
2 ever suggest that what he identified as
3 chlorinated diphenyl was too dangerous to use
4 in PCB electrical fluid?
5 A.
No, he did not.
6
Q.
All right.
Did he suggest it was too
7 dangerous to use for any use?
8 A.
For what?
9 Q.
Any use.
Including the wire coating.
10 A.
Oh, you mean in electrical? I mean, if -
11 when you say "any," suggests use on a serial
12
or something like that.
But any electrical
13 use .
14
Q.
All right.
Let me ask more specifically.
15 A. Industrial use.
16
Q.
All right.
There was in -- there was a prior
17 industrial use of the substances, the various
18 Halowax compounds that had been used in a
19 prior industrial use where people had been
20 exposed to it and suffered serious injuries,
2 1 including some deaths.
22 A.
Yes.
23 Q.
Did Dr. Drinker suggest this as a result of
24 his tests, that the substances that he
25 tested, including chlorinated naphthalene and
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1 what he identified as chlorinated diphenyl,
2 was too dangerous to use in the wire coating
3 use ?
4 A.
No, he did not.
5 Q.
Did anyone at the Drinker symposium state
6 that the substances chlorinated naphthalene
7 or what was identified as chlorinated
8 diphenyl were too dangerous to use as
9 industrial chemicals?
10 A .
No.
There were several -- on the contrary,
11 there were several people from the Government
12 that said, "There's no reason why these
13 things can't be handled safely."
14 Q.
Did anyone at the Drinker symposium state the
15 opinion that chlorinated naphthalenes or
16 chlorinated diphenyls were too dangerous to
17 use in electrical equipment such as
18 transformers or capacitors?
19 A .
No, sir.
20 Q.
Do you recall a Dr. Schwartz who was at the
2 1 symposium?
22 A .
Yes .
23 Q.
Who is he?
24 A .
Dr. Schwartz was a dermatologist who worked
25 for the United States Public Health Service
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1 2 3 4
5 Q.
6 7 A. 8 Q. 9 10 11 12 A .
13 Q.
14 A .
15 Q.
16 A . 17
18 Q.
19 A .
20 Q.
21 22 23 24 A . 25
for a long, long time.
I don't know how
long.
He was guite a man, fairly well-known
for his work with skin -- skin problems in
the industry.
Would you turn next to what's been marked
Exhibit 4 in your binder. Dr. Kelly?
Yes .
That's a report to Monsanto with a cover
sheet that states -- that's dated
September 15, 1938, and on the second page
says "Report on 4465."
Yes, sir.
Did you receive a copy of Exhibit 4 in 1938?
Yes, I did.
Can you tell us what this report is?
It's a report of work done by Drinker /
sponsored by Monsanto.
4465 are material --
He --
-- which was --
Let me stop you there.
He identifies 4465 in
this paper as chlorinated diphenyl.
Do you
recall whether this paper was written before
or after your discussions with him?
Oh, if he -- if he referred to it as
chlorinated diphenyl, it was written before
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1 my discussion with him.
2 Q. Okay.
3 A.
I mean, I don't know when he -- this paper,
4
am I looking at the same one you have?
It
5
says June, 1937.
I don't know what that
6 means.
7 Q.
It says June of 1937 in handwriting on the
8 top of the first page?
9 A. Yes .
10 Q. But it has a typed date of what on the
11 first -- on --
12 A. Of the report, right.
13 Q. Let's go over that again.
14 The typed date on the first page of
15 the report is what?
16 A.
Is September 15th, 1938.
17
Q.
All right.
And what's the handwritten date
18 on the first page of the text?
19 A. June, 1937.
2 0 Q. And do you recall now whether the substance
2 1 that was talked about at the 1937 symposium
22 was reported by him to be 65 percent
23 chlorine?
24 A. Yes.
25
Q.
All right.
Now, you testified a few minutes
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1 2 3 4 5 A. 6 Q. 7 8 9 10 A. 11 Q. 12 13 14 A. 15 Q. 16 17 18 19 20 21 A. 22 Q. 23 24 25
ago that you submitted two samples to
Dr. Drinker after you had the conversation
with him of two Aroclors.
Would you turn
next to what's been marked as Exhibit 5?
Yes .
That's another document entitled, "Report to
the Monsanto Chemical Company," by Cecil K.
Drinker, with a date on the first page of
September 15, 1938.
That's correct.
And it has four compounds identified as being
tested, on the second page.
Did you receive
a copy of Exhibit 5 in 1938?
Yes, I did. The third -- on the second page of the
document, which lists -- it's the table of
contents.
It lists, Compound No. 3,
"Chlorinated diphenyl #1268."
Is that the
sample of chlorinated diphenyl that you sent
to Dr. Drinker?
Yes.
Does the report marked as Exhibit 5 contain
the contents of Dr. Drinker's studies that -
for the portion of the work that you
testified earlier that Monsanto paid 100
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1 percent of the work of?
2 A . Yes .
3
Q.
All right.
Is Exhibit 4, the prior exhibit.
4 Exhibit 4, the paper that shows the work that
5 was funded jointly by Halowax and Monsanto?
6 A . Yes .
7 Q. What did Dr. Drinker conclude with respect to 8 Chlorinated Diphenyl No. 1268 in Exhibit 5?
9 A.
He concluded that Chlorinated Diphenyl 1268
10 was much less toxic than his report on what
11 he had previously identified as a chlorinated
12
diphenyl.
He said he was surprised about the
13 low order of magnitude of toxicity of 1268.
14 Q. 15
Did Dr. Drinker publish a subsequent published article after 1938 when he did the
16 report -
17 A .
Yes .
18 Q. 19 A .
-- that's marked as Exhibit 5? Yes, he did.
20 Q. And is that what we've marked as Exhibit 6?
21 A.
Yes, sir.
22 Q. 23
And was that also a paper published in the Journal of Industrial Hygiene and Toxicology?
24 A .
Yes, it was.
25 Q.
Did Dr. Drinker include in this paper a
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1 2 3 A. 4 Q. 5 A. 6 Q. 7 8 9 10 A . 11 Q. 12 13 14 15 16 A . 17 Q. 18 A . 19 20 2 1 Q. 22 23 24 25
statement of his earlier misidentification of
chlorinated diphenyl?
Yes.
Where is that?
It's on Page 158, the third paragraph.
It's the -- is it the paragraph that starts
on the bottom of Page 158 -- the bottom of
the first column on Page 158 and carries
over?
Yes .
All right.
Now, Dr. Kelly, are you
testifying that because of Dr. Drinker's
misidentification of the compound initially,
that chlorinated diphenyl had no toxic
properties at all?
No, I'm not testifying to that.
All right.
I'm testifying that it didn't have the toxic
properties that he stated it had.
But it had
some, certainly.
And as a result of those toxic properties,
was it your opinion in the 1930's, the
1940's, and the 1950's that it was prudent to
take steps to limit human exposure to
chlorinated diphenyl?
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1 A. 2 Q. 3 4 5 6 A. 7 Q. 8 A. 9 Q. 10 11 A . 12 13 14 15 16 17 18 Q. 19 A . 20 Q. 21 22 A . 23 Q. 24 25
Yes .
Did the literature in the 1930's, Forties,
and Fifties also demonstrate to you that
there was a safe level of exposure to
chlorinated diphenyl?
What years?
Thirties, Forties, and Fifties.
Yes .
Would you turn next to what's been marked
Exhibit 7 and identify that for us?
Yes.
This is an article by Dr. Meigs,
M--e-i-g-s, which appeared in -- someplace.
Oh, the Journal of the American Medical
Association, April of 1954, entitled,
"Chloracne from an Unusual Exposure to
Arochlor."
He spelled "Aroclor" wrong, but
it's --
Did you read Dr. Meigs' article in 1954?
Yes, I did.
.
Did you write a letter to Dr. Meigs after you
read Exhibit 7?
Yes, I did.
Would you turn to Exhibit 8 and tell us
whether that's a copy of the letter that you
wrote to Dr. Meigs?
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1 A. Yes, it is.
2
Q.
There's no signature on Exhibit 8.
Did you
3 have a practice in the 1950's of maintaining
4 file copies of correspondence that were
5 unsigned?
6
A.
Yes.
I never signed the carbon copy.
7
Q.
Okay.
Is Exhibit 8 a copy of the letter that
8 you sent to Dr. Meigs in 1954?
9 A.
Yes, it is.
10 Q. Now, you state in the first sentence of
11
Exhibit 8:
"Your article in the current
12 number of the JAMA is certainly confusing to
13 me . "
14 Why did you tell that to Dr. Meigs?
15
A.
Well, the second sentence explains it:
"We
16 have had men exposed to concentrations of
17 chlorinated diphenyl four or five times what
18
you have recorded..."
We have had them
19 exposed for five to ten years and have no
20
chloracne.
Here you've said you've got
2 1 something one fifth this level for a period
22 of definite months, not years, and you get
23
chloracne.
How come?
I mean, no wonder I'm
24 confused.
25
Q.
All right.
Now, the article that's been
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marked Exhibit 7 has a report in it, on the
first column on Page 1418, that the state
Department of Health had done some air
concentration samples several months before
the diagnosis of chloracne and there were
reports of point one milligram per cubic
meter of chlorinated hydrocarbon in the air.
Right.
Do you recall how that related to what was
considered the safe level of exposure at that
time?
It was one-fifth the level for 1242 and
one-tenth the level -- or for 1254 and
one-tenth the level for either 42 or 48.
I
don't know which.
I think it was 42.
Work
sponsored by Monsanto showed that the
material could be used at levels of point
five milligrams per cubic meter in the
atmosphere of workers for an eight-hour day
for their working lifetime.
And I'm not sure
whether the point five was 42 or 40.
The
point five was 1254.
The point -
Well, let me stop you there.
There was --
from work that Monsanto sponsored in the
1950's, there was a different safe level
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established for Aroclor 1254 versus
Aroclor 1242?
Yes .
All right.
Was that called a maximum
allowable concentration at the time?
I presume it was.
I don't know whether
the -- whether that industrial hygienist
changed the phraseology from "maximum
allowable concentration" to "threshold limit
value."
But regardless of the semantics, it
was a safe level .
You ask in the second paragraph to
Dr. Meigs:
"Could you tell me which Aroclor
was used?"
And then you go on in that
paragraph to ask about whether certain other
substances were used at that plant.
Why did
you ask Dr. Meigs those questions?
Because I was looking for a reason for the
chloracne.
I could not believe that the
chloracne would occur at levels of one tenth
of a milligram per cubic meter of air.
If
the chloracne were due to
pentachlorophenol -- pentachlor -- I mean,
the chlorinated diphenyl -- biphenyl, it
doesn't have an exclusive franchise on
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2 3 4 5 Q. 6 7 A. 8 Q 9 10 A . 11 12 13 Q. 14 15 16 17 A . 18 19 Q. 20 21 A 22 23 24 25
causing chloracne.
There are a number of
things that cause chloracne.
So I asked him
if there was any other thing around that
could be doing it.
And did Dr. Meigs respond to your letter
which we've marked as Exhibit 8?
Yes, he did.
Would you turn to Exhibit 9 and identify that
for us , please.
This is a letter from Dr. Meigs dated
May 7th, 1954, in which he answered my letter
of April the 28th of the same year.
Did Dr. Meigs respond to your inquiry about
being confused about the report of chloracne
at point one milligram per cubic meter of air
for the chlorinated hydrocarbon?
Yes.
He responded by saying he was confused,
too .
And did he tell you anything about the air
concentrations?
He said the air concentrations were taken by
the state health department quite some time
before he wrote his paper and quite some time
before the rash -- the chloracne showed up.
He also suggested -- he also stated he was
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1 2 Q. 3 A. 4 Q. 5 6 A. 7 Q. 8 A. 9 Q. 10 A . 11 Q. 12 13 A . 14 Q. 15 16 17 18 19 20 21 A. 22 Q. 23 A . 24 25
not suggesting the MAC was set too high.
Okay.
Now, that's in the last paragraph.
Right .
It says "M," period, "A," period. "C , "
period?
Yes .
And what --
MAC .
And what's that?
Maximum allowable concentration.
That MAC is an acronym for "maximum allowable
concentration"?
Right.
Uh-huh.
Okay.
Did Dr. Drinker conduct -- strike
that.
Still on Dr. Drinker, Dr. Kelly.
We're on Dr. Meigs now.
Did Dr. Meigs conduct his own
samples of the air at the time he was working
with the people at this plant in Connecticut
who developed chloracne?
No, he did not.
All right.
He also stated in this letter -- I think it
was pretty important.
He said:
"My
conclusion is that chlorinated hydrocarbons
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93
should be ultimately judged as safe or
hazardous in relation to observations of the
workers themselves," which is really what I
told him.
I said, "We've watched our
workers, and we don't have any problem."
All right.
There is a reference to the state
health department survey people at the end of
the first paragraph.
Yes, sir.
And there is a reference to -- well, the
sentence says:
"None of us here (including
the State Health Department Survey people)
have any good answer to why the air samples
were so low."
And the next sentence says:
"We
assume that somehow other conditions may have
existed for a few weeks or months prior to
the recognition of chloracne," closed quote.
Now, when you read that, what was
your understanding thereafter about this
cause of the chloracne problem in
Connecticut?
Well, my understanding was that they did not
get the chloracne from exposures of one tenth
of a milligram of Aroclor -- of chlorinated
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1
biphenyl per cubic meter of air.
Regardless
2 of anything else, whatever their -- their
3 figures were wrong or the exposure was not --
4 the figures were not indicative of the
5 exposure that these people had when they got
6 the chloracne.
7 Q. Well, was your concern and confusion after
8 reading the article lessened by receiving the
9 letter from Dr. Meigs?
10
A.
Well, no.
I was just -- I welcomed him to
11
the club.
He was confused, also.
12 Q. Did Dr. Meigs -- was Dr. Meigs able to
13 respond to your inquiry from Exhibit 8 about
14 which Aroclor was used?
15 A.
No, he was not.
He said it was a combination
16
of high boiling chlorinated hydrocarbons.
So
17
it was a little confusing to me.
A
18
combination?
Does that mean he mixed several
19
together?
Did he mix chlorinated diphenyl
20
benzene along with these other things?
I
21
don't know.
I don't know what they tested,
22 what they had in that -- in that heat
23 transfer medium.
24 Q.
Was there another common name within Monsanto
25 for chlorinated diphenyl benzene at this
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1 2 A. 3 Q. 4
5 A,
6 7 Q. 8 9 A. 10 11 Q. 12 A. 13 14 15 16 17 18 19 20 Q. 21 22 23 24 25
time ?
Chlor -- yes.
5460.
Well, separate and apart from the trade name,
a reference to --
Chlorinated terphenyl.
What was the question?
Do you recognize the name "chlorinated
diphenyl high boiler"?
Oh.
No.
I don't know -- we didn't use
that.
I don't know what that was. .
Okay.
I don't know what he -- and I don't know what
he was saying as a combination.
I thought
the heat transfer -- the material we sold for
heat transfer -- remember, I get back, this
is not electrical.
This is heat transfer.
I
don't think we sold a combination of PCBs for
this.
We certainly didn't sell a chlorinated
diphenyl benzene for it, either.
I understand that.
That wasn't my question.
Dr. Kelly.
Was there -- was there -- was there
a substance at Monsanto that you sometimes
called -- rather than its trade name, you
sometimes called it "chlorinated diphenyl
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1 high boiler"?
2 A.
I don't recall Monsanto using that particular
3 term.
4 Q. All right.
.
5
MR. BAUER:
Take a short break?
6
MR. KIM:
Sure.
7
THE VIDEOGRAPHER:
We're going off
8
the record.
It's ten minutes after 11:00
9
o'clock.
This is the end of Tape No. 1.
10
11 (A recess was taken.)
12
13
THE VIDEOGRAPHER:
It's 26 minutes
14
after 11:00 o'clock.
This is the beginning
15
of Tape No. 2.
We're back on the record.
16 Q.
(By Mr. Bauer)
Dr. Kelly, in your answers
17 about the correspondence that you had with
18 Dr. Meigs, you talked about the maximum
19 allowable concentration for chlorinated
2 0 diphenyl and that his report of chloracne was
2 1 from an exposure that was lower than the
22 maximum allowable concentration.
23 A. That's correct.
24 Q. Do you recall who set maximum allowable
25 concentrations?
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1
A.
Yes.
It all depends on the year you're
2
talking about.
The first group that set the
3 maximum allowable concentrations was the
4 American Conference of Governmental
5
Industrial Hygienists.
That was a group of
6 industrial hygienists who worked either for
7
city, county, state, or U.S. Government.
It
8 did not include anybody from industry, and it
9
did not include anybody from academia.
Then
10 after when OSHA came along, they set the
11 concentrations; but they used -- in the vast
12 majority of cases, the OSHA people used the
13 ACGIH figures.
14 Q.
Now, what was -- what was the maximum
15 allowable concentration in terms of -- I
16 mean, what did it mean to have something set
17 at a maximum allowable concentration?
18 A.
It meant that you should keep your levels
19 under that, the working levels under that,
20 that they believe that if you stay under that
2 1 maximum allowable concentration, no harm will
22 exist even if you worked there eight hours a
2 3 day for 40 years.
24 Q.
And was the initial maximum allowable
25 concentration for chlorinated diphenyl
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1 2 A. 3 4 5 6 7 8 9 Q. 10 A . 11 Q. 12 13 A . 14 Q. 15 A . 16 Q. 17 18 19 20 21 22 23 24 25
1 milligram per cubic meter of air?
Yes.
It was the one that was -- the official
one, Joe Treon, who did the work, he believed
that it could be two.
But the Government
people were -- the Government hygienists were
a little more conservative.
He said it
should be -- they should be one for 1242 and
point five for 1254.
Was that Dr. Treon at Kettering Laboratory?
Yes, it was.
And do you -- would you recall whether that
was later in 1956?
'54, I thought.
1954 is when he did his work?
Yes .
Was it significant to you that Dr. Meigs
stated in his letter to you, which has been
marked Exhibit 9, that he's not suggesting
that the maximum allowable for
concentra -- strike that.
Was it significant to you that
Dr. Meigs wrote in Exhibit 9 that he was not
suggesting that the maximum allowable
concentration for Aroclor had been set too
high?
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1
A.
Well, it wasn't too significant.
He just
2 made -- just meant -- he was really not an
3
expert in this field.
Even though you write
4
a paper doesn't make you an expert.
So he
5 was just joining the forces with everybody,
6 all the industrial hygienists who had worked
7 in -- who had supervised the workers in the
8
field.
He -- so I was glad that he was
9
agreeing with the rest of the Country.
In
10 spite of his paper that said he got chloracne
11 at point one, it seemed to me that he didn't
12 believe it himself.
13 Q.
I'd like to turn now to the topic. Dr. Kelly,
14 of toxicological testing sponsored by
15 Monsanto.
16 You've already testified to some
17 extent about Monsanto's role in Dr. Drinker's
18 work, funding in part for Dr. Drinker's
19
work.
Did Monsanto continue to sponsor
20 toxicological testing after the 1930's?
2 1 A.
Yes.
They continued up until the time I
22 retired and are still doing it.
23 Q.
With respect to chlorinated diphenyl or what
24 we call today "PCBs," did those tests
25 include -- did the work that Monsanto
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1 2 A. 3 Q. 4 A. 5 6 7 8 9 10 Q, 11 12 13 A 14 15 16 17 18 19 20 21 22 23 24 25
sponsored include animal studies?
Yes .
Did Monsanto perform those tests in-house?
No.
Up till 1974 we did not have a
laboratory inside.
We made preparations for
building a laboratory around the time I was
retiring, and I think that came to
fulfillment in 1975 or '76.
But I don't know
if they did any work on PCBs at that time.
All right.
Do you recall the names of some
of the outside laboratories that Monsanto
retained over the years?
Yes.
We -- there were two laboratories in
St. Louis, which are relatively small
laboratories which we used for acute
studies.
Acute is roughly one shot of the
material.
That was the Younger Laboratories,
Y-o-u-n-g-e-r, and Scientific Associates,
both in St. Louis.
We used the Kettering Laboratory at
the university of -- K-e-t-t-e-r-i-n-g -
Laboratory of the University of Cincinnati
for inhalation studies in 1954.
We used the
Industrial Bio-Test Laboratories of
Northbrook, Chicago, for dermal testing and
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feeding testing, quite an extensive array of
tests that started in 1968.
In your view, during the decades when you
were Monsanto's medical director, was it
possible to extrapolate directly from the
results of those animal studies to human
beings ?
No, it was not.
But the -- it's the only way
you can test it.
In this Country you're not
supposed to test on people.
And so did you rely on the results of animal
testing?
Notwithstanding what you just said,
did you rely on the results of animal testing
in part in exercising your judgment as to the
relative toxicity of various Monsanto
compounds ?
Oh, certainly.
You have really three points
that you make a judgment on.
One is the
inherent toxicity of the product itself.
You
get that from animal testing.
Two, you make
a judgment from the exposure.
One sort of
exposure, is this going to be an open
centrifuges.
Is this going to be a
plasticizer where it's dropped onto a hot
rolling mill.
Or three, what -- and most
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Q. A.
important in my point of view -- from my
point of view, what is the clinical record of
the workers that have been exposed to this
product during its manufacture or use.
In
fact, that's what Meigs said.
He said it
should be judged safe or hazardous by
relation to observation of the workers
themselves .
So you got really a three -- a
three-legged stool, that you have to make a
judgment call using all three of those
items.
With respect to testing, in an answer a
minute ago, you mentioned "acute testing."
Would you elaborate on that for us, please,
what you mean by "acute testing."
Well, it's a testing to show what would
happen if you have a one-shot dose of the
material, either one or over a short period
of time, several days.
We would have a package where we
dropped the material in the ice to see what
happened to the ice.
We put it on the skin
sometimes for 24, 48 hours, sometime
repeatedly over two or three days; but that
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was a small time frame of testing to see
whether it was absorbed through the skin or
what it did to the skin.
Third, we tried to
get a saturated atmosphere of the material to
see how rats handled six- or eight-hour
exposure, one exposure.
Then we fed it to
find out what was called first the minimum
"lethal dose," later changed it to the
Lethal Dose 50, or LD^^, to give a benchmark
of the rough toxicity from an acute, which
means a short exposure.
Q.
All right.
Now, Lethal Dose 50, or LD5q,
what did that mean when a substance was given
an LD50?
A. It means that you take a batch of rats,
usually 20 or 50, and see what dose kills
half of them.
Q. And was that a commonly accepted -- strike
that.
Was that a commonly used method of
determining a relative toxicity of compounds
in the chemical industry in the 1950's?
A.
Yes.
As far as the rats were concerned.
Q. Okay.
A. I mean, when you use it on a rat, that
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1 doesn't mean it would have the same toxicity
2 effect on a dog or a -- but it was a common
3 benchmark to get a relative toxicity index of
4 the product.
5 Q- Did Monsanto conduct studies in the 1950's to 6 get a LD,_g, or Lethal Dose 50, for various
7 PCB products?
8 A.
Yes.
Not only the Fifties.
I think almost
9 up to the time we -- I retired.
10 Q. 11
Would you turn, please, to Exhibit 10, which
is dated November 10, 1953.
And it's a
12 certificate of analysis from Scientific
13
Associates.
Can you identify that for us,
14 please?
15 A .
Yes.
That's -- "Subject:
The Acute Oral
16 Toxicity of Aroclor 1254 for Rats."
17 Q. 18
All right.
Is this a report of work
sponsored by Monsanto?
19 A .
Yes .
20 Q. 21
Who at Monsanto made the decision to request
this study?
'
22
A.
Ultimately I did.
Whether or not -- '53,
23 yes, I did it.
24 Q. 25
Did you receive and review a copy of Exhibit 10 in 1953?
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1 A. Yes.
2 Q. Were similar LD^g tests performed by
3 Scientific Associates for other Aroclor
4 products ?
5 A. Yes .
6 Q. Is -- well, strike that.
7 Can you identify Exhibit'll,
8 please?
9 A. That's by the same organization on 1242 for
10 rats, dated the same day, I think,
11
December, '53.
The same year, at any rate.
12
Yes.
The same year.
13 Q. Did the results of the LDr. work in the 50
14 1950's performed by Scientific Associates -
15 of which we've seen two examples now.
16
Exhibit 10 and Exhibit 11.
Did the results
17 of those tests change your opinion about the
18 relative toxicity of PCBs?
19
A.
No.
I always thought the PCBs, as far as an
20 industrial chemical was concerned, was a mild
21
to moderate toxicity.
And that certainly
22 falls in that range of four to four point
23 three milliliters per kilogram.
24 Q. And you're now referring to the "Discussion"
25 section of Exhibit 11?
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1 A. That's correct.
2 Q. Would you turn next to Exhibit 12, please,
3 and identify that for us?
4
A.
Yes.
This is a report from the Kettering
5 Laboratory of the University of Cincinnati.
6 The principal author is a Dr. Treon,
7 T-r-e-o-n, on "The Toxicity of the Vapor of
8 Aroclors 1242 and 1254."
9 Q. And what's the date?
10 A. June the 22nd, 1955.
11 Q. And would you tell us what Exhibit 13 is?
12 A. Beg pardon?
13 Q. Exhibit 13.
14 A.
That's the toxicity of 1254 by the same
15 author and the same organization.
16 Q. And what's the date of the second report?
17 A. June the 28th, 1955.
18
Q.
All right.
Now, what company requested that
19 Dr. Treon of Kettering Laboratory undertake
20 tests of the toxicity of the vapor of
2 1 Aroclors 1242 and 1254 in 1950's -- in the
22 1950 ' s?
23 A.
Monsanto Company.
24
Q.
All right.
Who at Monsanto made that
25 request?
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1 A. 2 Q. 3 A. 4 5 6 7
8 9 Q. 10 11 12 13 A. 14 Q. 15 16 17 A. 18 19 20 21 22 23 24 25
I did. What was Kettering's reputation at the time?
Well, it was top drawer.
It was excellent.
It was a university.
It was -- the head of
it was Dr. Keel, who had spent his life
investigating the toxicology of lead.
And it
was an extremely well-recommended
organization.
All right.
What type of tests did Dr. Treon
and his co-workers perform in terms of
ingestion versus skin contact versus
inhalation?
Repeated inhalation studies. Why did you ask Dr. Treon to do repeated
inhalation studies on twelve -- Aroclor 1242
and Aroclor 1254 in the 1950's?
Because these materials were beginning to be
used in applications where elevated
temperatures were used, such as the hydraulic
fluids in the die-cast industry and there
would be a possibility of repeated levels -
repeated exposures to the material at
elevated temperatures.
At room temperatures
we didn't -- weren't worried at all.
You can
have a bucketful of Aroclor sitting in this
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1 room here with no lid on it, it wouldn't
2
bother anybody.
But if you heated it up,
3 you've got enough of it in the air, at some
4
time it would be harmful.
We wanted to see
5 what a safe level was.
6 Q.
Did you have -- did you understand in the
7 1950's that if Aroclors were heated and
8 openly exposed to the air, one might
9 eventually exceed the maximum allowable
10 concentration?
11 A . Oh, certainly.
Q.12 Just to make sure we're clear about what
13 we're talking about, the toxicity of the
14 vapor of Aroclors 1242 and 1254 is what the
15
report is about.
Is Aroclor 1242 a
16 chlorinated biphenyl product?
17 A .
18 Q.
19
Yes , it is. And is Aroclor 1254 a chlorinated biphenyl product ?
20 A .
Yes, it is.
2 1 Q.
And the "42" in the 1242 means what?
22
A.
The chlorinated concentration.
The biphenyls
23 chlorinated to average concentration of 42
24 percent.
Q.25
Okay.
Were those two specific Aroclors being
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1 used for some of these new uses that you were
2 describing earlier?
3 A. Yes, they were.
4 Q. Do you recall what types of animals Dr. Treon
5 performed his work on?
6
A.
He did a sort of a mixed bag of animals.
He
7
did rabbits, rats, mice.
He did about five
8
cats.
He did a cat in there.
He did quite a
9 f ew.
10 Q. So there were tests on two PCB products on a
11 number of different species?
12 A.
That's correct.
13 Q.
Do you recall the length of time of the study
14 that is set forth in the initial report?
15 A.
The initial report, he did two studies.
One
16 was with a fairly high concentration for
17 something like -- I'm not sure -- 120 days or
18
something.
Maybe less than 120 days.
Then
19 he did another series of experiments with a
20 higher -- with a smaller concentration for a
2 1 150 days, which is close to five and a
22 half -- five months.
23 Q.
All right.
24 A.
That was pretty long for the 1950's.
In
25 fact, it's long for any inhalation study even
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1 today.
2 Q. Do you recall whether the two reports relate
3 to the two different lengths of times of the
4 studies ?
5 A. Yes.
6 Q. And the first report was for which, the
7 report that we've marked Exhibit 12, from
8 June 22 of 1955?
9 A. The first one was the lower level -- I mean,
10 the higher levels.
11 Q. For the shorter periods of time?
12
A.
Yes.
Correct.
13 Q. Were your previous conclusions about the
14 toxicity and safe handling of PCBs changed by
15 the results of the Kettering Laboratory tests
16 that were reported in Exhibit 12 and
17 Exhibit 13?
18 A.
No.
We had proved two things:
One, if you
19 get too much of it, you can get problems.
20 No. 2, which is the more important thing,
2 1 there are safe levels that you don't get any
22
problems with.
So they bolstered our
23 clinical thinking along this line.
24 Q. What kind of problems were reported in the
25 animals that the exposure was too high?
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1 A. There was some pulmonary irritation; but I
2 think, as I recall, the animals developed
3 some systemic effects on the liver when the
4 level was too high.
5 Q. Was -- the liver being the organ that would
6 be of concern if the exposure to chlorinated
7 diphenyl was too high, was that conclusion by
8 Dr. Treon a surprise to you in the 1950's?
9
A.
No.
Because getting back to Drinker, he
10 found that the liver was a target organ
11 anyway.
12
Q.
After -- well, let me ask you this:
Did you
13 receive and review both Exhibit 12 and
14 Exhibit 13?
15 A. Yes.
16 Q.
After you received and reviewed those two
17 documents, were you of the opinion that
18 chlorinated diphenyl could be used in
19 transformers and capacitors safely so long as
20 certain precautions were taken?
2 1 A. That's correct.
22 Q. And generally what were the precautions that
23 would be required?
24 A.
Avoid breathing in elevated temperatures or
25
in confined spaces.
Avoid repeated or
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1 continuous skin contact.
2 Q.
Did Dr. Treon publish the results of his
3 tests in a scientific journal?
4 A.
Yes, he did.
5 Q.
Is Exhibit 14 a copy of his publication?
6 A.
Yes, it is.
7 Q.
It's identified as a publication from 1956 in
8
Industrial Hygiene Quarterly.
Did Monsanto
9 subscribe to Industrial Hygiene Quarterly in
10 1956?
11 A.
Yes, it did.
12 Q.
Was Industrial Hygiene Quarterly a widely
13 read periodical in the occupational medicine
14 and industrial hygiene field?
15 A.
I don't know how many occupational physicians
16 read it, but certainly every industrial
17
hygienist in the United States read it.
And
18 anybody who had an industrial hygiene group,
19 if a physician was their supervisor, he read
20 it, also.
21 Q.
Did you read Exhibit 14 in the 1950's?
22 A .
Did I read it?
23 Q.
Yes .
24 A.
Yes.
As soon as it came out.
25 Q.
Were the conclusions in the published article
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1 2 3 4 5 A. 6 7 8 9 10 11 12 13 14 15 Q. 16 17 18 19 A. 20 21 22 23 24 25
by Dr. Treon the same as the conclusions from
his -- from the fuller reports we've marked
as Exhibit 12 and Exhibit 13 that you've
already described?
To the best of my recollection, yes.
Yes.
In fact. I'll read his
conclusions.
"Prolonged intermittent
exposure of animals to vapors of Aroclor 1242
1.0 to 8.6 micrograms per liter" -- that's
parts per million -- "demonstrated no
injury.
Prolonged exposure to comparable
concentrations of 1254 resulted in reversible
degenerative changes of certain viscera."
That's the liver.
Did Dr. Treon suggest that the prior maximum
allowable concentration for Aroclor 1242 set
by the American Counsel of Governmental
Hygienist -- Hygienists could be made higher?
There wasn't any prior -- until this work,
there was no prior maximum allowable
concentration -- or TLV, whichever they
used -- because they didn't have any
information on prolonged vapor inhalation.
So he sent all his work, his
reports in to the American Government
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1 Industrial Hygienists; and he said, "I think 2 we can use one point zero for 1254 and two
3
point zero for 1244."
They looked it all
4 over and said, "Well, we're going to be a
5
little more conservative than you.
We're
6 going to use" -- "cut these levels in half."
7 And which is sort of par for a regulatory
8 body.
9
Q.
All right.
Who --
10 A.
Even though they were not regulatory.
They
11 didn't have the force of law, but it was -
12 in essence, it did.
13 Q. 14
Who was it that concluded that they were going to set the maximum allowable
15 concentration at one half the level suggested
16 by Dr. Treon?
17 A.
The American Government Industrial
18
Hygienists.
And that eventually was picked
19 up by OSHA, but OSHA didn't commit until
20 considerably after that.
21
THE WITNESS:
You know "OSHA" is
22 all caps?
23
THE COURT REPORTER:
Yes.
Yes.
24 Q.
(By Mr. Bauer)
Would you identify Exhibit 15
25 for us, please, Dr. Kelly?
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1
A.
Yes.
This is a acute study, "Toxicological
2 Investigation of Inerteen PPO," by Younger
3 Laboratories, March the 4th, 1963.
4 Q. And who requested that Younger Laboratories
5 do this toxicological investigation?
6 A.
Either myself -- the medical department.
I
7 don't know if it was I or if I was the one or
8 Wheeler was.
9 Q. Was it the medical department -
10 A. It was the medical department --
11 Q.
-- of Monsanto Company?
12 A.
-- the medical department at Monsanto,
13 right.
14 Q. And would you identify Exhibit 16, please?
15 A. 16 is the same type of work, done by the same
16 laboratory, with the same date, on Pyranol
17 1470 .
18 Q. The experimental procedures identified in
19 Exhibit 15 and Exhibit 16 are "Oral LD5q,, and
20 "Skin Absorption MLD," "Skin Irritation,"
2 1 "Eye Irritation," and "Vapor Inhalation"?
22 A. Yes.
23 Q. Were those all acute toxicity tests?
24 A.
Yes, they all were.
That was in that package
25 that I referred to earlier.
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1 Q. 2 3 4 5 6 A. 7 Q. 8 9 10 11 12 A. 13 Q. 14 15 A. 16 Q. 17 A. 18 19 20 21 22 23 24 25
All right.
Did the -- strike that.
At this time in March of 1963, was
Younger Laboratories also doing similar acute
toxicity studies on other PCB products than
the ones we've identified here?
Yes.
Did the results of those acute toxicity tests
in the 1960's done by Younger Laboratories
change your earlier conclusion about the
ability to use PCBs safely in electrical
fluid?
Well, it reinforced my thinking.
Would you turn next to what is marked
Exhibit 17, please?
Yes.
Would you identify that?
This is a report to the Monsanto Chemical
Company entitled, "Subacute Dermal Toxicity
of Aroclor 1254," by the Industrial Bio-Test
Laboratories in Northbrook, Chicago.
I must make a statement here that
they call "subacute."
I don't know how you
could have anything shorter than short time,
which is what "acute" is.
So the term they
finally got around to using was subchronic.
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1 Q. 2 3 4 5 A.
6 Q.
7 8 9 10 A .
11 Q.
12 13 A .
14 Q.
15 16 A .
17 Q.
18 A . 19 20 21
22
23 24 25
All right.
At some date after this paper was
written, it was common in industry to refer
to this length of time period as a subchronic
study?
Yes . All right.
Who -- well, strike that.
Let me
ask this first.
Well, did Monsanto Chemical Company
sponsor these studies?
Yes, they did.
It did.
Did the medical department request that
Industrial Bio-Test do these tests?
Yes, it did. Who selected Industrial Bio-Test as the
outside contractor?
I did .
Why did you select Industrial Bio-Test?
Well, we had used them before.
Almost from
their inception, we were one of their
earliest clients.
We knew they were held in
quite high regard.
The Army used them.
The
FDA used it.
The large chemical companies,
even those that had their own toxicological
laboratories like Dow and DuPont, used it.
So it was recognized as the premier
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1 commercial toxicological laboratory in the
2 United States.
3 Q. Did you receive and review Exhibit 17 in
4 1963?
5 A. Yes, I did.
6 Q. Did Monsanto perform other subacute dermal
7 toxicity testings on other Aroclor
8 products -- strike that.
9 Did Industrial Bio-Test do similar
10 work on other Aroclor products at the time?
11 A.
Yes.
12 Q. This one is Aroclor 1254.
13 A.
In 1963?.
14 Q.
(Nods head.)
15 A.
I don't know if they did right at that time;
16 but subsequent to it, I think around that
17
time, they did it.
But I don't recall.
18
Q.
All right.
Did the results of the studies
19 done by Industrial Bio-Test in the early
20 1960's on the toxicity of Aroclor products
2 1 alter your opinion about the ability to use
22 PCBs safely in transformers and capacitors?
23
A.
No, it did not.
I still believed they are
24 saf e .
25 Q. Was there any information in any of the
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1 2 3 4 5 6 7 8 9
10
11 12 13 14 15 16 17 18 19
20
21
22
23 24 25
A.
Q.
A. Q.
A.
Q.
A.
reports that we've reviewed here today or in
any of the other reports that you received at
the same time on other PCB products that made
you question in any way whether chlorinated
diphenyl could be used safely if the
precautions you've talked about earlier were
used?
No.
And I think that was backed up by the
fact that 40 years that we were making the
material, we didn't have any -- we had very
minor episodes of acute exposure from
nonindus -- nonelectrical uses.
But
surprisingly few, judging by the tonnage that
we manufactured.
Now, let's turn to the topic of toxicity and
safe handling information distributed to
customers.
All right?
,
All right.
Would you identify Exhibit 18 for us, please?
Yes .
Could you identify it for us, please?
It's a memorandum of L. A. Watt, W-a-t-t, to
somebody.
I don't know to whom because
there's no -- it doesn't show who it went
to.
Dated October the 11th, 1937, in which
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1
2 3 4 5 6 7 8 9 Q. 10 11 A. 12 Q. 13 14 15 A. 16 Q. 17 18 19 20 21 22 A , 23 24 25
he talks about what the experimental work in
animals showed and what can happen if we -
if you got too much of it on your skin.
And
also, the statement of -- that adequate
ventilation should be taken care of -- should
take care of any problems.
And he mentioned
that he and I discussed this, and we agreed
that this is the way we ought to write it up.
Is the language in Exhibit 18 language that
you approved in 1937?
Yes .
In terms of information to customers about
toxicity and safe handling of chlorinated
diphenyl?
Yes .
To put this in perspective in time a little
bit, is this the time period when you were -
you didn't have the title of medical director
but -- did not have the title of medical
director but were performing some of those
functions ?
I think so.
Probably it was the beginning of
it.
Around '37 and '38 I was really more
involved in it; but '37, I was just getting
started in it.
At least they knew I was
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12 1
there, and they came in to see me.
Watt was
in what would be called the technical
services department of the organic division,
or what division manufactured Aroclors at
that time.
You described earlier that there were
different kinds of ways to disseminate
information to customers, to get out
information about the toxic properties of a
Monsanto product to customers; and you talked
about labels and bulletins and direct
contact.
Did you, as medical director of
Monsanto, have a philosophy about what type
of information would go on the labels as
opposed to the other types of methods?
Yes .
What was that?
Well, remember first of all, on the label you
are generally targeting the information to a
group who are not scientific in training or
wage roll employees who are not supposed to
be chemists or scientists.
And you put on
information that you want them to read, and
you put on information that will protect
them.
And my philosophy was, and always has
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122
been, that if you can get the material in a
crisp, succinct form -- s-u-c-c-i-n -
MR. FEATHERSTONE:
-- c-t.
-- c-t -- that -
(By Mr. Bauer)
She'll get the words down.
Dr. Kelly.
You don't have to try to spell
too many of them.
Well, I couldn't even pronounce that for a
while.
That if you've got adequate
information, the less you put on, the
better.
Nobody is going to read a label that
stretches around the entire circumference of
a 55-gallon drum.
But if you put on there,
"Don't get it on your skin in repeated doses
or in large amounts.
Don't breathe it in
elevated temperatures.
Don't breathe it in
confined spaces," you've got information
there that would protect the worker.
And
anybody who sees the label and reads it,
he'll remember that.
Do you recall anything about the role of a
committee formed by the surgeon general in
the 1930's concerning the specific language
put on warning labels for chlorinated
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10 11 12
13 14 15 16 17 18 19
20
21
22
23 24 25
12 3
naphthalene and chlorinated diphenyl?
I don't know too much about it.
I don't
recall too much.
I was not on that
committee.
We had a labeling expert in
St. Louis.
I mean a labeling director, who
directed himself, I think.
I don't know how
large a group he had.
First it was a Robert
Mentier, then it was a Robert Sido, S-i-d-o.
And the surgeon general had for some time
this committee that would approve warning or
cautionary material, safe handling data on
various compounds, including chlorinated
biphenyls.
And they had approved the type of
warning that we had on there.
' Later that group was suspended; and
the duties were taken over by a committee of
the Manufacturing Chemists Association, LAPI,
L-A-P-I, Label and Protective Information, I
guess, Committee.
I wasn't on that one,
either; but the director was -- of the
labeling department was on that.
The director of Monsanto's labeling
department?
Of Monsanto's labeling department.
All right.
Would you turn next to what's
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1 been marked as Exhibit 19?
2 A. Oh, I got to get a new book.
3 Q. Fair enough.
4
A.
Yes.
I'm all set.
5 Q. Can you identify that for us, please?
6
A.
Yes.
It's a label for Aroclor 1260 by the
7 Monsanto Company.
8 Q. Can you tell us the, approximately, time
9 frame when this type of label with that kind
10 of information on it was used by Monsanto?
11 A.
I can't tell the earliest time.
I've seen
12 these labels on drums, but I think it was
13 . sometime -- gosh, the Forties or Fifties. I
14 don't know how -- the earliest date, I just
15 can't tell you that.
16
Q.
All right.
Now, the language of this label,
17
"Caution:
Avoid prolonged and repeated
18
contact with skin.
Avoid prolonged breathing
19 of vapor and dust," was that language that
20 you approved for this label?
21
A.
Yes.
I wrote it.
22 Q. The next exhibit is marked Exhibit 20, and
23 it's a different label for Transformer
24 Pyrano1.
25 A.
Yes.
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Can -- and this has some additional
2 statements in terms of precautionary
3
information.
Can you tell us approximately
4 when that was added?
5A
6
I think this was added sometime in the Fifties, I believe, to the best of my
7 recollection.
8 Q.
The two statements about if skin contact
9 occurs ?
10 A .
It's removed by washing.
"If clothing
11 becomes soaked, launder before wearing
12
again."
I think we put that on then.
13 Q. 14 A .
In the 1950's? I think so.
15
Q.
All right.
Whenever the exact date is, was
16 that also language that you approved -
17 A . Yes .
18 Q.
-- to be added to the label?
19
A.
Yes.
I wrote it.
20 Q. Would you turn next to Exhibit 21 and 2 1 identify that for us, please.
22 A . That's the same type of label that Monsanto
23 put on Inerteen PPO, which was made for
24
General Electric -- or Westinghouse.
It was
2 5 a trademark compound of Western Electric -
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1
2 Q.
3 A. 4 5 Q.
6
7
8 A.
9
10 Q.
11
12
13 14 A. 15 16 17 18 19
20
21
22
23 24 25
Westinghouse Electric.
All right.
Now -
It also had -- it also has an environmental
statement on this.
All right.
Can you give us the approximate
date that that environmental warning label
language was added?
'69, '70, something around that.
Probably '70.
All right.
Was there someone in addition to
yourself who was involved in the evaluation
of the appropriate precautionary language
with respect to the environmental label?
Yes.
William Papageorge, who was appointed
as the environmental point man, I guess -- I
don't know the exact term -- for
environmental products of the organic
division.
I don't know the -- whether that
was called Monsanto Chemical Company at that
time, a subsidiary of Monsanto Company, I
don't know.
Or a division of Monsanto
Company.
But anyway, he was the guy.
Papageorge was also involved.
All the
medical department, especially Wheeler, had a
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1
lot of input in it.
And I knew this was
2 going on the label, and I approved it from
3 the medical department view.
4 Q. So the -
5 A. The medical department point of view.
6 Q. The addition of the environmental warning
7 label, was that a -
8 A. Yes.
9 Q.
10
-- was that -- deciding that language, was that a joint responsibility?
11 A.
I guess it was.
12
Q.
Now, let's back up to Exhibit 20.
That's a
13 label that deals specifically with
14
Transformer Pyranol.
At the time that that
15 particular warning language was being used,
16 which you've identified as approximately
17 sometime in the 1950's, was the same language
18 also used on Inerteen?
19 A. Yes.
20 Q. Now, Pyranol was the product that was blended
2 1 for whom?
22 A. General Electric.
23
Q.
All right.
And did it contain PCBs?
24 A. Yes .
25 Q.
And Inerteen was manufactured for whom?
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1 A. Westinghouse Electric.
2 Q. And did it contain PCBs?
3 A. Yes .
4
Q.
All right.
Was the same warning language
5 used during this period of time also on drums
6 of Aroclor?
7 A. Was the same what?
8 Q. This precautionary language here --
9
A.
Oh, yes.
The precautionary language was.
10
Q.
All right.
And that was -- Aroclor was whose
11 trade name for PCBs products?
12 A. Monsanto.
13 Q. All right.
14
MR. FEATHERSTONE:
Scott, why don't
15 you take a break here for a second.
16
MR. BAUER:
All right.
17
THE VIDEOGRAPHER:
We're going off
18 the record at six minutes after 12:00
19 o'clock.
20
2 1 (A recess was taken.)
22
23
THE VIDEOGRAPHER:
It's eight
24
minutes after 12:00 o'clock.
We're back on
25 the record.
Martin & Associates (409) 762-2222
WATER PCB-SD0000030338
12 9
(By Mr. Bauer)
Dr. Kelly, did you, as
2 Monsanto's medical director, also approve
3 precautionary language that was put into
4 product bulletins?
5 A. Yes .
Q.6 Would you identify Exhibit 22, please.
7 A.
It's a bulletin of the Monsanto Chemical
8 Company entitled, "The Proper Handling of
9 Aroclors and Their Mixtures in the Electrical
10 Industry."
Q.11
Chapter 9 -- excuse me.
Chapter 12, which is
12 on Pages 98 to 100, is entitled, "Dermatology
13
and Toxicology."
Did the medical department
14 approve the language of that particular
15 chapter of this bulletin?
16 A . Up to what page?
17 Q. 98 .
18 A . Yes, we approved it.
Q-19 Who was responsible -- this -- the document
20 that you call -- you say was entitled,
2 1 "Proper Handling of Aroclors and Their
22 Mixtures in the Electrical Industry," has the
23 name P. G. Benignus on it.
24 A . That's right.
Q.25 Who is that?
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1 A. He is a retired Monsanto employee who was
2 involved in the electrical use of PCBs for a
3
number of years until his retirement.
I
4 think he started in that field in the Forties
5
or Fifties.
I don't know what he was -- he
6 retired after I did.
7 Q. You're saying he's retired now?
8 A. Yes.
9 Q. All right.
10 A. Retired after I did.
11 Q. And was he involved in marketing of PCB
12 products ?
13 A.
I guess it was marketing, whether it was
14 development and marketing or marketing
15
alone.
I think it was both, though.
16 Q. Which department -- well, strike that.
17
Let me ask this:
Was the medical
18 department or Mr. Benignus' department
19 actually responsible for sending this out to
20 people, the document that we've marked
2 1 Exhibit 22?
22 A. Well, certainly the medical department was
23 not .
24
Q.
Okay.
Would you turn next to what's been
25 marked Exhibit 23?
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13 1
1 A.
Yes.
2 Q. Can you identify that for us, please?
3 A. This is a Monsanto bulletin in which -- the
4 inspection and maintenance guide of Monsanto,
5 askarel, a-s-k-a-r-e-1.
6 Q. And here's yet another name -
7 A. Yeah.
8 Q.
-- that we haven't used today?
9 A.
10 11 12
That's a generic name for a relatively noninflammable compound dielectric for electrical use in capacitors and trans formers.
13 Q.
Okay.
Was askarel a generic name that
14 sometimes people used for fluids that
15 contained PCBs?
16 A. Yes.
17 Q. There is a discussion of handling directions
18 on the bottom of Page 4 and the top of
19
Page 5.
Would you review that language,
20 please?
2 1 A.
Yes.
22 Q. Did the medical department approve that
23 language for this bulletin?
24 A.
Yes, we did.
25 Q.
Was this also a bulletin that was
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1 disseminated by some department of Monsanto,
2 sent out to customers or whoever by some
3 department other than the medical department?
4 A. That's correct.
5 Q.
Is this -- you talked earlier about
6 development bulletins and product bulletins.
7 Where does this bulletin fall in in that --
8 those descriptions?
9 A.
10 11 12
Well, this -- this even later, it says
development is trying to offer it for sale to
people.
The sales bulletin is just what the
name implies, where we're trying to get the
13
people to use it.
And this after they use
14 it, we tell them how to use it as far as the
15 maintenance of the -- of the apparatus is
16 concerned.
17 Q.
All right.
18 A.
Where it talks about leaks and cleanup spills
19 and stuff like that.
20 Q. All right.
2 1 A. That is what happens down the road when
22 you're using the product.
23
Q.
All right.
Now, you testified earlier that
24 the medical department also was involved in
25 direct communications with customers about
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1
Monsanto products.
Was that true of PCBs?
2 A.
Yes.
Now, remember, when you say "direct
3
communi" -- if they called us or wrote us.
I
4
didn't write out de novo to a customer.
They
5
had to write in or call in.
Anyplace in the
6 company, if they asked about safety or safe
7 handling information or toxicity, that phone
8 call or letter was referred to the central
9
medical department.
It was answered by
10 somebody in the medical department.
11 Q. Were you one of the people that answered some 12 of those inquiries?
13 A .
Oh, yes.
For a long time I was the only one;
14 but then after we got a couple more doctors
15 and industrial hygienists, they did some of
16 the answering.
17 Q. Did -- do you recall whether some of the
18 correspondence that you personally were
19 involved in dealt with chlorinated diphenyl
20 or PCBs?
21 A.
Yes .
22 Q. 23
Would you turn to Exhibit 24, please, and identify that for us?
24 A .
Yes.
This is a letter from me -- from me
25 to -- signed by me to J. C. Sullivan of the
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1 2 3 4 5 6 7 Q. 8 9 10 11 A . 12 Q. 13 14 15 A . 16 17 18 19 20 21 22 Q 23 24 25
Linck, L-i-n-c-k, Company, March the 8th,
1961.
But it seems it's an answer to an
inquiry or a request from one of our
salespeople, Howard Bergen, who received a
request for oral toxicity information on
Aroclor products.
All right.
Is this exhibit. Exhibit 24, the
file copy of a letter that you, in fact,
signed and sent out on or about March 8th of
196 1?
Yes, it is .
Is this letter a typical example of a
response that you would write to an inquiry
about chlorinated diphenyl specifically?
Yes.
I answered his question.
I mean, he
asked just for the oral toxicity of it; and I
gave him the oral toxicity and told him how
to avoid exposure to the product.
If
somebody had asked specifically about, "How
should I use this?" it might have been a
different type of letter.
All right.
Is there anything in this letter.
Exhibit 24, that you sent to Mr. Sullivan of
the Linck Company that you somehow or for
some reason would not want to share with
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1 other Monsanto customers?
2 A . No .
3 Q. You tell Mr. Sullivan that the maximum
4 allowable concentration set by the American
5 Counsel of Governmental Industrial Hygienists
6 was 1 milligram per cubic meter for
7 Aroclor 1242 and point five milligrams per
8 cubic meter for Aroclor 1254.
9 A. That's correct.
10 Q.
Is that your recollection of the differences
11 in what was the recommended safe level for
12 those two products at the time?
13
A.
Yes.
That was what the Government Industrial
14
Hygiene Conference set.
They said according
15 to them, they think Aroclor 1254 is more
16
toxic than Aroclor 1242.
So they picked
17 point five and wanted one or the other.
18 That's not really a very high concentration
19 if you look over the list of things that they
20 have and that they set for various industrial
2 1 products.
22 Q. All right.
23 A.
It falls into a mild to moderate industrial
24 toxic product.
25 Q. Was there a specific maximum allowable
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1 concentration for Aroclor 1260?
2 A . No .
3 Q. Do you recall what you told people about
4 exposure to inhalation vapors from that
5 Aroclor product?
6 A.
I would say I would -- I probably told them
7 that -- in fact, I know I told them, "We
8 haven't run it on 1260; but if you run it on
9 1250, use the same level as 1254, you'll be
10
home free.
You won't get any problem.
It
11 will be harder to get point five milligrams
12 of 1260 because of the vapor pressure is a
13
lot less.
You've got to heat it up a lot
14 higher."
15 Q. What does it mean, that "the vapor pressure
16 is a lot less"?
17 A.
If the vapor pressure is a lot less, you
18
don't get anything in the air.
It takes a
19 larger amount of heat to disperse the vapors
20 from the liquid material.
2 1 Q. Was Aroclor 1260 also a chlorinated diphenyl
22 product that was used in transformer fluids
23 and capacitor fluids?
24 A.
I don't know about capacitors, but they -- it
25 was used in transformers.
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
137
You state in this letter, as of March 8 of
1969:
"I do not have chronic oral toxicity
information on these products."
Why was it that you didn't have
chronic oral toxicity on those products at
that time?
Because the material was not supposed to be a
additive -- food additive or either an actual
or inadvertent food additive.
We didn't know
that it was eventually going to get into the
food of the United States at that -- in
1961.
So there was -- in an industrial
chemical you really do not run chronic oral
toxicity because you don't expect somebody to
be taking a couple teaspoonsful of this every
day .
What was the practice in the chemical
industry in the United States about getting
oral chronic toxicity information on
industrial chemicals that were not intended
for being used in food residues, becoming a
food residue because it was used in food
crops or the like?
Well, the current thinking was, you do enough
to find out the acute hazard if a man spills
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
Q. A. Q. A. Q. A.
Q. A. Q.
it on himself or inhales too much of it.
You
try to get some idea of the target organ.
Of
course, we had that from the Drinker work.
We had -- he did chronic work back in 1938,
which is still valid in 1961.
But as far as
running long-term testing, nobody did it.
Industrial chemicals were not expected to be
used in food for chronic testing -- for
chronic oral testing.
Chronic and -- chronic testing of ingestion
or - -
Yes.
-- or eating it?
That's right.
All right.
Would you turn next, please, to
Exhibit No. 25 and identify that for us.
That's a letter to a Mr. Speicher of
industrial hygiene of the Westinghouse
Electric Corporation by Mr. Wheeler, who was
the assistant director of the medical
department at that time.
Do you recognize Mr. Wheeler's signature,
"Elmer" -
Yes .
-- on the second page?
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1 A. Yes .
2 Q. What was the practice in the medical
3 department in 1956 about distribution of
4 correspondence such as Exhibit 25?
5 A. We had a practice; and we put a stamp on it,
6 on the carbon, and then on the file copy.
7 And the person who wrote the letter would
8 check off whether the toxicologist would get
9 it, whether I would get it, whether the
10 assistant medical director would get it.
11 So we were pretty cognizant of what
12 was going on in other people's
13
correspondence.
And if they sent out
14 material on safe handling, concerning safe
15 handling data or toxicological effects, I
16 would always see that.
17
Q.
All right.
And did you and Mr. Wheeler have
18 conversations over the years about the type
19 of information that should go into
20 correspondence that he wrote to customers?
21
A.
Oh, yes.
We got on the same wavelength after
22 not too long a period.
23
Q.
All right.
Now, Mr. Speicher at Westinghouse
24 was someone that you knew from the industrial
25 hygiene department there?
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1 A.
I didn't know him.
Wheeler knew him.
2
Q.
All right.
And what did -
3 A.
I knew where he was.
I mean, I knew of him.
4 I knew he had been in some state place, I
5
thought, some state organization.
But he was
6 a friend of Wheeler's, and Wheeler saw him at
7 all their meetings.
8
Q.
All right.
Did Mr. Wheeler talk with you
9 about anyone else in the Westinghouse
10 industrial hygiene department with whom he
11 dealt?
12 A. There's a man -- I get a little confused on
13
the name.
I thought it was Brandt,
14 B-r-a-n-d-t, or Barnes or something like
15
that.
That was -- he was a Ph.D., and I
16 believe he may have been -- I don't know what
17 his type relationship was as far as Speicher
18
was concerned.
But I think he was the head
19 of the organization, of the industrial
20
hygiene group.
They had a fair size group at
2 1 Westinghouse.
22
Q.
All right.
While we're on the topic of
2 3 Westinghouse's organization, did Westinghouse
24 also have a medical department?
25 A.
Yes, they had one.
I was never at Pittsburg,
Martin & Associates (409) 762-2222
WATER PCB-SD0000030350
14 1
1
but I knew their medical director.
He was a
2
pioneer in industrial medicine.
His name was
3 T. Lyle, L-y-l-e, Hazlett, H-a-z-1-e-t-t.
4 When I came into the industrial -- in the
5 occupational medical field, he was already in
6
there.
He had been in there for quite some
7 time, and he was a well-known fellow.
8
Q.
All right.
Was it a common practice of
9 medical departments at companies such as
10 General Electric and Westinghouse in the
11 Thirties, Forties, and Fifties to keep
12 current with the scientific literature about
13 substances that they used?
14 A.
I can't talk about GE or Westinghouse.
It
15
certainly was me.
And certainly from -- by
16 talking with Hazlett and Vosburgh and other
17 people of the other companies, they knew it.
18 I think it was common practice, yes; but I
19 can't be sure.
20
Q.
All right.
Did you have an understanding
2 1 from talking to Dr. Vosburgh of GE and
22 Dr. Hazlett of Westinghouse about whether
23 they were reading the literature about PCBs?
24 A. They knew probably more about it than I did.
25 Q. Let's go back, then, to Exhibit 25, the
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1 letter in 1956 from Mr. Wheeler to
2
Mr. Speicher.
It says that he include -
3
he's enclosing -- I'm sorry.
That's not what
4 he says.
5 He says he's sending under separate
6 cover two detailed reports published by
7 personnel at the Kettering Laboratories
8 entitled, "The Toxicity of the Vapors of
9
Aroclors 1242 and 1254."
Are those the two
10 exhibits that we looked at earlier today -
11 A. Yes.
12 Q. -- and marked?
13
A.
Treon's work.
Yes.
14 Q. Exhibits 12 and Exhibit 13?
15 A. That's correct.
16 Q. Would you turn next to what's been marked as
17 Exhibit 26?
18 A. Yes.
19 Q.
Can you identify that for us, please?
20 A. That's another letter to Dr. Speicher by -
21
Mr. Speicher by Wheeler.
He wanted more
22
information.
So he gave him a three-page
23
letter this time.
And it was a little more
24
exhaustive.
I don't know why -- why
25
Mr. Speicher was asking him again.
Maybe he
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1 2 3 Q. 4 5 6 A. 7 Q. 8 9 A. 10 Q. 11 12 13 14 15 16 A . 17 Q . 18 A . 19 Q. 20 21 22 23 A 24 25
lost the first letter or something.
I don't
know.
But anyway -
Is Exhibit 26 the unsigned file copy of a
letter that was sent out to Mr. Speicher in
1959?
Yes.
Exhibit 26, yes.
Yes.
The top of Page 2, Mr. Wheeler
states --
Yes .
-- "...sufficient exposure, whether by
inhalation of vapors or skin contact, can
result in chloracne which I think we must
assume could be an indication of more serious
systemic injury if the exposure was allowed
to continued."
That's correct.
Was that your view in 1959, as well?
Yes .
Was that information that -- was that
information that was shared only with
Westinghouse?
I mean, was there any reason
why Mr. Wheeler was -
No.
I think that was the general impression
of everybody in the field.
They thought that
chloracne was the sort of hallmark of
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
excessive PCB -- chlorinated PCB exposure.
And they thought that this was a systemic
reaction on the skin rather than a local
reaction, as a sunburn or an irritation from
paint remover.
So that we thought if you got
the systemic reaction on the fat cells of the
skin, you could very well get problems
elsewhere in the body.
And that's why we
were concerned if chloracne occurred.
Q. And was that information that Monsanto shared
with any health professional that asked
questions about the toxic properties of
chlorinated diphenyl?
A.
Oh, yes.
That was -- other people who were
working in the same field had written about
itortalkedaboutit.
Q.
All right.
Now, Exhibit 25, which we talked
about just a minute ago, is a letter that's
about Aroclors?
A. Right. Q. Again, is that Monsanto's trade name for
chlorinated diphenyl or PCB products?
A. Yes, it is .
Q. Now, Exhibit 26 is a reference to
Aroclor 1242 and a combination known as
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1 Inerteen PPO.
2 A. Yes .
3 Q.
Is this letter also about PCB products?
4
A.
Yes, it is.
Mixed with trichlorobenzene.
5
Q.
Right.
Would you identify Exhibit 27,
6 please?
7
A.
Yes.
This is a letter signed by me to a
8 Mr. Crow, someplace in Alaska, the U.S. Naval
9 Station in Kodiak, Alaska, who must have
10 written a letter to Monsanto and eventually
11 got to the medical department to ask for
12 information concerning fire resistant
13 transformer fluids which of the generic name
14 askarel.
15
Q.
All right.
Now, this letter is about
16 askarel.
17 A.
Right.
18 Q.
Is that -- is that also a name for fluids
19 that contain PCBs?
20
A.
Yes.
But all askarels are not PCB
2 1 containers.
22
Q.
All right.
In the terms of ones that the --
23 the askarels that Monsanto manufactured --
24 A. -- were all PCBs.
25
Q.
All right.
Is Exhibit 27 the file copy of a
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1 letter that you, in fact, signed and sent out
2 to Mr. Crow responding to his inquiries about
3 the toxic properties and safe handling of
4 askarel?
5 A. Yes, it is.
6 Q. Did you tell Mr. Crow anything in this letter
7 that you were hiding from other companies
8 that were using PCB electrical equipment?
9
A.
No.
Of course not.
10 Q.
Is this, again, a letter that was typical of
11 the letters that you wrote to people who
12 asked you questions about the toxic
13 properties of chlorinated diphenyl, also
14 known as PCBs?
15
A.
Yes.
Correct.
16
Q.
There are two enclosures to Exhibit 27.
The
17 first is entitled -- the bottom of the second
18
page says, "Enclosure:
Ask" --
"Enclosure:
19
Askarel booklet."
Is that the booklet that
20 we talked about earlier that's marked
2 1 Exhibit 23?
22 A.
I think so.
I'm not sure, but I don't know
23
if there's another askarel bulletin.
But to
24 the best of my recollection, that's the one
25 we would have sent because that's the only
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1 one I remember Monsanto had with the term
2 "askarel" on it.
3 Q. The other enclosure is entitled, "Hygienic
4 Guide 'Chlorodiphenyls.'"
5 A. Uh-huh.
6 Q. Can you tell us what that is?
7 A. This is a -- it was a series of guides put
8 out by the Industrial Hygiene Association.
9 At that particular time they were sort of
10 associated with the Industrial Medical
11
Association, and it was put out.
But mainly
12 it was put out by the industrial hygiene
13
group.
It discusses the standards, the toxic
14 properties, the industrial hygiene practices,
15 and the medical information as far as
16 treatment is concerned.
17 Q. You're looking now at Exhibit 28; is that
18 correct?
19 A. That's correct.
20
Q.
All right.
Is that the hygienic series guide
2 1 from 1965 entitled, "Chlorodiphenyls"?
22 A.
"Chlorodiphenyls," right.
23 Q. Well, is that the enclosure that you
24 referenced in Exhibit 27?
25 A.
Yes.
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1 Q. The last page of Exhibit 28 identifies the
2 hygienic guides committee of the American
3
Industrial Hygiene Association.
Is that the
4 committee that you were talking about in your
5 answer a minute ago?
6
A.
Yes.
But -- and I see in here they're mostly
7
industrial hygienists.
The ones I
8 recommend -- I mean, the ones I remember --
9
Sutton was a physician.
He was with Eastman
10
Kodak.
But Elkins was an industrial
11 hygienist for Massachusetts, I believe, or
12
Connecticut.
Halley, H-a -- Halley was --
13 H-a-l-l-e-y, was the industrial hygienist for
14
the State of West Virginia.
I don't know the
15 other people.
16
Q.
All right.
The footnote on the first page of
17
Exhibit 28 states:
"The Committee wishes to
18 acknowledge the preparation of the medical
19 information section of this Guide by the
20 Industrial Hygiene and Clinical Toxicology
2 1 Committee of I.M.A., and to acknowledge also
22 the assistance of Elmer P. Wheeler and Jack
23 T. Garrett in the writing of this guide."
24 First, what was the "IMA"?
25 A.
Industrial Medical Association.
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1 Q. And Mr. Wheeler is the same Mr. Wheeler that
2 you earlier identified as being an industrial
3 hygienist who worked for you?
4
A.
Right.
Correct.
5 Q. And who is Mr. Garrett?
6 A. He was also an industrial hygienist, a second
7
industrial hygienist.
And he reported to
8
Mr. Wheeler.
Mr. Wheeler had more
9
functions.
He was administrator in charge of
10 our toxicological section and our industrial
11 hygiene section, although he was an
12 industrial hygienist by training.
13 Q.
Did the medical department of Monsanto have a
14 set of reprints of this hygienic series -
15 hygienic guide series on chlorodiphenyls --
16 A. Oh, yeah.
17 Q.
-- which has been marked as Exhibit 28, that
18 were available to distribution and response
19 to inquiries from customers?
20 A.
We had it not only on chlorodiphenyls, but on
2 1 every product we made that they had a
22
hygienic guide series on.
We sent it out to
23 anybody who asked for it.
24 Q. Were --
25 A. And some that didn't ask.
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1 Q.
Did the medical department also keep a set of
2 reprints of Dr. Treon's 1956 article on
3 Aroclor 1242 and Aroclor 1254 that were
4 disseminated to people who made an inquiry?
5 A.
Yes.
We didn't send that out as much as we
6 did this one .
7
Q.
All right.
To whom did you send out the
8 hygienic guide series?
9 A. To whom?
10 Q. Yes .
11 A. Anybody that would write in inquiring about
12 the safe handling of the material or the
13 toxicity information or any medical problems
14 that might be associated with excessive or
15 undue exposure.
16 Q. And to whom would you send a reprint of the
17 Treon articles?
18 A.
Anybody who was interested in the same thing
19 but it was a physician or a toxicologist or
20 an industrial hygienist.
2 1 Q. Would you identify Exhibit 29, please?
22
A.
Yes.
This is a memorandum of mine on the
23 toxicity and safe handling of askarel, dated
24 March the 4th, 1971.
25 Q.
Is that your signature on Exhibit 29?
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1 A.
Yes, it is .
2 Q. And what was the purpose of this page?
3 A. I think this was probably written to be a
4 suitable packet of information that people
5 would write about, asking the problems that
6 maybe occurred in accidental ingestion or a
7 skin absorption -- acute skin absorption,
8 like a spill on it, as well as safe handling
9
data.
It sort of was a -- just a handy guide
10 for anybody who was on the work floor that -
11 or in charge of the use of askarel.
12 Q. The date of this document is March 4 of
13
1971.
Was the focus of this exhibit.
14 Exhibit 29, worker safety concerns; or was it
15 also intended to cover environmental
16 precautions ?
.17
A.
No.
It was just safety concerns.
This
18 was - -
19 Q. For workers?
20
A.
For workers.
This was written because we had
2 1 talked -- we had bulletins talking about
22 Aroclors all the time but people might -- I
2 3 don't know how they got -- I do not know how
24 customers of Monsanto knew that Monsanto was
25
using the generic term of "askarel."
I don't
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1 2 3 4 5 6
7 Q.
8 9 10 A . 11
12 Q-
13 14 15 A .
16 Q.
17 18 19 20 21 22 23 24 25
know that.
I don't remember that.
But
that -- obviously they would be -- write and must have written in enough times saying.
"We're using askarel produced by Monsanto
What do you know about it?
What can you tell
us about it?"
And you prepared this sheet so you could use
it as a common response to many such
inquiries ?
That's correct.
I don't know how many -- I
don't know how much we used i t.
All right.
But in response to inquiries
specifically about askarel. this sheet was
available to send out?
That's correct.
All right.
MR. BAUER:
Let's take another
short break.
THE VIDEOGRAPHER:
We're going off
the record.
It's 38 minutes after 12:00
o'clock.
(A recess was taken.)
THE VIDEOGRAPHER:
It's 51 minutes
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1 2 3 Q. 4 5 6 7 8 9 A. 10 Q. 11 12 A . 13 Q. 14 A . 15 16 Q. 17 18 19 A , 20 21 Q 22 23 A 24 25
after 12:00 o'clock.
We're back on the
record.
(By Mr. Bauer)
Dr. Kelly, I'd like to turn
now to the topic of PCBs in the environment.
Did there come a time when Monsanto
heard reports that PCBs were being found in
wildlife samples from different parts of the
environment?
Yes . When did Monsanto first learn of such
reports ?
It was either in late '66 or '67.
Where did the first reports come from?
From Sweden.
In Europe.
I think it was
Sweden.
Do you recall the name or -- the name or
names of any of the researchers who were
involved in that first work?
Dr. Widmark, W-i-d-m-a-r-k, and Jensen,
J-e-n-s-e-n.
Did you personally hear about those reports
sometime at the end of 1966 or early in 1967?
Well, yes.
I heard about it from people -
it was third-hand.
They had read it, and
people in our European office heard about
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Q. A.
Q. A.
it.
We don't subscribe to the Swedish
newspapers in the United States.
So we had
an office in Brussels and an office in
London; and they also manufactured PCB, along
with several other European manufacturers.
We were relatively small amount of -- small
percentage of the total tonnage over there.
So, yes, we heard about it; and I heard about
it from them.
What did you do after first hearing these
reports about Dr. Jensen and Dr. Widmark's
work?
Said, "We ought to find out more about
this."
Sent it to our analytical people, to
our management people, to our merchandising
people.
All right.
Would you look at Exhibit 30,
please, and tell me what that is.
Yes.
This is a letter from Dr. Wood, who is
a research man in our Brussels office.
He's
English.
And he enclosed a copy of Soren
Jensen's paper.
And I must have written to
him on the 10th of February of that year,
asking -- or a telephone conversation the day
before he dictated this letter, saying, "What
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do you know about" -- I must have said, "What
do you know about it?
Send me anything you
know so I can get the information out to
people here . "
Is this a letter written by David Wood to
you ?
Yes .
And did you receive a copy of this in early
1967?
Yes .
Is Dr. Jensen's typed manuscript paper
attached?
Yes , it is.
What did you do with Exhibit 30, with
Dr. Jensen's paper in Exhibit 30, when you
received it in early 1967?
Well, I photostated it and sent it to the
people in our management group in -- who were
the product managers for PCB.
I sent it to
our analytical people.
And I guess those are
the ones I sent it to.
I said, "What are we
going to do about this?"
Who do you -- well, strike that.
Do you recall the names of some of
the analytical people who were involved in
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1 Monsanto's research department at that time?
2 A.
Dr. Robert Keller, K-e-l-l-e-r, and a Scott
3 Tucker, a Dr. Scott Tucker.
4 Q. Was it clear at the outset that the Swedish
5 scientist -- the Swedish scientists'
6 identification of these substances as PCBs
7 was correct?
8
A.
No, it was not.
I'm not an analytical
9 chemist; but the analytical chemists that I
10 talked to and the research people, both in
11 the United States and England, said, "We're
12 not sure this is" -- that this is the right
13 designation for this peak in their
14 chromatograph.
15 Q.
Were you told that by any of the analytical
16 people at Monsanto?
17 A.
Yes .
18 Q.
Did Monsanto confirm at some point in time
19 that these substances that were being found
20 in the environment, the peaks on the
2 1 chromatograms that you talked about, that
22 they were PCBs?
23 A.
Yes.
There was a gradual awareness that they
24
were -- they really were PCBs.
But still
25 there was still some scepticism among some of
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1 the people at Monsanto as late as 1970 that
2 we're really talking about PCBs because
3
Jensen first was looking for DDT.
And
4 according to my information, DDT and PCBs are
5 pretty close on a gas chromatography or --
6
Q.
All right.
You mentioned gas chromatogram
7
now and gas chromatography.
And knowing that
8 you're not an analytical chemist, would you
9 generally describe what your understanding is
10 of what's involved there?
11 A.
Yes.
It's a pretty involved apparatus that
12 is supposed to pick up small amounts, parts
13 per million, of substances and a bunch of
14 interfering -- a bunch of other material.
15
There were also some additions to it.
Some
16
people used electron capture in it.
Some
17 people used a mass spectroscope in addition
18
to this gas chromatograph.
It was a pretty
19 involved, sophisticated analytical tool.
20 Q.
Okay.
And --
2 1 A. I can't know any more about it than that.
22
Q.
Sure.
Well, you mentioned peaks, similarity
23 between peaks of DDT and PCB, in one of your
24
answers.
What did you mean by "peaks"?
25 A. Well, a peak in a chromatograph is almost the
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2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
Q.
A. Q. A. Q. A.
Q.
same as the balance analytical scale.
You
run this thing through this -- you run the
sample through this apparatus, and you get
readings of -- the needle jumps up and down .
in some different places.
And you got a peak
here and a certain wavelength, and you know
that's DDT.
You got another peak here, you
don't know what that is.
And sometimes
they're so close that it's awful hard to
identify individual compounds.
So is the chromat -- the peaks in the
chromatogram that you were talking about
actually a drawing of -
Well, peaks --
-- peaks and valleys -
Yes.
-- in a chart?
Yes.
I apologize for my lack of knowledge
about analytical chemistry.
There's no need for you to apologize.
Dr. Ke1ly.
Would you generally describe -- you
mentioned after you got Dr. Jensen's paper
that one of the things you did personally was
give it to the analytical people.
Would you
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generally describe the response within
Monsanto to the detection of PCBs in the
environment in the late 1960's?
Well, we don't know if it's there or not
because there were spots.
Let's be sure this
man knows what he's talking about.
So what did that mean the initial response
was ?
What did the what?
What was the initial response, then?
It was sort of, "Maybe it's true, maybe it
isn't true."
But there was a very healthy
amount of scepticism -- among not only
Monsanto people, but an awful lot of other
people outside of Monsanto -- that what
Jensen and Widmark were identifying was
really honest to goodness PCBs.
Did Monsanto undertake any analytical work to
try to verify whether he was correct or not?
Well, we did by the means we had at our
disposal; but we did not have the
sophisticated instruments we had -- he had.
So we ordered some.
But this you don't go
down to Radio Shack and order one of these
things off the shelf, you know.
So it took
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1 quite some time before we got one.
2
Q.
Do you recall -- was that a GCMS?
Is that
3 what they called that?
4 A.
I think so.
5 Q. Do you recall how soon after -- how soon
6 after 1967 Monsanto ordered a GCMS?
7 A. No, I don't.
8
Q.
Okay.
Was that -
9 A. Pretty short time. 10 Q. Was that the research department that did
11 that?
12
A.
Yes.
It wasn't the medical department.
13 Q.
So that would have been Dr. Keller and -
14 A. Keller.
15 Q.
-- and Scott Tucker?
16 A.
Right.
17
Q.
All right.
And do you know the approximate
18 date when Monsanto actually received a GCMS?
19 A. No, I do not.
.
20
Q.
All right.
At some point in time, did
2 1 Monsanto also initiate degradation studies?
22 A. Yes .
23 Q. What's a "degradation study"?
24 A.
A "degradation study" is a -- consists of a
25 series of experiments to see whether a
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1 compound can be broken down by bacterial
2 action, sunlight, other chemicals that the
3 compound you're concerned about is in close
4 proximity to.
5 Q. Do you recall where and within what
6 department of Monsanto that work was being
7 done?
8 A.
It was done in the research department.
I
9 don't know whether it was central research or
10 the research department or agricultural
11 chemicals division or the organic division,
12
the one that made PCBs.
I don't know to this
13 day.
14
Q.
All right.
Do you know approximately when
15 Monsanto started degradation studies on PCB
16 products ?
17 A.
I think sometime in '68, I believe.
18 Q.
Did Monsanto consider doing additional
19 toxicological studies in the end of the
20 1960's as a result of the information learned
2 1 about PCBs being in the environment?
22 A.
Yes, it did.
23 Q. Do you recall when that started, the
24 discussions about additional toxicological
25 testing?
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1 A. Well, it's -- I would say that started as
2 soon as -- whenever they found out that the
3 material was ending up in birds and in fish.
4
And we thought we better find out.
Somebody
5 may be eating the fish and eating the birds.
6 So we started that, I guess -- we certainly
7 started discussing it in 1977 or so.
8
Q.
I'm sorry.
Did you -
9
A.
'66, '67.
Sixty -- yeah.
'67.
10
Q.
All right.
Would you turn to Exhibit 31,
11
please.
And Exhibit 31 is a September 11,
12 1968, memo from Elmer Wheeler to Dr. W. R.
13
Richard with several carbon copies.
And
14 attached to that is a letter dated
15 September 9, 1968, to Mr. Wheeler from
16
Industrial Bio-Test.
And that attachment has
17 its own attachments.
18 First of all, were you one of the
19 people that received a carbon copy of
20 Mr. Wheeler's September 11 memorandum?
2 1 A.
Yes.
22 Q. The attachments to Mr. Wheeler's letter
23 include documents entitled, "Proposed
24 Protocols for Aroclor Toxicity Studies"; is
25 that correct?
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Right.
Did you receive and review those proposed
protocols in the fall of 1968?
Yes, I did.
Was Industrial Bio-Test eventually selected
to do additional toxicological testing on a
long-term chronic feeding basis with respect
to PCBs ?
Yes.
It was not only at that, there was
quite an array of testing they carried out.
Yes, they were.
What do you recall about the scope of the
testing program that was actually undertaken?
It was pretty extensive, in fact.
We went
down with Dr. Joe Calandra, who was the head
of Bio-Test, to the food and drug
department.
At that time, obviously, they
were interested, too, because they seemed to
have evidence that the material may be
getting into the food chain and they didn't
know anything about the toxicity -- the
chronic toxicity of it.
And I said, "Well, here's what
we're going to do.
We're all set to go.
This is what we're going to do.
What do you
' .
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1 think of it?"
2 And whether they have anything
3 addition -- additional to add, I don't know.
4 But they certainly approved the final
5
protocol.
They didn't have to; but I mean,
6 they -- they said, "This is" -- "yeah, this
7 is it."
8
Q.
Okay.
Was this in 1968 that you had these
9 discussions with the FDA?
10 A. Yes.
11 Q. And with whom at the FDA did you have such
12 discussions?
13
A.
Fitsu, Arnold Leiman, Herb Blumenthal.
These
14
are all Ph.D.s.
Leiman was head of the
15 toxicological section of the -- of the FDA.
16 Blumenthal was head of the biochemistry
17 section, and Fitsu was the associate director
18 of the toxicological program.
19 Q. Were you personally involved in face-to-face
20 meetings with those officials about the scope
2 1 of the toxicological program that Monsanto
22 was proposing?
23 A.
Yes.
I was there, just like here.
24
Q.
Okay.
And --
25 A.
They were at the table, I was at the table.
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11 Q.
12 13 14 15 16 17 A . 18 19 Q. 20 21 22
23 24 25 A
All right.
And do you recall whether anyone
from Industrial Bio-Test was there?
Calandra was there.
I don't know if anyone
else -- I don't recall anyone else there; but
I remember Joe was, Joe Calandra.
Did you provide the protocols to the FDA for
their review?
Yes .
Did you invite their comments?
Yes .
Did the FDA, anyone from the FDA -
Mr. Leiman or Fitsu or Blumenthal -
criticize the selection of Industrial
Bio-Test as the outside contract lab retained
to do this -- the work that was being
discussed?
Not then or not at any other time that I knew
of .
Did anyone from the FDA suggest an
alternative to Industrial Bio-Test -- suggest
an alternative to Industrial Bio-Test as the
outside contract lab to perform the
toxicological testing being discussed with
the FDA?
No, sir, they did not.
No one did.
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1 Q. How many different PCB products were tested
2 by Industrial Bio-Test?
3 A. Three.
4
Q.
All right.
And the first attachment to
5 Exhibit 31, the letter from Dr. Calandra,
6 talks about a number of different types of
7
tests to be performed.
It's the September 9
8 letter.
9 A.
It wasn't from Calandra.
It was from
10 Dr. Fancher.
11 Q.
I'm sorry.
Dr. Fancher?
12 A.
Right.
13 Q.
He worked for Joe Calandra?
14
A.
Yes.
He was No. 2 or 3 person.
15 Q. All right.
16
A.
Yes.
He said we got three different Aroclors
17
plus a control plus two levels.
We were
18 going to do chicken toxicity, reproduction,
19 and meat and egg residue study, mallard
20 ducks, three-generation reproduction study in
2 1 rats, two-year chronic toxicity testing in
22 rats and dogs, fish studies.
23 Q. Do you recall whether Monsanto, in fact,
24 initiated through Industrial Bio-Test in the
25 late 1960's two-year oral chronic testing of
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1 PCBs in rats?
2 A. Yes, they did.
3 Q . Also in dogs?
4 A. Yes.
5 Q. What about a three-generation reproduction
6 study in rats?
7 A. Yes.
8 Q. What about a mutagenicity study in rats?
9 A. Yes.
10 Q. And were there also chicken toxicity and
11 reproduction studies?
12
A.
Yes.
The only one I'm a little confused
13
about is the mallard ducks.
We were -- we
14 had been working with the fish and wildlife
15 people, but wild ducks -- and I guess a
16 mallard is a wild duck -- have a peculiar
17 habit -- not peculiar, but a habit of laying
18
eggs only twice a year.
So if you miss one
19 chance of the eggs, you can't do anything.
20
So that sort of fell through.
The wild ones
21
fell through.
I don't know if he did the
22
domestic mallards or not.
I don't know.
23 Q.
Okay.
So although there's a proposed
24 protocol in here for duck studies, your
25 recollection, for the reason you stated, the
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duck study was never initiated?
I'm not sure.
I know the wild one was given
up.
That was the one we were -- it was -
the fish and wildlife people were supposed to
trap wild mallards and test them.
But that
didn't work out.
Whether Joe did mallards or
not, I don't know.
I know he did the
chickens, but I'm not -- I don't recall
having seen the mallard duck study.
All right.
Do you recall an effort to do
range finding before the long-term, two-year
study started?
Oh, sure.
That's the usual situation.
If
you start a two-year study, before you start
it, there's about a -- six months that you
have to -- first you got to get the animals.
You got to put them in a quarantine.
When we
started, we told Joe -- I told Joe, "Start
getting these animals.
This is going to go
through.
We're going to okay it.
Start
getting the rats and dogs and quarantine them
and be sure that they aren't going to break
down with worms or white diarrhea or God
knows what laboratory animals get."
Then you run a range finding test
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because you want to find out that you aren't -- if you're going to run this for two
years, you don't want to kill the animals by
giving them too much so they die in 6 months,
12 months.
You've got to try to analyze
under a 30-day -- a 90-day test what level
the animal can take.
In a two-year testing,
you want a level that won't harm them.
You
want to get a safe level.
You want to get a
level that you know they can live for two
years and will harm them, and then you want
to see what pathology will occur and what the
target organ is.
Then you want to get a
level in between so that you get a safe
level.
You know you got a safe level.
You
hope this middle one will be safe, too; but
you don't want to give them a middle level
that's going to kill all the animals and
screw up the results.
Q.
All right.
So were each of the -- the three
Aroclors that you talked about before, the
three PCB products, were they each given these various tests at three dose levels?
A. Yes .
Q.
All right.
Do you recall when the range
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1 finding studies that you described earlier
2 commenced ?
3
A.
As soon as we approved the protocol.
They
4 got the dogs -- they got the dogs, and they
5
wanted to hurry it up.
I mean, they wanted
6
to get started.
So they got the rats and
7
dogs and isolated them earlier.
But I
8 don't -- I'll have to find out when they
9 actually started it.
10 Q. Well, why don't you identify Exhibit 32 for
11 us .
12 A. We authorized it in '68, and I think they
13 started it almost immediately afterwards.
14 Q. What is Exhibit -- Exhibit 32?
15 A.
Exhibit 32 is an authorization for two of the
16
Aroclor studies.
He had two batches of
17
Aroclor studies.
He had four of them there
18
at first.
The fourth -- the fourth was --
19 Q. The first being?
20 A. The first one was of fowl, the gross
21
toxicity.
And then the other one was a rat
22
tissue study.
And when he started the
23 two-year feeding --
24 Q. Well, let's back up to Exhibit 32.
25 A. Yeah.
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Is that a letter that Mr. Wheeler sent to Dr. Calandra in 1968 authorizing the
initiation of some of these studies?
That's correct.
All right.
Now, you said there was -- there
was a fourth there, fourth Aroclor.
There's -- the first three Aroclors
referenced are Aroclor 1242, 1254, and 1260.
Right.
Were all three of those PCB products?
Yes . And the fourth one you mentioned is
Aroclor 5460?
That's chlorinated diphenyl benzene.
All right.
After the tests were initiated,
did you continue to have contacts with the
FDA?
Oh, yes.
We had written contacts, and we
kept in touch personally.
I sent them -
every time I got a quarterly report, I sent
it up to Leiman.
And I would see Leiman at
least -- or Fitsu -- once a year, maybe once
every eight months, every time I was in
Washington.
I saw them at least between once
a year and twice a year in those years of '69
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and '70.
How often did you get summary reports on the
various studies being conducted by Industrial
Bio-Test that you sent out to the FDA?
We got a bundle.
Would you look at Exhibit 33, please, and
identify that for us.
Yes.
This is a letter from me to
Blumenthal.
And I told him what we were
doing, and I sent him copies of the status
report for the chronic testing at Industrial
Bio-Test.
And what's the date of Exhibit 33?
April 8th, 1970.
And that was the end of six
months' administration under rats.
So that
meant we really -- six months -- we
started -- must have started about nine
months before April the 8th, 1970, because as
I said, it takes that long to get the thing
rolling.
When you sent status report -- well, strike
that.
Let me back up.
Is Exhibit 33 the file copy of a
letter that you sent to Mr. Blumenthal, or
Dr. Blumenthal, in April of 1970?
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1
A.
Right.
Yes.
2 Q. And when you sent it to Dr. Blumenthal, there
3 were -- were there a series of status reports
4 attached ?
5 A. Yes.
6 Q. Were there status reports attached with this
7 letter and other similar letters with respect
8 to each of the studies and each of the
9 species ?
10
A.
Yes.
We sent them everything we got from
11
Bio-Test.
We sent food and drug everything
12 we got.
13 Q. Would you turn next to Exhibit 34, please,
14 which is a document entitled,
15 "Three-Generation Reproduction Study in
16 Albino Rats with Aroclor 1242, Aroclor 1254,
17 Aroclor 1260, Results of the First
18 Generation," September 4, 1970, submitted by
19
R. Emmet Kelly, M.D.
And that's on Monsanto
20
letterhead.
Attached is a document bearing
2 1 the same title, dated September 4, 1970, with
22 the Industrial Bio-Test letterhead.
23 A.
Right.
24 Q.
Is this one of the summary reports that you
25 submitted to the FDA?
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1 A. Yes, it is.
2 Q. This is a summary report specifically with
3 one study, the three-generation reproduction
4 study, for all three Aroclors?
5
A.
Well, it's 1242, 1254, and 1260.
Yes, all
6 three.
7 Q. The fourth page of Exhibit 34 has an outline
8 of the study which includes the starting
9
date.
Do you see that there?
10 A. Yes.
11 Q. And what does it say the starting date was
12 for the three-generation?
13 A.
May the 8th, 1969.
14
Q.
All right.
Does that comport with your
15 recollection as to when these long-term
16 feeding studies were actually on feeding, if
17 you will?
18 A.
Well, these aren't the long-term.
This is
19
three-generation rats.
That's a different
20 experiment.
2 1 Q. Different than the two-year -
22
A.
Yes.
The two-year --
,
23 Q. -- lifetime studies?
24 A.
-- you take a batch of animals; and once you
25 get a dose that you're sure that the rats
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10
11
12
13 14 15 16 17 18 19
20
21
22
23 24 25
could take over a period of two years, you
start them on it.
A three -- and you keep it
going for two years.
This, you get the --
reproduction study, you get male and female
rats.
You feed them, mate them, then check
the pups, mate and feed those and mate them.
That's the first generation.
Go to the
second generation, you get another series of
pups.
Then you go on and check the -- feed
the third generation.
So it's a different
story.
It takes pretty long.
I don't know
what the gestation period of rats are.
It's
not too -- it doesn't take long.
But by the
time you get all this business taken care of,
it takes quite a while because --
Q. So is what you're saying that May of 1969 was
the starting date for the three-generation
reproduction study?
A. That's correct.
Q. And do you recall approximately when the
other two -- the two-year feeding studies '
were in relation to that?
A.
I think they were started before that.
I'm
sure they were.
Q. Do you know -- well, strike that.
Martin & Associates ( 409 ) 762-2222
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Compare the scope of this
toxicological program with the kinds of
toxicologic work that Monsanto was doing in
the late 1960's with pesticides that would
leave residues on food.
This was certainly as involved, as extensive
as anything used either on a direct food
additive or an inadvertent food additive.
It
was probably more so because I don't think
they were having three-generation studies in
those days on food additives.
So this was as
wide a test as the Government could figure
out and as well as our toxicological
consultant could figure out.
They're in
essence given a blank check, and they run
everything.
MR. BAUER:
This is a convenient
breaking time if we can pick up with the rest
of it tomorrow.
MR. KIM:
Certainly.
THE VIDEOGRAPHER:
We're going off
the record.
It's 19 minutes after 1:00
o'clock.
This is the end of Tape No. 2.
Martin & Associates (409) 762-2222
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(Whereupon the deposition of Robert Emmet Kelly, M.D., was recessed at 1:19 p.m. and is to be continued 9:00 a.m. on February 16 , 1994 . )
(f
THE STATE OF /ft t 5 S o U /&. C COUNTY OF ST. (--OQ/:
:
I, ROBERT EMMET KELLY, M.D., hereby
certify that I have read the foregoing
transcript of my testimony given in the
foregoing numbered and styled case and that
same is true and correct to the best of my
knowledge and belief.
I further certify that any and all
corrections have been made on a separate page
and initialed by me.
This the -3o
'"TV! CLT C
________________, 1994.
day of
ROBERT EMMET KELLY, M . / .
this the
SUBSCRIBED AND SWORN TO BEFORE ME,
day of _JSXL^jULL/
1994.
Notary Public in and for
the State of Jr) / 'ssou /U
My Commission Expires Job No. 94-511
------------------
fWARy PUBLfC STATE OF MISSOURI ST. LGUI3 COUNTY
MY COMMISSION EXP. JAN. )S.t93
Martin & Associates (409) 762-2222
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THE STATE OF TEXAS :
I, Irma L. Reyes, Certified Shorthand Reporter in and for the State of Texas, hereby certify that this deposition transcript is a true record of the testimony given by the witness named herein, after said witness was duly sworn or affirmed by me.
I further certify that I am neither
attorney nor counsel for, related to, nor
employed by any of the parties to the action
in which this testimony was taken.
Further,
I am not a relative or employee of any
attorney of record in this cause, nor do I
have a financial interest in the action.
Further certification requirements, if any, pursuant to the Rules will be certified to in the Supplemental Certificate after they have occurred.
the
-- a Subscribed and sworn to on this,
day of March, 19 9 4.
Irma L. Reyes, CSR Certificate No. 4071 Expires December 31,
1994
My Notary Commission expires September 21, 1996
Martin & Associates ( 409 ) 762-2222
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LIST OF CHANGES OR CORRECTIONS
To the Deposition of
If there are any .changes or corrections, please list them below giving the page number, line number, and reason for the change.
The reasons for making changes are:
(1) (2) (3)
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clarify conform correct
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