Document oDgX74yXMa9gbdZNgyyGwLXyR
i
i Superior Court of the State of California For the County of Los Angeles
i TRANSWESTERN PIPELINE )
COMPANY,
)
Plaintiff,
)
)
)
vs. ) Case No. BC 026959
)
MONSANTO COMPANY and )
DOES 1 through 200, inclusive, )
Defendant
)
)
November 2,1992
Deposition of GEORGE J. LEVINSKAS, taken on behalf
of Plaintiff.
GORE REPORTING COMPANY
Boatmen's Tower, Suite 1175 - 100 North Broadway St Louis, Missouri 63102 (314) 241-6750
STLCOPCB4029241
1 Superior Court of the State of California 2 For the County of Los Angeles
3
4
TRANSWESTERN PIPELINE
)
5 COMPANY,
)
6
Plaintiff ,
)
7)
8 v.
) No. BC 026959
9)
10
MONSANTO COMPANY and
)
11
DOES 1 through 200,
)
1 2 inclusive ,
)
13
Defendants .
)
14
15
16
17
1 8 Deposition of GEORGE J. LEVINSKAS,
1 9 taken on behalf of Plaintiff, at the offices 2 0 of Bryan Cave, One Metropoli t-a n Square 500
2 1 North Broadway in the City of St. Louis, 2 2 State of Missouri, on the 2nd day of
2 3 November, 1992, before J. Bryan Jordan,
2 4 certified shorthand reporter and notary
2 5 public .
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1 APPEARANCES: 2 3 FOR THE PLAINTIFF: 4 Ms. Dana K. Welch 5 Shearman & Sterling 6 21st Floor 7 725 South Figueroa Street 8 Los Angeles, California 90017 9 (213) 239-0300 10 1 1 FOR THE DEFENDANTS: 1 2 Mr. Charles F. Preuss 1 3 Bronson, Bronson & McKinnon 1 4 505 Montgomery Street } t: San Francisco, California 94111-2514 1 6 (415) 986-4200 17 18 19 20 21 22 23 24 25
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1 INDEX
2 PAGE
3 EXAMINATION BY MS. WELCH:
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4
5
6 EXHIBITS
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8
Plaintiff'1 s Exhibit 1 0 7 3 ................... ...................
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Plaintiff 11 s Exhibit 1 0 7 4 ................... ...................
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Plaintiff 1 s Exhibit 1 0 7 5 ................... ...................
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Plaintiff 1 s Exhibit 1 0 7 6 ................... ...................
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Plaintiff 1 s Exhibit 1 0 7 7 ................... ...................
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Plaintiff 1 s Exhibit 1 0 7 8 ................... ...................
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1 4 Plaintiff'1 s Exhibit 1 0 7 9 ................... ................... 10 0
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1 Whereupon
2 GEORGE J. LEVINSKAS,
3 of sound mind, having been first duly sworn
4 to tell the truth, the whole truth, and
5 nothing but the truth in the case aforesaid,
6 testified upon his oath as follows, to-wit:
7 EXAMINATION
8 QUESTIONS BY MS. WELCH:
9 Q. Good morning, Mr. Levinskas.
1 0 A. Good morning.
11
Q.
My name is Dana Welch.
I
1 2 represent Transwestern Pipeline Company in
1 3 litigation that it has instituted against
14
Monsanto Company.
Could you please state
1 5 your name for the record and spell it?
16
A.
It's George J. Levinskas.
That's
1 7 L-e-v as in Victor, -i-n-s-k-a-s.
1 8 Q Have you ever been deposed, Dr
1 9 Levinskas?
20
A . Yes , I have .
% '
2 1 Q. In how many cases?
2 2 A. Perhaps a dozen or so.
2 3 Q. How many of those cases, if any
2 4 related to polychlorinated biphenyls?
2 5 A. Probably half of them.
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1 Q - Do you recall the names of any of 2 those cases?
3 A . Not particularly.
4 Q When was the last time you were 5 depos ed ?
6 A . Probably about a year, year and
7 half ago.
8 Q Do you r e c all the name o f that
9 case?
1 0 A I t was a n acrylonitril e 1 a w s u i t . 1 1 Q E x c use me? 1 2 A Acry1oni tr i 1e . 1 3 Q S o t h a t ' s not related t o P C B s ? 1 4 A No , I don' t recall the 1 a s t -- n o 1 5 the las t P C B d e p o s i t i on, I really d o n ' t
1 6 recall.
1 7 Q You a r e p r obably famil i a r with 1 8 rules o f d e p o s i t i o n s , but let me r e fresh you
19
r e c o 11 e c t i o n , i f I m a y.
The firs t and mo s t
2 0 i m p o r t a n t rule f o r o u r court repo r t e r , as h e
2 1 will t e 11 you , i s pie ase wait unt i 1 I fin i s h
2 2 a quest ion and I will attempt to d o the s a m e
23
for you for an s w e r s .
That's very i mportant,
2 4 so the court r e p o r t e r can get eve r y t h i n g
2 5 down.
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1 Another rule is that I ' d like t o
2 get your best reco llection and a n s w e r to any
3 q u e s t i on t h a t I p o s e , but i f you don' t
4 u n d e r s t a n d a q u e s t i o n t h a t I pose t please
5
me to r e p h r a s e i t a n d I w ill do s o .
If y
6 answer a q u e s t i o n , I w ill a s s u m e t h a t you
7 understood my question, so anytime you need
8 rephrasing, please ask me to.
9 After the transcript is prepared,
1 0 you'll have a chance to review it and make
1 1 any corrections that you need to make, and --
1 2 off the record.
1 3 (Brief interruption. )
1 4 BY MS. WELCH:
1 5 Q. I should tell you that if you do
1 6 make any corrections, that I or another
1 7 attorney for Transwestern Pipeline Company
1 8 may make comments or may point that out to a
1 9 jury when this case does go to trial.
2 0 You understand today; sir, that
2 1 you are under oath, do you not?
2 2 A . Yes , I d o .
2 3 Q And s o that means that even though
2 4 this is an inf ormal setting in a conference
2 5 room,. that i t i s just as if you are in a
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1 court of law.
2 A That is correc t .
3
Q
All right.
Co u 1 d you please tell
4 me what your educational b a c kground is?
5 A I have a Bache lor 's degree in 6 chemistry and a doctorate i n pharmacology .
7 Q Where did you o b t a in your 8 B a c h e 1 o r ' s degree from?
9 A Wesleyan Unive r s i t y .
1 0 Q In what year? 1 1 A 1 9 4 9. 1 2 Q And from what s c h ool did you 1 3 obtain y o u r P h . D . ?
1 4 A The University o f Rochester.
I 5 Q In what year?
1 6 A 1 9 5 3. 1 7 Q When did you s tar t working at
1 8 M o n s a n t o Company?
1 9 A July 1971.
2 0 Q What was your job position at that
2 1 point?
2 2 A I think the ti tie was Product 2 3 Safety Manager or somethi ng of that sort.
2 4 Q What were your j o b 2 5 responsibilities?
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1 A. I was hired to formalize and
2 consolidate the environmental assessment
3 activities of the company and to centralize
4 them in the Medical Department.
5 Q. What do you mean by environmental,
6 environmental policies of the company?
7 A. I don't -- did I use the word
8 "policy"? The environmental -- what Monsanto
9 decided was that they should formalize the
1 0 environmental review to look at their
1 1 product, s, the kinds of questions that were
1 2 being raised about the products, and to
1 3 recommend actions that could be taken to
1 4 resolve the questi o n s that were being raised
1 5 Q. Do you know how that process was
1 6 conducted before you were hired?
1 7 A. It was done separately byvarious
18
people within the company.
I do not have
1 9 details on it.
2 0 Q. So to the best of -your
2 1 understanding, was it done by the various
2 2 product groups, as opposed to one person
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within the Medical
Department?
2 4 A. That's correct.
25
Q.
So if there werea question
about
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1 a product in, for instance the Functional
2 Fluids Group, there would be a person there
3 who would develop information on that
4 product, to the bes t o f your under standing?
5 A . I would ass ume that the re was a
6 person a nd that he w o u Id interact with others
7 in the c ompany, inc 1 u d ing the Medi cal
8 Departme nt, to deci d e what should be done.
9 Q Was this a new position that was
1 0 created for you?
1 1 A . Yes.
1 2 Q Did you eve r become awa re of why
1 3 Monsanto decided to c r eate this po sition in
1 4 July of 19 7 1? 1 5 A . Not spec i f i c a 1 1 y .
1 6 Q How about g enerally?
1 7 A . I really , I really have n o 1 8 background as to why or what initiated it.
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1 9 Q. Who did you report to?
2 0 A. Mr. Elmer Wheeler was my immediate
2 1 supervisor.
2 2 Q. Did he report to Dr. Kelly?
2 3 A. He reported to Dr. Kelly, in turn,
2 4 yes.
2 5 Q. So you were within the auspices of
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1 the Medical Department?
2 A. Yes.
3 Q. Were you responsible for all
4 products that the company was developing at
5 that point?
6 A. The initial purpose was to look at
7 new products and new uses of existing
8 products .
9 Q. And what, particularly, were you
1 0 supposed to look at in terms of new products
1 1 or new uses of existing products?
1 2 A. The operating units were to inform
1 3 the Medical Department either at an early
1 4 stage that they had a new product or they
1 5 were anticipating a new use of an existing
16
product.
The physician then required a
1 7 review of this, some estimates of the
1 8 potential exposures from the use, review of
1 9 available information, and could include
2 0 recommendations for additional testing.
2 1 Q. Now, are you speaking about
2 2 toxicological testing?
2 3 A. Yes. 2 4 Q. Any other kind of testing? 2 5 A. If deemed necessary, it could be
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1 recommendations for other types of testing
2 Q. Were you to recommend the kinds of
3 testing to any particular product needed?
4 A I ' 11 go b a c k and 1 imit myself to 5 the new pr o d u c t s an d new us e s , and I would be
6 one o f the e 1 e m e n t s m a k i n g r e commendations
7 for sue h t e s t i n g .
8 Q. Are you trained as a toxicologist?
9 A. My first employment was teaching
1 0 toxicology .
1 1 Q. Would youconsider that your area
1 2 of expertise?
1 3 A . Yes.
1 4 Q . In July of 1971, when you came to
i 5 Monsanto, were there any other kinds of
1 6 testings -- testing besides toxicological
1 7 experiments that you were involved in
1 8 recommending?
19
A.
The first
several months was, was
2 0 getting just familiarized with what people
2 1 were doing, familiarity with the kinds of
22
products, and I really can't
get more
23
specific than that.
I don't
recall.
2 4 Q. When, after you came, did you
2 5 become aware of PCBs?
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1 A. Probably within a few months to
2 relatively soon.
3 Q W h a t p e r c e n t a g e o f your time in
4 19 7 1 was spent w o r king o n the Product Group
5 that included P C B s o r - - 1 e t me strike
6 that -- w ere s pent w o r king o n PCB s ?
7 A . I c o u 1 d not m a k e a n estimate, but
8 I w o u Id s ay v e r y 1 i 111 e .
9 Q . How did you bee o m e aware of PCB s ?
1 0 A . Rea d a b out them i n the scientif i c
1 1 liter a t u r e , in the new s p a p e r accounts, and
1 2 since Mon santo was a m a n u f act urer of PCBs,
1 3 d i s c u s s i o ns by p e o pie with i n the company.
1 4 Q Whe n y o u f i r s t bee ame aware of
1 5 P C B s when you came t o the company, did any one
1 6 tell you that M o n s a n t o was engaged in any
1 7 kind of PCB program?
18
MR. PREUSS:
Well, object as
1 9 ambiguous as to what do you mean by "PCB
2 0 program."
G`
2 1 BY MS. WELCH:
2 2 Q. Go ahead and answer if you
2 3 understand .
2 4 A. Well, I would ask the same thing:
2 5 What, what's the program that you are
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1 referring to?
2 Q For instance, did anybody ever 3 tell you that there was a phased withdrawal
4 of P C B p r o d u c t s ? 5 A . No, at that time, I had no 6 knowledge of such.
7 Q - Did anyone ever tell you that
8 there wer e ongoing tests concerning the 9 effects o f P C B s ? 1 0 A. The effects in what systems? 1 1 Q.. Any systems. 1 2 A. I don't recall specifically, I 1 3 don't recall anybody specifically telling me 1 4 that there were tests going on with PCBs, in 1 5 the sense that someone came up and said, 1 6 "Hey, here's something you should know about. 1 7 And as I said, gradual discussions, and so 1 8 forth, the information started coming out 1 9 that there were PCBs, and Monsanto was a 2 0 maker and Monsanto had an interest in those 2 1 products. 2 2 Q Did you become aware in those 2 3 first few months that PCBs were being found 2 4 to be p e r s i s t e n t in the environment? 2 5 A . Yes, that would have been
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1 generally reported, and I probably knew that
2 before I came to Monsanto, but that was being
3 reported generally in the literature.
4 Q. Did anyone at Monsanto bring this
5 to your attention?
6 A. I cannot recall.
7 Q. When you say that i t was generally
8 being reported in the litera t u r e , what
9 literature are you referring to ?
1 0 A. Various scientific journals,
1 1 technical journals .
12
Q. Do you recall any of those right
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1 3 now?
1 4 A. No, not specifically.
1 5 Q. Do you recall at the time that you
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read these what journals you were subscribing
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1 7 to that would have reported persistence of
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1 8 PCBs in the environment?
1 9 A. I know the journals I was
2 0 subscribing to, but I also had Access to
2 1 library resources where there were additional
2 2 journals , and it would b e d i f f i cult t o
2 3 pinpoint a journal or a n a r t i c 1 e at t h i
2 4 time.
2 5 Q. At,the time, were you reading a
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1 scientific journal by the name of "Nature"?
2 A. Not very often, no.
3 Q. Do you read "Scientific American"
4 or did you at the time?
5 A. Not very often.
6
Q.Was there
any reason beforeyou
7 came to Monsanto that you had a particular
8 interest in PCBs?
9 A. I do not think I indicated a
10
specific interest in PCBs.
I meant to convey
1 1 that in my general reading of scientific
1 2 literature, I became aware of PCBs, as I did
1 3 become aware of many other chemicals.
1 4 Q. When you came to Monsanto in July
15
1971, say, untilthe end
of the year, did
1 6 anyone ever tell you that h i gher-ch1orinated
1 7 biphenyls tended to persist as opposed to the
1 8 lower chlorinated biphenyls?
1 9 A. Again, I would have to say that
2 0 somewhere along the line, I b*e came aware of
2 1 that, but I cannot specifically pinpoint when
2 2 or how.
2 3 Q. When you came to Monsanto, did you
2 4 do any reading to familiarize yourself with
2 5 issues of toxicity with respect to PCBs?
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1 A . Not specifically. 2 Q. Did you do so with respect to 3 other chemicals that were being produced by 4 Monsanto? 5 A. My general recollection would be 6 that I was reading up or trying to find out 7 more information on the new products and the 8 new uses of products as they were brought to 9 my attention. 1 0 Q. Were there any new uses of PCBs 1 1 that were being considered at the time? 1 2 A. I cannot recall that there were. 1 3 Q. What products do you recall that 1 4 you were involved with at that point? 1 5 A. Predominantly, it would have been 1 6 agricultural products which Monsanto was 1 7 trying to bring to market. 1 8 Q. Were these chlorinated 1 9 hydrocarbons? 2 0 A . No 2 1 Q. How long did you hold the position 2 2 of Product Safety Manager? 2 3 A. About a year or two 2 4 Q. What was your next position? 2 5 It was Manager of Environmental
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1 Assessment and Toxicology.
2 Q Did your job responsibilities 3 change?
4 A. They had enlarged at that point,
5 and I had assumed responsibility for
6 toxicology .
7 Q Who had responsibility for
8 toxicology pri or to that time?
9 A . 11 was Dr. William Hunt.
1 0 Q Did Monsanto, up to this point
1 1 when you a s s u m ed your new position, have 1 2 in-house c a p a b ility for toxicology tests?
1 3 A . Not that I know of.
1 4 Q Was there an outside laboratory
i 5 that was p r i m a rily contracted with for
1 6 toxicology tes ts by Monsanto?
1 7 A . All the testing was done at
1 8 several o u t s i d e laboratories.
1 9 0 Can you tell me the names of those 2 0 laboratories ?
2 1 A . The predominant one was Industrial
22
Bio-Test.
The re were --
2 3 Q Go ahead .
2 4 A . She lanski Laboratories.
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2 5 Q . C o u Id you please spell that?
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1 A . S-h-e-l-a-n-s-k-i. There were
2 contacts, work being done at several
3 universities, and there was a small
4 laboratory here in St. Louis, Younger
5 Laboratories.
6 Q. Where were the PCB toxicological
7 tests conducted, to your knowledge, up to
8 1972?
9 A. Industrial Bio-Test.
1 0 Q. When you say you assumed the
1 1 responsibility for toxicology, what did that
1 2 entail?
1 3 A. Along with the environmental
1 4 assessment which was being centralized in the
1 5 Medical Department, we were beginning to
1 6 centralize toxicity testing within the
1 7 Medical Department, so as we were making the
1 8 recommendations for possible testing, we
1 9 would then give them responsibility seeing
2 0 that that testing was carried^out.
2 1 Q. I want to go back to what you mean
2 2 by environmental assessment with your first
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job.
Could you give me a description of what
2 4 environmental assessment meant in July 1971?
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MR. PREUSS:
I'm going to object
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t o mischaracterizing his testimony.
I think
2 h e said that environment al assessment was
3 par t of his second job.
4 BY MS. WELCH:
5 Q. Was it also part of your first job
6 in 1971?
7 A. Can wego back to an earlier
8
question?
I think I, I think I indicated
9 that it was to try to anticipate the kinds of
1 0 questions that might be arising, and that we
1 1 would recommend testing to see if we could
1 2 answer those questions.
1 3 Q. In terms of the impact of a
1 4 particular product on the environment?
1 5 A. It was not specifically
1 6 environment; it was to look at, if a product
1 7 was to be marketed, what kinds of questions
1 8 might logically or reasonably be raised by
19
people who would
buy/use the product, and to
2 0 attempt to anticipate the kin4 s > o f questions
21
that would arise,
assess those questions and
2 2 see if they needed some sort of testing to
2 3 provide information from which those
24
questions could be answered.
So it would
2 5 include toxicity questions and it would,
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1 could include some environmental aspects.
2 Q. Do you know how long Dr. William
3 Hunt had worked at Monsanto until 1972?
4 A. It was ten or twelve years,
5 something on that order.
6 Q And was he responsible for 7 overseeing all t o x i c o logy?
8 A . H e was the only toxicologist; I
9 would assume he was.
1 0 Q. Was he also responsible for
1 1 environmental assessment before you assumed
1 2 that position?
1 3 A. I can only indicate that my, my
1 4 position was intended to focus and centralize
15
these in the Medical Department.
I'm not
1 6 aware of who or to what extent others
1 7 participated prior to that.
1 8 Q. Going back to the first job, did
1 9 you have contact with individuals within the
2 0 various product groups, as well -as people in
2 1 the Medical Department?
2 2 A . Yes.
2 3 Q. So did you do some amount of
2 4 interfacing between the product groups and
2 5 the Medical Department?
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1 A . Yes.
2 Q. Did you, in 1971, have contact
3 with the Functional Fluids Group?
4 A . Yes.
5 Q. Who in the Functional Fluids Group
6 did you have contact with at that point?
7 A. It would be difficult to recall
8 all the names because the Functional Fluids
9 Group was a large group with a variety of
10
products.
John Herber was one, Bill Richard
1 1 was another; I don't know that 0. P. Tanner
12
was in there or not.
Ralph Munch.
There may
1 3 be others, but I can't recall.
1 4 Q. How long did you stay in your
1 5 position as Manager of Environmental
1 6 Assessment and Toxicology?
1 7 A. In about '80 or '81.
1 8 Q. And what happened then?
1 9 A. I was named Director of
2 0 Environmental Assessment and /Toxicology.
2 1 Q. How long did you remain in that
2 2 position?
2 3 A. Till about 1986.
2 4 Q. What happened then?
2 5 A. I was named SeniorToxicology
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1 Consultant
2 Q. How long did you remain in that
3 position?
4 A. September 1991.
5 Q. And what happened then?
6 A. I retired.
7
Q.
Congratulations.
Have you
8 consulted for Monsanto since that time?
9 A. This is my first contact with,
1 0 official contact with Monsanto since I
1 1 retired.
1 2 Q. Have there been any unofficial
1 3 contacts?
1 4 A . I go back t o visit with my old
1 5 crew for 1 u n c h and t h a t sort of thing, but
1 6 those were informal.
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MS . WELCH:
All right, I'd like
1 8 introduce and have mar k e d this exhibit as
1 9 Exhibit 1073.
2 0 (Plain tiff ' s B,e position
2 1 Exhibit 1073 marked for
2 2 identification. )
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MS. WELCH:
Exhibit 1073 is a
2 4 four-page document that bears the identifying
25
stamp of TRAN
013693 to TRAN 013696.
It is
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1 entitled "A Listing of Toxicity and Related 2 Studies of Polychlorinated Biphenyls," and 3 I'd like to have you take a few minutes and 4 go over this document, if you could. 5 (Witness peruses said 6 document.) 7 A. Okay. 8 BY MS . WELCH :
9 Q H a v e you e v e r seen t h i s document
1 0 before r Mr . Levi n s k a s ?
1 1 A.. I d o not re call s e e i n g this
1 2 d o c u m e n t b e f ore.
1 3 Q I ' d 1 ike to go t h r o u g h the
1 4 1 i s t i n g s o f the report s and s t u d i e s , and the 1 5 q u e s t i o n I h a v e to you with r e s p e c t to e a c h 1 6 one t h a t i s date d p r i o r to or up through the 1 7 end of 19 7 1 i s , to the best o f your 1 8 recoil e c t i o n , w h ether you r e c all examini n g 1 9 that r e p o r t some time i n 19 7 1 when you, a f t e r
2 0 you arrived at M o n s a n t o . `f^ 2 1 F i r s t , the listing for the Ha r v a r
2 2 School of Public Health report, do you recall 2 3 having examined that report? 2 4 MR. PREUSS: Is this at any time 2 5 after he joined Monsanto up through December
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J1. 31, 1971?
2
MS. WELCH:
That's correct,
3 through -- July 1st, 1971, through December
4 31st, 1971.
5 A. I do not recall looking at those
6 reports during that time.
7 BY MS. WELCH:
8 Q. You mean the first report?
9 A. Right.
1 0 Q. Have you ever looked at that
1 1 report subsequent to December 31st, 1971?
1 2 A. I think those reports are, the
13
results of thosereports
are published in
1 4 some of the literature, and I can recall
15
reading about them at some later date.
I do
1 6 not recall having looked at the specific
1 7 original report.
1 8 Q. Do you recall having read about
1 9 them prior to December 31st, 1971?
2 0 A. No, I do not thinks I - read them
2 1 before December 1971.
2 2 Q. Allright, the second one is the
23
Bernard Free Skin and Cancer Hospital.
The
2 4 same question with respect to July 1st, 1971
2 5 through December 31st, 1971.
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1 A . No . 2 Q Have you ever read the report 3 subsequent to Decemb er 31st, 1971? 4 A . Yes. 5 Q Do you re call approximately when 6 you read the report? 7 A . I would s ay probably in the latter 8 Seventies . 9 Q. Was there some kind of medical 1 0 library or any other kind of library that 1 1 contained reports of the various -- of 1 2 testing on various chemicals that Monsanto 1 3 produced? 1 4 A . Yes, there was a m e d i c a 1 1 i b r ary. 1 5 Q And that was in 19 7 1 7 1 6 A . Yes. 1 7 Q Do y ou know whe t h e r that 1 i b r ary 1 8 divide d i n t o sections on p r o d u c t s p 1 9 A . T h e r e was a , a trend , I d o n ' t know 2 0 that it was always followed, /but there was a 2 1 trend to keep information either by products 2 2 or by laboratory. 2 3 Q. So if you wanted to go to the 2 4 library and read up on the reports to date on 2 5 PCBs, would those be easily accessible to
GORE REPORTING COMPANY - ST. LOUIS, MISSOURI 26
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1 you?
2 A . Well, at that time, I would have
3 had to ask somebody how to find my way in and
4
around the library.
I would not have direct
5
access to the inform ation.
I me an, I
6 couldn't find my way around in the library to
7
access the information.
I would have had to
8 ask someone for assistance.
9 Q . Why was that?
1 0 A. I wasn't familiar with how the
1 1 library was set up or organized.
1 2 Q. Do you know if these first-year
1 3 reports that we've looked at were in the
1 4 library in 1971?
1 5 A. Idonotknowthat.
]
1 6 Q. Who maintained the library in
1 7 19 7 1?
18
A.
I, I do not specifically know.
I
1 9 did not make that inquiry.
2 0 Q. If you were to wa rut to go into the
2 1 library and find a particular product group
2 2 or laboratory, who would you ask?
23
MR . PREUS S:
In 1971?
24
MS. WELCH:
Yes.
2 5 A. I would have asked one of the
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1 coworkers. Bill Hunt or Mr. Wheeler, what
2 they knew and where could I find out more
3 about it.
4 BY MS. WELCH:
5 Q. Number 3 is t h e Kettering
6 L a b o r a tory report s , da ted 1953 and 1955.
7 With r espect to J u 1 y 1 s t , 1971, to Dec ember
8 3 1st, 1971, do yo u r e c all having read this 9 report ?
1 0 A. No, I do no t .
1 1 Q. Do you r e c a 11 having read
1 2 s u m m a r ies of this repo r t in any other
1 3 a r t i c 1 es with res p e c t t o 19 7 1?
1 4 A . The s e cond one , yes, becaus e --
15
the f i r s t one, I do no t r ecall.
I don ' t
1 6 recall if I ever read i t .
1 7 Q . The s e cond one or the first one?
1 8 A. I don' t r e c all if I ever re ad the
19
first one.
The s e c o n d o n e I did read.
2 0 Q . Do you r e c a 1 1 -- ajjd - was th at in
2 1 19 7 1?
2 2 A. No, that would have been much
2 3 later.
2 4 Q. Approximately when do you think
2 5 you read that report?
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X1 A. Mid to latter Seventies.
2 Q. Was there some reason that you
3 turned to this report and the other report
4 that you recalled seeing later in the mid to
5 late Seventies?
6 A. I can't recall a specific reason
7 for it.
8 Q. Did you develop some kind of
9 interest in, in looking at PCBs from a
1 0 professional standpoint at that point?
1 1 A.. They were of increasing interest
1 2 and I, part of my keeping up-to-date, I did
1 3 more reading on them.
1 4 Q And this was mid to late 1 9 7 0 ' s ?
1 5 A . Probably t h a t time.
1 6 Q Is there any particular incident 1 7 or series of inciden t s that sparked your
1 8 interests at that point?
1 9 A. I cannot recall.
2 0 Q. With respect to the next.
2 1 S c i e n tific Associates, there are two reports
22
that are listed there.
Do you r e c a 1 1 having
2 3 read those reports in 19 7 1?
2 4 A. I don't recall ever reading those 2 5 reports .
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1
Q-
All right.
The next lists a
2 report by Industrial Bio-Test Laboratories,
3 and you testified tha t Industrial Bio-Test
4 Laboratories was the outside lab that
5
conducted PCB tests f or Monsanto.
Were you
6 aware of th is fact in 19 7 1?
7 A . I was awar e that studies were
8 underway or being fin ished up, yes.
9 Q - At Industr ial Bio-Test?
1 0 A . At Industr ial Bio-Test,
1 1 g The first report is subacute 1 2 dermal toxi city of Ar oclor 1221, March 28th,
13
1963.
Duri ng 1971, d id you everexamine that
1 4 report?
1 5 A . I do not r ecall doing so.
1 6 Q - Did you ev er look at that report
1 7 subsequent to 1971?
1 8 A . Yes, I b e1 ieve I did.
1 9 Q Do you rec all approximately when? 2 0 A . Again, thi s would baye been the
2 1 late, latte r part of, mid to latter
2 2 Seventies .
23
Q
Number 2 i
"Acute Toxicity
24
Studies with Aroclor.
It says 122.
That
2 5 might be 1221,, might be a misprint, "Aroclor
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1 5442 and MCS 1016," dated March 25th, 1971.
2 Did you review that report in1971?
3 A. I do not recall that I did so.
4 Q. Do you recall having reviewed it
5 subsequently?
6 A. I really do not recall having
7 looked at that report.
8 Q. Number 3 is, "Toxicity, Mutagenic
9 Teratogenic" -- I'm probably mispronouncing
1 0 that -- "Reproduction and Residue Studies as
1 1 to Various Aroclors in Rats, Chickens, Mice
12
and Dogs," dated November 17th, 1971.
Do you
1 3 recall having reviewed that report in 1971?
1 4 A. No, I do not.
1 5 Q. Is that the report that -- or the
1 6 studies that you testified were underway or
17
that you knew were underwaywhen
you arrived
1 8 at Monsanto?
1 9 A. They could be; I do not know.
2 0 Q. Do you recall ever-', having reviewed
2 1 that report later?
2 2 A. I do not recall having reviewed
2 3 that report, but --
2 4 Q. How about number 4, "90 days
2 5 Subacute Oral Toxicity Study with Aroclor
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1 12 2 1 i n Beagle Dogs, 11 dated December 30th,
I
2 19 7 1; do you recall reviewing that report i n
3 19 7 1?
4 A . Not in 1971.
5 Q. Do you recall reviewing it
6 subsequently?
7 A. I may have but I don't recall.
8 Q. Okay, how about 5, 6 and 7? Those
9
are reports that are dated in 1972:
Did you
1 0 review those reports at any time subsequent
1 1 to 1971?
1 2 A. I don't recall reviewing number 5.
1 3 I may have looked at number 6 somewhat later.
1 4 I am not sure about number 7, whether I did 1 5 or not.
1 6 Q. There are three reports that are
1 7 referred to under "Biological consultants."
1 8 One is an interim report for fish residue
1 9 analyses; the next is a report covering the 2 0 December 1 9 7 0, Marc h 19 7 1, Juae -19 7 1 , 2 1 September 19 7 1 , for fish residue data, and
2 2 the other is the fi nal progress report for
23
residue data.
Did you review those at any
2 4 time?
2 5 A. I do not recall looking at any one
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1 of those three reports at any time.
2
Q.
Allright, I'd
like you to take a
3 look at the six reports that are referred to
4 under Younger Laboratories and tell me
5 whether you reviewed any of those reports at
6 any time in 1971.
7
A.
I do not think Ilooked
at any of
8 those in 1971.
9 Q. Did you look at any of them
1 0 subsequent to 1971?
1 1 A. I may have looked at the -- at 4,
12
5 and 6 at some later date.
I, when I say I
1 3 may have looked at reports, if someone had
1 4 told me that the report was there and the
1 5 information, I would not have looked at the
1 6 report, or if someone said they were
17
uncertain, I may have gone back andlooked
at
18
the reports.
That's why I have difficulty
1 9 saying whether I looked at the specific
2 0 reportornot.
`
2 1 g. Could you please explain your
2 2 answer a little bit better?
2 3 A. Well, if I asked someone and said
2 4 "Do we have a specific piece of information"
2 5 or a question, if he answered it, then I
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1
would just leave it at that.
If he said "Oh,
2 I think we have a report in the files," then
3 I would have gone and looked for the report,
4 and so, you know, specific items of
5 information, I can't always be sure just how
6 I got the m, when I got them. or where I got
7 them.
8 Q So if s o m e o n e had said to you.
9 "This i s the sub stance of t h e report,"
1 0 s o m e b o dy on your staff, then you would have
1 1 relied .o n tha t ?
1 2 A . Yes.
1 3 Q. That's what you are saying, as
1 4 opposed to just "The report exists, I don't
1 5 know what the substance is," then you would
1 6 have turned to the report?
1 7 A. That's correct.
1 8 Q. The last three are Monsanto
19
Industrial Chemicals Company's reports.
Do
2 0 you recall having seen the first one in 1971?
2 1 A. No, I did not.
2 2 Q. Was Mr. Mees a colleague of yours?
2 3 A. Bill Mees was in the -- he was an
24
analytical chemist.
I do not know what
2 5 specific unit of Monsanto he was assigned to.
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1 Q. And he was not in the Medical
2 Department?
3 A. He was not in the Medical
4 Department .
5 Q. How about E. S. Tucker?
6 A. Scott Tucker was similar to Bill
7 Mees, a Monsanto employee but not in the
8 Medical Department.
9 Q. And how about W . J. Litschgi?
1 0 A. I do not recall the name Litschgi.
1 1 I don't know if I met him or not.
1 2 Q. With respect to the second report,
i
13
which relates to toxicity, determination of
j
14
polychlorinated biphenyl residues in beagle
|
I]
1 5 dog tissues, dated December 1971, did you
|
1 6 review that at some point in your career?
! j
17
A. I do not recall reviewing that at
i
l
1 8 all.
|
i
19
Q. How about the next one, which
|
ti
2 0 refers to residues in white leghorn chickens? !
2 1 A. Same response; I donot recall
2 2 looking at that report.
j
i I
i
23
Q. At some point in 1971, did you
:
2 4 ever learn that the liver was the target
2 5 organ for PCBs?
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i
1
MR. PREUSS:
Object. Assuming
2 facts not in evidence.
3 EY MS . WELCH :
4 Q. You can answer.
5 A. Like all chlorinatedhydrocarbons,
6
PCBsattack the
liver. When and how I became
7 aware of this, I cannot recall.
8 Q. By"attack the liver," what do you
9 mean?
10
A. Well,they injure
the liver at
1 1 very high doses.
12
Q.In 1971, did
you ever become aware
1 3 that PCBs were an enzyme reducer?
1 4 A. I do not recall when I became
1 5 aware of that.
1 6 Q. Did youever become aware that
1 7 PCBs are an enzyme inducer?
1 8 A. That's a well-accepted scientific
19
fact.
I do not recall when I became aware of
20 it .
-
2 1 Q. Could you explain to me what
2 2 "enzyme inducer" means?
2 3 A. It produces an increase in the
2 4 enzyme activity of, in this case, the liver.
2 5 That's as general a description as I can give
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MISSOURI 36
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1 you.
2 Q. And what effect does that have,
3 other than just the fact of increasing enzyme
4 production?
5 A. I'm not -- I guess I have to ask
6 what -- your definition of "effect," I guess
7
I don't understand.
I need some
8
clarification of the question.
I just don't
9 think I understand the question.
1 0 Q. Well, you said that it produces an
1 1 increase in the enzyme activity of the liver.
1 2 A. That's an observation, yes.
1 3 Q. All right, what effect does that
1 4 have when the enzyme activity of the liver is
1 5 increased? What happens?
1 6 A. The specific enzymes thatthey
1 7 want to look at in the liver tissue have a
1 8 greater activity than they normally do.
1 9 Q. Would you classify that as an
2 0 adverseeffect?
`
2 1 A. I think it can be adverse or
2 2 beneficial .
2 3 Q. With respect to PCBs, it can be
2 4 beneficial?
2 5 A. I don't know which to expect in
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1 the case of PCBs, but the effect could be
2 adverse or beneficial.
3 Q. Could you give me an example of
4 when an increase in enzyme activity of the
5 liver is beneficial?
6 A. The liver, among its many
7 functions, detoxifies chemicals, so if you
8 induce the activity of an enzyme that
9
detoxifies, diminishes thetoxicity of
a
1 0 harmful chemical, that would be abeneficial
1 1 effect.
1 2 Q I s the r e a son that e n z y m e activity 1 3 is i n c r e a s e d i s that t h e r e is a toxic
1 4 chemic a 1 which i s i n t r o d u c e d i n the c a s e of
1 5 PCBs s o the 1 i v e r i s , i n e f f e c t , work i n g
1 6 harder?
17
MR. P REU S S :
Let me just ask for
1 8 clarification. Are yo u saying the only time
1 9 that you get increased liver enzyme is
20
because of a chemical?
Is t h_,,a t , the
2 1 implication of the que s t i o n ?
22
MS . WELCH :
No, I'm talking, I'm
2 3 speaking with respect to PCBs and trying to
2 4 understand the process of why there is 2 5 induction of liver enz ymes when a PCB is
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1 introduced into an animal.
2 A. I think that as I said, a function
3 of the liver is to metabolize or detoxify,
4 attempt to modify foreign chemicals, so many
5 foreign chemicals, including PCBs, when they
6 are introduced into the animal body, the
7
liver responds as it should.
It makes an
8 effort or increases its effort to eliminate
9 or somehow mitigate the effects of that corn
1 0 chemical, and that's, if the liver is doing
1 1 what i t. should be doing in a n e n h a n c e d
1 2 f a s h i o n , I think that's a ben e f i c i a 1 e f f e c t .
1 3 Q By "beneficial e f f ect, " d o you
1 4 mean t h a t it, that the org a n i s m is. is he 1 p e d
1 5 by t h a t effect?
1 6 A . Yes, it detects a foreign c h e m i c a 1
1 7 and i t ' s making an increas e d effort to g e t
1 8 rid o f i t .
1 9 Q In the studies t h a t you a re aw are
2 0 of w i t h PCBs, have you obs e r v d -any n e g a t i v e 2 1 e f f e c t s from enzyme induct ion 7
2 2 A . I don't, I don' t r e c a 1 1 , nor c an I
2 3 d e c i d e how one would know o r how one would
2 4 detect the negative effects from enzyme
2 5 induction in PCB studies.
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1
MS . WELCH:
I'd like to introduce
ii
2 this as Exhibit 1074.
3 (Plaintiff's Deposition
4 Exhibit 1074 marked for
5 identification. )
6
MS. WELCH :
Exhibit 1 0 7 4 is a
7 two-page document that bears a number of
8
identifying marks.
I'll use the one that's
9 on the back page, which is SCM 052788, and
10
it's dated October 13th, 1971.
It appears to
1 1 be a memorandum from Dr. Levinskas to file:
1 2 Subject, Aroclor 1260, and could you please
1 3 take a minute to review this document.
1 4 (Witness peruses said
1 5 document. )
1 6 BY MS . WELCH :
1 7 Q. All right, Dr. Levinskas, are
1 8 these your initials and your handwriting on
1 9 the back page?
2 0 A . Yes.
'
2 1 Q. Is this a document that you
2 2 prepared?
2 3 A . Yes.
2 4 Q. Did you prepare it in the normal
2 5 course of business?
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1 A . Yes.
2 Q. At or around October 13th, 1971?
3 A. Yes.
4 Q. And was it part of your regular
5 duties to prepare a document like this?
6 A. I frequently committed
7 conversations and items to documents such as
8
this.
Whether or not it was considered part
9 of my duties or not, I don't know, but that
1 0 was my practice.
11
Q. Do you recallpreparing
this
1 2 document?
1 3 A . Yes.
1 4 Q Do you recall the conversation 1 5 D r . Kimbrough
1 6 A . Yes, in general .
1 7 Q - So you know who Dr. Kimbrough is? 1 8 A . Yes, I ' d known her for several
1 9 years before I came to Monsanto.
2 0 Q. How did you know her?
2 1 A. I met her supervisor, Dr. Waylon
2 2 Hayes, in 1955, I believe, and then Dr. Hayes
2 3 had an interest in pesticides and when I was
2 4 at Cyanamid, working on pesticides, we
2 5 cemented our relationships; somewhere along
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1 the line, he introduced me to Dr. Kimbrough.
2 Q. Do you regard Dr. Kimbrough as a
3 respected scientist?
4 A. Yes, I think she's very competent,
5 very capable.
6 Q. So you have a recollection of this
7 conversation with her?
8 A. In very general terms, yes.
9 Q. Do you recall anything other than
1 0 what's in this document about the
1 1 conversation with respect to Dr. Kimbrough's
1 2 finding of lesions on rat livers from
1 3 exposure to Aroclor? Or excuse me, it's
14
bladders.
No, liver; strike that.
First,
1 5 liver.
16
MR. PREUSS:
Well, the question
1 7 is, does he recall anything about that
1 8 conversation, other than what's contained in
1 9 here relative to the issue of liver lesions?
20
MS. WELCH:
That's/, correct.
2 1 A. My general recollection is that,
2 2 as I indicated earlier, like all chlorinated
2 3 hydrocarbons -- and there are pesticides,
2 4 many pesticides that are chlorinated
2 5 hydrocarbons -- this produced enlargement of
i
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1 the liver, and she was proposing to present 2 those findings at the spring Society of 3 Toxicology meeting , which would have been in 4 the spring of '72.
5 Q Did she contact you?
6 A . No, I called her.
7 Q Do you recall why you called her?
8 A . Someone had indicated that they 9 thought she had found a bladder tumor, and it 1 0 was to inquire of her as to what information 1 1 she could provide me with respect to the 1 2 bladder tumors, and what I did then was 1 3 summarize the results of that phone 1 4 conversation for the record. 1 5 Q. Did she provide you with any 1 6 information about the bladder tumor? 1 7 A. Just beyond what's indicated in 1 8 the memo, no. 1 9 Q. Do you have any recollection of 2 0 any other discussion about the. findings of 2 1 bladder tumor from exposure to Aroclor 1260? 2 2 A . Not w it h Dr. Kimbrough. 2 3 Q With anyone else? 2 4 A . There was a meeting in the -- 2 5 the end o f '71, at a place called
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1
Quail Roost, as I recall.
I did not attend
2 the meeting, but several Monsanto people and
3 various other people were there, and I was
4 told that they had discussed this bladder
5 tumor and the conclusion, the consensus of
6 people that represented Monsanto, contract
7 lab, government regulatory agencies and
8 others, that the bladder was not related or
9 the bladder tumor was not related to the
1 0 feeding of the animals with the Aroclor.
1 1 Q. Was there -- did Monsanto have any
1 2 d i s p u t e w i t h the f i n d i n g s of Dr K i m b r o ugh
1 3 with r e s p e c t t o li v e r lesions?
1 4 A . I d o not r e call that we, we did or
1 5 said anything about it.
1 6 Q. Were you surprised that she had
1 7 found liver lesions from exposure to Aroclor
18 1260?
1 9 A. No, as I've indicated, this is a
2 0 characteristic of chlorinate dr, hydrocarbons .
2 1 Q. And you knew that at the time?
2 2 A. Yes.
2 3 Q. What is porphyria that's referred
2 4 to in the last paragraph?
2 5 A. It's an excretion of porphyrins in
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1 the urine.
2 Q. And what are porphyrins?
3 A. Porphyrins are rather large
4 structures somewhat related, picture it
5 somewhat like the hemoglobin in blood, and
6 they appear in urine of animals, sometimes
7 spontaneously, sometimes as a result of
8 injury to tissues.
9 Q. And what does their appearance
1 0 indicate to the scientific observer?
1 1 A. Well, it would be, raise a
1 2 question for further -- to try to determine
1 3 where it was coming from, what was causing
14 it .
1 5 Q. In other words, it's not a normal
1 6 occurrence?
1 7 A . It may occu r spontaneously, but
1 8 its incide nee would be low.
1 9 Q . And what co uld cause porphyria?
2 0 A . A variety o f things.. `
I!
I
2 1 Q . Can you giv e me some examples?
2 2 A . I think wha t one will find
2 3 increased urinated por phyrins with lead
2 4 exposure, exposure to lead, for example,
2 5 Q. Was, it a su rprise to you to hear
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1 that rats who had been exposed to Aroclor
2 1260 exhibited porphyria in their urine?
3 A. It did not particularly strike me.
4 I -- she did not give me sufficient details
5
about the degreeof exposure,
the duration of
6 exposure to make a rigorous assessment of
7 what she said.
8 Q. My question to you was, did it
9 surprise you?
1 0 A. I said not particularly.
1 1 Q. All right, on the second page,
1 2 there is a reference or there's a statement
1 3 made, here, "As a final note, Dr. Kimbrough
1 4 expressed concern over whetherPCBs presented
1 5 an additional hazard to the employees who
16
manufacture it.
I told her that because of
1 7 the chloracne and liver hazards, that there
1 8 had been medical supervision of the
19
employees.
However, I would raise this point
2 0 with Dr. Kelly and Johnson f o% their review."
21
How did you become
aware that
2 2 there had been medical supervision of the
2 3 employeesbecause of the chloracne and liver
2 4 hazards?
2 5 A. I do not know that there were
GORE REPORTING COMPANY - ST. LOUIS, MISSOURI 46
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1 specific measures taken on these employees.
2 That was a reference to the fact that we had
3 a Medical Department and physicians in
4 Monsanto's employ whose purpose was to assess
5 the health of employees, and I was intending
6 to convey, there, that all of our employees
7
weresubject to medical
supervision, and
8 therefore, I presumed whatever hazards people
9 might envision were being addressed.
1 0 Q. When did you become aware of the
1 1 effect of chloracne from exposure to PCBs?
1 2 A . I , I c anno t spec i f i c a1 1 y r e c a 1 3 Q But you d i d become aware of i 1 4 some point i n 19 7 1?
1 5 A. I probably was aware of it before
1 6 I came to Monsanto.
1 7 Q. Did you have any discussions with
1 8 anyone at the Medical Department about
1 9 chloracne?
2 0 A . No.
2 1 Q. Did you have any discussions with
2 2 anyone in the Medical Department in 1971
2 3 about liver hazards with respect to PCBs?
2 4 A . No .
2 5 Q. Did you have any discussions with
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1 anyone in the Medical D e partment about 2 particular a 11 e n t i o n b e i ng paid to chloracne 3 and liver h a z a r d s ? 4 A . No .
5 Q Th i s was j u s t based on your
6 general unders t a n d i n g o f how the Medical 7 Department ope rated? 8 A . Yes
9 g Did you r a i s e the point with Dr .
1 0 Kelly and John son for t h eir review? 1 1 A . The i n c 1 u s ion of them on this memo 1 2 was a means of b r i n g i ng it to their 1 3 attention.
1 4 Q D o you r e c all any discussions you
1 5 had with them s u b s e q u e n t to this memo about 1 6 this point ? 1 7 A . I d o not.
1 8 Q Did the Medic al Department,
1 9 including you. have r e g u lar meetings? 2 0 A . We did not h a ve regularly 2 1 scheduled meetings in t h e sense that of a 2 2 fixed agenda or fixed calendar. 2 3 Q. Were there frequent meetings, even 2 4 if there weren't fixed agendas? 2 5 A . Our offices were in close
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1 proximity and much of our discussion came up,
2 as subjects came up, they were discussed
3 without a formal meeting being called or
4 without everybody being included.
5 Q. So in the normal course of events,
6 would you have expected to discuss this
7 Kimbrough discussion with Dr. Kelly?
8 A. No, I would not have expected to.
9 Q. Why is that?
1 0 A. Dr. Kelly was my ultimate boss; I
11
brought-the matter to his attention.
If he
1 2 felt i n c 1 i ned to come d i s c u s s it with
1 3 would list en or discus s it; I would n
1 4 appro a c h h i m .
1 5 Secondly, we respect the
1 6 confidentiality of medical records, and I am
1 7 not a physician and I would not have
1 8 knowledge or access to the medical records,
1 9 nor would I expect, to have knowledge or
2 0 access to the medical records;, '
2 1 Q. Did you bring to Mr. Wheeler's
2 2 attention the Kimbrough discussion, aside
2 3 from this memo?
2 4 A. He was my immediate supervisor, so
2 5 he should be informed as to what I'm doing,
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1 yes.
2 Q. Do you recall any discussions you
3 had with him about this issue?
4 A. Oh, I suspect he came back and
5 asked me questions, but I don't recall
6 specifics .
7 MS. WELCH: I'm introducing
8 Exhibit 1075.
9 (Plaintiff's Deposition
1 0 Exhibit 1075 marked for
1 1 identification. )
1 2 MS. WELCH: Exhibit 1075 is a
1 3 multipage document with various identifying
!i
14
stamps.
I'm going to use SCM 058930 to SCM
!
I
15
058945, and it's entitled "Report Number M.S.
!
i l
1 6 12002," dated October 14th, 1981, by Dr.
!
1 7 Levinskas and it is on Monsanto Technology
I j
1 8 paper, form, and please take a few minutes to
1 9 review this document. 2 0 (Witness peruses said 2 1 document.) 2 2 (Witness peruses said
j
i
j
fI
j i| ;
2 3 document.)
1
24
THE WITNESS:
I think I'm familiar
25
enough with this.
I may want to go back and
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1 look at it again if you ask questions,
2 but -- :
3
MS. WELCH:
Oh, sure.
4 BY MS . WELCH:
5 Q . Dr. Levinskas, is this a report
6 that you authored?
7 A. Yes.
8 Q. And you recall authoring this
9 report?
1 0 A. Yes, I do.
1 1 Q. Did you prepare this report in the
1 2 normal course of business?
1 3 A. Yes.
1 4 Q . And i t was part of your job
1 5 responsibility t o prepare a report such
1 6 this?
1 7 A. I considered it so.
1 8 Q. Did you author it on or about
1 9 October 14th, 1981?
2 0 A. Actually, I did i t,J h s t before
21
that.
That's the date it was issued.
2 2 Q. How long did you work on this
2 3 report for?
2 4 A. It's hard to recall, but I could
2 5 have spent a couple of weeks checking data
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1 and references and putting it together. 2 Q. Now, you are aware that Monsanto 3 stopped producing PCBs in 1977, are you not? 4 A. Yes. 5 Q. Why were you preparing a report 6 some four years after the end of production 7 of PCBs? 8 A. PCBs were being increasingly 9 discussed by the world in general, and I have 1 0 indicated, I think, in the introduction, 1 1 here, that the Monsanto studies, while they 1 2 had been made available to regulatory 1 3 agencies, had -- there was no, really, 1 4 available point at which they could be 1 5 referenced, so I decided it would be useful 1 6 to pull together the information we had so 1 7 that in subsequent discussions, we could have 1 8 a source reference from whatever we knew 1 9 about -- whatever we knew, I say whatever 2 0 Monsanto, data Monsanto had developed with 2 1 respect to the possibility of PCBs in one 2 2 place, so it was pulling together to have a 2 3 reference and it was a tabulation, results of 2 4 those studies. 2 5 Q. Do you recall this as a complete
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1 tabulation up to 1981 of the studies that had
2 been done?
3 A. No, this was --
4 MR. PREUSS: By Monsanto or -- he
5 said studies that had been done.
6
MS. WELCH:
Studies had been done
7 in general.
8 A. No, he's indicating in the
9 abstract this is a tabulation of results of
1 0 microscopic evaluation of liver sections from
1 1 rats fed Aroclor 1242 and 1254 or 1260.
1 2 There is some general discussion leading into
1 3 it to point out that this information has
1 4 been distributed to various regulatory
1 5 agencies, but there was no single source
1 6 reference or summary that people could
1 7 access, and i t was my hope that this could
1 8 provide such a single -source ref e r e n c e .
1 9 BY MR. WELCH:
20
Q
With re s p e c t to --
`
2 1 A . The t h r e e ?
2 2 Q The 1 i v e r sections from rat s fed
2 3 Aroclor 1 2 4 2, A r o c lor 1254 or A r o c lor 12 6 0
2 4 for two years?
2 5 A. That's correct.
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1
Q.I'd
like to turn to the
2 introduction which was onthe page that's
3
enumerated number 1.
There's a reference to
4 Monsanto sponsoring a series of animal tests
5 at Industrial Bio-Test in 1969. Are those
6 the tests that you referred to that you were
7 aware were underway in 1971 when you arrived?
8 A . Yes.
9 Q. And those tests consisted of
1 0 feeding studies to rats and dogs, one of the
1 1 tests? .
1 2 A. Yes.
13
Q.Three-generation
rat reproduction
1 4 study?
1 5 A. Yes.
1 6 Q. A rat teratology study?
1 7 A. Yes .
1 8 Q. Whatis teratology?
1 9 A. It's from the Greek word "terata, "
20
meaning monster.
It's a study of birth
2 1 defects .
2 2 Q. A dominant lethalmutagenic study
2 3 in mice?
2 4 A. Yes.
2 5 Q. And what is lethal mutagenic
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1 study?
2 A. That specific study involves
3 dosing male animals with a chemical to see if
4 it affects their sperm, and then mating those
5 animals with females to determine whether the
6
offspring will live or die.
If there is a
7 dominant lethal defect, the pups will die, so
8 it measures the effects on the male sperm.
9 Q. And the last was a toxicity
1 0 reproduction study in chickens on each of the
1 1 three Aroclor products?
1 2 A. Yes.
1 3 Q. Do you recall if there were any
1 4 preliminary results that were issued when you
1 5 first got to Monsanto from these studies?
16
MR. PREUSS:
Do you mean issued
1 7 before he started, or after the time he
1 8 started?
1 9 MS. WELCH: Well, whenever, did he
2 0 become aware of any prelimin aur y results when
2 1 he arrived at Monsanto.
2 2 A. I did not -- well, I do not recall
23
being told of preliminaryresults
in the
24
sense of results on ongoingstudies.
I
2 5 became aware that the studies were underway.
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1 Mr. Wheeler was dealing predominantly with
2 polychlorinated biphenyl issues, and I had my
3 own assignments and I was not particularly
4 involved.
5 BY MS. WELCH:
6 Q. Did you become aware that, as this
7 document said, that the studies were
8 initiated by reports that PCBs had been
9 detected in the environment?
1 0 A. Yes, I was told that somewhat
.1 1
later, or somewhere along the line.
I don't
1 2 know just when.
1 3 Q. With respect to the protocols for
1 4 these, these experiments or these tests, were
1 5 they new protocols in 1969?
1 6 A. I do not know what the protocols
1 7 were when these studies were initiated
1 8 because I was not there a t the time.
1 9 Q. Did you become aware of the
2 0 protocols when you reviewed the `reports or if
2 1 you reviewed the reports?
2 2 A. I do not recall specific ,
23
specifics about the protocols.
That may or
2 4 may not have been there.
2 5 Q. Well, let me phrase it in this
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1 way. Prior to 1969, were toxicologists
2 carrying out chronic feeding studies on rats
3 and dogs with respect to various other
4 chemicals, to your knowledge, besides PCBs?
5 A. Yes.
6 Q. Do you know in your background
7 when chronic feeding studies on rats and dogs
8 began to become a testing mechanism?
9 A. When I joined Monsanto in -- or
1 0 Cyanamid in 1958, there were two-year feeding
1 1 studies in progress, so with that as a
1 2 reference point, certainly in the 1950's, at
1 3 least .
1 4 Q. Okay, same question with respect
1 5 to three-generation rat reproduction study.
1 6 A. I would give a similar answer;
1 7 they were underway when I came to Cyanamid.
1 8 Q. That was in the mid Fifties?
1 9 A. I got there in 1958.
20 .
Q. How about with respect to a rat
2 1 teratology study?
2 2 A. Teratology studies did not
23
become -- terra -- let me start back.
Some
2 4 aspects of teratology would be detected in a
25
reproduction study.
What's labeled as a
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1 teratology study, it really did not gain
2 prominence until the 1 9 6 0 ' s , with the
3 thalidomide tragedy.
4 Q . That was the early 1960's? 5 A . It would have been early 19 60 ' s 6 It was during the Kennedy administration,
7 '62, '61, '2, '3. 8 Q. How about the dominant lethal
9 mutagenic study; when did that become
1 0 available?
1 1 A . Oh , I don't know when it became
12
avai 1 ab1e .
11 probably had been around a
13
long time.
11 was infrequently done, even in
1 4 the 1969 time frame, and sort of fell out of 1 5 favor, and it's probably getting a little bit
1 6 of a resurrection again.
1 7 Q. Was it available prior to 1969,
1 8 even if it was conducted infrequently? 1 9 A. Oh, I don't know the history of it
2 0 well enough, but the feature of it certainly
2 1 were, were well -- known well before this,
2 2 yes.
2 3 Q. How about a toxicity reproduction
2 4 study in chickens; was that available prior 2 5 to 1969?
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1 A. That would have been done, yes.
2
Q.
Inyour experience, when
were you
3 first aware of these kinds of studies with
4 respect to the toxicity reproduction studies
5 in chickens?
6 A. Outside of agricultural products,
7 I don't think they would have been done
8
particularly.
It certainly was not a common,
9 a commonly done test in chickensunless there
10
was -- itwas intended for
either medication
1 1 of chickens or it was intended for poultry
1 2 treatments of some sort or it was a pesticide
13
product.
Other than that, I doubt that
1 4 anybody was really doing it.
1 5 Q. How about with respect to either
1 6 pesticides or medicinal products for poultry?
1 7 A. That's what I said, veterinary or
1 8 things intended to treat chickens or
1 9 pesticides that could be a residue on crops
2 0 fedtochickens.
^
2 1 Q . Were those being done in the
22 1950 ' s?
23
A.
I don't -- I can't say.
They were
2 4 not frequently done, is the best I could say,
2 5 because they were not being -- my earliest
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1 chickens reproduction study that I would have
2 experienced would have been in the early
3 Sixties, by personal experience.
4 Q. Was this when you were at
5 Cyanamide (Phonetic)?
6 A . Yes.
7 Q Am I pronouncing that right?
8 A . Sigh-AN-a -mid.
9
Q
Cyanamid.
There''s a reference
1 0 bottom paragraph on the first page,
1 1 "Starting in 1969, while these studies still
1 2 were in progress, information regarding them
1 3 was made available to various government
1 4 groups." Do you know what information
1 5 regarding them was made available to various
1 6 government groups? There is a reference to a
1 7 footnote .
1 8 A. My -- the basis for that comment
1 9 in my recollection is, in part, document
2 0 footnotes on page 8 that's information which
2 1 was in the files, and it is, my recollection
2 2 is that as interim reports or progress
2 3 reports, or whatever was being received by
2 4 Monsanto, it was being forwarded to the
2 5 regulatory personnel.
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1 Q Do you know whether the final
2 reports confirmed the interim reports or was
3 there a change in the results?
4 A. I did not compare interim to final
5 reports, but they have been widely
6
distributed.
If there were inconsistencies
7 in the conclusions, I would expect that they
8 would have been brought to our a 11 e n t i o n .
9 Q So by that, are you saying that
1 0 you don't think there were i n c onsisten c i e s ?
1 1 A . I do not think t h e r e were
1 2 inconsistencies, but I do not recall
1 3 comparing interim reports with final reports.
1 4 Q. How often do you know were interim
1 5 reports issued with respect to these tests?
1 6 A. I've indicated earlier, Mr.
1 7 Wheeler was dealing on the PCB issues, and I
1 8 really have no knowledge of that.
1 9 Q. I'd like to turn to page, the page
2 0 that's enumerated number 4 un4er "Methods."
2 1 What is a threshold limit value?
2 2 A. There is a group in the second
2 3 line, "ACGIH, the American Conference of
2 4 Governmental Industrial Hygienists, they set
|
2 5 standards of chemicals in the air that are I
i
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1 acceptable or, some say, permissible for
2
employee exposure.
They revise that list
3 annually, they document the basis for those
4 numbers, and it is through that -- and this
5 1969, the second line refers to the latest
6 revision, but when I say I may have learned
7 of PCBs I have used the ACGIH threshold limit
8 value list many times, and I have read their
9 documentation, and I may well have gotten my
1 0 first exposures to PCBs by reading that
1 1 documen.t in their documentation.
1 2 Q. Is there an encyclopedia or
1 3 dictionary of threshold limit values that's
1 4 issued by this group?
1 5 A. It's issued as a small pamphlet
1 6 annually.
1 7 Q. Was that available to people at
1 8 Monsanto?
1 9 A. Yes. It's available to everybody.
2 0 Q. Is it a respected reference book
2 1 for industrial hygienists?
2 2 A. Its membership consists of
2 3 industrial hygienists working for federal and
2 4 state governments, and I would have to
2 5 accept, assume and believe that it is highly
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1 reputable.
2 Q. Is this a -- is this handbook --
3 was this handbook available in the medical
4 library at Monsanto?
5 A . Yes.
6 Q. And it was used by you and others
7 with reference to threshold limit values?
8 A. Yes.
9 Q. Now, there'sa reference here in
1 0 the second line to the dosage that a person
1 1 would receive of PCBs, and then there is a
1 2 reference to dosages that rats would receive.
1 3 Why is there a reference under methods to the
1 4 dosage that a person would receive?
1 5 A. This is not a reference to a
16
dosage a person would receive.
This is an
1 7 illustration of how one would go about
1 8 estimating the levels to which you could
19
expose animals, andso it's a
calculation of
2 0 certain assumptions, and then-', taking those
2 1 assumptions from man over to the animal to
2 2 come up with some estimate as to what levels
2 3 would be tolerable by the animals.
2 4 Obviously, if the animals die on
2 5 the third day of exposure, it's very
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1 difficult to conduct a two-year study.
2
Q. So, of course,
toxicological
3 experiments are not conducted on human
4 beings; is that correct?
5 A. Not knowingly.
6 Q. Not intentional toxicological
7 experiments?
8
A.
I'll say not knowingly.
We hope
9 that we are -- we believe that we are not
10
conducting experiments on
people.
1 1 Q. So the intent in performing animal
1 2 experiments is to draw parallels between the
1 3 expo sure that a person wou Id receive?
1 4 A . Well, it's i1 1 u s t r ated the f a c t 1 5 that i n reaching any concl u s i on, you w a n t t o
1 6 cons i d e r all the available i n formation t h a t
1 7 you have and see how you c a n come up wi t h the
1 8 best possible conditions. and as I in di c a ted,
1 9 to s tart several hundred o r a thousand
2 0 animals on a test and find that `one has to i
2 1 abort the test because the animals have died
2 2 or something, that they don't tolerate it, so
2 3 one wants to minimize the false starts, and
2 4 one goes through these sorts of calculations
2 5 and assumptions to see whether there is a
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1 consistency and whether it will serve to pick 2 a point on something that nobody really knows 3 about when you start the study. 4 Q S o the idea of a threshold limit 5 value i s , you don't want to go over that 6 amount because you would kill the animal? 7 A. No, no, the threshold limit value 8 is a level that the American Conference of 9 Government Industrial Hygienists, an air 1 0 level that they said is acceptable for human 1 1 exposure in the workplace. So starting with 1 2 that, you say if that level is in the air, if 1 3 the person inhales, we know how much he 1 4 breathes in the course of a working day, and 1 5 if his lungs take everything out of the air 1 6 and keep it in the body, this is the amount 1 7 that that person will have gotten by the end 1 8 of the day, and we use that as a starting 1 9 calculation, but by no means is this the 2 0 level that people will get, b,e cause they are 2 1 not going to retain everything, the level may 2 2 be lower than the threshold limit value, and 2 3 so forth, but it's sort of calculating an 2 4 upper limit that one has a reasonable basis 2 5 for saying they should not get more than this
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1 and they should be able to tolerate this
2 Q. Is there any other reason for
3 drawing the parallel from people to rats, in
4 terms of dosage?
5 A. No, this is merely intended to
6 illustrate to people how -- the rationale for
7 picking the doses that were in the study.
8 I might add that Kimbrough's study
9 later on, others have used the same hundred
1 0 part per million is about as high as it'll go
1 1 in the rat without killing them.
1 2 Q. All right, turning to page 6,
1 3 under "Discussion," there is a statement,
14
here,
that, "Since there were increased
1 5 incidences of vascular changes in the
1 6 cytoplasm of the" -- you'll have to help me.
1 7 You should perhaps read this because you know
1 8 these words --
1 9 A. "-- hepatocytes."
2 0 Q. " -- hepatocytes and `focal
2 1 hypertrophy -- "?
2 2 A. Hypertrophy.
2 3 Q. " -- at all dose levels for all 3
2 4 Aroclor products at the 24-month sacrifice, a
2 5 'no-effect' level was not established for
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1 liver effects." Can you please explain to me 2 that conclusion? 3 A. That's evident from the data. A 4 no-effect level means that insofar as one can 5 tell through the measurement tools, no 6 effect, no, nothing was observed. Since 7 there was, this takes, let's take 8 specifically focal hypertrophy, which means 9 there are spots in the cell where there is an 1 0 increase in tissue, it's -- an old-timer once 1 1 used the analogy, if one goes out and chops 1 2 firewood for the winter, you will get muscle 1 3 hypertrophy. If you use muscles more, you 1 4 will get an increase in muscle mass. So if 1 5 the liver is doing -- we talked earlier 1 6 detoxification, it's got little spots, little 1 7 focal areas where there's an increase in cell 1 8 tissue, and that is an increase above 1 9 background, so there is an effect on the 2 0 liver. However, I don't things that could be 2 1 considered a deleterious effect, even though 2 2 there is an effect on the liver, so that's 2 3 the reason for saying a no-effect, in the 2 4 sense of nothing happening, was not 2 5 established for liver effects.
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1 Q. Turning to the next page, page 7,
2 you -- there is a statement, here, that
3 "focal" -- pronounce the word again for me?
4 A. High-PER-truh-fee.
5 Q. "-- hypertrophy of the liver
6 occurred at 3, 3, and 12 months for rats fed
7 Aroclor 1260, 1254 and 1242 respectively, and
8 was not seen in livers of control animals."
9 By "control animals," you are referring to
1 0 animals who are not exposed to Aroclor.
1 1 A . Yes .
I
12
Q. So in other words, the result,
!
!
!
13
here, is that the Aroclor conclusively caused
i
1 4 the focal hypertrophy; is that correct?
I
i
1 5 A . This is,, this is a restatement
1 6 what w e had talked about on the preceding
1 7 page o r on page -- where was it? The
1 8 preceding page.
1 9 MR. PREUSS: That's the preceding
2 0 page.
`
2 1 A. Yeah, the preceding page, there
2 2 were subtle changes in the livers at all
2 3 three dose levels, so a no-effect level was
2 4 not observed. This is a restatement of what
2 5 it just discussed on the previous page.
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1 BY MS. WELCH:
2 Q. The next statementis that,
3 "Livers of some animals fed 100 parts per
4 million of each Aroclor also had benign liver
5 tumors . "
6 A. Yes.
7
Q.
And then
there istwo kinds of
8 liver tumors, I assume, that are referred to.
9 Can you explain to me what the liver tumors
1 0 are that were seen at a hundred parts per
1 1 million?
1 2 A. A hepatoma is a benign tumor, not
1 3 malignant. A cho1 angiohepatoma is a, again,
14
a benign tumor in the bile duct.
These
i 5 findings had been reported in the initial
1 6 two-year feeding studies, so there's no
1 7 change in --
18
Q.
And those were thefeeding
studies
1 9 that began in 1969?
20
A. That's right.
G'
2 1 Q. So this is a confirmation of those
2 2 studies, or is it a summary ofthose studies?
2 3 A. Well, let me see what -- give me
24 a -
2 5 (Witness peruses document.)
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1
(Continuing)
If you look at page
2 2, in the second paragraph, starting, the
3 two-year studies were done in that, in the
4 two-year studies consistent with general
5 practices, they looked at the livers from ten
6 animals in each group. That is, they
7 autopsied the a n i m a 1 s , the y ' d loo k at t h e
8 livers and they would P i c k , i f t h e y s a w
9 nothing unusua 1 , they w e r e ins t r u c t e d t o look
1 0 at ten tissues f r o m , o r t i s s u e s f r o m ten
1 1 animals in eac h group a n d they r e port e d those
1 2 livers .
1 3 A t a later d a t e , wh e n the q u e s t i o n
1 4 came up as to w h ether t h e y c a u s e d 1 i v e r
1 5 cancer, we ins t r u c t e d t h e lab t o go b a c k and
1 6 look at all av a i 1 abl e 1 i v e r s , i n c 1 u d i ng
1 7 animals that h a d been o n t e s t s whose 1 i v e r s
1 8 had not previously been examined, and so this
1 9 report is looking at those to livers from
2 0 every available animal. In other words, the
2 1 ten that they looked at in the previous
2 2 studies and the ones that they had put in
2 3 formaldehyde and kept preserved, they looked
2 4 at all of them and when they looked at all of
2 5 them, basically they did not see any
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1 differences from what they saw the first 2 time. 3 Q. So these were preserved from even 4 the earliest studies? 5 A . Right. 6 Q. And is there some kind of library 7 of slides or organs that Monsanto maintains 8 for past -- from past experience? 9 A. I do not know the current 1 0 retention policies, but yes, the wet tissues 1 1 are r e t a i n e d in forma ldehyde and si i d e s can 1 2 be re t a i n e d , but they will deterior ate with 1 3 age , so I d o n ' t know the current re ten t i o n 1 4 policy . 1 5 Q For this r eport, the rev i e w was 1 6 made on eve r y t h i n g f r om 1969 forwar d on the 1 7 liver t i s s u e of rats? 1 8 A . The liver tissues from a 1 1 the 1 9 rats in the t hr e e two -year feeding studies 2 0 1 2 4 2, 12 5 4 and 1 2 6 0 w ere examined, and this 2 1 summarizes the liver findings from all the 2 2 animals on t h o s e three two-year studies. 2 3 Q . Now, you refer to the question o f 2 4 whether A r o c 1 o r s cause liver cancer. How did 2 5 that question arise?
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1 A. Dr. Kimbrough, we talked about
2 earlier, went back and started a two-year
3 feeding study --
4 MS . WELCH: Maybe w e should go off
5 the record.
6 (Discus s i o n off the record.)
7 BY MS. WELCH:
8 Q Go ahead. I ' m sorry, Doctor. 9 A . Dr . Kimbrough ini t i a t e d ,
1 0 u n b e k n o w n s t t o us, a two- yea r f e eding study
1 1 with female r a t s to fur t h e r e x p 1 ore the
1 2 q u e s t i o n of t h e bladder c a n c e r . She used
1 3 f e m a 1 e s bee a u s e that's w h ere she saw the
1 4 firs t b 1 a d d e r cancer sh e e n c o u n t ered and she 1 5 did only on e h ig h dose 1 e v e 1 1 6 Wh e n she -- i t w o u 1 d have been
1 7 a b o u t '83, ' 4 , I'm not s u r e ; t i m e's a blur --
1 8 she then c a lie d -- she th e n came to Monsanto.
1 9 MR . PREU S S : D i d say '83 or '73?
20
THE WITNESS :
I ' m ^or ry, '73.
2 1 '72, ' 3 , *4 ; s omewhere i n t h ere, yeah.
22
A.
(Continuing)
She then called
2 3 Monsanto and came up to visit with us and
2 4 told us that she had found liver cancers in
2 5 the female rats fed high levels of Aroclor
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1 1 2 6 0.
2 As a result, to attempt to
3 determine, since we have two contradictory
4 pieces of information, our study which -- at
5 IBT which said there was no cancer and
6 Kimbrough's findings, we said, "We want you
7 to go back and look at all available livers
8 on the chance that you may have missed
9
something.
We want to look at not just the
1 0 ten, but everything," and so this is the
1 1 result of all liver sections that were
1 2 reviewed.
1 3 BY MS. WELCH:
1 4 Q. Did Monsanto hire scientists to
1 5 review Dr. Kimbrough's findings, as well?
1 6 A. Yes.
1 7 Q. And what were the conclusions of
1 8 those scientists who reviewed her findings?
1 9 A. The -- there are two different
2 0 parts to this. The IBT, Industrial Bio-Test
2 1 pathologists went down and discussed their
2 2 findings with Kimbrough and they, they viewed
2 3 concurrently slides from, selected slides
2 4 from the Monsanto studies and selected slides
2 5 from Kimbrough's studies. Those conclusions
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1 in general were that Monsanto did not have.
2 the Mon santo s t u d i e s did not show liver
3
can c e r .
Some of t h e slides that Kimbrough
4 had / i f they u s e d a new c 1 a s sification th a t 5 D r . S q u ires w a s dev eloping, they would
6 con side r c a n c e r s by Dr . Squires' definiti o n .
7 We also went t o the Epley Institute of Ca n c e r
8 i n 0 m a h a , N e b r a s k a with Dr . Schubic, who is a
9 can c e r expert, and we as k e d what further
1 0 m e a sure s, what can we do i n an attempt to
1 1 res o 1 v e the d i f f e r e n t f i ndings, so he
1 2 r e c o mm e n d e d t h at we take D r . Pour, Parvis
1 3 Poo r , a p a t h o 1 o g i s t , and h e looked at all the
1 4 I B T s 1 i d e s and he 1 o o k e d a t all of
1 5 Kimbrough's slides, and he did not feel that
1 6 Kimbrough's slides showed any evidence of
1 7 carcinogenicity.
1 8 Q. Was there any pathologist besides
1 9 Dr. Squires who reviewed Dr. Kimbrough's
2 0 slides?
^`
2 1 MR. PREUSS: Well, I don't think
2 2 there's any testimony that Dr. Squires
2 3 reviewed them. It was Dr. Squires'
2 4 classification system.
25
MS. WELCH:I think
he testified
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1 that he reviewed both sets of slides
2 MR. PREUSS: You misunderstood
3 him.
4 A . No .
5 MR . PREUSS:
6
MR . PREUSS:
Dr. Pour, I think
7 A . An IBT pathol ogist took slides
8 that were representative of the lesion that
9 is found, the hepatomas, the benign tumors,
1 0 and they met with, in Dr. Squires' office
1 1 with Dr. Kimbrough, and I think there was a
12
Dr. Levitt there.
Squire and Levitt were the
1 3 originators of this new classification scheme
1 4 for liver tumors, and they looked at some
1 5 slides that this Dr. Kimbrough had brought, a
1 6 few slides that she thought illustrated her
1 7 points, and Industrial Bio-Test pathologists
1 8 did the same, so they looked at some slides,
1 9 but the only person who looked at all the
2 0 slides from all the studies was 'Dr. Pour.
2 1 Q. But the scientists who reviewed,
2 2 besides Dr. Pour, there were scientists who
2 3 agreed, looking at Dr. Kimbrough's slides,
2 4 that what she had found was, indeed, cancer?
2 5 MR. PREUSS: I'll object. That
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1 mischaracterizes what he said. 2 A. I think I, as far as I know, and I 3 think he said, is that at that meeting. Dr. 4 Squire and Dr. Levitt, using their 5 classification scheme, characterized those 6 liver lesions, some of those liver lesions, 7 as cancerous. 8 BY MS. WELCH: 9 Q Now, did Dr., up to the time that 1 0 you left Monsanto in 1991 , did you maintain 1 1 contact with Dr. Kimbrough? 1 2 A. I had informal contact with her 1 3 many times subsequent to this, yes, but I 1 4 can't -- 1 5 Q. Did Dr. Kimbrough, to your 1 6 knowledge, ever retract the findings of her 1 7 study or did she maintain that she had been 1 8 correct in her studies? 1 9 A. Well, she never -- she published 2 0 her data, and I don't know t hr a t there's ever 2 1 been a retracton, or -- she's never come up 2 2 to me and said, "I'm going to take it all 2 3 back, publish it," no. 2 4 Q. As far as you know, did she still 2 5 uphold the results of her studies?
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I
1 A. I think it's interesting, she I
2 wrote a review sometime later on the effects
3 of polychlorinated and po1ybrominated
4 biphenyls, and at the end of it, she says,
5 despite the interesting effects in animals,
6 there is no indication that theyhave caused
7 harm to man at the levels to which the
8 population is exposed.
9 Q. Was she speaking specifically of
1 0 carcinogenic harm?
1 1 A.. She's talking about the spectrum
1 2 of biological effects, including
1 3 carcinogenicity.
1 4 Q . And what article is this?
1 5 A. An annual review of pharmacology
16
and toxicology, oh, five years ago or so.
I
1 7 don't have the specific reference.
1 8 Q. With reference to her particular
1 9 findings, finding cancers in rats, that was
2 0 the question, did she ever, ta your
21
knowledge, or does she still, to
your
2 2 knowledge, uphold those findings, not with
2 3 reference to man but with reference to her
2 4 findings in rats?
2 5 A. I, I mean she's presented her
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1 findings to us and she's published them, and
2 I, you know, I really haven't specifically
3 discussed them with her to see whether she
4 upholds them or denounces them.
5 MS. WELCH: Okay, why don't we
6 take a break.
7 (Recess)
8 MS. WELCH: All right, back on the
9 record .
1 0 BY MS. WELCH:
1 1 Q. I'd like to introduce as Exhibit
1 2 0176 the following document.
1 3 (Plaintiff's Deposition
1 4 Exhibit 1076 marked for
1 5 identification.)
1 6 BY MS. WELCH:
i
1 7 Q. Exhibit 1076 is a multipage
1 8 document that has a number of identifying
1 9 stamps. I will use the one SCM 019639
| Il
20
through SCM 019645. It's entitled "Toxicity
i
|
2 1 and Environmental Effects of Commercial
22
P C B s , " and I note that on, the page stamped
I
2 3 SCM 019643 there appear to be the initials
24
"GJL."
Please take a few minutes to review
2 5 this document.
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1 (Witness peruses said 2 document.) 3 A . All right. 4 BY MS. WELCH: 5 Q All right, turning to the page 6 that is marked SCM 019643, is that your 7 handwritten , are those your handwritt e n 8 initials? 9 A . No , they are not.
1 0 Q D o you know whose initials those
1 1 are? 1 2 A . Well, they're my initials, but I 1 3 don't know who put them there. 1 4 Q - Did you author this docume n t ? 1 5 A . I b elieve I did. It sound s like, 1 6 reads like w h a t I would have written. 1 7 Q - D o you recall authoring th i s 1 8 document? 1 9 A . Not specifically . 2 0 0 But you believe that 'you d id? 2 1 A . Yes . This is the sort of summary 2 2 I would be i n c lined to prepare, or th e way I 2 3 would write i t 2 4 Q And did you author this ki n d of 2 5 document in the normal course of your
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1 business activities?
2 A. I would frequently summarize what
3 was going on with the product, yes.
4 Q. It was part of your job
5 responsibilities to do so?
6 A . Yes.
7 Q. Do you have any recollection of
8 the approximate time period that you authored
9 this document?
1 0 A . No.
1 1 Q. All right, turning to the section
1 2 that is entitled "Conclusions Based on
1 3 Monsanto Studies," the second part refers to
1 4 threshold limit values. That is the same as
1 5 in the document we discussed previously,
1 6 that's the same definition?
1 7 A . Yes.
1 8 Q . The next statement is, "The
1 9 effect level for these materials i n
2 0 onic rat and dog feeding s,t udies is about
2 1 parts per mi 11 i o n in the diet. " Does that
22
mean that any amount above
thatcauses some
2 3 kind of effect?
2 4 A. Yes, there would be observable
2 5 effects above that.
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1 Q. And when you said that no
2 hepatocellular carcinomas were present, you
3 mean that there were no, there was no
4 evidence of liver cancer?
5 A. That's correct.
6 Q. In dogs and rats in that feeding
7 study .
8 A . Right.
9 Q. The next statement is, "The
1 0 no-effect level on rat reproduction is
1 1 between 1 and 10 parts per million," and you
1 2 state, "Since higher levels result in low 1 3 mating indices, that means that above 10
I
1 4 parts per million, the incidence of mating
1 5 decreases"?
1 6 A . Yes.
1 7 Q. And no teratogenic or mutagenic
1 8 effects were observed in studies with rats
1 9 and mice; is that correct?
2 0 A . Yes.
^
2 1 Q. The next statement is that "In
2 2 chicken reproduction and teratology studies,
2 3 Aroclor 1242, which produced the most severe 2 4 effects, had a no-effect level of 2 to 4
25
parts per million in the diet."
Does that
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1 mean that above 4 parts per million, there
2 was an effect?
3 A. There were differences from the
4 controls that were statistically significant.
5 Q. And again, the controls were
6 chickens that were not fed any Aroclor?
7 A. That's right.
8 Q. The next statement is that "Acute
9 toxicity to fish varies from less than one
1 0 part per million to greater than 100 parts
1 1 per mil. lion depending upon the specific
1 2 Aroclors and species of fish tested." Is
1 3 that correct?
1 4 A. Yes.
1 5 Q. So there's a wide variety of
1 6 effects depending on the species and the type
1 7 of Aroclor?
1 8 A. Yes.
19
Q.
Do you know what
is acute toxicity
2 0 mean?
^`
2 1 A. It's an index or a measure of
2 2 either a single dose or several doses given
2 3 over a short period of time with respect to
2 4 the -- most generally, it's a measure of the
2 5 acute lethality of the compound; the death.
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1 Q So w h a t you are r e f e r rin g to
2 here. i s variety i n dosage with respect
3 death i n the fish
4 A. Yes, I believe that's what it is.
5 Q. The last statement is, "PCBs
i
6 containing three or less chlorine substitutes
7 per molecule are reasonably biodegradable."
8 Is that what your finding was?
9 A. I was told that by others.
1 0 Q. Do you know who told you that?
1 1 A. Not specifically.
1 2 Q. That was an assumption that you
1 3 based your work on, however? 1 4 A. I don't recall who told me or
I
1 5 when, but it was based on studies that
1 6 Monsanto had conducted.
1 7 Q. The next section is entitled
1 8 "Summaries of Monsanto's Long-Term Toxicity
19
Studies On Commercial PCBs."
Was the
2 0 reference to the Industrial B-d o-Test 1969 to
2 1 1971 tests?
ij
i
2 2 A . The two-year lifetime, yes, these
2 3 b e the studies at Industrial Bio -Test. 2 4 Q - That started i n 1 9 6 9 ? 2 5 A . Somewhere ab out that there.
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1 Q . In the earlier document, we saw a
2 reference to tests that began in 1969, and
3 I'm wondering whether these are the same
4 tests that --
5 A. These would be the same tests.
6 Q. There's a summary of the effect on
7 rats in the lifetime rat feeding studies.
8 Could you please -- and that's in that second
9
paragraph.
Could you please summarize those
1 0 results?
1 1 MR. PREUSS: Counsel, you've got
1 2 to give us a better reference, please.
1 3 BY MS. WELCH:
1 4 Q. All right, it's under "Summary of
1 5 Monsanto's Long-Term Toxicity Studies On
1 6 Commercial PCBs"?
1 7 MR . PREUS S : Right .
1 8 MS. WELCH: The second paragraph
1 9 begins, "The highest dietary level" --
2 0 MR. PREUSS: All right.
2 1 MS. WELCH: -- and I'm just asking
2 2 the doctor to summarize the results from
2 3 those Industrial Bio-Test tests with respect
2 4 to lifetime rat feeding studies.
2 5 MR. PREUSS: You want him just to
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1 read it?
2 MS. WELCH: Well, if he can
3 compress it, compress the findings in a few
4 sentences, that would be helpful.
5 MR. PREUSS: Well, I would say
6 that the document speaks for itself.
7 A. I've attempted to summarize
8 two-year studies, and I don't -- I attempted
9 to include everything I thought was relevant
1 0 for someone to know, and condensing it
1 1 further without going back and looking at the
1 2 other studies, I think, would be almost an
1 3 exercise in futility.
1 4 BY MS. WELCH:
1 5 Q All right, 1 e t ' s g o th rough i t . 1 6 The s t a t e m e n t , here, is that ft The high e s t
1 7 die t a r y 1 e v e 1 of 100 pa r t s p e r m i 1 1 i o n
1 8 pro d u c e d a w e i ght depre s s i o n a f t e r 2 4 months
19
i n f e m a 1 e s fed A r o c 1 o r 1 2 5 4. M
I s that
2 0 cor r e c t ?
*
2 1 MR . PREUSS: F e m a 1 e r a t s .
2 2 M S . WELCH: Well, i t j u s t s ays " i n
2 3 females , 11 but the refer e n c e , o f c o u r s e , i s t o
2 4 rats.
2 5 MR. PREUSS: Lifetime rat feeding
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1 studies. 2 MS. WELCH: We understand it's 3 rats. 4 MR. PREUSS: Let's make sure the 5 record does. 6 MS. WELCH: The record should 7 reflect it refers to rats. We already know 8 human beings were not intentionally fed 9 Aroclor 1254. 1 0 BY MS. WELCH: 1 i Q. Is that correct? 1 2 A . I would have to say, based on what 1 3 I've w ri tten here, that that is correct. 1 4 Q So that would be a we i g h t 1 5 compress ion of the overall body weight that 1 6 you are referring to? 1 7 A . Yes. 1 8 Q. And that is a liver weight 1 9 increase in all groups except males fed 2 0 Aroclor 1242; is that correct?-, ` 2 1 A. Yes. 2 2 Q. So that's referring to the three 2 3 Aroclors that were fed, 1254, 1242 and 1260? 2 4 A. With respect to these studies, in 2 5 body weight and liver weights are
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1 specifically referred to as Aroclor 1254 and
2 1242, but the 1260 did not have those
3 effects .
4 Q. So there were liver weight
5 increases in all groups except males fed
6 Aroclor 1242? Is that correct?
7 A. Yes.
8 Q. And the next statement isthat
9 "The important histopathologic changes were
1 0 present in the livers of animals sacrificed
11
at the end of the study."
What is a
1 2 histopathologic change?
1 3 A. The tissue is, a thin slice of
1 4 tissue is put under a microscope, stained, to
1 5 highlight various tissues within or
1 6 structures within the tissue, and then it's
1 7 looked at microscopically. In the judgment
1 8 of the pathologists who did the studies, the
1 9 important or the significant changes, they
2 0 felt, were confined to the livers.
2 1 Q. And those are reflected in the
22
nextsentence,
where it states thatit's
2 3 focal hypertrophy cytoplasmic lipid changes,
2 4 and in some animals from the 100 parts per
2 5 million group, hepatomas or
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1 cholangiohepatomas; is that correct?
2 A . Yes.
3 Q. And I believe that we defined all
4 of those earlier except for cytoplasmic lipid
5 changes. What are those?
6 A . The cytoplas m i s the fluid par t of
7 a cell t and 1 i pid would b e s ubstructur e s o r 8 p o r t i o n s in t h at fluid t h a t take up a fat
9 stain. s o some changes i n f a tty conten t , of a
1 0 fatty n a t u r e w ithin the c ell s . 1 1 Q S o there was i mp a c t on the 1 i v e r 1 2 in the animals sacrificed, but there was no
1 3 evidence of hepatocellular carcinogenicity of
1 4 the Aroclors. Is that correct?
j
1 5 A . Yes.
16
Q.
In terms of dogs, there were some
j
17
slight decreases in body weight gain?
Is
1 8 thatcorrect?
j
I
I
j
1 9 A . Ye s .
|
2 0 Q. And the next statement is, "At the j
ii
21
highest feeding level of a hundred parts per
i
iI
2 2 million, Aroclor 1260 produced an increase in !
2 3 serum alkaline phosphatase activity and liver 2 4 weights without concomitant histopatho1ogica 1
2 5 changes." Can you please explain to me what
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1 that sentence means?
2
A.
At a hundred ppm ofAroclor
1260,
3 there were no microscopic exchanges in the
4 appearance of the tissue. However, there was
5 an increase in serum alkaline phosphatase
6 activity, which is an enzyme in the blood,
7 and there was an increase in the weight of
8 the livers.
9 Q. Would this be an example of enzyme
1 0 induction?
1 1 A. Serum alkaline phosphatase is --
1 2 I'd have to go back and check specifically
1 3 which one, but would more likely be a rupture
1 4 of or a breakdown of a cell or somehow leaked
1 5 out of a cell. It would not -- I would not
1 6 consider it an induction of enzyme activity.
1 7 Q. In addition to those changes that
1 8 were noted, there were evidence of
1 9 gastrointestinal inflammatory lesions and
2 0 ulcerations? Is that correct? `
2 1 A . Yes.
2 2 Q. And those were similar to those
2 3 found by an experimenter by the name of Allen
2 4 in rhesus monkeys fed Aroclor 1248?
2 5 A. Yes.
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1 Q. The next reference in the 2 following paragraph is to rat reproduction 3 studies, and the effect that was found here 4 was that in the second and third generations, 5 there was a reduction in mating index at the 6 two highest feeding levels, which were 10 7 parts per million, a hundred parts per 8 million. Is that correct? 9 A . Yes. 1 0 Q. No other changes were noted in rat 1 1 reproduction studies? 1 2 A . That ' s r i g h t . 1 3 Q The next s t a t e m e n t is that there 1 4 was no e v i d e n c e o f t e r a t o g e nic or mutagenic 1 5 changes in rats and mice? 1 6 A . For the studies that w ere 1 7 conducted, there were no changes observed. 1 8 Q. With reference to the chicken 1 9 toxicity reproduction study, there was a 2 0 statement earlier that Aroclo? 1242 had the 2 1 most severe effect with respect to toxicity 2 2 and reproduction. Do you recall that? It's 2 3 on page -- the second full page. 2 4 A. Yes. 2 5 Q. And what was the effect of the
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1 Aroclor? 2 A. There was a decreased egg 3 hatchability. 4 Q What doe s t h a t mean? 5 A . The eggs are t aken from the hens 6 and they' re put in a n i n c u b a t o r and determine 7 how many. which one s ha t c h . 8 Q Was t h e r e a d e crease i n eggshell 9 thickness as the result of the Aroclor 1 0 exposure? 1 1 A. Yes, there was a reduction in the 1 2 eggshell thickness. 1 3 Q. Any other effects? 1 4 A. It says chick viability was 1 5 affected by both substances at a dietary 1 6 level of 10 ppm for 1242. 1 7 The young chicks did not survive 1 8 as well. 1 9 Q. And was this different for the 2 0 different Aroclors? In other.', words, 1242 had 2 1 a more severe effect than the 1254 or 1260? 2 2 A. Yes. 2 3 Q. All right, the statement in the 2 4 next paragraph refers to biodegradation 2 5 studies. The statement is made that higher
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1 ch1orine-containing members are more 2 resistant to biodegradation and they 3 accumulate more re adily and are less readily 4 metabolized and/or e x c r e ted from lipoid 5 tissue in animals. Does lipoid tissue refer 6 to fatty tissue? 7 A . Yes. 8 Q. Is fatty tissue where the PCBs are 9 accumulated? 1 0 A. Yes, similar to other chlorinated 1 1 hydrocarbons . 1 2 Q. So what you would expect to find 1 3 would be accumulation of the higher 1 4 chlorinated biphenyls and metabolism of the 1 5 lower chlorinated biphenyls. Is that right? 1 6 A. One would anticipate that as a 1 7 possibility. 1 8 MS. WELCH: Let me introduce the 1 9 following document as Exhibit 1077. 2 0 (Plaintiff's deposition 2 1 Exhibit 1077 marked for 2 2 identification. ) 2 3 MS. WELCH: Exhibit 1077 is a 2 4 three-page document bearing the identifying 2 5 stamp of TRAN 022439 to TRAN 022441. It is
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1 dated January 31st, 1972 and it is entitled
2 "Progress Report, Organic Chemical Division."
3 The project title is "Environmental
4 Analytical Program Toxicology Support
5 Studies," and it's reported by a number of
6 persons. The distribution includes a list
7 that includes Dr. Levinskas. Please take a
8 few minutes to review this document.
9 (Witness peruses said
1 0 document . )
1 1 MR. PREUSS: I think, just to be
1 2 accurate, it says, "Distribution to E. P.
1 3 Wheeler/G. Levinskas. "
1 4 (Witness peruses said
1 5 document . )
1 6 THE WITNESS: All right.
1 7 BY MS. WELCH:
1 8 Q. Dr. Levinskas, do you recognize
1 9 this document?
20
A. I do not recall see ing this
i|
2 1 documentbefore.
!
I
22
Q.
Is thisthe kind
ofdocument that
j
23
you would have received in your job in 1971
I
2 4 or 1972?
2 5 A. I could have received some, yes.
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1 Q. Were you aware that the persons 2 who were listed as reporting this document 3 were conducting studies of the selected 4 chic ken tissues in eggs from the Industrial 5 Bio- Test reports or studies? 6 A . I do not recall, I do not recall 7 w h a t they were doing for analyses. 8 Q. Can you tell me what a PCB lipid 9 s t o r age level is? 1 0 A . I can r e a d the s t a t e m e n t there 1 1 It's not a s t a n d a r d t e c h n i c a 1 term. s o I 1 2 can' t give you a f o r m a 1 d e f i n i t i o n for i t 1 3 Q. Do you know why just an 1 4 i n t e rpretation of the table, what the 1 5 r e f e rence is to one part per million, ten 1 6 part per million, 100 part per million? Is 1 7 that the amount that the animal is exposed 1 8 to? 1 9 A. That would be the -- that would 2 0 c o r r espond with the levels inc the diets that 2 1 were fed to the animals. 2 2 Q. So in other words, this would, 2 3 unde r one part per million, the analysis of 2 4 the tissue would be there would be a finding 2 5 of 2 8 parts per million that was retained by
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1 the tis s ue? For Aroclor 1 2 4 2, as an example? 2 A . Yes, that would be 28 parts per 3 million in lipids for 1242. 4 Q And similarly, for the animal that 5 was fed 10 parts per mill ion. there would be 6 196 part s per million in the 1 ipid tissue? 7 A . Yes.
8 Q And similarly, for a hundred parts
9 per mill ion, there would be 2 , 356 parts per 1 0 million? 1 1 A. Yes. 1 2 Q . And so on. 1 3 Turning to page number 2, the 1 4 fourth paragraph, the last line of the fourth 1 5 paragraph states, "Extensive alterations of 1 6 the homolog distributions of those less 1 7 chlorinated products are being observed on 1 8 the EC/GC chromatograms." Were you aware of 1 9 this fact at around the time? 2 0 A. I've indicated I h .-a v e not seen 2 1 this number before. There is a reference to 2 2 analysis, and I have no knowledge of it. 2 3 Q. You have no separate knowledge of 2 4 how the chromatograms looked when an animal 2 5 or a chicken had metabolized the PCBs?
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1 A . No.
2 MS. WELCH: I introduce this as
3 Exhibit 1078.
4 (Plaintiff's Deposition
5 Exhibit 1078 marked for
6 identification.)
7
MR. PREUSS:
Just to reference,
8
that lastparagraph referred
to dogs not
9 chickens .
1 0 MS. WELCH: You are right.
1 1 BY MS . WELCH :
1 2 Q. Do you have any knowledge of the
1 3 analysis of dog tissue?
1 4 A. I'm equally ignorant about dogs
1 5 and chickens.
1 6 BY MS . WELCH :
1 7 Q. Exhibit 1078 is a two-page
1 8 document bearing the identifying stamp of 1 9 TRAN 022437 to TRAN 0 2 2 4 3 8 . It is d a t
2 0 November 30th, 19 7 1, it's a r/g port by
2 1 persons, distribution to, amongst others, Mr.
2 2 Wheeler and Dr. Levinskas, and it is entitled
2 3 "Environmental Analytical Program --
2 4 Toxicology Support Studies." 2 5 Please take a few minutes to
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1 review this document.
2 (Witness peruses said
3 document.)
.4 BY MS. WELCH:
I
5 Q. Have you ever seen this document
6 before?
7 A. I do not recall having seen this
8 document before.
9 Q. Do you know what the toxicology
1 0 support studies were?
1 1 A. No, I do not know what that -- I'm
1 2 not aware of the meaning of that term in this
1 3 connection .
1 4 Q. How about the environmental
1 5 analytical program?
1 6 A. Again, I have not seen the report.
1 7 I have no, no knowledge as to what was
1 8 intended .
1 9 Q. Were you aware generally of an
2 0 environmental analytical program that was
2 1 going on in November 1971?
2 2 A. I knew that they had chemists who
2 3 were doing analyses. I have no knowledge as
2 4 to whether, whether the formal, informal
2 5 program or the details of such analysis.
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1 Q. With reference to the chart on the 2 bottom with PCB lipid storage levels, is your 3 testimony that I could read the chart the 4 same way as I could from the previous 5 document, which is the feeding level is one 6 part per million and the result is what is 7 found in the tissues? 8 A. I would say that the, the two are 9 analogous . 1 0 Q. And this refers to the beagle 1 1 dogs? 1 2 A. This refers to dogs. The other 1 3 was rats. 1 4 Q I b e 1 i eve the other was chickens 1 5 A . L a b o r a t o r y animals. Oh ,. it was 1 6 chickens, okay. Chickens. 1 7 Q. The statement is made on the 1 8 second page, "Alterations of the homolog 1 9 distributions were observed with all of the 2 0 products fed and were much m Q;X e - extensive 2 1 than previously noted in any of the other 2 2 tissue residue studies." Were you aware of 2 3 fact with r e f e r e n c e t o dogs ? 2 4 A . This i s -- no, I was not aware of 2 5 a s I was not aware o f the earlier ,
GORE REPORTING COMPANY - ST. LOUIS, MISSOURI
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1 somewhat similar comment.
2 Q Is there a reason in why the
3 species of chickens, rats and dogs were
4 chosen for the two-year study?
5 A . I do not know why those were
6 chosen .
7 Q. Is it fairly typical to experiment
8 on these three species with respect to
9 effects of chemicals?
1 0 A. I think we indicated earlier in
1 1 discussing the kinds of tests, certainly
1 2 rodent studies were very common. Dog studies
1 3 are fairly frequent, but less common, and
1 4 with the exception of veterinary
1 5 pharmaceuticals for poultry or possibly
1 6 pesticides, chicken reproduction studies
1 7 would be the least common.
1 8 Q. Are dog studies included because
1 9 it represents a higher form of mammal life
2 0 thanarodent?
O'
2 1 A. The rationale is to use different
2 2 species. If there is a similarity in
2 3 response between different species, one will
2 4 have a greater confidence that a human
2 5 response may be similar, may be more general
GORE REPORTING COMPANY - ST. LOUIS, MISSOURI 99
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1 biological. If there are wide variations or 2 differences between rats and dogs, then the 3 prudent assumption is that the most sensitive 4 species may well be indicative of man, but 5 that's an assumption that is made almost 6 automatically. 7 Q. So reflecting what you said, the 8 assumption would be that the species that 9 responds with the most adverse effects, the 1 0 assumption would be that's how man would 1 1 respond? 1 2 A . Correct, unless one had 1 3 information indicating that that particular 1 4 animal species was not necessarily 1 5 representative. 1 6 Q. And here, we're talking about 1 7 studies amongst mammals or are we talking 1 8 about studies amongst any species? 1 9 A. Ideally, one would like mammalian 2 0 data, but if one only had chicken data, one 2 1 would use chicken data in a similar manner. 2 2 MS. WELCH: I would introduce this 2 3 as Exhibit 1079. 2 4 (Plaintiff's Deposition 2 5 Exhibit 1079 marked for
GORE REPORTING COMPANY - ST. LOUIS, MISSOURI 10 0
STLCOPCB4029340
AX identification. )
2 MS. WELCH : Exhibit 1 0 7 9 is a
3
multipage document.
It's a progress report
4 from the Organic Chemicals Division dated
5 October 29th, 1971, entitled "Environmental
6 Analytical Studies Research and Development
7 Manufacturing and Outside Support Studies."
8 The distribution includes Mr. Wheeler and Dr.
9 Levinskas. The identifying stamp is TRAN
1 0 022427 to TRAN 022436.
1 1 (Witness peruses said
1 2 document.)
1 3 BY MS. WELCH: 1 4 Q. Do you recall having seen this
| |
1 5 document before?
1 6 A. I do not recall having seen it.
1 7 Q. There is a distribution list,
1 8 here, which you are included on and there is
1 9 an asterisk next to your name, as well as to
2 0 Mr. Wheeler's name and the statement is above
2 1 that, the asterisk refers to "with details,"
2 2 and then the document contains numbered pages
2 3 that are called details. Do you recall
2 4 having seen any of these details in the back? i
j
2 5 A. I do not recall.
i
i
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10 1
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1 Q. Turning to page 6, "Customer
2 Service, General Motors Corporation, Buick
3 Division," reviewing this section, do you
4 have any recollection of analyzing PCB
5 releases or PCB samples from Buick's plant
6 effluent in nearby drainage streams?
7 A. I have never analyzed any PCB
8 effluents .
9 Q. Did you ever hear of that having
1 0 been done by others?
1 1 A. I do not recall hearing of it.
1 2 Q. Do you recall hearing of any
1 3 pressure from the Michigan State Regulatory
1 4 Agency?
1 5 A. I do not recall hearing any
1 6 pressure from the state regulatory agency,
1 7 no .
1 8 MS. WELCH: All right, I don't
1 9 have any further questions.
2 0 MR. PREUSS: I have Mr. Papageorge
2 1 scheduled for tomorrow at 9:00. Is that
2 2 okay?
23
MS . WELCH :
Yes.
2 4 (Whereupon, the deposition
2 5 concluded at 11:35 a.m.)
GORE REPORTING COMPANY - ST. LOUIS, MISSOURI 10 2
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1 COMES NOW THE WITNESS, GEORGE
2 J. LEVINSKAS, and having read the foregoing
3 transcript of the deposition taken on the 2nd
4 day of November, 1992, acknowledges by
5 signature hereto that it is a true and
6 accurate transcript of the testimony given on
7 the date hereinabove mentioned.
8
9
10
1 1 GEORGE J. LEVINSKAS
12
13
1 4 Subscribed and sworn to before me
1 5 thisday of ,
1 9 9 2.
16
1 7 My Commission expires:
18
19
20
21
2 2 Notary Public
I
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GORE REPORTING COMPANY
ST . LOUIS , MIS SOURI 10 3
STLCOPCB4029343
1 STATE OF MISSOURI ) 2 SS : ) 3 CITY OF ST. LOUIS ) 4 I J. Bryan Jordan , notary public 5 in and for the State of Miss ouri, duly 6 commissioned, qualified and authorized to 7 administer oaths and to cert ify depositions, 8 do hereby certify that pursu ant to agreement 9 in the civil cause now pendi n g and 1 0 undetermined in the Superior Court of the 1 1 State of California, to be u sed in the trial 1 2 of said cause in said court, I was attended 1 3 at the offices of Bryan Cave , in the City of 1 4 St. Louis, State of Missouri , by the 1 5 aforesaid witness and by the aforesaid 1 6 attorneys, on the 2nd day of November, 1992. 1 7 The said witness, being of sound 1 8 mind and being by me first c arefully examined 1 9 and duly cautioned and sworn to testify the 2 0 truth, the whole truth, and nothing but the 2 1 truth in the case aforesaid, thereupon 2 2 testified as is shown in the foregoing 2 3 transcript, said testimony b eing by me 2 4 reported in shorthand and ca used to be 2 5 transcribed into typewriting , and that the
GORE REPORTING COMPANY - ST. LOUIS , MIS SOURI 10 4
STLCOPCB4029344
1 foregoing pages correctly set forth the
2 testimony of the aforementioned witness,
3 together with the questions propounded by
4 counsel and remarks and objections thereto,
5 and is in all respects a full, true, correct
6 and complete transcript of the questions
7 propounded to and the answers given by said
8 witness; that signatur e of the deponent was
9 not waived by agreemen t of counsel,
1 0 I further c ertify that I am not of
1 1 counsel or attorney fo r either of the parties
1 2 to said suit, not rela ted to nor interested
1 3 in any of the parties or their attorneys,
1 4 Witness my hand and notarial seal
1 5 at St. Louis, Missouri , this
day of
1 6 , 1 9 9 2.
1 7 My commissi on expires July 20,
1 8 1 9 9 4.
19
20
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2 2 Notary Public in and for the
2 3 State of Missouri
24
25
GORE REPORTING COMPANY - ST. LOUIS, MISSOURI 10 5
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M, ()
) DEPOSITION EXHIBIT
p/n
5^9
LISTING OF TOXICITY AND RELATED STUDIES
OF POLYCHLORINATED biphenyls
NOTE?
Those reports listed in addition to those included in
Exhibit ``c" of the Answers to the Holly Farms Interrocatories
indicated by an asterisk.
TRAN 013693
STLCOPCB4029346
Jh i m.
u.
.)
'
REPORTS & STUDIES
HARVARD SCHOOL OF PUBLIC HEALTH
1 Experiments to determine the possible toxicity of the
following substances?
--chlorinated diphenyl #1268
mixture of chlorinated diphenyl and
chlorinated diphenyl benzene #^460
Dated September 15* 1938
THE BARNARD FREE SKIN AND CANCER HOSPITAL St. Louis* Missouri
1 Project W-31 Aroclor (1254) Report on Patch Testing,
dated December 22, 1949
.
THE KETTERING LABORATORY Cincinnati, Ohio______ ___
' ..
1. The Toxicity of the Fogs Formed by Dropping Pydraul F-9> Aroclor 1248, and Tricresyl Phosphate, Upon the Surface of t>f a Heated Inconel - dated March 11, 1953
2. The Toxicity of the Vapor of Aroclor 1242 and of Aroclor 1254,
dated June 28, 1955
-
SCIENTIFIC ASSOCIATES St. Louis, Missouri '
-'
1. The Acute Oral Toxicity (LD50) dated November 10, 1953
Aroclor 1254 for Rats,
2. The Acute Oral Toxicity (LDc0) of Aroclor 1242 for Rats, dated December 11, 1953 0
INDUSTRIAL BIO-TEST LABORATORIES, INC Northbrook, Illinois________ ____________ _
* 1. Subacute Dermal Toxicity of Aroclor 1221, March 28, 1963 t^ `
* 2. Acute Toxicity Studies With Aroclor 122, Aroclor 5442, and . MCS 1016, March 25, 1971 IBT No A937&.
3 Toxicity, Mutagenic, Teratogenic, Reproduction, and Residue Studies As To Various Aroclors in Rats, Chickens, Mice and Dogs - November 17* 1971
* 4 Ninety-Day Subacute Oral Toxicity Study With Aroclor 1221 In
Beagle Dogs, December 30, 1971 IBT No C9885.
TRAN 013694
STLCOPCB4029347
2-
Industrial Blo-Tcst Laboratories, Inc, (continued)
5.
6.
Four-Day static Fish Toxicity Studies With Aroclor 1221, Aroclor 5^32, Aroclor 5442, Aroclor 5^60, and MCS 1016 In Bluegills and Channel Catfish, January 12, 1972. IBT No. A9380.
90-Day Subacute Oral Toxicity Study With Aroclor 1221 In Albino Rats, April 28, 1972. IBT No. B9888.
* 7,, Toxicity, Reproduction And Residue Study With Aroclor 1221 In White Leghorn Chickens, June 20, 1972. IET No. J900.
BIOLOGICAL CONSULTANTS Royal D. Suttkus, Ph.D. Gerald E. Gunning, Ph.D. New Orleans, La.
.
* 1. Interim Report - Fish Residue Analyses dated August 15, 1971
* 2 Report covering December 1970, March 1971, June 1971 and September, 1971 - Fish Residue Data - dated June 9, 1972.
* 3. Final Progress Report, Residue Data, November 1970 to - November, 1972 via letter dated February 27, 1973. -
YOUNGER LABORATORIES ' St. Louis, Missouri
1. Toxicological Investigation of OS-93 dated February 22, 1958.
2. Toxicological Investigation of OS-95 dated October 20, 1958.
3. The Toxicity of the Thermal Decomposition Products of OS-95, dated December 8, 1958
4 Oral Toxicity (LDcq) Rats and Skin Absorption (MLD) Rabbits Various Aroclors,''dated June 25, 1962
* 'f^
* 5. Toxicological Investigation Of: Aroclor 1221 dated June 13,
1962. Monsanto Project No. Y-62-41. Oral LD50 (rats) and Skin Absorption MLD (Rabbits)
* 6 Toxicological Investigation of: MCS 1109-Lot KA 801 dated
. October 27, 1971 Monsanto Project Ho. Y-71-153 Oral LD^q (Rats, Mixed Sex) and Acute Skin Absorption Minimal Lethal Dose
(Rabbits, Mixed Sex); Skin Irritation (Rabbits, Mixed Sex); Eye Irritation (Rabbits, Mixed Sex); Vapor Inhalation (Male Rats).
IRAN 013695
STLCOPCB4029348
:3- '
MONSANTO INDUSTRIAL CHEMICALS COMPANY Applied Sciences Section St. Louis, Missouri_________________
* 1.
Determination of Polychlorinated Biphenyl Rosidues in Albino Rats from a Two-Year Chronic Oral Toxicity Study dated October, 1971 - W M Mees, E S Tucher, W. J Litschgi. Special Study 71-7. Job #1348006.
* 2
Determination of Polychlorinated Biphenyl Residues in Beagle Dog Tissues from a Two-Year Oral Chronic Toxicity Study, dated December, 1972 - W. M Mees, E. S Tucker, W. J. Litschgi, J. Cowell. Special Study 71-9* Job #13840.
* 3 Determination of Polychlorinated Biphenyl Residues in White Leghorn Chickens from a Toxicity, Reproduction and Residue Study with Aroclor 1242, Aroclor 1254, and Aroclor 1250, dated March, 1973 - W. M. Mees, E. S. Tucker, VJ. J. Litschgi, J Cowell. Special Study 71-3 Job #1348006
IRAK 013696
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* -- -Monssats . .ea.w, Medical Department A2SA
wj8C"?
October 13-, 1971 AROCLOJ^ 1260
ecnercsQ
TO :
FILE
" R. E. Kelly M. H. Johnson B. P. Wheeler
1tra.fce saw ss
I spoke with: Tel:
Renate D. Kimbrough, M.D. Pathologist EPA Atlanta Tox. Branch 4770 Buford Highway Chamblee, Georgia 303&I
(kOH) 633-3311. ext. 5218
today regarding her observation of bladder tumors In rats fed AROCLOR 1260.
The observations of Voa and Koeman (Toxicol, and Applied Pharmacol. 17, 656-668, 1970) on polychlorinated biphenyls led them to undertake rat reproduction studies with AROCLOR 1254 (Lot AX38) and 1260 (Lot AX3) Th materials were obtained from Glasgow at FDA. Their primary findings have been lesions in the liver, and Dr. Kimbrough plans to present a paper on the liver lesions at the 1972 spring, meeting of the Society of Toxicology. In addition, she
has seen 2 lesions in the bladders of rata fed AROCLOR 1260. The first occurred in a female which died after 6 months on teat. This was diagnosed as a malignant anaplastic carcinoma of the bladder. The second was In a male killed after 8 months on test. The first diagnosis was of epithelial hyperplasia. Sections of both bladders were sent to NCI for diagnosis to Drs. Strauss (?) and Katherine Snell. The diagnosis of carcinoma In the female was confirmed. The lesion in the male was not resolved. Some pathologists believe It la a carcinoma,, other* believe It is : hyperplasia.
Dr. Kimbrough stated tbs t they were trying to analyze the AROCLOR 1260 sample for impurities, but were having sore difficulty with their equipment. I Indicated that we would try to track down material from the sample that they had received. In the event that we cannot locate this lot, we probably can get some material back through Thomas B. Gaines, Supervisory Research Pharmacologist, at the same location as Dr. Kimbrough. If we have an analysis^ of' this lot, we should,
make the results known to Dr. Kimbrough.
Dr. Kimbrough said that they had observed porphyria in some rata
with both compounds. - She also indicated that they were contem
plating doing a 2 year feeding study with larger numbers cf
rats to investigate the problem of bladder tumors. She is per
plexed by the bladder tumors, and ahe is not emphasizing them
In her discussions. However, she has mentioned her findings
when PCB'a have been discussed at various interagency meetings.
This is apparrently how Weiasburg learned about them. w
1. JcrmP 1 n
DEPOSmON EXHIBIT
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DEPOSITION i | EXHIBIT
1c^vnjs)c^%~ (p
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STLCOPCB4029350
FILS October 13, 1971 Pag - 2 -
As final note. Dr. Kimbrough axpreised concern over
whether PCB'8 presented an additional hazard to the employees who manufacture it. I told here that because f the chloracne and liver hazards, there had Men medical supervision f the employees. However, I would raise this point with Drs. Kelly and Johnson for their
_
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Toxicology Sect ion/St. Louis
~tCO./DlV./DePT ./LOCATION)
~~
SPECIAL mrpc of BiPORTi
REPORT
REPORT NO.: MSL- 2002 JO&/ProjCTNO.:
DAT1: October 14, 1981
TITLE: TOXICITY OF AROCLOR PRODUCTS 12 42 , 12 54 AND 1260 TO THE LIVER OF ALBINO'-RATS '
authors: George J. Levinskas, Ph.D.
A3S7RACT: This report is a tabulation of the results of microscopic evaluation of liver sections
from rats fed AROCLOR 1242, AROCLOR 1254 or AROCLOR 1260 for two years.
STLCOPCB4029352
DISTRIBUTION
COPY NUMBER
1 - Reports Library, R2C
2 - Reports Library, R2C
3 * Reports Library, R2C
4 - DMEH Library, C2WA
5 - DMEH Library, C2WA
6 - R.T. Berendt, E2ND
7 - J.H.Craddock, A2SA 8 - C.J. Levinskas, G2WF
9 - J.G. Nassif, E2ND
'
10 - J.M. Norris, Dow Chemical
11 - R.A. Stohr, B3NJ
ABSTRACT ONLY
This report has been assigned to you. When it is no longer needed, you are responsible for returning it to:
________ REPORTS LIBRARY, R2C___________ _
If you transfer it to anyone else, please let your librarian know, so the records can b changed.
R-iO#8(C) (REV.
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INTRODUCTION
The polychlorinated biphenyls (PCBs) comprise a family of compounds of variable chlorine content. PCBs manufactured by Monsanto (tradenamed "Aroclor") bear a four digit number, the '12' indicating' biphenyl and the last two digits indicating the chlorine content by weight percent. Since the chlorine atoms are randomly distributed among the 10 ring positions available for substitution, each material is a mixture of isomers.
In 1969, Monsanto sponsored a series of animal studies at Industrial BIO-TEST Laboratories in Northbrook, Illinois, on Aroclor 1242, 1254, and 1260 for the assessment of the health and environmental hazards of these materials. This series consisted of 2-year chronic feeding studies to rats and dogs, a 3-generation rat reproduction study, a rat teratology study, a dominant lethal mutagenic study in mice and a toxicity/reproduction study in chickens on each of the 3 Aroclor products. Even though no such action was contemplated, such a broad battery of tests would have been adequate to support Food Additive Petitions for each of these materials. These studies were initiated by reports that PCBs had been detected in the environment. A report (Nelson, 1972b) by a Panel on Hazardous Trace Substances of an Ad Hoc Committee on Environmental Health Research covers the development of information on the environmental and biological effects of PCBs. There have been subsequent literature reviews which need not be recapitulated here [DHEW, 1978; EPA, 1976; I ARC, 1978; NAS, 1979; Roberts, et al. (1978)].
Starting in 1969, while these studies still were in progress, information regarding them was made available to various government groups.1 Subsequently, data from these studies were presented at a conference
COO:'.13 1
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sponsored by the National Institute of Environmental Health Sciences at Rougemont, N.C. on December 20-21, 1971, but the account of these studies was omitted from the published proceedings (Keplinger, et a1. , 1972; Nelson, 1972a).
Subsequently, it was reported that female Sherman strain rats developed hepatocellular carcinomas when fed Aroclor 12602 from Lot No. AK-3; the same lot used for the earlier Monsanto study with this material. As a result, Monsanto requested the contract laboratory's pathologists to review livers from all available rats from the 3 Aroclor studies. That review (which could have included new sections of liver from animals examined previously in addition to sections from animals not examined previously) was presented in the reports of Gordon and Richter (1975a,b,c).
In November 1975, reports containing evaluations of liver sections from the
2-year rat feeding studies (Gordon and Richter, 1975a,b,c) and the results of
an independent evaluation of the same liver sections (Pour, 1975) were
presented to and discussed with several federal regulatory agencies3. Later
that month, a summary of data from all of the studies was presented at the
National Conference on Polychlorinated Biphenyls sponsored by the
Environmental Protection Agency and held in Chicago on November 19-21, 1975
(Calandra, 1976).
Only summaries of data from these and other toxicity
studies conducted over the years have been published (Jenkins, et al. , 1972;
Keplinger, et al., 1971; Monsanto, 1980). Knowledge of these efforts may
have prompted the statement in a recent article that "...Monsanto, whose
reaction to the possibility that polychlorinated biphenyls (PCBs) might be an
ecological disaster was a classic of how such issues should be handled, says
Ford4. Monsanto began to investigate the dangers as soon as they were
2
STLCOPCB4029355
seriously voiced. It insisted on keeping an open mind about them. As soon as evidence appeared that there was a strong chance PCBs were a hazard, it published the results of its investigations, admitting the danger. It thus established a reputation of honesty even among the environmentalists." (Clutterbuck 1981).
At a later meeting in Bethesda, MD.5, pathologists selected and reviewed some liver slides from the Monsanto-sponsored and Kimbrough studies. The pathologists differed in the terminology used to classify the lesions. They did conclude that the general incidence and severity of liver lesions (hyperplasia, nodular hyperplasia and neoplastic changes - carcinomas) were greater in the rats from the study subsequently published by Kimbrough, et al. (1975). No carcinomas were seen in the Monsanto-sponsored studies. It was noted that either the strain of rat or sex could have accounted for the differences. The spontaneous incidence of hyperplastic or neoplastic liver lesions in the Sherman strain rat was unknown, and the occurrence of such lesions appears to be higher in female rats and mice.
The different diagnoses were discussed with Dr. Philippe Shubik of the Eppley
Institute for Research in Cancer at the University of Nebraska. Dr. Shubik
suggested that the liver sections from these studies could be reviewed by Dr.
Parvis Pour. This was done.
1
This publication is an effort to make readily available information in the Gordon and Richter reports (1975a,b ,c) which are only summarized in the literature (Calandra, 1976).
- 3 SCM 05 893*?
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METHODS
It appears that the Threshold Limit Value of 0.5 mg'/m3 for chlorobiphenyl with 54% chlorine (ACGIH, 1969) was used to estimate suitable dose levels for the rat feeding studies. For that purpose the following assumptions were made: if the ambient air concentration of PCBs is 0.5 mg/m3, and if all of the inhaled PCBs are absorbed, and if 15 m3 of air are inhaled during the working day, a person would receive a PCB dose of 7.5 mg/day. The corresponding dosage would be approximately 0.1 mg/kg/day for a 70-kilogram person. Consequently, dosages of 0.1, 1, and 10 mg/kg/day were decided upon, and the dietary concentrations were set at 1, 10, and 100 ppm. As it turned out, the assumptions used to set dosages for the feeding study resulted in the low dose level rats receiving a dosage that was 100 times higher than the 0.001 mg/kg/day which FDA later calculated as allowable for protracted ingestion based on human data (FDA, 1973).
For the chronic toxicity study in rats6, weanling animals of the Charles River CD strain7 were divided into a control group and 9 treatment groups, each consisting of 50 males and 50 females, with 3 treatment groups assigned to each of the 3 Aroclor products studied (1242, 1254, and 1260). Not all of these animals started at the same time. After about 2 months on test, additional groups of males and females were assigned to each test diet and the controls. These animals were added to allow ir sufficient number of animals for sacrifices at 3, 6 and 12 months to provide some information prior to the completion of the 2-year study period. 'TheHrnmbrig--&equence
SCM 053935
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aj?^4h,E^AS2n.aiifia._of,.some_aiiimals_as_.J'ix^&"~suff^sts that additional animals were* piacifLon test.
Groups of 5 males and 5 females were scheduled to be sacrificed after 3, 6, and 12 months of feeding', and survivors were to be sacrificed at the end of the test period.8 Animals were to be given a gross autopsy and tissues were to be preserved for possible histologic examination. Tumors or lesions suggestive of tumors were to be examined.
RESULTS
Data from the Gordon and Richter reports (1975a,b,c) on liver slides are shown in Tables 1, 2, and 3 for Aroclor 1242, 1254, and 1260, respectively. While the text of the reports contained comments specific to the particular Aroclor, they also contained similar comments such as "There is evidence of a chemical effect on the liver.......... This consists of a hepatocellular alteration beginning as focal hypertrophy which progresses to nodular hyperplasia, and in a few animals to hepatoma or cholangiohepatoma" and "In the absence of metastasis, invasiveness, severe basophilia, mitoses, or other evidence of anaplasia; these are benign tumors rather than malignant carcinomas. There was no evidence of metastasis or invasiveness of these tumors in this study". The reports also stated that "The other treatment-related lesions reported are regarded as degenerative or hyperplastic in nature and they are morphologic manifestations of an adaptive response of the liver associated with biotrans formation of the test maternal" and "In most instances, the spectrum of treatment-related histopathological findings in the liver from this re-evaluation did not differ significantly from that previously reported in our original report.......... No hepatocellular carcinomas were observed".
-5-
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With respect to Aroclor 1254, it was noted that "One liver tumor (a hepatoma) previously reported in a T-II animal (No. 445) was re-classified as nodular hyperplasia" (Gordon and Richter, 1975a)10.
DISCUSSION
The initial reports of these studies concluded that the target organ was the liver for each Aroclor product. This was confirmed by the second evaluation of liver slides (Gordon and Richter, 1975a,b,c). These alterations were slow to develop, their incidence being related to both dose level and duration of treatment. Since there were increased incidences of vacuolar changes in the cytoplasm of the hepatocytes and focal hypertrophy at all dose levels for all 3 Aroclor products at the 24-month sacrifice, a "no-effect" level was not established for liver effects.
With respect to the slides from Industrial BIO-TEST, Pour (1975) concluded that Aroclor 1242, 1254, and 1260 "showed a dose-dependent hepatotoxic effect, characterized by degenerative and regenerative processes. With one exception, all lesions were considered non-neoplastic. Structures similar to cholangiocarcinomas and hepatomas were found in one rat. However, the possibility of metastases of a carcinoma into the liver has been also considered." In the report, he noted one lesion which seemed to "represent a metastatic tumor (probably a mammary gland carcinoma of the same animal from which ...[the particular liver section]... was submitted), rather than a cholangiocarcinoma". This occurred in an animal fed 100 ppm of Aroclor 1254. The contract laboratory pathologists diagnosed the presence of mammary tumor metastases in the liver of this rat (Gordon and Richter, 1975b).11
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SUMMARY and CONCLUSIONS
Groups of male and female rats were fed diets containing' either 1, 10, or 100 ppm of one of 3 Aroclor products, 1242, 1254, or 1260, for 2 years. Focal hypertrophy of the liver occurred at 3, 3, and 12 months for rats fed Aroclor 1260, 1254, and 1242, respectively. Focal hypertrophy was not seen in livers of control animals. At the 24-month sacrifice, livers of animals from all dose levels of the 3 Aroclor products had an increased incidence of vacuolar changes and focal hypertrophy. Livers of some animals fed 100 ppm of each Aroclor also had benign liver tumors (hepatoma or cholangiohepatoma). No hepatocellular carcinomas were observed.
-7
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Footnotes
1. Dates of initial correspondence and contacts. October 3, 1969. E.P Wheeler to A.R. Glasgow, Division of Pesticides. Food and Drug Administration. April 8, 1970. R.E. Kelly to H. Blumenthal, Petitions Review Branch, Food and Drug Administration. April 22, 1970. E.P. Wheeler to E.J. Burger, Jr., Office of Science
- and Technology.
June 1, 1970. E.P. Wheeler to H.E. Stokinger, Bureau of Occupational Safety and Health.
2. R.D. Kimbrough, personal communication.
3. November 13-14, 1975. Council on Environmental Quality.
Environmental Protection Agency.
'
Food and Drug Administration.
House Subcommittee Manpower, Compensation, Health and Safety.
National Cancer Institute.
National Institute for Environmental Health Sciences.
National Institute for Occupational Safety and Health.
4. Dr. David Ford of Bath University.
5. At National Cancer Institute on January 21, 1975. Present were D.E. Gordon, R.D. Kimbrough, G.J. Levinskas, R.A. Squire, W.R. Richter.
.`
6. Since the events described earlier, the validity of many toxicity studies
conducted by Industrial BIO-TEST Laboratories has been challenged.
Therefore, the available raw data supplied by Industrial BIO-TEST was
reviewed to determine whether this study could be validated. The review
showed that the data bases (including the lack of a protocol) were
insufficient for a complete validation of the study. It was decided to
focus on presenting the primary liver effects reported by Gordon and
Richter (1975a,b ,c). Therefore, a complete audit was not undertaken.
Available records were examined for a determination that the animals
were placed on test and of their ultimate fate. Necropsy and microscopic
reports were also examined for findings pertaining to livers of those
animals. Significant discrepancies which were found between data in
Tables 1, 2, and 3 and the data base for the Gordon and Richter reports
are noted in this report. On some records, the labels Aroclor 1242
and Aroclor 1260 are interchanged as determined by a check of the
animal numbers.
.
7. Charles River Breeding Laboratories, North Wilmington, Massachusetts.
8. Animals sacrificed at 6 and 12 months were placed on test about 2 months after the first group. Those sacrifice periods are sometimes labeled 8 and 14 months, respectively, which corresponds to the calendar time from the start of the test but overstates the time on test for those groups.
-8 SC*
ooo:U7
STLCOPCB4029361
9. As a result of the examination described in footnote 6, a few animals were reassigned to other dose levels on basis of assigned numbers. Three with no recorded liver lesions were deleted from the 24-month listing because of short duration on test: 14 months at 100 ppm Aroclor 1242, 15 months at 10 ppm Aroclor 1254 and 13 months at 100 ppm Aroclor 1254. Therefore, numbers in Tables vary slightly from those in reports of Gordon and Richter (1975a ,b ,c).
10. That change and comments in the footnotes to the Tables were noted ' during the examination described in footnote 6. In addition, the following also were noted during the examination.
Aroclor 1254 - 100 ppm animal marked "Extra3" with diagnosis of hepatoma in record of examination for original Industrial BIO-TEST report. Animal not listed in Gordon and Richter report.
- 100 ppm animal no. 542 with gross autopsy notation that liver appears tumorous and white foci has no record of examination.
Aroclor 1260 - 100 ppm animal no. 293 with gross autopsy notation of tumor on liver has no record of examination.
In some instances, diagnoses were crossed out on the available records.
These were included in the Tables. Crossed out diagnoses for hepatoma
or cholangiohepatoma are noted in the footnotes to the Tables.
'
11. Dr. Pour's report does not include the following liver sections noted by discrepancies between his tabulation and the Gordon and Richter reports.
1 from control at 12 month sacrifice, 5 from 100 ppm Aroclor 1242 at 24 months, 1 from 100 ppm Aroclor 1260 at 3 months.
None of these animals were reported as having hepatomas or cholangiohepatomas in the Gordon and Richter reports.
SCM 0589^0
ooo:'. :3
STLCOPCB4029362
References
1. ACGIH (1969). Threshold Limit Values of Airborne Contaminants. American Conference of Governmental Industrial Hygienists. Cincinnati.
2. Calandra, J.C. (1976). Summary of toxicological studies on commercial PCB's. In: National Conference on Polychlorinated Biphenyls, November 19-21, 1975. Chicago, Illinois . EPA Report No. 560/6-75-004. March.
. NTIS PB-253 248. pp.35-42.
3. Clutterback, D. (1981). What causes environmental conflict? New Scientist90, 176-177.
4. DHEW (1978). Final Report of the Subcommittee on Health Effects of PCBs and PBBs. Environ. Health Perspect., 24, 129-198.
5. EPA (1976). National Conference on Polychlorinated Biphenyls, November 19-21, 1975. Chicago, Illinois. U.S. Environmental Protection Agency. Washington, D.C. EPA-560/6-75-004, March. NTIS PB-253 248.
6. FDA (1973). Polychlorinated biphenyls (PCB's). Contamination of animal feeds, foods and food-packaging materials. Fed. Regis., July 6, 38, 18096-18103.
7. Gordon, D.E. and Richter, W.R. (1975a). Two-year chronic and toxicity study with Aroclor 1242 in albino rats. Histopathological evaluation of additional liver sections. March 24 (unpublished observations).
8. Gordon, D.E. and Richter, W.R. (1975b). Two-year chronic oral toxicity study with Aroclor 1254 in albino rats. Histopathological evaluation of additional liver sections. March 24 (unpublished observations).
9 . Gordon , D.E. and Richter, W.R. (1975c). Two-year chronic oral toxicity study with Aroclor 1260 in albino rats. Histopathological evaluation of additional liver sections. March 24 (unpublished observations).
10. IARC (1978). Polychlorinated biphenyls. IARC Monographs on the evaluation of the carcinogenic risk of chemicals to humans. 18, 43-103. International Agency for Research on Cancer. Lyon, France. October.
11. Jenkins, D.H., Keplinger, M.L., Fancher, O.E. , Wheeler, E.P. and Calandra, J.C. (1972). Reproductive effects of polychlorinated biphenyls in white leghorn chickens. Toxicol. Appl. Pharmacol. 22, 316.
12. Keplinger, M.L. , Fancher, O.E. , Calandra, J.C. (1971). Toxicologic studies with polychlorinated biphenyls. Toxicol. Appl. Pharmacol. 19, 402-403.
- 10 -
SCM 058941 non-: * n
STLCOPCB4029363
13. Kepiinfer, M.L., Fancher, O.E., Calandra, J.C., et ad. (1972). Toxicological studies with polychlorinated biphenyls. Read at PCB Conference, Quail Roost Conference Center, Rougemont, North Carolina, 20-21 December 1971. Cited in Polychlorinated Biphenyls Environmental Impact. A Review by the Panel on Hazardous Trace Substances. March 1972. Environ. Res. 5, 249-362.
14. Kimbrough, R.D. , Squire, R. A., Linder, R.E., Strandberg, J.D., ' Montali, R.J., and Burse, V.W. (1975). Induction of liver tumors in Sherman Strain female rats by polychlorinated biphenyl Aroclor 1260. J. Natl. Cancer Inst. 55, 1453-1459.
15. Monsanto Company (1980). Polychlorinated biphenyls. PCB's. A report on Uses, Environmental and Health Effects and Disposal.
16. NAS (1979). Polychlorinated biphenyls. National Academy of Sciences. Washington, D.C.
17. Nelson, N. (1972a). Comments on research needs. Environ. Health Perspect., 1^, 181-185.
18. Nelson, N. (1972b). Chairman , Panel on Hazardous Trace Substances.
' Polychlorinated biphenyls - environmental impact. Environ. Res. 5,
249-362.
"
19. Pour, P. (1975). Histopathological reevaluation of livers for rats treated with Aroclor. August 1 (unpublished observations).
-
20. Roberts, J.R., Rodgers, D.W., Bailey, J.A., Rorke, M.A. (1978). Polychlorinated Biphenyls: Biological criteria for an assessment of their effects on environmental quality. National Research Council of Canada. Ottawa. Publication No. NRCC 16077.
SC*
OOG0 0589^2
STLCOPCB4029364
Table 1 Aroclor 1242: Primary Liver Lesions Aong Albino Rata
Sacrifice Interval Diet Level (ppm)
3 Months
0 1 10 100
Mo. Animals Examined
Findings
Vacuolar change Focal necrosis Focal lymphoid infiltration Focal hypertrophy hepatocytes Modular hyperplasia Ductular hyperplasia .Hepatoma Cholangiohepatoma
10 a 10
9
202 0i0 000 000
000 000 000 000
1
0 0 0 0
1
0 0
6 Months
0 1 10 100
10 10 8
9
1 00 1 10
030 000 000
000
000
000
0 0 0 0 0 0 0 0
12 Months
0 1 10 100
10 10 10
9
1 24
000
00 1
000 000 101 000
000
0 0 0
1
0 0 0 0
a Te ranm1
0 1 10 100
23 32 29
19
118 11 1 s 00 02 3 11 1
533 00 0
000
9
0
0 8 8
3 3b
1C
Control group ha snieal dead at 19 Booths and 2 marked "Extre". 1 ppa group has toiule dead at 19, 22, 22, 23, 23 months.
100 ppm group has animals dead at 22, 22, 22 months and 2 marked "Extra".
^ 6 8 8 0 U3S
Includes 1 animal without record of examination in original IBT report. Mot listed as hepatoma in
Gordon and Richter report but appears and was crossed out on typed tabulation for animal marked "Extra".
for other 2 animals do not appear in records of examinations for original IBT report. O We) a Diagnosis does not appear in records of examinations for original IBT report.
i
for
Diagnoses
Sacrifice Interval Diet Level (ppm)
Table 2
Aroclor 1254: Prinary Liver Lesions Aoog Albino Rats
3 Months 0 1 10 100
6 Months 0 1 10 100
12 Months 0 1 10 100
& Termina 1 0 l 10 100
Mo. Animals Examined
Findings
Vacuolar change Focal necrosis Focal lymphoid infiltration Focal hypertrophy hepatocytea Nodular hyperplasia Ductular hyperplasia .Hepatoma Cholangiohepatoma
10 10 10 10
233 01 1 000 000 000 000 000 000
1 0 1 1 0 0 0 0
10 10 10 10
'
'
1 00
0
1 20
2
000
2
000
4
000
0
000
0
000
0
000
0
10 10 10 10
1 14 000 002 004 000 111 000 000
s 1 1 2 0 0 0 0
23 30 26 26
1 1 9 13
131
S
1 20
1
0 3 4 14
1 0 3 14
563 000
4 4b
000
2C
Control group has niul dead at 19 months and 2 Barked "Extra". 1 ppm group isis animale dead at 22, 22 nth, 1 narked "Extra" and 1 other for which date of death is not recorded. 10 ppm group ha animals dead at 22, 22, 22 months.
,,100 ppm group has animals dead at 23, 23 nonths and 9 Marked "Extra".
b Include* 2 aninala narked "Extra". Diagnose do not appear in records of examination for original IBT reports.
;oco
c Both aninala narked "Extra" with nac designation. 1 without apparent record of exanination for original 1 BT report . Diagnosis for other animal does not appear in records of examinations'for original IBT report.
c n
5f Pc
Table 3 Aroclor 1260: Primary Liver Lesions Aong Albino Rats
Sacrifice Interval Diet Level (ppm)
3 Honths 0 1 10 100
6 Months 0 1 10 100
No. Animals Examined
10
SO
b SO
10
10 6
Findings Vacuolar change Focal necrosis Focal lymphoid infiltration Focal hypertrophy hepatocytea Modular hyperplasia Ductular hyperplasia
202
3
0 0 4C 0
000
0
000
2
000
0
00 1
0
11 10 02 00 00 00
Mepatoa Cho1angiohepatoma
000 000
0 0
00 00
*.Control group has animal dead at
month* and 2 Barked "Extra".
5
2 !d 2 0 0 0 0 0
9
6 0 0 3 0 0 0 0
12 Honths 0 1 10 100
10 9 10
9
1 25 000 000 000 000 1 10 000 000
3 0 0 4 1 2 0 0
& Termina 1 0 1 10 100
23 26 25 25
15 7
9
143
6
10 1
0
0 3 13
9
107
6
5 6 7 12 0 0 le /
000
4 ,h
10 ppm group has iniuli dead at 19, 22, 22 sooths and 1 Mrked "Extra".
STLCOPCB4029367
Includes 1 marked "Extra".
Worksheet show listings unde'r this diagnoais with arrow pointing to Vacuolar change column.
^ Date of death off this amiss! not recorded.
e Mo record of examination for original IBT report. Listed on worksheets for Gordon and Richter report with diagnosis crossed out.
f Includes 2 animal without record of examination for original IBT report. Diagnoses for other 5 animals do not appear in i records of examinations for original IBT report. 2 off these diagnoses crossed out on worksheets for Gordon and Richter
3Q
0 h oo
S' . .
/i ` t; u
Includes one animal with both diagnoses. Hepatoma is 1 of 2 crossed out (superscript ff).
Include 3 aniea1b without record of examination for original IBT report. Diagnosis for other aniaia1 doe not appear in
records of examinations for original 1ST report. 2 of these diagnoses crossed out on worksheets for Gordon and Richter
report a.
.
)
Toxicity and Environmental Effects of Commercial PC]
Introduction . Polychlorinated biphenyls (PCBs) are not a single chemical
entity. They are produced by chlorinating biphenyl to acheive a final product with specified properties. These products, sold under the trade name AROCLQR by Monsanto, are mixtures of chlorine-containing biphenyls with different numbers and positions of the chlorine substituents.
Over the years, a series of investigations have been conducted to assess potential health and environmental hazards of PCBs. The 3 predominant commercial mixtures (AJROCLORS 1242, 1254 and 1260) have been studied most intensively. Toxicity' tests performed on these 3 commercial mixtures were typical in scope of those designed for the evaluation and establishment of the safety of direct and indirect food additives.
It may be noted that AROCLOR 1260 no longer is produced in this country since it does not meet the physical specifications for its restricted uses. Conclusions Based on Monsanto Studies
1) As a class, the AROCLORS are relatively harmless materials for routine industrial handling under ambient
conditions. 2) Threshold Limit Values of 1 mg/m^ and 0.5 tag/m^ have
been established for materials containing average chlorine values of 42# and 54#, respectively, of the available sites.
3) The no-effect level for these materials in chronic
DEPOSITION EXHIBIT
DEPOSITION
J EXHIBIT
S'2i-8~) oo/e
SCM 019639
// 2.-9 Z
9S*
STLCOPCB4029368
.u >
rat and dog feeding studies is about 10 ppm in the diet.
No hepatocellular carcinomas were present.
4) Hie no-effect level on rat reproduction is between
1 and 10 ppm in the diet since higher levels result in
- low mating indices.
5) No teratogenic or mutagenic effects were observed
in studies with rats and mice.
6) In chicken reproduction and teratology studies,
AROCLOR 1242, which produced the most severe effects, had
a no-effect level of 2-4 ppm in the diet.
7) Acute toxicity to fish Varies from less than 1 ppm
to greater than 100 ppm depending on the specific AROCLOR
and species of fish tested.
8) PCBs containing 3 or less chlorine substituents per
molecule are reasonably biodegradable. Summary of Monsanto's Long-term Toxicity Studies on Commercial PCBs.
These tests 'consisted of 2-year (lifetime) feeding to
rats, 2-year feeding to dogs, 3-generation rat reproduction
studies with 2 litters cast per generation, rat teratology studies and dominant lethal mutagenic studies in alee. Toxicity
and reproduction studies In chickens were performed to evaluate
possible untoward effects In birds such as decreases in eggshell
thickness. In addition, biodegradation and/,tissue accumulation
studies have been conducted.
The highest dietary level (100 ppm) in the lifetime rat feeding studies produced a weight depression at 24 months
in females fed AROCLOR 1254 and liver weight increases in all
SCM 0196^0
' Q00CG7 STLCOPCB4029369
u)
groups except males fed AROCLOR 1242, As with ether
halogenated hydrocarbons, the important histopathologic
changes were present in the livers of animals sacrificed
at the end of the study. These consisted of hepatocellular
alterations sUch as focal hypertrophy, cytoplasmic lipid
changes and in some animals from the 100 ppm groups, hepa
tomas or cholangiohepatom&s. No evidence of hepatocellular
carcinogenicity of the AROCLORS was found.
In the dog 2-year studies, some slight decreases in
body weight gain were noted. At the highest feeding level
(100 ppm), AROCLOR 1260 produced an increase in serum alkaline
phosphatase activity and liver weights without concomitant
histopathologic changes. However, there was evidence of
gastrointestinal inflammatory lesions and ulcerations
which appear to be similar to those found by Allen in rhesus
monkeys fed AROCLOR 1248. (AROCLOR 1248 was an experimental
product which never was commercialized.)
In the rat reproduction studies, none of the AROCLORS
produced adverse effects in the 2 litters of the first gen
eration; In the second and third generations, there was a
reduction in the mating index at the 2 highest feeding levels
(10 ppm and 100 ppm). The ability of females to conceive,
carry the delivery process to parturition, and to successfully
nourish the young was not affected by the 3 AROCLORS. No .
changes were produced in the reproductive tracts of either
male or female rats by any of the 3 AROCLORS.
There was no evidence of teratogenic or mutagenic changes
with any of the PCBs at maximally tolerated dose levels in
SCM 0196^1
' '0000G3
STLCOPCB4029370
(> )
rats and Bice*
In the chicken toxicity/reproduction study, AROCLOP.
' 1260 was without effect at all test levels. AEOCLORS 1242
and 1254 at 100 ppm in the diet decreased egg hatchability.
In fact, poor hatchability of eggs was found from hens
fed 8 ppm of AROCLOR 1242. In addition, AROCLOR 1242 at 10 '
and 100 ppm and AROCLOR 1254 at 100 ppm were associated with
reduced eggshell thickness. Chick viability was affected
by both substances at a dietary level of 10 ppm.
Biodegradation studies were conducted using semi-continuous
activated sludge systems and tissues of rats fed PCBs were
analyzed to measure accumulation and retention of these ma
terials. These factors are influenced by the number and '
position of the chlorine substituents. Higher chlorine-con
taining members are more resistant to biodegradation and they
accumulate more readily and are less readily metabolized and/or
excreted from lipoid tissue in animals. PCBs containing 3 or
less chlorine substituents per molecule are reasonably biode
gradable.
Comments
The conclusion that "No evidence of hepatocellular car
cinogenicity of the AROCLORS was found" in the 2-year r&t f_ `
feeding study was reached only after extensive re-evaluation
of the original liver slides as well as additional liver
.
sections from all of the animals after the Kimbrough results
on AROCLOR 1260 became known to us. The slides ware read
SCM 019fa4#2 000000
STLCOPCB4029371
independently by Dr. D. Cordon of Industrial BIO-TEST Labora
tories., Professor W. Richter of the University of Chicago, &nd
by Professor P. Pour of the Eppley Institute for Research in
Cancer. In addition, Dr. Pour evaluated the Kimbrough slides
and does not agree with the reported findings.
Barsotti and Allen have reported that 2.5 ppm of AROCLOR
1248 in the diet of rhesus monkeys adversely affected repro
duction. This approximates a dosage of 100 pg/kg/d&y. It
is higher than the safe human Intake (1 ^g/kg/day) estimated
by FDA from-human data when it promulgated its tolerances for
PCBs in food.
Ox
SCM 0196^3
000070
STLCOPCB4029372
0U
)
Human data
(F.R. July 6a 1973. p. 18097, Section (2))
Lowest level of PCBs producing effect in man - 500 g total.
500 ag consumed by 50 Kg individual over 50 days
500 og 4. 50 kg 1 5D days 200 u&Ag/day (effect level)
. Using 10-fold safety factor leads to estimate that 20 yg/kg/
day my ha-safe over a fjO-day interval
Since PCBs have long half-life; calculating same Intake over
a 22-month span arrives at aa, estimated safe intake for & pro
tracted period of 1 ugAs/day.
'
' Primate data
(Fed. Proc. 34:338 (1975) Abstract 675. B&rsotti k Allen)
At 2.5 ppm in diet, primates ingested 182 mg over 52 weeks-
182 ag jl 365 days 0.5 mg/day which produced effects.
Assuming 5 kg primate, 500 ug 5 kg 100 ugAg/d&y
Conclusions: Primate study done at dosages (100 ugA&Aay)
greater than the safe dosage (1 ug/kg/day) esimated from human
data-
'
Primate study does show effects at lower dosages over longer
time span (100 ugAg/365 days) than had been observed in man '
(200 ygAg/50 days). The to Cal amount of PCBs producing effects in primates (l89
ag) was lower than that producing effects in man (500 mg).'
(N.B. Abrahaason & Allen, Env. Health Perspectives. June, 1973 bl-86. Report that infant monkeys are aole to tolerate doses of PCBs that produce extreme morbidity in adult monkeys.)
' Dog and Rodent Data
(F.R. July 6, 1973. p. 18097, Section (1))
"No-effect" level for man using a 100-fold safety factor and
accepting 10 ppm as a "no-effect" level in animals would be
2.5 ^gAg/day based on dog data and 3 ugAfi/l&y based on rat
data.
' ' `'
-
' .. If rat data "no-effect" level drops to 1 ppp, then corres
ponding estimate of human "no-effect" level "drops to 0.3 u&/
kg/day
,,
Question: In & "collision between rat data using a 100-fold
safety factor and human data using a 10-fold safety factor,
which data base would you like to be riding cnf
Comment: Since human data is available, it could be argued
that the traditional 100-fold safety factor is not necessary.
Application of a 30-fold safety factor to rat data, supported
by dog and human data, makes present estimate of safe human
intake appear reasonable
SCM 0196^4
000071
STLCOPCB4029373
PCB primate and Human Residue Data,
Cone- in diet, ppm Intake, ugAg/day
Estimated safe dose, ugAg/d&y
Liver eone.,ug/g Pat cone., ng/g
Primates
25
Boo
loo2.5
56.3(0.01) 50.0(27.7)
Value in ( ) from infant primate. Allen et al., TAP 30: 440-451 (1974)
Yobs, Errr. Health Persp. ,79-81, April 1972
Hucan
--
/
-, . 0 (314 samples * <1 (125 samples 1-2 (165 samples >2 (33 samples)
SCH 0196^
000 o\ j rd ! STLCOPCB4029374
PROGRESS REPORT
ORGANIC CHEMICALS DIVISION TECHNOLOGY Df PAHTMENT
Ihil rtocvinrrtl It ihc paoisrtty ot MONSANTO COMPANY. It rawittsim CONFIDENTIAL INFORMATION which rmitt not be reiKoHoced,
revupted to unnutlMircd persons ot wnt outside Hie Company without ptoprt ulhotiielion. The recipient Is responsible lot Its safekeeping nri
dtr.titiction.
.
UjJsTRICTKD TO:
t)\Sl KIDUl ION
H. S. Bergen T. M. Patrick 0. D. Hinchen R. E. Keller R. H. Munch W. B. Papageorge
WITH t)f l AILS
C. W. Roos V?. R. Richard F.. P. Whecler/G. Lcvinskas E. S. Tucker/W. M. Mees/W. J. Litschgi
^7
i-fio;i c t 111 r ENVIRONMENTAL ANALYTICAL PROGRAM - TOXICOLOGY SUPPORT STUDIES
i-l.fJI t 1 OhJt Cl IVF
"'etennination of the type and level of polychlorinated biphenyls (PCR's)
otained in the tissues of laboratory animals fed Aroclor 1242, Aroclor
1254, Aroclor 1260, Aroclor 1016, and Aroclor 1221 for correlation with
toxicological effects.
SUMMARY
The PCD residue levels found in selected chicken tissues and eggs from the "Toxicity, Reproduction, and Residue Study of Aroclor in White Leghorn Chickens" (IBT J7300) were sudjected to a multiple regression analysis. The statistical analysis was used to develop an equation for predicting the PCD residues in the remaining tissues. From the predicted PCB residues the following conclusions were drawn.
Tne average PCB lipid storage level found in the tissues (male and female), for each product after six months exposure are shown in the following table.
Feed Level
Aroclor 1242 Aroclor 1254 Aroclor 1260
.
PCB Lipid Storage Level (PPM)
1 PPM
10 PPM
28 196 53 317 65 417
100 PPM
2356 4080 5176
Tissue and sex differences were also apparent in the data; the following patterns were observed?
1) At low exposure, muscle>fat>1iver. 2) At high exposure, muscle>liver^fat. 3) All cases, n.a Ie> f emttl e .
COMPANY
TRAN 022439
CONFIDENTIAL
STLCOPCB4029375
2-21-760.01-13430, 8SOI0, 85050 Page No. 2
PCB residues in the muscle, fat and egg tissues from animals fed the 30-day recovery .diet were significantly lower, while the PCB residues 'in the liver were only slightly less. Remobilization of the residues in the animals subjected to the highest exposure was noticeably slower.
Muscle and liver tissues have been excised and composited from the 30day chicks collected during this study. Analysis of these chick tissues has been completed and the PCB residues are being calculated at this time.
Analysis of selected chicken tissues, 30-day chick tissues and eggs from the supplementary study (IBT 8746) with Aroclor 1242 at lower exposures
has been completed. The complete clean-up procedure was required with the chicken tissues to remove several interferences to the accurate quantitation of the PCB residues on the EC/GC. The PCB residues are being calculated for comparison with the predicted residues from the equations developed in the study (IBT J7300) above.
Analysis of the tissues from dogs fed Aroclor 101.6 and 1221 is complete and the PCB residues are being calculated. The complete clean-up procedure was again required to remove several interferences to the quantitation of the PCB residues, confirming our experience with the two-year dogs. Extensive alterations of the homolog distributions of those loss chlorinated products are being observed on the EC/GC chromato grams .
Analysis of the tissues from rats fed Aroclor 1016 is complete and the PCB residues are being calculated. An abbreviated clean-up procedure, an alumina column treatment, was sufficient to remove any interferences to the quantitation of the PCB residues in these rat tissues. Again extensive alterations of the homolog distribution of this product are being observed.
With the rats fed Aroclor 1221 low levels of PCB residue eluting in the
Aroclor 1260 region of the chromatogram were observed. At these low
levels several interferences become significant and the extracts
required the complete clcan-up procedure before accurate quantitation of
the PCB residues could be carried out. Analysis of the rat tissues is
complete and the PCB residues are being calculated. r'-
''
The EC/GC procedure for PCT's has been extended to biological samples. Using chloroform for the extraction solvent, recoveries of 85% or batter were achieved. Selected samples from the 90-Day Subacute Toxicity Studies of Aroclor 5432 and 5442 in rats and dogs have been extracted. EC/GC analysis of the extracts and calculation of the PCT residues should be complete by 3-15-72.
Analysis of the samples from the Subacute Toxicity Studies of Aroclor 1016 and 1242 in catfish and bluegi3 Is have been started. These studies, encompassing seven levels of exposure in the range of 0.014 ppm to 0.300 ppm, were carried out at Bionomics, Inc. of War chain, Massachusetts.
''
COMPANY CONFIDENTIAL
than 0ZZh^0
STLCOPCB4029376
2-21=760.01-13480, 85030, 85050 e Pago No. 3
JTURI2 PLANS .
Anal ysis of selected tissue samples for tne level and type of PCB residues retained' from the following feeding studies carried out by `Industrial Bio-Test Laboratories.
90-Day Subacute Oral Toxicity Study of MCS 1109 with Beagle Dogs
90-Day Subacute Oral Toxicity Study of MCS 1109 with Albino Rats
Tissues Available 2-15-72"
2-15-72
Toxicity, Reproduction, and Residue Study of Aroclor 1016 with White Leghorn Chickens
,
7-72 '
Toxicity, Reproduction, and Residue Study of Aroclor 1221 with white Leghorn Chickens
'
7-72
db 2-2-72
W. M. Mees E. S. Tucker
COMPANY CONFIDENTIAL
'
TRAN 0224-41
STLCOPCB4029377
PROGRESS REPORT ORGANIC CHEMICALS DIVISION
TECHNOLOGY DEPARTMENT
CMU? *1T
iKs o
a*
^4e
1* . ^ r
biO C &
W. J. Litschgi
J. D. Hinchen
LDCA1
E. S. Tucker
r or 06 T AIV.B NovemberDecember 1971 NO
JO NOS
St. Louis - South Second Street
2-21-760.01-13480/
DEPOSITION EXHIBIT
&CL. /ar8
//- z - 9z
no. DATE
4 11-30-71
85010, 85050
TMe tJt*cv>rrcnl U bc fMC'peilv el MONSANTO COMPANY. It e^otsini CONFIDENTIAL INFORMATION w.hich mull not bn rep-edac'tl,
to unaotliofl/ed persons cm wnt outsida the Componv without proper outhorlioticn. The reciptcnt Is responsible (or its Mlekecping end
stelruction.
.
DIST R I6LIT ICN
WITH DE T AILS
R1 ^TiaCTCDJLO: s=-=
IaI
CGRFIBEIT !A1
h. S. Bergen t . M. Patrick
J. D. Hinchen R. E. Keller
.
R H. Munch W. B. Papageorge
Co W. Roo5 W. R. Richard E. P. Wheeler/G. Levinskas E. S. Tucker/W. M. Mees/W. J. I itschgi
phoji n nut
'
ENVIRONMENTAL ANALYTICAL PROGRAM - TOXICOLOGY SUPPORT STUDIES
Determination of the type and level of polychlorinated biphenyls (PCB's) retained in the tissues of laboratory animals fed Aroclor 12.42, Aroclor "'254, and Aroclor 1260 for correlation with toxicological effects.
SUMMARY
.
Analysis of selected tissue samples from the "Two Year Chronic Oral Toxicity Study of Aroclor in Beagle Dogs" has been completed and the data subjected to a multiple regression analysis. The predicting equation obtained indicated that, relative to the two rat studies completed earlier, there was more scatter in these data points. This increased variability is under standable in light of the fact that much lower storage levels were observed and that the tissue samples from the recovery sacrifices were from individual animals rather than the. group composite samples analyzed in the rat study.
The analysis of several addition selected samples reduced the equation's variability to an acceptable level and the storage levels, in the remaining tissues were calculated. Even with the analysis of the 'several additional, samples, a savings of ^$3700 was realized.
The following conclusions were drawn from the data. The average PCB lipid storage levels found in the tissues for each product after two years exposure are shown in the following table.
Feed Level
Aroclor 1242 Aroclor -1254 Aroclor' 1260
PCB Lipid Storage Level (PPM)
1 PPM
10 PPM
35 6 18 13 86
100 PPM
16 109 .. 579
COMPANY CONFIDENTIAL
TRAN 022437
STLCOPCB4029378
2-21-760.01-13480, 85010, 85050 Page No. 2
It should be noted that the above storage levels are at least an order of magnitude less than the storage levels observed with the rats.
The storage levels in the animals placed on the recovery diet decreased to approximately one-half the 24 month storage level in 60 days.
Alterations of the homolog distributions were observed with all of the
products fed and were much more extensive than previously noted in any of
the other tissue residue studies.
.
Selected tissue samples from the 'Toxicity, Reproduction, and Residue Study of Aroclor in White Leghorn Chickens"(IBT J7300) have also been analyzed and the data subjected to multiple regression analysis. Acceptable equations for predicting tissue residues and egg residues were determined, and the tissue storage levels predicted in the remaining samples. The excising, compositing and analysis of the chick samples collected from this study will be completed shortly. A savings of ^$8000 in analytical costs was realized using regression analysis and selected data points.
Samples from the "Toxicity, Reproduction and Residue Study of Aroclor 1242, Lot AK-255 in White Leghorn Chickens" IBT 18746, have been located in Bio-Test's freezer in Chicago. Bio-Test is presently identifying these samples with our matrix numbers and expects to be able to ship these samples to us the week of 12-L6-71.
Tissue samples from the "90 Day Subacute Oral Toxicity Studies" with Aroclors 1016, 1221, and 5442 in dogs and with Aroclors 1016, 1221, 5432,. and 5442 in rats have been received at South Second Street. Tissues from the 90 day study with Aroclor 5432 in dogs are to be shipped by Bio-Test as soon as possible. Tissues from the remaining 90 day studies with MCS 1109 in both beagle dogs and rats will not be available before 2-15-72.
The tissues in hand from the animals fed PCB's are being analyzed at this time.
The tissues from the animals fed PCT's arc awaiting extension of the PCT
methodology to biological samples (recovery data) oTissues from all
remaining studies will not be available before 1-15-72.at the earliest
and in some cases not until 2-15-72.
'
FUTURE PLANS
Analysis of selected tissue samples for the level and type of PCB residues
retained from the following feeding studies carried out by Industrial
Bio-Test Laboratories.
.
COMPANY CONFIDENTIAL
TRAN 022^38
STLCOPCB4029379
T I t Cj B Y
PROGRESS REPORT
ORGANIC CHEMICALS DIVISION
" W. M. Mees
TECHNOLOGY DEPARTMENT
P o* .
rD-S T jAeUz.sSssu.\jrrzi*-irR=o-n3Tr=mrsq-r* O* T &
W. J. Litschgi E. S i- Tucker
October 1971 YES
3 10-29-71
i, oc * 1
.
St. Louis - South Second Street
JO NOS 2-21-760.01- 13480, 85010, 16300
thit <Sotun*ent Is sh( propsrsy of MONSANTO COMPANY. Ii contains CONFIDENTIAL INFORMATION which must not ba rtproducsd,
rtveelad to wnsuthotiied pstsons Ot writ outside the Company without proper suthofitstion. The recipient is mponsiWe lor its safekeeping n<J
destruction.
.
RESTRICTED TO; ~
DISTRIBUTION
___________
H. S. Bergen M. We Farrar *P. B. Hodges W. K. Johnson *R. E. Keller *R. H. Munch *W. B. Papageorge
WITH OE 1 AILS
T. M. Patrick *W. Re Richard *C. Wo Roos
J . E. Springgate *E. S. Tucker/W. M. Mees/W. J. Litschgi *E. P. Wheeler/G. J Levinskas
I AOJCCT UtLl
ENVIRONMENTAL ANALYTICAL STUDIES -
RESEARCH AND DEVELOPMENT, MANUFACTURING AND OUTSIDE SUPPORT STUDIES
enojit i o Bje c t i vc
Identify, locate and assess the magnitude of Aroclor pollution problems, help determine what needs to be done to control pollution sources, verify the effectiveness of proposed pollution control procedures, guide develop ment of recycle and/or disposal methods, and provide collaborative data or legal and regulatory purposes.
SUMMARY
PCB's typical of our Aroclor products have been found at levels below and above recommended guidelines in:
Coated paper and paper coatings
Machine oils and plant effluents from one customer? manufacturing site
Fourteen Monsanto Industrial Chemical Company products from four
manufacturing sites
.
Chicken Chow used as feed by Industrial Bio-Test Laboratories
Sewer effluents from one Monsanto Plant site
Tissue turkey extrabts from the U.S.D.A.
Two competitive products.
Cr&PANY COnFIDNTial
TRAN 022427
a . p e tr v a.?*
DEPOSmON
EXHIBIT
P/P4 /Q79
STLCOPCB4029380
2-21-760,01-13480, 85010,1630U Page 2
PCT's typical of Aroclor 5432 were found in:
Plant effluent samples from one customer manufacturing site.
A table showing -the sample sources, types, and the level and type of Aroclor found as well as the support objective is presented in the details section.
Additional external and internal support has been provided in the form of:
An on site methodology review for F. B. Chamberlin (Director of Research and Development) and R. M. Wilkinson (Senior Project Manager) representatives of the Alton Packaging Division, Alton Box Board Co.
PCB Seminar presentation on analytical methodology for the Research Counci1 of Poultry and Egg Institute of America in Chicago, 111.
8 PCB problem and progress review for T. Katayama (Marketing Manager)
and S. Uneno (Product Director) from Mitsubishi Monsanto Chemical
Co.
Preliminary write up of methods for the determination of PCB's in Santoguin and CaMHA.
8 Evaluation of PCB perchlorination for quantitation of altered PCB residues.
- Analysis of Monsanto and Competitor Aroclor products for poly chlorinated dibenzofurans.
8 General internal and external analytical consultation.
Distribution of Aroclor methodology and reference standards.
FUTURE PLANS
PCB Analysis
1. Three to four J. F. Queeny monthly composite sewer effluent samples.
2. Forty-six machine oil and plant effluent samples from Saginaw Grey ' Iron Casting Plant, Chevrolet Motor Division.
3. Two oil samples skimmed off trade waste settling tanks from Buick Motor Div., General Motors Corp., Flint, Mich. (2 samples).
4. Four coated paper samples from Champion Papers, Hamilton Mill, Hamilton,
Ohio (4 samples) .
/, `
5. Four fluid samples from an imported VW automobile.
6. Five ACL-59 samples from the W.G. Krummrich Plant.
7. Three raw material samples from P.P.G. Industries.
8. Twelve film and paper extracts from St. Regis Paper Co.
9. One fish from a stream associated with a General Electric Plant.
10. Five intra-lab method check samples from a General Electric Plant Laboratory.
COMPANY
TRAN 022428
CONFIDENTIAL
STLCOPCB4029381
! . 2-21-760.01-13480, 85010, 16 3 0( Page 3
PCT Analysis 1. Ten plant effluent samples from Monsanto1s Anniston plant. 2. Saginaw Foundries, Chev. Motor Div. plant effluent samples. I
:IIt v I 1 ; W. J. Litschgi l
E. S. Tucker
COMPANY CONFIDENTIAL
022^9
STLCOPCB4029382
DET
Sample Source General Motors Corp., Buick Div,
Champion Paper Company
TABLE I
2-21-76001- 80,
85010, 16. j
Page 4
CUSTOMER SERVICE
Sample Matrix
Machine oils
Drainage streams around plant
No. of Samples
11
2
Level Found
Associated ' Aroclor
Per Cent A-1242
PPB
A-1242
Support Objective Pollution Control Pollution Control
Paper (writing)
Paper Coatings (Micron II)
3 PPM
A-1242 \
Per Cent A-54 3 2 1
3 PPM
. A-1242 1 Pollution Control
Per Cent A-5432 /
Jo F. Queeny
MANUFACTURING SUPPORT
Sewer effluent composites
HC1
5 PPB 1 PPB
A-1242 A-1242
\ / Pollution Control
J. F. Queeny, W. G. Krummrich, Del, River, and Everett
Finished Products
Ag. Division, Nitro
Santoquin CaMHA
o
Qo
5s o
*None Detected
a%
. 28 N.D.* to A-1242 PPB
COMPETITIVE PRODUCTS
6 PPB 3 PPB
A-1242 A-1242
Determination of level and sources of contamination of competitive animal feed additives
(Cont'd on next page)
TRAN
DET/^-LS (Cont'd)
Sample Source
Inter-Laboratory Round Robin (WGK, JFQ and Anniston)
Bio-Test
Laboratories,
Chicago, 111.
RESEARCH AND DEVELOPMENT
Sample Matrix
No. of Samples
Level Found
Distilled water
7 PPB to
spiked with known
PPM
quantitites of
Aroclor
Raiston-Purina Chicken Chow .
2 PPB
Associated Aroclor
A-1242 A-1254 A-1260
A-1242
USDA
Turkey Extract
1
A-1248
2-21-760.01- iO;
85010,, 15300 Page 5
Support Objective
Insure the maintenance
of precision and accuracy
in Monsanto laps analyzing
for PCB's
1
Determination of PCB back ground in feed used in the toxicity studies being performed at Bio-Test
Determination of type of PCB and how the PCB contamination occurred
a
oo So
O -n o fTI > f\J 33
STLCOPCB4029384
2-21-760.01-13480, 83010 / 16300
Page 6
DETAILS (Cont'd)
- - - Customer Service General Motors Corporation - Buick Division
Due to increased pressure from the Michigan State Regulatory Agency concerning PCB releases into the environment, Monsanto was requested to analyze samples of Buick's plant effluent and nearby drainage stream. At the same time, samples of oil used in their presses and machines were submitted to determine residual PCB levels remaining after Buick switched from Pydraul 312 to Pydraul 312A.
Sample Description
Water from trade waste prior to Hickory stream
Water from Hickory rain stream prior to river
Level Found
8 PPB 15 PPB
13 PPB <5 PPB
Aroclor
A-1242 , A-5432
A-1242 A-5432
Machine Machine Machine Machine Machine Machine Machine
fl 12 13 14 15 18 19
Trim Press Trim Press Trim Press Trim Press
11 12 18 19
14.8% 2.5%
13.8% 8.9% 3.9% 4.4%
24.3%
11.0% 0.9% 0.8%
16.8%
A-1242 A-1242 A-1242 A-1242 A-1242 A-1242 A-1242
A-1242 A-1242 A-1242 A-1242
Champion Paper Company
Coated paper and the used coating (Micron II) samples submitt<
Champion Paper Company were analyzed to determine the level o:
PCB's in the PCT's used In the paper coating fluid.
f^ `
Sample Description
Level Found
Aroclor
Paper - 3866F
203 PPM 0.29%
A-1242 A-5432
Paper - 3878P Paper - 3758M Micron II - Sample fl Micron II - Sample 12 Micron II - Sample 13
140 PPM 0.25%
217 PPM 0.28%
242 PPM 0.48%
331 PPM 0.75%
211 PPM 0.56%
A-1242 A-5432
A-1242 A-5432
A-1242 A-5432
A-1242 A-5432 A-1242 A-5432
gz
9CL LU
2
oO
o
LzL
c
4"
IN)
o
X <
aC
STLCOPCB4029385
2-21-760.01-13480, 85010 9 16300
Page 7
DETAILS (Cont'd)
Manufacturing Support
J. F. Queeny Plant
Sample Description
Level Found
Clean Acid Sewer (August) DA Sewer (August) MSD Gatewell (August) Clean Acid Sewer (September) MSD Gatewell (September)
19 PPB 29 PPB 77 PPB
3 PPB 31 PPB
Aroclor
A-1242 A-1242 A-1242 A-1242 A-1242
The DA sewer (August) was supposed to be the Clean Acid Sewer (August) spiked with ^20 PPB A-1242. As can be seen, our results reflect only a 501 recovery. Discussion with the J. F. Queeny pollution group is planned in an effort to resolve this problem.
Monsanto Industrial Chemicals Company
.
The following Monsanto Industrial Chemicals Company products have been analyzed for PCB's to determine if any of them were significantly contaminated with PCB's.
Sample Description
Level Found
Aspirin QA-1187 9-13-71 Aspirin QA-1213 10-4-71 Maleic Anhydride QA-1295 9-16-71 Maleic Anhydride QA-1333 10-6-71 Sodium Saccharin QA-153 8-31-71 Sodium Saccharin QA-168 9-11-71 Saccharin QA-209 5-5-71 Saccharin QA-1012 6-23-71 Vanillin USP Ba|1025 Vanillin USP Bail027 Tall Oil Rosin Rec'd 1-25-71 Tall Oil Rosin Rec'd 5-25-71
CDP-0R17 5000 14 CDP-04175000 13 KA-79 S-334F EUT IA-134 10-4-71 S-334F EUT lA-135 10-4-71 S-711 "A" Line 10-6-71 S-711 "B" Line 10-6-71
S-160 DA-614 S-160 DA-803 D.R. HFt-4 0 11 Stg Tk 10-7-71 HB-40 13 Stg Tk 10-6-71 AA-275C Biphenyl AA-194 9-27-71 Biphenyl 12 Stg Tk 10-6-71 Santowax R 10-6-71 Santowax R Rcc'd 9186 10-7-71
N.D. N.D. N.D. N.D. N.D. N.D . 0.03 PPM 0.02 PPM 0.20 PPM 0.18 PPM N.D. N.D. 0.17 PPM 0.12 PPM 0.26 PPM 0.21 PPM. 0.27 PPM 0.36 PPM 0.36 PPM 0.35 PPM N.D. N.D. 0.67 PPM 0.15 PPM N.D. N.D.
Aroclor
A-1242 A-1242 A-1242 A-1242
A-1242 A-1242
A-1242 A-1242 A-1242 A-1242 A-1242 A-1242
A-1242 A-1242
COMPANY CONFIDENTIAL
TRAN 022433
STLCOPCB4029386
DETAILS (Cont'd)
Sample Origin Thompson-llayward Chemical Co, H1C 7-21-71 Traveler's Rest Traveler's Rest Rexolin Chemical SNS 8-30-71
2-21-760.01-13480, 85010,
16300
Page 8
Competitive Products
Sample Description Ethoxyquin (66.7%)
Neoquin Santoquin Emulsion Santoquin Mix 6 Ethoxyquin (100%) Abiquin
Level Found
749 PPB
Aroclor A-1242
.184 PPB 151 PPB 570 PPB 155 PPB
133 PPB
A-1242 A-1242 A-1242 A-1242
A-1242
Our detection limit based upon observed background and sample was "50
Roche Ag Lot 2-4-71 Mfgd by Degussa
DL-Methionine
2.5 PPB A-1242
Upland, Calif. A3NG, SNS
DL-Methionine
21.4 PPB A-1242
Thompson-Hayward Chemical Co.
DL-Methionine
45 PPB
A-1242
These samples were analyzed to determine if products in competition with Monsanto's Santoguin and CaMHA were also contaminated with PCB's. In all cases, they were found to contain an equal or greater level than the corresponding Monsanto products.
Methods for the determination of polychlorinated biphenyls in Santoquin (Organic Research Method 71-26) and CaMIlA (Organic Research Method 71-27) have been written and will be sent to the Nitro plant where they will be used to monitor their Santoquin and CaMHA production.
- Research and Development
Analysis of Chicken Feed from Bio-Test
T- `
The chicken feed used in the Bio-Test toxicity studies was purchased from the Ralston-Purina Company. In the past months, attention has focused upon the fact that Ralston's feed has, in some instances, become contamin ated with PCB's. For this reason, two samples of the feed used in the chicken feeding studies were analyzed for PCB's.
Sample Origin
WCRF-1 WCRF-II
Sample Description
Chicken Feed Chicken Feed
'.Level Found
240 PPB 263 PPB
Aroclor
A-1242 A-1242
COMPANY CONFIDENTIAL
TRAN 022434-
STLCOPCB4029387
DETAILS (Cont'd)
2-21-760.01-13480, 85010,
16300 Page 9
USDA Turkey Extracts
A USDA extract of a PCB contaminated (Swift) turkey tissue sample was
submitted to our laboratory to see if we could establish what original
Aroclor product caused the contamination and possibly the type of
exposure. Using EC/GC and GC/Mass, we were able to determine that
(3) PCB8 s were really present, (2) Aroclor 124 8 was most probably the
product involved, and (3) the birds either received a large single
dose early in their lives or more probably a lower dose over an extended
period of time.
'
PCT Methodology Status
A method has been developed and presently is being written (Analytical Method f71-37) for analysis of water and SCAS sludge samples for PCT's. Recovery data obtained from samples spiked with A-5432 and 54 60 were essentially quantitative at a concentration level of >2 PPM.
This method is currently being used to analyze samples from the bio degradation studies and is at the same time being adapted for use on customer service and tissue samples.
Inter-Plant Round Robin
In order to establish the accuracy and precision of the PCB analysis being carried out in Monsanto laboratories, duplicate sets of spiked water samples have been analyzed by Anniston, WGK and Applied Sciences. The results were as follows:
PPM PCB (Spiked) A-1242 A-1254 A-1260
3W 2W 3W 4W 5W 6W 7W* 8W*
0.57
0.57 5.68 5.68
-
1.04 0.10 1.04 0.52 0.10
1.27 -
-
Anniston A-1242 A-1254 A-1260
1W 2W 3W 4W 5W 6W 7W* BW*
0.78 0.45 54 9.9
--
0.4 8.4
0.75
2.95
0.03 0.2
**"
-
--
2oX8
=* --
OB
Applied Sciences A-1242 A-1254 A-1260
WGK A -1242 A -1254 A-1260
0.74 0.86 1.07 5.25
-
0.92
0.92 0.07
0.52 0.06 0.06
-
1.04
1.05
-
-
0.57
0.15
-
6.70
-
2.84
-
6.55
1.20
-
-
-
0.07
-
- ---
f^ p . 80
-
4.16
Applied Sciences 7W * 3W
WGK
7W = 1W
8W = 4W
COMPANY
CONFIDENTIAL
Anniston 7W *= 2W
8W = 5W
TRAN 022435
The data have been submitted for statistical analyses.
STLCOPCB4029388
DETAILS (Cont'd)
2-21-760.01-13480, 85010, 16300
Page 10
National Broiler Council Intra-Laboratory PCB Methodology Check
Ten sets of soybean oil and chicken fat were prepared by Monsanto and distributed by Ralston-Purina to government and industrial laboratories analyzing samples for PCB's. The objective of this intra-laboratory check is to establish the validity of the different PCB methods currently being employed.
Listed below are the labs responding, however the individual laboratories
were not identified.
.
Results PPM
IS
2S
3S
4C
5C
6C
Spike Level
0
Lab A
0.25
Lab B
0.61
Lab C (Applied 0 78
Sciences)
*
Lab D
11)0.10
#2)0.10
Lab E
0.73
Lab F
0.32
Lab G
<0.10
Lab H
1.10
Lab I
Lab J
WGK
Anniston
0.38
5.0 5.31 3.7
5.78 4.17 3.58 4.40 5.10 2.9 1.5
1.54
2.5 2.56 3.0
3.64
1.81 1.83 2.24 ' 2.91 2.0 <0.6 No Report NO Report NO Report 0.61
5.0 4.00 1.8 .
4.13
2.05 2.18 2.42 2.62 3.0 <0.6 Received Received Received 0.57
5.0 5.06 4.2 4.08 2.05 2.09 2.68 2.66 3.6 5.5
0.14
2.0 3.86 2.1 3.26 1.53 1.55 2.14 2.22 2.9 5.0
*--
The results of this inter and intra sample exchange will be submitted for statistical analysis as soon as all laboratories have reported
Chlorodibenzofurans in PCB's and PCT's
Chlorodibenzofurans Found
Sample Description
Prodelec Phenoclor DP6 Prodelec Phenoclor DP6 Bayer Clophen A60,Lot 931134 Kaneclor KC-300 Shizuki,
July 1970 (Composition similar to A-1242) Monsanto A-1242,Lot AK-255 Monsanto A-1254,Lot AK-38 Monsanto A-1260,Lot AK-3 Monsanto MCS-1016,Drum B Monsanto. MCS-1016,KA-708 Monsanto A-5442,Lot AI-9
<4Cl/Mol.
ND(<2 PPM) ND (<2 PPM) ND (<2 PPM)
4Cl/Mol.
Detected Detected Detected
5Cl/Mol.
Detected (15-30PP! Detected (15-30PP' Detected
ND (<2 PPM)
ND(<2 PPM) ND(<2 PPM)
ND (<2 PPM) ND(<2 PPM) ND (<2 PPM) ND (<2 PPM) ND (<2 PPM) ND (<5 PPM)
ND (<2 PPM) ND(<2 PPM) ND(< 2 PPM) ND(<2 PPM) ND (<2 PPM) ND(<5 PPM)
ND (<2 PPM) ND {<2 PPM) ND (<2 PPM) ND(<2 PPM) ND (<2 PPM) ND(<5 PPM)
COMPANY
CONFIDENTIAL
TRAN 022436
STLCOPCB4029389
1 COMES NOW THE WITNESS, GEORGE 2 J. LEVINSKAS, and having read the foregoing 3 transcript of the deposition taken on the 2nd 4 day of November, 1992, acknowledges by 5 signature hereto that it is a true and 6 accurate transcript of the testimony given on 7 the date hereinabove mentioned. 8 9 10 11 12 13 1 4 Subscribed and sworn to before me
1 5 this JIM. day of CJ)^EmbjEjr , 1992.
16 1 7 My Commis sion expires: 18 19 20 21 22 2 3 HOTAW PUBLIC STATE OF MISSOURI
3T LOUIS COUNTY 24
2 5 ORIGINAL
GORE REPORTING COMPANY - ST. LOUIS, MISSOURI 10 3
STLCOPCB4029390
DEPOSITION CORRECTION SHEET
In Re: 7<?M>SM'S72/?/ P/Pg^/VIT CO. *S.
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STLCOPCB4029391
DEPOSITION CORRECTION SHEET
In Re:
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Upon reading the deposition and before subscribing thereto,
the deponent indicated the following changes should be made:
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STLCOPCB4029392