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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C. 20460
OFFICE OF SOLID WASTE AND EMERGENCY RESPONSE....
MEMORANDUM
DATE: November 15, 1990
SUBJECT: Criminal Investigation of Monsanto Corporation - Cover-up of
Dioxin Contamination in Products - Falsification of Dioxin
Health Studies.
FROM: Cate Jenkins, Ph.D., Chemist Regulatory Development Branch
(OS 332) Characterization and Assessment Division.
TO: John West, Special Agent in Charge Office of Criminal
Investigations Center U.S. Environmental Protection Agency
Building 53, Box 25227 (303) 236-5100 Kevin Guarino, Special Agent Office of
Criminal Investigations National Enforcement Investigations Center, EPA
As per our meeting yesterday, I am summarizing information available to
me supporting allegations of a long pattern of fraud by Monsanto
Corporation. The fraud concerns 2,3,7,7-tetrachlorodibenzodi (dioxin)
contamination of Monsanto's dioxin-exposed workers. You indicated that you
would contact me regarding the specific documents which would be useful to
your investigation.
SIGNIFICANCE OF MONSANTO'S DIOXIN FRAUD
You stated that pursuing a criminal prosecution against Monsanto would
require a prior determination of the significance of the fraud. In order
for proceedings to be initiated by EPA, the fraud would need to have
affected the regulatory process at EPA and Monsanto would need to have
knowingly submitted the falsified data and health studies to EPA in order
to affect the regulatory process.
Monsanto has in fact submitted false information to EPA which directly
resulted in weakened regulations under RCRA and FIFRA since these
regulations do not take into account tetrachlorinated dioxin contamination
in trig, tetra, and pentachlorophenols, as well as 2,4-dichlorophenol and
its phenoxy acetate (2,3-D, a currently used herbicide). In addition,
Monsanto's failure to report dioxin contamination of the disinfectant in
Lysol has prevented any ban or other alleviation of human exposures to
dioxins in this product.
The Monsanto human health studies have been submitted to EPA by Monsanto
as part of public comments on proposed dioxin rules and Agency-wide dioxin
health studies are continually relied upon by all offices of EPA to
conclude that dioxins have not caused cancer or other health effects (other
than chloracne) in humans. Thus, dioxin has been given a lesser
carcinogenic potential ranking, which continues to be the basis of less
stringent regulations and lesser degrees of environmental controls. The
Monsanto studies in question also have been a key basis for denying
compensation to Vietnam Veterans exposed to Agent Orange and their children
suffering birth defects from such parental exposures. (1)
Monsanto would not be able to support a claim that independent
researchers were responsible for the falsifications, because Monsanto
personnel compiled all data utilized by these researchers. In addition the
National Institute of Environmental Health Sciences partially funded one of
the Monsanto studies in question providing a basis for charges of the
fraudulent use of governmental funds.
DIOXIN CONTAMINATION OF MONSANTO PRODUCTS
Monsanto covered-up the dioxin contamination of a wide range of its
products. Monsanto either failed to report contamination, substituted false
information purporting to show no contamination or submitted samples to the
government for analysis which had been specially prepared so that dioxin
contamination did not exist.
The earliest known effort by Monsanto to cover-up dioxin contamination of
its products involved the herbicide used in Vietnam Agent Orange (2,4, 5-
trichlorophenoxy acetate, 2,4,5-T). Available internal Monsanto
correspondence in the 1960s shows a knowledge of this contamination and the
fact that the dioxin contaminant was responsible for kidney and liver
damage, as well as the skin condition chloracne."
Early internal Monsanto documents reveal that samples of 2,4,5-T and
other chlorinated herbicides and chlorophenols submitted to the U.S.
Department of Agriculture in the 1970s were "doctored." In other words,
highly contaminated samples were not submitted to the government, and
Monsanto samples of penta tetra-, tetra-, tri-, dichlorophenol, and
associated herbicides never contained tetrachlorinated dioxins. These
analyses were subsequently adopted by EPA in a 1980 publication and were
used without any data from other sources as the basis for 1984 regulations
under RCRA. As a result, these regulations do not control the chlorophenol
phenoxy acetate products as acutely hazardous due to their contamination of
tetrachlorinated dioxins.
Monsanto also submitted assertions to EPA that process chemistry would
preclude the formation of tetrachlorophenol or its phenoxy acetate.
Evidence from the Kemner v. Monsanto proceedings revealed that this process
chemistry claimed by Monsanto was not always used. In fact, off-
specification dichlorophenol, known to be contaminated with
tetrachlorinated dioxin, was being used as a feedstock to make
pentachlorophenol and other chlorinated products. The result of this
alternate synthesis route is the introduction of dioxins as a contaminants.
EPA also relied on these "process chemistry" arguments by Monsanto as a
basis for not regulating most chlorophenols and 2,4-D for their
tetrachlorinated dioxin content.
Another Monsanto document introduced as evidence in the above proceedings
shows cross-contamination of a range of Monsanto products with
tetrachlorinated dioxins by the following mechanism: The same production
equipment is used without cleaning for all chlorinated phenolic products.
In 1984, when promulgating the dioxin regulations under RCRA, EPA was only
made aware of the cross contamination problem in the event that 2,4-D was
made on equipment previously used to make 2,4,5-T. Thus, EPA again was
subverted from promulgating adequate regulations for products other than
2,4-D that were cross-contaminated with dioxins.
Members of the Canadian Parliament recently directed investigations by
the Royal Canadian Mounted Police and government scientist into the dioxin
contamination of disinfectants such as Lysol containing Monsanto's
Santophen (ortho-dichloro-para-phenol), and directed laboratory analyses of
existing stocks. This disinfectant uses the ortho-dichlorophenol, discussed
above, as a feedstock, which would introduce any dioxins present into the
disinfectant. In a 1984 letter to the Canadian government, Monsanto
asserted that their disinfectant contained no dioxin. This was later
refuted by testimony by Monsanto's chemist.
FRAUDULENT DIOXIN HEALTH STUDIES
As you indicated today, demonstrating criminal fraud in the
epidemiological studies performed by Monsanto on its dioxin-exposed workers
would necessitate bringing in appropriate groups in EPA capable of
performing scientific study audits.(3) You indicated, however, that NEIC
did not believe this would be a barrier to the investigation. The following
are a few key instances where obvious fraud was utilized in the conduct of
these studies:
Dr. Raymond Suskind at the University of Cincinnati was hired by Monsanto
to study the workers at Monsanto's Nitro, West Virginia plant. Dr. Suskind
stated in published studies in question that chloracne, a skin condition
was the prime indicator of high human dioxin exposures, and no other health
effects would be observed in the absence of this condition. Unpublished
studies by Suskind, however, indicate the fallacy of this statement. No
workers except those having chloracne were ever examined by Suskind or
included in his study. In other words, if no workers without chloracne were
ever examined for other health effects, there is no basis for asserting
that chloracne was "the hallmark of dioxin intoxication."(4) These
conclusions have been repeatedly utilized by EPA, the Veterans
Administration, etc., to deny any causation by dioxin of health effects of
exposed citizens, if these persons did not exhibit chloracne.
The results of Dr. Suskind's studies also were diluted by the fact that
the exposed group contained not only individuals having chloracne (a
genuine, but not the only effect of dioxin exposure), but also all workers
having any type of skin condition such as chemical rash. The workers could
have had no or negligible dioxin exposures, but they were included in the
study as part of the heavily exposed group. This fact was revealed only by
the careful reading of the published Suskind study.(5) Further, Dr. Suskind
utilized statistics on the skin conditions of workers compiled by a
Monsanto clerical worker, without any independent verification.(6)
Dr. Suskind also covered-up the documented neurological damage from
dioxin exposures. At Workers Compensation hearings, Suskind denied that the
workers experienced any neurological health effects. In the Kemner, et al.
v. Monsanto proceedings, however, it was revealed that Suskind had in his
possession at the time examinations of the workers by Monsanto's physician,
Dr. Nestman, documenting neurological health effects. In his later
published study, Dr. Suskind denied the continuing documented neurological
health effects suffered by the workers, falsely stating that symptoms "had
cleared."
All of the Monsanto dioxin studies also suffer another fatal flaw. The
purported "dioxin unexposed" control group was selected from other workers
at the same Monsanto plant. An earlier court settlement revealed not only
that these supposedly unexposed workers were exposed to dioxins, but also
to other carcinogens. One of these carcinogens, para-amino biphenyl, was
known by Monsanto to be a human carcinogen and it was also known that
workers were heavily exposed.
Another Monsanto study involved independent medical examinations of
surviving employees by Monsanto physicians. Several hundred former Monsanto
employees were too ill to travel to participate in the study. Monsanto
refused to use the attending physicians reports of the illness as part of
their study, saying that it would introduce inconsistencies. Thus, any
critically ill dioxin-exposed workers with cancers such as Non-Hodgkins
lymphoma (associated with dioxin exposures), were conveniently excluded
from the Monsanto study.
There are numerous other flaws in the Monsanto health studies. Each of
these misrepresentations and falsifications always served to negate any
conclusions of adverse health effects from dioxins. A careful audit of
these studies by EPA's epidemiological scientists should be obtained as
part of your investigation.
The false conclusions contained in the Monsanto studies have recently
been refuted by the findings of a recent study by the National Institute of
Occupation Safety and Health (NIOSH). This NIOSH study, recently circulated
by Dr. Marilyn Fingerhut for review, found a statistically significant
increase in cancers at all sites in the Monsanto workers, when dioxin
exposed workers at Monsanto and other industrial locations were examined as
an aggregate group.(7)
Please do not hesitate to contact me regarding documents to support your
investigation, which include testimony and evidentiary documents from the
on-going Kemner v Monsanto litigation, earlier litigation in West Virginia
brought by the Monsanto workers, ongoing investigations by the Canadian
government internal Monsanto documents, as well as documentation of the
submission of the fraudulent data and studies by Monsanto to support the
rulemaking process under RCRA and other EPA authorities.
CC: Admiral E. Zumwalt
Senator Thomas Daschel
Congressman Ted Weiss
American Legion
National Vietnam Veteran's Coalition
Oklahoma Agent Orange Foundation
Independent International Agent Orange Network
Vietnam Veterans of New Zealand
Greenpeace, U.S.A.
Earth First
Natural Resources Defense Council
Environmental Defense Fund
Lennart Hardell, M.D., Ph. D.
Mikael Eriksson, M.D.
Olaf Axelson, M.D.
Friedaman Rohleder, M.D.
Mike Petruska Chief, Regulatory Development Branch
Carrol G. Wills, Acting Director, NEIC, EPA/Denver
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(1) The American Medical Association, concerned about the veracity of one
of the Monsanto studies published in its journal, stated that a
reassessment would be undertaken if the outcome of appeal of the Kenmer v.
Monsanto litigation did not reverse the verdict impugning the credibility
of the Monsanto studies.
(2) You indicated that NEIC would be reticent to receive documents of this
nature suspected to be under a court protective order, but assured me that
you would pursue legal routes to obtain them independently.
(3) You should be cautioned regarding any consultation with Dr. Renate
Kimbrough at EPA regarding the review of the Monsanto studies. Dr.
Kimbrough was contacted by Monsanto during the Kenmer v. Monsanto
litigation and provided expert testimony, while an employee of the Centers
for Disease Control, on behalf of Monsanto. Dr. Kimbrough has provided
expert testimony on behalf of other defendant corporations responsible for
dioxin pollution even co-authoring papers with these defendants.
(4) Suskind examined only one worker without chloracne (Mr.Kiley), and
dismissed this individual's health complaints as being those of a
complainer.
(5) Later studies by the Centers for Disease Control have demonstrated
that any manifestation of chloracne in humans is not correlated with the
blood dioxin levels. In other words, individuals with lower blood dioxin
have been observed to develop chloracne, those with higher blood levels did
not.
(6) The deposition of Ms. Jan Young of Monsanto, previously under a
protective order, is in the process of release pursuant to a motion by
Greenpeace, USA.
(7) This NIOSH study does have a inherent design weakness that would
diminish the capability of detecting excess cancers. This is because
Monsanto and the other dioxin-producing companies were allowed to
independently select the group of dioxin-exposed workers to be studied by
NIOSH.
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