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[Lawrence London <lfljvenaura@gmail.com>]

Monsanto knew of glyphosate / cancer link 35 years ago | GM-Free Cymru
Special Report | gmfreecymru.org
http://www.gmfreecymru.org/documents/monsanto_knew_of_glyphosate.html

Monsanto knew of glyphosate / cancer link 35 years ago

GM-Free Cymru Special Report

8th April 2015

According to evidence unearthed from the archives of the EPA (Environmental
Protection Agency) in the United States, it has been established that
Monsanto was fully aware of the potential of glyphosate to cause cancer in
mammals as long ago as 1981.

Recently the WHO's International Agency for Research on Cancer (IARC)
issued a statement in which glyphosate (the main component of Roundup
herbicide) was classified as "probably carcinogenic" to humans and as
"sufficiently demonstrated" for genotoxicity in animals (1). This
announcement of a change to toxicity class 2A was given vast coverage in
the global media, causing Monsanto to move immediately into damage
limitation mode. The corporation demanded the retraction of the report,
although it has not yet been published! Predictably, there was more fury
from the industry-led Glyphosate Task Force (2). This Task Force also
sponsored a "rebuttal" review article (3) from a team of writers with
strong links with the biotechnology industry; but because of the clear bias
demonstrated in this paper (which suggests that glyphosate has no
carcinogenic potential in humans) it is best ignored until it has been
carefully scrutinized by independent researchers (4).

With Monsanto continuing to protest that glyphosate and Roundup are
effectively harmless (5) if used according to instructions, in spite of
accumulating evidence to the contrary, we undertook a search through
Environmental Protection Agency (EPA) records with a view to finding out
what was known about glyphosate at the time of its initial registration.
This followed up earlier investigations by Sustainable Pulse which
highlighted a sudden change in the EPA view on toxicity in 1991. What was
discovered was very revealing. There were many animal experiments (using
rats, mice and dogs) designed to test the acute and chronic toxicity of
glyphosate in the period 1978-1986, conducted by laboratories such as
Bio/dynamics Inc for Monsanto and submitted for EPA consideration. Two of
these reports relate to a three-generation reproduction study in rats (6)
(7), and another is called "A Lifetime Feeding Study Of Glyphosate In Rats"
(8); but like all the other older studies they were and still are treated
as Trade Secrets and cannot be freely accessed for independent scrutiny.
That in itself is suggestive that the studies contain data which Monsanto
still does not wish to be examined by experts in the toxicology field. It
is also deeply worrying that EPA acceded to the routine Monsanto requests
for secrecy on the flimsiest of pretexts.

However, archived and accessible EPA Memos from the early 1980's do give
some indications as to what the rat studies contain (9). Although the
studies predate the adoption of international test guidelines and GLP
standards they suggest that there was significant damage to the kidneys of
the rats in the 3-generational study -- the incidence of tubular dilation
in the kidney was higher in every treated group of rats when compared to
controls. Tubular dilation and nephrosis was also accompanied by
interstitial fibrosis in all test groups and in some of the lumens the
researchers found amorphous material and cellular debris. Less than a third
of the control rats showed signs of tubular dilation. In the rat study
results, the changes in the bladder mucosa are significant because
metabolites, concentrated by the kidneys, have led to hyperplasia that
could be considered as a very early and necessary step in tumour
initiation. EPA was worried in 1981 that these indications were sinister,
and at first declined to issue a NOEL (no observed adverse effect level) --
it asked for further information and additional research. In its 1982
Addendum, Monsanto presented evidence that minimised the effects and
confused the data -- and on that basis EPA accepted that glyphosate was
unlikely to be dangerous. But Monsanto knew that scrutiny of the data in
the studies would potentially threaten its commercial ambitions, and so it
asked for the research documents concerned to be withheld and treated as
Trade Secrets. So there was no effective independent scrutiny. Monsanto and
EPA connived in keeping these documents away from unbiased expert
assessment, in spite of the evidence of harm. (It is clear that EPA was
thinking about carcinogenic effects -- it knew in 1981 that glyphosate
caused tumorigenic growth and kidney disease but dismissed the finding as
"a mystery" in order to set the NOEL for the chemical and bring it to
market.)

In the rat studies, the glyphosate doses fed to the test groups were 1/100
of those used in a later mouse study (9). It is unclear why these very
small doses were decided upon by Monsanto and accepted by EPA, since there
must be a suspicion that the studies were manipulated or designed to avoid
signs of organ damage. In its 1986 Memo, EPA remarked on the very low
doses, and said that no dose tested was anywhere near the "maximally
tolerated dose." Then the Oncogenicity Peer Review Committee said: "At
doses close to an MTD, tumours might have been induced." A repeat rat study
was asked for. However, BioDynamics (which conducted the research for
Monsanto) used data from three unrelated studies, which they conducted in
house, as historical controls to create "experimental noise" and to
diminish the importance of the results obtained by experiment.

In a 1983 mouse study conducted by Bio/dynamics Inc for Monsanto (10),
there was a slight increase in the incidence of renal tubular adenomas
(benign tumours) in males at the highest dose tested. Malignant tumours
were found in the higher dose group. However, "it was the judgment of two
reviewing pathologists that the renal tumors were not treatment-related".
Other effects included centrilobular hypertrophy and necrosis of
hepatocytes, chronic interstitial nephritis, and proximal tubule epithelial
cell basophilia and hypertrophy in females. The EPA committee determined
there was a "weak oncogenic response" -- so evidence was suggestive of
early malignancy. The EPA Science Advisory Panel was asked for advice, and
they said the data were equivocal and called for further studies in mice
and rats. A further report was delivered in 1985. Part of the reason for
this dithering was the prevalent but false EPA belief that all
physiological effects had to be dose-related: namely, the higher the dose,
the greater the effect.

Even though pre-cancerous conditions were imperfectly understood 35 years
ago, and cortical adenomas in kidney were not thought dangerous at the
time, the evidence from the Memos is that Monsanto, BioDynamics Inc and the
EPA Committees involved were fully aware, probably before 1981, of the
carcinogenic potential of glyphosate when fed to mammals. In the Memos
there are references to many more "secret" animal experiments and data
reviews, which simply served to confuse the regulators with additional
conflicting data. Thus EPA publicly accepted the safety assurances of the
Monsanto Chief of Product Safety, Robert W. Street, and the status of the
product was confirmed for use in the field (11). But behind the scenes,
according to a later EPA memo (in 1991), its own experts knew before 1985
that glyphosate causes pancreatic, thyroid and kidney tumors.

On the EPA website (last updated 31.10.2014) reference is made to five
Monsanto studies of 1980 - 1985, and it is noteworthy that these studies
have not been made public in the light of current knowledge about malignant
tumours and pre-cancerous conditions (12). Neither have they been revisited
or reinterpreted by Monsanto and EPA, although one 1981 rat study and one
1983 mouse study are mentioned in the recent review by Greim et al (2015)
(3). Following the conclusion that glyphosate was "not classifiable as to
human carcinogenicity" nothing in the EPA advice about this chemical has
changed since 1990. Given the recent assessment by the WHO Panel, and given
the flood of scientific papers relating to health damage associated with
glyphosate (13) the EPA attitude smacks of complacency and even
incompetence.

Speaking for GM-Free Cymru, Dr Brian John says: "The evidence shows that by
1981 both Monsanto and the EPA were aware of malignant tumours and
pre-cancerous conditions in the test animals which were fed small doses of
glyphosate in the secret feeding experiments. Although concerns were
expressed at the time by EPA committees, these concerns were later
suppressed under the weight of conflicting evidence brought forward by
Monsanto, some of it involving the inappropriate use of historical control
data of dubious quality. None of these studies is available for independent
examination (14). That is a scandal in itself. There has been a protracted
and cynical cover-up in this matter (15). Glyphosate is a "probable human
carcinogen", as now confirmed by the WHO Working Group, and no matter what
protestations may now come from Monsanto and the EPA, they have been fully
aware of its potential to cause cancer for at least 35 years. If they had
acted in a precautionary fashion back then, instead of turning a blind eye
to scientific malpractice (16), glyphosate would never have been licensed,
and thousands of lives might have been saved."

Retired Academic Pathologist Dr Stanley Ewen says: "Glyphosate has been
implicated in human carcinogenesis by IARC and it is remarkable that, as
early as 1981, glyphosate was noted to be associated with pre neoplastic
changes in experimental mice. This finding was never revealed by the
regulatory process and one might therefore expect to see human malignancy
increasing on the record in the ensuing years. John Little (personal
communication) has demonstrated an unexpected and alarming 56% upsurge in
malignancy in England in those under 65 in the past 10 years. Presumably
British urinary excretion of glyphosate is similar to the documented urine
levels in Germany, and therefore everyone is at risk. The effect of
glyphosate on endocrine tissue such as breast and prostate, or even
placenta, is disruptive at least and an increased incidence of endocrine
neoplasia is likely to be seen in National Statistics. The Glyphosate Task
Force denies the involvement of glyphosate in human malignancy despite
their knowledge of many reports of lymphomas and pituitary adenomas in
experimental animals dosed with glyphosate. On the other hand, Prof. Don
Huber at a recent meeting in the Palace of Westminster, has warned of
severe consequences if rampant glyphosate consumption is not reined in. I
feel sure that the suppression of the experimental results of 1981 has
enhanced the global risk of malignancy."

Toxico-pathologist Professor Vyvyan Howard says: ""The drive towards
transparency in the testing of pharmaceuticals is gathering pace with
legislation in the EU, USA and Canada being developed. All trials for
licensed drugs will likely have to become available in the public domain.
In my opinion the case with agrochemicals should be no different. At least
with pharmaceuticals exposure is voluntary and under informed consent.
There are several biomonitoring studies which demonstrate that there is
widespread exposure of human populations to glyphosate, presumably without
informed consent. Given the clear level of mistrust over the licensing of
this herbicide and the emerging epidemiological evidence of its negative
effects there can, in my opinion, be no case whatsoever for keeping the
toxicological studies, used to justify licencing, a secret. They should be
put in the public domain."

Research scientist Dr Anthony Samsel says: "Monsanto's Trade Secret studies
of glyphosate show significant incidence of cell tumors of the testes and
tumorigenic growth in multiple organs and tissues. They also show
significant interstitial fibrosis of the kidney including effects in
particular to the Pituitary gland, mammary glands, liver, and skin.
Glyphosate has significant effects to the lungs indicative of chronic
respiratory disease. Glyphosate has an inverse dose response relationship,
and it appears that its effects are highly pH dependent. Both Monsanto and
the EPA knew of the deleterious effects of this chemical in 1980 at the
conclusion of their multiple long-term assessments, but the EPA hid the
results of their findings as "trade secrets." Monsanto has been lying and
covering up the truth about glyphosate's harmful effects on public health
and the environment for decades. The increases in multiple chronic
diseases, seen since its introduction into the food supply, continue to
rise in step with its use. Monsanto's Roundup glyphosate based herbicides
have a ubiquitous presence as residues in the food supply directly
associated with its crop use. Nations must stand together against Monsanto
and other chemical companies who continue to destroy the biosphere. We are
all part of that biosphere and we are all connected. What affects one
affects us all."
*NOTES*

(1)  Carcinogenicity of tetrachlorvinphos, parathion, malathion, diazinon,
and glyphosate (2015)
Kathryn Z Guyton, Dana Loomis, Yann Grosse, Fatiha El Ghissassi, Lamia
Benbrahim-Tallaa, Neela Guha, Chiara Scoccianti, Heidi Mattock, Kurt
Straif,  on behalf of the International Agency for Research on Cancer
Monograph Working Group, IARC, Lyon, France
Lancet Oncol 2015.  Published Online March 20, 2015 http://dx.doi.org/10.1016/
S1470-2045(15)70134-8
International Agency for Research on Cancer 16 Volume 112: Some
organophosphate insecticides and herbicides: tetrachlorvinphos, parathion,
malathion, diazinon and glyphosate. IARC Working Group. Lyon; 3–10 March
2015. IARC Monogr Eval Carcinog Risk Chem Hum (in press).

(2)  Monsanto seeks retraction for report linking herbicide to cancer
By Carey Gillam, Reuters
http://www.reuters.com/article/2015/03/24/us-monsanto-herbicide-idUSKBN0MK2GF20150324
The response by the pesticide industry association, the Glyphosate Task
Force, is here:
http://www.wmcactionnews5.com/story/28574811/statement-of-the-gtf-on-the-recent-iarc-decision-concerning-glyphosate

(3)  Helmut Greim, David Saltmiras, Volker Mostert, and Christian Strupp
(2015)  REVIEW ARTICLE:  Evaluation of carcinogenic potential of the
herbicide glyphosate, drawing on tumor incidence data from fourteen
chronic/carcinogenicity rodent studies. Crit Rev Toxicol, 2015; Early
Online: 1–24  DOI: 10.3109/10408444.2014.1003423

(4)  Not only is this paper written by authors who have strong industry
links, but the 14 carcinogenicity studies assessed are carefully selected
industry studies which have not been peer-reviewed and published in
mainstream scientific journals.  All of the studies were conducted for
clients (like Monsanto) who would have experienced gigantic commercial
repercussions if anything "inconvenient" had been reported upon, with
glyphosate already in use across the world.  Therefore the possibility of
fraud and data manipulation cannot be ruled out.  The 14 studies are all
secret, and cannot be examined by independent toxicology experts.  The fact
that the review article in question reproduces (as online supplementary
material) a series of tables and data sets is immaterial, since the data
are useless in the absence of clear explanations of the laboratory
protocols and practices of the research teams involved.

(5)  http://www.monsanto.com/glyphosate/pages/is-glyphosate-safe.aspx

(6)  "A Three-Generation Reproduction Study in Rats with Glyphosate" (Final
Report; Bio/dynamics Project No. 77-2063; March 31, 1981)  -- submitted by
Monsanto to EPA

(7)  "Addendum to Pathology Report for a Three-Generation Reproduction
Study in Rats with Glyphosate.  R.D. #374; Special Report MSL-1724; July 6,
1982" EPA Registration No 524-308, Action Code 401. Accession No 247793.
CASWELL#661A" -- submitted by Monsanto to EPA

(8)  "A Lifetime Feeding Study Of Glyphosate In Rats"  (Report by GR Lankas
and GK Hogan from Bio/dynamics for Monsanto.  Project #77-2062, 1981:  MRID
00093879) -- submitted by Monsanto to EPA
and Addendum Report  #77-2063

(9)  Archived EPA memos from 1982 and 1986:
http://www.epa.gov/pesticides/chemicalsearch/chemical/foia/cleared-reviews/reviews/103601/103601-135.pdf
http://www.epa.gov/pesticides/chemicalsearch/chemical/foia/cleared-reviews/reviews/103601/103601-210.pdf
The 1991 EPA Memo is accessible via:
http://sustainablepulse.com/2015/03/26/who-glyphosate-report-ends-thirty-year-cancer-cover-up/#.VSVPZ2Z3bJk

(10)  Knezevich, AL and Hogan, GK (1983) "A Chronic Feeding study of
Glyphosate (Roundup Technical) in Mice".  Project No 77-2061. Bio/dynamics
Inc for Monsanto.  Accession No #251007-251014  -- document not available
but cited in EPA 1986 Memo.
Follow-up study:  McConnel, R. "A chronic feeding study of glyphosate
(Roundup technical) in mice: pathology report on additional kidney
sections". Unpublished project no. 77-2061A, 1985, submitted to EPA by
BioDynamics, Inc.

(11)  Glyphosate was first registered for use by the United States
Environmental Protection Agency (U.S. EPA) in 1974, and after various
reviews reregistration was completed in 1993.
Glyphosate (CASRN 1071-83-6)
Classification — D (not classifiable as to human carcinogenicity)
Basis — Inadequate evidence for oncogenicity in animals. Glyphosate was
originally classified as C, possible human carcinogen, on the basis of
increased incidence of renal tumors in mice. Following independent review
of the slides the classification was changed to D on the basis of a lack of
statistical significance and uncertainty as to a treatment-related effect.
http://www.epa.gov/iris/subst/0057.htm
http://sustainablepulse.com/2015/03/26/who-glyphosate-report-ends-thirty-year-cancer-cover-up/
npic.orst.edu/factsheets/glyphotech.pdf

(12)  Monsanto Company. 1981a. MRID No. 0081674, 00105995. Available from
EPA. Write to FOI, EPA, Washington, DC 20460.
Monsanto Company. 1981b. MRID No. 00093879. Available from EPA. Write to
FOI, EPA, Washington, DC 20460.
Monsanto Company. 1985. MRID No. 00153374. Available from EPA. Write to
FOI, EPA, Washington, DC 20460.
Monsanto Company. 1980a. MRID No. 00046362. Available from EPA. Write to
FOI, EPA, Washington, DC 20460.
Monsanto Company. 1980b. MRID No. 00046363. Available from EPA. Write to
FOI, EPA, Washington, DC 20460.

(13)
 http://www.i-sis.org.uk/Scandal_of_Glyphosate_Reassessment_in_Europe.php
<http://www.i-sis.org.uk/Scandal_of_Glyphosate_Reassessment_in_Europe.php>
http://permaculturenews.org/2012/11/01/why-glyphosate-should-be-banned-a-review-of-its-hazards-to-health-and-the-environment/
Key studies showing toxic effects of glyphosate and Roundup.  Ch 4 in GMO
Myths and Truths
http://earthopensource.org/earth-open-source-reports/gmo-myths-and-truths-2nd-edition/
Antoniou, M. et al. Teratogenic Effects of Glyphosate-Based Herbicides:
Divergence of Regulatory Decisions from Scientific Evidence J Environ Anal
Toxicol 2012, S:4
http://dx.doi.org/10.4172/2161-0525.S4-006
http://www.earthopensource.org/files/pdfs/Roundup-and-birth-defects/RoundupandBirthDefectsv5.pdf
<http://dx.doi.org/10.4172/2161-0525.S4-006>
(14)  That having been said, Monsanto has allowed access to selected later
reports to selected researchers (Greim et al, 2015).  It is still uncertain
whether these selected reports are available in full, for detailed
independent scrutiny -- even though there can now be no possible
justification for "trade secret" designation, following the lapse of the US
glyphosate patent in 2000.

(15)
http://sustainablepulse.com/2015/03/26/who-glyphosate-report-ends-thirty-year-cancer-cover-up/
In 1985 the carcinogenic potential of glyphosate was first considered by an
EPA panel, called the Toxicology Branch Ad Hoc Committee. The Committee
then classified glyphosate as a Class C Carcinogen on the basis of its
carcinogenic potential.  This classification was changed by the EPA in 1991
to a Class E category on the basis of “evidence of non-carcinogenicity for
humans”.  Mysteriously this change in glyphosate’s classification occurred
during the same period that Monsanto was developing its first Roundup-Ready
(glyphosate-resistant) GM Crops.  Not for the first time, commercial
considerations were allowed to trump public health concerns.
The EPA scale of cancer-forming potential of substances:
Group A: Carcinogenic to humans
Group B: Likely to be carcinogenic to humans
Group C: Suggestive evidence of carcinogenic potential
Group D: Inadequate information to assess carcinogenic potential
Group E: Not likely to be carcinogenic to humans

(16)  Wikipedia 2012:  Internal EPA Memos Document Fraud
1983 EPA Scientist on EPA's public stance: “Our viewpoint is one of
protecting the public health when we see suspicious data.” Unfortunately,
EPA has not taken that conservative viewpoint in its assessment of
glyphosate’s cancer causing potential.”
“There are no studies available to NCAP evaluating the carcinogenicity of
Roundup or other glyphosate-containing products.  Without such tests, the
carcinogenicity of glyphosate-containing products is unknown.”
“Tests done on glyphosate to meet registration requirements have been
associated with fraudulent practices.”
“Countless deaths of rats & mice are not reported.”
“Data tables have been fabricated”
“There is a routine falsification of data”

<>

Excellent research and documentation in this discussion thread - ignore the
monsanto industry whores lying again to the public.

New evidence unearthed from the archives of the EPA has established that
Monsanto was fully aware of the potential of glyphosate to cause cancer in
mammals as long ago as 1981 (gmfreecymru.org)

http://www.gmfreecymru.org/documents/monsanto_knew_of_glyphosate.html

http://www.reddit.com/r/conspiracy/comments/3288h3/new_evidence_unearthed_from_the_archives_of_the/