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ISIS Report 13/07/11
EU Regulators and Monsanto Exposed for Hiding Glyphosate Toxicity
The European Commission approved glyphosate knowing, as Monsanto
did, that it causes birth defects, while the public were kept in the dark, the
herbicide must now be bannedDr Eva Sirinathsinghji and Dr.
Please forward widely to your political representatives and demand
a worldwide ban on glyphosate herbicides
A damning report co-authored by an international group of
scientists and researchers for non-government organisation Open Earth Source
(OES) reveals that studies from industry including those from Monsanto since
the 1990s showed glyphosate caused birth defects and the European Commission
approved the herbicide in full knowledge of those finding .
Monsanto’s Roundup formulation is the biggest selling
herbicide in the world, and its use has dramatically increased since the
company introduced glyphosate-tolerant genetically
modified (GM) crops such as RR (Roundup Ready) soybean. Today, almost 80
percent of the world’s soy production takes place in the US, Brazil and Argentina, and in 2009, RR soybean accounted for 91 percent, 99 percent and 71
percent respectively of total soybean acreage in those countries. Since
1997, RR soy production has increased from 5 to 30 million hectares of land in
the US alone . Soybeans have been found to contain
glyphosate residues up to 10 times as high asthe doses that
caused foetal malformations in chick and frog embryos.
With such widespread use of the herbicide, and
the EU considering approval of GM crops tolerant to glyphosate for cultivation
in Europe, there is an urgent need for a proper review of the herbicide, which
is in line with the more stringent new EU pesticide regulation that came into
force in June 2011. Indeed, just such a review was due to take place in 2012.
But shortly after the EC was notified of the latest research on glyphosate
causing birth defects (which the EC dismissed), it delayed the review on
glyphosate and 38 other dangerous pesticides to 2015 . Furthermore, the 2010
review will be under the old, less stringent regulations. The official reason
for the delay is that they have ‘too much workload’. This means that the safety
of glyphosate may not be reviewed under the new regulations until 2030.
The review delay is being challenged in a
lawsuit brought against the EC by Pesticides Action Network Europe and Greenpeace.
The co-authors of the OES report are also calling on the EC to conduct a prompt
review without delay, and to withdraw glyphosate and Roundup from the market.
Evidence of birth defects from industry and independent studies
The OES report reveals that studies carried out by industry in the
1990s showed embryonic lethality and birth defects in laboratory animals, including
dilation of the heart in rabbits at low doses of glyphosate. Higher doses were
shown to cause defects in independent studies as far back as 1980.
Monsanto has responded by denying its
own findings : “Regulatory authorities and independent experts around the
world agree that glyphosate does not cause adverse reproductive effects in
adult animals or birth defects in offspring of these adults exposed to
glyphosate, even at doses far higher than relevant environmental or
However, the ‘independent experts’ cited by
Monsanto were mired in conflicts of interests, both financial and professional,
and rely almost entirely on studies carried out by industry .
Independent studies have revealed links to
cancer, genetic damage and endocrine disruption, as well as developmental
defects, for example, craniofacial and vertebrae abnormalities in rats 
as well as craniofacial and mouth deformities, eye abnormalities and bent, curved tails in frog tadpoles . The most recent study
by Carrasco and colleagues found a mechanistic link between glyphosate and abnormal
retinoic acid signalling in embryonic development [5, 9]
Astonishingly, these and numerous other studies cited by the
OES report were dismissed by the European Commission
(EC) and the German Federal Office for Consumer Protection and Food Safety (BVL),
which is responsible for liaising between industry and the EC. BVL’s conclusion,
communicated to the EC via Germany’s 1998 ‘draft assessment report’ (DAR), was ‘‘no
evidence of teratogenicity” for glyphosate.
Germany’s 1998 DAR was crucial for
glyphosate gaining current EU approval. Despite concluding from industry’s dossier
of studies that “glyphosate does not cause teratogenicity”, the report
immediately went on to quality its conclusion by pointing out that higher doses
of glyphosate caused “reduced ossification and a higher incidence of
skeletal and/or visceral [internal organs] anomalies” in foetuses of rats and
rabbits. It also added that the industry studies on glyphosate given at high
doses showed reduced number of viable foetuses produced by rats and rabbits, as
consistent with increased birth defects. The skeletal anomalies found in those
early industry studies are also consistent with the recent findings reported by
Carrasco and colleagues [5, 9]. However, these abnormalities were dismissed on the
spurious grounds that the high doses poisoned the mother (maternally toxic
doses), and hence deemed irrelevant to human risk assessment, as poisoning the
mother with any substance can affect the foetus and lead to birth defects. This
absurd assumption is indeed contested in the independent scientific literature,
and much debated even within industry.
A history of manipulation and near-deception by German and EU
As evident from Germany’s 1998 DAR, Germany manipulated scientific
evidence using various ploys bothering on deceit, and with a total disregard of
the precautionary principle.
The glyphosate-treated animals in studies
submitted by industry practically all showed effects of treatment compared with
untreated animals, and at doses as low as 20 mg/kg body weight. So much so that
UK’s Pesticide Safety Directorate (PSD), which commented on the data,
supports the teratogenicity of glyphosate : “Taken in isolation, none of the
findings in these rabbit teratology studies would be clearly of concern. However,
overall there is an indication of a pattern.”
on the other hand, resorted to including ‘historical control groups’ in other (irrelevant)
unpublished studies, which had the effect of increasing the variation, and
hence cancelling out any statistical significance in the actual experiments
submitted by industry. UK’s PSD ended by asking Germany to make available the
historical control data, but it remains unclear whether PSD ever saw the data,
or if it did, how it responded. And to this day, the historical control data
are hidden from the public.
As the OES report commented : “The use of
historical rather than concurrent controls
adds variables to an experiment that aims to control variables, obscures the
teratogenic effects of glyphosate, and biases any conclusion. That is why the
use of historical control data is controversial. The practice should not be
allowed in evaluating animal toxicological and other studies for pesticide
Valid controls for an experiment are animals of
the same genetic strain and age, reared in the same environment and studied at
the same time as the treated animals. Furthermore, “the manner in which the
animals are examined and evaluated, and the data recorded, must be the same.”
The OES report went on to state: “If such
practices [of using historical controls] were uncovered in an independent
scientific study, they could be considered scientific fraud.”
In summary, the industry and regulators appeared
to have colluded in a saga of manipulating scientific evidence in approving
Industry (including Monsanto) has known since the 1980s that
glyphosate causes birth defects in animals at high concentrations
Industry has known since 1993 that those effects could also occur
at low to mid doses
The German government has known that glyphosate causes birth defects
since at least 1998, the year it submitted its DAR on glyphosate to the EC
The EC’s expert scientific review panel has known since 1999 that
glyphosate causes birth defects
The EC has known that glyphosate causes birth defects since 2002,
the year that its Directorate General of SANCO (Health and Consumer Protection)
published the final review report for the current approval of glyphosate.
Throughout all that time, the public have been
kept in the dark, and the work of independent scientists drawing attention to
the teratogenic effects of glyphosate and Roundup were ignored, dismissed, or
The LOAEL (lowest observable adverse effects
level) of glyphosate was similarly identified by Germany to be 60 mg/kg body
weight/day, at least 3 times higher than indicated by the industry data through
a sleight of hand that considered only ‘chronic exposure’ in the ‘most
sensitive species’ taken to be the rat; while independent studies indicated
LOAEL as low as 5 mg/kg body weight for endocrine disruption and liver damage
in rats. The LOAEL is used to set acceptable daily intake (ADI), which is 1/100
of the LOAEL. Consequently, the current ADI of 0.6 mg/kg/day is at least 10
times higher than warranted by data existing at the time the level was set.
Bad science shielded by industry’s own questionable guidelines and
In addition to outright manipulation of scientific evidence,
industry has erected an effective shield for its bad science under the guise of
‘Good Laboratory Practices’ (GLP) guidelines, set by the Organisation for
Economic Cooperation and Development (OECD), a development and trade, not
scientific, organisation. The GLP guidelines have already been strongly
criticised in a paper  co-authored by 30 scientists who point out that the GLP
“specifies nothing about the quality of the research design, the skills of the
technicians, the sensitivity of the assays, or whether the methods employed are
current or out-of-date.” The EC and the European Food Safety Authority (EFSA)
both accept the GLP guidelines and independent research that does not conform
can be ignored for assessment purposes. Thus, the research of Carrasco’s team
and other independent studies showing harm from glyphosate or Roundup were
dismissed on grounds that the testing systems are “unvalidated” and the studies
“inappropriate and irrelevant for human health risk assessment purposes”
(because they are not carried out on approved animals such as rats, mice and
dogs, for example), in other words, they are not in accordance with GLP. As
the OES report remarks , this “raises the question: why do governments fund
scientific research if they ignore its findings in almost every risk
In fact, GLP toxicity studies have been
criticised for using out of date protocols with very high doses at near
poisoning levels that may have little relevance to real world exposure levels,
and test animals are typically killed before old age, masking most developing
diseases. In short, GLP tests use protocols that can rarely find toxicity.
A comparison of NOAELs (no observable adverse
effects levels) from industry and independent tests on dozens of chemicals
found that in every case, independent studies detected important toxic effects
at levels well below those that industry claimed to be safe. Yet regulators
ignore the independent data in favour of those from industry because they
comply with the OECD GLP guidelines. Their rejection of the recent findings of
Carrasco’s team is indefensible but for the rigid adherence to the GLP
guidelines, as the OES report points out at length (see also ).
Furthermore, the OECD set rigid and
scientifically incorrect criteria regarding dose-response in toxicological
tests. They fail to take into account the fact that endocrine disrupting and
other effects are often stronger at low dose than at high dose, which
invalidates the assumption that there is a safe dose below which there is no
The new EU pesticide regulation has the
potential to end the tyranny of GLP by insisting on peer-reviewed independent
scientific studies in pesticide assessments. However, the new regulation
obliges industry to do its own scientific literature search in preparing a
pesticide dossier, thus giving industry full control of the studies it selects
for inclusion and may well reinforce the tyranny of the GLP.
Human evidence of health concerns is mounting
to obvious restrictions of experiments on humans, human data of glyphosate
toxicity is difficult to obtain in a laboratory setting. There are, however, results
obtained from human cell lines. One such experiment performed in 2009 by French scientist Giles-Eric Séralini and
colleagues found that Roundup caused total cell death in umbilical, embryonic
and placental cells within 24 hours [3, 11].
Further, with the widespread use of glyphosate in countries
such as Argentina and Canada, evidence of harm to
humans is now growing. A local Argentinean government report documented
tripling in numbers of childhood cancers from 2000 to 2009, and quadrupling
of birth defects in agrochemical use zones (ref see  Argentina’s Roundup
Human Tragedy, SiS 48). Carrasco noted in his study that  “The findings in
the lab are compatible with malformations observed in humans exposed to
glyphosate during pregnancy.”
An epidemiological study in Ontario, Canada, also found high levels of premature births and miscarriages in female members of farming
families that used pesticides, including glyphosate.
BVL’s response to those problems was that they are
irrelevant to the situation in Europe, even as plans to grow glyphosate-tolerant
crops are afoot: “Even if there were indications for an increase in
malformations because of extensive exposure to pesticides in South America, the
state authorities in these countries would be responsible to initiate more
in-depth investigations. Taking into account the very different
application conditions and the uncertainties with regard to the plant
protection products and human exposure, such findings would not automatically
give rise to concern about the safety of glyphosate-based herbicides in Europe.”
recent report released by a senior US scientist Dr Don Huber, Professor
Emeritus, Purdue University, warned of a novel pathogen associated with
glyphosate tolerant GM crops (see  Emergency! Pathogen New
to Science Found in Roundup Ready GM Crops?). A leaked letter
written by him to the USDA expressed deep concern for this pathogen that was
highly enriched in transgenic crops, and apparently associated with devastating
crops diseases and high rates of infertility and miscarriages in animals. This
is a novel concern that adds to the urgency with which glyphosate and GM
agriculture needs to be reviewed by the EU.
Conclusion & recommendation
authors of the OES report conclude that “the existing approval of glyphosate
and Roundup is out of date and scientifically unsupportable.” They recommend
the immediate withdrawal of glyphosate until a new review is performed with a
full range of up-to-date tests that are independently reviewed and publicly
We fully agree with their conclusion and recommendation.
M, Habib M, Howard CV, Jennings RC, Leifert C, Nodari RO, Robinson C, Fagan J.
Roundup and birth defects: Is the public being kept in the dark? Earth Open
E, Mantese FD. et al. 2003. The teratogenic potential of the herbicide
glyphosate-Roundup in Wistar rats. Toxicol Lett 142(1-2): 48
RC, Sandoval MT, Peltzer PM. 2003. Induction of mortality and malformation in Scinax
nasicus tadpoles exposed to glyphosate formulations. Bull.Environ.
Contam. Toxicol. 70, 612–18.
9. Paganelli A,
Gnazzo V, Acosta H, Lopez SL and Carrasco AD. Glyphosate-based herbicides
produce teratogenic effects on vertebrates by impairing retinoic acid
signalling. Chem Res Toxicol, August 9. http://pubs.acs.org/doi/abs/10.1021/tx1001749
Myers JP, Vom Saal FS. et al. Why public health agencies cannot
depend on good laboratory practices as a criterion for selecting data: The case
of bisphenol A. Environmental Health Perspectives 2009, 117, 309–15.
N, Séralini GE. 2009. Glyphosate formulations induce
apoptosis and necrosis in human umbilical, embryonic, and placental
cells. Chem Res Toxicol 22: 97–105.
Dr TONFACK Comment left 21st July 2011 22:10:48 This component is still widely used in Africa. Thank you very much for the information. African gouvernments and politics must act now.
Ann Comment left 25th July 2011 20:08:56 If it weren't for this article at this website, Mosanto would be bit better at "hiding," or least from being exposed. Information like this doesn't necessarily make it to the NY Times, despite the widespread use of glyphosate. Help keep the internet open and free.
Gary Comment left 7th September 2011 09:09:38 Anti-spam question - just to prove you are human
How many legs does a cat have?
Which brings up a story,My cat lost it's hair due to roundup.Nasty stuff!,It's agent orange,With a twist of lime.
Comment left 9th September 2011 10:10:21 Thank you Melissa,
I know the words "Thank You" can never be adequate enough to describe my gratitude to you for all that you do. It can't be easy. I'm am so greatful that, when I woke up to the words of Monsanto, "Own the food, control the people" that you appeared. We all must help & carry a little of the message of what HARM the US government is secretly allowing to happen to our health and environment and seed safety, via Chemical companies mainly Monsanto aka "MonSatan" thru GE
GMO & Roundup, just for starters.
With Deepest Gratitude.
James Pott Comment left 1st October 2011 08:08:21 there is a bothersome spelling error in this brief.
".......using various ploys bothering on deceit..."
That really should be bordering on.
diane angelino Comment left 24th March 2012 17:05:07 MONSANTO IS EVIL AND MUST BE STOPPED. GET THEM OUT OF OUR GOVERNMENT AND OFF OUR LAND!!!
Dr.Douglas Laing Comment left 1st June 2012 07:07:55 Glyphosate is widely used in the oil palm industry and is still being recommended by grower organizations worldwide. It is cheap and very effecive in weed control and probably causing or exacerbating a suite of diseases including such devastating conditions as basal stem rot that is associated with the ascomycete fungus Ganoderma. Unfortunately high quality research on the subject in this world crop is very limited and vested interests are heavily weighing into the decision- making process. The progress being made,especially in Europe, in other crops and in animal production research is demonstrating the relationship of this highly active cation chelator to a wide range of pathologies.We were duped by Monsanto and many producers are now hooked on the stuff in unsustainable cropping systems. Just look at Professor Don Huber of Purdue on YouTube if you need convincing.I am very worried.