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RISK ASSESSMENT / FOOD: New study reveals signs of toxicity ofMON863 Bt corn approved for human consumption



                                 PART I
------------------------------- GENET-news -------------------------------
TITLE:  New study reveals signs of toxicity of GE maize approved for human
        consumption
SOURCE: Greenpeace International, Netherlands
AUTHOR: Press Release
URL:    http://www.greenpeace.org/international/press/releases/
seralini_study_MON863
DATE:   13.03.2007
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New study reveals signs of toxicity of GE maize approved for human consumption
Greenpeace demands immediate withdrawal of high-risk GE products

BERLIN, Germany -- Laboratory rats, fed with a genetically engineered
(GE) maize produced by Monsanto, have shown signs of toxicity in kidney
and liver, according to a new study.(1) This is the first time that a GE
product which has been cleared for use as food for humans and animals
has shown signs of toxic effects on internal organs.

The study, published today in the journal "Archives of Environmental
Contamination and Toxicology", analysed results of safety tests
submitted by Monsanto to the European Commission when the company was
seeking authorisation to market its GE Maize variety MON863 in the EU. (2)

The data shows that MON863 has significant health risks associated with
it; nonetheless, the European Commission granted licences to market the
maize for consumption by both humans and animals. (3)

The incriminating evidence was obtained by Greenpeace following a court
case (4), and passed on for evaluation by a team of experts headed by
Professor Gilles Eric Séralini, a governmental expert in genetic
engineering technology from the University of Caen. (5)

In a joint press conference with Greenpeace at Berlin, Professor
Séralini said, "Monsanto's analyses do not stand up to rigorous scrutiny
- to begin with, their statistical protocols are highly questionable.
Worse, the company failed to run a sufficient analysis of the
differences in animal weight. Crucial data from urine tests were
concealed in the company's own publications."

Greenpeace is demanding the complete and immediate withdrawal of
Monsanto's MON 863 maize from the global market and is calling upon
governments to undertake an urgent reassessment of all other authorised
GE products and a strict review of current testing methods.

"This is the final nail in the coffin for the credibility of the current
authorisation system for GE products. Once it's known that a system
designed to protect human and animal health has approved a high-risk
product despite clear evidence of its dangers, we need to start 'strip-
searching' all GE products on the market, and immediately abort this
flawed approval procedure," said Christophe Then, Genetic Engineer
campaigner, Greenpeace International.

The data in question has been the subject of fierce debate since 2003,
when significant changes were identified in the blood of tested animals
fed on MON863. MON863 was approved by the European Commission, in spite
of opposition by a majority of EU member states, who raised concerns
over the safety of the maize. Professor Séralini's analysis now
scientifically confirms these concerns. As the study states, "with the
present data, it cannot be concluded that GM corn MON863 is a safe
product." And yet, MON863 has been authorised for markets in Australia,
Canada, China, Japan, Mexico, the Phillipines, and USA, besides the EU.

"This is an international emergency alert, requiring a global response,"
concluded Then, "Only a complete withdrawal from all markets will
curtail the possible damage."


Related Reports
Regulatory systems for GE crops a failure: the MON863 case, 13 March 2007
MON 863: A chronicle of systematic deception, 13 March 2007


Notes to Editor
1. The article is due to be published online (http://
www.springerlink.com/content/?k=1432-0703) by the American journal
Archives of Environmental Contamination and Toxicology; it will be
printed in May. A fax copy can be sent on request. A Greenpeace briefing
on the study is available at: http://www.greenpeace.org/international/
press/reports/gp_briefing_seralini_study
2. The tested GE maize named MON 863 produces a new insecticide called
"modified Cry3Bb1" able to kill a pest insect in the soil (Diabrotica
virgifera). This GE maize also contains a gene coding for antibiotic
resistance.
3. The European Commission granted a license for MON 863 to be used in
feed in August 2005, and subsequently approved it for human consumption
in January 2006.
4. For details, please refer to the Greenpeace paper: "The MON863 case -
a chronicle of systematic deception" http://www.greenpeace.org/
international/press/reports/mon863_chronicle_of_deception
5. The analysis team was headed by Professor Séralini from the
University of Caen and included experts from the French independent
scientific organisation CRIIGEN.

Further contact information for reporters to get video, photos or report
details

Christoph Then, Genetic Engineering campaigner, Greenpeace
International: +49 171 878 08 32 Namrata Chowdhary, Greenpeace
International Communications: +44 77 261 751 48 Prof. Gilles-Eric
Séralini, CRIIGEN : +33 231 56 56 84, criigen@unicaen.fr


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                                 PART II
------------------------------- GENET-news -------------------------------
TITLE:  Strong suspicions of toxicity in one GMO corn
SOURCE: truthout.org, USA, translation by Leslie Thatcher
AUTHOR: Le Monde, France, by Stèphane Foucart
URL:    http://www.truthout.org/docs_2006/031307T.shtml
DATE:   13.03.2007
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Strong suspicions of toxicity in one GMO corn

Allowed to go on the market in France and Europe, MON 863, a transgenic
corn invented by Monsanto, has been at the center of a controversy over
its innocuousness for over two years (April 23rd, 2004, Le Monde). These
debates could resume after the March 13th publication in "Archives of
Environmental Contamination and Toxicology" of a study suggesting this
genetically modified organism (GMO) is toxic to the liver and kidneys.

According to this work, consumption of MON 863 corn disturbs numerous
biological parameters in rats to a greater or lesser extent: weight of
the kidneys, weight of the liver, the level of reticulocytes (new red
blood cells), the level of triglycerides, etc. Urinary chemistry is also
changed, with reductions in excreted sodium and phosphorus going as high
as 35 percent. The effects vary with the sex of the animals. "Female
rats exhibit an increase in blood fat and sugar levels, and an increase
in body weight - all associated with greater hepatic sensitivity," says
Mr. Sèralini, principal author of this study and, moreover, president of
the Research Committee for Independent Research and Information on
Genetic Engineering (Criigen). "Among males, the impact is opposite,
with a drop in body and kidney weights."

The authors of this work used data drawn from an experiment sponsored by
Monsanto, which bore on the study of 400 rats for 90 days. The
statistical treatment applied to these data by the experts of the
agrochemical firm was published in August 2005, by "Food and Chemical
Toxicology." That work brought to light significant variations in
biological parameters between animals fed MON 863 and those fed with its
isogene - the same plant variety without the genetic modification.

Monsanto researchers, for their part, had concluded that those
disparities were within the frame of the natural variability of the
measured parameters. The effects produced by the GMO were therefore not
considered pathological. As for the "natural variability," it had been
established by measuring the same series of data on rats fed with other
varieties of non-GMO corn, with different nutritional values from MON
863 and its isogene.

The raw experimental data - over a thousand pages - were kept
confidential by the agrochemical firm until Greenpeace obtained an order
for its publication in spring 2005 from the Appeals Court of Munster
(Germany).

Criigen was thus able to examine the data in detail and to apply a new
statistical treatment to them. According to Mr. Sèralini, that, notably,
consisted of extracting from the raw data the most significant effects
specifically imputable to GMO absorption.

"Of the 58 parameters measured by Monsanto," the researcher details,
"all those that were altered concern kidney or liver functioning." He
continued, "furthermore, Monsanto had deemed that, because the males and
the females responded differently, there was no reason for worry." He
added, "Yet, the liver, for example, is an organ that reacts differently
as a function of sex." In the same way, the fact that the measured
biological response was not always in exact correlation with the dose of
GMO received was interpreted by the company's experts as proof that the
transgenic corn being tested was not the cause. Mr. Sèralini contests
that principle: "When the disturbances are hormonal, for example, the
impact may not be proportional to the dose."

Toxicologist Gèrard Pascal, a member, like Mr. Sèralini, of the
Committee on Bio-molecular Engineering, deems certain that Criigen's
conclusions are erroneous. "I reject the analysis of the animals' weight
curves, conducted without taking their feeding into account," says Mr.
Pascal. "But I agree that the biological responses may vary between
males and females and with the principle that the effects of a GMO corn
must be compared with its isogene only and not take into account effects
produced by other corn varieties."

According to Mr. Pascal, the lack of direct correlation between the GMO
doses received and the impacts observed on the hepatic parameters
disqualifies the conclusions about liver toxicity. Significant
differences with respect to "kidney weight" and "urinary sodium,
phosphorus, and potassium" suggest a renal impact. "However," Mr. Pascal
recalls, "at my request, the CGB pressed for investigations of the
kidneys and had not found any definitive evidence of toxicity" (December
15th, 2004, Le Monde). "The variations in the levels of reticulocytes
and eosinophiles (white blood cells) remain," adds M. Pascal. "I don't
know how to interpret that, but those are parameters that move around a
lot in experiments." As far as Mr. Pascal is concerned, the information
developed by Criigen is not of a nature to call into question the
favorable opinions delivered with respect to MON 863. "All that is
nothing but a personal interpretation," adds the toxicologist.

Criigen's work has been financed by Carrefour and Greenpeace, but, as
Mr. Sèralini explains, "Unfortunately, today there is no public budget
for conducting this type of research." A situation all the more harmful,
according to Mr. Sèralini, in that, "the whole toxicological study ought
to be redone, controlling for hormonal dosages" and, above all, the
tests should be continued well beyond 90 days and on species other than
the rat to reach a definitive conclusion.


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                                 PART III
------------------------------- GENET-news -------------------------------
TITLE:  GMO corn causes liver, kidney problems in rats: study
SOURCE: Reuters
AUTHOR:
URL:    http://www.reuters.com/article/scienceNews/idUSL1346840020070313
DATE:   13.03.2007
--------------------------------------------------------------------------


GMO corn causes liver, kidney problems in rats: study

PARIS (Reuters) - Environmental group Greenpeace launched a fresh attack
on genetically modified maize developed by U.S. biotech giant Monsanto,
saying on Tuesday that rats fed on one version developed liver and
kidney problems.

Greenpeace said a study it had commissioned that was published in the
journal Archives of Environmental Contamination and Technology showed
rats fed for 90 days on Monsanto's MON863 maize showed "signs of
toxicity" in the liver and kidneys.

"It is the first time that independent research, published in a peer-
reviewed journal, has proved that a GMO authorized for human consumption
presents signs of toxicity," Arnaud Apoteker, a spokesman for Greenpeace
France said in a statement.

Campaigners against Genetically Modified Organisms (GMO) say that
genetic modification technology is unproven and potentially dangerous
and that GMO crops can contaminate other crops.

The industry says the technology offers vast potential benefits, poses
no health risk and has never been shown to contaminate other crops.

"All the experts agree that the maize in question is as safe as
traditional maize," Yann Fichet, director external relations for
Monsanto France told France's TF1 television.

He said the maize had been authorized in more than 10 countries and in
the European Union but he declined to comment specifically on the
allegations raised by Greenpeace.

MON863 is a form of maize genetically modified to make it resistant to
corn rootworm. It has been authorized by the European Union for use in
animal feed since 2005 and for human consumption since January 2006.


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                                 PART IV
------------------------------- GENET-news -------------------------------
TITLE:  French scientists express doubt about genetically modified corn
SOURCE: Deutsche Welle, Germany
AUTHOR:
URL:    http://www.dw-world.de/dw/article/0,2144,2382626,00.html
DATE:   13.03.2007
--------------------------------------------------------------------------


French scientists express doubt about genetically modified corn

The environmental protection organization Greenpeace has long said
genetically modified maize could be a health hazard. Now, in a new
study, a group of French scientists have also expressed their doubts
about the corn.

Greenpeace has warned about the potential dangers of genetically
modified (GM) produce and maize for some time. On Tuesday they presented
a study in Berlin to backup their claims.

Professor Gilles-Eric Seralini of the University of Caen said that
according to studies by his group, CRIIGEN, Monsanto's maize type MON863
caused symptoms of poisoning and liver and kidney damage in rats that
were fed the product during experiments.

Seralini's results call into question an earlier report by Monsanto that
said genetically modified feed was harmless.

"There are significant deficits in the statistic evaluation of the
Monsanto report," Seralini said.

Genetically altered maize could therefore not be deemed safe, Séralini said.

Greenpeace genetic engineering expert Christoph Then said the case shows
that "German Consumer Affairs Minister Horst Seehofer must stop the
sowing of GM seeds and the import of GM food in Germany."


Built in pest control

MON863 has been cultivated since 2003 in several countries, including
the United States and Canada.

The GM maize, which can be legally imported into European Union
countries since 2006 as a food and feed product, contains a protein to
combat plant pests, allowing farmers largely to grow their maize crops
without having to use pesticides.

Seralini, however, said he found that GM maize produced around one
kilogram of poisonous substances per hectare. He said that is more than
farmers would use in pesticides.

The scientist also pointed out that Monsanto ran tests with animals fed
with MON863 for only 90 days. Long-term studies do not exist, he said.


As safe as unmodified corn

Andreas Thierfelder, spokesperson for Monsanto Agrar Germany, said
Greenpeace had already been unsuccessful in several attempts to question
studies done on the effects of MON863 in feed.

"But the allegations were refuted every time by competent authorities,"
Thierfelder said. He said the European Food Safety Authority and the
German Office of Consumer Protection and Food Safety had evaluated
Monsanto's experiments with GM feed.

Monsanto Germany's spokesman said the authorities had found that "MON863
to be as unquestionable for health and the environment as conventional maize."


-------------------- archived at  http://www.gene.ch/ --------------------


                                 PART V
------------------------------- GENET-news -------------------------------
TITLE:  Serious concerns raised over Monsanto GM maize variety
SOURCE: Food Navigator, France
AUTHOR: Stephen Daniells
URL:    http://www.foodnavigator.com/news/ng.asp?n=74954-monsanto-
greenpeace-mon-gm-maize
DATE:   14.03.2007
--------------------------------------------------------------------------


Serious concerns raised over Monsanto GM maize variety

14/03/2007 - Monsanto's genetically modified maize MON863, authorised
for human consumption since 2006, showed signs of liver and kidney
toxicity in a rat study, raising concerns about its safety.

The study, performed by French researchers from the independent CRIIGEN
(Committee for Independent Research and Genetic Engineering), based at
the University of Caen reports that rats fed the maize for three months
showed signs of liver and kidney toxicity, as well as differences in
weight gain between the sexes.

"Our counter-evaluation show that there are signs of toxicity and that
nobody can say scientifically and seriously that consumption of the
transgenic maize MON863 is safe and good for health," lead author of the
study, Professor Gilles Eric Séralini told France's TF1 television station.

MON863 is a transgenic maize genetically modified to express the Bt-
toxin (Cry3Bb1) which enables the plant to be insect repellent against
the corn rootworm pest. It is different from other GM corns of the
market since these express the Cry1Ab toxin which is toxic to the
European corn borer.

The study, published on-line in the peer-review journal Archives of
Environmental Contamination and Toxicology, fed young adult Sprague-
Dawley-derived rats (aged six weeks at the start of the experiment)
diets containing 11 or 30 per cent MON863, or diets containing non-GM
corn for 90 days.

At the end of the study, Séralini and his team found signs of toxicity
in the liver and kidneys of rats fed the MON863 maize, as well as
changes to weight between the sexes. Indeed, male rats were found to
have lost, on average, 3.3 per cent of their body weight, while females
gained 3.7 per cent.

Triglyceride levels also increased by between 24 and 40 per cent in
females, phosphorous and sodium excretion decreased in males.

"We have the first signs of toxicity that appear at the level of body
weight, the kidneys, and the liver, and that are also different between
the sexes indicating deeper effects at the hormone level," said Séralini.

The researchers raised concerns over the methods used by Monsanto to
initially show the safety and non-toxicity of the corn, saying that the
statistical methods used were insufficient to observed any possible
disruptions in biochemistry.

The mechanism behind the apparent toxicity is not known, but there is
some evidence that the Bt-toxin may perforate blood cells, they said.

"Considering that the human and animal populations could be exposed at
comparable levels to this kind of food or feed that has been authorised
by several countries, and that these are the best mammalian toxicity
tests available, we strongly recommend a new assessment and longer
exposure of mammals to these diets, with cautious clinical observations,
before concluding that MON863 is safe to eat," concluded the researchers.

Environmental group Greenpeace has demanded an immediate and complete
recall of MON863 from the global market, and also called on an urgent
reassessment of all other authorised GM foods by governments.

"It is the first time that independent research, published in a peer-
review journal, proves that a GMO authorised for human consumption
presents signs of toxicity," said Arnaud Apoteker from Greenpeace France.

"We must review urgently the authorisation of MON863, even more so
because we do not know is this maize is present in the French market and
if it is used for animal feed or for producing foods destined for humans."

Monsanto France has rejected the concerns. Yann Fichet, Monsanto
France's director of external relations told TF1: "[MON863] has already
been examined by competent authorities and scientific experts in more
than 10 countries worldwide, including the European Union and France,
and all the experts concluded unanimously that the maize in question is
as safe as traditional maize."

The corn is authorised in Australia, Canada, China, the EU, Japan,
Mexico, the Philippines and the USA.

Source: Archives of Environmental Contamination and Toxicology
Published on-line ahead of print, doi: 10.1007/s00244-006-0149-5
"New analysis of a rat feeding study with a genetically modified maize
reveals signs of hepatorenal toxicity"
Authors: G.-E. Séralini, D. Cellier, J. Spiroux de Vendomois


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