Say No To GMOs! - March 2007b

March 2007 Updates

Strong Suspicions of Toxicity in One GMO Corn

By Stephane Foucart
Le Monde
March 14, 2007

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. Seralini, 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. Seralini, 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. Seralini contests that principle: "When the disturbances are hormonal, for example, the impact may not be proportional to the dose."

Toxicologist Gerard Pascal, a member, like Mr. Seralini, 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. Seralini explains, "Unfortunately, today there is no public budget for conducting this type of research." A situation all the more harmful, according to Mr. Seralini, 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.

[Translation of the French original: t r u t h o u t French language correspondent Leslie Thatcher. ]

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A Serious Concern : Authorized GM Maize Is Unfit For Consumption

CRIIGEN
Press release
March 14, 2007

The case of Bt GM maize MON 863

Abstract

For the first time in the world, an independent study on the health risks of a GM maize authorized for consumption shows signs of hepatorenal toxicity (1). It is a countervaluation performed by CRIIGEN (France), of a regulatory study by the Monsanto Company, on rats fed with a GM maize (MON 863) over a three-month period. The raw data were used to obtain the commercial release of this GM maize at an international level. These revelations are certainly sufficient to require an immediate ban of GM maize MON 863 and all its hybrids from human or animal consumption, as well new and more carefully conducted feeding studies. This maize cannot now be considered safe to eat. We are calling urgently for a moratorium on other approved GMOs while the efficacy of current health testing methods is reassessed.

For the first time in the world, an independent study on the health risks of a GM maize authorized for consumption shows signs of hepatorenal toxicity (1).

It is a countervaluation performed by CRIIGEN (France), of a regulatory study by the Monsanto Company, on rats fed with a GM maize (MON 863) over a three-month period. The raw data were used to obtain the commercial release of this GM maize at an international level. The symptoms discovered in re-analyzing the data are consistent, and are evidenced in comparison to control rats of the same genetic origin, the same age, and caged in strictly similar conditions. They have eaten a diet of equilibrated chemical composition, assessed as equivalent to controls, but without the Bt toxin which is the insecticide produced by the GM maize itself. On average, females show a gain of weight, a significant increase of sugar and fat in the blood, an increase of liver weight relative to body weight, and disruption of renal function. Inversely, the males lose weight, they are more sensitive at the renal level, the kidneys also lose weight in comparison to the body, and ions analyses are modified in urine. This may have a relationship with the diagnosed nephropathies. This latter phenomenon may be naturally developed with age in this rat strain, but in this case the rats were young, reaching only five months by the end of the experiment. Markers of hepatic function are also reached. We can notice that toxic products such as pesticides regularly provoke different effects according to the sex, like during a cancer initiation. It is not possible for such short tests to identify the precise beginning of a particular disease. However, the detoxification organs are reacting.

The body weight variations of these animals were not statistically evaluated by Monsanto, who published a study on this subject in 2006. Monsanto's paper also omitted the urine chemistry analyses. The statistics were not detailed enough and their protocols were questionable.

We raise concern about the reasons for which the authorities did not require an independent study of the statistical analyses performed by Monsanto, which would have exposed these problems.
We question why the authorities did not require the renewal and the prolongation of these experiments, controversial since 2003.
And we question whether the authorities did not ask for the sexual hormones measurements, that may be disrupted because of the different effects based on gender.

The raw data of Monsanto that allowed this countervaluation were obtained via Court action. These data were considered as confidential not only by the Company, but also by European States and the European Community. The data thus concern the MON 863 maize producing a new insecticide called "modified Cry3Bb1" supposedly there to kill Chrysomelidae (coleopteran insect, Diabrotica virgifera). This insect is a particularly devastating pest to the maize. It was also recently introduced by plane several times in Europe. This recently authorized GM maize also contains a gene coding for antibiotic resistance. Monsanto's tests prove quite insufficient, although there are at the same time the most detailed, and the longest ones, ever performed over the world on mammals, after consumption of this plant ; and these are typical of actual regulatory tests for GMOs (lasting only 90 days maximum on rats).

Because it produces a new internal insecticide, this GMO belongs to the second most important category of cultivated and commercialized GMOs throughout the world. The other GMOs absorb an herbicide without dying. Thus, most of GMOs are pesticide-plants.

For the record, these tests were controversial from the outset in France, and in 2003 they provoked a disagreement between experts, in particular in the French CGB (Commission du Génie Biomoléculaire). CRIIGEN (the Committee for Independent Research and Information on Genetic Engineering) was concerned about possible scientific weakness, and asked the GM regulatory authorities for sight of the raw data. These data were kept confidential until Greenpeace Germany won a Court verdict against Monsanto; this forced the company to make public the blood and urine analyses of the rats under experiment. The raw data are contained within more than 1130 pages of tables of numbers and calculations. A group from CRIIGEN comprising Prof. Gilles-Eric Séralini (researcher on pesticides and governmental expert on GMOs, University of Caen), Dr. Dominique Cellier (biostatistician, University of Rouen), and Dr. Joël Spiroux de Vendomois (physician and specialist on environmental health), have concluded a study and re-evaluation of these data. The work has been done independently of Monsanto or any other GMO producer.

These revelations are certainly sufficient to require an immediate ban of GM maize MON 863 and all its hybrids from human or animal consumption, as well new and more carefully conducted feeding studies. This maize cannot now be considered safe to eat. We are calling urgently for a moratorium on other approved GMOs while the efficacy of current health testing methods is reassessed.

(1) The article, entitled "New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity" is by Gilles-Eric Séralini, Dominique Cellier, and Joël Spiroux de Vendomois. It is published on line http://dx.doi.org/10.1007/s00244-006-0149-5 (you may need to copy and paste the URL into your browser).) by the American journal Archives of Environmental Contamination and Toxicology. It will be printed in May. The editor is Dr. Doerge from the Food and Drug Administration (FDA).

Revealed: Why Monsanto Suppressed GM Maize Feeding Study

Press Notice
GM Free Cymru
March 13, 2007

Independent analysis of data uncovers evidence of scientific fraud

It has been revealed today, at a Paris Press Conference (1), that the Monsanto GM maize referred to as MON863 caused serious damage to the liver and kidneys of rats which consumed it during feeding trials. This is the first time in the world that a study on the health risks of a GM maize authorized for consumption shows signs of hepatorenal toxicity (2). The study is published today in the peer-reviewed journal "Archives of Environmental Contamination and Toxicology".

The study, completed at CRIIGEN (Caen, France), contains an examination of the raw data on MON863 feeding experiments initially suppressed by Monsanto but later obtained in 2005 after a Court action in Germany. Prior to that court action, Monsanto had refused public access to the data on the spurious grounds of "commercial confidentiality", although it had been widely leaked that the feeding studies showed statistically significant negative health effects on animals fed with the GM maize (3).

The GM maize in question produces a new insecticide called "modified Cry3Bb1" which has the capacity to kill the coleopteran insect Diabrotica virgifera. The plant also contains a gene coding for antibiotic resistance. (There are many other commercial GM varieties which produce new insecticides, and many others which are herbicide- tolerant or herbicide-resistant. Almost all of these new varieties have been heavily criticized by independent scientists on the grounds that their safety has never been fully established.) In America the variety is classified as a pesticide since every cell is toxic to insects. In spite of widespread concern and protests from the scientific community and consumer organizations, MON863 was given formal approval by the EC on 8th August 2005.

The new study (4) involved a new and rigorous statistical analysis of all the raw data in the 1130 page document, concentrating on the blood and urine analyses of the test animals. The French researchers claim that the Monsanto statistics were not detailed enough and that their protocols were questionable. Real damage to test animals was therefore masked by the analytical methods chosen -- and there can be little doubt that Monsanto knew this. Upon detailed analysis, the French team uncovered an increase of up to 40% in blood triglycerides in females, and a more than 30% decrease in urine phosphorus and sodium in males, specifically linked to the GM diet. The reasons for these changes are unclear, but they may provide clues to the deaths of many animals which have consumed Bt feed in other animal experiments (5).

Professor Seralini said: "These revelations are profoundly disturbing from a health point of view. They are certainly sufficient to require new and more carefully conducted feeding studies and an immediate ban from human or animal consumption of GM maize MON 863 and all its hybrids. This maize cannot now be considered safe to eat. We are now calling urgently for a moratorium on other approved GMOs while the efficacy of current health testing methods is reassessed."

Speaking for GM Free Cymru, Dr Brian John said: "Now we know why Monsanto wanted so desperately to keep this animal feeding study out of the public domain. There is scientific fraud here, and this must now be apparent to all of us, including the regulatory bodies. Goodness knows how many other studies showing real harm to animals fed on GM crops and foods have simply been hidden away from independent scrutiny. We support Professor Seralini's call for an immediate moratorium on ALL GM varieties, approved or unapproved, while the regulators put into place the robust and independent health testing methods that we have been calling for since 2001. There can now be no further doubt that GM crops and foods are damaging to health."

Notes

From the Independent Committee for Research and Information on Genetic Modification: Corinne LEPAGE, Présidente du CRIIGEN (Comité de Recherche et d'Information Indépendantes sur le Génie Génétique) vous convie à une conférence de presse le mardi 13 Mars 2007 à 17h30 sur le thème : « OGM : de nouvelles révélations » En présence du Professeur Gilles-Eric SERALINI, des Docteurs Dominique CELLIER et Joël SPIROUX de VENDOMOIS du Conseil Scientifique du CRIIGEN (www.criigen.org) Au Pain Quotidien 18 rue des Archives 75004 Paris Métro: Hôtel de Ville Merci de confirmer votre présence auprès de Céline ALONZO par téléphone au 06 03 53 19 07 ou par mail calonzo@free.fr

Un cas grave : un maïs OGM autorisé est impropre à la consommation Pour la première fois au monde, une étude des risques sur la santé d'un maïs transgénique autorisé à la consommation montre des signes de toxicité hépatique et rénale. Des exigences et recommandations seront formulées.
The article, entitled "New analysis of a rat feeding study with a genetically modified corn reveals signs of hepatorenal toxicity" is by Gilles-Eric Séralini, Dominique Cellier], and Joël Spiroux de Vendomois. It is published on line (www.springerlink.com/content/ 1432-0703) by the American journal Archives of Environmental Contamination and Toxicology. It will be printed in April.
The peer review of the MON863 feeding study by Dr Arpad Pusztai was subject to a gagging order imposed by Monsanto as a condition for the report to be examined. Dr Pusztai also revealed statistically significant differences between the "GM-fed" group of rats and the control, group. See these items: http://www.gmfreecymru.org/news/Press_Notice31May2005.htm http://www.gmfreecymru.org/pivotal_papers/monsanto.htm
From CRIIGEN press release: Animal feed made from MON863 maize was given to rats in a laboratory over a period of 13 weeks. The associated tests on the GM-fed group and control groups were the longest and most detailed ones involving mammals which have consumed this plant, and they were used in support of its authorization throughout the world. These tests were controversial from the outset in France, and in 2003 they provoked a disagreement between experts, in particular in the French CGB (Commission du Génie Biomoléculaire). CRIIGEN (the Committee for Indepent Research and Information on Genetic Engineering) was concerned about possible scientific fraud, and asked the GM regulatory authorities for sight of of the raw data. These data were kept confidential until Greenpeace Germany won a Court verdict against Monsanto; this forced the company to make public the blood and urine analyses of rats fed with MON863 during the 3 month feeding trials.

The data are contained within more than 1130 pages of tables of numbers and calculations. A group from CRIIGEN comprising Prof. Gilles-Eric Séralini (researcher on pesticides and governmental expert on GMOs, University of Caen), Dr. Dominique Cellier (biostatistician, University of Rouen), and Dr. Joël Spiroux de Vendomois (physician and specialist on environmental health), has now performed a re-evaluation of these data. The work has been done quite independently of Monsanto or any other GMO producer.

The effects of the GM maize on animal weight variations were not studied by the Monsanto scientists. In 2006 the company published certain studies based on the feeding trials , but the scientists did not analyse animal weight or urine data. The statistics were not detailed enough and their protocols were questionable. Upon detailed analysis, the data are now shown to reveal an increase of up to 40% in blood triglycerides in females, and a more than 30% decrease in urine phosphorus and sodium in males, specifically linked to the GM diet. However, these effects were not picked up by the regulatory authorities including EFSA, and they did not request any repeat or prolongation of these experiments.
(5) http://www.gmfreecymru.org/news/Press_Notice16Feb2007.htm http://www.gmfreecymru.org/pivotal_papers/ermakova.htm http://www.gmfreecymru.org/pivotal_papers/toxic.htm

EFSA to Review Monsanto Maize Concerns

By Stephen Daniells
GoodNavigator.com
March 15, 2007

The European Food Safety Authority (EFSA) has revealed that it will review the new data presented by French scientists that revealed toxicity concerns in rats fed the MON863 variety of GM maize from Monsanto.

The new data, from a 90-day rat study and published in the peer-review journal Archives of Environmental Contamination and Toxicology, indicated liver and kidney toxicity in the rats, as well as differences in weight gain between the sexes as a result of eating the transgenic maize.

Alun Jones, EFSA spokesperson told FoodNavigator.com that the authority has not yet had the opportunity to look at the new study in detail but this will be done by their scientific experts before any decisions is made regarding the maize.

The GMO panel will meet on March 22nd and 23rd to consider and discuss the new study.

Jones also stated that this was not the first time that EFSA have been requested to look at MON863. Indeed, the authority released a statement in October 2004 following a request by the German authorities following a 13-week rat study that suggested kidney toxicity.

"Following [the GMO Panel's] investigation of the report, and of the retrospective evaluation of renal tissues and data derived from the 13-week rat feeding study performed by independent peer reviewers, the GMO Panel concludes that there is no evidence presented in the report that changes the conclusions already reached by the GMO Panel earlier this year in its Opinions on the safety of the insect-protected genetically modified maize MON 863 (EFSA 2004a, b)," read the October 2004 statement.

"These opinions state that the results of the rodent toxicity study with MON 863 maize did not indicate concerns about its safety for human and animal consumption."

The researchers behind the new study, led by Professor Gilles Eric Séralini from the independent CRIIGEN (Committee for Independent Research and Genetic Engineering) based at the University of Caen questioned 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.

"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," said Séralini during a joint press conference with environmental group Greenpeace in Berlin.

Monsanto have continued to defend the safety record of their corn. Spokesperson, Lee Quarles, told FoodNavigator.com: "The important thing to note in all of this is the fact that the overwhelming opinion of expert authorities is that MON 863 is safe for human and animal consumption. This includes experts in Europe as the European competent authorities concur that MON 863 YieldGard Rootworm maize is safe for human and animal health and the environment.

"Please also note that MON 863 YieldGard Rootworm maize has completed full regulatory review and has been grown commercially in the United States and Canada since 2003. This product has also been approved for import and food use in many countries around the world, including Japan, Korea, Taiwan, the Philippines, Russia and Mexico," he added.

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.

It received European approval for use in animal feed in 2005 and for human consumption in 2006.

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