CRIIGEN on GM maize concerns / EFSA to review GM maize (15/3/2007)

1.A SERIOUS CONCERN : AUTHORIZED GM MAIZE IS UNFIT FOR CONSUMPTION - CRIIGEN
2.EFSA to review Monsanto maize concerns - FoodNavigator.com

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1.A SERIOUS CONCERN : AUTHORIZED GM MAIZE IS UNFIT FOR CONSUMPTION
The case of Bt GM maize MON 863
Press release CRIIGEN – March 2007

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.
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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.

1/ 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.

2/ We question why the authorities did not require the renewal and the prolongation of these experiments, controversial since 2003.

3/ 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. Joel 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).

Contacts : CRIIGEN Tel : +33 (0) 2 31 56 54 89 or 56 84 mail : criigen@unicaen.fr CRIIGEN President Corinne Lepage + 33 (0) 6 11 17 50 97

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2.EFSA to review Monsanto maize concerns
By Stephen Daniells GoodNavigator.com, 15 March 2007
http://www.ap-foodtechnology.com/news/ng.asp?n=74981-monsanto-efsa-mon-toxicity-gm

15/03/2007 - 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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