To the Ladies and Gentlemen of the Biomolecular Engineering Commission 

On 29 May 2007, we were summoned before the Commission about the international publication of our study on the signs of toxicity of the MON863 GMO maize. But due to the very conditions of the meeting, we never had a chance to express ourselves on the substance of our work.

We would like to underline in particular that the first point had to do with the weight charts of the rats and was relying on a report that was never forwarded to us, and that is a shame, because if we had had this report, a serene discussion on the matter would have ensued, however the question of the weight charts, I do wish to underline this, is not the focus point in our paper. 

The purpose of the present letter is to clarify certain elements. We confirm that our analysis is adequate after having studied your report. Our pragmatic approach consisted in initiating our study on average experimental curves. Moreover, all the possible comparisons with MON 863 hybrids would not enable us to conclude: on the one hand the insecticide levels are not well characterized and they are different too (if the effects we have been observing are actually due to the insecticide). On the other hand, the various genetic modifications prevent us from drawing, because of the possible interactions, a definite conclusion on these results. Furthermore, no statistics as thorough as ours were ever produced for the hybrids.

CRIIGEN APPEALS TO PUBLIC AUTHORITIES  - 6 July 2009 

Agricultural GMO developers and regulatory agencies have systematically neglected secondary effects of GMOs and pesticides. This was clearly demonstrated by the EFSA and the US FDA when each assessed the controversial GM maizes M0N863 and MON810 that produce artificial insecticides. The finding is contained in a study by eight international experts from three continents just published.

Regulatory tests conducted prior to commercial release analyse the blood of mammals that are fed GMOs. The length of these studies is generally dangerously short periods of exposure (3 months) and the number of animals tested is usually insufficient to determine safety.

However, when significant statistical results from these tests were observed that showed signs of toxicity, they were ignored and/or dismissed. Moreover, such effects are often judged to be of no importance if they are not similar in males and females, or do not show an increase with the dose of GMO fed to the animal. Such systematic bias results in a significant underestimation of initial signs of chronic diseases such as cancers, hormonal disruptions, immune, nervous or reproductive deficiencies, among others.

This is an inexcusable error in light of modern scientific knowledge. By endorsing techniques adopted by developers to mask statistically significant results, the authorities have demonstrated their inability to learn the lessons of past health scandals. In addition any regulatory study should be done long term by an independent body.

CRIIGEN calls on food safety regulators to immediately release the mammalian blood analyses and other such relevant safety data used to authorize GMOs and pesticides such as Roundup in the past. If they do not allow this information to be reviewed by independent third parties, they will become complicit if new health scandals arise involving prior approvals because they will have refused to allow the data to be independently evaluated when there is credible reason for doubt. Health scandals could arise more crucial than financial ones, at an international level, by transparency lack or too light controls in regulatory instances.

For details, see scientific paper published in June 2009 by Prof. Gilles-Eric Seralini et al. Int J Biol Sci 2009; 5:438-443. http://www.biolsci.org/v05p0438.htm For contact This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

http://www.biolsci.org/v05p0438.htm

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Press release

CAEN – A study carried out by eight international researchers is questioning the reliability of the tests run by the European Food Safety Authority (EFSA) and its American equivalent FDA to assess health risks of GMOs and pesticides.

The article signed by French, Italian, New-Zealander, British and American experts is published on the web site of the International Journal of Biological Science.

“Agricultural GMO developers and evaluation committees systematically overlook the side effects of GMOs and pesticides. This is clearly illustrated by the EFSA and the US FDA, which evaluated the controversial GM maize varieties MON 863 and MON 810”.

“It brings to light "a significant underestimation of the initial signs of diseases like cancer and diseases of the hormonal, immune, nervous and reproductive systems, among others”.

“We demand the systematic publication of the results of these tests, which we could only obtain on a case by case basis by taking legal action,” Gilles-Eric Séralini told Agence France Presse. He is one of the eight authors of the article, also a Professor at the University of Caen and Chairman of the Scientific Board of CRIIGEN.

“The health crises may be more important than the international financial crisis, because of the lack of transparency of the regulators”.

So far, France has rejected the findings of EFSA which judged that MON810 is not a health risk.

(©AFP / 08 juillet 2009 16h47)

  September 2007

Austria, backed by Ireland, Italy, Poland, Luxembourg, Belgium, the Czech Republic, France, Cyprus, Hungary, Malta, Greece and Slovakia, asked the Commission to consider, on the basis of an initiative of the main competent authority, the taking into account of appropiate measures in order to adjourn or limit the authorization of MON 863.

Austria suggested that a new long-term study on MON 863 maize should be carried out, based on modern toxicological methods, which should be appropriate to assess the biological performances of animals fed on this specific GMO. Such a study would need a long observation period, as a study of subchronic toxicity.

The Report of a Panel of Experts on the Monsanto Study on MON 863 and on the Counter-Evaluation of the Same Study by CRIIGEN

MON 863 is a variety of genetically modified maize, which has been tested within the framework of a regulatory study conducted by Monsanto Company on rats fed on this maize for three months, with a view to obtain a commercialization authorization. The same study re-analysed by Séralini et al demonstrates potential hepatorenal effects. A panel of experts was asked to assess the results of the original study conducted by Monsanto and the counter-evaluation conducted by Séralini et al. This panel of experts concluded that the re-analysis by Séralini et al did not provide evidence indicating that MON 863 was associated to unfavourable effects in the study on rats fed on GMOs for 90 days.

The panel of experts sent their warmest thanks to Monsanto Company for their financial and technical support. 

www.sciencedirect.com

 Analysis of the Study on MON 863 by CRIIGEN

"New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity" by Gilles-Eric Séralini, Dominique Cellier, and Joël Spiroux de Vendomois. For the first time in the world, a study on the health risks of a GM maize authorized for consumption shows signs of hepatorenal toxicity. 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. 

Paper reference:  Arch. Environ. Contam. Toxicol. 52, 596–602 (2007) http://www.springerlink.com DOI: 10.1007/s00244-006-0149-5

Download the article in French

Press release of New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity

CRIIGEN answers to "Food Standards Australia New Zealand” (FSANZ) critique

Different advisory bodies have already reviewed this CRIIGEN international peer-reviewed paper on the toxicology of a GMO, which remains the most detailed published toxicological analysis of a commercialized GMO. These bodies, each one waiting for the advice of the others (AFSSA, CGB, EFSA), have developed similar arguments. CRIIGEN has already answered them and we ask that our critique should be read and considered first. FSANZ was in any case waiting for the EFSA opinion, as indicated, before giving its own.

CRIIGEN answers to European Food Safety Authority critique 

In June 2007, the European Food Safety Authority (EFSA) issued a press release  describing recent analyses of our publication  in an international journal. Our study represents to date the most detailed statistical peer-reviewed paper on one of the longest toxicological studies on a commercialized GMO.
After careful consideration of the June 28 EFSA review on the GM maize MON 863 toxicological test, we indicate here our 5 main points of disagreement for the international scientific community, government authorities and the public. These are listed below by order of importance with EFSA views and supporting organisations or societies:

Dear Mr Editor, Dear Mr Journalist,

Following your article entitled: “European Experts claim GMO is harmless*” page 12 in the Figaro dated from 14-15 July 2007, we would like to draw your attention on a number of inaccuracies. Your article focuses on the reactions of the European Agency EFSA and of the French Commission CGB following our scientific paper entitled "New Analysis of a Rat Feeding Study with a Genetically Modified Maize Reveals Signs of Hepatorenal Toxicity by G.E. Séralini, D. Cellier & J. Spiroux de Vendômois, Arch. Environ. Contam. Toxicol. 52, 596–602 (2007)".

CRIIGEN’s official note following AFSSA’s opinion No 2007-SA-0109 dated 26 April 2007 on the publication by G.E. Séralini, D. Cellier, J. Spiroux de Vendomois, Arch. Environ. Contam. Toxicol. (2007) 52 (4) 596-602.

Not a single question was submitted to CRIIGEN by AFSSA during this analysis. However we wish to underline that a number of errors seem to have found their way into AFSSA’s official opinion, but this probably due to a rather speedy reading of the above mentioned publication.