Long Term Toxicity of a Roundup Herbicide and a Roundup-Tolerant GM Maize

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

Dear friends and colleagues

Worrying new results about the health impacts of the widely-used Roundup herbicide and the Roundup tolerant GM maize NK603 (cultivated with or without Roundup) have just been published in the journal Food and Chemical Toxicology (Item 1). The study was a long term animal feeding trial of greater duration (spanning the average life-span of rats, 2 years) and with more detailed analyses than any previous studies to date.

The impacts (see Item 2) included increased and more rapid mortality, coupled with hormonal non-linear and sex-related effects. Females developed significant and numerous mammary tumours, pituitary and kidney problems. Males died mostly from severe hepatorenal chronic deficiencies. The researchers hypothesized that the reason why NK603 maize, NK603 maize sprayed with Roundup, and Roundup on its own, all produce very similar impacts, is that both the GM maize and Roundup may cause hormonal disturbances in the same biochemical and physiological pathway.

The study provides evidence that lower levels of complete agricultural glyphosate herbicide formulations, at concentrations well below officially set safety limits, induced severe hormone-dependent mammary, hepatic and kidney disturbances. Similarly, disruption of biosynthetic pathways that may result from overexpression of the EPSPS transgene in the GM NK603 maize can give rise to comparable pathologies that may be linked to abnormal or unbalanced phenolic acids metabolites, or related compounds. Other mutagenic and metabolic effects of the edible GMO cannot be excluded.

In addition, these results call into question the adequacy of the current regulatory process for GM crops/food and herbicides. The French government has asked its health watchdog to investigate the findings and depending on the findings, will urge the European authorities to take all necessary measures to protect human and animal health (Item 3). Meanwhile, the Austrian government has called on the European Commission to review its approval process for GM food. The European Commission has said that it has asked the EU’s food safety authority, EFSA, to verify the results of the study.

With best wishes,

Third World Network

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Malaysia

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Item 1

Article in press: Séralini, G.-E., et al. Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Food Chem. Toxicol. (2012), http://dx.doi.org/10.1016/j.fct.2012.08.005

Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize

Gilles-Eric Séralini [a], Emilie Clair [a], Robin Mesnage [a], Steeve Gress [a], Nicolas Defarge [a], Manuela Malatesta [b], Didier Hennequin [c], Joël Spiroux de Vendômois [a]

[a] University of Caen, Institute of Biology, CRIIGEN and Risk Pole, MRSH-CNRS, EA 2608, Esplanade de la Paix, Caen Cedex 14032, France

[b] University of Verona, Department of Neurological, Neuropsychological, Morphological and Motor Sciences, Verona 37134, Italy

[c] University of Caen, UR ABTE, EA 4651, Bd Maréchal Juin, Caen Cedex 14032, France

ABSTRACT

The health effects of a Roundup-tolerant genetically modified maize (from 11% in the diet), cultivated with or without Roundup, and Roundup alone (from 0.1 ppb in water), were studied 2 years in rats. In females, all treated groups died 2-3 times more than controls, and more rapidly. This difference was visible in 3 male groups fed GMOs. All results were hormone and sex dependent, and the pathological profiles were comparable. Females developed large mammary tumors almost always more often than and before controls, the pituitary was the second most disabled organ; the sex hormonal balance was modified by GMO and Roundup treatments. In treated males, liver congestions and necrosis were 2.5-5.5 times higher. This pathology was confirmed by optic and transmission electron microscopy. Marked and severe kidney nephropathies were also generally 1.3-2.3 greater. Males presented 4 times more large palpable tumors than controls which occurred up to 600 days earlier. Biochemistry data confirmed very significant kidney chronic deficiencies; for all treatments and both sexes, 76% of the altered parameters were kidney related. These results can be explained by the non linear endocrine-disrupting effects of Roundup, but also by the overexpression of the transgene in the GMO and its metabolic consequences.

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Item 2

For the first time, the health impact of a GMO and a widely used pesticide have been comprehensively assessed* in a long term animal feeding trial of greater duration and with more detailed analyses than any previous studies, by environmental and food agencies, governments, industries or researchers institutes.

The two tested products are in very common use : (i) a transgenic maize made tolerant to Roundup, the characteristic shared by over 80% of food and animal feed GMOs, and (ii) Roundup itself, the most widely used herbicide on the planet. The regulatory approval process requires these products to be tested on rats as a surrogate for humans.

The new research took the form of a two year feeding trial on 200 rats, monitored for outcomes against more than 100 parameters. The doses were consistent with typical dietary/ environmental exposure (from 11% GMO in the diet, and 0.1 ppb in water).

The results, which are of serious concern, included increased and more rapid mortality, coupled with hormonal non linear and sex related effects. Females developed significant and numerous mammary tumours, pituitary and kidney problems. Males died mostly from severe hepatorenal chronic deficiencies. Professor Seralini’s team in the University of Caen is publishing this detailed study in one of the leading scientific international peer-reviewed journals of food toxicology, on line on Sept. 19, 2012.

The implications are extremely serious. They demonstrate the toxicity, both of a GMO with the most widely spread transgenic character and of the most widely used herbicide, even when ingested at extremely low levels, (corresponding to those found in surface or tap water). In addition, these results call into question the adequacy of the current regulatory process, used throughout the world by agencies involved in the assessment of health, food and chemicals, and industries seeking commercialisation of products

In view of these findings, the researchers consider that market authorisations for these products should be immediately reviewed. The 90 day test duration should be extended to 2 years for agricultural GMOs. In addition, all pesticides should be tested in their formulations (not the active principle alone) for 2 years, including at very low levels. Furthermore, in future the regulatory testing process for biotech and pesticide products should be transparent, open to public scrutiny, subject to independent review and performed independently of their firms in the future.

In the meantime, labelling of all GMOs in the feed/food should be mandatory, including livestock products from animals that have been fed GMO’s. Finally, the nature of all compounds present in pesticide formulations should be made public.

*”Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize”. Food and Chemical Toxicology, Séralini G.E. et al. 2012.

The results of these experiments, the story and its implications have been explained in a book ” Tous Cobayes ! ” by Gilles-Eric Séralini, published on Sept. 26 by Flammarion. Simultaneously, a film adapted from this book “All guinea pigs ?” by Jean-Paul Jaud will be launched. A TV documentary “GMO, a World Alert ?” by François Le Bayon will be shown. The legal and social impact has been written ” La vérité sur les OGM c’est notre affaire ” by Corinne Lepage from the European Parliament, published by Charles Léopold Mayer.

For more details see www.criigen.org; contact criigen@unicaen.fr, +33 (0)2 31 56 56 84

Contact Laurent Payet Press Agent, Professor Gilles-Eric Séralini

Phone: +33 6 89 95 48 87

Email: Laurent@lp-conseils.com

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Item 3

Agence France Presse, France

THE French government has asked the country’s health watchdog to carry out a probe, possibly leading to EU intervention, after a study said genetically modified corn caused cancer in rats.

In a joint statement, Agriculture Minister Stephane Le Foll, Ecology Minister Delphine Batho and Health and Social Affairs Minister Marisol Touraine said they had asked the National Agency for Health Safety (ANSES) to investigate the finding.

“Depending on ANSES’s opinion, the government will urge the European authorities to take all necessary measures to protect human and animal health,” they said.

“(The measures) could go as far as invoking emergency suspension of imports of NK603 corn to Europe pending a re-examination of this product on the basis of enhanced assessment methods.”

Earlier, French scientists led by Gilles-Eric Seralini at the University of Caen in Normandy said a study to be published later on Wednesday had found that rats which had been fed with NK603 corn developed tumours.

NK603 is a corn, also called maize, made by US agribusiness giant Monsanto.

It has been engineered to make it resistant to Roundup Ready, a herbicide, thus enabling farmers to douse fields with the weed-killer in a single go.

Genetically modified (GM) crops are widely grown in North America, Brazil and China but are a hot-button issue in Europe, where their introduction has been tightly constrained.

Green groups say the crops could be dangerous to health and the environment, although this claim has so far found no traction in large-scale studies.

In 2009, the European Food Safety Agency (EFA) panel on GM organisms determined that NK603 was “as safe as conventional maize”.

“Maize NK603 and derived products are unlikely to have any adverse effect on human and animal health in the context of the intended uses,” it said, delivering a judgement based in part on a 90-day feeding study on rats.