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

a b s t r a c t
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


Press Release

http://indiagminfo.org/?p=360 (RTI document downloadable at this link)

New Delhi/Bengaluru, February 6th 2012: Ahead of a regulators’ meeting on February 8th 2012, and reacting to the confirmed reports of Monsanto’s illegal planting of Herbicide Tolerant (HT) maize in its GM maize trial, the Coalition for a GM-Free India demanded that Monsanto be blacklisted immediately. The violation was revealed in a response of the Genetic Engineering Appraisal Committee to an RTI application. “This agri-business corporation has been caught violating the law and norms repeatedly. The Genetic Engineering Appraisal Committee (GEAC) has also been caught failing in its duties. GEAC, in spite of violations brought to its notice earlier also, has never taken up any deterrent and penal action against this MNC”, said the Coalition in a press statement issued in Delhi and a Press Conference held in Bengaluru. Monsanto’s illegal planting was known to the regulators (as the information was obtained through an RTI response from GEAC), but they chose not to look into the matter pro-actively and the regulators were in effect protecting Monsanto, alleged the Coalition.

The approval for the biosafety research level II trial (BRL-II , the penultimate stage before consideration for commercial cultivation) for Monsanto’s herbicide tolerant, insect resistant GM maize with stacked traits (two Bt genes and one herbicide tolerance gene) was granted during the GEAC meetings held on 15th November 2010 and 8th December 2010. This is also the first GM product of Monsanto in India in its own name and not in the name of associate companies like Mahyco. Monsanto and the biotech industry have been claiming that the herbicide tolerant, insect resistant GM maize with stacked traits would be approved soon.

“Monsanto’s GM maize trials have been going on for several seasons now in various locations around the country. It took a rare scientist in one monitoring team to point out the fact that planting of the herbicide-tolerant GM maize took place without permission from competent authorities! What is more damning is that there is no evidence of any discussion or action by the regulators on this finding. This clearly demonstrates that the regulators are unconcerned about biosafety violations or contamination and are protecting and supporting offenders like Monsanto”, said Kavitha Kuruganti, Member, Coalition for a GM-Free India.

The RTI response revealed that a team led by Dr Pradyumn Kumar of the Directorate of Maize Research (DMR is supposed to be supervising all the GM maize BRL II field trials), noted the following in its visit report (5th May 2011): “Before planting NK603 event treatment in future, the permission from competent authority may be obtained”. This clearly demonstrates that this field trial consisted of an unapproved, illegal GM herbicide tolerant maize while the trial is supposed to be for the hybrid of Bt genes’ line (MON89034) and herbicide tolerant line (NK603) (HT/Bt maize). A point to be noted is that trial protocols were prescribed by DMR along with GEAC and it was a DMR scientist who recorded the illegal planting of the HT maize line.

“This appears to be a repetition of an earlier episode of herbicide tolerant cotton (Roundup Ready Flex – RRF cotton) planted by Monsanto’s affiliate, Mahyco, without permission. The GEAC, in that instance, found the clarifications submitted by Mahyco highly unsatisfactory and warned that any non-compliance in future would attract punitive actions under EPA 1986, sought a resolution adopted by the Mahyco Board of Directors expressing regret and reaffirmation that such lapses would not be repeated, and that the data generated during the BRL II trials using the unapproved GMO shall not be considered for regulatory purpose. All of these were decisions recorded in the July 2011 meeting of the GEAC”, reminded the Coalition.

What is ironic in the case of the GM maize trials of Monsanto is that further field trials have been approved after this visit of the monitoring team on 5th May 2011 recorded the illegal planting!

Monsanto has also been caught violating several biosafety norms in its GM maize cultivation plot in Bijapur in early 2011, around the same time as this Monitoring Team’s finding of illegal planting inside the University in Dharwad. The Bijapur episode, documented by Greenpeace and a Kannada TV Channel had been brought to the notice of the regulators and no investigation has been completed so far into this complaint.  Egregious violations were also found during various other field trials from 2005 onwards.

“In the face of such impunity from these seed corporations and irresponsible inaction by the regulators, it is ironic that when civil society groups try to prevent contamination from these untested GMOs by objecting to such trials like in the case of the Bayer GM rice trial in Patancheru or DuPont GM rice trial in Doddaballapur, they are being treated as criminals! The history of GM crop regulation in India is replete with violations and illegal plantings and repeated failure on the part of the regulators in checking these or even taking serious action post facto. Therefore citizens are forced to step in to uphold biosafety.

“The Coalition demands that the Minister for Environment & Forests fix accountability on Monsanto and its Indian associates for violating Indian law. It also demands that MoEF take action against the regulators who repeatedly fail to check the violations of the corporations, and call on state governments of Andhra Pradesh and Karnataka to drop all charges against activists involved in biosafety protection”, added the Coalition.


For more information, contact:

Kavitha Kuruganti – 9393001550

Sridhar Radhakrishnan – 9995358205

ps: Page 10 to 14 in the attached scanned document do not pertain to the GM maize in question but got inadvertently included in the scanned document. Page 15 to 20 is the relevant monitoring report in this instance.


Safety of Monsanto’s Synthetic-Toxin maize to be re-examined

Testbiotech and GeneWatch UK formally request withdrawal of EU market authorisation of Monsanto´s genetically engineered maize Genuity VT Triple PRO Corn with synthetic toxins.
28 July 2011. The non-profit organisations Testbiotech (Germany) and GeneWatch UK have submitted a formal request to the European Commission re-examine market authorisation of a genetically engineered maize produced by Monsanto sold under brand Genuity VT Triple PRO Corn (event MON89034 x MON 88017) that produces a synthetic toxin, intended to kill insect pests. This maize was approved for usage in food and feed by the EU Commission on 17th of June. It produces a combination of three different insecticidal toxins, one of which is synthesised artificially. Further, the plants are made tolerant to the herbicide glyphosate (known as Roundup).
The organisations are filing a formal request for internal review of the EU Commission´s decision according Article 10 of Regulation (EC) No. 1367/2006 because the legally required high level of protection for consumers, farm animals and the environment are not met and legal requirements for monitoring of health effects have been ignored completely. They argue that the authorisation should be withdrawn.
“This maize produces a unique combination of insecticidal proteins. In the parts of this plant, a synthetic Bt toxin is produced. Its toxicity might affect a much wider spectrum of species than expected. Further combined effects have to be expected with the other toxins and the residues from spraying with the herbicide. These risks can impact both on health and the environment,” said Helen Wallace from GeneWatch UK. “But none of these risks were properly examined before approval was granted.”
The plants were not tested for health effects in feeding studies. Only a short term trial for its nutritional quality was performed in poultry. The residues from spraying with glyphosate formulations were also not considered by the European Food Safety Authority EFSA. There are further legal requirements for monitoring of potential health effects that were ignored by the EU Commission:
“No plan for monitoring as required by European regulation was made available that would allow identification of particular health impacts that might be related to the use of these genetically engineered plants in food and feed. There is not even a reliable method to measure the level of toxins produced in the maize and to trace the products within the market,” said Christoph Then from Testbiotech.
According the request prepared by the two organisations, this case is also of general relevance for the setting of risk assessment standards by EFSA that are currently under discussion before being adopted as EU regulations. This case shows that in general much more effort is needed to ensure the high level of protection for human health and the environment required by the framework of the EU regulations. Since this case is a precedent, the NGOs have the option of considering further legal steps such as a case at the European Court of Justice if the EU Commission reject their request for internal review
Currently, genetically engineered crops mainly enter the EU from North and South America as soya or maize for use in animal feed. Maize containing a single Bt toxin is also grown for use in animal feed in Spain. Numerous “stacked events” containing multiple Bt toxins and/or resistence to one or more herbicides are awaiting regulatory approval in the EU. Herbicide resistant “superweeds” are becoming a major problem for American farmers growing herbicide tolerant GM crops and pests are also developing resistance to the Bt toxins included in many GM crops. A recent Canadian study suggested that the assumption made by regulators that Bt toxins do not survive in the human gut may be incorrect.

Link to Testbiotech and the request as filed to the EU Commission: http://www.testbiotech.de/node/526

Link to GeneWatch UK: http://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/Document_Request_for_internal_review_MON89034xMON88017.pdf
Helen Wallace, + 44 7903 311584, helen.wallace@genewatch.org
Christoph Then, + 49 151 54638040, info@testbiotech.org.,