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Assessment & Impacts » Food Safety

Title: SÚralini Group Republishes Study, Confirms Results
Publication date: June 25, 2014
Posting date: June 25, 2014

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
 
Dear friends and colleagues 
 
Re: Séralini group republishes study, confirms results 

The chronic toxicity study on the glyphosate-based herbicide Roundup and a commercialized genetically modified (GM) maize, Monsanto’s NK603, led by Prof Gilles-Eric Séralini, has been republished. The republication restores the study to the peer-reviewed literature so that it can be consulted and built upon by other scientists. 

The study was originally published in 2012 in the journal Food and Chemical Toxicology. It found that the world’s best-selling herbicide, Roundup, causes severe liver and kidney deficiencies and hormonal disturbances, such as mammary tumours, at low environmentally relevant levels. Similar effects were observed from the chronic consumption of Roundup-tolerant GM maize. 

More than a year later and after a concerted campaign to discredit the study and under intense pressure, the journal retracted the study.  

Now the study has been republished by Environmental Sciences Europe. The republished version contains extra material addressing criticisms of the original publication. The raw data underlying the study’s findings are also published. The new paper presents the same results as before and the conclusions are unchanged. 

The republished study is accompanied by a separate commentary by Prof Séralini’s team describing the lobbying efforts to force the editor of Food and Chemical Toxicology to retract the original publication. 

The republished study is available here:

The accompanying commentary "Conflicts of interests, confidentiality and censorship in health risk assessment: the example of an herbicide and a GMO" can be found here:

 
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Third World Network
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Item 1
 
www.criigen.org 
 
Republication of Professor Séralini’s study: Time to be responsible 
Paris, 24 June 2014 

The 2012 study on the chronic toxicity of Roundup herbicide and the genetically modified Roundup-tolerant maize NK603 by Professor Gilles-Eric Séralini and colleagues has been republished by the Springer group, with open access to its raw data. Now there will be a few embarrassing questions for the authorities. 

After two years of controversy and pressure that led to the retraction of the study in November 2013, which was first published in 2012 by the Food and Chemical Toxicology (Elsevier group) journal, the research team of Professor Séralini has announced that they have republished the study in the Journal “Environmental Sciences Europe”, published by the Springer Group. 

By republishing their study with some new data which are available online, the team of Professor Séralini confirms that the world’s best-selling pesticide, Roundup, causes severe liver and kidney deficiencies and hormonal disturbances, such as mammary tumours, at low environmentally relevant levels. Similar effects were observed from the chronic consumption of Roundup-tolerant GM maize. This is due to residues of Roundup and to the specific genetic modification of this maize. The formulations of Roundup, as well as Roundup-tolerant GMOs, should therefore be considered endocrine (hormone) disruptors and should be re-evaluated for safety by the health authorities. 

Winfried Schröder, editor of the journal Environmental Sciences Europe of the Springer Group, stated: ‘’We want to enable a rational discussion about the study of Séralini et al. (Food Chem Toxicol 2012, 50:4221–4231) by republishing it. This methodological competition is the energy necessary for any scientific progress. The sole purpose is to enable some scientific transparency and on this basis, a discussion that does not try to hide, but focuses on these needed methodological controversies.” 

The research team of Prof Séralini made the choice of an open access publication in a peer-reviewed journal, which arranged the third peer-reviewed assessment of the study. The researchers have published online the raw data of the study with free access for the entire scientific community – something that the industry has always refused to do, claiming commercial confidentiality or intellectual property restrictions.  

Dr Joël Spiroux de Vendômois, medical doctor and President of CRIIGEN says, "Pesticides such as Roundup and agricultural GMOs cannot be ignored in the explanation of the epidemic of environmental pathologies”. In addition, he emphasizes “the deficiency of the regulatory assessment of pesticides and GMOs, which endangers public health." 

CRIIGEN is asking for free access to toxicological studies which have authorised the placing on the market of different formulations of Roundup, the free access to raw data on the toxicological urine and blood analyses for all products, and urges the legal authorities to undertake further public research, with a commitment to placing its findings in the public domain, regarding the possible toxicological and endocrine disrupting effects of GMOs and Roundup, as other pesticides, using long-term exposure periods to ensure a real protection of the public health. 

 
Tel: +33 2 31 56 56 84 / +33 7 60 45 56 77
 
 
Item 2
 
European Network of Scientists for Social and Environmental Responsibility (ENSSER)  
24.06.2014 
 
PRESS RELEASE 
 
RE-PUBLICATION of the Séralini et al. study on the "Long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize" 

ENSSER welcomes the re-publication of the data from the long-term rat feeding study with herbicide-tolerant NK603 maize and the associated Roundup herbicide plus the publication of the raw data by the researchers of Professor Séralini's group [1]. This study follows up on the Monsanto study submitted to the European regulator in support of its safety declaration for commercial approval. The study used the same type of rats as used by Monsanto. They were fed with Roundup-tolerant NK603 genetically modified (GM) maize (11% of the diet), cultivated with or without the application of Roundup together with Roundup alone (0.1 ppb of the full pesticide containing glyphosate and adjuvants) in drinking water for 2 years. EFSA accepts rat-feeding studies that are terminated after only 90 days, which constitutes a fraction of the entire lifespan of rats and, thus, addresses only short-term toxicity. Séralini and colleagues extended this period to a full lifespan in order to study chronic long term effects. 

The most significant results of the extended study by Séralini and colleagues are signs of toxicity for all treatments GM maize sprayed and unsprayed with Roundup- and Roundup-only treatments. Most of these signs occurred after 90 days. Biochemical analyses confirmed chronic kidney problems for all the treatments, for both sexes and also a higher number of severe liver problems. In females, all treatment groups showed a two- to threefold increase in mortality, and deaths occurred earlier. This difference was also evident in three male groups fed with GM maize. All results were hormone- and sex-dependent, and the pathological profiles were comparable. Last but not least, females developed large mammary tumors more frequently and earlier than the controls; the pituitary was the second most disabled organ; the sex hormonal balance was modified by consumption of GM maize and Roundup treatments. These data are worrying and call for follow-up studies designed to further consolidate whether these signs of toxicity are indeed proof of toxicity. These data must be contextualized with recently published data by other independent researchers in South America and Europe, releasing data that require us to re-consider previous toxicity evaluations of Roundup and Glyphosate [2]. 

When originally published in the Elsevier journal Food and Chemical Toxicology (FCT) in September 2012, a global campaign was launched within days by the GM industry and their associated scientists, and their sole aim was to 'shoot the messenger' hoping that the data will thus be invalidated. In an accompanying comment piece, now also being published, the team of Séralini and colleagues put the events that followed publication of their report on record. Here, they also address "conflicts of interest, confidentiality and censorship in health risk assessment" which ultimately resulted in the retraction of the paper over a year later after an ex-Monsanto employee was installed as associate editor [3]. The retraction was accompanied by a statement of the editor-in-chief Hayes asserting that there was no fraud, no misconduct or anything else wrong with the Séralini study other than the supposed 'inconclusiveness' of the data in the eyes of an shadowy group of scientists assembled for an undisclosed post-publication re-evaluation. This unprecedented move by FCT was challenged and has now been corrected. 

Scientific progress is only possible if research is conducted in an open fashion and research data is subjected to fair and critical (preferably transparent) peer-review and is subsequently put on record by being published in the scientific literature allowing then for a discourse of that research data and its various interpretations. While this holds true for all fields of science, it is a fundamental prerequisite for scientific progress when it comes to data that is relevant to environmental and human health. While scientific technological interventions have generated great benefits for human societies and contributed significantly to human progress, history has also shown over and over again, that research that lacks rigour regarding the safety and long term consequences of these technological interventions has caused massive suffering and destruction of environmental and human health. This has cancelled out many or all of their earlier benefits in a manner that could have been avoided if the initial research had been more rigorous. 

This attempt to censor inconvenient research data and suppress critical scientific discourse should have no place in the 21st century world. We face a convergence of massive environmental and social problems that put the collective well-being of humanity at risk. This is in many ways the result of the premature and injudicious release of technological interventions without proper safety evaluation for long term consequences. Solving these converging crises will fundamentally hinge on a critical scientific discourse and collective reflection. We need a debate about the various trajectories for progress. This should be informed by rigorous and independent (i.e. technology-disinterested) assessment of technology risks from various perspectives.
  

Lucas Wirl, Coordinator ENSSER
Mobile: 0049 (0) 176 6410 3500
Phone: 0049 (0) 30 2065 4857
 
For further information please view:  www.criigen.org / www.ensser.org 
[2] Paganelli A, Gnazzo V, Acosta H, Lopez SL and Carrasco AD. Glyphosate-based herbicides produce teratogenic effects on vertebrates by impairing retinoic acid signalling. Chem Res Toxicol, August 9.http://pubs.acs.org/doi/abs/10.1021/tx1001749
 
 
Item 3
 
Republication of the Séralini study: Science speaks for itself 
 
Press release
 
GMOSeralini.org, 24 June 2014
 

GMOSeralini.org welcomes the news of the republication of the chronic toxicity study on the glyphosate-based herbicide Roundup and a commercialized genetically modified (GM) maize, Monsanto’s NK603, led by Prof Gilles-Eric Séralini. The republication restores the study to the peer-reviewed literature so that it can be consulted and built upon by other scientists. 

The study found severe liver and kidney damage and hormonal disturbances in rats fed the GM maize and low levels of Roundup that are below those permitted in drinking water in the EU. Toxic effects were found from the GM maize tested alone, as well as from Roundup tested alone and together with the maize. Additional unexpected findings were higher rates of large tumours and mortality in most treatment groups. 

The study was first published in Food and Chemical Toxicology (FCT) in September 2012 [1] but was retracted by the editor-in-chief in November 2013 after a sustained campaign of criticism and defamation by pro-GMO scientists. [2] 

Now the study has been republished by Environmental Sciences Europe. The republished version contains extra material addressing criticisms of the original publication. The raw data underlying the study’s findings are also published – unlike the raw data for the industry studies that underlie regulatory approvals of Roundup, which are kept secret. However, the new paper presents the same results as before and the conclusions are unchanged. 

The republished study is accompanied by a separate commentary by Prof Séralini’s team describing the lobbying efforts of GMO crop supporters to force the editor of FCT to retract the original publication. 

GMOSeralini.org editor Claire Robinson commented: “This study has now successfully passed no less than three rounds of rigorous peer review. 

“The first was for the initial publication of the study in Food and Chemical Toxicology. It passed with only minor revisions, according to the authors. [3] 

“The second review took months. It involved a non-transparent examination of Prof Séralini’s raw data by a secret panel of unnamed persons organized by the editor-in-chief of FCT, A. Wallace Hayes, in response to criticisms of the study by pro-GMO scientists. [4,5] 

“In a letter to Prof Séralini, Hayes admitted that the anonymous reviewers found nothing ‘incorrect’ about the results presented. However, Hayes pointed to what he said was the ‘inconclusive’ nature of some aspects of the paper, namely the tumour and mortality observations, to justify his decision to retract the study. [6] 

“The rationale given for the retraction was widely criticized by scientists as an act of censorship and a bow to the interests of the GMO industry. [7,8] Some scientists pointed out that numerous published scientific papers contain inconclusive findings, including Monsanto’s own short (90-day) study on the same GM maize, and have not been retracted. [9] The retraction was even condemned by a former member of the editorial board of FCT. [10] 

“Now the study has passed a third peer review arranged by the journal that is republishing the study, Environmental Sciences Europe. 

Comments from scientists 

Dr Michael Antoniou, a molecular geneticist based in London, commented, “Few studies would survive such intensive scrutiny by fellow scientists. The republication of the study after three expert reviews is a testament to its rigour, as well as to the integrity of the researchers. 

“If anyone still doubts the quality of this study, they should simply read the republished paper. The science speaks for itself. 

“If even then they refuse to accept the results, they should launch their own research study on these two toxic products that have now been in the human food and animal feed chain for many years.” 

Dr Jack A Heinemann, Professor of Molecular Biology and Genetics, University of Canterbury, New Zealand, called the republication “an important demonstration of the resilience of the scientific community”. Dr Heinemann continued, “The first publication of these results revealed some of the viciousness that can be unleashed on researchers presenting uncomfortable findings. I applaud Environmental Sciences Europe for submitting the work to yet another round of rigorous blind peer review and then bravely standing by the process and the recommendations of its reviewers, especially after witnessing the events surrounding the first publication. 

“This study has arguably prevailed through the most comprehensive and independent review process to which any scientific study on GMOs has ever been subjected. 

“The work provides important new knowledge that must be taken into account by the community that evaluates and reports upon the risks of genetically modified organisms, indeed upon all sources of pesticide in our food and feed chains. In time these findings must be verified by repetition or challenged by superior experimentation. In my view, nothing constructive for risk assessment or promotion of GM biotechnology has been achieved by attempting to expunge these data from the public record.” 

ENDS 
Contact (not for publication) Claire Robinson: claire@clairejr.com ; Mobile +44 (0)752 753 6923 
Notes 

1. Seralini GE et al, 2012. RETRACTED: Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Food Chem Toxicol 50:4221–4231.

 
 
4. www.endsciencecensorship.org/en/page/statement#.U6XBuagoyBA ; Hayes AW (2013). Letter to Professor GE Séralini. 19 Nov. Available at: http://www.gmwatch.org/files/Letter_AWHayes_GES.pdf
 
 
6. Hayes AW (2013). Letter to Professor GE Séralini. 19 Nov. Available at: http://www.gmwatch.org/files/Letter_AWHayes_GES.pdf
 
 
 
 

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