GMO
"Some of the most important publications by scientific teams supported by CRIIGEN or by CRIIGEN members who have participated in them.
Traditionally, when a scientific study is cited, only the name of the first author is given. Exceptionally, all authors are cited to thank them for their efforts, cooperation and support of CRIIGEN.
(Authors who are members of CRIIGEN are underlined)
2014
Republished study: Long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Séralini, G.E., Clair, E., Mesnage, R., Gress, S., Defarge, N., Malatesta, M. Hennequin, D. Spiroux de Vendômois, J. (2014) Environ Sci Eur. 2014. doi: 10.1186/s12302-014-0014-5.
"Re-edited study: long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize".
An exceptional case! see special report...
Letter to the Editor regarding " Delaney et al., 2014 ": uncontrolled GMOs and their associated pesticides make the conclusions unreliable. Robin Mesnage, Nicolas Defarge, Joël Spiroux de Vendômois, Gilles-Eric Séralini. Food Chem Toxicol 2014. Doi : 10.1016/j.fct.2014.07.003
" Letter to the editor regarding "Delaney et al., 2014": uncontrolled GMOs and their associated pesticides make conclusions unreliable ".
We are concerned about the characterization of the diet tested in the study by Delaney et al. (2014), investigating the subchronic health effects of genetically modified Roundup-tolerant canola (DP-Ø73496-4) on rats. The conclusion can be used by regulatory authorities. Purina Certified Rodent LabDiet 5002 was not tested for the presence of other Roundup-tolerant GMOs and Roundup herbicide residues. According to our accredited PCR analyses, this control diet also contained 18% NK603 Roundup-tolerant maize and 14.9% MON810 (a GMO-producing modified Bt insecticide). We also found 110 ppb glyphosate and 200 ppb AMPA (the main metabolite of glyphosate). Although their toxicities are debated (Seralini et al., 2014), the uncontrolled presence of pesticide residues and other GMOs makes the study inconclusive. Any animal parameters measured after eating GM canola cannot be compared with controls eating a diet containing other GMOs with the same characteristic, and are not taken into account. By the standards of the editor of Food and Chemical Toxicology (Hayes, 2014), this study (Delaney et al., 2014) should be retracted.
Conclusiveness of toxicity data and double standards. Séralini, G.-E., Mesnage, R., Defarge, N., Spiroux, J. (2014) Food and Chem. Tox. 69:357-359.
" Conclusive toxicity data and double standards ".
We comment on the arguments of Mr Hayes, director of Food and Chemical Toxicology (Hayes2014) who took the decision to retract our study (Seralini et al., 2012). This publication highlights a double standard and inequity in choices to retract scientific publications.
2014
Conflicts of interests, confidentiality and censorship in health risk assessment: the example of an herbicide and a GMO. Gilles-Eric Séralini, Robin Mesnage, Nicolas Defarge, Joël Spiroux de Vendômois. Editorial Environ Sci Eur. 2014. doi: 10.1186/s12302-014-0013-6.
" Conflicts of interest, confidentiality and censorship in health risk assessment: the example of a herbicide and a GMO ".
We studied the long-term toxicity of Roundup-tolerant GM maize (NK603) and a whole formulation of Roundup pesticide at environmentally relevant levels from 0.1 ppb. This has caused turmoil in the scientific editorial world, highlighting conflicts of interest...
Our study was first published in Food and Chemical Toxicology (FCT) on September 19, 2012. The first wave of criticism arrived within a week, mainly from plant biologists with no toxicology experience. We responded to all these criticisms. The debate then encompassed scientific arguments, and a wave of ad hominem and potentially defamatory comments appeared in various journals by authors with serious but undisclosed conflicts of interest. At the same time, FCT recruited a former Monsanto employee as its new Associate Editor for Biotechnology after he had sent a letter to FCT complaining about our study. Not least because of this, FCT requested a post-hoc analysis of our raw data. On November 19, 2013, the editor requested the withdrawal of our study while acknowledging that the data were not incorrect and that there was no fault, fraud or intentional misinterpretation in our raw data set - an unusual, if not unprecedented, action in scientific publishing. The publisher argued that no conclusions could be drawn because we studied 10 rats per group for 2 years, because they were Sprague Dawley rats and because the data were inconclusive on cancer. This, however, was known at the time our study was submitted. However, our study was never considered a carcinogenicity study. We never used the word "cancer" in our paper. The present opinion is a summary of the debate that led to this retraction, as it is a historical example of conflicts of interest in scientific assessments of products marketed worldwide. We also show that the decision to retract cannot be rationalized on any discernible scientific or ethical basis. Censorship of health risk research undermines the value and credibility of science, so we are republishing our article.
2013
Answers to critics: Why there is a long term toxicity due to a Roundup-tolerant genetically modified maize and to a Roundup herbicide. Gilles-Eric Séralini, Emilie Clair, Robin Mesnage, Steeve Gress, Nicolas Defarge, Manuela Malatesta, Didier Hennequin, Joël Spiroux de Vendômois (2013). Food Chem. Toxicol. 53,461-468.
" Answers to critics: Why there is long-term toxicity from genetically modified Roundup-tolerant corn and Roundup herbicide "
Our recent work (Séralini et al., 2012) remains the most detailed study to date of the lifelong consumption of a genetically modified agricultural organism (GMO) and its associated herbicide. Nevertheless, this study has generated a violent polemic against us. We have responded to all the attacks in this publication...
This is particularly true for NK603 maize, for which only one 90-day marketing test has previously been carried out with the same rat strain (Hammond et al., 2004). This is also the first detailed long-term research on mammals exposed to a highly diluted pesticide in its total formulation with adjuvants. This may explain why 75% of our initial criticisms within a week, among the publication's authors, came from plant biologists, some developing patents on GMOs, even though this was a toxicological article on mammals, and the Monsanto company, which owns both NK603 GM maize and Roundup (R) herbicide. Our study has limitations like any other, and here we carefully respond to all the criticisms from agencies, consultants and scientists that have been directed at the publisher or ourselves. At this level, a full debate would be biased if the mammalian toxicity tests of NK603 and R obtained by Monsanto were to remain confidential and therefore unavailable in electronic format for the entire scientific community to conduct an independent review of the raw data. In our article, the conclusions on the long-term toxicity of NK603 and Roundup were based on statistically highly discriminating results at biochemical level in the treated groups compared to controls, as these results corresponded well in blind analysis to the pathologies observed in the organs, i.e. were in turn linked to deaths by anatomopathologists. GM NK603 and GM R cannot be considered safe at this time.
2012
Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Gilles-Eric Séralini, Emilie Clair, Robin Mesnage, Steeve Gress, Nicolas Defarge, Manuela Malatesta, Didier Hennequin, Joël Spiroux de Vendômois (2012). Food Chem. Tox. 50, 4221-4231.
This is the first study in the world to test Roundup and the glyphosate-tolerant GMO for two years...
This publication was retracted, but reissued in 2014, a rare occurrence...
2010
Debate on GMOs health risks after statistical findings in regulatory tests. Joël Spiroux de Vendômois 1, Dominique Cellier, Christian Vélot, Emilie Clair, Robin Mesnage, Gilles-Eric Séralini. Int J Biol Sci. 2010. Doi : 10.7150/ijbs.6.590. Royalty-free publication.
"Debate on the health risks of GMOs after the statistical results of regulatory tests".
This publication summarizes the main points of the international debate on health risk studies for the main edible GMOs on the market. These GMOs are soy, maize and rapeseed designed to contain new pesticide residues...
... since they have been modified to be tolerant to herbicides (mainly Roundup) or to produce mutated Bt toxins. Debated chronic food risks may arise from unpredictable effects of insertional mutagenesis, metabolic effects or new pesticide residues. The most detailed regulatory tests on GMOs are three-month feeding trials on laboratory rats, which are evaluated biochemically. The tests are not mandatory, nor are they conducted independently. Test data and corresponding results are kept secret by the companies. Our previous analyses of regulatory raw data at these levels, taking the representative examples of three GM maize varieties NK 603, MON 810 and MON 863, led us to conclude that hepatorenal toxicities were possible and that longer tests were necessary. Our study was criticized by the company developing the GMOs in question and by regulatory bodies, mainly on the grounds of differing biological interpretations of statistically significant biochemical and physiological effects. We present the scientific reasons for the widely differing biological interpretations, and also highlight the shortcomings of the experimental protocols designed by the company. The debate involves a huge responsibility towards public health, and is essential given the lack of traceability or epidemiological studies in GMO-producing countries.
2010
Genetically modified crop consumption at large scale: Possible negative health impacts due to holes in assessment. Overview of the safety studies of GMOs performed on mammals. Gilles-Eric Séralini, Joël Spiroux de Vendômois, Dominique Cellier, Robin Mesnage, Emilie Clair (2010). Editors : Breckling, B. and Verhoeven,R. Theorie in der ökologie 16.
" Large-scale consumption of genetically modified crops: possible negative health impacts due to gaps in assessment. Overview of GMO safety studies in mammals ".
Between 2008 and 2010, a debate arose over international regulations and their ability to predict and avoid the harmful effects on health and the environment of new products and feeds (GMOs, chemicals, pesticides, nanoparticles...).
Health risk assessment cannot avoid studying the blood analyses of mammals consuming these products in sub-chronic or chronic tests. Mammal feeding trials have therefore generally been carried out for regulatory purposes, in order to obtain authorizations or the marketing of foods or feeds derived from genetically modified plants. They may subsequently have been published in the scientific literature. Following legal action or official requests, we have obtained the raw data from several in vivo safety tests, lasting 28 or 90 days, on GMO rats (Séralini et al. 2007; Spiroux de Vendômois et al. 2009). We have examined these tests in detail from a biological and biostatistical point of view. In this study, we focus on the results of available 90-day (or longer) feeding trials with marketed GMOs, in the light of modern scientific knowledge.
2009
How subchronic and chronic health effects can be neglected for GMOs, pesticides or chemicals. Gilles-Eric Séralini, Joël Spiroux de Vendômois, Dominique Cellier, Charles Sultan, Marcello Buiatti, Lou Gallagher, Michael Antoniou, Krishna R Dronamraju. Review Int J Biol Sci. 2009 doi: 10.7150/ijbs.5.438. Royalty-free publication.
"How subchronic and chronic health effects can be overlooked for GMOs, pesticides or chemicals".
Chronic health effects are multiplying worldwide, including cancers, hormonal, reproductive, nervous and immune diseases, even in young people...
During regulatory sub-chronic toxicological testing to prevent mammalian health effects, in the pre-marketing of chemicals, particularly pesticides and drugs, or GMOs, certain statistically significant results may be revealed. This discussion focuses on the need to study the relevant criteria for considering them biologically significant. Gender differences and non-linear dose- or time-dependent effects must be considered in contrast to the claims of a Monsanto-backed expert panel on a GMO, MON 863 Bt maize, but also for pesticides or drugs, notably to reveal hormone-dependent diseases and early signs of toxicity.
2009
A comparison of the effects of three GM corn varieties on mammalian health. Joël Spiroux de Vendômois, François Roullier, Dominique Cellier, Gilles-Eric Séralini. Comparative Study Int J Biol Sci. 2009 doi : 10.7150/ijbs.5.706. Royalty-free publication.
"A comparison of the effects of three GM maize varieties on mammalian health ".
For the first time, we present a comparative analysis of blood and organ system data from trials involving rats fed three of the main genetically modified (GM) maize products on the market (NK 603, MON 810, MON 863), which are used in food and feed around the world.
NK 603 has been modified to be tolerant to the broad-spectrum herbicide Roundup, and therefore contains residues of this formulation. MON 810 and MON 863 are designed to synthesize two different Bt toxins used as insecticides. Around 60 different biochemical parameters were classified by organ and measured in serum and urine after 5 and 14 weeks of feeding. Rats fed genetically modified maize were first compared with their equivalent non-genetically modified isogenic or parental control groups. This was followed by a comparison with six reference groups, which had consumed various other non-GM corn varieties. We applied non-parametric methods, including several pairwise comparisons with a false discovery rate approach. Principal component analysis was used to study the dispersion of different factors (gender, weeks of feeding, diet, dose and group). Our analysis clearly reveals for all 3 GMOs new side effects linked to GM maize consumption, which were often gender- and dose-dependent. The effects were mainly associated with the kidneys and liver, the organs of dietary detoxification, although differing between the 3 GMOs. Other effects were also observed in the heart, adrenal glands, spleen and hematopoietic system. We conclude that these data point to signs of hepatorenal toxicity, possibly due to the new pesticides specific to each GM maize. In addition, direct or indirect unintended metabolic consequences of genetic modification cannot be ruled out.
2007
New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity. Gilles-Eric Séralini, Dominique Cellier, Joël Spiroux de Vendômois (2007). Arch. Environ. Contam. Toxicol. doi: 10.1007/s00244-006-0149-5.
" A new analysis of a rat feeding study with genetically modified maize reveals signs of hepatorenal toxicity ".
At the start of the 21st century, the assessment of health risks associated with genetically modified organisms (GMOs) grown for food or feed is the subject of debate worldwide...
... and very few data have been published on medium- or long-term toxicological studies in mammals. One such study, carried out under the responsibility of Monsanto using MON863 transgenic maize, came under questioning from the European regulatory authorities, where it was finally approved in 2005. This required a new assessment of the renal pathological results, and the results remained controversial. . An action before the German Court of Appeal (Münster) granted public access in June 2005 to all raw data from this 90-day rat feeding study. We have re-analyzed these data independently. Appropriate statistics were added, such as multivariate analysis of growth curves and comparisons of biochemical parameters between GMO-treated rats and controls fed an equivalent normal diet, and separately with six reference diets of different compositions. We observed that, after consumption of MON863, rats showed slight but significant dose-related variations in growth for both sexes, resulting in a 3.3% decrease in weight for males and a 3.7% increase for females. Chemical measurements revealed signs of hepato-renal toxicity, also marked by differential sensitivities in males and females. Triglycerides increased by 24% to 40% in females (either at week 14, dose 11%, or week 5, dose 33%, respectively); urinary phosphorus and sodium excretions decreased in males by 31% to 35% (week 14, dose 33%) for the most significant treatment-related findings compared to the seven diets tested. Longer experiments are essential to indicate the true nature and extent of possible pathology; with current data, it cannot be concluded that GM maize MON863 is a safe product.