ELSEVIER’S FOOD AND CHEMICAL TOXICOLOGY JOURNAL RETRACTS
THE PAPER BY SERALINI ET AL. (2012) ON HEALTH HAZARDS OF GM MAIZE
C Kameswara Rao
Foundation for Biotechnology Awareness and Education
1. In November 2012, Dr G.-E. Séralini and seven other authors published a paper on the ‘Long term toxicity of a roundup herbicide and a roundup-tolerant genetically modiﬁed maize’ in the Elsevier journal ‘Food and Chemical Toxicology’ (FCT). The paper (Seralini et al., 2012) was actually available online from September 19, 2012, itself.
2. The Roundup tolerant maize was NK603 of Monsanto Corp., USA, and Dr Seralini was critical of the safety of this transgenic even earlier (see Para 11(b) below). The 2012 paper reported the following as the ‘high lights’ of a two-year study: a) A Roundup-tolerant maize and Roundup provoked chronic hormone and sex dependent pathologies; b) Female mortality was 2–3 times increased mostly due to large mammary tumors and disabled pituitary; c) Males had liver congestions, necrosis, severe kidney nephropathies and large palpable tumors; d) This may be due to an endocrine disruption linked to Roundup and a new metabolism due to the transgene; and e) GMOs and formulated pesticides must be evaluated by long term studies to measure toxic effects. The paper included gruesome photographs of heavily tumoured rats which instantly generating deep pity for the rats and extreme fear of what the transgenic maize could do to animals and humans when consumed.
3. There was a battery of massive protests against Dr Seralini’s conclusions from Regulatory Authorities, Scientific bodies, Animal Rights Organizations, Journal editors, English and French Media, individual Scientists, and others. Over 700 Scientists demanded that Dr Seralini should release the raw data. Some 17 letters were published by the journal itself (Food and Chemical Toxicology, 2013, 53 (1), pp. 440-483). I was a signatory to one such letter containing a detailed discussion on the shortcomings of Dr Seralini’s paper, signed by 23 scientists, and published in FCT (2013, 53:440-441). A number of issues in Dr Seralini’s paper were questioned, more particularly the methodology, size of the samples, use of Sprague-Dawley rats whose high propensity to develop tumours is well known, and the adequacy of the data to warrant Dr Seralini’s conclusions. An impressively long list of protestors, compiled up to July 7, 2013, was published by Mahlangu (2013).
4. On November 28, 2013, the Editor-in-Chief of FCT, has finally published the following retraction notice: ‘The journal Food and Chemical Toxicology retracts the article “Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize,” which was published in this journal in November 2012. This retraction comes after a thorough and time-consuming analysis of the published article and the data it reports, along with an investigation into the peer-review behind the article’ (Elsevier, 2013). It looks that the authors were given an opportunity to withdraw the paper but they refused to do so. If the paper is now downloaded from the journal website, one would see that every page is stamped ‘RETRACTED’, in bold and red capitals.
5. The now retracted paper by Dr Serlini et al., (2012) was a godsend to the antitech activists the world over and was extensively used by them to scream out the ‘hazards’ of the new technology. The activists will continue to use the Dr Sèralini’s paper to publicize misinformation about the safety of GM crops, as the word of the retraction of the paper is unlikely to reach such a wider audience as Dr Seralini's paper, almost entirely through the efforts of the anti-GE groups.
6. The Technical Expert Committee (TEC) appointed by the Supreme Court of India has used Dr Seralini’s paper to the hilt, in its Final Report submitted on July 1, 2013 (TEC Final Report, 2013; Annexure 11; pp 179-183; publication details of Dr Seralini’s paper were given on p 81). The following was extracted from TEC’s final report. The authors’ emphasis in bold is retained, but note the barbs aimed at the industry and industry scientists:
“As this report is being written, there has arisen another similar case. This case offers an opportunity to the TEC to project its analyses to the Honourable Supreme Court which can readily perceive as to how the industry scientists misrepresent facts, deliberately omit the authors’ response to the critics, quote relevant.”
“The paper entitled, ‘Long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize’ in Food and Chemical Toxicology, , 50 (2012) 4221-4231, by Giles-Eric Seralini and seven other co-scientists from the University of Caen, Institute of Biology, Caen Cedex, France, and University of Verona, Department of Neurological, Neuropsychological, Morphological and Motor Sciences, Vienna, Italy created panic and shock worldwide among the Ht-transgenic crop developing industry as well as those who have introduced these crops in an authorative ‘top-down’ manner in their own countries. India, despite an advisory in the Task Force Recommendation in 2004, let the Ht-transgenics take root in the Indian soil.” TEC seems to be quite impressed by the European addresses of the authors and much concerned about the now largely forgotten recommendations of the Task Force on Agriculture.
TEC continues, “The above paper by Seralini et al (2012) evaluated the health effects of a Roundup-tolerant genetically modified maize, cultivated with or without Roundup, and Roundup alone (from 0.1 ppb in water) in Virgin albino Sprague-Dawley rats. The transgenic maize used in the studies was herbicide-tolerant maize (Monsanto 00603-6, commonly referred to as NK603). Usually, the biosafety studies involving genetically engineered foods are terminated by 90 days at the most. However, Seralini and his co-scientists extended the studies on the biological health effects in the rats upto two years. Briefly the essence of the findings sent shock-waves in the industry circles are:….”. The TEC report detailed Dr Seralini’s findings grouped under a) Mortality, b) Anthropological observations, and c) Biochemical analyses. The final conclusion of TEC’s final report is that “All criticisms of Seralini et al (2012) paper have been effectively answered and put to rest.” Now, of course, the paper itself is put to rest by the journal.
7. Some three thousand pages and a few months earlier than Dr Seralini’s paper, Snell et al., (2012) published in the same journal a review of the literature on the health impact of GM plant diets in long-term and multigenerational animal feeding trials. They reviewed 12 long term feeding studies of more than 90 days with transgenic maize, potato, soybean, and rice. The multigenerational studies involved two to five generations. There were 24 other studies involving many parameters in the review. No evidence of any possible health hazards was found in any of these studies. Snell et al., (2012) concluded that GM plants are nutritionally equivalent to their non-GM counter parts and can be safely used as food and feed. But for the activists and TEC, none of this cuts any ice, in the face of Dr Seralini’s single paper.
8. The TEC rubbishes 90-day feeding trials which are the global norm as recommended by the Codex Alimentarius, the World Health Organization (WHO) and the Food and Agricultural Organization (FAO), and adopted for long in the USA, Canada, Australia, Argentina, Brazil, etc. The 90 day period in the life of a laboratory mouse (or rat) is the most active growing phase and is equivalent to 24.5 years of human life, and beyond 90 days of feeding, no new data would emerge (Sesikeran, 2010). Of course, one can study till the end of the life span of the mice and report death of all of them attributed to lifelong consumption of GM foods.
9. The Parliamentary Standing Committee on Agriculture also would have been happy to use Dr Seralini’s paper in their report submitted in August 2012, but unfortunately for them the paper came a month later. And the then Honourable Minister for Environment and Forests (MoEF) missed it by about two and half years.
10. On December 5, 2013, The Economic Times ran a story on the retraction of Dr Seralini’s paper, but erred in assuming that “In India, then environment minister Jairam Ramesh used the paper as evidence against GM crops, and put a moratorium on Bt Brinjal commercialization”, but is correct in that “A committee set up by the Supreme Court also cited the paper and recommended stopping GM crop trials for the moment”.
11. The following issues were discussed in a review of moratorium on Bt brinjal (Kameswara Rao, 2010), but need to be reiterated to show that Dr Seralini has all the while been against GM crops and that his conclusions were dismissed by responsible international bodies:
a) The European Food Safety Authority (EFSA) has questioned Dr Seralini’s conclusions in the 2012 paper, and this is not the first time that the EFSA was critical of Dr Seralini’s data and interpretations. Earlier, at a meeting on January 27-28, 2010, EFSA has dismissed a paper by Dr Seralini and associates, published in the International Journal of Biological Sciences in 2009, on the adverse effects of three GE corn varieties, MON810, MON863 and particularly NK603 (which was the subject matter of the 2012 paper), on mammalian health. The 2009 paper was a statistical reanalysis of biosafety data from rat feeding studies (similar to what Dr Seralini did with the Indian Bt brinjal dossier). The EFSA concluded that there were no indications of adverse effects for human, animal health and the environment, from the three GE corn varieties. The EFSA had, on yet another occasion, dismissed a paper by Dr Seralini and associates, published in 2007 on MON 863.
b) Dr Seralini’s anti-GE publications were also questioned earlier (and now too) by a) the Food Standards Australia and New Zealand, b) the French Association of Plant Biotechnology and c) the French High Counsel on Biotechnology. In April 2010, the issue has become so serious that a ‘defend Seralini’ campaign was launched collecting signatures in his support (GMWatch, April 26, 2010).
c) The then MoEF actually used Dr Seralini's reinterpretation of the Indian Bt brinjal dossier. For the MoEF, Dr Seralini (with impressive credentials of affiliation with the University of Caen and President, Scientific Council of the Committee for Independent Research and Information on Genetic Engineering (CRIIGEN), Paris), was the brightest star among the anti-Bt brinjal scientists. In January 2009, Dr Seralini released a document which was well publicized by the activists. Dr Seralini titled this document as a ‘Critical review of Mahyco’s data on Bt brinjal’, which by Dr Seralini’s own admission, was ‘commissioned by Greenpeace.’ I requested Dr Seralini for this document which he sent in March 2009. In January 2010, Dr Seralini submitted a note to the then MoEF (see MoEF’s Moratorium Order of February 2010; Annexure IIIB, pp. 274-303; available at www.moef.nic.in), which was projected as ‘a detailed answer to the Mahyco and EC-II reports submitted to the GEAC in October 2009’. When the two documents of Dr Seralini are compared the essence is the same—Mahyco, Expert Committee II and the GEAC have done a bad job and Bt brinjal is unfit for human consumption.
12. In the light of D Seralini’s track record detailed in Para 11 (a) and (b) above, there should be no reason to consider Dr Seralini’s comments on Bt brinjal as more credible than his pronouncements on the biosafety risks from of GE corn dismissed by the EFSA and others.
13. The then MoEF preferred Seralini’s criticism of the Indian Bt brinjal dossier and totally disregarded the collective opinion of reputed Indian and foreign scientists who supported commercialization of Bt birnjal, as it suited his decision to impose an indefinite moratorium. That the moratorium on Bt brinjal had no safety or environmental concerns should be evident from the following statements of the then MoEF: a) ‘It is for the political system to decide whether to introduce Bt brinjal’ (The Hindu, January 10, 2011); b) ‘If I said yes to Bt brinjal, the civil society would have jumped on me’; c) ‘I had a personal bias’; d) ‘If 90% of the GM seed is going to be controlled by one company…’ (b,c and d: Malhotra, 2011, Current Science). In one of his press interviews, Dr MS Swaminathan did not consider that dominance of a few MNCs affects the country’s seed business and farmers. Bt brinjal has a component of public-private partnership and when such an effort is widely encouraged by the Central Government, prejudice against the private sector is unbecoming of a Minister of the same Government.
14. There were a few instances of challenging faulty and misleading research earlier, as for example, a) Sears et al. (2001) havedemonstrated the absence of any impact of Bt corn pollen on Monarch butterflies, in response to Losey et al., (1999) who reported that transgenic pollen harms Monarch butterfly larvae; and b) Ortiz-García et al. (2005) showed that there were no detectable transgenes in local landraces of maize in Oaxaca, Mexico, contesting Quist and Chapela (2001), who reported that transgenic DNA introgressed into traditional maize land races in Oaxaca. In the case of Losey et al., (1999) and Quist and Chapela (2001) there was no retraction of the papers. Nevertheless, in the context of the paper by Quist and Chapela (2001), the Editor of Nature wrote an editorial note saying that ‘in hindsight, the original paper's publication was unjustified’ (Nature, 416, 600, 2002). Then the protests were not of the same magnitude as those against Dr Seralini’s 2012 paper now.
15. This time for once, the scientific community staunchly rose to the occasion and fought to a logical end. Let us hope that, if a similar situation arises in the future, the scientific community would be alert, equally strongly concerned and determined. But, we must first publicize the retraction of Dr Seralini’s paper to undo some of the damage it caused.
Elsevier. 2013. Statement of retraction. http://www.elsevier.com/about/press-releases/research-and-journals/elsevier-announces-article-retraction-from-journal.
Kameswara Rao, C. 2010. Moratorium on Bt brinjal. A review of the order of the Minister of Environment and Forests, Government of India. Bangalore. Foundation for Biotechnology Awareness and Education. Pp. 70.
Losey, J., Rayor, L.S. and Carter, M.E. 1999. Transgenic pollen harms Monarch larvae. Nature, 399:214.
Mahlangu, S.P. 2013. http://www.scribd.com/doc/156151059/FInal-Assessment-Seralini-Et-Al-2012-Publication. (July 7, 2013).
Malhotra, R. 2011. In conversation: Jairam Ramesh. Curr. Sci., 100: 1010-12.
Ortiz-García, S., Ezcurra, E., Schoel, B., et al. 2005. Absence of detectable transgenes in local landraces of maize in Oaxaca, Mexico (2003–2004). PNAS, 102:12338-12343.
Quist, D. and Chapela, I. 2001. Transgenic DNA introgressed into traditional maize landraces in Oaxaca, Mexico. Nature, 414:541–543.
Sears, M.K., Hellmich, R.L., Stanley-Horn, D.E., et al., 2001. Impact of Bt corn pollen on monarch butterfly populations: A risk assessment. PNAS, 98:11937-11942.
Séralini, G.-E., Clair, E., Mesnage, R., et al., 2012. Long term toxicity of a roundup herbicide and a roundup-tolerant genetically modiﬁed maize. Food and Chemical Toxicology, 50: 4221–4231. http://www.sciencedirect.com/science/article/pii/S0278691512005637.
Sesikeran, B. 2010. GM crops: Human and animal safety. Biotech News, 5:72-74.
Snell, C., Bernheim, A.., Berge J-B., et al., 2012. Assessment of the health impact of GM plant diets in long-term and multigenerational animal feeding trials: a literature review. Food and Chemical Toxicology, 50: 1134-48.
December 9, 2013