Final assessment, 7July 2013

Final Assessment on Responses to the Sèralini et al. Feeding Study on GM Maize Prepared by John Komen and Muffy Koch, biotechnology and biosafety policy consultants
July 2013 This report summarizes the documented responses to the paper, Séralini, G.-E., et al. (2012) Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Food Chem. Toxicol., http://dx.doi.org/10.1016/j.fct.2012.08.005. The report follows on from the responses noted in the previous reports dated 20th September 2012, 31st October 2012, 3rd December 2012, and 31st January 2013. This is the final report in a series of short chronological summaries documenting the response internationally to the Sèralini, et al. (2012) paper. Reaction to the publication was followed in the scientific and regulatory literature; on pro-biotechnology websites; on activist websites; and in the media. In addition, the actions of biotechnology support organizations and the actions of the research team (Sèralini, et al.) were monitored. 1. Seralini et al., next steps The above paper by Sèralini’s research group was followed by a press release on February 21, 2013, calling attention to another recent paper specifically focusing on the toxicity of Roundup-type herbicides, and published in February 2013. This paper, titled “Ethoxylated adjuvants of glyphosatebased herbicides are active principles of human cell toxicity” (http://www.sciencedirect.com/science/article/pii/S0300483X12003459), claims that that the most toxic compound in nine glyphosate-containing herbicides is not glyphosate as such but an adjuvant called POE-15. While the methodology and results from this type of research has been rebutted before (see, for example, http://gmopundit.blogspot.nl/2012/03/curious-lack-of-evidence-for-herbicide.html) it confirms the pattern followed by Sèralini et al., and their support groups, of creating media furor and continuously casting doubts about biotech products and regulatory decisions. This is used to put political pressure on regulatory bodies such as EFSA: http://gmoseralini.org/meps-keep-gmo-petitions-alive-more-heavycriticism-of-efsa/, and on UN bodies including the CBD Secretariat (through an open letter). This campaign will continue in the coming period, following the recent release as a DVD of the movie “All guinea pigs?” based on the September 2012 paper. This movie is being featured in a range of European film festivals in 2013. 2. Scientific and regulatory responses: Final synthesis published A recent noteworthy scientific response was published as a letter to the editor of Food and Chemical Toxicology, submitted by the French Society of Toxicologic Pathology (SFPT, its French acronym) in March 2013: http://www.sciencedirect.com/science/article/pii/S0278691512007867 The letter concludes: “[...] the SFPT is deeply convinced that a thorough evaluation of all products is necessary before marketing but also during the product life, in order to guarantee as much as possible human, animal and environment safety. However, given this study presents serious deficiencies in the
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Final assessment, 7July 2013

protocol, the procedures and the interpretation of the results, the SFPT cannot support any of the scientific claims drawn by the authors, and any relevance for human risk assessment.” An excellent synthesis of all flaws and errors made by Sèralini et al. was published in February 2013. An international group of scientists provided a detailed review of the published paper identifying gaps in the methodology and data and mistakes in the analysis of the information and the conclusions drawn by the authors. This paper (Arjo et al., 2013. Plurality of opinion, scientific discourse and pseudoscience: An in depth analysis of the Sèralini et al. study claiming that RoundupTM Ready corn or the herbicide RoundupTM cause cancer in rats. Transgenic Res.) is included in full as Annex 1. The authors conclude that: “The Séralini paper is a regrettable example of failures at multiple levels during the execution and communication of research, including the inability to formulate a valid hypothesis, implement sound and unbiased experiments, analyze the results properly, report the experimental outcomes objectively, allow other researchers access to raw data, and separate accurate observations and conclusions from artefacts. With specific regard to the reported animal studies, there was also an abject failure to treat the experimental animals in a humane manner, within the standards of the national and international regulatory authorities.” The authors have reviewed the responsibilities of the publishers under the guidelines produced by the Committee on Publication Ethics and identified three areas of concern. They recommend that in the light of the inaccuracy of the information and the conclusions the editors should formally retract the paper. As noted by the authors, Sèralini’s research team has still not released the experimental data requested by the scientific community. They avoid scientific debate, for obvious reasons. In June 2013, Séralini and Jeffrey Smith (another prominent anti-GM activist) both withdrew from a debate on biotechnology and food production arranged by the CATO institute in Washington, D.C. http://www.biofortified.org/2013/05/anti-gmo-leaders-withdraw-from-great-biotech-debate/ 2.1 European Food Safety Authority, EFSA EFSA has not published additional information following its final assessment of the Sèralini paper in November 2012. A synthesis of information by EFSA was made available in February 2013: http://www.efsa.europa.eu/en/faqs/faqseralini.htm . A key question, “Has EFSA changed its view with respect to the length of feeding trials for GMOs?”, is answered unambiguously: “No. EFSA’s approach to animal feeding trials remains in line with the measures clearly set out in its guidance on GMO risk assessment. This guidance details when animal feeding trials are needed, as well as the type of animal feeding trials required and their duration.” 2.2 Food and Chemical Toxicology See letter to the editor cited above. As reported earlier, the editors of FCT decided not to retract the article.

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Final assessment, 7July 2013

3. Biosafety support network responses African Biosafety Network of Expertise (ABNE). ABNE maintains links on its News section to two reports assessing the validity of the Sèralini study. The first report is ABNE’s own assessment of the study and second is findings of the French High Council for Biotechnology (HCB) and the French Agency for Food, Environmental and Occupational Health & Safety (ANSES). This ANSES report reaffirmed earlier conclusions that the study was flawed and does not contribute new knowledge to the risk assessment of NK603 maize, GMOs in general, and glyphosate. ABNE reports that at a recent regional agricultural consultative and planning workshop in Abidjan an activist from Mali spoke out strongly against biotechnology using Sèralini’s study to support his opposition to the technology. In addition, work in Ghana indicates that awareness of the Sèralini study is low, but this is expected to change as activist increase their outreach in response to multi-location cotton trials. They have started to get questions about the recent pig feeding study and would like to have responses prepared for these discussions. AfricaBio. AfricaBio reports that they have needed to counter misinformation from parliamentarians based on the Sèralini study and are now addressing a concerted activist campaign against food companies that use GM ingredients, also supported by Sèralini’s paper. Food companies have capitulated and are sourcing non-GM ingredients in response to activist pressure. African Biotechnology Stakeholders Forum (ABSF). Covered in the Kenya update below. GMO Compass. This EU supported site has added a new article on its home page: “International scientists taking a stand on Séralini's GMO maize feeding study”, March 2013, which links to the Arjo, et al. paper mentioned above. 4. Activist responses Greenpeace. There is no new material related to the Séralini study on the Greenpeace international website. Natural Law and derived groups. In June 2013 the Sustainable Food Trust (http://www.sustainablefoodtrust.org/) has a front and centre banner titled ”Genetically modified orthodoxy” that reviews the current policy status on GM crops in the UK and reflects on the Séralini study, in particular the failure of media to run with news of the conclusions drawn from the data. They comment on the rapid rebuttal of the study and suggest that ‘there were vested interests involved’ to make sure that the message about non-safety of GM maize did not reach the public. (http://sustainablefoodtrust.org/articles/genetically-modified-orthodoxy/). This article posted on 30 May 2013 has received three comments in the subsequent four weeks; all of these supportive of the misinformation provided. Third World Network. There is no new information on the Séralini study on this website, but the original letter to their members (http://www.biosafety-info.net/article.php?aid=937) calling for long term health risk assessment of GMOs based on Séralini’s paper is still posted. A news entry dated June 14th 2013 advises readers that a new long term feeding study on pigs shows negative affects when feed contains GM maize and soya with stacked traits. (A quick review of the abstract of the paper indicates that all the effects were below the probability threshold of 0.05 and are not statistically attributable to the feed.) This pig feeding study has not yet triggered an international response.

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Final assessment, 7July 2013

Friends of the Earth, Europe. Friends of the Earth have not posted any new information on the Séralini study, but in mid-June 2013 they reported on a new study. Friends of the Earth, Europe, commissioned laboratory tests on urine samples from volunteers in 18 countries across Europe and found that on average 44% of samples contained glyphosate. (http://www.foeeurope.org/weed-killerglyphosate-found-human-urine-across-Europe-130613). This posting has not yet generated any large outcry or redistribution by anti-GM activists, but the study was reported on 94 websites within 2 days of the FOE press release. GM Watch. The Séralini study has moved off the home page of GM Watch and onto the GM Watch supported website www.gmoseralini.org . Furthermore, GM Watch posted an article on 16 June 2013 that uses the Séralini study to support why detection of glyphosate in human urine (see FOE report above) is dangerous. http://gmwatch.org/latest-listing/52-2013/14918-concern-over-roundup-use-growsin-malta ENSSER. In February 2013 the European Network of Scientists for Social and Environmental Responsibility (ENSSER; http://www.ensser.org/) issued a press release to publicise a new paper by Seralini’s group (see section 1 above) that evaluates the toxicity of an adjuvant compound in glyphosate formulations (http://www.ensser.org/media/0113/). Toxicity of formulation chemicals has been reviewed in the past and is not new. This may explain why this particular study has had very little observable impact to date. African Centre for Biosafety (ACB). This activist organisation has not continued its Séralini campaign although support for the study is still available on the website. http://www.acbio.org.za/index.php/publications/gmos-in-south-africa/406-setting-the-record-straight-onthe-seralini-gm-maize-rat-study-why-the-sa-government-must-urgently-intervene . The current focus of their anti-GM work is on identifying and discrediting food companies that use GM maize. Scientists support Sèralini: (http://www.democraticunderground.com/10022383573). In February 2013 this website posted about 50 letters of support from scientists for the Séralini study. The posting raised comments from four people opposed to GM crops and Monsanto. Independent Science News. This site is run by the Bioscience Resource Project (http://www.bioscienceresource.org/) and has a link on its home page to a lead article on the appointment of a former biotech industry employee as an editor on the Food Chemistry and Toxicology journal that published the Séralini study in 2012 (http://independentsciencenews.org/science-media/thegoodman-affair-monsanto-targets-the-heart-of-science/). The authors believe this is an illustration of the biotechnology companies taking over the independence of science journals. The new editor is an academic who last worked in the industry nine years ago. 5. Media coverage A search of the World News site (wn.com) that collates news stories from around the world, indicated 12 English language stories related to the Sèralini study from January to June 2013. Importantly, none of these media articles focused on the Sèralini study, but all mentioned it in relation to the topic they were presenting.   The five articles published in February and March were anti-GM articles that used the Sèralini paper to support claims of health hazards with GM foods. Two articles in May were reviews of GM crops and anti-GM activism and two in June were assessments of activist claims; all refuted the Sèralini study.
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Final assessment, 7July 2013

 

GM Free issued an anti-GM press release in May that challenged biosafety regulation in New Zealand and Australia. This press release does not appear to have been taken up by any of the activist sites or mainstream newspapers. One article in June was supportive of GM labelling and quoted Consumers International using Sèralini’s report to illustrate safety concerns with GM food.

This is a significant drop in coverage from the previous months and the ratio of balanced news articles to misinformation was encouraging. While the Séralini paper will continue to be used by activists, it is currently getting very little traction in the general press. 6. Country case studies Earlier updates included coverage of the situation in South Africa. In view of the fact that no new information or developments were reported, this section only focuses on Kenya. Kenya The Sèralini publication has been and is still used by both regulators and activists in the biotechnology / biosafety debate in Kenya. The ban on GM grain imports is still de facto in force. ABSF reports that as recent as June 14th, during a consultative meeting on a proposed regulation on handling, packaging and identification, Sèralini’s “findings” were mentioned by activists. The paper still influences discussions within the Ministry of Public Health, also under the new Cabinet Secretary for Health, and within KEMRI, who have jointly constituted a taskforce that’s expected to come up with a report on the way forward regarding the ban. In terms of media coverage, there have been quite a number of articles, both positive and negative, mentioning “Sèralini” such as on:    The 23rd of April in which it was reported that pro-biotechnology lobbyist were pushing for lifting of ban on GM food imports to boost food stocks; The 2nd of May when the then Permanent Secretary for Agriculture indicated that the ban on GM food imports was political, not based on science; The 15th of May when one Kamau Kaniaru went attacking pro biotech stakeholders including ABSF, Marc Fellous and others for having criticized the Sèralini publication.

ABSF coordinates a coalition of biotech / biosafety stakeholder organizations addressing the misinformation contained in the Sèralini paper and other similar publications, and intend to continue doing so. In addition, ABSF is working with AATF and other stakeholders to have the relevant wing of the Kenya National Academy of Sciences (KNAS) issue its own evaluation on safety of GM foods, as a national scientific authority. In Kenya, the Sèralini study had a significant negative impact that has derailed the process of biotechnology development in Kenya, affecting national food security and R&D. 7. Conclusion While it is clear that activists will continue to use the Sèralini paper to support misinformation about the safety of GM crops, there is sufficient scientific response to this paper to effectively counter these claims. The biosafety service providers in Africa believe the impact from the paper will continue for many months and that is has already had a large negative impact on top-level decision makers. It will remain important for biotech / biosafety stakeholder organizations, donor organizations, and technical

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Final assessment, 7July 2013

assistance providers to collaborate on any type of response and to ensure that local scientific organizations (such as the KNAS) weigh in as well. This will have to be a sustained effort as the Sèralini paper and movie is one part of a broader, concerted campaign to disrupt progress on agricultural biotechnology R&D. Recent examples include the publications on Roundup herbicides, cited above, and papers / media campaigns on topics such as:      “Hidden” viral genes in commercialized GM crops; Glyphosate's inhibition of cytochrome P450 (CYP) enzymes, supposedly causing a range of modern-day diseases including Parkinson’s and autism; Hematological changes in mice fed on Bt spores – suggesting a link to leukemia and anemia; Feeding studies allegedly showing increased stomach inflammations in pigs; The emergence of “superweeds” due to planting of herbicide-tolerant crops.

All the above papers received strong, scientific rebuttals yet they will continue to figure in public debates, media coverage and policy discussions across the globe. The service provider groups in Africa, particularly in Kenya, will need to maintain a rapid response mechanism to counter the misinformation. It is proposed that these groups receive this final assessment and copies of the Letter to the Editor and the scientific rebuttal of the Sèralini study, both mentioned above. They are included as annexes to this final update.

Annexes: Arjo et al., 2013. Plurality of opinion, scientific discourse and pseudoscience: An in depth analysis of the Sèralini et al. study claiming that RoundupTM Ready corn or the herbicide RoundupTM cause cancer in rats. Transgenic Res.) http://link.springer.com/article/10.1007/s11248-013-9692-9 PDF:

Arjo-Plurality-Opinion -Scientific-Discourse-S

French Society of Toxicologic Pathology (SFPT). 2013. Letter to the editor. Food and Chemical Toxicology. http://www.sciencedirect.com/science/article/pii/S0278691512007867 PDF:
1-s2.0-S0278691512 007867-main.pdf

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