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{{short description|Retracted study led by Gilles-Éric Séralini}}
{{Use dmy dates|date=March 2015}} {{Use dmy dates|date=March 2015}}
], in 2015]]
{{Genetic engineering sidebar}}


The '''Séralini affair''' was the controversy surrounding the publication, retraction, and republication of a ] by French ] ]. First published by ''] '' in September 2012, the article presented a two-year feeding study in rats, and reported an increase in ]s among rats fed ] and the ] ]. Scientists and regulatory agencies subsequently concluded that the study's design was flawed and its findings unsubstantiated. A chief criticism was that each part of the study had too few rats to obtain statistically useful data, particularly because the strain of rat used, ], develops tumors at a high rate over its lifetime.<ref name=Hayes2014/><ref name=CassasusNatureNews25June2014/>
The '''Séralini affair''' is a controversy over an experiment involving feeding ] (called corn in North America) to rats. The study claimed that the diet was toxic to the animals. The experiment was conducted by a group led by French ] ]. The experiments involved feeding ]'s ]-tolerant NK603 ] and the herbicide ] to rats.<ref name="Seralini2012">{{cite journal |doi=10.1016/j.fct.2012.08.005 |title=Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize |year=2012 |last1=Séralini |first1=Gilles-Eric |last2=Clair |first2=Emilie |last3=Mesnage |first3=Robin |last4=Gress |first4=Steeve |last5=Defarge |first5=Nicolas |last6=Malatesta |first6=Manuela |last7=Hennequin |first7=Didier |last8=De Vendômois |first8=Joël Spiroux |journal=Food and Chemical Toxicology |volume=50 |issue=11 |pages=4221–31 |pmid=22999595}}{{Retracted|intentional=yes}}<span class="" style="font-size:0.95em; color: #555;"> ('''Republished''' in ''Environmental Sciences Europe'', 24 June 2014, infra)</span></ref>


The publicity surrounding publication of the article also attracted criticism, with science writer Declan Butler calling it "a tightly orchestrated media offensive".<ref name="ButlerNatureNews10Oct2012">{{cite journal |doi=10.1038/490158a |title=Hyped GM maize study faces growing scrutiny |date=10 October 2012 |last1=Butler |first1=Declan |journal=Nature |volume=490 |issue=7419 |pages=158 |pmid=23060167|bibcode=2012Natur.490..158B |doi-access=free }}</ref> As part of a ], Séralini required journalists to sign an unusual ] in exchange for advance access to the article, prohibiting them from conferring with other scientists before the ] announcing publication.{{refn|group=n|], 20 September 2012: "Breaking with a long tradition in scientific journalism, the authors allowed a selected group of reporters to have access to the paper, provided they signed confidentiality agreements that prevented them from consulting other experts about the research before publication."<ref name=AFP20Sept2012/>}} At the press conference, Séralini emphasized the study's potential cancer implications, and photographs from the article of treated rats with large tumors were widely circulated by the media.<ref name=AFP20Sept2012>{{cite web|title=France orders probe after rat study links genetically modified corn to cancer|url=http://www.dawn.com/news/750751/france-orders-probe-after-rat-study-links-genetically-modified-corn-to-cancer|publisher=Agence France-Presse|date=20 September 2012}}</ref> The French Society of Toxicologic Pathology pointed out that, because such tumors are commonly found in older rats, the inclusion in the article of those images from treated rats, without also showing control rats, was misleading.<ref name=Barale-ThomasMarch2013/> Séralini also released a book and documentary film about the study in conjunction with the press conference.<ref name="ButlerNatureNews25Sept2012">{{cite journal|author=Butler, Declan|title=Rat study sparks GM furore|journal=Nature News|volume=489|issue=7417|pages=484|date=25 September 2012|doi=10.1038/489484a|pmid=23018942|bibcode=2012Natur.489..484B|doi-access=free}}</ref>
The group's conclusions and experimental design were heavily criticized, along with its publication strategy.<ref name="Arjo" /><ref name="Kuntz">{{cite journal |doi=10.1038/embor.2012.214 |title=Why the postmodern attitude towards science should be denounced |year=2013 |last1=Kuntz |first1=Marcel |journal=EMBO Reports |volume=14 |issue=2 |pages=114–6 |pmid=23306654 |pmc=3566841}}</ref> The paper also received support from the scientific community. At the press conference announcing the publication of the paper, Seralini displayed photographs of rats with large ]s, and emphasized his cancer findings.<ref name="Arjo"/> The press conference received extensive coverage in the media; "within hours, the news had been blogged and tweeted more than 1.5 million times. Lurid photos of tumor-ridden rats appeared on websites and in newspapers around the world..."<ref name="Arjo"/> At the press conference, Séralini also announced that he was releasing a book and a ] on the research. Séralini required journalists to sign a ] before viewing the study in advance of the conference.<ref name="Arjo">{{cite journal |doi= 10.1007/s11248-013-9692-9 |title= Plurality of opinion, scientific discourse and pseudoscience: An in depth analysis of the Séralini et al. Study claiming that Roundup™ Ready corn or the herbicide Roundup™ cause cancer in rats |year= 2013 |last1= Arjó |first1= Gemma |last2= Portero |first2= Manuel |last3= Piñol |first3= Carme |display-authors=3|last4= Viñas |first4= Juan |last5= Matias-Guiu |first5= Xavier |last6= Capell |first6= Teresa |last7= Bartholomaeus |first7= Andrew |last8= Parrott |first8= Wayne |last9= Christou |first9= Paul |journal= Transgenic Research |volume= 22 |issue= 2 |pages= 255–67 |pmid= 23430588}}</ref> The confidentiality agreement prohibited them from contacting other researchers in advance of the conference.


Following widespread criticism by scientists, ''Food and Chemical Toxicology'' retracted the paper in November 2013 after the authors refused to withdraw it.<ref name=Elsevier2013>{{cite web|title=Elsevier Announces Article Retraction from Journal Food and Chemical Toxicology|url=http://www.elsevier.com/about/press-releases/research-and-journals/elsevier-announces-article-retraction-from-journal-food-and-chemical-toxicology|publisher=Elsevier|date=28 November 2013}}</ref> The editor-in-chief said that the article was retracted because its data were inconclusive and its conclusions unreliable.<ref name=Hayes2014/> In June 2014 an amended version of the article was republished in '']'',<ref name="SeraliniRepublish2014" /> and the raw data were made public. According to writer Nathanael Johnson, not all of the raw data were, in fact, released.<ref>{{cite news|last1=Johnson|first1=Nathanael|title=Retracted Roundup-fed rat research republished|url=https://grist.org/food/retracted-roundup-fed-rat-research-republished/|access-date=4 April 2018|publisher=Grist|date=1 July 2014}}</ref> The journal did not conduct any further ]; reviewers checked only that the scientific content of the paper had not changed.<ref name=CassasusNatureNews25June2014>{{cite journal|doi=10.1038/nature.2014.15463|last1=Cassasus|first1=Barbara|title=Paper claiming GM link with tumours republished|journal=Nature|date=25 June 2014|s2cid=155666600|doi-access=free}}</ref>
After the paper was published, scientists and regulatory agencies concluded that the conclusions of the paper to be invalid on the basis of the experimental design; each arm in the study had too few rats to obtain useful data in a lifetime study of ]s, which get cancer at a high rate over their lifetime.<ref name="Ricroch" /> Other publicly funded long term studies uncovered no health issues.<ref name="Kuntz" /><ref name="Ricroch">{{cite journal |doi=10.1016/j.nbt.2012.12.001 |title=Assessment of GE food safety using '-omics' techniques and long-term animal feeding studies |year=2013 |last1=Ricroch |first1=Agnès E. |journal=New Biotechnology |volume=30 |issue=4 |pages=349–54 |pmid=23253614}}</ref>


==Background==
In November 2013, ''] ''(FCT), retracted Séralini's paper after the authors refused to withdraw it.<ref name=Elsevier2013>{{cite web|title=Elsevier Announces Article Retraction from Journal Food and Chemical Toxicology|url=http://www.elsevier.com/about/press-releases/research-and-journals/elsevier-announces-article-retraction-from-journal-food-and-chemical-toxicology|publisher=Elsevier|accessdate=2013-11-29}}</ref> The article was republished in June 2014 in the journal '']'', without further ]. Reviewers instead checked that the content of the paper matched the previously peer-reviewed version.<ref name="SeraliniRepublish2014">{{cite journal|last1=Séralini|first1=Gilles-Eric|last2=Clair|first2=Emilie|last3=Mesnage|first3=Robin|last4=Gress|first4=Steeve|last5=Defarge|first5=Nicolas|last6=Malatesta|first6=Manuela|last7=Hennequin|first7=Didier|last8=de Vendômois|first8=Joël|title=Republished study: long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize|journal=Environmental Sciences Europe|volume=26|issue=1|pages=14|doi=10.1186/s12302-014-0014-5}}</ref><ref>{{cite news|last1=Cassasus|first1=Barbara|title=Paper claiming GM link with tumours republished|url=http://www.nature.com/news/paper-claiming-gm-link-with-tumours-republished-1.15463|accessdate=31 August 2015|publisher=Nature|date=25 June 2014}}</ref>
{{main|Gilles-Éric Séralini}}


Séralini, a professor of molecular biology at the ], is president of the scientific advisory board of the Committee of Research and Independent Information on Genetic Engineering (CRIIGEN), which opposes ] (GM food). Séralini co-founded CRIIGEN in 1999 because he judged that studies on GM food safety were inadequate.<ref name="SeraliniBio"> {{Webarchive|url=https://web.archive.org/web/20151222080543/http://www.criigen.org/membre/46/display/Pr-Gilles-Eric-Seralini-President-du-Conseil-Scientifique |date=22 December 2015 }} and {{Webarchive|url=https://web.archive.org/web/20160105140319/http://www.criigen.org/user/pdf/PRESENTATION_CRIIGEN_EN.pdf |date=5 January 2016 }}, CRIIGEN.</ref><ref name="Carman2012">{{cite news|url=https://www.washingtonpost.com/blogs/all-we-can-eat/post/french-scientists-question-safety-of-gm-corn/2012/09/19/d2ed52e4-027c-11e2-8102-ebee9c66e190_blog.html|newspaper=The Washington Post|date=19 September 2012|title=French scientists question safety of GM corn|last=Carman|first=Tim}}</ref>
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Before 2012 Séralini had published other peer-reviewed papers that concluded there were health risks to GM foods. In 2007 he and two others published a Greenpeace-funded study (Séralini 2007).<ref name=Seralini2007>{{cite journal |doi=10.1007/s00244-006-0149-5 |title=New Analysis of a Rat Feeding Study with a Genetically Modified Maize Reveals Signs of Hepatorenal Toxicity |year=2007 |last1=Séralini |first1=Gilles-Eric |last2=Cellier |first2=Dominique |last3=De Vendomois |first3=Joël Spiroux |journal=Archives of Environmental Contamination and Toxicology |volume=52 |issue=4 |pages=596–602 |pmid=17356802|bibcode=2007ArECT..52..596S |s2cid=2521185 }}</ref><ref>{{cite web|url= http://www.gmo-compass.org/eng/news/messages/200703.docu.html|title= GM maize MON863: French scientists doubt safety|publisher= GMO Compass|date= 16 March 2007|access-date= 11 November 2010|url-status= dead|archive-url= https://web.archive.org/web/20101230200044/http://www.gmo-compass.org/eng/news/messages/200703.docu.html|archive-date= 30 December 2010|df= dmy-all}}</ref> It concluded that ], a ]-resistant ] developed by ], caused health problems in rats, including weight changes, triglyceride level increases in females, changes in urine composition in males, and reduced function or organ damage in the liver, kidney, adrenal glands, heart and ] system.<ref name=Seralini2007 /> The ] (EFSA) concluded that all blood chemistry and organ weight values fell within the normal range for control animals, and that the paper had used incorrect statistical methods.<ref name="EFSA2007 review of Seralini 2007">, EFSA, adopted 25 June 2007.</ref><ref name="EFSA2007 Statistical Review of Seralini2007">{{cite journal |doi=10.2903/j.efsa.2007.19r |title=EFSA review of statistical analyses conducted for the assessment of the MON 863 90-day rat feeding study |journal=EFSA Journal |volume=5 |issue=6 |pages=19r |url=http://www.efsa.europa.eu/en/efsajournal/pub/19r|author=European Food Safety Authority |year=2007|doi-access=free }}</ref><ref name = LeFigaro>, ''Le Figaro'', 13 July 2007.</ref> The French Commission du Génie Biomoléculaire (AFBV) also criticized the study's conclusions.<ref>{{cite web|url=http://www.strategie.gouv.fr/system/files/d1b51c34d01.pdf|archive-url=https://web.archive.org/web/20131231002713/http://www.strategie.gouv.fr/system/files/d1b51c34d01.pdf|archive-date=31 December 2013|title=Les Organismes Génétiquement Modifiés, Annexe B. Avis de la commission du génie biomoléculaire sur l'étude statistique du CRIIGEN du maïs MON863|date=20 July 2007|url-status=dead|df=dmy-all}}, report prepared for the French Prime Minister by the Centre d'Analyse Strategique, 20 July 2007. Retrieved 31 May 2013</ref>
==Background==
] is a professor of molecular biology at the ] in France. He is founder and president of the scientific advisory board of the Committee of Research and Independent Information on Genetic Engineering (CRIIGEN), which is publicly opposed to ] (GM food).<ref name=SeraliniBio>"HH", CRIIGEN, 12 November 12, 2008 </ref><ref name="Carman2012">{{cite news|url=http://www.washingtonpost.com/blogs/all-we-can-eat/post/french-scientists-question-safety-of-gm-corn/2012/09/19/d2ed52e4-027c-11e2-8102-ebee9c66e190_blog.html|publisher=Washington Post|date=September 19, 2012|title=French scientists question safety of GM corn|last=Carman|first=Tim|accessdate=May 20, 2013}}</ref><ref name=SFPonAcademies/> Séralini founded CRIIGEN because he judged that studies on GM food safety were inadequate, and questioned their acceptance.<ref name=SeraliniBio/>


In 2009 the Séralini lab published another study (Séralini 2009), which re-analyzed toxicity data for NK 603 (glyphosate resistant), MON 810 and MON 863 strains.<ref name="Seralini2009">{{cite journal |doi=10.7150/ijbs.5.706 |title=A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health |year=2009 |last1=De Vendômois |first1=Joël Spiroux |journal=International Journal of Biological Sciences |pages=706–26 |pmid=20011136 |pmc=2793308 |volume=5 |issue=7}}</ref> The data included three rat-feeding studies published by Monsanto scientists on MON 810.<ref name="pmid 15110110">{{cite journal |doi=10.1016/j.fct.2004.02.013 |title=Results of a 13 week safety assurance study with rats fed grain from glyphosate tolerant corn |year=2004 |last1=Hammond |first1=B |last2=Dudek |first2=R |last3=Lemen |first3=J |last4=Nemeth |first4=M |journal=Food and Chemical Toxicology |volume=42 |issue=6 |pages=1003–14 |pmid=15110110}}</ref><ref name="pmid 16084637">{{cite journal |doi=10.1016/j.fct.2005.06.008 |title=Results of a 90-day safety assurance study with rats fed grain from corn rootworm-protected corn |year=2006 |last1=Hammond |first1=B. |last2=Lemen |first2=J. |last3=Dudek |first3=R. |last4=Ward |first4=D. |last5=Jiang |first5=C. |last6=Nemeth |first6=M. |last7=Burns |first7=J. |journal=Food and Chemical Toxicology |volume=44 |issue=2 |pages=147–60 |pmid=16084637}}</ref><ref name="pmid 16487643">{{cite journal |doi=10.1016/j.fct.2006.01.003 |title=Results of a 90-day safety assurance study with rats fed grain from corn borer-protected corn |year=2006 |last1=Hammond |first1=B.G. |last2=Dudek |first2=R. |last3=Lemen |first3=J.K. |last4=Nemeth |first4=M.A. |journal=Food and Chemical Toxicology |volume=44 |issue=7 |pages=1092–9 |pmid=16487643}}</ref> This study concluded that the three crops caused liver, kidney and heart damage in the rats.<ref name=Seralini2009 /> The EFSA concluded that the authors' claims were not supported by their data, that many of the statistical criticisms of Séralini 2007 applied to Séralini 2009, and that the study included no new information that would change the EFSA's conclusions.<ref>{{cite web|url= http://www.efsa.europa.eu/sites/default/files/event/gmo100127-m.pdf|title= EFSA Minutes of the 55th Plenary Meeting of the Scientific Panel on Genetically Modified Organisms Held on 27–28 January 2010 IN Parma, Italy, Annex 1, Vendemois et al. 2009|publisher= European Food Safety Authority report|access-date=11 November 2010}}</ref> The French ] (High Council of Biotechnologies Scientific Committee or HCB) reviewed Séralini 2009 and concluded that it "presents no admissible scientific element likely to ascribe any haematological, hepatic or renal toxicity to the three re-analysed GMOs." The HCB questioned the authors' independence, noting that, in 2010, the "body to which the authors belong" displayed material from a 2008 Austrian anti-GM study, the results of which had been acknowledged as mistaken by the study's authors.<ref>{{cite web|url=http://www.food.gov.uk/multimedia/pdfs/acnfp9612a2 |title=Opinion relating to the deposition of 15 December 2009 by the Member of Parliament, François Grosdidier, as to the conclusions of the study entitled 'A comparison of the effects of three GM corn varieties on mammalian health' |publisher=UK Food Standards Agency |page=2 |access-date=11 November 2010 |url-status=unfit |archive-url=https://web.archive.org/web/20131105222929/http://www.food.gov.uk/multimedia/pdfs/acnfp9612a2 |archive-date=5 November 2013 }}</ref> ] concluded that the results of Séralini 2009 were due to chance alone.<ref>{{cite web |url=http://www.foodstandards.gov.au/scienceandeducation/factsheets/factsheets/feedingstudiesandgmc5604.cfm |title=Feeding studies and GM corn MON863 |publisher=Food Standards Australia New Zealand |date=July 2012 |access-date=10 October 2012 |url-status=dead |archive-url=https://web.archive.org/web/20121025134029/http://www.foodstandards.gov.au/scienceandeducation/factsheets/factsheets/feedingstudiesandgmc5604.cfm |archive-date=25 October 2012 |df=dmy-all }}</ref>
In 2004, Monsanto sought approval in Europe to introduce ] resistant (]) ], which led to controversy over acceptance by regulatory bodies of industry-funded toxicity studies and over their study design. Séralini was on the committee that reviewed MON 863 for the French government.<ref>{{cite web|url=http://www.criigen.org/SiteEn/index.php?option=com_content&task=view&id=57&Itemid=105|title=Comité de Recherche et d'Information Indépendantes sur le génie Génétique |work=CRIIGEN}}</ref> He was a major figure in those controversies and continues to be a critic of toxicity study design.<ref name=Seralini2011 />


In 2010 Séralini sued ], president of the ], for libel, after Fellous criticized Séralini's research, in part because it was funded by ]. The judge ruled that the charge about the funding was defamatory. Fellous was fined €1000; Séralini was awarded a symbolic €1 in damages.<ref>Olivier, Vincent. ("GM: two researchers in court"), ''L'Express'', 19 January 2011 ().</ref>
In 2004, the ] (GMO) Panel of the ] (EFSA) recommended the approval of MON 863.<ref name=EFSA2004-MON863>{{cite journal |doi=10.2903/j.efsa.2004.50 |title=Opinion of the Scientific Panel on genetically modified organisms on a request from the Commission related to the safety of foods and food ingredients derived from insect-protected genetically modified maize MON 863 and MON 863 x MON 810, for which a request for placing on the market was submitted under Article 4 of the Novel Food Regulation (EC) No 258/97 by Monsanto |author=EFSA Panel on Genetically Modified Organisms |journal=The EFSA Journal |year=2004 |volume=50 |pages=1–25}}</ref> Its report and referenced changes in ] parameters and in ] weights of tested rats.<ref name=EFSA2004-MON863/> ] sued for release of the rat feeding studies that Monsanto had provided. Monsanto contested the suit in order to protect its trade secrets.<ref name=NoSecrets /> In June 2005 a German court ordered the release of the original study.<ref name=NoSecrets>{{cite web|url=http://www.gmo-safety.eu/archive/246.secrets-safety-matters.html|title=MON863 maize: Court orders disclosure of all documents. No secrets in safety matters |work=GMO-Safety.eu}}</ref><ref>Monsanto, 2002. 13-Week Dietary Subchronic Comparison Study with MON 863 Corn in Rats Preceded by a 1-Week Baseline Food Consumption Determination with PMI Certified Rodent Diet #5002 </ref> With the full study in hand, critics of GM foods, including Séralini and ], pointed to differences in kidney size and blood composition, suggesting that the observed differences, as well as the study designs, challenged the regulatory concept of ].<ref>Jeffrey M. Smith January 2008. Biophile Magazine, Issue 6.</ref>


A 2011 article by the Séralini lab that reviewed 19 published animal-feeding studies, as well as data from animal-feeding studies submitted for regulatory approval, concluded that GM food had liver and kidney effects that were sex and dose dependent, and advocated for longer and more elaborate toxicology tests for regulatory approval.<ref name=Seralini2011>{{cite journal |doi=10.1186/2190-4715-23-10 |title=Genetically modified crops safety assessments: Present limits and possible improvements |year=2011 |last1=Séralini |first1=Gilles-Eric |last2=Mesnage |first2=Robin |last3=Clair |first3=Emilie |last4=Gress |first4=Steeve |last5=De Vendômois |first5=Joël |last6=Cellier |first6=Dominique |journal=Environmental Sciences Europe |volume=23 |pages=10|doi-access=free }}</ref>
===Previous Séralini papers===
Prior to 2012, Séralini had published other peer-reviewed papers that concluded there are health risks to GM foods. However, some members of the scientific community and food safety authorities questioned whether Séralini's data were sufficient to support his conclusions.


Séralini research was funded primarily by three organizations: Sustainable Food Alliance (organic food industry group), ] and Sevene Pharma (a French manufacturer of homeopathic "remedies").<ref>{{Cite web|title=Gilles-Éric Séralini: Activist professor and face of anti-GMO industry|url=https://geneticliteracyproject.org/glp-facts/gilles-eric-seralini-activist-professor-face-anti-gmo-industry/|access-date=2021-11-15|website=Genetic Literacy Project|language=en-US}}</ref><ref>{{Cite web|last=GRW|date=2013-01-07|title=La «part d'ombre» du professeur Séralini -|url=https://www.agriculture-environnement.fr/2013/01/07/la-part-d-ombre-du-professeur849|access-date=2021-11-15|website=www.agriculture-environnement.fr|language=fr-FR}}</ref>
In 2007, Séralini and two other authors from ] and the ] published a Greenpeace-funded study of these data.<ref name=Seralini2007>{{cite journal |doi=10.1007/s00244-006-0149-5 |title=New Analysis of a Rat Feeding Study with a Genetically Modified Maize Reveals Signs of Hepatorenal Toxicity |year=2007 |last1=Séralini |first1=Gilles-Eric |last2=Cellier |first2=Dominique |last3=De Vendomois |first3=Joël Spiroux |journal=Archives of Environmental Contamination and Toxicology |volume=52 |issue=4 |pages=596–602 |pmid=17356802}}</ref><ref>{{cite web|url= http://www.gmo-compass.org/eng/news/messages/200703.docu.html|title= GM maize MON863: French scientists doubt safety|publisher= GMO Compass|date= 16 March 2007|accessdate=11 November 2010}}</ref><ref name='Z Magazine Ananda 2010'>{{cite journal | title = Three Approved GMOs Linked to Organ Damage | journal = Z Magazine | year = 2010 | first = Rady | last = Ananda | volume = 23 | issue = 3| id = | url = http://www.zcommunications.org/three-approved-gmos-linked-to-organ-damage-by-rady-ananda.pdf | format = PDF | accessdate =21 July 2010|quote=The data 'clearly underlines adverse impacts on kidneys and liver, the dietary detoxifying organs, as well as different levels of damages to heart, adrenal glands, spleen, and haematopoietic system,' reported Gilles-Eric Séralini, a molecular biologist at Caen University.}}</ref> The study concluded that MON 863 caused health problems in rats, including weight changes, triglyceride level increases in females, changes in ] composition in males, and reduced function or organ damage in the ], ], ], ], and ] system.<ref name=Seralini2007 /> The study further recommended that safety experiments continue beyond than 90 days, as chronic organ problems are rarely evident in that amount of time.<ref name=Seralini2007 /> Greenpeace cited the study in a press release, in which it called for a MON 863 recall and a review of testing methods.<ref name='Greenpeace March 2007'>{{cite web | url = http://www.greenpeace.org/raw/content/international/press/reports/gp_briefing_seralini_study.pdf | title = Regulatory systems for GE crops a failure: the case of MON863 | accessdate =21 July 2010 | format = PDF | publisher = ] | quote = Greenpeace demands an immediate and complete recall of MON863 from the global market. We also call upon governments to undertake an urgent reassessment of all other authorised GE products and a strict review of current testing methods. |archiveurl=http://web.archive.org/web/20090330230559/http://www.greenpeace.org/raw/content/international/press/reports/gp_briefing_seralini_study.pdf |archivedate=30 March 2009 |deadurl=yes}}</ref>


== 2012 study ==
The paper prompted EFSA to reexamine the MON 863 safety data. It asked EU countries for any new data about the strain, new opinions on the original Monsanto study and a technical meeting with the authors of the 2007 CRIIGEN paper. EFSA concluded that all blood chemistry and organ weight values fell within the normal range for control animals<ref name="EFSA2007 review of Seralini 2007">Statement of the Scientific Panel on Genetically Modified Organisms on the analysis of data from a 90-day rat feeding study with MON 863 maize </ref> and that the paper used incorrect statistical methods.<ref name="EFSA2007 Statistical Review of Seralini2007">{{cite web |doi=10.2903/j.efsa.2007.19r |title=EFSA review of statistical analyses conducted for the assessment of the MON 863 90-day rat feeding study |url=http://www.efsa.europa.eu/en/efsajournal/pub/19r.htm |author=European Food Safety Authority |year=2007}}</ref> These conclusions were reported by ] (]) to the ] on 9 July 2010.<ref name = LeFigaro> Le Figaro, 13 July 2007. Retrieved 27 October 2010</ref> The French Commission du Génie Biomoléculaire (AFBV) also reached critical conclusions.<ref> Report prepared for the French Prime Minister by the Centre d'Analyse Strategique, 20 July 2007. Retrieved 31 May 2013</ref> ] reviewed the 2007 Séralini study and concluded that "...all of the statistical differences between rats fed MON 863 corn and control rats are attributable to normal biological variation."<ref>{{cite web|url= http://www.foodstandards.gov.au/_srcfiles/Review_of_Report_by_Seralini_et_al_July_2007.doc|title= Review of the report by Séralini et al., (2007): "New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity"|publisher= FSANZ final assessment report|accessdate=11 November 2010}}{{dead link|date=August 2013}}</ref><ref>{{cite web|url= http://www.foodstandards.gov.au/scienceandeducation/factsheets/factsheets2007/updatefsanzreaffirms3622.cfm|title= FSANZ reaffirms its risk assessment of genetically modified corn MON 863|publisher= FSANZ fact sheets 2007|date= 25 July 2010|accessdate=11 November 2010}}</ref>


=== Study background ===
In 2009, the Séralini lab published another study (Séralini 2009), which re-analyzed toxicity data for NK 603 (glyphosate resistant), ] and MON 863 strains.<ref name="Seralini2009">{{cite journal |doi=10.7150/ijbs.5.706 |title=A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health |year=2009 |last1=De Vendômois |first1=Joël Spiroux |journal=International Journal of Biological Sciences |pages=706–26 |pmid=20011136 |pmc=2793308 |volume=5 |issue=7}}</ref> The data included three rat feeding studies published by Monsanto scientists on ] (Bt corn).<ref name="pmid15110110">{{cite journal |doi=10.1016/j.fct.2004.02.013 |title=Results of a 13 week safety assurance study with rats fed grain from glyphosate tolerant corn |year=2004 |last1=Hammond |first1=B |last2=Dudek |first2=R |last3=Lemen |first3=J |last4=Nemeth |first4=M |journal=Food and Chemical Toxicology |volume=42 |issue=6 |pages=1003–14 |pmid=15110110}}</ref><ref name="pmid16084637">{{cite journal |doi=10.1016/j.fct.2005.06.008 |title=Results of a 90-day safety assurance study with rats fed grain from corn rootworm-protected corn |year=2006 |last1=Hammond |first1=B. |last2=Lemen |first2=J. |last3=Dudek |first3=R. |last4=Ward |first4=D. |last5=Jiang |first5=C. |last6=Nemeth |first6=M. |last7=Burns |first7=J. |journal=Food and Chemical Toxicology |volume=44 |issue=2 |pages=147–60 |pmid=16084637}}</ref><ref name="pmid16487643">{{cite journal |doi=10.1016/j.fct.2006.01.003 |title=Results of a 90-day safety assurance study with rats fed grain from corn borer-protected corn |year=2006 |last1=Hammond |first1=B.G. |last2=Dudek |first2=R. |last3=Lemen |first3=J.K. |last4=Nemeth |first4=M.A. |journal=Food and Chemical Toxicology |volume=44 |issue=7 |pages=1092–9 |pmid=16487643}}</ref> This study concluded that the three crops caused liver, kidney and heart damage in the rats.<ref name=Seralini2009 />
On 19 September 2012, the journal '']'' published a peer-reviewed paper entitled "Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize."<ref name=Seralini2012>{{cite journal | last1 = Séralini | first1 = Gilles-Eric | display-authors = etal | year = 2012 | title = Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize | journal = Food and Chemical Toxicology | volume = 50 | issue = 11| pages = 4221–4231 | doi=10.1016/j.fct.2012.08.005 | pmid=22999595| doi-access = free }}{{Retracted|doi=10.1016/j.fct.2013.11.047|pmid=24490213|http://retractionwatch.com/2013/11/28/controversial-seralini-gmo-rats-paper-to-be-retracted/ ''Retraction Watch''|http://retractionwatch.com/2017/08/10/unearthed-docs-monsanto-connected-campaign-retract-gmo-paper/ ''Retraction Watch''|http://retractionwatch.com/2014/01/16/journal-editor-defends-retraction-of-gmo-rats-study-while-authors-reveal-some-of-papers-history/ ''Retraction Watch''|http://retractionwatch.com/2014/06/24/retracted-seralini-gmo-rat-study-republished/ ''Retraction Watch''|intentional=yes}}</ref><ref name="ButlerNatureNews25Sept2012" /> The two-year toxicity study, which cost €3.2 million, was conducted at the University of Caen by Séralini and seven colleagues. It had been funded by and run with the collaboration of CRIIGEN.<ref name=ButlerNatureNews10Oct2012 /><ref name=GuardianSeralini/>


The study used 100 male and 100 female ] rats, divided into twenty groups with 10 rats each. Ten diets were tested separately on the males and females. The diets comprised 11 percent, 22 percent and 33 percent genetically modified corn (NK603) and the rest standard laboratory rat food; NK603 corn that had been treated with Roundup, also at 11, 22 and 33 percent; and corn that had not been genetically modified, accompanied by differing concentrations of Roundup in the water. A control group was fed 33 percent non-GMO corn; the rest of their diet was standard laboratory rat food.<ref name=VIB> {{Webarchive|url=https://web.archive.org/web/20130119112014/http://www.vib.be/en/news/Documents/20121008_EN_Analyse%20rattenstudie%20S%C3%A9ralini%20et%20al.pdf |date=19 January 2013 }}, Vlaams Interuniversitair Instituut voor Biotechnologie, 19 January 2013.</ref>{{rp|3–4}}
EFSA reviewed Séralini 2009 and concluded that the authors' claims were not supported by the data in their paper, that many of the statistical criticisms of the 2007 paper also applied to the 2009 paper and that it included no new information that would change the EFSA's conclusions.<ref>{{cite web|url= http://www.efsa.europa.eu/en/events/event/gmo100127-m.pdf|title= EFSA Minutes of the 55th Plenary Meeting of the Scientific Panel on Genetically Modified Organisms Held on 27–28 January 2010 IN Parma, Italy, Annex 1, Vendemois et al 2009|publisher= European Food Safety Authority report|accessdate=11 November 2010}}</ref> The French High Council of Biotechnologies Scientific Committee<ref name="hcb">]{{self-published inline|date=August 2013}}</ref> (HCB) reviewed Séralini 2009 and concluded that it "..presents no admissible scientific element likely to ascribe any haematological, hepatic or renal toxicity to the three re-analysed GMOs."<ref>{{cite web|url= http://www.food.gov.uk/multimedia/pdfs/acnfp9612a2|title= Opinion relating to the deposition of 15 December 2009 by the Member of Parliament, François Grosdidier, as to the conclusions of the study entitled "A comparison of the effects of three GM corn varieties on mammalian health"|publisher= English translation of French High Council of Biotechnologies Scientific Committee document|accessdate=11 November 2010}}</ref> The HCB also questioned the authors' independence, noting that, in 2010, the Séralini web page still showed a 2008 Austrian anti-GM article that had been previously withdrawn by the authors as flawed. Food Standards Australia New Zealand concluded that the results from Séralini 2009 were due to chance alone.<ref>{{cite web |url=http://www.foodstandards.gov.au/scienceandeducation/factsheets/factsheets/feedingstudiesandgmc5604.cfm |title=Feeding studies and GM corn MON863 |publisher=Food Standards Australia New Zealand |date=July 2012 |accessdate=10 October 2012}}</ref>


The paper's abstract stated: "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."
In 2010, Séralini sued ] ], president of the ] and the Association, for ]]<nowiki/>bel, claiming that they had unjustly criticized his scientific ability and his research because of its funder, Greenpeace. The judge ruled that because Fellous and other critics had financial ties to the agricultural biotechnology industry, their charge about the Greenpeace funding was defamatory, but refused to rule on the scientific matter. Fellous was fined 1000 euros. Séralini was awarded a symbolic 1 euro in damages and court costs.<ref>Vincent Olivier for L'Express. January 19, 2011. </ref>


=== Publication strategy ===
A 2011 review by the Séralini lab, which used 19 published animal feeding studies, as well as data from several animal feeding studies submitted for regulatory approval, continued to find that GM food had liver and kidney effects that were sex and dose dependent, and advocated for longer and more elaborate toxicology tests for regulatory approval.<ref name=Seralini2011>{{cite journal |doi=10.1186/2190-4715-23-10 |title=Genetically modified crops safety assessments: Present limits and possible improvements |year=2011 |last1=Séralini |first1=Gilles-Eric |last2=Mesnage |first2=Robin |last3=Clair |first3=Emilie |last4=Gress |first4=Steeve |last5=De Vendômois |first5=Joël |last6=Cellier |first6=Dominique |journal=Environmental Sciences Europe |volume=23 |pages=10}}{{Primary source-inline|date=May 2013}}</ref>
Séralini held a ] on the day the study was released in which he "promoted the cancer results as the study's major finding."<ref name="ButlerNatureNews10Oct2012"/> At the press conference he also announced the release of a book and film about the study.{{Citation needed|date=January 2016}}<ref>{{cite book |title=Tous Cobayes !: OGM, pesticides et produits chimiques |first=Gilles-Eric |last=Séralini |publisher=Editions Flammarion |year=2012 |isbn=978-2-08-126236-2}}</ref><ref>{{cite web |url=https://www.imdb.com/title/tt2411114/ |title=Tous cobayes? (2012) – IMDb |work=] |publisher=IMDB.com}}</ref> Selected journalists were given early access to the paper on condition they sign a confidentiality agreement, which meant they were unable to confer with other scientists before the ] expired.<ref name=AFP20Sept2012/> In contrast, embargo guidelines by journals such as ] allow reporters to check their stories with independent experts.{{refn|group=n|'']'' editorial, December 2011: "Giving the media advance notice of upcoming papers and full access to them several days before publication allows reporters time to research a story, and ask independent experts to comment on the full peer-reviewed paper."<ref name="naturepre">{{cite journal|title=Embargoes on the web|date=22 December 2011|volume=5|doi=10.1038/ngeo1365|page=1|journal=Nature Geoscience|doi-access=free}}</ref>}}


Seralini's approach was widely criticized. A ] editorial called it "a public-relations offensive." The result of the confidentiality agreement, the journal said, was that critical commentary was absent from the first round of stories, the ones most likely to be remembered.{{refn|group=n|], September 2012: "With such strong claims and the predictably large effect they will have on public opinion, researchers should take care how they present their findings to the public and the media. They should spell out their results clearly; emphasize the limitations and caveats; and make it clear that the data still need to be assessed, and replicated, by the scientific community. That didn't happen. The paper was promoted in a public-relations offensive, with a related book and film set for release this week. Furthermore, journalists wishing to report the research had to sign confidentiality agreements that prevented them from contacting other scientists for comment on the paper until after the embargo had expired. Some, to their credit, refused, or accepted and then revisited the story critically once their hands were no longer tied by these outrageous restrictions. The result was the exclusion of critical comment in many of the breaking stories — the ones that most people will remember."<ref name="NatureOnSeralini2012">{{cite journal | title = Poison postures | journal = Nature | volume = 489 | issue = 7417 | page = 474 |date=September 2012 | pmid = 23025010 | doi = 10.1038/489474a | doi-access = free }}</ref>}} The press conference and publication occurred weeks before the vote on ], which called for labeling ]. The study was cited by supporters of the proposition.<ref>{{Cite news|url=http://www.aljazeera.com/indepth/opinion/2012/09/20129257471016420.html|title=California's Prop 37: Monsanto, GMO labelling and the public interest|publisher=Al Jazeera|first=Charlotte|last=Silver|date=26 September 2012|access-date=28 December 2015}}</ref>
== 2012 study ==

On 19 September 2012, Séralini and his colleagues published a peer-reviewed paper titled "Long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize" in FCT. The research cost €3.2 million.<ref name=GuardianSeralini/> It was funded by and run with CRIIGEN. It involved a two-year study of NK603 fed to rats.<ref name=ButlerNatureNews />
The ethics committee of the ] wrote that Seralini's public-relations approach was "inappropriate for a high-quality and objective scientific debate."<ref name="ButlerNatureNews10Oct2012" /> Science journalist ] criticized the science journalists who participated.<ref>On the Media Radio Show, 2012 Sep 28 </ref> '']''{{'s}} ] said that the confidentiality clause had allowed Seralini's story to "prance unfettered" before second opinions arrived.<ref name=cosmos></ref>


== Reception ==
The abstract stated, "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." The study used 200 ], 100 male and 100 female, and divided them into twenty groups with 10 rats each; ten experimental conditions were separately tested on male and female rats for two years.<ref name=Seralini2012 />


=== Scientific evaluation === === Scientific evaluation ===
The study was criticized by various regulatory authorities and scientists. With few exceptions, the scientific community dismissed the study and called for a more rigorous peer-review system in scientific journals.<ref>{{cite journal|last1=Martinelli|first1=L|last2=Karbarz|first2=M|last3=Siipi|first3=H|title=Science, safety, and trust: the case of transgenic food.|journal=Croatian Medical Journal|date=February 2013|volume=54|issue=1|pages=91–6|doi=10.3325/cmj.2013.54.91|pmid=23444254|pmc=3584506}}</ref>
The study has been criticized by various regulatory authorities and scientists.


Many claimed that Séralini's conclusions were impossible to justify given the ] of the study. Sprague-Dawley rats have a lifespan of about two years and have a high risk of cancer over their lifespan (one study concluded that over eighty percent of males and over seventy percent of females developed cancer under normal conditions).<ref>{{cite journal |pmid=521452 |year=1979 |last1=Suzuki |first1=H |last2=Mohr |first2=U |last3=Kimmerle |first3=G |title=Spontaneous endocrine tumors in Sprague-Dawley rats |volume=95 |issue=2 |pages=187–96 |journal=Journal of cancer research and clinical oncology |doi=10.1007/BF00401012}}</ref><ref name=huntingdon_sprague_dawley_data/><ref name=harlan_sprague_dawley_data/> The Séralini experiment covered the normal lifespan of these rats. The longer an experiment continues, the more rats get cancer naturally, that makes it harder to separate statistical "noise" from the hypothetical signal. For the study to achieve such separation (]), each control and test group would have to include sufficiently many subjects.<ref name=ButlerNatureNews/> ] (OECD) guidelines recommend 20 rats for chemical-toxicity studies, and 50 rats for carcinogenicity studies.<ref name=EFSA/>{{rp|5–6}} In addition, if the survival of the rats is less than 50% at 104 weeks (which is likely for Sprague-Dawley rats) the recommended number of rats is 65.<ref name=ButlerNatureNews/><ref name="huntingdon_sprague_dawley_data"> Many said that Séralini's conclusions were impossible to justify given the ] of the study. Sprague-Dawley rats have a lifespan of about two years and have a high risk of cancer over their lifespan (one study concluded that over eighty percent of males and over seventy percent of females developed cancer under normal conditions).<ref>{{cite journal |pmid=521452 |year=1979 |last1=Suzuki |first1=H |last2=Mohr |first2=U |last3=Kimmerle |first3=G |title=Spontaneous endocrine tumors in Sprague-Dawley rats |volume=95 |issue=2 |pages=187–96 |journal=Journal of Cancer Research and Clinical Oncology |doi=10.1007/BF00401012|s2cid=33262883 }}</ref><ref name=huntingdon_sprague_dawley_data/><ref name=harlan_sprague_dawley_data/> The Séralini experiment covered the normal lifespan of these rats. The longer an experiment continues, the more rats get cancer naturally, that makes it harder to separate statistical "noise" from the hypothetical signal. For the study to achieve such separation (]), each control and test group would have to include sufficiently many subjects.<ref name=ButlerNatureNews10Oct2012/> ] (OECD) guidelines recommend 20 rats for chemical-toxicity studies, and 50 rats for carcinogenicity studies.<ref name=EFSA/>{{rp|5–6}} In addition, if the survival of the rats is less than 50% at 104 weeks (which is likely for Sprague-Dawley rats) the recommended number of rats is 65.<ref name=ButlerNatureNews10Oct2012/><ref name="huntingdon_sprague_dawley_data">
{{cite web |url=http://www.huntingdon.com/assets/Posters/Poster0458.pdf?1340119893 |title=Mortality and In-Life Patterns in Sprague-Dawley |publisher=Huntingdon Life Sciences |accessdate=26 October 2012}}</ref><ref name="harlan_sprague_dawley_data">{{cite web |url=http://www.harlan.com/download.axd/117b20f991764a5e98e32d366d83e876.pdf?d=spraguedawley%2520rat |title=Sprague Dawley |publisher=Harlan |accessdate=26 October 2012}}</ref> The Séralini study had only ten per group.<ref name="ButlerNatureNews" /> {{cite web |url=http://www.huntingdon.com/assets/Posters/Poster0458.pdf?1340119893 |archive-url=https://web.archive.org/web/20141025041949/http://www.huntingdon.com/assets/Posters/Poster0458.pdf?1340119893 |archive-date=25 October 2014 |title=Mortality and In-Life Patterns in Sprague-Dawley |publisher=Huntingdon Life Sciences |access-date=26 October 2012 |url-status=dead |df=dmy-all }}</ref><ref name="harlan_sprague_dawley_data">{{cite web|url=http://www.harlan.com/download.axd/117b20f991764a5e98e32d366d83e876.pdf?d=spraguedawley%2520rat|archive-url=https://web.archive.org/web/20141025052807/http://www.harlan.com/download.axd/117b20f991764a5e98e32d366d83e876.pdf?d=spraguedawley%2520rat|archive-date=25 October 2014|title=Sprague Dawley|publisher=Harlan|access-date=26 October 2012|url-status=dead|df=dmy-all}}</ref> The Séralini study had only ten per group.<ref name="ButlerNatureNews10Oct2012" />


Tom Sanders from ] noted a lack of data on amount of food given, and on growth rates. Further noting that rats are susceptible to mammary tumors when food intake is not restricted. Sanders said, "The statistical methods are unconventional ... and it would appear the authors have gone on a statistical fishing trip."<ref>Ben Hirschler and Kate Kelland. Reuters. September 20, 2012 </ref> Tom Sanders from ] noted a lack of data on amount of food given, and on growth rates, further noting that rats are susceptible to mammary tumors when food intake is not restricted. Sanders said, "The statistical methods are unconventional ... and it would appear the authors have gone on a statistical fishing trip."<ref>Ben Hirschler and Kate Kelland. Reuters. 20 September 2012 </ref>


The Washington Post quoted ], ] professor in the Department of Nutrition, Food Studies and Public Health at ] and food safety advocate: "' can’t figure it out yet....It’s weirdly complicated and unclear on key issues: what the controls were fed, relative rates of tumors, why no dose relationship, what the mechanism might be. I can’t think of a biological reason why GMO corn should do this.....So even though I strongly support labeling, I’m skeptical of this study.'"<ref>Tim Carman for the Washington Post. Posted at 07:30 PM ET, 19 September 2012. French scientists question safety of GM corn </ref> Likewise, Dan Charles, writing for ], noted that in the study, rats that ate 33% GM food developed fewer tumors than did those who ate 11% GM food, suggesting the absence of a dose response.<ref>{{cite web | url=http://www.npr.org/blogs/thesalt/2012/09/19/161424735/as-scientists-question-new-rat-study-gmo-debate-rages-on | title=As Scientists Question New Rat Study, GMO Debate Rages On | work=NPR | date=19 September 2012 | accessdate=1 November 2014 | author=Charles, Dan}}</ref> ] Professor ] publicly wondered why the paper contained so many pictures of treated rats with horrific tumors, but no pictures of control group rats.<ref>{{cite news | url=http://www.bbc.co.uk/news/science-environment-19654825 | title=French GM-fed rat study triggers furore | publisher=] | date=19 September 2012 | accessdate=22 August 2013 | author=Amos, Jonathan}}</ref> The ''Washington Post'' quoted ], the ] professor in the Department of Nutrition, Food Studies and Public Health at ] and food safety advocate: "' can't figure it out yet....It's weirdly complicated and unclear on key issues: what the controls were fed, relative rates of tumors, why no dose relationship, what the mechanism might be. I can't think of a biological reason why GMO corn should do this.....So even though I strongly support labeling, I'm skeptical of this study.'"<ref>{{cite news | first=Tim | last=Carman | newspaper=Washington Post | date=19 September 2012 | title=French scientists question safety of GM corn | url=https://www.washingtonpost.com/blogs/all-we-can-eat/post/french-scientists-question-safety-of-gm-corn/2012/09/19/d2ed52e4-027c-11e2-8102-ebee9c66e190_blog.html | access-date=20 September 2017 }}</ref> Likewise, Dan Charles, writing for ], noted that in the study, rats that ate 33% GM food developed fewer tumors than did those who ate 11% GM food, suggesting the absence of a dose response.<ref>{{cite web | url=https://www.npr.org/blogs/thesalt/2012/09/19/161424735/as-scientists-question-new-rat-study-gmo-debate-rages-on | title=As Scientists Question New Rat Study, GMO Debate Rages On | work=NPR | date=19 September 2012 | access-date=1 November 2014 | author=Charles, Dan}}</ref> ] Professor ] publicly wondered why the paper contained so many pictures of treated rats with horrific tumors, but no pictures of control group rats.<ref>{{cite news | url=https://www.bbc.co.uk/news/science-environment-19654825 | title=French GM-fed rat study triggers furore | work=] | date=19 September 2012 | access-date=22 August 2013 | author=Amos, Jonathan}}</ref>


Many national food safety and regulatory agencies condemned the paper. The German Federal Institute for Risk Assessment VP Reiner Wittkowski said in a statement, ""The study shows both shortcomings in study design and in the presentation of the collected data. This means that the conclusions drawn by the authors are not supported by the available data."<ref>Staff (1 October 2012) German Federal Institute for Risk Assessment (BfR). Retrieved 14 October 2012</ref> A joint report by three Canadian regulatory agencies also "identified significant shortcomings in the study design, implementation and reporting."<ref>Staff, Food Directorate, Health Products and Food Branch, Health Canada; Animal Feed Division, Animal Health Directorate, Canadian Food Inspection Agency; Pest Management Regulatory Agency, Health Canada. October 25, 2012 </ref> Similar conclusions were reached by the French HCB<ref name="hcb"/> and the National Agency for Food Safety,<ref name = 2012AFP>Staff (22 October 2012) ]. Retrieved 23 October 2012</ref> the ],<ref>Staff (8 October 2012) VIB Life Sciences Research Institute, Belgium. Retrieved 14 October 2012</ref> the ],<ref>Staff (October 2012) (In Danish) Technical University of Denmark, Danish National Food Institute, Rertrieved 23 October 2012</ref> ],<ref>{{cite web | url=http://www.foodstandards.gov.au/consumerinformation/gmfoods/gmfactsheets/responsetosralinipap5676.cfm | title=Response to Séralini paper on the long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize | work=] website | date=October 2012 | accessdate=13 November 2013 | archiveurl=http://web.archive.org/web/20121020112955/http://www.foodstandards.gov.au/consumerinformation/gmfoods/gmfactsheets/responsetosralinipap5676.cfm | archivedate=20 October 2012}}</ref> the Brazilian National Technical Commission on Biosafety,<ref>{{cite web|url=http://www.cibiogem.gob.mx/Sala-prensa/Documents/CTNBIO-Brasil-Seralini1725.pdf |title=Ministry of Science Technology and Innovation : Considered Opinion |publisher=Cibiogem.gob.mx |accessdate=2013-08-20}}</ref> and EFSA.<ref name=EFSA>{{cite journal |laysource=EFSA |laydate=4 October 2012 |laysummary=http://www.efsa.europa.eu/en/press/news/121004.htm |doi=10.2903/j.efsa.2012.2910 |url=http://www.efsa.europa.eu/en/efsajournal/pub/2986.htm |title=Final review of the Séralini et al. (2012a) publication on a 2-year rodent feeding study with glyphosate formulations and GM maize NK603 as published online on 19 September 2012 in Food and Chemical Toxicology |journal=EFSA Journal |year=2012 |volume=10 |issue=11 |pages=2986 |author=European Food Safety Authority}}</ref> EFSA concluded: Many national food safety and regulatory agencies condemned the paper. The German Federal Institute for Risk Assessment VP Reiner Wittkowski said in a statement, "The study shows both shortcomings in study design and in the presentation of the collected data. This means that the conclusions drawn by the authors are not supported by the available data."<ref>Staff (1 October 2012) German Federal Institute for Risk Assessment (BfR). Retrieved 14 October 2012</ref> A joint report by three Canadian regulatory agencies also "identified significant shortcomings in the study design, implementation and reporting."<ref>Staff, Food Directorate, Health Products and Food Branch, Health Canada; Animal Feed Division, Animal Health Directorate, Canadian Food Inspection Agency; Pest Management Regulatory Agency, Health Canada. 25 October 2012 </ref> Similar conclusions were reached by the French HCB and the National Agency for Food Safety,<ref name=2012AFP>Staff (22 October 2012) {{Webarchive|url=https://archive.today/20130201105722/http://www.afp.com/en/node/615056 |date=1 February 2013 }} ]. Retrieved 23 October 2012</ref> the ],<ref>Staff (8 October 2012) VIB Life Sciences Research Institute, Belgium. Retrieved 14 October 2012</ref> the ],<ref>Staff (October 2012) (In Danish) Technical University of Denmark, Danish National Food Institute, Retrieved 23 October 2012</ref> ],<ref>{{cite web | url=http://www.foodstandards.gov.au/consumerinformation/gmfoods/gmfactsheets/responsetosralinipap5676.cfm | title=Response to Séralini paper on the long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize | work=] website | date=October 2012 | access-date=13 November 2013 | archive-url=https://web.archive.org/web/20121020112955/http://www.foodstandards.gov.au/consumerinformation/gmfoods/gmfactsheets/responsetosralinipap5676.cfm | archive-date=20 October 2012}}</ref> the Brazilian National Technical Commission on Biosafety,<ref>{{cite web|url=http://www.cibiogem.gob.mx/Sala-prensa/Documents/CTNBIO-Brasil-Seralini1725.pdf |title=Ministry of Science Technology and Innovation: Considered Opinion |publisher=Cibiogem.gob.mx |access-date=2013-08-20 |archive-url=https://web.archive.org/web/20130928203911/http://www.cibiogem.gob.mx/Sala-prensa/Documents/CTNBIO-Brasil-Seralini1725.pdf |archive-date=28 September 2013 |url-status=dead |df=dmy-all}}</ref> and EFSA.<ref name=EFSA>{{cite journal |doi=10.2903/j.efsa.2012.2910 |url=http://www.efsa.europa.eu/en/efsajournal/pub/2986|title=Final review of the Séralini et al. (2012a) publication on a 2-year rodent feeding study with glyphosate formulations and GM maize NK603 as published online on 19 September 2012 in Food and Chemical Toxicology |journal=EFSA Journal |year=2012 |volume=10 |issue=11 |pages=2986 |author=European Food Safety Authority|doi-access=free }}</ref><ref name="EFSAb">{{cite journal | last1 = Devos | first1 = Y | last2 = Aguilera | first2 = J | last3 = Diveki | first3 = Z | last4 = Gomes | first4 = A | last5 = Liu | first5 = Y | last6 = Paoletti | first6 = C | display-authors = etal | year = 2014 | title = EFSA's scientific activities and achievements on the risk assessment of genetically modified organisms (GMOs) during its first decade of existence: looking back and ahead | pmid = 23963741 | journal = Transgenic Res | volume = 23 | issue = 1| pages = 1–25 | doi = 10.1007/s11248-013-9741-4 | s2cid = 781240}}
*{{cite press release |date=4 October 2012 |title=EFSA publishes initial review on GM maize and herbicide study |website=European Food Safety Administration |url=http://www.efsa.europa.eu/en/press/news/121004}}</ref> EFSA concluded:


<blockquote>The study as reported by Séralini ''et al.'' was found to be inadequately designed, analysed and reported...The study as described by Séralini et al. does not allow giving weight to their results and conclusions as published. Conclusions cannot be drawn on the difference in tumour incidence between treatment groups on the basis of the design, the analysis and the results as reported. Taking into consideration Member States’ assessments and the authors’ answer to critics, EFSA finds that the study as reported by Séralini et al. is of insufficient scientific quality for safety assessments.<ref name=EFSA/></blockquote> <blockquote>The study as reported by Séralini ''et al.'' was found to be inadequately designed, analysed and reported...The study as described by Séralini et al. does not allow giving weight to their results and conclusions as published. Conclusions cannot be drawn on the difference in tumour incidence between treatment groups on the basis of the design, the analysis and the results as reported. Taking into consideration Member States' assessments and the authors' answer to critics, EFSA finds that the study as reported by Séralini et al. is of insufficient scientific quality for safety assessments.<ref name=EFSA/></blockquote>


The ] ], which counts Monsanto and other ] firms among its members,<ref>EFB (2013) </ref> called for the paper to be retracted, calling its publication a "dangerous failure of the peer-review system."<ref name="ButlerNatureNews" /> Six French national academies (of Agriculture, Medicine, Pharmacy, Science, Technology and Veterinarians<ref name="avis"/>) issued a joint statement – "an extremely rare event in French science"<ref name=SFPonAcademies>Agence France-Presse. 19 October 2012, as posted on phys.org. </ref> – condemning the study and the journal that published it.<ref name="avis">Avis des Académies nationales d’Agriculture, de Médecine, de Pharmacie, des Sciences, des Technologies, et Vétérinaire sur la publication récente de G.E. Séralini et al. sur la toxicité d’un OGM </ref> The joint statement dismissed the study as 'a scientific non-event'.<ref name=SFPonAcademies /> FCT'','' an ] imprint, has a ] process, and at least three scientists reviewed the paper prior to publication. The journal published a statement in their November 2012 issue,<ref name="Seralini2012" /> that "the Editors have encouraged those people with concerns to write formally to the Editor-in-Chief, so that their views can be publicly aired." The ] ], which counts Monsanto and other ] firms among its members,<ref>EFB (2013) {{Webarchive|url=https://web.archive.org/web/20130501221733/http://www.efb-central.org/index.php/Members/efb_institutional_members_list |date=1 May 2013 }}</ref> called for the paper to be retracted, calling its publication a "dangerous failure of the peer-review system."<ref name="ButlerNatureNews10Oct2012" /> Six French national academies (of Agriculture, Medicine, Pharmacy, Science, Technology and Veterinarians<ref name="avis"/>) issued a joint statement – "an extremely rare event in French science"<ref name=AFP19Oct2012>, Agence France-Presse, 19 October 2012.</ref> – condemning the study and the journal that published it.<ref name="avis">Avis des Académies nationales d'Agriculture, de Médecine, de Pharmacie, des Sciences, des Technologies, et Vétérinaire sur la publication récente de G.E. Séralini et al. sur la toxicité d'un OGM {{Webarchive|url=https://web.archive.org/web/20150417084359/http://www.academie-sciences.fr/presse/communique/avis_1012.pdf |date=17 April 2015 }}</ref> The joint statement dismissed the study as 'a scientific non-event'.<ref name=AFP19Oct2012/> FCT'','' an ] imprint, has a ] process, and at least three scientists reviewed the paper prior to publication. The journal published a statement in their November 2012 issue, that "the Editors have encouraged those people with concerns to write formally to the Editor-in-Chief, so that their views can be publicly aired."


In March 2013 FCT published a letter<ref name=Barale-Thomas>{{cite journal |doi=10.1016/j.fct.2012.10.041 |title=Letter to the editor |year=2013 |last1=Barale-Thomas |first1=Erio |journal=Food and Chemical Toxicology |volume=53 |pages=473–4 |pmid=23165156}}</ref> from Erio Barale-Thomas,<ref></ref> Principal Scientist of ] and the President of the Conseil d’Administration of The Société Française de Pathologie Toxicologique (SFPT, French Society of Toxicologic Pathology<ref name=sfpt></ref>). SFPT is "a non governmental/non profit organization formed by veterinarians, physicians, pharmacists and biologists specialized in veterinary and toxicologic pathology. Its aim is to promote knowledge in pathology, toxicology and laboratory animal sciences for safety studies of drugs, chemicals and food products, and the role of the pathologist in the study design and data interpretation."<ref name=Barale-Thomas/> The letter criticized the Seralini study on several fronts, and concluded: "However, given this study presents serious deficiencies in the 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. This letter presents the consensus scientific opinion of the Conseil d’Administration of the SFPT."<ref name=Barale-Thomas/> In March 2013 FCT published a letter<ref name=Barale-ThomasMarch2013>{{cite journal |doi=10.1016/j.fct.2012.10.041 |title=Letter to the editor |year=2013 |last1=Barale-Thomas |first1=Erio |journal=Food and Chemical Toxicology |volume=53 |pages=473–4 |pmid=23165156|doi-access=free }}</ref> from Erio Barale-Thomas,<ref></ref> principal scientist of ] and the president of the Conseil d'Administration of The Société Française de Pathologie Toxicologique (SFPT, French Society of Toxicologic Pathology<ref name=sfpt></ref>). SFPT is "a non governmental/non profit organization formed by veterinarians, physicians, pharmacists and biologists specialized in veterinary and toxicologic pathology. Its aim is to promote knowledge in pathology, toxicology and laboratory animal sciences for safety studies of drugs, chemicals and food products, and the role of the pathologist in the study design and data interpretation."<ref name="Barale-ThomasMarch2013" /> The letter criticized the Seralini study on several fronts, and concluded: "However, given this study presents serious deficiencies in the 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. This letter presents the consensus scientific opinion of the Conseil d'Administration of the SFPT."<ref name="Barale-ThomasMarch2013" />


The Belgian Federal Minister of Public Health asked the Belgian Biosafety Advisory Council (BBAC) to evaluate the paper. The BBAC was asked to "inform the Minister whether this paper (i) contains new scientific information with regard to risks for human health of GM maize NK603 and (ii) whether this information triggers a revision of the current authorisation for commercialisation for food and feed use of this GM maize in the European Union (EU)."<ref name=Belgium>Bioveiligheidsraad Conseil de Biosécurité (Belgian Biosafety Advisory Council) (2012). </ref> The BBAC committee, whose members are drawn from the Belgian biotech Professoriat,<ref name=Belgium/> pointed out that "the long duration of this study is a positive aspect since most of the toxicity studies on GMOs are performed on shorter periods," and concluded that: The Belgian federal minister of public health asked the Belgian Biosafety Advisory Council (BBAC) to evaluate the paper. The BBAC was asked to "inform the Minister whether this paper (i) contains new scientific information with regard to risks for human health of GM maize NK603 and (ii) whether this information triggers a revision of the current authorisation for commercialisation for food and feed use of this GM maize in the European Union (EU)."<ref name=Belgium>Bioveiligheidsraad Conseil de Biosécurité (Belgian Biosafety Advisory Council) (2012). {{Dead link|date=May 2019 |bot=InternetArchiveBot |fix-attempted=yes }}</ref> The BBAC committee, whose members are drawn from the Belgian biotech Professoriat,<ref name=Belgium/> pointed out that "the long duration of this study is a positive aspect since most of the toxicity studies on GMOs are performed on shorter periods," and concluded that:
<blockquote>"Given the shortcomings identified by the experts regarding the experimental design, the statistical analysis, the interpretation of the results, the redaction of the article and the presentation of the results, the Biosafety Advisory Council concludes that this study does not contain new scientifically relevant elements that may lead to reconsider immediately the current authorisation for food and feed use of GM maize NK603. Considering the issues raised by the study (i.e. long term assessment), the Biosafety Advisory Council proposes EFSA urgently to study in depth the relevance of the actual guidelines and procedures. It can find inspiration in the GRACE project<ref>{{cite web|url=http://www.grace-fp7.eu/|title=GRACE project|work=grace-fp7.eu}}</ref> to find useful information and new concerted ideas."<ref name="Belgium"/>{{rp|9}} </blockquote> <blockquote>"Given the shortcomings identified by the experts regarding the experimental design, the statistical analysis, the interpretation of the results, the redaction of the article and the presentation of the results, the Biosafety Advisory Council concludes that this study does not contain new scientifically relevant elements that may lead to reconsider immediately the current authorisation for food and feed use of GM maize NK603. Considering the issues raised by the study (i.e. long term assessment), the Biosafety Advisory Council proposes EFSA urgently to study in depth the relevance of the actual guidelines and procedures. It can find inspiration in the GRACE project<ref>{{cite web|url=http://www.grace-fp7.eu/|title=GRACE project|work=grace-fp7.eu}}</ref> to find useful information and new concerted ideas."<ref name="Belgium"/>{{rp|9}} </blockquote>


The study was also criticized by the European Society of Toxicologic Pathology, which expressed shock at the way the rats in the study were treated and questioned whether the study was legal to perform under European law.<ref>{{Cite journal |last=Schorsch |first=Frederic |date=2013-03-01 |title=Serious inadequacies regarding the pathology data presented in the paper by Séralini et al. (2012) |journal=Food and Chemical Toxicology |volume=53 |pages=465–466 |doi=10.1016/j.fct.2012.10.043 |issn=0278-6915|doi-access=free |pmid=23142396 }}</ref><ref>{{cite journal|last1=Bartholomaeus|first1=A|last2=Parrott|first2=W|last3=Bondy|first3=G|last4=Walker|first4=K|last5=ILSI International Food Biotechnology Committee Task Force on Use of Mammalian Toxicology Studies in Safety Assessment of GM|first5=Foods|title=The use of whole food animal studies in the safety assessment of genetically modified crops: limitations and recommendations.|journal=Critical Reviews in Toxicology|date=November 2013|volume=43|issue=Suppl 2|pages=1–24|doi=10.3109/10408444.2013.842955|pmid=24164514|pmc=3833814}}</ref>
===Responses===


A 2015 reanalysis of multiple animal studies found that Seralini chose to forgo statistical tests in the main conclusions of the study. Using Seralini's published numerical data, the review found no ] effects on animal health after analysis with ]. The finding that "in females, all the treated groups died 2–3 times more than controls" was not statistically significant. The highest mortality was observed for the group of female rats fed 22% genetically modified ]. This difference was not statistically significant. Seralini also originally claimed males in groups fed 22% and 33% genetically modified maize had three times lower mortality than controls, but this was also not statistically significant. The findings of liver necrosis and mammary tumors were also not significant.<ref>{{Cite journal|title = Published GMO studies find no evidence of harm when corrected for multiple comparisons|journal = Critical Reviews in Biotechnology|date = 2016-01-14|issn = 0738-8551|pmid = 26767435|pages = 213–217|issue = 2|doi = 10.3109/07388551.2015.1130684|first1 = Alexander Y.|last1 = Panchin|first2 = Alexander I.|last2 = Tuzhikov|volume = 37|s2cid = 11786594}}</ref>
==== Support ====
Séralini and supporters defended the study design, the interpretation of the results, and manner and content of the publication.<ref>{{cite journal |doi=10.1016/j.fct.2012.11.007 |title=Answers to critics: Why there is a long term toxicity due to a Roundup-tolerant genetically modified maize and to a Roundup herbicide |year=2013 |last1=Séralini |first1=Gilles-Eric |last2=Mesnage |first2=Robin |last3=Defarge |first3=Nicolas |last4=Gress |first4=Steeve |last5=Hennequin |first5=Didier |last6=Clair |first6=Emilie |last7=Malatesta |first7=Manuela |last8=De Vendômois |first8=Joël Spiroux |journal=Food and Chemical Toxicology |volume=53 |pages=476–83 |pmid=23146697}}</ref><ref>{{Cite web|url=http://www.criigen.org/user/site/lettertocope_seralinial_en_3101214.pdf|title=Letter to the Committee On Publication Ethics (COPE)|authors=Séralini et al.|date=January 31, 2014|accessdate=June 28, 2014}}</ref><ref>{{cite web|url=http://www.gmoseralini.org/|title=GMOSeralini|accessdate=April 24, 2014}}</ref>


A 2017 study found that since it was retracted, Seralini et al. (2012) had been cited 60 times after it was retracted, and that more of these citations were negative (39%) than were positive (26%).<ref>{{Cite journal |last1=Bar-Ilan |first1=Judit|author-link= Judit Bar-Ilan |last2=Halevi |first2=Gali |date=2017-03-03 |title=Post retraction citations in context: a case study |journal=Scientometrics |volume=113 |issue=1 |language=en |pages=547–565 |doi=10.1007/s11192-017-2242-0 |pmid=29056790 |pmc=5629243 |issn=0138-9130}}</ref>
Support for the study came from the ] (ENSSER), of which CRIIGEN is a member.<ref>Staff, ENSSER. Page last modified: 10-18-2012. </ref><ref>European Network of Scientists for Social and Environmental Responsibility (ENSSER) (2012). </ref> An open letter in support of Seralini's article, signed by about 130 scientists, scholars, and activists, was published in ''Independent Science News'', a project of the ].<ref>Independent Science News (2012) , Oct 2 2012</ref> A study funded by and conducted in consultation with ENSSER also concluded that EFSA applied double standards.<ref>Hartmut Meyer and Angelika Hilbeck. Environmental Sciences Europe 2013, 25:33 </ref> Seralini


===Responses to criticism===
The German research group Testbiotech posted a report critical of the EFSA's reaction to the study as not applying the same standards to studies submitted by industry as it did to Séralini 's study.<ref>Staff, Testbiotech. </ref><ref>Then, C. (2012). </ref> Séralini supporters criticized the retraction of the study, concluding the response was a product of industry given campaign and regard this as a concerning example of industry interference in the scientific process.<ref>{{cite journal|last1=Fagan|first1=John|last2=Traavik|first2=Terje|last3=Bøhn|first3=Thomas|title=The Seralini affair: degeneration of Science to Re-Science?|journal=Environmental Sciences Europe|date=29 August 2015|volume=27|issue=19|doi=10.1186/s12302-015-0049-2|accessdate=3 September 2015|url=http://www.enveurope.com/content/27/1/19}}</ref>
Séralini and supporters defended the study design, the interpretation of the results, and manner and content of the publication.<ref>{{cite journal |doi=10.1016/j.fct.2012.11.007 |title=Answers to critics: Why there is a long term toxicity due to a Roundup-tolerant genetically modified maize and to a Roundup herbicide |year=2013 |last1=Séralini |first1=Gilles-Eric |last2=Mesnage |first2=Robin |last3=Defarge |first3=Nicolas |last4=Gress |first4=Steeve |last5=Hennequin |first5=Didier |last6=Clair |first6=Emilie |last7=Malatesta |first7=Manuela |last8=De Vendômois |first8=Joël Spiroux |journal=Food and Chemical Toxicology |volume=53 |pages=476–83 |pmid=23146697|doi-access=free }}</ref><ref>{{Cite web|url=http://www.criigen.org/user/site/lettertocope_seralinial_en_3101214.pdf |archive-url=https://web.archive.org/web/20150402150950/http://www.criigen.org/user/site/lettertocope_seralinial_en_3101214.pdf |archive-date=2015-04-02 |title=Letter to the Committee On Publication Ethics (COPE) |author=Gilles-Eric Séralini |author2=Emilie Clair |author3=Robin Mesnage |author4=Steeve Gress |author5=Nicolas Defarge |author6=Manuela Malatesta |author7=Didier Hennequin |author8=Joël Spiroux de Vendômois |date=31 January 2014|access-date=28 June 2014}}</ref><ref>{{cite web|url=http://www.gmoseralini.org/|title=GMOSeralini|access-date=24 April 2014}}</ref> Support for the study came from the ] (ENSSER), of which CRIIGEN is a member.<ref>Staff, ENSSER. Page last modified: 10-18-2012. {{Webarchive|url=https://web.archive.org/web/20130601124432/http://www.ensser.org/democratising-science-decision-making/ensser-comments-on-seralini-study/ |date=1 June 2013 }}</ref><ref>European Network of Scientists for Social and Environmental Responsibility (ENSSER) (2012). {{Webarchive|url=https://web.archive.org/web/20131227115423/http://www.ensser.org/fileadmin/files/ENSSER-Comments-Seralini-etal2012-en.pdf |date=27 December 2013 }}</ref> A subsequent study published in 2013 by ENSSER concluded that EFSA (]) applied double standards in evaluation of feeding studies, criticized EFSA's applied criteria.<ref>{{cite journal|author=Hartmut Meyer and Angelika Hilbeck|title=Rat feeding studies with genetically modified maize – a comparative evaluation of applied methods and risk assessment standards|journal=Environmental Sciences Europe|year=2013|doi=10.1186/2190-4715-25-33|volume=25|pages=33|doi-access=free|hdl=20.500.11850/76675|hdl-access=free}}</ref>


Séralini responded to criticisms of his methodology (and specifically a lack of difference between rodent groups at higher doses) with a July 2015 paper in '']'' claiming that all laboratory rodent diets are contaminated with "dangerous" levels of GMOs.<ref>{{cite journal |last1=Mesnage |first1=R |last2=Defarge |first2=N |last3=Rocque |first3=LM |last4=Spiroux de Vendômois |first4=J |last5=Séralini |first5=GE |title=Laboratory Rodent Diets Contain Toxic Levels of Environmental Contaminants: Implications for Regulatory Tests. |journal=] |date=2015 |volume=10 |issue=7 |pages=e0128429 |doi=10.1371/journal.pone.0128429 |pmid=26133768 |pmc=4489719|bibcode=2015PLoSO..1028429M |doi-access=free }}</ref> This has been strongly criticised by numerous experts,<ref name="smc-plos">{{cite web |url=http://www.sciencemediacentre.org/expert-reaction-to-study-investigating-content-of-and-contaminants-in-laboratory-rodent-diets/ |title=expert reaction to study investigating content of and contaminants in laboratory rodent diets |publisher=Science Media Center |date=2 July 2015 |access-date=9 September 2015}}</ref> for example, ] said that the study "speculates beyond the evidence presented in this paper".<ref name="news24-galloway">{{cite news |url=http://www.news24.com/Green/News/Pesticides-in-lab-rat-feed-causes-a-stir-20150703 |title=Pesticides in lab rat feed causes a stir |work=news24.com |date=3 July 2015 |access-date=9 September 2015}}</ref>
A statement opposing the controversy, and especially the attacks on Seralini, was published in ''],'' signed by 140 French scientists; the letter said: "''We are deeply shocked by the image of our community that this controversy gives citizens. Many of the threats to our planet have been revealed by scientists isolated and confirmed by many studies coming from the scientific community. In this case, it would be more efficient to implement research on the health and environmental risks of GMOs and pesticides, improve toxicological protocols used for placing on the market and finance a variety of researchers in this domain....''"<ref>Andalo C, Chercheuse AHS, Atlan A, Auclair D, Austerlitz F, Barot S. . Le Monde. 14 November 2012.</ref>


Other Séralini supporters criticized the retraction of the study, concluding the response was a product of industry-driven campaign and regard this as a concerning example of industry interference in the scientific process.<ref>{{cite journal|last1=Fagan|first1=John|last2=Traavik|first2=Terje|last3=Bøhn|first3=Thomas|title=The Seralini affair: degeneration of Science to Re-Science?|journal=Environmental Sciences Europe|date=29 August 2015|volume=27|issue=19|doi=10.1186/s12302-015-0049-2|doi-access=free|hdl=10037/8858|hdl-access=free}}</ref>
==== Public and government officials ====
At the time of the initial release, ] ] said that, if the results are confirmed, the government would press for a Europe-wide ban on the maize and The ] instructed the EFSA in Parma, Italy, to assess the study.<ref name="Furor" /> In late September 2012, Russia temporarily suspended importing GM corn as a result of the study<ref>Staff, Phys.org. September 26, 2012 </ref> and in November 2012, Kenya banned all GM crops.<ref>Emily Willingham for Forbes. December 9, 2012. </ref>


==== Media ==== === Officials ===
At the time of the initial release, ] ] said that, if the results are confirmed, the government would press for a Europe-wide ban on the maize and The ] instructed the EFSA in Parma, Italy, to assess the study.<ref name=ButlerNatureNews25Sept2012/> In late September 2012, Russia temporarily suspended importing GM corn as a result of the study<ref>Staff, Phys.org. 26 September 2012 </ref> and in November 2012, Kenya banned all GM crops.<ref>Emily Willingham for Forbes. 9 December 2012. </ref> In 2022, Kenya reversed the ban in its entirety.<ref>{{Cite web |last=GROUP |first=NTV KENYA-NATION MEDIA |title=NTV Kenya: State lifts ban on GMO, okays cultivation and importation |url=https://ntvkenya.co.ke/news/state-lifts-ban-on-gmo-okays-cultivation-and-importation/ |access-date=2022-10-03 |website=NTV Kenya |language=en-GB}}</ref>
The press conference led to wide media coverage, which "energized opponents of GM food, especially in Europe".<ref name="Furor">Declan Butler for Nature News. September 25, 2012 </ref> '']'' covered the press conference in a story called, "Yes, GMOs are poisons!".<ref>{{cite web|url=http://tempsreel.nouvelobs.com/ogm-le-scandale/20120918.OBS2686/exclusif-oui-les-ogm-sont-des-poisons.html |title=EXCLUSIF. Oui, les OGM sont des poisons ! – Le Nouvel Observateur |publisher=Tempsreel.nouvelobs.com |accessdate=2013-08-20}}</ref>


=== Media ===
] in '']'' stated, "Seralini's research is anomalous. Previous peer-reviewed rat feeding studies using the same products (NK603 and Roundup) have not found any negative food safety impacts. The Japanese Department of Environmental Health and Toxicology released a 52-week feeding study of GM soybeans in 2007, finding "no apparent adverse effect in rats." In 2012, a team of scientists at the University of Nottingham School of Biosciences released a review of 12 long-term studies (up to two years) and 12 multi-generational studies (up to 5 generations) of GM foods, concluding there is no evidence of health hazards."<ref>{{cite news|url=http://www.forbes.com/sites/jonentine/2012/09/30/does-the-seralini-corn-study-fiasco-mark-a-turning-point-in-the-debate-over-gm-food/|title=Does the Seralini Corn Study Fiasco Mark a Turning Point in the Debate Over GM Food? |accessdate= 11 May 2013|work= Forbes.com|first=Jon|last=Entine|date=30 September 2012}}</ref> ] dubbed it another instance of "single-study syndrome", and contended that the study was in support of an "agenda".<ref></ref>
The press conference led to widespread negative media coverage for GM food, especially in Europe.<ref name="ButlerNatureNews25Sept2012" /> '']'' covered the press conference in a story called, "Yes, GMOs are poisons!".<ref>{{cite web|url=http://tempsreel.nouvelobs.com/ogm-le-scandale/20120918.OBS2686/exclusif-oui-les-ogm-sont-des-poisons.html |author = Malaurie, Guillaume | title=EXCLUSIF. Oui, les OGM sont des poisons ! – Le Nouvel Observateur |publisher=Tempsreel.nouvelobs.com |date=20 September 2012}}</ref>


] in '']'' stated, "Seralini's research is anomalous. Previous peer-reviewed rat feeding studies using the same products (NK603 and Roundup) have not found any negative food safety impacts. The Japanese Department of Environmental Health and Toxicology released a 52-week feeding study of GM soybeans in 2007, finding "no apparent adverse effect in rats." In 2012, a team of scientists at the University of Nottingham School of Biosciences released a review of 12 long-term studies (up to two years) and 12 multi-generational studies (up to 5 generations) of GM foods, concluding there is no evidence of health hazards."<ref>{{cite news|url=https://www.forbes.com/sites/jonentine/2012/09/30/does-the-seralini-corn-study-fiasco-mark-a-turning-point-in-the-debate-over-gm-food/|title=Does the Seralini Corn Study Fiasco Mark a Turning Point in the Debate Over GM Food? |access-date= 11 May 2013|work= Forbes.com|first=Jon|last=Entine|date=30 September 2012}}</ref> ] wrote in a blog the study was another instance of "single-study syndrome", and that the study was in support of an "agenda".<ref>Andrew C. Revkin 20 September 2012, dotearth.blogs.nytimes</ref>
], writing for Forbes, said of the study that "the investigators have refused to release all the data from the experiment, which constitutes scientific misconduct."<ref>{{cite news|url=http://www.forbes.com/sites/henrymiller/2012/09/25/scientists-smell-a-rat-in-fraudulent-genetic-engineering-study/2/|title=Scientists Smell A Rat In Fraudulent Genetic Engineering Study | work=Forbes | first=Henry I.|last=Miller}}</ref> Séralini responded by saying, "...that he won't make any data available to the EFSA and the BfR until the EFSA makes public all the data under-pinning its 2003 approval of NK603 maize for human consumption and animal feed."<ref name="ButlerNatureNews"/>


], in an opinion piece for Forbes, said " has crossed the line from merely performing and reporting flawed experiments to committing gross ] and attempting ]."<ref>{{cite news|url=https://www.forbes.com/sites/henrymiller/2012/09/25/scientists-smell-a-rat-in-fraudulent-genetic-engineering-study/2/|archive-url=https://web.archive.org/web/20120929025756/http://www.forbes.com/sites/henrymiller/2012/09/25/scientists-smell-a-rat-in-fraudulent-genetic-engineering-study/2/|url-status=dead|archive-date=29 September 2012|title=Scientists Smell A Rat In Fraudulent Genetic Engineering Study | work=Forbes | format= opinion|first=Henry I.|last=Miller|date =25 September 2012}}</ref> Séralini responded by saying, "...that he won't make any data available to the EFSA and the BfR until the EFSA makes public all the data under-pinning its 2003 approval of NK603 maize for human consumption and animal feed."<ref name="ButlerNatureNews10Oct2012"/>
''The Guardian'''s Environmental Blog stated that the study linking GM maize to cancer "must be taken seriously by regulators" and that although it "attracted a torrent of abuse", "it cannot be swept under the carpet". They also noted CRIIGEN's funding of the research and reported Séralini's response: namely, that studies in support of GM food are usually funded by "corporates or by pro-biotech institutions".<ref name=GuardianSeralini>{{cite news|url = http://www.guardian.co.uk/environment/2012/sep/28/study-gm-maize-cancer|title = Study linking GM maize to cancer must be taken seriously by regulators|accessdate = 8 May 2013|work = The Guardian|location=London|first=John|last=Vidal|date=28 September 2012}}</ref> Proponents of California's GM labeling referendum, Proposition 37, hailed the study.<ref>Staff, Right to Know.</ref><ref>{{cite news | url=http://www.nytimes.com/2012/09/20/business/energy-environment/disputed-study-links-modified-corn-to-greater-health-risks.html | title=Foes of Modified Corn Find Support in a Study | date=20 September 2012 | agency=New York Times | accessdate=15 November 2014 | author=Pollack, Andrew}}</ref>


''The Guardian''{{'s}} Environmental Blog stated that the study linking GM maize to cancer "must be taken seriously by regulators" and that although it "attracted a torrent of abuse", "it cannot be swept under the carpet". They also noted CRIIGEN's funding of the research and reported Séralini's response: namely, that studies in support of GM food are usually funded by "corporates or by pro-biotech institutions".<ref name=GuardianSeralini>{{cite news|url = https://www.theguardian.com/environment/2012/sep/28/study-gm-maize-cancer|title = Study linking GM maize to cancer must be taken seriously by regulators|access-date = 8 May 2013|work = The Guardian|location=London|first=John|last=Vidal|date=28 September 2012}}</ref> Proponents of California's GM labeling referendum, Proposition 37, hailed the study.<ref>Staff, Right to Know.{{usurped|1=}}</ref><ref>{{cite news | url=https://www.nytimes.com/2012/09/20/business/energy-environment/disputed-study-links-modified-corn-to-greater-health-risks.html | title=Foes of Modified Corn Find Support in a Study | date=20 September 2012 | agency=New York Times | access-date=15 November 2014 | author=Pollack, Andrew| work=The New York Times }}</ref>
===Publication strategy===
Séralini held a press conference on the day the study was released in which he "promoted the cancer results as the study’s major finding"<ref name="ButlerNatureNews"/> and which featured large images of rats with tumors.<ref name="Arjo"/><ref>CBS News. November 29, 2013 </ref> At the press conference he also announced the release of a book and film about the study. Selected journalists were given early access to the paper on the condition that they sign a confidentiality agreement that prevented them from discussing the paper with other scientists before the ] expired. The agreement included a penalty for non-compliance: “A refund of the cost of the study of several million euros would be considered damages if the premature disclosure questioned the release of the study.”<ref name="ButlerNatureNews">{{cite journal |doi=10.1038/490158a |title=Hyped GM maize study faces growing scrutiny |year=2012 |last1=Butler |first1=Declan |journal=Nature |volume=490 |issue=7419 |pages=158 |pmid=23060167}}</ref> In contrast, embargo guidelines by journals such as ] allow such disclosures.<ref name="naturepre">{{cite web|url=http://www.nature.com/ngeo/journal/v5/n1/full/ngeo1365.html|title=Embargoes on the web|work=nature.com}}</ref>


A statement about the controversy, and especially the attacks on Seralini, was published in ''],'' signed by 140 French scientists; the letter said:
This approach was widely criticized. The original ''Agence France-Presse'' story noted: "Breaking with a long tradition in scientific journalism, the authors allowed a selected group of reporters to have access to the paper, provided they signed confidentiality agreements that prevented them from consulting other experts about the research before publication."<ref>Thomas Lumley for Stats Chat website. 20 September 2012 </ref><ref>Agence France-Presse 19th September 2012 </ref>
{{quote|"...the protocol followed in this study presents problems that are subject to debate within the scientific community. ...}}


{{quote|We are deeply shocked by the image of our community that this controversy gives citizens. The discipline of risks to human health and the environment is a difficult activity which is done in the face of many uncertainties. Many of the threats to our planet have been revealed by individual scientists and then confirmed by many studies by the scientific community. In this case, it would be more effective to implement research on the health and environmental risks of GMOs and pesticides, improve toxicological protocols used before entry into the market, and finance a variety of researchers in this field than to create clashes between two camps fed on prejudices and ideologies. We think our community should remember past mistakes..."<ref>Andalo C, Chercheuse AHS, Atlan A, Auclair D, Austerlitz F, Barot S. . Le Monde. 14 November 2012.</ref>}}
<nowiki> </nowiki>A ''Nature ''editorial noted: "With such strong claims and the predictably large effect they will have on public opinion, researchers should take care how they present their findings to the public and the media. They should spell out their results clearly; emphasize the limitations and caveats; and make it clear that the data still need to be assessed, and replicated, by the scientific community. That didn't happen. The paper was promoted in a public-relations offensive, with a related book and film set for release this week. Furthermore, journalists wishing to report the research had to sign confidentiality agreements that prevented them from contacting other scientists for comment on the paper until after the embargo had expired. Some, to their credit, refused, or accepted and then revisited the story critically once their hands were no longer tied by these outrageous restrictions. The result was the exclusion of critical comment in many of the breaking stories — the ones that most people will remember."<ref name="NatureOnSeralini2012">{{cite journal | title = Poison postures | journal = Nature | volume = 489 | issue = 7417 | page = 474 |date=September 2012 | pmid = 23025010 | doi = 10.1038/489474a }}</ref><ref>{{cite book |title=Tous Cobayes !: OGM, pesticides et produits chimiques |first=Gilles-Eric |last=Séralini |publisher=Editions Flammarion |year=2012 |isbn=978-2-08-126236-2}}</ref><ref>{{cite web |url=http://www.imdb.com/title/tt2411114/ |title=Tous cobayes? (2012) – IMDb |work=] |publisher=IMDB.com}}</ref>


=== Lawsuit ===
<nowiki> </nowiki>NPR program ''On the Media'' discussed the issue on 28 September 2012, with science journalist ], who criticized science journalists who participated, as well as criticizing the Séralini lab.<ref>On the Media Radio Show, 2012 Sep 28 </ref> Zimmer had earlier posted on his blog at ''Discover'' magazine, "This is a rancid, corrupt way to report about science."<ref>Carl Zimmer on Discover Magazine blog, The Loom. 21 September 2012 </ref> '']'''s ], wrote, "...a clause barring the gathering of independent opinions is extraordinary. What it meant was that Séralini’s story, when it broke, got to prance unfettered in the media limelight before second opinions could dull its shine. By the time the storm of criticism blew in, the media limelight had moved on."<ref name=cosmos></ref> The ethics committee of the ] (CNRS) also criticized the public-relations offensive as "inappropriate for a high-quality and objective scientific debate, and reminded researchers working on controversial topics of the need to report results responsibly to the public."<ref name="ButlerNatureNews" />
In 2012 Séralini sued the editor of '']'' and journalist Jean-Claude Jaillet for defamation after they accused him of fraud. The ] ruled in Seralini's favor in 2015. The court said that the fraud allegation had first been made by Henry I. Miller in ''Forbes''.<ref>{{cite news|author1=Elise Ferret|title=Le professeur Gilles-Eric Séralini remporte le procès en diffamation face à Marianne|url=http://france3-regions.francetvinfo.fr/basse-normandie/le-professeur-gilles-eric-seralini-remporte-le-proces-en-diffamation-face-marianne-864671.html|access-date=1 December 2015|work=France 3, Basse-Normandie|publisher=France Télévisions|date=27 November 2015}}</ref> The journalist was fined a total of 3,500 euros, while the editor was fined twice that amount because of past convictions.<ref>, 7 Sep 2016</ref>


== Retraction ==
===Retraction and republication===
In November 2013, Elsevier announced that FCT was retracting the paper, after the authors refused to withdraw it.<ref name="Elsevier2013" /><ref name="Casassus">Barbara Casassus for Nature News. November 28, 2013 </ref> The journal's editors concluded that, after an in-depth look at the study's raw data, no definitive conclusions could be reached regarding the role of either NK603 or glyphosate in overall mortality or tumor rates, given the high incidence of tumors in Sprague-Dawley rats and the small sample size. Normal variance could not be excluded as the cause of the results.<ref name="Elsevier2013" /><ref>Elsevier press release. December 10, 2013 </ref> In November 2013, Elsevier announced that FCT was retracting the paper, after the authors refused to withdraw it.<ref name="Elsevier2013" /><ref name="Casassus">Barbara Casassus for Nature News. 28 November 2013 </ref> The journal's editors concluded that while there was "no evidence of fraud or intentional misrepresentation of the data", the results were inconclusive and " not reach the threshold of publication for Food and Chemical Toxicology". After an in-depth look at the study's raw data, no definitive conclusions could be reached regarding the role of either NK603 or glyphosate in overall mortality or tumor rates, given the high incidence of tumors in Sprague-Dawley rats and the small sample size. Normal variance could not be excluded as the cause of the results.<ref name="Elsevier2013" /> Following many enquiries about the retraction, FCT's editor-in-chief said that:
{{Pull quote|The retraction statement could have been clearer, and should have referred to the relevant ] guidelines. The data are inconclusive, therefore the claim (i.e., conclusion) that Roundup Ready maize NK603 and/or the Roundup herbicide have a link to cancer is unreliable. Dr. Séralini deserves the benefit of the doubt that this unreliable conclusion was reached in honest error. The review of the data made it clear that there was no misconduct. However, to be very clear, it is the entire paper, with the claim that there is a definitive link between GMO and cancer that is being retracted. Dr. Séralini has been very vocal that he believes his conclusions are correct. In our analysis, his conclusions cannot be claimed from the data presented in this article.|author=A. Wallace Hayes|source=Editor-in-Chief of ''Food and Chemical Toxicology'' answers questions on retraction<ref name=Hayes2014>{{cite journal |vauthors=Wallace Hayes A |title=Editor in Chief of Food and Chemical Toxicology answers questions on retraction |journal=Food Chem. Toxicol. |volume=65 |pages=394–5 |year=2014 |pmid=24407018 |doi=10.1016/j.fct.2014.01.006 |doi-access=free }}</ref>}}


<nowiki> </nowiki>Séralini and his supporters strongly objected to the retraction,<ref name="Casassus" /><ref>Michael Hiltzik for the Los Angeles Times. November 29, 2013 </ref><ref>{{cite journal|last=Portier|first=Christopher J.|author2=Goldman, Lynn R. |author3=Goldstein, Bernard D. |title=Inconclusive Findings: Now You See Them, Now You Don’t!|journal=Environmental Health Perspectives|date=1 February 2014|volume=122|issue=2|pages=A36–A36|doi=10.1289/ehp.1408106}}</ref> and Séralini himself threatened to sue FCT.<ref>{{cite news | url=http://www.forbes.com/sites/jonentine/2013/11/29/notorious-seralini-gmo-cancer-rat-study-retracted-ugly-legal-battle-looms/ | title=Séralini Threatens Lawsuit In Wake Of Retraction Of Infamous GMO Cancer Rat Study | work=] | date=29 November 2013 | accessdate=19 February 2014 | author=Entine, Jon}}</ref> In January 2014, an online petition calling for the Séralini study be reinstated was posted by a group of Séralini's supporters from the Bioscience Resource Project.<ref>{{cite web|url=http://endsciencecensorship.org/en/page/Statement|title=Statement - Journal retraction of Séralini GMO study is invalid and an attack on scientific integrity|work=endsciencecensorship.org}}</ref> Séralini and his supporters strongly objected to the retraction,<ref name="Casassus" /><ref>Michael Hiltzik for the Los Angeles Times. 29 November 2013 </ref><ref>{{cite journal|last=Portier|first=Christopher J.|author2=Goldman, Lynn R. |author3=Goldstein, Bernard D. |title=Inconclusive Findings: Now You See Them, Now You Don't!|journal=Environmental Health Perspectives|date=1 February 2014|volume=122|issue=2|pages=A36|doi=10.1289/ehp.1408106|pmid=24486734|pmc=3915254}}</ref> and Séralini himself threatened to sue FCT.<ref>{{cite news | url=https://www.forbes.com/sites/jonentine/2013/11/29/notorious-seralini-gmo-cancer-rat-study-retracted-ugly-legal-battle-looms/ | title=Séralini Threatens Lawsuit In Wake Of Retraction Of Infamous GMO Cancer Rat Study | work=] | date=29 November 2013 | access-date=19 February 2014 | author=Entine, Jon}}</ref> A ] with the ] examined the case and wrote in the '']'' that articles should not be retracted for inconclusiveness, but that retraction due to flaws in study design or due to ethical violations may be appropriate, and that republication of retracted papers should occur only after additional peer review.<ref>{{cite journal|last1=Resnik|first1=David B.|title=Retracting Inconclusive Research: Lessons from the Séralini GM Maize Feeding Study|journal=Journal of Agricultural and Environmental Ethics|date=25 April 2015|volume=28|issue=4|pages=621–633|doi=10.1007/s10806-015-9546-y|pmid=26251636|pmc=4524344}}</ref>


On 1 August 2017, as part of a lawsuit against Monsanto, documents were released showing, among other things, that the editor-in-chief, Wallace Hayes, had once had a contractual relationship with Monsanto. Hayes said in an interview that he did not have a contract with Monsanto when he retracted Seralini's paper, and that his decision to retract it was not influenced by Monsanto at all.<ref>{{Cite news|url=https://www.nytimes.com/2017/08/01/business/monsantos-sway-over-research-is-seen-in-disclosed-emails.html|title=Monsanto Emails Raise Issue of Influencing Research on Roundup Weed Killer|last=Hakim|first=Danny|date=2017-08-01|work=The New York Times|access-date=2017-10-18|language=en-US|issn=0362-4331}}</ref>
In June 2014, the original study was republished in the journal ''Environmental Sciences Europe''.<ref name="SeraliniRepublish2014" /><ref name="Casassus2">{{cite web | url=http://www.nature.com/news/paper-claiming-gm-link-with-tumours-republished-1.15463 | title=Paper claiming GM link with tumours republished | work=Nature | date=26 June 2014 | accessdate=26 June 2014 | author=Casassus, Barbara}}</ref> The editor said that the paper was republished without further scientific peer review, "because this had already been conducted by ''Food and Chemical Toxicology'', and had concluded there had been no fraud nor misrepresentation".<ref name="Casassus2" /> The republication renewed the controversy, but now with additional controversy over the behavior of the editors of both journals.<ref>Science Media Centre. June 25th, 2014. http://www.sciencemediacentre.co.nz/2014/06/25/controversial-gm-study-republished-experts-respond/ Controversial GM study republished – experts respond]</ref>


==References== == Republication ==
In June 2014, the original study was republished with the addition of the entire data set, in the journal ''Environmental Sciences Europe''.<ref name="SeraliniRepublish2014">{{cite journal|last1=Séralini|first1=Gilles-Eric|last2=Clair|first2=Emilie|last3=Mesnage|first3=Robin|last4=Gress|first4=Steeve|last5=Defarge|first5=Nicolas|last6=Malatesta|first6=Manuela|last7=Hennequin|first7=Didier|last8=de Vendômois|first8=Joël|title=Republished study: long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize|journal=Environmental Sciences Europe|volume=26|issue=1|pages=14|doi=10.1186/s12302-014-0014-5|pmid=27752412|pmc=5044955|year=2014 |doi-access=free }}</ref><ref name="Casassus2">{{cite journal | url=http://www.nature.com/news/paper-claiming-gm-link-with-tumours-republished-1.15463 | title=Paper claiming GM link with tumours republished | journal=Nature | date=26 June 2014 | access-date=26 June 2014 | author=Casassus, Barbara| doi=10.1038/nature.2014.15463 | s2cid=155666600 | doi-access=free }}</ref> The entire data set was published because of requests from the national regulatory bodies ], ], ], ] and ].<ref>, 25 October 2012</ref>
{{Reflist|2}}


The editor said that the paper was republished without further scientific peer review, "because this had already been conducted by ''Food and Chemical Toxicology'', and had concluded there had been no fraud nor misrepresentation."<ref name="Casassus2" /> The republication renewed the controversy, but now with additional controversy over the behavior of the editors of both journals.<ref>Science Media Centre. 25 June 2014. </ref>

In July 2015, the ] published a monograph on glyphosate, which contained an evaluation of the Séralini paper as republished in June 2014 and the conclusion, that the study "was inadequate for evaluation because the number of animals per group was small, the histopathological description of tumours was poor, and incidences of tumours for individual animals were not provided."<ref></ref>

==See also==
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==Notes==
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==References==
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{{Genetic engineering}} {{Genetic engineering}}
{{Portal bar|Molecular and cellular biology}} {{Portal bar|Biology}}


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Latest revision as of 08:09, 8 January 2025

Retracted study led by Gilles-Éric Séralini

Gilles-Éric Séralini, in 2015
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The Séralini affair was the controversy surrounding the publication, retraction, and republication of a journal article by French molecular biologist Gilles-Éric Séralini. First published by Food and Chemical Toxicology in September 2012, the article presented a two-year feeding study in rats, and reported an increase in tumors among rats fed genetically modified corn and the herbicide RoundUp. Scientists and regulatory agencies subsequently concluded that the study's design was flawed and its findings unsubstantiated. A chief criticism was that each part of the study had too few rats to obtain statistically useful data, particularly because the strain of rat used, Sprague Dawley, develops tumors at a high rate over its lifetime.

The publicity surrounding publication of the article also attracted criticism, with science writer Declan Butler calling it "a tightly orchestrated media offensive". As part of a news embargo, Séralini required journalists to sign an unusual confidentiality agreement in exchange for advance access to the article, prohibiting them from conferring with other scientists before the press conference announcing publication. At the press conference, Séralini emphasized the study's potential cancer implications, and photographs from the article of treated rats with large tumors were widely circulated by the media. The French Society of Toxicologic Pathology pointed out that, because such tumors are commonly found in older rats, the inclusion in the article of those images from treated rats, without also showing control rats, was misleading. Séralini also released a book and documentary film about the study in conjunction with the press conference.

Following widespread criticism by scientists, Food and Chemical Toxicology retracted the paper in November 2013 after the authors refused to withdraw it. The editor-in-chief said that the article was retracted because its data were inconclusive and its conclusions unreliable. In June 2014 an amended version of the article was republished in Environmental Sciences Europe, and the raw data were made public. According to writer Nathanael Johnson, not all of the raw data were, in fact, released. The journal did not conduct any further peer review; reviewers checked only that the scientific content of the paper had not changed.

Background

Main article: Gilles-Éric Séralini

Séralini, a professor of molecular biology at the University of Caen, is president of the scientific advisory board of the Committee of Research and Independent Information on Genetic Engineering (CRIIGEN), which opposes genetically modified food (GM food). Séralini co-founded CRIIGEN in 1999 because he judged that studies on GM food safety were inadequate.

Before 2012 Séralini had published other peer-reviewed papers that concluded there were health risks to GM foods. In 2007 he and two others published a Greenpeace-funded study (Séralini 2007). It concluded that MON 863, a corn rootworm-resistant Bt corn developed by Monsanto, caused health problems in rats, including weight changes, triglyceride level increases in females, changes in urine composition in males, and reduced function or organ damage in the liver, kidney, adrenal glands, heart and haematopoietic system. The European Food Safety Authority (EFSA) concluded that all blood chemistry and organ weight values fell within the normal range for control animals, and that the paper had used incorrect statistical methods. The French Commission du Génie Biomoléculaire (AFBV) also criticized the study's conclusions.

In 2009 the Séralini lab published another study (Séralini 2009), which re-analyzed toxicity data for NK 603 (glyphosate resistant), MON 810 and MON 863 strains. The data included three rat-feeding studies published by Monsanto scientists on MON 810. This study concluded that the three crops caused liver, kidney and heart damage in the rats. The EFSA concluded that the authors' claims were not supported by their data, that many of the statistical criticisms of Séralini 2007 applied to Séralini 2009, and that the study included no new information that would change the EFSA's conclusions. The French Haut Conseil des biotechnologies (High Council of Biotechnologies Scientific Committee or HCB) reviewed Séralini 2009 and concluded that it "presents no admissible scientific element likely to ascribe any haematological, hepatic or renal toxicity to the three re-analysed GMOs." The HCB questioned the authors' independence, noting that, in 2010, the "body to which the authors belong" displayed material from a 2008 Austrian anti-GM study, the results of which had been acknowledged as mistaken by the study's authors. Food Standards Australia New Zealand concluded that the results of Séralini 2009 were due to chance alone.

In 2010 Séralini sued Marc Fellous, president of the French Association of Plant Biotechnology, for libel, after Fellous criticized Séralini's research, in part because it was funded by Greenpeace. The judge ruled that the charge about the funding was defamatory. Fellous was fined €1000; Séralini was awarded a symbolic €1 in damages.

A 2011 article by the Séralini lab that reviewed 19 published animal-feeding studies, as well as data from animal-feeding studies submitted for regulatory approval, concluded that GM food had liver and kidney effects that were sex and dose dependent, and advocated for longer and more elaborate toxicology tests for regulatory approval.

Séralini research was funded primarily by three organizations: Sustainable Food Alliance (organic food industry group), Greenpeace and Sevene Pharma (a French manufacturer of homeopathic "remedies").

2012 study

Study background

On 19 September 2012, the journal Food and Chemical Toxicology published a peer-reviewed paper entitled "Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize." The two-year toxicity study, which cost €3.2 million, was conducted at the University of Caen by Séralini and seven colleagues. It had been funded by and run with the collaboration of CRIIGEN.

The study used 100 male and 100 female Sprague Dawley rats, divided into twenty groups with 10 rats each. Ten diets were tested separately on the males and females. The diets comprised 11 percent, 22 percent and 33 percent genetically modified corn (NK603) and the rest standard laboratory rat food; NK603 corn that had been treated with Roundup, also at 11, 22 and 33 percent; and corn that had not been genetically modified, accompanied by differing concentrations of Roundup in the water. A control group was fed 33 percent non-GMO corn; the rest of their diet was standard laboratory rat food.

The paper's abstract stated: "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."

Publication strategy

Séralini held a press conference on the day the study was released in which he "promoted the cancer results as the study's major finding." At the press conference he also announced the release of a book and film about the study. Selected journalists were given early access to the paper on condition they sign a confidentiality agreement, which meant they were unable to confer with other scientists before the embargo expired. In contrast, embargo guidelines by journals such as Nature allow reporters to check their stories with independent experts.

Seralini's approach was widely criticized. A Nature editorial called it "a public-relations offensive." The result of the confidentiality agreement, the journal said, was that critical commentary was absent from the first round of stories, the ones most likely to be remembered. The press conference and publication occurred weeks before the vote on California Proposition 37, which called for labeling genetically modified food. The study was cited by supporters of the proposition.

The ethics committee of the French National Centre for Scientific Research wrote that Seralini's public-relations approach was "inappropriate for a high-quality and objective scientific debate." Science journalist Carl Zimmer criticized the science journalists who participated. Cosmos Magazine's Elizabeth Finkel said that the confidentiality clause had allowed Seralini's story to "prance unfettered" before second opinions arrived.

Reception

Scientific evaluation

The study was criticized by various regulatory authorities and scientists. With few exceptions, the scientific community dismissed the study and called for a more rigorous peer-review system in scientific journals.

Many said that Séralini's conclusions were impossible to justify given the statistical power of the study. Sprague-Dawley rats have a lifespan of about two years and have a high risk of cancer over their lifespan (one study concluded that over eighty percent of males and over seventy percent of females developed cancer under normal conditions). The Séralini experiment covered the normal lifespan of these rats. The longer an experiment continues, the more rats get cancer naturally, that makes it harder to separate statistical "noise" from the hypothetical signal. For the study to achieve such separation (statistical power), each control and test group would have to include sufficiently many subjects. Organisation for Economic Co-operation and Development (OECD) guidelines recommend 20 rats for chemical-toxicity studies, and 50 rats for carcinogenicity studies. In addition, if the survival of the rats is less than 50% at 104 weeks (which is likely for Sprague-Dawley rats) the recommended number of rats is 65. The Séralini study had only ten per group.

Tom Sanders from King's College London noted a lack of data on amount of food given, and on growth rates, further noting that rats are susceptible to mammary tumors when food intake is not restricted. Sanders said, "The statistical methods are unconventional ... and it would appear the authors have gone on a statistical fishing trip."

The Washington Post quoted Marion Nestle, the Paulette Goddard professor in the Department of Nutrition, Food Studies and Public Health at New York University and food safety advocate: "' can't figure it out yet....It's weirdly complicated and unclear on key issues: what the controls were fed, relative rates of tumors, why no dose relationship, what the mechanism might be. I can't think of a biological reason why GMO corn should do this.....So even though I strongly support labeling, I'm skeptical of this study.'" Likewise, Dan Charles, writing for NPR, noted that in the study, rats that ate 33% GM food developed fewer tumors than did those who ate 11% GM food, suggesting the absence of a dose response. University of Calgary Professor Maurice Moloney publicly wondered why the paper contained so many pictures of treated rats with horrific tumors, but no pictures of control group rats.

Many national food safety and regulatory agencies condemned the paper. The German Federal Institute for Risk Assessment VP Reiner Wittkowski said in a statement, "The study shows both shortcomings in study design and in the presentation of the collected data. This means that the conclusions drawn by the authors are not supported by the available data." A joint report by three Canadian regulatory agencies also "identified significant shortcomings in the study design, implementation and reporting." Similar conclusions were reached by the French HCB and the National Agency for Food Safety, the Vlaams Instituut voor Biotechnologie, the Technical University of Denmark, Food Standards Australia New Zealand, the Brazilian National Technical Commission on Biosafety, and EFSA. EFSA concluded:

The study as reported by Séralini et al. was found to be inadequately designed, analysed and reported...The study as described by Séralini et al. does not allow giving weight to their results and conclusions as published. Conclusions cannot be drawn on the difference in tumour incidence between treatment groups on the basis of the design, the analysis and the results as reported. Taking into consideration Member States' assessments and the authors' answer to critics, EFSA finds that the study as reported by Séralini et al. is of insufficient scientific quality for safety assessments.

The European Federation of Biotechnology industry association, which counts Monsanto and other biotech firms among its members, called for the paper to be retracted, calling its publication a "dangerous failure of the peer-review system." Six French national academies (of Agriculture, Medicine, Pharmacy, Science, Technology and Veterinarians) issued a joint statement – "an extremely rare event in French science" – condemning the study and the journal that published it. The joint statement dismissed the study as 'a scientific non-event'. FCT, an Elsevier imprint, has a peer review process, and at least three scientists reviewed the paper prior to publication. The journal published a statement in their November 2012 issue, that "the Editors have encouraged those people with concerns to write formally to the Editor-in-Chief, so that their views can be publicly aired."

In March 2013 FCT published a letter from Erio Barale-Thomas, principal scientist of Johnson & Johnson Pharmaceutical Research and Development and the president of the Conseil d'Administration of The Société Française de Pathologie Toxicologique (SFPT, French Society of Toxicologic Pathology). SFPT is "a non governmental/non profit organization formed by veterinarians, physicians, pharmacists and biologists specialized in veterinary and toxicologic pathology. Its aim is to promote knowledge in pathology, toxicology and laboratory animal sciences for safety studies of drugs, chemicals and food products, and the role of the pathologist in the study design and data interpretation." The letter criticized the Seralini study on several fronts, and concluded: "However, given this study presents serious deficiencies in the 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. This letter presents the consensus scientific opinion of the Conseil d'Administration of the SFPT."

The Belgian federal minister of public health asked the Belgian Biosafety Advisory Council (BBAC) to evaluate the paper. The BBAC was asked to "inform the Minister whether this paper (i) contains new scientific information with regard to risks for human health of GM maize NK603 and (ii) whether this information triggers a revision of the current authorisation for commercialisation for food and feed use of this GM maize in the European Union (EU)." The BBAC committee, whose members are drawn from the Belgian biotech Professoriat, pointed out that "the long duration of this study is a positive aspect since most of the toxicity studies on GMOs are performed on shorter periods," and concluded that:

"Given the shortcomings identified by the experts regarding the experimental design, the statistical analysis, the interpretation of the results, the redaction of the article and the presentation of the results, the Biosafety Advisory Council concludes that this study does not contain new scientifically relevant elements that may lead to reconsider immediately the current authorisation for food and feed use of GM maize NK603. Considering the issues raised by the study (i.e. long term assessment), the Biosafety Advisory Council proposes EFSA urgently to study in depth the relevance of the actual guidelines and procedures. It can find inspiration in the GRACE project to find useful information and new concerted ideas."

The study was also criticized by the European Society of Toxicologic Pathology, which expressed shock at the way the rats in the study were treated and questioned whether the study was legal to perform under European law.

A 2015 reanalysis of multiple animal studies found that Seralini chose to forgo statistical tests in the main conclusions of the study. Using Seralini's published numerical data, the review found no significant effects on animal health after analysis with statistical tests. The finding that "in females, all the treated groups died 2–3 times more than controls" was not statistically significant. The highest mortality was observed for the group of female rats fed 22% genetically modified maize. This difference was not statistically significant. Seralini also originally claimed males in groups fed 22% and 33% genetically modified maize had three times lower mortality than controls, but this was also not statistically significant. The findings of liver necrosis and mammary tumors were also not significant.

A 2017 study found that since it was retracted, Seralini et al. (2012) had been cited 60 times after it was retracted, and that more of these citations were negative (39%) than were positive (26%).

Responses to criticism

Séralini and supporters defended the study design, the interpretation of the results, and manner and content of the publication. Support for the study came from the European Network of Scientists for Social and Environmental Responsibility (ENSSER), of which CRIIGEN is a member. A subsequent study published in 2013 by ENSSER concluded that EFSA (European Food Safety Authority) applied double standards in evaluation of feeding studies, criticized EFSA's applied criteria.

Séralini responded to criticisms of his methodology (and specifically a lack of difference between rodent groups at higher doses) with a July 2015 paper in PLOS ONE claiming that all laboratory rodent diets are contaminated with "dangerous" levels of GMOs. This has been strongly criticised by numerous experts, for example, Tamara Galloway said that the study "speculates beyond the evidence presented in this paper".

Other Séralini supporters criticized the retraction of the study, concluding the response was a product of industry-driven campaign and regard this as a concerning example of industry interference in the scientific process.

Officials

At the time of the initial release, French Prime Minister Jean-Marc Ayrault said that, if the results are confirmed, the government would press for a Europe-wide ban on the maize and The European Commission instructed the EFSA in Parma, Italy, to assess the study. In late September 2012, Russia temporarily suspended importing GM corn as a result of the study and in November 2012, Kenya banned all GM crops. In 2022, Kenya reversed the ban in its entirety.

Media

The press conference led to widespread negative media coverage for GM food, especially in Europe. Le Nouvel Observateur covered the press conference in a story called, "Yes, GMOs are poisons!".

Jon Entine in Forbes stated, "Seralini's research is anomalous. Previous peer-reviewed rat feeding studies using the same products (NK603 and Roundup) have not found any negative food safety impacts. The Japanese Department of Environmental Health and Toxicology released a 52-week feeding study of GM soybeans in 2007, finding "no apparent adverse effect in rats." In 2012, a team of scientists at the University of Nottingham School of Biosciences released a review of 12 long-term studies (up to two years) and 12 multi-generational studies (up to 5 generations) of GM foods, concluding there is no evidence of health hazards." Andrew Revkin wrote in a blog the study was another instance of "single-study syndrome", and that the study was in support of an "agenda".

Henry I. Miller, in an opinion piece for Forbes, said " has crossed the line from merely performing and reporting flawed experiments to committing gross scientific misconduct and attempting fraud." Séralini responded by saying, "...that he won't make any data available to the EFSA and the BfR until the EFSA makes public all the data under-pinning its 2003 approval of NK603 maize for human consumption and animal feed."

The Guardian's Environmental Blog stated that the study linking GM maize to cancer "must be taken seriously by regulators" and that although it "attracted a torrent of abuse", "it cannot be swept under the carpet". They also noted CRIIGEN's funding of the research and reported Séralini's response: namely, that studies in support of GM food are usually funded by "corporates or by pro-biotech institutions". Proponents of California's GM labeling referendum, Proposition 37, hailed the study.

A statement about the controversy, and especially the attacks on Seralini, was published in Le Monde, signed by 140 French scientists; the letter said:

"...the protocol followed in this study presents problems that are subject to debate within the scientific community. ...

We are deeply shocked by the image of our community that this controversy gives citizens. The discipline of risks to human health and the environment is a difficult activity which is done in the face of many uncertainties. Many of the threats to our planet have been revealed by individual scientists and then confirmed by many studies by the scientific community. In this case, it would be more effective to implement research on the health and environmental risks of GMOs and pesticides, improve toxicological protocols used before entry into the market, and finance a variety of researchers in this field than to create clashes between two camps fed on prejudices and ideologies. We think our community should remember past mistakes..."

Lawsuit

In 2012 Séralini sued the editor of Marianne and journalist Jean-Claude Jaillet for defamation after they accused him of fraud. The High Court of Paris ruled in Seralini's favor in 2015. The court said that the fraud allegation had first been made by Henry I. Miller in Forbes. The journalist was fined a total of 3,500 euros, while the editor was fined twice that amount because of past convictions.

Retraction

In November 2013, Elsevier announced that FCT was retracting the paper, after the authors refused to withdraw it. The journal's editors concluded that while there was "no evidence of fraud or intentional misrepresentation of the data", the results were inconclusive and " not reach the threshold of publication for Food and Chemical Toxicology". After an in-depth look at the study's raw data, no definitive conclusions could be reached regarding the role of either NK603 or glyphosate in overall mortality or tumor rates, given the high incidence of tumors in Sprague-Dawley rats and the small sample size. Normal variance could not be excluded as the cause of the results. Following many enquiries about the retraction, FCT's editor-in-chief said that:

The retraction statement could have been clearer, and should have referred to the relevant COPE guidelines. The data are inconclusive, therefore the claim (i.e., conclusion) that Roundup Ready maize NK603 and/or the Roundup herbicide have a link to cancer is unreliable. Dr. Séralini deserves the benefit of the doubt that this unreliable conclusion was reached in honest error. The review of the data made it clear that there was no misconduct. However, to be very clear, it is the entire paper, with the claim that there is a definitive link between GMO and cancer that is being retracted. Dr. Séralini has been very vocal that he believes his conclusions are correct. In our analysis, his conclusions cannot be claimed from the data presented in this article.

— A. Wallace Hayes, Editor-in-Chief of Food and Chemical Toxicology answers questions on retraction

Séralini and his supporters strongly objected to the retraction, and Séralini himself threatened to sue FCT. A bioethicist with the NIH examined the case and wrote in the Journal of Agricultural and Environmental Ethics that articles should not be retracted for inconclusiveness, but that retraction due to flaws in study design or due to ethical violations may be appropriate, and that republication of retracted papers should occur only after additional peer review.

On 1 August 2017, as part of a lawsuit against Monsanto, documents were released showing, among other things, that the editor-in-chief, Wallace Hayes, had once had a contractual relationship with Monsanto. Hayes said in an interview that he did not have a contract with Monsanto when he retracted Seralini's paper, and that his decision to retract it was not influenced by Monsanto at all.

Republication

In June 2014, the original study was republished with the addition of the entire data set, in the journal Environmental Sciences Europe. The entire data set was published because of requests from the national regulatory bodies CFIA, EFSA, FSANZ, ANSES and BfR.

The editor said that the paper was republished without further scientific peer review, "because this had already been conducted by Food and Chemical Toxicology, and had concluded there had been no fraud nor misrepresentation." The republication renewed the controversy, but now with additional controversy over the behavior of the editors of both journals.

In July 2015, the International Agency for Research on Cancer published a monograph on glyphosate, which contained an evaluation of the Séralini paper as republished in June 2014 and the conclusion, that the study "was inadequate for evaluation because the number of animals per group was small, the histopathological description of tumours was poor, and incidences of tumours for individual animals were not provided."

See also

Notes

  1. Agence France-Presse, 20 September 2012: "Breaking with a long tradition in scientific journalism, the authors allowed a selected group of reporters to have access to the paper, provided they signed confidentiality agreements that prevented them from consulting other experts about the research before publication."
  2. Nature Geoscience editorial, December 2011: "Giving the media advance notice of upcoming papers and full access to them several days before publication allows reporters time to research a story, and ask independent experts to comment on the full peer-reviewed paper."
  3. Nature, September 2012: "With such strong claims and the predictably large effect they will have on public opinion, researchers should take care how they present their findings to the public and the media. They should spell out their results clearly; emphasize the limitations and caveats; and make it clear that the data still need to be assessed, and replicated, by the scientific community. That didn't happen. The paper was promoted in a public-relations offensive, with a related book and film set for release this week. Furthermore, journalists wishing to report the research had to sign confidentiality agreements that prevented them from contacting other scientists for comment on the paper until after the embargo had expired. Some, to their credit, refused, or accepted and then revisited the story critically once their hands were no longer tied by these outrageous restrictions. The result was the exclusion of critical comment in many of the breaking stories — the ones that most people will remember."

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