MON 863: Difference between revisions

==Effects of consumption==

===2007 CRIIGEN study===

Monsanto's research data was analyzed in 2007 by researchers from the [[Committee of Independent Research and Information on Genetic Engineering]], [[University of Caen Lower Normandy|Caen University]] and the [[University of Rouen]]<ref name='TGR'> {{cite web | url = http://www.youtube.com/watch?v=Qpq6C4VND0A | title = Monsanto GMOs Linked To Organ Failure | accessdate = 2010-07-21 | date = 2010-01-07 | work = The Global Report | publisher = [[YouTube]]}}</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 = 2010-07-21|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> and funded by Greenpeace.<ref>[http://www.gmo-compass.org/eng/news/messages/200703.docu.html GM maize MON863: French scientists doubt safety] GMO Compass, 16 March 2007, Retrieved 30 October 2010</ref> This study found that the weights of rats fed with MON 863 varied significantly when compared to the control groups. Female weight increased by 3.7%, while male weight decreased by 3.3%. These weight changes could be indicative of organ dysfunction. Triglyceride levels increased in females, and urine phosphorus and sodium excretions decreased in males. <ref>http://www.rapaluruguay.org/transgenicos/Maiz/Genetically_Maize.pdf</ref>This study concluded that experiments longer than 90-days must be conducted before the safety of MON 863 can be known, as chronic organ problems are rarely evident within such a short amount of time.<ref name='Goldstein 2010-03-18'> {{cite news | first = Katherine | last = Goldstein | coauthors = Gazelle Emami | title =Monsanto's GMO Corn Linked To Organ Failure, Study Reveals | date = 2010-03-18 | url = http://www.huffingtonpost.com/2010/01/12/monsantos-gmo-corn-linked_n_420365.html | work = The Huffington Post | accessdate = 2010-07-21}}</ref><ref name='Seralini 2007-03-13'> {{cite journal | title = New Analysis of a Rat Feeding Study with a Genetically Modified Maize Reveals Signs of Hepatorenal Toxicity | journal = Archives of Environmental Contamination and Toxicology | date = 2007-03-13 | first = Gilles-Eric | last = Séralini | coauthors = Dominique Cellier, Joël Spiroux de Vendomois | volume = 52 | issue = 4 | pages = 596–602| pmid = 17356802 |doi = 10.1007/s00244-006-0149-5 | accessdate = 2010-07-21|quote=Longer experiments are essential in order to indicate the real nature and extent of the possible pathology; with the present data it cannot be concluded that GM corn MON863 is a safe product}}</ref> Séralini claimed that MON 863 adversely affects [[liver]] and [[kidney]] function, as well as causes varying degrees of damage to the [[adrenal glands]], [[heart]], [[spleen]], and other components of the haematopoietic system.<ref name='Z Magazine Ananda 2010' /> Greenpeace also cited the study in a press report, in which it demanded that MON 863 be completely recalled from the global market and called for a strict review of current 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 = 2010-07-21 | format = PDF | publisher = [[Greenpeace]] | 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.}}</ref>

===The European Food Safety Authority evaluation of 2007 CRIIGEN study===

In response to a request from the [[European Commission]], the [[European Food Safety Authority]] set up a task force to evaluate the 2007 CRIIGEN reanalysis of the original Monsanto rat feeding study on MON 863 maize.<ref>[http://www.efsa.europa.eu/EFSA/Statement/GMO_statement_MON863.pdf 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] European Food Safety Authority, 25 June 2010, Retrieved 27 October 2010</ref> This task force also asked countries from the European Union if they had any new data on MON 863 or new views on the original Monsanto toxicity study and had a technical meeting with the authors of the 2007 CRIIGEN paper. The task force observed that "...differences in test parameters of exposed male and female rats were in general neither dose-related nor sex-dependent and were therefore considered as isolated phenomena occurring by chance." They also noted that variations in test results were relatively small and mostly within the range of natural variation. They did not consider any of the adverse effects reported by CRIIGEN as biologically relevant. They concluded that MON 863 "...would not have an adverse effect on human and animal health or the environment in the context of its proposed use." These conclusions were reported by [[Markos Kyprianou]] ([[European Commissioner for Health and Consumer Policy]]) to the [[European Parliament]] on 9 July 2010.<ref name = LeFigaro>[http://www.lefigaro.fr/sciences/20070713.WWW000000717_les_experts_europeens_innocentent_un_ogm.html Les experts européens innocentent un OGM] Le Figaro, 13 July 2007, Retrieved 27 October 2010</ref>

The EFSA's critical conclusions (and also those of the French Commission du Génie Biomoléculaire<ref>[http://www.strategie.gouv.fr/IMG/pdf/GRENELLE_OGM.pdf Les Organismes Génétiquement Modifiés Annexe B Avis de la commission du génie biomoléculaire sur l’étude statistique du CRIIGEN du maïs MON863] Report prepared for the French Prime Minister by the Centre d'Analyse Strategique, 20 July 2007, Retrieved 11 November 2010</ref>) were the subject of a subsequent article in ''[[Le Figaro]]'', titled "''European Experts claim GMO is harmless''",<ref name = LeFigaro/>

===Expert Panel evaluation of 2007 CRIIGEN study===

A panel of experts from the US, Germany, UK and Canada was commissioned to evaluate CRIIGEN's new conclusions from the original Monsanto rat feeding toxicity data<ref name='Doull 2007 conclusions'>{{cite journal | doi = 10.1016/j.fct.2007.08.033 | title = Report of an Expert Panel on the reanalysis by of a 90-day study conducted by Monsanto in support of the safety of a genetically modified corn variety (MON 863). | journal = Food and Chemical Toxicology | date = November 2007 | first = J. | last = Doull | coauthors = D. Gaylor, H.A. Greim, D.P. Lovell, B. Lynch, I.C. Munro | volume = 45 | issue = 11 | pages = 2073–2085| pmid = 17900781 | url = http://www.ask-force.org/web/Food/Doull-Report-Seralini-2007.pdf | format = PDF | accessdate = 2010-07-21|quote=The Se´ralini et al. reanalysis does not advance any new scientific data to indicate that MON 863 caused adverse effects in the 90-day rat study.}}</ref> and funded by Monsanto. The panel objected to CRIIGEN's findings on the grounds that it "...failed to demonstrate a dose–response relationship, reproducibility over time, association with other relevant changes (e.g., histopathology), occurrence in both sexes, difference outside the normal range of variation, or biological plausibility with respect to cause-and-effect."

===Food Standards Australia New Zealand review of 2007 CRIIGEN study===

[[Food Standards Australia New Zealand]] reviewed the 2007 CRIGEN 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>[http://www.foodstandards.gov.au/_srcfiles/Review_of_Report_by_Seralini_et_al_July_2007.doc 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”] FSANZ final assessment report, Retrieved 26 October 2010</ref><ref>[http://www.foodstandards.gov.au/scienceandeducation/factsheets/factsheets2007/updatefsanzreaffirms3622.cfm FSANZ reaffirms its risk assessment of genetically modified corn MON 863] FSANZ fact sheets 2007, 25 July 2010, Retrieved 26 October 2010</ref>

===2009 CRIIGEN study===

In December 2009, a second CRIIGEN study was published in the [[International Journal of Biological Sciences]]. This was a statistical re-analysis of three feeding trials that had previously been published by others as establishing the safety of genetically modified corn.<ref>{{Cite journal|author=Hammond B, Lemen J, Dudek R, ''et al.'' |title=Results of a 90-day safety assurance study with rats fed grain from corn rootworm-protected corn |journal=Food Chem. Toxicol. |volume=44 |issue=2 |pages=147–60 |year=2006 |month=February |pmid=16084637 |doi=10.1016/j.fct.2005.06.008 |url=}}</ref><ref>{{Cite journal|author=Hammond B, Dudek R, Lemen J, Nemeth M |title=Results of a 13 week safety assurance study with rats fed grain from glyphosate tolerant corn |journal=Food Chem. Toxicol. |volume=42 |issue=6 |pages=1003–14 |year=2004 |month=June |pmid=15110110 |doi=10.1016/j.fct.2004.02.013 |url=}}</ref><ref>{{Cite journal|author=Hammond BG, Dudek R, Lemen JK, Nemeth MA |title=Results of a 90-day safety assurance study with rats fed grain from corn borer-protected corn |journal=Food Chem. Toxicol. |volume=44 |issue=7 |pages=1092–9 |year=2006 |month=July |pmid=16487643 |doi=10.1016/j.fct.2006.01.003 |url=}}</ref> In the study, findings of hepatorenal toxicity were reaffirmed, and concerns of metabolic consequences were further raised.<ref name='IJBS 2009-12-10'>{{cite journal | title = A Comparison of the Effects of Three GM Corn Varieties on Mammalian Health | journal = International Journal of Biological Sciences | date = 2009-12-10 | first = Joël Spiroux | last = de Vendômois | coauthors = François Roullier, Dominique Cellier, Gilles-Eric Séralini | volume = 5 | issue = 7 | pages = 706–726| pmid = 20011136 | url = http://www.biolsci.org/v05p0706.htm | accessdate = 2010-07-21 | pmc = 2793308 | doi=10.7150/ijbs.5.706}}</ref>

The French High Council of Biotechnologies Scientific Committee (HCB) reviewed the 2009 study 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>[http://www.food.gov.uk/multimedia/pdfs/acnfp9612a2 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”] English translation of French High Council of Biotechnologies Scientific Committee document, Retrieved 9 November 2010</ref><ref>[http://www.ogm.gouv.fr/IMG/pdf/avisCSduHCB-Saisine-Grosdidier_cle0e6cfc.pdf Avis relatif à la saisine du 15 décembre 2009 de Monsieur le Député François Grosdidier, quant aux conclusions de l'étude intitulée “A comparison of the effects of three GM corn varieties on mammalian health”...] Original document in French by the French High Council of Biotechnologies Scientific Committee document, Retrieved 9 November 2010</ref> The HCB also questioned the author's independence. They noted that, in 2010, the CRIIGEN web page still showed a 2008 Austrian anti-GM article which had been previously withdrawn by the authors themselves as flawed.

An evaluation by the European Food Safety Authority (EFSA) GMO Panel of the 2009 statistical re-analyses concluded that the author's claims were not supported by the data in their paper. They noted that many of their fundamental statistical criticisms of the 2007 paper also applied to the 2009 paper. There was no new information that would change the EFSA's conclusions that the three GM maize types were safe for human, animal health and the environment<ref>[http://www.efsa.europa.eu/en/events/event/gmo100127-m.pdf EFSA Minutes of the 55th Plenary Meeting of the Scientific Panel on Genetically Mofified Organisms Held on 27-28 January 2010 IN Parma, Italy, Annex 1, Vendemois et al 2009] European Food Safety Authority report, Retrieved 9 November 2010</ref>

Food Standards Australia New Zealand concluded that the results from the 2009 CRIGEN study were due to chance alone.<ref>[http://www.foodstandards.gov.au/scienceandeducation/factsheets/factsheets2009/fsanzresponsetoseral4647.cfm FSANZ response to A comparison of the Effects of Three GM Corn Varieties on Mammalian Health, Int. J. Biol. Sci. 5 (7): 706-726] FSANZ fact sheets 2009, Retrieved 26 October 2010</ref>