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→The European Food Safety Authority evaluation of 2007 CRIIGEN study: removed special pleading; Seralini already has his say in the preceding section...
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→Effects of consumption: seems to be in wrong section - of course, greenpeace supported the results of the study they funded. Why would they praise EFSA's criticism?
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==Effects of consumption== |
==Effects of consumption== |
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===2007 CRIIGEN study=== |
===2007 CRIIGEN study=== |
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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> Furthermore, according to Séralini, the data is clear in 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' /> |
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> Furthermore, according to Séralini, the data is clear in 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> |
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===The European Food Safety Authority evaluation of 2007 CRIIGEN study=== |
===The European Food Safety Authority evaluation of 2007 CRIIGEN study=== |
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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> |
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> |
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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/ |
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/> |
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===Expert Panel evaluation of 2007 CRIIGEN study=== |
===Expert Panel evaluation of 2007 CRIIGEN study=== |
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MON 863 is a genetically engineered variety of maize produced by Monsanto.
Following legal action by parties including the Swedish Board of Agriculture and Greenpeace, a Münster appeals court ruled that Monsanto would be forced to publicly reveal its research data.[1]
MON 863 is genetically altered to express a modified version of Cry3Bb1, a delta endotoxin which originates from Bacillus thuringiensis.[2][3] This protects the plant from corn rootworm.[3][4] Unlike MON 810, Bt 11, and Bt 176 which each produce a modified Cry1Ab, MON 863 instead produces a modified Cry3Bb1 toxin and contains nptII, a marker gene for antibiotic resistance.[2][5]
Monsanto's research data was analyzed in 2007 by researchers from the Committee of Independent Research and Information on Genetic Engineering, Caen University and the University of Rouen[6][7] and funded by Greenpeace.[8] 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. [9]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.[10][11] Furthermore, according to Séralini, the data is clear in 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.[7] 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.[12]
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.[13] 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.[14]
The EFSA's critical conclusions (and also those of the French Commission du Génie Biomoléculaire[15]) were the subject of a subsequent article in Le Figaro, titled "European Experts claim GMO is harmless",[14]
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[16] 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 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."[17][18]
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.[19][20][21] In the study, findings of hepatorenal toxicity were reaffirmed, and concerns of metabolic consequences were further raised.[22]
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."[23][24] 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[25]
Food Standards Australia New Zealand concluded that the results from the 2009 CRIGEN study were due to chance alone.[26]
MON 863 is approved for use in Australia, Canada, China, the European Union, Japan, Mexico, New Zealand, the Philippines, Russia, Singapore, South Korea, Taiwan, and the United States.[27][28]
MON863 is a genetically modified corn that expresses a Bt-toxin. This toxin is a modified version of the delta endotoxin Cry3Bb1 which originates from the microorganism Bacillus thuringiensis. The genetic manipulation is aimed at protecting maize plants against a pest called corn rootworm (Diabrotica spp.). MON863 differs from other Bt-corns already placed on the market (MON810, BT11, Bt176), which produce a modified Cry1Ab toxin conferring resistance to a pest called European corn borer (Ostrinia nubilalis), in that it produces an artificial Cry3Bb1 toxin. In addition to the modified Cry3Bb1 toxin gene MON863 contains an antibiotic resistance marker gene.
MON 863, a genetically engineered corn variety that contains the gene for modified Bacillus thuringiensis Cry3Bb1 protein to protect against corn rootworm, was tested in a 90-day toxicity study as part of the process to gain regulatory approval.
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MON863 contains an GM antibiotic resistance gene (nptII) against kanamycin and neomycin.
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.
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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
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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.
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.
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Based on these reviews, this maize has been authorized for planting in the United States and Canada since 2003 and is additionally approved for import and food use in many countries around the world, including Japan, Korea, Taiwan, the Philippines, Australia/New Zealand, China, Russia, Singapore, Mexico and the European Union.[dead link]
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