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===Panel evaluation=== |
===Panel evaluation=== |
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Following the 2007 CRIIGEN study, a panel was commissioned to evaluate CRIIGEN's study.<ref name='Doull 2007 conclusions'> {{cite journal | 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| id = PMID 17900781 {{doi | 10.1016/j.fct.2007.08.033}} | 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> The panel objected to CRIIGEN's findings, and the panel's critical claims were also the subject of a subsequent article in ''[[Le Figaro]]'', titled "''European Experts claim GMO is harmless''", to which Séralini responded: "Our paper was not particularly alarmist, but by far, one of the longest and most detailed study ever published on a toxicological analysis on mammals consuming a commercialized GMO." There were also "39 signs of toxicity were observed on the livers and kidneys of the laboratory mammals consuming genetically modified (GM) maize MON863 over a 3 month period", and there was "confirmed tissue damage after the consumption of the MON863 GM maize, in the kidneys of young male rats aged 5 months, with a chronic nephropathy at stage 18/20 (the non-GM control group was only 14/20). This was also described by the Monsanto team themselves and then written between the lines", according to Séralini.<ref name='Séralini 2010-04-17'> {{cite web | url = http://www.criigen.org/SiteEn/index.php?option=com_content&task=view&id=188&Itemid=99 | title = CRIIGEN's Response to the Figaro | accessdate = 2010-07-21 | last = Séralini | first = Gilles-Eric | date = 2010-04-17 | work = The Committee for Research and Independent Information on Genetic Engineering | archivedate=2010-07-21|archiveurl = http://www.webcitation.org/5rNihFn4m}}</ref> 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> |
Following the 2007 CRIIGEN study, a panel was commissioned to evaluate CRIIGEN's study.<ref name='Doull 2007 conclusions'> {{cite journal | 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| id = PMID 17900781 {{doi | 10.1016/j.fct.2007.08.033}} | 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> The panel objected to CRIIGEN's findings, and the panel's critical claims were also the subject of a subsequent article in ''[[Le Figaro]]'', titled "''European Experts claim GMO is harmless''", to which Séralini responded: "Our paper was not particularly alarmist, but by far, one of the longest and most detailed study ever published on a toxicological analysis on mammals consuming a commercialized GMO." There were also "39 signs of toxicity were observed on the livers and kidneys of the laboratory mammals consuming genetically modified (GM) maize MON863 over a 3 month period", and there was "confirmed tissue damage after the consumption of the MON863 GM maize, in the kidneys of young male rats aged 5 months, with a chronic nephropathy at stage 18/20 (the non-GM control group was only 14/20). This was also described by the Monsanto team themselves and then written between the lines", according to Séralini.<ref name='Séralini 2010-04-17'> {{cite web | url = http://www.criigen.org/SiteEn/index.php?option=com_content&task=view&id=188&Itemid=99 | title = CRIIGEN's Response to the Figaro | accessdate = 2010-07-21 | last = Séralini | first = Gilles-Eric | date = 2010-04-17 | work = The Committee for Research and Independent Information on Genetic Engineering | archivedate=2010-07-21|archiveurl = http://www.webcitation.org/5rNihFn4m}}</ref> 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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===Food Standards Australia and New Zealand Review of 2007 CRIIGEN study=== |
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Food Standards Australia and New Zealand Food Standards reviewed the 2007 CRIGEN study and concluded that "...all of the statistical differences between rats fed MON863 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> |
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===2009 CRIIGEN study=== |
===2009 CRIIGEN study=== |
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In December 2009, a second CRIIGEN study was published in the [[International Journal of Biological Sciences]]. 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| id = PMID 20011136 | url = http://www.biolsci.org/v05p0706.htm | accessdate = 2010-07-21}}</ref> |
In December 2009, a second CRIIGEN study was published in the [[International Journal of Biological Sciences]]. 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| id = PMID 20011136 | url = http://www.biolsci.org/v05p0706.htm | accessdate = 2010-07-21}}</ref> |
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===Food Standards Australia and New Zealand Review of 2009 CRIIGEN study=== |
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Food Standards Australia and 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> |
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==Legal status== |
==Legal status== |
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] 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.[8][9] 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]
Following the 2007 CRIIGEN study, a panel was commissioned to evaluate CRIIGEN's study.[10] The panel objected to CRIIGEN's findings, and the panel's critical claims were also the subject of a subsequent article in Le Figaro, titled "European Experts claim GMO is harmless", to which Séralini responded: "Our paper was not particularly alarmist, but by far, one of the longest and most detailed study ever published on a toxicological analysis on mammals consuming a commercialized GMO." There were also "39 signs of toxicity were observed on the livers and kidneys of the laboratory mammals consuming genetically modified (GM) maize MON863 over a 3 month period", and there was "confirmed tissue damage after the consumption of the MON863 GM maize, in the kidneys of young male rats aged 5 months, with a chronic nephropathy at stage 18/20 (the non-GM control group was only 14/20). This was also described by the Monsanto team themselves and then written between the lines", according to Séralini.[11] 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]
Food Standards Australia and New Zealand Food Standards reviewed the 2007 CRIGEN study and concluded that "...all of the statistical differences between rats fed MON863 corn and control rats are attributable to normal biological variation." [13][14]
In December 2009, a second CRIIGEN study was published in the International Journal of Biological Sciences. In the study, findings of hepatorenal toxicity were reaffirmed, and concerns of metabolic consequences were further raised.[15]
Food Standards Australia and New Zealand concluded that the results from the 2009 CRIGEN study were due to chance alone.[16]
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.[17]
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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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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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.
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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]