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Technical & Safety Info

Focus on MON 863 / YieldGard® Rootworm

MON 863, a trait marketed in the United States and Canada under the name YieldGard® Rootworm, is a corn technology that contains a protein from Bacillus thuringiensis (Bt), a common soil microbe, that allows the plant to protect itself from the corn rootworm larvae. Corn rootworm is one of the most pernicious insect pests affecting maize crops around the world, and MON 863 offers farmers a way to effectively control this pest without the use of chemical insecticides.

Safety
MON 863 has been thoroughly reviewed by hundreds of independent scientists on behalf of regulatory authorities around the world and has completed regulatory review by a number of countries globally. 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. The overwhelming opinion of expert authorities around the world is that MON 863 is as safe as conventional maize for human and animal consumption and the environment.

As required by E.U. regulatory authorities, a 90-day rat feeding study was conducted with MON 863 grain at an independent toxicology testing laboratory. The results of the study were published as a peer-reviewed paper in 2006 . At the completion of the study, treatment, control and reference groups were extensively analyzed, including clinical pathology, organ weights, and examination for gross pathologic changes. More than 900 statistical comparisons were made from the data collected. A few statistically significant differences were observed in these comparisons, which were not unexpected given the large number of comparisons that were made. The differences appeared to occur randomly and were generally of small magnitude. Five independent experts concluded that these differences are not biologically meaningful and the study shows no effects on rats related to exposure to MON 863.

Furthermore, two additional 90-day rat feeding studies were conducted on MON 863 maize that showed no evidence of adverse effects in rats. These studies (MON 863 x MON 810; MON 863 x NK603) also were reviewed by the European Food Safety Authority (EFSA) and French regulatory agencies. The European regulatory process for MON 863 has included numerous steps:

  • Germany's Robert Koch Institut (RKI) reviewed the rat feeding study, and a finding of "no harmful effects" was subsequently circulated to all EU Member States.
  • The French Commission du Génie Biomoléculaire (CGB) raised a number of questions, and Monsanto transferred a supplemental analysis and the RKI assessment to the European Food Safety Authority GMO Panel for further analysis.
  • EFSA later issued a scientific opinion on Monsanto's dossier for MON 863: "The Panel considers that the information available for MON 863 addresses the outstanding questions raised by the Member States (including France) and considers that MON 863 will not have an adverse effect on human and animal health or the environment in the context of its proposed use."
  • After the EFSA opinion, the French CGB expressed a concern about findings in the kidneys of male rats fed MON 863 grain and requested an independent review of these findings.
  • This peer review was conducted by two expert pathologists that concluded "dietary administration of MON 863 maize did not induce toxic effects in the kidneys of rats."
  • Based on this report, the French CGB concluded that MON 863 has no toxic effects on rats (CGB opinion of 23 November 2004; http://www.ogm.gouv.fr/experimentations/evaluation_scientifique/cgb/CR_seances/CRsynth041123.pdf).
  • MON 863 was approved in the EU for import, feed and processing on 8 August 2005 and under the Novel Food and Food Ingredient Regulation on 13 January 2006.

Allegations
In March 2007, Greenpeace held several press conferences to present a new publication by Seralini et al. containing a modified statistical analysis of the MON 863 90-day rat study results. The lead author is associated with CRIIGEN (Committee for Independent Research and Genetic Engineering) an outspoken organization critical of agricultural biotechnology. The main allegations from this publication were (1) the Monsanto report is based on erroneous analyses of the data; and (2) the results indicate obvious health effects at the experimental dose rates.

The Seralini et al. publication does not contain new data. The authors conducted an inappropriate alternative statistical analysis of the raw data from the existing MON 863 rat feeding study. Different statistical tests can, and do, give different statistical results. The statistical results and associated conclusions do not represent new or significant findings.

The analyses conducted by these authors are not consistent with what has been traditionally accepted for use by regulatory toxicologists for analysis of rat toxicology data. Monsanto's evaluation as well as other independent reviews of the statistical evaluations carried out by these authors show that the analyses were not done appropriately and were technically flawed (See "Monsanto's Response" link below). Thus, the increased statistically significant differences reported in this publication are the result of misapplication of statistical methodology and are not attributable to the MON 863 corn test article. The data itself has not changed, and regardless of what analysis is used, the measured parameters for rats fed MON 863 were well within the range of values for rats fed traditional, non-genetically modified maize. The original statistical analysis carried out on the 90-day rat study used appropriate statistical methods. Therefore, the original conclusion that MON 863 did not cause adverse effects when fed to rats remains unchanged.

The authors allege that the new analysis of the data shows evidence of hepato/renal toxicity in MON 863 fed rats. This conclusion is at odds with the findings in the study where few statistically significant differences in serum protein values or triglycerides were, for the majority of the cases, limited to low dose MON 863-fed rats. Since they were not observed at the high dose, they were not related to MON 863 maize. In addition, the kidney data were reviewed by the pathologists conducting the study, as well as two external pathology experts and Dr Parodi, President of the French Association of Anatomo-Histopathology. All concurred that there was no evidence that MON 863 caused kidney toxicity in rats.

It is important to note that the Seralini group at CRIIGEN also repeated the statistical analysis conducted by Monsanto. They reported that their results were in concordance with those published in Hammond et al., 2006.

Lastly, the authors do not acknowledge the two other 90-day rat feeding studies conducted on MON 863 maize (MON 863 x MON 810; MON 863 x NK603) that show no evidence of adverse effects in rats.

In conclusion, the overwhelming opinion of expert authorities around the world is that MON 863 is as safe as conventional maize for human and animal consumption and the environment.

  1. Hammond B., Lemen J., Dudek R., Ward D., Jiang C., Nemeth M., Burns J. (2006). Results of a 90-day safety assurance study with rats fed grain from maize rootworm-protected maize. Food and Chemical Toxicology 44: 147-160. http://www.monsanto.com/pdf/products/fullratstudy863.pdf
  2. Séralini G.E., Cellier E., de Vendomois J.S. (2007). New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity. Arch. Environ. Contam. Toxicol. http://www.springerlink.com/content/1432-0703