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MON 863

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In 1989 a 90-day rat-feeding trial done by the FDA, 40 rats that were fed the Bt corn developed multiple reactions typically found in response to allergies, infections, toxins and diseases. Seralini et al.^[1] reviewed the study as part of the French Commission for Biomolecular Genetics and said that the response by the rats were similar to reactions caused by pesticides. Although the Bt-toxin is a pesticide, he points out that animal research on pesticide-producing corn is nowhere as thorough as that required for approval of pesticides. Follow-up studies on these serious findings were demanded from organisations worldwide. None were conducted and the corn was approved.

Monsanto defended its corn's safety in ways that disregarded accepted scientific methods and principles and claimed that the results of this study were not statistically significant. Monsanto researchers used six additional control groups, each fed commercial corn varieties with quite different genetics. While such comparisons are suitable for commercial studies, they are entirely inappropriate for safety assessments. Monsanto claimed that since some reactions were no longer significant when compared to these other groups, the changes were unimportant. For some results, that remained statistically significant even when compared to these irrelevant controls, Monsanto claimed the changes fell within a wide range of variability that is normal for rats. They stated, for example, that a 52% decrease in immature red blood cells (reticulocytes) was "attributable to normal biological variability", and a 10% increase in blood sugar levels was biologically insignificant. According to Arpad Pusztai an allowance of 5% variability is the norm in food experiments and a 10% rise in blood sugar has serious ramifications, given the epidemics of obesity and diabetes. Several changes were still significantly outside the generous range that Monsanto defined as normal and acceptable. For some of these, they claimed that the health effects were not diet-related because the reactions were not consistent between males and females. (Scientists studying cancer and endocrinology, for example, have established that genders can respond to toxins and disease quite differently). Monsanto also dismissed other findings on the basis that the intensity of reactions was greater in rats fed a diet with 11% of MON 863 compared to the group that ate 33%. (In endocrinology and immunology research responses are not always consistent with dosage. For example, a small amount of a hormone can cause a woman to ovulate, while a larger dose can make her infertile.)

An Appeal Court action in Germany (Münster) allowed public access in June 2005 to all the crude data from the original 90-day rat-feeding study.

In 2007, a reanalysis of the data provided in 2002 by Monsanto stated that "with the present data it cannot be concluded that GM corn MON 863 is a safe product."^[2] The French biomolecular engineering commission, the Commission du Génie Biomoléculaire (CGB), reviewed this study at the request of the French Ministry of Agriculture, but concluded that there were no new elements proving the toxicity of MON 863 in this new analysis, the statistical significance of the initial samples provided by Monsanto being too weak.^[3]

The Australian government analyzed the data and determined that the variations found were due to normal physiologic variation in test animals and also licensed MON 863 for food and feed use.^[4][5]

Effects of consumption

Monsanto's research data was analyzed in 2007 by researchers at the Committee of Independent Research and Information on Genetic Engineering, Caen University and the University of Rouen.^[6] This study concluded that experiments longer than 90-days must be conducted before the safety of MON 863 can be known.^[7] 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.^[6] Following the study, a panel was formed which objected to the study's findings.^[8] These critical claims were also the subject of a subsequent article in Le Figaro, titled "European Experts claim GMO is harmless", to which Seralini 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." "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 is 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".^[9]

In December 2009, a second 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.^[10]

The Huffington Post concurred that Monsanto's 90-day study was insufficient to determine potential health effects, as chronic organ problems are rarely evident within such a short amount of time.^[11]

See also

• MON 810

References