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The deficiency in kidney function we highlight to be present in male rats is different between animals fed NK 603 and MON 863. The latter is characterized by an increase in plasma creatinine levels and retention of ions, which were associated with a chronic interstitial nephropathy, as originally admitted in the Monsanto MON 863 report and by Hammond and coll. []. However, this disturbance in kidney function was dismissed in their conclusions because the strain of rat used in the feeding studies is apparently sensitive to this type of pathology, especially during aging, which was not the case here. However, this reasoning was admitted by various regulatory authorities (EFSA, CGB in France). These arguments again appear flawed as the rats were still relatively young, 5 months by the end of the experimental period and therefore below the age when they might be expected to spontaneously develop kidney diseases. More importantly, these kidney effects are clearly MON 863-specific since they are not observed with all three GM maize varieties and the control groups, and therefore could not have arisen from an inherent genetic predisposition of the strain of rat used, which in addition was the same in all cases. Overall, no kidney parameters in male animals are disrupted in the MON 810 feeding group, even though sensitivity to toxics appears in general to be greater in this sex [, ]. An additional contributory factor to this disturbance in kidney function could arise from either novel unintended toxic effect caused by the inherent mutagenic effect of the GM technology, or possibly due to the new mutant forms of Bt toxin produced by MON 863, which is completely different from that engineered into MON 810. However, MON 810-fed females have a slight kidney weight enhancement, which may correspond with a mild hyperplasia usually seen in association with immune inflammatory processes. A re-evaluation of the histological slides from these animals would be of interest to test this hypothesis. Furthermore, analysis of some pertinent markers of kidney function such as arterial tension or angiotensin levels are lacking from these studies. This type of investigation including controls where animals are fed a normal diet spiked with the corresponding purified Bt toxin, would allow a more rational and precise interpretation of the results.

In the case of the MON 863 feeding trials, which have previously been discussed [] and are at the center of a debate [, ], new results have been obtained by the re-evaluation of the data with more powerful statistical methods as we present here. In female rats, there is a risk of becoming pre-occupied with the reactions already ascribed to the GM feeding group since several parameters indicate increases in circulating glucose and triglyceride levels, with liver function parameters disrupted together with a slight increase in total body weight []. This physiological state is indicative of a pre-diabetic profile. We demonstrate here that in female animals triglycerides profile, creatinine or urine chloride excretion are differentially and specifically altered over time in comparison to control groups, depending on the GMO dose. All these disruptions and differences taken together could be interpreted as clear signs of toxicity.

The effects found after only 5 weeks of feeding or at lower 11% feed dose, cannot be neglected simply on the basis that they are less frequently observed. Compensation or recuperation could occur after tissues are harmed, as possibly observed in the case of mice fed a diet containing Roundup Ready GM soy []. Peak inflammatory processes may occur in damaged tissues, followed by a regeneration phase as observed after bacteria/viral infection or a chemical toxic insult [, ]. For instance, urine potassium decreases in male rats over time in the GM MON 863 group at the 11% feed dose, which was not observed in all but one of the controls. This effect is specifically time-dependent and thus does not appear to be artefactual. This type of punctual regeneration may be part of a carcinogenic process, and clearly even if total recovery occurs, this should not be taken as a sign that the GM feed is safe.

Patho-physiological profiles are unique for each GM crop/food, underlining the necessity for a case-by-case evaluation of their safety, as is largely admitted and agreed by regulators. It is not possible to make comments concerning any general, similar subchronic toxic effect for all GM foods. However, in the three GM maize varieties that formed the basis of this investigation, new side effects linked to the consumption of these cereals were revealed, which were sex- and often dose-dependent. Effects were mostly concentrated in kidney and liver function, the two major diet detoxification organs, but in detail differed with each GM type. In addition, some effects on heart, adrenal, spleen and blood cells were also frequently noted. As there normally exists sex differences in liver and kidney metabolism, the highly statistically significant disturbances in the function of these organs, seen between male and female rats, cannot be dismissed as biologically insignificant as has been proposed by others []. We therefore conclude that our data strongly suggests that these GM maize varieties induce a state of hepatorenal toxicity. This can be due to the new pesticides (herbicide or insecticide) present specifically in each type of GM maize, although unintended metabolic effects due to the mutagenic properties of the GM transformation process cannot be excluded []. All three GM maize varieties contain a distinctly different pesticide residue associated with their particular GM event (glyphosate and AMPA in NK 603, modified Cry1Ab in MON 810, modified Cry3Bb1 in MON 863). These substances have never before been an integral part of the human or animal diet and therefore their health consequences for those who consume them, especially over long time periods are currently unknown. Furthermore, any side effect linked to the GM event will be unique in each case as the site of transgene insertion and the spectrum of genome wide mutations will differ between the three modified maize types. In conclusion, our data presented here strongly recommend that additional long-term (up to 2 years) animal feeding studies be performed in at least three species, preferably also multi-generational, to provide true scientifically valid data on the acute and chronic toxic effects of GM crops, feed and foods. Our analysis highlights that the kidneys and liver as particularly important on which to focus such research as there was a clear negative impact on the function of these organs in rats consuming GM maize varieties for just 90 days.

GM: genetically modified; m: modified toxin by mutagenesis.

We thank Michael Antoniou for assistance and comments on the compilation of this manuscript. The support of the French Ministry of Research is gratefully acknowledged.