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EFSA rejects concerns over Monsanto maize

By Stephen Daniells , 29-Jun-2007

The European Food Safety Authority's (EFSA) GMO panel has no safety concerns after reviewing data from French scientists suggesting toxicity concerns in rats fed the MON863 variety of GM maize from Monsanto.

"Following a detailed statistical review and analysis by an EFSA Task Force, EFSA's GMO Panel has concluded that this re-analysis of the data does not raise any new safety concerns," stated the authority. 

The statement draws a line under the issue, raised when new data from a 90-day rat study, published in the peer-review journal Archives of Environmental Contamination and Toxicology in March, indicated liver and kidney toxicity in the rats, as well as differences in weight gain between the sexes as a result of eating the transgenic maize. 

MON863 is a transgenic maize genetically modified to express the Bt-toxin (Cry3Bb1) which enables the plant to be insect repellent against the corn rootworm pest. It is different from other GM corns of the market since these express the Cry1Ab toxin which is toxic to the European corn borer. 

It received European approval for use in animal feed in 2005 and for human consumption in 2006. The corn is also authorised in Australia, Canada, China, Japan, Mexico, the Philippines and the USA. 

In the US, no re-evaluation of the data was announced by FDA. 

The researchers behind the study, led by Professor Gilles Eric Séralini from the independent CRIIGEN (Committee for Independent Research and Genetic Engineering) based at the University of Caen, questioned the methods used by Monsanto to initially show the safety and non-toxicity of the corn, saying that the statistical methods used were insufficient to observed any possible disruptions in biochemistry. 

"Monsanto's analyses do not stand up to rigorous scrutiny - to begin with, their statistical protocols are highly questionable. Worse, the company failed to run a sufficient analysis of the differences in animal weight. Crucial data from urine tests were concealed in the company's own publications," said Séralini in March during a joint press conference with environmental group Greenpeace in Berlin. 

After re-evaluating the safety data relating to MON863, EFSA however have come to different set of conclusions, stating: "The statistical analysis made by the authors of the paper did not take into account certain important statistical considerations. The assumptions underlying the statistical methodology employed by the authors led to misleading results. 

"EFSA considers that the paper does not present a sound scientific justification in order to question the safety of MON 863 maize. 

"Observed statistically significant differences reported by Monsanto, Séralini et al., and EFSA, were considered not to be biologically relevant. In the absence of any indications that the observed differences are indicative of adverse effects, the GMO Panel does not consider that this paper raises new issues with respect to the safety of MON 863 maize. 

"Therefore, the GMO Panel sees no reason to revise its previous Opinions that the MON 863 maize would not have an adverse effect in the context of its proposed use," said the authority. 

This was not the first time that EFSA was requested to look at MON863. Indeed, the authority released a statement in October 2004 following a request by the German authorities following a 13-week rat study that suggested kidney toxicity. 

"Following [the GMO Panel's] investigation of the report, and of the retrospective evaluation of renal tissues and data derived from the 13-week rat feeding study performed by independent peer reviewers, the GMO Panel concludes that there is no evidence presented in the report that changes the conclusions already reached by the GMO Panel earlier this year in its Opinions on the safety of the insect-protected genetically modified maize MON 863 (EFSA 2004a, b)," read the October 2004 statement.

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