The European Commission asked EFSA two weeks ago to examine the recently published CRIIGEN study on genetically modified maize MON 863, and see whether it has any consequences for the authority's existing opinion on the safety of Monsanto's transgenic maize.
CRIIGENII is a 90-day rat study conducted by researchers at the University of Caen and published in the peer-review journal Archives of Environmental Contamination and Toxicology. It indicated liver and kidney toxicity in rats fed the transgenic maize, as well as differences in weight gain between the sexes.
EFSA's GMO panel has the job of addressing the statistical analysis in this study and any possible implications for human safety. The matter was discussed at EFSA's GMO Panel meeting last Thursday and Friday.
This is not the first time that EFSA has been asked to evaluate the safety of MON 863 as a result of a published study. A 13-week rat study conducted in Germany in 2004 raised concerns over liver toxicity.
However in October of that year the EFSA GMO panel concluded that there was "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)."
The initial opinions stated that the results of the rodent toxicity study with MON 863 maize did not indicate concerns about its safety for human and animal consumption.
The researchers behind the new 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 during a joint press conference with environmental group Greenpeace in Berlin.
Monsanto has continued to defend the safety record of its corn. Spokesperson Lee Quarles told FoodNavigator.com earlier this month: "The important thing to note in all of this is the fact that the overwhelming opinion of expert authorities is that MON 863 is safe for human and animal consumption. This includes experts in Europe as the European competent authorities concur that MON 863 YieldGard Rootworm maize is safe for human and animal health and the environment.
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 has been grown commercially in the United States and Canada since 2003, and approved for import and food use in countries including Japan, Korea, Taiwan, the Philippines, Russia and Mexico.
MON 863 received European approval for use in animal feed in 2005 and for human consumption in 2006.