Brussels, 04/10/2012 (Agence Europe) - The conception, methodology and analysis of the study by Professor Seralini, which concluded in the long-term toxicity on rats of the genetically engineered maize NK603 by Monsanto and the total weed-killer Roundup also by Monsanto, are insufficient, according to the European Food Safety Authority (EFSA). In its preliminary opinion published on Thursday 4 October on the paper which appeared on 19 September in the review Food and Chemical Toxicology, EFSA really lashes out.
EFSA considers the article is of insufficient scientific quality, which does not allow it to draw the slightest conclusion about the occurrence of tumours in rats tested (Ed.: 200 rats in total over two years). It therefore does not believe the conclusions reached by the authors of the paper are scientifically valid. Consequently, on the basis of the information published by the authors of the study, EFSA considers it is not necessary for it to review the previous evaluation on safety of NK603 maize, or that it should take into account these results in the context of the current assessment carried out on glyphosate. EFSA therefore invites the authors to share certain additional information concerning the documentation on which they based their views and the procedures used for their study “to enable the fullest understanding of the study” and to publish a more complete analysis by end October. This analysis will include a summary of the assessments set out in the paper by the EU member states and an analysis made by the German authorities responsible for assessing glyphosate. “Some may be surprised that EFSA's statement focuses on the methodology of this study rather than its outcome. However, this goes to the very heart of the matter”, said Per Bergman, the director for scientific assessment of regulated products, who led EFSA's work.
The multidisciplinary EFSA working group came to the preliminary conclusion that: - the strain of rat used in the two-year study is prone to developing tumours during the normal life expectancy of approximately two years, something that was not taken into account by the authors of the report; - the authors split the rats into 10 treatment sets but established only one control group (Ed.: of 20 rats), which meant there was no appropriate control for some 40% of the animals; - the paper did not comply with internationally recognised standard methods (protocols) for setting up and carrying out experiments; - for a study of this type, the relevant OECD guideline specifies the need for a minimum of 50 rats per treatment group; while Seralini et al used only 10 rodents per treatment set; - the authors have not stated any objectives for their research; - no information is given about the composition of the food given to the rats or on how it was stored; - it is not possible to properly evaluate the exposure of the rats to the herbicide as intake is not clearly reported; - the paper does not employ a commonly-used statistical analysis method; - and many endpoints - what is measured in the study - were not reported in the paper.
Lack of EU legislation. The NGO takes the view that the polemic surrounding the Seralini paper and this preliminary EFSA declaration highlight the fact that, to date, there are no adequate, universally-recognised protocols for carrying out this kind of long term tests, which begs one fundamental question: Why does the EU legislation not make it an obligation to assess the long term effects of genetically modified crops? Currently, transgenic crops consumed by citizens and animals in the EU have been approved on the basis of tests carried out by the biotechnology industry over 28-90 days. “There is an unacceptable gap in current EU safety testing which largely ignores potential long-term health and environmental impacts of GM crops”, deplores Marco Contiero, from the Greenpeace European office. The European Commission has authorised the cultivation of the transgenic potato Amflora which had been tested on 30 rats in total, and a transgenic soya after one month's testing on a group of ten rats. (AN/transl.jl)