Initial review finds design, reporting, analysis inadequate
The European Food Safety Authority has concluded that a recent paper raising concerns about the potential toxicity of Monsanto Co.’s genetically modified maize NK603 and of a herbicide containing glyphosate is of insufficient scientific quality to be considered as valid for risk assessment.
The authority’s initial review found that the design, reporting and analysis of the study, as outlined in the paper, are inadequate. To enable the fullest understanding of the study the authority has invited authors Séralini et al. to share key additional information. “Some may be surprised that the EFSA’s statement focuses on the methodology of this study rather than its outcomes; however, this goes to the very heart of the matter,” said Per Bergman, the director of scientific evaluation of regulated products and the one who led the authority’s work. “When conducting a study it is crucial to ensure a proper framework is in place. Having clear objectives and the correct design and methodology create a solid base from which accurate data and valid conclusions can follow. Without these elements a study is unlikely to be reliable and valid.”
The preliminary review is the first step in a two-stage process. A second analysis will be delivered by the end of October, and will take into account any additional information from the study authors, who will be given an opportunity to supply study documentation and procedures to the European Food Safety Authority to ensure the broadest possible understanding of their work. It will also include an overview of Member State assessments of the paper and an analysis from the German authorities responsible for the assessment of glyphosate.