Regulatory Sponsored by
The European Food Safety Authority (EFSA) has found that a recent paper raising concerns about the potential toxicity of genetically modified maize NK603 and of an herbicide containing glyphosate is of "insufficient scientific quality" to be considered as valid for risk assessment.
As reported, the GM maize and herbicide study has been widely criticized, and now the EFSA’s initial review says "the design, reporting and analysis of the study, as outlined in the paper, are inadequate."
The authority invited authors Séralini et al. to share key additional information. Although citing "shortcomings" in the study, the EFSA doesn't currently see the authors’ conclusions as scientifically sound. The numerous issues relating to the design and methodology of the study as described in the paper mean that "no conclusions can be made about the occurrence of tumors in the rats tested," the EFSA said in a written statement. Based on the authors' published information, the EFSA said it doesn't see a need to re-examine its previous safety evaluation of maize NK603 nor to consider these findings in the ongoing assessment of glyphosate.
EFSA’s preliminary review is the first step in a two-stage process. A second analysis, which will be delivered by the end of October 2012, will take into account any additional information from the study's authors, who will be given an opportunity to supply study documentation and procedures to the 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.
A task force, whose members were drawn from the authority’s GMO, pesticide and scientific assessment units, has outlined a list of issues about the paper that would need to be resolved before the EFSA can regard it as a "well-conducted and properly-reported" study. To view the detailed list, click here.