EFSA review of statistical analyses conducted for the assessment of the MON 863 90-day rat feeding study

No abstract available

In 2004 the EFSA GMO Panel gave its opinion (EFSA, 2004a,b) on the safety of MON 863 maize for import and processing, and released a statement on the safety of MON 863 shortly after (EFSA, 2004c). The EFSA GMO Panel based its opinions and statement on a wide range of evidence, which included data from a 90-day rat feeding study. This study was performed by Covance Laboratories, in compliance with internationally agreed GLP principles (OECD, 1998), for the applicant Monsanto.Subsequently Hammond et al. (2006) published a scientific paper based on the Monsanto report (2002), which provided fewer details than the original Monsanto report.

In a re-analysis of the MON 863 90-day rat study Séralini et al. (2007) claimed to have revealed significant variations in growth for both genders, as well as signs of hepatorenal toxicity in rats, and alleged that it cannot be concluded that MON 863 maize is a safe product.

The European Commission (DG SANCO, 2007) asked EFSA what impact the analysis performed by Séralini et al. (2007) study might have on its earlier opinion on MON 863 maize.

This EFSA report presents an assessment of the statistical methodology as applied by Monsanto (2002) and Séralini et al. (2007). It takes account of contributions from Member States, in particular the reports provided by the Commission du Génie Biomoléculaire of France (CGB) and information provided by the Agence Française de la Sécurité Sanitaire des Aliments of France (AFSSA).

The experimental design in the Monsanto study, adapted from the OECD Guideline 408 to make it more fit for the purpose of assessing GMOs, involved three factors, each at two levels: genotype (MON 863 and non-transgenic control LH82 x A634 maize); gender (Male and Female); and dose (11% and 33% level of MON 863 in the diet for the GM-fed rats). In addition to the near-isogenic control diets, rats were fed diets from six non-GMO reference lines, i.e. commercial hybrid maize genotypes.

Previous studies of these data have involved two separate statistical analyses: (1) body weight, body weight gain and food consumption;

EFSA review of statistical analyses conducted for the assessment of the MON 863 90-day rat feeding study