Report of an Expert Panel on the reanalysis by of a 90-day study conducted by Monsanto in support of the safety of a genetically modified corn variety (MON 863).
MON 863, a genetically engineered corn variety that contains the gene for modified Bacillus thuringiensis Cry3Bb1 protein to protect against corn rootworm, was tested in a 90-day toxicity study as part of the process to gain regulatory approval. This study was reanalyzed by Séralini et al. who contended that the study showed possible hepatorenal effects of MON 863. An Expert Panel was convened to assess the original study results as analyzed by the Monsanto Company and the reanalysis conducted by Séralini et al. The Expert Panel concludes that the Séralini et al. reanalysis provided no evidence to indicate that MON 863 was associated with adverse effects in the 90-day rat study. In each case, statistical findings reported by both Monsanto and Séralini et al. were considered to be unrelated to treatment or of no biological or clinical importance because they failed to demonstrate a dose-response relationship, reproducibility over time, association with other relevant changes (e.g., histopathology), occurrence in both sexes, difference outside the normal range of variation, or biological plausibility with respect to cause-and-effect. The Séralini et al. reanalysis does not advance any new scientific data to indicate that MON 863 caused adverse effects in the 90-day rat study.
Doull
J
J
Pharmacology, Toxicology and Therapeutics, Division of Toxicology, Department of Pharmacology, The University of Kansas Medical Center, 1018A Briedenthal Building, 3901 Rainbow Boulevard, Kansas City, KS 66160-7417, USA.
Gaylor
D
D
Greim
H A
HA
Lovell
D P
DP
Lynch
B
B
Munro
I C
IC
D000818:Animals; D004731:Endotoxins / Q000009:adverse effects* / Q000235:genetics*; D019649:Food Industry / Q000592:standards*; D030841:Food, Genetically Modified / Q000009:adverse effects / Q000592:standards*; D015203:Reproducibility of Results; D013997:Time Factors; D003313:Zea mays / Q000235:genetics*
C507666:Cry3Bbl endotoxin, Bacillus thuringiensis; D004731:Endotoxins