Monsanto UK

The 90-day MON 863 rat feeding study was conducted at an independent toxicology facility, Covance Laboratories, Inc. This laboratory is internationally recognized and routinely inspected by government regulatory authorities for compliance with Good Laboratory Practice standards. The study design followed internationally recognized (OECD) toxicology testing guidelines developed by a diverse group of experts using a science-based approach to ensure wide acceptability of these studies for regulatory purposes. The study conduct also adhered to OECD Good Laboratory Practice Regulations, thereby assuring data quality and accuracy.

The identity of MON 863, parental control, and reference maize grain was preserved by following Good Field Production Practices. In addition, PCR analysis was also used to confirm the identity of the test grain and its absence in parental control grain. Diets containing MON 863, parental control and reference grain were prepared by Purina Mills Inc. and nutritionally balanced to meet Purina specifications for certified diets. Purina Mills manufactures high quality animal diets for toxicology and research laboratories around the world.

The study included 400 rats divided into 10 groups of 20 male and female animals/group fed diets containing either MON 863 or control grain. During the course of the study, more than 900 statistical comparisons were made between test and control animals for the parameters that were measured. Based on chance alone, several statistically significant differences were expected that were not biologically meaningful. The results were reviewed by toxicology experts at Covance, the German RKI (rapporteur country), the Member States, EFSA, and independent toxicology experts from New Zealand, Italy, Germany, and England. All of these experts concluded that the statistical differences resulted from normal fluctuations that occur in rat studies, were not clinically related, and thus not biologically meaningful. Questions regarding the biological relevance of a few kidney pathology findings observed in male rats were independently reviewed a second time by expert pathologists who confirmed the conclusions of the Covance pathologist and EFSA that the findings were normal for rats and not related to MON 863.

In summary, the 90-day rat feeding study with MON 863 followed a harmonized, scientifically-based experimental design as specified in OECD guidelines as well as Good Laboratory Practices to insure the quality of the data. Independent scientists in Europe have concluded the study was appropriately conducted according to internationally accepted methods, and found no evidence of harmful effects of MON 863 maize. After a thorough analysis of study methodology and results, European regulatory authorities have concluded that MON 863 will have “no adverse effects on human or animal health.” The safety of MON 863 grain has also been confirmed by other regulatory authorities in the US, Canada, Japan, Korea, Taiwan, the Philippines, Russia, Australia/New Zealand and Mexico.