The Center for Food Safety (CFS) today alerted both the Environmental Protection Agency (EPA) and Monsanto about the failure of Monsanto to comply with the adverse reporting requirements of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) regarding the findings of a rat feeding study on the company’s MON 863 genetically engineered corn.

On April 23, 2004, the prominent French newspaper Le Monde reported on the results of a 90-day rat feeding study of engineered MON 863 corn. A reviewing agency, the French Commission for Genetic Engineering (CGA), is reported to have written that numerous, apparently abnormal indications in rats in that study prevented it from concluding that MON 863 corn would be safe for human consumption.

An examination of the EPA docket for MON 863 (Docket No. OPP-30509B) reveals that the agency has neither received nor reviewed the 90-day rat study referred to in the Le Monde account.  Furthermore, discussion with the Food and Drug Administration (FDA) indicates that FDA also has not reviewed this study.

“For a corn crop being eaten by a large part of the U.S. population, reasonable prudence demands that the rat study be reviewed immediately by EPA,” said Doug Gurian-Sherman, senior scientist with CFS. “Further delay in reviewing the study unnecessarily exposes U.S. consumers to unknown health risks. The lack of a clear finding of safety, so far, demonstrates that Monsanto’s MON 863 corn can no longer be considered safe to a reasonable certainty.”

CFS believes that the rat study clearly falls under the purview of adverse incident reporting under FIFRA section 6(a)2. Under section 6(a)(2), an adverse incident report is required when the registrant “has additional factual information regarding unreasonable adverse effects on the environment of the pesticide,” where “environment of the pesticide” is further defined in FIFRA to include human safety. Since the study was submitted to European authorities by the registrant, Monsanto, the registrant is clearly in possession of and aware of this adverse incident. Because Americans are currently consuming MON 863 corn while European consumers are not, CFS states that there is even more urgency for EPA to address this issue immediately.

Monsanto’s apparent refusal to submit this adverse incident reporting information to EPA is a violation of FIFRA [sections 12(a)(2)(B)(ii) and 12(a)(2)(N)], and the agency could impose civil and/or criminal penalties as allowed under section 14.  In keeping with EPA’s policies of transparency concerning safety data for Plant-Incorporated Protectant crops, CFS requested that the rat study, and EPA’s findings concerning that study, be submitted to the public for comment.

View CFS’ letter to the EPA