|
WASHINGTON, D.C., November 16, 2004: 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.
|
