St. Louis, Missouri
December 5, 2008
Monsanto Company confirmed today that it self-reported the
inadvertent harvest of an extremely small amount of regulated Bt
research cotton at a trial site in Dawson County, Texas, as
stated today by the U.S. Food and Drug Administration.
Approximately two-tenths of an acre of research cotton being
grown under USDA notification was inadvertently harvested with a
54-acre commercial field. The cotton was transported for ginning
and processing in late October.
The research cotton contains the protein Cry1A.105 which is
nearly identical to the protein in YieldGard VT PRO™ corn. This
safe and familiar protein already has regulatory approvals in
the U.S. and from various international regulatory agencies. The
U.S. Environmental Protection Agency and USDA have confirmed
that it poses no threat to humans or animals.
“Monsanto has taken responsibility for this release and for
resolving it in a manner that is satisfactory to the U.S.
Department of Agriculture, the Food and Drug Administration and
the Environmental Protection Agency,” said Jerry Hjelle, Ph. D.,
Vice President of Global Regulatory Affairs.“ We take product
stewardship extremely seriously, and we moved quickly to notify
the USDA, FDA and EPA as soon as we became aware of the
inadvertent harvest, following established government
procedures.”
The EPA has advised FDA that the presence of this protein in
cottonseed, cottonseed oil and other products meets the safety
standard under the Federal Food, Drug, and Cosmetic Act that
applies to all food and feed ingredients.
When Monsanto became aware of the harvest, the processor was
informed and quickly separated the material. With their
assistance, Monsanto researchers identified and tracked the
co-mingled cottonseed material from harvest to processing. The
FDA, EPA and USDA are working together to determine whether or
not a small amount of trial cotton hulls and meal may have been
fed to animals.
Monsanto continues to work diligently with the U.S. government
agencies to properly manage the cottonseed in inventory.
Monsanto Company (NYSE: MON) is a leading global provider of
technology- based solutions and agricultural products that
improve farm productivity and food quality. Monsanto remains
focused on enabling both small-holder and large-scale farmers to
produce more from their land while conserving more of our
world's natural resources such as water and energy. |
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