Washington, DC
February 22, 2008
The U.S. Department of
Agriculture’s Animal and Plant Health Inspection Service
(APHIS), the U.S. Environmental
Protection Agency (EPA), and the
Food and Drug Administration
(FDA) are coordinating efforts following notification by
Dow AgroSciences that the
company detected extremely low levels of an unregistered
genetically engineered (GE) pesticide product known as a
plant-incorporated protectant (PIP) in 3 of its commercial GE
hybrid corn seed lines. The unregistered product produces
proteins that are identical to a registered product. USDA, EPA
and FDA have concluded that there are no public health, food or
feed safety concerns. Additionally, USDA and EPA have determined
that the unregistered GE corn PIP poses no plant pest or
environmental concerns.
The unregistered GE corn PIP, known as Event 32, was found in
some Herculex® RW and Herculex® XTRA Rootworm Protection
products. Seed containing low levels of the unregistered Event
32 was inadvertently sold to farmers by Dow’s affiliate Mycogen
Seeds and planted in 2006 and 2007. EPA and USDA previously
approved Herculex® Rootworm Protection products containing a
closely related PIP, Event 22. These products are also approved
for use in several foreign countries.
Through careful analysis, EPA determined that the introduced
proteins produced by Event 32 are identical to those approved
for Event 22, and therefore they are covered by an existing
tolerance exemption (EPA food safety clearance). FDA has
concluded there are no food or feed safety concerns because EPA
has determined that the introduced proteins in Event 32 are safe
and because corn containing Event 32 is present in food or feed,
if at all, only at low levels. In addition, APHIS’ scientific
analysis concluded that Event 32 poses no plant pest or
environmental concerns.
The 2008 U.S. corn crop will not be affected. APHIS took steps
to ensure Dow recalled all affected seed that was shipped to
dealers for the 2008 planting season. APHIS and EPA are
coordinating on the investigation of potential violations under
their respective regulatory acts.
Corn Event 32 was found at extremely low levels—approximately 3
seeds per 1,000—in affected Herculex seed products. Dow reported
that in 2007 approximately 53,000 acres of the affected products
were planted in the United States. Total U.S. corn acreage in
2007 was more than 93 million acres. Taking into account, the
low levels of Event 32 in the Herculex seed products as well as
the very small proportion of these seeds that were planted, any
amount of Event 32 in harvested corn would be negligible. It is
estimated that no more than 0.0002 percent (two ten–thousandths
of one percent) of the 2007 corn crop may have contained Event
32.
For more information on the respective roles of USDA APHIS, EPA,
and FDA in the federal regulation of GE plants, see the United
States Agencies Unified Biotechnology Web site at
http://usbiotechreg.nbii.gov/.
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