(Washington, D.C. - Feb. 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
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 (–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, go to the United States Agencies Unified
Biotechnology Web site at: http://usbiotechreg.nbii.gov/
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