Cindy Ragin, APHIS (301) 734-7280
Dale Kemery, EPA (202) 564-7839
Stephanie Kwisnek, FDA (301) 436-1408
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/.