Evidence gathered by the USDA's Animal and Plant Health Inspection Service (APHIS) and testing conducted by two USDA laboratories as part of an ongoing investigation into the presence of minute levels of regulated genetic material found in Clearfield 131 (CL131) rice seed has identified LLRICE604 as the source of the genetic material. LLRICE604 was developed by Bayer Cropscience for herbicide tolerance as part of the LLRICE600 series. The protein contained in LLRICE604 phosphinothricin-N-acetyltransferase (PAT), has a long history of safe use and is present in many deregulated products.
The PAT protein has been repeatedly and thoroughly scientifically evaluated and is used safely in food and feed, cultivation and breeding in the United States as well as nearly a dozen other countries around the world. APHIS has previously deregulated similar genetically engineered herbicide-tolerant products such as corn, canola and soybean.
FDA has previously evaluated the PAT protein for safety on a number of occasions through the Agency's voluntary biotechnology consultation process. Therefore, FDA has concluded that the presence of rice from the LLRICE 600 series at low levels in food and feed would pose no food or feed safety concerns. Based on this determination, APHIS will not prevent movement or processing of CL131 rice from previous years.
In 1999, APHIS deregulated two similar herbicide tolerant rice lines, LLRICE62 and LLRICE06. After thorough safety evaluations, APHIS extended this deregulation in November 2006 to include LLRICE601.
APHIS was able to identify the regulated genetic material as a result of testing conducted by USDA's Agricultural Marketing Service and Grain Inspection, Packers and Stockyard Administration. The investigation continues to determine the circumstances surrounding the release and whether any USDA regulations were violated.
APHIS has issued emergency action notifications (EANs) since March 4, 2007, to distributors and processors of CL131 to stop the further distribution and planting of the rice seed. This early action helped to limit plantings of CL131. Horizon Ag notified the Agency that it believes only three acres of CL131 were planted by a single producer. APHIS is working with that producer to ensure crop destruction. APHIS will be providing anyone who was issued an EAN with specific instructions regarding appropriate seed disposition.
At this time, APHIS has not received a petition from Bayer to deregulate LLRICE604. Because LLRICE604 remains a regulated article, producers will not be permitted to plant any CL131 seed that is currently on hold. The EANs that have been issued will remain in place for regulatory reasons until APHIS can ensure the untreated rice seed has gone through a process that eliminates the possibility it can be germinated or grown.
APHIS has a comprehensive, science-based regulatory system in place to protect plant health and the environment by ensuring that biotechnology is developed and used in a safe manner. APHIS works in tandem with the Environmental Protection Agency to protect the environment and with FDA to protect the food supply.
Horizon Ag is licensed by BASF Corporation to market CL131 seed. Clearfield is a registered trademark of BASF Corporation. LibertyLink is a registered trademark of Bayer Cropscience Gmbh.