Washington, DC
March 22, 2007
Evidence gathered by the U.S.
Department of Agriculture’s Animal and Plant Health Inspection
Service 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.
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