Washington, DC
October 5, 2007
The U.S. Department of
Agriculture's Under Secretary for Marketing and Regulatory
Programs Bruce Knight today announced the conclusion of the
genetically engineered rice (GE) investigation. The
investigation, which was conducted by USDA's
Animal and Plant Health
Inspection Service (APHIS) Investigative and Enforcement
Services in coordination with USDA's Office of the Inspector
General, focused on the unintentional release of trace amounts
of regulated genetically engineered rice detected in two
commercial varieties of long-grain rice.
"USDA conducted an extensive investigation that involved more
than 8,500 staff hours and site visits to more than 45 locations
in 11 states and Puerto Rico," said Knight. "Based on our
findings, we are considering a number of actions to strengthen
our enforcement and investigation capabilities and to foster
better quality management practices."
Bayer CropScience developed and field tested the regulated GE
rice lines known as LLRICE601 and LLRICE604, which were designed
for herbicide tolerance. Both GE rice lines have the same added
protein, commonly referred to as the PAT protein, which has been
safely used in other deregulated products for more than ten
years.
The investigation was initiated on Aug. 1, 2006, after Bayer
CropScience reported that regulated LLRICE601 had been detected
in the long-grain rice variety Cheniere. LLRICE601, which is
similar to two previously deregulated lines, was subsequently
deregulated in November 2006. The investigation was expanded on
Feb. 16, 2007 to include the discovery of regulated GE rice,
later identified as LLRICE604, in the long-grain rice variety
Clearfield 131 (CL131).
To assist investigators, USDA officials tested 396 samples from
57 rice varieties that had been harvested between 2002 and 2006.
Other USDA agencies instrumental in this effort were the Grain
Inspection, Packers and Stockyards Administration, the
Agricultural Marketing Service and the Economic Research
Service.
As a result of this extensive sampling, investigators were able
to determine that the presence of LLRICE601 was limited to
Cheniere and that the presence of LLRICE604 was limited to
CL131. In both cases, only trace amounts of GE material were
present. No short- or medium-grain rice varieties tested
positive for either LLRICE601 or LLRICE604.
Investigators had hoped to identify how each GE rice line
entered the commercial rice supply, but the exact mechanism for
introduction could not be determined in either instance.
Investigators found that from 1999 to 2001, LLRICE601 and
Cheniere were both grown at the same time at the Rice Research
Station in Crowley, La which was operated by Louisiana State
University. The Crowley research station was working under a
Bayer CropScience contract. LLRICE604 and CL131 also were grown
at the Crowley research station, but the planting of LLRICE604
and CL131 did not occur at the same time. This means that the
most likely entry point for LLRICE604 into CL131 was through a
means other than direct cross-pollination.
Based upon the findings of the investigation, APHIS will not be
pursuing enforcement against Bayer CropScience. Given the lack
of available information and evidence, USDA was unable to make
any definitive determinations that could have resulted in
enforcement action.
APHIS is releasing a report of the findings as well as lessons
learned from this and other investigations and from its
experience as regulators. For example, APHIS is considering
establishing retention requirements for records. APHIS also is
considering greater isolation distances between seed breeding
fields and GE varieties in order to reduce the likelihood of
pollen flow.
The new Biotechnology Quality Management System, announced in
September, will help industry to establish best management
practices. APHIS will encourage universities, small businesses
and large companies to participate. The goal of the voluntary
program is to help developers establish policies and quality
control practices that proactively address potential issues
before they materialize.
Report:
http://www.aphis.usda.gov/newsroom/content/2007/10/content/printable/RiceReport10-2007.pdf
Lessons learned:
http://www.aphis.usda.gov/newsroom/content/2007/10/content/printable/LessonsLearned10-2007.pdf |
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