WASHINGTON, Oct. 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.