The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) today announced that after a thorough review of scientific evidence it will deregulate genetically engineered LLRICE601 based on the fact that it is as safe as its traditionally bred counterparts. The final environmental assessment is available on the APHIS web site at http://www.aphis.usda.gov/brs/aphisdocs/06_23401p_ea.pdf and will be published in the Federal Register on December 1.

On July 31, 2006 Bayer CropScience notified USDA and the U.S. Food and Drug Administration (FDA) that the company had detected trace amounts of this regulated rice in commercial long-grain rice. FDA has concluded that the presence of LLRICE601 in the food and feed supply poses no safety concerns. An investigation to determine the circumstances surrounding the release and whether any USDA regulations were violated is nearly complete. Deregulation, or regulatory approval of a particular product, is handled separately from determinations of compliance with APHIS regulations. USDA has approved LLRICE601 for deregulation, while an investigation of compliance is on-going.

Bayer submitted a petition to APHIS to deregulate LLRICE601, which was engineered to be tolerant to herbicides marketed under the brand name LibertyLink. APHIS deregulated two similar LibertyLink rice lines, LLRICE62 and LLRICE06, in 1999 after thorough safety evaluations and is extending its deregulation from the original two lines to include LLRICE601. This protein has been scientifically reviewed and approved for use in a dozen countries around the world.

APHIS published a Sept. 8 notice in the Federal Register seeking public comment on Bayer’s petition. The public comment period closed Oct. 10.

APHIS oversees the development and introduction (importation, interstate movement, and environmental release) of GE organisms. Deregulated items and their progeny are considered safe for the environment and can be grown without APHIS oversight. Developers may also need to consult with FDA and the Environmental Protection Agency before commercialization.