EXCERPT: "This rice variety, not intended for commercialization, was not submitted to FDA for evaluation under the Agency's voluntary biotechnology consultation process." - FDA
U.S. Food and Drug Administration's Statement on Report of Bioengineered Rice in the Food Supply
CFSAN/Office of Food Additive Safety
August 18 2006
Bayer CropSciences recently notified the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture Animal and Plant Health Inspection Service (APHIS) that trace amounts of a bioengineered variety of rice were detected in samples of commercial rice seed, and may have entered the food and feed supply in the United States. The bioengineered variety of rice, called LLRICE601, expresses the phosphinothricin-N-acetyltransferase (PAT) protein which provides tolerance to glufosinate-ammonium herbicide. This rice variety, not intended for commercialization, was not submitted to FDA for evaluation under the Agency's voluntary biotechnology consultation process. However, crops containing the PAT protein have previously been evaluated for safety by FDA on a number of occasions through the Agency's voluntary biotechnology consultation process. Bayer has informed the Agency that LLRICE601 is present in some samples of commercial rice seed at low levels. In addition, Bayer has provided information about the safety of the PAT protein, molecular characterization, and nutritional composition of grain from LLRICE601. Based on the available data and information, FDA has concluded that the presence of this bioengineered rice variety in the food and feed supply poses no food or feed safety concerns.
Statement by Agriculture Secretary Mike Johanns Regarding Genetically Engineered Rice
USDA, August 18 2006
Release No. 0307.06
"The U.S. Department of Agriculture and U.S. Food and Drug Administration have been notified by Bayer CropScience that the company has detected trace amounts of regulated genetically engineered (GE) rice in samples taken from commercial long grain rice. Both have reviewed the available scientific data and concluded that there are no human health, food safety, or environmental concerns associated with this GE rice.
"Bayer has developed many GE herbicide-tolerant products with the protein called Liberty Link, three of which are rice. The regulated line is LLRICE 601 and Bayer reports finding only trace amounts of it during testing. LLRICE 601 was field tested between 1998 and 2001. Two deregulated lines, LLRICE 62 and LLRICE 06, have been through thorough safety evaluations and have been deemed safe for use in food and safe in the environment, although these lines have not been commercialized.
"Based on the available data and information, the U.S. Food and Drug Administration has concluded that the presence of LLRICE 601 in the food and feed supply poses no safety concerns. USDA's Animal and Plant Health Inspection Service also conducted a risk assessment, which indicates LLRICE 601 is safe in the environment.
"Bayer indicated it had no plans to market LLRICE 601 and therefore had not requested deregulation. Based on reports that LLRICE 601 is in the marketplace and a petition from Bayer, APHIS will conduct a deregulation process, including an opportunity for public comment.
"Because the line of GE rice in question was regulated, APHIS is conducting an investigation to determine the circumstances surrounding the release and whether any violations of USDA regulations occurred.
"The protein found in LLRICE 601 is approved for use in other products. It has been repeatedly and thoroughly scientifically reviewed and used safely in food and feed, cultivation, import and breeding in the United States, as well as nearly a dozen other countries around the world.
"Since 1987, APHIS has deregulated more than 70 GE crop lines and in the last decade farmers have increasingly planted biotech varieties engineered mainly for herbicide tolerance, insect resistance, and enhanced quality traits. USDA's National Agricultural Statistics Service estimates that in 2006, 61 percent of the corn, 83 percent of the cotton and 89 percent of the soybeans planted in the United States were biotech varieties."
U.S. Food and Drug Administration's Statement On Report Of Bioengineered Rice In The Food Supply http://www.cfsan.fda.gov/~lrd/biorice.html
Fact Sheet: Genetically Engineered Rice http://www.usda.gov/2006/08/0306.xml
Karen Eggert (202) 720-2511
Ed Loyd (202) 720-4623
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