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U.S. Department of Health and Human Services


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U.S. Food and Drug Administration's Statement on Report of Bioengineered Rice in the Food Supply

CFSAN/Office of Food Additive Safety
August 2006

Bayer CropScience 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.