FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
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CFSAN/Office of Food Additive Safety
March 2007

U.S. Food and Drug Administration's
Statement on LLRICE 600 Series

The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) has informed the U.S. Food and Drug Administration (FDA) that, as part of APHIS's ongoing investigation into the presence of minute levels of APHIS-regulated genetic material found in Clearfield 131 (CL131) rice seed, LLRICE 604 has been identified as the source of the genetic material. LLRICE 604, from the LLRICE 600 series, was developed by Bayer CropScience for herbicide tolerance.

Bayer CropScience recently notified FDA that bioengineered rice varieties from the LLRICE 600 series express the phosphinothricin-N-acetyltransferase (PAT) protein which provides tolerance to glufosinate-ammonium herbicide.

As discussed in the FDA's June 2006 guidance document, "Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use" (available at http://www.cfsan.fda.gov/~dms/bioprgu2.html), in cases where a new plant variety intended for food use may be present in the food supply at only low levels, FDA believes that any food or feed safety concern is limited to the safety of the new protein (such as its potential toxicity or its potential to be allergenic). If a protein has previously been evaluated as part of a biotechnology or early food safety consultation and no safety concerns were identified, FDA would not have safety concerns about the low level presence in food or feed of a new plant variety containing that protein.

FDA has previously evaluated the PAT protein for safety on a number of occasions through the Agency's voluntary biotechnology consultation process. Therefore, FDA has concluded that the presence of rice from the LLRICE 600 series at low levels in food and feed would pose no food or feed safety concerns.


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