Agency Additional Corresondence Letter GRAS Notice No. GRN 000130
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CFSAN/Office of Food Additive Safety
Philip C. Olsson
Olsson, Frank and Weeda, P.C.
1400 Sixteenth Street NW
Washington, DC 20036-2220
Re: GRAS Notice No. GRN 000130
Dear Mr. Olsson:
In a letter dated August 21, 2003, the Food and Drug Administration (FDA) responded to the notice, dated May 23, 2003, that you submitted on behalf of aLF Ventures, LLC (aLF Ventures) in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS)). FDA received the notice on May 28, 2003, filed the notice on May 28, 2003, and designated the notice as GRAS Notice No. GRN 000130. The notice informed FDA of the view of aLF Ventures that bovine milk-derived lactoferrin is GRAS, through scientific procedures, for use as a component of an antimicrobial spray that would deliver one gram (g) of lactoferrin per dressed beef carcass, followed by a wash with tempered water and rinse with lactic acid, resulting in less than 800 micrograms (mg) lactoferrin per kilogram (kg) of edible beef.
In our letter of August 21, 2003, we described two previous GRAS notices involving bovine milk-derived lactoferrin, GRAS Notice No. GRN 000067 and GRAS Notice No. GRN 000077. In our description of GRN 000077, we mistakenly reported an incorrect estimated daily intake of bovine milk-derived lactoferrin from the intended use as an ingredient in sports foods and functional foods. In our August 21, 2003 letter we stated that the estimated daily intake of lactoferrin from this intended use is 1.0 gram per person per day (g/p/d) at the mean and 2.1 g/p/d at the 90th percentile. However, the actual estimated daily intake of lactoferrin from that use, as stated in our response to GRN 000077, is 105 milligrams per person per day (mg/p/d) at the mean and 196 mg/p/d at the 90th percentile. Although the mistake had no effect on our evaluation of GRN 000130, we are issuing this additional correspondence in order to establish the correct estimated daily intake for GRN 000077 in the record for GRN 000130. We apologize for any inconvenience or confusion that may have resulted from our mistake.
George H. Pauli, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: Dr. Robert Post, Director
Labeling and Consumer Protection Staff
Office of Policy, Program Development and Evaluation
Food Safety and Inspection Service
1400 Independence Ave., SW, Suite 602, Annex
Washington, DC 20250-3700