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U.S. Department of Health and Human Services


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Agency Response Letter GRAS Notice No. GRN 000174

CFSAN/Office of Food Additive Safety

September 21, 2005

Delia Bethell, Ph.D.
Ventria Bioscience
4110 N. Freeway Blvd.
Sacramento, CA 95834

Re: GRAS Notice No. GRN 000174

Dear Dr. Bethell:

The Food and Drug Administration (FDA) is responding to the notice, dated June 22, 2005, that you submitted 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 June 23, 2005, filed it on June 28, 2005, and designated it as GRAS Notice No. GRN 000174.

The subject of the notice is lysozyme (human) enzyme preparation from rice. The notice informs FDA of the view of Ventria Bioscience that lysozyme (human) enzyme preparation from rice is GRAS, through scientific procedures, for use as an antimicrobial agent in cheese, processed meats, beer production, and winemaking; and as an ingredient in meal replacements, frozen dairy desserts, yogurt, snack bars, sports beverages, and medical foods.

In a letter dated September 6, 2005, you withdrew your notice. Given your letter, we ceased to evaluate your GRAS notice, effective September 13, 2005, the date that we received your letter.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter, as well as a copy of the information in your notice that conforms to the information in proposed 21 CFR 170.36(c)(1), is available for public review and copying on the homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).


Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
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, and Employee Development
     Food Safety and Inspection Service
     1400 Independence Ave., SW, Suite 602, Annex
     Washington, DC 20250-3700