Agency Response Letter GRAS Notice No. GRN 000364
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CFSAN/Office of Food Additive Safety
March 24, 2011
Edward A. Steele
EAS Consulting Group, LLC
1940 Duke Street, Suite 200
Alexandria, VA 22314
Re: GRAS Notice No. GRN 000364
Dear Mr. Steele:
The Food and Drug Administration (FDA) is responding to the notice, dated December 9, 2010, that you submitted on behalf of OmniLytics, Inc. (OmniLytics) 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); the GRAS proposal). FDA received the notice on December 21, 2010, filed it on December 21, 2010, and designated it as GRAS Notice No. GRN 000364.
The subject of the notice is Bacteriophages LAND12, OLB1, TSRW1, DSMP1, and DP1. The notice informs FDA of the view of OmniLytics that Bacteriophages LAND12, OLB1, TSRW1, DSMP1, and DP1 is GRAS, through scientific procedures, for use as an antimicrobial in foods in general, including meat and poultry products, and in food contact applications to control Escherichia coli O157:H7 at a level up to 5 x 109 plaque forming units (pfu) per milliliter or pfu/gram.
In a letter dated March 14, 2011, on behalf of OmniLytics, you asked that FDA cease to evaluate the notice. Given your request, we ceased to evaluate OmniLytics’s notice, effective March 16, 2011, the date that we received your letter.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000364, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying at www.fda.gov/grasnoticeinventory.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: William K. Shaw, Jr. Ph.D., Director
Risk, Innovations, and Management Division
Office of Policy and Program Development
Food Safety and Inspection Service
U. S. Department of Agriculture
George Washington Carver Center (GWCC)
5601 Sunnyside Avenue, Mail STOP 5272
Beltsville, MD 20705-5272