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U.S. Department of Health and Human Services

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Agency Response Letter GRAS Notice No. GRN 000289

CFSAN/Office of Food Additive Safety

July 22, 2009

Charles D. Miller
Ivy Animal Health, Inc.
9111 Barton Street
Overland Park, KS 66214

Re: GRAS Notice No. GRN 000289

Dear Dr. Miller:

The Food and Drug Administration (FDA) is responding to the notice, dated March 23, 2009, 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); the GRAS proposal). FDA received the notice on April 16, 2009, filed it on April 16, 2009, and designated it as GRAS Notice No. GRN 000289.

The subject of the notice is colicin E1. The notice informs FDA of the view of Ivy Animal Health, Incorporated that colicin E1 is GRAS, through scientific procedures, for use as an antimicrobial to control Escherichia coli on fresh beef carcasses, beef cuts, and ground beef components pre-grind at a level not to exceed 5 milligrams per kilogram on cut meat and trim.

In an electronic mail message dated June 25, 2009, you withdrew your notice. Given your electronic mail message, we ceased to evaluate your GRAS notice, effective June 25, 2009, the date that we received your electronic mail message.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000289, 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 via the FDA home page at http://www.fda.gov. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the “Food” topic to the “Food Ingredients and Packaging” section to the “Generally Recognized as Safe (GRAS)” page where the GRAS Inventory is listed.

Sincerely,

Antonia Mattia, Ph.D.
Director
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition


 

cc: Dr. John M. Hicks, Jr. DVM, MPH
Risk and Innovations Management Division
Office of Policy and Program Development
Food Safety and Inspection Service
U. S. Department of Agriculture
5601 Sunnyside Avenue
Room 2-2105C, mailstop 5271
Beltsville, MD 20705