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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 1018

Intralytix, Inc.

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

Food Contact Substance: A mixture of equal proportions of lytic-type phages, ECML-4 (157,308 bp), ECML-117 (66,854 bp), and ECML-134 (166,783 bp), isolated from fresh and salt water environments in phosphate-buffered saline.
Notifier: Intralytix, Inc.
Manufacturer: Intralytix, Inc.
Intended Use: As an antimicrobial agent applied to red meat parts and trim prior to grinding.
Limitations/Specifications*: The food contact substance is diluted with water at a ratio of 1:10 and is applied only to red meat parts and trim that will subsequently be ground, to reduce E.coli O157:H7 contamination. An application rate of approximately 2 ml diluted solution per 500 cm2 of surface area may be used.
Effective Date: Feb 5, 2011
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)
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