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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. 1569

Pure Bioscience, 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 solution of silver dihydrogen citrate stabilized with sodium lauryl sulfate and citric acid
Notifier: Pure Bioscience, Inc.
Manufacturer/Supplier: Pure Bioscience, Inc.
Intended Use: As an antimicrobial solution applied by spray or dip to reduce the pathogen populations on poultry carcasses, parts and organs. (See Limitations/Specifications)
Limitations/Specifications: For use at levels up to 30 ppm silver dihydrogen citrate in the spray or dip applied to poultry carcasses parts and organs. The FCS is not for use in combination with any other silver containing antimicrobial and is not intended to be used in chiller baths.
Effective Date: Dec 18, 2015
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 640 kb)
FDA Decision: Finding of No Significant Impact (FONSI)

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