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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. 1768

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 160 ppm silver dihydrogen citrate (as silver) 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: May 18, 2017
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 189 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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