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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. 739

Bio-Cide International, 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: An aqueous solution of sodium chlorite and chlorine dioxide containing up to 1200 mg/kg sodium chlorite and up to 30 mg/kg chlorine dioxide.
Notifier: Bio-Cide International, Inc.
Manufacturer/Supplier: Bio-Cide International, Inc.
Intended Use: For use on poultry carcasses, carcass parts, poultry meat, organs, or related parts or trim as an antimicrobial agent in poultry processing waters, as a component of a carcass spray or a dip solution.
Limitations/Specifications: The additive is produced by mixing an aqueous solution of sodium chlorite with any generally recognized as safe acid to achieve a pH in the range of 2.2 to 3.0, then further diluting this solution with a pH elevating agent to achieve the final sodium chlorite concentration. When used as a carcass spray or dip on poultry carcasses, carcass parts, poultry meat, organs or related parts or trim, the final sodium chlorite concentration does not exceed 1200 mg/kg, and the chlorine dioxide concentration does not exceed 30 mg/kg. The pH of the use solution is between 5.0 and 7.5. When used in a pre-chiller or chiller solution on poultry carcasses and poultry carcass parts, the additive is used at a level that results in sodium chlorite concentrations between 50 and 150 parts per million. Contact times may be up to several minutes at temperatures between 0 and 15oC.
Effective Date: Oct 26, 2007
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 897 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement