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Government approvals of Ozone

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FDA — SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION (2004) 1 CFR 173.368

Since 2004, The FDA has deemed Ozone safe to use as an antimicrobial agent in the treatment, storage, and processing of foods, including meat and poultry.

 USDA — FSIS DIRECTIVE 7210.1

Since January 2000, the USDA/FSIS has officially accepted ozone as safe and suitable for use in the production of meat and poultry products. In accordance with current industry standards of good manufacturing practice.

FSIS — RESPONSE TO INTERPRETATION REQUEST (2001)

November 27, 2001, the American Meat Institute filed a letter with FSIS asking for interpretation on the scope of the FDA rule allowing the use of ozone as an antimicrobial agent. FSIS determined that, “the use of ozone on raw and ready-to-eat meat and poultry products just prior to packaging is acceptable”, and that there are “no labelling issues in regard to treated product”.

NOP — NATIONAL ORGANIC PROGRAM

Ozone can be used as an ingredient in or on organic foods and as surface sanitation on food contact surfaces in food processing, distribution, and retail centers and maintain an “Organic” or “Made with Organic Ingredients” label. (Please note this does not apply to products with “100% Organic” labeling requirements.). Refer to CFR 205.605 for details.

 OSHA — REGULATIONS FOR OZONE GAS

Ozone meets OHSA guidelines if ambient levels and exposure times are within limits listed below:

PEL (Permissible Exposure Limit): 8-hour Time Weighted Average 0.1 PPM Vol. 

STEL (Short Term Exposure Limit): 15 minutes 0.3 PPM Vol.

IDLH (Immediately Dangerous to Life and Health): 5 PPM Vol

USDA — APPROVAL AS A HARD SURFACE SANITIZER

The NSF White Book Listing replaces the terminated US Department of Agriculture (USDA) Listing of Proprietary Substances and Nonfood Compounds.

EPA — TRISTRATA GROUP IS REGISTERED AS A PESTICIDE-PRODUCING ESTABLISHMENT

The EPA regulates ozone as a pesticide. Thus, ozone equipment must be registered by the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The private labeling company’s EPA Establishment No. is 071472-CA-001 for TriStrata Group.