FDA Approval: Rules and Regulations - PDF (55kb)

On June 26, 2001 the U.S. FDA approved the use of ozone as an antimicrobial agent in the gas or liquid phases for direct contact with foods. In this paper, the author will discuss and interpret specific wordings of the FDA approval in terms of several food uses of ozone and existing safety regulations. This will be followed by discussions of gas- and liquid-phase applications of ozone in food and agricultural applications, and recommendations for determining appropriate dosages of ozone that should be applied to specific foodstuffs. Ozone has been approved for use under "Good Manufacturing Practices", meaning "exposure of foods to sufficient ozone (concentrations and times of exposure) to accomplish its intended purpose." This means determining the minimum exposure to ozone necessary to provide desired antimicrobial benefits on specific foodstuffs and also determining at what (presumably higher) level ozone causes damage to the foodstuffs and/or result in off-gassing of ozone sufficient to violate OSHA's PEL or STEL and/or EPA's environmental limits. It is therefore critical for the user of ozone to understand the meanings of "Good Manufacturing Practice" with respect to ozone and to determine, by actual testing, the minimum and maximum ozone dose/exposure conditions for each food application contemplated. An Ozone Evaluation Protocol is suggested for those new to ozone – as follows: 1) Select the candidate food item or process. 2) Identify specific spoilage microorganisms. 3) Establish ozone or process performance requirements. 4) Check literature for data. If insufficient data are available, then 5) Conduct laboratory studies to develop the required ozone performance data. 6) Apply ozonation conditions to specific food/process and confirm performance. 7) Determine costs and benefits obtained.

Download the USDA/ National Organic Program (NOP) Ozone Approval Document