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D. GRAHAM, R&D Enterprises, Walnut Creek, CA 94598

The efficacy of ozone as an antimicrobial agent was established in France in 1902, based on effective kill of microorganisms such as bacteria, fungi, viruses, Giardia and Chryptosporidium. Absence of chemical residues, less hazardous handling and improved taste favored ozonation.

In the U.S., cost, availability, and ease of use favored use of chlorine after World War I. Use of chlorine was established prior to the 1958 Food Additives Amendment. Regulatory barriers impeded the adoption of ozone in the U.S. Ozone was not in the 1958 GRAS list, since ozone then was not generally viewed as a food chemical. Subsequent interpretations of the Food and Drug regulations classified ozone as a food additive, requiring FDA regulation. FDA issued a limited GRAS Ruling in 1982 for use of ozone in bottled water. The ruling was issued under the highly restrictive section 184.1(b)2, which required any other use to be regulated, not subject to GRAS affirmation. A more appropriate ruling issued under 184.1(b)3 would have permitted other uses to be GRAS with adequate review and evaluation. Two petitions for use of ozone as a food additive were filed and subsequently withdrawn without prejudice.

In 1997, an EPRI Expert Panel reported a comprehensive evaluation of ozone use and declared ozone GRAS for use in food processing. The troublesome 184.1(b)2 ruling issued in 1982 emerged as a persistent impediment to the GRAS affirmation of ozone. A pending food additive petition in preparation attempts to rationalize the regulatory posture for use of ozone in food processing.

Relying on the 1997 GRAS declaration, numerous successful applications of ozone as an antimicrobial agent have emerged. These include equipment sanitation, sanitizing rinse for fresh-cut produce, apples, and strawberries, storage aid for onions and potatoes, etc.