In simple terms it was judged as a superior disinfectant and approved for use in 2001.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Federal Register: June 26, 2001 (Volume 66, Number 123)

Food and Drug Administration

Direct Food Additives Permitted in Food for Human
Consumption

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to provide for the safe use of ozone in gaseous
and aqueous phases as an antimicrobial agent on food, including meat
and poultry. This action is in response to a petition filed by the
Electric Power Research Institute, Agriculture and Food Technology
Alliance.

DATES: This rule is effective June 26, 2001.

FOR FURTHER INFORMATION CONTACT: Robert L. Martin, Center for Food
Safety and Applied Nutrition (HFS-215), Food and Drug Administration,
200 C St. SW., Washington, DC 20204-0001, 202-418-3074.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of September 13, 2000 (65 FR 55264), FDA announced that a petition (FAP 0A4721) had been filed by the Electric Power
Research Institute, Agriculture and Food Technology Alliance, 2747
Hutchinson Ct., Walnut Creek, CA 94598. The petition proposed to amend
the food additive regulations in part 173 (21 CFR part 173) to provide
for the safe use of ozone in gaseous and aqueous phases as an
antimicrobial agent.

The proposed use would include the use of this additive on raw
agricultural commodities (RACs) in the preparing, packing, or holding
of such commodities for commercial purposes, consistent with section
201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act.

The proposed use of the additive includes the use to reduce the
microbial contamination on RACs. Under ARTCA, the use of ozone as an
antimicrobial agent on RACs in the preparing, packing, or holding of
such RACs for commercial purposes, consistent with section
201(q)(1)(B)(i) of the act

Although this use of ozone as an antimicrobial agent on RACs is
regulated under section 409 of the act (21 U.S.C. 348) as a food
additive, the intended use may nevertheless be subject to regulation as
a pesticide under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA). Therefore, manufacturers intending to market ozone for
such use should contact the EPA to determine whether this use requires
a pesticide registration under FIFRA.

FDA has evaluated data in the petition and other relevant material.

Based on this information, the agency concludes that the proposed use
of the additive is safe, that the additive will achieve its intended
technical effect, and therefore, that the regulation in part 173 should
be amended as set forth below.

In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition are available for inspection at the
Center for Food Safety and Applied Nutrition by appointment with the
information contact person listed above

The agency has carefully considered the potential environmental
effects of this rule as announced in the notice of filing for FAP
0A4721. No new information or comments have been received that would
affect the agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.

This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 173 is amended.