USDA and FDA Ozone Regulations

Ozone has been given GRAS approval by the USDA and the FDA for direct contact with food products, including all meat and poultry products.

GRAS = Generally Regarded As Safe

GRAS approval allows ozone to be used in the food industry with no regulations on processing applications and levels of ozone provided good manufacturing procedures are in place.

The FDA granted ozone GRAS approval in 2001, the USDA followed with the final rule granting GRAS in 2002. References for these GRAS approvals are listed below.

 

History of ozone prior to GRAS status:

1957 - Ozone in the gaseous form was approved for the storage of meat by the USDA.

March 12, 1975 - FDA recognized ozone treatment to be a Good Manufacturing Practice (GMP) for the bottled water industry. The minimum ozone treatment for GMP is “0.1 part per million (0.1 mg/l) of ozone in water solution in an enclosed system for at least 5 minutes.”

Code 21 of Federal Regulations, Section 129.80 d.4 Federal Register 11566, 12 March 1975.

November 5, 1982 - FDA granted ozone GRAS approval specifically for bottled water applications, and as a sanitizing agent for bottled water treatment lines.  Unfortunately, the GRAS approval contained the statement "all other food additive applications for ozone must be the subject of appropriate food additive petitions."

21 CFR Part 184.1563

Original Federal Register Vol. 47, No 215 from Nov 5, 1982

 

June 14, 1997 - A panel of experts from food science, ozone technology,  declared GRAS status for ozone use in food processing.

This panel of experts was requested by the Energy Power Research Institute (EPRI).  The EPRI was instrumental in achieving GRAS status for ozone.  In 2000 the EPRI compiled the initial petition submitted to the FDA and USDA.

Excerpt from the 2000 EPRI petition below:

In 1999, recognizing that the 1982 ruling created confusion among the food processors, the FDA encouraged EPRI's FTA to pursue the development and submission of a Food Additive Petition (FAP) that would allow the use of ozone as a contact antimicrobial agent in food. Petitioners D.M. Graham of EPRI and R.G. Rice of RICE International Consulting Enterprises completed the FAP and submitted it to the FDA in August 2000. After an expedited and rigorous review by the FDA staff, the FDA recognized ozone as an antimicrobial agent suitable for use in Food Processing and Agricultural Production. Notice of this recognition appeared in the Federal Register, June 26, 2001.

 

Current Regulations:

 

USDA final rule on ozone dated 12/17/2002, FSIS Directive 7120.1

Safe and suitable ingredients used in the production of meat and poultry

FSIS Directive 7120.1 States:

Ozone for use on all meat and poultry products.  Ozone can be used in accordance with current industry standards of good manufacturing practice. No other guidelines are given on levels or dosages of ozone.

 

USDA 21 CFR 173.368 is the reference used in FSIS directive 7120.1

USDA 21 CFR 173.368 States:

Ozone (CAS Reg. No. 10028–15–6) may be safely used in the treatment, storage, and processing of foods, including meat and poultry (unless such use is precluded by standards of identity in 9 CFR part 319), in accordance with the following prescribed conditions: (a) The additive is an unstable, colorless gas with a pungent, characteristic odor, which occurs freely in nature. It is produced commercially by passing electrical discharges or ionizing radiation through air or oxygen. (b) The additive is used as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter. (c) The additive meets the specifications for ozone in the Food Chemicals Codex, 4th ed. (1996), p. 277, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20055, or may be examined at the Office of Premarket Approval (HFS–200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC, and the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (d) The additive is used in contact with food, including meat and poultry (unless such use is precluded by standards of identity in 9 CFR part 319 or 9 CFR part 381, subpart P), in the gaseous or aqueous phase in accordance with current industry standards of good manufacturing practice. (e) When used on raw agricultural commodities, the use is consistent with section 201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the act) and not applied for use under section 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act.

 

FDA Federal Register Vol. 66 No.123 June 26, 2001

Federal Register Vol. 66 No. 123

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.

This rule is effective June 26, 2001.

This also references § 173.368(c) listed above

Full FDA Volume 66, Number 123

 

Ozone is CAS Registry Number 10028-15-6

 

US Regulatory Approvals Summary paper

Below is a link to a wonderful summary of ozone regulatory information written by the grandfather of ozone, Rip G Rice, and his colleague Dee M Graham.  

U.S. FDA Regulatory Approval of Ozone as an Antimicrobial Agent – What Is Allowed and What Needs to Be Understood

 

 

Additional USDA Reference

Guidance on Ingredients and Sources of radiation Used to REduce Microorganisms on Carcasses, Ground Beef, and Beef Trimmings



National Organic Program and Ozone

USDA National Organic Program Summary

Ozone can be used as an ingredient in organic foods. However, these foods will not be able to maintain a 100% organic rating. They will only be allowed an Organic, or Made with an organic ingredients label.

Ozone can be used in the production of crops. Ozone is considered a synthetic substance and regulated as such in crop production. Ozone is allowed for the cleaning of irrigation systems only. Provided ozone is used in this manner, all crops will maintain 100% organic rating.

 

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