Research Data

Organisms Killed by Ozone

Ozone has the ability to kill most known bacteria and other common organisms that are found in the food and beverage industries.

Chemical Compatibility of Ozone with Other Materials

The following table displays the compatibility of ozone with a wide variety of materials. Please feel free to contact McClain with questions concerning ozone material compatibility.

ozone material compatibility.

Material	Compatibility
304 stainless steel	B-Good
316 stainless steel	A-Excellent
ABS plastic	B-Good
Polyoxymethylene (Delrin)	C-Good
Aluminum	B-Good
Brass	N/A
Bronze	B-Good
Buna N (Nitrile Rubber)	D-Severe Effect
Carbon graphite	N/A
Carbon Steel	C-Fair
Carpenter 20	N/A
Cast iron	N/A
Ceramic Al203	N/A
Ceramic magnet	N/A
ChemRaz (FFKM)	B-Good
Copper	A-Excellent
CPVC	A-Excellent
EPDM	A-Excellent
Epoxy	N/A
Fluorocarbon (FKM)	A-Excellent
Hastelloy-Cr	N/A
Hypalonr	A-Excellent
Hytrelr	C-Fair
Kalrez	A-Excellent
Kel-Fr	A-Excellent
LDPE	C-Fair
Natural rubber	D-Severe Effect
Neoprene	C-Fair
NORYLr	N/A
Nylon	D-Severe Effect
Polycarbonate	A-Excellent
Polyetherether Ketone (PEEK)	A-Excellent
Polypropylene	B-Good
Polyurethane	A-Excellent
PPS (Rytonr)	N/A
PTFE (Teflonr)	A-Excellent
PVC	B-Good
PVDF (Kynarr)	A-Excellent
Silicone	A-Excellent
Titanium	N/A
Tygonr	N/A
Vitonr	A-Excellent

Ratings – Chemical Effect

1. A = Excellent
2. B = Good – Minor effect, slight corrosion or discoloration.
3. C = Fair – Moderate effect, not recommended for continuous use.
4. Severe Effect – Not recommended for any use.

Ozone Solubility in Water (Saturation) Versus Temperature

Celsius	Fahrenheit	Grams/liter	ppm
0	32.0	0.0394	39.4
12	53.6	0.299	29.9
19	66.2	0.21	21.0
27	80.6	0.0139	13.9
40	104	0.0042	4.2
60	140	0.0	0.0

Source:

CRC Handbook of Chemistry and Physics
180th Edition 2001
David Lide, Editor
Published by CRC Press

Ozone Half Life vs. Temperature

Typical Ozone Half-Life vs. Temperature

Gaseous Ozone	Ozone Dissolved in Water (pH 7)
Temp(C) Half-Life -50 3 months -35 18 days -25 8 days 20 3 days 120 1.5 hours 250 1.5 seconds	Temp (C) Half-Life 15 30 minutes 20 20 minutes 25 15 minutes 30 12 minutes 35 8 minutes 35 8 minutes
* These values are based on thermal decomposition, no wall effects or other catalytic (reaction) effects are considered.

Properties of Ozone

Typical Ozone Half-Life vs. Temperature

Property	Ozone	Oxygen
Molecular Formula:	O3	O2
Molecular Weight:	48	32
Color:	Light Blue	Colorless
Smell:	Characteristic Odor Clothes after being outside on clothesline. Photocopy machines. Smell after lightning storms.	Odorless
Solubility in Water (@ O-deg C):	0.64	0.049
Density (g/l):	2.144	1.429
Electrochemical Potential, V:	2.07	1.23

MSDS

Material Safety Data Sheet

Ozone

Identity: Ozone (Triatomic Oxygen) Formula: O3

Description:

Ozone is naturally formed in the environment from the interaction of UV light and lightning with atmospheric oxygen. Commercially produced by passing air or oxygen through high voltage. It is also created as a by-product of human activities such as welding, copy equipment, high voltage equipment, and UV radiation.

As a gas, ozone is a powerful oxidizing agent and highly reactive. Ozone uses include air and water disinfection, microbial control (fungi, yeast, bacteria, etc.), bleaching, and as an oxidizing agent in manufacturing and waste disposal processes.

Exposure to ozone gas can produce respiratory complications from minor irritation to pulmonary endema; eye irritation; and affect the blood and nervous system.

Manufacturer/Supplier: Onsite generation equipment available from several suppliers including:

McClain Ozone, Inc.

EPA Est. # 074150-CA-001

1768 Tanen Street

Napa, CA 94559
707-254-0576

NIOSH RTECS Number: RS8225000       CAS Number: 10028-15-6

CAUTION! Olfactory fatigue develops rapidly and odor should not be used as a protective warning device.

Waste Disposal / Storage: Ozone gas rapidly decomposes to form oxygen and cannot be stored. Follow federal, state and local regulations.

FDA Final Ruling

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. Submit written objections and requests for a hearing by July 26, 2001. The Director of the Office of the Federal Register approves the incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a certain publication listed in Sec. 173.368(c), effective as of June 26, 2001.

ADDRESSES: Submit written objections to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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 food additive 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 for the treatment, storage, and processing of foods.

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 act) (21 U.S.C. 321(q)(1)(B)(i)), as amended by the Antimicrobial Regulation Technical Corrections Act of 1998 (ARTCA) (Public Law 105-324). The petitioner is not proposing that the additive be intended for use for any application under section 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act, which use would be subject to regulation by the Environmental Protection Agency (EPA) as a pesticide chemical. 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, and not otherwise included within the definition of “pesticide chemical” under section 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) is subject to regulation by FDA as a food additive.

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. As provided in Sec. 171.1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

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.

Any person who will be adversely affected by this regulation may at any time file with the Dockets Management Branch (address above) written objections by July 26, 2001. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents are to be submitted and are to be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 173

Food additives, Incorporation by reference.

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 as follows:

PART 173–SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION

1. The authority citation for 21 CFR part 173 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348.

2. Section 173.368 is added to subpart D to read as follows:

Sec. 173.368 Ozone.

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 Sec. 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), 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.
Dated: June 15, 2001.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied Nutrition.
[FR Doc. 01-15963 Filed 6-25-01; 8:45 am]
BILLING CODE 4160-01-S