Ozone has the ability to kill most known bacteria and other common organisms that are found in the food and beverage industries.
Achromobacter butyri NCI-9404
Aeromonas harveyi NC-2
Aeromonas salmonicida NC-1102
Bacillus megatherium sp.
Flavorbacterium SP A-3
Micrococcus caseolyticus KM-15
Vibrio alginolyticus & angwillarum
Virrio ichthyodermis NC-407
Candida albicans-all forms
Common yeast cake
Adenovirus (type 7a)
Coxackie A9, B3, & B5
Echovirus 1, 5, 12, &29
GD V11 Virus
Polio virus (Poliomyelitus) 1, 2 & 3
FUNGUS & MOLD SPORES
Aspergillus flavus (yellowish-green)
Aspergillus glaucus (bluish-green)
Aspergillus niger (black)
Aspergillus terreus, saitoi & oryzac
Mucor recomosus A & B (white-gray)
Oospora lactis (white)
P. chrysogenum & citrinum
Penicillium digitatum (olive)
Penicillium expansum (olive)
Penicillium roqueforti (green)
Rhizopus nigricans (black)
Chlorella vulgaris (Algae)
All Pathogenic and Non-pathogenic forms of Protozoa
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.
|304 stainless steel||B-Good|
|316 stainless steel||A-Excellent|
|Buna N (Nitrile Rubber)||D-Severe Effect|
|Natural rubber||D-Severe Effect|
|Polyetherether Ketone (PEEK)||A-Excellent|
Ratings – Chemical Effect
CRC Handbook of Chemistry and Physics
Typical Ozone Half-Life vs. Temperature
|Gaseous Ozone||Ozone Dissolved in Water (pH 7)|
|* These values are based on thermal decomposition, no wall effects or other catalytic (reaction) effects are considered.|
Typical Ozone Half-Life vs. Temperature
|Solubility in Water (@ O-deg C):||
|Electrochemical Potential, V:||2.07||1.23|
Material Safety Data Sheet
Section 1: Material Identification
Identity: Ozone (Triatomic Oxygen) Formula: O3
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
Section 2: Health Hazard Identification
NIOSH RTECS Number: RS8225000 CAS Number: 10028-15-6
|OSHA PEL:||8-hour TWA: 0.1 ppm (0.2 mg/m3) 15-minute STEL: 0.3 ppm (0.6 mg/m3)|
|ACGIH TLV:||Ceiling - 0.1 ppm (0.2 mg/m3)|
|NIOSH REL:||Ceiling - 0.1 ppm (0.2 mg/m3)|
CAUTION! Olfactory fatigue develops rapidly and odor should not be used as a protective warning device.
Section 3: Physical Data
|Boiling Point:||-170o F (-112o C)|
|Melting Point:||-313o F (-193o C)|
|Vapor Pressure:||> 1 atm|
|Vapor Density:||2.114 (Air = 1)|
|Solubility in Water:||0.5 ml in 100 gallons at 0o C 30 ppm at 20o C|
|Appearance and Odor:||Colorless gas with characteristic pungent odor.|
Section 4: Fire and Explosion Hazard
|Flash Point:||Non Flammable|
|Auto Ignition Temp.:||Non Applicable|
|Special Fire Fighting Procedure:||Ozone is an oxidizer, use media appropriate for surrounding materials.|
|Unusual Fire and Explosion Hazards:||Can react dangerously in high concentrations with analine, C6H6, Br2, diethyl ether, N2O2, ethylene, HB, HI, NO2, NO, NCl, nitroglycerin, organic liquids, organic matter, and Sn (Tin).|
Section 5: Reactivity Data
|Reactivity:||Reacts with any oxidizable materials, both organic and inorganic.|
|Conditions to Avoid:||Avoid strong reducing agents, combustible materials (i.e. grease, oils, fats, etc.), and ignition sources (i.e. heat, sparks, open flame).|
|Hazardous Decomposition:||Ozone rapidly decomposes to oxygen.|
Section 6: Health Hazard Data
|Carcinogenicity:||Ozone is not listed as a carcinogen by the NTP, IARC, or OSHA.|
|Routes of Entry:||Eyes and inhalation are the primary routes of entry.|
|Target Organs:||Respiratory system, eyes and blood.|
|Acute Effects:||Occurs primarily from the oxidation of tissue.|
|Chronic Effects:||Respiratory disease.|
|Medical Restrictions:||History of respiratory or heart disease. Persons with asthma or emphysema may be further aggravated by exposure to ozone.|
|Concentration (ppm)||Duration of Exposure||Effect|
|0.01 - 0.04 ppm||N/A||Odor Threshold|
|0.1 ppm||N/A||Minor eye, nose and throat irritation.|
|>0.1 ppm||Few minutes.||Continuous headache, shortness of breath.|
|0.25 - 0.5 ppm||2-5 hours.||Reduction in lung function and the ability to do physical work (for persons with a history of heart and lung disease).|
|>0.4 ppm||2 hours.||Reduction in lung function during moderate work for all persons.|
|>0.6 ppm||2 hours.||Chest pain, dry cough.|
|1 ppm||1 - 2 hours.||Lung irritation (coughing), severe fatigue.|
|>1.5 ppm||2 hours.||Reduced ability to think clearly. Continuing cough and extreme tiredness maybe lasting for 2 weeks. Severe lung irritation with fluid build-up.|
|9 ppm||Intermittent||Severe pneumonia (arc welders).|
|10 ppm||Immediate Danger to Life and Health!|
|11 ppm||15 minutes.||Rapid unconsciousness.|
|50 ppm||30 minutes.||Expected to be fatal.|
Section 7: First Aid Measures
|Inhalation:||Remove from area to fresh air and administer oxygen as needed. Seek medical attention.|
|Eyes:||Remove from area and flush eyes continuously for at least 15 minutes with water. Seek medical attention.|
Section 8: Precautions for Safe Handling and Use
|Employee Protection:||Respiratory Protection:||0.2 - 10 ppm - Canister type (carbon) respirators.
>10 ppm - MISH/NIOSH approved Self Contained Breathing Apparatus (SCBA).
|Eye Protection:||>10 ppm - Chemical safety goggles.|
|Engineering Controls:||Provide workplace engineering controls adequate to maintain ozone gas levels below recommended OSHA/ACGIH exposure limits. Such controls may include but are not limited to the following:
|Spill/Leak Procedures:||Emergency procedures should be developed and followed in the event of a spill/leak. Appropriate personal protective equipment should be available and utilized. All applicable laws and regulations as well as OSHA requirements should be followed.|
Waste Disposal / Storage: Ozone gas rapidly decomposes to form oxygen and cannot be stored. Follow federal, state and local regulations.
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