| Ozone Decontamination

Water and Wastewater Treatment Applications

Ozone is both a powerful oxidizer and effective disinfectant which makes it a natural fit for treating drinking water (i.e. public and private,
wells, etc.) and municipal/industrial wastewater.
In 1785, Van Marum no iced that air near his electrostatic machine acquired a characteristic odor when electric sparks werepassed. In 1840,
Shonbein named the substance, which gave off this odor, "ozone" from the Greek word "ozein" to smell. In 1886 ozone was recognized as
a disinfectant for water and in 1891 the first pilot plant in Germany proved ozone effective against bacteria. The first drinking water plant
began opera ions in Nice, France, in 1906 and Nice is generally referred to as the birthplace of ozonation for drinking water treatment.
Today more han 2000 installations worldwide use ozone to treat drinking water and its use is increasing rapidly. Environmental concerns
wi h the transport, storage, and disposal of chemicals combined with the health concerns with halogenated chemical byproducts (THMs)
make ozone a favorable alternative to halogen chemicals including chlorine.
Treating municipal and industrial wastewater with ozone was a key focus in the United States during he late 1970s and early 1980s. Today
the use of ozone in wastewater treatment is accelerating rapidly due to both wastewater discharge regulations and the environmental
concerns with halogenated chemicals (including chlorine) and the byproducts they produce.
Applica ions of ozone in water and wastewater treatment include the following:
1) Disinfection Ozone effectively destroys a broad spectrum of microbes and pathogens including bacteria, Cryptosporidium, Giardia,
Amoebae and all known viruses more rapidly than any other chemical.
Summary of Ct-Value Range for 99% Inactivation of Various Microorganisms by Disinfectants at 5oC
Organism

Free Chlorine pH 6-7

Preformed Chloramine pH 8-9

Chlorine Dioxide pH 6-7

Ozone

E. Coli

0.034-0.05

95-180

0.4-0.75

0.02

Polio I

0.1-2.5

768-3740

0.2-6.7

0.1-0.2

Rotavirus

0.01-0.05

3806-6476

0.2-2.1

0.006-0 06

Phage F2

0.08-0.18

---

---

---

Giardia Lamblla cysts

47-150

---

---

0.5-0.6

Giardia muris cysts

36-630

1400

7.2-18.5

1.8-2.0

Cryptosporidium

7200

7200

79

5-10

2) Taste, Odor and Color Removal The powerful oxidation potential of ozone allows it to be effective in the reduction or elimination of taste,
odor and color (including tannin).
3) Oxidation of Inorganics and Metals Many metals can be reduced to very low, safe levels in water and wastewater through ozone
oxida ion.
Lab results have shown that ozone can convert nitrite ions to nitrate ions and remove the following metals at 99.5% or above: iron,
manganese, copper, lead, arsenic, aluminum, cadmium, chromium, cobalt, zinc, mercury (complete removal at pH 4) and nickel (Coate,
1997). In addition, ozone oxidation can also be utilized to liberate organically bound heavy metals.
4) Oxidation of Organics Organic contaminants can be reduced and/or removed u ilizing ozone as an oxidizer.
Ozonation has also been shown to be effective in treating the following: acetic acid, butoxyethanol, isopropyl alcohol, Methyl-ethyl Ketone,
Acetone, Aetyl Alcohol, Alycerol, Aropylene glycol, n-butyl acetate, formaldehyde, methacrylic acid, benzene benzyl alcohol, resorcinol, nbutyl phthalate camphor, para-phenylenediamine, styrene trecresyl-phosphate, xylene, butane, liquefied-petroleum-gas, mineral spirits,
methylene-chloride, perchloroethylene, trichloroethylene, hydrogen cyanide, ammonium-hydroxide, ethanolamine, toluene, isobutane,
propane, methyl-chloroform, amino-phenol, ammonia, ammonium-persulfate-phenacetin, ethylene tetracetic acid (EDTA), alkylated silicates,
and non-ionic detergents (Coate, 1997).
Ozone can also be converted to hydroxyl radicals which are even more powerful oxidizers than ozone itself. Processes in which ozone is
converted to hydroxylradicals to achieve higher reaction rates are known as Advanced Oxidation Processes and can be utilized to treat many
wastewaters.
Ozone has the following advantages over other chemical alternatives:

Ozone is a very powerful oxidant (second only to fluorine) which is always generated on-site requiring no transportation or storage of
dangerous chemicals.
Ozone effectively destroys a broad spectrum of microbes and pathogens (Organisms Killed by Ozone including bacteria, Giardia,
Amoebae and all known viruses more rapidly than any other chemical (including chlorine compounds) and ozone is he only
recommended primary disinfectant for Cryptosporidium.
Ozone oxidizes organic and inorganic impurities and because it is a 50 percent stronger oxidizer than chlorine, ozone requires
significantly less contact time to remove inorganic/organic compounds.
Ozones powerful oxidation potential allows it to be effective in the reduction or elimination of taste, odor and color (including tannin).
Ozone reactions (unlike halogen chemicals) do not produce halogenated disinfection byproducts such as trihalomethanes (THMs)
and ozone rapidly decomposes to oxygen leaving nothing behind.
Ozone treated wastewaters do not contain chlorine or chlorinated disinfection byproducts, hereby making de-chlorination
unnecessary. In addition, treatment of wastewater with ozone increases dissolved oxygen levels eliminating the need for effluent reaeration.
Ozone increases coagulation effectiveness and does not alter the pH of the water.
Ozone systems can be highly automated and are very reliable.
In the United States, ozone has historically been used more frequently in large water and wastewater treatment systems. Ozones use in
small or medium-sized systems, where its benefits could reach more people, has been restricted by the size, cost and reliability of ozone
generating equipment.
The introduction of CLEAN AIRSOzone on demmand systems has made ozone available for these smaller systems and applications.

| Ozone Decontamination
CLEAN AIRS focuses on assisting small and medium sized systems and facilities (public and private) in the use of ozone. Our systems are
cost effective, highly reliable, can be designed and utilized in any size water or wastewater application. In addition, we take pride in assisting
our water and wastewater clients with design, technical support and training in the use of our systems.

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.
BACTERIA
Achromobacter butyri NCI-9404
Aeromonas harveyi NC-2
Aeromonas salmonicida NC-1102
Bacillus anthracis
Bacillus cereus
B. coagulans
Bacillus globigii
Bacillus licheniformis
Bacillus megatherium sp.
Bacillus paratyphosus
B. prodigiosus
Bacillus subtilis
B. stearo hermophilus
Clostridium botulinum
C. sporogenes
Clostridium tetoni
Cryptosporidium
Coliphage
Corynebacterium diphthriae
Eber hella typhosa
Endamoeba histolica
Escherichia coli
Escherichia coli
Flavorbacterium SP A-3
Leptospira canicola
Listeria
Micrococcus candidus
Micrococcus caseolyticus KM-15
Micrococcus spharaeroides
Mycobacterium leprae
Mycobacterium tuberculosis
Neisseria catarrhalis
Phytomonas tumefaciens

Botrytis allii
Colletotrichum lagenarium
Fusarium oxysporum
Grotrichum
Mucor recomosus A & B (white-gray)
Mucor piriformis
Oospora lactis (white)
Penicillium cyclopium
P. chrysogenum & citrinum
Penicillium digitatum (olive)
Penicillium glaucum
Penicillium expansum (olive)
Penicillium egyptiacum
Penicillium roqueforti (green)
Rhizopus nigricans (black)
Rhizopus stolonifer
PROTOZOA
Paramecium
Nematode eggs
Chlorella vulgaris (Algae)
All Pathogenic and Non-pathogenic forms of
Protozoa
Shigella flexnaria
Shigella paradysenteriae
Spirllum rubrum
Staphylococcus albus
Staphylococcus aureus
Streptococcus 'C'
Streptococcus faecalis
Streptococcus hemolyticus
Streptococcus lactis
Streptococcus salivarius
Streptococcus viridans

Proteus vulgaris
Pseudomonas aeruginosa
Pseudomonas
fluorscens (bioflims)
Pseudomonas putida
Salmonella choleraesuis
Salmonella enteritidis
Salmonella typhimurium
Salmonella typhosa
Salmonella paratyphi

Torula rubra
Vibrio alginolyticus & angwillarum
Vibrio clolarae
Vibrio comma
Virrio ichthyodermis NC-407
V. parahaemolyticus

Sarcina lutea
Sera ia marcescens
Shigella dysenteriae

Giardia muris

VIRUS
Adenovirus (type 7a)
Bacteriophage (E.coli)
Coxackie A9, B3, & B5
Cryptosporidium
Echovirus 1, 5, 12, &29
Encephalomyocarditis
Hepa itis A
HIV
GD V11 Virus
Onfectious hepatitis
Influenza
Legionella pneumophila
Polio virus (Poliomyelitus) 1, 2 & 3
Rotavirus
Tobacco mosaic
Vesicular Stomatitis
FUNGUS & MOLD SPORES
Aspergillus candidus
Aspergillus flavus (yellowish-green)

CYSTS
Cryptosporidium parvum
Giardia lamblia

YEAST
Baker's yeast
Candida albicans-all forms
Common yeast cake
saccharomyces cerevisiae
saccharomyces ellipsoideus
saccharomyces sp.
ALGAE
Chlorella vulgaris
Thamnidium
Trichoderma viride
Verticillium albo-atrum
Verticillium dahliae
FUNGAL PATHOGENS
Alternaria solani
Botrytis cinerea
Fusarium oxysporum
Monilinia fruiticola
Monilinia laxa
Pythium ultimum
Phytophthora erythroseptica

| Ozone Decontamination
Aspergillus glaucus (bluish-green)
Aspergillus niger (black)
Aspergillus terreus, saitoi & oryzac

Phytophthora parasitica
Rhizoctonia solani
Rhizopus stolonifera
Sclerotium rolfsii
Sclerotinia sclerotiorum

Chemical Compatibility of Ozone with Other Materials

The following table displays the compatibility of ozone with a wide variety of materials.
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

Polyethere her 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

| Ozone Decontamination
0

32.0

0.0394

12

53.6

0.299

39.4
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

Temp(C)

Half-Life

-50

3 months

15

30 minutes

-35

18 days

20

20 minutes

-25

days

25

15 minutes

20

3 days

30

12 minutes

120

1.5 hours

35

8 minutes

250

1.5 seconds

35

8 minutes

* These values are based on thermal decomposition, no wall effects or other cataly ic (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 Section 1: Material Identification

Identity: Ozone (Triatomic Oxygen) Formula: O3
Description:
Ozone is naturally formed in the environment from the interac ion 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 activi ies 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:
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)

IDLH:

10 ppm

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

| Ozone Decontamination
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

pH:

Not Available

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 e her, N2O2, ethylene, HB, HI, NO2, NO, NCl,
nitroglycerin, organic liquids, organic matter, and Sn (Tin).

Section 5: Reactivity Data

Stability:

Unstable

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 igni ion sources (i.e. heat, sparks, open flame).

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 Restric ions:

History of respiratory or heart disease. Persons with asthma or

emphysema may be further aggravated by exposure to ozone.

0.01 - 0.04 ppm

Dura ion of Exposure

Effect

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
iredness maybe lasting for 2 weeks.
Severe lung irritation wi h fluid buildup.

9 ppm

Intermittent

10 ppm

Severe pneumonia (arc welders).

Immediate Danger to Life and Health!

Concentration (ppm)

Dura ion 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.

Page 6 of 9

| Ozone Decontamination
>0.6 ppm

2 hours.

Chest pain, dry cough.

1 ppm

1 - 2 hours.

Lung irritation (coughing), severe

>1.5 ppm

2 hours.

Reduced ability to think clearly.

Continuing cough and extreme
iredness maybe lasting for 2 weeks.
Severe lung irritation wi h fluid buildup.

9 ppm

Intermittent

fatigue.

10 ppm

Severe pneumonia (arc welders).

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

Inhala ion:

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.

Skin:

Not applicable.

Ingestion:

Not applicable.

Section 8: Precautions for Safe Handling and Use

0 2 - 10 ppm - Canister type
Respiratory Protection:
Employee Protection:

Eye Protection:

(carbon) respirators. >10 ppm MISH/NIOSH approved Self

Contained Breathing Apparatus
(SCBA).
>10 ppm - Chemical safety
goggles.

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 he following:

Engineering Controls:

1. Develop standard workplace practices and emergency procedures

to be adhered to when working with ozone.
2. Provide employees training in equipment operation, safety and
emergency procedures.
3. Provide adequate workplace ven ilation systems.
4. Utilize appropriate instrumentation to monitor and control ozone
levels in the workplace (i.e. ambient ozone monitor(s), alarms,
generator controls, etc.).

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 regula ions
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.

FDA Final Ruling

SUMMARY: The Food and Drug Administration (FDA) is amending the food addi ive regulations to provide for the safe use of ozone in
gaseous and aqueous phases as an an imicrobial 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 objec ions and requests for a hearing by July 26, 2001. The Director of the Office
of the Federal Register approves the incorpora ion 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 (HFS215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204-0001, 202-418-3074.
SUPPLEMENTARY INFORMATION: In a notice published in he Federal Register of September 13, 2000 (65 FR
55264), FDA announced that a food additive petition (FAP 0A4721) had been filed by he Electric Power Research Institute, Agriculture and
Food Technology Alliance, 2747 Hutchinson Ct., Walnut Creek, CA 94598. The peti ion 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 sec ion 201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act ( he 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 applica ion under section 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)

| Ozone Decontamination
(i)(III) of the act, which use would be subject to regulation by the Environmental Protection Agency (EPA) as a pes icide chemical. The
proposed use of the additive includes the use to reduce he
microbial contamination on RACs. Under ARTCA, he 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 he act, and not otherwise included wi hin 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 never heless be subject to regulation as a pes icide 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 he 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 he 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 A4721. 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 bjection 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 objec ion 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
wi h 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 addi ives, 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 con inues 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

| Ozone Decontamination
Ozone increases coagulation effectiveness and does not alter the pH of the water.
Ozone systems can be highly automated and are very reliable.

In the United States, ozone has historically been used more frequently in large water and wastewater treatment systems. Ozones use in
small or medium-sized systems, where its benefits could reach more people, has been restricted by the size, cost and reliability of ozone
generating equipment.
The introduction of CLEAN AIRSOzone on demmand systems has made ozone available for these smaller systems and applications.
CLEAN AIRS focuses on assisting small and medium sized systems and facilities (public and private) in the use of ozone. Our systems are
cost effective, highly reliable, can be designed and utilized in any size water or wastewater application. In addition, we take pride in assisting
our water and wastewater clients with design, technical support and training in the use of our systems.