Government Regulations
FDA: FDA Summary of Final Rule Regarding Ozone FSIS Directive: Safe and Suitable Ingredients Used in the Production of Meat and Poultry Products (Updated - See Page 33)
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Seeking an Alternative to Chemical Sanitizers
In the past two decades, the consumption of fresh fruits, vegetables, seafood, meat and poultry in the U.S. and internationally has dramatically increased. In the meantime, the incidence of food borne illness due to food pathogens, chemicals, and wastewater has greatly increased. This continues to draw significant public and government attention.
The number of produce-associated food borne disease outbreaks and the number of cases of illness due to food pathogens have significantly increased in recent years. Moreover, losses in the fresh produce industry that are attributable to microbial spoilage between the time of harvest and consumption are estimated to be as high as 30%.
Chlorine is commonly used in the food industry to improve microbiological quality and control pathogens. However, many research studies have indicated that it is limited in its ability to kill bacteria on fruit and vegetable surfaces. Environmental and health organizations have expressed concerns with traditional sanitizing agents with respect to the formation of by-products, such as trihalomethanes (THMs) and other chemical residues formed in the wastewater returned to the environment. The food and beverage industry is concerned about the possibility of future regulatory constraints on the use of chlorine as a sanitation agent.
Large amounts of pesticides have been used annually to control insects on fruits and vegetables. Current technologies cannot totally destroy the chemical residues on the surface of fruits and vegetables. These chemical residues may react with pesticides to form chemical by-products. These residues ultimately will be consumed by customers and may directly and indirectly affect public health. An accumulation of toxic chemicals in the environment has increased the national focus on the safe use of disinfectants, sanitizers, bleaching agents, and other chemicals in the food processing industry.
The food and beverage industry is one of the largest and most important contributors to the world economy. It also generates billions of gallons of wastewater annually, with very high concentrations of bio-chemical oxygen demand (BOD) and chemical residues each year in the U.S. These waste waters have been linked to many serious problems such as cancer, fish death, water pollution, psychological and physiological diseases, and ecosystem damage. Moreover, the food and beverage industry is paying heavy charges and surcharges for discharging wastewater into public water and wastewater treatment systems.
In the past two decades, the consumption of fresh fruits, vegetables, seafood, meat and poultry in the U.S. and internationally has dramatically increased. In the meantime, the incidence of food borne illness due to food pathogens, chemicals, and wastewater has greatly increased. This continues to draw significant public and government attention.
The number of produce-associated food borne disease outbreaks and the number of cases of illness due to food pathogens have significantly increased in recent years. Moreover, losses in the fresh produce industry that are attributable to microbial spoilage between the time of harvest and consumption are estimated to be as high as 30%.
Chlorine is commonly used in the food industry to improve microbiological quality and control pathogens. However, many research studies have indicated that it is limited in its ability to kill bacteria on fruit and vegetable surfaces. Environmental and health organizations have expressed concerns with traditional sanitizing agents with respect to the formation of by-products, such as trihalomethanes (THMs) and other chemical residues formed in the wastewater returned to the environment. The food and beverage industry is concerned about the possibility of future regulatory constraints on the use of chlorine as a sanitation agent.
Large amounts of pesticides have been used annually to control insects on fruits and vegetables. Current technologies cannot totally destroy the chemical residues on the surface of fruits and vegetables. These chemical residues may react with pesticides to form chemical by-products. These residues ultimately will be consumed by customers and may directly and indirectly affect public health. An accumulation of toxic chemicals in the environment has increased the national focus on the safe use of disinfectants, sanitizers, bleaching agents, and other chemicals in the food processing industry.
The food and beverage industry is one of the largest and most important contributors to the world economy. It also generates billions of gallons of wastewater annually, with very high concentrations of bio-chemical oxygen demand (BOD) and chemical residues each year in the U.S. These waste waters have been linked to many serious problems such as cancer, fish death, water pollution, psychological and physiological diseases, and ecosystem damage. Moreover, the food and beverage industry is paying heavy charges and surcharges for discharging wastewater into public water and wastewater treatment systems.
In response to the public concerns about food safety, the President of the United States and Congress issued a new federal initiative in 1997 – the President’s Food Safety Initiative – to improve the nation’s food safety system and our environment. One of the approaches to improve food safety is to identify an alternative sanitizer to replace traditional sanitizing agents which can also be used to treat or recycle food processing wastewater.
Research and commercial applications have indicated that ozone can replace chlorine with more benefits. In 1997, ozone was self-affirmed as Generally Recognized As Safe (GRAS) as a disinfectant for foods by an independent panel of experts sponsored by EPRI . This self-affirmation was timely for the produce industry in light of the President’s Fruit and Vegetable Safety Initiative. The food and beverage industry is now using ozone very successfully.
Research and commercial applications have indicated that ozone can replace chlorine with more benefits. In 1997, ozone was self-affirmed as Generally Recognized As Safe (GRAS) as a disinfectant for foods by an independent panel of experts sponsored by EPRI . This self-affirmation was timely for the produce industry in light of the President’s Fruit and Vegetable Safety Initiative. The food and beverage industry is now using ozone very successfully.
[Code of Federal Regulations] [Title 21, Volume 3]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.368]
[Page 140]
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION--Table of Contents
Subpart D--Specific Usage Additives
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 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.
[66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, 2002]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.368]
[Page 140]
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION--Table of Contents
Subpart D--Specific Usage Additives
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 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.
[66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, 2002]
No Labelling Required
Ozone has been approved by the USDA as a secondary direct food additive and is considered a processing aid. As such, Ozone need not be declared in the ingredients statement, nor need it be mentioned in any way in relation to the finished food product.
Secondary Direct Food Additives
Acidified sodium chlorite, peroxyacids, and ozone are examples of substances that have been approved as secondary direct food additives. Secondary direct food additives provide a momentary technical effect and not a lasting effect in the treated food. These substances are ordinarily removed from the final food, and any residuals that may carry over to the final product are not expected to exhibit any technical effect. Thus, they would be considered processing aids under FDA’s definition of that term in 21 CFR, 101.100(a)(3), i.e., there is no lasting functional effect, and there is an insignificant amount present in the finished product under the proposed conditions of use. Even though FSIS has no definition of "processing aid" in its labeling regulations, the Agency, through the Labeling and Consumer Protection Staff (LCPS), which serves as FSIS’ focal point on the use and labeling of food ingredients, makes judgments on a case-by-case basis using FDA’s definition of a processing aid to decide whether the use of a substance is as a processing aid or as an ingredient of a food. If a substance is a processing aid, it need not be declared in the ingredients statement, nor need there be provision for its use in any standard of identity that is applicable to the finished food.
Ozone has been approved by the USDA as a secondary direct food additive and is considered a processing aid. As such, Ozone need not be declared in the ingredients statement, nor need it be mentioned in any way in relation to the finished food product.
Secondary Direct Food Additives
Acidified sodium chlorite, peroxyacids, and ozone are examples of substances that have been approved as secondary direct food additives. Secondary direct food additives provide a momentary technical effect and not a lasting effect in the treated food. These substances are ordinarily removed from the final food, and any residuals that may carry over to the final product are not expected to exhibit any technical effect. Thus, they would be considered processing aids under FDA’s definition of that term in 21 CFR, 101.100(a)(3), i.e., there is no lasting functional effect, and there is an insignificant amount present in the finished product under the proposed conditions of use. Even though FSIS has no definition of "processing aid" in its labeling regulations, the Agency, through the Labeling and Consumer Protection Staff (LCPS), which serves as FSIS’ focal point on the use and labeling of food ingredients, makes judgments on a case-by-case basis using FDA’s definition of a processing aid to decide whether the use of a substance is as a processing aid or as an ingredient of a food. If a substance is a processing aid, it need not be declared in the ingredients statement, nor need there be provision for its use in any standard of identity that is applicable to the finished food.
