[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]
 
                        TITLE 21--FOOD AND DRUGS
 
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]