[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR801.415]

[Page 26-27]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 801--LABELING--Table of Contents
 
          Subpart H--Special Requirements for Specific Devices
 
Sec. 801.415  Maximum acceptable level of ozone.

    (a) Ozone is a toxic gas with no known useful medical application in 
specific, adjunctive, or preventive therapy. In order for ozone to be 
effective as a germicide, it must be present in a concentration far 
greater than that which can be safely tolerated by man and animals.
    (b) Although undesirable physiological effects on the central 
nervous system, heart, and vision have been reported, the predominant 
physiological effect of ozone is primary irritation of the mucous 
membranes. Inhalation of ozone can cause sufficient irritation to the 
lungs to result in pulmonary edema. The onset of pulmonary edema is 
usually delayed for some hours after exposure; thus, symptomatic 
response is not a reliable warning of exposure to toxic concentrations 
of ozone. Since olfactory fatigue develops readily, the odor of ozone is 
not a reliable index of atmospheric ozone concentration.
    (c) A number of devices currently on the market generate ozone by 
design or as a byproduct. Since exposure to ozone above a certain 
concentration can be injurious to health, any such device will be 
considered adulterated and/or misbranded within the meaning of sections 
501 and 502 of the act if it is used or intended for use under the 
following conditions:
    (1) In such a manner that it generates ozone at a level in excess of 
0.05 part per million by volume of air circulating through the device or 
causes an accumulation of ozone in excess of 0.05 part per million by 
volume of air (when measured under standard conditions at 25 [deg]C (77 
[deg]F) and 760 millimeters of mercury) in the atmosphere of enclosed 
space intended to be occupied by people for extended periods of time, 
e.g., houses, apartments, hospitals, and offices. This applies to any 
such device, whether portable or permanent or part of any system, which 
generates ozone by design or as an inadvertent or incidental product.
    (2) To generate ozone and release it into the atmosphere in 
hospitals or other establishments occupied by the ill or infirm.
    (3) To generate ozone and release it into the atmosphere and does 
not indicate in its labeling the maximum acceptable concentration of 
ozone which may be generated (not to exceed 0.05 part per million by 
volume of air circulating through the device) as established herein and 
the smallest area in which such device can be used so as not to produce 
an ozone accumulation in excess of 0.05 part per million.
    (4) In any medical condition for which there is no proof of safety 
and effectiveness.
    (5) To generate ozone at a level less than 0.05 part per million by 
volume of air circulating through the device and

[[Page 27]]

it is labeled for use as a germicide or deodorizer.
    (d) This section does not affect the present threshold limit value 
of 0.10 part per million (0.2 milligram per cubic meter) of ozone 
exposure for an 8-hour-day exposure of industrial workers as recommended 
by the American Conference of Governmental Industrial Hygienists.
    (e) The method and apparatus specified in 40 CFR part 50, or any 
other equally sensitive and accurate method, may be employed in 
measuring ozone pursuant to this section.