Code of Federal Regulations
(Title 21, Volume 8) (Revised as of April 1, 2002)
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.
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(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 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.
FTC 1998.
While the filter's efficiency is a factor in assessing the
effectiveness of an air purifier in particulate removal, this
figure overstates the actual effectiveness of the air purifier
in removing pollutants from the air in a user's environment.
The actual effectiveness of an air purifier depends on a variety
of factors including, the amount of air that the air purifier
processes, the nature of the pollutant, and the rate at which
the pollutant is being introduced into the environment.
Additionally, there is no guarantee that
an individual who suffers from allergies or other respiratory
problems will derive a discernible reduction in symptoms through
the use of these or other air purifiers. Whether individuals
will derive such relief depends on many variables, including
the source and severity of their allergies, whether the allergens
at issue tend to remain airborne, the rate at which the allergens
are emitted into their homes or offices, and other environmental
factors.
Federal Trade Commission
First Published: early-December, 2002
Updated: September 2003
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