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More Information About Air Conditioning
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QUESTIONS AND ANSWERS
AIR CLEANERS DESIGNED TO INTENTIONALLY
GENERATE OZONE (OZONE GENERATORS)
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| Q.1 |
Why has Health Canada issued the warning on ozone generators?
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| A.1 |
A risk evaluation by Health Canada on ozone generators in January
1999, concluded that ozone generators pose a risk to the health and safety
of the public. The direct and purposeful introduction of ozone into occupied
indoor environments is unacceptable and therefore should be avoided. Health
Canada is concerned with the adverse health effects that may result from the
deliberate exposure of the public to ozone from air cleaners that
intentionally generate ozone gas (ozone generators). Ozone is an irritant
gas that can cause coughs, chest discomfort, and irritation of the nose,
throat, and trachea. Health Canada has received complaints from consumers of
respiratory problems when using an ozone generator.
Following a
review of current information and in consultation with Health Canada and
others, the Canadian Standards Association (CSA) recently made the decision
not to certify these products for household use and have issued new interim
requirements for commercial units. This warning is aimed at addressing the
devices previously certified and sold. |
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| Q.2 |
Which products are affected? |
| A.2 |
A list of ozone generators which Health Canada has been able to identify
to date has been prepared. This list includes only those ozone generators
which have been certified to Canadian requirements. The brand names may
differ from the company name and as such may not be included in this list.
One way to identify if a company is selling a product under another brand
name is to check the CSA LR number. The LR number is a file number assigned
by the CSA to identify a particular company. The LR number will be located
on the product usually below or to the right of the CSA certification mark.
This list will be updated as new information becomes available to Health
Canada. |
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| Q.3 |
What if my ozone generator is not on Health Canada’s list? |
| A.3 |
Health Canada is aware that other brands of ozone generators are being
sold in Canada and is investigating the certification status of these
products. Consumers are warned that all air cleaners which are designed to
intentionally or purposefully generate ozone gas are affected. The presence
of at least one ozone-generating plate distinguishes that the ozone
production is intentional and is not the unintentional by-product of normal
operation of an electrically-operated product. For household use, most
products are portable, bread-box sized units that plug into the wall and may
have an ozone detector built-in. Some devices may be battery powered and
some may be duct-mounted. Most devices have been sold door-to-door and not
through retail outlets. |
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| Q.4 |
How many ozone generators have been sold in Canada?
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| A.4 |
It is estimated that about 5,000 units have been sold in Canada over the
last two years. This estimate was obtained through data collected by Canada
Customs and Revenue Agency. However, one manufacturer has indicated that
business volumes in Canada are well over 100,000 units. |
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| Q.5 |
What is Health Canada’s warning to consumers?
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| A.5 |
Health Canada is warning consumers not to use an ozone generator in
their homes. |
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| Q.6 |
Does Health Canada’s warning apply to the use of an ozone generator
in unoccupied spaces? |
| A.6 |
Health Canada is concerned about the use of ozone generators in occupied
spaces where the public may be exposed to ozone gas. Health Canada’s warning
does not apply to ozone generators intended for use in unoccupied spaces by
trained individuals who are following appropriate occupational health and
safety requirements. |
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| Q.7 |
What is ozone? |
| A.7 |
Ozone is a gas. Its molecules consist of three oxygen atoms,
designated by the chemical symbol O3. It is created by lightning
in the lower atmosphere and by solar ultraviolet rays in the upper
atmosphere. The ozone layer in the upper atmosphere absorbs much of the
ultraviolet radiation from the sun, and thus protects life on earth from
these harmful rays. However, at ground level, ozone is generated by the
action of sunlight on emissions from industry and vehicle exhaust, and is an
air pollutant. In an ozone generator, ozone is produced by applying an
electrical current to at least one ozone-generating plate which then charges
oxygen in the incoming air and produces ozone. |
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| Q.8 |
Since I have used an ozone generator in my home, will I be sick?
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| A.8 |
The type of adverse health effects one may experience from exposure to
ozone will depend on what concentration was received and for how long. For
ozone, the dose is linked to the concentration of the gas in the air, the
duration of exposure and the rate of air intake (for example, exercising
increases the rate of air intake). Some people have reported headaches, sore
throats, irritated eyes and laryngitis from using an ozone generator. The
symptoms reportedly ceased when the device was turned off. Persons with
asthma are more sensitive than the general public to low levels of ozone.
Consumers should consult their physician for health concerns related to
ozone exposure. |
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| Q.9 |
What about other types of air cleaners?
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| A.9 |
The warning only applies to air cleaners that intentionally generate
ozone gas. Health Canada is aware that other air cleaners or other
electrically-operated devices may generate ozone as a by-product of their
normal operation. Consumers are reminded that other air cleaners such as
electrostatic precipitators should be properly installed and maintained
according to the manufacturer’s specifications. |
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| Q.10 |
What regulations cover ozone generators?
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| A.10 |
Both the Food and Drugs Act (FDA) and the Pest Control
Products Act (PCPA) cover ozone generators. The claimed purpose or
representation, as well as where and how the device is used determines which
regulations apply. In order to avoid being subject to regulation under the
Food and Drugs Act and/or the Pest Control Products Act, ozone
generators continue to be marketed in Canada as “air cleaners” or “pollution
control devices” without making medical or biocidal claims or being marked
for medical or biocidal purpose or use. |
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| Q.11 |
How are devices regulated under the Food and Drugs Act?
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| A.11 |
Prior to July 1, 1998, The Medical Devices Regulations of the
Food and Drugs Act prohibited medical devices which were designed to
generate airborne ozone to which humans may be exposed. A limit of 0.05 ppm
(vol/vol) was set for other medical devices which generated ozone incidental
to their normal operation. However, when the new Medical Devices
Regulations came into effect on July 1, 1998, the old regulations and
schedules ceased to exist and presently there are no regulations on medical
devices that produce ozone. To replace the old Schedule VIII, the
Therapeutic Products Programme has drafted a policy on ozone generators.
Meanwhile, the new Medical Devices Regulations establish general
safety and effectiveness requirements for medical devices. The policy
describes the performance and quality standards in which to measure the
safety and effectiveness of subject devices. Health Canada does not
recognize any health benefits from human exposure to ozone and therefore
precludes approval of such devices under the Medical Devices Regulations.
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| Q.12 |
How are devices regulated under the Pest Control Products Act?
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| A.12 |
The Pest Control Products Act requires that manufacturers of
devices making biocidal claims (e.g., destroys bacteria, prevents the growth
of mould), or that have a biocidal use or purpose, prove that those devices
are safe and efficacious before they are marketed in Canada. No applications
for registration of air cleaners that intentionally generate ozone have been
made to the Pest Management Regulatory Agency (PMRA) to date. |
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| Q.13 |
Does ozone kill germs? |
| A.13 |
To be effective as a germicide, the concentration of ozone must be far
greater than any human could tolerate. A study by the U.S. Environmental
Protection Agency indicated that ozone was not effective in killing airborne
moulds and fungi, even at concentrations as high as 6 to 9 ppm. |
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| Q.14 |
What regulations exist to cover ozone generators that are not subject
to the FDA or PCPA? |
| A.14 |
Presently, no regulations for ozone generators exist under the
Hazardous Products Act (HPA). The jurisdiction for electrical products
(such as plug-in type air cleaners) rests with provincial electrical
authorities. Each province has adopted an electrical code or regulation
which has general rules regarding the sale of electrical equipment. These
general rules direct that no person can sell electrical equipment unless it
conforms to the applicable standard as certified by an accredited
certification organization such as the Canadian Standards Association (CSA).
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| Q.15 |
What certification requirements apply to ozone generators?
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| A.15 |
Over the last few years, air cleaners that incorporate features that
intentionally generate ozone intended for both residential and commercial
use have been certified. The previous requirements for such products were
contained in Electrical Bulletins Numbers 750B, 750C, 750E and Electrical
Certification Notice No. 243C. These certification requirements have
recently been cancelled and superseded by the requirements contained in
Technical Information Letter (TIL) No. H-13.
On November 30, 1998, the Canadian Standards Association (CSA) announced
the publication of a TIL No. H-13 which incorporates additional requirements
for air cleaners that intentionally generate ozone. Effective November 30,
1998, the CSA does not certify air cleaners that intentionally generate
ozone for household use. Manufacturers of devices marked for use in
commercial establishments are required to meet additional marking
requirements before March 30, 1999 and additional testing requirements
before August 1, 1999 as contained in the TIL. |
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| Q.16 |
What standards apply to ozone generators?
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| A.16 |
Ozone generators are subject to common electrical standards, such as
those which address fire and shock hazards, as well as the TIL H-13
(effective November 30, 1998), which specifically addresses the intentional
exposure to ozone from air cleaners. |
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| Q.17 |
What should I do with my ozone generator now that Health Canada has
warned me not to use it in my home? |
| A.17 |
The public should discuss return policies with the manufacturer or
distributor from whom he/she purchased the product. |
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| Q.18 |
Have there been any complaints about ozone generators?
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| A.18 |
Health Canada has received complaints from consumers about ozone
generators. In two cases, a commercial device was used in the home, and in a
separate case residents of a seniors residence complained of respiratory
problems allegedly related to an ozone generator (type unknown). After the
advisory was issued on February 5, 1999, numerous calls were received from
consumers indicating that they had experienced respiratory problems when
using an ozone generator in their home. |
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| Q.19 |
Does the warning also apply to battery-operated air cleaners?
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| A.19 |
The warning applies to all air cleaners designed to intentionally
generate ozone whether they are plug-in, hard-wired or battery-operated.
Health Canada is aware that battery-operated devices will not be captured by
the CSA certification requirements. |
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| Q.20 |
Since Health Canada warns that I should not use my ozone generator in
my home, what else can I do? |
| A.20 |
There are a number of sanitary practices available to improve indoor air
quality and to prevent or solve problems for which ozone generators are
currently marketed. The three most common approaches to reducing indoor air
pollution, in order of effectiveness, are: source control (eliminate or
control the sources of pollution); ventilation (dilute and exhaust
pollutants through outdoor air ventilation); and air cleaning (remove
pollutants through proven air cleaning methods). The Canada Mortgage and
Housing Corporation (CMHC) has published The Clean Air Guide - How to
Identify and Correct Indoor Air Problems in Your Home. It can be ordered
for a nominal fee by calling 1-800-668-2642.
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April 3, 2000 |
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Updated:
10/26/2008
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aware consumer. Before hiring a contractor or an inspector,
verify their credentials and licenses. It may save you a lot
of headaches in the future. Individuals with credentials are
required to take CEU's to maintain their credibility and
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