Interim Order Respecting Ultraviolet Radiation-emitting Devices and Ozone-generating Devices
Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment;
Therefore, the Minister of Health, pursuant to subsection 67.1 (1)Footnote a of the Pest Control Products ActFootnote b, makes the annexed Interim Order Respecting Ultraviolet Radiation-emitting Devices and Ozone-generating Devices.
Ottawa, June 7, 2021
La ministre de la Santé,
Minister of Health
1 (1) The following definitions apply in this Interim Order.
Regulations means the Pest Control Products Regulations. (Règlement)
ultraviolet radiation-emitting device means a device that is manufactured, represented, distributed or used to control, destroy or inactivate viruses, bacteria or other micro-organisms that are human pathogens, or to reduce their levels - other than in swimming pools, spas or wastewater treatment systems - by means of ultraviolet radiation. (dispositif à rayonnement ultraviolet)
Words and expressions
(2) Unless the context requires otherwise, words and expressions used in this Interim Order have the same meaning as in the Regulations.
2 Despite paragraph 3 (1) (a) of the Regulations, a device of a type described in item 7 of Schedule 1 to the Regulations is exempt from the application of the Act if
- it meets the definition device in section 2 of the Food and Drugs Act; and
- it is classified as a Class II, III or IV medical device under the Medical Devices Regulations.
3 Despite paragraphs 3 (1) (d) and (e) of the Regulations, a device of a type described in item 7 of Schedule 1 to the Regulations is not exempt from the application of the Act.
Non-application - section 30 of Regulations
4 Section 30 of the Regulations does not apply to the label of a device of a type described in item 7 of Schedule 1 to the Regulations.
Ultraviolet Radiation-emitting Devices
Exemption from registration
5 An ultraviolet radiation-emitting device is exempt from the application of subsection 6 (1) of the Act if the following conditions are met:
- the device is certified by a standards development organization accredited by the Standards Council of Canada as meeting the applicable Canadian electrical safety requirements;
- the certification mark of the standards development organization appears on the label of the device;
- any efficacy claim that is made in respect of the device is only a claim of supplemental sanitization;
- no express or implied reference to prevention, treatment or mitigation of disease is made in respect of the device;
- the device has at least one of the following mechanisms:
- a mechanism that locks the device during operation, or
- a mechanism that automatically shuts off the device if it is opened during operation; and
- the ultraviolet lamp is fully shielded or enclosed in the device in a manner that prevents access to it by users of the device and prevents exposure to ultraviolet radiation.
Principal display panel and operating manual
6 The principal display panel and, if any, the operating manual of an ultraviolet radiation-emitting device that is exempt from registration must show the following information:
- the intended use of the device;
- if the device is to be distributed primarily to the general public for personal use in or around their homes, the statement "KEEP OUT OF THE REACH OF CHILDREN";
- the statement "READ THE LABEL AND ANY OPERATING MANUAL BEFORE USING"; and
- the name, postal address, telephone number and email address of a contact person in Canada to which public inquiries may be directed.
Secondary display panel and operating manual
7 The secondary display panel and, if any, the operating manual of an ultraviolet radiation-emitting device that is exempt from registration must show the following information:
- under the heading "PRECAUTIONS", the following statements:
- "WARNING - UV radiation emitted from this device.",
- "Unintended use of the device, or damage to the housing, may result in exposure to ultraviolet radiation.",
- "Ultraviolet radiation may cause eye and skin irritation.", and
- "Avoid exposing eyes and skin to ultraviolet radiation.";
- under the heading "DIRECTIONS FOR USE", the directions for the use of the device, including how to operate the device and any limitations on its use;
- the statement "The use of this device is a supplement to and not a substitute for standard infection control practices; users must continue to follow all current infection control practices, including those related to the cleaning and disinfection of environmental surfaces.";
- information that identifies any risks to health or the environment associated with the handling, storage, display, distribution, use and disposal of the device and instructions on procedures to reduce those risks; and
- under the heading "FIRST AID INSTRUCTIONS", instructions that set out the practical measures to be taken in the event of injury caused by the device.
Schedule 1 to the Regulations
Deeming - Schedule 1 to Regulations
8 Schedule 1 to the Regulations is deemed to include the following after item 6:
7 Devices that are manufactured, represented, distributed or used to control, destroy or inactivate viruses, bacteria or other micro-organisms that are human pathogens, or to reduce their levels - other than in swimming pools, spas or wastewater treatment systems - by means of ultraviolet radiation or ozone.
Application of subsections 6 (1) and (3) of Pest Control Products Act
9 During the period beginning on the day on which this Interim Order is made and ending on the 30th day after that day, a device that is of a type described in item 7 of Schedule 1 to the Regulations is exempt from the application of subsections 6 (1) and (3) of the Act.
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