Questions and Answers: Notice of Intent to Develop an Interim Order to Regulate Certain Ultraviolet Radiation-Emitting Devices and Ozone-Generating Devices under the Pest Control Products Act

Follow the link to read NOI2021-01, Notice of Intent: Interim order to regulate certain ultraviolet radiation-emitting devices and ozone-generating devices under the pest control products act.

1) Who is the Pest Management Regulatory Agency?

Health Canada's Pest Management Regulatory Agency (PMRA) is the regulatory authority in Canada responsible for the regulation of pesticides (pest control products) under the authority of the Pest Control Products Act (PCPA) and the Pest Control Products Regulations (PCPR). The PMRA's primary mandate is to protect Canadians and the environment and ensure that the products in the marketplace are safe and effective by regulating products used for the control of pests. Pests can include, but are not limited to, bacteria, viruses, fungi, mold, etc. All pesticides manufactured, imported, distributed, or used in Canada must be registered by the PMRA or otherwise authorized under the PCPA to ensure they meet Canadian health and environmental standards, bear the Canadian label and are used according to label directions.

2) Why are certain types of UV radiation-emitting and ozone-generating devices considered pesticides (pest control products)?

Certain types of UV radiation-emitting or ozone-generating devices are represented or used as a means to control, destroy or inactivate viruses, bacteria or other micro-organisms, or reduce their levels on surfaces and objects, in water and in air. These bacteria and viruses are considered "pests" under the PCPA.

A list of devices that are pest control products requiring registration under the PCPA is set out in Schedule 1 of the PCPR. These include certain types of UV radiation-emitting and ozone-generating devices, such as item 2 (devices used to attract or destroy flying insects); item 3 (devices that repel pests using electromagnetic radiation); and item 5 (devices that provide the automatic or unattended application of a pest control product). More of these UV radiation-emitting and ozone-generating devices would become subject to the requirements of the PCPA as a result of this interim order (IO).

3) What is the purpose of this IO?

The primary purpose of this IO would be to address the serious health and safety concerns of UV radiation-emitting or ozone-generating that are widely marketed in Canada for use in various settings, predominantly for use in domestic dwellings to kill bacteria and viruses on surfaces and objects such as cell phones, keys, remote controls, in water such as humidifiers and the air in small to large sized rooms.

Health Canada has not yet received sufficient evidence to demonstrate that UV radiation-emitting and ozone-generating devices are safe, nor as effective as claimed. These devices can pose serious health and safety concerns. For instance, depending on the UV wavelength, intensity, and duration of radiation exposure, exposure to ultraviolet light from these devices can result in serious injuries, including severe burns to the skin and eyes. Similarly, inhaling ozone can lead to decreased lung function, irritation of respiratory pathways, and inflammation of pulmonary tissues, as well as irreversible lung damage leading to higher susceptibility of respiratory infections.

This IO would make these devices subject to safety and efficacy assessments and registration or authorization prior to entering the Canadian market. For UV radiation-emitting devices, the higher risk devices would have to be registered, while lower risk devices could be marketed without being registered provided they meet requirements that would prevent UV exposure. There would also be labelling requirements for these lower risk UV radiation-emitting devices authorized under the PCPA.

In addition, the IO would close the regulatory gap that currently exists for UV radiation-emitting or ozone-generating devices that are represented as an effective means to kill human pathogens at a very high threshold of efficacy. The IO would also address the risks recently published in the Advisory to Canadians by ensuring UV radiation-emitting hand-held devices or hand-held ozone-generating devices, among others, are subject to a pre-market assessment and must be registered under the PCPA prior to entering the Canadian market.

4) What type of UV radiation-emitting or ozone-generating devices would be subject to this IO?

UV radiation-emitting or ozone-generating 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, would be subject to this IO. Some examples of UV radiation-emitting or ozone-generating devices are those marketed for use in domestic dwellings to kill bacteria and viruses on surfaces and objects such as cell phones, keys, remote controls, in water such as humidifiers, and in the air in small to large sized rooms. Other examples consist of UV radiation-emitting or ozone-generating devices that are used in commercial or health care settings, to kill bacteria and viruses on surfaces or in the air.

5) What would need to be met for a UV radiation-emitting device to be exempt from registration?

The IO would introduce requirements related to certification, specific device features and statements to exempt certain UV radiation-emitting devices from pre-market registration. Specifically, all of the following conditions are being considered for exempting certain UV radiation-emitting devices from registration:

  1. the device is certified by a standards development organization accredited by the Standards Council of Canada as meeting the applicable Canadian electrical safety requirements; (See Q 17 for further information)
  2. the certification mark of the standards development organization appears on the label;
  3. only a claim of supplemental sanitation may be made in respect of the device and there must not be any express or implied reference to prevention, treatment or mitigation of disease; (See Q 18 for further information)
  4. the device must have at least one of the following features: (See Q 19 for further information)
    1. a locking mechanism during operation, or
    2. an automatic shut off feature, if opened during operation; and
  5. the ultraviolet lamp is fully shielded or enclosed in the device in a manner that
    1. prevents access to it by users of the device; and
    2. prevents exposure to ultraviolet radiation.

6) Would there be any other requirements for UV radiation-emitting devices that meet the conditions for exemption?

The following informational requirements would need to appear on the specified display panels and any operating manual:

The principal display panel and the operating manual, if any, of the UV radiation-emitting device would have to show the following information:

  1. the intended use of the device;
  2. 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";
  3. the statement "READ THE LABEL AND ANY OPERATING MANUAL BEFORE USING"; and
  4. the name, postal address, telephone number and email address of a contact person in Canada to which public inquiries may be directed.

The secondary display panel and the operating manual, if any, of the UV radiation-emitting device would have to show the following information:

  1. under the heading "PRECAUTIONS", the following statements:
    1. "WARNING - UV radiation emitted from this device.";
    2. "Unintended use of the device, or damage to the housing, may result in exposure to ultraviolet radiation.";
    3. "Ultraviolet radiation may cause eye and skin irritation."; and
    4. "Avoid exposing eyes and skin to ultraviolet radiation.";
  2. 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;
  3. 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 practices related to cleaning and disinfection of environmental surfaces.";
  4. information that identifies any risks to health or the environment associated with the handling, storage, display, distribution and disposal of the device or anything in connection with which the device is to be used, and instructions on procedures to reduce those risks; and
  5. under the heading "FIRST AID INSTRUCTIONS", instructions in first aid that set out the practical measures to be taken in the event of injury caused by the device.

Scope of the IO

7) My UV radiation-emitting or ozone-generating device is solely sold or used as a means to sterilize medical devices. Would it be subject to this IO?

No. Any UV radiation-emitting or ozone-generating device that meets the definition of a device in section 2 of the Food and Drugs Act (FDA); and is classified as a Class II, III or IV medical device under the Medical Device Regulations (MDR) would be exempt from the application of the PCPA. UV radiation-emitting or ozone-generating devices solely intended to disinfect or sterilize another medical device or UV emitting devices used as a therapeutic device (e.g., to treat skin conditions) are regulated as Class II medical devices and subject to regulation under the MDR. For further information or guidance on the MDR or medical devices subject to regulation under the MDR contact meddevices-instrumentsmed@hc-sc.gc.ca.

8) My UV radiation-emitting or ozone-generating device is solely sold or used to improve air quality. Would it be subject to this IO?

No. UV radiation-emitting or ozone-generating devices represented, sold or used solely to deodorize or eliminate odors (i.e., cigarette, cooking, pet odors) would not be subject to this IO. These types of devices are considered as consumer products, and are subject to the Canada Consumer Product Safety Act (CCPSA). Any UV radiation-emitting or ozone-generating device with a claim to control, eliminate, kill bacteria, viruses or other micro-organisms, or claims to eliminate odors by killing the bacteria that causes them, on surfaces, objects, in water or in the air, are exempt from application of the CCPSA and subject to regulation under the PCPA. For further questions on products subject to the CCPSA, contact hc.cps-spc.sc@canada.ca.

9) What is the Radiation Emitting Devices Act (REDA)? Are UV radiation-emitting devices also subject to this regulatory authority?

The Radiation Emitting Devices Act (REDA) governs the radiation safety of devices that emit electromagnetic or acoustical radiation, including UV radiation. While the types of UV radiation-emitting devices that would be subject to this IO do not fall into any one of the prescribed device classes under the Radiation Emitting Devices Regulations, the general requirements of REDA apply to all products that emit UV radiation, whether they are classified as pest control products, medical devices, or consumer products. For more information about requirements under REDA, contact the Consumer and Clinical Radiation Protection Bureau: hc.ccrpb-pcrpcc.sc@canada.ca.

10) My UV radiation-emitting or ozone-generating device is solely sold or used to control or kill plant pathogens, such as in greenhouse settings. Would it be subject to this IO?

No. At this time, Health Canada's PMRA is focusing its attention on the immediate risks associated with the manufacture, importation, sale and use of UV radiation-emitting or ozone-generating devices that have proliferated in the market since the beginning of the pandemic. Although the PMRA is expecting to proceed with the regulatory amendments it had published for consultation in 2018, at this time only UV radiation-emitting and ozone-generating devices manufactured, represented, distributed or used to control, reduce, destroy or inactivate bacteria, viruses or other micro-organisms that are human pathogens would be subject to this IO.

11) My UV radiation-emitting or ozone-generating device is solely sold or used to control or kill viruses, bacteria or other micro-organisms that are human pathogens, in a swimming pool or spa, or in wastewater treatment systems. Would it be subject to this IO?

No. At this time, Health Canada's PMRA is focusing its attention on the immediate risks associated with the manufacture, importation, sale and use of UV radiation-emitting or ozone-generating devices that have proliferated in the market since the beginning of the pandemic. The PMRA is expecting to proceed with the regulatory amendments it had published for consultation in 2018. However, at this time, UV radiation-emitting and ozone-generating devices manufactured, represented, distributed or used to control, destroy or inactivate bacteria, viruses or other micro-organisms that are human pathogens, or to reduce their levels on environmental surfaces, on objects, in water or in air - other than those for use in swimming pools, spas or wastewater treatment systems - would be subject to this IO.

12) My UV radiation-emitting or ozone-generating device is sold or used as a means to disinfect or sanitize surfaces in hospital operating theatres as well as surfaces and objects in patient rooms and waiting areas. Would it be subject to this IO?

Yes. UV radiation-emitting or ozone-generating devices sold or used to disinfect or sanitize surfaces and objects, regardless of their setting (i.e., healthcare, commercial, domestic) would be subject to this IO. Only UV radiation-emitting or ozone-generating devices sold or used to disinfect another medical device (i.e., personal protective equipment (PPE), ultrasound probes, endoscopes) are regulated as Class II medical devices and subject to regulation under the Medical Device Regulations (MDR).

13) My UV radiation-emitting device would meet all the exemption conditions being considered, but it also generates ozone. Would the device require registration under the PCPA?

Yes. Any UV radiation-emitting device that also produces or generates ozone or another substance would require registration under the PCPA.

14) Would UV radiation-emitting or ozone-generating devices used in municipal water treatment be subject to this IO?

No. Municipal water treatment is regulated at the provincial or territorial level. For questions regarding the acceptability of UV emitting or ozone generating devices in municipal water treatment, please contact the appropriate provincial or territorial authority.

15) Would all types of ultraviolet (UV) radiation be subject to the IO (UVA, UVB, UVC)?

Yes. Regardless of whether the UV radiation-emitting device emits UVA, UVB or UVC wavelengths, if the device is manufactured, represented, distributed or used to control, reduce, destroy or inactivate viruses, bacteria or other micro-organisms that are human pathogens (for example, E. coli, Sars-CoV-2), the device would be subject to this IO.

Conditions for UV radiation-emitting devices to meet the requirements for exemption from registration

16) My UV radiation-emitting device is battery operated; and therefore, it is not subject to electrical safety certification requirements. My UV radiation-emitting device would meet all other exemption conditions and labelling requirements. Would my UV radiation-emitting device be exempt from registration?

Yes. For battery operated UV radiation-emitting devices, a certification to the applicable electrical safety requirements would not be required. If all other conditions for the exemption from registration were met, the UV radiation-emitting device would be exempt from registration.

17) Can the PMRA provide examples of recognized standards development organizations that are approved to provide certifications to the applicable standards?

Yes. Recognized standards development organizations that are approved to provide certifications to the applicable standards may include, but are not limited to, the Canadian Standards Association (CSA), Electrical Testing Laboratories (ETL) and the Underwriters Laboratories Inc. (UL). For more information about recognized standards development organizations, please consult https://www.scc.ca/en.

18) One of the criteria for a UV radiation-emitting device to be exempt from registration under the IO would be that ''Only a claim of supplemental sanitation may be made and there must not be any express or implied reference to prevention, treatment or mitigation of disease''. What does this mean?

Under the IO, to meet the above-mentioned condition for the exemption from registration, only a claim of supplemental sanitation would be able to be made in respect of the UV radiation-emitting device and there must not be any express or implied reference to prevention, treatment or mitigation of disease. Examples of supplemental sanitation include:

In addition to the supplemental sanitation claim, the label and any operating manual would have to indicate: 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 practices related to cleaning and disinfection of environmental surfaces.

Since a review of the efficacy claims would not be carried out for a UV radiation-emitting device that would be exempt from registration, a supplemental sanitation claim could not include reference to a threshold of efficacy or a specific pathogen name. If such claims were sought, an application for registration with supporting data to substantiate the claimed threshold of efficacy against the specific pathogen would be required.

19) One of the criteria for a UV radiation-emitting device to be exempt from registration would be that the UV lamp would be fully shielded or enclosed in the device and the device would have:

  1. a locking mechanism during operation, or
  2. an automatic shut off feature, if opened during operation.

What is meant by fully shielded or enclosed in the device?

A lamp is fully shielded when it is enclosed in the device in such a way that emission of UV radiation outside the device will not occur during operation, and therefore exposure to UV radiation will not occur. For example, a handheld UV radiation-emitting device with a clear plastic lens covering the UV lamp or a personal UV air sanitizer with slits on the sides that emit the UV radiation would not be considered fully shielded.

If my UV radiation-emitting device has a magnetic clasp or closes via a zipper and the UV lamp shuts off immediately once opened, would that be acceptable to meet the above condition for exemption?

Yes, it would meet the above condition of exemption if the UV radiation-emitting device has a locking mechanism and/or automatic shut-off that, when opened, would prevent exposure to UV light.

What if my UV radiation-emitting device has an automatic shut off feature if opened during operation without a locking mechanism?

Yes, a device would meet the above condition if it has either a locking mechanism during operation or an automatic shut-off feature if opened during operation.

Registration Process

20) I have an application to register a UV radiation-emitting device currently with the PMRA, however the device would meet the conditions being considered for exemption from registration. Can I withdraw my application and request a refund?

You can request withdrawal of your application by citing the application number to the science coordinator on your submission or, you can send the request to hc.pmra.info-arla.sc@canada.ca. For products qualifying for registration exemption, the withdrawn application would be subject to a refund.

21) What would be the timeline for registration for a UV radiation-emitting device that would be subject to the IO?

While the performance standard for the review of this type of application is 12 months, Health Canada would aim to expedite the review of these applications provided that a complete application containing all data and non-data requirements were to be received by the PMRA. The identification of deficiencies will result in the application being put on hold and an unsatisfactory response will result in the application being rejected.

22) What would be the timeline for registration for an ozone-generating device that would be subject to the IO?

As no ozone-generating device of this kind has been registered to date, the performance standard for the review of a major new use of a pest control product is 18 months. A proposed registration decision is published for all major decisions, as defined under subsection 28(1) of the PCPA, for a 45 day public consultation prior to granting a registration. Once Health Canada has registered one of these devices, any subsequent application would be reviewed within the shorter 12 month timeline.

Health Canada would aim to expedite the review of these applications provided that a complete application containing all data and non-data requirements were to be received by the PMRA. The identification of deficiencies would result in the application being put on hold and an unsatisfactory response would result in the application being rejected.

23) I don't have efficacy data to submit along with my application. Can I use published literature?

Efficacy information specific to the UV radiation-emitting or ozone-generating device that would require registration would be required. Information in the public domain (including use history information and published scientific literature) that addresses general effects of UV radiation or ozone would be insufficient on its own.

24) I want to proceed to hire a laboratory to generate efficacy data with my UV radiation-emitting or ozone-generating device. If I want a particular pathogen claim on the product label, would I have to include that specific strain as part of testing?

In order to include a specific pathogen claim on the product label, efficacy data specific to that pathogen or appropriate surrogate would have to be provided and demonstrate an acceptable level of control.

25) I have data to support the efficacy of my device as a sanitizer, 99.9% reduction, however the name of my device is UVC disinfection robot or UVC sterilization robot. Would that be an issue?

As per subsection 6(7) of the PCPA, no person shall package or advertise a pest control product in a way that is false, misleading or likely to create an erroneous impression regarding its character, value, quantity, composition, safety or registration. Therefore, a product that would only meet the efficacy standard for sanitizers (a minimum 99.9% reduction) could not include the descriptors 'disinfection' or 'sterilization' in the product name.

26) I have data for my UV radiation-emitting device, however the device is unable to achieve a 99.9% level of reduction of the tested micro-organisms. What would happen to my UV radiation-emitting device application?

Following a review of the information submitted in support of an application for registration, if PMRA determines that the UV radiation-emitting device would be unable to meet the minimal level of efficacy of 99.9% reduction (or 3 log) of test organisms compared to an untreated control using a scientifically sound test method, PMRA would deny registration. At this point, it would be up to the applicant to consider making changes to their UV radiation-emitting device and labelling to meet the conditions being considered for exemption from registration (i.e., only a supplemental sanitation claim) in order to be permitted on the market.

27) I manufacture, distribute or import a UV radiation-emitting or ozone-generating device and I am not certain if it is subject to regulation under the PCPA. How can I confirm if it is?

Health Canada's PMRA offers Subject to Regulation (StR) determinations, a no-cost service intended to provide manufacturers, importers or distributors the opportunity to confirm whether or not a product is subject to the PCPA and if the product requires registration. To request a Subject to Regulation determination, please email hc.pmra.subject.to.regulation-sujet.a.la.reglementation.arla.sc@canada.ca.

28) I manufacture, distribute or import a UV radiation-emitting or ozone-generating device that also produces or generates another substance, or it is used in combination with another product. I have confirmed it is subject to regulation under the PCPA. How can I obtain regulatory guidance on the requirements for registration?

Before submitting an application for registration, it is recommended that you request a pre-submission consultation. This is a no-cost service offered by the PMRA, which provides prospective applicants with written guidance to help them to generate and submit a complete application containing all data and non-data requirements to register a new pest control product. To request a copy of the pre-submission consultation guidance that has been prepared to outline the regulatory requirements to UV radiation-emitting or ozone-generating device, email the following hc.pmra.presubs-prealables.arla.sc@canada.ca. In the subject line, indicate UV radiation-emitting device pre-submission guidance or Ozone-generating device pre-submission guidance. The reply will include guidance in both official languages.

Compliance and Enforcement

29) Would Health Canada be enforcing compliance with the requirements of the IO?

As with any other pest control product, Health Canada would take a risk-based approach to addressing compliance of UV radiation-emitting or ozone-generating devices that would be subject to these new requirements. The risk-based approach would include compliance promotion activities, complaints-based compliance verifications and where warranted, proactive targeted compliance verifications.

30) What would happen to my device when the IO were to come into effect?

UV radiation-emitting devices that would meet the conditions for authorization (e.g. appropriate certification, specific structural features and required warning statements) could continue to be imported, manufactured, sold, distributed, advertised and used.

Authorized UV radiation-emitting devices that were found to be imported, manufactured, sold, distributed, advertised or in use that do not meet the required conditions as noted above once prohibitions apply would be in violation of the PCPA. Health Canada would take appropriate enforcement action under the PCPA.

UV radiation-emitting or ozone-generating devices that would require registration under the PCPA that are found to be imported, manufactured, sold, distributed advertised or in use after prohibitions apply would be in contravention of the PCPA. Health Canada would take appropriate enforcement action under the PCPA.

31) What would be the compliance and enforcement actions I could expect if my UV radiation-emitting device does not meet the criteria for the exemption or my UV radiation-emitting or ozone-generating device is not currently registered under the PCPA?

Health Canada would take enforcement action when non-compliant devices are found

Health Canada has a suite of enforcement tools at its disposal to address non-compliance under the Pest Control Products Act and its Regulations. Health Canada would apply the most appropriate tool commensurate with risk to address a non-compliance and mitigate the risks to human health. Enforcement actions that could be taken against regulated parties contravening the terms of this Interim Order include: warning letters; detention and seizure of products; compliance orders under the PCPA; and notices of violation with warning or monetary penalty under the Agriculture and Agri-Food Administrative Monetary Penalties Act.

General Public

32) How can I tell if the UV radiation-emitting or ozone-generating device that I bought is registered or if the UV radiation-emitting device would meet all the conditions being considered for exemption from registration?

The Pesticide Product Information Database provides information on products, active ingredients, and programs related to pesticides and other pest control products that are regulated by Health Canada. All UV radiation-emitting or ozone-generating devices, for which the PMRA granted a registration, can be accessed through the Pesticide Product Information. To confirm if a particular UV radiation-emitting device would meet all conditions that ensure that risks of UV exposure were being addressed, including labelling requirements, to be authorized without the need for registration, consult the manufacturer of the UV radiation-emitting device.

33) I purchased a UV radiation-emitting wand that claims to prevent COVID-19. Is it safe to use?

If you have purchased a UV radiation-emitting wand that claims to prevent COVID-19 or kills bacteria or viruses on surfaces or objects, stop using them immediately, especially if the product is for use on skin. Health Canada has published an advisory warning Canadians about the risks of using UV lights and wands that make unproven claims to kill SARS-CoV-2. To date, Health Canada has not received sufficient evidence to demonstrate that UV radiation-emitting devices are safe, nor as effective as claimed. UVC is also a known carcinogen that can damage the skin and eyes. Consult a healthcare professional if you have used these products on the skin and have any concerns.

The Pesticide Product Information Database provides information on products, active ingredients, and programs related to pesticides and other pest control products that are regulated by Health Canada. All UV radiation-emitting or ozone-generating devices, for which the PMRA granted a registration, can be accessed through the Pesticide Product Information Database. To confirm if a particular UV radiation-emitting device would meet all conditions to be authorized without the need for registration, consult the manufacturer of the UV radiation-emitting device.

You should immediately discontinue use of the product if it exposes you directly to the UV light or the ozone, or if you cannot confirm that it is compliant with the PCPA.

35) My building/ laboratory is equipped with a UV radiation-emitting device. How do I find out if it is registered? Is it safe to continue using?

The Pesticide Product Information Database provides information on products, active ingredients, and programs related to pesticides and other pest control products that are regulated by Health Canada. All UV radiation-emitting or ozone-generating devices, for which the PMRA granted a registration, can be accessed through the Pesticide Product Information Database. To confirm if a particular UV radiation-emitting device would meet all conditions required to be authorized without the need for registration, consult the manufacturer of the UV radiation-emitting device. You should not use the device until you can confirm that it is compliant with the PCPA.

36) How do I replace and dispose of the spent lamp in my UV radiation-emitting device?

UV devices can contain a variety of different types of lamps (e.g., mercury vapour lamps or light-emitting diodes (LEDs)). In the event that replacement of the lamp is necessary, follow the instructions in the operating manual for the device. For disposal of the lamp, dispose or recycle according to local applicable laws.

37) Can I use a UV radiation-emitting or ozone-generating device as a substitute for the currently recommended health measures?

UV radiation-emitting or ozone-generating device should not be used as a substitute for prevention measures such as frequent hand washing, physical distancing, mask-wearing, and cleaning and disinfecting. The Government of Canada has published a list of hand sanitizers and disinfectants that meet Health Canada's requirements.

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