Explanatory note: Interim order respecting ultraviolet radiation-emitting devices and ozone-generating devices

(This note is not part of the Order)

Proposal

The Interim Order Respecting Ultraviolet Radiation-emitting Devices and Ozone-generating Devices (the IO), was made by the Minister of Health on June 7, 2021. The IO brings certain ultraviolet radiation- emitting (referred to in this note as "UV") and ozone-generating devices under the Pest Control Products Act (PCPA). These devices are marketed to control or kill bacteria, viruses including SARS-CoV-2 (the coronavirus that causes COVID-19 disease), and other microorganisms on surfaces, on objects, in water or in air.

Under the IO, certain UV and ozone-generating devices are subject to safety and efficacy assessments, and must be registered prior to entering the Canadian market. It exempts certain UV devices from registration (meaning it is authorized for sale and use without the need for registration) if they meet certain conditions.

The Minister may make an interim order under subsection 67.1(1) of the PCPA if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment. The IO will remain in effect for 14 days, in accordance with paragraph 67.1(2)(a) of the PCPA, unless it is approved by the Administrator of the Government of Canada in Council, in which case it would remain in effect for up to one year.

Objective

The objective of the IO is to protect the health and safety of Canadians by providing appropriate oversight of UV and ozone-generating devices.

Background

UV and ozone-generating devices that make claims to control or kill bacteria and viruses on surfaces, objects, in water, and in the air are widely and increasingly available for sale in Canada during the pandemic. Thousands of these devices are being sold for use predominantly in domestic dwellings, including UV wands and UV cleaners (for example, represented and sold to disinfect or sanitize toys, bags, or cellphones). Based on a preliminary search of e-commerce sites, over 2000 UV devices marketed to sanitize cellphones and over 550 UV devices marketed to sanitize toys are available to purchase online from a single retailer. The availability of these devices was precipitated by the pandemic. The marketplace also includes devices that emit ultraviolet radiation (for example, represented and sold to disinfect small to large rooms) and ozone-generating devices intended to treat surfaces, air within an enclosed space, or water (for example, in humidifiers or as a cleaning solution).

To date, Health Canada has not yet received sufficient evidence to demonstrate that they can be used safely or that they work as claimed.

Regulatory authorities, such as Health Canada and the United States Food and Drug Administration, continue to advise the public that the effectiveness of these devices in inactivating SARS-CoV-2 is unknown. For UV devices, there is limited published data about the wavelength, dose, and duration of the radiation required to inactivate this virus, which now also includes variants. Because some of these UV devices are used by the general public, there is a risk of exposure through high dose or prolonged low dose use. Exposure to these devices can result in serious eye disorders (for example, cataracts), severe skin burns, and skin cancer. The Canadian Centre for Occupational Health and Safety (CCOHS) also reports similar adverse health effects due to exposure to ultraviolet radiation. The World Health Organization International Agency for Research on Cancer has classified ultraviolet A, B, and C as probably carcinogenic to humans. Similarly, the United States Environmental Protection Agency and other organizations have found that 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, which is very serious given the respiratory effects associated from exposure to this virus.

The health effects of both ultraviolet radiation and ozone have been well-characterized. However, Canadians may not realize that they have been putting themselves at risk, and that their symptoms are related to the use of such devices. This is because the acute effects associated with exposure to ultraviolet radiation and ozone can easily be attributed to other causes, and chronic health effects take time to manifest.

Due to health and safety concerns and the current availability of these devices on the market, on November 18, 2020, Health Canada published an advisory warning Canadians about the risks of using UV lights and wands that make unproven claims to kill SARS-CoV-2. Health Canada advises Canadians to stop using UV lights and wands that claim to disinfect against the virus that causes COVID-19 especially if the product is for use on the skin.

The Minister of Health's primary mandate under the PCPA is to prevent unacceptable risks to human health and the environment from the use of pest control products. Currently, there is a gap in regulating these devices and as the pandemic continues more Canadians may rely on unsafe and unproven products, with the belief that they are protecting themselves from COVID-19 while they may, in fact, be inadvertently putting themselves at risk. The IO allows immediate action to protect Canadians and address the significant risks described above.

Implications

Under the IO, certain 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, are subject to regulation under the PCPA. The IO provides an exemption from the application of the PCPA to Class II, III, and IV medical devices regulated under the Food and Drugs Act Medical Devices Regulations.

By bringing certain UV and ozone-generating devices under the PCPA, they need to be registered or otherwise authorized in order to be on the Canadian market. An application to register a pest control product must be submitted to Health Canada in the form and manner directed by the Minister and must include any information and other material that is required by the Pest Control Products Regulations to accompany the application. Applications to register devices consist of a number of information and data requirements, including a cover letter stating the purpose of the application, an application and fee estimate forms, the proposed English and French product labels, as well as data to support the safety and efficacy of the device. A registration will be granted under the PCPA if the Minister considers that the health and environmental risks and the value of the device are acceptable after any required assessments.

The PCPA prohibits the manufacture, possession, distribution, importation, and use of a pest control product unless it is registered or otherwise authorized. It is a contravention of subsection 6(7) of the PCPA to package, label 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.

A UV device is exempt from registration if it meets certain conditions, including: the device being certified to the applicable Canadian electrical safety requirements; 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; and only claims of supplemental sanitization (for example, this UV device helps reduce microorganisms on surfaces, and this UV device helps reduce the spread of viruses in the air) can be made in respect of the device. UV devices that meet the conditions are considered to have acceptable risk and value and therefore, they are exempt from registration.

UV devices that are exempt from registration must meet the label requirements for the principal and secondary display panels and the operating manual. These label requirements include a number of precautionary statements, directions for use, and information about a contact in Canada for inquiries.

Stakeholders will have a 30-day transition period after the IO is made before having to comply with its requirements. A transition period of 30 days balances the immediate need to protect Canadians and the need to provide stakeholders some time to take necessary steps to comply with the IO (for example, removing from the market devices that have unproven claims or devices that do not meet electrical safety requirements).

Fees associated with assessing applications are set out in the Pest Control Products Fees and Charges Regulations. It is estimated that it would cost applicants approximately $2,200 to process an application for UV or ozone-generating devices; however, additional fees may apply if a preliminary assessment of a device determines that further information is required to support the application.

UV and ozone-generating devices, including authorized devices that are manufactured, imported, distributed or used, will be subject to risk-based compliance verification following the transition period and subject to enforcement actions where non-compliance is confirmed. These enforcement actions may 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. Health Canada will continue to conduct compliance promotion with regulated parties to increase their awareness and understanding of these new requirements.

Consultation

In 2018, Health Canada published a regulatory pre-consultation discussion paper (PRO2018-02, Pre-Consultation - Proposed Regulatory Amendments to the Pest Control Products Regulations (Pest Control Devices). This paper proposed amendments to regulate pest control devices, including UV and ozone-generating devices. Health Canada also hosted a stakeholder webinar on the proposal following the publication of the paper. No concerns relating to regulatory and administrative burden were received. Six stakeholders submitted comments seeking clarification regarding the conditions for exemption from registration. Comments provided through engagement opportunities have been considered in the development of conditions for exemption from registration.

Health Canada's Pest Management Regulatory Agency (PMRA) has taken various steps to keep stakeholders and the public informed. For instance, on April 30, 2021, a Notice of Intent was published to inform stakeholders and Canadians of Health Canada's intent to regulate UV and ozone-generating devices. To date, stakeholders have sought clarification of the scope of the IO, requirements for registration, and conditions for exemption. No concerns were raised. In addition, on May 12, 2021, PMRA published a Questions and Answers document providing stakeholders and the public information, including the requirements and conditions for exemptions that were being considered and devices that would be subject to the IO. Health Canada will continue to conduct compliance promotion activities to increase awareness of the new requirements.

Contact

Please direct all questions and inquiries to:

Brenda Tang
Policy and Operations Directorate
Pest Management Regulatory Agency
Health Canada
2720 Riverside Drive
Ottawa, Ontario
K1A 0K9
Email: hc.pmra.regulatory.affairs-affaires.reglementaires.arla.sc@canada.ca

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