Regulations Amending the Pest Control Products Regulations (Ultraviolet Radiation-emitting Devices and Ozone-generating Devices): SOR/2022-99
Canada Gazette, Part II, Volume 156, Number 11
SOR/2022-99 May 12, 2022
PEST CONTROL PRODUCTS ACT
P.C. 2022-469 May 10, 2022
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 67footnote a of the Pest Control Products Actfootnote b, makes the annexed Regulations Amending the Pest Control Products Regulations (Ultraviolet Radiation-emitting Devices and Ozone-generating Devices).
Regulations Amending the Pest Control Products Regulations (Ultraviolet Radiation-emitting Devices and Ozone-generating Devices)
1 Subsection 1(1) of the Pest Control Products Regulations footnote 1 is amended by adding the following in alphabetical order:
- ozone-generating 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 population levels — other than in swimming pools, spas or wastewater or drinking-water treatment systems — by means of the generation of ozone. (dispositif générateur d’ozone)
- product certification body
- means a body that is accredited by the Standards Council of Canada to give third-party written assurance that a product meets the specified requirements for the product, including initial certification and maintenance of that certification. (organisme de certification de produits)
- 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 population levels — other than in swimming pools, spas or wastewater or drinking-water treatment systems — by means of ultraviolet radiation. (dispositif à rayonnement ultraviolet)
2 (1) Subsection 3(1) of the Regulations is amended by adding the following after paragraph (a):
- (a.1) despite paragraph (a), an ultraviolet radiation-emitting device or ozone-generating device that is a device as defined in section 2 of the Food and Drugs Act and classified as a Class II, III or IV medical device under the Medical Devices Regulations;
(2) Paragraph 3(1)(d) of the Regulations is replaced by the following:
- (d) a pest control product — other than an ultraviolet radiation-emitting device or ozone-generating device — that is used to destroy or inactivate viruses, bacteria or other micro-organisms in order to treat, mitigate or prevent disease in humans or animals, except in respect of its use in a swimming pool or spa;
(3) The portion of paragraph 3(1)(e) of the Regulations before subparagraph (i) is replaced by the following:
- (e) except in respect of its uses as a preservative for wood or other material, as a slimicide or in a swimming pool or spa, a pest control product — other than an ultraviolet radiation-emitting device or ozone-generating device — that is used to
(4) Subparagraph 3(1)(e)(ii) of the English version of the Regulations is replaced by the following:
- (ii) reduce the population levels of viruses, bacteria or other micro-organisms that cause mould, mildew or odour, or disease in humans or animals; and
3 Subsection 3.1(2) of the Regulations is replaced by the following:
Activities — section 41.1 of Act
(2) A person may possess, handle, store or transport the imported pest control product for the purpose of export.
4 The heading before section 4 of the Regulations is replaced by the following:
Unregistered Pest Control Products
5 (1) The portion of subsection 4(1) of the Regulations before paragraph (a) is replaced by the following:
4 (1) A person may manufacture, possess, handle, store, transport, import, distribute or use the following unregistered pest control products under the Act:
(2) Paragraphs 4(1)(c) to (e) of the Regulations are replaced by the following:
- (c) a pest control product that is an ultraviolet radiation-emitting device, other than an ultraviolet lamp or other component that emits ultraviolet radiation, if
- (i) the device is certified by a product certification body as meeting the applicable Canadian electrical safety requirements,
- (ii) the certification mark of the product certification body appears on the label of the device,
- (iii) any claim of efficacy that is made in respect of the device is made only in relation to supplemental sanitization,
- (iv) no express or implied claim in relation to the treatment, mitigation or prevention of disease is made in respect of the device,
- (v) its ultraviolet lamp, or other component that emits ultraviolet radiation, is fully shielded or enclosed in the device, in a manner that prevents exposure to ultraviolet radiation,
- (vi) the device has a mechanism that
- (A) locks the device to prevent access to the ultraviolet lamp, or other component that emits ultraviolet radiation, during operation, or
- (B) automatically shuts off the device if it is opened during operation,
- (vii) a user of the device who follows the instructions referred to in paragraph 30.1(3)(c) for replacing the ultraviolet lamp or any other component that emits ultraviolet radiation is not exposed to the radiation,
- (viii) the device does not produce or generate any other substance, including ozone or hydroxyl, that may be harmful to human health during operation, and
- (ix) the device is used in commercial or industrial premises or in educational institutions, health care facilities or similar institutions or facilities and, as applicable,
- (A) it does not meet the requirement set out in subparagraph (v), is contained within the ventilation system in a manner that prevents exposure to ultraviolet radiation and is installed by an electrician who is the holder of a licence issued by the applicable provincial licensing authority, or
- (B) it does not meet one of the requirements set out in subparagraph (v) or (vi) and is certified by a product certification body either as being part of the Exempt group classification set out in the IEC 62471 standard developed by the International Electrotechnical Commission entitled Photobiological safety of lamps and lamp systems, as amended from time to time, or as meeting the applicable requirements of one of the standards set out in the List of Equivalent Standards for Ultraviolet Photobiological Hazard Assessment, published by the Government of Canada on its website, as amended from time to time;
- (d) an ultraviolet radiation-emitting device that is an ultraviolet lamp, or other component that emits ultraviolet radiation, if the component
- (i) is manufactured, represented or distributed solely for use in a device referred to in paragraph (c), and
- (ii) meets the conditions set out in subparagraphs (c)(iii) and (iv); and
- (e) an ultraviolet radiation-emitting device that is an ultraviolet lamp, or other component that emits ultraviolet radiation, that is manufactured, represented or distributed for use as a component in a registered device, if
- (i) the component is evaluated as part of an application to register, amend or renew the registration of the device, and
- (ii) the label of the component contains any information specified by the Minister in the conditions of registration.
(3) Subsections 4(2) to (4) of the Regulations are replaced by the following:
Used in manufacture only
(2) A pest control product referred to in paragraph (1)(a) must not be used for any purpose other than the manufacture of a registered pest control product.
Permitted activities — foreign product
(3) A person may possess, handle, store, transport, import or use a foreign product that is imported under a foreign product use certificate.
Permitted activities — for conducting research
(4) A person may manufacture, possess, handle, store, transport, import or use a pest control product for the purpose of conducting research in accordance with sections 46 to 70.
6 The Regulations are amended by adding the following after section 4:
Unregistered Pest Control Products for Export
Permitted activities — for exportation of certain products
4.1 (1) A person may manufacture, possess, handle, store or transport — or import for use in manufacturing — the following unregistered pest control products under the Act, solely for the purpose of export:
- (a) an ultraviolet radiation-emitting device;
- (b) an ultraviolet lamp or other component that emits ultraviolet radiation;
- (c) an ozone-generating device; and
- (d) a pest control product that contains an active ingredient that is registered in Canada.
(2) Before a pest control product referred to in any of paragraphs (1)(a) to (c) is shipped, the manufacturer must prepare an export certificate, in the manner specified by the Minister, indicating that the product does not contravene any known requirements of the law of the countries to which it is shipped, consigned or about to be consigned.
(3) If the pest control product or the country of export changes, the manufacturer must prepare a new certificate.
Period of retention
(4) The manufacturer must keep a record of the certificate for five years after the date of the last shipment.
Provision of records
(5) The manufacturer must provide the certificate to the Minister on request and within the period specified.
Requirements — information and packaging
(6) Subsections 3.2(1) to (3), and (6) to (10) apply to the pest control products referred to in paragraphs (1)(a) to (c).
Requirements of section 3.2
(7) A pest control product referred to in paragraph (1)(d) must meet the requirements of section 3.2.
Non-application of section 33
(8) Section 33 does not apply to a pest control product referred to in subsection (1).
7 Section 25 of the Regulations is replaced by the following:
Principal and secondary display panels
25 A registered pest control product must have a display panel consisting of a principal display panel and a secondary display panel.
8 (1) The portion of subsection 26(1) of the Regulations before paragraph (a) is replaced by the following:
Principal display panel
26 (1) The principal display panel of a registered pest control product must show the following information:
(2) The portion of subsection 26(2) of the Regulations before paragraph (a) is replaced by the following:
Secondary display panel
(2) The secondary display panel of a registered pest control product must show the following information:
(3) The portion of subsection 26(3) of the Regulations before paragraph (a) is replaced by the following:
(3) If a pest control product is contained in more than one package, the outermost package that is visible under normal conditions of storage, transportation or handling must bear a label that shows the following information:
9 Section 30 of the Regulations is replaced by the following:
Schedule 1 devices
30 Despite subsections 26(1) and (2), the display panel of a registered pest control product that is a device of a type described in Schedule 1 must show
- (a) on the principal display panel, the information set out in paragraphs 26(1)(i), (k) and (l); and
- (b) on its secondary display panel, the information set out in paragraphs 26(2)(a) to (c).
Unregistered device — display panel
30.1 (1) An ultraviolet radiation-emitting device referred to in paragraph 4(1)(c) must have a display panel consisting of a principal display panel and a secondary display panel.
Principal display panel
(2) The principal display panel and, if any, the operating manual of the device must show the following information:
- (a) its intended use;
- (b) if it 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”;
- (c) the statement
- (i) if there is an accompanying operating manual, “READ THE LABEL AND ANY OPERATING MANUAL BEFORE USING”, and
- (ii) “READ THE LABEL BEFORE USING” in any other case; and
- (d) 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
(3) The secondary display panel of the device must show the following information:
- (a) under the heading “PRECAUTIONS”, the statements
- (i) “WARNING – Ultraviolet radiation emitted from this device.”,
- (ii) “Unintended use of the device, or damage to the housing, may result in exposure to ultraviolet radiation.”,
- (iii) “Ultraviolet radiation may cause eye and skin irritation.”, and
- (iv) “Avoid exposing eyes and skin to ultraviolet radiation.”;
- (b) the statement “The use of this device is a supplement to and not a substitute for following best practices to control transmission of infections; users are to follow those best practices, including those related to the cleaning and disinfection of surfaces.”;
- (c) under the heading “DIRECTIONS FOR USE”, the directions for the use of the device, notably on how to operate the device, any limitation on its use and, if applicable, instructions on how users may replace the ultraviolet lamp or any other component that emits ultraviolet light without exposure to ultraviolet radiation, including instructions on the frequency required for those replacements; and
- (d) other information that identifies any risk to health or the environment associated with the handling, storage, display, distribution, use or disposal of the device, or of any of its components, and instructions on procedures for reducing those risks.
(4) If there is insufficient space to fit the information on the secondary display panel, that information must be shown in an accompanying operating manual and the secondary display panel must show
- (a) the information set out in paragraphs (2)(a) and (b); and
- (b) as much of the other information set out in subsection (2) as possible.
10 Schedule 1 to the Regulations is amended by adding the following after item 6:
7 Ultraviolet radiation-emitting devices and ozone-generating devices.
11 Schedule 2 to the Regulations is amended by replacing the references after the heading “SCHEDULE 2” with the following:
12 The heading of Schedule 2 to the Regulations is replaced by the following:
Unregistered Pest Control Products
13 (1) The following definitions apply in this section.
- commencement day
- means the day on which these Regulations come into force. (date d’entrée en vigueur)
- new Regulations
- means the Pest Control Products Regulations as they read on the commencement day. (nouveau règlement)
- secondary display panel
- has the same meaning as in subsection 1(1) of the Pest Control Products Regulations. (aire d’affichage secondaire)
- ultraviolet radiation-emitting device
- has the same meaning as in subsection 1(1) of the new Regulations. (dispositif à rayonnement ultraviolet)
Secondary display panel — statement
(2) During the period beginning on commencement day and ending six months after that day, the secondary display panel of an ultraviolet radiation-emitting device referred to in paragraph 4(1)(c) of the new Regulations must contain the statement referred to in paragraph 30.1(3)(b) of the new Regulations or 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.”.
Coming into Force
14 These Regulations come into force on the day after the day on which the Interim Order Respecting Ultraviolet Radiation- emitting Devices and Ozone-generating Devices, made on June 7, 2021 and published in the Canada Gazette, Part I, on June 26, 2021, ceases to have effect, but if they are registered after that day, they come into force on the day on which they are registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
Ultraviolet radiation-emitting (UV) and ozone-generating devices that make claims to control or kill bacteria and viruses on surfaces, objects, in water, and in the air have been more widely and increasingly available for sale in Canada during the pandemic. Health Canada has not yet received sufficient evidence to demonstrate that all UV and ozone-generating devices can be used safely or work as claimed.
Regulatory authorities in Canada and abroad continue to advise the public that the effectiveness of certain 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. Because some of these UV devices are used by the public, there is a risk of exposure through high or prolonged low dose use. Exposure to these devices can result in serious eye disorders, severe skin burns, and skin cancer. Moreover, 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, or 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.
To address the significant health and safety concerns identified above, a regulatory framework that requires registration of these products so that Health Canada can assess their value (including their efficacy) and safety (or authorization of products under certain conditions), was put in place on a temporary basis through the Interim Order Respecting Ultraviolet Radiation-emitting Devices and Ozone-generating Devices (IO). However, the IO expires on June 7, 2022, and therefore amendments need to be made to the Pest Control Products Regulations (PCPR) to continue to protect human health and safety.
The Minister of Health’s primary mandate under the Pest Control Products Act (PCPA) is to prevent unacceptable risks to individuals and the environment from the use of pest control products. To meet this objective, the PCPA requires the Minister of Health to conduct pre-market assessments of pest control products to determine if the risks to human health and the environment are acceptable, and the products are effective in their uses so that they have value. The PCPA also allows regulations to be made that authorize the manufacture, distribution or use of unregistered pest control products, based on specified conditions. In addition, the PCPA prohibits the packaging, labelling or advertising of a pest control product in a way that is false, misleading or likely to create an incorrect impression regarding its safety, effectiveness or regulatory status (e.g. it is approved or not approved).
Regulatory authorities, including 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, and about the health risks involved with exposure.
The health risks associated with exposure to ultraviolet radiation, however, are well characterized. Exposure to ultraviolet radiation can result in serious eye disorders (e.g. 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, and publishes guidelines to reduce exposure. The World Health Organization International Agency for Research on Cancer has similarly classified ultraviolet A, B, and C as probably carcinogenic to humans. Because many UV devices are intended to be used by the general public, there is a clear risk of exposure to ultraviolet radiation associated with these devices, both through high-dose or prolonged low-dose use.
The United States Environmental Protection Agency and other organizations have also 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.
Taken as a whole, UV and ozone-generating devices pose a significant risk to health and safety of Canadians based on their ready availability, unproven safety and efficacy, and known health effects. As a result, Health Canada took steps to protect and inform Canadians. As the devices first became available, an Advisory note to Canadians warned of the risks of using certain UV devices with unproven claims. Given the continued risk, in April 2021 a Notice of Intent (NOI2021-01) was published to indicate the Minister of Health’s intent to regulate UV and ozone-generating devices via the IO and this proposal.
The Minister made the IO on June 7, 2021. The Administrator of the Government of Canada in Council approved the IO on June 18, 2021, thereby extending its effective period for up to one year. The IO came into force immediately, with a 30-day transition period. To facilitate understanding of the requirements under the IO, Health Canada provided further details and clarifications on its webpage.
Given the health and safety concerns identified, this regulation will provide a regulatory pathway for UV and ozone-generating devices (continuing the pathway established by the IO). This will protect the health and safety of Canadians by providing appropriate oversight of UV and ozone-generating devices through either registration or authorization of certain uses. This is consistent with the primary objective of the PCPA, which is to prevent unacceptable risks to individuals and the environment from the use of pest control products. Moreover, the regulatory pathway will ensure that registered pest control products in the Canadian market have value (e.g. that they are efficacious), and that authorized UV pest control products do not make unsubstantiated claims regarding their efficacy.
In order to address the issues identified, the proposed regulations will continue the protections introduced under the IO with some clarifications. This will be done by amending the PCPR as follows:
Aspects that specify regulatory requirements
Prescribing certain UV and ozone-generating devices as pest control products
The regulatory amendments prescribe UV and ozone-generating devices as pest control products in Schedule 1 of the PCPR. This will mean that UV and ozone-generating devices, as defined below, will require registration unless otherwise authorized under the regulations. Additionally, the section of the regulations that removes certain pest control products from being subject to the PCPA, section 3, will be clarified to ensure that the PCPA also applies to all UV and ozone-generating devices that meet the definitions described below.
Adding definitions for UV and ozone-generating devices
The regulations will define the terms “ultraviolet radiation-emitting device” and “ozone-generating device” to capture specific types of devices.
The definitions capture 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 population levels — other than in swimming pools, spas or wastewater or drinking-water treatment systems — by means of ultraviolet radiation or generation of ozone respectively.
Scope of products that are subject to the proposed amendments
Like the IO, the scope of the proposed amendments is targeted to the highest human health risks from pesticidal devices that use ultraviolet radiation or ozone generation, as defined. Notably, devices that use ultraviolet radiation to treat animal and plant pathogens (e.g. to control fungi) are not captured by amendments at this time. Health Canada intends to proceed with the Proposed Regulations Amending the Pest Control Products Regulations (Exemptions and Devices) to address these lower risk uses of UV or ozone-generating devices in the future.
Moreover, the proposal will exempt certain medical devices from the application of the PCPA to avoid an unnecessary duplication of resources and burden on stakeholders. The PCPA will not apply to any UV or ozone-generating device that is also a Class II, III, or IV medical device regulated under the Food and Drugs Act’s Medical Devices Regulations.
Lastly, UV and ozone-generating devices used to control, destroy, or reduce levels of viruses, bacteria, or other micro-organisms that are human pathogens in swimming pools, spas, and water treatment systems (drinking and wastewater) are not captured by these amendments. A combination of long-standing federal, provincial or territorial regulations or standards, as well as certification or guidance provides sufficient oversight of water treatment systems and methods that make use of ultraviolet radiation, and there is operational support and funding for drinking water treatment on First Nations reserves. Therefore, existing oversight and support address the risks in respect of water treatment, and regulating this through the PCPA would be duplicative. The regulatory framework for UV and ozone-generating devices used for swimming pools, spas, and water systems treatment (drinking and wastewater) will not be affected by the proposed amendments.
Authorizing the manufacture for export of certain devices
Conditions will be added to section 4.1 of the PCPR for UV and ozone-generating devices to be manufactured for export. This will include a requirement that the product be permitted on the basis that the manufacturer meets the labelling requirements for safe transport and certifies that the exported product meets the legal requirements in the importing country. The certification requirement will be in alignment to the manufacture for export requirements in the Food and Drugs Act. This change will benefit Canadian industry, with no negative health or safety implications.
Establishing the criteria for authorization for certain UV devices
The required conditions under the IO for UV devices to be manufactured, imported and sold without a registration will be added to section 4 of the PCPR. A UV device will not require registration (i.e. it will be authorized) if it is certified to the applicable Canadian electrical safety requirements; its ultraviolet lamp (or UV component) is enclosed in a device, or fully shielded, in a manner that prevents exposure to ultraviolet radiation; the device has a locking or automatic shut-off mechanism; and only claims of supplemental sanitizationfootnote 2 are made in respect of the device. The authorization criteria will also clarify that the UV device must not produce other harmful substances such as ozone or hydroxyls.
In addition to the IO conditions, two alternatives are included specifically for UV devices used in commercial, institutional, and industrial settings. As an alternative to the requirement for the ultraviolet lamp (or UV component) being enclosed in a device, or fully shielded, UV devices that are installed within a ventilation system, in a manner that prevents exposure to ultraviolet radiation, will meet the conditions for authorization. In addition, UV devices that are certified as Exempt Group (i.e. low risk in its photobiological assessment) per the International Electrotechnical Commission’s (IEC) standard IEC 62471, by a product certification body accredited by the Standards Council of Canada, will be an acceptable alternative to having the device fully shielded as well as having automatic shut-off or locking mechanism. A list of equivalent standards for ultraviolet radiation photobiological hazard assessment will be maintained on the Health Canada website.
As was provided in the IO, UV devices that will not require registration must meet the specified label requirements for the principal and secondary display panels and the operating manual. These label requirements will be added to section 30.1 of the PCPR. These label requirements will include a number of precautionary statements, directions for use, and information about a contact in Canada for inquiries.
The proposed conditions for authorization and labelling requirements will mitigate health and safety risks, by preventing the risk of exposure to ultraviolet radiation, and by ensuring that devices that had not been evaluated by Health Canada would not bear unsubstantiated efficacy claims.
Clarifying that UV components may be replaced in authorized UV devices
Access to the UV component, such as an ultraviolet lamp or Ultraviolet Light Emitting Diode (UV LED), will be permitted for the authorized UV devices described above, provided there are instructions related to safe handling and disposal procedures. The instructions must also include the frequency of replacement for the UV component so that the device can be used effectively.
Clarifying that certain UV components do not require registration
A UV device that is an ultraviolet lamp or any other UV component (such as a UV LED) manufactured, represented, or distributed for use in another UV device that is registered or authorized under the Act and Regulations, will not require registration as long as it meets the specified requirements.
A UV component for use in an authorized UV device must be represented solely for use in UV devices that meet the conditions, must only have a claim of supplemental sanitization, and must not claim to prevent, treat or mitigate any disease. A UV component for use in a registered pest control product must be evaluated alongside its end-use device to ensure that the pest control product has value. Therefore, the UV component for use in a registered pest control product will not require registration if it was evaluated and labelled according to any conditions set out in its end-use pest control product’s registration.
The following technical amendments are administrative in nature and do not affect stakeholders.
Modernizing PCPR text referring to authorized devices and labelling
Section 4 of the PCPR pertains to the conditions under which certain pest control products do not need to be registered under the PCPA and are therefore authorized under the regulations for the purposes of subsection 6(1) of the PCPA. Under the amendments, this section will be updated to modernize the provision and improve readability, including reorganizing, removing and consolidating some provisions to avoid unnecessary duplication.
Additionally, the new provisions relating to authorizing UV devices and UV components will be inserted into paragraphs 4(1)(c) to (e) as a result of this reorganization of section 4.
Sections 25, 26 and 30 of the PCPR describe labelling requirements for registered pest control products. However, section 30 is worded in such a way that, for registered devices, both sections 26 and 30 apply. The proposed amendments will clarify that, for registered devices, only section 30 labelling requirements apply. Moreover, various amendments to the text of sections 25, 26 and 30 update the PCPR to improve readability, which will not result in any substantive changes to the PCPR.
Clarifying conditions for certifying of UV devices
For clarity, reference to a “standards development organization accredited by the Standards Council of Canada” will be replaced with a “product certification body accredited by the Standards Council of Canada.” Additionally, a definition would be added for a product certification body that aligns with other federal regulations.
Modernizing PCPR text for manufacture for export
The provisions regarding manufacture for export of pest control products that contain a registered active ingredient in paragraph 4(1)(c) will be moved to subsection 4.1(1). They will be combined with the provisions for exporting UV devices and ozone-generating devices, which will not result in any substantive changes to the PCPR.
Health Canada has conducted several consultations on the amendments.
On November 30, 2018, Health Canada published Regulatory Proposal PRO2018-02, Pre-Consultation - Proposed Regulatory Amendments to the Pest Control Products Regulations (Pest Control Devices). This publication proposed broader amendments in respect of devices that included the regulatory approach for UV and ozone-generating devices, and was accompanied by a stakeholder webinar that took place on December 13, 2018. The consultation period lasted 90 days. Stakeholders were generally supportive of the proposed approach, and no concerns were raised during this process.
On April 30, 2021, Health Canada published Notice of Intent NOI2021-01. This NOI outlined the proposed IO, and was followed by stakeholder webinars that took place in early May 2021. No concerns were raised during this process, but stakeholders requested further clarification. As well, several stakeholders indicated their desire for further engagement. On May 12, 2021, Health Canada published an IO Questions and Answers document to address the questions raised.
Following the publication of the IO, Health Canada continued open dialogue with stakeholders. Stakeholder input ranged from offers of assistance to questions for clarification. One stakeholder supported the initiative, as it provides oversight in this sector. One organization inquired as to whether UV devices being used as part of drinking water treatment systems are captured under the IO. In response to this inquiry, Health Canada published clarification for these types of devices on the web page, indicating that Health Canada does not intend to regulate UV or ozone-generating devices used as drinking water treatment systems under the IO. The regulatory amendments are aligned with the clarification provided for the IO. While no significant concerns were raised at this time, some stakeholders contacted Health Canada afterwards indicating that data required to support registration were too stringent.
On December 4, 2021, Health Canada published a Notice of Intent: Consultation on proposed amendments to the Pest Control Products Regulations (Ultraviolet Radiation-emitting Devices and Ozone-generating Devices) in the Canada Gazette, Part I. This notice of intent detailed the IO provisions, described planned amendments, explained the costing methodology and impacts, and invited comments. The comment period was open for 45 days. To support the consultation, Health Canada also sent industry stakeholders, non-governmental organizations, Indigenous organizations, and Federal/Provincial/Territorial partners invitations to participate in a webinar discussing the regulatory package. The webinar was held on December 14, 2021.
Comments were received from 13 stakeholders during this consultation. Some comments indicated general support, while others expressed concern over certain provisions. Responses were reviewed in light of Health Canada’s mandate to protect human health and safety, and to help ensure that products do not make false or misleading claims and that they work as claimed. Amendments were made to the regulation where possible to provide additional flexibilities in the regulation of UV and ozone-generating devices in Canada.
Some respondents noted a desire that UV and ozone-generating devices not be subject to regulation, that regulation be temporary, or that regulation of certain subtypes of UV devices be eased. No changes were made to the proposal because of these comments: Health Canada’s priority is to prevent significant risks to Canadians that may be caused by these devices. While the proliferation of these devices was tied to the pandemic, these devices would remain in the market thereafter. Regulatory amendments are necessary to continue the protections established in the Interim Order.
Three respondents had comments related to the scope of products included. These comments included the possibility of expanding the scope to include animal and plant pathogens, or narrowing the scope to exclude devices used in laboratory settings or for specific purposes (e.g. Class I medical devices). No changes were made to the proposal because of these comments: Devices used to control animal and plant pathogens would be included in a future amendment, as mentioned in Health Canada’s Forward Regulatory Plan. Class I medical devices and devices used in laboratory settings do not have the same level of protection as under the PCPA.
One respondent requested that the manufacture for export of UV devices and ozone-generating devices be authorized. Similar flexibilities exist for other pest control products and for other products regulated by the Department. Health Canada concurs and implemented the comment by modifying the regulation to include these devices manufactured solely for the purpose of export in the authorization provisions. This will reduce regulatory burden while being consistent with the mandate of the PCPA.
A few respondents requested the development of regulations specific to each type of UV technology. No changes were made to the proposal because of these comments: The regulatory amendments apply to devices that make use of the UV spectrum as a whole, with authorization conditions for UV devices that protect health and safety. For products that do not meet the conditions for authorization, device-specific requirements will be assessed on a case-by-case basis during the registration process.
Several respondents raised potential opportunities for expanding the authorization criteria, citing devices with possibly lower exposure risks, or opportunities for what they felt could be greater international alignment. Suggested criteria included setting thresholds, containing devices in larger systems, use of motion control sensors instead of locking or shut-off mechanisms, or conforming to foreign standards. This comment has been implemented in part: rather than being fully shielded or enclosed, UV devices that meet a specific international standardfootnote 7 will meet the condition, as will devices used in ducted ventilation systems, when used in commercial or industrial premises, or institutions and facilities for healthcare and education. UV devices that produce ozone will continue to require registration so that the various risk factors may be properly assessed. Similar to the United States Centers for Disease Control, devices may make claims of supplemental sanitization. However, to meet the objectives under the PCPA, specific claims to control or mitigate a disease must be determined solely through the registration process.
Lastly, in accordance with best practices, Health Canada notified international trading partners of both the NOI for the Interim Order and the NOI for the regulations through the notification process of the World Trade Organization Committee on Technical Barriers to Trade. Health Canada received one comment, suggesting that the exporting countries’ electrical certification be acceptable in place of Standards Council of Canada (SCC) accreditation. The SCC accreditation process is already open to international organizations and their subsidiaries. For clarification, a definition for “product certification body” is being added to the PCPR to reflect this process. No further changes to the regulations were required.
All comments pertinent to the proposal were considered in the regulatory development process, including those received outside of the formal consultation period. Several responses pertained to the registration process and to specific applications. This includes comments related to meeting Health Canada’s acceptable risk and value thresholds (established by the PCPA), guidance documents, and communications strategy. These comments are considered to be out of scope for the proposal, and will be handled on a case-by-case basis.
Modern treaty obligations and Indigenous engagement and consultation
No impacts have been identified in respect of the Government’s obligations in relation to Indigenous rights protected by section 35 of the Constitution Act, 1982, or its modern treaty obligations.
For each issue that will be addressed by the proposed amendments, an analysis of issues was performed to evaluate whether the baseline scenario (no action), a change to policy, or a regulatory amendment would be the best option. In each instance, the issue is best addressed by a regulatory amendment, as the baseline scenario would not address the issue identified, and an exclusively policy-level approach would not allow Health Canada to meet its mandate for health protection under the PCPA.
Benefits and costs
Requirements and incremental impacts
The proposal will continue to subject certain UV and ozone-generating devices to the requirements of the PCPA/PCPR. Those devices will need to be registered or authorized under the PCPR in order to be on the Canadian market. Applications to register devices consist of a number of information and data requirements, including a cover letter stating the purpose of the application, 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.
For the purpose of registration or authorization, these devices require certification by a product certification body accredited by the SCC as meeting the applicable Canadian electrical safety requirements, such as the Canadian Standards Association (CSA), Electrical Testing Laboratories (ETL) or the Underwriters Laboratories Inc. (UL).
- These devices are electrical products. According to Electrical Product Safety, electrical products that plug into an electrical outlet must meet Canadian national safety standards and be certified by an accredited product certification body, such as CSA, UL, or ETL, before they are sold in Canada. Stakeholders who apply for Health Canada registration and who are authorized must obtain the CSA or equivalent certificate. Therefore, costs from obtaining this certification are not associated with the proposal.
- In order to get CSA/UL/ETL approval, stakeholders need to collect sufficient data (research/lab) to support their applications and stringent assessment in terms of health and safety risks. All the data collected for CSA/UL/ETL will be sufficient and could be used for Health Canada applications to register devices. It is assumed that they will not have to incur additional costs related to research and data preparation to support these elements of a Health Canada application. Therefore, the costs related to research and data preparation for CSA certification are not considered as incremental costs to business.
Fees associated with assessing applications for registration are set out in the Pest Control Products Fees and Charges Regulations. It is estimated that it will cost applicants $2,167 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. In addition to fees associated with the application, applicants will have to prepare a submission and review their label.
If a device is registered, the registrant of the device will be subjected to the Pest Control Products Sales Information Reporting Regulations (sales reporting), the Regulations Amending the Pest Control Products Incident Reporting Regulations (incident reporting), and the Pest Control Products Fees and Charges Regulations for annual charges (ranging from $100–$3,600, depending on sale volumes). Therefore, registrants will be expected to incur some incremental costs associated with sales and incident reporting and the annual charge.
A UV device will be authorized if it meets certain conditions (as set out in the “Description” section, above). Authorized devices must meet the label requirements for the principal and secondary display panels and the operating manual if there is one. These label requirements include a number of precautionary statements, directions for use, and information about a contact in Canada for inquiries. Therefore, manufacturers of authorized devices will be expected to incur some costs associated with making some minor label changes to comply with the requirements. Authorized products are not subject to sales reporting, incident reporting, or annual charge requirements.
- The IO ceases to have effect after June 7, 2022. This proposal will not be implemented after the IO expires.
- After the IO expires, products that are registered during the IO year would no longer be regulated, and their registration (or ongoing applications to be registered) would be cancelled during the 10-year period of the baseline scenario (2022–2032).
- The devices are electrical products and therefore must already meet Canadian national safety standards and be certified by an accredited certification body, before they are sold in the Canadian market.
- There is no voluntary compliance with the IO after June 7, 2022 (e.g. that there would be no new registrations, manufacturers would not adjust the products to meet the conditions for authorization, etc.).
- After the IO expires, the manufacturers would not make false or misleading representations for their product (per the Competition Act) and, therefore, products entering the market thereafter would continue to have general research supporting that they are efficacious to a degree.
- The IO ceases to have effect after June 7, 2022, and the proposed amendments come into force.
- The incremental costs after the IO expires would mainly consist of three components:
- Post-market costs for existing devices registered before the IO expires, such as the annual charge, and the cost of making sales and incident reports;
- Pre-market (application fee, preparation cost) and post-market (annual charge, sales and incident reports) costs for newly registered devices, and pre-market costs (labelling change) for new authorized devices; and
- Costs to Government to assess applications for new devices.
- Costs to Government consist of costs associated with assessing applications. While there may be risk-based compliance and enforcement activities after the IO period, Health Canada would use its existing compliance and enforcement resources in support of the regulation.
- It is difficult to estimate the number of new registrations in any given year. There is a supply uncertainty as the decision to register a product is a private/business decision. There is also a demand uncertainty. Depending on whether or not the pandemic worsens, and the latest information on effectiveness of surface disinfection for controlling the spread, Canadians may rely more or less on those devices for sanitizing/disinfecting purposes.
- Most manufacturers would have registered their products during the IO year (June 7, 2021–June 7, 2022) and the first year of the analytical period (June 7, 2022– June 7, 2023).
- Costs incurred by the stakeholders are not passed onto consumers, and no price change is expected to occur because the market is competitive.
- It is assumed all stakeholders and their products have standing, which means all products are represented by businesses present in Canada.
- Based on the data, it is assumed that there would be about 30 applications submitted in the IO year and 30 applications submitted in the first year. It is also assumed that all applications would be approved for registration in the application year. According to the most recent submission data, to date, Health Canada has received 52 applications (49 UV devices and 3 ozone-generating devices). Among the 52 applications, 35 were received prior to IO, and 17 were received after IO started. Additionally, among the 35 applications prior to IO, 1 was approved, 9 were denied, 4 were withdrawn, and the remaining 21 are still pending. As for the 17 applications received after IO, 11 are pending, 2 were denied and 4 were withdrawn.
- As a result of the assumptions, there would be 52 products registered during the IO year (21 pending + 1 approved applications for registration submitted prior to the IO and 30 applications for registration submitted under the IO). The 52 products would retain their registration during the analytical period. All the post-market costs after the IO period (such as annual charge, cost of sales and incidence reports) related to these existing registrations would be considered as incremental costs due to the proposal.
- Similar assumptions are made for authorized products. Specifically, in the first year, it is assumed 30 products would meet the conditions for authorization and require minor label changes to meet the label requirements.
- Based on the amendments, manufacturers of unregistered products for export must fill a new form to obtain the certification to meet the legal requirements in the importing country, and they also must meet the labelling requirements for the safe transit of the device. For the purposes of the cost-benefit analysis, it is assumed that stakeholders would incur the greater cost of applying to register or meeting the authorization requirements rather than incurring costs to manufacture devices solely for export.
- It is assumed that the number of both registered products and authorized products grow by 10%footnote 8 starting the second year of the analytical period 2022–2032.
- In the year prior to the IO, Health Canada received 35 applications from 19 stakeholders. Thus, it is assumed that on average, each stakeholder would register 2 products, which means for year 1, 15 stakeholders would incur costs to make label changes for 30 new authorized products, and 15 stakeholders would require registrations for 30 new products. Note that the number of affected stakeholders changes as the numbers of registered products and authorized products change over time. Similar assumptions are made for the existing 52 products, that is, about 26 stakeholders would apply for registration for 52 products.
- According to findings of a research project conducted by Health Canada in collaboration with Statistics Canada in 2018, it is estimated that about 80% of Health Canada registrants are small businesses. Thus, about 24 of the 30 new stakeholders are small businesses for year 1. Similar assumptions are made for 26 existing stakeholders, of which 24 are small businesses.
- It is estimated that there would be about 10 incident reports in year 1 for UV/ozone-generating devices.footnote 3
Based on assumptions stated in the baseline and policy scenarios above, the total incremental cost is estimated to be approximately $2,033,000 for the 10 years 2022–2032 (not discounted).
- The cost to business is estimated to be approximately $1,675,000 over 10 years.
- Over the 10-year analysis period, manufacturers of the existing 52 products registered during the IO year would pay annual fees totalling $525,000 and incur administrative time costs (8 hours per sales report) of $195,000 for sales reporting.
- Over the 10-year analysis period, new products (30 new products in year 1 with 10% yearly growth afterwards) will require registration and registration fees ($2,167) will need to be paid, costing industry about $153,000, plus time to prepare the registration applications (16 hours per registration application) valued at $53,000. Furthermore, for the 71 new products that will be introduced over the next 10 years, industry will need to pay annual fees (on average $1,010 per year) resulting in a total cost of $483,000, and incur administrative time costs (8 hours per sales report) of about $179,000 for sales reporting.
- It is assumed that about 159 incidents will be reported to Health Canada over the 10-year period resulting in administrative time costs (8 hours per incident report) for reporting of $60,000.
- For those 71 products that are authorized over the 10-year period, applicants will have to incur costs to do a label review (8 hours on average) resulting in $27,000 in total costs.
- The cost to Government is expected to be about $358,000 for the 10 years (2022–2032). This cost is mainly the processing cost to review/assess new registrations net of fees collected, estimated based on the average cost recovery rate of 30%.footnote 4 Potential implementation costs to update guidance/website/forms are assumed to be minimal. While there may be risk-based compliance and enforcement activities, Health Canada would use its existing compliance and enforcement resources in support of the regulation.
- No cost is anticipated to the Canadian public. It is assumed that costs incurred by businesses are not passed onto consumers, and no price change is expected to occur because the market is competitive.
UV and ozone-generating devices that will be subject to registration will be assessed on a case-by-case basis for their safety and value (e.g. efficacy). Manufacturers who register their products with Health Canada will be required to prove that unacceptable risk will not result from operating the devices. This will include an assessment of proposed uses, application techniques, safety features, and label statements to ensure that there are no unacceptable risks to users and bystanders, including children. Moreover, manufacturers would be required to submit laboratory data proving any efficacy claims on the labels can be substantiated.
The conditions for authorization will continue to permit authorized UV devices to be used safely. The features include electrical certification, locking or shut-off mechanisms during operation, and design features that fully shield the lamp to prevent any exposure to UV light. Additionally, expanding the IO’s authorization criteria, allowing the replacement of components under safe conditions, and authorizing the manufacturing for export is likely to decrease the number of devices that would require registration. The proposal also clarifies that UV devices that generate other substances such as ozone and hydroxyls would be subject to registration so they can be assessed for their safety and value (e.g. efficacy).
With the requirements for registration and conditions for authorization (in the latter case for UV devices only), it is expected that the proposal will address human health concerns regarding exposure to UV and ozone — thereby preventing serious eye disorders (for example, cataracts), severe skin burns, and skin cancer. It will also prevent other health problems such as decreased lung function, irritation of respiratory pathways, inflammation of pulmonary tissues and irreversible lung damage leading to higher susceptibility of respiratory infections.
The regulatory framework for these devices will support Canada’s effort in controlling the spread of SARS CoV-2, by validating the efficacy of registered devices (e.g. in inactivating SARS-CoV-2) and preventing the manufacturers of these devices from making unsubstantiated efficacy claims, which will limit any potentially false sense of protection from these devices).
Note that it is not possible to quantify and monetize the benefits above due to lack of data (e.g. number of injuries, type of injury, severity of the injury, productivity loss due to hospitalization/sickness caused by the use of these devices). However, it is expected that the benefit would be significant.
Small business lens
The proposal is expected to affect small businesses. As it is assumed that about 80% of the 56 expected registrants would be small businesses (i.e. 45 of them), the total incremental cost to small businesses (i.e. collectively) is expected to be approximately $1,626,000 for the 10 years.
The Pest Control Products Fees and Charges Regulations (PCPFCR) recognizes the potential impact on niche products and small businesses and offers flexibility to limit any associated costs. Small business often have low sales and thus, if they seek to register a product with predicted low sales, they can apply to have their pre-market fees reduced to the lesser value of 10% of the fees or 10% of gross revenues for the product. If used, this flexible option would reduce upfront costs to small businesses entering the market. Moreover, annual charges for registrations can also be reduced according to sales. Registrants would be charged annually the lesser value of $3,600 or 4% of their actual gross revenue for the fiscal year (but not less than the minimum, $100). Therefore, small businesses with low sales would be eligible for lower annual charges.
This estimated impact to small businesses does not take into account the potential for them to reduce their compliance costs using these flexibilities in the PCPFCR.
The one-for-one rule applies since there is an incremental increase in administrative burden on business. This is anticipated to include time spent by stakeholders on reviewing, collecting information, and filling out and submitting forms for sales and incident reporting.
Additionally, the requirement to obtain a certification for businesses who manufacture unregistered devices solely for the purpose of export, would generate administrative burden costs. However, these costs would not be faced by companies that apply for the increased administrative cost of applying to register in order to have access to both the Canadian and foreign markets. Since the number of companies that may export is uncertain and registration provides an additional benefit of access to the Canadian market, it is assumed that all manufacturers would seek registration, even though administratively this is a more burdensome process than certification. Based on informal comments by stakeholders, a very limited number of companies may opt to solely manufacture UV devices and ozone generating devices for export, which in practice would lower the estimated administrative burden costs reported here.
The annualized administrative costs are estimated to be $19,871 (present value based on 2012 dollars) for all 56 businesses, and approximately $354.83 per business.
- It is assumed that it would take a scientist (Can$41.76/hr, 2012 dollars) 7 hours to review and collect information, and 1 hour to fill out one sales report and then submit it to Health Canada.
- It is assumed that for each registered product, one sales report would be submitted annually over the 10 years (2022–2032). In year 1, there will be 52 existing products for 26 businesses, and 30 new products for 15 new businesses. The market would then grow by 10% (in new products) starting the second year of the analytical period, ending with 71 new products in year 10. Each of the new businesses will spend 16 hours (2 products × 8 hours per product) to complete sales reporting.
- Similarly, it is assumed that it would cost a scientist 7 hours to review and collect information, and 1 hour to fill out one incident report and then submit it to Health Canada at a wage of Can$41.76/hr in 2012 dollars.
- Over the 10 years, it is assumed there will be about 159 incident reports to be submitted, taking 8 hours for each incident reporting.
Costs related to applying to register a UV or ozone-generating device are part of pesticide pre-market approval processes and therefore calculated as compliance costs, according to the Policy on Limiting Regulatory Burden on Businesses, and are outside the scope of the one-for-one rule. The remaining costs associated with annual charges and label changes are considered as compliance costs.
Regulatory cooperation and alignment
With the implementation of the IO, Canada is one of the first countries to take concrete steps in regulating UV and ozone-generating devices. In assessing regulatory alignment, Belgium and the United States (U.S.) were considered jurisdictional comparators.
In the European Union (EU), UV devices that generate radicals (a type of reactive molecules) or ozone using a catalyzer (e.g. titanium dioxide) with the intent to control or kill micro-organisms such as the COVID-19 virus require authorization prior to being placed on the market. The amended regulations have a similar requirement. In addition, UV lamps are regulated under the Low Voltage Directive (LVD) [PDF], which relies on IEC technical standards to guide product design, including safe use of UV. Canada also makes use of the IEC technical standards when assessing UV devices, and references the standard in one of the authorization conditions.
Belgium has taken a similar approach to Canada regarding the health risks associated with products used to purify air using UVC light and/or ozone, including their effectiveness against the control of the COVID-19 virus.
- On November 29, 2021, Belgium announced a six-month extension to the Ministerial Order issued on May 12, 2021 (available in French only). The order banned the sale and use of UVC lamps for disinfection purposes in non-hospital settings in the context of the fight against COVID-19. The Order follows similar principles to Canada’s IO:
- requiring UVC devices to be sealed to prevent radiation exposure,
- restricting use of UVC lamps in an open-emitting system, and
- permitting the replacement of UV-emitting components provided there are instructions for handling, disposal and frequency of replacement.
In contrast to Belgium’s focus on devices used in air purification equipment in the control of COVID-19, Health Canada’s scope is broader in order to address concerns with exposure to radiation across the UV spectrum and with exposure to human pathogens in or on all substances (air, surfaces, objects, water).
In the U.S., UV devices can be regulated by the Environmental Protection Agency (EPA) as pesticides or the Food and Drug Administration (FDA) as medical instruments or machines used to kill pests in or on living humans or animals.
- The U.S. uses post-market controls, such as EPA establishment numbers for manufacturers,footnote 5 a prohibition on false and misleading claims, and a requirement that scientific data to support claims be available upon request. Restrictions around the types of claims are similar in Canada and the U.S.
- On October 30, 2020, the U.S. EPA issued a Compliance Advisory (PDF) for UV lights claiming to kill or control viruses and bacteria. Canada and Australia have each issued a similar Advisory.footnote 6 Both Canada and the U.S. have taken action against UV devices that do not meet requirements, or are found to pose an unacceptable risk (e.g. FDA safety communication).
- The U.S. Centers for Disease Control (CDC) recommend the use of multiple tools for controlling the spread of the COVID-19 virus in the air, including supplemental treatments in buildings such as Ultraviolet Germicidal Irradiation (UVGI) used in ducts, and Upper Room UVGI used in occupied spaces. These UV devices are not considered a replacement for other practices for controlling the spread of the COVID-19 virus. Currently, the CDC do not recommend the use of UV devices to disinfect surfaces.
The U.S. recognizes the limited published data about the efficacy of UV devices, and has similar efficacy standards to Canada.
In addition, the World Health Organization (WHO) indicated, in the context of COVID-19, that several factors may affect the efficacy of UV irradiation and therefore these technologies supplement but do not replace the need for manual cleaning procedures. The proposed regulations are consistent with this approach, as authorized devices may only claim supplemental sanitization of substances.
- The guideline development group of the WHO noted that more scientific evidence is needed to confirm effectiveness and feasibility of UV light as a community mitigation measure for epidemics and pandemics. It is their recommendation that installing UV lights in enclosed and crowded places (e.g. educational institutions and workplaces) is not recommended for reasons of feasibility and safety.
Strategic environmental assessment
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.
Gender-based analysis plus
No gender-based analysis plus (GBA+) impacts have been identified for this proposal.
Implementation, compliance and enforcement, and service standards
The Regulations come into force on June 8, 2022, or on the day they are registered if it is after the IO ceases to have effect. As introduced under the IO and continued under this proposal, certain UV and ozone-generating devices must be registered or must meet the conditions for authorization in order to be imported, sold and used in Canada. 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 PCPR 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, 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 would be granted under the PCPA, within the 12-month service standard, if the Minister considers the health and environmental risks and the value of the device to be acceptable after any required assessments. There is no application associated with UV products that meet the conditions for authorization.
Health Canada’s Pest Management Regulatory Agency (PMRA) will continue to offer its no-cost services: PMRA Subject to Regulation provides manufacturers, importers or distributors the opportunity to confirm whether or not a product is subject to the PCPA and if the product requires registration; and PMRA Pre-submission Consultation service provides prospective applicants with written guidance to help them generate and submit a complete application containing all data and non-data requirements to register a new pest control product.
The regulatory amendments associated with this proposal may result in changes to related policies and interpretive guidance. Consistent with Health Canada’s obligations under the PCPA, consultation on those changes to policies and guidance would take place as required.
Compliance and enforcement
Health Canada encourages, promotes, maintains and enforces compliance with the PCPA through compliance promotion; compliance monitoring, including targeted, demand driven and repeat compliance verifications; and enforcement actions. Compliance promotion aims to inform, facilitate and promote compliance as well as to communicate regulatory information. Compliance verifications are designed to determine the level of compliance of users, distributors, importers, and registrants of pesticides with the provisions of the PCPA and its regulations, as well as with specific terms and conditions of registration.
Enforcement response may include warning letters; detention, seizure and forfeiture 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.
Compliance with the PCPA and its regulations is overseen through a network of officers and inspectors across Canada. Health Canada regional offices also have formal agreements with provincial pesticide regulatory departments, providing a basis for collaboration and information sharing.
Health Canada follows an established compliance and enforcement policy to promote and enhance fair treatment of the regulated community.
Health Canada follows established service standards, or defined timelines, for evaluating potential new or amended registrations, as outlined in PMRA’s Management of Submissions Policy.
Policy and Operations Directorate
Pest Management Regulatory Agency
2720 Riverside Drive