Pesticide Device Regulation in Canada
13 Jul 2021
New Developments for UV and Ozone-Generating Devices
During the pandemic-related challenges of the past year, antimicrobial pesticides and pesticide devices have been at the forefront of new products entering the Canadian marketplace. These products are regulated by the Pest Management Regulatory Agency (PMRA) under the Pest Control Products Act (PCPA), and pre-market approval must be obtained before they can be manufactured, imported, sold, or distributed in Canada. While the path forward for the registration of pesticides is well-understood, there has been uncertainty surrounding the future of the registration requirements for pesticide devices.
In 2018, the PMRA published Regulatory Proposal PRO2018-02, Pre-Consultation – Proposed Regulatory Amendments to the Pest Control Products Regulations (Pest Control Devices). Under this proposed regulatory amendment, certain pest control devices (those that operate by strictly mechanical or physical means) were proposed to be exempt from registration, although they would continue to be regulated under the PCPA.
Notice of Intent NOI2021-01
On 30 April 2021, the PMRA published Notice of Intent NOI2021-01: Interim order to regulate certain ultraviolet radiation-emitting devices and ozone-generating devices under the pest control products act. Under this interim order, ultraviolet (UV) and ozone-generating devices would continue to be subject to a pre-market assessment and would require registration prior to import, sale, or distribution in Canada. Health Canada indicated that they have not yet received sufficient evidence to demonstrate that UV and ozone-generating devices are safe or as effective as claimed. Further, given that users of these types of devices expect the efficacy claimed on the product's label, and given that many of these devices bear claims against the SARS-CoV-2 virus and other pathogenic microbes, strong product-specific evidence supporting the conditions of use will need to be reviewed by the PMRA prior to each product being placed on the Canadian market.
Devices that do not rely on UV light or ozone generation to produce a pesticidal effect may still be exempt from registration under the proposed regulatory amendment PRO2018-02 once this regulatory modernization is adopted. Health Canada intends to provide additional information about the interim order, the registration process, and the conditions under which certain devices would be exempt from registration in 2021.
Registration Requirements for Pesticide Devices
In order to obtain pre-market approval for UV and ozone-generating devices, a registration application must be submitted to the PMRA that includes, but is not limited to, the following information:
- Labelling that complies with PMRA requirements;
- Certification for devices that contain electronic components;
- Exposure assessments; and
- Efficacy support.
It is crucial that any pesticidal claims on the product labelling can be substantiated with product performance (efficacy) data produced using the product as described in the directions for use.
Conclusion
It is important to understand the registration requirements for pesticide devices, including which devices require pre-market approval prior to being manufactured, imported, sold, or distributed in Canada. Do you have questions about this topic, regulation of pesticides in Canada, the Pest Control Products Act (PCPA), or a related topic? Do you need assistance preparing a registration dossier for a pesticide or pesticide device? Contact our experts at Intertek. We're here to help!
References:
The Pest Control Products Act (S.C. 2002, c. 28)
https://laws-lois.justice.gc.ca/eng/acts/p-9.01/
Notice of Intent NOI2021-01: Interim order to regulate certain ultraviolet radiation-emitting devices and ozone-generating devices under the pest control products act
Regulatory Proposal PRO2018-02, Pre-Consultation - Proposed Regulatory Amendments to the Pest Control Products Regulations (Pest Control Devices)
Michaela Marshall,
Associate II, Chemicals Group
Health, Environmental & Regulatory Services (HERS)
Today's expert blogger is Michaela Marshall. Michaela is an Associate II in Intertek's Chemicals Group. As part of the biocides team, she assists clients with the regulatory requirements for pesticides and pesticide devices in Canada and the United States. This includes product registrations, label reviews, and other regulatory support to comply with the PMRA and U.S. EPA regulations. Michaela holds a M.Sc. in Environmental Chemistry from the University of Toronto.