Consultation Summary: Notice of Intent to allow labelling of human pathogens on products regulated under the Pest Control Products Act, NOI2021-02
Pest Management Regulatory Agency
4 July 2022
Table of contents
The consultation
On 13 August 2021, the Pest Management Regulatory Agency (PMRA) initiated a 30-day consultation on a proposal (NOI2021-02) to allow the labelling of human pathogens on products regulated under the Pest Control Products Act. This approach would align with the Interim Order regulating certain ultra-violet (UV) radiation-emitting and ozone-generating devices to control, destroy, inactivate, or reduce levels of bacteria, viruses and other micro-organisms that are human pathogens. It would also align with current labelling practices for certain products regulated under the Food and Drugs Act (for example, hard surface disinfectants).
Overview of comments received
In total, eight comments were received. Five comments were from industry stakeholders, one from a provincial government, one from another federal department, and one from an individual.
Six of the comments supported the proposal. The remaining two comments were neutral.
Addressing stakeholder comments
In addition to expressing support for the proposal, various comments and requests for clarifications were received, and are addressed below:
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Comments were received related to the scope of the proposal in terms of the types of pathogens and the types of products to which it would apply.
PMRA response:
The proposal applies to any product regulated under the Pest Control Products Act and to any human pathogen.
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Comments were received related to data requirements, submission categories, review timelines and fees.
PMRA response:
The proposal would not result in any changes to data requirements, submission categories, review timelines or fees. These would remain as described in existing guidance documents. As is currently the case for any pest that appears on a pest control product label, data specific to any human pathogen proposed for labelling would be required.
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Comments were received related to chemical disinfectants and public health claims.
PMRA response:
Chemical disinfectants are regulated under the Food and Drugs Act and are not within scope of the proposal. Guidance related to acceptable public health claims for pest control products can be found in Regulatory Directive DIR2016-01, Guidelines for the Advertising of Pest Control Products.
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Comments were received related to UV radiation-emitting devices that are exempt from registration under the Interim Order.
PMRA response:
The requirements established by the Interim Order have now been replaced by amendments to the Pest Control Products Regulations. As a result, this response will refer to requirements under the Pest Control Products Regulations rather than the Interim Order.
UV radiation-emitting devices that are authorized (meaning that registration is not required) are out of scope of the proposal. Human pathogen names may not appear on the labels of authorized UV radiation-emitting devices. Authorized devices must only have a claim of supplemental sanitization, and must not claim to prevent, treat or mitigate any disease.
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Comments were received related to the prevention of off-label claims and uses.
PMRA response:
Although compliance and enforcement actions are not within scope of the proposal, all pest control products are subject to compliance and enforcement activities. Information related to pesticides compliance and enforcement is available on the Pesticides section of the Canada.ca website.
Conclusion
Following consideration of the comments received from stakeholders, as of the publication date of this document, the PMRA will implement the proposal and will allow human pathogens to appear on the labels of registered pest control products, after a scientific review has confirmed the efficacy of the product against the pathogens.
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