Proposed Amendments to the Pest Control Products Regulations in Canada
20 Nov 2024
The Potential Impacts of PMRA’s Transformation on Your Business
In Canada, the Pest Management Regulatory Agency (PMRA) is responsible for the regulation and registration of pest control products. As part of a push to increase transparency, make use of real-world data, and protect human health and the environment, the PMRA is currently undergoing a period of transformation intended to strengthen the Pest Control Products Regulations (PCPR).
To this end, proposed amendments to the PCPR were published in the Canada Gazette, Part I, on June 15, 2024. These amendments will come into force once they are published in the Canada Gazette, Part II, and cover the following areas:
- Confidential test data (CTD);
- Maximum residue limits (MRLs);
- Cumulative effects on the environment (CEE); and
- Species at risk (SAR).
Read on for additional details on each of the proposed amendments.
Confidential Test Data
Under the Pest Control Products Act (PCPA), test data refer to any scientific or technical information regarding the value of a pest control product or the health or environmental risks associated with a product. CTD are test data that are typically held confidential but can be inspected upon request if certain conditions are met, including submission of an affidavit stating the purpose of the inspection and certifying that the data will not be used in support of a product registration or amendment. Access to CTD was previously granted only on an in-person basis at the PMRA’s offices in Ottawa, Ontario, but, in recent years, CTD have been provided remotely via an encrypted USB key.
The proposed amendments to the PCPR would facilitate increased access to CTD for research and reanalysis conditions by removing the need to submit an affidavit. Confidential business information and private information would not be disclosed, but applicants and registrants would need to provide sufficient information for the Minister of Health to determine whether given test data meet the criteria to be considered CTD. The proposed amendments also include new definitions for “research” and “reanalysis.”
Concerns about the increased access to CTD have been expressed regarding the protection of data against unfair commercial use, the potential for misinterpretation, and the lack of control over who would have access to the CTD. The proposed amendments endeavour to incorporate measures to protect against unfair commercial use of CTD.
Maximum Residue Limits
An MRL refers to the maximum amount of pest control residue permitted to remain on or in food after the product has been used according to its label directions. As of Spring 2024, a public notification process was implemented for MRL applications for imported foods treated with an unregistered product or with a registered product that has not been approved for the specified use. The proposed amendments would stipulate the information that must be included in these applications.
The PMRA has largely received support for the proposed increase in transparency with regard to MRLs thus far.
Cumulative Effects on the Environment
As part of the pesticide registration process, the risk posed by the product to the environment is determined by assessing the exposure and hazard potential. CEE represent the combined risks from multiple agents or stressors and are challenging to assess.
The proposed CEE amendments would require pest control product applicants and registrants to submit CEE for products that have a common mechanism of toxicity—i.e., a common toxic effect to environmental health caused by two or more substances. The Minister of Health would also be required to consider CEE information provided for a proposed pest control product when an environmental risk assessment is conducted.
Conflicting feedback has been received by the PMRA so far in response to the proposed changes. Some groups have suggested broadening the proposed CEE amendments to strengthen environmental risk assessments by including synergistic and additive effects, or by adding mandatory data requirements for applicants and registrants. Other groups feel that the proposed amendments are premature given that there are currently no international recognized methodologies to determine CEE. Health Canada has proposed these amendments as a proactive approach to the lack of methodologies, suggesting that the requirement to address CEE will encourage development of such methodologies.
Species at Risk
Risks to wildlife and SAR are currently being evaluated as part of the environmental risk assessment for proposed pest control products. However, there is no explicit reference to SAR in the PCPA or PCPR. The proposed amendments would grant the Minister of Health the explicit authority to require submission of information on SAR with the caveat that testing on SAR would not be required.
The PMRA received feedback from some groups that the proposed changes are acceptable as-is. Other groups requested that the amendments be broadened to include further data requirements and consider other environmental effects.
Questions? Intertek Can Help!
Companies with pest control products registered in Canada—or with an intention to register—must understand how these proposed regulatory amendments could impact their registrations and, ultimately, their business. Do you have questions about this topic, the regulation of pesticides in Canada, the Pest Control Products Act (PCPA), or something related? 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:
Canada Gazette, Part I, Volume 158, Number 24: Regulations Amending the Pest Control Products Regulations (Strengthening the Regulation of Pest Control Products in Canada)
https://www.gazette.gc.ca/rp-pr/p1/2024/2024-06-15/html/reg2-eng.html
How We’re Transforming the Pest Management Regulatory Agency
