As noted in our Field Notes blog of earlier this year, the Pest Management Regulatory Agency (PMRA) has now published the draft regulations amending the Pest Control Products Regulations (Strengthening the Regulation of Pest Control Products in Canada) in the Canada Gazette, Part 1, Volume 158, Number 24. These are now open for stakeholder input until August 24, 2024.

The proposed amendments are part of Health Canada’s targeted review of the Pest Control Products Act (PCPA) and the Pest Control Products Regulations under the PCPA with the stated goals being two-fold: (1) to improve trust in the federal pesticide regulatory system; and (2) to address the public's growing expectations to improve environmental risk assessments.

Stakeholder consultations relating to the targeted review of the PCPA began in the spring of 2022 when the PMRA published a discussion document on the topics of interest to it. Following that consultation, in the fall of 2022, it published a report entitled "What We Heard", reflecting the comments received by interested parties. On June 20, 2023, in response to the feedback received, Health Canada published a notice of intent (NOI2023-01), which outlined the general proposal to amend the PCPR. Comments were received from multiple sources and two webinars and Q&A sessions were held.

The changes set out in the Regulations Amending the Pest Control Products Regulations (Strengthening the Regulation of Pest Control Products in Canada) are focused on:

• facilitating timelier and improved access to confidential test data (CTD) for research and re-analysis purposes, while maintaining the appropriate levels of protection against unfair commercial use of the CTD;
• increasing transparency for maximum residue limit (MRL) applications for imported products and require the Minister of Health (Minister) to issue a public notification once an application to change an import MRL is accepted for review;
• granting the Minister the explicit authority to require the submission of available information on cumulative environmental effects (CEE) that have a common mechanism of toxicity and require the Minister to consider CEE during risk assessments where information and methodology are available; and
• granting the Minister the explicit authority to require registrants and applicants to submit available information on species at risk (SAR), in an effort to increase consideration of SAR throughout environmental risk assessments.

In terms of the proposed amendments to the disclosure of CTD, some of the concerns that were raised included who would have access to the data, how the data would be protected against unfair commercial use and the potential for misinterpretation or misinformation. To address these concerns, Health Canada has published a Regulatory Proposal, PRO2024-02, Accessing confidential test data under pest control products regulations—proposed guidance document, dated June 17, 2024.

If the proposed regulations as currently drafted are confirmed, there are some key items for applicants and registrants to note relating to the disclosure of CTD:

• information meeting the definition of confidential business information under the PCPA will not be subject to inspection. This includes information concerning manufacturing or quality control processes, methods for determining the composition of the product, the monetary value of sales and other financial or commercial information or information that contains the identity and concentration of formulants and contaminants in a pest control product (other than those listed on the List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern.
• on an application to register a pest control product, or whenever data is submitted to the PMRA, applicants and registrants must provide sufficient information for the PMRA to determine if the data submitted is CTD. This would include information on whether the data constitutes a trade secret and whether its disclosure could reasonably be expected to prejudice the applicant or registrant. Additional information may be requested by the PMRA. The PMRA will consider the information submitted and may conclude that it is not CTD.
• there are new definitions for the terms “research” and “reanalysis”, which will solely apply to the public disclosure of CTD. These definitions drive when a third party is able to seek to access CTD through the process to be established under the amended regulations.
• the registrant would not receive notice of the request for access to the CTD until the PMRA has granted access and the identity of the individual accessing the CTD would not be disclosed. The requester would potentially have access to the data for up to five years.
• the Minister of Health would be granted discretion to refuse a request where access is not reasonably related to the purpose of the research or reanalysis or where the Minister determines it would be unreasonable to respond to the request. To make this determination, the Minister would be entitled to consider the volume of CTD requested, the repetitive or systematic nature of the request and the impact on Health Canada’s operations in relation to the regulation of pest control products.
• the regulations expressly state the requirements relating to access:
  • the individual requesting access to the CTD must be a Canadian resident;
  • no copies can be made of the data;
  • the data cannot be used to register or amend a registration of a pest control product in Canada or elsewhere;
  • the data cannot be published or disseminated;
  • if the requester becomes aware of any unauthorized disclosure or any possible unauthorized disclosure, they must notify the Minister of Health immediately;
  • the CTD must be stored in a secure location in Canada and not in the cloud;
  • the data must be accessed in Canada. failure to comply with the requirements, would result in the revocation of the requester’s access and denial of future requests; and
  • the requester could publish general findings or conclusions based on the CTD accessed, as long as the CTD cannot be extrapolated from the research.

The consultation period is open until August 24, 2024. The final amended regulations are expected to be published in the Canada Gazette, Part II in the spring of 2025.