Canada: Field Notes: Pesticide News In Canada—Part II

Our Field Notes series is intended to provide a high-level overview of the emerging issues in the landscape of pesticides in Canada, including happenings at the Pest Management Regulatory Agency (PMRA). In Part II of our Field Notes series, we provide an update on PMRA's recent and current initiatives and highlight what we expect to see from the PMRA in the coming year.

PMRA Initiatives

As we noted in Part I, the PMRA announced several pesticide-related initiatives to be carried out throughout 2023, including vertical farming, a sales reporting enforcement program and enhanced transparency for the Public Registry. In 2024, we expect to see the PMRA's focus on enhancing transparency to continue, along with efforts to clarify or refine existing processes. Some of those initiatives are described in more detail below.

1. Amendments to the Pest Control Products Act (PCPA) and the Pest Control Product Regulations (PCPR)

Health Canada's 2023-2025 Forward Regulatory Plan includes a series of proposed amendments to the PCPA and PCPR, each focused on distinct aspects of the existing regulatory framework:

a) Amendments to the PCPA/PCPR re: Product Exemptions and Pest Control Product Devices

The current regulatory framework for pest control devices under the PCPA and PCPR is being overhauled. Currently, devices which fall under any of the categories listed in Schedule 1 of the PCPR are required to be registered with the PMRA. Devices which do not fall under a category listed in Schedule 1 are exempt from the PCPA entirely. Determining whether or not a device falls under a category listed in Schedule 1 often requires a complex review, taking into consideration historical interpretation of the device, previous regulatory decisions and the level of risk of the device.

Health Canada has itself acknowledged that the current approach to regulating devices lacks clarity and has led to regulatory uncertainty, with many manufacturers unsure of the correct category their device may fall into, or entirely unaware that their devices are subject to the PCPA and its requirements. To address this regulatory uncertainty, Health Canada published the Regulatory Proposal PRO2018-02, Pre-Consultation in November 2018 and received comments from stakeholders at that time. Health Canada will be proposing Regulations Amending the Pest Control Products Regulations (Product Exemptions and Pest Control Product Devices) to revise the framework for pest control devices. It claims that the amendments aim to modernize its regulatory oversight for pest control devices in Canada by:

• requiring all pest control devices to be regulated under the authority of the PCPA, with some exceptions;
• exempting from registration certain devices that operate strictly by mechanical or physical means, with no conditions; and
• replacing Schedule 1 in the PCPR with a category of products exempt from registration, with conditions.

With these amendments, Health Canada seeks to eliminate regulatory duplication, codify current policies, ensure appropriate oversight of regulated products and clarify the scope of the requirements related to devices to close any regulatory gaps. The amendments will add predictability for businesses in determining whether their products or devices must be registered and aim to exempt products with low or well-characterized risks from the registration requirements under the PCPA. Those devices will still be subject to the other requirements under the PCPA, including with respect to labeling and advertising.

The public will have an opportunity to comment on the proposed amendments that are expected to be published in the Canada Gazette, Part I in the spring of 2024, with the final amendments expected to be published in the Canada Gazette, Part II this fall.

b) Amendments to the PCPA/PCPR to Strengthen the Regulation of Pest Control Products in Canada

Health Canada is carrying out a targeted review of the PCPA and PCPR, having undertaken stakeholder consultation and published a discussion document and a report entitled "What We Heard" (published in 2022) reflecting the comments received by interested parties. Health Canada has proposed amendments to the PCPR in an effort to strengthen the protection of human health and the environment, including wildlife, from risks posed by pesticides. The Regulations Amending the Pest Control Products Regulations (Strengthening the Regulation of Pest Control Products in Canada) seek to:

• facilitate 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;
• increase 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;
• grant 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
• grant 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.

The goal of the proposed amendments is stated to be 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.

The proposed amendments will follow the Notice of Intent, published by the PMRA in June 2023, which sought stakeholder input. According to Health Canada, that review determined that the PMRA can achieve most of the transformation objectives within the current provisions of the PCPA. The public is expected to once again have an opportunity to comment on the proposed amendments when they are published in the Canada Gazette, Part I, this spring. The amended regulations are expected to be published in the Canada Gazette, Part II in the spring of 2025.

c) Amendments to the PCPA/PCPR to Expand Research Definition

Pest control products are required to be registered with the PMRA subject to certain exceptions. One such exception relates to the use of unregistered active ingredients and experimental uses of registered products for research purposes. These exemptions are aimed at permitting researchers to generate test data that provide information on the human health and environmental effects of pesticides and their value, though only for the purposes of applying for, or amending, a registration of a pest control product.

Health Canada is now seeking to expand the scope of the exception provisions to permit research involving all pest control products, not simply for research for the purposes of an application for, or an amendment to, a registration of a pest control product. This is driven by Health Canada's view that there is value in research and additional scientific data in improving pesticide protections, The Regulations Amending the Pest Control Products Regulations (Research) therefore propose to expand the definition of "research" to allow for research to be carried out that is not aimed at registration, including purely academic research examining health, safety or environmental impacts of pest control products, or research which examines the efficacy of a pesticide active ingredient for a non-pesticidal purpose.

The PCPR also currently only allows research involving a microbial agent if certain requirements are met. Microbial agents are not distinguished in the current regulatory framework. The PMRA has since however determined that risks associated with certain microbial agent research are well-defined and low, while other microbial agents (involving human, animal or plant diseases or pathogens) pose inherent risks and should always require a research authorization from the PMRA. Taking into consideration the differences that exist in microbial agents, the proposed amendments will exempt research for certain microbial agents from having to meet the currently prescribed requirements, unless the research involves human participants or involves diseases or pathogens of humans, animals or plants.

Pre-consultation for the proposed amendments was held in the fall of 2022. The public can expect to have an additional opportunity to comment on the proposed regulatory amendments when they are published in the Canada Gazette, Part I in the spring of 2024, with the amended regulations set to be published in the Canada Gazette, Part II this fall.

d) Amendments to the PCPR to Modernize the Labelling Procedure

To improve alignment with international markets and to improve labels' readability, Health Canada has proposed amendments to the PCPR, which would (1) provide consistency in the way information is presented in labels; and (2) permit the use of electronic labels and the internationally aligned Globally Harmonized System of Classification of Labelling of Chemicals.

Parties hoping to comment on the proposed amendments can participate in the pre-consultation for these amendments, set to be held in the winter of 2024, and in the comment period when published in the Canada Gazette, Part I, which is expected to take place in the winter of 2025. Health Canada plans to publish the amended regulations in the Canada Gazette, Part II in the fall of 2025.

2. Updated Guidance for Registrants and Data Holders

Beyond amendments to the PCPA and the PCPR, in December 2023, the PMRA published updated guidance with respect to the process for use or reliance by one registrant on another registrant's test data under the PCPR in the context of re-evaluations or special reviews. The guidance follows the coming into force of the Regulations Amending the Pest Control Products Regulations (exclusive rights and compensable data) (the Amended Regulations) on December 4, 2023.

The Amended Regulations, a more detailed overview of which can be found in our previous blog post, The PMRA has Provided Clarity for Data Compensation in the Re-Evaluation and Special Review Contexts, set out the data compensation process where both parties are registrants in the market already, and new data is required to satisfy the PMRA's re-evaluation or special review analyses. The guidance provides a welcome clarification on a process that was difficult to reconcile with the PCPA and the PCPR as previously drafted.

3. Consultation Open on the Proposed Policy on Continuous Oversight of Pesticides

Consultation is currently open on Health Canada's recently introduced Continuous Oversight Pesticides Policy (Policy). The Policy, which seeks to strengthen the safety of pesticides, builds on the PMRA's existing monitoring system which currently requires a scientific review of available data upon the application for registration, and a re-evaluation of the pesticide once registered, at least every 15 years.

Under the proposed Policy, the PMRA will collect, on an ongoing basis, data related to the pesticide throughout its regulatory lifecycle, beginning upon its registration under the PCPA. The continuous oversight program would include consideration of new information such as published scientific data, water monitoring data, information received as part of the incident reporting provisions in the PCPA and regulatory decisions made by other Organization for Economic Co-Operation and Development member countries. This ongoing process is intended to enhance (and not replace) the re-evaluation and special review processes. The PMRA will publish all relevant studies that are collected through the continuous oversight process. The public is invited to comment on the Consultation Document until March 3, 2024.

A separate consultation and proposed policy will be issued by the PMRA with respect to a framework on how relevant published studies are evaluated and used in the risk assessment process.

4. No More Pesticides for Cosmetic Purposes on Federal Lands

The federal government announced its intention to eliminate the use of pesticides for cosmetic purposes on federal lands, where operational requirements permit. A commitment to this effect will be added to the Greening Government Strategy, which sets out how Canada plans to reduce environmental impacts to waste, water and biodiversity, and transition to net-zero carbon and climate-resilient operations by 2050. This will be in line with Canada's commitments to the Global Biodiversity Framework, adopted at COP15 in December 2022.

5. An End to PMRA's Transformation Agenda

The PMRA's Transformation Agenda, which we explored in our first issue, identifies a number of initiatives intended to improve transparency and public access to information and data across the regulatory pesticide processes. Although its mandate ends in March of 2024, we still expect to see certain initiatives completed, including:

• the establishment of the Proportional Effort Framework, which will recognize the spectrum of regulatory oversight required for pesticides and seeks to allocate resources based on the level of oversight required;
• continued progress on the National Water Monitoring Program for Pesticides Framework, which aims to provide guidance for pesticide water monitoring programs and sets out the development and implementation of a long-term national-scale collaborative water monitoring program for pesticides; and
• the development of the National Pesticide Use Information Program (see the PMRA's Newsletter, Vol. 3, Issue 1, October 2023), a framework which will provide a systematic approach to identifying, accessing and managing pesticide use information, expected to be completed this March, 2024.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.