Report to agriculture ministers from the FPT Working Group on Pesticides Management

Executive summary

As directed by the Ministers of Agriculture, federal, provincial and territorial (FPT) government experts formed a working group to examine challenges and opportunities in Canada's current approach to pest control. The working group drafted 5 recommendations to improve pesticide management in Canada.

Enhancing engagement and collaboration in risk assessment

Canada's pesticide regulator, the Pest Management Regulatory Agency (PMRA), needs access to more real-world data, in-depth studies and expertise to refine their assessments of health and environmental risks. Additional expertise and data could prevent the loss of critical pesticides resulting from post-market reviews that rely on conservative models and assumptions.

Recognizing the value of pest management tools

PMRA needs a clearer understanding of a product's health, safety, environmental benefits and, social and economic impact. Additional expertise would allow regulators to better consider these factors when evaluating a critical pesticide or determining the suitability of its alternatives.

Supporting access to integrated pest management solutions, including biopesticides and lower-risk products

Pest control needs can vary greatly, and producers require access to a diverse selection of products and approaches to manage pest damage by the most economical means, and with the least possible hazard to people, property, and the environment.

Although pesticides can pose risks if used inappropriately, they can play an important role in sustainable agriculture by helping farmers grow food more efficiently, contributing to soil health and controlling invasive species. All governments should work together to better support Canadian agricultural producers and their need for varied crop protection tools.

Background

In July of 2023, the Government of Canada co-hosted with New Brunswick an annual conference of FPT Ministers of Agriculture in Fredericton, New Brunswick. At the conference, Ministers recognized that science and evidence-based decision making on the regulation of crop protection products is essential to ensure Canadian agricultural producers have access to effective pest management tools. They also recognized the importance of supporting research into pest management tools, practices and solutions such as biopesticides and integrated pest management approaches. Following the PMRA presentation, and recognizing the difficulties faced by our agricultural producers, Ministers agreed to create an FPT working group which will explore the challenges of pesticide management in the current regulatory system.

In the fall of 2023, Agriculture and Agri-Food Canada (AAFC) hosted 5 roundtable discussions with representatives from federal, provincial and territorial departments of agriculture. The working group also welcomed participation from the PMRA, the Canadian Food Inspection Agency (CFIA), and the United States Environmental Protection Agency (US EPA) Office of Pesticide Programs (OPP).

The discussions focused on:

• the regulatory system for pesticides in Canada
• legislation and policies guiding pesticide regulation
• examples of regulatory decisions to illustrate how the regulatory framework is applied
• alternative frameworks used by the United States that can lead to different product assessments
• opportunities to improve pesticide management in Canada

The following report serves as a record of discussion and assessment of key items related to the regulation of pest management tools in Canada. It also provides a number of recommendations as a key outcome of the working group discussions.

Overview of pesticide regulations

Canada's science-based regulatory process

Pesticides play an essential role in managing pests that could otherwise threaten human health, food and fibre production, and Canada's natural resources. However, pesticides can also pose risks to human health and the environment and require a robust regulatory framework to manage these risks. In Canada, pesticides are regulated by Health Canada's PMRA in a manner consistent with comparable member countries of the Organization for Economic Co-operation and Development (OECD). The OECD Pesticide Programme produces technical standards and guidance for data generation and assessment to harmonize regulatory approaches across jurisdictions. For the last 25 years, PMRA and the US EPA OPP have conducted joint reviews and shared work on submissions for new active ingredients^{Endnote 1} and minor uses^{Endnote 2}, demonstrating the generally high level of agreement between the 2 regulators and their scientific approaches to assessing risk. Although similar, Canadian and American regulators work under different legislation and can take different approaches to risk management and applying margins of safety, leading to differing regulatory decisions on pest control products.

Before a new pesticide is approved for use, Health Canada scientists complete a thorough, science-based risk assessment to determine if these products can be used safely. Once a pesticide is approved, Health Canada scientists conduct post-market reviews. They re-evaluate products every 15 years to consider new data requirements or changes in risk assessment approaches to ensure they continue to meet modern standards. Special Reviews can also be triggered by information from sources such as new studies, monitoring data, incident reports, or exposure information that can be submitted by registrants, provincial authorities and the public. Most often, special reviews are triggered when an OECD member country prohibits all uses of pesticide for health or environmental reasons. If a post-market re-evaluation demonstrates unacceptable risks, its authorized use will be changed, or the products can be taken off the market all together. Only pesticides that are registered or otherwise authorized can be sold or used in Canada, and they must be used as directed.

While this regulatory system exists to protect human and environmental health, it is important to recognize that re-evaluation and special reviews can result in a loss of important tools for agricultural producers. This may have wide-reaching implications for the agriculture sector and for Canada.

Enhancing engagement and collaboration in risk assessment

PMRA's primary objective in administering the Pest Control Products Act is to prevent unacceptable risks to individuals and the environment from the use of pest control products. PMRA must act in a timely manner to cancel a product registration or remove a use if, during a post-market review, there are reasonable grounds to believe that the cancellation or amendment is necessary to deal with a situation that endangers human health or safety, or the environment. Protecting the health and safety of agricultural workers, their families, consumers and the environment is paramount in the regulation of pesticides.

During a re-evaluation, PMRA is responsible for conducting scientific assessments to determine if the risks associated with registered products remain acceptable. However, it is the registrant that has the burden of providing the data and research demonstrating to the PMRA that the health and environmental risks and the value of the pest control product are acceptable during that re-evaluation. Registrants also bear this burden of demonstration with new registrations and amendments.

When an initial assessment indicates certain uses are no longer acceptable, registrants can submit new information to refine a risk assessment, thereby reducing the use of conservative models and their assumptions^{Endnote 3}. This is usually accomplished through the generation of additional data to present a more accurate representation of how the pesticide is used and responds in the real world. This can include monitoring data, field studies or use information. By reducing the uncertainty in risk assessments and removing certain conservative assumptions, these refinements can lead to PMRA retaining registrations for uses or products that were previously identified as having unacceptable risks.

If registrants choose not to generate new refined data, or the refinements are not sufficient to demonstrate an acceptable risk, uses for that product may need to be removed from a product label. In these situations, PMRA relies on the registrant to propose a use pattern that demonstrates an acceptable level of risk, or otherwise, the registration needs to be cancelled and the product(s) removed from the market. Producers and other agriculture stakeholders are only made aware of reduced use patterns or cancelled products when PMRA publishes their proposed decision.

The working group discussions highlighted the need for provinces and producer groups to be engaged in a meaningful way, earlier in the risk assessment process. When PMRA initiates a post-market review, provinces are asked to provide information, and then must wait until the public consultation on a proposed decision to learn if there are any issues identified in the risk assessment. In situations where registrants are not willing or able to generate information to refine a risk assessment, provincial governments and other federal departments or agencies may be able to assist in refining PMRA's risk assessment.

It was acknowledged by the working group that a registrant's decision to remove a registered use during a re-evaluation is usually based on the registrant's financial returns for a product, while noting that this can have a disproportionate impact on minor uses for agricultural producers. Working Group members felt that there could be a role for producers and other agricultural stakeholders in deciding which uses could remain, and in the generation of supporting scientific data.

The working group was supportive of PMRA's efforts to identify and address potential risks sooner through a continuous oversight process, while recognizing that more immediate action is needed to address products that are already scheduled for re-evaluation or are already being reassessed. Conducting grower surveys or the generation of new scientific studies can take months or years to complete. Therefore, sufficient lead time is required to produce the information required to refine a risk assessment before a regulatory decision is made. This is especially true for pesticides on PMRA's workplan with few or no alternatives who are near the threshold in which certain uses would need to be removed should the re-evaluation identify new risks.

Recognizing the value of pest management tools

In addition to protecting against risks, the Pest Control Products Act has an ancillary objective to "ensure that only those pest control products that are determined to be of acceptable value^{Endnote 4} are approved for use in Canada." The legislative test for pesticides is that "the health and environmental risks and the value of the pest control product are acceptable." This means that in Canada, a pesticide must pass a human health risk assessment, an environmental assessment and a value assessment before it can be registered.

In its research, the working group explored the U.S. regulatory system as a comparator. While both countries employ harmonized risk assessment approaches, there are small but significant differences in the how those risks are managed and how "value" or the benefit of a pesticide is considered. Under U.S. law, products cannot have "any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or a human dietary risk from residues that result from a use of a pesticide in or on any food." This risk-benefit consideration is unique to the U.S. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and is not included in any of the other U.S. federal legislation that applies to pesticides (that is, Federal Food, Drug, and Cosmetic Act as amended by the Food Quality Protection Act of 1996 or the Endangered Species Act).

Cancellations and amendments

In considering the cancellation of product registrations, the working group looked at the risk-benefit approach used by U.S. regulators and how certain of its aspects could be applied in a Canadian context. While PMRA cannot legally take into account socio-economic costs and benefits in determining the acceptability of risks, the working group felt that the value of a pesticide should be considered in other aspects of PMRA's work.

All pesticides in Canada would have had acceptable risks and value at the time they were registered and the acceptability of these risks confirmed during the most recent re-evaluation, special review or major use expansion^{Endnote 5}. When unacceptable risks are found during a post-market review, history has shown that it is rare that the product poses an imminent and serious risk to health or the environment. Findings of unacceptable risk are more commonly characterized as not meeting the margins of safety required by legislation. Often, the margins of safety are surpassed due to conservative assumptions in the risk assessment. The actual risk of the product could be better assessed with additional data.

The working group felt that a pesticide's value or benefits should be considered when PMRA is determining how far to refine a risk assessment. The loss of high-value pesticides can have a significant impact on agriculture production and farmers' livelihoods, which emphasizes the importance of relying on risk assessments based on real-world evidence if critical products or uses may be lost. Acknowledging the need for improved technical and regional data to inform value assessments, federal and provincial government departments and agencies may play an essential role in this process by contributing their expertise and access to data to improve the quality of PMRA value assessments.

Suitability of alternatives

It was also noted by the working group that, in the U.S., regulators are legally obligated to examine what available alternative pest control methods could be used as substitutes for a pesticide being considered for cancellation. Furthermore, regulators need to study the economic impact to pesticide users and consumers that would occur if these alternative pest control methods were used. The information to support this analysis comes from a combination of in-house experts (that is, agricultural scientists, chemists, economists, information management specialists, microbiologists, policy analysts, statisticians, and toxicologists) as well as external sources including state regulators, land-grant universities, grower surveys and commercially available data and analytics.

When the registration of a pest control product is cancelled in Canada, or the registration is amended to remove uses, the effective date of that decision can be delayed if no suitable alternatives are available. This only occurs in the event that the risks continue to be acceptable until the effective date, considering any conditions placed on the registration. When considering the suitability of an alternative product, the PMRA relies almost exclusively on whether it is registered in Canada for the uses being cancelled. Little consideration is given to the availability in the marketplace, or the relative cost, among other factors. The working group therefore felt that an up-to-date pesticide value assessment, including benefits and social and economic impacts and regional considerations, should be considered when determining the suitability of alternatives when cancelling product registrations or uses.

While PMRA may have access to some data sources comparable to those used by the US EPA, the working group recognized that the scope and scale of information available from all sources in Canada is much less. It was acknowledged that PMRA's transformation initiative may generate more Canadian pesticide use information if longer-term funding is secured. However, more diverse information sources would be required to assess the social and economic impacts regulatory decisions may have on various regions of the country–including impacts on farmers' livelihood and well-being. The working group felt that more factors needed to be taken into account when considering the suitability of alternatives.

Supporting access to integrated pest management solutions, including biopesticides and lower-risk products

Most Canadian agricultural producers apply some degree of Integrated Pest Management (IPM) in their operations. IPM is an approach to pest management that uses information on the life cycles of pests and their interaction with the environment in combination with available pest control methods to manage pest damage by the most economical means, and with the least possible hazard to people, property and the environment. IPM is not a single pest control method but, rather, a series of pest management evaluations, decisions and controls that includes preventive practices like crop rotation, setting action thresholds for pest populations, monitoring and identifying pests and choosing the least risky approach to achieving cost-effective control of pest damage.

An important theme throughout the working group discussions was the need for agricultural producers to have access to a broad range of pest management solutions, not limited to conventional pesticides. The environmental risks associated with a particular pesticide can vary from one area to another. Farmers, working with agronomists and other experts, are often best placed to manage risks specific to their farms when choosing how to control a pest problem. To do this effectively, agricultural producers require a larger number of pest management tools in their tool box. These include biological solutions such as pheromones or other biopesticides, mechanical or physical solutions like weeding equipment or row covers, synthetic chemicals, genetic approaches such as RNAi, and new application technologies such as drones and artificial intelligence driven precision agriculture.

The working group noted that many smaller registrants have voiced concerns that there appears to be regulatory barriers to registering products in Canada that do not exist elsewhere, particularly for biopesticides. It was noted that some of the initiatives to support smaller applicants, such as pre-submission consultations, were not seen as effective in addressing this perception. There are various factors that can impact a decision to register a product in Canada including: regulatory costs in time, data generation, and fees; geographic considerations and distribution networks, and support for adoption of new technology. The working group voiced concerns about a growing technology gap in crop protection products between Canada and the U.S. that could put Canadian agriculture producers at a competitive disadvantage in the marketplace. Attracting new active ingredients for pest control and associated products to Canada and encouraging adoption of new biopesticides and low-risk products, will be vital for a competitive and sustainable agriculture sector.

The working group felt that there should be greater recognition of the time required to register a new pest control product, or use, if no suitable alternatives are available when a product is being cancelled. If risks cannot be managed and registrations are cancelled or amended, transition strategies should be developed to help agricultural producers move to suitable alternatives. In some situations, a maximum 2-year delay in implementing a cancellation may not be sufficient to bring an alternative to market. Furthermore, the PMRA should make greater use of the new 3-year maximum for emergency registrations when it is clear that registration applications and decisions will require the maximum time.

In addition to the loss of minor use pesticides through re-evaluation, the working group voiced concerns regarding the shrinking capacity at AAFC's Pest Management Centre to support the registration of new minor uses, noting that funding has not increased since the centre opened in 2002. Working Group members familiar with the minor use program noted an increasing reliance on emergency registrations and the need for increased federal and provincial funding to address the growing need for minor use registrations in Canada. The shrinking capacity of the Pesticide Risk Reduction Program was also raised.

The working group also outlined the importance of developing and transferring knowledge in the area of pest management. Producers do not simply need access to various alternatives to pesticides, they also require the knowledge and expertise to use these methods and products efficiently and to choose the best solutions for their situation. The working group noted that provincial and federal governments could play a bigger role in researching alternatives to synthetic pesticides and in supporting the knowledge transfer agricultural producers require to implement these integrated pest management techniques.

Conclusions

Pesticides play an important role in agriculture when label directions are followed. Insecticides and fungicides protect crops and livestock from pests and disease as well as help farmers grow more food on less land. Sustainable agriculture practices like no-till farming that improve soil health rely on the strategic use of herbicides. The judicious use of pesticides can also play a role in protecting Canada's biodiversity by helping to control invasive species and protecting natural areas through the efficient use of agricultural land. In the context of climate change with increasing temperatures, flooding and extreme weather events, it has never been more important to protect the environment and maximize the sustainability of the agricultural sector.

Pesticides can also pose risks to health and the environment if used inappropriately. Therefore, a strong, predictable, science-based regulatory system is required to assess and manage these risks. Recognizing that pest control needs can vary based on region, crop type or agricultural practice, access to a diverse selection of pest control products and approaches is required. An agile regulatory system is also required to respond to the needs of the agriculture sector while protecting health and the environment in Canada.

Now more than ever, varied and effective pest management tools are critical to Canada's agriculture sector and food security. Agricultural producers must have access to a vast array of products that will help them safely and effectively maintain sustainable agricultural yields, while limiting their potentially negative impacts. Therefore, all governments should work together to support Canadian producers and their need for increased and varied crop protection tools.