Pest Management Regulatory Agency

In 1990, the Pesticides Registration Review Team was tasked with developing recommendations to improve the federal pesticide regulatory system. The Review Team consulted with Canadians across the country proposing a major reform to the federal pest management regulatory system.[http://amicus.collectionscanada.ca/aaweb-bin/aamain/itemdisp?sessionKey=999999999_142&l=0&d=2&v=0&lvl=1&itm=10465527 Recommendations for a Revised Federal Pest Management Regulatory System]{{Dead link|date=May 2020 |bot=InternetArchiveBot |fix-attempted=yes }}, Final Report, December 1990 Proposed reforms from the Review Team were to establish a multi-stakeholder advisory council and the federal/provincial/territorial committee. Furthermore to increase public participation they recommended providing access to information on regulatory decisions with the intention of increasing openness and transparency. Additional suggestions to improve operation included:

• The use of a risk management approach
• Labeling provisions for safe use
• Re-evaluation of older pesticides and special reviews that may result from new information
• Data protection policy
• A cost recovery scheme
• Mandatory incident reporting
• Compliance and enforcement strategies and provisions

The Canadian government provided a response in 1994 recognizing the principles of environmental sustainability: to protect human health, safety and the environment by minimizing the risks associated with pesticides all while enabling access to pest control products and pest management strategies. The goals listed above helped work to set up the agency’s mandate.Government Proposal for the Pest Management Regulatory System, October 1994

In 1995, the formation of the Pest Management Regulatory Agency was approved with the purpose of consolidating the resources and responsibilities for pest management regulation.{{Cite web|url=http://publications.gc.ca/site/archivee-archived.html?url=http://publications.gc.ca/collections/collection_2012/sc-hc/H111-2-1998-eng.pdf|archive-url=https://web.archive.org/web/20230108120334/https://publications.gc.ca/site/archivee-archived.html?url=http://publications.gc.ca/collections/collection_2012/sc-hc/H111-2-1998-eng.pdf|url-status=dead|archive-date=January 8, 2023|title=PMRA Strategic Plan 1998-2003|website=Government of Canada Publications}} Staff and resources were consolidated from several federal departments — Agriculture and Agri-Food Canada, Environment Canada, Natural Resources Canada, Fisheries and Oceans Canada and Health Canada — into a single branch under Health Canada.[https://web.archive.org/web/20230108120401/https://publications.gc.ca/site/archivee-archived.html?url=http://publications.gc.ca/collections/Collection/H113-2-1-1999E.pdf canada.ca: Fact Sheet on the Pest Management Regulatory Agency], written and self-published February 1997 Although the other departments are no longer officially involved in the decision-making process, they support the work of the PMRA through research and monitoring activities in their respective fields of expertise.{{Cite web|url=http://www.ourcommons.ca/DocumentViewer/en/36-2/ENVI/report-1/page-24|title=Report of the Standing Committee on Environment and Sustainable Development|website=House of Commons}} Subsequently, the administration of the Pest Control Products Act was transferred from the Minister of Agriculture and Agri-Food to the Minister of Health.[https://pubs.acs.org/doi/abs/10.1021%2Fbk-1999-0724.ch023 The Canadian Pesticide Registration System in the Context of International Harmonization], Daniel Chaput, June 16, 1999, 190-199. DOI:10.1021/bk-1999-0724.ch023

By 1998, the PMRA had set up policies for product evaluations in which additional protection was required for vulnerable sectors like children and pregnant women, and pesticide exposure from all sources had to be taken into account, including food and water.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/fact-sheets-other-resources/new-pest-control-products-act.html|title=Information Note: The New Pest Control Products Act|date=June 28, 2006|website=Government of Canada}} These policies were formalized when a new Pest Control Products Act was approved in 2002 and came into force on June 28, 2006, replacing the 35-year old Act. On 31 January 2008, the Review Panel Regulations were instituted, to administer sections 35 to 40 of the then-renewed Act.[http://orders-in-council.canada.ca/attachment.php?attach=17990&lang=en orders-in-council.canada.ca: "PC Number: 2008-0178 Date: 2008-01-31"] A statutory review of the Pest Control Products Act was held by the Health Committee of Parliament on 27 January 2015. Three witnesses from the Pest Management Regulatory Agency were called to speak on the legislation.[https://openparliament.ca/committees/health/41-2/47/the-chair-21/ openparliament.ca: "Health Committee on Jan. 27th, 2015"], 27 Jan 2015 Aucoin, the Executive Director of the PMRA, stressed the science based and OECD-collaborative nature of the review process.

The PMRA is managed by an Executive Director who reports to the Deputy Minister of Health:

• Claire Franklin, 1995-2005
• Karen Dodds:,[http://canlii.ca/t/1qbtf canlii.ca: "Synowski v. Treasury Board (Department of Health), 2007 PSLRB 6 (CanLII)"], 2007-01-11 2005-2008{{Cite web|url=https://openparliament.ca/committees/agriculture/39-2/10/karen-dodds-1/only/|title=Statement by Ms. Karen Dodds at the Agriculture and Agri-Food Committee on January 29th, 2008.|website=Openparliament}}
• Richard Aucoin:, 2008-

Directorates

• Executive Director’s Office
• Registration Directorate
• Health Evaluation Directorate
• Environmental Assessment Directorate
• Value Assessment and Re-Evaluation Management Directorate
• Compliance, Laboratory Services and Regional Operations Directorate
• Policy, Communications and Regulatory Affairs Directorate
• Strategic Planning, Financial and Business Operations Division

The PMRA is responsible for administering the Pest Control Products Act (PCPA) and its associated regulations on behalf of the Minister of Health.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/public/protecting-your-health-environment/pest-control-products-acts-and-regulations-en.html|title=Pest control products (pesticides) acts and regulations|date=2017-10-12|website=Government of Canada}}

The PCPA and the Pest Control Products Regulations (PCPR) maintain that:{{Cite web|url=https://laws-lois.justice.gc.ca/eng/acts/P-9.01/page-1.html|title=Pest Control Products Act (S.C. 2002, c. 28)|date=2019-04-08|website=Justice Laws Website}}{{Cite web|url=https://laws-lois.justice.gc.ca/eng/regulations/SOR-2006-124/index.html|title=Pest Control Products Regulations (SOR/2006-124)|date=2019-06-17|website=Justice Laws Website}}

• No person manufactures, stores, displays, distributes, or uses any pest control product under unsafe conditions
• No person packages, labels, or advertises any pest control product in a manner that is false, misleading, or deceptive, or is likely to create a false impression about the pest control product
• No person sells or imports a pest control product unless it is registered

Other Acts which have an impact on pest management are the Pesticide Residue Compensation Act (PRCA) and the Food and Drugs Act (FDA). Additionally, the PMRA uses the Agriculture and Agri-Food Administrative Monetary Penalties Act and its associated regulations as an enforcement tool for the PCPA.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/legislation-guidelines/acts-regulations.html|title=Consumer product safety acts and regulations|date=2009-05-27|website=Government of Canada}}

In addition, Health Canada maintains a lengthy list of Policies and Guidelines which must be observed by the Agency.{{cite news |title=Policies and Guidelines |url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/policies-guidelines.html#dir-dh |publisher=Health Canada |date=2022-10-19}}

The primary role of the PMRA is to determine if a proposed pest control product can be used safely when label directions are followed and if the product is effective for its intended use.

Under the Pest Control Products Act (PCPA) a “pest control product” is defined as:

(a) a product, an organism or a substance, including a product, an organism or a substance derived through biotechnology, that consists of its active ingredient, formulants and contaminants, and that is manufactured, represented, distributed or used as a means for directly or indirectly controlling, destroying, attracting or repelling a pest or for mitigating or preventing its injurious, noxious or troublesome effects;

(b) an active ingredient that is used to manufacture anything described in paragraph (a); or

(c) any other thing that is prescribed to be a pest control product.

Before a product can be submitted for evaluation, the PMRA has over 200 types of mandated tests that developers must perform to verify that the end product does not pose unacceptable risks. The PMRA then uses the given data to perform independent assessments in accordance with the PCPA.{{Cite web|url=https://croplife.ca/protecting-people-planet/pesticide-regulations/|title=Regulating pesticide use in Canada|website=Croplife Canada}} A product will only be registered if there is sufficient scientific evidence to show it does not pose an unacceptable health or environmental risk and that it serves a useful purpose. In all cases the conditions of registration are specified, including label direction instructions, so that the product can be used safely.

Re-evaluations are used to access any changes in data requirements and verify that the products comply with modern day standards. A re-evaluation must be initiated if 15 years have passed since the last major risk assessment.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/public/protecting-your-health-environment/pesticide-registration-process/reevaluation-program.html|title=Re-evaluation Program|date=2009-04-14|website=Government of Canada}} Re-evaluations can result in amendments to the use pattern, label statements, or classification of a product. However, if it is determined that the risks to human health or the environment are no longer acceptable, or that the product is without value for its intended purpose, the registration is cancelled.

Special reviews allow the PMRA to cancel or amend the registration of one or more registered pest control products without waiting for its scheduled re-evaluation. The special review of a product is initiated if there is reason to believe that risks may no longer acceptable based on new scientific information.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/policies-guidelines/regulatory-directive/2014/dir2014-01-approach-special-reviews-dir2014-01.html|title=Regulatory Directive DIR2014-01, Approach to Special Reviews|website=Government of Canada|date=23 May 2014}}

To continue to monitor for safety after products are registered, registrants are required to report pesticide sales volumes along with any incidents associated with their products. Under the PCPA, company reports include adverse human and environmental effects as well as new data. Product users and the public can also report incidents.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/public/protecting-your-health-environment/report-pesticide-incident.html|title=Report a Pesticide Incident|date=2009-01-13|website=Government of Canada}}

Health Canada works to promote, monitor, and enforce pesticide compliance activities under the National Pesticides Compliance Program (NPCP).{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/corporate-plans-reports/pesticide-compliance-enforcement-annual-reports.html|title=Pesticide Compliance and Enforcement Annual Reports|date=2016-04-27|website=Government of Canada}} The program is administered jointly by the Pest Management Regulatory Agency and the Regulatory Operations and Enforcement Branch (ROEB) of Health Canada.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/corporate-plans-reports/pesticide-compliance-enforcement-report-2016-2017.html|title=Pesticide Compliance and Enforcement Report for 2016-2017|website=Government of Canada|date=2018-02-19}} The PMRA inspects reports of illegal pesticides or misuse through its network of regional officers. Additionally, laboratory scientists test pesticides to determine if they comply with the specifications for which registration was granted.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/public/protecting-your-health-environment/compliance-enforcement.html|title=Pesticides Compliance and Enforcement|date=2016-04-19|website=Government of Canada}}

Violations of the PCPA or PCPR are responded to with appropriate compliance and enforcement measures.

These measures include:

• Encouraging voluntary removal of product by the distributor
• Seizing the product
• Refusing entry of the product into Canada
• Issuing a compliance order, warning or penalty{{Cite book|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/fact-sheets-other-resources/administrative-monetary-penalties.html|title=Administrative Monetary Penalties (AMPs)|date=2009-01-13|website=Government of Canada|publisher=Health Canada = Santé Canada |isbn=978-0-660-29218-2}}
• Amending suspending or cancelling the product registration

The PMRA applies science-based decision making to premarket and post market reviews. These reviews incorporate human health and environmental risk assessments, as well as value and product chemistry.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/policies-guidelines/science-policy-notes/2000/technical-paper-decision-framework-risk-assessment-risk-management-pest-management-regulatory-agency-spn2000-01.html|title=A decision framework for risk assessment and risk management in the Pest Management Regulatory Agency|date=December 22, 2000|website=Government of Canada|publisher=Health Canada}} A guidance document is regularly updated by the PMRA, and sources its approach with accepted international standards.{{cite news |title=PMRA Guidance Document, A Framework for Risk Assessment and Risk Management of Pest Control Products |url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/policies-guidelines/risk-management-pest-control-products.html |publisher=Pest Management Regulatory Agency |date=28 July 2021}}

Through scientific evaluations the PMRA establishes standards of protection for human health and the environment. These evaluations consist of a risk-based approach which assesses hazardous properties and possible exposure.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/policies-guidelines/science-policy-notes/2014/general-exposure-factor-inputs-dietary-occupational-residential-exposure-assessments-spn2014-01.html|title=Science Policy Note SPN2014-01, General Exposure Factor Inputs for Dietary, Occupational, and Residential Exposure Assessments|date=6 November 2014|website=Government of Canada|issn=2368-1861}} Risk is calculated by multiplying toxicity by exposure. Therefore, a pesticide with low toxicity and high exposure could pose a similar risk as a pesticide with high toxicity and low exposure.{{Cite book|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/policies-guidelines/science-policy-notes/2003/assessing-exposure-pesticides-food-user-guide-spn2003-03.html|title=Science Policy Note: Assessing Exposure from Pesticides in Food - A User's Guide|date=July 28, 2003|website=Government of Canada|isbn=0-662-34734-X}} Built-in safety factors are designed to take into account the potential variability of response, both within the same species (e.g., adults versus children) and between species (e.g., animals versus humans). Additional risk mitigation and communication measures are put in place with more hazardous pesticides.

Toxicological evaluations identify the possible human health effects of pesticides and establish the levels at which humans can be exposed to products without any harm. The required studies are designed to assess the possible adverse health effects on a variety of species that may result from single, multiple or lifetime exposure from pesticides via various routes of exposure. Major studies include acute, short- and long-term toxicity; carcinogenicity; genetic, reproductive, and developmental toxicity; and teratology.

Occupational Exposure Assessments (OEA) are performed to determine how much exposure to a pesticide could occur in a typical day. When performing the assessments, scientists take into account the different ways people are exposed to pesticides. One consideration is the different exposures of those who work with pesticides (formulators, applicators, and farmers) versus bystanders (people working or living near where a pesticide is used). Another consideration is the different exposures at various ages (i.e. adults and children).{{Cite book|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/policies-guidelines/science-policy-notes/2002/children-health-priorities-within-pest-management-regulatory-agency-spn2002-01.html|title=Science Policy Note: Children's Health Priorities within the Pest Management Regulatory Agency|date=January 3, 2002|website=Government of Canada|publisher=The Agency |isbn=0-662-31482-4}} The assessments are based on factors like routes and duration of exposure, the species tested in toxicity studies and the endpoint of toxicological concern. OEAs also include the effectiveness of personal protective equipment (PPE).

Dietary Exposure Assessments evaluates all possibilities in which a product could come in contact with food. The purpose of the evaluations is to set the maximum residue limits (MRLs) for pesticides on food, both domestic and imported, under the Food and Drugs Act. Dietary Risk Assessments (DRAs) are also carried out to assess the potential daily intake of pesticide residues from all possible food sources. DRAs take into account the distinctive eating patterns of infants, toddlers, children, adolescents and adults. Toxicological evaluations also help to set the Acceptable Daily Intake (ADI); the amount of a compound that can be consumed daily for a lifetime with no adverse effects.

The environmental risk posed by a pesticide is a function of its environmental fate and environmental toxicology.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/policies-guidelines/value-new-plant-protection-products-label-amendments.html|title=Value Guidelines for New Plant Protection Products and Label Amendments|date=14 April 2016|website=Government of Canada}} The environmental fate provides an indication of what will happen to the product once it enters the environment.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/public/protecting-your-health-environment/pesticide-registration-process/reviews/environmental-fate.html|title=Environmental Fate|date=2018-05-16|website=Government of Canada}} Factors such as the behaviour of the product in soil, water and air, the potential for its uptake by plants and animals and the possibility of bioaccumulation are evaluated.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/public/protecting-your-health-environment/pesticide-registration-process/reviews/environmental-risk-assessment.html|title=Environmental Risk Assessment|date=2018-05-16|website=Government of Canada}} During the environmental toxicology assessments, scientists examine the effects the product has on non-target terrestrial and aquatic species.

The primary consideration in a value assessment is determining a product’s efficacy; put differently, ‘does it do what it is claimed to do’. The assessment helps certify that only products that make a positive contribution to pest management are registered; helping to protect users from deceptive claims regarding the effectiveness of pest control products. The product is evaluated based on its health, safety and environmental benefits along with its social and economic impact.{{Cite web|url=https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/cps-spc/alt_formats/pacrb-dgapcr/pdf/pubs/pest/pol-guide/spn/spn2003-05-eng.pdf|title=Guidance for Refining Anticipated Residue Estimates for Use in Acute Dietary Probabilistic Risk Assessment|date=November 28, 2003|website=Pest Management Regulatory Agency|publisher=Alternative Strategies and Regulatory Affairs Division}} Furthermore, value assessments are used to establish the lowest effective rate at which pesticides can be applied to minimize the risks to health and the environment.

In addition to carrying out evaluations, recommendations on how to best mitigate risk are made during the risk assessment process. Based on the information gathered during the above-mentioned assessments, risk management strategies are explored to see if any are available that might sufficiently mitigate the determined risk. Evaluators must decide if risk management strategies are necessary to mitigate environmental or health risks. Mitigation options reduce exposure; examples include protective clothing for applicators, buffer zones to protect the environment, reduction of application rates, etc. Label statements outline the risk mitigation measures identified during the review process. All registered products must bear a label, which is a legal document that dictates the use instructions and safety precautions.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management.html|title=Pesticides and Pest Management|date=2004-07-26|website=Government of Canada}} During the re-evaluation process, interim mitigation measures such as rate reductions or use restrictions can be put in place to revise label instructions that are outdated or no longer supported.{{Cite web|url=http://www.oag-bvg.gc.ca/internet/English/pet_320_e_36442.html|title=The pesticide evaluation process under the Pest Control Products Act|last=Minister of Health|date=December 2, 2011|website=Government of Canada}}

Approximately 30% of PMRA’s operating budget comes from cost recovery fees. This model realigns a portion of the costs of the product registration process from federal taxpayers to the private sector ensuring there is an appropriate cost-sharing balance.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/registrants-applicants/product-application/cost-recovery.html|title=Pesticide registration cost recovery|date=2009-01-13|website=Government of Canada}}

Present day, fees and charges fall under the Pest Control Products Fees and Charges Regulations, pursuant to section 67 of the Pest Control Products Act.{{Cite web|url=http://laws-lois.justice.gc.ca/eng/regulations/SOR-2017-9/|title=Pest Control Products Fees and Charges Regulations (SOR/2017-9)|date=2019-04-08|website=Justice Laws Website}} The regulations were published on February 22, 2017, and came into effect on April 1, 2017.{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/registrants-applicants/product-application/questions-answers.html|title=Pesticide Cost Recovery (FAQs)|date=2017-03-13|website=Government of Canada}} They are adjusted annually to account for inflation.

As of 2018, individual fees can range from $80 to > $100, 000. Multiple fees may also apply to one application,{{Cite web|url=https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/policies-guidelines/fees-charges-regulations.html|title=Guidance Document: Pest Control Products Fees and Charges Regulations|date=8 March 2017|website=Government of Canada}} therefore cost of a major new registration can be in the area of $400, 000.

Robert Arnason, a journalist at the time working The Western Producer, wrote in September 2015 an open letter to the PMRA that remarked the lack of transparency with respect to pesticide sales figures, which had ostensibly been legislated in 2006.[https://www.producer.com/2015/09/an-open-letter-to-leaders-of-pest-management-regulatory-agency/ producer.com: "An open letter to leaders of Pest Management Regulatory Agency"], 16 Sep 2015

In April 2015, the PMRA announced that glyphosate was due for a periodic review, and asked for public submissions. Both the active ingredient glyphosate and its formulated products were considered during the re-evaluation. Some glyphosate products also contain POEAs, which function as surfactants. The product labels were revised to ensure that a limit of 20% POEA by weight is directed. As of April 2017, all registered glyphosate end-use products in Canada meet the 20% limit.[https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/fact-sheets-other-resources/request-special-review-glyphosate-herbicides-containing-polyethoxylated-tallowamine/frequently-asked-questions.html PMRA: "Frequently Asked Questions on the Re-evaluation of Glyphosate"], 28 Apr 2017 By 2019, the labels will be changed to reflect the concerns of householders, addressing buffer zones and run-offs near aquatic zones. The statement "when used according to the label, products containing glyphosate are not a concern to human health and the environment" was explicitly made.[https://www.newswire.ca/news-releases/statement-from-health-canada---final-re-evaluation-decision-on-glyphosate-620745213.html "Statement from Health Canada - Final Re-evaluation Decision on Glyphosate"], 28 Apr 2017 The Seralini affair was noted in response to one (or several) complaint, and the agency explained its conduct with a link to its [https://www.canada.ca/en/health-canada/services/food-nutrition/genetically-modified-foods-other-novel-foods/canadian-food-inspection-agency-statement-seralini-2012-publication-2-year-rodent-feeding-study-glyphosate-formulations-maize-nk603.html 25 October 2012 statement on Seralini]. A report generated by the PMRA said that more than 25 million kilograms of glyphosate were sold in 2014.[http://www.cbc.ca/news/health/cfia-report-glyphosate-1.4070275 cbc.ca: "Nearly a third of food samples in CFIA testing contain glyphosate residues"], 13 Apr 2017

In June 2017, a prothonotary in the Federal Court ruled in David Suzuki Foundation v. Canada (Health) that, in a review of the neonicotinoid clothianidin, Bayer CropScience "failed to satisfy the first branch of the Sierra Club test". The PMRA was dragged into court because they attempted to justify their ban on publication of Bayer's sensitive commercial information, which in the event, was found to be already in the public domain. In a stinging rebuke, it was held that the Applicants were "put to the expense of responding to the ever-changing nature of Bayer’s motion".[http://canlii.ca/t/hqsmk canlii.ca: "David Suzuki Foundation v. Canada (Health), 2017 FC 625 (CanLII)"], 2017-06-27

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