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. 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. 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. 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. 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. Subsequently, the administration of the Pest Control Products Act was transferred from the Minister of Agriculture and Agri-Food to the Minister of Health. 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. 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. 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. Aucoin, the Executive Director of the PMRA, stressed the science based and OECD-collaborative nature of the review process. == Organization ==

The PMRA is managed by an Executive Director who reports to the Deputy Minister of Health: • Claire Franklin, 1995-2005 • Karen Dodds:, 2005-2008 • 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 == Related Legislation ==

The PMRA is responsible for administering the Pest Control Products Act (PCPA) and its associated regulations on behalf of the Minister of Health. The PCPA and the Pest Control Products Regulations (PCPR) maintain that: • 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). In addition, Health Canada maintains a lengthy list of Policies and Guidelines which must be observed by the Agency. == Main Activities ==

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 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 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. 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. Compliance and Enforcement Health Canada works to promote, monitor, and enforce pesticide compliance activities under the National Pesticides Compliance Program (NPCP). The program is administered jointly by the Pest Management Regulatory Agency and the Regulatory Operations and Enforcement Branch (ROEB) of Health Canada. The PMRA inspects reports of illegal pesticides or misuse through its network of regional officers. Violations of the PCPA or PCPR are responded to with appropriate compliance and enforcement measures. • Amending suspending or cancelling the product registration == Risk Assessment Process ==

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. A guidance document is regularly updated by the PMRA, and sources its approach with accepted international standards. 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. 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. 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). 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). The environmental fate provides an indication of what will happen to the product once it enters the environment. 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. During the environmental toxicology assessments, scientists examine the effects the product has on non-target terrestrial and aquatic species. Value Assessment The primary consideration in a value assessment is determining a product’s efficacy; put differently, ‘does it do what it is claimed to do’. 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. 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. == Service Fees ==

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. 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. The regulations were published on February 22, 2017, and came into effect on April 1, 2017. They are adjusted annually to account for inflation. therefore cost of a major new registration can be in the area of $400, 000. == Controversies ==

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. 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. By 2019, the labels will be changed to reflect the concerns of householders, addressing buffer zones and run-offs near aquatic zones. The Seralini affair was noted in response to one (or several) complaint, and the agency explained its conduct with a link to its 25 October 2012 statement on Seralini. 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". == References ==