Pest Management Regulatory Agency Annual Report 2017–2018
Message from the Executive Director
Health Canada's Pest Management Regulatory Agency (PMRA) is pleased to present the 2017-2018 Annual Report to Parliament, which details PMRA's accomplishments and activities over the last fiscal year.
Year over year, the purpose of PMRA's work is unchanging: to protect the health and environment of Canadians by using modern, evidence-based, scientific approaches to pesticide regulation, in an open and transparent manner.
While our mandate remains unchanged, our work must adapt to constantly evolving pressures and opportunities such as changes to resources, new science, and a growing global marketplace. The work it takes to adapt to these changes is significant.
In 2017-2018, new processes were developed and implemented in several key program areas to improve efficiency, transparency, and health and environmental protection. These include new procedures for emergency registrations, registration of generic products, cumulative risk assessments, and compliance and enforcement.
Collaboration with our international counterparts is an ongoing and increasing necessity. In 2017-2018, PMRA piloted a new joint review approach with the United States Environmental Protection Agency (USEPA) that will hopefully also facilitate more international participation in these cooperative pesticide reviews. PMRA has also worked with the USEPA on scientific approaches for reducing the need for animal testing.
In addition to joint reviews, Canada participated in international activities through Codex Alimentarius, trilateral US/Mexico/Canada meetings, the Organisation for Economic Co-operation and Development (OECD) and the Regulatory Cooperation Council (RCC) aimed at aligning approaches to the establishment of Maximum Residue Limits (MRLs) and reducing barriers to trade.
Meanwhile, PMRA's re-evaluation of older pesticides continues to be a significant and increasing workload pressure. PMRA updated the re-evaluation workplan for 2018-2023, and the need for a new approach to this key activity is clear. We have established a team dedicated to examining various potential regulatory, resource and process options to develop a more sustainable re-evaluation program. This includes a comparative analysis of international approaches to re-evaluation, broad stakeholder consultation, and recommendations for the anticipated 2020 statutory review of the Pest Control Products Act (PCPA).
The accomplishments highlighted in this report reflect the dedication of our highly trained workforce, whose focus remains upholding the highest standards of health and environmental protection for Canadians.
Richard Aucoin, Ph.D.
Executive Director Pest Management Regulatory Agency Director
Table of Contents
- Message from the Executive Director
- About the Pest Management Regulatory Agency
- New Pesticide Registrations
- Regulation of Pesticides on the Market
- Re-evaluation/Special Review Programs
- Pest Control Product Sales Information Reporting
- Incident Reporting
- Pesticide Compliance and Enforcement Program
- Keeping Pace with Change
- Neonicotinoid Pesticides
- Maximum Residue Limits
- Cumulative Risk Assessment
- Integrated Approaches to Testing and Assessment/21st Century Alternative Testing Methods
- Service Fees Act
- Globally Harmonized System of Classifying and Labelling of Chemicals (GHS)
- International Scientific and Regulatory Cooperation
- Financial Profile
- Audit Commitments and Outcomes
- Table 1 - Product Submission Categories
- Figure 1 - Number of Submissions Completed by PMRA from April 1, 2015 to March 31, 2018
- Figure 2 - Performance Against Review Timelines for Category A, B and C Submissions Completed from April 1, 2015 to March 31, 2018
- Figure 3 - Number of New Active Ingredients Registered by PMRA from April 1, 2015 to March 31, 2018
- Table 2 - NEW Active Ingredients Registered in 2017-2018
- Table 3 - Approved GROU Products 2017-2018
- Table 4 - Re-evaluation/Special Review Documents Published in 2017-2018
About the Pest Management Regulatory Agency
The Pest Management Regulatory Agency (PMRA) is the branch of Health Canada responsible for regulating pesticides under the authority of the Pest Control Products Act. PMRA's primary mandate is to prevent unacceptable risks to Canadians and the environment from the use of these products.
PMRA applies current, evidence-based scientific approaches to assess whether the health and environmental risks of pesticides proposed for registration are acceptable, and if the products have value.
This same approach is used to regularly and systematically review whether pesticides already on the Canadian market continue to meet modern scientific standards.
In collaboration with Health Canada's Regulatory Operations and Regions Branch, PMRA also promotes, monitors and enforces compliance with the Pest Control Products Act across Canada. PMRA is committed to doing this in a collaborative, open and transparent manner.
This work is carried out by a highly skilled workforce, the majority of whom are scientists, with additional expertise in areas such as regulatory and policy development, stakeholder engagement and international collaboration and information management.
Canadians are confident that Canada's pesticide regulatory system protects their health and the environment.
To protect the health and environment of Canadians by using modern, evidence-based, scientific approaches to pesticide regulation, in an open and transparent manner.
New Pesticide Registrations
Pesticides are regulated in Canada by Health Canada, reflecting the importance placed on human health and environmental protection in the regulation of these products. The Pest Control Products Act governs how pesticides are risk-assessed and risk-managed, before and after they are registered for use.
Before a pesticide can be registered for sale in Canada, pesticide applicants are required to provide PMRA with large volumes of scientific data to show that their product does not pose unacceptable risks to health and the environment, and that the product has value. These data are reviewed by PMRA scientists to determine whether a product is acceptable for registration in Canada.
PMRA's science-based risk assessment includes the following:
- an examination of all sources and routes (oral, dermal, inhalation) of potential exposure to a given pesticide, including exposure through diet, from drinking water and from contact with treated areas like lawns and gardens;
- an estimation of the amount of pesticides that people, including children, may come in contact with, both during and after a pesticide application;
- a human health risk assessment with a particular focus on vulnerable populations, including pregnant women, infants, children, women and seniors; this considers the potential for a pesticide to cause adverse health effects such as cancer, birth defects and endocrine disruption, and allows registration only for those pesticides with exposures well below levels that cause adverse effects;
- an environmental risk assessment that considers the fate (movement, persistence and transformation), toxicity, and risks to plants, birds, mammals, beneficial insects and aquatic organisms; and,
- a value assessment that considers the contribution of the product to pest management, as well as its health, safety and environmental benefits, and social and economic impact.
For some currently registered pesticides, registrants may request changes to the use pattern. For these types of registrations, PMRA may also assess:
- additional environmental data, such as levels of pesticides detected through monitoring of pesticide concentrations in water across Canada and/or the United States;
- any incident reports from Canada or other jurisdictions where the pesticide is already registered; and,
- any other information that the Minister may require to evaluate the health and environmental risks and the value of the pest control product.
Various factors determine which studies are required to be submitted by applicants for registration, such as the nature of the product, the intended use, and the type of registration (for an overview of product submission types, please see Appendix Table 1). PMRA follows established service standards, or defined timelines, for these evaluations as outlined in the "Management of Submissions Policy" (Regulatory Directive DIR2017-01). The number and type of submissions reviewed by PMRA can vary significantly by year, as shown in Appendix Figure 1. Despite these shifts, PMRA continues to work to meet review timelines consistently across all submission categories (Appendix Figure 2).
New Active Ingredients Registered in 2017-2018
In 2017-2018, seven new active ingredients (the substance with the pesticidal effect) were registered for use in Canada, resulting in the registration of nine new related end-use products (different formulations of products containing the active ingredient). Of the seven new active ingredients, two were biopesticides (derived from natural sources such as bacteria, fungi, viruses, plants, animals and minerals) and five were conventional (in other words, chemical) pesticides (Appendix Figure 3).
Please see Appendix Table 2 for a full list of new active ingredients registered, and their uses.
Update on the Status of Conditional Registrations
Conditional registrations were previously granted only when the review of the scientific data showed that the risks of a pesticide were acceptable, but PMRA required additional information, such as monitoring data after a product registration to confirm the results of the risk assessment.
In June 2016, Health Canada published its Final Decision Regarding Conditional Registrations under the Pest Control Products Regulations, informing Canadians and interested stakeholders that Health Canada was no longer granting conditional registrations as a matter of policy. As of November 30, 2017, PMRA entrenched the policy in law thereby eliminating the ability to issue new conditional registrations. However, existing conditional registrations will remain in effect until final decisions are made for each.
Information about existing conditional registrations, such as what data is needed, the timeframe for providing it, as well as the current status, is available on PMRA's website.
PMRA is working to address remaining conditionally registered products. As of March 31, 2018, there remained 34 conditionally registered pesticides, representing less than 1% of all registered products.
Joint reviews are pesticide assessments conducted in cooperation with other jurisdictions. In the last two decades, Canada has progressed from developing pilot pesticide joint review approaches with the United States, to conducting international joint reviews as a primary course of business.
In 2017-2018, of the seven new active ingredients registered, six were joint reviews. PMRA is currently piloting a new joint review approach with the USEPA to increase efficiencies on the review process. The pilot approach has been shared with international partners with the aim of increasing international interest in joint reviews, potentially leading to more global joint reviews moving forward.
A minor use is defined as a necessary use of a pest control product for which the anticipated volume of sales is not sufficient to persuade a manufacturer to register and sell the product in Canada. The definition emphasizes that it is the projected sales of the pest control product that is minor and not necessarily the size of the crop. A minor use may be registered on a major crop because the use may be needed only occasionally or is limited to a small percentage of the total area of the crop. Restrictions on volume of use or area are considered on a case-by-case basis.
To help resolve these pesticide access issues for Canadian growers, PMRA works with Agriculture and Agri-Food Canada's Pest Management Centre to provide regulatory advice that supports growers and grower associations in identifying priorities for new minor use registrations in Canada. PMRA also works directly with the provinces to assist in addressing the regional minor use needs.
In 2017-2018, PMRA reviewed the minor use submissions from Agriculture and Agri-Food Canada and the provinces, and made 51 regulatory decisions of which nine were joint reviews or workshares with the USEPA. Final label reviews resulted in the registration of 782 new minor uses.
A pest control product can be registered for up to one year for the emergency control of seriously detrimental pest infestations, such as during the spread of invasive species. The product must be already registered for another use, must be effective, and the human health and environmental risks must be acceptable.
Emergency registrations are not intended as a solution to an ongoing pest-management problem and may not be extended or renewed. However, they may be considered again if the emergency situation continues. The number of emergency registration submissions that PMRA receives can vary from year to year, depending on pest outbreaks, environmental conditions and the availability of alternative products and methods. In 2017-2018, PMRA granted 15 emergency registrations.
In August 2017, PMRA published updated procedures for the emergency registration process (Regulatory Directive DIR2017-03, Registration of Pesticides for Emergency Use: Revised Procedures). This replaced the directive published in 2001.
When a new pesticide is developed, the innovator invests substantial funds into the studies required to show that the product works as intended, and poses no unacceptable health and environmental risks. The data supporting a new innovation to Canada (in other words, a new active ingredient) receives exclusive use protection for a period of time, to prevent it from being used for the benefit of a competitor without the innovator's approval. Data subsequently used to amend or maintain a registration or register a new product are given compensable protection.
This practice allows the innovator the opportunity to recover their investment, but also encourages further innovation by allowing competition on the market after a period of time. Allowing timely introduction of equivalent products by generic manufacturers following the exclusive period can enhance market competition to the benefit of users, including growers. These regulations are important to innovators, generic companies and to growers.
In 2017-2018, the PMRA received 190 applications to register generic products. There has been an increase in the number of generic applications received over the past two years. Process improvements have been implemented that are allowing PMRA to continue to meet its performance targets. There were 54 generic products (24 technical or manufacturing products and 30 end-use products) registered in 2017-2018. The PMRA continues to seek ways to improve the data protection program for innovator registrants, generic companies and PMRA.
Grower Requested Own Use
Grower Requested Own Use (GROU) is an initiative that aims to make it easier for Canadian growers to import less expensive, equivalent pest control products available in foreign jurisdictions. Prior to 2014 this program was based on policy; however, in August 2014, GROU was formalized in the Pest Control Products Regulations (under the Use of Foreign Products provisions). Through continued support from not-for-profit national grower associations, growers are able to request product nominations for the program. Growers with an approved import certificate can legally obtain an equivalent version of a Canadian-registered product from outside Canada. Please see Appendix Table 3 for a list of approved GROU products for 2017-2018.
Regulation of Pesticides on the Market
Once a pesticide has been granted registration status, it becomes subject to a system of post-market risk management controls under the Pest Control Products Act. This includes re-evaluations and special reviews of registered pesticides, compliance and enforcement activities, and response to health and environmental incidents. This section will also describe activities addressing pollinator impacts and outreach activities targeted at users.
Re-evaluation/Special Review Programs
Under the Pest Control Products Act, registered pesticides currently available on the market are subject to re-evaluations, which are initiated 15 years after a registration decision at the latest. Under this program, new methodologies, data, and scientific approaches are incorporated into the assessments to ensure that registered pesticides continue to meet modern standards for health and environmental protection, and have value.
Special reviews are another mechanism used under the Pest Control Products Act to determine the continued acceptability of registered pesticides. These reviews focus on addressing specific aspects of concern, such as concerns raised by an OECD member country decision to prohibit all uses of an active ingredient.
Five-year Re-evaluation and Special Review Work Plan
As part of our commitment to improve transparency, PMRA updated the five-year work plan for re-evaluations and special reviews for the period from April 2018 to March 2023. This work plan includes the target timelines to publish proposed and final decisions for re-evaluations and special reviews, as well as the list of anticipated re-evaluation initiations in the next five years.
In 2017-2018, PMRA did not meet the 80% performance target for the publication of re-evaluation and special review final decisions, as outlined in the published work plan. The major contributors to this performance result were due to complex science issues, additional refinements to the risk assessments, resources dedicated to neonicotinoid re-evaluations, and increasing workload. However, it is anticipated that the assessments that missed targets will be completed in the next fiscal year.
Overall, final decisions were published for 23 re-evaluations and eight special reviews. This includes an additional 13 re-evaluations and two special reviews that were completed in 2017-2018 ahead of the published schedule. This corresponds to 557 end-use products affected by these decisions, some of which required updated use conditions to further protect human health and the environment. Public consultations on 45 proposed re-evaluation decisions and five proposed special review decisions were conducted during this fiscal year. Appendix Table 4 provides a list of re-evaluation and special review proposed and final decision documents published in 2017-2018. An additional six re-evaluations were initiated in accordance with the Pest Control Products Act.
Outreach and Stakeholder Engagement in Re-evaluation and Special Review Programs
In 2017-2018, PMRA continued its increased outreach and stakeholder engagement activities with respect to re-evaluations and special reviews. Where proposed decisions indicated further information was required to refine risk assessments, or risk management actions were proposed, PMRA engaged specific stakeholder sectors near the publication date of the consultation document to facilitate and maximize their participation.
Final decision documents have been improved to clearly indicate the time frame to implement decisions, and now provide a list of end-use products that are involved, so the public can be better informed of when changes will take effect and which products are impacted. In certain cases, PMRA also engages user and stakeholder groups to better inform their members of required changes to products as a result of re-evaluation, such as new use directions, or removal of products from the marketplace. This collaborative approach promotes user awareness and timely implementation of changes to the product's conditions of use.
In March 2018, PMRA published Regulatory Directive (DIR2018-01) "Policy on Cancellations and Amendments Following Re-evaluation and Special Review", after taking into consideration the comments received in response to the Regulatory Proposal PRO2016-04 "Policy on Cancellations and Amendments Following Re-evaluation and Special Review", published on December 21, 2016. This policy outlines the process, and associated timelines, as well as how the timelines for cancellation or amendment of pesticide products are established. The intent of this policy is to enhance the transparency of the process and the associated timelines when regulatory action is required to remove products from the market, change approved uses, or introduce amendments to labels. It will also facilitate efficient and effective implementation of re-evaluation and special review decisions with standardized timelines aimed at clarifying expectations, obligations and communications around the implementation of regulatory decisions.
Pest Control Product Sales Information Reporting
Since 2007, PMRA's Pest Control Product Sales Information Reporting Program has been collecting sales information, in the form of total quantity (in other words, by volume or mass), for all registered products available for sale. These data are reported by calendar year (January 1 to December 31). The purpose of the program is to collect sales data to be used by PMRA to better understand pesticide use in Canada.
Sales data are considered in risk assessments of pesticides, in policy decisions, in identifying trends in pesticide use, and in providing guidance for risk-reduction strategies. For example, sales data are used in the re-evaluation of older pesticides to help understand the presence and scale of use of the pesticide in the Canadian marketplace, as well as the potential impacts if changes are made to the registration status of the pesticide.
Sales data are also used to inform the Pesticide Incident Reporting Program on the market share of particular pesticides to help identify potential risks that may require attention. In 2017-2018, PMRA published annual sales reports for the 2015 calendar year.
Since April 2007, PMRA's Pesticide Incident Reporting Program has been collecting incident reports, which can help detect adverse effects that are not evident during the initial registration of a pesticide.
PMRA uses incident report data to identify and characterize potential risk to humans, domestic animals and the environment from the use of pesticides. Incident report assessments are prioritized based on the type of incident. Serious adverse effects such as death are evaluated immediately and mitigation measures are put into place if warranted. If a potential risk is identified, it is investigated and protective action may be taken, such as changes to how a pesticide may be manufactured, packaged, labelled, or used.
Incident report data also inform risk assessments for new registrations and re-evaluations. Scientific studies may also be submitted to the PMRA through this program by registrants if the study demonstrates any new hazard, any risk that may be greater than the risk determined at the time of registration, or the presence of a previously undetected component or derivative of a pest control product. Monitoring incidents for unanticipated effects is an ongoing process that includes re-assessing previous conclusions, as necessary. In cases where mitigation strategies have been adopted, the PMRA also monitors incident report data to determine if the actions were effective in managing the identified risk.
In the 2017-2018 fiscal year, 2402 incident reports were filed, 1611 of which occurred in Canada. Details of these reports can be found on the Health Canada website.
The following are some examples of actions taken by PMRA following evaluation of incident reports:
- Incident data for pesticide products containing permethrin (excluding spot-on flea and tick products) supported proposed mitigation measures pertaining to application, re-entry and ventilation needs.
- Label statements of some products were modified or proposed to ensure that these pesticides are not accessible to people and/or pets.
- Changes were proposed to the labels for dichlorvos-impregnated indoor pest strip products to more clearly indicate allowed areas of use.
Pesticide Compliance and Enforcement Program
The National Pesticide Compliance Program (NPCP) is responsible for promoting, monitoring and enforcing compliance with the Pest Control Products Act and its Regulations. The program is administered jointly by Health Canada's PMRA and the Regulatory Operations and Regions Branch (RORB). PMRA sets the strategic direction, program priorities and policies, and determines how those priorities are implemented nationally. RORB is responsible for the delivery of compliance and enforcement activities and for maintaining valuable relationships with provincial partners and stakeholders.
The scope of the NPCP covers the full range of parties regulated by the Pest Control Products Act, including registrants, manufacturers, importers, vendors, retailers, and users. To align activities with these regulated parties and better capture work conducted, the NPCP adopted a new framework starting in 2017-2018. The NPCP is now divided into seven sectors: Registrants, Importation, Marketplace, Users, Re-evaluation, Surveillance, and Inquiries and Complaints.
To account for regional variations, the NPCP includes both national and regional activities. The diversity of NPCP programs allows the Pesticide Compliance and Enforcement Program to assess a sample of users from a variety of subsectors and provides the PMRA with information about compliance issues or potential trends.
Compliance activities are prioritised based on risk. In some instances, when non-compliance is known or suspected, a targeted approach may be used, which may result in the appearance of high rates of non-compliance. In other situations, random inspections are conducted. Compliance rates presented in this section reflect the regulated parties inspected and are not representative of the industry as a whole. NPCP highlights are noted below, with details provided in the 2017-2018 Compliance and Enforcement Annual Report.
2017-2018 Key Statistics
- 253 compliance outreach activities were conducted to promote compliance with the PCPA. These activities included presentations, meetings, exhibit booths at trade shows, and other activities such as providing publications for mail-outs and contributing to association newsletters.
- 933 inspections were conducted.
- 428 samples were analyzed by the PMRA's laboratory.
- The rate of compliance varied by subsector, ranging from 11% to 100%.
- The most common violation types noted for all inspections were sale (34%), possession (25%), and importation (10%). These include violations noted during planned activities (1288) and compliance verifications (242). The breakdown of violations by type is presented in the figure below:
- 796 enforcement responses were issued to non-compliant parties. Enforcement responses included verbal education (75), written education (359), enforcement letters (341), and Compliance Orders (21).
- 30 Notices of Violation (NOVs) with penalty and 2 Notices of Violation (NOVs) with warning were issued under the Agriculture and Agri-Food Administrative Monetary Penalties [AMPs] Act.
Keeping Pace with Change
Globalization, rapid technological advances, evolving science, economic pressures and various other challenges and opportunities require a pesticide regulatory system that is flexible and responsive to change. PMRA is continuously modernizing risk assessment and risk management approaches, refining business practices to ensure the needs of all stakeholders are met, and responding to major scientific and environmental developments, in Canada and abroad, with the goal of improving health and environmental protection.
Neonicotinoids are a group of pesticides used in agriculture to protect crops from various insects. They are also used for other purposes, including killing insects in homes, controlling fleas on pets, and protecting trees from invasive insects such as the Emerald Ash Borer. There are three important neonicotinoids currently approved for agricultural use in Canada, imidacloprid, clothianidin, and thiamethoxam.
In the last few years, neonicotinoid pesticides have been the focus of significant scientific, environmental and public interest. PMRA has worked with scientists from around the world to study the relationship between the use of neonicotinoid pesticides and pollinator (for example, bees and butterflies) health. PMRA continued to be an active participant at Agriculture and Agri-food Canada's Bee Health Roundtable, and international working groups, including the two following OECD pesticide working groups: Pesticide Effects on Insect Pollinators (co-led by Canada, the United States and Germany) and the International Commission for Plant-Pollinator Relationships' Bee Protection Group.
Imidacloprid - Health and Environment Assessments
On November 23, 2016, PMRA published a proposed re-evaluation decision for imidacloprid (PRVD2016-20 - Imidacloprid). The health assessment did not identify human health concerns from any exposure route when used according to current label standards. An extensive body of information was considered for any potential toxicity and exposure, including sensitive populations such as children. To date, our assessments of the available data and published literature do not point to unacceptable risks to human health from the use of neonicotinoids, including any potential exposure from drinking water or food.
However, the environmental risk assessment determined that imidacloprid is being measured in Canadian surface waters at levels that are harmful to aquatic insects. These insects are an important part of the ecosystem, including as a food source for fish, birds and other animals. As a result, PMRA proposed to phase out all the agricultural and a majority of other outdoor uses of imidacloprid over three to five years.
This finding also triggered the launch of a special review process for thiamethoxam and clothianidin, focussing specifically on aquatic risks.
The comments received during the consultation on imidacloprid are currently being reviewed by PMRA. In addition, stakeholders, working collectively through Agriculture and Agri-Food Canada's Multi-Stakeholder Forum, provided extensive new information to PMRA, including additional water monitoring data, in the fall of 2017. This information is currently under review.
Pollinator Assessments and Incident Reports
In 2012, in response to reports of bee deaths linked to neonicotinoids (primarily in corn and soybean growing regions), the PMRA increased incident monitoring and continues to monitor the situation in collaboration with the provinces. Since 2014, the number of incidents related to honeybees has remained low. In January 2017, PMRA published an Update on Canadian Bee Incident Reports 2012-2016, which contains a summary of pollinator incidents that have been reported to potentially be associated with pesticides. The report includes incidents that have been reported for clothianidin, imidacloprid and thiamethoxam.
Pollinator risk assessments for all three major neonicotinoids are being conducted in collaboration with the USEPA and California Department of Pesticide Regulation. For the assessments, PMRA reviewed studies received from registrants or obtained from published literature. PMRA published proposed pollinator re-evaluation decisions for clothianidin (PRVD2017-23) and thiamethoxam (PRVD2017-24) in December 2017. The proposals included similar mitigation measures:
- cancellation of: foliar uses on orchards, all soil application and most foliar application on berries, soil and foliar application to ornamentals that resulted in pollinator exposure, and outdoor soil applications to a number of vegetables; and,
- changes in application timing to foliar application on a number of crops, including strawberries, a variety of vegetables, and turf.
Since publication of the preliminary imidacloprid pollinator assessment in 2016, PMRA has been updating the risk assessment based on additional data from the registrants, additional literature that has been recently published, and comments that were received during the public consultation period.
Maximum Residue Limits
A Maximum Residue Limit (MRL) is the maximum amount of residue that is expected to remain on food products when a pesticide is used according to label directions. These are set at levels well below the amount that could pose a health concern, and are established around the world for each combination of pesticide and treated agricultural product.
International differences in MRLs can occur as a result of differences in both methods and data available to regulators at the time of MRL establishment, as well as other factors. Though MRL differences rarely reflect differences in risk, aligning MRLs globally has become increasingly important to reduce barriers to the movement of treated agricultural products around the world. Domestic and international collaboration is critical in resolving these issues, which are of high importance to registrants, growers, and the Canadian economy.
PMRA continued work with its international partners under the North American Free Trade Agreement (NAFTA), OECD and Codex on science policies relevant to establishing MRLs internationally. Through its involvement in RCC, PMRA also continued to develop new scientific methods and process improvement strategies to further streamline data requirements for establishing MRLs between jurisdictions. This included the streamlining of Joint Canada/United States Field Trial Requirements, which was published in June, 2017.
Cumulative Risk Assessment
A cumulative risk assessment is undertaken to explore whether exposure to similar chemicals could lead to the same or increased health risk relative to a higher level of exposure to any of these chemicals individually. As an emerging area in regulatory science, PMRA continues to work with international partners to develop approaches for applying the principles of cumulative risk assessment in protecting the health and safety of Canadians.
In April 2018, as a follow-up to the March 2017 public consultation document, PMRA published a Science Policy Note on the Cumulative Risk Assessment Framework for pesticides. This Science Policy Note outlines the methodology that is being applied to pesticides that have a common mechanism of toxicity.
Cumulative risk assessments have been completed for some pesticide groups (for example, captan and folpet), and will be initiated for more complex pesticide clusters (for example, N-methyl carbamate class) in 2018-2019.
Integrated Approaches to Testing and Assessment/21st Century Alternative Testing Methods
PMRA continues to seek opportunities to reduce the need for animal testing wherever possible, while continuing to ensure scientifically robust approaches are in place for assessing risk.
Integrated Approaches to Testing and Assessment (IATA) involve using data from existing laboratory animal studies, in vitro high throughput screening assays, predictive models, mechanistic studies and other data in order to refine, reduce and in some cases even replace laboratory animal studies for human health and ecological risk assessment of pesticides. PMRA is also actively involved in scientific discussions related to the application and implementation of new approach methodologies (NAMs).
In collaboration with the USEPA under NAFTA and the RCC, several activities are underway or have been completed through this initiative during the past year. Following consultation, the PMRA published a Science Policy Note on Waiving Acute Dermal Toxicity Studies in June, 2017, and is currently involved in assessing NAMs for other types of studies (for example, acute eye irritation, skin sensitization, and quantitative structure-activity relationship models ((Q)SAR predictions) in an effort to further reduce animal testing.
Service Fees Act
On June 22nd, 2017 as part of Bill C-44 Budget Implementation Act, the User Fees Act (UFA) was repealed by Parliament and replaced by the Service Fees Act (SFA).
Throughout 2017-2018, PMRA worked with its Departmental partners on the implementation of the SFA and to develop a remittance policy that adheres to the requirements of the SFA and to Treasury Board directives. Work will continue into 2018-2019 before a policy is consulted upon and finalized.
Globally Harmonized System of Classifying and Labelling of Chemicals (GHS)
Safety data sheets (SDSs, previously called "material safety data sheets" or MSDSs) are an important part of communicating the hazards associated with pest control products and other chemicals. The SDS format adopted by the Globally Harmonized System of Classifying and Labelling of Chemicals (GHS) has become the international standard format for SDSs used in workplaces.
In January 2018, PMRA published guidelines on the expected format and content of GHS-consistent SDSs for registered pest control products in Canada. These SDSs help maintain the health and safety of Canadians by providing a consistent, predictable format for information that can be used by workers involved in pest control product application and handling, emergency responders, consumers, and those involved in the transportation of dangerous goods.
International Scientific and Regulatory Cooperation
Canada's internationally respected regulatory model has allowed Canada to form strong partnerships, and to play a significant role in developing collaborative approaches to joint pesticide reviews, promoting international regulatory alignment, and addressing barriers to agricultural innovation and trade. This leadership role has also afforded Canada the capacity to ensure that terms of trade are compatible with Canada's unique market conditions, and our commitment to health and environmental protection.
Comprehensive-Economic and Trade Agreement (CETA)
The Comprehensive-Economic and Trade Agreement (CETA) between Canada and the European Union (EU) that was signed in October 2016 during the 16th EU-Canada Summit in Brussels is a progressive trade agreement that upholds and promotes the values that Canada shares with the EU. To inform the trade negotiations, PMRA provided expertise on the PCPA and on plant protection product (pesticide) intellectual property provisions.
Both Canada and the EU are committed to protecting the rights of registrants from the unfair commercial use of data they generate, and to providing a fair and balanced regulatory framework for all. Article 20.30 of CETA reflects this alignment between Canada and the EU, and also includes a specific commitment for establishing rules to avoid duplicative testing on vertebrate animals.
Similar to the EU, Canada is engaged in ongoing efforts to develop and implement testing methods that avoid the use of live animals, and adheres to the Three Rs (reduce, refine, replace), which are the guiding principles for more ethical use of animals in testing.
To help implement the requirement to reduce duplicative animal testing, the PCPA was amended via Bill C-30 (which received Royal Assent on May 16, 2017). This amendment provides the flexibility to adjust Health Canada's pest control product data protection program to allow an applicant or registrant of a pest control product to rely on any previous study involving animals (if the Minister determines that study is necessary to support the decision), rather than completing a new, duplicative one. Proposed amendments aligning the Pest Control Product Regulations with the PCPA to meet the CETA commitment were pre-published in Canada Gazette Part I on July 15, 2017 for a 15-day consultation period and came into force on September 21, 2017.
The Stockholm Convention is a legally binding international treaty that addresses international management of chemicals with the focus on the production and use of persistent organic pollutants.
PMRA collaborated with other federal partners in the development of Canadian positions and submissions to the Persistent Organic Pollutants Review Committee and the Conference of the Parties of the Stockholm Convention (POPRC) and by providing the Canadian technical expert to the POPRC. The PMRA is the responsible federal authority for meeting the obligations and for ongoing participation at the Stockholm Convention as it pertains to pesticides.
The Rotterdam Convention promotes information exchange and informed consent in the international trade of chemicals, with the aim of protecting human health and the environment. Canada is a party to this Convention. In collaboration with Environment and Climate Change Canada, PMRA participated in the development of Canadian positions and submissions to the Convention.
In 2017-2018, PMRA participated in the Convention's annual technical committee meeting, where the committee recommended adding two new pesticides (acetochlor and phorate) to the Convention's Prior Informed Consent (PIC) list. PMRA also participated in the 8th meeting of the Convention's Conference of Parties, who decided to list two new pesticides, carbofuran and trichlorfon, to the Convention's PIC list. PMRA continues to administer Canada's obligations concerning import and export of all other pesticides currently subject to the Convention.
PMRA is involved with several OECD initiatives, including several OECD task forces and subcommittee expert group projects. PMRA participated in meetings of both the OECD Working Group on Pesticides (WGP - Canada was the chair) as well as the OECD Working Group on Biocides (WGB). PMRA routinely provides advice to the OECD WGP Expert Groups on: Residue Chemistry, Pesticide Effects on Insect Pollinators, and Bio-Pesticides. In addition, PMRA continues to be the lead on an OECD project (launched in 2017) to securely share key information within the regulatory community, such as pesticide bans, registration cancellations, and significant enforcement actions. PMRA is also leading an initiative on post-market re-evaluation reviews to explore opportunities for international collaboration.
In 2017-2018, PMRA continued to participate with OECD members in collaborative science policy work, including IATA-related initiatives described earlier in this report, and an ad hoc Expert Group on Novel Technologies and their Use as Pesticides (with the initial focus being on ribonucleic acid interference (RNAi) technology and its potential non-target environmental effects).
Regulatory Cooperation Council
In 2017, PMRA continued work on the pollinator risk assessment of the neonicotinoids under the Regulatory Cooperation Council (RCC). Pollinator risk assessments for clothianidin and thiamethoxam were published by PMRA and the USEPA. Moving forward, PMRA and the USEPA will continue to work together on the re-evaluation of the neonicotinoid pesticides, including the non-pollinator risk assessment work. The end result of this cooperation is a more consistent risk assessment approach to this class of pesticides.
Through its involvement in NAFTA (as noted in the following section) and the RCC initiative, PMRA also continued to develop new scientific methods and process improvement strategies to further streamline data requirements between jurisdictions. This included the streamlining of Joint Canada/United States Field Trial Requirements, which was published in June 2017, as well as the Residue Chemistry Data Requirements for Seed Treatment Uses, which was published in March 2018. Continued work on IATA also contributed RCC-related work.
Our intergovernmental collaboration has resulted in success in aligning pesticide regulation in North America to create and maintain high standards of protection for human health and the environment.
The streamlining of data requirements as described in the RCC section above will allow regulatory programs in Canada and the United States as well as pesticide applicants to use their resources more efficiently, and facilitate increased joint American/Canadian registrations.
The NAFTA Technical Working Group on Pesticides met in Guanajuato City, Guanajuato, Mexico in November 2017 to discuss various issues, including:
- innovations in technology and in plant sciences;
- MRLs and implications in trade;
- joint review process improvements; and,
- a Mexican project on risk and stress factors impacting bee colonies.
Financial Profile (in millions of dollars)
- A-Base 29.4
- Respendable Revenue 11.6
- Growing Forward 3.3
- Chemicals Management Plan 5.0
PMRA received $3.3M through the Growing Forward initiative to support the registration of minor use products. As a result, newer, more environmentally sustainable, and more modern products have been made available to Canadian producers, which helps sustain Canada's competitive position globally.
Through Canada's Chemicals Management Plan, PMRA received $5M to re-evaluate older pesticides, improve risk management approaches through Incident Reporting and Sales Reporting regulations, and contribute to the development of scientific and regulatory approaches with other jurisdictions on high-priority issues. For more information, please consult the Chemicals Management Plan webpage.
Audit Commitments and Outcomes
In 2017-2018, PMRA completed all remaining outstanding actions from previous audits and evaluations, leaving just one item scheduled for completion by 2020: re-evaluation of the 46 remaining active ingredients registered before 1995.
The following actions completed the remaining commitments under the Commissioner of the Environment and Sustainable Development's (CESD) Audit of Pesticide Safety (2015):
- Published Science Policy Note SPN2018-02 in April, 2018, which supports the application of a methodology for cumulative risk assessment.
- Published Regulatory Directive DIR2018-01 (March 2018) Policy on Cancellations and Amendments Following Re-evaluation and Special Review, which establishes phase-out schedules for instances where PMRA determines that the risks posed by a pesticide are unacceptable for all uses.
Under the internal Evaluation of the Pesticide Program (2015), PMRA completed a Performance Information Profile (November 2017) as required by the Treasury Board Secretariat Policy on Results (July 2016). This document describes expected results and related measures for the program. This addressed the internal audit recommendation to develop a Performance Measurement Strategy.
Table 1 Product Submission Categories
- Category A
- Submissions to register new active ingredients and their related end-use product(s) and manufacturing-use products; submissions to add a major new use to a registered pesticide; submissions to specify a maximum residue limit for a previously non-assessed active ingredient; and submissions for user requested minor use registrations. Category A submissions require a full, supporting data package.
- Category B
- Submissions to register new pest control products containing registered active ingredients; submissions to amend existing pest control products (for example, changes in application rates, timing of applications, new pests, changes to precautionary statements); submissions for emergency registrations; and submissions to specify a maximum residue limit for a previously assessed active ingredient. Supporting data must be provided.
- Category C
- Submissions to register or amend a pest control product with no data requirements. These applications involve minor label or formulation reviews, such as product registration based on registered precedent products.
- Category D
- Submissions within particular programs such as the Import for Manufacture and Export Program (IMEP), Own-Use Import (OUI), Grower Requested Own Use (GROU), Master Copies, Private Labels, registration renewal and discontinuations.
- Category E
- Submissions for research authorizations and research notifications, when the research is carried out in Canada.
- Category F
- Submissions to register or amend a pest control product via notification
- Category L
- Submissions to register or amend a pest control product including new sources of technical grade active ingredient, manufacturing concentrates and end use products where the applicant wishes to use or rely upon data provided by another registrant; and requests to extend the exclusive use protection period based upon minor uses.
- Category P
- Pre-submission consultations.
Trends and Limitations:
- Most Category A and many Category B submissions have a review timeline greater than 12 months; therefore work on many of the submissions reported as being completed in 2017-2018 was conducted in previous years.
- For Category A submissions, the number in parentheses reflects the number of new active ingredients completed.
- The number of submissions completed includes registered, withdrawn and rejected submissions.
- Category D excludes User Requested Minor Use Label Expansions (URMULE) pre-submission consultations and in 2017-2018 excludes URMULE submissions
- Category L includes submissions for equivalency and data compensation assessment, regulatory decision and requests to extend the exclusive use protection period based on minor uses. Prior to the addition of Category L in 2017-2018, these were previously category B and F submissions.
- Category P excludes joint review pre-submission consultations and subject to registration inquiries.
- Effective April 1, 2017 categories F, L and P were added to the Management of Submissions Policy.
- This figure shows the percentages of submissions by submission category that met the applicable review timelines outlined in the Management of Submissions Policy over the last three fiscal years.
- All categories of pre-market submissions have a performance standard of 90% against the established review timelines for the different submission categories.
- Performance was largely met for pre-market reviews, but fell short on category E and P submissions. Pre-submission consultations (Category P) are not cost recovered.
- This figure provides the number of new active ingredients registered over the course of the last three fiscal years. It represents active ingredients that have been registered for use in Canada and excludes any new active ingredients for which only a maximum residue limit on imported food was established.
- The number of new active ingredients being registered for use in Canada has declined over the last three years, which corresponds to a period of consolidation across the sector. This is reflective of global trends in registration.
|Product Type||Registration Status||Product Category||Uses/Sites|
|1||Azamethiphos||Salmosan Vet||Acaricide||Full||Conventional Chemical||Atlantic Salmon in marine aquaculture sites|
|2||Beauveria bassiana strain PPRI 5339||Velifer||Insecticide||Full||Biopesticide||Greenhouse vegetables including: Bell Pepper, Cucumber, Eggplant, Lima Bean, Romaine Lettuce, Tomato Greenhouse ornamentals including: Chrysanthemum (Belgian and Daisy), Gerbera, Lantana, Marigold (African and French), Poinsettia|
|3||Cyclaniliprole||Cyclaniliprole 50SL Insecticide||Insecticide||Full||Conventional Chemical||Pome Fruits (Crop Group 11-09): apple; azarole; crabapple; mayhaw; medlar; pear; pear, Asian; quince; quince, Chinese; quince, Japanese; tejocote; cultivars, varieties, and/or hybrids of these. Tree Nuts (Crop Group 14-11): almond; beechnut; bur oak; butternut; chestnut; chinquapin; ginkgo; hazelnut (filbert); heartnut; hickory nut; Japanese horse-chestnut; monkey puzzle nut; pecan; pine nut; walnut, black; walnut, English; yellowhorn; cultivars, varieties and/or hybrids of these. Stone Fruits (Crop Group 12-11): apricot; apricot, Japanese; cherry, black; cherry, Nanking; cherry, sweet; cherry, tart; jujube, Chinese; nectarine; peach; plum; plum, American; plum, beach; plum, Canada; plum, cherry; plum, Chickasaw; plum, Damson; plum, Japanese; plum, Klamath; plum, prune; plumcot; sloe; cultivars, varieties, and/or hybrids of these. Leafy Vegetables (Crop Group 4-13): amaranth, Chinese; amaranth, leafy; arugula; aster, Indian; blackjack; broccoli raab; broccoli, Chinese; cabbage, Abyssinian; cabbage, seakale; cat's whiskers; cham-chwi; cham-na-mul; chervil, fresh leaves; Chinese cabbage, bok choy; chipilin; chrysanthemum, garland; cilantro, fresh leaves; collards; corn salad; cosmos; cress, garden; cress, upland; dandelion; dang-gwi; dillweed, fresh leaves; dock; dol-nam-mul; ebolo; endive; escarole; fameflower; feather cockscomb; Good King Henry; Hanover salad; huauzontle; jute leaves; kale; lettuce, bitter; lettuce, head; lettuce, leaf (romaine); maca; mizuna; mustard greens; orach; parsley, fresh leaves; plantain, buckhorn; primrose, English; purslane, garden; purslane, winter; radicchio (red chicory); radish, leaves; rape greens; rocket, wild; shepherd's purse; spinach; spinach, Malabar; spinach, New Zealand; spinach, tree (giant lambsquarter); Swiss chard; tanier spinach; turnip greens; violet, Chinese; watercress; cultivars, varieties and/or hybrids of these. Brassica Head and Stem Vegetables (Crop Group 5-13): broccoli; Brussels sprouts; cabbage; cabbage, Chinese (napa); cauliflower; cultivars, varieties and/or hybrids of these. Fruiting Vegetables (Crop Group 8-09): African eggplant; bell pepper; currant tomato; eggplant; garden huckleberry; goji berry; groundcherry; martynia; okra; pea eggplant; pepino; nonbell pepper; scarlet eggplant; sunberry; tomatillo; tomato; cultivars, varieties, and/or hybrids of these. Cucurbits Vegetables (Crop Group 9): Chinese waxgourd (Chinese preserving melon); citron melon; cucumber; gherkin; gourd, edible (for example, hyotan, cucuzza, hechima, Chinese okra); Momordica spp (for example, balsam apple, balsam pear, bitter melon, Chinese cucumber); muskmelon, hybrids and/or cultivars of Cucumis melo (for example, true cantaloupe, cantaloupe, casaba, crenshaw melon, golden pershaw melon, honeydew melon, honey balls, mango melon, Persian melon, pineapple melon, Santa Claus melon, and snake melon); pumpkin; squash, summer (for example, crookneck squash, scallop squash, straightneck squash, vegetable marrow, zucchini); squash, winter (for example, butternut squash, calabaza, hubbard squash, acorn squash, spaghetti squash); watermelon (includes hybrids and/or varieties of Citrullus lanatus) Small Fruit Vine Climbing, Except Fuzzy Kiwifruit (Crop Subgroup 13-07F): Amur river grape; gooseberry; grape; kiwifruit, hardy; maypop; schisandra berry; cultivars, varieties, and/or hybrids of these.|
|4||Fluensulfone||Nimitz 480 EC||Nematicide||Full||Conventional Chemical||Crop Groups 8-09 and 9: including cucumbers, melons (cantaloupes, watermelon, honeydew), squash, tomatoes (except small tomatoes), okra, eggplant, and peppers (bell and non-bell).|
|5||Polyoxin D Zinc Salt||Polyoxin D Zinc Salt 5SC Fungicide||Fungicide||Full||Biopesticide||Greenhouse ornamentals Outdoor-grown and greenhouse-grown fruit and vegetable crops: Cucurbit Vegetables (Crop Group 9): Chayote (fruit), Chinese waxgourd (Chinese preserving melon), Citron melon, Cucumber, Gherkin, Gourd (edible, including hyotan, cucuzza, hechima, Chinese okra), Momordica spp. (includes balsam apple, balsam pear, bitter melon, Chinese cucumber), Muskmelon (includes true cantaloupe, cantaloupe, casaba, crenshaw melon, golden pershaw melon, honeydew melon, honey balls, mango melon, Persian melon, pineapple melon, Santa Claus melon, and snake melon), Pumpkin, Squash (including acorn squash, butternut squash, calabaza, crookneck squash, hubbard squash, scallop squash, spaghetti squash, straightneck squash, vegetable marrow, zucchini), Watermelon, and Hybrids and varieties of these. Berries and Small Fruits (Crop Group 13), excluding Grapes: Amur river grape, Aronia berry, Bayberry, Bearberry, Bilberry, Blackberry, Blueberry, Buffalo currant, Buffaloberry, Che, Chilean Guava, Chokecherry, Cloudberry, Cranberry, Currant (red and black), Elderberry, European barberry, Gooseberry, Highbush cranberry, Honeysuckle (edible), Huckleberry, Jostaberry, Juneberry, Kiwi (fuzzy and hardy), Loganberry, Maypop, Mountain pepper berries, Mulberry, Muntries, Native currant, Partridgeberry, Phalsa, Pincherry, Raspberry (black and red), Riberry, Salal, Schisandra berry, Sea buckthorn, Serviceberry, Strawberry, Wild raspberries, Cultivars, varieties, and/or hybrids of these. Ginseng, Potato, Tomatoes (all types), Apple, Pear, Grapes and Strawberries|
|Polyoxin D Zinc Salt 11.3% WDG Fungicide||Fungicide||Full||Biopesticide||Turfgrass (Golf courses, sod farms, commercial/industrial lawns): Creeping bentgrass, Creeping fescues, Kentucky bluegrasses, Perennial ryegrasses, and Poa annua. Outdoor-grown ornamentals.|
|Polyoxin D Zinc Salt 11.3% WDG Domestic Fungicide||Fungicide||Full||Biopesticide||Domestic Turf and Domestic Ornamentals Turfgrasses: Creeping bentgrass, Creeping fescues, Kentucky bluegrasses, Perennial ryegrasses, and Poa annua. Outdoor-grown ornamentals.|
|6||Tioxazafen||Acceleron Nemastrike ST||Nematicide||Full||Conventional Chemical||Field corn and soybean|
|7||Tolpyralate||Tolpyralate 400SC Herbicide||Herbicide||Full||Conventional Chemical||Field corn, seed corn, sweet corn and popcorn.|
Table 3 Approved GROU Products 2017-2018
In 2017-2018, 23 products were available under the Grower Requested Own Use (GROU) Program:
- SWITCH 62.5 WG Fungicide (Pest Control Product # 28189) - Canadian Registered Version of the GROU Approved Product, Switch 62.5 WG (U.S. EPA #100-953), GROU Equivalency Certificate #046 [expires December 31, 2019]
- Agri-Mek SC Insecticide (Pest Control Product # 31607) - Canadian Registered Version of the GROU Approved Product, Agri-Mek SC Miticide/Insecticide (U.S. EPA #100-1351), GROU Equivalency Certificate #045 [expires December 31, 2018]
- Upbeet Herbicide Dry Flowable 50% (Pest Control Product # 25813) - Canadian Registered Version of the GROU Approved Product, Dupont Upbeet Herbicide (U.S. EPA #352-569), GROU Equivalency Certificate #044 [expires December 31, 2018]
- Ridomil Gold 480SL Fungicide (Pest Control Product # 28474) - Canadian Registered Version of the GROU Approved Product, Ridomil Gold SL (U.S. EPA #100-1202), GROU Equivalency Certificate #043 [expires December 31, 2020]
- Assail 70 WP Insecticide (Pest Control Product # 27128) - Canadian Registered Version of the GROU Approved Product, Assail 70 WP Insecticide (U.S. EPA #8033-23), GROU Equivalency Certificate #042 [expires December 31, 2020]
- Tattoo Fungicide (Pest Control Product # 29554) - Canadian Registered Version of the GROU Approved Product, Previcur Flex (U.S. EPA #264-678), GROU Equivalency Certificate #041 [expires December 31, 2019]
- QUADRIS Flowable Fungicide (Pest Control Product # 26153) - Canadian Registered Version of the GROU Approved Product, Abound Flowable Fungicide (U.S. EPA #100-1098), GROU Equivalency Certificate #040 [expires December 31, 2019]
- Elevate 50 WDG Fungicide (Pest Control Product #25900) - Canadian Registered Version of the GROU Approved Product, Elevate 50 WDG Fungicide (U.S. EPA #66330-35), GROU Equivalency Certificate #038 [expires December 31, 2020]
- FirstRate Herbicide (Pest Control Product #26697) - Canadian Registered Version of the GROU Approved Product, FirstRate (U.S. EPA #62719-275), GROU Equivalency Certificate #036 [expires December 31, 2019]
- Pursuit 240 (Pest Control Product #23844) - Canadian Registered Version of the GROU Approved Product, Pursuit Herbicide (U.S. EPA #241-310), GROU Equivalency Certificate #026 [expires December 31, 2018]
- Pursuit Herbicide (Pest Control Product #21537) - Canadian Registered Version of the GROU Approved Product, Pursuit Herbicide (U.S. EPA #241-310), GROU Equivalency Certificate #025 [expires December 31, 2018]
- B-Nine WSG Plant Growth Regulator (Pest Control Product #17465) - Canadian Registered Version of the GROU Approved Product, B-Nine WSG (U.S. EPA #400-478), GROU Equivalency Certificate #023 [expires December 31, 2018]
- A-Rest Solution (Pest Control Product #16393) - Canadian Registered Version of the GROU Approved Product, A-Rest Solution (U.S. EPA #67690-2), GROU Equivalency Certificate #022 [expires December 31, 2020]
- SUMAGIC Plant Growth Regulator (Pest Control Product #25781) - Canadian Registered Version of the GROU Approved Product, SUMAGIC Plant Growth Regulator (U.S. EPA #59639-37), GROU Equivalency Certificate #020 [expires December 31, 2019]
- Bonzi Plant Growth Regulator (Pest Control Product #25453) - Canadian Registered Version of the GROU Approved Product, Bonzi Ornamental Growth Regulator (U.S. EPA #100-996), GROU Equivalency Certificate #021 [expires December 31, 2020]
- Assure II Herbicide (Pest Control Product #25462) - Canadian Registered Version of the GROU Approved Product, Assure II Herbicide (U.S. EPA #352-541), GROU Equivalency Certificate #017 [expires December 31, 2020]
- Reglone Desiccant (Pest Control Product #26396) - Canadian Registered Version of the GROU Approved Product, Reglone Desiccant (U.S. EPA #100-1061), GROU Equivalency Certificate #016 [expires December 31, 2019]
- Reflex Liquid Herbicide(Pest Control Product #24779) - Canadian Registered Version of the GROU Approved Product, Reflex Herbicide (U.S. EPA #100-993), GROU Equivalency Certificate #008 [expires December 31, 2018]
- Roundup WeatherMAX with Transorb 2 Technology Liquid Herbicide (Pest Control Product #27487) - Canadian Registered Version of the GROU Approved Product, Roundup WeatherMAX Herbicide (U.S. EPA #524-537), GROU Equivalency Certificate #007 [expires December 31, 2018]
- Basagran Liquid Herbicide (Pest Control Product #12221) - Canadian Registered Version of the GROU Approved Product, Basagran T&O Herbicide (U.S. EPA #7969-326), GROU Equivalency Certificate #005 [expires December 31, 2018]
- Armezon Herbicide (Pest Control Product #30131) - Canadian Registered Version of the GROU Approved Product, Armezon Herbicide (U.S. EPA #7969-262), GROU Equivalency Certificate #047 [expires December 31, 2020]
- Lance WDG Fungicide (Pest Control Product #27495) - Canadian Registered Version of the GROU Approved Product, Endura Fungicide (U.S. EPA #7969-197), GROU Equivalency Certificate #048 [expires December 31, 2020]
- Pristine WG Fungicide (Pest Control Product #27985) - Canadian Registered Version of the GROU Approved Product, Pristine Fungicide (U.S. EPA #7969-199), GROU Equivalency Certificate #049 [expires December 31, 2020]
|Active Ingredient||Document Number||Summary of Decision or Proposed Decision|
|Final Decisions - Re-evaluations|
|Glyphosate Cluster (5 actives)||RVD2017-01||Acceptable for continued registration. Mitigation includes new/revised label statements to further protect human health and the environment.|
|Octhilinone||RVD2017-02||Acceptable for continued registration for certain uses. Mitigation includes new/revised label statements to further protect human health and the environment. Cancellation of other uses due to health risk concerns.|
|Antisapstain and Joinery Uses of Propiconazole||RVD2017-03||Acceptable for continued registration. Mitigation includes new/revised label statements to further protect human health and the environment.|
|Antisapstain and Joinery Uses of Boron||RVD2017-04||Acceptable for continued registration. Mitigation includes new/revised label statements to further protect human health and the environment.|
|Antisapstain and Joinery Uses of Iodocarb||RVD2017-05|
|Joinery Use of Tebuconazole||RVD2017-06|
|Antisapstain Use of Copper-8-quinolinolate||RVD2017-07|
|Antisapstain Use of 2-(Thiocyanomethylthio) benzothiazole (TCMTB)||RVD2017-08|
|Antisapstain and Joinery Uses of Didecyl Dimethyl Ammonium Chloride (DDAC)||RVD2017-09|
|Clethodim||RVD2017-10||Acceptable for continued registration. Mitigation includes new/revised label statements to further protect the environment.|
|Tetramethrin||RVD2018-01||Acceptable for continued registration for certain uses. Mitigation includes new/revised label statements to further protect human health and the environment. Cancellation of other uses due to health risk concerns.|
|Amitraz (dog collar use)||RVD2018-02||Use cancelled due to health risk concerns.|
|Potassium Peroxymonosulfate present as Potassium Peroxymonosulfate Sulfate||RVD2018-03||Acceptable for continued registration.|
|Methomyl||RVD2018-05||Acceptable for continued registration. Mitigation includes new/revised label statements to further protect human health and the environment. Certain uses are no longer supported by manufacturers and will be removed from labels.|
|E-8-dodecenyl acetate, Z-8-dodecenol and Z-8-dodecenyl acetate||RVD2018-07||Acceptable for continued registration.|
|Final Decisions - Special Reviews|
|2,4-D||REV2017-08||Acceptable for continued registration.|
|Sodium chlorate||REV2017-27||Acceptable for continued registration.|
|Carbaryl||REV2017-28||Acceptable for continued registration.|
|Chlorthal dimethyl||REV2018-04||Acceptable for continued registration.|
|Diphenylamine||REV2018-05||Acceptable for continued registration.|
|Proposed Decisions for Public Consultation - Re-evaluations|
|Chloropicrin (soil fumigant)||PRVD2017-01||Proposed for continued registration.|
|Potassium peroxymonosulfate||PRVD2017-02||Proposed for continued registration.|
|Lambda-cyhalothrin||PRVD2017-03||Proposed for continued registration for certain uses with implementation of new/revised mitigation measures to further protect human health and the environment. Proposed cancellation of other uses due to health risk concerns.|
|Diflufenzopyr-sodium||PRVD2017-04||Proposed for continued registration with implementation of new/revised mitigation measures to further protect human health and the environment.|
|E-8-Dodecen-1-yl Acetate, Z-8-Dodecen-1-ol, Z-8-Dodecen-1-yl Acetate||PRVD2017-05||Proposed for continued registration.|
|Amitraz (dog collar use)||PRVD2017-06||Proposed for cancellation.|
|Phosmet||PRVD2017-07||Proposed for cancellation.|
|Acetic acid||PRVD2017-08||Proposed for continued registration with implementation of new/revised mitigation measures to further protect the environment.|
|Isopropyl alcohol||PRVD2017-09||Proposed for continued registration.|
|Sodium bromide||PRVD2017-10||Proposed for continued registration for certain uses with implementation of new/revised mitigation measures to further protect human health and the environment. Proposed cancellation of other uses due to health risk concerns.|
|Fluoroxypyr||PRVD2017-11||Proposed for continued registration with implementation of new/revised mitigation measures to further protect human health and the environment.|
|Hydrogen peroxide||PRVD2017-12||Proposed for continued registration with implementation of new/revised mitigation measures to further protect human health and the environment.|
|Peroxyacetic acid||PRVD2017-13||Proposed for continued registration with implementation of new/revised mitigation measures to further protect the environment.|
|Aminoethoxyvinylglycine||PRVD2017-14||Proposed for continued registration with implementation of new/revised mitigation measures to further protect the environment.|
|N-octyl bicyclo heptene dicarboximide (MGK-264)||PRVD2017-15||Proposed for continued registration with implementation of new/revised mitigation measures to further protect human health.|
|Dichlorvos||PRVD2017-16||Proposed for continued registration for certain uses with implementation of new/revised mitigation measures to further protect human health. Proposed cancellation of other uses due to environmental risk concerns.|
|Zinc oxide||PRVD2017-17||Proposed for continued registration.|
|Permethrin||PRVD2017-18||Proposed for continued registration for certain uses with implementation of new/revised mitigation measures to further protect human health and the environment. Proposed cancellation of other uses due to health risk concerns.|
|Trichoderma harzianum Rifai strain KRL AG2||PRVD2017-20|
|Iron (ferric phosphate)||PRVD2017-21||Proposed for continued registration.|
|Metam sodium and Metam potassium||PRVD2017-22|
|Clothianidin (pollinator)||PRVD2017-23||Proposed for continued registration for certain uses with implementation of new/revised mitigation measures to further protect the environment. Proposed cancellation of other uses due to environmental risk concerns.|
|Thiamethoxam (pollinator)||PRVD2017-24||Proposed for continued registration for certain uses with implementation of new/revised mitigation measures to further protect the environment.|
|Piperine and Oil of black pepper||PRVD2017-25||Proposed for continued registration.|
|Soybean oil||PRVD2018-02||Proposed for continued registration.|
|Oil of Geranium, Camphor Oil, Eucalyptus Oil, Lemon Oil, and Pine Needle Oil||PRVD2018-03||Proposed for continued registration.|
|Ethyl alcohol||PRVD2018-04||Proposed for continued registration.|
|(Z,Z)-3,13-Octadecadienyl Acetate||PRVD2018-07||Proposed for continued registration.|
|Dazomet||PRVD2018-09||Proposed for continued registration with implementation of new/revised mitigation measures to further protect human health.|
|Azadirachtin||PRVD2018-10||Proposed for continued registration.|
|Cydia pmonella Granulovirus strain CMGv4||PRVD2018-11||Proposed for continued registration.|
|Proposed Decisions for Public Consultation - Special Reviews|
|Sodium chlorate||REV2017-17||Proposed for continued registration.|
|Chlorthal dimethyl||REV2017-19||Proposed for continued registration.|
|Diphenylamine||REV2017-25||Proposed for continued registration.|
|Fluopicolide||REV2018-03||Proposed for continued registration.|
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