Re-evaluation Note REV2021-03, Pest Management Regulatory Agency Re-evaluation and Special Review Work Plan 2021-2026

Pest Management Regulatory Agency
22 June 2021
ISSN: 1925-0649 (PDF version)
Catalogue number: H113-5/2021-3E-PDF

Table of contents

• Background
• Part A - Current re-evaluation and special review work plan (Tables 1-5)
  • Part A, Table 1 Targets for consultation and final decisions for legacy active ingredients
  • Part A, Table 2 Targets for consultation and final decisions of special reviews
  • Part A, Table 3a Targets for consultation and final decisions of cyclical active ingredients (currently under review)
  • Part A, Table 3b Status of other active ingredients (currently delayed)
• Re-evaluations initiated between 1 April 2020 and 31 March 2021
  • Part A, Table 4 Status of re-evaluations initiated between 1 April 2020 and 31 March 2021
  • Part A, Table 5 Re-evaluations to be initiated between 1 April 2021 and 31 March 2022
• Part B - Future re-evaluation initiations (Table 1)
  • Part B, Table 1 Future re-evaluation initiations between 1 April 2022 and 31 March 2026

Background

The purpose of this document is to inform registrants, pesticide regulatory officials and the Canadian public of the re-evaluation and special review work planned by Health Canada's Pest Management Regulatory Agency (PMRA) from 1 April 2021 to 31 March 2026.

This work plan includes the proposed and final decisions published since 1 April 2021, all open re-evaluations and special reviews, as well as new re-evaluations expected to be initiated in this time frame (1 April 2021 to 31 March 2026). This document presents updates to the information last published in Re-evaluation Note REV2020-01, Pest Management Regulatory Agency Re-evaluation and Special Review Work Plan 2020-2025.

Health Canada regulates pesticides in Canada, with the primary objective of protecting the health of Canadians and the environment. A pesticide may only be sold or used in Canada if it has been registered or otherwise authorized under the authority of the Pest Control Products Act. Health Canada uses a rigorous science-based risk assessment approach to ensure that the product meets health and environmental protection standards and has value.

As part of the post-market program, registered pesticides are re-evaluated on a cyclical basis to determine their continued acceptability. Pesticides may also be re-evaluated as a result of changes in the information required or the procedures used by Health Canada to determine that the pesticide meets current health, environment and value standards. The re-evaluation process is described in Regulatory Directive DIR2016-04, Management of Pesticides Re- evaluation Policy. In addition, a special review may be initiated at any time if there are reasonable grounds to believe that the health or environmental risks, or the value of a pesticide, are no longer acceptable. Special reviews differ from re-evaluation in that a special review is intended to examine only specific aspects of a pesticide. Additional information on special reviews can be found in the Guidance Document, Approach to Special Reviews of Pesticides.

Health Canada publishes all post-market proposed decisions for public consultation. Following consultation, comments and information submitted by the public and other stakeholders are considered before Health Canada issues a final decision. Stakeholders are encouraged to stay informed of upcoming consultations, and new initiations, for active ingredients by visiting the Pesticides section of Canada.ca (canada.ca/pesticides).

This five-year work plan may change in response to workload and emerging issues that require priority action. While this work plan will be updated annually, during the course of the year interested stakeholders can monitor the PMRA's Public Registry to view the announcement of new re-evaluations and special reviews, as well as the publication of proposed and final decisions.

Part A - Current re-evaluation and special review work plan (Tables 1-5)

The post-market review program workload is significant, surpassing existing resources and increasing. In response, Health Canada is developing new approaches for pesticide evaluations that will support a sustainable program that makes timely science-based decisions. As part of program renewal, Health Canada is implementing several initiatives to manage the post-market workload such as a risk-based prioritization of re-evaluations.

Re-evaluations for the remaining legacy pesticides; that is, older pesticide active ingredients registered before 1995, older cyclical re-evaluations, and certain neonicotinoid reviews as well as older special reviews, continue to be prioritized for completion. In recent years, as Health Canada has focussed its resources on the review of these priority chemicals, reviews of many of the cyclical re-evaluations were paused. For improved transparency, the work plan identifies the re-evaluations and special reviews that are actively worked on, and those that are delayed. As resources become available, these reviews will resume, and timelines of these re-evaluations will be reflected in future work plans.

As the number of re-evaluation initiations required by the Pest Control Products Act continues to be high, beginning in 2019-2020, Health Canada implemented a risk-based triaging framework to prioritize the scoping and review phases of newer re-evaluation initiations to manage higher risks in a timely manner, and to manage workload efficiently. While new initiations are divided into higher priority or lower priority groupings based on this risk-based prioritization framework, all active ingredients initiated for re-evaluation will continue to be subject to the requirements of the Pest Control Products Act. In addition, beginning in April 2021, Health Canada introduced several measures to help streamline the processing of these newer initiations to help minimize the growing backlog.

Health Canada has made every effort to minimize the impact of the COVID-19 pandemic on regular operations, including the redeployment of resources from the pesticide review program to support other critical Government activities. Also, the delay in publication of decision documents due to the shift in departmental priorities to COVID-19 communications is expected to continue.

The anticipated publication dates outlined in the work plan represent the most up-to-date information on the status of the re-evaluations or special reviews.

Part A, Table 1 Targets for consultation and final decisions for legacy active ingredients

Part A, Table 2 Targets for consultation and final decisions of special reviews

Part A, Table 3a Targets for consultation and final decisions of cyclical active ingredients (currently under review)

Part A, Table 3b Status of other active ingredients (currently delayed)

To direct resources for the work (reviews and publication phases) on active ingredients in Tables 1-3a, the re-evaluations of the following active ingredients are delayed. As resources become available, work on these active ingredients will resume and Health Canada will provide an updated status in the next work plan to be published in spring 2022.

Re-evaluations initiated between 1 April 2020 and 31 March 2021

As noted above, the number of re-evaluation initiations currently required as per the 15-year legislative requirement continues to be high. Therefore, Health Canada is maintaining its risk-based triaging and prioritization framework for conducting the scoping and re-evaluation reviews of newer cyclical re-evaluation initiations to manage risks in a timely manner, and to help manage workload efficiently. This prioritization is based on various considerations such as the nature and outcome of existing assessments and overall human health and environmental risk profile, other health and environmental concerns such as information from incident reports received by Health Canada and status in other jurisdictions (for example, decisions from other Organisation for Economic Co-operation and Development member countries), use pattern, sales and use information, knowledge of new information, new data requirements, and, possible clustering of reviews of related active ingredients. Based on the above considerations, a weight-of-evidence approach is taken for prioritization, and Health Canada has grouped the active ingredients into higher priority and lower priority active ingredients for the scoping and review phases. The outcome of scoping reviews will further inform the prioritization of active ingredients for the review phase. All active ingredients initiated for re-evaluation will be subject to the various steps of re-evaluation before making a final re-evaluation decision (in other words, scoping, additional information request when needed, scientific review, public consultation and final decision) as per the Regulatory Directive DIR2016-04, Management of Pesticides Re-evaluation Policy. However, given current capacity considerations, the active ingredients identified as higher priority based on the above factors will be considered first. In some cases, lower priority re-evaluations that can be completed with minimal effort and resources are also considered.

Beginning in April 2021, Health Canada introduced several measures to streamline the processing of the newer initiations to focus on addressing risk concerns, improve timeliness of decisions, and to minimize re-evaluation backlog.

For lower priority active ingredients, a data list of available studies will no longer be requested at initiation. The study list and additional information may be requested, if necessary, once the review of the active ingredient is ready to proceed. Registrants, however, are required to meet their obligations under paragraph 2(f) Pest Control Products Incident Reporting Regulations (https://laws-lois.justice.gc.ca/eng/regulations/SOR-2006-260/page-1.html#h-725576), which indicates: registrants must provide a scientific study they have sponsored if it indicates either a new health or environmental hazard, increased health or environmental risk or the presence of a component or derivative that has not been previously detected. These studies must be submitted to PMRA according to the timelines outlined in the Incident Reporting Regulations. Failure to do so may be subject to regulatory action. Further, a streamlined approach will be considered; for example, scientific assessments of lower priority active ingredients will not be updated unless necessary, PMRA's efforts and resources will focus on the higher priority active ingredients.

For higher priority active ingredients, in addition to providing the data list of available scientific studies at initiation, registrants are required to provide an executive summary of each of the studies listed. These summaries will provide pertinent information about the study methodology and results, which will inform Health Canada in determining the relevance of the study, and to determine data requirements during the scoping and review phases.

Resources will continue to focus on the risk profile of the active ingredient, ensuring that the level of effort is commensurate with the risk. Thus, comprehensive new evaluations and requests for additional information/scientific studies will only be conducted if necessary to address the risks of concern.

For the active ingredients initiated for re-evaluation between 1April 2020 and 31 March 2021, the prioritization exercise described above has been completed. The higher and lower priority groupings are outlined in Table 4 along with the current status in the re-evaluation process.

As resources become available, scoping of the active ingredients in Table 4 will be completed, and the status will be updated in the next upcoming work plan (2022-2027), planned to be published in spring 2022.

Part A, Table 4 Status of re-evaluations initiated between 1 April 2020 and 31 March 2021

Part A, Table 5 Re-evaluations to be initiated between 1 April 2021 and 31 March 2022

In accordance with the Pest Control Products Act, the active ingredients listed in Table 5 must be initiated between 1 April 2021 and 21 March 2022 depending on the initial registration date, or the date of the last completed re-evaluation. Information related to the re-evaluation initiation will be posted to the PMRA's Public Registry. Risk-based triaging and prioritization will be applied.

Part B - Future re-evaluation initiations (Table 1)

In general, the initiation date of the re-evaluation of a particular active ingredient is based on the date of its initial registration, or the date of the last completed re-evaluation. A complete list of all re-evaluation initiations anticipated between April 2022 and March 2026 is included in Table 1.

Part B, Table 1 Future re-evaluation initiations between 1 April 2022 and 31 March 2026