Canada issues cancellation of flufenacet registration after re-evaluation

Re-evaluation decision for flufenacet and associated end-use products

Under the authority of the Pest Control Products Act (or the Act), all registered pesticides must be re-evaluated by Health Canada's Pest Management Regulatory Agency (PMRA) to ensure that they meet current health and environmental standards and have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies, as well as comments received during public consultations. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies. More details, on the legislative framework, risk assessment and risk management approach, are provided under the Evaluation Approach Section of the full version of Re-evaluation Decision RVD2024-10, Flufenacet and Its Associated End-use Products.

Flufenacet is a herbicide registered for use on field corn and soybeans to control annual grasses and broadleaf weeds in Eastern Canada. The application timing is preplant, pre-emergent and early post-emergent, with one application per season. Currently registered products containing flufenacet can be found in the Pesticide Product Information Database and in Appendix I.

The Proposed Re-evaluation Decision PRVD2021-01, Flufenacet and Its Associated End-use Products containing the evaluation of flufenacet and proposed decision was published on 28 January 2021 for a 90-day consultation period. PRVD2021-01 proposed the cancellation of flufenacet products due to dietary and occupational (mixing/loading/application) risks of concern.

Health Canada received comments and information relating to the health (toxicology and occupational exposure), environmental and value assessments. Commenters are listed in Appendix II of RVD2024-10. These comments are summarized in Appendix III of RVD2024-10 along with the responses by Health Canada. These comments and new data/information resulted in revisions to the toxicology and occupational exposure assessments (see Science evaluation update of RVD2024-10) but did not result in changes to the risk assessment outcomes as described in PRVD2021-01. The comments relating to the environmental and value assessments did not result in changes to the assessments or the outcomes of these assessments described in PRVD2021-01.

A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2021-01, and further information used in the re-evaluation decision is listed in Appendix VI of RVD2024-10. Therefore, the complete reference list of all information used in this final re-evaluation decision includes both the information set out in PRVD2021-01 and the information set out in Appendix VI of RVD2024-10.

This document (RVD2024-10) presents the final re-evaluation decision for the re-evaluation of flufenacet. All products containing flufenacet that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for flufenacet

Health Canada has completed the re-evaluation of flufenacet. Under the authority of the Pest Control Products Act, Health Canada is cancelling the registration of flufenacet and all associated end-use products in Canada. An evaluation of available scientific information found that flufenacet has acceptable value and the environmental risks associated with the use of flufenacet, and its associated end-use products were shown to be acceptable with mitigation measures such as precautionary label statements and spray buffer zones for the protection of terrestrial and aquatic habitats. However, the risks to human health were not shown to be acceptable when flufenacet is used according to the current conditions of registration, or when additional mitigation is considered. The cancellation of flufenacet products is not expected to significantly impact growers, as more effective herbicides are already in use for field corn and soybean production in Canada.

Implementation of the re-evaluation decision

Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review provides general timelines for implementation of post-market decisions (in other words, up to 24-month timeline for label amendments and up to 36-month timeline for cancellation), and Information Note: update on implementation of post-market decisions provides additional information on phase-out measures for post-market decisions that include cancellations. The post-market decision considers potential health and environmental risks regarding the use of the pest control product, and its value, when establishing the implementation timelines.

When a re-evaluation or special review decision requires cancellation of pest control products, consistent with Health Canada's Information Note: update on implementation of post-market decisions (2021), Health Canada will immediately cancel pest control product registrations on the date of a decision made under paragraph 21(2)(b) of the Pest Control Products Act.

If there are no serious and imminent risks to human health or the environment, Health Canada will allow for a phase-out period consistent with the Cancellation Policy and will impose any conditions necessary for carrying out the purposes of the Pest Control Products Act under the authority of paragraph 21(5)(a) of the Pest Control Products Act.

Health and environmental considerations

Users may be in possession of some limited stock of flufenacet products, and a one-year phase-out period is permitted for it to be used. Based on the available post-market surveillance data, which includes the absence of any health or environmental-related incidents, it is not expected that imminent and serious risks to human health and the environment will occur during a one-year phase-out period. Taking into consideration these factors, a one-year phase-out period is considered appropriate from a human health and environmental perspective under the current label use conditions.

Next steps

To comply with this decision, all flufenacet products are cancelled (as of the publication date of this decision document) pursuant to paragraph 21(2)(b) of the Pest Control Products Act. Existing stocks of cancelled products in Canada will be subject to the following phase-out schedule:

• Last date of sale (of existing stocks in Canada) by registrant and by retailer/distributor: Date of the decision, followed by;

• Authorized for use: one (1) year from the date of decision.

During the phase-out period, importing or manufacturing pest control products containing flufenacet in Canada is prohibited. Existing stocks of the cancelled products in Canada will be authorized for continued possession, handling, storage, and use over the phase-out period as per paragraph 21(5)(a) of the Pest Control Products Act.

Refer to Appendix I for details on specific products impacted by this decision.

Other information

Any person may file a notice of objection regarding this decision on Flufenacet and its associated end-use products within 60 days from the date of publication of this Re-evaluation Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides and pest management section of the Canada.ca website (Public Engagement Portal - Public Engagement Forms - Notice of Objection) or contact PMRA's Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PRVD2021-01) are available for public inspection, upon application, in PMRA's Reading Room. For more information, please contact the Pest Management Information Service.

Appendix I Registered products containing flufenacet in Canada