Proposed re-evaluation decision PRVD2026-04, Fenamidone and its associated end-use product

Health Canada
Healthy Environments and Consumer Safety Branch
Pesticides Regulatory Directorate
29 September 2026
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2026-4E-PDF (PDF version)

Summary

Table of contents

• Proposed re-evaluation decision for fenamidone and associated end-use product
• Proposed re-evaluation decision for fenamidone
• Risk mitigation measures
• International context
• Next steps
• Other information
• Additional scientific information

Proposed re-evaluation decision for fenamidone and associated end-use product

Under the authority of the Pest Control Products Act, all registered pesticides must be re-evaluated by Health Canada to ensure that they continue to meet current health and environmental standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Fenamidone is a preventative, protectant fungicide registered to manage diseases in a variety of field crops, vegetables, and specialty crop. Currently registered products containing fenamidone can be found in the Pesticide Product Information Database and in Appendix I of the full version of Proposed Re-evaluation Decision PRVD2026-04, Fenamidone and its associated end-use product. Appendix II of PRVD2026-04 lists all uses for which fenamidone is presently registered. All uses were supported by the registrant at the time of re-evaluation initiation and were therefore considered in the health and environmental risk assessments and value assessment of fenamidone.

This document (PRVD2026-04) presents the proposed re-evaluation decision for fenamidone, including the proposed amendments (risk mitigation measures) to protect human health and the environment, as well as the Science evaluation on which the proposed decision is based. All products containing fenamidone that are registered in Canada are subject to this proposed re-evaluation decision. PRVD2026-04 is subject to a 90-day public consultation period,^{Footnote 1} during which the public (including the pesticide manufacturers and stakeholders) may submit written comments and additional information to the Pesticides Publications Section. The final re-evaluation decision will be published after taking into consideration the comments and additional information received during the consultation period that are directly related to this proposed re-evaluation decision.

Proposed re-evaluation decision for fenamidone

Health Canada, under the authority of the Pest Control Products Act, has conducted all evaluations considered necessary with respect to the health and environmental risks and value of fenamidone based on available scientific information in accordance with subsection 16(6) of the Pest Control Products Act. Based on these evaluations, Health Canada is proposing for public consultation, pursuant to section 28 of the Pest Control Products Act, the continued registration of uses of fenamidone and the associated end-use product registered for sale and use in Canada under section 21 of the Pest Control Products Act.

With respect to human health, dietary (food and drinking water), occupational (handler and postapplication), and non-occupational (bystander) risks were shown to be acceptable when fenamidone is used according to proposed conditions of registration, which includes new mitigation measures such as restricted-entry intervals (up to 4 days) and additional personal protective equipment for specific workers during planting of treated potato seed pieces.

The environmental risk assessment found that the risks to the environment were shown to be acceptable when fenamidone is used according to proposed conditions of registration, which includes new mitigation measures such as additional precautionary label statements and spray buffer zones.

When used as a seed piece treatment on potato seeds infected with late blight, fenamidone increases levels of emergence and may prevent the spread of late blight spores when handling and planting seed pieces. The ability to tank mix fenamidone provides users with the ability to increase the spectrum of diseases controlled with a single seed treatment application. With the exception of potatoes, tomatoes, and turnip greens, fenamidone was registered for use on all other labelled crops under the User Requested Minor Use Label Expansion program, and as such is important to the minor use community.

Risk mitigation measures

Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health, the environment and ensure the product has acceptable value which must be followed by law. The proposed label amendments including the revised/updated label statements and/or mitigation measures, as a result of the re-evaluation of fenamidone, are summarized below. Refer to Appendix IX of PRVD2026-04 for details.

Human health

Risk mitigation:

• To protect workers during mixing/loading/application, the following risk-reduction measures are proposed:
  • Require that workers wear addition personal protective equipment (PPE) when in the back of planters during planting of treated potato seed pieces.
• To protect workers entering treated sites, the following risk-reduction measures are proposed:
  • Require the minimum restricted-entry interval (REI) of 12 hours.
  • Increase the REIs for some postapplication activities in some crops.

Label improvements to meet current standards:

• Due to updates of the crop groups nomenclature, the label statement “Brassica leafy greens” is proposed to be replaced by “Leafy vegetables”.
• Updates to personal protective equipment and REI label statements as per current labelling standards.
• Add statement to clarify that fenamidone is registered for outdoor application only.
• Require an additional statement specific to potato seed piece treatment to promote best management practices to minimize human exposure from spray drift or spray residues resulting from drift.

Environment

Risk mitigation:

• To protect the environment, the following risk-reduction measures are proposed:
  • Precautionary label statements to inform users of toxicity to aquatic organisms and beneficial arthropods.
  • Advisory statement to minimize risk to beneficial arthropods.
  • A spray buffer zone of 1 m is required to protect sensitive aquatic habitats from spray drift.
  • Best management label statement to reduce the runoff entering sensitive aquatic habitats.

International context

Fenamidone is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including New Zealand, Colombia, and the United States. As announced on 18 December 2020, the European Union (EU) prohibited all uses of fenamidone based on human health and environmental concerns in 2019 (Commission Implementing Regulation (EU) 2018/1043). Following a preliminary analysis of the EU regulatory decision, and pursuant to subsection 17(7) of the Pest Control Products Act, the scope of the re-evaluation of products containing fenamidone was expanded to include all the aspects of concern identified in the EU decision and a special review was not initiated. Therefore, this re-evaluation addresses the following aspects of concern identified in the EU decision on fenamidone:

• Potential for genotoxicity.
• Potential for groundwater leaching by metabolite RPA 412708.
• Potential risk to aquatic organisms from exposure to the metabolite acetophenone.

Next steps

Upon publication of this proposed re-evaluation decision, the public, including the registrants and stakeholders are encouraged to submit additional information that could be used to refine risk assessments during the 90-day public consultation period.

Health Canada will accept written comments and additional information on this proposal up to 90 days from the date of publication of PRVD2026-04 (“consultation period”). Comments and additional information on the proposed decision can be submitted during the consultation period to Health Canada through Pesticides Publications Section, or the Public Engagement Portal (Public Engagement Portal forms - Consultation Comment). For more information or if you have questions, contact Health Canada’s Pesticides Information Service.

Before making a re-evaluation decision on fenamidone under section 21 of the Pest Control Products Act, the comments and additional information received during the consultation period that are directly related to this proposed decision, such as comments directed to the science evaluation, will be taken into consideration in preparation of the final re-evaluation decision document. A science-based approach will be applied in making a final decision on fenamidone. In accordance with subsection 28(5) of the Pest Control Products Act, Health Canada will then publish a final re-evaluation decision document, which will include the decision, the reasons for it, a summary of the comments received directly related to the proposed re-evaluation decision during the consultation period, and Health Canada’s response to these comments.

Refer to Appendix I of PRVD2026-04 for details on specific products impacted by this proposed decision.

Other information

The relevant confidential test data on which the proposed decision is based (in the References section of PRVD2026-04) are available for public inspection, upon application, in Pesticides Regulatory Directorate’s Reading Room. For more information, please contact Health Canada’s Pesticides Information Service.

Additional scientific information

The following additional data may be submitted during the consultation for consideration during the final decision phase:

Value

Risks were shown to be acceptable for most uses at the minimum restricted-entry interval (REI) of 12 hours. For some uses and activities, longer REIs (up to 4 days) were required to mitigate risks. Most REIs are likely to be agronomically feasible. Feedback is requested regarding the feasibility of the REIs for the following crops and activities:

• Hand set irrigation: basil, spinach, baby spinach, carrot, brassica leafy greens, edible podded legume vegetables, succulent shelled pea and bean, ginseng, turnip greens.
• Scouting: edible podded beans, succulent shelled pea and bean.