Proposed special review decision PSRD2024-03, Proposed special review decision of pydiflumetofen and its associated end-use products

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Pest Management Regulatory Agency
29 November 2024
ISSN: 2561-636 (PDF version)
Catalogue number: H113-30/2024-3E-PDF (PDF version)

Summary

Table of contents

• Proposed special review decision for pydiflumetofen and associated end-use products
• Proposed special review decision for pydiflumetofen
• Risk mitigation measures
• Other updates
• Next steps
• Other information

Proposed special review decision for pydiflumetofen and associated end-use products

Under the authority of the Pest Control Products Act, pesticides are regulated by Health Canada's Pest Management Regulatory Agency (PMRA) on behalf of the Minister of Health. The Pest Control Products Act prescribes both the pre-market and post-market assessment (re-evaluations and special reviews) of pesticides to determine the acceptability or continued acceptability of human health and environmental risks, and, acceptable value of a pesticide in Canada. Unlike a re-evaluation, a special review is triggered only under certain circumstances, as described in section 17 of the Pest Control Products Act, and the intent of a special review is to address specifically the identified aspect(s) of concern. The special review approach is described in the PMRA Guidance Document: Approach to Special Reviews of Pesticides.

Health Canada evaluates the aspect(s) of concern that prompted the special review in accordance with subsection 18(4) of the Pest Control Products Act. The internationally accepted science-based approach is used for the assessment of the aspect(s) of concern, similar to all other scientific assessments (for example, new product registrations, re-evaluations). This step includes both risk (or value, if applicable) assessment and risk management to address the concerns identified. Health Canada's approach to risk and value assessment as well as risk management is outlined in the Framework for Risk Assessment and Risk Management of Pest Control Products.^{Footnote 1}

Pursuant to subsection 17(1) of the Pest Control Products Act, Health Canada initiated a special review of all registered pest control products containing pydiflumetofen, based on a 28-day inhalation study in rat that was submitted under the incident reporting program (IRP). The identified aspect of concern is:

• Occupational inhalation exposure

Pursuant to subsection 18(4) of the Pest Control Products Act, Health Canada has evaluated the aspects of concern that prompted the special review of pest control products containing pydiflumetofen, which are relevant to human health.

Pydiflumetofen is a broad-spectrum fungicide currently registered as a foliar application, seed treatment or both, on various field food and feed crops, greenhouse food and non-food crops, outdoor ornamentals and turf for the control and suppression of certain diseases. All currently registered products containing pydiflumetofen have been considered in this special review. Currently registered pest control products containing pydiflumetofen are listed in Appendix I of PSRD2024-03, Proposed special review decision of pydiflumetofen and its associated end-use products.

This document (PSRD2024-03) presents the proposed special review decision for pydiflumetofen, including the proposed amendments (risk mitigation measures) to protection human health, as well as the science evaluation on which the proposed special review decision is based. All products containing pydiflumetofen that are registered in Canada are subject to this proposed special review decision. PSRD2024-03 is subject to a 45-day public consultation period^{Footnote 2} during which the public (including the pesticide manufacturers and stakeholders) may submit written comments and additional information to PMRA Publications. The final special review decision will be published after taking into consideration the comments and information received during the consultation period.

Proposed special review decision for pydiflumetofen

Health Canada, under the authority of the Pest Control Products Act, has conducted an evaluation of available relevant scientific information related to the aspect of concern for human health in accordance with subsection 18(4) of the Pest Control Products Act. Based on the evaluation of the aspect of concern, Health Canada is proposing for public consultation, pursuant to section 28 of the Pest Control Products Act, the continued registration of pydiflumetofen and associated end-use products registered for sale and use in Canada under section 21 of the Pest Control Products Act.

The evaluation of available relevant scientific information related to the aspect of concern indicated that pydiflumetofen showed acceptable risk when pydiflumetofen is used according to the proposed conditions of registration, which includes new mitigation measures.

The proposed additional mitigation measures are summarized below, and details are outlined in Appendix IV of PSRD2024-03.

Risk mitigation measures

Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment and must be followed by law. The proposed label amendments including any revised/updated label statements and/or mitigation measures, as a result of the special review of pydiflumetofen, are summarized below. Refer to Appendix IV of PSRD2024-03 for details.

Human health

The following risk mitigation measures are proposed to address potential inhalation risks to workers in commercial facilities treating corn seed and workers using handheld equipment on agricultural crops:

• Commercial seed treatment of corn:
  • A filtering facepiece respirator (dust mask) is proposed during bagging, sewing, and stacking of treated seed.
  • A respirator is proposed during cleaning and repairing.
• Handheld application on agricultural crops:
  • Eye, head and respiratory protection are proposed when applying above waist-height, including overhead.

Other updates

The following label updates are proposed to correct errors relating to pre-harvest interval and application rate:

• For A20259 Fungicide (Registration Number 33020), correction to the pre-harvest interval from 3 days to 5 days.
• For Miravis Neo 300SE (Registration Number 33391), correction to the maximum product application rate from 1.5 L/ha to 0.75 L/ha.

Next steps

Health Canada will accept written comments on this proposal up to 45 days from the date of publication of this document ("consultation period"). Comments on the proposed decision can be submitted during the consultation period to the PMRA through PMRA Publications, or the Public Engagement Portal (Public Engagement Forms - Consultation Comment). For more information or if you have questions, contact the PMRA's Pest Management Information Service.

Before making a special review decision on pydiflumetofen under section 21 of the Pest Control Products Act, the comments received during the consultation period will be taken into consideration in preparation of the final special review decision document. A science-based approach will be applied in making a final decision on pydiflumetofen. In accordance with subsection 28(5) of the Pest Control Products Act, Health Canada will then publish a final special review decision document, which will include the decision, the reasons for it, a summary of the comments received on the proposed special review decision during the consultation period, and Health Canada's response to these comments.

Refer to Appendix I of PSRD2024-03 for details on specific products impacted by this proposed decision.

Other information

The relevant confidential test data on which the proposed decision is based (see References section of this document) are available for public inspection, upon application, in PMRA's Reading Room. For more information, please contact the Pest Management Information Service.