Proposed Re-evaluation Decision PRVD2023-02, Azoxystrobin and Its Associated End-use Products

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Pest Management Regulatory Agency
15 June 2023
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2023-2E-PDF (PDF version)

Table of contents

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

Proposed re-evaluation decision for azoxystrobin and associated end-use products

Under the authority of the Pest Control Products Act, all registered pesticides must be re-evaluated by Health Canada's Pest Management Regulatory Agency (PMRA) 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.

Azoxystrobin is a fungicide registered for the control of various fungal diseases on a wide range of agricultural crops including, fruits, vegetables, specialty crops, greenhouse and outdoor ornamentals, turf and seed treatment. Currently registered products containing azoxystrobin can be found in the Pesticide Product Information Database and in Appendix I of PRVD2023-02. Appendix II of PRVD2023-02 lists all uses for which azoxystrobin is presently registered.

This summary presents the proposed re-evaluation decision for azoxystrobin, 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 azoxystrobin that are registered in Canada are subject to this proposed re-evaluation decision.This document (PRVD2023-02) 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 PMRA Publications. The final re-evaluation decision will be published after taking into consideration the comments and information received during the consultation period.

Proposed re-evaluation decision for azoxystrobin

Under the authority of the Pest Control Products Act and based on an evaluation of available scientific information, Health Canada is proposing continued registration of azoxystrobin and associated end-use products registered for sale and use in Canada.

With respect to human health, potential risks from dietary (food and drinking water), occupational, non-occupational and postapplication risks were shown to be acceptable when azoxystrobin is used according to proposed conditions of registration, which includes risk mitigation measures related to human health as identified below.

Potential risks to the environment were shown to be acceptable when azoxystrobin is used according to the proposed conditions of registration, which includes new mitigation measures, as identified below.

Azoxystrobin is one of the few systemic fungicides registered for control of various fungal diseases on a wide range of agricultural crops including ornamentals, vegetables and fruit crops, cereals and turf. Due to its curative and eradicative properties, post-infection application reduces disease development.

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 re-evaluation of azoxystrobin, are summarized below. Refer to Appendix IX of PRVD2023-02 for details.

Human health

As a result of the re-evaluation of azoxystrobin, Health Canada is proposing further risk-reduction measures in addition to those already present on the product labels. Additional revisions to the azoxystrobin labels are also proposed to meet the current labelling standards.

To protect human health and improve label statements to meet current standards, the following risk reduction measures are proposed:

• Rotational plant-back intervals (PBIs) of 30 days for broadleaf or root crops and 45 days for cereal crops that are not registered uses of azoxystrobin are proposed, unless the current label directions are more restrictive.
• Updated standard restricted-entry intervals (REI) and re-entry statements.
• Updated re-treatment intervals of 21–28 days for barley, rye and wheat.
• A prohibition of the use of handheld mist blower/airblast or handheld fogging equipment in greenhouse.
• A prohibition of the use of the commercial products on residential turf sites.
• Updated standard drift statement.
• Increased or updated personal protective equipment (PPE), updated precautionary statements and engineering controls for seed treatment uses (requirement for a closed transfer system)
• A standard statement to seed treatment labels and seed tags to keep products out of reach of children and animals.

Environment

To protect the environment, the following risk-reduction measures are proposed:

• Updated environmental precautionary statements.
• New or updated spray buffer zones ranging from 0–20 meters for all uses.

International context

Azoxystrobin is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including the United States, Australia, and the European Union.

No decision by an OECD member country to prohibit all uses of azoxystrobin for health or environmental reasons has been identified as of December 2022.

Next steps

Upon publication of this proposed re-evaluation decision, the public, including the registrants and stakeholders are encouraged to submit comments during the 90-day public consultation period.

All comments received during the 90-day public consultation period will be taken into consideration in preparation of re-evaluation decision document^{Footnote 2}, which could result in revised risk mitigation measures. The re-evaluation decision document will include the final re-evaluation decision, the reasons for it and a summary of comments received on the proposed re-evaluation decision with Health Canada's responses.

Refer to Appendix I of PRVD2023-02 for details on specific products impacted by this proposed decision.

Other information

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

Additional scientific information

The PMRA has identified the following information which is required to further inform the assessment of azoxystrobin. The PMRA will issue a data call-in for this information.

Additional scientific information required

DACO	Description/Reference
Toxicology
4.8	Any available studies that elaborate on the toxicity profile of azoxystrobin, including additional endocrine disruption and reproductive toxicity studies. Data should be submitted during consultation, if not already submitted.