Proposed Re-evaluation Decision PRVD2022-06, Zoxamide and Its Associated End-use Products

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Pest Management Regulatory Agency
28 March 2022
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2022-6E-PDF (PDF version)

Table of contents

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

Proposed re-evaluation decision for zoxamide 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.

Zoxamide is a fungicide registered for the control of fungal diseases on potatoes, grapes and onions (bulb). Currently registered products containing zoxamide can be found in the Pesticide Label Search and in Appendix I of the full version of Proposed Re-evaluation Decision PRVD2022-06, Zoxamide and Its Associated End-use Products.

This document (PRVD2022-06,) presents the proposed re-evaluation decision for zoxamide, 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 zoxamide that are registered in Canada are subject to this proposed re-evaluation decision. PRVD2022-06 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 zoxamide

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 zoxamide and associated end-use products registered for sale and use in Canada.

Zoxamide is a valuable disease management tool for vegetable and grape growers due its rainfastness, residual properties and low to medium risk for resistance development.

With respect to human health, dietary as well as occupational and non-occupational risks from all uses were shown to be acceptable under the current conditions of use. Therefore, no additional mitigation measures are proposed.

Zoxamide risk to non-target terrestrial organisms (earthworms, beneficial arthropods, honeybees, birds, wild small mammals and terrestrial plants) are considered to be acceptable for all registered uses with no additional mitigation measures. No terrestrial buffer zones are required.

Risks from spray drift and runoff of zoxamide, at the currently registered rates, were identified for certain aquatic organisms. To protect aquatic organisms, the risk mitigation measures proposed include additional precautionary label statements and spray buffer zones.

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 zoxamide, are summarized below. Refer to Appendix IX of PRVD2022-06 for details.

Risk mitigation

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

• Precautionary label statements to inform users of the potential toxicity of zoxamide to aquatic organisms.
• Spray buffer zones for the protection of freshwater aquatic habitats such as:
  • 1–10 m for field sprayer; 5–45 m for airblast; 5–350 m for aerial
• To reduce the potential for runoff of zoxamide to adjacent aquatic habitats, precautionary label statements for sites with characteristics that may be conducive to runoff and when heavy rain is forecast.

Other label updates

• An update to the standard statement to minimize human exposure from spray drift.
• Clarify the application method for bulb onion (specify ground application).

International context

Zoxamide is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including the United States, the European Union and Switzerland. Internationally and within the available information, no evidence of a ban as of 27 August 2021 to prohibit all uses of zoxamide for health or environmental reasons has been identified.

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.

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 PRVD2022-06 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 PRVD2022-06) are available for public inspection, upon application, in Health Canada’s Reading Room. For more information, please contact Health Canada’s Pest Management Information Service.

Additional scientific information

Additional scientific data are not required at this time.