Re-evaluation Decision RVD2023-04, Zoxamide and Its Associated End-use Products

• Pest Management Regulatory Agency
• 9 February 2023
• ISSN: 1925-1025 (PDF version)
• Catalogue number: H113-28/2023-4E-PDF (PDF version)

Summary

Table of contents

• Re-evaluation decision for zoxamide and associated end-use products
• Re-evaluation decision for zoxamide
• Risk mitigation measures
• Next steps
• Other information
• Appendix I - Registered products containing zoxamide in Canada

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 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.

Zoxamide is a benzamide fungicide registered for use on potatoes, grapes and onions (bulb) for control of various oomycete diseases (for example, late blight and downy mildew). It is registered for application using ground (boom and airblast) and aerial equipment (potato only). Currently registered products containing zoxamide can be found in the Pesticide Product Information Database and in Appendix I.

This document (Re-evaluation Decision RVD2023-04, Zoxamide and Its Associated End-use Products) presents the final re-evaluation decision^{Footnote 1} for the re-evaluation of zoxamide, including the required amendments (risk mitigation measures) to protect human health and the environment, as well as label amendments required to bring labels to current standards. All products containing zoxamide that are registered in Canada are subject to this re-evaluation decision.

Prior to finalizing this decision, Health Canada published the Proposed Re-evaluation Decision, PRVD2022-06, Zoxamide and Its Associated End-use Products,^{Footnote 2} for a 90-day consultation period ending on 26 June 2022. PRVD2022-06 proposed that products containing zoxamide are acceptable for continued registration in Canada, provided that the additional proposed risk mitigation measures are in place. The proposed risk mitigation measures included environmental precautionary label statements and spray buffer zones, updating the standard statement to minimize human exposure from spray drift, and clarifying the ground application method for bulb onion.

No comments were received during the consultation period. Therefore, this decision is consistent with the proposed re-evaluation decision stated in PRVD2022-06, which lists all information used as the basis for the re-evaluation decision.

A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2022-06.

Re-evaluation decision for zoxamide

Health Canada has completed the re-evaluation of zoxamide. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing zoxamide is acceptable. An evaluation of available scientific information found that the uses of zoxamide products meet current standards for protection of human health and the environment and have acceptable value when used according to revised conditions of registration which includes new mitigation measures. Label amendments, as summarized below and listed in Appendix II of RVD2023-04, are required.

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 required 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 II of RVD2023-04 for details.

Environment

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

• 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 to 10 m for field sprayer; 5 to 45 m for airblast; 5 to 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).

Next steps

To comply with this decision, the required amendments (mitigation measures and label updates) must be implemented on all product labels no later than 24 months after the publication date of this decision document. Accordingly, both registrants and retailers will have up to 24 months from the date of this decision document to transition to selling the product with the newly amended labels. Similarly, users will also have the same 24-month period from the date of this decision document to transition to using the newly amended labels, which will be available on the Public Registry.

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

Other information

Any person may file a notice of objection^{Footnote 3} regarding this decision on zoxamide 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 section of the Canada.ca website (Request a Reconsideration of Decision) or contact Health Canada's Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in 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.

Appendix I Registered products containing zoxamide in Canada

Table 1 Products containing zoxamide requiring (label) amendments^{Table 1 Footnote 1}

Registration number	Marketing class	Registrant	Product name	Formulation type	Active ingredient (%, g/LTable 1 Footnote 2)
26841	Technical	Gowan Company, L.L.C	Zoxamide Technical Fungicide	Solid	zoxamide: 98%
26840	Commercial		Zoxium 80W	Wettable Powder	zoxamide: 80%
26842			Gavel DF Fungicide	Dry Flowable	zoxamide: 8.3 %; mancozeb 66.7 %
32363			Zing Fungicide	Suspension	zoxamide: 85 g/L; chlorothalonil 500 g/L