Re-evaluation Decision RVD2021-09, Cymoxanil and Its Associated End-use Products

Pest Management Regulatory Agency
16 December 2021
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2021-9-PDF (PDF version)

Summary

To obtain a full copy of Re-evaluation Decision RVD2021-09, Cymoxanil and Its Associated End-use Products please contact our publications office.

Should you require further information please contact the Pest Management Information Service .

Table of contents

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

Re-evaluation decision for cymoxanil 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, 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.

Cymoxanil is a fungicide registered for use on potatoes, field tomatoes and caneberries. Currently registered products containing cymoxanil can be found in the Pesticide Label Search and in Appendix I.

The Proposed Re-evaluation Decision PRVD2021-04, Cymoxanil and its End-use Products, ^{Footnote 1} containing the evaluation of cymoxanil and proposed decision, underwent a 90-day consultation period ending on 26 May 2021. PRVD2021-04 proposed continued registration of cymoxanil and all associated end-use products registered for sale and use in Canada, provided that the proposed risk mitigation measures are in place.

The only comment received during the consultation period was from a technical grade active ingredient registrant, supporting the proposal and mitigation measures. Therefore, this decision document is consistent with the proposed re-evaluation decision stated in PRVD2021-04. A complete reference list of all information used in this final re-evaluation decision is included in the PRVD2021-04.

This document (Re-evaluation Decision RVD2021-09, Cymoxanil and Its Associated End-use Products) presents the final re-evaluation decision ^{Footnote 2} for the re-evaluation of cymoxanil, 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 cymoxanil that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for cymoxanil

Health Canada has completed the re-evaluation of cymoxanil. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing cymoxanil is acceptable. An evaluation of available scientific information found that cymoxanil 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. The required risk mitigation measures are summarized below and listed in Appendix II of RVD2021-09.

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 cymoxanil, are summarized below. Refer to Appendix II of RVD2021-09 for details.

Human health

Label improvements to meet current standards:

• The spray volume for all aerial application is 50 L/ha (for consistency between product labels).

Risk mitigation:

The following risk-reduction measures are required for continued registration of cymoxanil in Canada:

1. To protect mixers/loaders/applicators (M/L/A) from occupational exposure:

• Groundboom application for potatoes:
  • Chemical-resistant coveralls over long-sleeved shirt and long pants, chemical-resistant gloves for mixers/loaders and applicators, plus a respirator for mixers/loaders.
  • Limit of 35 kg a.i./day cymoxanil products handled.
• Airblast application for caneberries:
  • Chemical-resistant coveralls over long-sleeved shirt and long pants, chemical-resistant gloves for mixers/loaders and applicators (no gloves if enclosed cab).
  • Chemical resistant headgear for applicators using open cab airblast equipment.
• Handheld application (spot applications):
  • Chemical-resistant coveralls over a single layer of clothing, chemical-resistant gloves for mixers/loaders and applicators, plus a respirator for mixers/loaders.
• Aerial application:
  • For potatoes:
    • Chemical-resistant coveralls over long-sleeved shirt and long pants, chemical resistant gloves for mixing/loading, plus a respirator for workers mixing/loading of cymoxanil products.
    • Limit of 52.5 kg a.i./day cymoxanil products handled.

2. To protect workers entering treated sites from occupational exposure:

• Revised Restricted-Entry Intervals (REIs):
  • 18 days for hand-set irritation for potatoes.
  • 6 days for roguing potatoes.
  • 8 days for hand-set irrigation for field tomatoes.
  • 11 days for hand-set irrigation for caneberries.

3. To protect by-standers from exposure to spray drift:

• A statement to promote best management practices to minimize human exposure from spray drift or spray residues resulting from drift.

Environment

Label improvements to meet current standards:

• Update label statements related to disposal of the product containers and product storage.

Risk mitigation:

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

• Standard hazard statements are required to inform users of the potential toxic effects on non-target aquatic organisms.
• Spray buffer zones are required on the co-formulated product of cymoxanil and famoxadone to protect sensitive aquatic habitats from spray drift.
• To reduce the potential for runoff of cymoxanil to adjacent aquatic habitats, precautionary label statements for sites with characteristics that may be conducive to runoff and when heavy rain is forecast are required.

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 cymoxanil 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 the PMRA's Pest Management Information Service by phone (1-800-267-6315) or by e-mail ( pmra.info-arla@hc-sc.gc.ca ).

The relevant confidential test data on which the decision is based (as referenced in PRVD2021-04) are available for public inspection, upon application, in the PMRA's Reading Room. For more information, please contact the PMRA's Pest Management Information Service.

Appendix I Registered products containing cymoxanil in Canada

Table 1 Registered products containing cymoxanil in Canada ^{Footnote 1} requiring (label) amendments

Registration number	Marketing class	Registrant	Product name	Formulation type	Active ingredient(%, g/L)
26285	Technical	Production Agriscience Canada Company	Cymoxanil Technical Fungicide	Solid	Cymoxanil 98.7%
32385	Technical	SIPCAM Agro USA, Inc.	Cymoxanil Technical	Solid	Cymoxanil 98.8%
26284	Commercial	Production Agriscience Canada Company	Curzate Fungicide	Dry Flowable	Cymoxanil 60%
27435	Commercial	Production Agriscience Canada Company	Tanos Fungicide	Dry Flowable	Famoxadone 25%; Cymoxanil 25%
Footnote 1 as of 28 June 2021 excluding discontinued products or products with a submission for discontinuation Return to footnote 1 referrer