Re-evaluation Decision RVD2022-02, Triticonazole and its associated end-use products

• Pest Management Regulatory Agency
• 25 February 2022
• ISSN: 1925-1025 (PDF version)
• Catalogue number: H113-28/2022-2E-PDF (PDF version)

Summary

Table of contents

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

Re-evaluation decision for triticonazole 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.

Triticonazole is a systemic fungicide registered for control or suppression of foliar, seed-borne and soil-borne diseases on cereals, corn and turf. Currently registered products containing triticonazole can be found in the Pesticide Label Search and in Appendix I. The Proposed Re-evaluation Decision PRVD2021-05, Triticonazole and Its Associated End-use Products^{Footnote 1} containing the evaluation of triticonazole and proposed decision, underwent a 90-day consultation period ending on 28 June 2021. PRVD2021-05 proposed continued registration of all uses of triticonazole and associated end-use products with additional mitigation measures and no cancellations of uses.

Health Canada received comments relating to the environmental assessment. Commenters are listed in Appendix II of Re-evaluation Decision RVD2022-02, Triticonazole and its associated end-use products. These comments are summarized in Appendix III of RVD2022-02 along with the responses by Health Canada. These comments did not result in revisions to the environmental risk assessment and did not result in changes to the proposed re-evaluation decision as described in PRVD2021-05.

A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2021-05. There was no further additional information used in the re-evaluation decision of RVD2022-02. Therefore, the reference list of all information used in the proposed re-evaluation decision, set out in PRVD2021-05, represents the complete reference of information used in this final re-evaluation decision.

This document presents the final re-evaluation decision^{Footnote 2} for the re-evaluation of triticonazole, 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 triticonazole that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for triticonazole

Health Canada has completed the re-evaluation of triticonazole. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing triticonazole is acceptable. An evaluation of available scientific information found that the uses of triticonazole 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.

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 triticonazole, are summarized below. Refer to Appendix IV of RVD2022-02 for details.

Human health

Label improvements to meet current standards

For turf products

• Update drift and tank mix partner label statements.
• Update re-entry restriction statement for golf courses.
• Update personal protective equipment (PPE) label statements.

For seed treatment products

• Update PPE label statements.

Risk mitigation – Dietary exposure

To protect the general population from dietary exposure including through drinking water:

• For golf course turf use, reduce the maximum label rate to one application at 420 g a.i./ha
• For crops or seeds not listed on labels, add a rotational plantback interval of 30 days.

Occupational and non-occupational exposure from seed treatment products

To protect workers, bystanders, children and animals, the following risk-reduction measures are required for continued registration of triticonazole in Canada:

• Add statements to labels and seed bag/tags to keep products out of reach of children and animals.
• Add drift statements to labels.
• Add/update the standard statements on the label that identify the type of seed treatment facility that can be used for a specific product and seed type.
  • For corn seed treatment, only closed transfer systems in commercial facilities and mobile treaters are permitted. On-farm seed treatment is prohibited.
  • For products used for wheat and other cereal seed treatment that are co-formulated, only closed transfer systems in commercial facilities and mobile treaters are permitted.
  • On-farm seed treatment is permitted.
• Add/update personal protective equipment (PPE) for the following activities:
  • Products for use on wheat and other cereal seeds that are co-formulated.
    • Increased PPE for workers involved in clean-up and repair activities and workers handling and planting treated seed.
  • For planting treated seed (all types) only a closed-cab tractor is permitted.

Environment

Risk mitigation

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

• Precautionary statements and additional application instructions on product labels with foliar applications and seed treatments.
• Terrestrial and aquatic buffer zones to mitigate risk from spray drift.

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 RVD2022-02. 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 triticonazole 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 PRVD2021-05) 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 triticonazole in Canada

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

Registration number	Marketing class	Registrant	Product name	Formulation type	Active ingredient (% or g/L)
26454	Technical	BASF Canada Inc.	Triticonazole Technical	Solid	Triticonazole 92.5%
30684	Manufacturing concentrate	BASF Canada Inc.	Insure Cereal Bulk	Suspension	Metalaxyl 10 g/L; Pyraclostrobin 17 g/L; Triticonazole 17 g/L
33211	Manufacturing concentrate	BASF Canada Inc.	Insure Cereal FX4 Bulk	Suspension	Fluxapyroxad 8.35 g/L; Metalaxyl 10 g/L; Pyraclostrobin 16.7 g/L; Triticonazole 16.7 g/L
28387	Commercial	BASF Canada Inc.	Premis 200 F Fungicide	Suspension	Triticonazole 200 g/L
29109	Commercial	Bayer CropScience Inc.	Chipco Triton Fungicide	Suspension	Triticonazole 19.2 %
29400	Commercial	BASF Canada Inc.	Charter RTU Seed Treatment Fungicide	Suspension	Triticonazole 16.8 g/L
30226	Commercial	BASF Canada Inc.	Armour RTU	Suspension	Triticonazole 16.8 g/L
30685	Commercial	BASF Canada Inc.	Insure Cereal	Suspension	MetalaxyL 10 g/L; Pyraclostrobin 17 g/L; Triticonazole 17 g/L
31114	Commercial	BASF Canada Inc.	Charter HL	Suspension concentrate	Triticonazole 500 g/L
33210	Commercial	BASF Canada Inc.	Insure Cereal FX4	Suspension	Fluxapyroxad 8.35 g/L; Metalaxyl 10 g/L; Pyraclostrobin 16.7 g/L; Triticonazole 16.7 g/L
33667	Commercial	BASF Canada Inc.	Teraxxa F4	Suspension	Broflanilide 16.7 g/L; Fluxapyroxad 8.35 g/L; Metalaxyl 10 g/L; Pyraclostrobin 16.7 g/L; Triticonazole 16.7 g/L