Re-evaluation Decision RVD2022-05, Difenoconazole and Its Associated End-use Products

Pest Management Regulatory Agency
21 April 2022
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2022-5E-PDF (PDF version)

Summary

Table of contents

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

Re-evaluation decision for difenoconazole 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.

Difenoconazole is a systemic fungicide registered for the control of a wide range of fungal diseases on diverse field crops, fruits and vegetables, and turf. Currently registered products containing difenoconazole can be found in the Pesticide Product Information Database and in Appendix I. The Proposed Re-evaluation Decision PRVD2021-06, Difenoconazole and Its Associated End-use Products,^{Footnote 1} containing the evaluation of difenoconazole and proposed decision, underwent a 90 day consultation period ending on 26 August 2021. PRVD2021-06 proposed that products containing difenoconazole are acceptable for continued registration in Canada, provided that the additional proposed risk mitigation measures are in place. The proposed risk mitigation measures included updated engineering controls, personal protective equipment, statements reducing potential drift, hazard statements on seed tags, environmental precautionary label statements, and spray buffer zones.

Health Canada received comments relating to the health and environmental assessments. Commenters are listed in Appendix II of the full version of Re-evaluation Decision RVD2022-05, Difenoconazole and Its Associated End-use Products. These comments are summarized in Appendix III of RVD2022-05 along with the responses by Health Canada. These comments did not result in revisions to the health risk assessments; however, they did result in revisions to the freshwater and terrestrial spray buffer zones for aerial application to potatoes. There are no other changes to the proposed risk mitigation measures as described in PRVD2021-06.

A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2021-06: no further information was used in the final re-evaluation decision. Therefore, the complete reference list of all information used is set out in PRVD2021-06.

This document (RVD2022-05) presents the final re-evaluation decision^{Footnote 2} for the re-evaluation of difenoconazole, 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 difenoconazole that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for difenoconazole

Health Canada has completed the re-evaluation of difenoconazole. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing difenoconazole is acceptable. An evaluation of available scientific information found that the uses of difenoconazole products meets current standards for protection of human health and the environment and has acceptable value when used according to conditions of registration, which includes additional mitigation measures. Label amendments, as summarized below and listed in Appendix IV of RVD2022-05, 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 difenoconazole, are summarized below. Refer to Appendix IV of RVD2022-05 for details.

Human health

Risk mitigation

To protect workers, the general population and animals, the following risk-reduction measures are required for continued registration of difenoconazole in Canada:

• Corn, canola, rapeseed, mustard seed treatment
  • Closed transfer systems for commercial treatment
• Cereal seed treatment
  • Chemical-resistant coveralls for cleaners for commercial treatment
  • Closed cab planters
  • Coveralls when loading seed for planting
• Add statements to labels and seed tags to keep products out of reach of children and animals.
• Add statements to promote best management practices to minimize human exposure from spray drift or spray residues resulting from drift.

Environment

Risk mitigation

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

• Precautionary label statements to inform users of the potential hazard to beneficial arthropods, non-target terrestrial plants and aquatic organisms.
• Add label statement to inform users of the potential hazard to birds and small wild mammals where spilled or exposed treated seed must be incorporated into the soil or removed.
• Update terrestrial and aquatic spray drift buffer zones to protect non-target terrestrial plants and aquatic organisms.
• Add label statement to indicate the potential for carryover.

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 difenoconazole 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 PRVD2021-06) 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 difenoconazole in Canada

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

Registration number	Marketing classTable 1 Footnote 2	Registrant	Product name	Formulation typeTable 1 Footnote 3	Active ingredient (%, g/L)
25776	M	Syngenta Canada Inc.	Dividend MG for use in Manufacturing	SU	Difenoconazole 32.8%
25777	C		Dividend XL RTA Fungicide	SU	Metalaxyl-M and S-Isomer 0.27%, Difenoconazole 3.37%
26637	C		Helix Liquid Seed Treatment	SU	Thiamethoxam 10.3%; Metalaxyl-M and S-Isomer 0.39%; Fludioxonil 0.13%; Difenoconazole 1.24%
29490	C		Dividend Extreme Fungicide	SU	Metalaxyl-M and S-Isomer 1.93%; Difenoconazole 7.73%
30004	C		Inspire Fungicide	EC	Difenoconazole 250 g/L
30436	C		Cruiser Maxx®Vibrance™ Cereal Seed Treatment	SU	Thiamethoxam 30.7 g/L; Sedaxane 8.0 g/L; Metalaxyl-M and S-Isomer9.5 g/L; Difenoconazole 36.9 g/L
30437	C		Vibrance XL Seed Treatment	SU	Sedaxane 13.8 g/L; Metalaxyl-M and S-Isomer 16.5 g/L; Difenoconazole 66.2 g/L
30518	C		Quadris Top	SU	Difenoconazole 125 g/L; Azoxystrobin 200 g/L
30599	C		Maxim D	SU	Fludioxonil 19.4 g/L; Difenoconazole 19.4 g/L
30827	C		Inspire Super Fungicide	EC	Difenoconazole 86 g/L; Cyprodinil 249 g/L
31024	C		Cruiser Maxx Potato Extreme	SU	Thiamethoxam 250 g/L; Fludioxonil 62.5 g/L; Difenoconazole 123g/L
31050	C		Stadium Fungicide	SU	Fludioxonil 142 g/L; Difenoconazole 112 g/L; Azoxystrobin 142 g/L
31408	C		Vibrance Quattro	SU	Sedaxane 15.4 g/L; Metalaxyl-M and S-Isomer 9.2 g/L; Fludioxonil 7.6 g/L; Difenoconazole 36.8 g/L
31453	C		Cruiser Vibrance Quattro	SU	Thiamethoxam 61.5 g/L; Sedaxane 15.4 g/L; Metalaxyl-M and S-Isomer 9.2 g/L; Fludioxonil 7.7g/L; Difenoconazole 36.9 g/L
31454	C		Helix Vibrance	SU	Thiamethoxam 269 g/L; Sedaxane 3.4 g/L; Metalaxyl-M and S-Isomer 5 g/L; Fludioxonil 1.7g/L; Difenoconazole 16 g/L
31526	C		Aprovia Top	EC	Difenoconazole 117 g/L; Benzovindiflupyr 78 g/L
31527	C		Ascernity Fungicide	EC	Difenoconazole 79 g/L; Benzovindiflupyr 24 g/L
31537	C		Bravo Top Fungicide	SU	Chlorothalonil 500 g/L; Difenoconazole 50 g/L
31564	C		Academy Fungicide	SU	Fludioxonil 147 g/L; Difenoconazole 247 g/L
32015	C		Exempla Fungicide	SU	Difenoconazole 225 g/L; Azoxystrobin 225 g/L
32624	C		Vibrance Flexi Canola	SU	Sedaxane 8.4 g/L; Metalaxyl-M and S-Isomer 12.5 g/L; Fludioxonil 4.2g/L; Difenoconazole 40 g/L
32625	C		Vibrance Flexi Cereals	SU	Sedaxane 8.4 g/L; Metalaxyl-M and S-Isomer 12.5 g/L; Fludioxonil 4.2g/L; Difenoconazole 40 g/L
33020	C		A20259 Fungicide	SU	Pydiflumetofen 75 g/L; Difenoconazole 125 g/L
33171	C		Vibrance Ultra Potato	SU	Sedaxane 77.2 g/L; Mandipropamid 154.3 g/L; Difenoconazole 77.2 g/L
33206	C		Miravis Duo Fungicide	SU	Pydiflumetofen 75 g/L; Difenoconazole 125 g/L
33489	C		Bravo Top 550 Fungicide	SU	Chlorothalonil 500 g/L; Difenoconazole 50 g/L
34228	C	NewAgco Inc.	Revenue Fungicide	EC	Difenoconazole 250 g/L
34196	C	Sharda CropChem Limited	Interest Forte	SU	Metalaxyl-M and S-Isomer 0.27%; Difenoconazole 3.37%
Table 1 Footnote 1 as of 17 December 2021, excluding discontinued products or products with a submission for discontinuation Table 1 Return to footnote 1 referrer Table 1 Footnote 2 T = Technical Active, M= Manufacturing concentrate, C= Commercial Table 1 Return to footnote 2 referrer Table 1 Footnote 3 SO= Solid, SU= Suspension, EC= Emulsifiable concentrate or emulsion Table 1 Return to footnote 3 referrer

Table 2 Products containing difenoconazole not requiring (label) amendments^{Table 2 Footnote 1}

Registration number	Marketing classTable 2 Footnote 2	Registrant	Product name	Formulation typeTable 2 Footnote 3	Active ingredient (%, g/L)
25631	T	Syngenta Canada Inc.	Difenoconazole Technical Fungicide	SO	Difenoconazole 95%
34191	T	NewAgco Inc.	NewAgco Difenoconazole Technical	SO	Difenoconazole 97.46%
34193	T	Sharda CropChem Limited	Sharda Difenoconazole Technical	SO	Difenoconazole 97.84%
Table 2 Footnote 1 as of 17 December 2021, excluding discontinued products or products with a submission for discontinuation Table 2 Return to footnote 1 referrer Table 2 Footnote 2 T = Technical Active Table 2 Return to footnote 2 referrer Table 2 Footnote 3 SO= Solid Table 2 Return to footnote 3 referrer