Re-evaluation Decision RVD2022-01, Kresoxim-methyl and Its Associated End-use Products

• Pest Management Regulatory Agency
• 31 January 2022
• ISSN: 1925-1025 (PDF version)
• Catalogue number: H113-28/2022-1E-PDF (PDF version)

Summary

Table of contents

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

Re-evaluation decision for kresoxim-methyl 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.

Kresoxim-methyl is a fungicide registered for use on apples, pears and grapes and can be applied by ground application equipment only. Currently registered products containing kresoxim-methyl can be found in the Pesticide Label Search and in Appendix I.

The Proposed Re-evaluation Decision PRVD2020-10, Kresoxim-methyl and Its Associated End-use Products,^{Footnote 1} containing the evaluation of kresoxim-methyl and proposed decision, underwent a 90 day consultation period ending on 14 October 2020. PRVD2020-10 proposed that products containing kresoxim-methyl are acceptable for continued registration in Canada, provided that the additional proposed risk mitigation measures are in place. The proposed risk mitigation measures included additional personal protective equipment (PPE), standard spray drift statements, reduction in number of applications for all crops, environmental hazard statements including terrestrial spray buffer zones, and standard statements regarding runoff, food/feed/water contamination and toxicity to non-target organisms.

The Re-evaluation Decision document was first published on 30 June 2021 (RVD2021-07). Subsequently, on 22 December 2021, the PMRA indicated that it will be re-issuing the Re-evaluation Decision document (RVD) regarding kresoxim-methyl and its associated end-use products. Although RVD2021-07 for kresoxim-methyl outlined continued registration with risk mitigation measures, due to a technical issue, the associated comments received were inadvertently not included. The final decision should have included the response to these comments rather than stating that no comments were received. As per the Pest Control Products Act, the Minister shall make public a decision which should include any comments that the Minister received on the proposed decision.

The present document (Re-evaluation Decision RVD2022-01, Kresoxim-methyl and its associated end-use products) replaces RVD2021-07. It includes a complete summary of the comments received on PRVD2020-10 and the Health Canada responses (Appendix II of RVD2022-01). The comments received did not change the risk assessment or the regulatory decision, including the required mitigation measures, as described in RVD2021-07.

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

Re-evaluation decision for kresoxim-methyl

Health Canada has completed the re-evaluation of kresoxim-methyl. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing kresoxim-methyl is acceptable. An evaluation of available scientific information found that the use of kresoxim-methyl products meets current standards for protection of human health and the environment and has 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 kresoxim-methyl, are summarized below. Refer to Appendix II of RVD2022-01 for details.

Human health

Risk mitigation:

To protect human health, the following risk-reduction measures are required for continued registration of kresoxim-methyl in Canada:

Occupational Exposure:

• Add standard spray drift statement.
• For mixers/loaders and applicators (M/L/A), update PPE label statements:
  • For application using handheld airblast/mistblower, wear chemical-resistant coveralls with a chemical-resistant hood over long-sleeved shirt, long pants, chemical-resistant gloves, socks, chemical-resistant footwear, and a respirator with an organic-vapour-removing cartridge approved by the National Institute for Occupational Safety and Health (NIOSH) with a prefilter approved for pesticides OR a NIOSH-approved canister approved for pesticides.
  • For mixing and loading as well as using all other types of application equipment, wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during mixing, loading, applications, clean-up, and repair. Gloves are not required within a closed cab during application.

Dietary Exposure:

• Reduce the maximum number of applications for the lower application rates (90–120 g a.i./ha) from 4 to 2 applications per year, for all crops (apples, pears, and grapes) and pests.
• Reduce the maximum number of applications for all higher rates (121–225 g a.i./ha) from 4 to 1 application per year, for all crops (apples, pears, and grapes) and pests.
• Update total seasonal rates according to the revised number of applications.

Environment

Risk mitigation:

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

• Add precautionary label statements to inform users that kresoxim-methyl is toxic to aquatic organisms, birds and certain beneficial arthropods.
• Add statement to inform users that the product demonstrates the properties and characteristics associated with chemicals detected in groundwater.
• Add statements prohibiting the use of kresoxim-methyl products to control aquatic pests, and to reduce the risk of contamination of water, food or feed.
• Add statement prohibiting the use of aerial application equipment.
• Include buffer zones to protect freshwater (≤ 10 m) and estuarine/marine (≤ 2 m) habitats.

Value

Label improvements to meet current standards:

• Update resistance management statements.

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 kresoxim-methyl 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 PRVD2020-10) 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 kresoxim-methyl in Canada