Re-evaluation Note REV2017-20, Re-evaluation Project Plan for Kresoxim-Methyl

Table of Contents

• Background
• Re-evaluation Project Plan
• Additional Information
• Appendix I - Data Required Under Subsection 19(1) of the Pest Control Products Act for the Re-evaluation of Kresoxim-Methyl

Background

In Canada, kresoxim-methyl is under re-evaluation by Health Canada's Pest Management Regulatory Agency (PMRA). The PMRA re-evaluates registered pesticides to determine whether the use of these products continues to be acceptable in terms of value, human health and the environment according to current standards.

Kresoxim-methyl is registered as a fungicide used on apples, grapes and pears. As of 13 June 2017, there are two technical grade products and one end-use product containing kresoxim-methyl registered for use in Canada.

Under the authority of section 16 of the Pest Control Products Act, the registrant of kresoxim-methyl was notified of the initiation of the re-evaluation of kresoxim-methyl. Following this, the registrant of kresoxim-methyl technical grade active ingredients in Canada indicated its support of all uses included on the labels of end-use products in Canada.

The re-evaluation project plan below outlines the timeline, the anticipated areas of focus for the risk assessments, and the data requirements for the re-evaluation of kresoxim-methyl.

Re-evaluation Project Plan

Anticipated Re-evaluation Timeline

The re-evaluation of kresoxim-methyl is defined as a Category 1 as described in Regulatory Directive DIR2016-04, Management of Pesticides Re-evaluation Policy. However, because this re-evaluation was initiated prior to the publication of DIR2016-04, the proposed re-evaluation decision for kresoxim-methyl is anticipated to be published for consultation by April 2019. The re-evaluation timeline may be updated if, during the risk assessment, the PMRA identifies additional areas of focus that should be considered.

Human Health Risk Assessment

New assessments will be conducted for toxicology, dietary exposure, occupational exposure, and residential exposure.

Environmental Risk Assessment

New assessments will be conducted for environmental fate, water modelling, environmental monitoring, and ecotoxicology.

Value

The value of kresoxim-methyl will be considered. The viability of alternatives will be examined for certain uses if risks of concern which require mitigation are identified.

Data Requirements

The PMRA has identified the need for the technical registrant to provide data for kresoxim-methyl related to toxicology and to the environment. Relevant data/studies have been requested from the technical registrant. A summary of the data call-in is found in the PMRA's Public Registry found online. For a list of data categories that have been requested from the technical registrant, see Appendix I. In addition, information regarding the registered use pattern has been requested from the registrant, to inform the risk assessments.

Additional Information

The PMRA documents can be found in the Pesticides and Pest Management portion of Canada.ca. The PMRA documents are also available through the Pest Management Information Service.

Appendix I - Data Required Under Subsection 19(1) of the Pest Control Products Act for the Re-evaluation of Kresoxim-Methyl

I. Toxicology Data

• DACO 4.5.1: Immunotoxicity
• DACO 4.5.8: Cytotoxicity

II. Environmental Data (Other than for Pollinators)

• DACO 8.2.3.4.2: Aerobic Soil Metabolism
• DACO 8.3.2: Terrestrial Dissipation
• DACO 8.6: Estimation of the Leaching Potential
• DACO 9.5.3.1: Toxicity to Fish
• DACO 9.9: Chronic Effects on Juvenile Fish in Small Field Microcosms

III. Pollinator Data

The following data requirements are to be addressed, in line with the new risk assessment framework for pollinators:

• DACO 9.2.4.3: Bee larvae toxicity (required)
• DACO 9.2.4.4: Bee adult chronic toxicity (required)
• DACO 9.2.4.5: Bee toxicity of residues on foliage (may be required)^Footnote *
• DACO 9.2.4.6: Semi-field studies for pollinators (may be required)^Footnote *
• DACO 9.2.4.7: Field studies for pollinators (may be required)^Footnote *
• DACO 9.2.4.8: Residue studies for pollinators (may be required)^Footnote *