Proposed Registration Decision PRD2020-05 Fenpropathrin and Danitol EC Spray (publié aussi en français) 8 June 2020 This document is published by the Health Canada Pest Management Regulatory Agency. For further information, please contact: Publications Internet: canada.ca/pesticides Pest Management Regulatory Agency [email protected] Health Canada Facsimile: 613-736-3758 2720 Riverside Drive Information Service: A.L. 6607 D 1-800-267-6315 or 613-736-3799 Ottawa, Ontario K1A 0K9 [email protected] ISSN: 1925-0878 (print) 1925-0886 (online) Catalogue number: H113-9/2020-5E (print version) H113-9/2020-5E-PDF (PDF version) © Her Majesty the Queen in Right of Canada, as represented by the Minister of Health Canada, 2020 All rights reserved. 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Table of Contents Overview ......................................................................................................................................... 1 Proposed Registration Decision for Fenpropathrin ..................................................................... 1 What Does Health Canada Consider When Making a Registration Decision? ........................... 1 What Is Fenpropathrin? ............................................................................................................... 2 Health Considerations .................................................................................................................. 2 Environmental Considerations .................................................................................................... 5 Value Considerations ................................................................................................................... 5 Measures to Minimize Risk ......................................................................................................... 5 Next Steps .................................................................................................................................... 7 Other Information ........................................................................................................................ 8 Science Evaluation .......................................................................................................................... 9 1.0 The Active Ingredient, Its Properties and Uses ................................................................. 9 1.1 Identity of the Active Ingredient .................................................................................. 9 1.2 Physical and Chemical Properties of the Active Ingredient and End-Use Product .... 10 1.3 Directions for Use ....................................................................................................... 11 1.4 Mode of Action ........................................................................................................... 11 2.0 Methods of Analysis ........................................................................................................ 11 2.1 Methods for Analysis of the Active Ingredient .......................................................... 11 2.2 Method for Formulation Analysis .............................................................................. 11 2.3 Methods for Residue Analysis .................................................................................... 11 3.0 Impact on Human and Animal Health ............................................................................. 12 3.1 Toxicology Summary ................................................................................................. 12 3.1.1 Pest Control Products Act Hazard Characterization .............................................. 15 3.2 Acute Reference Dose ................................................................................................ 16 3.3 Acceptable Daily Intake ............................................................................................. 16 3.4 Occupational and Residential Risk Assessment ......................................................... 17 3.4.1 Toxicological Reference Values ............................................................................. 17 3.4.2 Occupational Exposure and Risk ............................................................................ 19 3.4.3 Residential Exposure and Risk Assessment ........................................................... 20 3.4.4 Bystander Exposure and Risk ................................................................................. 21 3.5 Aggregate Exposure and Risk .................................................................................... 21 3.5.1 Pick-Your-Own (PYO) Scenario ............................................................................ 21 3.6 Exposure From Drinking Water ................................................................................. 21 3.6.1 Concentrations in Drinking Water .......................................................................... 21 3.7 Food Residues Exposure Assessment ......................................................................... 22 3.7.1 Residues in Plant and Animal Foodstuffs ............................................................... 22 3.7.2 Dietary Risk Assessment ........................................................................................ 23 3.7.3 Aggregate Exposure and Risk ................................................................................. 24 3.7.4 Maximum Residue Limits....................................................................................... 24 4.0 Impact on the Environment ............................................................................................. 24 4.1 Fate and Behaviour in the Environment ..................................................................... 24 Proposed Registration Decision - PRD2020-05 4.2 Environmental Risk Characterization ......................................................................... 26 4.2.1 Risks to Terrestrial Organisms ................................................................................ 26 4.2.2 Risks to Aquatic Organisms.................................................................................... 31 4.2.3 Environmental Incident Reports ............................................................................. 35 5.0 Value ................................................................................................................................ 35 6.0 Pest Control Product Policy Considerations .................................................................... 36 6.1 Assessment of the Active Ingredient under the Toxic substances Management Policy .......................................................................................................................... 36 6.2 Formulants and Contaminants of Health or Environmental Concern ........................ 36 7.0 Summary .......................................................................................................................... 37 7.1 Human Health and Safety ........................................................................................... 37 7.2 Environmental Risk .................................................................................................... 38 7.3 Value ........................................................................................................................... 38 8.0 Proposed Regulatory Decision ........................................................................................ 38 List of Abbreviations ................................................................................................................. 39 Appendix I Tables and Figures .............................................................................................. 43 Table 1a Residue Analysis ................................................................................................. 43 Table 1b Residue Analysis ................................................................................................. 43 Table 2 Toxicity Profile of Danitol EC Spray Containing Fenpropathrin ....................... 43 Table 3 Summary of Selected Toxicity Studies for Technical Fenpropathrin6 ................ 44 Table 4 Toxicological Reference Values for Use in Health Risk Assessment for Fenpropathrin ...................................................................................................... 48 Table 5 AHETF/PHED/NDETF Unit Exposure Estimates for Mixer/Loaders and Applicators Handling Danitol EC Spray (µg/kg a.i. handled) ............................ 49 Table 6 Mixer/Loader/Applicator Risk Assessment for Chemical Handlers ................... 50 Table 7 Postapplication Dermal Exposure and Risk for Fenpropathrin ........................... 52 Table 8 Integrated Food Residue Chemistry Summary ................................................... 54 Table 9 Food Residue Chemistry Overview of Metabolism Studies and Risk Assessment .......................................................................................................... 60 Table 10 Fate and Behaviour in the Environment .............................................................. 61 Table 11 Transformation Products Formed in the Environment .......................................