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Proposed Registration Decision PRD2020-05, Fenpropathrin And

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Proposed Registration Decision PRD2020-05, Fenpropathrin And 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. No part of this information (publication or product) may be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, or stored in a retrieval system, without prior written permission of Health Canada, Ottawa, Ontario K1A 0K9. 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 .......................................
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