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Environmental Assessment for Investigational Use of Aedes Aegypti OX513A

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Environmental Assessment for Investigational Use of Aedes Aegypti OX513A Environmental Assessment for Investigational Use of Aedes aegypti OX513A In support of a proposed field trial of genetically engineered (GE) male Ae. aegypti mosquitoes of the line OX513A in Key Haven, Monroe County, Florida under an investigational new animal drug exemption August 5, 2016 Prepared by Center for Veterinary Medicine United States Food and Drug Administration Department of Health and Human Services 1 Table of Contents 1 Table of Contents .................................................................................................................................. 2 2 List of Figures ........................................................................................................................................ 8 3 List of Tables ......................................................................................................................................... 9 4 List of acronyms, abbreviations, and technical terms ........................................................................ 10 5 List of definitions ................................................................................................................................. 14 6 List of appendices ............................................................................................................................... 15 7 Executive Summary ............................................................................................................................. 16 8 Purpose and Need ............................................................................................................................... 18 8.1 Alternative action ........................................................................................................................ 20 9 Overview of the rDNA construct in the Ae. aegypti mosquito ........................................................... 21 9.1 Description of the product .......................................................................................................... 21 9.1.1 Putative mechanism by which tTAV causes developmental failure in Ae. aegypti ............ 22 9.2 The rDNA construct used for transformation ............................................................................. 22 9.2.1 Potential for transposon-mediated remobilization ............................................................ 24 9.2.2 Assessment of the introduced genetic elements for their likelihood to pose potential hazards 24 9.2.3 Production of the OX513A line ........................................................................................... 25 9.2.4 Molecular characterization of the #OX513 rDNA construct ............................................... 26 9.2.5 Confirmation of a single insertion site ................................................................................ 26 9.2.6 Detecting the absence of the plasmid backbone in OX513A Ae. aegypti ........................... 27 9.2.7 Conclusion ........................................................................................................................... 27 10 Product ............................................................................................................................................ 28 10.1 Product Identity .......................................................................................................................... 28 10.2 Proposed Product Claim.............................................................................................................. 28 10.3 Conditions for use ....................................................................................................................... 28 10.4 Product sources .......................................................................................................................... 29 10.4.1 General overview of Ae. aegypti OX513A production ........................................................ 29 10.4.1.1 Mosquito life cycle ...................................................................................................... 29 10.4.1.2 Mosquito breeding and husbandry ............................................................................. 30 2 10.4.1.3 Mosquito production for investigational use ............................................................. 31 10.4.1.4 Egg production ............................................................................................................ 33 10.4.1.5 Blood feeding females for egg production ................................................................. 34 10.4.1.6 Shipment of eggs to the United States ....................................................................... 34 10.4.2 Activities based in the United States .................................................................................. 35 10.4.2.1 Production of adults .................................................................................................... 35 10.4.2.2 Disposal of female insects ........................................................................................... 37 10.4.2.3 Release devices ........................................................................................................... 37 10.4.2.4 Transport to release site ............................................................................................. 37 11 Investigational Field Trial ................................................................................................................ 38 11.1 Proposed Field Trial .................................................................................................................... 38 11.2 Data collection ............................................................................................................................ 40 11.3 Sample Analysis and Disposal ..................................................................................................... 40 11.3.1 Ovitrap analysis ................................................................................................................... 40 11.3.2 Adult analysis ...................................................................................................................... 41 11.3.3 Testing of functional adult mortality .................................................................................. 41 11.3.4 Estimating Ae. aegypti suppression at the proposed trial site ........................................... 41 12 Environmental Risk Analysis ........................................................................................................... 42 12.1 Accessible environments ............................................................................................................ 42 12.1.1 Aedes aegypti habitat ......................................................................................................... 42 12.1.1.1 Aquatic habitats .......................................................................................................... 42 12.1.1.2 Terrestrial habitats ...................................................................................................... 43 12.1.2 Monroe County, Florida ...................................................................................................... 43 12.1.2.1 Occurrence of natural disasters .................................................................................. 44 12.1.2.2 Biological and ecological properties ........................................................................... 45 12.1.2.2.1 Threatened and endangered species ..................................................................... 45 12.1.2.2.2 National Wildlife Refuges (NWR) ............................................................................ 46 12.1.2.2.3 Conclusion ............................................................................................................... 48 3 12.1.2.3 Proposed release site .................................................................................................. 48 12.1.2.3.1 Environment ........................................................................................................... 49 12.1.2.3.2 Water ...................................................................................................................... 50 12.1.2.3.3 The HRU site ............................................................................................................ 51 12.2 Survivability ................................................................................................................................. 53 12.2.1 Influence of abiotic factors on survivability of OX513A Ae. aegypti ................................... 53 12.2.1.1 Sensitivity to tetracycline ............................................................................................ 54 12.2.1.1.1 Dose-response study to tetracycline ...................................................................... 54 12.2.1.1.2 Conclusion ............................................................................................................... 57 12.2.1.2 Longevity of OX513A reared on/off tetracycline ........................................................ 58 12.2.1.2.1 The evaluation of the potential for changes in penetrance of the introduced traits on exposure to high doses of tetracycline in blood feeding ....................................................... 59 12.2.1.2.2 Conclusion ..............................................................................................................
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