EPA Document# EPA-R-20-012 August 2020 United States Office of Chemical Safety and Environmental Protection Agency Pollution Prevention Final Scope of the Risk Evaluation for Ethylene Dibromide CASRN 106-93-4 August 2020 TABLE OF CONTENTS ACKNOWLEDGEMENTS ......................................................................................................................6 ABBREVIATIONS AND ACRONYMS ..................................................................................................7 EXECUTIVE SUMMARY .....................................................................................................................10 1 INTRODUCTION ............................................................................................................................13 2 SCOPE OF THE EVALUATION ...................................................................................................13 2.1 Reasonably Available Information..............................................................................................13 Search of Gray Literature ...................................................................................................... 14 Search of Literature from Publicly Available Databases (Peer-Reviewed Literature) .......... 15 Search of TSCA Submissions ................................................................................................ 24 2.2 Conditions of Use ........................................................................................................................25 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk Evaluation .............................................................................................................................. 26 Activities Excluded from the Scope of the Risk Evaluation ................................................. 26 Production Volume ................................................................................................................ 27 Overview of Conditions of Use and Lifecycle Diagram ....................................................... 27 2.3 Exposures ....................................................................................................................................29 Physical and Chemical Properties ......................................................................................... 29 Environmental Fate and Transport ........................................................................................ 31 Releases to the Environment ................................................................................................. 31 Environmental Exposures ...................................................................................................... 33 Occupational Exposures ........................................................................................................ 33 Consumer Exposures ............................................................................................................. 34 General Population Exposures ............................................................................................... 35 2.4 Hazards (Effects) .........................................................................................................................35 Environmental Hazards ......................................................................................................... 35 Human Health Hazards .......................................................................................................... 36 2.5 Potentially Exposed or Susceptible Subpopulations ...................................................................36 2.6 Conceptual Models ......................................................................................................................37 Conceptual Model for Industrial and Commercial Activities and Uses: Potential Exposures and Hazards ........................................................................................................................... 37 Conceptual Model for Consumer Activities and Uses .......................................................... 39 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and Hazards (Regulatory Overlay) ............................................................................................... 41 2.6.3.1 Exposure Pathways and Risks Addressed by Other EPA Administered Statutes .......... 43 2.6.3.2 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and Hazards ................................................................................................................ 49 2.7 Analysis Plan ...............................................................................................................................52 Physical and Chemical Properties and Environmental Fate .................................................. 52 Exposure ................................................................................................................................ 52 2.7.2.1 Environmental Releases ................................................................................................. 53 2.7.2.2 Environmental Exposures ............................................................................................... 54 2.7.2.3 Occupational Exposures ................................................................................................. 56 2.7.2.4 Consumer Exposures ...................................................................................................... 57 2 2.7.2.5 General Population ......................................................................................................... 59 Hazards (Effects) ................................................................................................................... 60 2.7.3.1 Environmental Hazards .................................................................................................. 60 2.7.3.2 Human Health Hazards ................................................................................................... 62 Summary of Risk Approaches for Characterization .............................................................. 64 2.8 Peer Review.................................................................................................................................65 REFERENCES .........................................................................................................................................66 APPENDICES ..........................................................................................................................................72 ABBREVIATED METHODS FOR SEARCHING AND SCREENING ................... 72 A.1.1 Search Term Genesis and Chemical Verification ...................................................................72 A.1.2 Publicly Available Database Searches ....................................................................................73 A.1.2.1 Query Strings for the Publicly Available Database Searches on Ethylene Dibromide ...74 A.1.2.2 Data Prioritization for Environmental Hazard, Human Health Hazard, Fate and Physical Chemistry ................................................................................................................80 A.1.2.3 Data Prioritization for Occupational Exposures and Environmental Releases and General Population, Consumer and Environmental Exposures ..............................81 A.2.1 Inclusion/Exclusion Criteria ...................................................................................................81 A.2.1.1 PECO for Environmental and Human Health Hazards ...................................................82 A.2.1.2 PECO for Consumer, Environmental, and General Population Exposures .....................85 A.2.1.3 RESO for Occupational Exposure and Environmental Releases ....................................85 A.2.1.4 PESO for Fate and Transport ..........................................................................................87 A.2.1.5 Generation of Hazard Heat Maps ....................................................................................89 A.3.1 Screening of Gray Literature ..................................................................................................90 A.3.2 Initial Screening of Sources using Decision Logic Tree ........................................................91 A.3.3 TSCA Submission Searching and Title Screening .................................................................92 A.3.4 Gray Literature Search Results for Ethylene Dibromide ........................................................93 PHYSICAL AND CHEMICAL PROPERTIES OF ETHYLENE DIBROMIDE ... 97 ENVIRONMENTAL FATE AND TRANSPORT PROPERTIES OF ETHYLENE DIBROMIDE................................................................................................................... 98 REGULATORY HISTORY ........................................................................................ 100 PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION 107 E.1.1 Manufacture (Including Import) ...........................................................................................107 E.1.2 Processing and Distribution ..................................................................................................108 E.1.2.1 Incorporated into a Formulation, Mixture or Reaction Product ....................................108 E.1.3 Uses .......................................................................................................................................109