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Problem Formulation of the Risk Evaluation for Carbon Tetrachloride (Methane, Tetrachloro-)

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Problem Formulation of the Risk Evaluation for Carbon Tetrachloride (Methane, Tetrachloro-) EPA Document# EPA-740-R1-7020 May 2018 United States Office of Chemical Safety and Environmental Protection Agency Pollution Prevention Problem Formulation of the Risk Evaluation for Carbon Tetrachloride (Methane, Tetrachloro-) CASRN: 56-23-5 May 2018 TABLE OF CONTENTS ABBREVIATIONS ....................................................................................................................................7 EXECUTIVE SUMMARY .....................................................................................................................10 1 INTRODUCTION ............................................................................................................................12 1.1 Regulatory History ......................................................................................................................14 1.2 Assessment History .....................................................................................................................14 1.3 Data and Information Collection .................................................................................................15 1.4 Data Screening During Problem Formulation .............................................................................17 2 PROBLEM FORMULATION ........................................................................................................18 2.1 Physical and Chemical Properties ...............................................................................................18 2.2 Conditions of Use ........................................................................................................................19 Data and Information Sources ............................................................................................... 19 Identification of Conditions of Use ....................................................................................... 19 2.2.2.1 Categories and Subcategories Determined Not to be Conditions of Use or Otherwise Excluded During Problem Formulation ......................................................................................... 20 2.2.2.2 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk Evaluation ...................................................................................................................................... 23 2.2.2.3 Overview of Conditions of Use and Lifecycle Diagram ................................................ 26 2.3 Exposures ....................................................................................................................................30 Fate and Transport ................................................................................................................. 30 Releases to the Environment ................................................................................................. 32 Presence in the Environment and Biota ................................................................................. 34 Environmental Exposures ...................................................................................................... 35 Human Exposures .................................................................................................................. 36 2.3.5.1 Occupational Exposures ................................................................................................ 36 2.3.5.2 Consumer Exposures ...................................................................................................... 37 2.3.5.3 General Population Exposures ....................................................................................... 37 2.3.5.4 Potentially Exposed or Susceptible Subpopulations ...................................................... 38 2.4 Hazards (Effects) .........................................................................................................................39 Environmental Hazards ......................................................................................................... 39 Human Health Hazards .......................................................................................................... 41 2.4.2.1 Non-Cancer Hazards ...................................................................................................... 41 2.4.2.2 Genotoxicity and Cancer Hazards .................................................................................. 42 2.4.2.3 Potentially Exposed or Susceptible Subpopulations ...................................................... 42 2.5 Conceptual Models ......................................................................................................................43 Conceptual Model for Industrial and Commercial Activities and Uses: Potential Exposures and Hazards ........................................................................................................................... 44 Conceptual Model for Consumer Activities and Uses: Potential Exposures and Hazards .... 47 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and Hazards .................................................................................................................................. 47 2.5.3.1 Pathways That EPA Expects to Include But Not Further Analyze ................................ 47 2.5.3.2 Pathways that EPA Does Not Expect to Include in the Risk Evaluation ....................... 48 2.6 Analysis Plan ...............................................................................................................................53 Exposure ................................................................................................................................ 53 2.6.1.1 Environmental Releases, Fate and Exposures ................................................................ 53 Page 2 of 112 2.6.1.2 Occupational Exposures ................................................................................................. 54 2.6.1.3 Consumer Exposures ...................................................................................................... 56 2.6.1.4 General Population ......................................................................................................... 56 Hazards (Effects) ................................................................................................................... 56 2.6.2.1 Environmental Hazards .................................................................................................. 56 2.6.2.2 Human Health Hazards ................................................................................................... 56 Risk Characterization ............................................................................................................. 58 REFERENCES .........................................................................................................................................60 APPENDICES ..........................................................................................................................................65 Appendix A REGULATORY HISTORY .......................................................................................... 65 Appendix B SECOND SCREENING OF PEER-REVIEWED LITERATURE ON CARBON TETRACHLORIDE ............................................................................................................................... 74 B.1.1 Identifying Studies for Title/Abstract Re-screening ...............................................................74 B.2.1 First Round of Prioritization for Re-screening .......................................................................75 B.2.1.1 Keyword Search Method .................................................................................................75 B.2.1.2 DoCTER Method .............................................................................................................76 B.2.1.3 List of Prioritized References for Re-Screening .............................................................77 B.2.2 Second Round of Prioritization for Re-screening ...................................................................77 B.2.2.1 Keyword Search Method .................................................................................................77 B.2.2.2 DoCTER Method .............................................................................................................77 B.2.2.3 List of Prioritized References for Re-Screening .............................................................78 B.3.1 Re-screening Process ..............................................................................................................79 B.3.2 Re-screening Criteria ..............................................................................................................79 Appendix C PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION .... 82 C.1.1 Manufacture (Including Import) .............................................................................................82 C.1.1.1 Domestic Manufacture ....................................................................................................82 C.1.1.2 Import ..............................................................................................................................83 C.1.2 Processing and Distribution ....................................................................................................83 C.1.2.1 Reactant or Intermediate ..................................................................................................83
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