Final Scope of the Risk Evaluation for Formaldehyde CASRN 50-00-0
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EPA Document# EPA-740-R-20-014 August 2020 United States Office of Chemical Safety and Environmental Protection Agency Pollution Prevention Final Scope of the Risk Evaluation for Formaldehyde CASRN 50-00-0 August 2020 TABLE OF CONTENTS ACKNOWLEDGEMENTS ......................................................................................................................6 ABBREVIATIONS AND ACRONYMS ..................................................................................................7 EXECUTIVE SUMMARY .....................................................................................................................11 1 INTRODUCTION ............................................................................................................................14 2 SCOPE OF THE EVALUATION ...................................................................................................14 2.1 Reasonably Available Information ..............................................................................................14 Search of Gray Literature ...................................................................................................... 15 Search of Literature from Publicly Available Databases (Peer-reviewed Literature) ........... 16 Search of TSCA Submissions ................................................................................................ 24 2.2 Conditions of Use ........................................................................................................................25 Conditions of Use Included in the Scope of the Risk Evaluation .......................................... 26 Activities Excluded from the Scope of the Risk Evaluation ................................................. 33 Production Volume ................................................................................................................ 34 Overview of Conditions of Use and Lifecycle Diagram ....................................................... 34 2.3 Exposures ....................................................................................................................................36 Physical and Chemical Properties ......................................................................................... 36 Environmental Fate and Transport ........................................................................................ 38 Releases to the Environment ................................................................................................. 38 Environmental Exposures ...................................................................................................... 40 Occupational Exposures ........................................................................................................ 41 Consumer Exposures ............................................................................................................. 42 General Population Exposures ............................................................................................... 42 2.4 Hazards (Effects) .........................................................................................................................43 Environmental Hazards ......................................................................................................... 43 Human Health Hazards .......................................................................................................... 43 2.5 Potentially Exposed or Susceptible Subpopulations ...................................................................44 2.6 Conceptual Models ......................................................................................................................44 Conceptual Model for Industrial and Commercial Activities and Uses ................................ 44 Conceptual Model for Consumer Activities and Uses .......................................................... 47 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and Hazards (Regulatory Overlay) ............................................................................................... 49 2.6.3.1 Exposure Pathways and Risks Addressed by Other EPA Administered Statutes .......... 51 2.6.3.2 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and Hazards 59 2.7 Analysis Plan ...............................................................................................................................61 Physical/Chemical Properties and Environmental Fate ......................................................... 61 Exposure ................................................................................................................................ 61 2.7.2.1 Environmental Releases ................................................................................................. 62 2.7.2.2 Environmental Exposures ............................................................................................... 64 2.7.2.3 Occupational Exposures ................................................................................................. 66 2.7.2.4 Consumer Exposures ...................................................................................................... 68 2.7.2.5 General Population ......................................................................................................... 70 2 Hazards (Effects) ................................................................................................................... 73 2.7.3.1 Environmental Hazards .................................................................................................. 73 2.7.3.2 Human Health Hazards ................................................................................................... 74 Summary of Risk Approaches for Characterization .............................................................. 77 2.8 Peer Review .................................................................................................................................77 REFERENCES .........................................................................................................................................78 APPENDICES ..........................................................................................................................................85 ABBREVIATED METHODS FOR SEARCHING AND SCREENING ................... 85 Search Term Genesis and Chemical Verification ...................................................................85 Publicly Available Database Searches ....................................................................................86 A.1.2.1 Query Strings for the Publicly-Available Database Searches on Formaldehyde ............86 A.1.2.2 Data Prioritization for Environmental Hazard, Human Health Hazard, Fate and Physical Chemistry ........................................................................................................................................94 A.1.2.3 Data Prioritization for Occupational Exposures and Environmental Releases and General Population, Consumer and Environmental Exposures ......................................................95 Inclusion/Exclusion Criteria ...................................................................................................95 A.2.1.1 PECO for Environmental and Human Health Hazards ...................................................96 A.2.1.2 PECO for Consumer, Environmental, and General Population Exposures. ....................98 A.2.1.3 RESO for Occupational Exposure and Environmental Releases ....................................98 A.2.1.4 PESO for Fate and Transport ........................................................................................101 A.2.1.5 Generation of Hazard Heat Maps ..................................................................................103 Screening of Gray Literature ................................................................................................104 Initial Screening of Sources using Decision Logic Tree ......................................................105 TSCA Submission Searching and Title Screening ...............................................................106 Gray Literature Search Results for Formaldehyde ...............................................................107 PHYSICAL AND CHEMICAL PROPERTIES ........................................................ 111 ENVIRONMENTAL FATE AND TRANSPORT PROPERTIES .......................... 112 REGULATORY HISTORY ........................................................................................ 114 PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION 130 Manufacture (Including Import) ...........................................................................................130 E.1.1.1 Manufacture ...................................................................................................................130 E.1.1.2 Import ............................................................................................................................131 Processing and Distribution ..................................................................................................131 E.1.2.1 Processing as a Reactant or Intermediate ......................................................................131 E.1.2.2 Incorporated into an Article ...........................................................................................133 E.1.2.3 Incorporated into a Formulation, Mixture or Reaction Product