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EPA Document# EPA-740-R1-8010
October 2019 DRAFT
Office of Chemical Safety and
Pollution Prevention
Draft Risk Evaluation for
Methylene Chloride
(Dichloromethane, DCM)
CASRN: 75-09-2
H
..OlCI
H^CI
ACDA HMW.
Jr ImI Environmental Protection Agency
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 20
ABBREVIATIONS 21
EXECUTIVE SUMMARY 27
1 INTRODUCTION 37
1.1 Physical and Chemical Properties 38
1.2 Uses and Production Volume 39
1.3 Regulatory and Assessment History 40
1.4 Scope of the Evaluation 42
1.4.1 Conditions of Use Included in the Risk Evaluation 42
1.4.2 Conceptual Models 52
1.5 Systematic Review 55
1.5.1 Data and Information Collection 55
2 EXPOSURES 62
2.1 Fate and Transport 62
2.1.1 Fate and Transport Approach and Methodology 62
2.1.2 Summary of Fate and Transport 63
2.2 Releases to the Environment 65
2.2.1 Water Release Assessment Approach and Methodology 65
2.2.2 Water Release Estimates by Occupational Exposure Scenario 66
2.2.2.1 Manufacturing 66
2.2.2.2 Processing as a Reactant 68
2.2.2.3 Processing - Incorporation into Formulation, Mixture, or Reaction Product 68
2.2.2.4 Repackaging 69
2.2.2.5 Batch Open-Top Vapor Degreasing 70
2.2.2.6 Conveyorized Vapor Degreasing 70
2.2.2.7 Cold Cleaning 70
2.2.2.8 Commercial Aerosol Products 71
2.2.2.9 Adhesives and Sealants 71
2.2.2.10 Paints and Coatings 71
2.2.2.11 Adhesive and Caulk Removers 71
2.2.2.12 Fabric Finishing 71
2.2.2.13 Spot Cleaning 71
2.2.2.14 Cellulose Triacetate Film Production 72
2.2.2.15 Flexible Polyurethane Foam Manufacturing 72
2.2.2.16 Laboratory Use 73
2.2.2.17 Plastic Product Manufacturing 73
2.2.2.18 Pharmaceutical Production 74
2.2.2.19 Lithographic Printing Plate Cleaning 75
2.2.2.20 Non-Aerosol Commercial Uses 76
2.2.2.21 Waste Handling, Disposal, Treatment, and Recycling 76
2.2.2.22 Other Unclassified Facilities 78
2.2.3 Summary of Water Release Assessment 79
2.3 Environmental Exposures 79
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2.3.1 Environmental Exposures Approach and Methodology 79
2.3.1.1 Methodology for Obtaining Measured Surface Water Concentrations 80
2.3.1.2 Methodology for Modeling Surface Water Concentrations from Facility Releases (E-
FAST 2014) 81
2.3.1.2.1 E-FAST Calculations 82
2.3.1.2.2 Model Inputs 83
2.3.1.3 Methodology for Geospatial Analysis of Measured Surface Water Monitoring and
Modeled Facility Releases 84
2.3.2 Environmental Exposure Results 85
2.3.2.1 Measured Surface Water Concentrations 85
2.3.2.2 E-F AST Modeling Results 89
2.3.2.3 Geospatial Analysis 91
2.4 Human Exposures 100
2.4.1 Occupational Exposures 105
2.4.1.1 Occupational Exposures Approach and Methodology 106
2.4.1.2 Occupational Exposure Estimates by Scenario 112
2.4.1.2.1 Manufacturing 114
2.4.1.2.2 Processing as aReactant 116
2.4.1.2.3 Processing - Incorporation into Formulation, Mixture, or Reaction Product 118
2.4.1.2.4 Repackaging 120
2.4.1.2.5 Batch Open-Top Vapor Degreasing 122
2.4.1.2.6 Conveyorized Vapor Degreasing 124
2.4.1.2.7 Cold Cleaning 125
2.4.1.2.8 Commercial Aerosol Products (Aerosol Degreasing, Aerosol Lubricants,
Automotive Care Products) 127
2.4.1.2.9 Adhesives and Sealants 129
2.4.1.2.10 Paints and Coatings 132
2.4.1.2.11 Adhesive and Caulk Removers 137
2.4.1.2.12 Fabric Finishing 139
2.4.1.2.13 Spot Cleaning 140
2.4.1.2.14 Cellulose Triacetate Film Production 143
2.4.1.2.15 Flexible Polyurethane Foam Manufacturing 144
2.4.1.2.16 Laboratory Use 147
2.4.1.2.17 Plastic Product Manufacturing 151
2.4.1.2.18 Pharmaceutical Production 154
2.4.1.2.19 Lithographic Printing Plate Cleaning 156
2.4.1.2.20 Miscellaneous Non-Aerosol Industrial and Commercial Uses 158
2.4.1.2.21 Waste Handling, Disposal, Treatment, and Recycling 160
2.4.1.3 Summary of Occupational Exposure Assessment 162
2.4.2 Consumer Exposures 166
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2.4.2.1 Consumer Exposures Approach and Methodology 166
2.4.2.2 Exposure Routes 167
2.4.2.3 Modeling Approach 168
2.4.2.3.1 CEM Model and Scenarios (e.g., table of scenarios), 169
2.4.2.3.2 CEM Scenario Inputs 171
2.4.2.3.3 Sensitivity Analysis 179
2.4.2.4 Consumer Use Scenario Specific Results 179
2.4.2.4.1 Auto Leak Sealer 179
2.4.2.4.2 Auto AC Refrigerant 180
2.4.2.4.3 Adhesives 181
2.4.2.4.4 Adhesive Remover 182
2.4.2.4.5 Brake Cleaner 183
2.4.2.4.6 Brush Cleaner 184
2.4.2.4.7 Carbon Remover 185
2.4.2.4.8 Carburetor Cleaner 186
2.4.2.4.9 Coil Cleaner 187
2.4.2.4.10 Cold Pipe Insulation Spray 188
2.4.2.4.11 Electronics Cleaner 189
2.4.2.4.12 Engine Cleaner 190
2.4.2.4.13 Gasket Remover 191
2.4.2.4.14 Sealants 192
2.4.2.4.15 Weld Spatter Protectant 193
2.4.2.5 Monitoring Data 194
2.4.2.5.1 Indoor Residential Air 194
2.4.2.5.2 Personal Breathing Zone Data 196
2.4.2.6 Modeling Confidence in Consumer Exposure Results 197
3 HAZARDS 202
3.1 Environmental Hazards 202
3.1.1 Approach and Methodology 202
3.1.2 Hazard Identification 202
3.1.3 Weight of Scientific Evidence 208
3.1.4 Concentrations of Concern (COC) 210
3.1.5 Summary of Environmental Hazard 212
3.2 Human Health Hazards 213
3.2.1 Approach and Methodol ogy 213
3.2.2 Toxicokinetics 217
3.2.3 Hazard Identification 219
3.2.3.1 Non-Cancer Hazards 219
3.2.3.1.1 Toxicity from Acute/Short-Term Exposure 220
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3.2.3.1.2 Liver Effects 228
3.2.3.1.3 Immune System Effects 234
3.2.3.1.4 Nervous System Effects 237
3.2.3.1.5 Reproductive and Developmental Effects 241
3.2.3.1.6 Irritation/Burns 244
3.2.3.2 Genotoxicity and Cancer Hazards 245
3.2.3.2.1 Genotoxicity and MOA Information 245
3.2.3.2.2 Carcinogenicity 247
3.2.4 Weight of Scientific Evidence 258
3.2.4.1 Non-Cancer Hazards 258
3.2.4.1.1 Toxicity from Acute/Short-Term Exposure 258
3.2.4.1.2 Liver Effects 260
3.2.4.1.3 Immune System Effects 260
3.2.4.1.4 Nervous System Effects 261
3.2.4.1.5 Reproductive and Developmental Effects 263
3.2.4.1.6 Irritation/Burns 263
3.2.4.2 Genotoxicity and Carcinogenicity 264
3.2.5 Dose-Response Assessment 266
3.2.5.1 Selection of Studies for Dose-Response Assessment 266
3.2.5.1.1 Toxicity from Acute/Short-Term Exposure 266
3.2.5.1.2 Toxicity from Chronic Exposure 267
3.2.5.2 Derivation of PODs and UFs for Benchmark Margins of Exposures (MOEs) 273
3.2.5.2.1 PODs for Acute/Short-term Inhalation Exposure 273
3.2.5.2.2 PODs for Chronic Inhalation Exposure 275
3.2.5.2.3 Route to Route Extrapolation for Dermal PODs 282
3.2.5.3 PODs for Human Health Hazard Endpoints and Confidence Levels 282
4 RISK CHARACTERIZATION 285
4.1 Environmental Risk 285
4.1.1 Risk Estimation Approach 286
4.1.2 Risk Estimation for Aquatic Environment 286
4.1.3 Risk Estimation for Sediment 299
4.1.4 Risk Estimation for Terrestrial 299
4.2 Human Health Risk 299
4.2.1 Risk Estimation Approach 300
4.2.2 Risk Estimation for Inhalation and Dermal Exposures 304
4.2.2.1 Risk Estimation for Inhalation Exposures to Workers 304
4.2.2.1.1 Manufacturing 304
4.2.2.1.2 Processing as a Reactant 306
4.2.2.1.3 Processing - Incorporation into Formulation, Mixture, or Reaction Product 308
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4.2.2.1.4 Repackaging 310
4.2.2.1.5 Waste Handling, Disposal, Treatment, and Recycling 311
4.2.2.1.6 Batch Open-Top Vapor Degreasing 313
4.2.2.1.7 Conveyorized Vapor Degreasing 315
4.2.2.1.8 Cold Cleaning 316
4.2.2.1.9 Commercial Aerosol Products (Aerosol Degreasing, Aerosol Lubricants,
Automotive Care Products) 318
4.2.2.1.10 Adhesives and Sealants 319
4.2.2.1.11 Paints and Coatings 322
4.2.2.1.12 Adhesive and Caulk Removers 327
4.2.2.1.13 Miscellaneous Non-Aerosol Commercial and Industrial Uses 329
4.2.2.1.14 Fabric Finishing 330
4.2.2.1.15 Spot Cleaning 332
4.2.2.1.16 Cellulose Triacetate Film Production 333
4.2.2.1.17 Plastic Product Manufacturing 335
4.2.2.1.18 Flexible Polyurethane Foam Manufacturing 337
4.2.2.1.19 Laboratory Use 339
4.2.2.1.20 Pharmaceutical Production 340
4.2.2.1.21 Lithographic Printing Plate Cleaning 342
4.2.2.2 Risk Estimation for Dermal Exposures to Workers 344
4.2.2.3 Risk Estimation for Inhalation and Dermal Exposures to Consumers 349
4.2.2.3.1 Brake Cleaner 349
4.2.2.3.2 Carbon Remover 351
4.2.2.3.3 Carburetor Cleaner 352
4.2.2.3.4 Coil Cleaner 353
4.2.2.3.5 Electronics Cleaner 355
4.2.2.3.6 Engine Cleaner 356
4.2.2.3.7 Gasket Remover 357
4.2.2.3.8 Adhesives 358
4.2.2.3.9 Auto Leak Sealer 360
4.2.2.3.10 Brush Cleaner 361
4.2.2.3.11 Adhesive Remover 362
4.2.2.3.12 Auto AC Refrigerant 363
4.2.2.3.13 Cold Pipe Insulation Spray 364
4.2.2.3.14 Sealants 365
4.2.2.3.15 Weld Spatter Protectant 366
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4.3 Assumptions and Key Sources of Uncertainty 368
4.3.1 Key Assumptions and Uncertainties in the Environmental Exposure Assessment 368
4.3.2 Key Assumptions and Uncertainties in the Occupational Exposure Assessment 370
4.3.2.1 Occupational Inhalation Exposure Concentration Estimates 370
4.3.2.2 Near-Field/Far-Field Model Framework 373
4.3.2.2.1 Vapor Degreasing Models 373
4.3.2.2.2 Brake Servicing Model 374
4.3.2.3 Occupational Dermal Exposure Dose Estimates 374
4.3.3 Key Assumptions and Uncertainties in the Consumer Exposure Assessment 375
4.3.4 Key Assumptions and Uncertainties in Environmental Hazards 378
4.3.5 Key Assumptions and Uncertainties in the Human Health Hazards 378
4.3.6 Key Assumptions and Uncertainties in the Environmental Risk Estimation 382
4.3.7 Key Assumptions and Uncertainties in the Human Health Risk Estimation 383
4.4 Potentially Exposed or Susceptible Subpopulations 385
4.5 Aggregate and Sentinel Exposures 387
4.6 Risk Conclusions 389
4.6.1 Summary of Environmental Risk 389
4.6.2 Summary of Risk Estimates for Inhalation and Dermal Exposures to Workers 393
4.6.3 Summary of Risk Estimates for Inhalation and Dermal Exposures to Consumers and
Bystanders 411
5 RISK DETERMINATION 424
5.1 Unreasonable Risk 424
5.1.1 Overview 424
5.1.2 Risks to Human Health 425
5.1.2.1 Determining Non-Cancer Risks 425
5.1.2.2 Determining Cancer Risks 426
5.1.3 Determining Environmental Risk 427
5.2 Risk Determination for Methylene Chloride 427
REFERENCES 507
APPENDICES 534
Appendix A REGULATORY HISTORY 534
A.l Federal Laws and Regulations 534
A.2 State Laws and Regulations ....544
A.3 International Laws and Regulations..... ..546
Appendix B LIST OF SUPPLEMENTAL DOCUMENTS 548
Appendix C FATE AND TRANSPORT 550
Appendix D RELEASES TO THE ENVIRONMENT 551
Appendix E ENVIRONMENTAL EXPOSURES 557
Appendix F OCCUPATIONAL EXPOSURES 593
F.l Information on Respirators and Gloves for Methylene Chloride including Paint and Coating
Removal .......593
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F.2 Summary of Information on Gloves from SDS for Methylene Chloride and Formulations
containing Methylene Chloride..,,,...,.,.,.,.......,...,, .599
Appendix G CONSUMER EXPOSURES 603
Appendix H ENVIRONMENTAL HAZARDS 604
H. 1 Aquatic Toxicity Data Extraction Table for Methylene Chloride. 604
H.2 Risk Quotients for All Facilities Modeled in E-FAST 617
Appendix I DERIVATION OF IUR AND NON-CANCER HUMAN EQUIVALENT
CONCENTRATION FOR CHRONIC EXPOSURES 658
I.1 Cancer Inhalation Unit Risk... ..658
1.2 Non-Cancer Hazard Value ....660
Appendix J CASE REPORTS OF FATALITIES ASSOCIATED WITH METHYLENE
CHLORIDE EXPOSURE 662
Appendix K SUMMARY OF METHYLENE CHLORIDE GENOTOXICITY DATA 668
Appendix L SUMMARY OF OCCUPATIONAL EXPOSURES AND RISKS FOR PAINT AND
COATING REMOVERS 685
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LIST OF TABLES
Table 1-1. Physical and Chemical Properties of Methylene Chloride 39
Table 1-2. Production Volume of Methylene Chloride in CDR Reporting Period (2012 to 2015)a 40
Table 1-3. Assessment History of Methylene Chloride 41
Table 1-4. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 45
Table 2-1. Environmental Fate Characteristics of Methylene Chloride 63
Table 2-2. Reported TRI Releases for Organic Chemical Manufacturing Facilities 67
Table 2-3. Reported 2016 TRI and DMR Releases for Potential Processing as Reactant Facilities 68
Table 2-4. Potential Industries Conducting Methylene Chloride Processing - Incorporation into
Formulation, Mixture, or Reaction Product in 2016 TRI or DMR 68
Table 2-5. Reported 2016 TRI and DMR Releases for Potential Processing—Incorporation into
Formulation, Mixture, or Reaction Product Facilities 69
Table 2-6. Reported 2016 TRI and DMR Releases for Repackaging Facilities 70
Table 2-7. Surface Water Releases of Methylene Chloride During Spot Cleaning 72
Table 2-8. Reported 2016 TRI and DMR Releases for CTA Manufacturing Facilities 72
Table 2-9. Water Releases Reported in 2016 TRI for Polyurethane Foam Manufacturing 73
Table 2-10. Potential Industries Conducting Plastics Product Manufacturing in 2016 TRI or DMR 73
Table 2-11. Reported 2016 TRI and DMR Releases for Potential Plastics Product Manufacturing
Facilities 73
Table 2-12. Potential Industries Conducting Pharmaceutical Production in 2016 TRI or DMR 74
Table 2-13. Reported 2016 TRI and DMR Releases for Pharmaceutical Manufacturing Facilities 75
Table 2-14. Reported 2016 TRI and DMR Releases for Potential Lithographic Printing Facilities 76
Table 2-15. Potential Industries Conducting Waste Handling, Disposal, Treatment, and Recycling in
2016 TRI or DMR 76
Table 2-16. Reported 2016 TRI and DMR Releases for Potential Recycling/Disposal Facilities 77
Table 2-17. Reported 2016 TRI and DMR Releases for Other Unclassified Facilities 78
Table 2-18. Measured Concentrations of Methylene Chloride in Surface Water Obtained from the Water
Quality Portal (WQP): 2013-2017a 86
Table 2-19. Sample Information for Water Quality Exchange (WQX) Surface Water Observations With
Concentrations Above the Reported Detection Limit: Year 2016a 87
Table 2-20. Summary of Published Literature with Surface Water Monitoring Data 88
Table 2-21. Summary of Surface Water Concentrations by Occupational Exposure Scenario (OES) for
Maximum Days of Release Scenario 89
Table 2-22. Summary of Surface Water Concentrations by Occupational Exposure Summary (OES) for
20 Days of Release Scenario 91
Table 2-23. Co-Location of Facility Releases and Monitoring Sites within HUC 8 Boundaries (Year
2016) 98
Table 2-24. Crosswalk of Conditions of Use to Occupational and Consumer Scenarios Assessed in the
Risk Evaluation 101
Table 2-25. Assigned Protection Factors for Respirators in OSHA Standard 29 CFR 1910.134a 109
Table 2-26. Glove Protection Factors for Different Dermal Protection Strategies from ECETOC TRA v3
Ill
Table 2-27. Estimated Numbers of Workers in the Assessed Industry Scenarios for Methylene Chloride
113
Table 2-28. Worker Exposure to Methylene Chloride During Manufacturing3 114
Table 2-29. Short-Term Worker Exposure to Methylene Chloride During Manufacturing 115
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Table 2-30. Summary of Dermal Exposure Doses to Methylene Chloride for Manufacturing 115
Table 2-31. Worker Exposure to Methylene Chloride During Processing as a Reactant During
Fluorochemicals Manufacturing51 116
Table 2-32. Summary of Personal Short-Term Exposure Data for Methylene Chloride During Processing
as a Reactant 117
Table 2-33. Summary of Dermal Exposure Doses to Methylene Chloride for Processing as a Reactant
118
Table 2-34. Worker Exposure to Methylene Chloride During Processing - Incorporation into
Formulation, Mixture, or Reaction Producta 119
Table 2-35. Summary of Dermal Exposure Doses to Methylene Chloride for Processing - Incorporation
into Formulation, Mixture, or Reaction Product 119
Table 2-36. Worker Exposure to Methylene Chloride During Repackaging51 120
Table 2-37. Summary of Personal Short-Term Exposure Data for Methylene Chloride During
Repackaging 121
Table 2-38. Summary of Dermal Exposure Doses to Methylene Chloride for Repackaging 121
Table 2-39. Statistical Summary of Methylene Chloride 8-hr TWA Exposures (ADC and LADC) for
Workers and ONUs for Batch Open-Top Vapor Degreasing 122
Table 2-40. Summary of Dermal Exposure Doses to Methylene Chloride for Batch Open-Top Vapor
Degreasing 123
Table 2-41. Statistical Summary of Methylene Chloride 8-hr TWA Exposures (ADC and LADC) for
Workers and ONUs for Conveyorized Vapor Degreasing 124
Table 2-42. Summary of Dermal Exposure Doses to Methylene Chloride for Conveyorized Vapor
Degreasing 125
Table 2-43. Worker Exposure to Methylene Chloride During Cold Cleaning51 126
Table 2-44. Summary of Dermal Exposure Doses to Methylene Chloride for Cold Cleaning 127
Table 2-45. Statistical Summary of Methylene Chloride 8-hr and 1-hr TWA Exposures (ADC and
LADC) for Workers and ONUs for Aerosol Products Based on Modeling 128
Table 2-46. Summary of Dermal Exposure Doses to Methylene Chloride for Commercial Aerosol
Product Uses 128
Table 2-47. Worker Exposure to Methylene Chloride During Industrial Non-Spray Adhesives Usea .. 130
Table 2-48. Worker Exposure to Methylene Chloride During Industrial Spray Adhesives Usea 130
Table 2-49. Summary of Personal Short-Term Exposure Data for Methylene Chloride During Industrial
Adhesives Use 131
Table 2-50. Summary of Dermal Exposure Doses to Methylene Chloride for Adhesives and Sealants
Uses 132
Table 2-51. Worker Exposure to Methylene Chloride During Paint/Coating Spray Application11 134
Table 2-52. Worker Exposure to Methylene Chloride During Paint/Coating Application (Unknown
Application Method)51 134
Table 2-53. Summary of Personal Short-Term Exposure Data for Methylene Chloride During
Paint/Coating Use 135
Table 2-54. Summary of Dermal Exposure Doses to Methylene Chloride for Paint and Coatings Uses
136
Table 2-55. Worker Exposure to Methylene Chloride for During Use of Adhesive and Caulk Removers51
137
Table 2-56. Short-Term Exposure to Methylene Chloride During Use of Adhesive and Caulk Removers
138
Table 2-57. Summary of Dermal Exposure Doses to Methylene Chloride for Adhesive and Caulk
Removers 138
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Table 2-58. Worker Exposure to Methylene Chloride During Fabric Finishing3 139
Table 2-59. Summary of Dermal Exposure Doses to Methylene Chloride for Fabric Finishing 140
Table 2-60. Worker Exposure to Methylene Chloride for During Spot Cleaning3 141
Table 2-61. Summary of Personal Short-Term Exposure Data for Methylene Chloride During Spot
Cleaning 141
Table 2-62. Summary of Dermal Exposure Doses to Methylene Chloride for Spot Cleaning 142
Table 2-63. Worker Exposure to Methylene Chloride During CTA Film Manufacturing3 143
Table 2-64. Summary of Dermal Exposure Doses to Methylene Chloride for CTA Film Manufacturing
144
Table 2-65. Worker Exposure to Methylene Chloride During Industrial Polyurethane Foam
Manufacturing3 145
Table 2-66. Summary of Personal Short-Term Exposure Data for Methylene Chloride During
Polyurethane Foam Manufacturing 145
Table 2-67. Summary of Dermal Exposure Doses to Methylene Chloride for Polyurethane Foam
Manufacturing 146
Table 2-68. Worker Exposure to Methylene Chloride During Laboratory Use3 148
Table 2-69. Worker Personal Short-Term Exposure Data for Methylene Chloride During Laboratory Use
148
Table 2-70. Summary of Dermal Exposure Doses to Methylene Chloride for Laboratory Use 150
Table 2-71. Worker and ONU Exposure to Methylene Chloride During Plastic Product Manufacturing
151
Table 2-72. Worker Short-Term Exposure Data for Methylene Chloride During Plastic Product
Manufacturing 153
Table 2-73. Summary of Dermal Exposure Doses to Methylene Chloride for Plastic Product
Manufacturing 154
Table 2-74. Worker Exposure to Methylene Chloride During Pharmaceutical Production3 155
Table 2-75. Summary of Dermal Exposure Doses to Methylene Chloride for Pharmaceutical Production
156
Table 2-76. Worker Exposure to Methylene Chloride During Printing Plate Cleaning3 157
Table 2-77. Worker Short-Term Exposure Data for Methylene Chloride During Printing Plate Cleaning
157
Table 2-78. Summary of Dermal Exposure Doses to Methylene Chloride for Lithographic Printing Plate
Cleaner 158
Table 2-79. Worker Exposure to Methylene Chloride During Miscellaneous Industrial and Commercial
Non-Aerosol Use3 159
Table 2-80. Summary of Dermal Exposure Doses to Methylene Chloride for Miscellaneous Industrial
and Commercial Non-Aerosol Use 159
Table 2-81. Worker Exposure to Methylene Chloride During Waste Handling and Disposal3 161
Table 2-82. Worker Short-Term Exposure Data for Methylene Chloride During Waste Handling and
Disposal 161
Table 2-83. Summary of Dermal Exposure Doses to Methylene Chloride for Waste Handling, Disposal,
Treatment, and Recycling 162
Table 2-84. Summary of Acute and Chronic Inhalation Exposures to Methylene Chloride for Central and
Higher-End Scenarios by Occupational Exposure Scenario 163
Table 2-85. Summary of Dermal Exposure Doses to Methylene Chloride by Occupational Exposure
Scenario and Potential Glove Use 165
Table 2-86. Evaluated Consumer Uses for Products Containing Methylene Chloride 166
Table 2-87. Fixed Consumer Use Scenario Modeling Parameters 172
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Table 2-88. Consumer Use Non-Varying Scenario Specific Inputs for Evaluation of Inhalation and
Dermal Exposure 175
Table 2-89. Consumer Use Scenario Specific Values of Duration of Use, Weight Fraction, and Mass of
Product Used Derived from U.S. EPA (1987) 177
Table 2-90. Consumer User and Bystander Inhalation Exposure to Methylene Chloride During Auto
Leak Sealer Use 180
Table 2-91. Consumer Dermal Exposure to Methylene Chloride During Use as an Auto Leak Sealer. 180
Table 2-92. Consumer User and Bystander Inhalation Exposure to Methylene Chloride During Auto Air
Conditioning Refrigerant Use 181
Table 2-93. Consumer Dermal Exposure to Methylene Chloride During Use as an Auto Air
Conditioning Refrigerant 181
Table 2-94. Consumer User and Bystander Inhalation Exposure to Methylene Chloride During Use as an
Adhesive 182
Table 2-95. Consumer Dermal Exposure to Methylene Chloride During Use as an Adhesive 182
Table 2-96. Consumer User and Bystander Inhalation Exposure to Methylene Chloride During Use as an
Adhesives Remover 183
Table 2-97. Consumer Dermal Exposure to Methylene Chloride During Use as an Adhesive Remover
183
Table 2-98. Consumer User and Bystander Inhalation Exposure to Methylene Chloride During Use as a
Brake Cleaner 184
Table 2-99. Consumer Dermal Exposure to Methylene Chloride During Use as a Brake Cleaner 184
Table 2-100. Consumer User and Bystander Inhalation Exposure to Methylene Chloride During Use as a
Brush Cleaner 185
Table 2-101. Consumer Dermal Exposure to Methylene Chloride During Use as a Brush Cleaner 185
Table 2-102. Consumer User and Bystander Inhalation Exposure to Methylene Chloride During Use as a
Carbon Remover 186
Table 2-103. Consumer Dermal Exposure to Methylene Chloride During Use as a Carbon Remover. 186
Table 2-104. Consumer User and Bystander Inhalation Exposure to Methylene Chloride During Use as a
Carburetor Cleaner 187
Table 2-105. Consumer Dermal Exposure to Methylene Chloride During Use as a Carburetor Cleaner
187
Table 2-106. Consumer User and Bystander Inhalation Exposure to Methylene Chloride During use as a
Coil Cleaner 188
Table 2-107. Consumer Dermal Exposure to Methylene Chloride During Use as a Coil Cleaner 188
Table 2-108. Consumer User and Bystander Inhalation Exposure to Methylene Chloride During Cold
Pipe Insulation Spray Use 189
Table 2-109. Consumer Dermal Exposure to Methylene Chloride During Use as a Cold Pipe Insulation
Spray 189
Table 2-110. Consumer User and Bystander Inhalation Exposure to Methylene Chloride During Use as
an Electronics Cleaner 190
Table 2-111. Consumer Dermal Exposure to Methylene Chloride During Use as an Electronics Cleaner
190
Table 2-112. Consumer User and Bystander Inhalation Exposure to Methylene Chloride During Use as
an Engine Cleaner 191
Table 2-113. Consumer Dermal Exposure to Methylene Chloride During Use as an Engine Cleaner.. 191
Table 2-114. Consumer User and Bystander Inhalation Exposure to Methylene Chloride During Use as a
Gasket Remover 192
Table 2-115. Consumer Dermal Exposure to Methylene Chloride During Use as a Gasket Remover.. 192
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Table 2-116. Consumer User and Bystander Inhalation Exposure to Methylene Chloride During Use as a
Sealant 193
Table 2-117. Consumer Dermal Exposure to Methylene Chloride During Use as a Sealant 193
Table 2-118. Consumer User and Bystander Inhalation Exposure to Methylene Chloride During Use as a
Weld Spatter Protectant 194
Table 2-119. Consumer Dermal Exposure to Methylene Chloride During Use as a Weld Spatter
Protectant 194
Table 2-120. Concentrations of Methylene Chloride in the Indoor Air of Residential Homes in the U.S.
and Canada from Studies Identified During Systematic Review 195
Table 2-121. Concentrations of Methylene Chloride in the Personal Breathing Zones of Residents in the
U.S 197
Table 2-122. Confidence in Individual Consumer Conditions of Use Inhalation Exposure Evaluations
198
Table 2-123. Confidence in individual consumer conditions of use for dermal exposure evaluations.. 200
Table 3-1. Ecological Hazard Characterization of Methylene Chloride for Aquatic Organisms 206
Table 3-2. COCs for Environmental Toxicity 213
Table 3-3. Human Controlled Inhalation Experiments Measuring Effects on the Nervous System* .... 225
Table 3-4. Liver Effects Identified in Chronic and Subchronic Animal Toxicity Studies of Methylene
Chloride 231
Table 3-5. Selected Effect Estimates for Epidemiological Studies of Liver Cancers 248
Table 3-6. Summary of Significantly Increased Liver Tumor Incidences in Inhalation Studies of
Methylene Chloride 248
Table 3-7. Summary of Significantly Increased Liver Tumor Incidences in Oral Studies of Methylene
Chloride 250
Table 3-8. Selected Effect Estimates for Epidemiological Studies of Lung Cancers 251
Table 3-9. Summary of Significantly Increased Lung Tumor Incidences in Inhalation Studies of
Methylene Chloride 251
Table 3-10. Selected Effect Estimates for Epidemiological Studies of Breast Cancers 253
Table 3-11. Summary of Significantly Increased Mammary Tumor Incidences in Inhalation Studies of
Methylene Chloride 253
Table 3-12. Selected Effect Estimates for Epidemiological Studies of Hematopoietic Cancers 255
Table 3-13. Summary of Mononuclear Cell Leukemia Incidences in Inhalation Studies of Methylene
Chloride 256
Table 3-14. Selected Effect Estimates for Epidemiological Studies of Brain and CNS Cancers 257
Table 3-15. Candidate Non-Cancer Liver Effects for Dose-Response Modeling 269
Table 3-16. Candidate Tumor Data for Dose-Response Modeling 271
Table 3-17. Conversion of Acute PODs for Different Exposure Durations 274
Table 3-18. Results of BMD Modeling of Internal Doses Associated with Liver Lesions in Female Rates
from Nitschke et al. (1988a) 276
Table 3-19. BMD Modeling Results and HECs Determined for 10% Extra Risk, Liver Endpoints from
Two Studies 278
Table 3-20. BMD Modeling Results and Tumor Risk Factors/HECs Determined for 10% Extra Risk,
Various Endpoints From Aiso (2014a) and NTP (1986) 280
Table 3-21. Summary of PODs for Evaluating Human Health Hazards from Acute and Chronic
Inhalation Scenarios 283
Table 3-22. Summary of PODs for Evaluating Human Health Hazards from Acute and Chronic Dermal
Exposure Scenarios 284
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Table 4-1. Modeled Facilities Showing Acute and/or Chronic Risk from the Release of Methylene
Chloride; RQ Greater Than One are Shown in Bold 289
Table 4-2. RQs Calculated using Monitored Environmental Concentrations from WQP 292
Table 4-3. Use Scenarios, Populations of Interest and Toxicological Endpoints for Assessing
Occupational Risks Following Acute Exposures to Methylene Chloride 300
Table 4-4. Use Scenarios, Populations of Interest and Toxicological Endpoints for Assessing Consumer
Risks Following Acute Exposures to Methylene Chloride 301
Table 4-5. Use Scenarios, Populations of Interest and Toxicological Endpoints for Assessing
Occupational Risks Following Chronic Exposures to Methylene Chloride 302
Table 4-6. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Manufacturing 305
Table 4-7. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Manufacturing 305
Table 4-8. Risk Estimation for Chronic, Cancer Inhalation Exposures for Manufacturing 306
Table 4-9. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Processing as a Reactant307
Table 4-10. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Processing as a Reactant
307
Table 4-11. Risk Estimation for Chronic, Cancer Inhalation Exposures for Processing as a Reactant.. 308
Table 4-12. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Processing - Incorporation
into Formulation, Mixture, or Reaction Product 309
Table 4-13. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Processing -
Incorporation into Formulation, Mixture, or Reaction Product 309
Table 4-14. Risk Estimation for Chronic, Cancer Inhalation Exposures for Processing - Incorporation
into Formulation, Mixture, or Reaction Product 309
Table 4-15. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Repackaging 310
Table 4-16. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Repackaging 311
Table 4-17. Risk Estimation for Chronic, Cancer Inhalation Exposures for Repackaging 311
Table 4-18. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Waste Handling, Disposal,
Treatment, and Recycling 312
Table 4-19. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Waste Handling,
Disposal, Treatment, and Recycling 312
Table 4-20. Risk Estimation for Chronic, Cancer Inhalation Exposures for Waste Handling, Disposal,
Treatment, and Recycling 313
Table 4-21. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Batch Open-Top Vapor
Degreasing 313
Table 4-22. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Batch Open-Top Vapor
Degreasing 314
Table 4-23. Risk Estimation for Chronic, Cancer Inhalation Exposures for Batch Open-Top Vapor
Degreasing 314
Table 4-24. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Conveyorized Vapor
Degreasing 315
Table 4-25. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Conveyorized Vapor
Degreasing 315
Table 4-26. Risk Estimation for Chronic, Cancer Inhalation Exposures for Conveyorized Vapor
Degreasing 316
Table 4-27. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Cold Cleaning 317
Table 4-28. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Cold Cleaning 317
Table 4-29. Risk Estimation for Chronic, Cancer Inhalation Exposures for Cold Cleaning 317
Table 4-30. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Commercial Aerosol
Products (Aerosol Degreasing, Aerosol Lubricants, Automotive Care Products) 318
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Table 4-31. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Commercial Aerosol
Products (Aerosol Degreasing, Aerosol Lubricants, Automotive Care Products) 319
Table 4-32. Risk Estimation for Chronic, Cancer Inhalation Exposures for Commercial Aerosol Products
(Aerosol Degreasing, Aerosol Lubricants, Automotive Care Products) 319
Table 4-33. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Adhesives and Sealants
320
Table 4-34. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Adhesives and Sealants
321
Table 4-35. Risk Estimation for Chronic, Cancer Inhalation Exposures for Adhesives and Sealants ... 321
Table 4-36. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Paints and Coatings
Including Commercial Paint and Coating Removers 323
Table 4-37. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Paints and Coatings. 324
Table 4-38. Risk Estimation for Chronic, Cancer Inhalation Exposures for Paints and Coatings 326
Table 4-39. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Adhesive and Caulk
Removers 327
Table 4-40. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Adhesive and Caulk
Removers 328
Table 4-41. Risk Estimation for Chronic, Cancer Inhalation Exposures for Adhesive and Caulk
Removers 328
Table 4-42. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Non-Aerosol Commercial
and Industrial Uses 329
Table 4-43. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Non-Aerosol
Commercial and Industrial Uses 329
Table 4-44. Risk Estimation for Chronic, Cancer Inhalation Exposures for Non-Aerosol Commercial and
Industrial Uses 330
Table 4-45. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Fabric Finishing 331
Table 4-46. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Fabric Finishing 331
Table 4-47. Risk Estimation for Chronic, Cancer Inhalation Exposures for Fabric Finishing 331
Table 4-48. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Spot Cleaning 332
Table 4-49. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Spot Cleaning 333
Table 4-50. Risk Estimation for Chronic, Cancer Inhalation Exposures for Spot Cleaning 333
Table 4-51. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Cellulose Triacetate Film
Production 334
Table 4-52. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Cellulose Triacetate
Film Production 334
Table 4-53. Risk Estimation for Chronic, Cancer Inhalation Exposures for Cellulose Triacetate Film
Production 335
Table 4-54. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Plastic Product
Manufacturing 336
Table 4-55. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Plastic Product
Manufacturing 336
Table 4-56. Risk Estimation for Chronic, Cancer Inhalation Exposures for Plastic Product
Manufacturing 337
Table 4-57. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Flexible Polyurethane
Foam Manufacturing 337
Table 4-58. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Flexible Polyurethane
Foam Manufacturing 338
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Table 4-59. Risk Estimation for Chronic, Cancer Inhalation Exposures for Flexible Polyurethane Foam
Manufacturing 338
Table 4-60. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Laboratory Use 339
Table 4-61. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Laboratory Use 340
Table 4-62. Risk Estimation for Chronic, Cancer Inhalation Exposures for Laboratory Use 340
Table 4-63. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Pharmaceutical Production
341
Table 4-64. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Pharmaceutical
Production 341
Risk Estimation for Chronic, Cancer Inhalation Exposures for Pharmaceutical Production
342
Table 4-65
Table 4-66
Table 4-67.
Table 4-68.
Table 4-69.
Table 4-70.
Table 4-71.
Table 4-72.
Table 4-73.
Table 4-74.
Table 4-75.
Table 4-76.
Table 4-77.
Table 4-78.
Table 4-79.
Table 4-80.
Table 4-81.
Table 4-82.
Table 4-83.
Table 4-84.
Table 4-85.
Table 4-86.
Table 4-87.
Table 4-88.
Table 4-89.
Table 4-90.
Table 4-91.
Table 4-92.
Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Lithographic Printing Plate
Cleaning 343
Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Lithographic Printing
Plate Cleaning 343
Risk Estimation for Chronic, Cancer Inhalation Exposures for Lithographic Printing Plate
Cleaning 343
MOEs for Acute Dermal Exposures to Workers, by Occupational Exposure Scenario for
CNS Effects POD 16 mg/kg/day, Benchmark MOE 30 344
MOEs for Chronic Dermal Exposures to Workers, by Occupational Exposure Scenario for
Liver Effects POD 2.15 mg/kg/day, Benchmark MOE =10 346
Cancer Risk for Chronic Dermal Exposures to Workers, by Occupational Exposure Scenario
CSF 1.1 x 10"5 per mg/kg/day 348
Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Brake Cleaner Use 350
Risk Estimation for Acute, Non-Cancer Dermal Exposures for Brake Cleaner Use 350
Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Carbon Remover Use .351
Risk Estimation for Acute, Non-Cancer Dermal Exposures for Carbon Remover Use 352
Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Carburetor Cleaner Use
353
Risk Estimation for Acute, Non-Cancer
Risk Estimation for Acute, Non-Cancer
Risk Estimation for Acute, Non-Cancer
Risk Estimation for Acute, Non-Cancer
Risk
Risk
Risk
Risk
Risk
Risk
Risk
Risk
Risk
Risk
Risk
Risk
Dermal Exposures for Carburetor Cleaner Use ..353
Inhalation Exposures for Coil Cleaner Use 354
Dermal Exposures for Coil Cleaner Use 354
Inhalation Exposures for Electronics Cleaner Use
355
Estimation for Acute, Non-Cancer
Estimation for Acute, Non-Cancer
Estimation for Acute, Non-Cancer
Estimation for Acute, Non-Cancer
Estimation for Acute, Non-Cancer
Estimation for Acute, Non-Cancer
Estimation for Acute, Non-Cancer
Estimation for Acute, Non-Cancer
Estimation for Acute, Non-Cancer
Estimation for Acute, Non-Cancer
Estimation for Acute, Non-Cancer
Estimation for Acute, Non-Cancer
Table 4-93. Risk Estimation for Acute, Non-Cancer
Dermal Exposures for Electronics Cleaner Use.. 356
Inhalation Exposures for Engine Cleaner Use.... 356
Dermal Exposures for Engine Cleaner Use 357
Inhalation Exposures for Gasket Remover Use.. 358
Dermal Exposures for Gasket Remover Use 358
Inhalation Exposures for Adhesives Use 359
Dermal Exposures for Adhesives Use 359
Inhalation Exposures for Auto Leak Sealer Use. 360
Dermal Exposures for Auto Leak Sealer Use 360
Inhalation Exposures for Brush Cleaner Use 361
Dermal Exposures for Brush Cleaner Use 362
Inhalation Exposures for Adhesive Remover Use
362
Dermal Exposures for Adhesive Remover Use .. 363
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Table 4-94. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Auto AC Refrigerant Use
364
Table 4-95. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Auto AC Refrigerant Use 364
Table 4-96. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Cold Pipe Insulation Spray
Use 365
Table 4-97. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Cold Pipe Insulation Spray
Use 365
Table 4-98. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Sealants Use 366
Table 4-99. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Sealants Use 366
Table 4-100. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Weld Spatter Protectant
Use 367
Table 4-101. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Weld Spatter Protectant Use
367
Table 4-102 Table of Occupational Exposure Assessment Approach for Inhalation 371
Table 4-103. Modeled Facilities Showing Acute and/or Chronic Risk from the Release of Methylene
Chloride; RQ Greater Than One are Shown in Bold 390
Table 4-104 Summary of Risk Estimates for Inhalation and Dermal Exposures to Workers by Condition
of Use 395
Table 4-105 Summary of Risk Estimates for CNS effects from Acute Inhalation and Dermal Exposures
to Consumers by Conditions of Use 413
Table 5-1 Unreasonable Risk Determinations by Condition of Use 430
LIST OF FIGURES
Figure 1-1. Methylene Chloride Life Cycle Diagram 44
Figure 1-2. Methylene Chloride Conceptual Model for Industrial and Commercial Activities and Uses:
Potential Exposure and Hazards 52
Figure 1-3. Methylene Chloride Conceptual Model for Consumer Activities and Uses: Potential
Exposure and Hazards 53
Figure 1-4. Methylene Chloride Conceptual Model for Environmental Releases and Wastes: Potential
Exposures and Hazards 54
Figure 1-5. Literature Flow Diagram for Environmental Fate and Transport Data Sources 57
Figure 1-6. Releases and Occupational Exposures Literature Flow Diagram for Methylene Chloride... 58
Figure 1-7. Literature Flow Diagram for General Population, Consumer and Environmental Exposure
Data Sources 59
Figure 1-8. Literature Flow Diagram for Environmental Hazard Data Sources 60
Figure 1-9. Literature Flow Diagram for Human Health Hazard Data Sources 61
Figure 2-1 Environmental transport, partitioning, and degradation processes for methylene chloride.... 65
Figure 2-2. Surface Water Concentrations of Methylene Chloride from Releasing Facilities (Maximum
Days of Release Scenario) and Water Quality Exchange (WQX) Monitoring Stations:
Year 2016, Eastern U.S 92
Figure 2-3. Surface Water Concentrations of Methylene Chloride from Releasing Facilities (Maximum
Days of Release Scenario) and Water Quality Exchange (WQX) Monitoring Stations:
Year 2016, Western U.S 93
Figure 2-4. Concentrations of Methylene Chloride from Releasing Facilities (20 Days of Release
Scenario) and Water Quality Exchange (WQX)Monitoring Stations: Year 2016, East U.S.
94
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Figure 2-5. Concentrations of Methylene Chloride from Releasing Facilities (20 Days of Release
Scenario) and Water Quality Exchange (WQX) Monitoring Stations: Year 2016, West
U.S 95
Figure 2-6. Co-location of Methylene Chloride Releasing Facilities and Water Quality Exchange
(WQX) Monitoring Stations at the HUC 8 and HUC 12 Level 97
Figure 2-7. Search of CDR, DMR (NPDES), Superfund, and TRI facilities in 2016 within HUC-8 of
Water Quality Portal (WQP) Station 21NC03WQ-AMS20161206 -B8484000 99
Figure 2-8. Search of CDR, NPDES, Superfund, and TRI facilities in 2016 within HUC-8 of Water
Quality Portal (WQP) Stations 21NC03WQ-E1485000 and 21NC03WQ-E3475000... 100
Figure 3-1. EPA Approach to Hazard Identification, Data Integration, and Dose-Response Analysis for
Methylene Chloride 214
Figure 3-2. Biotransformation Scheme of Methylene Chloride (modified after Gargas et al., 1986).... 219
Figure 4-1. Surface Water Concentrations of Methylene Chloride from Releasing Facilities (Maximum
Days of Release Scenario) and WQX Monitoring Stations: Year 2016, East U.S 294
Figure 4-2. Surface Water Concentrations of Methylene Chloride from Releasing Facilities (Maximum
Days of Release Scenario) and WQX Monitoring Stations: Year 2016, West U.S 295
Figure 4-3. Concentrations of Methylene Chloride from Releasing Facilities (20 Days of Release
Scenario) and WQX Monitoring Stations: Year 2016, East U.S 296
Figure 4-4. Concentrations of Methylene Chloride from Methylene Chloride-Releasing Facilities (20
Days of Release Scenario) and WQX Monitoring Stations: Year 2016, West U.S 297
Figure 4-5. Co-location of Methylene Chloride Releasing Facilities and WQX Monitoring Stations at the
HUC 8 and HUC 12 Level 298
LIST OF APPENDIX TABLES
Table_Apx A-l. Federal Laws and Regulations 534
Table_Apx A-2. State Laws and Regulations 544
Table_Apx A-3. Regulatory Actions by other Governments and Tribes 546
TableApx D-l. Water Releases Reported in 2016 TRI or DMR for Occupational Exposure Scenarios
551
TableApx E-l. Occurrence of Methylene Dichloride Releases (Facilities) and Monitoring Sites By
HUC-8 557
Table Apx E-2. Occurrence of Methylene Dichloride Releases (Facilities) and Monitoring Sites By
IILC-12 561
Table Apx E-3. Sample Information for WQX Surface Water Observations With Concentrations Above
the Reported Detection Limit: 2013-2017a 569
Table Apx E-4. E-FAST Modeling Results for Known Direct and Indirect Releasing Facilities for 2016
572
Table_Apx E-5. States with Monitoring Sites or Facilities in 2016 592
Table Apx F-l. Respirator Specifications by APF for Use in Paint and Coating Removal Scenarios with
Methylene Chloride Exposure 593
Table_Apx F-2. Glove Types Evaluated for Pure Methylene Chloride 595
Table Apx F-3. Recommended Glove Materials Methylene Chloride and Methylene Chloride-
Containing Products from SDSs 601
Table Apx H-l. Aquatic Toxicity Data Extraction Table for Methylene Chloride 604
Table Apx H-2. Risk Quotients for All Facilities Modeled in E-FAST 617
Table_Apx J-l. Examples of Fatalities 663
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TableApx K-l Methylene Chloride Genotoxicity Studies Published After the 2011 IRIS Assessment
669
Table Apx L-l. Raw Air Sampling Data for Methylene Chloride During DoD Uses in Paint and Coating
Removers 685
Table Apx L-2. Acute and Chronic Exposures for Methylene Chloride During DoD Uses in Paint and
Coating Removers 685
Table Apx L-3. Summary of Dermal Exposure Doses to Methylene Chloride for Paint and Coatings
Removal Uses 686
LIST OF APPENDIX FIGURES
FigureApx C-l. EPI Suite Model Inputs for Estimating Methylene Chloride Fate and Transport
Properties 550
Figure Apx 1-1. Process of Deriving the Cancer Inhalation Unit Risk for Methylene Chloride 660
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ACKNOWLEDGEMENTS
This report was developed by the United States Environmental Protection Agency (U.S. EPA), Office of
Chemical Safety and Pollution Prevention (OCSPP), Office of Pollution Prevention and Toxics (OPPT).
Acknowledgements
The OPPT Assessment Team gratefully acknowledges participation and/or input from Intra-agency
reviewers that included multiple offices within EPA, Inter-agency reviewers that included multiple
Federal agencies, and assistance from EPA contractors GDIT (Contract No. CIO-SP3,
HHSN316201200013W), ERG (Contract No. EP-W-12-006), Versar (Contract No. EP-W-17-006), ICF
(Contract No. EPC14001) and SRC (Contract No. EP-W-12-003).
Docket
Supporting information can be found in public docket:
Disclaimer
Reference herein to any specific commercial products, process or service by trade name, trademark,
manufacturer or otherwise does not constitute or imply its endorsement, recommendation or favoring by
the United States Government.
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ABBREVIATIONS
°c
Degrees Celsius
ACGM
American Conference of Government Industrial Hygienists
ACh
Acetylcholine
ACR
Acute-to-chronic Ratio
ADC
Average Daily Concentration
ADR
Acute Dose Rate
AEGL
Acute Exposure Guideline Level
AF
Assessment Factor
AhR
Aryl Hydrocarbon Receptor
AIC
Akaike information criterion
ALT
Alanine Transaminase
ANOVA
Analysis of Variance
APF
Assigned Protection Factor
ASD
Autism Spectrum Disorder
AST
Aspartate Amino Transferase
atm
Atmosphere(s)
ATSDR
Agency for Toxic Substances and Disease Registry
BAF
Bioaccumulation Factor
BCF
Bioconcentration Factor
BMD
Benchmark Dose
BMDL
Benchmark Dose Lower Confidence Limit
BMR
Benchmark Response
BMDS
Benchmark Dose Software
CAA
Clean Air Act
CADD
Chronic Average Daily Dose
CAR
Constitutive Androstane Receptor
CASRN
Chemical Abstracts Service Registry Number
CARB
California Air Resources Board
CBI
Confidential Business Information
CDR
Chemical Data Reporting
CEM
Consumer Exposure Model
CEPA
Canadian Environmental Protection Act
CERCLA
Comprehensive Environmental Response, Compensation and Liability Act
CFF
Critical Flicker Function
CFR
Code of Federal Regulations
CHIRP
Chemical Risk Information Platform
ChV
Chronic Value
CI
Confidence Interval
cm3
Cubic Centimeter(s)
CNS
Central Nervous System
coc
Concentration of Concern
CoCAP
Cooperative Chemicals Assessment Program
COHb
Carboxyhemoglobin
COU
Conditions of Use
CPDat
Chemical and Products Database
CPSC
Consumer Product Safety Commission
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CSCL
Chemical Substances Control Law
CWA
Clean Water Act
CYP450
Cytochrome P450
DCM
Dichloromethane (Methylene Chloride)
DF
Dilution Factor
DFq
Detection frequency
DMR
Discharge Monitoring Report
DNA
Deoxyribonucleic Acid
DoD
Department of Defense
EC50
Effect concentration at which 50% of test organisms exhibit an effect
ECHA
European Chemicals Agency
ECHO
Enforcement and Compliance History Online
ECOTOX
ECOTOXicology Knowledgebase System
EEG
El ectroencephal ogram
EF
Exposure Frequency
E-FAST
Exposure and Fate Assessment Screening Tool
ELCR
Excess Lifetime Cancer Risk
EPA
Environmental Protection Agency
EPCRA
Emergency Planning and Community Right-to-Know Act
EPI Suite™
Estimation Programs Interface suite of models
ER
Extra Risk
EU
European Union
EVOH
Ethylene Vinyl Alcohol
FACE
Fatality Assessment and Control Evaluation
FDA
Food and Drug Administration
FFDCA
Federal Food, Drug, and Cosmetic Act
FR
Federal Register
FRS ID
Facility Registry Service Identification
g
Gram(s)
GABA
Gamma-aminobutyric Acid
GC
Gas Chromatography
GD(s)
Gestational Day
GM
Geometric Mean
GSD
Geometric Standard Deviation
GSH
Glutathione
GST
Glutathione S-transferase
GSTT1
Theta 1 Isozyme
HAP
Hazardous Air Pollutant
HEC
Human Equivalent Concentration(s)
HED
Human Equivalent Dose(s)
HEDD
Human Equivalent Dermal Dose
HFC
Hydrofluorocarbon
HHE
Health Hazard Evaluation
HMTA
Hazardous Materials Transportation Act
Hr
Hour(s)
HR
Hazard Ratio
HSE
Health and Safety Executive
HSIA
Halogenated Solvents Industry Alliance
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HUC
I ARC
ICIS
IDLH
IH
IMAP
IPCS
IRIS
IRR
ISHA
IUR
Koc
Kow
kg
L
LA DC
lb
LC50
LCL
LOAEC
LOAEL
LOD
LOEC
Log Koc
Log Kow
3
m
MACT
MCL
MCLG
MFO
mg
Min
MLD
mmHg
MOA
MOE
mPas
MSDS
MSW
N/A
NAC
NAICS
NATA
NAWQA
ND
NEI
NESHAP
NHANES
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Hydrologic Unit Code
International Agency for Research on Cancer
Integrated Compliance Information System
Immediately Dangerous to Life or Health
Industrial Hygiene
Inventory Multi-Tiered Assessment and Prioritisation
International Programme on Chemical Safety
Integrated Risk Information System
Incidence rate ratios
Industrial Safety and Health Act
Inhalation Unit Risk
Soil Organic Carbon-Water Partitioning Coefficient
Octanol/Water Partition Coefficient
Kilogram(s)
Liter(s)
Lifetime Average Daily Concentration
Pound(s)
Lethal Concentration at which 50% of test organisms die
Lower confidence limit
Lowest Observed Adverse Effect Concentration
Lowest Observed Adverse Effect Level
Limit of Detection
Lowest Observable Effect Concentration
Logarithmic Organic Carbon:Water Partition Coefficient
Logarithmic Octanol: Water Partition Coefficient
Cubic Meter(s)
Maximum Achievable Control Technology
Maximum Contaminant Level
Maximum Contaminant Level Goal
Mixed Function Oxidase
Milligram(s)
Minute(s)
Millions of Liters per Day
Millimeter(s) of Mercury
Mode of Action
Margin of Exposure
Millipascal(s)-Second
Material Safety Data Sheet
Municipal Solid Waste
Not Applicable
National Advisory Committee
North American Industry Classification System
National Air Toxics Assessment
National Water Quality Assessment Program
Not Detected
National Emissions Inventory
National Emission Standards for Hazardous Air Pollutants
National Health and Nutrition Examination Survey
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NHL
Non-Hodgkin Lymphoma
NICNAS
National Industrial Chemicals Notification and Assessment Scheme
NIH
National Institutes of Health
NIOSH
National Institute for Occupational Safety and Health
NITE
National Institute of Technology and Evaluation
NMDA
N-Methyl-D-Aspartate
NMP
N-Methylpyrroli done
NO
Nitric Oxide
NOAEL
No Observed Adverse Effect Level
NOEC
No Observed Effect Concentration
NPDES
National Pollutant Discharge Elimination System
NPDWR
National Primary Drinking Water Regulation
NPL
National Priority List
NRC
National Research Council
NT
Not testedNTP National Toxicology Program
NTP
National Toxicology Program
NWIS
National Water Information System
OCSPP
Office of Chemical Safety and Pollution Prevention
OECD
Organisation for Economic Co-operation and Development
OEHHA
Office of Environmental Health Hazard Assessment
OEL
Occupational Exposure Limits
OES
Occupational Exposure Scenario
ONU
Occupational Non-User
OPPT
Office of Pollution Prevention and Toxics
OR
Odds Ratio
ORD
Office of Research and Development
OSHA
Occupational Safety and Health Administration
OTVD
Open-Top Vapor Degreaser
OW
Office of Water
PAH
Polycyclic Aromatic Hydrocarbons
PBMC
Peripheral Blood Mononuclear Cells
PBPK
Physiologically-Based Pharmacokinetic
PBPK/PD
Physiologically-Based Pharmacokinetic/Pharmacodynamic
PDM
Probabilistic Dilution Model
PE
Polyethylene
PECO
Population, Exposure, Comparator, and Outcome
PEL
Permissible Exposure Limit
PESS
Potentially Exposed or Susceptible Subpopulations
PF
Protection Factor
POD
Point of Departure
POTW
Publicly Owned Treatment Works
ppb
Part(s) per Billion
PPE
Personal Protective Equipment
ppm
Part(s) per Million
PVA
Polyvinyl Alcohol
PXR
Pregnane X Receptor
QC
Quality Control
QSAR
Quantitative Structure-Activity Relationships
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RBC Red blood cell
RCRA Resource Conservation and Recovery Act
RD Relative Deviation
REACH Registration, Evaluation, Authorisation and Restriction of Chemicals
REL Reference Exposure Level for California EPA OEHHA
RfC Reference Concentration
RfD Reference Dose
RICE Reciprocating Internal Combustion Engines
ROS Reactive Oxygen Species
RQ Risk Quotient
RTR Risk and Technology Review
SAR Supplied Air Respirator
SCBA Self-Contained Breathing Apparatus
SD Standard Deviation
SDH Succinate Dehydrogenase
SDS Safety Data Sheets
SDWA Safe Drinking Water Act
SEMS Superfund Enterprise Management System
SIC Standard Industrial Classification
SIDS Screening Information Data Set
SIR Standard Incidence Rate
SMAC Spacecraft Maximum Allowable Concentrations
SMR Standardized Mortality Ratio
SNAP Significant New Alternatives Policy
SpERC Specific Environmental Release Categories
STEL Short-Term Exposure Limit
STEWARDS Sustaining The Earth's Watersheds - Agricultural Research Database System
STORET STOrage and RETrieval database
SVOC Semivolatile Organic Compounds
SWC Surface Water Concentration
TLV Threshold Limit Value
TNO The Netherlands Organisation for Applied Scientific Research
TRI Toxics Release Inventory
TSCA Toxic Substances Control Act
TSDF Treatment, Storage, and Disposal Facility
TTO Total Toxic Organics
TWA Time-Weighted Average
UCL Upper confidence limit
UF Uncertainty Factor
UFa Interspecies Uncertainty/Variability Factor
UFh Interspecies Uncertainty Factor
UFl LOAEL-to-NOAEL Uncertainty Factor
U.K. United Kingdom
U.S. United States
U.S.C. United States Code
USGS United States Geological Survey
VOC Volatile Organic Compound
VER Visual Evoked Response
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WHO World Health Organization
wk Week
WQP Water Quality Portal
WQX Water Quality Exchange
WY Exposed Working Years per Lifetime
Yr Year(s)
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EXECUTIVE SUMMARY
This draft risk evaluation for methylene chloride was performed in accordance with the Frank R.
Lautenberg Chemical Safety for the 21st Century Act and is being disseminated for public comment
and peer review. The Frank R. Lautenberg Chemical Safety for the 21st Century Act amended the
Toxic Substances Control Act (TSCA), the Nation's primary chemicals management law, in June
2016. As per EPA's final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic
Substances Control Act (82 FR 33726). EPA is taking comment on this draft, and will also obtain peer
review on this draft risk evaluation for methylene chloride. All conclusions, findings, and
determinations in this document are preliminary and subject to comment. The final risk evaluation may
change in response to public comments received on the draft risk evaluation and/or in response to peer
review, which itself may be informed by public comments. The preliminary conclusions, findings, and
determinations in this draft risk evaluation are for the purpose of identifying whether the chemical
substance presents unreasonable risk or no unreasonable risk under the conditions of use, in
accordance with TSCA section 6, and are not intended to represent any findings under TSCA section
7.
TSCA § 26(h) and (i) require EPA to use scientific information, technical procedures, measures,
methods, protocols, methodologies and models consistent with the best available science and to base
its decisions on the weight of the scientific evidence. To meet these TSCA § 26 science standards,
EPA used the TSCA systematic review process described in the Application of Systematic Review in
TSCA Risk Evaluations document ( 018a). The data collection, evaluation, and integration
stages of the systematic review process are used to develop the exposure, fate, and hazard assessments
for risk evaluations.
Methylene chloride has a wide-range of uses, including as a solvent, propellent, or processing aid or
functional fluid in the manufacturing of other chemicals. A variety of consumer and commercial
products use methylene chloride as a solvent including sealants, automotive products, and paint and
coating removers. Methylene chloride is subject to federal and state regulations and reporting
requirements. Methylene chloride has been reportable to Toxics Release Inventory (TRI) chemical under
Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) since 1987. It is
designated a Hazardous Air Pollutant (HAP) under the Clean Air Act (CAA), and is a hazardous
substance under the Comprehensive Environmental Response, Compensation and Liability Act
(CERCLA). It is subject to National Primary Drinking Water Regulations (NPDWR) under the Safe
Drinking Water Act (SDWA) and designated as a toxic pollutant under the Clean Water Act (CWA) and
as such is subject to effluent limitations. Under TSCA, EPA previously assessed paint removers
containing methylene chloride in a previous risk assessment and finalized an unreasonable risk
determination for the consumer paint and coating remover condition of use ( 2014). A final
rule addressing unreasonable risks associated with methylene chloride in consumer paint and coating
removal was issued in March 2019 (84 FR 1140).
Methylene chloride is currently manufactured, processed, distributed, used, and disposed of as part of
industrial, commercial, and consumer conditions of use. Leading applications for methylene chloride
include: as a solvent in the production of pharmaceuticals and polymers, metal cleaning, production of
HFC-32, and as an ingredient in adhesives and paint removers. EPA evaluated the following categories
of conditions of use: manufacturing; processing; distribution in commerce, industrial, commercial and
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consumer uses and disposal. The total aggregate production volume ranged from 230 to 264 million
pounds between 2012 and 2015.
Approach
EPA used reasonably available information (defined in 40 CFR 702.33 as "information that EPA
possesses, or can reasonably obtain and synthesize for use in risk evaluations, considering the
deadlines for completing the evaluation"), in a fit-for-purpose approach, to develop a risk evaluation
that relies on the best available science and is based on the weight of the scientific evidence. EPA used
previous analyses as a starting point for identifying key and supporting studies to inform the exposure,
fate, and hazard assessments. EPA also evaluated other studies published since the publication of
previous analyses. EPA reviewed the information and evaluated the quality of the methods and
reporting of results of the individual studies using the evaluation strategies described in Application of
Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2018a).
In the problem formulation, EPA identified the conditions of use and presented three conceptual models
and an analysis plan for this draft risk evaluation. These have been carried into the draft risk evaluation
where EPA has quantitatively evaluated the risk to the environment and human health, using both
monitoring data and modeling approaches, for the conditions of use (identified in Section 1.4.1 of this
draft risk evaluation). EPA quantitatively evaluated the risk to aquatic species from exposure to surface
water, where as a result of the manufacturing, processing, use, or disposal of methylene chloride, there
were releases to the environment via air, water, sediment, biosolids or soil. EPA evaluated the risk to
workers, from inhalation and dermal exposures, and occupational non-users (ONUs)1, from inhalation
exposures, by comparing the estimated exposures to acute and chronic human health hazards. EPA also
evaluated the risk to consumers, from inhalation and dermal exposures, and bystanders, from inhalation
exposures, by comparing the estimated exposures to acute human health hazards.
EPA used environmental fate parameters, physical-chemical properties, modelling, and monitoring
data to assess ambient water exposure to aquatic organisms and sediment-dwelling organisms. While
methylene chloride is present in various environmental media, such as groundwater, surface water, and
air, EPA determined during problem formulation that no further analysis beyond what was presented
in the problem formulation document would be done for environmental exposure pathways in this
draft risk evaluation. However, exposures to aquatic organisms from ambient surface water, are
assessed and presented in this draft risk evaluation and used to inform the risk determination. These
analyses are described in sections 2.1, 2.3, and 4.1.
EPA evaluated exposures to methylene chloride in occupational and consumer settings for the
conditions of use included in the scope of the risk evaluation, listed in section 1.4 (Scope of the
Evaluation). In occupational settings, EPA evaluated acute and chronic inhalation exposures to workers
and ONUs, and acute and chronic dermal exposures to workers. EPA used inhalation monitoring data
from literature sources, where reasonably available and that met data evaluation criteria, as well as,
modeling approaches, where reasonably available, to estimate potential inhalation exposures. Dermal
doses for workers were estimated in these scenarios since dermal monitoring data was not reasonably
available. In consumer settings, EPA evaluated acute inhalation exposures to both consumers and
bystanders, and acute dermal exposures to consumers. Inhalation exposures and dermal doses for
consumers and bystanders in these scenarios was estimated since inhalation and dermal monitoring
1 ONUs are workers who do not directly handle methylene chloride but perform work in an area where methylene chloride is
present.
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data were not reasonably available. These analyses are described in section 2.4 of this draft risk
evaluation.
EPA reviewed the environmental hazard data using the data quality review evaluation metrics and the
rating criteria described in the Application of Systematic Review in TSCA Risk Evaluations (
2018a). EPA concluded that methylene chloride poses a hazard to environmental aquatic receptors with
amphibians being the most sensitive taxa for both acute and chronic exposures. The results of the
environmental hazard assessment are in section 3.1.
EPA evaluated reasonably available information for human health hazards and identified hazard
endpoints including acute and chronic toxicity for non-cancer effects and cancer. EPA used the
Framework for Human Health Risk Assessment to Inform Decision Making (EPA... 2014a) to evaluate,
extract, and integrate methylene chloride's human health hazard and dose-response information. EPA
reviewed key and supporting information from previous hazard assessments [EPA OPPT Risk
Assessment (U.S. EPA. 2014). EPA IRIS Toxicologic Review (U.S. EPA. 2.011). an AT SDR
Toxicological Profile ( \ i'l. 2000) and ( \ ['SDR. 2010) addendum, an Interim AEGL (Nac/Aegl.
2008). Spacecraft Maximum Allowable Concentrations Assessment (Nrc. 1996). Report on
Carcinogens, Twelfth Edition, Dichloromethane (NIH.: ), Occupational Exposure to Methylene
Chloride OSHA (1997b). Acute Reference Exposure Level (REL) and Toxicity Summary for
Methylene Chloride (Oehha. 2008a) and other international assessments listed in Table 1-3], EPA also
screened and evaluated new studies that were published since these reviews (i.e., from 2011 - 2018).
EPA developed a hazard and dose-response analysis using endpoints observed in inhalation and oral
hazard studies, evaluated the weight of the scientific evidence considering EPA and National Research
Council (NRC), risk assessment guidance and selected the points of departure (POD) for acute and
chronic, non-cancer endpoints, and inhalation unit risk and cancer slope factors for cancer risk
estimates. Potential health effects of methylene chloride exposure described in the literature include:
effects on the central nervous system (CNS), liver, immune system, as well as irritation/burns, and
cancer. EPA identified acute PODs for inhalation and dermal exposures based on acute CNS effects
observed in humans (Putz et al. 1979). The chronic POD for inhalation exposures are based on a study
observing increased liver vacuolation in rats (Nitscfake et al.. 1988a). EPA used a probabilistic
physiologically-based pharmacokinetic (PBPK) model for interspecies extrapolation from rats to
humans and for toxicokinetic variability among humans. EPA searched for but did not identify toxicity
studies by the dermal route that were adequate for dose-response assessment. Therefore, dermal
candidate values were derived by route-to-route extrapolation from the inhalation PODs mentioned
above. In accordance with U.S. EPA (2005a) Guidelines for Carcinogen Risk Assessment, methylene
chloride is considered "likely to be carcinogenic to humans" based on sufficient evidence in animals,
limited supporting evidence in humans, and mechanistic data showing a mutagenic mode of action
(MOA) relevant to humans. EPA calculated cancer risk with a linear model using cancer slope factors
based on evidence of increased risk of cancer in mice exposed to methylene chloride through air (Also
et al.. 2014a; NTP. 1986). The results of these analyses are described in section 3.2.
Risk Characterization
Environmental Risk: For environmental risk, EPA utilized a risk quotient (RQ) to compare the
environmental concentration to the effect level to characterize the risk to aquatic organisms. EPA
included a qualitive assessment describing methylene chloride exposure from sediments and land-
applied biosolids. Methylene chloride is not expected to accumulate in sediments, and is expected to be
mobile in soil, and migrate to water or volatilize to air. The results of the risk characterization are in
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section 4.1, including a table that summarizes the RQs for acute and chronic risks.
EPA identified expected environmental exposures for aquatic species under the conditions of use in the
scope of the risk evaluation. While the estimated releases from specific facilities result in modeled
surface water concentrations that were equal to or exceed the aquatic benchmark (RQ >1), all but two
conditions of use (recycling and disposal) had RQs < 1, indicating that exposures resulting from
environmental concentrations were less than the effect concentration, or the concentration of concern.
Details of these estimates are in section 4.1.2.
Human Health Risks: For human health risks to workers and consumers, EPA identified potential
cancer and non-cancer human health risks. Risks from acute exposures include central nervous system
risks such as central nervous system depression and a decrease in peripheral vision, each of which can
lead to workplace accidents and which are precursors to more severe central nervous system effects
such as incapacitation, loss of consciousness, and death. For chronic exposures, EPA identified risks of
non-cancer liver effects as well as liver and lung tumors.
For workers and ONUs, EPA estimated potential cancer risk from chronic exposures to methylene
chloride using inhalation unit risk or dermal cancer slope factors values multiplied by the chronic
exposure for each COU. For workers and ONUs, EPA also estimated potential non-cancer risks
resulting from acute or chronic inhalation or dermal exposures and used a Margin of Exposure (MOE)
approach. For workers, EPA estimated risks using several occupational exposure scenarios, which
varied assumptions regarding the expected use of personal protective equipment (PPE) for respiratory
and dermal exposures for workers directly handling methylene chloride. More information on
respiratory and dermal protection, including EPA's approach regarding the occupational exposure
scenarios for methylene chloride, is in section 2.4.1.1.
For workers, acute and chronic non-cancer risks (i.e., central nervous system effects and non-cancer
liver effects) were indicated for all conditions of use under high-end inhalation or dermal exposure
scenarios if PPE was not used. For most industrial and commercial use conditions of use, cancer risks
were also identified for high-end inhalation or dermal occupational exposure scenarios if PPE was not
used. With use of expected PPE during relevant conditions of use, worker exposures were estimated to
be reduced. This resulted in fewer conditions of use with estimated acute, chronic non-cancer, or cancer
inhalation or dermal risks. With expected use of respiratory protection, cancer risks from chronic
inhalation exposures were not indicated for most conditions of use. Similarly, with expected dermal
protection, acute, chronic non-cancer, and cancer risks were not indicated for most conditions of use.
However, some conditions of use continued to present non-cancer inhalation risks to workers under high
end occupational exposure scenarios even with expected PPE (respirators APF 25 or 50, and gloves of
various protection factors). Specifically, even with use of respirators (APF 25 or 50), acute and chronic
non-cancer risks were indicated for processing methylene chloride as part of one condition of use and
for most industrial and commercial uses of methylene chloride. EPA's estimates for worker risks for
each occupational exposure scenario are presented in section 4.2.2.1 and summarized in table 4-103 in
section 4.6.2.
For ONUs, acute and chronic non-cancer risks (i.e., central nervous system effects and non-cancer liver
effects) were indicated for high-end inhalation occupational exposure scenarios for processing
methylene chloride as part of several conditions of use, and for most industrial and commercial uses of
methylene chloride. Central tendency estimates of inhalation exposures showed that while fewer
conditions of use indicated acute or chronic non-cancer risks to ONUs, under many conditions of use,
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inhalation risks remained. ONUs were not expected to be using PPE to reduce exposures to methylene
chloride used in their vicinity. ONUs are not expected to be dermally exposed to methylene chloride and
dermal risks to ONUs were not identified. EPA's estimates for ONU risks for each occupational
exposure scenario are presented in sections 4.2.2.1 and 4.2.2.2 and table 4-103 in section 4.6.2.
For consumers and bystanders for consumer use, EPA estimated non-cancer risks resulting from acute
inhalation or dermal exposures that were modeled with a range of user intensities, described in detail
in section 2.4.2.1. EPA assumed that consumers or bystanders would not use PPE and that all
exposures would be acute, rather than chronic.
For consumers and bystanders, acute risks (of central nervous system effects) were indicated for most
conditions of use for consumers for medium and high intensity acute inhalation and dermal consumer
exposure scenarios. Conditions of use that indicated acute risks to consumer users (for inhalation and
dermal exposure) also indicated risks to bystanders (for inhalation exposures only). Some consumer
conditions of use did not indicate risks for consumer or bystanders. EPA's estimates for consumer and
bystander risks for each consumer use exposure scenario are presented in section 4.2.2.3 and
summarized in table 4-104 in section 4.6.3.
Uncertainties: Key assumptions and uncertainties in the environmental risk estimation include the
uncertainty around modeled releases that have surface water concentrations greater than the highest
concentration of concern for fish. For the human health risk estimation, key assumptions and
uncertainties are related to the estimates for ONU inhalation exposures, because monitoring data were
not readily available for many of the conditions of use evaluated. An additional source of uncertainty is
the inhalation to dermal route-to-route extrapolations, which is a source of uncertainty in the dermal
risk assessment for dermal cancer and non-cancer risk estimates. Similarly, for assessing cancer risks,
although EPA chose to model the combination of liver and lung tumor results from a cancer bioassay
using mice, there is uncertainty regarding the modeling of these tumor types for humans. Assumptions
and key sources of uncertainty are detailed in section 4.3.
Potentially Exposed Susceptible Subpopulations: TSCA § 6(b)(4) requires that EPA consider exposure
to " 'potentially exposed or susceptible subpopulation' means a group of individuals within the general
population identified by the Administrator who, due to either greater susceptibility or greater exposure,
may be at greater risk than the general population of adverse health effects from exposure to a chemical
substance or mixture, such as infants, children, pregnant women, workers, or the elderly." per TSCA §
3(12).
In developing the risk evaluation, EPA analyzed the reasonably available information to ascertain
whether some human receptor groups may have greater exposure or greater susceptibility than the
general population to the hazard posed by a chemical. For consideration of the most highly exposed
groups, EPA considered methylene chloride exposures to be higher among workers using methylene
chloride and ONUs in the vicinity of methylene chloride use than the exposures experienced by the
general population. Additionally, variability of susceptibility to methylene chloride may be correlated
with genetic polymorphism in its metabolizing enzymes. Factors other than polymorphisms that
regulate CYP2E1 may have greater influence on the formation of COHb, a metabolic product of
methylene chloride exposure. The CYP2E1 enzyme is easily inducible by many substances, resulting
in increased metabolism. For example, alcohol drinkers may have increased CO and COHb (Nac/Aegl.
2.008). Additionally, the COHb generated from methylene chloride is expected to be additive to COHb
from other sources. Populations of particular concern are smokers who maintain significant constant
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levels of COHb, persons with existing cardiovascular disease (ATSDR. 20001 and fetuses and infants.
Hemoglobin in the fetus has a higher affinity for CO than does adult hemoglobin. Thus, the neurotoxic
and cardiovascular effects may be exacerbated in fetuses and infants with higher residual levels of fetal
hemoglobin when exposed to high concentrations of methylene chloride (OEHHA... 2008b).
Aggregate and Sentinel Exposures Section 2605(b)(4)(F)(ii) of TSCA requires the EPA, as a part of the
risk evaluation, to describe whether aggregate or sentinel exposures under the conditions of use were
considered and the basis for their consideration. The EPA has defined aggregate exposure as "the
combined exposures to an individual from a single chemical substance across multiple routes and
across multiple pathways (40 CFR § 702.33)." Exposures to methylene chloride were evaluated by
inhalation and dermal routes separately. Inhalation and dermal exposures are assumed to occur
simultaneously for workers and consumers. EPA chose not to employ simply additivity of exposure
pathways at this time within a condition of use because of the uncertainties present in the current
exposure estimation procedures and this may lead to an underestimate of exposure.
The EPA defines sentinel exposure as "the exposure to a single chemical substance that represents the
plausible upper bound of exposure relative to all other exposures within a broad category of similar or
related exposures (40 CFR § 702.33)." In this risk evaluation, the EPA considered sentinel exposure the
highest exposure given the details of the conditions of use and the potential exposure scenarios.
Risk Determination
In each risk evaluation under TSCA section 6(b), EPA determines whether a chemical substance
presents an unreasonable risk of injury to health or the environment, under the conditions of use. The
determination does not consider costs or other non-risk factors. In making this determination, EPA
considers relevant risk-related factors, including, but not limited to: the effects of the chemical substance
on health and human exposure to such substance under the conditions of use (including cancer and non-
cancer risks); the effects of the chemical substance on the environment and environmental exposure
under the conditions of use; the population exposed (including any potentially exposed or susceptible
subpopulations); the severity of hazard (including the nature of the hazard, the irreversibility of the
hazard); and uncertainties. EPA also takes into consideration the Agency's confidence in the data used
in the risk estimate. This includes an evaluation of the strengths, limitations, and uncertainties associated
with the information used to inform the risk estimate and the risk characterization. The rationale for the
risk determination is discussed in section 5.2.
Environmental Unreasonable Risks: All but two conditions of use evaluated had RQs < 1, and EPA
determined that these conditions of use do not present unreasonable risks. Chronic risk was identified for
those facilities where RQ exceeded 1 and threshold days of exceedance were surpassed. In general, the
majority of releases of methylene chloride to the aquatic environment do not exceed the aquatic
benchmark. However, there are specific facilities where estimate releases resulted in modeled surface
water concentrations exceeding the aquatic benchmark (RQ >1). Given the uncertainties in the data for
the limited number of data points above the RQ, EPA does not consider these risks unreasonable (see
Section 5.2).
Unreasonable Risks of Injury to Health: EPA's determination of unreasonable risk for specific
conditions of use of methylene chloride listed below are based on health risks to workers, occupational
non-users, consumers, or bystanders from consumer use. As described below, risks to general population
either were not relevant for these conditions of use or were evaluated and not found to be unreasonable.
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Risks from acute exposures include central nervous system risks such as central nervous system
depression and a decrease in peripheral vision, each of which can lead to workplace accidents and which
are precursors to more severe central nervous system effects such as incapacitation, loss of
consciousness, and death. For chronic exposures, EPA identified risks of non-cancer liver effects
(including vacuolization, necrosis, hemosiderosis and hepatocellular degeneration) as well as liver and
lung tumors.
Unreasonable Risk to the General Population: As part of the problem formulation for methylene
chloride, EPA identified exposure pathways covered under the jurisdiction of other environmental
statutes, administered by EPA, which adequately assess and effectively manage exposures and for which
long-standing regulatory and analytical processes already exist, i.e., CAA, SDWA, CWA, and RCRA.
The Office of Chemical Safety and Pollution Prevention works closely with EPA offices that administer
and implement the regulatory programs under these statutes. EPA believes this TSCA risk evaluation
should focus on those exposure pathways associated with TSCA uses that are not subject to the
regulatory regimes discussed above because these pathways are likely to represent the greatest areas of
concern to EPA. Exposures to methylene chloride by receptors (i.e., general population) may occur from
industrial and/or commercial uses; industrial releases to air, water or land; and other conditions of use,
and as described above, other environmental statutes administered by EPA adequately assess and
effectively manage these exposures. Therefore, EPA did not evaluate hazards or exposures to the general
population in this risk evaluation, and there is no risk determination for the general population (U.S.
!8c).
Unreasonable Risk to Workers: EPA evaluated workers' acute and chronic inhalation and dermal
occupational exposures for cancer and non-cancer risks and determined whether any risks indicated are
unreasonable. The drivers for EPA's determination of unreasonable risk for workers are central nervous
system effects resulting from acute inhalation exposure, liver adverse effects from chronic inhalation
exposure, or both. Generally, risks identified for workers are linked to acute and chronic inhalation
exposures.
EPA evaluated dermal exposure for workers and did not find these risks to be unreasonable. The
determinations reflect the severity of the effects associated with the occupational exposures to
methylene chloride and incorporate consideration of expected PPE (frequently estimated to be a
respirator of APF 25 or 50 and gloves with PF 5 - 20). For workers, EPA determined that the conditions
of use that presented unreasonable risks included processing methylene chloride into a formulation or
mixture; all but two industrial and commercial uses; and disposal. A full description of EPA's
determination for each condition of use is in section 5.2.
Unreasonable Risks to Occupational Non-Users (ONUs): EPA evaluated ONU acute and chronic
inhalation occupational exposures for cancer and non-cancer risks and determined whether any risks
indicated are unreasonable. The drivers for EPA's determination of unreasonable risks to ONUs are
central nervous system effects resulting from acute inhalation exposure, liver adverse effects resulting
from chronic inhalation exposure, and cancer effects (liver and lung tumors) from chronic inhalation
exposure. Generally, risks identified for ONUs are linked to acute and chronic inhalation exposures. The
determinations reflect the severity of the effects associated with the occupational exposures to
methylene chloride and the expected absence of PPE for ONUs. For dermal exposures, because ONUs
are not expected to be dermally exposed to methylene chloride, dermal risks to ONUs generally were
not identified. For inhalation exposures, EPA, where possible, estimated ONU exposures and described
the risks separately from workers directly exposed. While the difference between ONU exposures and
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workers directly handling the chemical generally cannot be quantified, EPA assumed that, in most cases,
ONU inhalation exposures are expected to be lower than inhalation exposures for workers directly
handling the chemical substance. To account for those instances where monitoring data or modeling did
not distinguish between worker and ONU inhalation exposure estimates, EPA considered the central
tendency risk estimate when determining ONU risk. For ONUs, EPA determined that the conditions of
use that presented unreasonable risks included import of methylene chloride, processing methylene
chloride as a reactant in sever industrial sectors, some industrial and commercial uses, and disposal.
EPA determined in some cases that a condition of use presented an unreasonable risk to not only
workers but also ONUs; in other cases, EPA determined that a condition of use presented an
unreasonable risk only to one or the other. This resulted from expectations regarding PPE use by
workers or uncertainty regarding ONU exposures. A full description of EPA's determination for each
condition of use is in section 5.2.
Unreasonable Risk to Consumers: EPA evaluated consumer acute inhalation and dermal exposures for
non-cancer risks and determined whether the risks indicated are unreasonable. The driver for EPA's
determination of unreasonable risk is central nervous system effects from acute inhalation or dermal
exposure. Generally, risks for consumers were indicated by acute inhalation and dermal exposure at
medium and high intensity use. For consumers, EPA determined that all but two consumer conditions of
use present unreasonable risks. A full description of EPA's determination for each condition of use is in
section 5.2.
Unreasonable Risk to Bystanders (from consumer uses): EPA evaluated bystander acute inhalation
exposures for non-cancer risks and determined whether the risks indicated are unreasonable. The driver
for EPA's determination of unreasonable risk is central nervous system effects from acute inhalation
exposure. Generally, risks for bystanders were indicated by acute inhalation exposure scenarios at
medium and high intensity use. Because bystanders are not expected to be dermally exposed to
methylene chloride, dermal non-cancer risks to bystanders were not identified. When EPA determined
that a condition of use presented risks to consumers, unreasonable risks were, often, but not always,
identified for bystanders. A full description of EPA's determination for each condition of use is in
section 5.2.
Summary of Risk Determinations:
EPA has determined that the following conditions of use of methylene chloride do not present an
unreasonable risk of injury to health. The details of these determinations are presented in table 5-1 in
section 5.2.
Conditions of I so llisit Do Not Present sin I nreiisonnhle Kisk
• Domestic manufacture
• Processing as a reactant
• Distribution in commerce
• Industrial and commercial use as a laboratory chemical for all other chemical product and preparation
manufacturing
• Consumer use as a brush cleaner for paints and coatings
• Consumer use as a brush cleaner for other uses
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368 EPA has determined that the following conditions of use of methylene chloride present an unreasonable
369 risk of injury to health to workers (including, in some cases, occupational non-users) or to consumers
370 (including, in some cases, bystanders). The details of these determinations are presented in table 5-1 in
371 section 5.2.
372
MiHiMl'su'luring I so Ih:it Presents ;in I nresisonsihle Risk
• Import
373
Processing I ses (lint Present 2111 I nresisonsihle Risk
• Incorporation into a formulation, mixture or reaction product
• Repackaging
• Recycling
374
Indnslrisil sinri ( oniniercinl I ses llisil Present 2111 I nresisonsihle Kisk
• As a solvent for batch vapor degreasing
• As a solvent for in-line vapor degreasing
• As a solvent for cold cleaning
• As a solvent for aerosol spray degreaser/cleaner
• In single component glues and adhesives and sealants and caulks
• For paints and coatings
• For paints and coatings remover
• For adhesive/caulk removers
• As a metal products aerosol spray degreaser/cleaner
• For metal products not covered elsewhere for non-aerosol degreases
• As a fabric, textile, and leather product not covered elsewhere
• As automotive care products for function fluids for air conditioners
• As an automotive care product for interior car care
• As an automotive care product for degreasers
• As an apparel and footwear care product for post market waxes and polishes
• As a laundry and dishwashing product
• As a lubricant and grease in spray lubricants and greases
• As a lubricant and grease in liquid lubricants and greases
• As a lubricant and grease in aerosol degreasers and cleaners
• As a lubricant and grease in non-aerosol degreasers and cleaners
• As a building construction material not covered elsewhere for cold pipe insulations
• As a solvent for all other chemical product and preparation manufacturing
• As a processing aid not otherwise listed for multiple manufacturing sectors
• As a propellant and blowing agent for flexible polyurethane foam manufacturing
• As other uses for electrical equipment, appliance, and component manufacturing
• For plastic and rubber products (plastic manufacturing)
• For plastic and rubber products (cellulose triacetate film production)
• For other uses as an anti-spatter welding aerosol
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Inriuslrisil sinri ( oinincreinl I sos thill Present 2111 I nresisonsihle Kisk
• As other uses for oil and gas drilling, extraction, and support activities
• For functional fluids in pharmaceutical and medicine manufacturing
• As other uses for toys, playground, and sporting equipment including novelty articles
• As a lithographic printing cleaner
• In other uses for carbon remover, wood floor cleaner, and brush cleaner
375
Consumer I ses Unit Prcscnl ;i 11 I nrcnsonnhlc Kisk
• As a solvent in an aerosol spray degreaser/cleaner (brake cleaner)
• As a solvent in an aerosol spray degreaser/cleaner (carbon remover)
• Consumer use as a solvent in an aerosol spray degreaser/cleaner (carburetor cleaner)
• As a solvent in an aerosol spray degreaser/cleaner (coil cleaner)
• As a solvent in an aerosol spray degreaser/cleaner (electronics cleaner)
• As a solvent in an aerosol spray degreaser/cleaner (engine cleaner)
• As a solvent in an aerosol spray degreaser/cleaner (gasket remover)
• As an adhesive and sealant for single component glues and adhesives and sealants and caulks
(adhesives)
• As an adhesive and sealant for single component glues and adhesives and sealants and caulks (sealants)
• As an adhesive/caulk remover
• As a metal product not covered elsewhere in aerosol and non-aerosol degreasers (carbon remover)
• As a metal product not covered elsewhere in aerosol and non-aerosol degreasers (coil cleaner)
• As a metal product not covered elsewhere in aerosol and non-aerosol degreaser (electronics cleaner)
• As an automotive care product for functional fluids for air conditioners: refrigerant, treatment, leak
sealer (automotive air conditioning leak sealer)
• As an automotive care product for functional fluids for air conditioners: refrigerant, treatment, leak
sealer (automotive air conditioning refrigerant)
• As an automotive care product in degreasers (brake cleaner)
• As an automotive care product in degreasers (carburetor cleaner)
• As an automotive care product in degreasers (engine cleaner)
• As an automotive care product in degreasers (gasket remover)
• As a lubricant and grease in degreasers (brake cleaner)
• As a lubricant and grease in degreasers (carburetor cleaner)
• As a lubricant and grease in degreasers (engine cleaner)
• As a lubricant and grease in degreasers (gasket remover)
• As a building construction material not covered elsewhere for cold pipe insulation
• As an arts, crafts, and hobby materials for crafting glue and cement/concrete
• As other uses for anti-adhesive agent - anti-spatter welding aerosol
• As other uses for carbon remover
376
Disposal I selhsil Presents sin I nre:ison;ihle Kisk
• Disposal
377
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1 INTRODUCTION
This document presents for comment the draft risk evaluation for methylene chloride under the Frank R.
Lautenberg Chemical Safety for the 21st Century Act. The Frank R. Lautenberg Chemical Safety for the
21st Century Act amended the Toxic Substances Control Act (TSCA), the Nation's primary chemicals
management law, passed in June 2016.
The Environmental Protection Agency (EPA) published the Scope of the Risk Evaluation for methylene
chloride in June 2017 (U.S. EPA. 2017c). and the problem formulation in June, 2018 (
2018c). These which represented the analytical phase of risk evaluation in which "the purpose for the
assessment is articulated, the problem is defined, and a plan for analyzing and characterizing risk is
determined" as described in Section 2.2 of the Framework for Human Health Risk Assessment to Inform
Decision Making. The problem formulation identified conditions of use and presented three conceptual
models and an analysis plan. Based on EPA's analysis of the conditions of use, physical-chemical and
fate properties, environmental releases, and exposure pathways, the problem formulation preliminarily
concluded that further analysis was necessary for exposure pathways to ecological receptors exposed via
surface water, workers, and consumers. The conclusions of the problem formulation were that no further
analysis is necessary in the risk evaluation for sediment, soil and land-applied biosolid pathways leading
to exposure to terrestrial and aquatic organisms. Further analysis was not conducted for biosolid, soil
and sediment pathways based on a qualitative assessment of the physical-chemical properties and fate of
methylene chloride in the environment and a quantitative comparison of hazards and exposures for
aquatic and terrestrial organisms. The qualitative assessment for methylene chloride is presented in
Appendix H. EPA also excluded from risk evaluation ambient air, drinking water, land disposal, ambient
water, and waste incineration pathways leading to exposures to the general population and terrestrial
organisms since those pathways are regulated under other environmental statutes administered by EPA
which adequately assess and effectively manage exposures. The qualitative assessment for methylene
chloride is presented in Appendix H. EPA received comments on the published problem formulation for
methylene chloride and has considered the comments specific to methylene chloride, as well as more
general comments regarding EPA's chemical risk evaluation approach for developing the draft risk
evaluations for the first 10 chemicals EPA is evaluating.
In this draft risk evaluation, Section 1.1 presents the basic physical-chemical characteristics of
methylene chloride, as well as a background on regulatory history, conditions of use, and conceptual
models, with particular emphasis on any changes since the publication of the problem formulation. This
section also includes a discussion of the systematic review process utilized in this draft risk evaluation.
Section 1 provides a discussion and analysis of the exposures, both health and environmental, that can
be expected based on the conditions of use for methylene chloride. Section 3 discusses environmental
and health hazards of methylene chloride. Section 4 presents the risk characterization, where EPA
integrates and assesses reasonably available information on health and environmental hazards and
exposures, as required by TSCA (15 U.S.C. 2605(b)(4)(F)). This section also includes a discussion of
any uncertainties and how they impact the draft risk evaluation. Section 5 presents EPA's proposed
determination of whether the chemical presents an unreasonable risk under the conditions of use, as
required under TSCA (15 U.S.C. 2605(b)(4)).
As per EPA's final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic
Substances Control Act (82 FR 33726 (July 20, 2017)), this draft risk evaluation will be subject to both
public comment and peer review, which are distinct but related processes. EPA is providing 60 days for
public comment on any and all aspects of this draft risk evaluation, including the submission of any
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additional information that might be relevant to the science underlying the risk evaluation and the
outcome of the systematic review associated with methylene chloride. This satisfies TSCA (15 U.S.C.
2605(b)(4)(H)), which requires EPA to provide public notice and an opportunity for comment on a draft
risk evaluation prior to publishing a final risk evaluation.
Peer review will be conducted in accordance with EPA's regulatory procedures for chemical risk
evaluations, including using the EPA Peer Review Handbook and other methods consistent with section
26 of TSCA (See 40 CFR 702.45). As explained in the Risk Evaluation Rule (82 FR 33726 (July 20,
2017)), the purpose of peer review is for the independent review of the science underlying the risk
assessment. Peer review will therefore address aspects of the underlying science as outlined in the
charge to the peer review panel such as hazard assessment, assessment of dose-response, exposure
assessment, and risk characterization.
As EPA explained in the Risk Evaluation Rule (82 FR 33726 (July 20, 2017)), it is important for peer
reviewers to consider how the underlying risk evaluation analyses fit together to produce an integrated
risk characterization, which forms the basis of an unreasonable risk determination. EPA believes peer
reviewers will be most effective in this role if they receive the benefit of public comments on draft risk
evaluations prior to peer review. For this reason, and consistent with standard Agency practice, the
public comment period will precede peer review on this draft risk evaluation. The final risk evaluation
may change in response to public comments received on the draft risk evaluation and/or in response to
peer review, which itself may be informed by public comments. EPA will respond to public and peer
review comments received on the draft risk evaluation and will explain changes made to the draft risk
evaluation for methylene chloride in response to those comments in the final risk evaluation.
EPA solicited input on the first 10 chemicals as it developed use documents, scope documents, and
problem formulations. At each step, EPA has received information and comments specific to individual
chemicals and of a more general nature relating to various aspects of the risk evaluation process,
technical issues, and the regulatory and statutory requirements. EPA has considered comments and
information received at each step in the process and factored in the information and comments as the
Agency deemed appropriate and relevant including comments on the published problem formulation of
methylene chloride. Thus, in addition to any new comments on the draft risk evaluation, the public
should re-submit or clearly identify at this point any previously filed comments, modified as appropriate,
that are relevant to this risk evaluation and that the submitter feels have not been addressed. EPA does
not intend to further respond to comments submitted prior to the publication of this draft risk evaluation
unless they are clearly identified in comments on this draft risk evaluation.
1.1 Physical and Chemical Properties
Physical-chemical properties influence the environmental behavior and the toxic properties of a
chemical, thereby informing the potential conditions of use, exposure pathways and routes and hazards
that EPA is evaluating. For scope development, EPA considered the measured or estimated physical-
chemical properties set forth in Table 1-1; EPA found no additional information during problem
formulation or development of this draft risk evaluation that would change these values.
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Table 1-1. Physical and Chemical Properties of Methylene Chloride
Property
Measured Values
References
Data Quality
Rating
Molecular formula
CH2CI2
Molecular weight
84.93 g/mol
Physical form
Colorless liquid; sweet,
pleasant odor resembling
chloroform
U.S. Coast Guard (1984)
High
Melting point
-95°C
O'Neil (2013)
High
Boiling point
39.7°C
O'Neil (2013)
High
Density
1.33 g/cm3 at 20°C
O'Neil (2013)
High
Vapor pressure
435 mmHg at 25°C
Boublik et al. (1984)
High
Vapor density
2.93 (relative to air)
Holbrook (2003)
High
Water solubility
13 g/L at 25°C
Horvath (1982)
High
Octanol/water partition
coefficient (log Kow)
1.25
Hansch et al. (1995)
High
Henry's Law constant
0.00291 atm-m3/mole
Leighton and Calo (1981)
High
Flash point
Not readily available
Autoflammability
Not readily available
Viscosity
0.437 mPa-s at 20°C
Rossberg et al. (2011)
High
Refractive index
1.4244 at 20°C
O'Neil (2013)
High
Dielectric constant
9.02 at 20°C
Laurence et al. (1994)
High
1.2 Uses and Production Volume
Methylene chloride has a wide-range of uses, including in sealants, automotive products, and paint and
coating removers. EPA assessed paint removers containing methylene chloride in a previous risk
assessment but only finalized an unreasonable risk determination for the consumer paint and coating
remover condition of use (U.S. EPA. 2014). Methylene chloride is also used by federal agencies in a
variety of uses, including those deemed mission critical. The use of paint and coating removers
containing methylene chloride in industrial or commercial sectors are included in this risk evaluation;
the resultant analysis is described in Appendix L.
Methylene chloride has known applications as a process solvent in paint removers and the manufacture
of pharmaceuticals and film coatings. It is used as an agent in urethane foam blowing and in the
manufacture of hydrofluorocarbon (HFC) refrigerants, such as HFC-32. It can also be found in aerosol
propellants and in solvents for electronics manufacturing, metal cleaning and degreasing, and furniture
finishing. Additionally, it has been used for agricultural and food processing purposes such as an
extraction solvent for spice oleoresins, hops, and for the removal of caffeine from coffee, a degreening
agent for citrus fruits, and a postharvest fumigant for grains and strawberries (Processing Magazine.
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2015; U.S. EPA. 2000). However methylene chloride is no longer contained in any registered pesticide
products and was removed from the list of pesticide product inert ingredients (63 FR 34384, June 24,
1998) and tolerance exemptions for methylene chloride in foods were revoked (67 FR 16027, April 4,
2002) (see Appendix A for more information).
In 2005, the use percentages of methylene chloride by sector were as follows: paint stripping and
removal (30%), adhesives (22%), pharmaceuticals (11%), metal cleaning (8%), aerosols (8%), chemical
processing (8%), flexible polyurethane foam (5%), and miscellaneous (8%) (ICIS. 2005).
As of 2016, the leading applications for methylene chloride are as a solvent in the production of
pharmaceuticals and polymers and paint removers, although recent regulations are expected to decrease
the chemical's use in the paint remover sector. An estimated 35 percent of consumption is attributable to
pharmaceuticals and chemical processing, with pharmaceutical production accounting for roughly 30
percent of methylene chloride's use. Other applications include metal cleaning, production of HFC-32,
and as an ingredient in adhesives and paint removers. Foam blowing is a minor use of methylene
chloride (IHS Markit. 2016).
The Chemical Data Reporting (CDR) Rule under TSCA requires U.S. manufacturers (including
importers) to provide EPA with information on the chemicals they manufacture or import into the U.S.
For the 2016 CDR cycle, data collected per chemical include the company name, volume of each
chemical manufactured/imported, the number of workers at each site, and information on whether the
chemical is used in the Commercial, Industrial, and/or Consumer sector. However, only companies that
manufactured or imported 25,000 pounds or more of methylene chloride at each of their sites during the
2015 calendar year were required to report information under the CDR rule (U.S. EPA. 2016).
The 2016 CDR reporting data for methylene chloride are provided in Table 1-2. from EPA's CDR
database.
Table 1-2. Production Volume of Methylene Chloride in CDR Reporting Periot
(2012 to 2015)a
Reporting Year
2012
2013
2014
2015
Total Aggregate
Production Volume (lbs)
230,896,388
230,498,027
248,241,495
263,971,494
a The CDR data for the 2016 rcDortina period is available via ChemView (httDs://ia\ a.cDa.ao\ /chcin\ ic\\ ) (U.S. EPA.
2016). Because of an onsoins Confidential Business Information (CBI) substantiation oroccss reauired bv amended TSCA.
the CDR data available in the risk evaluation is more specific than currently in ChemView.
1.3 Regulatory and Assessment History
EPA conducted a search of existing domestic and international laws, regulations and assessments
pertaining to methylene chloride. EPA compiled this summary from available federal, state,
international and other government data sources, as cited in Appendix A.
Federal Laws and Regulations
Methylene chloride is subject to other federal statutes and regulations that are implemented by other
offices within EPA and/or other federal agencies/departments. A summary of federal laws, regulations
and implementing authorities is provided in Appendix A.l.
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State Laws and Regulations
Methylene chloride is subject to state statutes and regulations implemented by state agencies or
departments. A summary of state laws, regulations and implementing authorities is provided in
Appendix A. 2.
Laws and Regulations in Other Countries and International Treaties or Agreements
Methylene chloride is subject to statutes and regulations in countries other than the U.S. and/or
international treaties and/or agreements. A summary of these laws, regulations, treaties and/or
agreements is provided in Appendix A.3.
Assessment History
EPA identified assessments conducted by other EPA Programs and other organizations (see Table 1-3).
Depending on the source, these assessments may include information on conditions of use, hazards,
exposures and potentially exposed or susceptible subpopulations (PESS). EPA found no additional
assessments beyond those listed in the Problem Formulation document (see Table 1-1 in Methylene
Chloride Problem Formulation document).
Table 1-3. Assessment History of Methylene Chloride
Authoring Organization
Assessment
EPA Assessments
U.S. EPA, Office of Pollution Prevention and
Toxics (OPPT)
TSCA Work Plan Chemical Risk Assessment
Methylene Chloride: Paint StriDDins Use CASRN:
75-09-2 U.S. EPA (2014)
U.S. EPA, Integrated Risk Information System
(IRIS)
Toxicolosical Review of Dichloromethane
(Methylene Chloride) (CAS No. 75-09-2) U.S.
EPA (2011)
U.S. EPA, Office of Water (OW)
Ambient Water Oualitv Criteria for the Protection
of Human Health U.S. EPA (2015)
Other U.S.-Based Organizations
Agency for Toxic Substances and Disease Registry
(AT SDR)
Toxicolosical Profile for Methylene Chloride
AT SDR (2000) and ATSDR (2010) addendum
National Advisory Committee for Acute Exposure
Guideline Levels for Hazardous Substances
(NAC/AEGL Committee)
Interim Acute Exposure Guideline Levels (AEGL)
for Methylene Chloride Nac/Aesl (2008)
U.S. National Academies, National Research
Council (NRC)
Spacecraft Maximum Allowable Concentrations
(SMAC) for Selected Airborne Contaminants:
Methylene chloride (Volume 2) Nrc (1996)
National Toxicology Program (NTP), National
Institutes of Health (NIH)
Report on Carcinogens, Twelfth Edition,
Dichloromethane NIH (2016)
Occupational Safety and Health Administration
(OSHA)
Occupational Exposure to Methylene Chloride
OSHA (1997b)
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Authoring Organization
Assessment
California Environmental Protection Agency,
Office of Environmental Health Hazard
Assessment (OEHHA)
Acute Reference Exposure Level (REL) and
Toxicitv Summary for Methylene Chloride Oehha
(2008a)
Public Health Goal for Methylene Chloride in
Drinking Water Oehha (2000)
International
Organisation for Economic Co-operation and
Development (OECD), Cooperative Chemicals
Assessment Program (CoCAP)
Dichloromethane: SIDS Initial Assessment Profile
OECD (2011)
International Agency for Research on Cancer
(IARC)
IARC Monographs on the Evaluation of
Carcinogenic Risks to Humans Volume 110 IARC
(2016)
World Health Organization (WHO)
Air Oualitv Guidelines for Europe WHO (2000)
WHO International Programme on Chemical
Safety (IPCS)
Environmental Health Criteria 164 Methylene
Chloride WHO (1996b)
Government of Canada, Environment Canada,
Health Canada
Dichloromethane. Priority substances list
assessment report. Health Canada (1993)
National Industrial Chemicals Notification and
Assessment Scheme (NICNAS), Australian
Government
Human Health Tier II Assessment for Methane,
dichloro- CAS Number: 75-09-2 NICNAS (2016)
1.4 Scope of the Evaluation
1.4.1 Conditions of Use Included in the Risk Evaluation
TSCA § 3(4) defines the conditions of use as "the circumstances, as determined by the Administrator,
under which a chemical substance is intended, known, or reasonably foreseen to be manufactured,
processed, distributed in commerce, used, or disposed of." Following the publication of the problem
formulation, EPA finalized a rule that prohibits the manufacture (including import), processing and
distribution of methylene chloride in all paint and coating removers for consumer use (40 CFR Part 751,
Part B). EPA did not finalize any unreasonable risk determination for or regulate methylene chloride in
commercial paint and coating removal as part of that rule; thus, this draft risk evaluation now includes
commercial paint and coating remover uses (see Appendix L). This change is identified in Table 1-4,
which identifies the conditions of use being evaluated, including those presented in the use document
(EPA-HQ-QPPT-2016-0742). the life cycle diagram as presented in the problem formulation (U.S. EPA.
2018c). or received through public comment. Problem formulation also included mention of consumer
uses such as metal products not covered elsewhere, apparel and footwear care products and laundry and
dishwashing products. Those conditions of use are not evaluated here as no applicable consumer
products were found for these uses after additional review.
The life cycle diagram is presented below in Figure 1-1.
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MFG/IMPORT
PROCESSING
INDUSTRIAL, COMMERCIAL, CONSUMER USES a
RELEASES and WASTE DISPOSAL
558
559
560
561
562
563
564
565
566
Solvents for Cleaning or Degreasing
(Volume CBI)
Adhesives and Sealants
(Volume CBI)
e.g., glues and caulks
Paints and Coatings
(> 839,000 lbs)
Including Paint and coating removers for
furniture stripping and adhesive removers
Metal Products
(Volume CBI)
Fabric, Textile, and Leather Products
(Volume CBI)
Automotive Care Products
(11,000 lbs)
Apparel and Footwear Care Products
(Volume CBI)
See Figure 1-4 for Environmental
Releases and Wastes
Laundry and Dishwashing Products
(Volume CBI)
] Manufacturing (includes import)
Lubricants and Greases
(187,000 lbs)
Processing
Other Uses including
Building/Construction Materials Not Covered
Elsewhere; Solvents (which become part of
product formation or mixture); Processing Aids
Not Otherwise Listed; Propellantsand Blowing
Agents; Arts, Crafts and Hobby Materials;
Functional fluids (closed systems); Laboratory
Chemicals
~ Uses. At the level of detail in the life cycle
diagram EPA is not distinguishing between
industrial/commercial/consumer uses. The
differences between these uses will be
further investigated and defined during risk
evaluation.
Recycling
(Volume CBI)
Repackaging
(> 227,000 lbs)
Manufacturing
(includes import)
(264 million lbs)
Processing as Reactant
(Volume CBI)
e.g., intermediate for
refrigerant manufacture
Incorporated into
Formulation, Mixture
or Reaction Product
(> 557,000 lbs)
e.g., Polyurethane Foam
Blowing
Disposal
Figure 1-1. Methylene Chloride Life Cycle Diagram
The life cycle diagram depicts the conditions of use that are within the scope of the risk evaluation during various life cycle stages including manufacturing, processing,
use (industrial, commercial, consumer), distribution and disposal. The production volumes shown are for reporting year 2015 from the 2016 CDR reporting period (U.S.
EPA. 2016). Activities related to distribution (e.g., loading and unloading) are evaluated throughout the methylene chloride life cycle, rather than using a single
distribution scenario.
a See Table 1-4 for additional uses not mentioned specifically in this diagram.
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567 Table 1-4. Categories and Subcategories of Conditions of Use Included in the Scope of the
568 Risk Evaluation
Life Cycle
Stage
Category a
Subcategory b
References
Manufacturing
Domestic
manufacturing
Manufacturing
U.S. EPA (2016)
Import
Import
U.S. EPA (2016)
Processing
Processing as a
reactant
Intermediate in industrial gas
manufacturing (e.g.,
manufacture of fluorinated
gases used as refrigerants)
U.S. EPA (2016); U.S.
EPA (2014) Market
profile EPA-HQ-OPPT-
2016-0742 Public
Comments EPA-HO-
OPPT-2016-0742-0016.
EP A-HO-OPPT-2016-
0742-0017. EPA-HO-
OPPT-2016-0742-0019
Intermediate for pesticide,
fertilizer, and other agricultural
chemical manufacturing
U.S. EPA (2016)
petrochemical manufacturing*
U.S. EPA (2016)
Intermediate for other
chemicals
Public Comment EPA-
HO-OPPT-2016-0742-
0008
Incorporated into
formulation,
mixture, or
reaction product
Solvents (for cleaning or
degreasing), including
manufacturing of:
• All other basic organic
chemical
• Soap, cleaning
compound and toilet
preparation
U.S. EPA (2016)
Solvents (which become part of
product formulation or
mixture), including
manufacturing of:
• All other chemical
product and preparation
• Paints and coatings
U.S. EPA (2016)
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Life Cycle
Stage
Category a
Subcategory b
References
Propellants and blowing agents
for all other chemical product
and preparation manufacturing;
U.S. EPA (2016)
Propellants and blowing agents
for plastics product
manufacturing
Use document EPA-HO-
OPPT-2016-0742-0003.
Market profile EPA-HO-
OPPT-2016-0742
Paint additives and coating
additives not described by
other codes for CBI industrial
sector*
U.S. EPA (2016)
Laboratory chemicals for all
other chemical product and
preparation manufacturing
U.S. EPA (2016). EPA-
HO-OPPT-2016-0742-
0005. EPA-HO-OPPT-
2016-0742-0014
Laboratory chemicals*
U.S. EPA (2016)
Processing aid, not otherwise
listed for petrochemical
manufacturing
U.S. EPA (2016)
Adhesive and sealant
chemicals in adhesive
manufacturing
Use document EPA-HO-
OPPT-2016-0742-0003;
U.S. EPA (2016)
oil and gas drilling, extraction,
and support activities*
Use document EPA-HO-
OPPT-2016-0742-0003;
U.S. EPA (2016)
Repackaging
Solvents (which become part of
product formulation or
mixture) for all other chemical
product and preparation
manufacturing
Use document EPA-HO-
OPPT-2016-0742-0003;
U.S. EPA (2016)
all other chemical product and
preparation manufacturing*
Use document EPA-HO-
OPPT-2016-0742-0003;
U.S. EPA (2016)
Recycling
Recycling
U.S. EPA (2017e)
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Life Cycle
Stage
Category a
Subcategory b
References
Distribution in
commerce
Distribution
Distribution
Use document EPA-HO-
OPPT-2016-0742-0003
U.S. EPA (2016)
Industrial,
commercial and
consumer uses
Solvents (for
cleaning or
degreasing)c
Batch vapor degreaser (e.g.,
open-top, closed-loop)
Use document EPA-HO-
OPPT-2016-0742-0003;
U.S. EPA (2016); Public
comment EPA-HO-
OPPT-2016-0742-0017
In-line vapor degreaser (e.g.,
conveyorized, web cleaner)
Use document EPA-HO-
OPPT-2016-0742-0003;
U.S. EPA (2016); Public
comment EPA-HO-
OPPT-2016-0742-0017
Cold cleaner
Use document EPA-HO-
OPPT-2016-0742-0003;
U.S. EPA (2016. 2014)
Aerosol spray
degreaser/cleaner
U.S. EPA (2016b.
2014b) EPA-HO-OPPT-
2016-0742-0003; Market
profile EPA-HO-OPPT-
2016-0742
Adhesives and
sealants
Single component glues and
adhesives and sealants and
caulks
Use document EPA-HO-
OPPT-2016-0742-0003;
U.S. EPA (2016); Public
comments EPA-HO-
OPPT-2016-0742-0005.
EP A-HO-OPPT-2016-
0742-0013. EPA-HO-
OPPT-2016-0742-0014.
EP A-HO-OPPT-2016-
0742-0017. EPA-HO-
OPPT-2016-0742-0021.
EP A-HO-OPPT-2016-
0742-0033
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Life Cycle
Stage
Category a
Subcategory b
References
Paints and
coatings
including
commercial paint
and coating
removers e
Paints and coatings use and
commercial paints and coating
removers
U.S. EPA (2016b.
2014b); Market profile
EP A-HO-OPPT-2016-
0742 Public Comments
EP A-HO-OPPT-2016-
0742-0005. EPA-HO-
OPPT-2016-0742-0009.
EP A-HO-OPPT-2016-
0742-0014. EPA-HO-
OPPT-2016-0742-0017.
EP A-HO-OPPT-2016-
0742-0021. EPA-HO-
OPPT-2016-0742-0025
Adhesive/caulk removers
Use document EPA-HO-
OPPT-2016-0742-0003.
Market profile EPA-HO-
OPPT-2016-0742
Metal products
not covered
elsewhere
Degreasers - aerosol and non-
aerosol degreasers and cleaners
(e.g., coil cleaners)
Market profile EPA-HO-
OPPT-2016-0742 U.S.
EPA (2016)
Fabric, textile
and leather
products not
covered
elsewhere
Textile finishing and
impregnating/surface treatment
products (e.g., water repellant)
Market profile EPA-HO-
OPPT-2016-0742
Automotive care
products
Function fluids for air
conditioners: refrigerant,
treatment, leak sealer
Use document EPA-HO-
OPPT-2016-0742-0003;
Market profile EPA-HO-
OPPT-2016-0742. U.S.
EPA (2016)
Interior car care - spot remover
Use document EPA-HO-
OPPT-2016-0742-0003
Degreasers: gasket remover,
transmission cleaners,
carburetor cleaner, brake
quieter/cleaner
Use document EPA-HO-
OPPT-2016-0742-0003.
Market profile EPA-HO-
OPPT-2016-0742. U.S.
EPA (2016)
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Life Cycle
Stage
Category a
Subcategory b
References
Apparel and
footwear care
products
Post-market waxes and
polishes applied to footwear
(e.g., shoe polish)
Market profile E
OPPT-2016-0742
Laundry and
dishwashing
products
Spot remover for apparel and
textiles
Use document EPA-HO-
OPPT-2016-0742-0003
Lubricants and
greases
Liquid and spray lubricants and
greases
U.S. EPA (2016); EPA-
HO-OPPT-2016-0742-
0003; Market profile
EP A-HO-OPPT-2016-
0742; Public Comment
EP A-HO-OPPT-2016-
0742-0021
Degreasers - aerosol and non-
aerosol degreasers and cleaners
U.S. EPA (2016); EPA-
HO-OPPT-2016-0742-
0003; Market profile
EP A-HO-OPPT-2016-
0742; Public Comments
EP A-HO-OPPT-2016-
0742-0005. EPA-HO-
OPPT-2016-0742-0014
Building/
construction
materials not
covered
elsewhere
Cold pipe insulation
Use document EPA-HO-
OPPT-2016-0742-0003
Solvents (which
become part of
product
formulation or
mixture)
All other chemical product and
preparation manufacturing
U.S. EPA (2016)
Processing aid
not otherwise
listed
In multiple manufacturing
sectors'1
Use document EPA-HO-
OPPT-2016-0742-0003;
Market profile EPA-HO-
OPPT-2016-0742; U.S.
EPA (2016)
Propellants and
blowing agents
Flexible polyurethane foam
manufacturing
Market profile EPA-HO-
OPPT-2016-0742
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Life Cycle
Stage
Category a
Subcategory b
References
Arts, crafts and
hobby materials
Crafting glue and
cement/concrete
Use document EPA-HO-
OPPT-2016-0742-0003
Other Uses
Laboratory chemicals - all
other chemical product and
preparation manufacturing
Use document EPA-HO-
OPPT-2016-0742-0003;
Market profile EPA-HO-
OPPT-2016-0742; Public
Comment: EPA-HO-
OPPT-2016-0742-0066
Electrical equipment,
appliance, and component
manufacturing
US. EPA (2016). Public
Comment EPA-HO-
OPPT-2016-0742-0017
Plastic and rubber products
U.S. EPA (2016)
Anti-adhesive agent - anti-
spatter welding aerosol
Use document EPA-HO-
OPPT-2016-0742-0003;
Market profile EPA-HO-
OPPT-2016-0742; Public
Comment EPA-HO-
OPPT-2016-0742-0005
Oil and gas drilling, extraction,
and support activities
Use document EPA-HO-
OPPT-2016-0742-0003;
U.S. EPA (2016)
Functional fluids (closed
systems) in pharmaceutical and
medicine manufacturing
U.S. EPA (2016)
Toys, playground, and sporting
equipment - including novelty
articles (toys, gifts, etc.)
Use document EPA-HO-
OPPT-2016-0742-0003;
EP A-HO-OPPT-2016-
0742-0069;
Carbon remover, lithographic
printing cleaner, brush cleaner,
use in taxidermy, and wood
floor cleaner
Use document EPA-HO-
OPPT-2016-0742-0003;
Market profile EPA-HO-
OPPT-2016-0742; U.S.
EPA (2016)
Disposal
Disposal
Industrial pre-treatment
U.S. EPA (2017e)
Industrial wastewater treatment
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Life Cycle
Stage
Category a
Subcategory b
References
Publicly owned treatment
works (POTW)
Underground injection
Municipal landfill
Hazardous landfill
Other land disposal
Municipal waste incinerator
Hazardous waste incinerator
Off-site waste transfer
Note that methylene chloride is used by federal agencies in a variety of uses, including some deemed mission
critical.
a These categories of conditions of use appear in the initial life cycle diagram reflect CDR codes and broadly
represent conditions of use for methylene chloride in industrial and/or commercial settings.
b These subcategories reflect more specific uses of methylene chloride.
0 Reported for the following sectors in the 2016 CDR for manufacturing of: plastic materials and resins, plastics
Droducts. miscellaneous, all other chemical oroduct and oreoaration (U.S. EPA. 2016).
d Reported for the following sectors in the 2016 CDR for manufacturing of: petrochemicals, plastic materials and
resins, plasties Droducts. miscellaneous and all other chemical Droducts * (U.S. EPA. 2016) also including as a
chemical processor for polycarbonate resins and cellulose triacetate (photographic film).
e Consumer paint and coating remover uses are already addressed through rulemaking (see 40 CFR Part 751,
Subpart B) and are outside the scope of this draft risk evaluation.
* Conditions of use with CBI or unknown function were evaluated considering the non-CBI elements of the
category, subcategory, function and industrial sector and this applies to: CBI function for petrochemical
manufacturing. Paint additives and coating additives not described by other codes for CBI industrial sector.
Laboratory chemicals for CBI industrial sectors, manufacturing of CBI and oil and gas drilling, extraction, and
support activities.
569
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1.4.2 Conceptual Models
The conceptual model in Figure 1-2 presents the exposure pathways, exposure routes and hazards to human receptors from industrial
and commercial activities and uses of methylene chloride.
INDUSTRIAL AND COMMERCIAL EXPOSURE PATHWAY EXPOSURE ROUTE RECEPTORS* HAZARDS
ACTIVITIES /USES
* Incorporated Into
Formulation, Mixture, or
Reaction Product
* Repackaging
Hazards Potentially Associated
with Acute and/or Chronic
Exposures
Recycling
Solvent* for Cleaning or
Degreasing
Paints and Coatings
including Paints and
Coatings Removers
Fabric, Textile, and
Leather Products
Apparel and Footwear
Care Products
laundry and Dishwashing
Products
Other Uses *
Waste Handling, _
Treatment and Disposal
W Wastewater or Liquid Wastes
Figure 1-2. Methylene Chloride Conceptual Model for Industrial and Commercial Activities and Uses: Potential Exposure and
Hazards
a Some products are used in both commercial and consumer applications such adhesives and sealants. Additional uses of methylene chloride are included in
Table 1-4.
b Fugitive air emissions are those that are not stack emissions and include fugitive equipment leaks from valves, pump seals, flanges, compressors, sampling
connections and open-ended lines; evaporative losses from surface impoundment and spills; and releases from building ventilation systems.
0 Exposure may occur through mists that deposit in the upper respiratory tract. However, based on physical chemical properties, mists of methylene chloride will
likely be rapidly absorbed in the respiratory tract or evaporate, and were evaluated as an inhalation exposure.
d Receptors include PESS.
e When data and information were available to support the analysis, EPA also considered the effect that engineering controls and/or personal protective
equipment (PPE) have on occupational exposure levels.
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The conceptual model in Figure 1-3 presents the exposure pathways, exposure routes and hazards to human receptors from consumer
activities and uses of methylene chloride.
CONSUMER ACTIVITIES/USES EXPOSURE PATHWAY EXPOSURE ROUTE RECEPTORS11 HAZARDS
Solvents for Cleaning or
Degreasing
Adheslves and Sealants
Hazards Potentially
Associated with Acute
and/or Chronic
Exposures.
Consumers
Metal Products
Bystanders
Fabric, Textile, and
Leather Products
Automotive Care Products
Apparel and Footwear
Care Products
Laundry and Dishwashing
Products
Lubricants and Greases
Other Uses
Consumer Handling of
Disposal and Waste
Figure 1-3. Methylene Chloride Conceptual Model for Consumer Activities and Uses: Potential Exposure and Hazards
a Some products are used in both commercial and consumer applications. Additional uses of methylene chloride are included in Table 1-4.
b Receptors include PESS.
0 Exposure may occur via transfer of methylene chloride from hand to mouth, however this exposure pathway will be limited by a combination of dermal
absorption and volatilization; therefore, this pathway will not be further evaluated.
The conceptual model in Figure 1-4 presents the exposure pathways, exposure routes and hazards to human and environmental receptors from environmental
releases and wastes of methylene chloride.
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RELEASES AND WASTES FROM
INDUSTRIAL / COMMERCIAL USES
EXPOSURE PATHWAY
RECEPTORS
HAZARDS
Water,
Sediment
-*•
Indirec: discharge
Blosollds
Soil
POTW
Wastewater or
Liquid Wastes*
Industrial Pre-
Treatmentor
Industrial WWT
Haz Potentially Associated with
Acute and Chronic Exposures
601
602 Figure 1-4. Methylene Chloride Conceptual Model for Environmental Releases and Wastes: Potential Exposures and Hazards
603
604 a Industrial wastewater may be treated on-site and then released to surface water (direct discharge), or pre-treated and released to POTW (indirect discharge).
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1.5 Systematic Review
TSCA requires EPA to use scientific information, technical procedures, measures, methods,
protocols, methodologies and models consistent with the best available science and base
decisions under section 6 on the weight of scientific evidence. Within the TSCA risk evaluation
context, the weight of the scientific evidence is defined as "a systematic review method, applied
in a manner suited to the nature of the evidence or decision, that uses a pre-established protocol
to comprehensively, objectively, transparently, and consistently identify and evaluate each
stream of evidence, including strengths, limitations, and relevance of each study and to integrate
evidence as necessary and appropriate based upon strengths, limitations, and relevance " (40
CFR 702.33).
To meet the TSCA § 26(h) science standards, EPA used the TSCA systematic review process
described in the Application of Systematic Review in TSCA Risk Evaluations document (U.S.
E 18b). The process complements the risk evaluation process in that the data collection,
data evaluation and data integration stages of the systematic review process are used to develop
the exposure and hazard assessments based on reasonably available information. EPA defines
"reasonably available information" to mean information that EPA possesses, or can reasonably
obtain and synthesize for use in risk evaluations, considering the deadlines for completing the
evaluation (40 CFR 702.33).
EPA is implementing systematic review methods and approaches within the regulatory context
of the amended TSCA. Although EPA will make an effort to adopt as many best practices as
practicable from the systematic review community, EPA expects modifications to the process to
ensure that the identification, screening, evaluation and integration of data and information can
support timely regulatory decision making under the timelines of the statute.
1.5.1 Data and Information Collection
EPA planned and conducted a comprehensive literature search based on key words related to the
different discipline-specific evidence supporting the risk evaluation (e.g., environmental fate and
transport; environmental releases and occupational exposure; exposure to general population,
consumers and environmental exposure; and environmental and human health hazard). EPA then
developed and applied inclusion and exclusion criteria during the title/abstract screening to
identify information potentially relevant for the risk evaluation process. The literature and
screening strategy as specifically applied to methylene chloride is described in Strategy for
Conducting Literature Searches for Methylene Chloride (DCM): Supplemental File to the TSCA
Scope Document (U.S. EPA. 2017d) and the results of the title and abstract screening process
were published in Methylene Chloride (DCM) (CASRN: 75-09-2) Bibliography: Supplemental
File for the TSCA Scope Document (l_ ^ i'P \ 2017a).
For studies determined to be on-topic (or relevant) after title and abstract screening, EPA
conducted a full text screening to further exclude references that were not relevant to the risk
evaluation. Screening decisions were made based on eligibility criteria documented in the form
of the populations, exposures, comparators, and outcomes (PECO) framework or a modified
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framework2. Data sources that met the criteria were carried forward to the data evaluation stage.
The inclusion and exclusion criteria for full text screening for methylene chloride are available in
in Appendix F of Problem Formulation of the Risk Evaluation for Methylene Chloride
(Dichloromethane, DCM) ( 18c).
In addition to the comprehensive search and screening process conducted as described above,
EPA made the decision to leverage the literature published in previous assessments3 to identify
key and supporting data4 and information for developing the methylene chloride risk evaluation.
This is discussed in Strategy for Conducting Literature Searches for Methylene Chloride (DCM):
Supplemental File to the TSCA Scope Document ( )17d). In general, many of the key
and supporting data sources were identified in the comprehensive Methylene Chloride (DCM)
(CASRN: 75-09-2) Bibliography: Supplemental File for the TSCA Scope Document (U.S. EPA.
2017a). However, there was an instance during the releases and occupational exposure data
search for which EPA missed relevant references that were not captured in the initial
categorization of the on-topic references. EPA found additional relevant data and information
using backward reference searching, which was a technique that will be included in future search
strategies. This issue was discussed in Section 4 of Application of Systematic Review for TSCA
Risk Evaluations ( .018b). Other relevant key and supporting references were
identified through targeted supplemental searches to support the analytical approaches and
methods in the methylene chloride risk evaluation (e.g., to locate specific information for
exposure modeling).
EPA used previous chemical assessments to quickly identify relevant key and supporting
information as a pragmatic approach to expedite the quality evaluation of the data sources, but
many of those data sources were already captured in the comprehensive literature as explained
above. EPA also considered newer information not taken into account by previous chemical
assessments as described in Strategy for Conducting Literature Searches for Methylene Chloride
(DCM): Supplemental File to the TSCA Scope Document (U.S. EPA. ^ ). EPA then
evaluated the confidence of the key and supporting data sources as well as newer information
instead of evaluating the confidence of all the underlying evidence ever published on a chemical
substance's fate and transport, environmental releases, environmental and human exposure and
hazards. Such comprehensive evaluation of all of the data and information ever published for a
chemical substance would be extremely labor intensive and could not be achieved under the
TSCA statutory deadlines for most chemical substances especially those that have a data-rich
database. Furthermore, EPA considered how evaluation of newer information in addition to the
key and supporting data and information would change the conclusions presented in previous
assessments.
2 A PESO statement was used during the Ml text screening of environmental fate and transport data sources. PESO
stands for Pathways and Processes, Exposure, Setting or Scenario, and Outcomes. A RESO statement was used
during the full text screening of the engineering and occupational exposure literature. RESO stands for Receptors,
Exposure, Setting or Scenario, and Outcomes.
3 Examples of existing assessments are EPA's chemical assessments (e.g., previous work plan risk assessments,
problem formulation documents), ATSDR's Toxicological Profiles and EPA's IRIS assessments. This is described
in more detail in Strategy for Conducting Literature Searches for Methylene Chloride (DCM):
Supplemental File to the TSCA Scope Document (U.S. EPA. 2017d).
4 Key and supporting data and information are those that support key analyses, arguments, and/or conclusions in the
risk evaluation.
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Figure 1-5 to Figure 1-9 depict literature flow diagrams illustrating the results of this process for
each scientific discipline-specific evidence supporting the draft risk evaluation. Each diagram
provides the total number of references at the start of each systematic review stage (i.e., data
search, data screening, data evaluation, data extraction/data integration) and those excluded
based on criteria guiding the screening and data quality evaluation decisions.
EPA made the decision to bypass the data screening step for data sources that were highly
relevant to the draft risk evaluation as described above. These data sources are depicted as
"key/supporting data sources" in the literature flow diagrams. Note that the number of
"key/supporting data sources" were excluded from the total count during the data screening stage
and added, for the most part, to the data evaluation stage depending on the discipline-specific
evidence. The exception was the releases and occupational exposure data sources that were
subject to a combined data extraction and evaluation step (Figure 1-6).
The number of publications considered in each step of the systematic review of methylene
chloride for environmental fate and transport literature is summarized in Figure 1-5.
Data Search Results (n=7,216]
Data Screening (n=7,216)
Data Evaluation (n=47
Data Extraction/Data Integration (n=43)
~Key/Supporting
Data Sources (n=l)
Excluded References
(n=7,170)
Excluded: Ref that are
unacceptable based on the
evaluation criteria (n=4)
"This is a key and supporting source from existing assessments, the EPI Suite™ set of models, that was highly relevant
for the TSCA risk evaluation. This source bypassed the data screening step and moved directly to the data evaluation
step.
Figure 1-5. Literature Flow Diagram for Environmental Fate and Transport Data Sources
Note: Literature search results for the environmental fate and transport of methylene chloride yielded 7,216 studies.
During problem formulation, following data screening, most environmental exposure pathways were removed from
the conceptual models. As a result, 7,170 studies were deemed off-topic and excluded. One key source and the
remaining 46 studies related to environmental exposure pathways retained in the conceptual models entered data
evaluation, where 4 studies were deemed unacceptable and 43 moved into data extraction and integration.
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The number of publications considered in each step of the systematic review of methylene
chloride for releases and occupational exposure literature is summarized in Figure 1-6.
Data Search Results |n=T,4S4)
Data Screening fn»7,484)
z\Voe'ete^c
\?v si Dtcr; *g
*j Data ExtractionfData Evaluation (n=1?S;
E2 -r. ci ; ves-* scuces r-i'i ,vsre 3IC5-."e *c- i 5r asses;- ,ei* pi' uses ;jt **¦€•'
Mit j* .re.: * ..."scs-a" tajei ^ E"A; r'- ej 2: :¦> a,.*-;a;!" *c
seas- r«a >~-::iprtor-i -st.e "-ra -nan.Ec^s atc-'aii .-ses a cr.
r*p Seises !*i3' no.e „ei s i*1? atru . es : i are -; • ,'eu *;•>
a^a « i s ,~;-j :•ir. -*e e-. re>ce"Sr a~,i " :u;ii rsu-e
3;se:^e''"s pie'e.s -s nj 02*2 v ['i "~e no-es" vec c.,3 u j rose ;re r 3'e> eve*;*
"is ;• •: c cis'i - ^ :;cj; :-*'c t? ixi-ru6 .rts. tcc?s~ ri>
.'3. :-n:e<: E=« t?j, is? ila-3, :*•- e1 atfi a; s„vt<" ' « e. -JS"r~ ,r "3 ecs • r 'siess-^ers
Figure 1-6. Releases and Occupational Exposures Literature Flow Diagram for Methylene
Chloride
Note: Literature search results for environmental release and occupational exposure yielded 7,484 data sources. Of these data
sources, initially 268 were determined to be relevant for the risk evaluation through the data screening process. Due to the scope
changing the initial 268 data sources were reevaluated and it was determined 157 data sources to be relevant for the risk
evaluation through the data screening process. These relevant data sources were entered into the data extraction/evaluation phase.
After data extraction/evaluation, EPA identified several data gaps and performed a supplemental, targeted search to fill these
gaps (e.g., to locate information needed for exposure modeling). The supplemental search yielded 22 relevant data sources that
bypassed the data screening step and were evaluated and extracted in accordance with Appendix D of Data Quality Criteria for
Occupational Exposure and Release Data of the Application of Systematic Review for TSCA Risk Evaluations document (U.S.
EPA. 201.8b). Of the 179 sources from which data were extracted and evaluated, 36 sources only contained data that were rated
as unacceptable based on serious flaws detected during the evaluation. Of the 143 sources forwarded for data integration, data
from 44 sources were integrated, and 99 sources contained data that were not integrated (e.g., lower quality data that were not
needed due to the existence of higher quality data, data for release media that were removed from scope after data collection).
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731
732 The number of publications considered in each step of the systematic review of methylene
733 chloride for non-occupational exposure literature is summarized in Figure 1-7.
Excluded References (n - 383)
Data Extraction/Data in lea ration jn = 36!
Data Evaluation {r> = 79)
Data Screening (n - 462)
Data Search Results (n - 462)
"Excluded References (n = 43)
Unacceptable based on data evaluation criteria (n - 8)
Mot primary sou res, not extractatsle or
not most relevant (n = 37)
•The quality of data in these soyrces were acceptable for nsK assessment purposes and considered for
integration. The sources; however, were not extracted tor a variety of reasons, such as tbay contained, onty
secondary source data, duplicate data, or non-extractable data (i,e., charts or figures). Additional*, some
data sources were not as relevant to the PECO as other data sources which were extracted.
734
735 Figure 1-7. Literature Flow Diagram for General Population, Consumer and
736 Environmental Exposure Data Sources
737
738 Note: EPA conducted a literature search to determine relevant data sources for assessing exposures for methylene
739 chloride within the scope of the risk evaluation. This search identified 462 data sources including relevant
740 supplemental documents. Of these, 383 were excluded during the screening of the title, abstract, and/or full text and
741 79 data sources were recommended for data evaluation across up to five major study types in accordance with
742 Appendix E: Data Quality Criteria for Studies on Consumer, General Population and Environmental Exposure of
743 the Application of Systematic Review for TSCA Risk Evaluations document. (U.S. EPA. 2018b). Following the
744 evaluation process, 36 references were forwarded for further extraction and data integration.
745
746 The conceptual model for environmental exposures was modified during problem formulation,
747 which changed 63 previously on-topic references to off-topic between data screening and data
748 evaluation, leaving 79 publications in the data evaluation stage.
749
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The number of publications considered in each step of the systematic review of methylene
chloride for environmental hazard literature is summarized in Figure 1-8.
Data Search Results (n = 4930)
Title/Abstract Screening |n = 4929}
Full Text Screening {n = 224)
-r
Excluded References due to
ECOTOX Criteria
(o = 4705)
xduded References due to
ECOTOX Criferia
{n = 180)
SvpCQl'lt
e:
: :i = 11
Data Evaluation (n = 45)
>
f
Data Extraction I Data Integration {n = 14)
i
Exr „>-r that are
s W'* 1= >S8{J
on € imBof are
out of scope
Figure 1-8. Literature Flow Diagram for Environmental Hazard Data Sources
Note: The environmental hazard data sources were identified through literature searches and screening strategies
using the ECOTOXicology Knowledgebase System (ECOTOX) Standing Operating Procedures. For studies
determined to be on-topic after title and abstract screening, EPA conducted a full text screening to further exclude
references that were not relevant to the risk evaluation. Screening decisions were made based on eligibility criteria
as documented in the ECOTOX User Guide (EPA. 2018b')'). Additional details can be found in the Strategy for
Conducting Literature Searches for Methylene Chloride Supplemental Document to the TSCA Scope Document
(U.S. EPA. 20ndl.
The "Key/Supporting Studies" box represents data sources typically cited in existing assessments and considered
highly relevant for the TSCA risk evaluation because they were used as key and supporting information by
regulatory and non-regulatory organizations to support their chemical hazard and risk assessments. These citations
were found independently from the ECOTOX process. These studies bypassed the data screening step and moved
directly to the data evaluation step.
Studies could be considered "out of scope" after the screening steps, and therefore excluded from data evaluation,
due to the elimination of pathways during scoping/problem formulation.
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The number of publications considered in each step of the systematic review of methylene
chloride for human health hazard literature is summarized in Figure 1-9.
ita Search Results |n = 736?:
n=3?
- -¦ " data
Excluded References (n = 7293)
Excluded: Ref sr.at are
unacceptable based on
evaluation crieria (n = 9)
Extraction/Data Integration (n = 655
Data Evaluation (n = 74)
Data Screening In - 7330
Figure 1-9. Literature Flow Diagram for Human Health Hazard Data Sources
Note: Literature search results for human health hazard of methylene chloride yielded 7,367 studies. This included
37 key and supporting studies identified from previous EPA assessments. Of the 7,330 new studies screened for
relevance, 7,293 were excluded as off topic. The remaining 74 new studies entered full text screening for the
determination of relevance to the risk evaluation. Thirty-seven studies went straight to data evaluation. Nine studies
were deemed unacceptable based on the evaluation criteria human health hazard and the remaining 65 studies were
carried forward to data extraction/data integration.
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2 EXPOSURES
2.1 Fate and Transport
Environmental fate includes both environmental transport and transformation processes.
Environmental transport is the movement of the chemical within and between environmental
media. Transformation occurs through the degradation or reaction of the chemical in the
environment. Hence, understanding the environmental fate of methylene chloride informs the
determination of the specific exposure pathways, and potential human and environmental
receptors which EPA considered in its risk evaluation.
2.1.1 Fate and Transport Approach and Methodology
EPA gathered and evaluated environmental fate information according to the process described
in the Application of Systematic Review in TSCA Risk Evaluations ( i).
Reasonably available environmental fate data, including biotic and abiotic degradation rates,
removal during wastewater treatment, volatilization from lakes and rivers, and organic
carbon:water partition coefficient (Koc) were selected for use in the current evaluation.
Sufficient numbers of high-confidence biodegradation studies were available, so it was not
necessary to use lower-quality data for that endpoint; thus, in assessing the environmental fate
and transport of methylene chloride, EPA considered the full range of results from sources that
were rated high confidence. Complete data extraction tables are available in the supplemental file
Data Extraction Tables for Environmental Fate and Transport Studies (EPA. 2019e) and
complete data evaluation information is available in the supplemental fileData Quality
Evaluation of Environmental Fate and Transport Studies ( :").
Other fate estimates were based on modeling results from EPI (Estimation Programs Interface)
Suite™ (U.S. EPA. 2012). a predictive tool for physical/chemical and environmental fate
properties (https://www.epa.gov/tsca-screening-tools/epi-suitetm-estimation-program-
interface). Information regarding the EPI Suite™ model inputs is available in Appendix C and
model outputs are available in the supplemental file Data Extraction Tables for Environmental
Fate and Transport Studies (EPA. 2.019e). EPI Suite™ was reviewed by the EPA Science
Advisory Board
F9CFCFA8525735200739805/$File/s " " :) and the individual models have been peer-
reviewed in numerous articles published in technical journals. Citations for such articles are
available in the EPI Suite™ help files.
Table 2-1 provides environmental fate data that EPA considered while assessing the fate of
methylene chloride. The data in Table 2-1 were updated after problem formulation with
information identified through systematic review.
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Table 2-1. Environmental Fate Characteristics of Methylene Chloride
Property or
Kndpoinl
Value 11
References
Data Quality
Rating
Indirect
photodegradati on
79 days (estimated)13
i S ?'PA
High
Hydrolysis half-
life
18 months
4.3x107 yrs (estimated) b
Billing et al. (1975)
U.S. EPA. a
Low
High
Biodegradation
Aerobic activated sludge:
0% in 28 days
100% in 7 days
Aerobic marine water:
90% in 6 days
Anaerobic culture (pre-adapted):
58% in 30 hrs
Anaerobic sediment:
65-84% in 31 hrs
Approx. 75%) in 22 days
Anaerobic digested sludge:
100%) in 10 days
Laoertot and Pulsarin
(2006)
Krausova et al. (2006);
Tabak et d a VSI)
Krausova et al. (2006)
Braus-Stromever et al.
Melin et al. (1996)
Peiinenburg et< 8)
Goss 15)
High
High
High
High
High
High
High
Bioconcentration
factor (BCF)
3.1 (estimated by linear regression
from octanol-water partition
coefficient)b
2.6 (estimated by Arnot-Gobas
quantitative structure-activity
relationship [QSAR]) b
U.S. EPA. a
High
Bioaccumulation
factor (BAF)
2.6 (estimated by Arnot-Gobas
QSAR)b
1 ? 1 ^\LIO|^
High
log Koc
1.4 (estimated)b
U.S. EPA. a
High
a Measured unless otherwise noted.
information was estimated usina EPI Suite™ (IIS. EPA. 2012)
2.1.2 Summary of Fate and Transport
The EPI Suite™ ( ) module that predicts removal in wastewater treatment
(STPWIN; see Appendix C for information regarding inputs used for EPI Suite™) estimated that
< 1% of methylene chloride in influent water will be removed via adsorption to sludge. The
organic water-carbon partition coefficient (log Koc) is estimated to be 1.4, which is associated
with low adsorption to sludge, soil, and sediment. Due to its Henry's Law constant (0.00325
atm-m3/mole), methylene chloride is expected to volatilize rapidly from water; STPWIN
estimated that approximately 56% of methylene chloride in influent would be removed by
volatilization to the air. Reported aerobic biodegradation rates are mixed, ranging from slow
(e.g., negligible degradation in 28 days) to fast (e.g., complete degradation in 7 days) (Krausova
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et at.. 2006; Lapertot and Pulgarin. 2.006; Tabak et at.. 1981). so biodegradation of methylene
chloride by activated sludge and in settled biosolids may be negligible to high depending on the
microorganisms present and previous adaptation to methylene chloride. Thus, overall removal of
methylene chloride from wastewater treatment is expected to range from 57% (based on
STPWIN estimates for volatilization to air and adsorption to sludge, with negligible
biodegradation) to complete (based on volatilization, adsorption, and high biodegradation). The
low end of this range is similar to the methylene chloride removal efficiency (54%) reported by
the EPA Toxics Release Inventory (TRI) (U1SiEPAa_2017f).
Based on high volatilization, negligible adsorption, and possible biodegradation, concentrations
of methylene chloride in land-applied biosolids are expected to be lower than concentrations in
wastewater treatment plant effluents. Similarly, based on its low partitioning to organic matter
and rapid biodegradation in anaerobic environments (Peiinenburg et at... 1998; Melin et at.. 1996;
Braus-Strornever et at.. 1993; Gossett. 1985). methylene chloride is expected to be present in
sediments at concentrations lower than those of the overlying water. Methylene chloride in the
biosolids or sediment compartments is expected to be in the pore water rather than adsorbed to
the biosolids or sediment organic matter.
Due to its high Henry's Law constant and vapor pressure (435 mmHg at 25°C), methylene
chloride is expected to volatilize rapidly from surface water and soil. The EPI Suite™ module
that estimates volatilization from lakes and rivers (water volatilization model) was run using
default settings to evaluate the volatilization half-life of methylene chloride in surface water and
estimated that the half-life of methylene chloride in a model river will be 1.1 hours and the half-
life in a model lake will be less than 4 days. In the atmosphere, methylene chloride will slowly
react with hydroxyl radicals (OH*), with an indirect photolysis half-life of 79 days. Due to its
persistence, methylene chloride is expected to be subject to local and long-range atmospheric
transport. Based on its vapor density (2.93 relative to air), volatilized methylene chloride is
expected to remain near ground level.
Although methylene chloride released to the environment is likely to evaporate to the
atmosphere, due to its low partitioning to organic matter it may migrate to groundwater. Indeed,
detections of methylene chloride in groundwater have been reported (e.g., in the EPA's Water
Quality portal, http://www. waterqualitvdata.us/portal j sp; reports of detection in groundwater did
not go through data evaluation and extraction because groundwater pathways are outside the
scope of this risk evaluation). In groundwater, methylene chloride may slowly hydrolyze.
The bioconcentration potential of methylene chloride is low; the EPI Suite™ BCFBAF model
estimates a bioconcentration factor of 2.6 to 3.1 and a bioaccumulation factor of 2.6.
Overall, methylene chloride is not expected to accumulate in wastewater biosolids, soil,
sediment, or biota. Methylene chloride released to surface water or soil is likely to volatilize to
the atmosphere, where it will slowly photooxidize. Methylene chloride may migrate to
groundwater, where it may slowly hydrolyze. Figure 2-1 summarizes the overall environmental
partitioning and degradation expected for methylene chloride.
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Land-applied biosolids [
Photolysis
Hydrolysis
Surface Water
Aerobic
Biodegradation
Anaerobic
Biodegradation
Sediment
Groundwater
Figure 2-1 Environmental transport, partitioning, and degradation processes for methylene
chloride.
Narrower arrows indicate less likely or slower transport, partitioning, or degradation and wider
arrows indicate more likely or faster transport, partitioning, or degradation. The "???" indicate
uncertain rate of aerobic biodegradation processes. Green arrows indicate transport and
partitioning processes, and orange arrows indicate degradation processes.
2.2 Releases to the Environment
2.2.1 Water Release Assessment Approach and Methodology
EPA performed a literature search to identify process operations that could potentially result in
direct or indirect discharges to water for each condition of use. Where available, EPA used 2016
Toxics Release Inventory (TRI) (U.S. EPA. 2017f) and 2016 Discharge Monitoring Report
(DMR) (EPA. 2016) data to provide a basis for estimating releases. Facilities are only required to
report to TRI if the facility has 10 or more full-time employees, is included in an applicable
North American Industry Classification System (NAICS) code, and manufactures, processes, or
uses the chemical in quantities greater than a certain threshold (25,000 pounds for manufacturers
and processors of methylene chloride and 10,000 pounds for users of methylene chloride). Due
to these limitations, some sites that manufacture, process, or use methylene chloride may not
report to TRI and are therefore not included in these datasets.
For the 2016 DMR, EPA used the Water Pollutant Loading Tool within EPA's Enforcement and
Compliance History Online (ECHO), https://echo.epa.gov/trends/loading-tool/water-pollution-
search/. to query all methylene chloride point source water discharges in 2016. DMR data are
submitted by National Pollutant Discharge Elimination System (NPDES) permit holders to states
or directly to the EPA according to the monitoring requirements of the facility's permit. States
are only required to load major discharger data into DMR and thus, may or may not load minor
discharger data. The definition of major vs. minor discharger is set by each state and could be
based on discharge volume or facility size. Due to these limitations, some sites that discharge
methylene chloride may not be included in the DMR dataset.
Facilities reporting releases in TRI and DMR also report associated NAICS and Standard
Industrial Classification (SIC) industry codes, respectively. Where possible, EPA reviewed the
NAICS and SIC descriptions for each reported release and mapped each facility to a potential
condition of use associated with occupational exposure scenarios (OES, see Table 2-24). For
facilities that did not report a NAICS or SIC code, EPA performed a supplemental internet
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search of the specific facility to determine the mapping. Facilities that could not be mapped were
grouped together into an "Other" category.
When possible for each OES covering conditions of use, EPA estimated annual releases, average
daily releases, and number of release days/yr. Where TRI and/or DMR were available, EPA used
the reported annual releases for each site and estimated the daily release by averaging the annual
release over the estimated release days/yr. Where releases are expected but TRI and DMR data
were not available, EPA included a qualitative discussion of potential release sources.
EPA did not locate data on number of release days/yr for facilities. The following guidelines
were used to estimate the number of release days/yr:
• Manufacturing: For the manufacture of the solvents with large production volumes, EPA
assumes 350 days/yr for release frequency. This frequency assumes that the facility
operates 7 days/week and 50 weeks/yr (with two weeks down for turnaround) and that the
facility is producing and releasing the chemical daily during operation.
• Processing as Reactant: Methylene chloride is used to manufacture other commodity
chemicals, such as refrigerants or other chlorinated compounds, which will likely occur
year-round. Therefore, EPA assumes 350 days/yr for release frequency based on the same
assumptions for Manufacturing.
• Processing into Formulation Product: For these facilities, EPA does not expect that
methylene chloride will be used year-round, even if the facility operates year-round.
Therefore, EPA assumes 300 days/yr for release frequency, which is based on a European
Union SpERC that uses a default of 300 days/yr for release frequency for the chemical
industry (Echa. 2013).
• Wastewater Treatment Plants: For these facilities, EPA expects that they will be used
year-round. Therefore, EPA assumes 365 days/yr for release frequency.
• All Other Scenarios: For all other scenarios, EPA does not expect that methylene chloride
will be used year-round and assumes 250 days/yr for release frequency (5 days/week, 50
weeks/yr).
2.2.2 Water Release Estimates by Occupational Exposure Scenario
As noted in the previous section, EPA mapped each facility to a potential condition of use
associated with occupational exposure scenarios (OES, see Table 2-24). Facilities that could not
be mapped were grouped together into an "Other" category. The following sections show release
estimates per facility for each OES. The supplemental document titled "Risk Evaluation for
Methylene Chloride (Dichloromethane, DCM) CASRN: 75-09-2, Supplemental Information on
Releases and Occupational Exposure Assessment"( j) provides background details on
industries that may use methylene chloride, processes, and numbers of sites for each OES.
2.2.2.1 Manufacturing
EPA assumed that sites under NAICS 325199 (All Other Basic Organic Chemical
Manufacturing) or SIC 2869 (Industrial Organic Chemicals, Not Elsewhere Classified) are
potentially applicable to manufacturing of methylene chloride. These NAICS codes may be
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applicable to other conditions of use (processing as a reactant, processing—incorporation into
formulation, mixture, or reaction product); however, insufficient information was reasonably
available to make these determinations.
Table 2-2 lists all facilities under these NAICS and SIC codes that reported direct or indirect
water releases in the 2016 TRI or 2016 DMR. Of the potential manufacturing sites listed in CDR,
only one facility was present in Table 2-2, which reported 128 pounds (58 kg) of methylene
chloride transferred off-site to wastewater treatment (Olin Blue Cube, Freeport, TX) (U.S. EPA.
2017f). For the sites reporting for this scenario, the release estimates range from 0.01 to 76
kg/site-yr over 350 days/yr.
Table 2-2. Reported TRI Releases for Organic Chemical Manufacturing Facilities
Site Identity
City
State
Annual
Release
(kg/site-yr)
Annual
Release Days
(days/yr)
Daily
Release
(kg/site-day)
Release
Media
Sources &
Notes
COVESTRO LLC
BAYTOWN
TX
1
350
0.004
Surface
Water
U.S. EPA
(2017f)
EMERALD
PERFORMANCE
MATERIALS LLC
HENRY
IL
0.5
350
0.001
Surface
Water
U.S. EPA
(2017f)
FISHER SCIENTIFIC
CO LLC
FAIR LAWN
N.T
2
350
0.01
POTW
U.S. EPA
(2017f)
FISHER SCIENTIFIC
CO LLC
BRIDGEWALER
N.T
2
350
0.01
POTW
U.S. EPA
(2017f)
OLIN BLUE CUBE
FREEPORT LX
FREEPORT
TX
58
350
0.2
Non-
POTW
WWT
U.S. EPA
(2017f)
REGIS
TECHNOLOGIES
INC
MORTON
GROVE
IL
2
350
0.01
POTW
U.S. EPA
(2017f)
SIGMA-ALDRICH
MANUFACTURING
LLC
SAINT LOUIS
MO
2
350
0.01
POTW
U.S. EPA
(2017f)
VANDERBILT
CHEMICALS LLC-
MURRAY DIV
MURRAY
KY
0.5
350
0.001
Non-
POTW
WWT
U.S. EPA
(2017f)
E I DUPONT DE
NEMOURS -
CHAMBERS
WORKS
DEEPWALER
N.T
76
350
0.2
Surface
Water
EPA
(2016)
BAYER
MATERIALSCIENCE
BAYTOWN
BAYTOWN
TX
10
350
0.03
Surface
Water
EPA
(2016)
INSTITUTE PLANT
INSTITUTE
WV
3
350
0.01
Surface
Water
EPA
(2016)
MPM SILICONES
LLC
FRIENDLY
WV
2
350
0.005
Surface
Water
EPA
(2016)
BASF
CORPORATION
WEST
MEMPHIS
AR
1
350
0.003
Surface
Water
EPA
(2016)
ARKEMAINC
PIFFARD
NY
0.3
350
0.001
Surface
Water
EPA
(2016)
EAGLE US 2 LLC -
LAKE CHARLES
COMPLEX
LAKE
CHARLES
LA
0.2
350
0.001
Surface
Water
EPA
(2016)
BAYER
MATERIALSCIENCE
NEW
MARTINSVILLE
WV
0.2
350
0.001
Surface
Water
EPA
(2016)
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Site Identity
City
State
Annual
Release
(kg/site-yr)
Annual
Release Days
(days/yr)
Daily
Release
(kg/site-day)
Release
Media
Sources &
Notes
ICL-IP AMERICA
INC
GALLIPOLIS
FERRY
WV
0.1
350
0.0004
Surface
Water
(EPA,
2016)
KEESHANAND
BOST CHEMICAL
CO., INC.
MANVEL
TX
0.02
350
0.00005
Surface
Water
EPA
(2016)
INDORAMA
VENTURES
OLEFINS, LLC
SULPHUR
LA
0.01
350
0.00003
Surface
Water
EPA
(2016)
CHEMTURA NORTH
AND SOUTH
PLANTS
MORGANTOWN
WV
0.01
350
0.00002
Surface
Water
EPA
(2016)
2.2.2.2 Processing as a Reactant
EPA assumed that sites classified under NAICS 325320 (Pesticide and Other Agricultural
Chemical Manufacturing) or SIC 2879 (Pesticides and Agricultural Chemicals, Not Elsewhere
Classified) are potentially applicable to processing of methylene chloride as a reactant. Table 2-3
lists all facilities under these NAICS and SIC codes that reported direct or indirect water releases
in the 2016 TRI or 2016 DMR. For the sites reporting for this scenario, the release estimates
range from 0.1 to 213 kg/site-yr over 350 days/yr.
Table 2-3. Reported 2016 TRI and DMR Releases for Potential Processing as Reactant
Facilities
Site Identity
City
State
Annual
Release
(kg/site-yr)
Annual Release
Days (days/yr)
Daily Release
(kg/site-day)
Release
Media
Sources &
Notes
AMVAC
CHEMICAL CO
AXIS
AL
213
350
0.6
Non-
POTW
WWT
U.S. EPA
(2017f)
THE DOW
CHEMICAL CO
MIDLAND
MI
25
350
0.1
Surface
Water
U.S. EPA
(2017f)
FMC
CORPORATION
MIDDLEPORT
NY
0.1
350
0.0003
Surface
Water
EPA
(2016)
2.2.2.3 Processing - Incorporation into Formulation, Mixture, or Reaction Product
EPA identified six NAICS and SIC codes, listed in Table 2-4, that reported water releases in the
2016 TRI and may be related to use as Processing - Incorporation into Formulation, Mixture, or
Reaction Product. Table 2-4 lists all facilities classified under these NAICS and SIC codes that
reported direct or indirect water releases in the 2016 TRI or 2016 DMR. For the sites reporting
for this scenario, the release estimates range from 0.2 to 5,785 kg/site-yr over 350 days/yr.
Table 2-4. Potential Industries Conducting Methylene Chloride Processing - Incorporation
into Formulation, Mixture, or Reaction Product in 2016 TRI or DMR
NAICS Code
NAICS Description
325180
Other Basic Inorganic Chemical Manufacturing
325510
Paint and Coating Manufacturing
325998
All Other Miscellaneous Chemical Product and Preparation Manufacturing
2819
INDUSTRIAL INORGANIC CHEMICALS
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NAICS Code
NAICS Description
2843
SURF ACTIVE AGENT, FIN AGENTS
2899
CHEMICALS & CHEM PREP, NEC
Table 2-5. Reported 2016 TRI and DMR Releases for Potential Processing—Incorporation
into Formulation, Mixture, or Reaction Product Facilities
Site Identity
City
State
Annual
Release
(kg/site-yr)
Annual
Release
Days
(days/yr)
Daily
Release
(kg/site-
day)
Release
Media
Sources &
Notes
ARKEMA INC
CALVERT
CITY
KY
31
300
0.1
Surface Water
U.S. EPA
(2017f)
MCGEAN-ROHCO
INC
LIVONIA
MI
113
300
0.4
POTW
U.S. EPA
(2017f)
WM BARR & CO
INC
MEMPHIS
TN
0.5
300
0.002
POTW
U.S. EPA
(2017f)
BUCKMAN
LABORATORIES
INC
MEMPHIS
TN
254
300
1
POTW
U.S. EPA
(2017f)
EUROFINS MWG
OPERON LLC
LOUISVILLE
KY
5,785
300
19
POTW
U.S. EPA
(2017f)
SOLVAY-
HOUSTON
PLANT
HOUSTON
TX
12
300
0.04
Surface Water
EPA (2016)
HONEYWELL
INTERNATIONAL
INC - GEISMAR
COMPLEX
GEISMAR
LA
4
300
0.01
Surface Water
EPA (2016)
STEP AN CO
MILLSDALE
ROAD
EL WOOD
IL
2
300
0.01
Surface Water
EPA (2016)
ELEMENTIS
SPECIALTIES,
INC.
CHARLESTO
N
WV
0.2
300
0.001
Surface Water
EPA (2016)
2.2.2.4 Repackaging
EPA assumed that sites classified under NAICS 424690 (Other Chemical and Allied Products
Merchant Wholesalers) or SIC 5169 (Chemicals and Allied Products) are potentially applicable
to repackaging of methylene chloride. Table 2-6 lists all facilities in these industries that reported
direct or indirect water release to the 2016 TRI or 2016 DMR. None of the potential repackaging
sites listed in CDR reported water releases to TRI or DMR in reporting year 2016. For the sites
reporting for this scenario, the release estimates range from 0.03 to 144 kg/site-yr over 250
days/yr.
Page 69 of 725
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1008
1009
1010
1011
1012
1013
1014
1015
1016
1017
1018
1019
1020
1021
1022
1023
1024
1025
1026
1027
1028
1029
1030
1031
1032
1033
1034
1035
1036
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 2-6. Reported 2016 TRI ant
DMRRe
eases for
Repackaging Facilities
Site Identity
City
State
Annual
Release
(kg/site-
yr)
Annual
Release
Days
(days/yr)
Daily Release
(kg/site-day)
Release
Media
Sources &
Notes
CHEMISPHERE
CORP
SAINT LOUIS
MO
2
250
0.01
POTW
U.S. EPA
(2017ft
HUBBARD-
HALL INC
WATERBURY
CT
144
250
1
Non-POTW
WWT
U.S. EPA
(2017ft
WEBB
CHEMICAL
SERVICE
CORP
MUSKEGON
HEIGHTS
MI
98
250
0.4
POTW
U.S. EPA
(2017ft
RESEARCH
SOLUTIONS
GROUP INC
PELHAM
AL
0.09
250
0.0003
Surface
Water
EPA (2016)
EMD
MILLIPORE
CORP
CINCINNATI
OH
0.03
250
0.0001
Surface
Water
EPA (2016)
2.2.2.5 Batch Open-Top Vapor Degreasing
EPA did not identify quantitative information about water releases during batch open-top vapor
degreasing (OTVD). The primary source of water releases from OTVDs is wastewater from the
water separator. Water in the OTVD may come from two sources: 1) Moisture in the atmosphere
that condenses into the solvent when exposed to the condensation coils on the OTVD; and/or 2)
steam used to regenerate carbon adsorbers used to control solvent emissions on OTVDs with
enclosures (Durkee. 2014; Kanegsberg and Kanegsberg. 2011; (NIOSH). 2002a. b; Niosh.
2002a. b). The water is removed in a gravity separator and sent for disposal ((NIOSH). 2002a. b;
Niosh. 2002a. b). The current disposal practices of the wastewater are unknown; however, a U.S.
EPA (1982) report estimated 20% of water releases from metal cleaning (including batch
systems, conveyorized systems, and vapor and cold systems) were direct discharges to surface
water and 80% of water releases were discharged indirectly to a POTW.
2.2.2.6 Conveyorized Vapor Degreasing
EPA did not identify quantitative information about water releases during vapor degreasing. The
current disposal practices of the wastewater are unknown; however, a U.S. EPA (1982) report
estimated 20% of water releases from metal cleaning (including batch systems, conveyorized
systems, and vapor and cold systems) were direct discharges to surface water and 80% of water
releases were discharged indirectly to a POTW.
2.2.2.7 Cold Cleaning
EPA did not identify quantitative information about water releases during cold cleaning. The
current disposal practices of the wastewater are unknown; however, a U.S. EPA (1982) report
estimated 20% of water releases from metal cleaning (including batch systems, conveyorized
systems, and vapor and cold systems) were direct discharges to surface water and 80% of water
releases were discharged indirectly to a POTW.
Page 70 of 725
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1037
1038
1039
1040
1041
1042
1043
1044
1045
1046
1047
1048
1049
1050
1051
1052
1053
1054
1055
1056
1057
1058
1059
1060
1061
1062
1063
1064
1065
1066
1067
1068
1069
1070
1071
1072
1073
1074
1075
1076
1077
1078
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
2.2.2.8 Commercial Aerosol Products
EPA does not expect releases of methylene chloride to water from the use of aerosol products.
Due to the volatility of methylene chloride the majority of releases from the use of aerosol
products will likely be to air as methylene chloride evaporates from the aerosolized mist and the
substrate surface. There is a potential that methylene chloride that deposits on shop floors during
the application process could possibly end up in a floor drain (if the shop has one) or could
runoff outdoors if garage doors are open. However, EPA expects the potential release to water
from this to be minimal as there would be time for methylene chloride to evaporate before
entering one of these pathways. This is consistent with estimates from the International
Association for Soaps, Detergents and Maintenance Products (AISE) Specific Environmental
Release Categories (SpERC) for Wide Dispersive Use of Cleaning and Maintenance Products,
which estimates 100% of volatiles are released to air (AISE. 2012). EPA expects residuals in the
aerosol containers to be disposed of with shop trash that is either picked up by local waste
management or by a waste handler that disposes shop wastes as hazardous waste.
2.2.2.9 Adhesives and Sealants
Based on a mass balance study on the Dutch use of methylene chloride as adhesives, the
Netherlands Organisation for Applied Scientific Research (TNO) calculated an emission of
100% to air (TO 99). EPA did not find information on potential water releases.
Water releases may occur if equipment is cleaned with water.
2.2.2.10 Paints and Coatings
EPA did not identify information about potential water releases during application of paints and
coatings. Water releases may occur if equipment is cleaned with water; however, industrial and
commercial sites would likely be expected to dispose of solvent-based paints as hazardous waste.
2.2.2.11 Adhesive and Caulk Removers
EPA did not find specific industry information or release data for use of adhesive and caulk
removers. EPA did not identify quantitative information in the 2016 TRI or 2016 DMR for this
use. Professional contractors who may use adhesive and caulk removers likely do not handle
enough methylene chloride to meet the reporting thresholds of TRI and would not likely report to
DMR because they are not industrial facilities. The majority of methylene chloride is expected to
evaporate into the air, but releases to water may occur if equipment is cleaned with water.
2.2.2.12 Fabric Finishing
EPA did not identify quantitative information about potential water releases during use of
methylene chloride in fabric finishing. The majority of methylene chloride is expected to
evaporate into the air, but releases to water may occur if equipment or fabric is cleaned with
water.
2.2.2.13 Spot Cleaning
The majority of methylene chloride in spot removers is expected to evaporate into the air, but
releases to water may occur if residue remains in the garment during washing. EPA identified
Page 71 of 725
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1079
1080
1081
1082
1083
1084
1085
1086
1087
1088
1089
1090
1091
1092
1093
1094
1095
1096
1097
1098
1099
1100
1101
1102
1103
1104
1105
1106
1107
1108
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
one facility in the 2016 DMR with SIC code 7216 (Drycleaning Plants, Excluding Rug
Cleaning). This facility reported 0.1 kg annual release of methylene chloride to surface water, as
shown in Table 2-7. EPA did not identify any potential spot cleaning facilities in the 2016 TRI
that reported water releases. Other facilities in this industry may not dispose to water or use
methylene chloride in quantities that meet the TRI reporting threshold. For the site reporting for
this scenario, the release estimate is 0.1 kg/site-yr over 250 days/yr.
Table 2-7. Surface Water Releases of Methylene Chloride During Spot Cleaning
Site Identity
City
State
Annual Release
(kg/site-yr)
Annual Release
Days (days/yr)
Daily Release
(kg/site-day)
Release
Media
Sources & Notes
BOISE STATE
UNIVERSITY
BOISE
ID
0.1
250
0.0002
Surface
Water
EPA (2016)
2.2.2.14 Cellulose Triacetate Film Production
EPA identified one facility in the 2016 DMR, potentially related to CTA manufacturing (SIC
code 3861 - Photographic Equipment and Supplies) that reported water releases. Release for this
facility is summarized in Table 2-8. EPA did not identify any potential CTA manufacturing
facilities in the 2016 TRI that reported water releases. For the site reporting for this scenario, the
release estimate is 29 kg/site-yr over 250 days/yr.
Table 2-8. Reported 2016 TRI and DMR Releases for CTA Manufacturing Facilities
Site Identity
City
State
Annual
Release
(kg/site-yr)
Annual
Release Days
(days/yr)
Daily Release
(kg/site-day)
Release
Media
Sources &
Notes
KODAK
PARK
DIVISION
ROCHESTER
NY
29
250
0.1
Surface
Water
EPA (2016)
2.2.2.15 Flexible Polyurethane Foam Manufacturing
EPA assumed that sites classified under NAICS code 326150 (Urethane and Other Foam Product
(except Polystyrene) Manufacturing) are potentially applicable to polyurethane foam
manufacturing.
Table 2-9 lists one facility under this NAICS code that reported direct or indirect water releases
in the 2016 TRI. EPA did not identify water releases for polyurethane manufacturing sites in the
2016 DMR. This facility (Previs Innovative Packaging, Inc. in Wurtland, KY) reported 2
kilograms release to surface water (U.S. EPA. 2017f). and EPA estimates 250 days/yr release.
Other facilities in this industry may not dispose to water or use methylene chloride in quantities
that meet the TRI reporting threshold.
Page 72 of 725
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1109
1110
1111
1112
1113
1114
1115
1116
1117
1118
1119
1120
1121
1122
1123
1124
1125
1126
1127
1128
1129
1130
1131
1132
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 2-9. Water Releases Reported in 2016 TRI for Polyurethane Foam Manufacturing
Site Identity
City
State
Annual
Release
(kg/site-yr)
Annual
Release Days
(days/yr)
Daily
Release
(kg/site-
day)
Release
Media
Sources
& Notes
PREGIS
INNOVATIVE
PACKAGING INC
WURTLAND
KY
2
250
0.01
Surface
Water
U.S. EPA
(2017f)
For chemical industries (including blowing agent in PUR production, which is applicable to this
OES), calculations for the Dutch chemical industry estimated emissions of 0.2 % to water, 64.8
% to air and 35 % to waste, based on a mass balance study (TNO (CIVO). 1999).
2.2.2.16 Laboratory Use
EPA did not identify quantitative information about potential water releases during laboratory
use of methylene chloride. The majority of methylene chloride is expected to evaporate into the
air or disposed as hazardous waste, but releases to water may occur if equipment is cleaned with
water.
2.2.2.17 Plastic Product Manufacturing
EPA identified facilities classified under four NAICS and SIC codes, listed in Table 2-10, that
reported water releases in the 2016 TRI and 2016 DMR and may be related to plastic product
manufacturing. Table 2-11 lists all facilities classified under these NAICS and SIC codes that
reported direct or indirect water releases in the 2016 TRI or 2016 DMR. For the sites reporting
for this scenario, the release estimates range from 0.02 to 28 kg/site-yr over 250 days/yr.
Table 2-10. Potential Industries Conducting Plastics Product Manufacturing in 2016 TRI
or DMR
NAICS Code
NAICS Description
325211
Plastics Material and Resin Manufacturing
2821
PLSTC MAT./SYN RESINS/NV ELAST
2822
SYN RUBBER (VULCAN ELASTOMERS)
3081
UNSUPPORTED PLSTICS FILM/SHEET
Table 2-11. Reported 2016 TRI and DMR Releases for Potential Plastics Product
Manufacturing Facilities
Site Identity
City
State
Annual
Release
(kg/site-yr)
Annual
Release Days
(days/yr)
Daily Release
(kg/site-day)
Release
Media
Sources &
Notes
SABIC
INNOVATIVE
PLASTICS US
LLC
BURKVILLE
AL
8
250
0.03
Surface
Water
U.S. EPA
(2017f)
SABIC
INNOVATIVE
MOUNT
VERNON
IN
28
250
0.1
Surface
Water
EPA (2016)
Page 73 of 725
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1133
1134
1135
1136
1137
1138
1139
1140
1141
1142
1143
1144
1145
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Site Identity
City
State
Annual
Release
(kg/site-yr)
Annual
Release Days
(days/yr)
Daily Release
(kg/site-day)
Release
Media
Sources &
Notes
PLASTICS MT.
VERNON, LLC
SABIC
INNOVATIVE
PLASTICS US
LLC
SELKIRK
NY
9
250
0.03
Surface
Water
EPA (2016)
EQUISTAR
CHEMICALS LP
LA PORTE
TX
9
250
0.03
Surface
Water
EPA (2016)
CHEMOURS
COMPANY FC
LLC
WASHINGTON
WV
7
250
0.03
Surface
Water
EPA (2016)
SHINTECH
ADDIS PLANT
A
ADDIS
LA
3
250
0.01
Surface
Water
EPA (2016)
STYROLUTION
AMERICA LLC
CHANNAHON
IL
0.2
250
0.001
Surface
Water
EPA (2016)
DOW
CHEMICAL CO
DALTON
PLANT
DALTON
GA
0.3
250
0.001
Surface
Water
EPA (2016)
PREGIS
INNOVATIVE
PACKAGING
INC
WURTLAND
KY
0.02
250
0.0001
Surface
Water
EPA (2016)
2.2.2.18 Pharmaceutical Production
EPA identified facilities classified under three NAICS and SIC codes, listed in Table 2-12, that
reported water releases in the 2016 TRI or 2016 DMR and may be related to use in
pharmaceutical manufacturing. Table 2-12 lists all facilities classified under these NAICS and
SIC codes that reported direct or indirect water releases. Other facilities in this industry may not
dispose to water or use methylene chloride in quantities that meet the TRI reporting threshold.
For the sites reporting for this scenario, the release estimates range from 0.5 to 2,588 kg/site-yr
over 300 days/yr.
Table 2-12. Potential Industries Conducting Pharmaceutical Production in 2016 TRI or
DMR
NAICS Code
NAICS Description
325411
Medicinal and Botanical Manufacturing
325412
Pharmaceutical Preparation Manufacturing
2833
MEDICINAL CHEM/BOTANICAL PRODU
Page 74 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
1146 Table 2-13. Reported 2016 TRI and DMR Releases for Pharmaceutical Manufacturing
1147 Facilities
Site Identity
City
State
Annual
Release
(kg/site-yr)
Annual
Release
Days
(days/yr)
Daily
Release
(kg/site-
day)
Release
Media
Sources &
Notes
ABB VIE-NORTH
CHICAGO FACILITY
NORTH
CHICAGO
IL
2
300
0.01
POTW
U.S. EPA
(2017f)
EUTICALS INC
SPRINGFIELD
MO
0.5
300
0.002
POTW
U.S. EPA
(2017f)
MALLIN CKRODT
LLC
SAINT LOUIS
MO
7
300
0.02
POTW
U.S. EPA
(2017f)
NORAMCO INC
WILMINGTON
DE
2
300
0.01
POTW
U.S. EPA
(2017f)
AMRI RENSSELAER
INC
RENSSELAER
NY
340
300
1
POTW
U.S. EPA
(2017f)
E R SQUIBB & SONS
LLC
NORTH
BRUNSWICK
NJ
113
300
0.4
POTW
U.S. EPA
(2017f)
EVONIK CORP
TIPPECANOE
LABORATORIES
LAFAYETTE
IN
2
300
0.01
Surface
Water
U.S. EPA
(2017f)
PACIRA
PHARMACEUTICALS
INC
SAN DIEGO
CA
40
300
0.1
POTW
U.S. EPA
(2017f)
PCI SYNTHESIS
NEWBURYPORT
MA
0.5
300
0.002
POTW
U.S. EPA
(2017f)
PFIZER
PHARMACEUTICALS
LLC
BARCELONETA
PR
20
300
0.1
POTW
U.S. EPA
(2017f)
PHARMACIA &
UPJOHN CO LLC A
SUBSIDIARY OF
PFIZER INC
PORTAGE
MI
2,588
300
9
99.9%
POTW
0.1%
Surface
Water
U.S. EPA
(2017f)
SI GROUP INC
ORANGEBURG
SC
42
300
0.1
Surface
Water
U.S. EPA
(2017f)
TEVA
PHARMACEUTICALS
USA
MEXICO
MO
10
300
0.03
POTW
U.S. EPA
(2017f)
EVONIK DEGUSSA
CORP TIPPECANOE
LABORATORIES
LAFAYETTE
IN
3
300
0.01
Surface
Water
EPA (2016)
1148
1149 2.2.2.19 Lithographic Printing Plate Cleaning
1150 EPA identified one facility in the 2016 DMR, potentially related to lithographic printing (SIC
1151 code 2752 - Commercial Printing, Lithographic) that reported water releases. Release for this
1152 facility is summarized in Table 2-14. EPA did not identify any potential lithographic printing
1153 facilities in the 2016 TRI that reported water releases. Other facilities in this industry may not
Page 75 of 725
-------
1154
1155
1156
1157
1158
1159
1160
1161
1162
1163
1164
1165
1166
1167
1168
1169
1170
1171
1172
1173
1174
1175
1176
1177
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
dispose to water or use methylene chloride in quantities that meet the TRI reporting threshold.
For the site reporting for this scenario, the release estimate is 0.001 kg/site-yr over 250 days/yr.
Table 2-14. Reported 2016 TRI and DMR Releases for Potential Lithographic Printing
Facilities
Site Identity
City
State
Annual
Release
(kg/site-
yr)
Annual
Release
Days
(days/yr)
Daily
Release
(kg/site-
day)
Release
Media
Sources & Notes
FORMER
REXON
FACILITY
AKA ENJEMS
MILLWORKS
WAYNE
TWP
NJ
0.001
250
0.000004
Surface
Water
EPA (2016)
2.2.2.20 Non-Aerosol Commercial Uses
EPA did not identify quantitative information about potential water releases during non-aerosol
use of methylene chloride. The majority of methylene chloride is expected to evaporate into the
air, but releases to water may occur if equipment is cleaned with water.
2.2.2.21 Waste Handling, Disposal, Treatment, and Recycling
EPA identified facilities classified under five NAICS and SIC codes, listed in Table 2-15, that
reported water releases in the 2016 TRI and 2016 DMR and may be related to recycling/disposal.
Table 2-16 lists all facilities classified under these NAICS and SIC codes that reported direct or
indirect water releases in the 2016 TRI or 2016 DMR. To estimate the daily release, EPA used a
default assumption of 250 days/yr of operation and averaged the annual release over the
operating days. For the sites reporting for this scenario, the release estimates range from 0.02 to
115,059 kg/site-yr over 250 days/yr.
Table 2-15. Potential Industries Conducting Waste Handling, Disposal, Treatment, and
Recycling in 20]
L6 TRI or DMR
NAICS/SIC
Code
NAICS/SIC Description
331492
Secondary Smelting, Refining, and Alloying of Nonferrous Metal (except
Copper and Aluminum)
562211
Hazardous Waste Treatment and Disposal
4953
REFUSE SYSTEMS
7699
REPAIR SHOPS & RELATED SERVICE
9511
AIR & WATER RES & SOL WSTE MGT
Page 76 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
1178 Table 2-16. Reported 2016 TRI and DMR Releases for Potential Recycling/Disposal
1179 Facilities
Site Identity
City
State
Annual
Release
(kg/site-yr)
Annual
Release Days
(days/yr)
Daily
Release
(kg/site-
day)
Release
Media
Sources &
Notes
JOHNSON
MATTHEY
WEST DEPTFORD
NJ
620
250
2
Non-
POTW
WWT
U.S. EPA
(2017f)
CLEAN
HARBORS DEER
PARK LLC
LA PORTE
TX
522
250
2
Non-
POTW
WWT
U.S. EPA
(2017f)
CLEAN
HARBORS EL
DORADO LLC
EL DORADO
AR
113
250
0.5
Non-
POTW
WWT
U.S. EPA
(2017f)
TRADEBE
TREATMENT &
RECYCLING LLC
EAST CHICAGO
IN
19
250
0.1
Non-
POTW
WWT
U.S. EPA
(2017f)
VEOLIA ES
TECHNICAL
SOLUTIONS LLC
WEST
CARROLLTON
OH
2
250
0.01
POTW
U.S. EPA
(2017f)
VEOLIA ES
TECHNICAL
SOLUTIONS LLC
AZUSA
CA
0.5
250
0.002
POTW
U.S. EPA
(2017f)
VEOLIA ES
TECHNICAL
SOLUTIONS LLC
MIDDLESEX
NJ
115,059
250
460
99.996%
Non-
POTW
WWT
0.004%
POTW
U.S. EPA
(2017f)
CHEMICAL
WASTE
MANAGEMENT
F.MF.LLF.
AL
4
250
0.01
Surface
Water
EPA (2016)
OILTANKING
HOUSTON INC
HOUSTON
TX
1
250
0.003
Surface
Water
EPA (2016)
HOWARD CO
ALFA RIDGE
LANDFILL
MARRIOTTSVILLE
MD
0.1
250
0.0002
Surface
Water
EPA (2016)
CLIFFORD G
HIGGINS
DISPOSAL
SERVICE INC SLF
KINGSTON
NJ
0.02
250
0.0001
Surface
Water
EPA (2016)
CLEAN WATER
OF NEW YORK
INC
STATEN ISLAND
NY
2
250
0.01
Surface
Water
EPA (2016)
FORMER
CARBORUNDUM
COMPLEX
SANBORN
NY
0.2
250
0.001
Surface
Water
EPA (2016)
1180
Page 77 of 725
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1181
1182
1183
1184
1185
1186
2.2.2.22
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Other Unclassified Facilities
Table 2-17 summarizes TRI and DMR releases for facilities that were unable to be classified in
one of the assessed scenarios. For the sites reporting for unclassified scenarios, the release
estimates range from 0.0002 to 42 kg/site-yr over 250 days/yr.
Table 2-17. Reported 2016 TRI and DMR Releases for Other Unclassified Facilities
Site Identity
City
State
Annual
Release
(kg/site-yr)
Annual
Release Days
(days/yr)
Daily
Release
(kg/site-
day)
Release
Media
Sources &
Notes
APPLIED
BIOSYSTEMS
LLC
PLEAS ANTON
CA
42
250
0.2
Non-
POTW
WWT
U.S. EPA
(2017f)
EMD
MILLIPORE
CORP
JAFFREY
NH
2
250
0.01
POTW
U.S. EPA
(2017f)
GBC METALS
LLC SOMERS
THIN STRIP
WATERBURY
CT
0.2
250
0.001
Surface
Water
EPA (2016)
HYSTER-
YALE GROUP,
INC
SULLIGENT
AL
0.0002
250
0.000001
Surface
Water
EPA (2016)
AVNET INC
(FORMER
IMPERIAL
SCHRADE)
ELLENVILLE
NY
0.005
250
0.00002
Surface
Water
EPA (2016)
BARGE
CLEANING
AND REPAIR
CHANNEL VIEW
TX
0.1
250
0.0003
Surface
Water
EPA (2016)
AC & S INC
NITRO
WV
0.01
250
0.00005
Surface
Water
EPA (2016)
MOOG INC -
MOOGIN-
SPACE
PROPULSION
ISP
NIAGARA FALLS
NY
0.003
250
0.00001
Surface
Water
EPA (2016)
OILTANKING
JOLIET
CHANNAHON
IL
1
250
0.003
Surface
Water
EPA (2016)
NIPPON
DYNAWAVE
PACKAGING
COMPANY
LONGVIEW
WA
22
250
0.1
Surface
Water
EPA (2016)
TREE TOP INC
WENATCHEE
PLANT
WENATCHEE
WA
0.01
250
0.00003
Surface
Water
EPA (2016)
CAROUSEL
CENTER
SYRACUSE
NY
0.001
250
0.000002
Surface
Water
EPA (2016)
1187
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2.2.3 Summary of Water Release Assessment
EPA found that most of the facilities reporting water releases to TRI and DMR could be
classified into scenarios associated with conditions of use of methylene chloride. Magnitudes of
releases can vary highly (e.g., orders of magnitude) within most scenarios, ranging from 0.0002
to 115,059 kg/site-yr, likely due to site-specific processes and handling of methylene chloride.
Some of the largest releases reported are associated with the Waste Handling, Disposal,
Treatment, and Recycling; Processing - incorporation into formulation, mixture, or reaction
product; and Pharmaceutical Production scenarios. Data or information and methods needed to
estimate releases were not found for Adhesives and Sealants, Paints and Coatings, Aerosol
Degreasing/ Lubricants, Batch Open-Top Vapor Degreasing, Conveyorized Vapor Degreasing,
Cold Cleaning, Adhesive and Caulk Removers, Fabric Finishing, Laboratory Use, Non-Aerosol
Industrial and Commercial Use scenarios. While some sites in some of these scenarios without
quantitative water release estimates may have water releases, it is reasonable to assume that such
water releases would be less than most releases reported to TRI and DMR, which are expected to
have the highest volumes and releases of methylene chloride. A table of facilities for all
scenarios is in Appendix E. Uncertainties are discussed in Key Assumptions and Uncertainties in
the Environmental Exposure Assessment section 4.3.1.
2.3 Environmental Exposures
2.3.1 Environmental Exposures Approach and Methodology
The environmental exposure characterization focuses on aquatic releases of methylene chloride
from facilities that use, manufacture, or process methylene chloride under industrial and/or
commercial conditions of use. To characterize environmental exposure, EPA assessed point
estimate exposures derived from both measured and predicted concentrations of methylene
chloride in surface water in the U.S. Measured surface water concentrations were obtained from
EPA's Water Quality Exchange (WQX) using the Water Quality Portal (WQP) tool, which is the
nation's largest source of water quality monitoring data and includes results from EPA's
STOrage and RETrieval (STORET) Data Warehouse, the United States Geological Service
(USGS) National Water Information System (NWIS), and other federal, state, and tribal sources.
A literature search was also conducted to identify other peer-reviewed or grey literature5 sources
of measured surface water concentrations in the U.S., however, no data were found after 2000.
Predicted surface water concentrations were modeled for facility releases as detailed in Section
2.2 for reporting year 2016, as determined from EPA's TRI and from DMR; through EPA's
Water Pollutant Loading Tool). The aquatic modeling was conducted with EPA's Exposure and
Fate Assessment Screening Tool, version 2014 (E-FAST 2014) ( 37), using reported
annual release/loading amounts (kg/yr) and estimates of the number of days/yr that the annual
load is released (see Section 2.2 for more information). As appropriate, two scenarios were
modeled per release: release of the annual load over an estimated maximum number of operating
days/yr and over only 20 days/yr. Twenty days of release was modeled as the low-end release
5 Grey literature refers to sources of scientific information that are not formally published and distributed in peer
reviewed journal articles. These references are still valuable and consulted in the TSCA risk evaluation process.
Examples of grey literature are theses and dissertations, technical reports, guideline studies, conference proceedings,
publicly-available industry reports, unpublished industry data, trade association resources, and government reports.
( ENREF 350)
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frequency at which possible ecologic chronic risk could be determined. Additionally, the
Probabilistic Dilution Model (PDM), a module of E-FAST 2014 was run to predict the number
of days a stream concentration will exceed the designated concentration of concern (COC) value.
The measured concentrations reflect localized ambient exposures at the monitoring sites, and the
modeled concentrations reflect near-site estimates at the point of release. A geospatial analysis at
the subbasin and subwatershed level (Hydrologic Unit Code (HUC)-8 and HUC-12 level
respectively) was conducted to compare the measured and predicted surface water concentrations
and investigate if the facility releases may be associated with the observed concentrations in
surface water. Hydrologic Unit Codes are a geographically hierarchical tiered approach to
organizing stream networks across the United States from regions to subwatersheds and part of
the Watershed Boundary Dataset developed by U.S. Geological Survey and U.S. Department of
Agriculture (TISGS. 2013). HUC-8 and HUC-12 sized units were selected as they were expected
to give a representative geographic size range over which predicted SWCs would be relevant to
measured concentrations.
2.3.1.1 Methodology for Obtaining Measured Surface Water Concentrations
To characterize environmental exposure in ambient water for methylene chloride, EPA used two
approaches to obtain measured surface water concentrations. One approach was to pull
monitoring data on surface water concentrations from the WQP, and the second was to conduct a
systematic review of surface water concentrations in peer reviewed and gray literature.
The primary source of ambient surface water monitoring data was the WQP, which integrates
publicly available U.S. water quality data from multiple databases: 1) USGS NWIS, 2)
STORET, and 3) the USDA ARS Sustaining The Earth's Watersheds - Agricultural Research
Database System (STEWARDS). For methylene chloride, the data retrieved originated from the
NWIS and STORET databases. NWIS is the Nation's principal repository of water resources data
USGS collects from over 1.5 million sites, including sites from the National Water-Quality
Assessment (NAWQA). STORET refers to an electronic data system originally created by EPA
in the 1960's to compile water quality monitoring data. NWIS and STORET now use common
web services, allowing data to be published through WQP tool. The WQP tool and User Guide is
accessed from the following website: (http://www.wateraualitvdata.us/portal.isp).
Surface water data for methylene chloride were downloaded from the WQP on October 3, 2018.
The WQP can be searched through three different search options: Location Parameters, Site
Parameters, and Sampling Parameters. The methylene chloride data were queried through the
Sampling Parameters search using the Characteristics parameter (selected "Methylene Chloride
(NWIS, STORET)") and Date Range parameter (selected "01-01-2013 to 12-31-2017"). Both the
"Site data only" and "Sample results (physical/chemical metadata)" were selected for download
in "MS Excel 2007+" format. The "Site data only" file contains monitoring site information (i.e.,
location in hydrologic cycle, HUC and geographic coordinates); whereas the "Sample result" file
contains the sample collection data and analytical results for individual samples.
The "Site data only" and "Sample results (physical/chemical metadata)" files were linked
together using the common field "Monitoring Location Identifier" and then filtered and cleansed
to obtain surface water samples for years 2013 through 2017. Specifically, cleansing focused on
obtaining samples that were only for the media of interest (i.e., surface water), were not quality
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control (QC) samples (i.e., field blanks), were of high analytical quality (i.e., no QC issues,
sample contamination, or estimated values), and were not associated with contaminated sites
(i.e., Superfund).
Following filtering to obtain the final dataset, additional domains were examined to identify
samples with non-detect concentrations. All non-detect samples were tagged and the
concentrations were converted to V2 the reported detection limit for summary calculation
purposes. If a detection limit was not provided, calculations were performed using the average of
the reported detection limits in all samples (calculated as 1.46 |ig/L).
In addition to using data from WQP, EPA conducted a full systematic review of published
literature to identify studies reporting concentrations of methylene chloride in surface water
associated with background levels of contamination or potential releases from facilities that
manufacture, process, use and/or dispose of methylene chloride in the U.S. Studies clearly
associated with releases from Superfund sites, improper disposal methods, and landfills were
considered out of scope due to being regulated under other environmental statutes administered
by EPA and excluded from data evaluation and extraction. The systematic review process is
described in detail in Section 1.5. A total of seven surface water studies were extracted and the
results are summarized in Section 2.3.2.1. No concentration data from the U.S. was identified
prior to 2000.
2.3.1.2 Methodology for Modeling Surface Water Concentrations from Facility Releases
(E-FAST 2014)
Surface water concentrations resulting from wastewater releases of methylene chloride from
facilities that use, manufacture, or process methylene chloride were modeled using EPA's E-
FAST, Version 2014 (EPA, 2007). E-FAST 2014 is a model that estimates chemical
concentrations in water to which aquatic life may be exposed using upper percentile and/or mean
exposure parametric values, resulting in possible conservative exposure estimates. Other
assumptions and uncertainties in the model, including ways it may be underestimating or
overestimating exposure, are discussed in the Sections 4.3.1 and 4.3.6. Advantages to this model
are that it requires minimal input parameters and it has undergone extensive peer review by
experts outside of EPA. A brief description of the calculations performed within the tool, as well
as a description of required inputs and the methodology to obtaining and using inputs specific to
this assessment is described in Section 2.3.1.2.1. To obtain more detailed information on the E-
FAST 2014 tool from the user guide/background document, visit this web address:
https://www.epa.gov/tsca-screening-tools/e-fast-exposure-and-fate-assessment-screening-tool-
version-2014/. All model runs for this assessment were conducted between December 2018 and
June 2019.
In some ways the E-FAST estimates are underestimating exposure, because data used in E-FAST
include TRI and DMR data, and TRI does not include smaller facilities with fewer than 10 full
time employees, nor does it cover certain sectors, such as dry cleaners, or oil and gas extraction.
In some ways the E-FAST estimates are overestimating exposure, because methylene chloride is
a volatile chemical, but E-FAST doesn't take volatilization into consideration; and, for static
water bodies, E-FAST doesn't take dilution into consideration.
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2.3.1.2.1 E-FAST Calculations
Surface Water Concentrations
EPA used E-FAST 2014 to estimate site-specific surface water concentrations for discharges to
both free-flowing water bodies (i.e., rivers and streams) and for still water bodies (i.e., bays,
lakes, and estuaries).
For free-flowing water body assessments, E-FAST 2014 calculates surface water concentrations
for four streamflow conditions (7Q10, harmonic mean, 30Q5, and 1Q10 flows) using the
following equation:
where:
swc
WWR
WWT
SF
CF1
CF2
SWC =
WWR xCF1 x 1
WWT\
SF xCF2
(Eq. 2-1)
Surface water concentration (parts per billion (ppb) or |ig/L)
Chemical release to wastewater (kg/day)
Removal from wastewater treatment (%)
Estimated flow of the receiving stream (million liters/day (MLD))
Conversion factor (109 |ig/kg)
Conversion factor (106 L/day/MLD)
For still water body assessments, no simple streamflow value represents dilution in these types of
water bodies. As such, E-FAST 2014 accounts for dilution by incorporating an acute or chronic
dilution factor for the water body of interest instead of streamflows. Dilution factors in E-FAST
2014 are typically 1 (representing no dilution) to 200, based on NPDES permits or regulatory
policy. The following equation is used to calculate surface water concentrations in still water
bodies:
SWC =
WWRx
WWT\
xCF 1
PFXCF2XDF
(Eq. 2-2)
where:
SWC
WWR
WWT
PF
DF
CF1
CF2
(typically
Surface water concentration (ppb or |ig/L)
Chemical release to wastewater (kg/day)
Removal from wastewater treatment (%)
Effluent flow of the discharging facility (MLD)
Acute or chronic dilution factor (DF) used for the water body
between 1 and 200)
Conversion factor (109 |ig/kg)
Conversion factor (106 L/day/MLD)
Outputs
There are two main outputs from E-FAST that EPA used in characterizing environmental exposures:
surface water concentration estimates, and the number of days a certain surface water concentration
was exceeded. Site-specific surface water concentration estimates for free-flowing water bodies are
reported for the 7Q10 stream flows. The 7Q10 stream flow is the lowest consecutive 7-day average
flow during any 10-year period. Site-specific surface water concentration estimates for still water
bodies are reported for calculations using the acute dilution factors. In cases where site-specific
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flow/dilution data were not available, the releases were modeled using stream flows of a
representative industry sector, as calculated from all facilities assigned to the industry sector in
the E-FAST database (discussed below). Estimates from this calculation method are reported for the
10th percentile 7Q10 stream flows.
The PDM portion of E-FAST 2014 was also run for free-flowing water bodies. The PDM
predicts the number of days/yr a chemical's COC in an ambient water body will be exceeded.
COCs are threshold concentrations below which adverse effects on aquatic life are expected to
be minimal. The model is based on a simple mass balance approach presented by (Pi Toro.
1984) that uses probability distributions as inputs to reflect that streams follow a highly variable
seasonal flow pattern and there are numerous variables in a manufacturing process that can affect
the chemical concentration and flow rate of the effluent. PDM does not estimate exceedances for
chemicals discharged to still waters, such as lakes, bays, or estuaries. For these water bodies, the
days of exceedance is assumed to be zero unless the predicted surface water concentration
exceeds the COC. In these cases, the days of exceedance is set to the number of release days/yr
(see required inputs below).
2.3.1.2.2 Model Inputs
Individual model inputs and accompanying considerations for the surface water modeling are described
in this section.
Chemical Release to Wastewater (WWR)
Annual wastewater loading estimates (kg/site/year or lb/site/year) were obtained from 2016 TRI and
2016 DMR, as discussed in Section 2.2 To model these releases within E-FAST 2014, the annual
release is converted to a daily release using an estimated days of release per year. Below is an example
calculation:
WWR (kg/day) = Annual loading (kg/site/year) * Days released per year (days/year) (Eq. 2-3)
In cases where the total annual release amount from one facility was discharged via multiple
mechanisms (i.e., direct to surface water and/or indirectly through one or more WWTPs), the annual
release amount was divided accordingly based on reported information in TRI (Form R).
Release Days (days/yr)
The number of days/yr that the chemical is discharged is used to calculate a daily release amount from
annual loading estimates (see above). Current regulations do not require facilities to report the number
of days associated with reported releases. Therefore, two release scenarios were modeled for direct
discharging facilities to provide upper and lower bounds for the range of surface water concentrations
predicted by E-FAST 2014. The two scenarios modeled are a maximum release frequency (250 to 365
days) based on estimates specific to the facility's condition of use (see Section 2.2.1 for more details)
and a low-end release frequency of 20 days of release per year as an estimate of releases that could lead
to chronic risk. The 20-day chronic risk criterion is derived from partial life cycle tests (e.g.,
daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in
duration. For indirect dischargers, only the maximum estimated days of release per year was modeled
because it was assumed that the actual release to surface water would mostly occur at receiving
treatment facilities, which were assumed to typically operate greater than 20 days/yr.
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Removalfrom Wastewater Treatment (WWT%)
The WWT% is the percentage of the chemical removed from wastewater during treatment before
discharge to a body of water. As discussed in Section 2.1, the WWT% for methylene chloride
was estimated as 57% using the "STP" module within EPI Suite™, which was run using default
settings to evaluate the potential for methylene chloride to volatilize to air or adsorb to sludge
during wastewater treatment. The WWT% of 57% was applied to releases from indirect
discharging facilities because the releases are transferred off-site for treatment at a WWTP prior
to discharge to surface water. A WWT% of zero was used for direct releasing facilities because
the release reported in TRI and DMR already accounts for any wastewater treatment which may
have occurred.
Facility or Industry Sector
The required site-specific stream flow or dilution factor information for a given facility is
contained in the E-FAST 2014 database and is selected by searching by a facility's NPDES permit
number, name, or the known discharging waterbody reach code. For facilities that directly discharge to
surface water (i.e., "direct dischargers"), the NPDES code of the direct discharger was selected from the
database. For facilities that indirectly discharge to surface water (i.e., "indirect dischargers" because the
release is sent to a WWTP prior to discharge to surface water), the NPDES of the receiving WWTP was
selected. The receiving facility name and location was obtained from the TRI database (Form R), if
available. As TRI does not contain the NPDES code of receiving facilities, the NPDES was obtained
using EPA's Envirofacts search tool (https://www3.epa.gOv/enviro/facts/multisvstem.htm.l). If a facility
NPDES was not available in the E-FAST-2014 database, the release was modeled using water body data
for a surrogate NPDES code (preferred) or an industry sector, as described below.
Surrogate NPDES: In cases where the site-specific NPDES code was not available in the
E-FAST 2014 database, the preferred alternative was to select the NPDES for a nearby facility
that discharges to the same waterbody. The surrogate NPDES was chosen to best represent flow
conditions in the waterbody that both the methylene chloride releasing facility and surrogate
facility discharge to and not actual releases associated with the surrogate facility NPDES.
Industry Sector (SIC Code Option): If the NPDES code is unknown, no close analog could
be identified, or the exact location of a chemical loading is unknown, surface water
concentrations were modeled using the "SIC Code Option" within E-FAST 2014. This option
uses the 10th and 50th percentile receiving 7Q10 stream flows for dischargers in a given industry
sector, as defined by the SIC codes of the industry. The industrial activity associated with the
SIC or alternatively the NAICS of the facility in question was examined to select the most
representative industry sector for modeling in E-FAST 2014.
2.3.1.3 Methodology for Geospatial Analysis of Measured Surface Water Monitoring and
Modeled Facility Releases
Using 2016 data, the measured surface water concentrations from the WQP and predicted
concentrations from the modeled facility releases were mapped in ArcGIS Version 10.6 to
conduct a watershed analysis at the HUC-8 and HUC-12 level (these results are shown in Section
2.3.2.3 in Figure 2-6 through Figure 2-8). The purpose of the analysis was to identify if any of
the observed surface water concentrations could be attributable to the modeled facility releases.
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In addition, the analysis included a search for Superfund sites within 1 to 5 miles of the surface
water monitoring stations.
The locations of the monitoring stations were determined from the geographic coordinates
(latitude and longitude) provided in WQP. Location of releases from facilities were located based
on the geographic coordinates for the NPDES, TRI, and/or Facility Registry Service
Identification (FRS ID) of the mapped facility, as provided by FRS. For indirect dischargers, the
location of the receiving facility was mapped if known. If the receiving facility was not known,
the location of the indirect discharger was mapped. Superfund sites in 2016 were identified and
mapped using geographic coordinates of the "front door", as reported in the Superfund
Enterprise Management System (SEMS) database in Envirofacts
(https://www.epa.gov/enviro/sems-search).
A U.S. scale map was developed to provide a spatial representation of the measured
concentrations from monitoring and predicted instream concentrations from discharging facilities
(Section 2.3.2.3). HUC-8s or HUC-12s with co-located monitoring stations and facility releases
were identified and examined further through development of localized maps at the HUC scale.
2.3.2 Environmental Exposure Results
2.3.2.1 Measured Surface Water Concentrations
Measured Surface Water Concentrations from WQX/WQP
The original dataset downloaded contained 29,084 entries for sample years 2013 through 2017.
Following the filtering and cleansing procedure, only 8% of the samples remained (n = 2,286 for
2013-2017). The majority of the samples were removed because they were an off-topic media
(i.e., groundwater, artificial, bulk deposition, leachate, municipal waste, or stormwater) or
location type (i.e., landfill, seep, spring, or well). Those media and locations deemed off-topic
are discussed more fully in Section 1 and ( ;). Of the surface water samples that
were removed, -99% were QC samples (field or laboratory blanks, spikes, or replicates). Other
samples were removed because of their association with a Superfund site (i.e., Palermo Wellfield
Superfund Site) or QC issues.
For the 2016 final dataset (n = 471 samples), observations were made in 10 states (AZ, KS, MN,
MO, NJ, NM, NC, PA, TN, TX) at 109 unique monitoring sites, with 1 to 47 samples collected
per site. On a watershed level, observations were made in 44 HUC-8 areas and 98 HUC-12 areas.
The majority of HUCs had only one monitoring site (55% for HUC-8; 93% for HUC-12). Up to
12 sites were present in an HUC-8 and up to 4 sites in an HUC-12. A list of individual HUCs,
including the number of monitoring sites and samples in each HUC, is provided in TableApx
E-l for HUC-8 and Table Apx E-2 for HUC-12. For geospatial representation of these measured
samples see Figures rough 2-5.
A summary of the WQX data obtained from the WQP is provided in Table 2-18 below for years
2013-2017. Per year, the final evaluated datasets contained between 52 and 797 surface water
samples collected from 28 to 116 unique monitoring stations. Detection frequencies were low,
ranging from 1.1 to 5.1%. Concentrations ranged from not detected (ND; <0.04-10) to 2.5 |ig/L
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in 2013, ND (<0.04-5) to 1.2 |ig/L in 2014, ND (<0.04-4) to 0.5 |ig/L in 2015, ND (<0.04-5) to
29 |ig/L in 2016, and ND (<0.04-5) to 0.61 |ig/L in 2017. Non detect values are reported as a
range because of differences in reported detection limits in measured samples due to likely
differences in sampling routine, methodology, and precision in available analysis tools. The
highest measured value was observed in 2016; however, caution should be used in interpreting
trends with this data due to the small number of samples and the lack of samples collected from
the same sites over multiple years.
Table 2-18. Measured Concentrations of Methylene Chloride in Surface Water Obtained
from the Water Quality Portal (WQP): 2013-2017"
Year
Detection
Frequency
Concentration in All Samples (jig/L)
Concentrations (ju.g/L) in Only Samples
Above the Detection Limit
No. of Samples
(No. of Unique
Stations)
Range b
Average ±
Standard
Deviation
(SD)C
No. of Samples
(No. of Unique
Stations)
Range
Average ± SD
C
2013
5.1%
797 (166)
ND (<0.04-10)
to 2.5
1.38 ±2.0
41 (26)
0.5 to 2.5
0.57 ±0.33
2014
1.8%
611 (157)
ND (<0.04-5) to
1.2
0.34 ±0.32
11(11)
0.13 to 1.2
0.53 ±0.29
2015
1.1%
355 (94)
ND (<0.04-4) to
0.5
0.43 ±0.21
4(2)
0.04 to
0.07
0.05 ± 0.02
2016
1.1%
471 (109)
ND (<0.04-5) to
29
0.61 ± 1.9
5(3)
1.2 to 29
13.1 ± 14.6
2017
1.9%
52 (28)
ND (<0.04-5) to
0.61
0.59 ± 1.0
KD
0.61
0.61
All 5
Years
2.7%
2,286 (389)
ND (<0.04-10)
to 29
0.78 ± 1.5
62 (42)
0.04 to 29
1.54 ±5.10
a. Data were downloaded from the WQP (www.waterqualitvdata.us) on 10/3/2018. NWIS and STORET surface
water data were obtained by selecting "Methylene chloride (NWIS, STORET)" for the Characteristic and
selecting for surface water media and locations only. Results were reviewed and filtered to obtain a cleansed
dataset (i.e., samples/sites were eliminated if identified as estimated, QC, media type other than surface water,
Superfund, landfill, failed laboratory QC, etc.).
b. ND = Not Detected. Reported detection limits in all samples ranged from 0.04 to 10 |ig/L.
c. Calculations were performed using 'A the reported detection limit when results were reported as not detected. If a
detection limit was not provided, calculations were performed using the average of the reported detection limits
in all samples (1.46 |ig/L).
The quantitative environmental assessment used the 2016 data set only to allow direct
comparison with known TRI and DMR releasers from the same year. For the 2016 data, only 5
samples from 3 monitoring sites (all in North Carolina) had methylene chloride concentrations
above the detection limit, as shown in Table 2-19. The average of these samples was 13.1 |ig/L.
It should be noted that two of the sites (Clinton, NC and Mills River, NC) each had two samples
collected on the same day within 5-15 minutes (min) of each other. Both samples had identical
measured concentrations: 1.2 |ig/L in Clinton, NC and 29 |ig/L in Mills River, NC. The last site
(Ashville, NC) had a concentration of 5 |ig/L in one sample. No samples were collected at these
three sites in other years between 2013 and 2017.
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A detailed summary of results for all samples collected between 2013 and 2017 with
concentrations above the detection limit is provided in Table Apx E-3.
Table 2-19. Sample Information for Water Quality Exchange (WQX) Surface Water
Observations With Concentrations Above the Reported Detection Limit: Year 2016a
Monitoring Site Information
Sample Information
Monitoring Site ID
and Organization
Waterbody
Type and
Location
Lat/Long
HUC 8
Sample ID
Date and
Time
Concentration
Qig/L)b
21NC03WQ-B8484000
North Carolina
Department of
Enviromnental
Resources NCDENR
-DWQ WQX
River/Stream
BEARSKIN
SWAMP AT
SR 1325 NR
Clinton, NC
35.08754/
-78.43463
3030006
21NC03WQ-
AMS20161206-
B8484000-
370870277
2016-12-06
11:40:00
EST
1.2
21NC03WQ-
AMS20161206-
B8484000-
381057619
2016-12-06
11:55:00
EST
1.2
21NC03WQ-E1485000
North Carolina
Department of
Enviromnental
Resources NCDENR
-DWQ WQX
River/Stream
North Mills
River at SR
1343 (River
Loop Rd) nr
Mills River,
NC
35.39412/
-82.61646
6010105
21NC03WQ-
AMS20160822-
E1485000-
381059366
2016-08-22
15:55:00
EST
29
21NC03WQ-
AMS20160822
-E1485000-
381059612
2016-08-22
16:00:00
EST
29
21NC03WQ-E3475000
North Carolina
Department of
Enviromnental
Resources NCDENR
-DWQ WQX
River/Stream
Hominy
Creek at Pond
Rd in
Asheville,
NC°
35.54683/
-82.60264
6010105
21NC03WQ-
RAMS20160817-
E3475000-
370533933
2016-08-17
17:05:00
EST
5
a. Data were downloaded from the WQP (www.waterqualitvdata.us) on 10/3/2018. NWIS and STORET surface
water data were obtained by selecting "Methylene chloride (NWIS, STORET)" for the Characteristic and
selecting for surface water media and locations only. Results were reviewed and filtered to obtain a cleansed
dataset (i.e., samples/sites were eliminated if identified as estimated, QC, media type other than surface water,
Superfund, landfill, failed laboratory QC, etc.).
Measured Concentrations in Published Literature
Using systematic review, the published literature yielded only a minimal amount of surface water
monitoring data for methylene chloride; a summary of the individual studies is provided in Table
2-20. Only two U.S. studies were identified. In one, a USGS nation-wide random survey of
rivers and reservoirs used for drinking water sources, methylene chloride was detected at 2.6
|ig/L in one out of 375 samples collected between 1999 and 2000 (detection limit of 0.2 |ig/L)
(Usgs, 2003). In the other U.S. study, conducted in 1979-1981, methylene chloride was detected
in 93% of samples collected from the Eastern Pacific Ocean (Singh et al„ 1983). Concentrations
ranged from below the detection limit (<0.0004) to 0.008 |ig/L, with a mean of 0.0031 |ig/L
(n=30). No U.S. monitoring data were identified for year 2016.
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The systematic review approach also identified data from various other countries and regions,
including Brazil, China, Japan, France, and Europe (Bianchi et al.. 2017; Ma et al.. 2014;
Christof et al.. 2002; Duclos et al.. 2000; Yamamoto et al.. 1997). Collectively, these studies
encompass 332 samples collected between 1993 and 2013 from rivers and estuaries. The
reported methylene chloride concentrations range from below the detection limit to 134 |ig/L,
with reported central tendency values ranging from 0.0019 to 1.7 |ig/L. The highest
concentration was from an industrialized area of Osaka, Japan in 1993-1995 (Yamamoto et al..
1997). The next highest reported concentrations were in the range of 4.5 to 5 |ig/L in
industrialized or urban areas of China, France, and Europe (1993-2011).
Table 2-20. Summary of Published Literature with Surface Water Monitoring Data
Country
Site Information
Date
Sampled
N
(Detection
Frequency)
Concentration (jig/L)
Source
Data
Quality
Score
Range
Central
Tendency
±SD)
North America
U.S.
Nation-wide; Surface
water for drinking
water sources (rivers
and reservoirs)
1999-2000
375
(0.0027)
ND (<0.2) -
2.6
NR
(Uses,
2003)
Medium
U.S. to
Chile
Eastern Pacific Ocean
(California, U.S. to
Valparaiso, Chile)
1979-1981
30
(0.93)
ND (<0.0004)
-0.008
Mean: 0.0031
±0.0032
(Sinali et
al.. 1983)
Medium
Europe and Asia
Brazil
Santo Antonio da
Patrulha, Tres Coroas,
and Parobe in the
Sinos River Basin;
River samples
collected from seven
points on the three
main rivers of the
Sinos River Basin
2012-2013
60
(0.72)
ND -0.0058
Mean: 0.0019
(Bianchi et
al.. 2017)
Medium
China
Daliao River (n=20
sites), heavily
industrialized
2011
20
(0.75)
ND (<0.675) -
4.47
Mean: 0.678
(Ma et al..
2014)
High
Europe
Estuaries of the
Scheldt, Thames,
Loire, Rhine
1997-1999
73
(1)
0.0003 -4.98
NR
(Christof et
al.. 2002)
High
France
Paris; River samples
(raw) collected from
the River Seine (n=14
stations). River Marne
(n=l station) and
River Oise (n=l
station). WWTPs are
located on the river.
1994-1995
43
(1)
0.016-4.92
Mean: 1.004 ±
1.218; Median:
0.473
(Duclos et
al.. 2000)
Medium
Japan
Osaka; Rivers and
estuaries (30 sites) in
industrialized city
1993-1995
136
(NR)
NR - 134
Median: 1.7
(Yamamoto
et al.. 1997)
High
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NR = Not reported
ND = Not detected; detection limit reported in parenthesis if available.
2.3.2.2 E-FAST Modeling Results
Summary
As discussed in Section 2.2, releases of methylene chloride were determined from two data
sources (TRI and DMR) for the 2016 calendar year, and assigned to 14 TSCA condition of use
categories. Overall, 124 releases originating from 26 states were modeled, with the most in
California (14%) and New York (11%). The location of the actual releases, when accounting for
indirect dischargers, occurred in 23 U.S. states/territories (AL, AZ, CA, CT, GA, ID, IL, IN, KY,
LA, MD, MI, MO, NH, NJ, NY, OH, PR, SC, TN, TX, WA, WV). With respect to watersheds,
the releases occurred across 85 HUC-8 areas and 105 HUC-12 areas. At the HUC-8 level,
approximately three quarters of the HUCs contained only one identified facility release (67%),
and the remaining HUCs contained 3 to 12 facility releases. Direct and indirect dischargers
accounted for 70% and 30% of the total releases modeled, respectively. The majority of the
releases were modeled using site-specific NPDES codes (66%); surrogate NPDES codes were
used in only 9% of the cases, with the remaining cases (25%) run using a representative industry
sector SIC code. For releases modeled with a NPDES code (including a surrogate NPDES),
surface water concentrations were calculated for free-flowing water bodies in 76% of the cases,
and still water bodies for the remaining cases (24%). A detailed summary table by facility is
provided in Table Apx E-4.
Summary by OES
A summary of the surface water concentration estimates modeled using E-FAST 2014 based on
lifecycle release analysis summarized in Section 2.2.2, with release estimates based on reported
releases to TRI and DMR for the year 2016, is summarized by OES category in Table 2-21 for
the maximum release scenario and Table 2-22 for the 20-day release scenario. For the maximum
days of release scenarios, surface water concentrations under 7Q10 flow conditions ranged from
3.48E-07 to 17,000 ppb. For the 20-day release scenarios, surface water concentrations ranged
from 4.40E-06 to 5,878 ppb. On a per facility basis, the 20-day release scenario yielded higher
surface water concentrations than the maximum day of release scenario.
Table 2-21. Summary of Surface Water Concentrations by Occupational Exposure
Scenario (OES) for Maximum Days of Release Scenario
Sum of
Annual
No. of Releases
Releases Modeled
OES Modeled (kg/yr)
Annual Release by
Facility
(kg/site-yr)
Surfac
Conce
(7QH
e Water
ntration
} Flow)
g/L)
Min
Max
Min
Max
Manufacturing
20
162
0.0083
75.9
1.20E-05
5.00
Import and Repackaging
5
245
0.0281
144
5.28E-05
32.1
Processing as a Reactant
3
238
0.115
213
0.0140
0.24
Processing: Formulation
9
6,202
0.226
5785
3.43E-06
1,527
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Sum of
Annual
No. of Releases
Releases Modeled
OES Modeled (kg/yr)
Annual Release by
Facility
(kg/site-yr)
Surfac
Conce
(7QH
e Water
ntration
} Flow)
g/L)
Min
Max
Min
Max
Polyurethane Foam
1
2.27
2.27
2.27
1.25
1.25
Plastics Manufacturing
9
64.1
0.0233
28.0
4.05E-05
3.74
Pharmaceutical
15
2,854
0.454
2268
1.06E-04
5.80
CTA Film Manufacturing
1
28.6
28.6
28.6
0.0949
0.0949
Lithographic Printer Cleaner
1
0.00093
0.00093
0.000927
5.83E-05
0.000058
Spot Cleaner
1
0.0600
0.0600
0.0600
5.02E-03
0.0050
Recycling and Disposal
16
116,344
0.0241
76451
4.02E-03
17,000
Other
12
67.16
0.00023
42.2
3.48E-07
11.1
Department of Defense (DoD)
1
0.45
0.454
0.454
2.01E-03
0.0020
WWTP
29
5,596
0.112
2730
1.47E-04
301.5
Overall 123
2.35E-04 76,451
3.48E-07 17,000
1593
1594
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Table 2-22. Summary of Surface Water Concentrations by Occupational Exposure
Summary (PES) for 20 Days of Release Scenario
Surface Water
Sum of
Annual Release by
Concentration
No. of
Annual
Facility
(7Q10)
Releases
Releases
(kg/site-yr)
(PPb)
OES
Modeled
(kg/yr)
Min
Max
Min
Max
Manufacturing
14
95
0.0083
75.9
2.35E-04
83.0
Import and Repackaging
2
0.11
0.028
0.086
0.18
0.55
Processing as a Reactant
2
25
0.115
24.9
1.90
4.52
Processing: Formulation
5
49
0.226
30.8
8.90E-04
107.4
Polyurethane Foam
1
2.27
2.268
2.27
13.7
13.7
Plastics Manufacturing
9
64.1
0.023
28.0
5.26E-04
53.6
Pharmaceutical
4
49
2.24
42
0.09.51
18.7
CTA Film Manufacturing
1
28.6
28.6
28.59
1.33
1.33
0.0006.71
Lithographic Printer Cleaner
1
9.3E-04
9.3E-04
9.3E-04
6.71E-04
E-04
Spot Cleaner
1
0.060
0.060
0.060
0.0753
0.0753
Recycling and Disposal
6
7
0.024
3.58
0.15
352.9
Other
10
22.7
2.35E-04
21.8
4.40E-06
1.14
DoD
1
0.45
0.454
0.45
0.0231
0.0231
WWTP
29
5,596
0.112
2,730
1.47E-03
5,778
Overall
86
2.35E-04
2,730
4.40E-06
5,778
2.3.2.3 Geospatial Analysis
A geospatial analysis at the watershed level (HUC-8 and HUC-12) was conducted to compare
the measured and predicted surface water concentrations in 2016 and investigate if the facility
releases may be associated with the observed concentrations in surface water. A geographic
distribution of the concentrations is shown in Figures 2-1 and 2-2 (east and west U.S.) for the
maximum days of release scenario, and in Figures 2-3 and 2-4 (east and west U.S.) for the 20-
days of release scenario. Overall, there are 28 U.S. states/territories with either a measured
concentration (n=10) or a predicted concentration (n=23); at the watershed level, there are 127
HUC-8 areas and 198 HUC-12 areas with either measured or predicted concentrations.
Table Apx E-5 provides a list of states/territories with facility releases (as mapped) and/or
monitoring sites.
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Miles
Concentration Levels Concentration Type
H > 8146 pg/L Q Modeled - Direct Release (250 - 365 days/yr)
H 1527 - 8145.9 |jg/L A Modeled - Indirect Release (250-365 days/yr)
32 -1526.9 pg/L O Measured - NWIS/STORET Monitoring Sites
H 7 - 31.9 pg/L '// States with no modeled or measured concentrations
¦ 1-6.9 pg/L
< 1 pg/L
Not detected
1610
1611 Figure 2-2. Surface Water Concentrations of Methylene Chloride from Releasing Facilities
1612 (Maximum Days of Release Scenario) and Water Quality Exchange (WQX) Monitoring
1613 Stations: Year 2016, Eastern U.S.
1614 All indirect releases are mapped at the receiving facility unless the receiving facility is unknown.
1615
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Concentration Levels
¦ > 8146 (jg/L
¦ 1527 -8145.9 Mg/L
32- 1526.9 pg/L
¦ 7 - 31.9 pg/L
1 - 6.9 ng/L
< 1 Jjg/L
Not detected
Concentration Type
Modeled - Direct Release (250 - 365 days/yr)
A Modeled - Indirect Release (250 - 365 days/yr)
O Measured - NWIS/STORET Monitoring Sites
[/VIStates with no modeled or measured concentrations
1616
1617 Figure 2-3. Surface Water Concentrations of Methylene Chloride from Releasing Facilities
1618 (Maximum Days of Release Scenario) and Water Quality Exchange (WQX) Monitoring
1619 Stations: Year 2016, Western U.S.
1620 All indirect releases are mapped at the receiving facility unless the receiving facility is unknown.
1621
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Concentration Levels Concentration Type
H =¦ 8146 jjg/L | Modeled - Direct Release (20 days/yr)
¦ 1527 - 8145.9 pg/L O Measured - NWIS/STORET Monitoring Sites
32 - 1526.9 (jg/L [/Vjstates with no modeled or measured concentrations
¦ 7-31.9 pg/L
¦ 1-6.9 pg/L
< 1 MS/L
Not detected
tiJ
300
H Miles
1622
1623 Figure 2-4. Concentrations of Methylene Chloride from Releasing Facilities (20 Days of
1624 Release Scenario) and Water Quality Exchange (WQX)Monitoring Stations: Year 2016,
1625 East U.S.
1626
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Concentration Levels
> 8146 |jg/L
1527 - 8145.9 pg/L
32 - 1526.9 |jg/L
7 - 31.9 (jg/L
1-6.9 pg/L
< 1 Mg/L
Not detected
Concentration Type
I I Modeled - Direct Release (20 days/yr)
O Measured - NWIS/STORET Monitoring Sites
\//\ States with no modeled or measured concentrations
1627
1628 Figure 2-5. Concentrations of Methylene Chloride from Releasing Facilities (20 Days of
1629 Release Scenario) and Water Quality Exchange (WQX) Monitoring Stations: Year 2016,
1630 West U.S.
1631
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Superfund Analysis
An analysis of the 2016 dataset was conducted to determine if any monitoring stations may be
associated with nearby Superfund sites that may potentially contain methylene chloride releases,
and thus would not fall under the scope of this TSCA evaluation. In the dataset, six surface water
monitoring stations were within 1 mile of one or more Superfund sites in SEMS. Overall, 12
Superfund sites were identified, although only one of the 12 Superfund sites is on the National
Priority List (NPL), the others are identified as Non-NPL. All measured surface water
concentrations at the six monitoring sites were below the detection limit. For monitoring stations
that had detectable concentrations in 2016, the search was expanded to 5 miles. Sample
21NC03WQ-E3475000, located at Hominy Creek at Pond Rd in Asheville, NC, met this
criterion. However, the monitoring station is located on a separate tributary to the French Broad
River and its catchment does not include the Superfund site. Therefore, no monitoring stations
were removed from the geospatial analysis based on proximity to Superfund sites.
Co-location of Methylene Chloride Releasing Facilities and Monitoring Stations
The co-occurrence of methylene chloride releasing facilities and monitoring stations in a HUC is
shown in Figure 2-6. There are two adjacent HUC-8 areas (and one HUC-12) in Arizona that
have both measured and predicted concentrations. The associated facility and monitoring site
information are provided in Table 2-23. HUC 15070102 (Aqua Fria), has three direct releasing
facilities with modeled 7Q10 SWCs ranging from 0.11 to 7.99 ppb, and 7 monitoring stations all
with concentration less than the reported detection limit (0.8 to 5 ppb). Three of the monitoring
sites were 7.5 to 15.8 miles downstream of two facilities, the remaining monitoring sites were
neither up or downstream of facilities. HUC 15060106 (Lower Salt), has one direct releasing
facility with modeled 7Q10 SWCs ranging from 0.13 to 1.95 ppb, and 5 monitoring stations all
with concentration less than the reported detection limit (0.8 to 5 ppb).
As the measured concentrations were below the detection limit and the number of samples
collected was small, definitive conclusions could not be drawn on possible associations between
measured concentrations in surface water and predicted concentrations from facility releases.
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1662
1663
1664
1665
Lake Pleasant}
AZ0020559
AZ0020001
Theodore ;
maw It Lake
AZ0020524
Figure 2-6. Co-location of Methylene Chloride Releasing Facilities and Water Quality
Exchange (WQX) Monitoring Stations at the HUC 8 and HUC 12 Level
Aqua Fria
15070102
* Only one HUC-12 contains both
a facility and a monitoring station
Lower Salt
15060106
AZ0023931
Measured - NWIS/STORET Monitoring
Not detected
Modeled - Direct Release (250 - 365 days/yr)
Maximum days of release: 0.26 to 2.83 pg/mL
20 days of release: 2.49 to 18.59 (jg/mL
l~~l HUC-8 boundary
I I HUC-12 boundary*
¦ Miles
Data refreshed October. 2018.
The National Map: National Hydrography Dataset.
Concentrations
U.S. Locations
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1666 Table 2-23. Co-Location of Facility Releases and Monitoring Sites within HUC 8 Boundaries (Year 2016)
Facilities in HUC
Monitoring Sites in HUC
Measured
Surface Water
Modeled 7Q10
No. of
Concentrations
Location Comments Relative to
Site
SWCsa (ug/L)
Monitoring Site ID
Samples
(M-g/L)
Facilitiesb
HUC 15070102: Aqua Fria
3 Direct Releasing Facilities
7 Monitoring Sites
1 . PIMA COUNTY - INA ROAD
365 days: 1.36*
USGS-333238112165201
1
ND (< 5)
Downstream of AZ0020001 (14 mi) and
WWTP; TUCSON, AZ
20 days: 18.59*
AZ0020559 (15.8 mi)
NPDES: AZ0020001
USGS-333658112113200
1
ND (< 5)
Downstream of AZ0020001 (7.5 mi) and
AZ0020559 (9.4 mi)
USGS-333751112133801
1
ND (< 5)
Downstream of AZ0020001 (9.4 mi) and
AZ0020559 (11.4 mi)
2. 23RD AVENUE WWTP;
365 days: 0.26
USGS-09513925
1
ND (< 5)
Upstream or neither up or down stream
PHOENIX, AZ
20 days: 2.49
NPDES: AZ0020559
USGS-333407112045401d
3
ND (<0.3 - < 0.8)
Upstream or neither up or down stream
USGS-333840112123601
1
ND (< 5)
Upstream or neither up or down stream
3. APACHE JUNCTION WWTP
365 days: 0.0387
APACHE JUNCTION, AZ;
20 days: 0.72
USGS-334811112070700
3
ND (< 0.3 - < 4)
Upstream or neither up or down stream
NPDES: AZ0023931
HUC 15060106: Lower Salt
1 Direct Releasing Facility
5 Monitoring Sites
1. 91ST AVE WWTP;
365 days: 0.29
USGS-09512403°'d
2
ND (<0.3 - < 0.8)
Neither up or down stream
TOLLESON, AZ
NPDES: AZ0020524
20 days: 4.52
USGS-332333112080301
USGS-332409111594101cd
3
2
ND (<0.3 - < 0.8)
ND (<0.3 - < 0.8)
Neither up or down stream
Neither up or down stream
USGS-332430112101001
2
ND (<0.3 - < 0.8)
Neither up or down stream
USGS-333557111594201
3
ND (< 0.3)
Neither up or down stream
1667
1668
1669
1670
1671
a. Concentrations leading to modeled days of exceedance are indicated by an asterisks (*).
b. The number of miles between the facility and monitoring site are based on Euclidean distance.
c. The monitoring sites are also co-located with the facility in the same HUC 12 (150601060306; City of Phoenix-Salt River).
d. The monitoring sites are located within 1.02 to 1.08 miles of Superfund sites.
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1672 1.3.1 Co-location of Monitoring Stations and DM R/TRI/CDR/Superfund Sites
1673 Three monitoring sites in the 2016 dataset had detectable concentrations but were not co-located
1674 with other identified methylene chloride-releasing facilities. As such these monitoring stations
1675 were further characterized by evaluating their location with respect to any DMR (NPDES), TRI,
1676 CDR, or Superfund site in 2016 as shown in Figure 2-7 and Figure 2-8.
1677
21NC03WQ-B8484000
U.S. Location
Black
03030006
National Map: jifational
< \ ! ! i f
Concentrations
I Lake
Waccamaw
Measured - NWIS/STORET
Monitoring Sites
• 1.2 ijg/L
Facilitv Type
I CDR
NPDES
i Superfund
i TRI
B~~l HUC-8 boundary
11 I HUC-12 boundary
Miles
Hydrography Dataset. Data refreshed October. 2018.
1678 Figure 2-7. Search of CDR, DMR (NPDES), Superfund, and TRI facilities in 2016 within
1679 HUC-8 of Water Quality Portal (WQP) Station 21NC03WQ-AMS20161206 -B8484000.
1680 Two samples with concentrations of 1.2 ppb were detected at this monitoring site on 2016.
1681
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21NC03WQ-E3475000
La
U.S. Location
Upper French Broad
06010105
Concentrations
Measured - NWIS/STORET
Monitoring Sites
29 (jg L
• 5 mQ/L
Facility Type
gp
n NPDES
Superfund
TRI
HUC-8 boundary
I I HUC-12 boundary
LilKt J.life
Rivrr.
21NC03WQ-E1485000
Thotfic Lake
XSu/uJj
I'H
30
Miles
SGS The National Map: National Hydrography Dataset. Data refreshed October, 2018.
Figure 2-8. Search of CDR, NPDES, Superfund, and TRI facilities in 2016 within HUC-8 of
Water Quality Portal (WQP) Stations 21NC03WQ-E1485000 and 21NC03WQ-E3475000.
Station 21NC03WQ-E1485000 had two samples with concentrations of 29 ppb and station
21NC03WQ-E3475000 had one sample with concentration of 5 ppb.
2.4 Human Exposures
EPA evaluated acute and chronic exposures to workers and occupational non-users (ONUs) and
acute exposures to consumers by dermal and inhalation routes in association with methylene
chloride use in industri al, commercial and consumer applications. The assessed conditions of use
are described above in Table 1-4; however, due to expected similarities in or lack of data to
distinguish some conditions of use, both exposures/releases and occupational and consumer
exposures for several of the subcategories of use in Table 1-4 were grouped and assessed
together during risk evaluation. For example, formulation of paints, coatings, adhesives, sealants,
and other product subcategories may generally have similar worker activities, and EPA does not
have data to distinguish whether workers are differently exposed for these different formulations.
Therefore, EPA has grouped these formulating conditions of use into one occupational scenario.
A crosswalk of the conditions of use in Table 1-4 to the occupational and consumer scenarios
assessed in this report is provided in Table 2-24 below. It is possible that an individual can fall
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into multiple PESS categories. For example, an individual may be exposed as a worker or ONU
and also outside of the workplace as a consumer.
Table 2-24. Crosswalk of Conditions of Use to Occupational and Consumer Scenarios
Assessed in the Risk Evaluation
Life Cycle
Stage
Category a
Subcategory b
Occupational Scenario
Consumer
Scenario
Manufacturing
Domestic
manufacturing
Manufacturing
Manufacturing
N/A
Import
Import
Repackaging
N/A
Processing
Processing as a
reactant
Intermediate in
industrial gas
manufacturing (e.g.,
manufacture of
fluorinated gases used
as refrigerants)
Processing as a Reactant
N/A
Intermediate for
pesticide, fertilizer, and
other agricultural
chemical manufacturing
petrochemical
manufacturing
Intermediate for other
chemicals
Incorporated
into
formulation,
mixture, or
reaction
product
Solvents (for cleaning
or degreasing),
including
manufacturing of:
• All other basic
organic
chemical
• Soap, cleaning
compound and
toilet
preparation
Processing - Incorporation into
Formulation Mixture, or Reaction
Product
N/A
Solvents (which
become part of product
formulation or mixture),
including
manufacturing of:
• All other
chemical
product and
preparation
• Paints and
coatings
Propellants and blowing
agents for all other
chemical product and
N/A
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Life Cycle
Stage
Category a
Subcategory b
Occupational Scenario
Consumer
Scenario
preparation
manufacturing
Propellants and blowing
agents for plastics
product manufacturing
Paint additives and
coating additives not
described by other
codes
Laboratory chemicals
for all other chemical
product and preparation
manufacturing
Laboratory chemicals
Processing aid, not
otherwise listed for
petrochemical
manufacturing
Adhesive and sealant
chemicals in adhesive
manufacturing
oil and gas drilling,
extraction and support
activities
Repackaging
Solvents (which
become part of product
formulation or mixture)
for all other chemical
product and preparation
manufacturing
Repackaging
N/A
all other chemical
product and preparation
manufacturing
Recycling
Recycling
Waste Handling, Disposal, Treatment,
and Recycling
N/A
Distribution in
commerce
Distribution
Distribution
Repackaging
Industrial,
commercial
and consumer
uses
Solvents (for
cleaning or
degreasing)0
Batch vapor degreaser
(e.g., open-top, closed-
loop)
Batch Open-Top Vapor Degreasing
N/A
In-line vapor degreaser
(e.g., conveyorized,
web cleaner)
Conveyorized Vapor Degreasing
N/A
Cold cleaner
Cold Cleaning
N/A
Aerosol spray
degreaser/cleaner
Commercial Aerosol Products
(Aerosol Degreasing, Aerosol
Lubricants, Automotive Care
Products)
Brake Cleaner,
Carbon Remover,
Carburetor
Cleaner, Coil
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Life Cycle
Stage
Category a
Subcategory b
Occupational Scenario
Consumer
Scenario
Cleaner,
Electronics
Cleaner, Engine
Cleaner, Gasket
Remover
Adhesives and
sealants
Single component glues
and adhesives and
sealants and caulks
Adhesives and Sealants
Adhesives,
Sealants
Paints and
coatings
Paints and coatings use
and paints and coating
Paints and Coatings
Brush Cleaner
including
commercial
paint and
coating
removers
removers, including
furniture refinisher
Paint and Coating Removers
Adhesive/caulk
removers
Adhesive and Caulk Removers
Adhesives
Removers
Metal products
not covered
elsewhere
Degreasers - aerosol
and non-aerosol
degreasers and cleaners
e.g., coil cleaners
Commercial Aerosol Products
(Aerosol Degreasing, Aerosol
Lubricants, Automotive Care
Products)
Miscellaneous Non-Aerosol Industrial
and Commercial Uses
Carbon Remover,
Coil Cleaner,
Electronics
Cleaner
Fabric, textile
and leather
products not
covered
elsewhere
Textile finishing and
impregnating/ surface
treatment products e.g.,
water repellant
Fabric Finishing
N/A
Automotive
care products
Function fluids for air
conditioners:
refrigerant, treatment,
leak sealer
Miscellaneous Non-Aerosol Industrial
and Commercial Uses
Automotive Air
Conditioning
Leak Sealer,
Automotive Air
Conditioning
Refrigerant
Interior car care - spot
remover
Commercial Aerosol Products
(Aerosol Degreasing, Aerosol
Lubricants, Automotive Care
Products)
N/A
Automotive
care products
Degreasers: gasket
remover, transmission
cleaners, carburetor
cleaner, brake
quieter/cleaner
Commercial Aerosol Products
(Aerosol Degreasing, Aerosol
Lubricants, Automotive Care
Products)
Brake Cleaner,
Carburetor
Cleaner, Engine
Cleaner, Gasket
Remover
Apparel and
footwear care
products
Post-market waxes and
polishes applied to
footwear e.g., shoe
polish
Commercial Aerosol Products
(Aerosol Degreasing, Aerosol
Lubricants, Automotive Care
Products)
N/A
Laundry and
dishwashing
products
Spot remover for
apparel and textiles
Spot Cleaning
N/A
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Life Cycle
Stage
Category a
Subcategory b
Occupational Scenario
Consumer
Scenario
Lubricants and
greases
Liquid and spray
lubricants and greases
Commercial Aerosol Products
(Aerosol Degreasing, Aerosol
Lubricants, Automotive Care
Products)
Miscellaneous Non-Aerosol Industrial
and Commercial Uses
Brake Cleaner,
Carburetor
Cleaner, Engine
Cleaner, Gasket
Remover
Degreasers - aerosol
and non-aerosol
degreasers and cleaners
Building/
construction
materials not
covered
elsewhere
Cold pipe insulation
Commercial Aerosol Products
(Aerosol Degreasing, Aerosol
Lubricants, Automotive Care
Products)
Cold Pipe
Insulation
Solvents
(which become
part of product
formulation or
mixture)
All other chemical
product and preparation
manufacturing
Processing - Incorporation into
Formulation Mixture, or Reaction
Product
N/A
Processing aid
not otherwise
listed
In multiple
manufacturing sectors6
Cellulose Triacetate Film Production
N/A
Propellants and
blowing agents
Flexible polyurethane
foam manufacturing
Flexible Polyurethane Foam
Manufacturing
N/A
Arts, crafts and
hobby
materials
Crafting glue and
cement/concrete
N/A
Adhesives
Other Uses
Laboratory chemicals -
all other chemical
product and preparation
manufacturing
Laboratory Use
N/A
Electrical equipment,
appliance, and
component
manufacturing
Miscellaneous Non-Aerosol Industrial
and Commercial Uses
N/A
Plastic and rubber
Plastic Product Manufacturing
N/A
products
Cellulose Triacetate Film Production
N/A
Anti-adhesive agent -
anti-spatter welding
aerosol
Commercial Aerosol Products
(Aerosol Degreasing, Aerosol
Lubricants, Automotive Care
Products)
Weld Spatter
Protectant
Oil and gas drilling,
extraction and support
activities
Miscellaneous Non-Aerosol Industrial
and Commercial Uses
N/A
Functional fluids
(closed systems) in
pharmaceutical and
medicine manufacturing
Pharmaceutical Production
N/A
Toys, playground, and
sporting equipment -
Miscellaneous Non-Aerosol Industrial
and Commercial Uses
N/A
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Life Cycle
Stage
Category a
Subcategory b
Occupational Scenario
Consumer
Scenario
including novelty
articles (toys, gifts, etc.)
Carbon remover,
lithographic printing
cleaner, wood floor
cleaner, brush cleaner
Lithographic Printing Plate Cleaning
Miscellaneous Non-Aerosol Industrial
and Commercial Uses
Brush Cleaner,
Carbon Remover
Disposal
Disposal
Industrial pre-treatment
Waste Handling, Disposal, Treatment,
and Recycling
N/A
Industrial wastewater
treatment
Publicly owned
treatment works
(POTW)
Underground injection
Municipal landfill
Hazardous landfill
Other land disposal
Municipal waste
incinerator
Hazardous waste
incinerator
Off-site waste transfer
a - These categories of conditions of use appear in the initial life cycle diagram, reflect CDR codes and broadly
represent conditions of use for methylene chloride in industrial and/or commercial settings,
b - These subcategories reflect more specific uses of methylene chloride.
c - Reported for the following sectors in the 2016 CDR for manufacturing of: plastic materials and resins, plastics
products, miscellaneous, all other chemical product and preparation (U.S. EPA. 2016).
e -Reported for the following sectors in the 2016 CDR for manufacturing of: petrochemicals, plastic materials and
resins, plastics products, miscellaneous and all other chemical products (U.S. EPA. 2016) which may include
chemical processor for polycarbonate resins and cellulose triacetate - photographic film, developer EPA's Use and
Market Profile for Methylene Chloride (U.S. EPA. 2017g).
N/A means these scenarios are not consumer conditions of use
2.4.1 Occupational Exposures
For the purpose of this assessment, EPA considered occupational exposure of the total workforce
of exposed users and non-users, which include but are not limited to male and female workers of
reproductive age who are >16 years of age. Female workers of reproductive age are >16 to less
than 50 years old. Adolescents (>16 to <21 years old) are a small part of this total workforce.
The occupational exposure assessment is applicable to and covers the entire workforce who are
exposed to methylene chloride.
Occupational Exposures Approach and Methodology Section 2.4.1.1 summarizes the
occupational acute and chronic inhalation exposure concentration and dermal dose models for
methylene chloride.
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These models were then applied for the various industries and scenarios identified in Table 2-24.
Occupational Exposure Estimates by Scenario Section 2.4.1.2 summarizes air concentrations,
including both 8-hr time-weighted averages (TWA) and shorter-term averages, and inhalation
exposure concentrations and dermal doses by occupational exposure scenario (OES), and overall
summaries of model outputs and numbers of workers by OES.
The supplemental document titled "Risk Evaluation for Methylene Chloride (Dichloromethane,
DCM) CASRN: 75-09-2, Supplemental Information on Releases and Occupational Exposure
Assessment"(EPA. 2019b) provides background details on industries that may use methylene
chloride, worker activities, processes, numbers of sites and number of potentially exposed
workers. This supplemental document also provides detailed discussion on the values of the
exposure parameters and air concentrations and associated worker inhalation and dermal
exposure results presented in this section.
For each scenario, EPA distinguishes exposures for workers and occupational non-users (ONUs).
Normally, a primary difference between workers and ONUs is that workers may handle chemical
substances and have direct dermal contact with chemicals that they handle, while ONUs are
working in the general vicinity of workers but do not handle chemical substances and do not
have direct dermal contact with chemicals being handled by the workers. EPA expects that
ONUs may often have lower inhalation exposures than workers since they may be further from
the exposure source than workers. For inhalation, if EPA cannot distinguish ONU exposures
from workers, EPA assumes that ONU inhalation to be less than the inhalation estimates for
workers.
2.4.1.1 Occupational Exposures Approach and Methodology
This section summarizes the key occupational acute and chronic inhalation exposure
concentration and dermal dose models for methylene chloride. The supplemental document titled
"Risk Evaluation for Methylene Chloride (Dichloromethane, DCM) CASRN: 75-09-2,
Supplemental Information on Releases and Occupational Exposure Assessment" (EP A. 2019b)
provides detailed discussion on the values of the exposure parameters and air concentrations
input into these models.
Acute and Chronic Inhalation Exposure Concentrations Models
A key input to the acute and chronic models for occupational assessment is 8-hr time-weighted
average (TWA) air concentration. The 8-hr TWA air concentrations are time averaged to
calculate acute exposure, average daily concentration (ADC) for chronic, non-cancer risks, and
lifetime average daily concentration (LADC) for chronic, cancer risks.
Acute workplace exposures are assumed to be equal to the contaminant concentration in air (8-hr
TWA), per Equation 2-4.
at a
Where:
(Eq. 2-4)
AEC = CXED
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AEC = acute exposure concentration (mg/m3)
C = contaminant concentration in air (mg/m3, 8-hr TWA)
ED = exposure duration (8 hr/day)
ATacute = acute averaging time (8 hr)
ADC and LADC are used to estimate workplace chronic exposures for non-cancer and cancer
risks, respectively. These exposures are estimated as follows:
(Eq. 2-5)
C x ED x EF x WY
ADC or LADC = — —
AT or ATc
Where:
ADC = average daily concentration (mg/m3) used for chronic non-cancer risk calculations
LADC = lifetime average daily concentration (mg/m3) used for chronic cancer risk
calculations
C = contaminant concentration in air (mg/m3, 8-hr TWA)
ED = exposure duration (8 hr/day)
EF = exposure frequency (250 days/yr)
WY = exposed working years per lifetime (tenure values used to represent: 50th
percentile = 31; 95th percentile = 40)
AT = averaging time, non-cancer risks (WY x 365 days/yr x 24 hr/day)
ATC = averaging time, cancer risks (lifetime (LT) x 250 days/year x 8 hr/day; where LT
= 78 years); this averaging time corresponds to the cancer benchmark as
indicated in Chapter 3 HAZARDS
EPA reviewed workplace inhalation monitoring data collected by government agencies such as
OSHA and NIOSH, and monitoring data found in published literature (i.e., personal exposure
monitoring data and area monitoring data). Data were evaluated using the evaluation strategies
laid out in the Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2018a).
and the evaluation details are shown in two supplemental files: Risk Evaluation for Methylene
Chloride, Systematic Review Supplemental File: Data Quality Evaluation of Environmental
Releases and Occupational Exposure Data ( 19d) Risk Evaluation for Methylene
Chloride, Systematic Review Supplemental File: Data Quality Evaluation of Environmental
Releases and Occupational Exposure Common Sources (EPA. 2019c). Where available, EPA
used air concentration data and estimates found in government or published literature sources.
Where air concentration data were not available, modeling estimates were used. Details on which
models EPA used are included in Section 2.4.1.2 for the applicable OESs and discussion of the
uncertainties associated with these models is included in Section 4.3.2.
EPA evaluated inhalation exposure for workers using personal monitoring data or modeled near-
field exposure concentrations. Since ONUs do not directly handle methylene chloride, EPA
reviewed personal monitoring data, modeled far-field exposure concentrations, and area
monitoring data in evaluating potential inhalation exposures for ONUs. Because modeled results
are typically intended to capture exposures in the near-field, modeling that does not contain a
specific far-field component are not considered to be suitable for ONUs. Area monitoring data
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may potentially represent ONU exposures depending on the monitor placement and the intended
sample population.
OSHA Standards and Respiratory Protection
The Occupational Safety and Health Administration (OSHA) Respiratory Protection Standard
(29 CFR 1910.134) provides a summary of respirator types by their assigned protection factor
(APF). Assigned Protection Factor (APF) "means the workplace level of respiratory protection
that a respirator or class of respirators is expected to provide to employees when the employer
implements a continuing, effective respiratory protection program" according to the
requirements of OSHA's Respiratory Protection Standard. Because methylene chloride may
cause eye irritation or damage, the OSHA standard for methylene chloride (29 CFR 1910.1052)
prohibits use of quarter and half mask respirators; additionally, only supplied air respirators
(SARs) can be used because methylene chloride may pass through air purifying respirators.
Respirator types and corresponding APFs indicated in bold font in Table 2-25. comply with the
OSHA standard for protection against methylene chloride. APFs are intended to guide the
selection of an appropriate class of respirators to protect workers after a substance is determined
to be hazardous, after an occupational exposure limit is established, and only when the exposure
limit is exceeded after feasible engineering, work practice, and administrative controls have been
put in place. For methylene chloride, the OSHA PEL is 25 ppm, or 87 mg/m3 as an 8-hr TWA,
and the OSHA short-term exposure limit (STEL) is 125 ppm, or 433 mg/m3 as a 15-min TWA.
For each occupational exposure scenario in section 2.4.1.2, EPA compares the exposure data and
estimates to the PEL and STEL.
The current OSHA PEL was updated in 1997; prior to the change the OSHA PEL had been 500
ppm as an 8-hr TWA, which was 20 times higher than the current PEL. An analysis of more than
12,000 personal samples from 1984 to 2016 obtained from OSHA by Finkel ( ) shows the
PEL change appears to have produced a general average reduction from 85 ppm to 72 ppm
(about 15%) in methylene chloride exposures. Excluding non-detects from the sample set
increases the reduction from 149 ppm to 85 ppm (about 43%) (with a higher fraction of non-
detects in the data before the updated PEL in 1997 than after 1997). An alternative considering
non-detects as half the limit of detection (LOD) was considered however the dataset does not
contain the LOD with each measurement or a reference to the test method and this was not
calculated. Half the LOD would result in an estimate between the alternative estimates setting
non-detects equal to zero (15%) and excluding non-detects (43%). Note that the sites used to
collect occupational exposure monitoring data for workers were not selected randomly;
therefore, the reported data may not be representative of all occupational exposures. Overall, this
range of incremental general exposure reductions due to the PEL change indicates that exposure
data from before the PEL (over 20 years old) are adequate for EPA's risk evaluation purposes.
EPA has sought additional data regarding exposures, particularly during the public comment
phases on the documents preceding this draft risk evaluation (e.g., the methylene chloride section
6 rule and the problem formulation). With the exception of paint and coating removers, EPA has
not received information to date to indicate that workplace changes have occurred broadly in
particular sectors over the past 40 years.
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Based on the protection standards, inhalation exposures may be reduced by a factor of 25, 50,
1,000, or 10,000, if respirators are required and properly worn and fitted. Air concentration data
are assumed to be pre-APF unless indicated otherwise in the source, and APFs acceptable under
the OSHA standards are not otherwise considered or used in the occupational exposure
assessment but are considered in the risk characterization and risk determination.
Table 2-25. Assigned Protection Factors for Respirators in OSHA Standard 29 CFR
1910.134 a
Type of Respirator
Quarter
Mask
Half Mask
Full
Facepiece
Helmet/
Hood
Loose-
fitting
Facepiece
1. Air Purifying Respirator
5
10
50
2. Powered Air-Purifying Respirator
50
1,000
25/1,000
25
3. Supplied-Air Respirator (SAR) or Airline
Respirator
• Demand mode
• Continuous flow mode
• Pressure-demand or other positive-
pressure mode
10
50
50
50
1,000
1,000
25/1,000
25
4. Self-Contained Breathing Apparatus
(SCBA)
• Demand mode
• Pressure-demand or other positive-
pressure mode
10
50
10,000
50
10,000
Note that only APFs indicated in bold are acceptable to OSHA for methylene chloride protection. Other respirators
from the Respiratory Protection Standard that are not acceptable for methylene chloride protection are indicated in
shaded cells.
Key Dermal Exposure Dose Models
Current EPA dermal models do not incorporate the evaporation of material from the dermis. The
dermal potential dose rate, Dexp (mg/day), is calculated as (EPA. 2013a):
(Eq. 2-6)
Dexp — S x Qu x Yderm x FT
Where:
S is the surface area of contact (cm2; defaults: 535 cm2 (central tendency); 1,070 cm2
(high end) = full area of one hand (central tendency) or two hands (high end), a mean
value for men > 21 yr (EPA. 2011a). the highest exposed population)
Qu is the quantity remaining on the skin (mg/cm2-event; defaults: 1.4 mg/cm2-event
(central tendency); 2.1 mg/cm2-event (high end))
Yderm is the weight fraction of the chemical of interest in the liquid (0 < Yderm < 1)
FT is the frequency of events (integer number per day; default: 1 event/day).
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Here Qu does not represent the quantity remaining after evaporation, but represents the quantity
remaining after the bulk liquid has fallen from the hand that cannot be removed by wiping the
skin (e.g., the film that remains on the skin).
One way to account for evaporation of a volatile solvent would be to add a multiplicative factor
to the EPA model to represent the proportion of chemical that remains on the skin after
evaporation,/abs (0
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European Centre For Ecotoxicology and Toxicology of Chemicals Targeted Risk Assessment
(ECETOC TRA) model represents the protection factor of gloves as a fixed, assigned protection
factor equal to 5, 10, or 20 (Marquart et at.. 2017). where, similar to the APR for respiratory
protection, the inverse of the protection factor is the fraction of the chemical that penetrates the
glove. Dermal doses without glove use are estimated in the occupational exposure sections below
and summarized in Table 2-26. Potential impacts of these protection factors are presented as
what-if scenarios in the dermal exposure summary Table 2-83. As indicated in Table 2-26, use of
protection factors above 1 is valid only for glove materials that have been tested for permeation
against the methylene chloride-containing liquids associated with the condition of use. EPA has
not found information that would indicate specific activity training (e.g., procedure for glove
removal and disposal) for tasks where dermal exposure can be expected to occur in a majority of
sites in industrial only OESs, so the PF of 20 would usually not be expected to be achieved.
Table 2-26. Glove Protection Factors for Different Dermal Protection Strategies from
ECETOC TRA v3
Dermal Protection Characteristics
Setting
Protection
l-'actor. PI-"
a. No gloves used, or any glove / gauntlet without
permeation data and without employee training
1
b. Gloves with available permeation data indicating that the
material of construction offers good protection for the
substance
Industrial and
Commercial
Uses
5
c. Chemically resistant gloves (i.e., as b above) with "basic"
employee training
10
d. Chemically resistant gloves in combination with specific
activity training (e.g., procedure for glove removal and
disposal) for tasks where dermal exposure can be expected to
occur
Industrial Uses
Only
20
EPA also considered potential dermal exposure in cases where exposure is occluded. See further
discussion on occlusion in Appendix E of the Supplemental Information on Releases and
Occupational Exposure Assessment document (EPA. 2019b).
It is important to note that the occupational dermal exposure approach and modeling differs from
that for consumer exposure approach outlined in Section 2.4.2.3.1 due to different data
availability and assessment needs and may result in different exposure values for similar
conditions of use.
Appendix F contains information gathered by EPA in support of understanding glove use for
pure methylene chloride and for paint and coatings removal using methylene chloride
formulations. This information may be generally useful for a broader range of uses of methylene
chloride and is presented for illustrative purposes. This appendix also contains a summary of
information on gloves from Safety Data Sheets (SDS) for methylene chloride and formulations
containing methylene chloride.
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For most scenarios, EPA did not find enough data to determine statistical distributions of the
actual exposure parameters and concentration inputs to the inhalation and dermal models
described above. Within the distributions, central tendencies describe 50th percentile or the
substitute that most closely represents the 50th percentile. The high-end of a distribution
describes the range of the distribution above 90th percentile ( ). Ideally, EPA
would use the 50th and 95th percentiles for each parameter. Where these statistics were
unknown, the mean or median (mean is preferable to median) served as substitutes for 50th
percentile and the high-end of ranges served as a substitute for 95th percentile. However, these
substitutes were highly uncertain and not ideal substitutes for the percentiles. EPA could not
determine whether these substitutes were suitable to represent statistical distributions of real-
world scenarios.
2.4.1.2 Occupational Exposure Estimates by Scenario
Details of the occupational exposure assessments for each of the Occupational Exposure
Scenarios (OES) listed in Table 2-24, with one exception, are available in the supplemental
document titled "Risk Evaluation for Methylene Chloride (Dichloromethane, DCM) CASRN: 75-
09-2, Supplemental Information on Releases and Occupational Exposure Assessment" (EPA.
2019b). The exception is for Paint and Coating Removers, which are covered in Appendix L.
The following subsections contain a summary of inhalation and dermal estimates for each OES.
Details on the inhalation and dermal estimates as well as process descriptions, numbers of sites
and potentially exposed workers, and worker activities for each OES are available in the
supplemental document (EPA. 2019b). Lists of all inhalation monitoring data found in data
sources and associated systematic review data quality ratings are available in Appendix A of this
supplemental document.
Key uncertainties toward exposure estimates in these scenarios are summarized in Section 4.3.2.
Table 2-27 presents estimated numbers of workers in the OESs assessed for methylene chloride.
Where available, EPA used publicly available data (typically CDR) to provide a basis to estimate
the number of sites, workers and ONUs. EPA supplemented the available CDR data with U.S.
economic data using the following method:
1. Identify the North American Industry Classification System (NAICS) codes for the
industry sectors associated with these uses.
2. Estimate total employment by industry/occupation combination using the Bureau of
Labor Statistics' Occupational Employment Statistics data (BLS Data).
3. Refine the OES estimates where they are not sufficiently granular by using the U.S.
Census' Statistics of US Businesses (SUSB) (SUSB Data) data on total employment by
6-digit NAICS.
4. Use market penetration data to estimate the percentage of employees likely to be using
methylene chloride instead of other chemicals.
5. Where market penetration data are not available, use the estimated workers/ONUs per
site in the 6-digit NAICS code and multiply by the number of sites estimated from CDR,
TRI, or National Emissions Inventory (NEI).
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2012
2013
2014
2015
2016
2017
2018
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EPA combined the data generated in Steps 1 through 5 to produce an estimate of the number of
employees using methylene chloride in each industry/occupation combination (if available), and
then summed these to arrive at a total estimate of the number of employees with exposure within
the occupational exposure scenario. More details on the data are provided in the supplemental
document titled "Risk Evaluation for Methylene Chloride (Dichloromethane, DCM) CASRN: 75-
09-2, Supplemental Information on Releases and Occupational Exposure Assessment" (EPA.
2019b).
Table 2-27. Estimated Numbers of Workers in the Assessed Industry Scenarios for
Methylene Chloride
Occupational Kxposure Scenario
N umber of Workers
Number of ONI s
Manufacturing
1,200
*
Processing as a Reactant
460
120A
Processing - Incorporation into
Formulation
4,500
*
Repackaging
2,300
*
Batch Open-Top Vapor Degreasing
270
*
Conveyorized Vapor Degreasing
180
*
Cold Cleaning
95,000
*
Aerosol Degreasing/Lubricants
250,000
29,000
Adhesives
2,700,000
810,000
Paints and Coatings
1,800,000
340,000
Adhesive and Caulk Removers
190,000
18,000
Fabric Finishing
19,000
12,000
Spot Cleaning
76,000
7,900
CTA Manufacturing
700
*
Flexible PU Foam Manufacturing
9,600
2,700
Laboratory Use
17,000
150,000
Plastic Product Manufacturing
210,000
90,000
Pharmaceutical
77,000
47,000
Lithographic Printing Cleaner
40,000
19,000
Miscellaneous Non-Aerosol Industrial and
Commercial Use (Cleaning Solvent)
<1,400,000
*
Waste Handling, Disposal, Treatment, and
Recycling
12,000
7,600
* - Data did not distinguish ONUs from workers.
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A - One data source distinguished ONUs from workers and the other source did not.
2.4.1.2.1 Manufacturing
The Halogenated Solvents Industry Alliance (HSIA) provided personal monitoring data from
2005 through 2018 at two manufacturing facilities (Halogenated Solvents Industry Alliance.
2018V
Overall, 136 8-hr TWA personal monitoring data samples were available; EPA calculated the
50th and 95th percentile 8-hr TWA concentrations to represent a central tendency and high-end
estimate of potential occupational inhalation exposures, respectively, for this scenario. Both the
central tendency and high-end 8-hr TWA exposure concentrations for this scenario are at least
one order of magnitude below the OSHA Permissible Exposure Limit (PEL) value of 87 mg/m3
(25 ppm) as an 8-hr TWA.
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC as
described in Section 2.4.1.1 and are summarized in Table 2-28.
Table 2-28. Worker Exposure to Methylene Chloride During Manufacturing3
Data Quality
Central
Rating of
N il in her of
Tendency
Iligh-Knd
Associated Air
Samples
(mg/nr')
(mg/nr*)
Concentration Data
8-hr TWA Exposure
Concentration
0.36
4.6
Average Daily Concentration
(ADC)
136
0.08
1.1
High
Lifetime Average Daily
Concentration (LADC)
0.14
2.4
Sources: Halogenated Solvents Industry Alliance (20.1.8)
a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures.
Table 2-29 summarizes available short-term exposure data for workers provided by HSIA
(Halogenated Solvents Industry Alliance. 2018).
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2047
2048
2049
2050
2051
2052
2053
2054
2055
2056
2057
2058
2059
2060
2061
2062
2063
2064
2065
2066
2067
2068
2069
2070
2071
2072
2073
2074
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Table 2-29. Short-1
"erm Wor
ter Exposure to Met
lylene Chloride During Manufacturing
Data Quality
Number
Rating of
of
Central Tendency
Iligh-Knd
Associated Air
Samples
(mg/m3)
(ing/nr')
Concentration Data
15-min a
148
9.6
180
30-min b
1
2.6
High
1-hr
3
6.6
15
Source: Haloeenated Solvents Industry Alliance (20.1.8).
a - EPA assumed sampling times of 15 mins to 29 mins as 15-min exposures,
b - EPA assumed sampling times of 30 mins to 59 mins as 30-min exposures.
Note: The OSHA Short-term exposure limit (STEL) is 433 mg/m3 as a 15-min TWA. One sample of 486 mg/m3
among the 148 15-min samples exceeded this limit, and the remaining 147 samples were below this limit.
EPA has not identified personal or area data on or parameters for modeling potential ONU
inhalation exposures from methylene chloride manufacturing. Since ONUs do not directly handle
methylene chloride (otherwise they would be considered workers), ONU inhalation exposures
could be lower than worker inhalation exposures. Information on activities where ONUs may be
present are insufficient to determine the proximity of ONUs to workers and sources of emissions,
so relative exposure of ONUs to workers cannot be quantified.
Table 2-30 presents estimated dermal exposures during domestic manufacturing.
Table 2-30. Summary of Dermal Exposure Doses to Methylene Chloride for Manufacturing
Occupational
Kxposurc
Scenario
I se Setting
(Industrial vs.
Commercial)
.Maximum
Weight
l-'raction.
^ ilt-nii'1
Dermal K\|
(mg/
No Clove
Central
Tendency
losure Dose
day)
sdV i)
nigh r.iui
Calculated
l-'raction
Absorbed.
I1 iiIin
Manufacturing
Industrial
1.0
60
180
0.08
a - EPA assumes methylene chloride manufactured at 100% concentration.
Potential impacts of protection factors are presented as what-if scenarios in the dermal exposure summary Table
2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA data. For the inhalation air
concentration data, the primary strengths include the assessment approach, which is the use of
monitoring data, the highest of the inhalation approach hierarchy. These monitoring data include
136 data points from 1 source, and the data quality ratings from systematic review for these data
were high. The primary limitations of these data include the uncertainty of the representativeness
of these data toward the true distribution of inhalation concentrations for the industries and sites
covered by this scenario. Based on these strengths and limitations of the inhalation air
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concentration data, the overall confidence for these 8-hr TWA data in this scenario is medium to
high.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.2 Processing as a Reactant
HSIA provided monitoring data from 2010 through 2017 from a fluorochemical manufacturing
facility, where methylene chloride could be used as an intermediate for the production of
fluorocarbon blends (Halogenated Solvents Industry Alliance. 2.018).
Overall, 15 8-hr TWA personal monitoring data samples were available; EPA calculated the 50th
and 95th percentile 8-hr TWA concentrations to represent a central tendency and worst-case
estimate of potential occupational inhalation exposures, respectively, for this scenario. The
central tendency 8-hr TWA exposure concentration is more than an order of magnitude lower
than the OSHA PEL value of 87 mg/m3 (25 ppm) as an 8-hr TWA, while the high-end 8-hr TWA
exposure concentrations for this scenario is more than 8 times lower than the OSHA PEL. Based
on available short-term exposure data, 10-minute TWAs could be up to 350 mg/m3 during
specific operations such as filter changing, charging and discharging, etc.
Table 2-31 presents the calculated the AEC, ADC, and LADC for these 8-hr TWA exposure
concentrations, as described in Section 2.4.1.1.
Table 2-31. Worker Exposure to Methylene Chloride During Processing as a Reactant
During Fluorochemicals Manufacturing3
Data Qualify
Rating of
Number
Central
Associated Air
<»r
Tendency
High End
Concentration
Samples
(ing/nr')
(ing/nr*)
Data
8-hr TWA Exposure
Concentration
1.6
10
Average Daily Concentration
(ADC)
15
0.37
2.4
High
Lifetime Average Daily
Concentration (LADC)
0.65
5.3
Sources: Halogenated Solvents Industry Alliance (20.1.8)
a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures.
Table 2-32 summarizes available short-term exposure data available for "other chemical
industry" and during drumming at a pesticide manufacturing site.
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2111
2112
2113
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2115
2116
2117
2118
2119
2120
2121
2122
2123
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2125
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Table 2-32. Summary of Personal Short-Term Exposure Data for Methylene Chloride
During Processing as a Reactant
Occupational
Kxposure
Scenario
Source
Worker
Activity
Methylene
Chloride
Short-Term
Concentration
(mg/nr')
Kxposurc
Duration
(mill)
Data Quality
Rating of
Associated Air
Concentration
Data
Other Chemical
Industry
TNG
filter
changing,
charging and
discharging,
etc.
350 (max)
10
Low
Pesticides Mfg
Olin
(1979)
Drumming
1,700
25
Medium
Note: The OSHA Short-term exposure limit (STEL) is 433 mg/m3 as a 15-min TWA.
EPA has not identified personal data on or parameters for modeling potential ONU inhalation
exposures. Limited area monitoring data were identified (see Appendix A.2 of the supplemental
document titled "Risk Evaluation for Methylene Chloride (Dichloromethane, DCM) CASRN: 75-
09-2, Supplemental Information on Releases and Occupational Exposure Assessment" (EPA.
2019b)). However, the representativeness of these data for ONU exposures is not clear because
of uncertainty concerning the intended sample population and the selection of the specific
monitoring location. ONUs are employees who work at the facilities that process and use
methylene chloride, but who do not directly handle the material. ONUs may also be exposed to
methylene chloride but are expected to have lower inhalation exposures and are not expected to
have dermal exposures. ONUs for this condition of use may include supervisors, managers,
engineers, and other personnel in nearby production areas. Since ONUs do not directly handle
formulations containing methylene chloride (otherwise they would be considered workers), EPA
expects ONU inhalation exposures to be lower than worker inhalation exposures. Information on
processes and worker activities are insufficient to determine the proximity of ONUs to workers
and sources of emissions, so relative exposure of ONUs to workers cannot be quantified.
Table 2-33 presents modeled dermal exposures during processing as a reactant.
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2134
2135
2136
2137
2138
2139
2140
2141
2142
2143
2144
2145
2146
2147
2148
2149
2150
2151
2152
2153
2154
2155
2156
2157
2158
2159
2160
2161
2162
2163
2164
2165
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Table 2-33. Summary of Dermal Exposure Doses to Methylene Chloride for Processing as a
Reactant
Occupational
Kxposurc
Scenario
I se Selling
(Industrial vs.
Commercial)
Maximum
Weigh!
l-'raclion.
^ ilt-nii'1
Dermal K\|
(mg/
No(Jove
Ccnl nil
Tendency
losure Dose
dav)
s(PI 1)
High l iul
Calculated
l-'raclion
Absorbed.
I1 iiIin
Processing as a
Reactant
Industrial
1.0
60
180
0.08
a - EPA assumes methylene chloride is received at 100% concentration.
Potential impacts of protection factors are presented as what-if scenarios in the dermal exposure summary Table
2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA data. For the inhalation air
concentration data, the primary strengths include the assessment approach, which is the use of
monitoring data, the highest of the inhalation approach hierarchy. These monitoring data include
15 data points from 1 source, and the data quality ratings from systematic review for these data
were high. The primary limitations of these data include the uncertainty of the representativeness
of these data toward the true distribution of inhalation concentrations for the industries and sites
covered by this scenario. Based on these strengths and limitations of the inhalation air
concentration data, the overall confidence for these 8-hr TWA data in this scenario is medium to
high.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.3 Processing - Incorporation into Formulation, Mixture, or Reaction
Product
U.S. EPA (1985) provided exposure data for packing at paint/varnish and cleaning products sites,
ranging from 52 mg/m3 (mixing) to 2,223 mg/m3 (valve dropper).
Overall, 10 personal monitoring data samples were available; EPA calculated the 50th and 95th
percentile 8-hr TWA concentrations to represent a central tendency and high-end estimate of
potential occupational inhalation exposures, respectively, for this scenario. The central tendency
8-hr TWA exposure concentration for this scenario is approximately twice the OSHA PEL value
of 87 mg/m3 (25 ppm) as an 8-hr TWA, while the high-end estimate is approximately 21 times
higher.
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC as
described in Section 2.4.1.1 and are listed in Table 2-34.
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2169
2170
2171
2172
2173
2174
2175
2176
2177
2178
2179
2180
2181
2182
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2184
2185
2186
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Table 2-34. Worker Exposure to Methylene Chloride During Processing - Incorporation
into Formulation, Mixture, or Reacl
tion Product"
Data Qualify
Rating of
Number
Central
Associated Air
of
Tendency
Nigh-I.nd
Concentration
Samples
(mg/iir*)
(mg/m')
Data
8-hr TWA Exposure Concentration
180
1,800
Average Daily Concentration
(ADC)
10
41
410
High
Lifetime Average Daily
Concentration (LADC)
72
920
Sources: EPA (.1.985).
a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures.
TNO (CIVO) (1999) indicated that the peak exposure during filling may be up to 180 mg/m3 but
did not provide exposure duration.
EPA has not identified personal or area data on or parameters for modeling potential ONU
inhalation exposures. Since ONUs do not directly handle formulations containing methylene
chloride, ONU inhalation exposures could be lower than worker inhalation exposures.
Information on processes and worker activities are insufficient to determine the proximity of
ONUs to workers and sources of emissions, so relative exposure of ONUs to workers cannot be
quantified.
Table 2-35 presents modeled dermal exposures during processing - incorporation into
formulation, mixture or reaction product.
Table 2-35. Summary of Dermal Exposure Doses to Methylene Chloride for Processing -
Incorporation into Formulation, Mixture, or Reaction Product.
Occupational
Kxposurc
Scenario
I se Setting
(Industrial \ s.
Commercial)
.Maximum
Weight
l-'raction.
^ ilt-nii'1
Dermal K\|
(mg/
No (Jo\e
Central
Tendency
losure Dose
day)
s(PI 1)
High 1.11(1
Calculated
l-'raction
Absorbed.
I1 iiIin
Processing -
Incorporation
into Formulation,
Mixture, or
Reaction Product
Industrial
1.0
60
180
0.08
a - EPA assumes methylene chloride is received at 100% concentration.
Potential impacts of PFs are presented as what-if scenarios in the dermal exposure summary Table 2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
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2193
2194
2195
2196
2197
2198
2199
2200
2201
2202
2203
2204
2205
2206
2207
2208
2209
2210
2211
2212
2213
2214
2215
2216
2217
2218
2219
2220
2221
2222
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA data. For the inhalation air
concentration data, the primary strengths include the assessment approach, which is the use of
monitoring data, the highest of the inhalation approach hierarchy. These monitoring data include
10 data points from 1 source, and the data quality ratings from systematic review for these data
were high. The primary limitations of these data include the uncertainty of the representativeness
of these data toward the true distribution of inhalation concentrations for the industries and sites
covered by this scenario. Based on these strengths and limitations of the inhalation air
concentration data, the overall confidence for these 8-hr TWA data in this scenario is medium to
high.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.4 Repackaging
EPA found limited inhalation monitoring data for repackaging from published literature sources.
A 1986 Industrial Hygiene (IH) study at Unocal Corporation found full-shift exposures during
filling drums, loading trucks, and transfer loading to be between 6.0 and 137.8 mg/m3 (5 data
points) (Tin ocal Corporation. 1986).
Because only five 8-hr TWA data points were available, EPA assessed the median value of 8.8
mg/m3 as the central tendency, and the maximum reported value of 137.8 mg/m3 as the high-end
estimate of potential occupational inhalation exposures, respectively, for this scenario. The
central tendency 8-hr TWA exposure concentration for this scenario is approximately 10 times
lower the OSHA PEL value of 87 mg/m3 (25 ppm) as an 8-hr TWA, while the high-end estimate
is approximately 1.5 times higher.
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC. The
results of these calculations are shown in Table 2-36.
Table 2-36. Worker Exposure to Methylene Chloride During Repackaging3
Central
Data Qualify Kaling
N il in her of
Tendency
lligh-lnd
of Associated Air
Samples
(nig/nr')
(mg/m5)
Concentration Data
8-hr TWA Exposure Concentration
8.8
140
Average Daily Concentration (ADC)
5
2.0
31
Medium
Lifetime Average Daily
Concentration (LADC)
3.5
71
2223
2224
2225
2226
2227
2228
Source: Unocal Corporation (1.986)
a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures.
Table 2-37 summarizes available short-term exposure data available from the same OSHA
source identified above for the 8-hr TWA data.
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2230
2231
2232
2233
2234
2235
2236
2237
2238
2239
2240
2241
2242
2243
2244
2245
2246
2247
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Table 2-37. Summary of Personal Short-Term Exposure Data for Methylene Chloride
During Repackaging
Occupational
Kxposure
Scenario
Source
Worker
Activity
.Methylene
Chloride
Short-Term
Concentration
(mg/nr')
Kxposurc
Duration
(mill)
Data Quality
Rating of
Associated Air
Concent rat ion
Data
Distribution
Unocal
Corporation
0986)
Transfer loading
from truck to
storage tank
(4,100 gallons)
0.35
30
Medium
Truck loading
(2,000 gallons)
330
50
Truck loading
(800 gallons)
35
30
Truck loading
(250 gallons)
30
47
Note: The OSHA STEL is 433 mg/m3 as a 15-min TWA.
EPA has not identified personal or area data on or parameters for modeling potential ONU
inhalation exposures. ONUs are employees who work at the site where methylene chloride is
repackaged, but who do not directly perform the repackaging activity. ONUs for repackaging
include supervisors, managers, and tradesmen that may be in the repackaging area but do not
perform tasks that result in the same level of exposures as repackaging workers.
Since ONUs do not directly handle formulations containing methylene chloride, EPA expects
ONU inhalation exposures to be lower than worker inhalation exposures. Information on
processes and worker activities are insufficient to determine the proximity of ONUs to workers
and sources of emissions, so relative exposure of ONUs to workers cannot be quantified.
Table 2-38 presents modeled dermal exposures during repackaging.
Table 2-38. Summary of Dermal Exposure Doses to Methylene Chloride for Repackaging
Occupational
Kxposurc
Scenario
I se Setting
(Industrial vs.
Commercial)
.Maximum
Weight
l-'raction.
^ ilt-nii'1
Dermal Kx|
(mg/
No(Jove
Central
Tendency
losure Dose
day)
s(PI 1)
High 1.11(1
Calculated
l-'raction
Absorbed.
I1 iiIin
Repackaging
Industrial
1.0
60
180
0.08
a - EPA assumes repackaging of methylene chloride at 100% concentration.
Potential impacts of PFs are presented as what-if scenarios in the dermal exposure summary Table 2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
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EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA data. For the inhalation air
concentration data, the primary strengths include the assessment approach, which is the use of
monitoring data, the highest of the inhalation approach hierarchy. These monitoring data include
5 data points from 1 source, and the data quality ratings from systematic review for these data
were medium. The primary limitations of these data include the uncertainty of the
representativeness of these data toward the true distribution of inhalation concentrations for the
industries and sites covered by this scenario. Based on these strengths and limitations of the
inhalation air concentration data, the overall confidence for these 8-hr TWA data in this scenario
is medium to low.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.5 Batch Open-Top Vapor Decreasing
EPA found no monitoring data for methylene chloride in this use. To fill this data gap, EPA
performed modeling of near-field and far-field exposure concentrations in the OTVD scenario
for both workers and ONUs. Modeling details are in Appendix F of the supplemental document
titled "Risk Evaluation for Methylene Chloride (Dichlorome thane, DCM) CASRN: 75-09-2,
Supplemental Information on Releases and Occupational Exposure Assessment" (EPA, 2019b).
The central tendency and high-end 8-hr TWA exposure concentrations for this scenario exceed
the OSHA PEL value of 87 mg/m3 (25 ppm) as an 8-hr TWA.
Estimates of ADC and LADC for use in assessing risk were made using the approach and
equations described in Section 2.4.1.1 and are presented in Table 2-39.
Table 2-39. Statistical Summary of Methylene Chloride 8-hr TWA Exposures (ADC and
LADC) for Workers and ONUs for Batch Open-Top Vapor Degreasing
Data Quality
Rating of
Associated Air
Central Tendency
Iligh-Knd
Concent rat ion
(nig/nr*)
(ing/nr*)
Data
Workers (Near-Field)
8-hr TWA Exposure Concentration
170
740
Average Daily Concentration
(ADC)
29
130
N/A - Modeled
Data
Lifetime Average Daily
Concentration (LADC)
15
66
ONUs (Far-Field)
8-hr TWA Exposure Concentration
86
460
N/A - Modeled
Data
Average Daily Concentration
(ADC)
15
78
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Central Tendency
(ing/nr*)
Iligh-Knd
(ing/nr*)
Data Quality
Rating of
Associated Air
Concentration
Data
Lifetime Average Daily
Concentration (LADC)
7.6
40
Table 2-40 presents modeled dermal exposures during batch open-top vapor degreasing use.
Table 2-40. Summary of Dermal Exposure Doses to Methylene Chloride for Batch Open-
Top Vapor Degreasing
Occupational
Kxposurc
Scenario
I se Setting
(Industrial vs.
Commercial)
.Maximum
Weight
l-'radion.
^ ilt-nii'1
Dermal K\|
(mg/
No(Jove
Central
Tendency
losure Dose
day)
sdV i)
nigh r.iui
Calculated
Kraction
Absorbed.
r nils
Batch Open-Top
Vapor
Degreasing
Industrial
1.0
60
180
0.08
a - EPA assumes that 100% methylene chloride is used for vapor degreasing operations.
Potential impacts of PFs are presented as what-if scenarios in the dermal exposure summary Table 2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA inhalation air concentrations. The
primary strengths include the assessment approach, which is the use of modeling, in the middle
of the inhalation approach hierarchy. A Monte Carlo simulation with 100,000 iterations was used
to capture the range of potential input parameters. Vapor generation rates were derived from
methylene chloride unit emissions and operating hours reported in the 2014 NEI (EPA. 2018a).
The primary limitations of the air concentration outputs from the model include the uncertainty
of the representativeness of these data toward the true distribution of inhalation concentrations
for the industries and sites covered by this scenario. Added uncertainties include that emissions
data available in the 2014 NEI were only found for eight total units, and the underlying
methodologies used to estimate these emissions are unknown. Based on these strengths and
limitations of the air concentrations, the overall confidence for these 8-hr TWA data in this
scenario is medium to low.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
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2.4.1.2.6 Conveyorized Vapor Degreasing
EPA found no monitoring data for methylene chloride in this use. To fill this data gap, EPA
performed modeling of near-field and far-field exposure concentrations in the conveyorized
vapor degreasing scenario for both workers and ONUs. Modeling details are in Appendix F of
the supplemental document titled "Risk Evaluation for Methylene Chloride (Dichlorome thane,
DCM) CASRN: 75-09-2, Supplemental Information on Releases and Occupational Exposure
Assessment"(EPA.., 2019b). The central tendency 8-hr TWA worker exposure concentration for
this scenario is approximately twice the OSHA PEL value of 87 mg/m3 (25 ppm) as an 8-hr
TWA, while the high-end estimate is approximately five times higher. Exposure concentrations
for ONUs are also considerably higher than the OSHA PEL.
Estimates of ADC and LADC for use in assessing risk were made using the approach and
equations described in Section 2.4.1.1 and are presented in Table 2-41.
Table 2-41. Statistical Summary of Methylene Chloride 8-hr TWA Exposures (ADC and
LADC) for Workers and ONUs for Conveyorized Vapor Degreasing
Central Tendency
(nig/nr*)
lligh-lnd
(ing/nr*)
Dala Quality
Rating of
Associated Air
Concentration
Dala
Workers (Near-Field)
8-hr TWA Exposure
Concentration
490
1,400
N/A - Modeled
Data
Average Daily Concentration
(ADC)
84
240
Lifetime Average Daily
Concentration (LADC)
43
120
ONUs (Far-Field)
8-hr TWA Exposure
Concentration
250
900
N/A - Modeled
Data
Average Daily Concentration
(ADC)
44
150
Lifetime Average Daily
Concentration (LADC)
22
79
Table 2-42 presents modeled dermal exposures during conveyorized vapor degreasing use.
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Table 2-42. Summary of Dermal Exposure Doses to Methylene Chloride for Conveyorized
Vapor Degreasing
Occupational
Kxposurc
Scenario
I se Selling
(Industrial vs.
Commercial)
.Maximum
Weigh!
l-'raction.
^ ilt-nii'1
Dermal K\|
(mg/
No(Jove
Central
Tendency
losure Dose
dav)
s(PI 1)
High l iul
Calculated
l-'raction
Absorbed.
I1 iiIin
Conveyorized
Vapor
Degreasing
Industrial
1.0
60
180
0.08
a - EPA assumes that 100% methylene chloride is used for vapor degreasing operations.
Potential impacts of PFs are presented as what-if scenarios in the dermal exposure summary Table 2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA inhalation air concentrations. The
primary strengths include the assessment approach, which is the use of modeling, in the middle
of the inhalation approach hierarchy. A Monte Carlo simulation with 100,000 iterations was used
to capture the range of potential input parameters. Vapor generation rates were derived from
methylene chloride unit emissions and operating hours reported in the 2014 NEI CEP A. 2018a).
The primary limitations of the air concentration outputs from the model include the uncertainty
of the representativeness of these data toward the true distribution of inhalation concentrations
for the industries and sites covered by this scenario. Added uncertainties include that emissions
data available in the 2014 NEI were only found for two total units, and the underlying
methodologies used to estimate these emissions are unknown. Based on these strengths and
limitations of the air concentrations, the overall confidence for these 8-hr TWA data in this
scenario is medium to low.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.7 Cold Cleaning
EPA found limited inhalation monitoring data for cold cleaning manufacturing from published
literature sources. TNO (C1VO) (1999) indicated that mean exposure values for cold degreasing
were found to be approximately 280 mg/m3 on average, ranging from 14 to over 1,000 mg/m3.
The referenced data were from United Kingdom (U.K.) Health and Safety Executive (HSE)
reports from 1998, but details, including specific worker activities and sampling times were not
available.
Because the underlying data were not available, EPA assessed the average value of 280 mg/m3 as
the central tendency, and the maximum reported value of 1,000 mg/m3 as the high-end estimate
of potential occupational inhalation exposure for this scenario. The central tendency 8-hr TWA
exposure concentration for this scenario is approximately three times the OSHA PEL value of
87 mg/m3 (25 ppm) as an 8-hr TWA, while the high-end estimate is almost 12 times higher.
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Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC. The
results of these calculations are shown in Table 2-43.
Table 2-43. Worker Exposure to Methylene C
lloride During
Cold Cleaning"
Data Qualify
Rating of
N il in her
Central
Associated Air
of
Tendency
11 igh-lnd
Concentration
Samples
(ing/nr*)
(nig/nr')
Data
8-hr TWA Exposure
Concentration
280
1,000
Average Daily Concentration
(ADC)
unknownb
64
230
Low
Lifetime Average Daily
Concentration (LADC)
110
510
Source: TNO (CIVO) (.1.999)
a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures,
b - One source provided a range of values for an unknown number of samples.
EPA has not identified short-term exposure data from cold cleaning using methylene chloride,
nor personal or area data on or parameters for modeling potential ONU inhalation exposures.
Since ONUs do not directly handle formulations containing methylene chloride, EPA expects
ONU inhalation exposures to be lower than worker inhalation exposures. Information on
processes and worker activities are insufficient to determine the proximity of ONUs to workers
and sources of emissions, so relative exposure of ONUs to workers cannot be quantified.
Note that EPA also performed a Monte Carlo simulation with 100,000 iterations and the Latin
hypercube sampling method to model near-field and far-field exposure concentrations for the
cold cleaning scenario. EPA calculated the 50th and 95th percentile 8-hr TWA concentrations to
represent a central tendency and worst-case estimate of potential occupational inhalation
exposures, respectively, for this life cycle stage. For workers, the modeled 8-hr TWA exposures
are 1 mg/m3 at the 50th percentile and 103.8 mg/m3 at the 95th percentile. For ONUs, the modeled
8-hr TWA exposures are 0.5 mg/m3 at the 50th percentile and 60 mg/m3 at the 95th percentile. For
the risk evaluation, EPA used the available monitoring data as discussed above, because the
modeled data do not capture the full range of possible exposure concentrations identified by the
monitored data. Modeling details are in Appendix F of the supplemental document titled "Risk
Evaluation for Methylene Chloride (Dichloromethane, DCM) CASRN: 75-09-2, Supplemental
Information on Releases and Occupational Exposure Assessment" (EPA. 2.019b).
Table 2-44 presents modeled dermal exposures during cold cleaning use.
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Table 2-44. Summary of Dermal Exposure Doses to Methylene Chloride for Cold Cleaning
Occupational
Kxposure
Scenario
I se Selling
(Industrial vs.
Commercial)
.Maximum
Weigh!
l-'radion.
^ ilt-nii'1
Dermal K\|
(mg/
No(Jove
Central
Tendency
losure Dose
dav)
s
-------
2425
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Estimates of ADC and LADC for use in assessing risk were made using the approach and
equations described in the Section 2.4.1.1 and are presented in Table 2-45. EPA also modeled
maximum 1-hr TWA exposures, which are also shown in the table.
Table 2-45. Statistical Summary of Methylene Chloride 8-hr and 1-hr TWA Exposures
ADC and LADC) for Workers and ONUs for Aerosol Products Based on Modeling
Central
Tendency
(in «/nr')
Iligh-Knd
Data Qualify Rating
of Associated Air
('onccnlralion Data
Workers (Near-Field)
8-hr TWA Exposure Concentration
22
79
N/A - Modeled Data
Average Daily Concentration
(ADC)
3.8
14
Lifetime Average Daily
Concentration (LADC)
1.9
6.9
Maximum 1-hr TWA Exposures
68
230
ONUs (Far-Field)
8-hr TWA Exposure Concentration
0.40
3.3
N/A - Modeled Data
Average Daily Concentration
(ADC)
0.07
0.56
Lifetime Average Daily
Concentration (LADC)
0.04
0.29
Maximum 1-hr TWA Exposures
1.2
9.7
Table 2-46 presents modeled dermal exposures during commercial aerosol use.
Table 2-46. Summary of Dermal Exposure Doses to Methylene Chloride for Commercial
Aerosol Product Uses
Occupational
Kxposurc
Scenario
I se Setting
(Industrial \ s.
Commercial)
.Maximum
Weight
l-'radion.
^ ilt-nii'1
Dermal K\|
(mg/
No (Jo\e
Central
Tendency
)osurc Dose
day)
s (PI 1)
High I nd
Calculated
Kraction
Absorbed.
r nils
Commercial
Aerosol Product
Uses
Commercial
1.0
94
280
0.13
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA inhalation air concentrations. The
primary strengths include the assessment approach, which is the use of modeling, in the middle
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of the inhalation approach hierarchy. A Monte Carlo simulation with 100,000 iterations was used
to capture the range of potential input parameters. Various model parameters were derived from
a California Air Resources Board (CARB) brake service study at 137 automotive maintenance
and repair shops in California. The primary limitations of the air concentration outputs from the
model include the uncertainty of the representativeness of these data toward the true distribution
of inhalation concentrations for the industries and sites covered by this scenario. Based on these
strengths and limitations of the air concentrations, the overall confidence for these 8-hr TWA
data in this scenario is medium.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.9 Adhesives and Sealants
EPA found inhalation exposure data for both spray and non-spray industrial adhesive
application; EPA did not identify non-industrial data. 8-hr TWA data for non-spray uses are
primarily from a 1985 EPA Risk Assessment that compiled laminating and gluing activities in
various industries, ranging from ND to 575 mg/m3 (97 samples) (EPA. 1985). A 1984 National
Institute for Occupational Safety and Health (NIOSH) Health Hazard Evaluation (HHE)
performed at a flexible circuit board manufacturing site encompassed various worker activities in
adhesive mixing and laminating areas, ranging from 86.8 to 458.5 mg/m3 (12 samples) (NIOSH.
1985). 8-hr TWA data for spray uses are available from three sources TN<
WHO (1996b): ] 985).
Considering 8-hr TWA samples, 98 personal monitoring samples were available for industrial
non-spray adhesives use, while 16 personal monitoring samples were available for industrial
spray adhesives use. EPA calculated the 50th and 95th percentile 8-hr TWA concentrations to
represent a central tendency and high-end estimate of potential occupational inhalation
exposures, respectively, for this scenario. Central tendency 8-hr TWA exposure concentrations
for these scenarios are less than half of the OSHA PEL value of 87 mg/m3 (25 ppm) as an 8-hr
TWA, while high-end estimates are between three and seven times the OSHA PEL.
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC as
described in Section 2.4.1.1. The results of these calculations are shown in Table 2-47 and Table
2-48 for industrial non-spray and spray adhesives application, respectively.
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2477 Table 2-47. Worker Exposure to Methylene Chloride During Industrial Non-Spray
2478 Adhesives Use3
Number of
Samples
Central
Tendency
(ing/nr*)
Iligh-Knd
(ing/nr')
Data Qualify Ualing
ol" Associated Air
Concentration Data
S-hr TWA Exposure Concentration
98
10
300
High
Average Daily Concentration
(ADC)
2.4
70
Lifetime Average Daily
Concentration (LADC)
4.2
150
2479 Sources: NIOSH (.1.985); H'.'x ^'85)
2480 a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures.
2481
2482 Table 2-48. Worker Exposure to Methylene Chloride During Industrial Spray Adhesives
2483 Usea
Central
Data Quality Ualing
Number of
Tendency
Iligh-Knd
of Associated Air
Samples
(ing/nr*)
(ing/nr*)
Concentration Data
8-hr TWA Exposure
39
560
Concentration
Average Daily Concentration
(ADC)
16
8.9
130
Low to High
Lifetime Average Daily
Concentration (LADC)
16
290
2484 Sources: TNO (CI VP) (.1.999); WHO (1996b): EPA (.1.985)
2485 a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures.
2486
2487 Table 2-49 summarizes available short-term exposure data available from the same references
2488 and industries identified above for the 8-hr TWA data. Data range from 12 mg/m3 to 720 mg/m3
2489 during adhesive spraying.
2490
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2491
2492
Table 2-49. Summary of Personal Short-Term Exposure Data for Methylene Chloride
Methylene
Diitii Quality
Chloride Short-
killing of
Occn p:itioii
-------
2509
2510
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Table 2-50. Summary of Dermal Exposure Doses to Methylene Chloride for Adhesives and
Sealants Uses
Occupational
Kxposurc
Scenario
I se Selling
(Industrial vs.
Commercial)
Maximum
Weigh!
l-'raclion.
^ ilt-nii'1
Dermal K\|
(mg/
No(Jove
Ccnl nil
Tendency
losure Dose
dav)
s(PI 1)
High l iul
Calculated
l-'raclion
Absorbed.
I1 iiIin
Adhesives and
Sealants Uses
Industrial
1.0
60
180
0.08
a - The 2017 Preliminary Use Document (U.S. EPA. 2017b) and EPA's Use and Market Profile for Methylene
Chloride (U.S. EPA. 20.1..7g) list commercial products containing between 30 and 100% methylene chloride.
Potential impacts of protection factors are presented as what-if scenarios in the dermal exposure summary Table
2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA data. For the non-spray inhalation air
concentration data, the primary strengths include the assessment approach, which is the use of
monitoring data, the highest of the inhalation approach hierarchy. These monitoring data include
98 data points from 2 sources, and the data quality ratings from systematic review for these data
were high. The primary limitations of these data include the uncertainty of the representativeness
of these data toward the true distribution of inhalation concentrations for the industries and sites
covered by this scenario. Based on these strengths and limitations of the non-spray inhalation air
concentration data, the overall confidence for these 8-hr TWA data in this scenario is medium to
high.
For the spray inhalation air concentration data, the primary strengths include the assessment
approach, which is the use of monitoring data, the highest of the approach hierarchy. These
monitoring data include 16 data points from 3 sources, and the data quality ratings from
systematic review for these data were low to high. The primary limitations of these data include
the uncertainty of the representativeness of these data toward the true distribution of inhalation
concentrations for the industries and sites covered by this scenario. Based on these strengths and
limitations of the spray inhalation air concentration data, the overall confidence for these 8-hr
TWA data in this scenario is medium.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.10 Paints and Coatings
Occupational exposures for use of paints and coatings containing methylene chloride are
described in this section. Occupational exposures for methylene chloride-based paint and coating
removers were assessed in EPA's TSCA Work Plan Chemical Risk Assessment Methylene
Chloride: Paint Stripping Use (U.S. EPA. 2014). and those results are included in Appendix L.
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EPA found 8-hr TWA spray coating data primarily from monitoring data at various facility
types, such as sporting goods stores, metal products, air conditioning equipment, etc., as
compiled in the 1985 EPA assessment, ranging from ND to 439.7 mg/m3 (25 data points) (EPA.
1985). Two additional spray-painting data points were available from OSHA inspections
between 2012 and 2016, one in the general automotive repair sector, and the other in the Wood
Kitchen Cabinet and Countertop Manufacturing sector, of 14.2 and 222.3 mg/m3 (OSHA. 2019).
The U.S. Department of Defense (DoD) provided five monitoring data points from painting
operations during structural repair. The worker activities did not indicate the method of paint
application. The activities were also stated to have low durations (0-15 minutes) but provided
sampling data that occurred over 2-hr periods. EPA assumed that there was no exposure to
methylene chloride over the remainder of the shift and calculated 8-hr TWA exposures; this
assumption may not capture the entire exposure scenario, and the calculated result is the
minimum exposure during the shift.
Because the method of paint application is unknown, EPA presents the spray application data
and the unknown application data separately.
For spray painting/coating operations, 27 personal monitoring data samples were available; EPA
calculated the 50th and 95th percentile 8-hr TWA concentrations to represent a central tendency
and high-end estimate of potential occupational inhalation exposures, respectively, for this
scenario. The central tendency 8-hr TWA exposure concentration for this scenario is below the
OSHA PEL value of 87 mg/m3 (25 ppm) as an 8-hr TWA, but the high-end estimate is
approximately four times higher.
For unknown application method operations, because only five data points were available, EPA
assessed the median value of 7.1 mg/m3 as the central tendency, and the maximum reported
value of 10.7 mg/m3 as the high-end estimate of potential occupational inhalation exposures. The
central tendency 8-hr TWA exposure concentration for this scenario is an order of magnitude
below the OSHA PEL value of 87 mg/m3 (25 ppm) as an 8-hr TWA, and the high-end estimate is
approximately eight times lower.
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC as
described in the Section 2.4.1.1. The results of these calculations are shown in Table 2-51 and
Table 2-52 for spray coating and unknown paint/coating application, respectively.
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2581 Table 2-51. Worker Exposure to Methylene Chloride During Paint/Coating Spray
2582 Application3
Number
of
Samples
Central
Tendency
(ing/nr*)
Iligh-Knd
(nig/nr')
Data Qualify Rating
of Associated Air
Concentration Data
8-hr TWA Exposure
Concentration
27
70
360
High
Average Daily Concentration
(ADC)
16
83
Lifetime Average Daily
Concentration (LADC)
28
190
2583 Sources: OSHA (20.1.9): EPA (.1.985)
2584 a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures.
2585
2586 Table 2-52. Worker Exposure to Methylene Chloride During Paint/Coating Application
2587 (Unknown Application Method)"
Number
Central
Data Quality Rating
of
Tendency
lligh-lnd
of Associated Air
Samples
(ing/nr*)
(ing/nr*)
Concentration Data
8-hr TWA Exposure
Concentration
7.1
11
Average Daily Concentration
(ADC)
5
1.6
2.4
High
Lifetime Average Daily
Concentration (LADC)
2.8
5.5
2588 Sources: Defense Occupational and Environmental Health Readiness System - Industrial Hygiene (DOEHRS-IH)
2589 (20.1.8)
2590 a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures.
2591
2592 Table 2-53 summarizes available short-term exposure data available from the DoD sampling
2593 identified above for the 8-hr TWA data, as well as short-term exposure data during painting at a
2594 Metro bus maintenance shop in 1981, and spray painting in a spray booth at a metal fabrication
2595 plant in 1973.
2596
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2597 Table 2-53. Summary of Personal Short-Term Exposure Data for Methylene Chloride
2598 During Paint/Coating Use
Occupational
Exposure
Scenario
Source
Worker
Activity
Methylene Chloride
Short-Term
Concentration
(mg/m3)
Exposure
Duration
(min)
Data Quality
Rating of
Associated Air
Concentration
Data
Metro Bus
Maintenance
Shop
Love and
Kern (1981)
Painting
ND (<0.01)
Painting
ND (<0.01)
40
50
Medium
64
Metal
Fabrication
Plant
Vandervort
and Polakoff
(1973)
Spray Painter in
Aisle No. 2
(Front) Spray
Booth
54
63
36
74
Spray Painter in
Aisle No. 1
(Rear) Spray
Booth
1.0
3.0
4.0
32
32
27
20
29
Medium
18
23
22
Painting
Operations
4.1
Painting
Operations
4.1
Painting
Operations
4.1
Painting
Operations
4.1
Department of
Defense -
Painting and
Coating
Operations
Defense
Occupational
and
Enviromnental
Health
Readiness
System -
Industrial
Hygiene
(DOEHRS-
IH) (2018)
Priming
Operations
5.2
IND-002-00
Chemical
cleaning multi
ops.
1.7
IND-006-00
Coating
Operations,
Multiple
Operations
1.9
IND-006-00
Coating
Operations,
Multiple
Operations
1.9
NPS ECE
aerosol can
painting
13.5
15
High
2599 ND - not detected
2600 Note: The OSHA Short-term exposure limit (STEL) is 433 mg/m3 as a 15-min TWA.
2601
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EPA has not identified personal or area data on or parameters for modeling potential ONU
inhalation exposures. Since ONUs do not directly handle formulations containing methylene
chloride, EPA expects ONU inhalation exposures to be lower than worker inhalation exposures.
Information on processes and worker activities are insufficient to determine the proximity of
ONUs to workers and sources of emissions, so relative exposure of ONUs to workers cannot be
quantified.
Table 2-54 presents modeled dermal exposures during paint and coatings uses.
Table 2-54. Summary of Dermal Exposure Doses to Methylene Chloride for Paint and
Coatings Uses
Occupational
Kxposure
Scenario
I se Selling
(Industrial vs.
Commercial)
.Maximum
\\ eight
l-'radion.
^ ilt-nii'1
Dermal K\|
(nig/
No(Jove
Central
Tendency
losure Dose
day)
s90% concentration during commercial and consumer use
(U.S. EPA. 20.1.6'). EPA assumes up to 100% concentration, and that similar concentrations will be used for
industrial paints and coatings.
Potential impacts of protection factors are presented as what-if scenarios in the dermal exposure summary Table
2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA inhalation data. For the spray
inhalation air concentration data, the primary strengths include the assessment approach, which
is the use of monitoring data, the highest of the inhalation approach hierarchy. These monitoring
data include 27 data points from 2 sources, and the data quality ratings from systematic review
for these data were high and medium. The primary limitations of these data include the
uncertainty of the representativeness of these data toward the true distribution of inhalation
concentrations for the industries and sites covered by this scenario. Based on these strengths and
limitations of the inhalation air concentration data, the overall confidence for these 8-hr TWA
data in this scenario is medium to high.
For the unknown application method spray inhalation air concentration data, the primary
strengths include the assessment approach, which is the use of monitoring data, the highest of the
approach hierarchy. These monitoring data include 5 data points from 1 source, and the data
quality ratings from systematic review for these data were high. The primary limitations of these
data include the uncertainty of the representativeness of these data toward the true distribution of
inhalation concentrations for the industries and sites covered by this scenario. Based on these
strengths and limitations of the spray inhalation air concentration data, the overall confidence for
these 8-hr TWA data in this scenario is medium.
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2644
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2646
2647
2648
2649
2650
2651
2652
2653
2654
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2657
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The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.11 Adhesive and Caulk Removers
EPA did not find specific industry information exposure data for adhesive and caulk removers.
Products listed in EPA's Use and Market Profile for Methylene Chloride (U.S. EPA. )
indicate potential use in flooring adhesive removal. Based on expected worker activities, EPA
assumes that the use of adhesive and caulk removers is similar to paint stripping by professional
contractors, as discussed in the supplemental document titled "Risk Evaluation for Methylene
Chloride (Dichloromethane, DCM) CASRN: 75-09-2, Supplemental Information on Releases and
Occupational Exposure Assessment" (EPA, 2019b). Therefore, EPA uses the air concentration
data from the 2014 Risk Assessment on Paint Stripping Use for Methylene Chloride (U.S. EPA.
2014).
EPA calculated the 50th and 95th percentile 8-hr TWA concentrations to represent a central
tendency and high-end estimate of potential occupational inhalation exposures, respectively, for
this scenario. The central tendency 8-hr TWA exposure concentration for this scenario is
approximately 17 times the OSHA PEL value of 87 mg/m3 (25 ppm) as an 8-hr TWA, while the
high-end estimate is almost 34 times higher.
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC as
described in Section 2.4.1.1 and shown in Table 2-55.
Table 2-55. Worker Exposure to Methylene Chloride for During Use of Adhesive and
Caulk Removers"
Data Quality
Rating of
Nil m her
Central
Associated Air
of
Tendency
Nigh-End
Concentration
Samples
(ing/nr*)
(ing/nr')
Data
8-hr TWA Exposure
Concentration
1,500
3,00
Average Daily Concentration
(ADC)
unknown
350
680
High
Lifetime Average Daily
Concentration (LADC)
600
1,500
Source: U.S. EPA (20.1.4)
a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures.
Table 2-56 summarizes available short-term exposure data from paint stripping using methylene
chloride, which is assumed similar to use of adhesive and caulk removers.
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2682
2683
2684
2685
2686
2687
2688
2689
2690
2691
2692
2693
2694
2695
2696
2697
2698
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Table 2-56. Short-Term Exposure to Methylene Chloride During Use of Adhesive and
Caulk Removers
Data Quality
Central
Rating of
Number
Tendency
Associated Air
of
(Midpoint)
Iligh-Knd
Concentration
Samples
(ing/nr')
(ing/nr')
Data
Professional Contractors
unknown
7,100
14,000
High
Source: U.S. EPA (20.1.4)
Note: The OSHA Short-term exposure limit (STEL) is 433 mg/m3 as a 15-min TWA. Durations of the short-term
samples in the summary data set are not known.
EPA did not identify personal or area data on or parameters for modeling potential ONU
inhalation exposures. Since ONUs do not directly handle formulations containing methylene
chloride, EPA expects ONU inhalation exposures to be lower than worker inhalation exposures.
Information on processes and worker activities are insufficient to determine the proximity of
ONUs to workers and sources of emissions, so relative exposure of ONUs to workers cannot be
quantified.
Table 2-57 presents modeled dermal exposures during adhesive and caulk removal.
Table 2-57. Summary of Dermal Exposure Doses to Methylene Chloride for Adhesive and
Caulk Removers
Occupational
Kxposurc
Scenario
I se Setting
(Industrial vs.
Commercial)
.Maximum
Weight
l-'raction.
^ ilt-nii'1
Dermal K\|
(mg/
No(Jove
Central
Tendency
losure Dose
day)
s(PI 1)
High 1.11(1
Calculated
l-'raction
Absorbed.
I1 iiIin
Adhesive and
Caulk Removers
Commercial
1.0
85
260
0.13
a - EPA's Use and Market Profile for Methylene Chloride (U.S. EPA, 20.1.7 a) lists commercial products containing
up to 90% methylene chloride.
Potential impacts of protection factors are presented as what-if scenarios in the dermal exposure summary Table
2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA data. For the inhalation air
concentration data, the primary strengths include the assessment approach, which is the use of
monitoring data, the highest of the inhalation approach hierarchy. These monitoring data include
>4 data points from 1 source, and the data quality ratings from systematic review for these data
were high. The primary limitations of these data include the uncertainty of the representativeness
of these data toward the true distribution of inhalation concentrations for the industries and sites
covered by this scenario. Additional uncertainties are that the data available were compiled from
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2712
2713
2714
2715
2716
2717
2718
2719
2720
2721
2722
2723
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a secondary source, which only presented the high, median, and low values. Based on these
strengths and limitations of the inhalation air concentration data, the overall confidence for these
8-hr TWA data in this scenario is medium.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.12 Fabric Finishing
EPA found 8-hr TWA data from monitoring data from various OSHA inspections between 1985
and 2008 at apparel manufacturing sites, which ranged from 42.0 mg/m3 to 164.6 mg/m3(14 data
points). Specific worker activities were not identified. Exposures at these facilities was assumed
to be representative of exposures for fabric finishing activities (Finkel. 2017).
Overall, 15 personal monitoring data samples were available; EPA calculated the 50th and 95th
percentile 8-hr TWA concentrations to represent a central tendency and high-end estimate of
potential occupational inhalation exposures, respectively, for this scenario. The central tendency
8-hr TWA exposure concentration for workers is approximately the OSHA PEL value of
87 mg/m3 (25 ppm) as an 8-hr TWA, while the high-end estimate for workers is approximately
twice the PEL value.
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC as
described in Section 2.4.1.1 and shown in Table 2-58.
Table 2-58. Worker Exposure to Methylene Chloride During Fabric Finishing3
Data Qualify
Rating of
Number
Central
Associated Air
of
Tendency
lligh-lnd
Concentration
Samples
(ing/nr*)
(ing/nr*)
Data
8-hr TWA Exposure
Concentration
87
160
Average Daily Concentration
(ADC)
15
20
37
Medium and
Low
Lifetime Average Daily
Concentration (LADC)
35
84
Source: TNO (CI VP) (.1.999): Finkel (20.1.7).
a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures.
EPA has not identified personal or area data on or parameters for modeling potential ONU
inhalation exposures. Since ONUs do not directly handle formulations containing methylene
chloride, EPA expects ONU inhalation exposures to be lower than worker inhalation exposures.
Information on processes and worker activities are insufficient to determine the proximity of
ONUs to workers and sources of emissions, so relative exposure of ONUs to workers cannot be
quantified.
Table 2-59 presents modeled dermal exposures during fabric finishing.
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2742
2743
2744
2745
2746
2747
2748
2749
2750
2751
2752
2753
2754
2755
2756
2757
2758
2759
2760
2761
2762
2763
2764
2765
2766
2767
2768
2769
2770
2771
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Table 2-59. Summary of Dermal Exposure Doses to Methylene Chloride for Fabric
Finishing
Occupational
Kxposure
Scenario
I se Selling
(Industrial vs.
Commercial)
.Maximum
Weight
l-'radion.
^ ilt-nii'1
Dermal K\|
(mg/
No(Jove
Central
Tendency
losure Dose
day)
sdV i)
nigh r.iui
Calculated
Kraction
Absorbed.
r nils
Fabric Finishing
Commercial
0.95
90
270
0.13
a - EPA's Use and Market Profile for Methylene Chloride (U.S. EPA. 2017el lists commercial products containing
up to 95% methylene chloride.
Potential impacts of protection factors are presented as what-if scenarios in the dermal exposure summary Table
2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA data. For the inhalation air
concentration data, the primary strengths include the assessment approach, which is the use of
monitoring data, the highest of the inhalation approach hierarchy. These monitoring data include
15 data points from 2 sources, and the data quality ratings from systematic review for these data
were medium and low. The primary limitations of these data include the uncertainty of the
representativeness of these data toward the true distribution of inhalation concentrations for the
industries and sites covered by this scenario. Additional uncertainties are that one data point was
a surrogate value presented as representative for open industrial applications, including fabric
coating, and the other 14 data points did not specify specific worker activities; therefore, the
representative of these data specifically for fabric finishing is also uncertain. Based on these
strengths and limitations of the inhalation air concentration data, the overall confidence for these
8-hr TWA data in this scenario is medium to low.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.13 Spot Cleaning
EPA did not find any specific exposure monitoring data for methylene chloride-containing
products during use as a spot cleaner. EPA used OSHA data for Industrial Launderers and Dry
cleaning and Laundry Services (except Coin-Operated) (Finkel. 2017). Sample times ranged
from 173 to 270 minutes. EPA used exposure concentrations with sample times greater than 240
minutes (4 hrs) and converted the exposures to 8-hr TWAs assuming zero concentrations outside
sampling time.
Overall, six 8-hr TWA personal monitoring data samples were used; EPA calculated the 50th
and 95th percentile 8-hr TWA concentrations to represent a central tendency and high-end
estimate of potential occupational inhalation exposures, respectively, for this scenario. Both the
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central tendency and high-end 8-hr TWA exposure concentrations for this scenario are below the
OSHA PEL value of 87 mg/m3 (25 ppm) as an 8-hr TWA.
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC as
described in Section 2.4.1.1 and shown in Table 2-60.
Table 2-60. Worker Exposure to IV
ethylene Chloride for During Spot Cleaning"
Dala Quality
Ualing of
Number
Central
Associated Air
of
Tendency
lligh-lnd
Concentration
Samples
(mg/m5)
(nig/nr*)
Dala
8-hr TWA Exposure
Concentration
2.6
64
Average Daily Concentration
(ADC)
6
0.58
15
Medium
Lifetime Average Daily
Concentration (LADC)
1.0
33
Source: Finket (20.1.7)
a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures.
Table 2-61 summarizes available short-term exposure data available from the same OSHA
source (Finkel. 2017) identified above for the 8-hr TWA data.
Table 2-61. Summary of Personal Short-Term Exposure Data for Methylene Chloride
During Spot Cleaning
Occupational
Kxposurc
Scenario
Source
Worker
Actiyity
Methylene Chloride
Short-Term
Concentration
(ing/nr*)
Kxposurc
Duration (mill)
Dala Quality
Ualing of
Associated
Air
Concentration
Dala
Industrial
Launderers
Finkel (2
Unknown
67
197
Medium
230
185
160
187
8.7
173
12
174
980
202
980
202
0.29
225
Note: The OSHA Short-term exposure limit (STEL) is 433 mg/m3 as a 15-min TWA.
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2799
2800
2801
2802
2803
2804
2805
2806
2807
2808
2809
2810
2811
2812
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2814
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2818
2819
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EPA has not identified personal or area data on potential ONU inhalation exposures. EPA has
developed a model to evaluate potential worker and ONU exposures during spot cleaning for
various solvents; however, the specific methylene chloride use rate during spot cleaning was not
reasonably available. This s a critical data gap and other solvent use rates may not be applicable.
EPA classified retail sales workers (e.g., cashiers), sewers, tailors, and other textile workers as
"occupational non-users" because they perform work at the dry cleaning shop, but do not directly
handle dry cleaning solvents. Since ONUs do not directly handle formulations containing
methylene chloride, EPA expects ONU inhalation exposures to be lower than worker inhalation
exposures. Information on processes and worker activities are insufficient to determine the
proximity of ONUs to workers and sources of emissions, so relative exposure of ONUs to
workers cannot be quantified.
Table 2-62 presents modeled dermal exposures during spot cleaning.
Table 2-62. Summary of Dermal Exposure Doses to Methylene Chloride for Spot Cleaning
Occupational
Kxposure
Scenario
I se Selling
(Industrial vs.
Commercial)
.Maximum
\\ eight
l-'raclion.
^ ilt-nii'1
Dermal K\|
(nig/
No(Jove
Central
Tendency
losure Dose
day)
sdV i)
nigh r.iui
Calculated
Kraclion
Absorbed.
r nils
Spot Cleaning
Commercial
0.9
85
260
0.13
a - EPA's Use and Market Profile for Methylene Chloride (U.S. EPA. 2017g) lists commercial products containing
up to 90% methylene chloride.
Potential impacts of protection factors are presented as what-if scenarios in the dermal exposure summary Table
2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA data. For the inhalation air
concentration data, the primary strengths include the assessment approach, which is the use of
monitoring data, the highest of the inhalation approach hierarchy. These monitoring data include
6 data points from 1 source, and the data quality ratings from systematic review for these data
were medium. The primary limitations of these data include the uncertainty of the
representativeness of these data toward the true distribution of inhalation concentrations for the
industries and sites covered by this scenario. Additionally, the data source did not specify
specific worker activities; therefore, the representative of these data specifically for spot cleaning
is also uncertain. Based on these strengths and limitations of the inhalation air concentration
data, the overall confidence for these 8-hr TWA data in this scenario is medium to low.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
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2.4.1.2.14 Cellulose Triacetate Film Production
EPA found 8-hr TWA data primarily from six studies performed in the 1970s and 1980s. Worker
activities encompassed various areas of CTA production, including preparation, extrusion, and
coating, but each study compiled data into overall statistics for each worker type instead of
presenting separate data points (Oft et ai. 1983a); (Dell et a ?); (TNO (CIYO). 1999).
Because the individual data points were not available, EPA presents the average of the median,
and average of maximum values as central tendency and high end, respectively, in Table 2-73.
The central tendency and high end 8-hr TWA exposure concentrations for this scenario are
approximately 12 to 16 times the OSHA PEL value of 87 mg/m3 (25 ppm) as an 8-hr TWA,
respectively.
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC as
described in Section 2.4.1.1 and shown in Table 2-63 for CTA film manufacturing.
Table 2-63. Worker Exposure to Methylene Chloride During Cr
"A Film Manufacturing3
Data Quality
Ualing of
Central
Associated Air
Nil in her of
Tendency
Migh-lnd
Concentration
Samples
(ing/nr*)
(ing/nr*)
Data
8-hr TWA Exposure Concentration
1,000
1,400
Average Daily Concentration
(ADC)
>166b
240
320
Medium and
Low
Lifetime Average Daily
Concentration (LADC)
410
560
Sources: Dell et at (.1.999): TNO (CIYO) (.1.999): Oii et at. (1983a)
a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures,
b - Various studies were compiled to determine central tendency and high-end estimates; however, not all indicated
the number of samples. Therefore, actual number of samples is unknown.
Specific short-term data or personal or area data on or parameters for modeling potential ONU
inhalation exposures were not found. Since ONUs do not directly handle methylene chloride,
ONU inhalation exposures could be lower than worker inhalation exposures. Information on
processes and worker activities are insufficient to determine the proximity of ONUs to workers
and sources of emissions, so relative exposure of ONUs to workers cannot be quantified.
Table 2-64 presents estimated dermal exposures during CTA film manufacturing.
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2860
2861
2862
2863
2864
2865
2866
2867
2868
2869
2870
2871
2872
2873
2874
2875
2876
2877
2878
2879
2880
2881
2882
2883
2884
2885
2886
2887
2888
2889
2890
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Table 2-64. Summary of Dermal Exposure Doses to Methylene Chloride for CTA Film
Manufacturing
Occupational
Kxposurc
Scenario
I se Selling
(Industrial vs.
Commercial)
.Maximum
Weigh!
l-'raction.
^ ilt-nii'1
Dermal K\|
(mg/
No(Jove
Central
Tendency
losure Dose
dav)
s(PI 1)
High I nd
Calculated
l-'raction
Absorbed.
I1 iiIin
CTA Film
Manufacturing
Industrial
1
60
180
0.08
a - EPA assumes methylene chloride is received at 100% concentration.
Potential impacts of protection factors are presented as what-if scenarios in the dermal exposure summary Table
2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA data. For the inhalation air
concentration data, the primary strengths include the assessment approach, which is the use of
monitoring data, the highest of the inhalation approach hierarchy. These monitoring data include
>166 data points from 3 sources, and the data quality ratings from systematic review for these
data were medium and low. The primary limitations of these data include the uncertainty of the
representativeness of these data toward the true distribution of inhalation concentrations for the
industries and sites covered by this scenario. An additional uncertainty for these sources is that
only concentration ranges were provided rather than discrete data points. Based on these
strengths and limitations of the inhalation air concentration data, the overall confidence for these
8-hr TWA data in this scenario is medium to low.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.15 Flexible Polyurethane Foam Manufacturing
EPA found 8-hr TWA data from various sources, and cover activities such as application of mold
release, foam manufacturing (blowing), blending, and sawing in the foam or plastic industry and
tractor trailer construction. Exposures varied from 0.3 mg/m3 from purge operations, to
2,200.9 mg/m3 during laboratory operations ("IARC. I SO (CIVO). 1999; WHO. 1996b;
Vulcan Chemicals. 1991; Reh and Lushniak. 19!1', H \ _ 1985; Cone Mills Corp. 1981a. b; Olin
Chemica 7).
Overall, 82 8-hr TWA personal monitoring data samples were available; EPA calculated the 50th
and 95th percentile 8-hr TWA concentrations to represent a central tendency and high-end
estimate of potential occupational inhalation exposures, respectively, for this scenario. The
central tendency 8-hr TWA exposure concentration for this scenario is approximately 2.5 times
higher than the OSHA PEL value of 87 mg/m3 (25 ppm) as an 8-hr TWA, while the high-end
estimate is almost 12 times higher.
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2895
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2897
2898
2899
2900
2901
2902
2903
2904
2905
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC. The
results of these calculations are shown in Table 2-65.
Table 2-65. Worker Exposure to Methylene Chloride During Industrial Polyurethane
Foam Manufacturing3
Number
of
S:i m pics
Ccn Ir ill
Tendency
(in i*/in "*)
Ilijih-Kiul
(m»/nr()
Diilii Qiiiilitv
killing ol'
Associated Air
Concent nilion
Diilii
8-hr TWA Exposure Concentration
82
210
1,000
High to Low
Average Daily Concentration (ADC)
48
230
Lifetime Average Daily
Concentration (LADC)
84
510
Sources: IARC (20.1.6): TNO (CIVP") (.1.999): WHO (1996b): Vulcan Chemicals (.1.991): Reh and Lushniak (.1.990):
Cone Mills Corp (1.981a): Cone Mills Corp (1.981b): I S5):PIin Chemicals (.1.977)
a - No data for PNUs were found; EPA assumes that PNU exposures are less than worker exposures.
Table 2-66 summarizes available short-term exposure data available from the 1985 EPA
assessment.
Table 2-66. Summary of Personal Short-Term Exposure Data for Methylene Chloride
During Polyurethane Foam Manufacturing
Methylene
Data Quality
Chloride Short-
Rating of
Occupational
Term
Kxposurc
Associated Air
Kxposure
Worker
Concentration
Duration
Concentration
Scenario
Source
Activity
(nig/nr')
(mill)
Data
Foam
5.2
360
Blowing
Foam
Blowing
13
360
Polyurethane
Foam
Manufacturing
Foam
Blowing
19
360
EPA.
35)
Foam
Blowing
17
360
High
Foam
5.2
240
Blowing
Foam
Blowing
38
360
Foam
11
360
Blowing
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2907
2908
2909
2910
2911
2912
2913
2914
2915
2916
2917
2918
2919
2920
2921
2922
2923
2924
2925
2926
2927
2928
2929
2930
2931
2932
2933
2934
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Occupational
Kxposure
Scenario
Source
Worker
Activity
.Methylene
Chloride Short-
Term
Concentration
(nig/in^)
Kxposurc
Duration
(mill)
Data Quality
Rating of
Associated Air
Concentration
Data
Nozzle
Cleaning
55
30
Note: The OSHA Short-term exposure limit (STEL) is 433 mg/m3 as a 15-min TWA.
EPA has not identified personal or area data on or parameters for modeling potential ONU
inhalation exposures. Since ONUs do not directly handle formulations containing methylene
chloride, EPA expects ONU inhalation exposures to be lower than worker inhalation exposures.
Information on processes and worker activities are insufficient to determine the proximity of
ONUs to workers and sources of emissions, so relative exposure of ONUs to workers cannot be
quantified.
Table 2-67 presents modeled dermal exposures during polyurethane foam blowing.
Table 2-67. Summary of Dermal Exposure Doses to Methylene Chloride for Polyurethane
Foam Manufacturing
Occupational
Kxposurc
Scenario
I se Setting
(Industrial vs.
Commercial)
.Maximum
Weight
l-'raction.
^ iln in'1
Dermal Kx|
(mg/
No(Jove
Central
Tendency
losure Dose
dav)
s(PI 1)
High Knd
Calculated
l-'raction
Absorbed.
r niiN
Polyurethane
Foam
Manufacturing
Industrial
1
60
180
0.08
a - EPA assumes workers may be exposed to 100% methylene chloride solvent during equipment cleaning.
Potential impacts of protection factors are presented as what-if scenarios in the dermal exposure summary Table
2-85.
In summary, dermal and inhalation exposures are expected for this scenario. In addition to the
uncertainties identified for this scenario discussed in Section 4.3.2, regulations have limited the
use of methylene chloride in polyurethane foam production and fabrication. OAR's July 16,
2007 Final National Emissions Standards for Hazardous Air Pollutants (NESHAP) for Area
Sources: Polyurethane Foam Production and Fabrication (72 FR 38864) prohibited the use of
methylene chloride-based mold release agents at molded and rebond foam facilities, methylene
chloride-based equipment cleaners at molded foam facilities, and the use of methylene chloride
to clean mix heads and other equipment at slabstock facilities. Slabstock area source facilities are
required to comply with emissions limitations for methylene chloride used as an auxiliary
blowing agent, install controls on storage vessels, and comply with management practices for
equipment leaks. The rule also prohibits methylene chloride-based adhesives for foam
fabrication. The effect of these rules on current exposure levels is unclear.
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2938
2939
2940
2941
2942
2943
2944
2945
2946
2947
2948
2949
2950
2951
2952
2953
2954
2955
2956
2957
2958
2959
2960
2961
2962
2963
2964
2965
2966
2967
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA inhalation data. The primary
strengths include the assessment approach, which is the use of monitoring data, the highest of the
inhalation approach hierarchy. These monitoring data include 82 data points from 9 sources, and
the data quality ratings from systematic review for these data were high to low. The primary
limitations of these data include the uncertainty of the representativeness of these data toward the
true distribution of inhalation concentrations for the industries and sites covered by this scenario.
An additional uncertainty is that some sources provided only concentration ranges rather than
discrete data points. Based on these strengths and limitations of the non-spray inhalation air
concentration data, the overall confidence for these 8-hr TWA data in this scenario is low.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.16 Laboratory Use
EPA found 8-hr TWA data from a 1989 NIOSH inspection of an analytical laboratory an IH
study at Texaco (Texaco Inc. 1993). and samples from the U.S. Department of Defense (DoD)
(Defense Occupational and Environmental Health Readiness System - Industrial Hygiene
(DQEHRS-IB). 2018). Worker descriptions include laboratory staff, and activities include
sample preparation and transfer. Note that the NIOSH data were for various sample durations;
EPA included samples that were more than 4 hrs long as full-shift exposures and adjusted the
exposures to 8-hr TWAs, assuming that the exposure concentration for the remainder of the time
was zero, because workers were not expected to perform the activities all day.
Overall, 10 8-hr TWA personal monitoring data samples were available; EPA calculated the 50th
and 95th percentile 8-hr TWA concentrations to represent a central tendency and high-end
estimate of potential occupational inhalation exposures, respectively, for this scenario. The
central tendency 8-hr TWA exposure concentration for this scenario is an order of magnitude
lower than the OSHA PEL value of 87 mg/m3 (25 ppm) as an 8-hr TWA, while the high-end
estimate is seven times lower.
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC as
described in Section 2.4.1.1 and are summarized in Table 2-68.
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 2-68. Worker Exposure to Methylene C
lloride During Laboratory Usea
Data Qualify
Ualing of
Number
Central
Associated Air
of
Tendency
lligh-lnd
Concentration
Samples
(ing/nr*)
(ing/nr*)
Data
8-hr TWA Exposure
Concentration
3.5
12
Average Daily Concentration
(ADC)
10
0.79
2.7
High and
Medium
Lifetime Average Daily
Concentration (LADC)
1.4
6.0
2969 Sources: Defense Occupational and Environmental Health Readiness System - Industrial Hygiene (DOEHRS-IH)
2970 (20.1.8); Texaco Inc (.1.993); Mccammon (1.990);
2971 a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures.
2972
2973 Table 2-69 summarizes short-term exposure data available from the same inspection identified
2974 above for the 8-hr TWA data.
2975
2976 Table 2-69. Worker Personal Short-Term Exposure Data for Methylene Chloride During
2977 Laboratory Use
Mi-llnk-nc
Diilii Qii;ilil>
Chloriik*
Killing of
Occn p;il i«iii;il
Sliorl- lorin
l'l\|)OMIIV
Associiilcd Air
r.\|)nsurc
( oiiiTiilr;ilion
Diinilioii
( cincenI r;i 1 ion
Scenario
Source
Worker Acli\ il\
(inu/iirM
(mill)
Diilii
sample concentrating
2.7
233
sample sonification
3.9
218
sample sonification
4.5
218
washing separatory funnels
in sink near continuous
110
10
liquid/liquid extraction
column cleaning
10
200
Mccammon
sample concentrating
30
210
Medium
(1.990)
sample concentrating
4.2
234
sample concentrating
6.8
198
Analytical
transferring 100 mL
Laboratory
methylene chloride into
soil samples
9.8
115
collecting waste chemicals
& dumping into waste
1,000
24
chemical storage
Defense
Miscellaneous lab
3.1
244
Occupational
operations
and
Environmental
Miscellaneous lab
operations
3.1
238
High
Health Readiness
Sample extraction and
34.7
180
System -
analysis (3809, OCD)
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Mcllnlcnc
Diilii Qu;ili(\
Chloride
Killing of
Occn p:il i«iii;il
Shorl-Term
l'l\|)OMirc
Associiilcd Air
I'lxposuiv
( oiiceuli'iiliou
Dui'iiliou
( ciiiccii 1 r;i 1 ion
Scenario
Source
Worker Acli\ it \
(niii/nrM
(mini
Diilii
Industrial
(3)Gas Chromatograpy
0.7
154
Hygiene
(GC) Extraction
(DOEHRS-IH)
134: Extraction of PCB in
(20.1.8)
water samples (Rm 221 -
Prep & Rm 227 - GC)
22.5
130
134: Extraction of total
volatiles (Toxcity
Characteristic Leaching
64.7
130
Procedure (TCLP))(Rm
227)
Analysis, chemical
1.7
59
(Laboratory Operations)
Analysis, chemical
2.4
48
(Laboratory Operations)
LAB ACTIVITIES
3.3
31
LAB ACTIVITIES
6.4
30
LAB ACTIVITIES
16.6
30
LAB ACTIVITIES
3.4
30
LAB ACTIVITIES
3.4
30
LAB ACTIVITIES
3.4
30
LAB ACTIVITIES
3.4
30
PRO-OOl-Ol
LABORATORY
5.4
30
CHEMICAL
ANALYSIS/SAMPLING
514 A Using Solvents
1830.0
25
EXTRACTION OP
3.6
19
EXTRACTION OP
24.8
19
(3)GC Extraction
10.4
15
(3)GC Extraction
10.4
15
Sample extraction and
62.5
15
analysis (3809, OCD)
Miscellaneous lab
operations
6.7
15
EXTRACTION OP
4.6
15
EXTRACTION OP
4.6
15
134: Extraction of PCB in
water samples (Rm 221 -
5.3
15
Prep & Rm 227 - GC)
134: Extraction of total
5.0
15
volatiles (TCLP)(Rm 227)
PRO-OOl-Ol
LABORATORY
5.4
15
CHEMICAL
ANALYSIS/SAMPLING
Page 149 of 725
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2979
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2981
2982
2983
2984
2985
2986
2987
2988
2989
2990
2991
2992
2993
2994
2995
2996
2997
2998
2999
3000
3001
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Occn p:il i«iii;il
l-lxposure
Scenario
Source
Worker Acli\ it\
Mellnlene
Chloride
Shorl-Term
( oiiceuli'iiliou
(inii/in1)
l'l\|)OMirc
Dui'iiliou
(mini
Diilii Qu;ili(\
Killing of
Associiilcd Air
( ciiiccii 1 r;i 1 ion
Diilii
IND-025-10 HM/HW
HANDLING CLEANUP,
CONTAINER
SAMPLE/OPEN
6.1
15
PRO-001-01
LABORATORY
CHEMICAL
ANALYSIS/SAMPLING
10.9
15
PRO-001-01
LABORATORY
CHEMICAL
ANALYSIS/SAMPLING
13.2
15
Note: The OSHA Short-term exposure limit (STEL) is 433 mg/m3 as a 15-min TWA.
EPA has not identified personal or area data on or parameters for modeling potential ONU
inhalation exposures. Since ONUs do not directly handle products containing methylene
chloride, ONU inhalation exposures could be lower than worker inhalation exposures.
Information on processes and worker activities are insufficient to determine the proximity of
ONUs to workers and sources of emissions, so relative exposure of ONUs to workers cannot be
quantified.
Table 2-70 presents modeled dermal exposures during laboratory use.
Table 2-70. Summary of Dermal Exposure Doses to Methylene Chloride for Laboratory
Use
Occupational
Kxposurc
Scenario
I se Selling
(Industrial vs.
Commercial)
.Maximum
Weigh!
l-'raction.
^ ilt-nii'1
Dermal K\|
(mg/
No(Jove
Central
Tendency
losure Dose
dav)
s(PI 1)
High 1.11(1
Calculated
l-'raction
Absorbed.
I1 iiIin
Laboratory Use
Commercial
1
94
280
0.13
a - EPA's Use and Market Profile for Methylene Chloride (U.S. EPA. 2017a") lists commercial products containing
up to 100% methylene chloride.
Potential impacts of protection factors are presented as what-if scenarios in the dermal exposure summary Table
2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA data. For the inhalation air
concentration data, the primary strengths include the assessment approach, which is the use of
Page 150 of 725
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3002
3003
3004
3005
3006
3007
3008
3009
3010
3011
3012
3013
3014
3015
3016
3017
3018
3019
3020
3021
3022
3023
3024
3025
3026
3027
3028
3029
3030
3031
3032
3033
3034
3035
3036
3037
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
monitoring data, the highest of the inhalation approach hierarchy. These monitoring data include
10 data points from 3 sources, and the data quality ratings from systematic review for these data
were high and medium. The primary limitations of these data include the uncertainty of the
representativeness of these data toward the true distribution of inhalation concentrations for the
industries and sites covered by this scenario. Based on these strengths and limitations of the
inhalation air concentration data, the overall confidence for these 8-hr TWA data in this scenario
is medium.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.17 Plastic Product Manufacturing
EPA found 8-hr TWA data primarily from monitoring data from HSIA sampling from 2005
through 2017, for production technicians during plastic product manufacturing. Exposure
concentrations ranged from 3.9 to 134.1 mg/m3 (20 samples) (Halogenated Solvents Industry
Alliance. 2018). Additional data were found for various other sources that ranged from 9 mg/m3
to 2,685.1 mg/m3 (for hop area operatorMFairfax and Porter. 2006); (WHO. 1996b);
(Halogenated Solvents Industry Alliance. 2018); (General Electric Co. 1989).
Overall for the 8-hr TWA, 30 personal monitoring data samples were available for workers, and
one sample was for an OSHA inspector and may or may not be reflective of industry ONUs;
ONUs are employees who work at the facilities that process and use methylene chloride, but who
do not directly handle the material. ONUs may also be exposed to methylene chloride, but are
expected to have lower inhalation exposures and are not expected to have dermal exposures.
ONUs for this condition of use may include supervisors, managers, engineers, and other
personnel in nearby production areas. EPA calculated the 50th and 95th percentile 8-hr TWA
concentrations to represent a central tendency and high-end estimate of potential occupational
inhalation exposures, respectively, for this scenario. The central tendency 8-hr TWA exposure
concentrations for workers and ONUs is approximately six times lower the OSHA PEL value of
87 mg/m3 (25 ppm) as an 8-hr TWA, while the high-end estimate for workers is three times
higher.
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC as
described in Section 2.4.1.1 and are summarized in Table 2-71.
Table 2-71. Worker and ONU Exposure to Methylene Chloride During Plastic Product
Manufacturing
Kxposure
Nil in her of
Samples
Central
Tendency
(ing/nr*)
Iligh-Knd
(ing/nr')
Data Qualify
Rating of
Associated Air
Concentration
Data
Workers
8-hr TWA Exposure Concentration
30
14
260
High to Low
Average Daily Concentration
(ADC)
3.2
60
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l);il;i Qusililv
Killing of
Ccnl ml
Associated Air
N il in her of
ToihIoiicy
Iligh-Kml
('onccnlnilion
Kxposiirc
Sn in pies
(nig/in-')
(m«/iir5)
l);il;i
Lifetime Average Daily
Concentration (LADC)
5.5
130
ONUs
8-hr TWA Exposure Concentration
9.0
9.0
Average Daily Concentration
(ADC)
1
2.1
2.1
High
Lifetime Average Daily
Concentration (LADC)
3.6
4.6
3038 Sources: OSHA (20.1.9): Halogenated Solvents Industry Alliance (20.1.8): Fairfax and Potter (2006): WHO (1996b):
3039 General Electric Co (.1.989).
3040
3041 Table 2-72 summarizes available short-term exposure data for workers and ONUs from the same
3042 OSHA inspections identified above for the 8-hr TWA data, as well as short-term data provided
3043 by HSIA (2018). EPA has not identified area data on or parameters for modeling potential ONU
3044 inhalation exposures.
3045
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3046 Table 2-72. Worker Short-Term Exposure Data for Methylene Chloride During Plastic
3047 Product Manufacturing
Mcllnlciic Chloride
Occn p;il i
-------
3052
3053
3054
3055
3056
3057
3058
3059
3060
3061
3062
3063
3064
3065
3066
3067
3068
3069
3070
3071
3072
3073
3074
3075
3076
3077
3078
3079
3080
3081
3082
3083
3084
3085
3086
3087
3088
3089
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 2-73. Summary of Dermal Exposure Doses to Methylene Chloride for Plastic Product
Manufacturing
Occupational
Kxposurc
Scenario
I se Selling
(Industrial vs.
Commercial)
.Maximum
Weigh!
l-'raclion.
^ ilt-nii'1
Dermal K\|
(mg/
No(Jove
Ccnl nil
Tendency
losure Dose
dav)
s(PI 1)
High I nd
Calculated
l-'raclion
Absorbed.
I1 iiIin
Plastic Product
Manufacturing
Industrial
1
60
180
0.08
a - EPA assumes methylene chloride is received at 100% concentration.
Potential impacts of protection factors are presented as what-if scenarios in the dermal exposure summary Table
2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA data. For the worker inhalation air
concentration data, the primary strengths include the assessment approach, which is the use of
monitoring data, the highest of the inhalation approach hierarchy. These monitoring data include
30 data points from 5 sources, and the data quality ratings from systematic review for these data
were high to low. The primary limitations of these data include the uncertainty of the
representativeness of these data toward the true distribution of inhalation concentrations for the
industries and sites covered by this scenario. Based on these strengths and limitations of the
worker inhalation air concentration data, the overall confidence for these 8-hr TWA data in this
scenario is medium to low.
For the ONU inhalation air concentration data, the primary strengths include the assessment
approach, which is the use of monitoring data, the highest of the inhalation approach hierarchy.
These monitoring data include 1 data point from 1 source, and the data quality ratings from
systematic review for the data point was high. The primary limitations of this single data point
include the uncertainty of the representativeness of these data toward the true distribution of
inhalation concentrations for the industries and sites covered by this scenario. Based on these
strengths and limitations of the inhalation air concentration data, the overall confidence for these
8-hr TWA data in this scenario is low.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.18 Pharmaceutical Production
EPA found 8-hr exposure concentration inhalation monitoring data for methylene chloride at
pharmaceutical process operators from published literature sources. TNO (CIVO) (1999)
reported that for pharmaceutical process operators, 8-hr exposure concentrations can be between
3.5 to 10 mg/m3. WHO (1996b) also indicated that sealed processes, high recovery rates, and
careful handling of discharges can bring exposure rates to around 106 mg/m3. Additional data
were available from the 1985 EPA assessment, which covered production workers at
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3090
3091
3092
3093
3094
3095
3096
3097
3098
3099
3100
3101
3102
3103
3104
3105
3106
3107
3108
3109
3110
3111
3112
3113
3114
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
pharmaceutical manufacturing facilities and reported exposures between ND (during film
coating) and 4,628 mg/m3 (during production) (12 data points).
Overall, 15 personal monitoring data samples were available; EPA calculated the 50th and 95th
percentile 8-hr TWA concentrations to represent a central tendency and high-end estimate of
potential occupational inhalation exposures, respectively, for this scenario. The central tendency
8-hr TWA exposure concentration for this scenario is approximately three times higher than the
OSHA PEL value of 87 mg/m3 (25 ppm) as an 8-hr TWA, while the high-end estimate is
approximately 41 times higher than the PEL.
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC. The
results of these calculations are shown in Table 2-74.
Table 2-74. Worker Exposure to Methylene Chloride During Pharmaceutical Production3
N il in her of
Samples
Central
Tendency
(mg/nr')
Mi«h-i:nd
(ing/nr*)
Data Qualify
Rating of
Associated Air
Concentration
Data
8-hr TWA Exposure
Concentration
15
230
3,600
High and Low
Average Daily Concentration
(ADC)
52
820
Lifetime Average Daily
Concentration (LADC)
91
1,800
Sources: TNO (CIVO) (.1.99 S5}.
a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures.
EPA has not identified short-term exposure data or personal or area data on or parameters for
modeling potential ONU inhalation exposures. Since ONUs do not directly handle methylene
chloride, EPA expects ONU inhalation exposures to be lower than worker inhalation exposures.
Information on processes and worker activities are insufficient to determine the proximity of
ONUs to workers and sources of emissions, so relative exposure of ONUs to workers cannot be
quantified.
Table 2-75 presents estimated dermal exposures during pharmaceutical production.
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3115
3116
3117
3118
3119
3120
3121
3122
3123
3124
3125
3126
3127
3128
3129
3130
3131
3132
3133
3134
3135
3136
3137
3138
3139
3140
3141
3142
3143
3144
3145
3146
3147
3148
3149
3150
3151
3152
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 2-75. Summary of Dermal Exposure Doses to Methylene Chloride for
Pharmaceutical Production
Occupational
Kxposurc
Scenario
I se Setting
(Industrial vs.
Commercial)
.Maximum
Weight
l-'raction.
^ ilt-nii'1
Dermal K\|
(mg/
No(Jove
Central
Tendency
losure Dose
dav)
s(PI 1)
High I nd
Calculated
l-'raction
Absorbed.
I1 iiIin
Pharmaceutical
Production
Industrial
1
60
180
0.08
a - EPA assumes methylene chloride is received at 100% concentration.
Potential impacts of protection factors are presented as what-if scenarios in the dermal exposure summary Table
2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA data. For the inhalation air
concentration data, the primary strengths include the assessment approach, which is the use of
monitoring data, the highest of the inhalation approach hierarchy. These monitoring data include
15 data points from 2 sources, and the data quality ratings from systematic review for these data
were high and low. The primary limitations of these data include the uncertainty of the
representativeness of these data toward the true distribution of inhalation concentrations for the
industries and sites covered by this scenario. Based on these strengths and limitations of the
inhalation air concentration data, the overall confidence for these 8-hr TWA data in this scenario
is medium.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.19 Lithographic Printing Plate Cleaning
EPA found 8-hr TWA inhalation monitoring data primarily from the 1985 EPA assessment
covering various printers and activities, which ranged from ND (during printing) to 547.9 mg/m3
(during screen making for commercial letterpress) (44 data points) ( |5). Additional data
were also obtained from a 1998 occupational exposure study and a 1980 NIOSH inspection of a
printing facility (TJkai et ai. 1998); ("Ahrenholz. 1980). Exposure data were for workers involved
in the printing plate/roll cleaning. The 1998 occupational exposure study only presented the min,
mean, and max values for 61 samples, while the 1980 NIOSH inspection included two full-shift
readings (ND to 17.0 mg/m3; ND was assessed as zero).
Overall, EPA calculated the 50th and 95th percentile 8-hr TWA concentrations to represent a
central tendency and worst-case estimate of potential occupational inhalation exposures,
respectively, for this scenario. The central tendency 8-hr TWA exposure concentrations for this
scenario is one order of magnitude lower than the OSHA PEL value of 87 mg/m3 (25 ppm) as an
8-hr TWA, while the high-end estimate is approximately three times higher.
Page 156 of 725
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3156
3157
3158
3159
3160
3161
3162
3163
3164
3165
3166
3167
3168
3169
3170
3171
3172
3173
3174
3175
3176
3177
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC. The
results of these calculations are shown in Table 2-76 for workers during plastic product
manufacturing.
Table 2-76. Worker Exposure to Methylene Chloride During Printing Plate Cleaning3
Number
(on (nil
Data Quality Ualing
ol"
Tendency
Iligh-Knd
of Associated Air
Samples
(mg/m5)
(mg/nr')
Concentration Data
8-hr TWA Exposure Concentration
3.7
270
Average Daily Concentration
(ADC)
>105b
0.84
62
High and Medium
Lifetime Average Daily
Concentration (LADC)
1.5
140
Sources: Ukai et at. (.1.998): EPA (.1.985): Ahrenholz (1.980)
a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures,
b - One study indicated that statistics were based on 61 samples, but only provided the minimum, maximum, and
mean values. Another study provided two exposure values, one of which was ND. ND was assessed as zero
Table 2-77 summarizes the available 4-hr TWA exposure data for workers from the same source
identified above for the 8-hr TWA data. Data were taken in two 4-hr shifts.
Table 2-77. Worker Short-Term Exposure Data for Methylene Chloride During Printing
Plate Cleaning
Methylene
Data Quality
Chloride Short-
Ualing of
Occupational
Term
Kxposurc
Associated Air
Kxposurc
Worker
Concentration
Duration
Concentration
Scenario
Source
Activity
(mg/nr")
(mill)
Data
Lithographic
Printing Plate
Cleaning
Ukai et
ol
Cleaning of
3.5
printing rolls /
940
240
Medium
£11.
(1998)
solvent in
3.6
production
480
Note: The OSHA Short-term exposure limit (STEL) is 433 mg/m3 as a 15-min TWA.
EPA has not identified personal or area data on or parameters for modeling potential ONU
inhalation exposures. Since ONUs do not directly handle methylene chloride, EPA expects ONU
inhalation exposures to be lower than worker inhalation exposures. Information on processes and
worker activities are insufficient to determine the proximity of ONUs to workers and sources of
emissions, so relative exposure of ONUs to workers cannot be quantified.
Table 2-78 presents estimated dermal exposures during lithographic printing plate cleaning.
Page 157 of 725
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3178
3179
3180
3181
3182
3183
3184
3185
3186
3187
3188
3189
3190
3191
3192
3193
3194
3195
3196
3197
3198
3199
3200
3201
3202
3203
3204
3205
3206
3207
3208
3209
3210
3211
3212
3213
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 2-78. Summary of Dermal Exposure Doses to Methylene Chloride for Lithographic
Printing Plate Cleaner
Occupational
Kxposurc
Scenario
I se Setting
(Industrial vs.
Commercial)
.Maximum
Weight
l-'raction.
^ ilt-nii'1
Dermal K\|
(mg/
No(Jove
Central
Tendency
losure Dose
dav)
s(PI 1)
High I nd
Calculated
l-'raction
Absorbed.
I1 iiIin
Lithographic
Printing Plate
Cleaner
Commercial
0.885
84
250
0.13
a - The 2017 Preliminary Use Document (U.S. EPA. 2017b) lists commercial/industrial products containing up to
88.5% methylene chloride.
Potential impacts of protection factors are presented as what-if scenarios in the dermal exposure summary Table
2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA data. For the inhalation air
concentration data, the primary strengths include the assessment approach, which is the use of
monitoring data, the highest of the inhalation approach hierarchy. These monitoring data include
>105 data points from 3 sources, and the data quality ratings from systematic review for these
data were high and medium. The primary limitations of these data include the uncertainty of the
representativeness of these data toward the true distribution of inhalation concentrations for the
industries and sites covered by this scenario. Based on these strengths and limitations of the
inhalation air concentration data, the overall confidence for these 8-hr TWA data in this scenario
is medium.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.20 Miscellaneous Non-Aerosol Industrial and Commercial Uses
EPA compiled various monitoring data for miscellaneous non-aerosol industrial and commercial
settings, including 8-hr TWA data. 8-hr TWA data are from various OSHA inspection at
wholesalers and retail stores, and include generic worker activities, such as plant workers,
service workers, laborers, etc. Exposure concentrations for various workers ranged from ND to
1,294.8 mg/m3 (EPA. 19851
Overall, 108 personal monitoring data samples were available; EPA calculated the 50th and 95th
percentile 8-hr TWA concentrations to represent a central tendency and high-end estimate of
potential occupational inhalation exposures, respectively, for this scenario. The central tendency
8-hr TWA exposure concentrations for workers is approximately three times higher than the
OSHA PEL value of 87 mg/m3 (25 ppm) as an 8-hr TWA, while the high-end estimate for
workers is more than nine times higher.
Page 158 of 725
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3214
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3217
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3219
3220
3221
3222
3223
3224
3225
3226
3227
3228
3229
3230
3231
3232
3233
3234
3235
3236
3237
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC as
described in Section 2.4.1.1. The results of these calculations are shown in Table 2-79 for
workers during plastic commercial non-aerosol use.
Table 2-79. Worker Exposure to Methylene Chloride During Miscellaneous Industrial and
Commercial Non-Aerosol Usea
Data Qualify
Rating of
Number
Central
Associated Air
of
Tendency
Nigh-Knd
Concentration
Samples
(ing/nr*)
(ing/nr*)
Data
8-hr TWA Exposure Concentration
57
930
Average Daily Concentration
(ADC)
108
13
210
High
Lifetime Average Daily
Concentration (LADC)
23
480
Sources: EPA (.1.985).
a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures.
EPA has not identified short-term exposure data or personal or area data on or parameters for
modeling potential ONU inhalation exposures. Since ONUs do not directly handle methylene
chloride, EPA expects ONU inhalation exposures to be lower than worker inhalation exposures.
Information on processes and worker activities are insufficient to determine the proximity of
ONUs to workers and sources of emissions, so relative exposure of ONUs to workers cannot be
quantified.
Table 2-80 presents estimated dermal exposures during industrial and commercial non-aerosol
use.
Table 2-80. Summary of Dermal Exposure Doses to Methylene Chloride for Miscellaneous
Industrial and Commercial Non-Aerosol Use
Occupational
Kxposurc
Scenario
I se Setting
(Industrial \ s.
Commercial)
.Maximum
Weight
l-'raction.
^ ilt-nii'1
Dermal K\|
(mg/
No (Jo\e
Central
Tendency
losure Dose
day)
s
-------
3238
3239
3240
3241
3242
3243
3244
3245
3246
3247
3248
3249
3250
3251
3252
3253
3254
3255
3256
3257
3258
3259
3260
3261
3262
3263
3264
3265
3266
3267
3268
3269
3270
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA data. For the inhalation air
concentration data, the primary strengths include the assessment approach, which is the use of
monitoring data, the highest of the inhalation approach hierarchy. These monitoring data include
108 data points from 1 source, and the data quality ratings from systematic review for these data
were high. The primary limitations of these data include the uncertainty of the representativeness
of these data toward the true distribution of inhalation concentrations for the industries and sites
covered by this scenario. Based on these strengths and limitations of the inhalation air
concentration data, the overall confidence for these 8-hr TWA data in this scenario is medium.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.2.21 Waste Handling, Disposal, Treatment, and Recycling
EPA's 1985 assessment included three full-shift data points for solvent reclaimers at solvent
recovery sites, ranging from 10.5 to 19.2 mg/m3 (EPA... 1985). The U.S. Department of Defense
(DoD) also provided four data points during waste disposal and sludge operations ranging from
0.4 to 2.3 mg/m3 (Defense Occupational and Environmental Health Readiness System -
Industrial Hygie RS-IB). 2018).
Overall for the 8-hr TWA samples, 7 personal monitoring data samples were available; EPA
assessed the 50th percentile value of 18.5 mg/m3 as the central tendency, and the 95% percentile
value of 19.0 mg/m3 as the high-end estimate of potential occupational inhalation exposures for
this life cycle stage. The central tendency exposure concentration for this scenario is an order of
magnitude lower than the OSHA PEL value of 87 mg/m3 (25 ppm) as an 8-hr TWA and high-
end 8-hr TWA exposure concentration is approximately 4.5 times lower.
Using these 8-hr TWA exposure concentrations, EPA calculated the ADC and LADC as
described in Section 2.4.1.1 and are summarized in Table 2-81.
Page 160 of 725
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3276
3277
3278
3279
3280
3281
3282
3283
3284
3285
3286
3287
3288
3289
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 2-81. Worker Exposure to Methylene Chloride During Waste Handling and
Disposal3
Data Quality
Ualing of
Number
Central
Associated Air
of
Tendency
lligh-lnd
Concentration
Samples
(ing/nr')
(ing/nr')
Data
8-hr TWA Exposure
Concentration
2.3
19
Average Daily Concentration
(ADC)
7
0.5
4.4
High
Lifetime Average Daily
Concentration (LADC)
0.9
9.7
Source: Defense Occupational and Environmental Health Readiness System - Industrial Hygiene (DOEHRS-IH)
(20.1.8): EPA (.1.985)
a - No data for ONUs were found; EPA assumes that ONU exposures are less than worker exposures.
Table 2-82 summarizes the available short-term exposure data for workers from the DoD data.
Table 2-82. Worker Short-Term Exposure Data for Methylene Chloride During Waste
Handling and Disposal
Methylene
Data Quality
Chloride
Ualing of
Occupational
Short-Term
Kxposurc
Associated Air
Kxposure
Worker
Concentration
Duration
Concentration
Scenario
Source
Activity
(nig/nr*)
(mill)
Data
Defense
2.9
30
Occupational and
Transfer
of
solvent
during
waste
2.9
30
Environmental
1.8
144
Waste
Handling
Health Readiness
5.8
158
System -
2.7
159
High
Industrial
2.8
163
Hygiene
disposal
0.8
173
(DOEHRS-HD
(2018)
3.4
156
Note: The OSHA Short-term exposure limit (STEL) is 433 mg/m3 as a 15-min TWA.
EPA has not identified personal or area data on or parameters for modeling potential ONU
inhalation exposures. Since ONUs do not directly handle formulations containing methylene
chloride, EPA expects ONU inhalation exposures to be lower than worker inhalation exposures.
Information on processes and worker activities are insufficient to determine the proximity of
ONUs to workers and sources of emissions, so relative exposure of ONUs to workers cannot be
quantified.
Page 161 of 725
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3290
3291
3292
3293
3294
3295
3296
3297
3298
3299
3300
3301
3302
3303
3304
3305
3306
3307
3308
3309
3310
3311
3312
3313
3314
3315
3316
3317
3318
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 2-83 presents estimated dermal exposures during waste handling, disposal, treatment and
recycling.
Table 2-83. Summary of Dermal Exposure Doses to Methylene Chloride for Waste
Handling, Disposal, Treatment, and Recycling
Occupational
Kxposurc
Scenario
I se Selling
(Industrial vs.
Commercial)
.Maximum
Weigh!
l-'raclion.
^ ilt-nii'1
Dermal K\|
(mg/
No(Jove
Ccnl nil
Tendency
losure Dose
dav)
s(PI 1)
High I nd
Calculalcd
l-'raclion
Absorbed.
I1 iiIin
Waste Handling,
Disposal,
Treatment, and
Recycling
Industrial
1
60
180
0.08
a - EPA assumes potential exposure to methylene chloride at 100% concentration for recovered solvent.
Potential impacts of protection factors are presented as what-if scenarios in the dermal exposure summary Table
2-85.
In summary, dermal and inhalation exposures are expected for this scenario. EPA has not
identified additional uncertainties for this scenario beyond those discussed in Section 4.3.2.
EPA considered the assessment approach, the quality of the data, and uncertainties in assessment
results to determine a level of confidence for the 8-hr TWA data. For the inhalation air
concentration data, the primary strengths include the assessment approach, which is the use of
monitoring data, the highest of the inhalation approach hierarchy. These monitoring data include
7 data points from 2 sources, and the data quality ratings from systematic review for these data
were high. The primary limitations of these data include the uncertainty of the representativeness
of these data toward the true distribution of inhalation concentrations for the industries and sites
covered by this scenario. Based on these strengths and limitations of the inhalation air
concentration data, the overall confidence for these 8-hr TWA data in this scenario is medium.
The overall confidence of the dermal dose results is medium (full discussion in Section 2.4.1.3).
2.4.1.3 Summary of Occupational Exposure Assessment
The following tables summarize the exposures estimated for the inhalation (Table 2-84) and
dermal (Table 2-85) routes for all occupational exposure scenarios.
Page 162 of 725
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3319
3320
Table 2-84. Summary of Acute and Chronic Inhalation Exposures to Methylene Chloride
Occnpiilioiiiil
l'l\pOMII'C Sccilill'io
C.ilcfiory1
Acnlc I'.xposurcs
Chronic. \on-
Ciinccr llxposnrcs
Chronic. Ciinccr
l''.\i)osiircs
Diilii Qu;ih(\
Killing ol°
Associiilcd Air
( onccn 1 r;il ion
Diilii
\l.( . X-ln
(inii/n
( I'll(ml
Tcii(lcnc\
TW A
lli»h
l.ii(l
ADC. 24-h
(inii/n
Ccnl nil
1 cndcno
r TW A
r')
llilili
IikI
I .AIK . 24-
(iii^/i
(ciilnil
TcihIciio
lir TWA
n M
llilili
IikI
Manufacturing
Worker
0.36
4.6
0.08
1.1
0.14
2.4
High
Processing as a
Reactant
Worker
1.6
10
0.37
2.4
0.65
5.3
High
Processing -
Incorporation into
Formulation
Worker
180
1,800
41
410
72
920
High
Repackaging
Worker
8.8
140
2.0
31
3.50
71
Medium
Batch Open-Top
Vapor Degreasing
Worker
170
740
29
130
15
66
N/A - Modeled
Data
Batch Open-Top
Vapor Degreasing
ONU
86
460
15
78
7.6
40
N/A - Modeled
Data
Conveyorized
Vapor Degreasing
Worker
490
1,400
84
240
43
120
N/A - Modeled
Data
Conveyorized
Vapor Degreasing
ONU
250
900
44
150
22
79
N/A - Modeled
Data
Cold Cleaning
Worker
280
1,000
64
230
110
510
Medium
Aerosol
Degreasing/Lubrica
nts
Worker
22
79
3.8
14
1.9
6.9
N/A - Modeled
Data
Aerosol
Degreasing/Lubrica
nts
ONU
0.40
3.3
0.07
0.56
0.04
0.29
N/A - Modeled
Data
Adhesives (Spray)
Worker
39
560
8.9
130
16.0
290
High to Low
Adhesives (Non-
Spray)
Worker
10
300
2.4
68
4.2
150
High
Paints and Coatings
(Spray)
Worker
70
360
16
83
28
190
High
Paints and Coatings
(Unknown
Application
Method)
Worker
7.1
11
1.6
2.4
2.80
5.5
High
Adhesive and
Caulk Removers
Worker
1,500
3,000
350
680
600
1,500
High
Fabric Finishing
Worker
87
160
20
37
35.0
84
Medium
Spot Cleaning
Worker
2.6
64
0.6
15
410
560
Medium
CTA
Manufacturing
Worker
1,000
1,400
240
320
84
510
Medium and
Low
Page 163 of 725
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()ccii|>;ilion;il
Kxposnrc Scenario
( iik'jioiy1
Acnlo Iaixisiiivs
Chronic. Non-
Ciinccr I aixisii ivs
Chronic. Ciinccr
l'l\i)osiircs
Diilii Qu;ilil\
Killing ol'
Associiilcd Air
Conccnlriilion
Diilii
\l.( . X-ln
(inii/n
( I'll(ml
TcihIoiio
TW A
lli»h
l.ii(l
ADC. 24-h
(inii/n
( on I ml
TcihIoiio
r TW A
r')
llilili
Ind
I .AIK . 24-
(in^/i
(cnlnil
lcndcnc\
lir TWA
n M
llilili
Ind
Flexible PU Foam
Manufacturing
Worker
210
1,000
48
230
1.40
6
High to Low
Laboratory Use
Worker
3.5
12.0
0.8
2.7
5.5
130
Medium
Plastic Product
Manufacturing
Worker
14
260
3.2
60
3.6
4.6
High to Low
Plastic Product
Manufacturing
ONU
9.0
9.0
2.1
2.1
91
1,800
High
Pharmaceutical
Worker
230
3,600
53
820
1.50
140
High and Low
Lithographic
Printing Cleaner
Worker
3.7
270
0.84
62
23.0
480
High and
Medium
Miscellaneous
Non-Aerosol
Industrial and
Commercial Use
(Cleaning Solvent)
Worker
57
930
13
210
1.00
33.0
High
Waste Handling,
Disposal,
Treatment, and
Recycling
Worker
2.3
19
0.5
4.3
0.9
9.7
High
3321 a - Where no ONU data or estimates are available, EPA assumes that ONU exposures are less than worker
3322 exposures in categories indicated as Worker.
3323
Page 164 of 725
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3324
3325
3326
3327
3328
3329
3330
3331
3332
3333
3334
3335
3336
3337
3338
3339
3340
3341
3342
3343
3344
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 2-85. Summary of Dermal Exposure Doses to Methylene Chloride by Occupational
Exposure Scenario and Potentia
Glove Use
Occnp:ilioiiiil r.\|)<>Miiv Smiiirio
M ;i\iiiin in
Weight
l-'i'iiclion.
^ ill-Mil
1)
( cm ml
No CJo\os''
(H; 1)
oi'niiil I'Imnimii
IVink'iio
W illi (.Iom'n
(PI)
v Dose (ni'j/da
High
No Clo\es''
lo\os
(I'll
Manufacturing, Repackaging,
Processing as a Reactant, Processing -
Incorporation into Formulation,
Mixture, or Reaction Product,
Pharmaceutical, Waste Handling,
Disposal, Treatment, and Recycling
1
60
12 (PF = 5)
6 (PF = 10)
3 (PF = 20)
180
36 (PF = 5)
18 (PF = 10)
9 (PF = 20)
Industrial: Use of Adhesives, Use of
Paints and Coatings, Flexible PU Foam
Manufacturing, Batch Open-Top Vapor
Degreasing, Conveyorized Vapor
Degreasing, Cold Cleaning, CTA Film
Production, Plastic Product
Manufacturing, Miscellaneous Non-
aerosol Industrial Uses
1
60
12 (PF = 5)
6 (PF = 10)
3 (PF = 20)
180
36 (PF = 5)
18 (PF = 10)
9 (PF = 20)
Commercial: Use of Adhesives, Use of
Paints and Coatings, Laboratory Use,
Miscellaneous Non-aerosol Commercial
Uses, Commercial Aerosol Products
1
94
19 (PF = 5)
9 (PF = 10)
280
57 (PF = 5)
28 (PF = 10)
Commercial: Fabric Finishing
0.95
90
18 (PF = 5)
9 (PF = 10)
270
54 (PF = 5)
27 (PF = 10)
Commercial: Adhesive and Caulk
Removers, Spot Cleaning
0.9
85
17 (PF = 5)
9 (PF = 10)
260
51 (PF = 5)
26 (PF = 10)
Commercial: Lithographic Printing
Cleaner
0.885
84
17 (PF = 5)
8 (PF = 10)
250
50 (PF = 5)
25 (PF = 10)
Note on Protection Factors (PFs): All PF values are what-if type values where use of PF above 1 is valid only for
glove materials that have been tested for permeation against the methylene chloride-containing liquids associated
with the condition of use. For scenarios with only industrial sites, EPA assumes that some workers wear protective
gloves and have activity-specific training on the proper usage of these gloves, which assumes a PF of 20. For
scenarios covering a broader variety of commercial and industrial sites, EPA assumes either the use of gloves with
minimal to no employee training, which assumes a PF of 5, or the use of gloves with basic training, which assumes a
PF of 10.
a If less-protective gloves are used, a PF of 1 may be assumed.
EPA identified primary strengths and limitations and assigned an overall confidence to the
occupational dermal assessment, as discussed below. EPA considered the assessment approach,
the quality of the data, and uncertainties to determine the level of confidence.
The Dermal Exposure to Volatile Liquids Model used for modeling occupational dermal
exposures accounts for the effect of evaporation on dermal absorption for volatile chemicals and
the potential exposure reduction due to glove use. The model does not account for the transient
exposure and exposure duration effect, which likely overestimates exposures. The model
assumes one exposure event per day, which likely underestimates exposure as workers often
come into repeat contact with the chemical throughout their work day. Surface areas of skin
Page 165 of 725
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3346
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3348
3349
3350
3351
3352
3353
3354
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exposure are based on skin surface area of hands from EPA's Exposure Factors Handbook, but
actual surface areas with liquid contact are unknown and uncertain for all occupational scenarios
OESs. For many OESs, the assumption of contact over the full area of two hands likely
overestimates exposures. Weight fractions are usually reported to CDR and shown in other
literature sources as ranges, and EPA assessed only upper ends of ranges. The glove protection
factors are "what-if' assumptions and are uncertain. EPA does not know the actual frequency,
type, and effectiveness of glove use in specific workplaces of the OESs. Except where specified
above, it is unknown whether most of these uncertainties overestimate or underestimate
exposures. The representativeness of the modeling results toward the true distribution of dermal
doses for the OESs is uncertain. These and other limitations are more fully discussed in Section
4.3.2.3.
Considering these primary strengths and limitations, the overall confidence of the dermal dose
results is medium.
2.4.2 Consumer Exposures
Methylene chloride is found in a variety of consumer products and/or commercial products that
are readily available for public purchase at common retailers. These products are found across a
suite of categories and uses as outlined in the Use and Market Profile for Methylene Chloride
(I ). Based on a combination of information gained from individual products
containing methylene chloride and product use scenarios, consumer exposures due to inhalation
or dermal contact were modeled across a suite of identified conditions of use.
2.4.2.1 Consumer Exposures Approach and Methodology
Following problem formulation, EPA compiled a comprehensive list of current products
available for consumer household use. As noted in Section 1.4.1, problem formulation,
mentioned uses such as metal products not covered elsewhere, apparel and footwear care
products and laundry and dishwashing products. Those conditions of use are not evaluated here
as no applicable consumer products were found for these uses after additional review. Products
were grouped into 15 subcategories ranging from 1-10 identified products in each category, but
with most characterized by 4 or less (Table 2-86). Additionally, these products are primarily
aerosol in nature, but are found in liquid form as well for subcategories Adhesives, Adhesives
Removers, and Brush Cleaners.
Table 2-86. Evaluated Consumer Uses for Products Containing Methylene Chloride
Consumer I se Subcategory
I'orm
Number of Products Identified
Auto AC Leak Sealer
Aerosol
1
Auto AC Refrigerant Fill
Aerosol
10
Adhesives
Liquid
4
Adhesives-Remover
Liquid
1
Brake Cleaner
Aerosol
3
Brush Cleaner
Liquid
2
Carbon Remover
Aerosol
1
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Carburetor Cleaner
Aerosol
3
Coil Cleaner
Aerosol
1
Cold Pipe Insulation Spray
Aerosol
2
Electronics Cleaner
Aerosol
1
Engine Cleaner/Degreaser
Aerosol
2
Gasket Remover
Aerosol
1
Sealants
Aerosol
1
Weld Spatter/Soldering Protectant
Aerosol
1
2.4.2.2 Exposure Routes
As described in Table 2-86, exposures were evaluated for 15 conditions of use for products
containing methylene chloride. For each of the listed conditions of use, inhalation and dermal
exposures were evaluated, with inhalation being the primary route of exposure.
Inhalation
Consumer and bystander inhalation exposure to methylene chloride is expected to be the most
significant route of exposure through the direct inhalation of sprays, vapors and mists. EPA
assumed mists are absorbed via inhalation, rather than ingestion, due to the deposition of vapors
and mists in the upper respiratory tract. This principal exposure pathway is in line with EPA's
2014 risk assessment of methylene chloride paint stripping use, which assumed that inhalation
was the main exposure pathway based on physical-chemical properties (e.g., high vapor
pressure). All fifteen identified consumer use scenarios were evaluated for exposure via the
inhalation pathway to both consumer users and bystanders. The majority of these uses were
evaluated as sprays or aerosol products, but several products (adhesives, adhesive removers, and
brush cleaners) were evaluated as liquids that have the expectation of inhalation of vapors
emitted from the product due to methylene chloride's high vapor pressure.
Dermal
Dermal exposure to consumer uses of methylene chloride was also evaluated. Dermal exposure
may occur via contact with vapor or mist deposition on the skin or via direct liquid contact
during use. Exposures to skin would be expected to evaporate rapidly (0.06 mol/s) based on
physical chemical properties including vapor pressure, water solubility and log Kow, but some
methylene chloride would also dermally absorb. When evaporation of methylene chloride is
reduced or impeded (e.g., continued contact with a methylene chloride soaked rag), dermal
absorption would be higher due to the longer duration of exposure. These dermal exposures
would be concurrent with inhalation exposures and the overall contribution of dermal exposure
to total exposure is expected to be smaller than via inhalation. Dermal exposures were evaluated
for all 15 consumer use scenarios across a range of user age groups including adults (>21 years),
youths aged 16-20 years and youths aged 11-15 years due to the possible consumer uses of these
products by younger age groups. Bystander dermal exposure was not evaluated as the incidence
of those exposures are expected to be low and not contribute significantly to overall exposure.
Ingestion
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Consumers may be exposed to methylene chloride via transfer from hand to mouth, but this
exposure pathway is expected to be limited due to physical chemical properties including dermal
absorption and volatilization from skin. Due to the limited expected exposure to consumers via
this route, EPA did not further assess this pathway.
2.4.2.3 Modeling Approach
EPA estimated consumer exposures for all currently known, intended or reasonably foreseen use
scenarios for products containing methylene chloride. A variety of sources were reviewed during
the Systematic Review process to identify these products and/or articles, including:
• Safety Data Sheets (SDS)
• NIH Household Products Database
• The Chemical and Products (CPDat) Database
• Peer-reviewed and gray literature
• Kirk-Othmer Encyclopedia of Chemical Technology
Consumer exposures were assessed for all methylene chloride containing products identified, as
described in Section 2.4.2.1. As no chemical-specific personal monitoring data was identified
during Systematic Review, a modeling approach was used to estimate the potential consumer
exposures. All consumer use scenarios were assessed using EPA's Consumer Exposure Model
Version 2.1.7 (CEM), as described in Section 2.4.2.3.1, for both inhalation and dermal routes.
To characterize consumer exposures, inhalation modeling for each scenario was conducted by
varying one to three key parameters, while keeping all other input parameters constant. The key
varied parameters included:
1) duration of use per event (minutes/use);
2) amount of chemical in the product/article (weight fraction); and/or
3) mass of product/article used per event (grams/use).
Duration of use and amount of chemical used were varied to correspond to the 10th percentile,
50th percentile and 95th percentile values as reported in U.S. EPA (1987) to encompass a range of
possible exposure conditions. Weight fractions were varied based on reported values of
methylene chloride in Material Safety Data Sheet (MSDS) sheets for evaluated products in
individual consumer use scenarios. At times, the given weight fraction was reported as a single
value whereby weight fraction was not varied in the modeling framework. However, oftentimes
the weight fraction for a single product was reported as a range of possible weight fractions or if
multiple products were identified for a consumer use scenario, the weight fractions making up
that scenario resulted in a range. In instances, where the range in weight fractions was <40% of
the product, the maximum and minimum values of the range were evaluated. In instances where
the range of possible weight fractions was >40%, the minimum, maximum, and midpoint weight
fractions were evaluated. The variation of modeling inputs for the three parameters resulted in up
to 27 different exposure cases per scenario.
For dermal modeling, the varying parameters were limited to duration of use and weight fraction,
since mass of product is not an input for the dermal models used. Therefore, there were up to 9
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different exposure cases per scenario for dermal exposure estimates. The model inputs are
described in Section 2.4.2.3.1 for CEM and shown in Tables 2-87, 2-88, and 2-89.
For all product scenarios, both acute and chronic exposures were expected to occur, but only
acute exposures are evaluated here. Acute exposures were defined as those occurring within a
single day; whereas chronic exposures were defined as exposures comprising 10% or more of a
lifetime ((EPA.: ). The acute exposure metric selected was a 1-hr TWA.
2.4.2.3.1 CEM Model and Scenarios (e.g., table of scenarios),
Consumer exposures have been assessed using CEM for fifteen consumer use scenarios as
described in Section 2.4.2.1.
CEM Version 2.1.7 (EPA. 2017) was selected for the consumer exposure modeling as the most
appropriate model to estimate consumer exposures to methylene chloride, primarily due to the
lack of chemical-specific emission data and other required input parameter data that are needed
to run more complex indoor air models CEM predicts indoor air concentrations from consumer
product use by implementing a deterministic, mass-balance calculation utilizing an emission
profile determined by implementing appropriate emission scenarios. The advantages of CEM are
the following:
• CEM has been peer-reviewed.
• CEM includes several distinct models (see (I )) appropriate for evaluating
specific product and article types and use scenarios.
• CEM includes pre-populated scenarios for a variety of products and articles, which have
been pre-parameterized with default use patterns, human exposure factors, environmental
conditions, and product-specific properties.
• CEM has flexibility to alter default parameters, with the exception of user and bystander
activity patterns.
• CEM can accommodate chemical-specific inputs.
• CEM uses the same calculation engine to compute indoor air concentrations from a
source as the higher-tier Multi-Chamber Concentration and Exposure Model (MCCEM),
but does not require emission rates and emission factors derived from chamber studies.
2.4.2.3.1.1 Inhalation
CEM predicts indoor air concentrations from product use by implementing a deterministic, mass-
balance calculation selected by the user depending on the relevant submodel (El through E5; see
(EPA. 2017)). The model uses a two-zone representation of the building of use, with Zone 1
representing the room where the consumer product is used and Zone 2 being the remainder of the
building. The product user is placed within Zone 1 for the hour(s) encompassing the duration of
use, while the bystander population remained in Zone 2 during this time period. A bystander
entering the room of use during the period of product use was not modeled since the inhalable air
concentrations they would be exposed to would be similar to the evaluated user scenario.
Following the time period of product use, product users and bystanders follow prescribed activity
patterns and inhale airborne concentrations of those zones.
The general steps of the calculation engine within CEM include:
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1. Introduction of the chemical (i.e., methylene chloride) into the room of use (Zone 1),
2. Transfer of the chemical to the rest of the house (Zone 2) due to exchange of air
between the different rooms,
3. Exchange of the house air with outdoor air and,
4. Summation of the exposure doses as the modeled occupant moves about the house.
EPA applied the default activity pattern in CEM based on the occupant being present in the home
for most of the day. As the occupants move between zones in the model, the associated zonal air
concentrations at each 30-second time step were compiled to reflect the air concentrations a user
and bystanders would be exposed to throughout the simulation period. For the El and E3
submodels, the near-field option that captures the higher concentration in the breathing zone of
the product user during use was selected. TWAs were then computed based on these user and
bystander concentration time series per available human health hazard data. For methylene
chloride, 1-hr and 8-hr TWAs were calculated for use in this risk evaluation (see Section 2.4.2.4
"Consumer Use Scenario Specific Results").
The emissions models used for evaluating methylene airborne concentrations were either the El,
E2, or E3 emissions model depending on the given consumer use scenario (see Table 2-88). The
El model estimates emission and inhalation exposures from a product applied to an indoor
surface (incremental source model) and is mostly applicable to liquid products that are applied to
a surface and evaporate from that surface (e.g., a cleaner). The E2 model estimates emission and
inhalation exposures from a product applied to an indoor surface (double exponential model) and
is applicable to liquid products that are applied to a surface and dry or cure over time (e.g.,
paints). Finally, the E3 model estimates emission and exposure from a sprayed product. For
specifics on the varied emission models utilized, their assumptions, and underlying algorithms,
EPA refers you to the user's guide for CEM (EPA. 2017).
2.4.2.3.1.2 Dermal
For methylene chloride, dermal exposures to products directly contacting skin were evaluated
using the fraction absorbed model within CEM (P_DER2a). Within this model, the potential
dose is the amount of the chemical contained in bulk material that is applied to the skin and the
absorbed dose is the amount of the substance that penetrates across the dermal barrier. The
model is essentially the measure of two competing processes, evaporation of the chemical from
the skin surface and penetration deeper into the skin. The fraction absorbed is estimated for
methylene chloride based on Frasch and Bunge ( ) and described in full within the CEM
User's Guide (EPA... 2017). This model assumes the skin surface layer is "filled" once during
product use to an input thickness with subsequent absorption over an estimated absorption time.
CEM offers another submodel for estimating dermal exposures that is based on the permeability
of a given chemical across the skin layer (P_DER2b). This approach does not consider processes
such as evaporation from the skin surface. Due to the volatility of methylene chloride and the
fact that many consumer use scenarios may involve situations where evaporation would not be
impeded, a model which incorporates evaporation was expected to be more representative.
However, with the inclusion of evaporation into the fraction absorbed method, scenarios that
may have impeded evaporation could result in higher exposures than modeled here depending on
model inputs.
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As first outlined in Section 2.4.1.1, it is important to note that while occupational and consumer
dermal exposure assessments have a common underlying methodology using dermal fractional
absorption, they use different parametric approaches for dermal exposures due to different data
availability and assessment needs. For example, the occupational approach accounts for glove
use using protection factors, while the consumer approach does not consider glove use since
consumers are not expected to always use gloves constructed with appropriate materials. The
consumer approach factors in duration of use because consumer activities as a function of
product duration of use are much better defined and characterized, while duration of dermal
exposure times for different occupational activities across various workplaces are often not
known. Additionally, the consumer dermal exposure assessments include scenario specific inputs
for fractional surface area of the body exposed in certain consumer activities and offers different
default values for film thickness (ranging from 1.88E-03 to 0.01 cm), and skin surface area
(ranging from 10% of hands to inside of both hands) for different product users across different
life stages (youth to adult) (Table 2-88 and Section 2.4.2.3.2). While these approaches both
represent fractional absorption methodologies, the different models may result in different
exposure values for similar conditions of use.
2.4.2.3.2 CEM Scenario Inputs
The complete CEM model inputs are provided in Supplemental Information on Consumer
Exposure Assessment. A discussion of the key inputs is provided below. The inputs are
categorized into three types: 1) parameters which are the same among all scenarios (Table 2-87);
2) Scenario-specific parameters which were not varied (Table 2-88); and 3) Scenario-specific
scenarios which were varied to obtain the range of exposure estimates (Table 2-89). A discussion
of key inputs is provided below.
2.4.2.3.2.1 Fixed Scenario Inputs
Parameters used that were the same across all consumer use modeling scenarios parameters are
shown in Table 2-87 and described briefly below. They include populations modeled for both
inhalation and dermal exposure, receptor exposure factors and product properties, activity
patterns, and environmental inputs.
Population
For all methylene chloride scenarios, the consumer user was assumed to be an adult (age 21+)
and two youth age groups (16-20 years and 11-15 years), while a non-user bystander can include
individuals of any age. Results are presented for users and non-user bystanders for inhalation
exposures and users only for dermal exposures. Inhalation exposure results are presented as
concentrations encountered by users and non-user bystanders and are independent of age group.
EPA presents all three evaluated user age groups for dermal exposures as reported doses are age
group specific. More information about how generated exposure estimates are used to evaluate
consumer risk for specific age groups can be found in Section 4.2
Receptor Exposure Factors and Product Properties
Default receptor exposure factors in CEM, as determined from the Exposure Factors Handbook
(EPA. 201 la) were used for body weight and inhalation rate during and after use. Aerosol
fraction was set at the CEM default of 0.06. Exposure duration remained a value of 1 for acute
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exposures. For calculation of dermal exposure, the skin permeability coefficient was an
estimated input based on the log octonol water partitioning coefficient and molecular weight of
methylene chloride and was set to a CEM default value of the chemical was set at an estimated
value of 7.17E-03 cm/hr.
Activity Patterns and Product Use Start Time
The activity pattern selected for the user (i.e., room/building location throughout the exposure
period on an hourly basis) was the default "stay-at-home" resident which places the user
primarily in the home during and after use of the product. The activity patterns were developed
based on Consolidated Human Activity Database (CHAD) (Isaacs. 2014) data of activity
patterns.
The use environment (room of product use) was the default in CEM for pre-populated scenarios,
unless professional judgement was used based on review of specific product information and/or
consumer behavior pattern data in the U.S. EPA (1987) survey of product users for various
consumer product categories. In all cases, the product use was assumed to start at 9:00 AM in the
morning.
Environmental Inputs
All environmental inputs (building volume, air exchange, interzonal air flow) were based on a
residence environment and used CEM default values obtained from Exposure Factors Handbook
(EPA. 201 la). Building volume (492 m3) is used to calculate air concentrations in Zone 2 and
room volume is used to calculate air concentrations in Zone 1 (see below). The volume of the
near-field bubble in Zone 1 was assumed to be 1 m3 in all cases, with the remaining as the far-
field volume. The default interzonal air flows are a function of the overall air exchange rate and
volume of the building, as well as the "openness" of the room itself. Kitchens, living rooms,
garages, schools, and offices are considered to be more open to the rest of the home or building
of use; bedrooms, bathrooms, laundry rooms, and utility rooms are usually accessed through one
door and are considered more closed. Background concentration was set to a CEM default value
of 0 mg/m3.
Table 2-87. Fixed Consumer Use Scenario Modeling Parameters
Parameter
1 nils
Value / Description
MODEL SELECTION / SCENARIO INPUTS
Pathways Selected
n/a
Inhalation and Dermal
Inhalation Model
n/a
Inhalation of Product Used in Environment (Near-
Field / Far-Field) ( P INH2)
Emission Rate
n/a
Let CEM Estimate Emission Rate
Product User (s)
n/a
Adult (>21 years) and Youth (Age 11-20 years)
Activity Pattern
n/a
User Stays at home entire day
Product Use Start Time
n/a
9:00 AM
Background Concentration
mg/m3
0
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Pa ram el or
I nils
Value / Description
PRODUCT/ARTICLE PROPERTIES
Frequency of Use (Acute)
events/day
Fixed at 1 event/day (CEM default)
Aerosol Fraction
-
CEM default (0.06)
Fraction Product Ingested
n/a
0
Skin Permeability Coefficient
cm/hr
Let CEM estimate (7.17E-3)
Product Dilution Factor
unitless
Fixed at 1 (i.e., no dilution)
ENVIRONMENT INPUTS
Building Volume (Residence)
m3
492
Air Exchange Rate, Zone 1
(Residence)
hr"1
CEM default (0.45)
Air Exchange Rate, Zone 2
(Residence)
hr"1
CEM default (0.45)
Air Exchange Rate, Near-Field
Boundary
hr"1
CEM default (402)
2.4.2.3.2.2. Non-varying Scenario Specific Inputs
Consumer use non-varying scenario specific inputs for evaluation of inhalation and dermal
exposure are shown in Table 2-88 and described in more detail below.
Product Density
Product density was derived for each consumer use scenario from individual product derived
information found on company websites and/or available SDSs. As multiple products with
varying densities may be found within the same use scenario, the highest reported density was
used in the CEM modeling.
Dermal Exposure Inputs
For the evaluation of dermal exposures from the use of methylene chloride, multiple scenario
specific inputs were used. Surface area to body weight ratio inputs were based on the default
CEM use scenario input or when a generic product scenario was developed, the SA/BW ratio
was set to 10% of hand based on best professional judgement when comparing to similar product
uses with given default values. Similarly, film thickness was input based on CEM scenario
specific default inputs or set to a default value of 0.01 cm. Amount of chemical retained on skin
is a calculated parameter dependent on film thickness and methylene chloride density for the
given use scenario. Absorption fraction is an estimated input that is dependent on the chemical
duration of use (described below)
Room of use
The input room of use is based on information derived from U.S. EPA (1987) for developed use
scenarios, CEM scenario default inputs, or information on chemical use from product labeling or
company websites.
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2.4.2.3.2.3. Scenario specific varied inputs
Consumer use non-varying scenario specific inputs for evaluation of inhalation and dermal
exposure are shown in Table 2-89 and described in more detail below.
Duration of Use
The amount of time that a product is used per event was based on the U.S. EPA (1987) survey of
consumer behavior patterns. The most representative product use category in the survey was
selected for each scenario assessed. This input parameter was varied using the 10th, 50th, and 95th
values.
Product Weight Fractions
Product weight fractions were determined from review of product SDSs and any other
information identified during Systematic Review. This input parameter was varied using the 10th,
50th, and 95th values, unless only single products were identified. Different weight fractions
could potentially make a product more or less efficient in time used or amount used however,
EPA is not able to quantify that change.
Mass of Product Used
The amount of product used per event was based on the U.S. EPA (1987) survey of consumer
behavior patterns. The most representative product use category in the survey was selected for
each scenario assessed. This input parameter was varied using the 10th, 50th, and 95th values.
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3671 Table 2-88. Consumer Use Non-Varying Scenario Specific Inputs for Evaluation of Inha
Consumer
( 'on di I ions ul° I so
I 'd nil
(# of Prod.)1
Selected ( I'M
2.1.6 Modeling
Scenario2
Product
Density
(ii/cnrV
I'linission
Model
Applied4
Derniiil
I'lxposuiv
Model
Applied*
Derniiil
SA/HW '¦
Derniiil
l-'ilni
Thickness
(em)
Amount
Relumed
on Skin
(li/Clll-)~
Absorption
l"r;ictions
Room ol°
Use
(mJ)9
Automotive AC
Leak Sealer
Aerosol
(1)
Generic Product
0.994
E3
P_DER2a
10% of
hand
0.01
0.010
0.134
Garage
(90)
Automotive AC
Refrigerant
Aerosol
(10)
Generic Product
1.208
E3
P_DER2a
10% of
hand
0.01
0.012
0.333
Garage
(90)
Adhesives
Liquid
(4)
Glue and
Adhesives
(small scale)
1.375
El
P_DER2a
Inside of
one hand
4.99E-03
0.012
0.333
Utility
Room
(20)
Adhesives Remover
Liquid
(1)
Adhesive/Caulk
Removers, 12
years
1.114
E2
P_DER2a
Inside of
both
hands
0.01
0.011
0.089
Utility
Room
(20)
Brake Cleaner
Aerosol
(3)
Degreasers
1.5322
E3
P_DER2a
10% of
hand
0.01
0.007
0.017
Garage
(90)
Brush Cleaner
Liquid
(2)
Paint Strippers/
Removers
0.9032
E2
P_DER2a
Inside of
both
hands
1.88E-03
0.011
0.089
Utility
Room
(20)
Carbon Remover
Aerosol
(1)
Degreasers
1.17
E3
P_DER2a
10% of
hand
0.01
0.012
0.062
Kitchen
(24)
Carburetor Cleaner
Aerosol
(3)
Degreasers
1.13
E3
P_DER2a
10% of
hand
0.01
0.015
0.033
Garage
(90)
Coil Cleaner
Aerosol
(1)
Generic Product
1.34
E3
P_DER2a
10% of
hand
0.01
0.013
0.062
Kitchen
(24)
Cold Pipe Insulating
Spray
Aerosol
(2)
Generic Product
1.2
E3
P_DER2a
10% of
hand
0.01
0.002
0.134
Kitchen
(24)
Electronics Cleaner
Aerosol
(1)
Degreasers
1.27
E3
P_DER2a
10% of
hand
0.01
0.013
0.318
Living
Room
(50)
Engine Cleaner
Aerosol
(2)
Degreasers
1.13
E3
P_DER2a
10% of
hand
0.01
0.012
0.062
Garage
(90)
Gasket Remover
Aerosol
(1)
Degreasers
1.038
E3
P_DER2a
10% of
hand
0.01
0.010
0.062
Garage
(90)
Sealant
Aerosol
(1)
Generic Product
1.05
E3
P_DER2a
10% of
hand
0.01
0.001
0.033
Garage
(90)
ation and Dermal Exposure
Page 175 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
('oilSlllllor
( 'on di I ions ul° I so
I 'd nil
(# of Prod.)1
Sok-clod ( I' M
2.1.6 Modeling
Soon;irio:
Product
l)cnsil\
(ii/cnrV
I'mission
Modol
Applied4
Dorniiil
l'.\posurc
Modol
Appliod'
Dorniiil
S A/IJW '¦
Dorniiil
l-'ilin
Thickness
(0111)
Amount
Returned
011 Skin
(••/onrf
Absorption
l-'r;iolions
Room ol'
I so
tmV
Weld Spatter
Protectant
Aerosol
(1)
Generic Product
1.31
E3
P DER2a
10% of
hand
0.01
0.009
0.017
Utility
Room
3672
1 Number of products identified for a condition of use scenario is based on product lists within EPA's 2017 Market and use Report.
2 The listed CEM 2.1.6 modeling scenario reflects the default product options within the model, which are prepopulated with certain default parameters. However, due to
EPA choosing to select and vary many key inputs, the specific model scenario matters less than the associated emission and dermal exposure models (e.g., El, E3,
P_DER2a).
3 Selected product densities were primarily sourced from product SDSs and MSDSs unless otherwise noted. Where a range of densities was identified for a given
condition of use, the highest reported product density was used.
4 Selected emissions model used is based on CEM scenario used or best professional judgement.
5 Selected dermal model is based on selection of absorption model for dermal exposure evaluation.
6 Selected dermal SA/BW ratio used is based on CEM scenario used or best professional judgement for Generic Scenario.
7 The amount retained on the skin is an estimated parameter within CEM based on film thickness and chemical density.
8 Absorption fraction is an estimated parameter with CEM with values varying based on exposure time. Values shown here represent values derived from 10th percentile
time used scenarios. Values would differ for 50th and 95th percentile time of use (see Table 2-87).
9 Room of use is either default scenario option within CEM, based on survey results from U.S. EPA (.1.9871. or derived from product use information on product labels or
websites.
Page 176 of 725
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3673 Table 2-89. Consumer Use Scenario Specific Values of Duration of Use, Weight Fraction, and Mass of Product Used Derived from
3674 U.S. EPA (1987)
Diinilioii of I so
Miiss of Product I sod
Soloolod I .S. I.l» A
(mill)
\\
oijilil lr;ic(ion
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
CoilSII 11101'
( ondilions of I so
!¦"< trm
Soloolod I .S. I.l» A
UWiSiinoj
Scoiiiirio1
Diinilioii of I so
(mill)
Woslsil Soon;irio Porooiililo
10%2 50% 95%
Weight l-motion
(V-ii mollnleiie chloride)1
Mill Mid M;i\
Miiss of Product I sod
-------
3676
3677
3678
3679
3680
3681
3682
3683
3684
3685
3686
3687
3688
3689
3690
3691
3692
3693
3694
3695
3696
3697
3698
3699
3700
3701
3702
3703
3704
3705
3706
3707
3708
3709
3710
3711
3712
3713
3714
3715
3716
3717
3718
3719
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
2.4.2.3.3 Sensitivity Analysis
The CEM developers conducted a detailed sensitivity analysis for CEM version 1.5. A
discussion of that sensitivity analysis is presented in Supplemental Information on Consumer
Exposure Assessment and is described in full within Appendix C of the CEM User Guide (EPA.
2017). In brief, the analysis was conducted on non-linear, continuous variables and categorical
variables that were used in CEM models. A base run of different models using various product or
article categories along with CEM defaults was used (see Table 1 of Appendix C in U.S. EPA
(2017)). Individual variables were modified, one at a time, and the resulting Chronic Average
Daily Dose (CADD) and Acute Dose Rate (ADR) were then compared to the corresponding
results for the base run.
2.4.2.4 Consumer Use Scenario Specific Results
Consumer use scenarios for 15 different conditions of use for both possible inhalation and
dermal exposures were evaluated across a range of user intensities based on differences in
duration of use, weight fraction and mass of product used. While up to 27 different scenarios
were evaluated for inhalation and 18 scenarios for dermal exposure, for the purposes of
presenting the inhalation and dermal results, three combinations are presented to provide results
across a range of use patterns modeled. EPA uses the following descriptors for these three use
patterns: high intensity, moderate intensity, and low intensity use. These descriptors are based on
three key input parameters varied during the modeling (duration of use, weight fraction, and
mass of product used) which are summarized in Section 2.4.2.4.2.3 and Table 2-89, but included
here for ease of reference.
For inhalation results, high intensity use refers to the model iteration that utilized the 95th
percentile duration of use and mass of product used (as presented in U.S. EPA (1987)) and the
maximum weight fraction derived from product specific SDS, when available. Moderate
intensity use refers to the model iteration that utilized the median (50th percentile) duration of use
and mass of product used (as presented U.S. EPA (1987)) and the midpoint weight fraction
derived from product specific SDS, when available. In instances where only two weight fractions
were modeled, the maximum weight fraction was used to represent the moderate intensity user.
Low intensity use refers to the model iteration that utilized the 10th percentile duration of use and
mass of product used (as presented in U.S. EPA (1987)) and the minimum weight fraction
derived from product specific SDS, when available. For dermal results, only the duration of use
and weight fraction inputs were varied across scenarios. Characterization of high intensity,
moderate intensity use and low intensity users following the same protocol as those described for
the inhalation results, but only encompassing the two varied parameters. For certain situations,
only a single value was identified for weight fraction in the product specific SDS. For those
situations, that parameter is labeled single value and the same value in all three use patterns in
the summary tables below.
2.4.2.4.1 Auto Leak Sealer
An automotive AC leak sealant containing methylene chloride was identified as available for
consumer use with a weight fraction of <1% (Table 2-90). Inhalation exposures were evaluated
for users and bystanders for three different scenarios of duration of use, weight fraction and mass
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3720 of use. One-hour maximum TWA concentrations ranged from 400 - 700 mg/m3 for users and
3721 from 75.2 - 82.8 mg/m3 for bystanders across scenarios. Dermal exposures were evaluated for
3722 three scenarios and ranged from 1.54 - 4.21 mg/kg/day across all evaluated scenarios and age
3723 groups (Table 2-91).
3724
Table 2-90. Consumer User and Bystander Inhalation Exposure to Methylene Chloride
During Auto Leak Sealer Use
Duriilion
Weight
Mass
Product
Peak
1 lir Max
S lir Max
Scenario
of I so
Traction
or l se
I ser or
Cone.
TWA
TWA
Description
(mill)
(%)
(Si)
Bystander
(in *»/ni4)
(in *»/ni4)
(m»/nr()
1 IisjIi
95%
(120)
Single
Single
I ser
4(i(i
|t Hi
Intensity
User
Value
(1)
Value
(88.18)
Bystander
430
75.2
29.6
Moderate
50%
(15)
Single
Single
User
681
112
Intensity
User
Value
(1)
Value
(88.18)
Bystander
1660
82.80
26.90
Low
10%
(5)
Single
Single
User
700
114
Intensity
User
Value
(1)
Value
(88.18)
Bystander
3.47E+03
81.5
26.2
3725
Table 2-91. Consumer Dermal Exposure to Methylene Chloride During Use as an Auto
Leak Sealer
Scenario
Description
Duration of
I se
(mill)
Weight Traction
(%)
Ueceptor
Acute ADU
(mg/kg/dav)
High
Intensity
User
95%
(120)
Single Value
(1)
Adult (>21 years)
4.11
Youth (16-20 years)
3.85
Youth (11-15 years)
4.21
Moderate
Intensity
User
50%
(15)
Single Value
(1)
Adult (>21 years)
3.23
Youth (16-20 years)
3.02
Youth (11-15 years)
3.31
Low
Intensity
User
10%
(5)
Single Value
(1)
Adult (>21 years)
1.65
Youth (16-20 years)
1.54
Youth (11-15 years)
1.69
3726
3727 2.4.2.4.2 Auto AC Refrigerant
3728 Ten consumer products used as an automotive AC refrigerant were found to contain methylene
3729 chloride in weight fractions of <1% - 3% (Table 2-92). Inhalation exposures were evaluated for
3730 users and bystanders for 18 different scenarios of duration of use, weight fraction and mass of
3731 use. Three scenarios are presented below as low intensity user, high intensity user and moderate
3732 intensity user scenarios, with 1-hr maximum TWA concentrations ranging from 8.26 -
3733 233 mg/m3 for users and from 0.96 - 43.9 mg/m3 for bystanders across scenarios. Dermal
Page 180 of 725
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3734 exposures were evaluated for six scenarios. Selected scenarios representing low intensity user,
3735 moderate intensity user and high intensity user scenarios ranged from 1.54 - 4.21 mg/kg/day
3736 across all evaluated scenarios and age groups (Table 2-93).
3737
Table 2-92. Consumer User and Bystander Inhalation Exposure to Methylene Chloride
During Auto Air Conditioning Refrigerant Use
Scennrio
Description
Duriilion
of I so
(mill)
Wei «hl
liiiclion
(%)
Miiss of
I so
(Si)
Product
I sor or
liystiindor
I'osik ( one.
(m»/m()
1 hr M;i\
TWA
(in "/in *)
S lir Msi\
TWA
(111 "/ill ")
High Intensity
95%
Max
95%
User
251
233
61.7
User
(120)
(3)
(1714.59)
Bystander
43.9
17.3
Moderate
50%
Max
50%
User
234
96.0
15.8
Intensity User
(15)
(3)
(414.36)
Bystander
11.7
3.80
Low Intensity
10%
Min
10%
User
40.9
8.26
1.34
User
(5)
(1)
(103.95)
Bystander
0.96
0.31
3738
Table 2-93. Consumer Dermal Exposure to Methylene Chloride During Use as an Auto Air
Conditioning Refrigerant
Scenario Description
Duriilion of
I so
(min)
Woijihl
liitclion
(%)
Receptor
Acute ADR
(m»/k»/diiv)
High Intensity User
95%
(120)
Max
(3)
Adult (>21 years)
0.15
Youth (16-20 years)
0.14
Youth (11-15 years)
0.15
Moderate Intensity
User
50%
(15)
Max
(3)
Adult (>21 years)
0.12
Youth (16-20 years)
0.11
Youth (11-15 years)
0.12
Low Intensity User
10%
(5)
Min
(1)
Adult (>21 years)
0.02
Youth (16-20 years)
0.02
Youth (11-15 years)
0.02
3739
3740 2.4.2.4.3 Adhesives
3741 Four consumer products used as an adhesive were found to contain methylene chloride in weight
3742 fractions between 30% - 90% (Table 2-94). Inhalation exposures were evaluated for users and
3743 bystanders for 27 different scenarios of duration of use, weight fraction and mass of use. Three
3744 scenarios are presented below as low intensity user, high intensity user and moderate intensity
3745 user scenarios, with 1-hr maximum TWA concentrations ranging from 1.26 - 1,580 mg/m3 for
3746 users and from 0.384 - 200 mg/m3 for bystanders across scenarios. Dermal exposures were
3747 evaluated for nine scenarios. Selected scenarios representing low intensity user, moderate
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3748 intensity user and high intensity user scenarios ranged from 0.107 - 6.51 mg/kg/day across all
3749 evaluated scenarios and age groups (Table 2-95).
3750
Table 2-94. Consumer User and Bystander Inhalation Exposure to Methylene Chloride
During Use as an Adhesive
Scenario
Description
Diii'iilion
or I so
(mill)
Weight
liitclion
(%)
M:iss of
I si-
tu)
Product
I scr or
Bystander
I'osik Cone.
(in *»/ni-4)
1 lir M:i\
TWA (ni»/ni()
S lir Msix
TWA
(m "/nr')
High
Intensity
User
95%
(60)
Max
(90)
95%
(175.65)
User
1900
1580
258
Bystander
200
61.1
Moderate
Intensity
User
50%
(4.25)
Midpoint
(60)
50%
(10.16)
User
429
29.2
5.57
Bystander
6.49
1.93
Low
Intensity
User
10%
(0.33)1
Min
(30)
10%
(1.22)
User
94.8
1.26
0.27
Bystander
0.38
0.11
1 Low -end durations reported by U.S. EPA (1987) that are less than 0.5 minutes (30 seconds) are modeled as being
equal to 0.5 minutes due to that being the minimum timestep available within the model used.
3751
Table 2-95. Consumer Dermal Exposure to Methylene Chloride During Use as an
Adhesive
Scenario
Duration of I sc
Weight Inulion
Acute ADR
Description
(min)
(%)
Receptor
(ni»/k»/d;iv)
95%
(60)
Max
(90)
Adult (>21 years)
6.36
High Intensity User
Youth (16-20 years)
5.96
Youth (11-15 years)
6.51
Moderate Intensity
User
50%
(4.25)
Midpoint
(60)
Adult (>21 years)
1.51
Youth (16-20 years)
1.41
Youth (11-15 years)
1.54
10%
(0.33)1
Min
(30)
Adult (>21 years)
0.11
Low Intensity User
Youth (16-20 years)
0.10
Youth (11-15 years)
0.11
1 Low-end durations reported by U.S. EPA (.1.987) that are less than 0.5 minutes (30 seconds) are modeled as being
equal to 0.5 minutes due to that being the minimum timestep available within the model used.
3752
3753 2.4.2.4.4 Adhesive Remover
3754 A consumer product used as an adhesive remover were found to contain methylene chloride in
3755 weight fractions between 50% - 75% (Table 2-96). Inhalation exposures were evaluated for users
3756 and bystanders for 18 different scenarios of duration of use, weight fraction and mass of use.
3757 Three scenarios are presented below as low intensity user, high intensity user and moderate
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3758 intensity user scenarios, with 1-hr maximum TWA concentrations ranging from 1.33 -
3759 6.17 mg/m3 for users and from 0.293 - 1.67 mg/m3 for bystanders across scenarios. Dermal
3760 exposures were evaluated for six scenarios. Selected scenarios representing low intensity user,
3761 moderate intensity user and high intensity user scenarios ranged from 2.86 - 17.6 mg/kg/day
3762 across all evaluated scenarios and age groups (Table 2-97).
3763
Table 2-96. Consumer User and Bystander Inhalation Exposure to Methylene Chloride
During Use as an Adhesives Remover
Duration
Weight
Miiss of
Product
1 lir Max
S lir Mjix
Scenario
of I so
Traction
I se
I sor or
I'eak Cone.
TWA
TWA
Description
(mill)
(%)
)
High Intensity
User
95%
(480)
Max
(75)
Adult (>21 years)
17.3
Youth (16-20 years)
16.1
Youth (11-15 years)
17.6
Moderate Intensity
User
50%
(60)
Max
(75)
Adult (>21 years)
17.3
Youth (16-20 years)
16.1
Youth (11-15 years)
17.6
Low Intensity
User
10%
(3)
Min
(50)
Adult (>21 years)
3.06
Youth (16-20 years)
2.86
Youth (11-15 years)
3.13
3765
3766 2.4.2.4.5 Brake Cleaner
3767 Three products used as a brake cleaner were found to contain methylene chloride in weight
3768 fractions between 10% - 60% (Table 2-98). Inhalation exposures were evaluated for users and
3769 bystanders for 27 different scenarios of duration of use, weight fraction and mass of use. Three
3770 scenarios are presented below as low intensity user, high intensity user and moderate intensity
3771 user scenarios, with 1-hr maximum TWA concentrations ranging from 35.6 - 1,970 mg/m3 for
3772 users and from 4.16 - 371 mg/m3 for bystanders across scenarios. Dermal exposures were
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3773 evaluated for nine scenarios. Selected scenarios representing low intensity user, moderate
3774 intensity user and high intensity user scenarios ranged from 0.0580 - 3.89 mg/kg/day across all
3775 evaluated scenarios and age groups (Table 2-99).
3776
Table 2-98. Consumer User and Bystander Inhalation Exposure to Methylene Chloride
During Use as a Brake Cleaner
Scenario
Description
Diii'iilion
of I so
(mill)
Weight
1 niclion
(%)
Miiss of
I si-
tU)
Product
I ser or
liysliiiHlcr
I'eak Cone.
(in "/in'*)
1 lir Msix
TWA
(in "/in"')
S lir Mjix
TWA
(111 «/lll')
High Intensity
95%
Max
95%
User
2120
1970
522
User
(120)
(60)
(724.91)
Bystander
371
146
Moderate
50%
Midpoint
50%
User
1190
490
80.50
Intensity User
(15)
(35)
(181.23)
Bystander
59.5
19.4
Low Intensity
10%
Min
10%
User
698
35.6
5.78
User
(1)
(10)
(45.31)
Bystander
4.16
1.33
3777
Table 2-99. Consumer Dermal Exposure to Methylene Chloride During Use as a Brake
Cleaner
Sceiiiirio Description
Duration of I se
(min)
Weight I-'niclion
(%)
Receptor
Acute ADR
(ni»/k»/il:iv)
High Intensity User
95%
(120)
Max
(65)
Adult (>21 years)
3.80
Youth (16-20 years)
3.55
Youth (11-15 years)
3.89
Moderate Intensity
User
50%
(15)
Medium
(35)
Adult (>21 years)
1.74
Youth (16-20 years)
1.63
Youth (11-15 years)
1.78
Low Intensity User
10%
(1)
Low
(10)
Adult (>21 years)
0.06
Youth (16-20 years)
0.06
Youth (11-15 years)
0.06
3778
3779 2.4.2.4.6 Brush Cleaner
3780 Two products used as a brush cleaner were found to contain methylene chloride in weight
3781 fractions <1% (Table 2-100). Inhalation exposures were evaluated for users and bystanders for
3782 nine different scenarios of duration of use, weight fraction and mass of use. Three scenarios are
3783 presented below as low intensity user, high intensity user and moderate intensity user scenarios,
3784 with 1-hr maximum TWA concentrations ranging from 0.212 - 1.82 mg/m3 for users and from
3785 0.01.91 - 0.65 mg/m3 for bystanders across scenarios. Dermal exposures were evaluated for
3786 three scenarios. Selected scenarios representing low intensity user, moderate intensity user and
3787 high intensity user scenarios ranged from 0.0132 - 0.0359 mg/kg/day across all evaluated
3788 scenarios and age groups (Table 2-101).
Page 184 of 725
-------
3789
3790
3791
3792
3793
3794
3795
3796
3797
3798
3799
3800
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 2-100. Consumer User and Bystander Inhalation Exposure to Methylene Chloride
During Use as a Brush Cleaner
Scenario
Description
Dui'iition
of I so
(mill)
Weigh!
Traction
(%)
M:iss of
I se
(Si)
Product
I ser or
Bystander
Peak
Cone.
(in *»/m4)
1 lir Max
TWA
(in "/in'*)
S lir Max
TWA (in "/in*)
High Intensity
User
95%
(420)
Single
Value
(1)
95%
(3418.58)
User
1.83
1.82
1.52
Bystander
0.65
0.32
Moderate
Intensity User
50%
(60)
Single
Value
(1)
50%
(427.32)
User
1.29
1.07
0.18
Bystander
0.14
0.04
Low Intensity
User
10%
(5)
Single
Value
(1)
10%
(71.31)
User
1.21
0.21
0.03
Bystander
0.02
0.01
Table 2-101. Consumer Dermal Exposure to Methylene Chloride During Use as a Brush
Cleaner
Scenario Description
Duration of
Use
(mill)
Weight
Traction
(%)
Receptor
Acute ADR
(m "/kg/day)
High Intensity User
95%
(420)
Single Value
(1)
Adult (>21 years)
0.035
Youth (16-20 years)
0.033
Youth (11-15 years)
0.036
Moderate Intensity
User
50%
(60)
Single Value
(1)
Adult (>21 years)
0.035
Youth (16-20 years)
0.033
Youth (11-15 years)
0.036
Low Intensity User
10%
(5)
Single Value
(1)
Adult (>21 years)
0.014
Youth (16-20 years)
0.013
Youth (11-15 years)
0.014
2.4.2.4.7 Carbon Remover
One product used as a carbon remover (e.g., to clean appliances, pots and pans, etc.) was found
to contain methylene chloride in weight fractions between 40-70% (Table 2-102). Inhalation
exposures were evaluated for users and bystanders for 18 different scenarios of duration of use,
weight fraction and mass of use. Three scenarios are presented below as low intensity user, high
intensity user and moderate intensity user scenarios, with 1-hr maximum TWA concentrations
ranging from 88.7 - 4,750 mg/m3 for users and from 8.16- 847 mg/m3 for bystanders across
scenarios. Dermal exposures were evaluated for six scenarios. Selected scenarios representing
low intensity user, moderate intensity user and high intensity user scenarios ranged from 0.336 -
3.47 mg/kg/day across all evaluated scenarios and age groups (Table 2-103).
Page 185 of 725
-------
3801
3802
3803
3804
3805
3806
3807
3808
3809
3810
3811
3812
3813
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 2-102. Consumer User and Bystander Inhalation Exposure to Methylene Chloride
During Use as a Carbon Remover
Scenario
Description
Duriilion
of I so
(mill)
Weight
liitclioii
(%)
Mjiss of
I so
(a)
Product
I sor or
li\sl:iiuler
I'osik (one.
(m»/m()
1 hr M;i\
TWA
(in "/in *)
S hr Mjix
TWA
(m»/m()
High Intensity
95%
Max
95%
User
4940
4750
1280
User
(120)
(70)
(1107.10)
Bystander
847
311
Moderate
50%
Max
50%
User
2640
896
138
Intensity User
(15)
(70)
(112.44)
Bystander
86.90
26
Low Intensity
10%
Min
10%
User
814
88.7
13.5
User
(2)
(40)
(19.37)
Bystander
8.16
2.43
Table 2-103. Consumer Dermal Exposure to Methylene Chloride During Use as a Carbon
Remover
Scenario
Description
Duration of
Use
(min)
Weight
Irnction
(%)
Receptor
Acute ADR
(m»/k»/ihiv)
95%
(120)
Max
(70)
Adult (>21 years)
3.38
High Intensity User
Youth (16-20 years)
3.16
Youth (11-15 years)
3.47
Moderate Intensity
User
50%
(15)
Max
(70)
Adult (>21 years)
2.66
Youth (16-20 years)
2.49
Youth (11-15 years)
2.72
10%
(2)
Min
(40)
Adult (>21 years)
0.36
Low Intensity User
Youth (16-20 years)
0.34
Youth (11-15 years)
0.37
2.4.2.4.8 Carburetor Cleaner
Three products used as a carburetor cleaner were found to contain methylene chloride in weight
fractions between 20-70% (Table 2-104). Inhalation exposures were evaluated for users and
bystanders for 27 different scenarios of duration of use, weight fraction and mass of use. Three
scenarios are presented below as low intensity user, high intensity user and moderate intensity
user scenarios, with 1-hr maximum TWA concentrations ranging from 65.7 - 3,020 mg/m3 for
users and from 7.66 - 428 mg/m3 for bystanders across scenarios. Dermal exposures were
evaluated for nine scenarios. Selected scenarios representing low intensity user, moderate
intensity user and high intensity user scenarios ranged from 0.0856 - 3.31 mg/kg/day across all
evaluated scenarios and age groups (Table 2-105).
Page 186 of 725
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3814
3815
3816
3817
3818
3819
3820
3821
3822
3823
3824
3825
3826
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 2-104. Consumer User and Bystander Inhalation Exposure to Methylene Chloride
During Use as a Carburetor Cleaner
Scenario
Description
Diii'iilion
of I se
(mill)
Weight
1 niclion
(%)
Miiss of
I si-
tU)
Product
I ser or
livst:iiuler
I'esik (one.
(m»/m()
1 lir M:i\
TWA
(m»/m()
S lir Mjix
TWA
(111 «/lll')
High Intensity
95%
Max
95%
User
4420
3020
525
User
(45)
(70)
(644.89)
Bystander
428
148
Moderate
50%
Midpoint
50%
User
2320
595
96.7
Intensity User
(7)
(45)
(167.07)
Bystander
69.7
22.5
Low Intensity
10%
Min
10%
User
1290
65.7
10.7
User
(1)
(20)
(41.77)
Bystander
7.66
2.45
Table 2-105. Consumer Dermal Exposure to Methylene Chloride During Use as a
Carburetor Cleaner
Scenario
Duriilion of I so
Weight l iitctioii
Acute ADR
Description
(min)
(%)
Receptor
(iii»/k»/il:iv)
95%
(45)
Max
(70)
Adult (>21 years)
3.23
High Intensity User
Youth (16-20 years)
3.02
Youth (11-15 years)
3.31
Moderate Intensity
User
50%
(7)
Midpoint
(45)
Adult (>21 years)
1.08
Youth (16-20 years)
1.01
Youth (11-15 years)
1.10
10%
(1)
Min
(20)
Adult (>21 years)
0.09
Low Intensity User
Youth (16-20 years)
0.09
Youth (11-15 years)
0.09
2.4.2.4.9 Coil Cleaner
One product used as a coil cleaner (e.g., air conditioner condensing coils) was found to contain
methylene chloride in weight fractions between 60-100% (Table 2-106). Inhalation exposures
were evaluated for users and bystanders for 18 different scenarios of duration of use, weight
fraction and mass of use. Three scenarios are presented below as low intensity user, high
intensity user and moderate intensity user scenarios, with 1-hr maximum TWA concentrations
ranging from 152 - 7,770 mg/m3 for users and from 14.0 - 1,390 mg/m3 for bystanders across
scenarios. Dermal exposures were evaluated for six scenarios. Selected scenarios representing
low intensity user, moderate intensity user and high intensity user scenarios ranged from 0.58 -
5.67 mg/kg/day across all evaluated scenarios and age groups (Table 2-107).
Page 187 of 725
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3827
3828
3829
3830
3831
3832
3833
3834
3835
3836
3837
3838
3839
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 2-106. Consumer User and Bystander Inhalation Exposure to Methylene Chloride
During use as a Coil Cleaner
Scenario
Description
Diii'iilion
of I se
(mill)
Weight
liitctioii
(%)
Muss of
I so
(Si)
Product
I ser or
livst:iiulor
I'osik (one.
(m»/iir()
1 hr M;i\
TWA
(in "/m*)
S hr Mjix
TWA
(m»/m()
High Intensity
95%
Max
95%
User
8080
7770
2090
User
(120)
(100)
(1267.96)
Bystander
139
509
Moderate
50%
Max
50%
User
4330
147
225
Intensity User
(15)
(100)
(128.78)
Bystander
142
42.5
Low Intensity
10%
Min
10%
User
1400
152
23.2
User
(2)
(60)
(22.19)
Bystander
14
4.18
Table 2-107. Consumer Dermal Exposure to Methylene Chloride During Use as a Coil
Cleaner
Scenario
Description
Diirnlion of
Use
(min)
Weight
liitctioii
(%)
Receptor
Acute ADR
(m»/k»/il:iv)
95%
(120)
Max
(100)
Adult (>21 years)
5.55
High Intensity User
Youth (16-20 years)
5.19
Youth (11-15 years)
5.67
Moderate Intensity
User
50%
(15)
Max
(100)
Adult (>21 years)
4.35
Youth (16-20 years)
4.07
Youth (11-15 years)
4.46
10%
(2)
Min
(60)
Adult (>21 years)
0.62
Low Intensity User
Youth (16-20 years)
0.58
Youth (11-15 years)
0.63
2.4.2.4.10 Cold Pipe Insulation Spray
Two products used as a cold pipe insulation spray were found to contain methylene chloride in
weight fractions between 30-60% (Table 2-108). Inhalation exposures were evaluated for users
and bystanders for 18 different scenarios of duration of use, weight fraction and mass of use.
Three scenarios are presented below as low intensity user, high intensity user and moderate
intensity user scenarios, with 1-hr maximum TWA concentrations ranging from 53.6 -
2,970 mg/m3 for users and from 5.02 - 390 mg/m3 for bystanders across scenarios. Dermal
exposures were evaluated for six scenarios. Selected scenarios representing low intensity user,
moderate intensity user and high intensity user scenarios ranged from 0.0703 - 3.04 mg/kg/day
across all evaluated scenarios and age groups (Table 2-109).
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 2-108. Consumer User and Bystander Inhalation Exposure to Methylene Chloride
During Cold Pipe Insulation Spray Use
Scenario
Description
Duriilion
or I se
(mill)
Wei «hl
liitclion
(%)
Muss of
I se
(a)
Product
I sor or
liystiiiulor
I'osik ( one.
(m»/nr()
1 hr M;i\
TWA
(in "/in *)
S lir Mjix
TWA
(111 «/lll')
High Intensity
95%
Max
95%
User
3630
2970
491
User
(60)
(60)
(521.61)
Bystander
390
120
Moderate
50%
Max
50%
User
2840
530
80.9
Intensity User
(5)
(60)
(77.00)
Bystander
49.2
14.7
Low Intensity
10%
Min
10%
User
1250
53.6
8.19
User
(0.25)1
(30)
(15.97)
Bystander
5.02
1.50
1 Low-end durations reported by U.S. EPA (.1.9871 that are less than 0.5 minutes (30 seconds) are modeled as being
equal to 0.5 minutes due to that being the minimum timestep available within the model used.
3840
Table 2-109. Consumer Dermal Exposure to Methylene Chloride During Use as a Cold
Pipe Insulation Spray
Scenario
Description
Duriilion of
Use
(min)
Weight
liitclion
(%)
Receptor
Acute ADR
(m»/k»/cl:iv)
High Intensity User
95%
(60)
Max
(60)
Adult (>21 years)
2.97
Youth (16-20 years)
2.78
Youth (11-15 years)
3.04
Moderate Intensity
User
50%
(5)
Max
(60)
Adult (>21 years)
1.20
Youth (16-20 years)
1.12
Youth (11-15 years)
1.23
Low Intensity User
10%
(0.25)1
Min
(30)
Adult (>21 years)
0.08
Youth (16-20 years)
0.07
Youth (11-15 years)
0.08
1 Low-end durations reported by U.S. EPA (1987) that are less than 0.5 minutes (30 seconds) are modeled as being
equal to 0.5 minutes due to that being the minimum timestep available within the model used.
3841
3842 2.4.2.4.11 Electronics Cleaner
3843 One product used as an electronics cleaner was found to contain methylene chloride with a
3844 weight fraction of 5% (Table 2-110). Inhalation exposures were evaluated for users and
3845 bystanders for 9 different scenarios of duration of use, weight fraction and mass of use. Three
3846 scenarios are presented below as low intensity user, high intensity user and moderate intensity
3847 user scenarios, with 1-hr maximum TWA concentrations ranging from 0.717 - 130 mg/m3 for
3848 users and from 0.105 - 27.3 mg/m3 for bystanders across scenarios. Dermal exposures were
3849 evaluated for three scenarios. Selected scenarios representing low intensity user, moderate
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
3850 intensity user and high intensity user scenarios ranged from 0.01.24 - 0.256 mg/kg/day across all
3851 evaluated scenarios and age groups (Table 2-111).
3852
Table 2-110. Consumer User and Bystander Inhalation Exposure to Methylene Chloride
During Use as an Electronics Cleaner
Scenario
Description
Dm ml ion
or I so
(mill)
Weight
Inulion
(%)
Muss of
I se
(a)
Product
I ser or
liystiiiuler
I'esik ( one.
(ni»/ni()
1 lir M:i\
TWA
(m»/m()
8 lir Mjix
TWA
(nig/in*)
High Intensity
User
95%
(30)
Single
Value
(5)
95%
(281.65)
User
228
130
22.5
Bystander
27.3
6.34
Moderate
Intensity User
50%
(2)
Single
Value
(5)
50%
(18.78)
User
84.1
9.23
1.49
Bystander
1.33
0.34
Low Intensity
User
10%
(0.17)1
Single
Value
(5)
10%
(1.50)
User
19.1
0.72
0.12
Bystander
0.11
0.03
1 Low-end durations reported by U.S. EPA (.1.9871 that are less than 0.5 minutes (30 seconds) are modeled as being
equal to 0.5 minutes due to that being the minimum timestep available within the model used.
3853
Table 2-111. Consumer Dermal Exposure to Methylene Chloride During Use as an
Electronics Cleaner
Diii'iition of I so
Weight I-'met ion
Acute ADR
Sccnnrio Description
(mill)
(%)
Receptor
(m»/k»/il:iv)
95%
(30)
Single Value
(5)
Adult (>21 years)
0.250
High Intensity User
Youth (16-20 years)
0.234
Youth (11-15 years)
0.256
Moderate Intensity
User
50%
(2)
Single Value
(5)
Adult (>21 years)
0.049
Youth (16-20 years)
0.046
Youth (11-15 years)
0.050
10%
(0.17)1
Single Value
(5)
Adult (>21 years)
0.013
Low Intensity User
Youth (16-20 years)
0.012
Youth (11-15 years)
0.014
1 Low-end durations reported by U.S. EPA (.1.9871 that are less than 0.5 minutes (30 seconds) are modeled as being
equal to 0.5 minutes due to that being the minimum timestep available within the model used.
3854
3855 2.4.2.4.12 Engine Cleaner
3856 Two products used as an engine cleaner were found to contain methylene chloride in weight
3857 fractions between 20-70% (Table 2-112). Inhalation exposures were evaluated for users and
3858 bystanders for 27 different scenarios of duration of use, weight fraction and mass of use. Three
3859 scenarios are presented below as low intensity user, high intensity user and moderate intensity
Page 190 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
3860 user scenarios, with 1-hr maximum TWA concentrations ranging from 154-5,100 mg/m3 for
3861 users and from 18.0 - 958 mg/m3 for bystanders across scenarios. Dermal exposures were
3862 evaluated for nine scenarios. Selected scenarios representing low intensity user, moderate
3863 intensity user and high intensity user scenarios ranged from 0.352 - 3.35 mg/kg/day across all
3864 evaluated scenarios and age groups (Table 2-113).
3865
Table 2-112. Consumer User and Bystander Inhalation Exposure to Methylene Chloride
During Use as an Engine Cleaner
Scenario
Description
Diii'iilion
of I se
(mill)
Wei «hl
liitclioii
(%)
Muss of
I si-
tu)
Product
I ser or
li\sl:iiulcr
I'esik ( one.
(m»/m()
1 hr Msix
TWA
(in "/in"')
S lir Mjix
TWA
(nig/nr')
High Intensity
95%
Max
95%
User
5480
5100
1350
User
(120)
(70)
(1603.88)
Bystander
958
377
Moderate
50%
Midpoint
50%
User
3280
1350
221
Intensity User
(15)
(45)
(387.60)
Bystander
164
53.3
Low Intensity
10%
Min
10%
User
764
154
25.1
User
(5)
(20)
(97.24)
Bystander
18
5.78
3866
Table 2-113. Consumer Dermal Exposure to Methylene Chloride During Use as an Engine
Cleaner
Scenario Description
Dunition of I se
(min)
Weight l iitclioii
(%)
Receptor
Acute ADR
(ni»/k»/d;iv)
High Intensity User
95%
(120)
Max
(70)
Adult (>21 years)
3.27
Youth (16-20 years)
3.06
Youth (11-15 years)
3.35
Moderate Intensity
User
50%
(15)
Midpoint
(45)
Adult (>21 years)
1.65
Youth (16-20 years)
1.54
Youth (11-15 years)
1.69
Low Intensity User
10%
(5)
Min
(20)
Adult (>21 years)
0.38
Youth (16-20 years)
0.35
Youth (11-15 years)
0.38
3867
3868 2.4.2.4.13 Gasket Remover
3869 One product used as a gasket remover was found to contain methylene chloride in weight
3870 fractions between 60-80% (Table 2-114). Inhalation exposures were evaluated for users and
3871 bystanders for 18 different scenarios of duration of use, weight fraction and mass of use. Three
3872 scenarios are presented below as low intensity user, high intensity user and moderate intensity
3873 user scenarios, with 1-hr maximum TWA concentrations ranging from 142 - 3,770 mg/m3 for
3874 users and from 16.4 - 590 mg/m3 for bystanders across scenarios. Dermal exposures were
3875 evaluated for six scenarios. Selected scenarios representing low intensity user, moderate intensity
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3876 user and high intensity user scenarios ranged from 0.448 - 3.50 mg/kg/day across all evaluated
3877 scenarios and age groups (Table 2-115).
3878
Table 2-114. Consumer User and Bystander Inhalation Exposure to Methylene Chloride
During Use as a Gasket Remover
Scenario
Description
Dunilion
or I so
(mill)
Wei «hl
liitclioii
(%)
Muss of
I se
(Si)
Product
I sor or
liystiiniler
I'esik ( one.
(in «/iii"*)
1 lir M:i\
TWA
(m»/m()
8 lir Msix
TWA
(nig/nr*)
High Intensity
95%
Max
95%
User
5120
3770
682
User
(60)
(80)
(790.05)
Bystander
590
212
Moderate
50%
Max
50%
User
1850
758
125
Intensity User
(15)
(80)
(122.77)
Bystander
92.2
30
Low Intensity
10%
Min
10%
User
1480
142
23
User
(2)
(60)
(29.77)
Bystander
16.4
5.26
3879
Table 2-115. Consumer Dermal Exposure to Methylene Chloride During Use as a Gasket
Remover
Scenario Description
Duration of
Use
(min)
Weight l iitctioii
(%)
Receptor
Acute ADR
(m»/k»/il:iv)
High Intensity User
95%
(60)
Max
(80)
Adult (>21 years)
3.42
Youth (16-20 years)
3.20
Youth (11-15 years)
3.50
Moderate Intensity
User
50%
(15)
Max
(80)
Adult (>21 years)
2.70
Youth (16-20 years)
2.52
Youth (11-15 years)
2.76
Low Intensity User
10%
(2)
Min
(60)
Adult (>21 years)
0.48
Youth (16-20 years)
0.45
Youth (11-15 years)
0.49
3880
3881 2.4.2.4.14 Sealants
3882 One product used as a sealant was found to contain methylene chloride in weight fractions
3883 between 10-30% (Table 2-116). Inhalation exposures were evaluated for users and bystanders for
3884 18 different scenarios of duration of use, weight fraction and mass of use. Three scenarios are
3885 presented below as low intensity user, high intensity user and moderate intensity user scenarios,
3886 with 1-hr maximum TWA concentrations ranging from 23.9 - 2,390 mg/m3 for users and from
3887 2.77 - 303 mg/m3 for bystanders across scenarios. Dermal exposures were evaluated for six
3888 scenarios. Selected scenarios representing low intensity user, moderate intensity user and high
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3889 intensity user scenarios ranged from 0.0754 - 1.33 mg/kg/day across all evaluated scenarios and
3890 age groups (Table 2-117).
3891
Table 2-116. Consumer User and Bystander Inhalation Exposure to Methylene Chloride
During Use as a Sealant
Scenario
Description
Dunition
or I so
(mill)
Weight
Inulion
(%)
M:iss of
I so
(a)
Product
I sor or
liysliiniler
I'osik (one.
(ni»/nr()
1 lir M:i\
TWA
(in «/ni-4)
8 lir Mjix
TWA
(in «/ni-4)
High Intensity
95%
Max
95%
User
2880
2390
391
User
(60)
(30)
(799.19)
Bystander
303
92.7
Moderate
50%
Max
50%
User
700
288
47.3
Intensity User
(15)
(30)
(124.19)
Bystander
35
11.4
Low Intensity
10%
Min
10%
User
250
23.9
3.88
User
(2)
(10)
(30.12)
Bystander
2.77
0.89
3892
Table 2-117. Consumer Dermal Exposure to Methylene Chloride During Use as a Sealant
Sceiiiirio Description
Diii'iilion of
Use
(min)
Weight
Inulion
(%)
Receptor
Acute ADR
(ni»/k»/il:iv)
High Intensity User
95%
(60)
Max
(30)
Adult (>21 years)
1.30
Youth (16-20 years)
1.22
Youth (11-15 years)
1.33
Moderate Intensity
User
50%
(15)
Max
(30)
Adult (>21 years)
1.02
Youth (16-20 years)
0.96
Youth (11-15 years)
1.05
Low Intensity User
10%
(2)
Min
(10)
Adult (>21 years)
0.08
Youth (16-20 years)
0.08
Youth (11-15 years)
0.08
3893
3894 2.4.2.4.15 Weld Spatter Protectant
3895 One product used as a weld spatter protectant was found to contain methylene chloride in weight
3896 fractions >90% (Table 2-118). Inhalation exposures were evaluated for users and bystanders for
3897 nine different scenarios of duration of use, weight fraction and mass of use. Three scenarios are
3898 presented below as low intensity user, high intensity user and moderate intensity user scenarios,
3899 with 1-hr maximum TWA concentrations ranging from 181 -5,110 mg/m3 for users and from
3900 16.5 - 648 mg/m3 for bystanders across scenarios. Dermal exposures were evaluated for six
3901 scenarios. Selected scenarios representing low intensity user, moderate intensity user and high
3902 intensity user scenarios ranged from 0.230 - 4.98 mg/kg/day across all evaluated scenarios and
3903 age groups (Table 2-119).
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Table 2-118. Consumer User and Bystander Inhalation Exposure to Methylene Chloride
During Use as a Weld Spatter Protectant
Scenario
Description
Duration
ol-1 se
(mill)
Weight
Traction
(%)
Muss of
I se
(a)
Product
I sor or
Bystander
Peak
Cone.
(m »/nr()
1 lir M:i\
TWA
(m "/m')
S lir Max
TWA
(nig/m4)
Midi
InlonsilA
User
w5"..
(60)
SlIlLik"
Value
(90)
W5"..
(569.43)
l SCI'
6150
511"
X.Vi
Bystander
648
198
Moderate
Intensity
User
50%
(5)
Single
Value
(90)
50%
(84.06)
User
5050
897
136
Bystander
80.7
24
Low
Intensity
User
10%
(0.25)1
Single
Value
(90)
10%
(17.43)
User
4130
181
27.6
Bystander
16.5
4.90
'Low-end durations reported by U.S. EPA (1987) that are less than 0.5 minutes (30 seconds) are modeled as
being equal to 0.5 minutes due to that being the minimum timestep available within the model used.
3904
Table 2-119. Consumer Dermal Exposure to Methylene Chloride During Use as a Weld
Spatter Protectant
Scenario Description
Duration ol'
Use
(mill)
Weight
Traction
(%)
Receptor
Acute ADR
(m "/kg/day)
High Intensity User
95%
(60)
Single Value
(90)
Adult (>21 years)
4.86
Youth (16-20 years)
4.55
Youth (11-15 years)
4.98
Moderate Intensity
User
50%
(5)
Single Value
(90)
Adult (>21 years)
1.96
Youth (16-20 years)
1.83
Youth (11-15 years)
2.01
Low Intensity User
10%
(0.25)1
Single Value
(90)
Adult (>21 years)
0.25
Youth (16-20 years)
0.23
Youth (11-15 years)
0.25
1 Low-end durations reported by U.S. EPA (.1.987) that are less than 0.5 minutes (30 seconds) are modeled as being
equal to 0.5 minutes due to that being the minimum timestep available within the model used.
3905
3906 2.4.2.5 Monitoring Data
3907
3908 2.4.2.5.1 Indoor Residential Air
3909
3910 Concentrations of methylene chloride in the indoor air of residential homes in the U.S. and
3911 Canada from 9 studies identified during Systematic Review are summarized in Table 2-120.
3912 Overall, more than 700 samples were collected between 1986 and 2010 in five U.S. states (CO,
Page 194 of 725
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3913
3914
3915
3916
3917
3918
3919
3920
3921
3922
3923
3924
3925
3926
3927
3928
3929
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
IL, MA, MI, and MN) and Canada (exact location not reported). Concentrations ranged from
non-detect (limits varied) to 1,190 |ig/m3. The highest concentrations were from the Van Winkle
et. al. (2001) study, which notes that the high methylene chloride concentrations are likely
associated with analytical artifacts. Excluding this study, maximum concentrations of 147 and
176 |ig/m3 were observed in garages of residences in Boston, MA (Dodson et al.. 2008) and in
inner city homes in New York, NY (Sax et al.. 2004). respectively. Maximum concentrations
were much lower in other studies, generally less than 15 |ig/m3. Excluding the Van Winkle et. al.
(2001) study, measures of central tendency (reported average or median) across all datasets were
generally less than 10 |ig/m3, except for the Canadian study at 27 |ig/m3.
Data extracted for residential indoor air samples from studies conducted outside of North
America, as well as studies conducted in schools and commercial establishments in the U.S. and
other countries, is provided in Systematic Review Supplemental File: Data Extraction Tables for
Consumer and Environmental Exposure Studies.
Table 2-120. Concentrations of Methylene Chloride in the Indoor Air of Residential Homes
in the U.S. and Canada from Studies Identified During Systematic Review
Diilii
Deled.
I.Mll.
Siuclj lulu
Silo Description
Limit
Min.
M o;i n
Mediiin
M;i\.
\ iiriiinee
Score
(CMn et al, 2014);
Detroit, MI area;
0.71
ND
0.54
0.71
7.85
0.91
High
U.S., 2009-2010
Homes (n=126)
(SD)
(n=126; DFq = 0.06)
with asthmatic
children, sampled
in living rooms and
bedroom
(Dodson et al., 2008):
Boston, MA;
0.39-
ND
9.8
0.3
147
36
High
U.S., 2004-2005
(n=16; DFq = 0.25)
Garage of
residences
1.25
(95th)
(SD)
(Dodson et al., 2008):
Boston, MA;
0.39-
ND
2.6
0.4
15
4.6
High
U.S., 2004-2005
(n=10; DFq = 0.2)
Apartment hallway
of residences
1.25
(95th)
(SD)
(Dodson et al., 2008):
Boston, MA;
0.39-
ND
9.5
0.4
0.66
28
High
U.S., 2004-2005
Basement of
1.25
(95th)
(SD)
(n=52; DFq = 0.42)
residences
(Dodson et al., 2008):
Boston, MA;
0.39-
ND
0.28
0.21
10
8.7
High
U.S., 2004-2005
Interior room of
1.25
(95th)
(SD)
(n=83; DFq = 0.4)
residences
U.S., 2000
(n=113; DFq = 0.202)
Minneapolis, MN
in spring; Child's
primary residence
ND
(0.2
10th)
0.3
1.2
(90th)
Medium
(Adsate et al, 2004):
Minneapolis, MN
ND
0.4
1.3
Medium
U.S., 2000
in winter; Child's
(0.2
(90th)
(n=113; DFq = 0.232)
primary residence.
10th)
(Suxetal., 2004):
U.S., 2000
Los Angeles, CA in
fall; Homes in
0.22
0.2
1.4
1.1
4.3
1.2
(SD)
High
(n=32; DFq = 1)
inner-city
(Suxetal., 2004):
Los Angeles, CA in
0.27
0.27
2.4
1.9
8.7
2
High
U.S., 2000
winter; Homes in
(SD)
(n=40; DFq = 0.95)
inner-city
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Diilii
Deled.
I.Mll.
Siuclj lulu
Silo Description
Limit
Min.
M o;i n
Mediiin
Msi\.
\ ;iri;iiKT
Score
C . •. ¦. J
New York. \Y in
1 <¦'
1 <¦'
lu
1 4
n.
11 lull
U.S., 1999
summer; Homes in
(SD)
(n=30; DFq = 0.28)
inner-city
(Soxetai, 2004):
New York, NY in
0.22
0.2
5.5
2.2
69
12.3
High
U.S., 1999
winter; Homes in
(SD)
(n=36; DFq = 0.97)
inner-city
(Van Winkle and Scheff,
Southeast Chicago,
0.76b
140 b
60.5 b
1190 b
235
High
2001):
IL; Urban homes
(SD)
U.S., 1994-1995
(n=48; DFq = 1)
(n=10) sampled
over a 10-month
period, from the
kitchen in the
breathing zone.
(Lindstrom et al, 1995):
Denver, CO;
0.14
0.14
2.64
1.57
—
2.63
Medium
U.S., 1994 (n=9; DFq =
0.78) Homes, pre-
occupancy (n=8)
(SD)
(Chan et al., 1990):
Homes (n=12),
—
ND
9.1
—
--
—
Medium
Canada, 1986
main floor
(n=12; DFq = 0.92)
(Chan et al, 1990):
Homes (n=6), main
—
4
26.9
—
--
—
Medium
Canada, 1987
floor
(n=6; DFq = 1)
Abbreviations: If a value was not reported, it is shown in this table as ND = not detected at the reported detection limit. GM
= geometric mean. GSD = geometric standard deviation. DFq = detection frequency. NR = Not reported. U.S.
Parameters: All statistics are shown as reported in the study. Some reported statistics may be less than the detection limit; the
method of handling non-detects varied by study. All minimum values determined to be less than the detection limit are shown in
this table as "ND". If a maximum value was not provided, the highest percentile available is shown (as indicated in parentheses);
if a minimum value was not provided, the lowest percentile available is shown (as indicated in parentheses),
a Samples from this study (Dodsom et al. 2008) were collected as part of the BEAMS study.
b Elevated methylene chloride concentrations likely associated with analytical artifact (Van Winkle and Scheff.
2001).
2.4.2.5.2 Personal Breathing Zone Data
Concentrations of methylene chloride in the personal breathing zones of residents in the U.S.
from two studies identified during Systematic Review are summarized in Table 2-121. Overall,
more than 500 personal monitoring samples from 48-hr monitoring periods were collected
between 1999 and 2000 in one U.S. state (MN). Reported concentrations ranged from non-detect
(limits varied) to 13.6 |ig/m3; and central tendency values (reported mean or median) ranged
from 0.3 to 6.7 |ig/m3. The maximum concentration of 13.6 |ig/m3 is a 90th percentile value
based on an overall average of 70 non-smoking adults during spring, summer, and fall sampling
and spending 89% of their time indoors (home, work, school), 6.4% outdoors, and 4.5% in
transit (Sexton et al.. 2007). The second study ("Adgate et al.. 2004) observed personal exposure
to methylene chloride for 80 children while spending 66% of their time at home, 25.2% of their
time at school, 1.5% of their time playing outdoors, and 3.8% of their time in transit during the
spring and winter. There was a 10-fold difference between the maximum values reported in the
two studies.
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Data extracted for residential personal breathing zone samples from studies conducted outside of
North America, as well as studies conducted in schools and commercial establishments in the
U.S. and other countries, is provided in the Supplemental Information on Consumer Exposure
Assessment (EPA. 2019e).
Table 2-121. Concentrations of Methylene Chloride in the Personal Breathing Zones of
Residents in the U.S.
Sludj lulu
Silo Description
Deled,
limit
Min.
Mesin
Mediiin
Msi\.
\ iiriiinee
Diilii
I.Mll.
Score
(Sexton et al.,
U.S.! 1999
(n=333; DFq =
1)
Minneapolis-St. Paul, MN;
Non-smoking adults (n=70);
three neighborhoods : (inner-
city/economically
disadvantaged, blue-
collar/near manufacturing
plants, and affluent); indoors,
outdoors, and in transit.
0.4
(10)
6.7
1.4
13.6
(90th)
High
(Adsate et al,
2004);
U.S., 2000
(n=113; DFq =
0.17)
Minneapolis, MN in spring;
Child's primary residence,
school, outside, and in transit
ND
(0.2
10th)
0.3
1.3
(90th)
Medium
(Adsate et al,
2004);
U.S., 2000
(n=113; DFq =
0.194)
Minneapolis, MN in winter;
Child's primary residence,
school, outside, and in transit.
ND
(0.2
10th)
0.4
1.3
(90th)
Medium
Abbreviations: If a value was not reported, it is shown in this table as ND = not detected at the reported detection limit.
Parameters: All statistics are shown as reported in the study. Some reported statistics may be less than the detection limit; the
method of handling non-detects varied by study. All minimum values determined to be less than the detection limit are shown in
this table as "ND". If a maximum value was not provided, the highest percentile available is shown (as indicated in parentheses);
if a minimum value was not provided, the lowest percentile available is shown (as indicated in parentheses).
2.4.2.6 Modeling Confidence in Consumer Exposure Results
Overall, there is medium to high or high confidence in the consumer inhalation exposure
modeling approach and results (Table 2-122). This is based on the strength of the model
employed, as well as the quality and relevance of the default, user-selected and varied modeling
inputs. CEM 2.1.7 is a peer reviewed, publicly available model that was designed to estimate
inhalation and dermal exposures from household products and articles. CEM uses central-
tendency default values for sensitive inputs such as building and room volumes, interzonal
ventilation rate, and air exchange rates. These parameters were not varied by EPA due to EPA
having greater confidence in the central tendency inputs for such factors that are outside of a
user's control (unlike, e.g., mass of product used or use duration). These central tendency
defaults are sourced from EPA's Exposure Factors Handbook (EPA. 201 la). The confidence in
the user-selected varied inputs (i.e., mass used, use duration, and weight fraction) are medium to
high, depending on the condition of use. The sources of these data are U.S. EPA (1987) (high-
quality) and company-generated SDSs. What reduces confidence for particular conditions of use
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is the relevance or similarity of the U.S. EPA (1987) survey product category for the modeled
condition of use. For instance, the evaluated brake cleaner scenario had surveyed information
directly about this condition of use within U.S. EPA (1987). resulting in a high confidence in
model default values. In contrast, the coil cleaner scenario did not have an exact match within
U.S. EPA (1987). resulting in use of a surrogate scenario selected by professional judgement that
most closely approximates the use amount and duration associated with this condition of use.
Additionally, in some cases, professional judgment or surveyed information from U.S. EPA
(198?) was used in selection of room of use, which sets the volume for modeling zone 1.
Dermal exposure modeling results overall were rated as medium or medium to high confidence
(Table 2-123). The processes and inputs described for the inhalation scenarios above are also
valid for the dermal exposure scenarios. While the model used for dermal exposure estimates
was the same as used for the inhalation exposure estimates, there is overall medium (vs. high for
inhalation) confidence in the model used due to the used dermal submodel. As described in
Section 2.4.2.3.1.2, the evaluation of dermal exposures used a faction absorbed submodel. Due to
this model incorporating evaporation from the skin surface, occluded scenarios may result in
higher than estimated values presented here. Additionally, depending on the absorption and
product usage time of the chemical the model has the ability to under or overestimate dermal
exposures.
Table 2-122. Confidence in Individual Consumer Conditions of Use Inhalation Exposure
Evaluations
Consumer
Condition of
I so
Form
( onlltlence
in Model
I sod1
Confidence
in Model
Deliiull
\ ;ilucs:
('on 111
Miiss
I sell4
lencc in I sc
1 up
I se
Dumlion"
i-Seleeleil
ills'
WeiiilH
1'i'iielion''
;irietl
Room
ol' I se"
(hersill
Confidence
Automotive
AC Leak
Sealer
Aerosol
High
High
Medium
Medium
High
High
Medium to
High
Automotive
AC
Refrigerant
Aerosol
High
High
Medium
Medium
High
High
Medium to
High
Adhesives
Liquid
High
High
High
High
High
Medium
High
Adhesives
Remover
Liquid
High
High
High
High
High
Medium
High
Brake Cleaner
Aerosol
High
High
High
High
High
High
High
Brush Cleaner
Liquid
High
High
Medium
Medium
High
Medium
Medium to
High
Carbon
Remover
Aerosol
High
High
High
High
High
High
High
Carburetor
Cleaner
Aerosol
High
High
High
High
High
High
High
Coil Cleaner
Aerosol
High
High
Medium
Medium
High
High
Medium to
High
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Consumer
Condition of
I so
I'orm
( onlldonoo
in Model
I sod1
( onl'idonoo
in Model
Delimit
\ 'sillies2
('Oil111
Miiss
I sod4
lonco in I si
Inp
I so
Dumlioir
r-Soloc(od
ills'
WoiiilK
I'riKiion''
'siriod
Room
ol' I so"
(horsill
( onlldonoo
Cold Pipe
Insulating
Spray
Aerosol
High
High
Medium
Medium
High
High
Medium to
High
Electronics
Cleaner
Aerosol
High
High
High
High
High
High
High
Engine
Cleaner
Aerosol
High
High
High
High
High
High
High
Gasket
Remover
Aerosol
High
High
High
High
High
High
High
Sealant
Aerosol
High
High
High
High
High
High
High
Weld Spatter
Protectant
Aerosol
High
High
Medium
Medium
High
High
Medium to
High
Confidence in Model Used considers whether model has been peer reviewed and whether model is applied in a
manner appropriate to its design and objective. The model used (CEM 2.1) has been peer reviewed, is publicly
available, and has been applied in a manner intended.
Confidence in Model Default Values considers default value data source(s) such as building and room volumes,
interzonal ventilation rates, and air exchange rates. These default values are all central tendency values (i.e., mean
or median values) sourced from EPA's Exposure Factors Handbook CEP A. 201 la). The one default value with a
high-end input is the overspray fraction, which is used in the aerosol or spray scenarios and assumes a certain
percentage is immediately available for inhalation.
Confidence in User-Selected Varied Inputs considers the quality of their data sources, as well as relevance of the
inputs for the selected consumer condition of use.
'Mass Used is primarily sourced from the U.S. EPA (1987). which received a hieh-aualitv ratine durine data
evaluation and has been applied in previous agency assessments. Automotive AC Leak Sealer mass used was
derived by directions on product.
5Use Duration is Drimarilv sourced from U.S. EPA (1987). which received a hieh-aualitv ratine durine data
evaluation and has been applied in previous agency assessments.
6Weight fraction of methylene chloride in products is sourced from product SDSs, which were not reviewed as part
of systematic review but were taken as authoritative sources on a product's ingredients.
Room of use (zone 1 in modeline) is informed bv responses in U.S. EPA (1987) which received a hieh-aualitv
rating during data evaluation, although professional judgment is also applied for some scenarios.
4005
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Table 2-123. Confidence in individual consumer conditions of use for dermal exposure
evaluations
CoilSlllllCI'
Condition
or i so
lo rm
Confidcncc
in Model
Used1
Confidence
in Model
Deliinll
Values2
(on fidei
V.
Use
Dunilion4
ee in I ser-f
iricd Inpuh
Weigh 1
l"r;ic(ion;
¦ieleeled
Room ol°
I se'1
(hci'iill Confidence
Automotive
AC Leak
Sealer
Aerosol
Medium
High
Medium
High
High
Medium
Automotive
AC
Refrigerant
Aerosol
Medium
High
Medium
High
High
Medium
Adhesives
Liquid
Medium
High
High
High
Medium
Medium to High
Adhesives
Remover
Liquid
Medium
High
High
High
Medium
Medium to High
Brake
Cleaner
Aerosol
Medium
High
High
High
High
Medium to High
Brush
Cleaner
Liquid
Medium
High
Medium
High
Medium
Medium
Carbon
Remover
Aerosol
Medium
High
High
High
High
Medium to High
Carburetor
Cleaner
Aerosol
Medium
High
High
High
High
Medium to High
Coil Cleaner
Aerosol
Medium
High
Medium
High
High
Medium
Cold Pipe
Insulating
Spray
Aerosol
Medium
High
Medium
High
High
Medium
Electronics
Cleaner
Aerosol
Medium
High
High
High
High
Medium to High
Engine
Cleaner
Aerosol
Medium
High
High
High
High
Medium to High
Gasket
Remover
Aerosol
Medium
High
High
High
High
Medium to High
Sealant
Aerosol
Medium
High
High
High
High
Medium to High
Weld Spatter
Protectant
Aerosol
Medium
High
Medium
High
High
Medium
Confidence in Model Used considers whether model has been peer reviewed and whether model is applied in a
manner appropriate to its design and objective. The model used (CEM 2.1) has been peer reviewed, is publicly
available, and has been applied in a manner intended.
Confidence in Model Default Values considers default value data source(s) such as surface area to body weight
ratios for the dermal contact area. These default values are all central tendency values (i.e., mean or median
values) sourced from EPA's Exposure Factors Handbook CEP A, 201 la).
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Table 2-123. Confidence in individual consumer conditions of use for dermal exposure
evaluations
Confidence in User-Selected Varied Inputs considers the quality of their data sources, as well as relevance of the
inputs for the selected consumer condition of use.
4Use Duration is primarily sourced from U.S. EPA (1987). which received a high-quality rating during data
evaluation and has been applied in previous agency assessments.
5Weight fraction of methylene chloride in products is sourced from product SDSs, which were not reviewed as
part of systematic review but were taken as authoritative sources on a product's ingredients.
' Room of use (zone 1 in modeling) is informed by responses in U.S. EPA (1.987) which received a high-quality
rating during data evaluation, although professional judgment is also applied for some scenarios.
4006
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3 HAZARDS
3.1 Environmental Hazards
3.1.1 Approach and Methodology
During scoping and problem formulation, EPA reviewed potential environmental health hazards
associated with methylene chloride. EPA identified the following sources of environmental
hazard data: TSCA Work Plan Chemical Risk Assessment Methylene Chloride: Paint Stripping
Use CASRN 75-09-2 (U.S. EPA. 2014). Dichloromethane: Screening Information DataSet
(SIDS) Initial Assessment Profile (OECD. 2.011). Environmental Health Criteria 164 Methylene
Chloride (WHO. 1996a). Canadian Environmental Protection Act Priority Substances List
Assessment Report: Dichloromethane (Health Can a 3), and Ecological Hazard Literature
Search Results in Methylene Chloride (CASRN 75-09-2) Bibliography: Supplemental File for
the TSCA Scope Document (EPA-HQ-OPPT-2016-0742-0059) (U.S. EPA. 2 ).
EPA completed the review of environmental hazard data/information sources during risk
evaluation using the data quality review evaluation metrics and the rating criteria described in the
Application of Systematic Review in TSCA Risk Evaluations ( 18a). Studies were
assigned an overall quality level of high, medium, or low. The data quality evaluation results are
outlined in Supplemental File: Data Quality Evaluation of Environmental Hazard Studies (EPA.
2Q19r). With the data available, EPA only used studies with an overall quality level of high or
medium for quantitative analysis during data integration. Studies assigned an overall quality
level of low were used qualitatively to characterize the environmental hazards of methylene
chloride. Any study assigned an overall quality level of unacceptable was not used for data
integration.
3.1.2 Hazard Identification
Toxicity to Aquatic Organisms
EPA assigned an overall quality level of high, medium, or low to 14 acceptable studies,
including two studies submitted as "substantial risk" notifications under section 8(e). These
studies contained relevant aquatic toxicity data for amphibians, fish, aquatic invertebrates, and
aquatic plants. EPA identified 11 aquatic toxicity studies, displayed in Table 3-1, as the most
relevant for quantitative assessment. The rationale for selecting these studies is provided in
Section 3.1.3 Weight of Scientific Evidence.
Aquatic Environmental Hazards from Acute Exposures to Methylene Chloride
Amphibians: Seven amphibian species were exposed to methylene chloride for up to five and a
half days in two flow-through studies, which EPA assigned an overall quality level of high
(Black et at.. 1982: Birge et ai. 1980). Birge (1980) exposed embryos and larvae of Anaxyrus
fowleri (Fowler's toad, hatches in 3 days), Lithobatespalustris (pickerel frog, hatches in 4 days),
and Rana catesbeiana (American bullfrog, hatches in 4 days) to methylene chloride through 4
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4064
4065
4066
4067
4068
4069
4070
4071
4072
4073
4074
4075
4076
4077
4078
4079
4080
4081
4082
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days post-hatch. Black (1982) tested Rana temporaria (common European frog, hatches in 5
days), Xenopus laevis (African clawed frog, hatches in 2 days), Lithobatespipiens (leopard frog,
hatches in 5 days), and Ambystoma gracile (Northwestern salamander) through 4 days post-
hatch. The concentration of methylene chloride lethal to half the population (median lethal
concentration, or LCso) of R catesbeiana embryos, exposed for 4 days, was 30.61 mg/L, and for
R. temporaria embryos exposed for 5 days was 23.03 mg/L (Biree et at.. 1980). Definitive LCsos
were not established for embryos of A. fowleri (> 32 mg/L), L. palustris (> 32 mg/L), X laevis (>
29 mg/L), and L. pipiens (> 48 mg/L), which were exposed from 2 to 5 days to the highest
concentrations tested. The embryos of the Northwestern salamander, A. gracile, had an LCso of
23.86 mg/L after 5.5 days of exposure, similar to R temporaria and R. catesbeiana (Black et ai.
1982). However, because the exposure duration was a borderline sub-chronic value, and because
salamanders have a different biology (i.e. gill structure) from the frogs tested, EPA did not
integrate this hazard value with the frog results. The two amphibian studies demonstrate the
variation in amphibian species sensitivity to methylene chloride, with the bullfrog, R
catesbeiana having the greatest sensitivity to the chemical substance. Both study authors
included embryo teratogenesis, which they defined as the percent of survivors with gross and
debilitating abnormalities likely to result in eventual mortality, into the LCso values and adjusted
for controls. EPA integrated the definitive LCso values fori?, temporaria (common European
frog) and R catesbeiana (American bullfrog) into a geometric mean of 26.35 mg/L (Black et at..
1982; Biree et at.. 1980).
Fish: EPA assigned an overall quality level of high to three acute (96-hr; flow-through) fish
toxicity studies, which evaluated the median lethal concentrations (LCsos) of methylene chloride
to Pimephalespromelas (fathead minnow) or Oncorhynchus mykiss (rainbow trout) (Dill et at..
Jj " , ' ' ! >upont Denemours & Co Inc. 1987b; Geigeretal. 1986). EPA assigned one study
that used adult P. promelas obtained from a bait company with an overall quality level of
medium (Alexander et al.. 1978). Dill (1987) noted loss of equilibrium, a sub-lethal effect, in
juvenile P. promelas exposed to methylene chloride at concentrations > 357 mg/L for exposures
from 24 hours to test termination at 196 hours. The 96-hour LCso was 502 mg/L. Alexander
(J_078) established an LCso of 193 mg/L for adult P. promelas exposed to methylene chloride for
96 hours. The authors also reported an ECso of 99 mg/L for immobilization in fathead minnows
exposed to methylene chloride. The authors defined immobilization as fish with loss of
equilibrium, melanization, narcosis, and swollen, hemorrhaging gills. E I Dupont Denemours &
Co Inc (1987b) established a 96-hour LCso of 108 mg/L in O. mykiss. The authors observed
rainbow trout exposed to methylene chloride concentrations >39 mg/L swimming at the surface,
swimming erratically, and/or exhibiting melanization. The 96-hr LCsos from the high and
medium quality-level studies ranged from 108 mg/L to 502 mg/L. EPA integrated the acute 96-
hour LCso values for hazard evaluation into a geometric mean of 242.41 mg/L.
Aquatic Invertebrates: For freshwater aquatic invertebrates, EPA assigned two studies with
Daphnia magna (water flea) acute (48-hr ECso; static) exposures to methylene chloride with an
overall quality level of high Q \ Oupont Denemours & Co Inc. 1987a; Lebtamc lCj80). EPA
assigned one study on J). magna an overall quality level of medium (Abernethy et al.. 1986). and
one study an overall quality level of low (Kufan et al.. 1989). The ECso values for the studies that
EPA assigned medium or high overall quality levels ranged from 135.81 mg/L to 177 mg/L for
48-hour exposures to methylene chloride. LeBlanc (1980) established a 48-hour LCso of 176
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mg/L. For aquatic invertebrates, ECsos and LCsos are calculated using the same methodologies
and integrated together, because mortality is difficult to distinguish from immobilization. EPA
integrated these hazard values into a geometric mean of 179.98 mg/L. LeBlanc (1980) also
established a no observed effect concentration (NOEC) for mortality in D. magna exposed to
methylene chloride concentrations of 54.4 mg/L for 48 hrs. This NOEC value is used to contrast
with the ECsos and LC50S as the concentration at which methylene chloride is not expected to
have an effect on aquatic invertebrates on an acute exposure basis.
EPA assigned one saltwater invertebrate (Palaemonetespugio, daggerblade grass shrimp) study
an overall quality level of high (Wilson. 1998). however, the authors did not provide a test
substance source or substance purity information. The authors reported up to a three-day
developmental delay for saltwater shrimp embryos exposed to 0.1 % v/v of methylene chloride
for 96-hrs, and complete developmental arrest for embryo and larvae exposed to > 0.5 % v/v for
96-hrs. However, the test concentrations were reported in percent volume to volume (% v/v), and
EPA could not accurately convert these values to weight per volume (mg/L) without making an
assumption about the test substance purity. Because the study could not be compared to other
data (i.e. freshwater invertebrates), it had lower relevance and, therefore, was not integrated into
the risk evaluation.
There were no aquatic sediment studies available for methylene chloride; however, EPA was
able to use a surrogate species to estimate toxicity. EPA considered using data on sediment
species from analogous chemicals, but no appropriate analogue with appropriate data was
identified for methylene chloride. Instead, because sediment organisms are expected be exposed
to freely dissolved methylene chloride in the surface water or pore water, daphnids were used as
a surrogate species for estimating hazard in sediment invertebrates.
Aquatic Environmental Hazards from Subchronic and Chronic Exposures to Methylene
Chloride
Amphibians: There were no chronic studies that encompassed amphibian metamorphoses and
adult reproductive stages of the amphibian life-cycle. However, in the available, acceptable
studies, amphibian embryo and larvae were the most sensitive life stages to subchronic exposures
to methylene chloride in the aquatic environment. In the two studies by Birge (1980) and Black
( 2) that EPA assigned an overall quality level of high, the authors continued exposures of
embryos and larvae of seven amphibian species (A. fowleri, R catesbeiana, L. palustris, R.
temporaria, X. laevis, L. pipiens, and A. gracile) to methylene chloride for an additional 4 days
post-hatch under flow-through conditions. The study authors included teratogenic embryos and
larvae in mortality calculations to establish a 10% impairment value (LC10) and LC50 fori?.
catesbeiana (Birge et at.. 1980) and R temporaria (Black et ai. 1982) exposed for 8 days and 9
days to methylene chloride, respectively. At control-adjusted concentrations, the LC10 fori?.
catesbeiana was 0.98 mg/L, and the LC10 fori?, temporaria was 0.82 mg/L. The control-adjusted
LC50 fori?, catesbeiana embryo and larvae exposed for 8 days was 17.78 mg/L, and fori?.
temporaria embryo and larvae exposed for 9 days was 16.93 mg/L. Impairment values and
definitive LC50S were not established for embryos of A. fowleri, L. palustris, X. laevis, and L.
pipiens exposed for 6 to 9 days to the highest concentrations tested, because these species were
considerably more tolerant to exposures to methylene chloride. The authors determined a 9.5-day
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LCso of 17.82 mg/L for A. gracile, which is similar to the bullfrog and common frog hazard
values, but because salamanders have a different biology from frogs, EPA did not integrate the
data for A. gracile. A LC10 was not established for this species. EPA integrated the bullfrog and
common European frog LCios into a geometric mean of 0.9 mg/L, and their LC50S into a
geometric mean of 17.35 mg/L.
Fish: In fish, there were two studies with chronic exposure aquatic toxicity data, an 0. mykiss
(rainbow trout) study with embryos and larvae exposed to methylene chloride under flow-
through conditions for up to 27 days (Black et al. 1982). and a study with P. promelas embryos
and larvae exposed for 32 days (Dill et al.. 1987). Both authors also had sub-chronic toxicity
values fori5, promelas (fathead minnow). After 9 days of exposure to methylene chloride, the
minnow embryo and larvae (which hatched on day 4 of exposures) in the Black (1982) study had
LC50S > 34 mg/L, the highest concentration tested. In the chronic test with 0. mykiss by Black
(1982). the LC50 for rainbow trout embryos exposed up to hatching at 23 days was 13.5 1 mg/L,
and the LC50 for larvae exposed up to four days post-hatch at 27 days was 13.16 mg/L. EPA
integrated the trout data into a geometric mean of 13.33 mg/L. The Black (1982) study also
indicated that there were no effects on survival of 0. mykiss larvae exposed to methylene
chloride at concentrations of 0.008 mg/L with survival decreasing to 85% at 0.41 mg/L, and 44%
at 23.1 mg/L. The authors did not establish that the decreased survival at 0.41 mg/L was
statistically significant. The authors noted teratic larvae were observed at exposure
concentrations of 5.55 mg/L or greater. EPA considered the concentration of 0.41 mg/L as the
NOEC for this study, and the 5.55 mg/L as the lowest observed effect concentration (LOEC),
and integrated these values into a geometric mean chronic toxicity value (ChV) for fish of 1.51
mg/L. P. promelas juveniles exposed for 8-days in the Dill (1987) sub-chronic study had and
LC50 of 471 mg/L. In the Dill (1987) 32-day study, there was statistically significant reduction in
larval survival at the two highest concentrations tested, 209 and 321 mg/L, with 100% mortality
within 96-hours post-hatch at 321 mg/L, which EPA interpreted as the 8-day LC100 value fori5.
promelas embryos and larvae. The studies suggest that fathead minnow embryo and larvae are
more sensitive to methylene chloride exposures than juveniles. The 32-day no observed effect
concentration (NOEC) for mortality was 142 mg/L, and the lowest observed effect concentration
(LOEC) for mortality was 209 mg/L. EPA integrated the 32-day NOEC and LOEC for mortality
into a geometric mean, or maximum acceptable toxicant concentration (MATC) of 172.3 mg/L.
Dill (1987) established a NOEC of 82.5 mg/L and a LOEC of 142 mg/L for loss of body weight
in P. promelas exposed to methylene chloride, and a MATC of 108 mg/L from the geometric
mean of the NOEC and LOEC.
Aquatic Invertebrates: There were no acceptable chronic exposure aquatic invertebrate studies,
so EPA applied the acute-to-chronic ratio (ACR) of 10 to the D. magna (water flea) acute
EC50/LC50 integrated geometric mean of 179.98 mg/L to estimate the freshwater aquatic
invertebrate chronic exposure toxicity value of 18 mg/L( ipont Denemours & Co Inc.
1987a; Abernethy et al.. 1986; Leblar )). In the absence of chronic exposure duration
studies for aquatic invertebrates, EPA also used ECOSAR v.2.0, the Agency's application for
estimating environmental hazards from industrial chemicals. ECOSAR classified methylene
chloride as a neutral organic, with a freshwater aquatic invertebrate ChV of 12 mg/L. ECOSAR
also estimated a saltwater mysid ChV of 41.8 mg/L, which also falls within range of the aquatic
invertebrate hazard value. The ECOSAR predicted ChVs support the freshwater invertebrate
chronic hazard value of 29.04 mg/L.
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Aquatic Plants (Algae): For aquatic plants hazard studies, algae are the common test species.
Algae are cellular organisms which will cycle through several generations in hours to days,
therefore the data for algae was assessed together regardless of duration (i.e., 48-hrs to 96-hrs).
For algae, there were two studies (under static conditions) that EPA assigned an overall quality
level of high, a 72-hr exposure biomass inhibition in the green algae species Chlamydomonas
reinhardtii (Brack and Rottler. 1994) and a 96-hr biomass inhibition (characterized by the
authors as "the net production of algal cell density") study with the green algae
Pseudokirchneriella subcapitata (Tsai and Chen. 2007). The 96-hr EC 50 fori5, subcapitata
biomass inhibition was 33.09 mg/L, while the 72-hr EC50 for C. reinhardtii, was 242 mg/L. The
hazard value for C. reinhardtii is nearly an order of magnitude higher than the 96-hr EC50 fori5.
subcapitata. While it is likely the hazard value for C. reinhardtii would have decreased had the
study been extended to 96-hrs, the 72-hr EC 10 of 115 mg/L for 10% biomass inhibition in C.
reinhardtii established by Brack (1994) is higher than the 96-hr EC50 fori5, subcapitata. The
studies suggest thati5. subcapitata, a static algal species that is an obligate phototroph, is more
sensitive to methylene chloride exposures relative to C. reinhardtii, a motile algal species with
two flagella that is a facultative heterotroph. In addition to the functional differences between the
two algal species, the study durations vary by 24 hours, in which time multiple generations of
algal cells would be produced. Therefore, the two hazard values were not integrated, and EPA
used the 96-hour EC50 of 33.09 mg/L for the more sensitive species, P. subcapitata, as the more
protective value to represent hazards to green algae as a whole.
In one study that EPA assigned an overall quality level of medium, growth was measured via
relative chlorophyll a absorbance in three green algae species, C. vulgaris, P. subcapitata, and
Volvulina steinii exposed to methylene chloride under static conditions for 10 days (Ando et at..
2003). The study did not have critical details, such as analytical measurement of test
concentrations, chemical substance source or purity, or an EC50 calculated from the relative
absorbance results; therefore, it was not integrated into the environmental hazard calculation, but
is used here qualitatively. Chlorophyll a is a pigment in the cells of algae that is an indirect
indicator of growth. There was no significant change in the relative absorbance of chlorophyll a
for C. vulgaris or P. subcapitata up to the highest nominal concentration tested, 2 mg/L.
However, methylene chloride killed V. steinii, a flagellar algae, at the lowest nominal
concentration tested, 0.002 mg/L. The authors attributed the variation in algal species sensitivity
to methylene chloride to V. steinii's high metabolism. The study supports the need for
assessment factors to establish the hazard values to account for more sensitive species.
Table 3-1. Ecological Hazard Characterization of Methylene Chloride for Aquatic
Organisms
Dui'iilion
Tesl
or^iiiiism
Kmlpoini
(l"ivsh\\;ilor)
Ihi/iinl
MllllC'S
(mji/l.)
(ii'oiiK'li'ic
M oil n1
(inii/l.)
IHTecl l.ndpoiiK
( iliilion (l)iilii l.\;ilu;i(ion
Kiilinur
Acute
Amphibian
4 to 5-day
LC50
(frog
embryos &
larvae)
23.03 ->
48
26.35
Teratogenesis
Leading to
Mortality
(Birge et al. 1980) (Hiuli):
(Black et al. 1982) (High)
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Diii'iilion
Tesl
oi'^iiiiism
Kmlpoini
(l"ivsli\\;i(i'r)
Ihi/iinl
MllllC'S
(inii/l.)
(ii'oiiK'li'ic
M oil n1
(111^/1.)
l-llTccl l.ndpoinl
( iliilion (l)iilii l.\;ilu;i(ion
Rnliniir
5.5-day
LC50
(salamander
embryos &
larvae)
23.86
Teratogenesis
Leading to
Mortality
(Black et a.L 1982) (Hi ah)
96-hour
EC50
(adults)
99
Immobilization3
(Alexander et al.. 1978)
(Medium)
Fish
96-hour
LC50
(juveniles
and adults)
108 - 502
242.41
Mortality
(Alexander et al. 1978)
(Medium); (Dill et al. 1987)
(Hish); (Geieeret al. 1986)
(High); (EI Dupont Denemours
& Co Inc. 1987b) (Hish)
(Abernetlw et al, 1986)
Aquatic
48-hour
EC50/LC50
135.81 -
177
179.98
Immobilization
(Medium); ( 00nt
Denemours & Co Inc. 1987a)
Invertebrate
and Mortality
(Hish); (Leblanc. 1980) (Hish);
48-hr NOEC
54.4
(Lebtane. .1.980) (High)
Amphibian
8 to 9-day
LC10
LC50
(frog
embryos &
larvae)
0.822-
0.981
16.93 ->
48
0.9
17.35
Teratogenesis
Leading to
Mortality
(Black et al. .1.982) (Hish);
(Birge et al. .1.980) (Hish)
9.5-day
LC50
(salamander
embryos &
larvae)
17.82
Teratogenesis
Leading to
Mortality
(Black et al. .1.982) (Hish)
Subchronic
/Chronic
8-day
LC50
(juveniles)
LC100
(embryos &
larvae)
471
321
Mortality
(Dill et al. .1.987) (Hish)
Fish
9-day
LC50
(embryo &
larvae)
>34
Teratogenesis
Leading to
Mortality
(Black et al. 1982) (Hish)
23 to 27-day
LC50
(embryo &
larvae)
13.16-
13.51
13.33
Teratogenesis
Leading to
Mortality
(Black et al. .1.982) (Hish)
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Diii'iilion
Tesl
oi'^iiiiism
Kmlpoini
(l"ivsli\\;i(i'r)
Ihi/iinl
MllllC'S
(inii/l.)
(ii'oiiK'li'ic
M oil n1
(111^/1.)
l-llTccl l.ndpoinl
( iliilion (l)iilii l.\;ilu;i(ion
Killing
23 to 27-day
NOEC
LOEC
(embryo &
larvae)
0.41
5.55
1.51
Teratogenesis
(Black et aL 1982) (Hiah)
32-day
NOEC
LOEC
(embryo &
larvae)
142
209
172.3
(MATC)
Mortality
(Dill et aL. 1987) (Hish)
82.5
142
108
Growth (Body
Weight)
Aquatic
invertebrate
48-hrs4
EC50/LC50
184
Immobilization
and Mortality
(Abernethv et al.. 1986)
(Medium); ( oont
Denemours & Co Inc. 1987a)
(High); (Leblanc. .1.980) (High)
Algae
72-hour EC50
96-hour EC50
242
33.09
Biomass
(Tsai and Chen. 20071 (High);
(Brack and Rottler, .1.994) (High)
EC10
115
Biomass
(Brack: and Rattier. .1.994) (Hish)
1 Geometric mean of definitive values only (i.e., > 48 mg/L was not used in the calculation).
2 While the hazard values are presented in ranges, the citations represent all of the data included in the range
presented.
3 Immobilization was reported by Alexander (1978) as loss of equilibrium, melanization, narcosis and swollen,
hemorrhaging gills.
4 EPA applied the ACR of 10 to the geometric mean of the integrated acute duration aquatic invertebrate studies.
3.1.3 Weight of Scientific Evidence
During the data integration stage of systematic review EPA analyzed, synthesized, and integrated
the data/information into Table 3-1. This involved weighing scientific evidence for quality and
relevance, using a weight-of-scientific-evidence approach, as defined in 40 CFR 702.33, and
noted in TSCA 26(i) ( ,018a).
During data evaluation, EPA assigned studies an overall quality level of high, medium, or low
based on the TSCA criteria described in the Application of Systematic Review in TSCA Risk
Evaluations ( ). While integrating environmental hazard data for methylene
chloride, EPA gave more weight to relevant data/information that were assigned an overall
quality level of high or medium. Only data/information that EPA assigned an overall quality
level of high or medium was used for the environmental risk assessment. Data that EPA assigned
an overall quality level of medium or low was used to provide qualitative characterization of the
effects of methylene chloride exposures in aquatic organisms. Any information that EPA
assigned an overall quality of unacceptable was not used. EPA determined that data and
information were relevant based on whether it had biological, physical/chemical, and
environmental relevance ( ):
• Biological relevance: correspondence among the taxa, life stages, and processes
measured or observed and the assessment endpoint.
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• Physical/chemical relevance: correspondence between the chemical or physical agent
tested and the chemical or physical agent constituting the stressor of concern.
• Environmental relevance: correspondence between test conditions and conditions in the
environment (EPA. 1998).
EPA used this weight-of-evidence approach to assess hazard data and develop COCs. Given the
available data, EPA only used studies assigned an overall quality level of high or medium to
derive COCs for each taxonomic group. To calculate COCs, EPA derived geometric means for
each trophic level that had comparable toxicity values (e.g., multiple ECsos measuring the same
or comparable effects from various species within a trophic level). EPA did not use non-
definitive toxicity values (e.g., ECso > 48 mg/L) to derive geometric means because these
concentrations of methylene chloride were not high enough to establish an effect on the test
organism.
To assess aquatic toxicity from acute exposures, data for three taxonomic groups were available:
amphibians, fish, and aquatic invertebrates. For each taxonomic group, adequate data were
available to calculate geometric means as shown in Table 3-1. The geometric mean of the LCsos
for amphibians, 26.35 mg/L, represented the most sensitive toxicity value derived from each of
the three taxonomic groups, and this value was used to derive an acute COC as described in
Section 3.1.4. This value is from two studies that EPA assigned an overall quality of high and
represents two species of amphibians. The geometric mean of ECsos/LCsos for aquatic
invertebrates, 179.98 mg/L, was used to derive an acute COC to use as a surrogate species
hazard value for sediment aquatic organisms. This geometric mean is from three studies that
EPA assigned an overall quality level of medium and high and represents one aquatic
invertebrate species.
To assess aquatic toxicity from chronic exposures, data for two taxonomic groups were described
in the acceptable literature: fish, and aquatic invertebrates. Because the most sensitive taxonomic
group from the acute data, amphibians, was not represented in the available chronic data, EPA
considered the acute hazard geometric mean of the LCios for amphibians for teratogenicity
leading to mortality to estimate chronic hazard values for amphibians. When comparing these
values to the other chronic data from fish and aquatic invertebrates, amphibians were again the
most sensitive taxonomic group. Therefore, the amphibian ChV of 0.9 mg/L was used to derive a
chronic COC in Section 3.1.4. This value was from two studies that EPA assigned an overall
quality level of high and represents two species of amphibians. For comparison, EPA calculated
a ChV for fish of 1.51 mg/L for teratogenesis from a study that EPA assigned an overall quality
level of high, representing one species.
To assess the toxicity of methylene chloride to algae, data for two species were available from
studies that EPA assigned an overall quality level of high. ECsos measuring biomass inhibition
ranged from 33.09 mg/L to 242 mg/L, and an ECio of 115 mg/L was also reported. The exposure
durations for the two tests differed by 24 hours, and the two algal species were functionally
different, so EPA used the EC so for biomass inhibition from the more sensitive species to
represent algae as a whole. This value, 33.09 mg/L, from one high quality algae study
representing one species, was used to derive an algae COC in Section 3.1.4.
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Based on the estimated bioconcentration factor and bioaccumulation potential described in
Section 2.1, methylene chloride does not bioaccumulate in biological organisms. Therefore, EPA
did not assess hazards to aquatic species from trophic transfer and bioconcentration or
accumulation of methylene chloride.
3.1.4 Concentrations of Concern (COC)
EPA calculated the COCs for aquatic species based on the environmental hazard data for
methylene chloride, using EPA methods (EPA. 2013b. 2012b). While there was data
representing amphibians, fish, aquatic invertebrates, and aquatic plants, the data were not robust
enough to conduct a more detailed species sensitivity distribution analysis. Therefore, EPA chose
to establish COC as protective cut-off standards above which acute or chronic exposures to
methylene chloride are expected to cause effects for each taxonomic group in the aquatic
environment. The COC is typically based on the most sensitive species or the species with the
lowest toxicity value reported in that environment. For methylene chloride, EPA derived an
acute and a chronic COC for amphibians, which represent the most sensitive taxonomic group to
methylene chloride exposure. Because other chronic toxicity data were relatively close to the
amphibian data, EPA also calculated a chronic COC for fish, and a chronic COC for aquatic
invertebrates for comparison. An algal COC was also calculated. Algae was assessed separately
and not incorporated into acute or chronic COCs, because durations normally considered acute
for other species (e.g., 48, 72 hrs) can encompass several generations of algae.
After weighing the scientific evidence and selecting the appropriate toxicity values from the
integrated data to calculate acute, subchronic/chronic, and algal COCs, EPA applied an
assessment factor (AF) according to EPA methods (EPA. 2013b. 2012b). when possible. The
application of AFs provides a lower bound effect level that would likely encompass more
sensitive species not specifically represented by the available experimental data. AFs can also
account for differences in inter- and intra-species variability, as well as laboratory-to-field
variability. These AFs are dependent on the availability of datasets that can be used to
characterize relative sensitivities across multiple species within a given taxa or species group.
However, they are often standardized in risk assessments conducted under TSCA, since the data
available for most industrial chemicals are limited. For fish and aquatic invertebrates (e.g.,
daphnia) the acute COC values are divided by an AF of 5. EPA does not have a standardized AF
for amphibians. For amphibians, there may be more uncertainty in the subchronic studies,
necessitating a more protective AF of 10. For chronic COCs, an AF of 10 is used. The COC for
the aquatic plant endpoint is determined based on the lowest value in the dataset and application
of an AF of 10 (EPA. 2013b. 2012b).
After applying AFs, EPA converts COC units from mg/L to |ig/L (or ppb) in order to more easily
compare COCs to surface water concentrations during risk characterization.
Acute COC
To derive an acute COC for methylene chloride, EPA used the geometric mean of the LCsos for
amphibians, which is the most sensitive acute value for aquatic species from the data integrated
for methylene chloride, from two studies EPA assigned overall quality levels of high (Black et
at.. 1982; Birge et at.. 1980). The geometric mean of 26.35 mg/L was divided by the AF of 10
for amphibians and multiplied by 1,000 to convert from mg/L to |ig/L, or ppb.
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The acute COC = (26.35 mg/L) / AF of 10 = 2.63 mg/L x 1,000 = 2,630 |ig/L or ppb.
• The acute COC for methylene chloride is 2,630 ppb.
EPA used aquatic invertebrate hazard values as surrogate species to address hazards to sediment
invertebrates. EPA derived an acute COC from the geometric mean of the ECsos and LCsos from
two Daphnia magna studies that EPA assigned an overall quality level of high (E I Dupont
Denemours & Co Inc. 1987a; Leblanc. 1980). and one study that EPA gave an overall quality
levels of medium ("Abernethy et at.. 1986). The geometric mean of 179.98 mg/L, rounded to 180
mg/L, was divided by the AF of 5 and multiplied by 1,000 to convert from mg/L to |ig/L, or ppb.
The acute aquatic invertebrate COC = (180 mg/L) / AF of 5 = 36 mg/L x 1,000 = 36,000 |ig/L or
ppb.
• The acute aquatic invertebrate COC for methylene chloride is 36,000 ppb.
Chronic COC
EPA derived the amphibian chronic COC from the lowest chronic toxicity value from the
integrated data, the amphibian geometric mean of LCio for developmental effects and mortality
in common frogs and American bullfrogs in two studies EPA assigned overall quality levels of
high (Black et ai. 1982; Birge et a )). The LCio was then divided by an assessment factor
of 10, and then multiplied by 1,000 to convert from mg/L to |ig/L, or ppb.
The chronic COC = (0.9 mg/L) / AF of 10 = 0.09 mg/L x 1,000 = 90 |ig/L or ppb.
• The amphibian chronic COC for methylene chloride is 90 ppb.
EPA also derived a chronic COC for fish and aquatic invertebrates for comparison to the
amphibian chronic data. The fish chronic COC was derived from the most sensitive chronic
toxicity value from the integrated data, the ChV measuring teratogenesis in rainbow trout from a
study that EPA assigned a quality level of high ( ck et at.. 1982). The ChV was then divided
by an assessment factor of 10, and then multiplied by 1,000 to convert from mg/L to |ig/L, or
ppb.
The chronic COC = (1.51 mg/L) / AF of 10 = 0.151 mg/L x 1,000 = 151 |ig/L or ppb.
• The fish chronic COC for methylene chloride is 151 ppb.
To derive a chronic COC for aquatic invertebrates, EPA used the toxicity value derived from the
integrated acute toxicity data, the geometric mean of 179.98 mg/L, calculated from data on the
freshwater invertebrate species, Daphnia magna. EPA applied the acute-to-chronic ratio of 10,
resulting in a chronic aquatic invertebrate ChV of 17.99 mg/L, rounded to 18 mg/L. This ChV
was then divided by an AF of 10 and multiplied by 1,000 to convert mg/L to |ig/L, or ppb.
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The chronic COC for aquatic invertebrates = (18 mg/L) / AF of 10 = 1.8 mg/L x 1,000 = 1,800
|ig/L or ppb.
• The aquatic invertebrate chronic COC for methylene chloride is 1,800 ppb.
Algal COC
The algal COC was derived from the hazard value for the static algae Pseudokirchneriella
subcapitata from one study that EPA assigned an overall quality level of high (Tsai and Chen.
2007). This algal species was selected as the more sensitive species from the available data to
represent algal species as a whole. The 96-hour ECso for biomass inhibition of 33.09 mg/L was
divided by an assessment factor of 10, and then multiplied by 1,000 to convert from mg/L to
|ig/L, or ppb.
The algal COC = (33.09 mg/L) / AF of 10 = 3.31 mg/L x 1000 = 3,310 |ig/L or ppb.
• The algal COC is 3,310 ppb.
3.1.5 Summary of Environmental Hazard
EPA concludes that acute exposures to methylene chloride present hazards for amphibians, with
toxicity values ranging from 23.03 to > 48 mg/L, integrated into a geometric mean of 26.35
mg/L from the definitive hazard values for two frog species (based on teratogenesis leading to
lethality in embryos and larvae). Acute exposures to methylene chloride also present hazards for
fish, with an immobilization hazard value of 99 mg/L in adult fish. Juvenile and adult fish
mortality hazard values from acute exposures ranged from 108 to 502 mg/L, and EPA integrated
these values into a geometric mean of 242.41 mg/L. For freshwater aquatic invertebrates, acute
exposure hazard values for immobilization and mortality ranged from 135.81 mg/L to 177 mg/L,
integrated into a geometric mean of 179.98 mg/L.
For chronic exposures, methylene chloride presents a hazard to amphibians, with toxicity values
ranging from 0.82 to > 48 mg/L. The lowest chronic hazard values for amphibians, 0.82 mg/L
and 0.98 mg/L, for teratogenesis and lethality in embryos and larvae of two frog species,
integrated into a geometric mean of 0.9 mg/L. For chronic exposures, methylene chloride also
presents a risk to fish, with hazard values ranging from 0.41 to 209 mg/L for teratogenesis,
teratogenesis leading to mortality, mortality, and growth inhibition. EPA assessed aNOEC and
LOEC of 0.41 mg/L and 5.55 mg/L, respectively, for fish larvae mortality in one study, and
integrated these hazard values into a geometric mean of 1.5 mg/L. There were no chronic
duration hazard data for aquatic invertebrates, so EPA applied the acute-to-chronic ratio of 10 to
the acute exposure aquatic invertebrate hazard value of 179.98 mg/L, resulting in a chronic
exposure hazard value (rounded) for aquatic invertebrates of 18 mg/L. For algae, hazard values
for exposures to methylene chloride from two algal species were 33.09 mg/L and 242 mg/L. The
hazard value for the more sensitive green algae species, 33.09 mg/L, is used to represent algal
species as a whole.
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Concentrations of Concern (COC):
The acute and chronic COCs derived for aquatic organisms are summarized in Table 3-2. EPA
calculated the acute COC for methylene chloride exposures in amphibians as 2,630 ppb, based
on the geometric mean of LCsos for amphibians from two studies that EPA assigned an overall
quality level of high (Black et al.. 1982; Btree et al. 1980). EPA also calculated an acute aquatic
invertebrate COC of 36,000 ppb, to address sediment invertebrate hazards. EPA calculated the
chronic COC for methylene chloride in amphibians as 90 ppb, based on the chronic toxicity
value derived from the geometric mean of the LCio.
For comparison with other trophic levels, EPA calculated a fish chronic COC of 151 ppb, based
on a geometric mean of a NOEC and LOEC from a study measuring teratogenesis in rainbow
trout that EPA assigned a quality level of high (Black et al.. 1982). EPA also calculated an
aquatic invertebrate chronic COC for methylene chloride of 1,800 ppb, based on the geometric
mean of ECsos and LCsos from aquatic invertebrate studies that EPA assigned overall quality
levels of medium and high. As noted previously, algal hazard values from exposures to
methylene chloride, for durations ranging from 48 hrs to 96 hrs, are considered separately from
other aquatic species, because algae can cycle through several generations in this time frame.
The algal COC of 3,310 ppb is based on the lowest ECso value for one study that EPA assigned
overall quality levels of high.
Table 3-2. COCs for Environmental Toxicity
Knvironinenlal Aquatic
Toxicity
Hazard Value
)
Assessment
l-actor
COC
(u«/l. or pph)
Toxicity to Amphibians from
Acute Exposures
26,300
10
2,630
Toxicity to Aquatic Invertebrates
from Acute Exposures
179,980
5
36,000
Toxicity to Amphibians from
Chronic Exposures
900
10
90
Toxicity to Fish from Chronic
Exposures
1,510
10
151
Toxicity to Aquatic Invertebrates
from Chronic Exposures
18,000
10
1,800
Algal Toxicity
33,100
10
3,310
3.2 Human Health Hazards
3.2.1 Approach and Methodology
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EPA used the approach described in Figure 3-1 to evaluate, extract and integrate methylene
chloride's human health hazard and dose-response information. This approach is based on the
Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2018a) and the
Framework for Human Health Risk Assessment to Inform Decision Making (EPA. 2014a).
Data
Summaries for
Adverse
Endpoints
(Supplemental
Human Health
Document)
Risk Characterization
Data
Extraction
Extract data from
key. supporting
and new studies
Human Health Hazard Assessment
Data Evaluation
After full-text screening,
apply pre-determined data
quality evaluation criteria
to assess the confidence of
key and supporting studies
identified from previous
assessments as well as
new studies not
considered in the previous
assessments
• Uncertainty and variability
• Data quality
• PESS
• Alternative interpretations
Risk Characterization
Analysis
Determine the qualitative
and/or quantitative human
health risks and include, as
appropriate, a discussion of:
Data Integration
Integrate hazard information by considering quality (i.e.,
strengths, limitations), consistency, relevancy, coherence and
biological plausibility
Hazard ED
Confirm potential
hazards identified
during
scoping/problem
formulation and
identify new hazards
from new literature (if
applicable)
Dose-Response
Analysis
Benchmark dose
modeling for
endpoints with
adequate data;
Selection of PODs
Systematic
Review
Stage
Output of
Systematic
Review
Stage
WOE
Narrative by
Adverse
Endpoint
(Section 3.2.4)
Summary of
Results and
PODs
(Section 3.2.5)
Risk Estimates
and
Uncertainties
(Section 4.2)
Figure 3-1. EPA Approach to Hazard Identification, Data Integration, and Dose-Response
Analysis for Methylene Chloride
Specifically, EPA reviewed key and supporting information from previous hazard assessments as
well as the existing body of knowledge on methylene chloride's human health hazards, which
includes information published after these hazard assessments. The previous hazard assessments
consulted by EPA include the following:
• Spacecraft Maximum Allowable Concentrations (SMAC) for Selected Airborne
Contaminants: Methylene chloride (Volume 2) published by the U.S. National Academies
(Nrc. 1996);
• OSHA Final Rides, Occupational Exposure to Methylene Chloride by the Occupational
Health and Safety Administration (OSHA. 1997a);
• Toxicological Profile for Methylene Chloride by the Agency for Toxic Substances
Disease Registry (ATSDR 2000);
• Interim Acute Exposure Guideline Levels (AEGLs) for Methylene Chloride developed by
the U.S. NAC on AEGLs (Nrc. 2008);
• Acute Reference Exposure Level (REL) and Toxicity Summary for Methylene Chloride
published by the California Office of Environmental Health Hazard Assessment (Oehha.
2008a);
• Toxicological Review of Methylene Chloride published in 2011 by EPA's IRIS (U.S.
EPA. 2011); and
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• TSCA Work Plan Risk Assessment, Methylene Chloride: Paint Stripping Use (
2014).
The health hazards of methylene chloride previously identified in these reviews were described
and reviewed in this draft risk evaluation, including: acute toxicity, neurotoxicity, liver toxicity,
immunotoxicity, reproductive/ developmental toxicity, irritation/burns and
genotoxicity/carcinogenicity. EPA relied heavily on the aforementioned existing reviews along
with scientific support from the Office of Research and Development (ORD) in preparing this
draft risk evaluation. Development of the methylene chloride hazard and dose-response
assessments considered EPA and NRC risk assessment guidance.
In addition to primary literature cited in these previous assessments, EPA also conducted a
search of newer literature to obtain information on all health domains. This process is outlined in
Section 1.5. For human health hazard data, peer reviewed studies published from January 1, 2008
through March 2, 2017 were obtained. EPA also searched gray literature; studies submitted
under certain sections of TSCA may have older dates (e.g., 1970s) but were still considered if
they were not referenced in previous assessments.
The new literature was screened against inclusion criteria in the PECO statement. Relevant
animal studies (i.e., potentially useful for dose-response) were further evaluated for data quality
using criteria for animal studies described in Application of Systematic Review in TSCA Risk
Evaluations (U.S. EPA. 2018a). Epidemiological studies were evaluated using Risk Evaluation
for Methylene Chloride (DCM) Systematic Review Supplemental File: Updates to the Data
Quality Criteria for Epidemiological Studies (EPA. 2019a). Because the key and supporting
studies were considered in previous assessments to be studies useful and relevant for hazard
identification, EPA skipped the screening step of the key and supporting studies and entered
them directly into the data evaluation step based on their relevance to the risk evaluation.
For methylene chloride, the chosen key and supporting studies were initially identified as those
used as the basis of acute values (California REL, SMAC, AEGLs and ATSDR minimum risk
levels (MRLs)) and those from the IRIS assessment considered for the derivation of the
inhalation reference concentration (RfC) and oral reference dose (RfD) as well as the suite of
animal cancer bioassays that evaluated liver and lung tumors in addition to other tumor types that
match those evaluated in recent epidemiology studies. In some cases, EPA expanded this list of
studies reviewed to support the hazard assessment for a particular endpoint. For example, EPA
evaluated the quality of all epidemiological studies that examined cancer endpoints to determine
differences in quality and to understand patterns among the study results. Section 3.2.3 describes
what was evaluated for data quality for each of the health domains.
EPA has not yet developed data quality criteria for all types of hazard information. For example,
data quality criteria have not been developed for toxicokinetics and many types of mechanistic
data that EPA typically uses for qualitative support when synthesizing evidence. Despite the lack
of formal criteria, for methylene chloride, EPA qualitatively evaluated and summarized data
(e.g., from human controlled experiments) if they were considered for the dose-response analysis
or to determine their utility in supporting the risk evaluation.
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Following the data quality evaluation, EPA extracted the toxicological information from each
acceptable study into summary tables that include the endpoints considered for this assessment,
the no-observed- or lowest-observed-adverse-effect levels (NOAEL and LOAEL) for non-cancer
health endpoints by target organ/system, the incidence for cancer endpoints, and the overall data
quality evaluation ratings. The key/supporting studies and the newly identified studies found
through searching recent literature are identified. Risk Evaluation for Methylene Chloride,
Systematic Review Supplemental File: Data Extraction of Human Health Hazard Studies (EPA.
2019o) presents these tables.
Section 3.2.3 (Hazard Identification) discusses the body of studies for relevant health domains.
EPA considered studies of low, medium or high confidence for hazard identification and focused
on the following health domains considered relevant for methylene chloride: acute toxicity,
neurotoxicity, liver toxicity, immunotoxicity, reproductive/ developmental toxicity, irritation and
genotoxicity/carcinogenicity. Information from studies that were rated unacceptable were only
discussed on a case-by-case basis for hazard identification and weight of scientific evidence
assessment but were not considered for dose-response analysis. In some cases, additional studies
not evaluated were also described within the hazard identification section as described in the
health domain specific sections.
The weight of scientific evidence analysis (Section 3.2.4) included integrating information from
toxicokinetic and toxicodynamic studies for the health domains described in Section 3.2.3. In
particular, data integration considered consistency among the data, data quality, biological
plausibility and relevance (although this was also considered during data screening). For each
health domain, EPA determined whether the body of scientific evidence was adequate to
consider the domain for dose-response modeling.
As presented in Section 3.2.5. (Dose-Response Assessment), data for the health domains with
adequate evidence were modeled to determine the dose-response relationships (Appendix I and
U.S. EPA (20j9h)6). For the relevant health domains, EPA considered points of departure (POD)
from studies that were PECO relevant, scored acceptable in the data quality evaluation and
contained adequate dose-response information. For methylene chloride, studies used for dose-
response modeling received high or medium quality ratings from the following health domains:
acute toxicity (based on neurotoxicity), non-cancer liver toxicity and
genotoxi city/carcinogeni city.
The POD is used as the starting point for subsequent dose-response (or concentration-response)
extrapolations and analyses. PODs can be a NOAEL, a LOAEL for an observed incidence, or
change in level of response, or the lower confidence limit on the benchmark dose (BMD)7. The
BMD analysis is discussed in Appendix I and the Risk Evaluation for Methylene Chloride,
Supplemental File - Methylene Chloride Benchmark Dose and PBPK Modeling Report (EPA.
2019h). PODs were adjusted as appropriate to conform to the specific exposure scenarios
evaluated (see Sections 3.2.5 and 4.2).
6 Risk Evaluation for Methylene Chloride - Methylene Chloride Benchmark Dose and PBPK Modeling Report
(EPA. 20.1.91i)
H
The BMD is a dose or concentration that produces a predetermined change in response range or rate of an adverse
effect (called the benchmark response or BMR) compared to baseline.
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Inhalation acute human controlled experimental data and inhalation repeat-dose toxicity studies
in animals were available for methylene chloride and were considered for dose-response
assessment. No acceptable toxicological data are available by the dermal route. Furthermore,
dermal absorption data and physiologically-based pharmacokinetic/pharmacodynamic
(PBPK/PD) models that would facilitate route-to-route extrapolation to the dermal route have not
been identified for methylene chloride. Therefore, inhalation PODs were extrapolated for use via
the dermal route using models that incorporate volatilization, penetration and absorption as
described in both Sections 2.4.2.3.1 and Risk Evaluation for Methylene Chloride
(Dichloromethane, DCM) CASRN: 75-09-2, Supplemental Information on Releases and
Occupational Exposure Assessment(EP A. 2019b). EPA considered studies conducted via the
inhalation route for this extrapolation for two primary reasons. First, these studies are already
being used to calculate risks from inhalation in the current risk evaluation. Second, for cancer,
the toxic moieties are metabolites of methylene chloride and both the inhalation and dermal
routes are similar due to the fact that neither route includes a first pass through the liver (and
subsequent metabolism) before entering the general circulation whereas first pass metabolism is
important for the oral route. The PODs estimated based on effects in adult animals were
converted to Human Equivalent Concentrations (HECs) for inhalation studies and Human
Equivalent Doses (HEDs) when converting to the dermal route using species-specific PBPK
models.
3.2.2 Toxicokinetics
Methylene chloride is quickly absorbed through inhalation exposure in humans and animals
(ATSDR. 2000). Pulmonary uptake ranges between 40 and 60 percent (Andersen et ai. 1991;
Gamberale et at.. 1975) and Stewart (1976). but may be up to 70 percent during the first minutes
of exposure (Riley et at.. 1966). In humans, uptake decreases as exposure duration and
concentration increase (Peterson. 1978) and (Stewart et at.. 1976). A steady-state absorption rate
is generally achieved within 2 hrs for exposures up to 200 ppm in humans (Divincenzo and
Kaplan. 1981; Divincenzo et at.. 1972).
Methylene chloride is rapidly distributed throughout the body, including the liver, brain and
subcutaneous adipose tissue, as identified in animal studies (U.S. EPA. 2011; ATSDR. 2000;
C art s son, an d Hut ten eren.. 1975). The plasma half-life is estimated to be 40 minutes after
inhalation exposure by human subjects ( DR. 2000; Divincenzo et at.. 1972.). Metabolism
occurs predominantly in the liver, with additional transformation in the lungs and kidneys
(ATSDR. 2000).
In the liver, two primary pathways are involved in the metabolism of methylene chloride. The
cytochrome P450 (CYP450) mixed function oxidase (MFO) pathway produces CO and C02, and
saturation occurs at a few hundred ppm after inhalation exposure. The second pathway operates
via glutathione S-transferase (GST); individuals with the theta 1 isozyme (GSTT1) metabolize
methylene chloride to form formaldehyde and formic acid. In animals, saturation occurs at
>10,000 ppm after inhalation exposure. Figure 3-2 outlines the biotransformation pathways for
methylene chloride.
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The CYP450 MFO pathway appears similar among species although mice have exhibited
bronchiolar club cell damage (Nac/Aegl. 2.008). Overall, mice have higher GSTT1 activity in
hepatocytes compared with rats or humans. Among humans, the percent of GSTT1 +/+
individuals is 32%, whereas GSTT 1 +/- is 48% and GSTT1 -/- is 20% (Haber et ai. 2002).
Acute toxic effects (i.e., central nervous system (CNS) depression) may persist for hours after
cessation of exposure because of continued metabolism of methylene chloride released from
tissue storage ("ATSDR. 2000). Carboxyhemoglobin (COHb) levels resulting from methylene
chloride's metabolism to CO can continue to increase and can reach peak levels 5 to 6 hrs after
exposure (ATSDR. 2000).
Unmetabolized methylene chloride is eliminated primarily through the lungs. Urine and feces
also contain small quantities of unchanged methylene chloride (ATSDR. 2000). At low doses, a
large percent of methylene chloride is transformed into COHb and eliminated as CO. At higher
doses, more of the unchanged parent compound is exhaled (ATSDR. 2000).
Methylene chloride has been detected in human breast milk (Pellizzari et at.. 1982); thus, infants
may be exposed to methylene chloride through maternal exposures.
Blood concentrations of methylene chloride were lower than the detection level in 2,878
individuals who participated in the recent National Health and Nutrition Examination Survey
(NHANES) based on subsamples of the U.S. population taken from the years 2009 and 2010
(CDC. 2019). Methylene chloride was found in the urine of workers employed at a
pharmaceutical factory during a four-hour work-shift but was nearly eliminated during the
overnight period after exposure occurred (Hsdfa. ).
Pisoiiii
~ OCHCI -
fanny! cWbride
*r CO
€35
1
1 ' "¦ ¦, ! I >
CHjP + CiSH
G5-CHO
Ki I,
1
1
I
CO2
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Figure 3-2. Biotransformation Scheme of Methylene Chloride (modified after Gargas et al.,
1986).
Source: NAC/AEGL (2008)
3.2.3 Hazard Identification
The methylene chloride database includes epidemiological studies, animal studies and in vitro
studies. The epidemiological studies examined associations between methylene chloride
exposure limited liver effects (changes in bilirubin), immune system effects, neurodevelopmental
effects, reproductive/developmental effects, and several types of cancer. Certain characteristics
of the evaluation of methylene chloride epidemiology studies are discussed throughout this
section. Experimental animal studies of methylene chloride consist of studies that evaluated
CNS, liver, immune system, reproductive/developmental effects and cancer. The following
sections also describe several in vitro and some animal studies that evaluated biochemical and
other endpoints used to consider the evidence related to modes of action.
EPA considered many of the studies as informative and useful for characterizing the health
hazards associated with exposure to methylene chloride. EPA extracted the results of key and
supporting studies from previous assessments and studies identified in the updated literature
search into tables included in Risk Evaluation for Methylene Chloride, Systematic Review
Supplemental File: Data Extraction of Human Health Hazard Studies (EPA... 2019o). Several
sections within Section 3.2.3 contain tables of data for given health domains.
Supplemental files contain data evaluations of these studies, including study strengths and
limitations:
• Risk Evaluation for Methylene Chloride, Systematic Review Supplemental File: Data
Quality Evaluation of Human Health Hazard Studies - Epidemiological Studies (EPA.
20198^:
• Risk Evaluation for Methylene Chloride, Systematic Review Supplemental File: Data
Quality Evaluation of Human Health Hazard Studies - Human Controlled Experiments
(EPA. 2019ft: and
• Risk Evaluation for Methylene Chloride, Systematic Review Supplemental File: Data
Quality Evaluation of Human Health Hazard Studies - Animal Studies (R1 \, .-.Ob.1!1)
The weight of scientific evidence section (3.2.4) identifies any study evaluation concerns that
may have meaningfully influenced the reliability or interpretation of the results. Studies
considered for dose-response assessment are discussed in Section 3.2.5.1.
3.2.3.1 Non-Cancer Hazards
EPA reviewed relevant available data as presented in supplemental materials (EPA. 2019s. t, u)
and based on systematic approaches described in Sections 1.5 and 3.2.1. The following sections
present descriptions of these studies. EPA identified six adverse health effect domains from the
scientific literature: effects from acute/short-term exposure, liver effects, immune system effects,
nervous system effects, reproductive/developmental effects and irritation/burns.
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3.2.3.1.1 Toxicity from Acute/Short-Term Exposure
Because EPA didn't develop formal data evaluation criteria for human acute controlled
experiments, EPA evaluated these studies in a qualitative manner. This section presents results of
animal studies but most were not evaluated for data quality because EPA relied on the human
controlled experiments for dose-response and risk estimation and used a single study (Putz et al..
1979) for dose-response. Previous peer-reviewed assessments discuss many of the animal
studies, and they are considered acceptable for supporting the weight of scientific evidence for
acute endpoints. Several case reports in humans are also describe here but were also not
evaluated for quality.
Humans
The brain is most often affected from exposures to high levels of methylene chloride. Effects on
lung, liver or kidney have also been reported in humans as primary signs of methylene chloride
toxicity (Nac/Aegl. 2008). In some cases, high COHb levels (i.e., up to 40 percent) are also
observed (Nac/Aegl. 2008).
Acute lethality in humans following inhalation exposure relates to CNS depressant effects. These
effects include loss of consciousness and respiratory depression resulting in irreversible coma,
hypoxia and eventual death (Nac/Aegl. 2008). At exposure to high concentrations in which death
occurs within a relatively short time, the formation of CO is unlikely to result in life-threatening
levels of COHb (Nac/Aegl. 2008). A few cases exhibited cardiotoxic effects; one fatality was
reported to be due to myocardial infarction {i.e., heart attack) without any signs of reported CNS
depression, but others have not been reported (Nac/Aegl. 2008). However, underlying heart
disease may lead to dysrhythmia and contribute to the cause of death (Macisaac et al.. 2013).
NIOSH lists a value of 2300 ppm (7981 mg/m3) as immediately dangerous to life or health
(1DLH) (NIOSH. 1994). Individuals should not be exposed to methylene chloride at this level for
any length of time. The IDLH is based on acute inhalation toxicity data in humans. The AEGL-3
values for death range from 12,000 ppm (42,000 mg/m3) to 2100 ppm (7400 mg/m3) for 10-min
to 8-hr time periods, respectively. The AEGL-3 value is based on mortality from CNS effects in
rats and COHb formation in humans (Nac/Aegl. 2008). Appendix J describes several case reports
of fatalities associated with over-exposure to methylene chloride.
Similar to lethality cases, acute non-lethal effects in humans are also most frequently described
as CNS-related (Nac/Aegl. 2008). A few case reports of cardiotoxic effects {i.e., evidenced by
electrocardiogram [ECG] changes) were reported in humans but at concentrations higher than
those associated with CNS effects ( HI; AT SDR. 2000). However, other symptoms
have also been reported after acute methylene chloride exposures. For example, Preisser et al.
(2011) reported chest tightness, nausea and irritation along with nervous system effects in cases
of methylene chloride intoxication.
Several of the acute human experimental studies resulting in CNS-related effects form the basis
of acute exposure values such as the Spacecraft Maximum Allowable Concentration for Selected
Airborne Contaminant (SMAC) CNrc. 1996). Acute Exposure Guideline Levels 1 and 2 (AEGLs)
(Nac/Aegl. 2.008) and the California Reference Exposure Level (REL) (Oehha. 2008a). EPA
qualitatively reviewed these studies and other studies identified through backwards searching.
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See Risk Evaluation Methylene Chloride, Systematic Review Supplemental File: Data Quality
Evaluation of Human Health Hazard Studies - Human Controlled Experiments ( 3190 for
details regarding these reviews.
Table 3-3 outline the studies that evaluated neurobehavioral effects.8 Putz et al. (1979) exposed
12 individuals to 195 ppm methylene chloride (measured) and separately to 70 ppm CO, each for
four hours; both exposures were designed to result in a COHb level of 5%. In a dual task,
participants manipulated a lever to position a beam in the center of an oscilloscope as the eye-
hand coordination portion of the task and also monitored peripheral stimuli visually for presence
of an increase in light intensity of signal as the visual peripheral component. At the one and one-
half hour time point, methylene chloride resulted in a 7% decrease in the visual peripheral
portion of the dual task. At the end of the four-hour exposure, methylene chloride exposure
resulted in a 36 percent decrease in eye-hand coordination, whereas CO resulted in a 23 percent
decrease versus controls. For the visual peripheral component of the dual task, methylene
chloride resulted in a 17 percent decline at 4 hours, while CO resulted in an 11 percent
decrement. Both chemicals resulted in similar decrements (~ 16-20 percent) in the auditory
evaluation. The authors conclude that the tasks resulted in a decrease in speed and precision of
psychomotor performance, which in turn, is hypothesized to indicate a temporary decrease in
CNS activation. They also note that effects were observed usually only when the task was
difficult or demanding (Putz et al. 1979). The study used a double-blind design but use of a
single exposure concentration resulted in a medium confidence rating.
Stewart et al. (1972) evaluated three subjects and reported changes in visual evoked responses
(VER) after a one-hour exposure to 514 ppm. All effects returned to control levels soon after
exposure ceased. COHb levels increased in these subjects as well. These types of VER changes
have been observed to accompany initial phases of CNS depression (Stewart et al.. 1972.).
Stewart (1972.) also reported symptoms of lightheadedness (two of three volunteers) and
difficulty enunciating words (one of three volunteers). Although the more objective measures
from this study such as VER are of higher quality (with a medium confidence rating), EPA has
low confidence in the symptom reports because it is not known whether subjects and
investigators were blinded to the subjects' exposure status.
Winneke (1974) showed similar effects as Putz et al. (1979). Subjects (ranging from 8 to 18
individuals) were exposed to 300, 500 or 800 ppm methylene chloride. Additional subjects were
exposed to 50 or 100 ppm CO. At 800 ppm for four hours, methylene chloride resulted in
decreases in all psychomotor performance measures except one, and a majority of the measures
(10 of 14) were statistically significantly different from controls (p < 0.05 or < 0.01). Methylene
chloride also resulted in decrements in a visual task (flicker fusion performance) at > 300 ppm,
with marked depression at 800 ppm (p < 0.05 or < 0.01). Auditory tasks also showed changes (p
< 0.05) in several of the experiments, including at 300 ppm. However, visual and auditory effects
weren't consistent; for example, another experiment within this publication did not result in
effects at 300 or 500 ppm. The authors concluded that this impaired performance was a sign of
CNS-depression due to methylene chloride exposure. In contrast, no changes were observed after
four hours of CO exposure (Winneke. 1974). Overall, EPA gave this study a medium confidence
8 Several additional studies that linked methylene chloride exposure with COHb levels were also used in setting the
SMAC.
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rating based on multiple exposure concentrations but use of a single blind method that was not
well described.
Another study (Gamberale et at.. 1975) used an inhalation method with 14 males that included a
breathing valve rather than a chamber to generate methylene chloride concentrations in air.
Gamberale (1975) did not identify significant decreases in tests of reaction time (two simple tests
of responding to stimuli, and a third test of adding numbers) or a short-term memory test. These
tests used a repeated-measure design (exposure to 250, 500, 750 or 1000 ppm methylene chloride
consecutively for 30 minutes each, starting with the lowest exposure and successively moving to
the highest with no breaks in exposure). Each test was administered within each of the 30-minute
time periods. The subjects' exhibited differences in perception of their own condition when all
measures were taken together (p < 0.005); the authors noted this to be a subjectively favorable
change. Heart rate was slightly lower with methylene chloride but not statistically significantly
different from controls. Other measures were not statistically significantly different from controls
except for the simple reaction time test number one in exposure period number four. The authors
provided very few details on the method of methylene chloride generation, and they did not
measure methylene chloride levels in the breathing valve in inspiratory air. Also, it is not known
how the addition of menthol used to disguise the odor of methylene chloride may have affected
the results. Thus, EPA gave the study a low confidence rating.
DiVincenzo et al. (1972) evaluated cerebral and motor functions of males exposed to 100 or 200
ppm methylene chloride for two or four hours. The authors evaluated the time it took to insert
wooden pegs in a pegboard while simultaneously performing an arithmetic task. However, the
authors provided only a brief statement that no changes were observed in the pegboard exercise
or in subjective measures (also not defined). The authors did not report on results of the
arithmetic task. Based on lack of information regarding results as well as whether negative
controls were used, EPA gave this study a low confidence rating. Also, blinding was not
mentioned, further resulting in low confidence regarding any subjective measures.
Kozena et al. (1990) examined sixteen healthy male volunteers exposed to methylene chloride
for 1 hour using a double-blind experiment. Methylene chloride concentrations increased in
geometrical steps (five minutes each except for the last exposure, which was 10 minutes) from
zero to 720 ppm. The authors evaluated reactions to weak auditory stimuli and subjective
feelings (including sleepiness, fatigue, mood changes) before, during and after exposure and
found no differences from controls. Based on lack of details regarding exposure generation and
confusing information regarding use of half masks, EPA gave this study a low confidence rating.
Winneke and Fodor (1976) performed two experiments. In the first experiment, females exposed
to methylene chloride in an exposure chamber conducted tasks that included adding numbers and
letter cancelling (not further described), which were then interrupted to determine performance
on critical flicker frequency (CFF). The authors report a methylene chloride-induced depression
of CFF (p of 0.005). Winneke (1974) also apparently described the second experiment so it is not
described here again. EPA gave this study a low data quality rating because details were limited
regarding the outcome assessment methodology and the outcomes regarding adding of numbers.
The CNS depressant effects in the human experimental studies show the dose-response curve of
increasing concentration and duration of exposure with more severe effects, including death, may
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be steep. Nerve conduction and more severe motor impairment effects observed in human studies
occur in exposures ranging from 195 ppm for one and one half hours to 800 ppm for four hours
(see Table 3 3). Such exposures may lead to increased accidents at work. Benignus et al. (2.011)
predicted that accidents (specifically fatal car accidents) resulting from neurobehavioral changes
associated with solvent exposure may increase at a concentration of less than 1 ppm. The more
severe disabling effects in the Acute Exposure Guideline Level set for disability (AEGL-2) are
predicted to occur in this same concentration range of 60 ppm for an eight-hour exposure up to
1700 ppm for a 10-min exposure (Nac/Aegl. 2008). The estimated or measured concentrations
associated with human fatalities include the same concentration range 64 - 1711 ppm and higher
concentrations. Exposures to higher concentrations for short durations have also resulted in
human fatalities for example multiple persons were found dead after two and one half hours
exposure and one person was found dead 20 to 30 minutes after being seen alive (Macisaac et al..
2013; Nac/Aegl. 2008). Appendix J presents additional details regarding fatalities associated
with methylene chloride exposure. Given uncertainty regarding concentrations and exposure
durations that may lead to severe effects and death from inhalation of methylene chloride and the
potential for a steep dose-response leading to death as suggested by these case reports and the
analysis by Benignus et al. (2011). EPA considers Putz et al. (1979) to be the most relevant study
for this risk evaluation.
Although endpoints other than CNS effects have been reported in humans (such as effects on
liver, lungs or heart), they are reported in lethal or non-lethal case reports of accidents from
exposures at high or suspected high exposures and may have involved other chemical exposures
(Nac/Aegl. 2008). Furthermore, methylene chloride concentrations are most often highest in the
brain after acute lethal concentrations (Nac/Aegl. 2008).
Animals
Neurological evaluations in animals during and after acute inhalation exposure to methylene
chloride have resulted in CNS depressant effects that include decreased motor activity, impaired
memory and changes in responses to sensory stimuli ( 011). Several acute and short-
term studies identified changes in spontaneous activity in rodents. Wein stein (1972.) and Heppel
and Neal (1944) reported decreased spontaneous activity in rodents after exposure to 5000 ppm
for up to sven or 10 days, respectively. Clinical signs along with decreased activity reported by
Wein stein (1972) suggested CNS depression. Another study (Kiel! strand et al.. 1985) found that
mice exhibited an initial increase in activity, and then decreased activity, after acute exposure >
600 to 2500 ppm. Repert (1989) identified visual and somatosensory responses in an acute study
at concentrations up to 15,000 ppm that collectively suggested CNS depressive effects. Alexeef
and Kilgore (1983) identified a decrease in the ability of mice to learn a passive-avoidance
conditioning task during acute exposure (~ 47,000 ppm). Savolainen (1981) identified increased
preening by rats exposed to 500 ppm for six days. Dow (1988) found changes observed on an
electroencephalogram (EEG) and effects on somatosensory evoked responses after acute
exposure by rats to > 2000 ppm methylene chloride.
Bornschein et al. (1980). reported increased general activity and delayed rates of habituation to a
novel environment in rats exposed to 4500 ppm before (about 21 days) and/or during gestation
(to day 17). Neurological endpoints have not been measured in other animal reproductive or
developmental studies of methylene chloride.
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Effects other than those related to the nervous system have also been reported in animals after
acute exposure. Evidence of a localized immunosuppressive effect in the lung resulting from
inhalation of methylene chloride exposure was observed in CD-I mice acutely exposed to 100
ppm for three hours (Aranyi etal... 1986). Shell Oil (1986) compared effects in rats and mice at
2000 and 4000 ppm after one or 10 days of exposure. Mice exhibited changes in liver weights
and rats showed increased numbers of eosinophils in centrilobular cells (both concentrations) and
increased incidence of mitotic figures (highest concentration) but no changes in liver weights
(Shell Oil. 1986). Mice exhibited lung effects (on club cells) in this study at one day but not after
10 days (Shell Oil. 1986).
Sections on liver effects (Section 3.2.3.1.2), nervous system effects (Section 3.2.3.1.4) and
immune system effects (Section 3.2.3.1.3) describe studies considered for modes of action for
these endpoints.
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4881 Table 3-3. Human Controlled Inhalation Experiments Measuring Effects on the Nervous System
Suhji-ils
( i>ihviiInilimi
s
Dumliiiii
l!ii(l|)iiiiiis (;ind liiiu-piiinis)
iiu'iisuml
COIII) \iilik-
KI'IWlS (ll)SlTM-(l
Ki-li-mui-
Qll;ilil;iliw- d;il;i
(|ii;ilil\
i-\ :¦ 1 n:i 1 ii ill
6 males/6 females,
18-40 yrs,
nonsmokers,
good vision,
no prior solvent exposure
[subjects served as their
own controls],
Double blind design
(n = 12)
0, 195 ppma
(measured)
4 hrs = three
80-min
blocks,
8-9 min rest
btwn blocks
1) Dual task:
Eye-hand coordination/ visual
peripheral (4x, before/through
exposure, ending at 4 hrs)
2) Auditory vigilance
(3x, early during and through
exposure period)
5.1% post-
exposure
After 4 hrs:
1) 36% j hand/eye; 17%j visual
peripheral (p < 0.01)
2) -17%) b| auditory vigilance
(p<0.01)
After 1.5 hrs:
1) 7% I visual peripheral (p <
0.01)
Putz (1979)
Medium; double-
blinded, single
concentration
11 males,
23-43 yrs,
nonsmokers
[pre-exposure values for
each subject served as
controls]
Experiment 2 e
(n=3):
986 ppm
(measured)
2 hrs
1) Symptoms (1 hr pre-
exposure; throughout exposure)
2) Visual evoked response
(VER) (lx before, 2x during
exposure and at 1 hr post-
exposure)
3) Hematology/clinical
chemistry/urinary urobilinogen
(pre-exposure; up to 24 hrs post
exposure)
10.1% @
1 hr post-
exposure;
3.9% @ 17hrs
1) Mild lightheadedness (2
subjects); difficult enunciation (1
subject)c
2) VER - Alterations in all 3
subjects d
Experiment 3
(n=3):
mean = 691
ppm;
(514 ppm 1st hr;
868 ppm 2nd hr)
vapor
(measured)
2 hrs
1) Symptoms (1 hr pre-
exposure; throughout exposure)
2) VER (lx before, 2x during
exposure and ~ 1 hr post-
exposure)
3) Hematology/clinical
chemistry/urinary urobilinogen
(pre-exposure; up to 24 hrs post
exposure)
8.5% @2.5
hrs post-
exposure b
1) Lightheadedness (1 subject;
2nd hr)
2) VER - alterations (3 subjects)
3) No changes
Stewart (1972)
Medium for
VER; Low for
symptoms due to
lack of blinding
Experiment 4:
(n=8):
515 ppm
1 hr
1) Symptoms (1 hr pre-
exposure; throughout exposure)
2) Hematology/clinical
chemistry {presumably pre-
exposure; up to 24 hrs post
exposure)
3.4% @
1 hr post-
exposure
1) None identified
2) No t in RBC (red blood cell)
destruction
Females
[unclear whether subjects
served as their own
controls],
Experiment 1
g,h
(n=8):
0, 500 ppm
3.8 hrs
1) Auditory vigilance (4x
during exposure)
2) Visual critical flicker fusion
(CFF)
1) Auditory: omission errors (p <
0.05)
2) Visual CFF: Not stat. sig
(ANOVA1 for both)
Winneke, (1.974)
Medium; single
blinded
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Suhji-ils
( i>ihviiInilimi
s
Dumliiiii
l!ii(l|)iiiiiis (;ind liiiu-piiinis)
IlK'ilSlllvd
COIII) \iilik-
KI'IWlS (ll)SlTM-(l
Ki-li-mui-
Qlllllihlliw d;il;i
(|ll;ilil\
i-\ :¦ 1 n:il ion
authors conclude that the
study was single-blinded
based on lack of odor
(expect at 800 ppm)
Experiment 2
(n = 6):
0, 300, 800
ppm
3.8 hrs
1) Auditory vigilance (4\
during exposure)
2) Visual CFF (lx before; 4x
during exposure)
1) Auditor}': omission errors (p <
0.05)
2) Visual CFF (p < 0.05)
(ANOVA for both)
Experiment 3
(n = 6):
0, 300, 500
ppm
3.8 hrs
1) Auditory vigilance (4x
during exposure)
2) Visual CFF (lxbefore; 4x
during exposure)
1) Auditory: not stat. sig.
2) Visual CFF: not stat. sig.
(ANOVA for both)
Experiment 2 +
3
(n = 12):
0, 300 ppm
3.8 hrs
1) Auditory vigilance (4x
during exposure)
2) Visual CFF (lxbefore; 4x
during exposure)
1) Auditory: omission errors (p <
0.05)
2) Visual CFF (p< 0.01)
(ANOVA for both)
Experiment 4 a
(n = 18):
0, 800 ppm
4 hrs
1) Auditory vigilance (2x
during exposure)
2) Visual CFF (lxbefore; 3x
during exposure)
2) Comprehensive battery of 14
psychomotor tests f (near end of
exposure)
1) Auditory: reaction time
(p < 0.05; ANOVA)
2) Visual CFF: not stat. sig.
3) 10 tests I (5 @p < 0.01; 5 @ p
< 0.05); Steadiness (1 test),
Eland precision (2 right hand
tests), pursuit tracking (single test)
not stat. sig. (paired t-values)
Males,
20-30 yrs, identified as
healthy
(n = 14)
0, 250, 500,
750, 1000 ppm
2 hrs
(30 min each
to increasing
concentration
without a
break in
exposure)
1) Subjective perceptions
2) Reaction time (RT) -
addition
3) Simple reaction test 1
4) Short-term memory
5) Simple reaction test
(Each test conducted during
each exposure concentration
and for controls)
-5%
1) Perceptions - individual
measures not statistically
significant; as a whole, changes
were observed (p < 0.005),
although authors described this as
subjectively positive
3) Simple RT 1 - changes only at
the highest concentration (p <
0.05)
2, 4 and 5) RT addition, Short-
term memory, simple RT 2 - no
stat. sig. changes
Gamberale et al.
(1.975)
Low - use of
breathing valve
with limited
details and no
analytical
monitoring;
Impact of using
menthol not
known
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Suhji-ils
( i>ihviiInilimi
s
Dumliiiii
l!ii(l|)iiiiiis (;ind liiiu-piiinis)
IlK'ilSlllvd
COIII) \iilik-
KI'IWlS (ll)SlTM-(l
Ki-li-mui-
Qll.ilihiliw- d;il;i
(|ll;ilil\
i-\ :¦ 1 n:il ion
Males, 28 to 60 yrs,
inclusion required medical
approval
100, 200 ppm
(n=ll)
2 and 4 hrs
1) l'egboard activity - time
required to place pegs in proper
holes (for 2 hr: at beginning, 1
hr and lhr/40 min; for 4 hr:
added time at 2 and 3 hrs; 5
trials at each timepoint),
2) Subjective measures
(continuous surveillance)
1) No changes (details not
provided)
2) No changes (details not
provided)
DiVincenzo et
al. (1972)
Low - lack of
detail regarding
results and use of
controls
Males, 19-21 yrs, healthy,
paid volunteers,
double-blind design
0 (n = 42)
Increasing cone
to approximate
144 ppm
(w/peak of 720
ppm at end of
exposure)
(n = 16)
1 hr
1) weak auditory stimuli (5 to
25 sec during 1 hr, repeated 3x
- before, during and after
exposure)
2) Subjective measures
(sleepiness, fatigue, changes in
mood)
NA
1) No changes
2) No changes
Kozena et al.
(1990)
Low - lack of
information on
exposures
Females, 22-31 yrs,
single-blind design not
well described
[subjects served as their
own controls]
0, 500 ppm
(n = 12, groups
of 3)
2 hrs 20 min
1) alternating task of adding
numbers and letter cancelling
2) Visual CFF (4 x during
exposure)
NA
1) No changes
2) Visual CFF (p of 0.005)
Winneke and
Fodor (1976)
Low - limited
details on
outcome method
and results
¦"Hematology measured in one study
a CO also evaluated but not included in table
b Estimated from graph
c Individuals were inadvertently exposed to methylene chloride before exposure, resulting in breath levels of 10 ppm and higher (graph is exponential and difficult to read above 10); this
didn't appreciably alter COHb levels.
d Information on statistical significance not presented.
e Experiment 1 measured COHb in one individual after 213 ppm vapor exposure for 1 hour; a value of 2.4% @ 3 hrs post-exposure was observed
f Tapping (hand movements without eye-hand coordination- 1 test); two plate tapping (arm movements: some eye-hand coordination - 1 test); steadiness (hand/arm - 2 tests); hand precision
(6 total tests - 3 for each hand); pursuit tracking (visual-motor control of large muscle groups - 1 test); reaction speed (visual/gross motor reaction - 3 tests)
B There was an experiment 0 (pilot study) - 0, 500 ppm (n = 12) - results of visual CFF show a decrement (p < 0.01); auditory vigilance and other un-named tasks were not s.s.
11 The authors state that the measured values are 317 ppm, 470 ppm and 751 ppm; those values are not included in the table because it is not clear whether they represent averages across
experiments or are specific to one of the experiments.
1ANOVA = analysis of variance
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3.2.3.1.2 Liver Effects
A limited number of human studies and multiple animal studies have identified liver effects associated
with methylene chloride exposure. EPA focused on evaluating human epidemiological studies as well as
chronic inhalation studies in animals. Other animal studies discussed in previous peer-reviewed
assessments are considered acceptable for supporting the weight of scientific evidence.
Humans
Few epidemiological studies evaluated non-cancer liver effects, and limited evidence was identified in
studies that measured relevant endpoints. Three acceptable epidemiological studies measured bilirubin
and serum enzyme concentrations in workers exposed to methylene chloride (Soden. 1993; General
Electric Co. 1990; Ott et al. 1983b).9 Two of these studies found some evidence of increasing levels of
serum bilirubin with increasing exposure but no consistent trends for other serum hepatic enzyme levels
(y-glutamyl transferase, aspartate amino transferase (AST) and alanine transaminase (ALT)) (General
Electric Co. 1990; Ott et al.. 1983b). Data quality ratings are medium (2.2), medium (1.9) and medium
(2.2) for Soden (1993). General Electric Co (1990) and Ott (1983b). respectively. Although increased
bilirubin is of concern, EPA did not consider this to be an endpoint appropriate for considering in the
current risk evaluation because these data don't provide clear evidence of adverse liver effects.
In the updated literature search, EPA identified only one additional study that evaluated any liver
effects. Silver et al. (2014) reported no increase in standardized mortality ratios (SMR) for cirrhosis and
other chronic liver diseases in a cohort of microelectronics and business machine workers exposed to
multiple solvents, metals, glycol ethers and other chemicals. Individuals were exposed for an average of
5.2 to 9.8 yrs. depending on sex and whether they were salaried or hourly from 1969 to 2001 when
compared with death rates in the U.S. population. There was some exposure to methylene chloride, but
the SMRs were not specific for methylene chloride exposure. Silver et al. (2014) received a medium
(1.8) data quality rating.
Overall, the human data are not conclusive with respect to methylene chloride's association with liver
effects based on the limited database and endpoints evaluated.
Animals
Table 3-4 outlines liver effects in chronic and subchronic studies. In chronic inhalation studies in
animals, liver effects were often the most sensitive effects. In chronic inhalation studies, rats exhibited
vacuolization and sometimes necrosis (Nitschke et al s ^3a; NTP. 1986; Burek et at ! *4),
hemosiderosis (NTP. 1986) and acidophilic and basophilic foci (Also et al.. 2014a). Mice showed
degenerative changes in hepatocytes in one chronic inhalation study (NTP. 1986). No liver effects were
observed in hamsters after chronic inhalation (Burek et al.. 1984). U.S. EPA (2011) notes that
vacuolization was consistently identified, and lipids were observed in the vacuoles. Data evaluation
ratings for the chronic studies are high (1.3) for NTP (1986). high (1.5) for Burek et al. (1984). high
(1.3) for Nitschke et al. (1988a) and high (1.1) for Aiso (2014a).
In subchronic inhalation studies, rats and dogs exhibited fatty livers, mice exhibited hepatic
degeneration and vacuolization and monkeys exhibited borderline effects (N1 6; Haun et al... 1972;
Haun et al.. 1971). However, a 90-day study by Leuschner (1984) found no changes in liver weights,
related biochemistry or histopathology in Sprague-Dawley rats or Beagle dogs at concentrations as high
or higher than other studies that showed effects. The reason for this negative study is not clear but
9 General Electric Co (1990) is the same reference as Kolodner (.1.990). which is cited in U.S. EPA (20.1.1).
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Leuschner (1984) did not identify the organs evaluated histologically and identified results of
biochemical and other analyses in the text only as "no intolerance phenomena" without any tabular
information presented.
In the updated literature search, Aiso et al. (2014a). a chronic inhalation study, found that relative liver
weights of rats were decreased at the lowest concentration (1000 ppm) in males (by more than 10%; p <
0.01) but were not decreased at higher concentrations. In females, absolute liver weights were increased
by 11%, 25% and 25% and relative liver weights were increased by 11%, 22% and 29% at 1000, 2000
and 4000 ppm, respectively (all p < 0.01) and by 11%, 22% and 29%. In contrast, no significant weight
changes were observed in other organs and no significant clinical signs were observed. The authors
determined that the altered acidophilic and basophilic cell foci were classified as preneoplastic
proliferative lesions. In males, these lesions were increased at 1000 or 2000 ppm but did not show a dose
response. In females, lesions were increased and showed more of a dose-response, although Aiso et al.
(2014a) did not report results of trend tests. EPA did not observe correlations between the pre-neoplastic
foci and tumors in this study. For example, no statistically significant increases in hepatocellular
adenoma or carcinoma were observed in rats, and the only significant trend was for combined
hepatocellular adenoma/carcinoma in males whereas no dose-response trends were observed for liver
foci in males. In contrast, no trends were observed in female rats with respect to adenomas and
carcinomas but there was a trend in acidophilic foci. These foci were not significantly increased in mice,
even though the incidences of hepatocellular adenomas and carcinomas were significantly increased in a
dose-response trend. Thus, based on the lack of correlation with tumors, EPA considers the foci
identified in this study to be non-neoplastic and rats appear to be more sensitive to the effect due to lack
of dose-response and lower incidences in the mice that were evaluated in this study.
Other studies identified in the updated literature search included a 1- and 10-day inhalation study in
mice and rats at 2000 and 4000 ppm (Shell Oil. 1986) submitted under TSCA. The authors reported
changes in liver weights in mice (decreased after one day, increased after 10 days), but no changes in
liver morphology. In contrast, all exposed rats had increased numbers of eosinophils in centrilobular
cells and seven of 10 rats at the highest concentration exhibited increased incidence of mitotic figures in
the midzone, adjacent to the area with eosinophilia. No changes in liver weights were observed in rats
(Shell Oil. 1986). The overall data quality rating for this study is high (1.5).
In addition, EPA identified a 90-day oral dog study submitted under TSCA that was not reported in U.S.
EPA (2011). Four dogs at the highest dose of 200 mg/kg-tnv/day exhibited inflammatory cell foci in
livers compared with one control animal with the effect (General Electric Co. 1976b). Foci were slight
or very slight in severity and not accompanied by biochemical changes. This study received a high (1.5)
overall data quality rating.
Although U.S. EPA (2011) discussed modes of action related to liver tumors, limited research has
focused on the mechanisms related to non-cancer liver effects. When U.S. EPA ( ) investigated
metrics for dose-response modeling, considering the metabolites of the CYP pathway showed more
consistency between the inhalation and oral routes compared with results of the GST pathway or
considering AUC of the parent compound. Although not definitive, this could suggest metabolites of the
CYP pathway may be involved in non-cancer liver endpoints. U.S. EPA ( ) indicated exposure of
Wistar rats to 500 ppm resulted in increased hemochrome content in liver microsomal cytochrome P450
(CYP) (Savolainen et al. 1977). which could represent an adaptive response. Also, mouse hepatocyte
degeneration was related to dissociated polyribosomes and rough endoplasmic reticulum swelling
(Weinstein et al.. 1972).
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In the updated literature search, EPA identified a few studies that examined changes in gene and protein
expression and enzymatic activities in livers of rats or in one case, fish.
Oral studies in rats and one study in fish identified liver-related biochemical changes but none provide
definitive or specific information on modes of action for methylene chloride related to non-cancer liver
toxicity. In rats, methylene chloride was associated with increased biliary output after induction of nitric
oxide (NO) by carbon monoxide (CO), which increased biliary excretion of glutathione (GSH) (Chen et
at.. 2013). Kim et al. (2010) found expression of the protein a-2 |i globulin was decreased (0.92 vs. 1),
whereas GST-a (1.13 vs. 1) and phenylalanine hydroxylase (1.17 vs. 1) were increased in livers of rats
orally exposed to methylene chloride. Likewise, seven of 1,100 proteins (three paralogues of GST, P-l-
globin, is part of hemoglobin that binds C02, two hemoglobin P-2 subunits and a-2 globulin) in livers of
rats dosed orally with methylene chloride were downregulated compared with controls (Park and Lee.
2014). In rat livers, methylene chloride also downregulated genes that are downregulated in T-cell
prolymphocyte leukemia (Kim et al.. ). Dzul-Caamal (2.013) didn't identify increased
formaldehyde or reactive oxygen species (ROS) as H202 in livers of fish but identified increasing lipid
peroxidation and oxidation of proteins with increasing doses of methylene chloride.
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5006 Table 3-4. Liver Effects Identified in Chronic and Subchronic Animal Toxicitv Studies of Methylene Chloride
T;ir»e(
Orjiiin/
S\s(em
Sluclj
Tj |)l'
Species/
S(r;iin/Sc\
(Nil in hoi'/
jiroup)
I'ApoSIII'C RoillC
Doses/
Conccnlmlions
Diii'iilion
n().\i:i./i.()\i:i.
reported In slntl>
iiulhors
NOAI'.I./
1.OA 111. (ing/nr*
or niii/kti-)
(Sex)
r.lTeel
Rel'erenee
Diilii
Qu;ilil>
l-'.\ iiliiiiiion
Hepatic
Chronic
Rat, F344,
M/F
(n=100/group)
Inhalation, vapor,
whole body
0, 3510, 7019 or
14,038 mg/m3 (0,
1000, 2000 or
4000 ppm)
6 hours/day,
5 days/week
for 2 years
NA
LOAEL= 3510
(M/F)
Hepatocyte
vacuolation and
necrosis,
hemosiderosis
in liver (M/F);
hepatocyte-
megaly (F)
NTP
(1986)
High (1.3)
Hepatic
Chronic
Rat, Sprague-
Dawley, M/F
(n~190/group)
Inhalation, vapor,
whole body
0, 1755, 5264 or
12,283 mg/m3 (0,
500, 1500 or
3500 ppm)
6 hours/day,
5 days/week
for 2 years
NA
LOAEL= 1755
(M/F)
Hepatocyte
vacuolation
(M/F);
multinucleated
hepatocytes (F)
Burek
(.1.984)
High (1.5)
Hepatic
Chronic
Rat, Sprague
Dawley, M/F
(n=180/group)
Inhalation, vapor,
whole body
0, 176, 702 or
1755 mg/m3 (0,
50, 200 or 500
ppm)
6 hours/day,
5 days/week
for 2 years
NA
NOAEL= 702
(F)
Hepatic lipid
vacuolation and
multinucleated
hepatocytes
Nitschke
(1.988a)
High (1.3)
Hepatic
Chronic
Mouse,
B6C3F1, M/F
(n=100/group)
Inhalation, vapor,
whole body
0, 7019 or 14,038
mg/m3 (0, 2000
or 4000 ppm)
6 hours/day,
5 days/week
for 2 years
NA
LOAEL = 7019
(F)
Hepatocyte
degeneration;
(t
hepatocellular
adenoma or
carcinoma)
NTP
(.1.986)
High (1.3)
Hepatic
Chronic
Mouse,
B6C3F1, M/F
(n=20/group)
Inhalation, vapor,
whole body
0, 1843, 3685,
7371, 14,742 or
29,483 mg/m3
(0, 525, 1050,
2100, 4200 or
8400 ppm)
6 hours/day,
5 days/week
for 13 weeks
NA
NOAEL= 7371
(F); NOAEL =
14,742 (M)
Hepatocyte
centrilobular
degeneration
NTP
(.1.986)
High (1.3)
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T;irjie(
Ortiiin/
Sjslcm
Sliulx
Tx pc
Species/
S(r;iin/Scx
(Nil in hoi'/
lil'Olip)
l-lxposurc Roulc
Doses/
(onccnlmlions
Dui'iilioii
n()\i:i./i.()\i:i.
reported In slntl>
iiulhoi's
\o\i:i./
I.OAI'.I. (mg/iir¦'
or mii/k;i-(l;i\)
(Sex)
r.lTeel
Reference
Diilii
Qu;ili(\
r.\ iiiuiiiion
Hepatic
Chronic
Rat, F344,
M/F
(n=170/group
+ 270
controls)
Oral, drinking
water
0, 6, 52, 125 or
235 mg/kg-day
(M);
0, 6,58, 136 or
263 mg/kg-day
(F)
104 weeks
NA
NOAEL= 6
(M/F)
t Non-
neoplastic
Foci/areas of
alteration
(M/F); t
incidence of
neoplastic
nodules; fatty
liver changes
(incidence
N/A)
Serota et
al. (1986a)
High (1.3)
Hepatic
Subchroni
c
Rat, F344,
M/F
(n=30/group)
Oral, drinking
water
0, 166, 420 or
1200 mg/kg-day
(M);
0, 209, 607 or
1469 mg/kg-day
(F)
90 days
NA
LOAEL= 166
(M); LOAEL =
209 (F)
Hepatic
vacuolation
(generalized,
centrilobular,
or periportal)
Kirschman
et al.
(.1.986)
Low (2.5)
Hepatic
Chronic
Mouse,
B6C3F1, M/F
(n=125, 200,
100, 100 and
125 [M];
n=100, 100,
50, 50 and 50
[F])
Oral, drinking
water
0,61, 124, 177 or
234 mg/kg-day
(M);
0, 59, 118, 172 or
238 mg/kg-day
(F)
104 weeks
NA
NOAEL= 185
(M/F)
Some evidence
of fatty liver;
marginal
increase in the
Oil Red-O-
positive
material in the
liver
Hazleton
Labs
(.1.983)
Medium
(1.7)
Hepatic
Subchroni
c
Mouse,
B6C3F1, M/F
(n=30/group)
Oral, drinking
water
0, 226, 587 or
1911 mg/kg-day
(M);
0, 231,586 or
2030 mg/kg-day
(F)
90 days
NA
NOAEL= 226
(M)
Hepatic
vacuolation
(increased
severity of
centrilobular
fatty change)
Kirschman
(.1.986)
Low (2.5)
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T;u»c(
Ortiiin/
SjsU'in
Sluclj
Tj pc
Species/
Simin/Scx
(Nil in hoi'/
liroiip)
l''.\posuiv Roulc
Doses/
(onccnlmlions
Diii'iilion
n()\i:i./i.()\i:i.
reported In slntl>
iiulhors
\o\i:i./
I.OAI'.I. (iiiii/m-4
or mii/k;i-(l;i\)
(Sex)
r.riw-i
Reference
Diilii
Qii;ilil>
l'.\ iiliiiilion
Hepatic
Chronic
Rat.
F344/DuCrj
Inhalation, vapor,
whole body
0.3510. 7019 or
14.038 mg/m' (0.
1000,2000 or
4000 ppm)
6 hours/day.
5 days/week
for 2 years
NA
LOAEL = 3510
mg/m' (F)
Increased
basophilic foci
and increased
abs/rcl liver wt
(p<0.01)
Aiso ct al.
(2014a)
High (1.1)
Hepatic
Subclironi
c
Dog/Beagle
(MZF)
(4/scx/ group)
Oral
0. 12.5. 50. 200
mg/kg-bw/dav
90 days
Not Reported
NOAEL = 200
mg/kg-bw/dav
No changes in
clinical
chemistry.
gross
pathology.
organ weight.
or
histopathologic
al lesions
General
Electric
(1976)
High
(1.5)
5007
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3.2.3.1.3 Immune System Effects
From the updated literature search, EPA identified one epidemiological study that addressed an
immune-related endpoint. Chaigne et al. ( ) is a case control study that identified 175 cases
of primary Sjogren's syndrome at three university hospitals in France. Sjogren's syndrome is an
autoimmune epithelitis characterized by dry eyes and mouth, physical weakness and joint pain.
Systemic symptoms are possible and individuals with this syndrome have an increased risk of
lymphoma. The comparison group included healthy individuals from the same hospitals and
departments. The authors assessed exposure using a published job exposure matrix that
accounted for probability of exposure, intensity, frequency and duration of exposure. The study
authors did not adjust for confounding when modeling the relationship between methylene
chloride and the outcome. However, the authors did match cases and controls for age and gender.
The cases and controls had similar smoking rates and socio-economic and socio-professional
levels.
Occupational exposure to methylene chloride was associated with Sjogren's syndrome based on
an odds ratio (OR) of 9.28 (95% confidence interval (CI): 2.60-33.0) (p< 0.0001) when
compared with matched controls (13 cases vs. 3 controls). Among the patients that had anti-SSA
or anti-SSB antibodies10, the OR for association with methylene chloride was 11.1 (95% CI:
2.38-51.8) when compared with matched controls (p < 0.001). For these two measures,
methylene chloride had the highest ORs compared with other studied compounds. High
cumulative exposure (exposure score > 1) to methylene chloride was not statistically
significantly associated with Sjogren's syndrome, although the association was still greater than
1.0 (OR: 3.04; 95% CI: 0.50 - 18.3) (Chaigne et al.. 2015V
EPA determined an overall confidence rating of medium (1.8) for Chaigne (2015).11 The article
lacks information on recruitment procedures and participation rates. Due to a lack of information
or estimates of methylene chloride exposure concentrations, the study cannot be used to estimate
a quantitative dose-response relationship. Furthermore, the number of cases and controls are
small and no other studies have investigated the association between Sjogren's syndrome and
occupational exposures. Thus, conclusions specifically regarding associations with methylene
chloride are limited.
Among U.S. Air Force base workers, men exhibited an increased risk of bronchitis-related
mortality when exposed to methylene chloride (hazard ratio (HR): 9.21; 95% CI: 1.03-82.69)
(Radican et al.. 2008). The HR is based on a total of four exposed cases. This HR compared exposed
and unexposed male workers. Bronchitis included both acute and chronic bronchitis and could
include simple and mucopurulent chronic bronchitis, so there could be multiple causes of the
bronchitis (e.g., infection or other inflammatory processes). The authors used employment for at least
one year between 1952 and 1956 as the exposure criteria. Actual exposure levels were not estimated
for methylene chloride, due to limited data on air monitoring and methylene chloride use linked to
specific departments at the air base (Radican et al.. 2008). The model adjusted for age (used as a
10 SSA and SSB refer to Ro and La, respectively. These are ribonucleoprotein complexes (not compounds foreign to
the body) and anti-SSA and anti-SSB are antibodies mounted in response to these complexes (Montsoponlos and
Zerva. 1990).
11 High rating is 1 to 1.6, medium is 1.7-2.2 and low is 2.3-3.0.
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measure of time), race and gender, and evaluated 5-calendar year ranges but didn't adjust for
socioeconomic status, which was quite different between exposed and control workers (i.e., the
proportion of non-exposed persons that were salaried as 61% compared with < 1% among cases).
The study also did not adjust for co-exposures, even though 21 additional solvents and chemicals
were evaluated in this study. The study received a data quality rating of medium (1.8). Because
there may be multiple causes of the observed bronchitis, it is not possible to determine whether
the outcome is related to infection or to another inflammatory process. Lack of more quantitative
exposure data, limited numbers of cases and the lack of adjustment for other chemical co-
exposures makes it difficult to make strong conclusions regarding the association between
methylene chloride and bronchitis.
Hoechst Celanese Corporation (1992)12 evaluated deaths from multiple causes in workers at a
CTA fiber production work site in Maryland, as identified on death certificates, for workers
employed from 1970 to 1989. Slight elevations in risk of mortality due to influenza and
pneumonia were observed (SMR - males: 1.25; females: 4.36) when comparing workers ever
exposed to the highest exposure group (> 350 ppm - ~ 700 ppm) to the Maryland county
population in which the plant was located. The authors reported no statistically significant
excesses of deaths but did not report the 95th % confidence intervals for the SMR. Workers in
this highest group could have had portions of their work history exposed to lower concentrations
or could have been not exposed at all. Employees may have also been exposed to other
chemicals including ethers, halogenated hydrocarbons, hydrazines, inorganic dusts and many
others. EPA gave this study a data quality rating of medium (1.9). Because the comparison group
included the working and non-working population, there is potential that any possible effects of
methylene chloride could be attenuated based on greater illness in the controls unrelated to
methylene chloride exposure. Also, the analysis did not adjust for the many other chemical
exposures. For these reasons, firm conclusions regarding the association with methylene chloride
cannot be made from this study.
Hearne and Pifer (1999), in Part I of their study, found significantly lower than expected
numbers of deaths due to infectious and parasitic diseases among triacetate film production
workers compared with death rates/causes of individuals in the general population in New York
(excluding New York City) in a 1946-70 cohort (employed in multiple divisions) followed
through 1994 (SMR = 0; 95% CI: 0-66; pS0.05). Although the study did not control for other
chemical exposures, this analysis of employees in all divisions was limited to employees hired
after methylene chloride became the principal solvent; the authors did note however, that an 80%
methylene chloride/20%) methanol mixture was used in one of the divisions. Employees worked
for at least one year in one or more of the studied divisions. Exposure measures were computed
by multiplying methylene chloride air concentrations by the number of years exposure. For all
diseases of the respiratory system, the SMR was 90 (95%> CI: 58-134) in this same cohort (also
compared with the New York state population). Similar to the previous study (Hoechst Celanese
Corporation (1992). the comparison populations included working and non-working individuals
and thus, the comparison group could include individuals who may be not working due to illness.
12 Also cited as Gibbs (.1.9921 in U.S. EPA (20111
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Hearne and Pifer (1999) also conducted an analysis of only the employees in the roll coating
department (Part II). In this analysis, about 30% of the employees were hired before methylene
chloride was introduced. Similar to the Part I analysis, workers were employed for at least 1
year. The SMR for infectious and parasitic diseases was 67 (95% CI: 14-197) when compared
with Kodak Rochester employees unexposed to methylene chloride. The study's strength
included its use of air monitoring values (> 1500 area samples and > 2500 personal monitoring
samples for the Part I analysis). This study was rated high (1.6). The authors note that for Part I,
regression modeling was adjusted for age, calendar year and time from first exposure, but it is
not clear whether this was also done for the Part II analysis.
Lanes et al. (1993) assessed mortality among employees at a CTA fiber manufacturing plant in
Rock Hill, South Carolina. Workers were employed for at least three months in jobs that entailed
exposure to the highest concentrations of methylene chloride (median exposures of 140 to 745
ppm as 8-hr time-weighted averages). Methanol and acetone were also present but Lanes et al.
(1993) didn't control specifically for these compounds. The analysis did control for age, race,
gender and calendar period. The authors did not identify an increased risk of death from
nonmalignant respiratory disease (SMR = 0.97; 95% CI: 0.42-1.90). The comparison death rates
were taken from York County, South Carolina and could mask effects from methylene chloride
if the illness rates unrelated to methylene chloride differed between workers and the county
population. This study received a data quality rating of medium (1.8).
No new animal studies were located that specifically addressed immunomodulation in the
updated literature search. U.S. EPA (2011) summarized two animal toxicity studies. Aranyi et al.
(1986) evaluated several measures of immune response in acute inhalation studies using female
CD-I mice. Mice were challenged with live aerosolized Streptococcus zooepidemicus while
simultaneously being exposed to methylene chloride vapor or filtered air. The authors recorded
deaths over a 14-day period. Similarly, the authors measured clearance of aerosolized Klebsiella
pneumoniae by pulmonary macrophages from CD-I mouse lungs 3 hours after infection,
comparing methylene chloride to air exposures. After a single 3-hour exposure to 95 ppm
methylene chloride, deaths were significantly increased by 12.2% (p < 0.01) from S.
zooepidemicus infection compared with controls. Bactericidal activity of macrophages against K.
pneumoniae was decreased by 12% (p < 0.001). In contrast, no changes in mortality rates or
bactericidal activity were observed with either single or five daily 3-hr exposures to 51-52 ppm.
No similar information is available from longer studies. EPA evaluated this study, which
received a data quality rating of medium (1.8). Note, however, that several systematic review
metrics were given low ratings. For example, lack of information of preparation of test substance
and respiratory rate as well as lack of information on allocation of animals to groups were all
rated low.
Warbrick et al. (2003) exposed Sprague-Dawley rats to 0 or 5187 ppm methylene chloride for 6
hrs/day, 5 days/week for 28 days. On day 23, all rats were injected with sheep red blood cells.
Immunoglobulin M (IgM) antibody responses did not differ between methylene chloride-
exposed rats and negative controls. Relative spleen weights were reduced in females. This study
received a data quality rating of high (1.3).
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Two-year inhalation and oral studies (Nitsehke et at.. 1988a; Serota et at.. 1986a; Hazleton
Laboratories. 1983) did not identify histopathological changes in lymph nodes, thymus or
spleens of rats, although these studies did not test for differences in functional immunity.
Nitschke et al. (1988a) and Serota (1986a) each received a high data quality rating whereas
Hazleton (1983) received a medium (1.7) quality rating.
U.S. EPA (2011) did not discuss any mechanistic//'// vitro studies related to immunotoxicity.
Only a couple relevant studies were identified from the updated literature search that address
immune-related activity by methylene chloride. Methylene chloride has been shown to affect
cytokine levels. In a complex experiment, Kubulus et al. (2008) treated male rats with hemin
arginate, induced hemorrhage, treated with a heme oxygenase-1 blocker, and then administered
methylene chloride. Methylene chloride treatment resulted in decreased pro-inflammatory
cytokine TNF-alpha and increased the anti-inflammatory cytokine IL-10 levels, similar to
treatment with hemin arginate alone. The authors hypothesized that the MOA for these changes
in cytokine levels was related to carbon monoxide generation (Kubulus et at.. 2008).
Mitochondrial activity was assessed by measuring cell viability of peripheral blood mononuclear
cells (PBMC) of carp (Cyprinus carpio carpio), and ROS were also evaluated in PBMC by
measuring oxidation of substrates that generate fluorescent compounds (Uraga-Tovar et al..
2014). Methylene chloride increased mitochondrial activity and H202 in a dose-dependent
fashion. Overall, the authors demonstrated immunomodulary effects of methylene chloride in
PBMC of carp (Cyprinus carpio carpio) that included an acute pro-inflammatory state. Reports
of measuring ROS have not been performed on PBMC of the carp prior to publication by Uraga-
Tovar et al. ( ). Therefore, conclusions from the study should be considered with caution and
cannot be compared with other compounds.
3.2.3.1.4 Nervous System Effects
Nervous system effects related to methylene chloride exposure include CNS depression in
humans, the critical effect identified in previous assessments for acute/short-term scenarios as
well as decreased spontaneous activity and other effects in humans, animals and/or mechanistic
studies. A primary focus of these endpoints was human data, which EPA evaluated for data
quality. This section presents the results of animal and in vitro studies but EPA did not evaluate
all of these studies for data quality. Previous peer-reviewed assessments discussed the animal
and in vitro studies and these are considered acceptable for supporting the weight of scientific
evidence.
Nervous System Effects13
Humans
Silver et al. ( ) reported no increased deaths from malignancies (SMR of 0.07 with 95% CI
of 0.0 to 3.83) or nonmalignant diseases of the nervous system from methylene chloride
l 3ln an evaluation of acetate film workers with similar results to other studies, Cherry et al. (1983) found exposure to
methylene chloride was statistically significantly associated with sleepiness and tiredness during the morning shift,
changes in mood and also found a deterioration in digit symbol substitution tests. However, due to a loss of more
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exposure (SMR 1.04 with 95% CI of 0.83 to 1.31) in a cohort of microelectronics and business
machine workers exposed at least 91 days from 1969 to 2001 when compared with death rates in
the U.S. population. The characteristics of the general population used as controls are likely to
differ from the characteristics of the population of workers being evaluated; often, morbidity and
mortality rates are lower in workers than the full population. For example, the full population
includes individuals who are unable to work due to illness (11 and Sung. 1999). Therefore, using
this dissimilar control group could mask possible effects observed in the worker population. The
model didn't adjust for other chemical exposures. In contrast, in a separate model,
perchloroethylene was associated with increased deaths from nonmalignant nervous system
diseases (SMR 1.31; 95% CI 1.01 to 1.69). This study received a data quality rating of medium
(1.8).
As identified in Section 3.2.3.1.1, acute controlled inhalation exposure by humans to methylene
chloride concentrations of > 195 ppm results in neurobehavioral deficits measured in
psychomotor tasks including tests of hand-eye coordination, visual evoked response changes and
auditory vigilance (Putz et al. 1979; Winneke. 1974; Stewart et at.. 1972). Gamberale et al.
(1975). in contrast, showed minimal effects and generally at higher concentrations, however, the
limited exposure information and difference in method of evaluating exposure (use of a
breathing valve) makes it difficult to compare results of this study with the other studies that
employed exposure chambers. Stewart et al. (1972) also reported symptoms of lightheadedness
(two of three volunteers) and difficulty enunciating words (one of three volunteers). EPA has
low confidence in the subjective symptom reports from Stewart et al. (1972) (but not the
objective measures) because it is not known whether subjects and investigators were blinded to
their exposure status.
In a case-control study of occupational exposure in a plastic polymer plant that received a data
quality rating of medium (1.9), exposure to methylene chloride was associated with neurological
symptoms (i.e., dizziness and vertigo) (General Electric Co. 1990). The high methylene chloride
exposure group was exposed to a mean concentration of 49 ppm. It is likely that workers were
exposed to other chemicals in addition to methylene chloride (e.g., phenol and small amounts of
other chemicals).
In a study designed to evaluate persistence of nervous system effects, Lash et al. (1991)
examined retired aircraft maintenance workers employed in jobs associated with paint stripping,
which mainly use methylene chloride. Workers were exposed for > 6 years between 1970 and
1984 with an average length of retirement of approximately five years. Controls were retired
mechanics at the same base that had little solvent exposure. The study evaluated 33 symptoms
primarily related to CNS effects and physiological measurements that included odor and color
vision, auditory response, hand grip strength, reaction time, visual memory, attention and spatial
ability. The only large differences between the exposed and control groups was a lower score on
attention tasks (effect size approximately -0.55,p = 0.08) and complex reaction time (effect size
approximately -0.40, p = 0.18) and a higher score on verbal memory tasks (effect size
approximately 0.45, p = 0.11). Sample sizes are low and the study does not discuss other
than 50% of the participants without explanation or comparison in attributes with those that remained in the study,
the study was given an unacceptable rating. Therefore, these results cannot be relied upon to make conclusions.
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possible pollutant exposures (Lash et al. 1991). EPA gave this study an overall rating of medium
(1.8).
Data from several cohorts report SMRs related to suicide risk. Hearne and Pifer (1999) report
SMRs of 1.8 in two separate cohorts of workers in triacetate film production in Rochester, New
York (95% CI: 0.98-3.0 for one cohort and 0.81-3.4 for the other cohort). Although Hoechst
Celanese Corporation, (1992)14 reports increased risk for the highest exposure group of 350-700
ppm in Maryland triacetate fiber production workers (SMR = 1.8; 95% CI: 0.78- 3.6). Tomenson
et al. (2011) didn't identify increased risk. Data quality ratings are high (1.6) for Hearne and
Pifer (1999). medium (1.9) for Hoechst Celanese Corporation, (1992.) and medium (1.7) for
Tomenson et al. (2011).
Lanes et al. (1993) identified an SMR of 1.19 for suicide risk but U.S. EPA (2011) states that the
SMR appears to be incorrect and should be 0.77 (based on numbers of reported expected and
observed cases).
Between 2006 and 2015, five studies (Talbott et al. (2015): Roberts et al. (2013): Kalkbrenner
(2010): Windham et al. (2006): von Ehrenstein et al. (2014)) investigated the association
between numerous chemicals (often starting with the 33-37 HAPs, although Roberts et al. (2013)
investigated many more pollutants to start) listed on the US EPA National Air Toxic
Assessment, which includes methylene chloride, and ASD in regions across the United States.
All studies received medium or high data quality ratings using EPA's systematic review criteria.
The odds ratio from these studies range from 1.9 to 1.08. Most of the results lacked statistical
significance. There is no good single animal model for the complex syndrome that constitutes
autism spectrum disorder and specifically animal data that evaluate reciprocal social
communicative behavior or repetitive and stereotyped behavior have not been identified for
methylene chloride (Fetch, et al.. 2019).
Animals
In inhalation studies conducted with animals, several acute and short-term studies identified
changes in spontaneous activity in rodents. Wein stein (1972) and Heppel and Neal (1944)
reported decreased spontaneous activity in rodents after exposure to 5000 ppm for up to 7 or 10
days, respectively. Clinical signs along with decreased activity reported by Wein stein (1972)
suggested CNS depression. Another study (Kiellstrand et al.. 1985) found that mice had an initial
increase in activity, but then the mice exhibited decreased activity after acute exposure > 600 to
2500 ppm. A subchronic study also identified CNS depressive effects (incoordination, lethargy)
in dogs, monkeys and mice, but not rats; brain edema was also observed in dogs (Haun et al..
1971). Thomas et al. (1972.) identified increased activity in mice after 14 weeks exposure to 25
ppm but no effects at 100 ppm.
Repert (1989) identified visual and somatosensory responses in an acute study at a concentration
up to 15,000 ppm that collectively suggested CNS depressive effects. In contrast, a 13-week
study using concentrations up to 2000 ppm did not identify any changes in sensory stimuli
responses (Mattssom et al.. 1990) but the measurements were conducted at least 65 hrs after the
14 Also cited as Gibbs (.1.9921 in U.S. EPA (20111
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last exposure and thus, the study could only assess persistence of effects, not reversible effects
that occurred during exposure.
A limited number of additional nervous system effects have been identified in animal studies
conducted via inhalation. Alexeef and Kilgore (1983) identified a decrease in the ability of mice
to learn a passive-avoidance conditioning task during acute exposure (~ 47,000 ppm). Savolainen
(1981) identified increased preening by rats exposed to 500 ppm for 6 days.
Bornschein et al. (1980) found delayed rates of behavioral habituation to novel environments in
offspring from female rats exposed to 4500 ppm methylene chloride via inhalation before and/or
during gestation. The effects were observed as early as 10 days of age in both sexes and still
observed in 150-day male (but not female) rats.
Mechanistic/MOA studies
CNS Depression, Locomotion, Cognition
Solvents are known to produce generalized CNS depression (Moser et al.. 2008) General
depressants may initially suppress inhibitory systems at low doses to produce excitation, and lead
to a continuum of effects from excitation to sedation, motor impairment, coma, and ultimately
death by depression of respiratory centers (Moser et al... 2008). Moser et al. (2008) discusses
several hypotheses regarding mechanisms related to generalized CNS depression but notes that
none are definitive. Across solvents, potency has been shown to be correlated with the olive
oil: water or octanol: water partition coefficients, suggesting possible disruption of the lipid
portions of cell membranes. CNS depression could result from membrane expansion or effects
on mitochondrial calcium transport. The effect may also be related to interactions with ligand-
gated ion channels and voltage-gated calcium channels, with specific gamma-aminobutyric acid
(GABA) type A, N-methyl-D-aspartate (NMDA) and glycine receptors possibly involved (Moser
et at. 2008).
MOA information specific to methylene chloride is described for primary nervous system effects
related to CNS depression including changes in locomotor activity as well as effects on motor
coordination and learning and memory. Bale et al. (2011) reviewed possible mechanisms
regarding methylene chloride and other solvents' association with effects on the nervous system.
They note that the solvents may act on several molecular targets in the CNS and likely through
multiple mechanisms.
Some of the primary effects of methylene chloride are related to CNS depression and motor
incoordination and abnormal gait. Studies have shown that GABA and glutamate receptors in the
cerebellum may be involved in motor coordination and general CNS depression. Also, studies
with toluene indicate that the dopaminergic system may be involved in changes in locomotion
(Bale et al... 2011). Methylene chloride has been shown to increase dopamine along with
serotonin in the medulla and increase GABA and glutamate in the cerebellum (Kanada et al..
1994). However, this study did not measure functional changes resulting from these
neurochemical changes so definitive associations between these changes and CNS depression
and motor changes are not possible. Bale, (Bale et al.. 2011) also states that studies have not
been conducted to evaluate the neurochemical basis for changes in spontaneous activity for
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methylene chloride. Data suggest that increased COHb levels result in CNS depression (Putz et
ai. 1979) but doesn't fully explain the independent and possible additive effect of methylene
chloride because a weaker effect (or no effect) on the nervous system was observed with
administration of exogenous CO compared with methylene chloride administration (Putz et at.
1979; Winneke. 1974V
Changes in deoxyribonucleic acid (DNA) concentration and enzyme activities in the cerebellum
(Rosemerem et al. 1986; Savolainen etai. 1981) may be associated with changes in motor
activity and neuromuscular function. Among other neurochemical endpoints, Savolainen (1981)
measured changes in succinate dehydrogenase (SDH) from exposure to methylene chloride. SDH
is a tricarboxylic acid cycle enzyme that is also part of the mitochondrial electron transport chain
(Quintan et al.. 2013). Savolainen (1981) reported decreased SDH in the cerebellum, which
coordinates motor activity. SDH levels recovered somewhat but still remained lower than
controls during a second week of exposure and after a week-long recovery period. Effects were
generally greater for a TWA concentration of 1000 ppm methylene chloride, which included 2
daily 1-hr exposures to 2800 ppm compared with a constant concentration of 1000 ppm
(Savolainen et al.. 1981). This greater effect may partly explain effects (e.g., respiratory
depression, death) experienced by humans after high acute exposures.
Alexeef and Kilgore (1983) showed that at 47,000 ppm, methylene chloride may affect learning
and memory as evidenced by a change in passive avoidance conditioning, and Kanada (1994)
showed that acetylcholine (ACh) levels were increased in response to methylene chloride and
Bale (2011) notes that memory and cognition deficits are thought to be due to decreased
cholinergic system functioning. The increase in ACh seen by Kanada (1994) could lead to
altered cognition as a response to inhibiting nuclear ACh receptors to maintain normal function
(Bale et al.. 2011). Alternately, decreases in learning and memory function may be affected by
decreased motor function and CNS depression (Bale et al..: ); because learning and memory
have not been routinely associated with methylene chloride and because the study (Alexeeff and
Kilgc 3) that identified changes in learning and memory was conducted at a very high
concentration, it seems plausible that the effects from methylene chloride may be at least
partially related to CNS depression.
Decreased catecholamine in the caudate nucleus and decreased DNA content in the hippocampus
as a result of methylene chloride may also suggest possible learning and memory impairment
(Rosengren et al.. 1986; Fuxe et al.. 1984) based on the location of the changes. However, as
noted above, changes in learning and memory have been identified in only limited studies in
humans and animals.
3.2.3.1.5 Reproductive and Developmental Effects
In addition to the epidemiological studies related to nervous system effects noted previously,
EPA identified several other relevant epidemiological studies of reproductive and developmental
effects.
Brender (2014) was identified during the recent literature search. These authors evaluated the
association between industrial air releases of chlorinated solvents (including methylene chloride)
and birth defects in children. Cases and controls were mothers recruited during 1996-2008 from
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the same regions in Texas. Birth defects were identified from the Texas Birth Defects Registry.
Exposure was estimated based on proximity of mothers' residences to emissions and the quantity
of methylene chloride released. The resulting estimates were positively associated with air
measurements. Differences in certain characteristics such as race, ethnicity and education were
controlled for in the statistical analyses. Although methylene chloride was not associated with
most birth defects in mothers, statistically significant relationships were observed among
mothers 35 years or older for two defects: any oral cleft defect (OR = 1.38, with 95% CI: 1.14,
1.67) and cleft lip with or without cleft palate (OR = 1.53, with 95% CI: 1.21, 1.93). The authors
also reported that significant linear trends were observed for the association between methylene
chloride and isolated conotruncal heart defects in mothers of all age groups (OR for the highest
exposure risk value was 1.56, 95% CI: 1.05, 2.32). The potential for selection bias appeared to be
low, exclusions from the study were limited and the potential for exposure misclassification was
considered to be low. In evaluating the outcomes of interest there is some uncertainty regarding
whether exposure occurred during the first trimester. Because the models used to estimate the
ORs did not account for co-exposures to other chlorinated solvents or other chemicals, the
association between individual chemicals and the birth outcomes is less certain. In other studies
(e.g., the ASD epidemiological studies), methylene chloride was sometimes highly correlated
with other compounds. Indeed, some of the other chemicals measured in separate models in this
assessment were associated with some of these birth defects more often (e.g., for all mothers'
ages) or showed more positive associations (higher ORs) than methylene chloride. The data
quality rating for this study is medium (1.8).
Other studies evaluated reproductive/developmental effects. Bell (1991) examined the
association between estimated methylene chloride air concentrations in the community
surrounding the Eastman Kodak triacetate film facility in Rochester, New York and birth weight
of children born to mothers in the surrounding population. Air dispersion modeling was used to
estimate exposures; the highest predicted average methylene chloride air concentration in the
studied community was 50 |ig/m3. Birth certificates were obtained for the years 1976-1987.
Because the number of births in non-whites was small, the analysis was restricted to the white
population. At the levels of methylene chloride in this study, no significant adverse effect was
found between any combination of methylene chloride exposure levels and birthweight.
Comparing participants residing in the census tracts with the highest exposure group (of three
groups) to the census tracts with no predicted exposure, the OR was 1.0 (95% CI: 0.81, 1.24).
The authors note that the exposure estimates from the air dispersion modeling were higher than
monitored values in the area. Also, the assignment of methylene chloride exposures to each birth
was made using the predominant value of the isopleth for a census tract, and this could have led
to some exposure misclassification. This study received a data quality rating of high (1.5).
Taskinen (1986) examined spontaneous abortion rates in female workers employed in
pharmaceutical factories in Finland from 1973 to 1980. This work was initiated based on
suggestions of increased risk of spontaneous abortions in hospital and pharmaceutical
laboratories, with organic solvents as the suspected exposures of interest. In addition to
examining overall rates, Taskinen (1986) conducted a case-control analysis to estimate
association between spontaneous abortions and methylene chloride, a solvent commonly used in
the pharmaceutical industry, as well as other chemicals. Forty-four cases and 130 controls were
identified. For methylene chloride exposure, the prevalence of exposure was 29% and 14% in the
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cases and controls, respectively. The OR was 2.3 (95% CI: 1.0-5.7; p = 0.06); this OR didn't
appear to account for co-exposure and possible confounders although controls were matched on
maternal age. Less precise results (higher p values) that were similar in magnitude were noted for
other solvents (OR range: 1.6 to 3.2). The OR for exposure to four or more solvents (OR: 3.5, p
= 0.05) was greater than for one to three solvents (OR: 0.8, p = 0.74). EPA gave this a data
quality score of low (2.3) based on several measures including method of identifying exposures,
temporality, covariate adjustment and characterization and confounding from co-exposures.
Male reproductive effects were investigated in a couple of case series reports. Kelly et al. (1988)
cited in U.S. EPA (2011) studied 34 men working in the automotive industry who self-referred to
a health clinic. Eight men who worked as bonders and routinely dipped hand-held pads (and
didn't always use gloves) in buckets of methylene chloride had symptoms of testicular and
epididymal tenderness, and sperm counts were 25 xl06/cm3 (oligospermia can be defined as 20 x
106/cm3). Despite not using contraception, the men had not conceived any children (and one
reported a miscarriage) - conclusions about these results are not possible because there was no
comparison group. Wells et al. (1989). however, reported a mean sperm count of 54 x 106/cm3 in
eleven furniture refinishers (none with oligospermia), slightly higher than the population value of
47 x 106/cm3.
Animal studies show reproductive/developmental effects in some studies but not others. A two-
generation inhalation toxicity study revealed no significant effects on fertility, litter size,
neonatal survival, histopathological changes or growth rates in either generation (F1 or F2) of
rats exposed up to 1,500 ppm methylene chloride (Nitschke et al. 1988b).
Raje et al. (1988) found some evidence of a decrease in fertility index after male mice were
exposed to 144 and 212 ppm for 2 hrs/day for 6 weeks and then mated with unexposed females;
fertility index values were 80% at each concentration compared with 95% at 0 and 100 ppm, but
not statistically significant (overall X2 p-value of 0.27). U.S. EPA (2011) conducted some
statistical analyses - the trend test using a Cochran-Armitage exact trend test yielded a one-sided
p-value of 0.059. Using the Fisher's exact test, one-sided p-value was 0.048 when comparing the
combined 144 and 212 ppm groups with the 0 and 100 ppm groups; U.S. EPA (2011) suggested
a NOAEC of 100 ppm (103 ppm) and lowest observable adverse effect concentration (LOAEC)
of 150 ppm (144 ppm). This data quality rating is medium (1.9).
Pregnant mice and rats were exposed to 1,250 ppm methylene chloride for 7 hrs/day during
gestation days 6-15 (S ch wetz et al... 1975) and exhibited certain skeletal variants after exposure.
In rats, the incidence of ribs or spurs was decreased and incidence of delayed ossification of
sternebrae was increased (p < 0.05 for both). Mice exhibited an increased number of litters with
pups that had a single extra center of ossification in the sternum (p < 0.05) (Schwetz et a >).
Hardin and Man son (1980) did not identify statistically significant changes in the incidence of
external, skeletal or soft-tissue anomalies in fetuses of female Long-Evans hooded rats exposed
to 4500 ppm methylene chloride before and/or during gestation. However, decreased fetal body
weights (by 9-11%) were observed when dams were exposed during gestation only (days 1-17)
or both before (12-14 days) and during gestation (1-17 days) (p < 0.05 by two-way ANOVA).
In an experiment similar to Hardin and Man son (1980) but with 21 days exposure prior to
gestation and evaluation of offspring to an age of 150 days, Bornschein et al. (1980) found
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altered rates of behavioral habituation to novel environments in offspring from dams exposed to
4500 ppm methylene chloride before and/or during gestation. The effects were observed as early
as 10 days of age in both sexes and still observed in 150-day male (but not female) rats.
Results of oral animal studies did not identify reproductive or developmental effects. Narotsky
and Kavlock (1995) did not observe effects on pup survival, resorptions or weight after pregnant
F344 rats were administered doses as high as 450 mg/kg-day on gestational days (GDs) 6-19,
although maternal weight was decreased. No effects on reproductive performance endpoints
(fertility index, number of pups per litter, pup survival) were found in studies in male and female
Charles River CD rats administered methylene chloride via gavage for 18 weeks and
administered doses up to 225 mg/kg-day with subsequent exposure to offspring for 13 weeks
(General Electric Company. 1976).
Other than studies measuring general modes of action of methylene chloride (e.g., oxidative
stress, genotoxicity, increased COHb), EPA did not identify studies that link reproductive and
developmental effects with specific cellular mechanisms.
3.2.3.1.6 Irritation/Burns
Human and animal data that evaluated and/or reported irritation and burns of gastrointestinal
tract, skin, eyes and respiratory tract after use of methylene chloride are summarized below.
Several human studies are case reports and although not evaluated for data quality, were
reviewed to understand circumstances of the cases. A human controlled experiment was
qualitatively reviewed (in consideration of using it for CNS effects from acute/short-term
exposure - see Section 3.2.3.1.1); however, other studies were not evaluated for quality.
After 2 hrs of exposure to 986 ppm methylene chloride in air, volunteers reported no symptoms
of eye, nose or throat irritation (Stewart et at.. 1972). This study was evaluated qualitatively
(I >19t) and although the lack of blinding suggests low confidence in the subjective
symptom results, the subjects would be likely to over-report (rather than under-report) symptoms
if they knew they were exposed to methylene chloride.
Anundi et al. (1993) did report irritation to the eyes and upper respiratory tract among graffiti
removers in an underground station in Sweden. The workers had been on the job between 3
months and 4.7 years. TWA exposures of 18-1,200 mg/m3 (5-340 ppm) were measured in this
study and reported exposures to other chemicals were much lower and found in only a limited
number of samples (Anundi et al.. 1993).
A 21-year old male working in a furniture stripping shop had first and second-degree burns from
direct contact with the liquid after being found slumped over a tank of methylene chloride (Hall
andRumack. 1990). Direct contact of eyes with methylene chloride in a workplace accident
resulted in severe corneal burns; duration of contact is not known. Furthermore, air
concentrations of 2300-7200 ppm resulted in irritation after 5-8 minutes (Hall and Rumack.
1990). Other case reports also indicate that methylene chloride can cause second and third degree
burns upon direct contact with the liquid (Wells and Waldron. 1984).
In one suicide case, ingestion of paint remover containing 75-80% methylene chloride, resulted
in death from corrosion of the gastrointestinal tract (Hughes and Trace v. 1993). The individual
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was exposed to methanol as well, which can cause respiratory (e.g., nasal) irritation (EPA.
2013c).
Small increases in corneal thickness and intraocular tension were reported after exposure of
rabbits to vapors of > 490 ppm methylene chloride reversible within 2 days after exposure
ceased. Following direct eye contact with methylene chloride (0.1 mL), rabbits exhibited
inflammation of the conjunctivae and eyelids and increases in corneal thickness and intraocular
tension. The effects were reversible within 3 to 9 days (Ballantvne ). NTP (1986) note
that inflammation and metaplasia in nasal cavities of rats exposed to methylene chloride may
have been due to irritation.
3.2.3.2 Genotoxicity and Cancer Hazards
EPA has identified several epidemiological studies published subsequent to the 2011 IRIS
assessment (U.S. EPA. ) as well as one animal bioassay. EPA evaluated these studies as
well as epidemiological and chronic animal bioassays from the IRIS assessment. The overall data
evaluation ratings for all studies evaluated for data quality are included in the tables throughout
this section.
A summary of genotoxicity and other mechanistic studies is also included here. EPA has not re-
evaluated genotoxicity studies for quality but is relying on previous assessments, such as the
IRIS assessment for detailed tables of genotoxicity study results. The conclusions regarding the
genotoxicity data for methylene chloride are summarized below.
3.2.3.2.1 Genotoxicity and MOA Information
Genotoxicity
Methylene chloride has been tested for genotoxicity in both in vivo and in vitro systems and in
mammalian and non-mammalian organisms. The following paragraphs summarize these results
and Appendix K presents detailed tables of results.
Positive results have generally been identified in systems that exhibit GST activity. Increased
frequencies of micronuclei and DNA damage were found in peripheral blood lymphocyte or
leukocyte samples from workers exposed to methylene chloride (Zeliezic et ai. 2016).
Studies in mice exposed to methylene chloride showed significant increases in chromosomal
aberrations in the lung (and bone marrow at the highest concentration) (Allen et at.. 1990);
micronuclei in peripheral erythrocytes (Allen et ai. 1990); and DNA damage in the liver, lung,
and peripheral lymphocytes (Sasaki et ai. 1998; Casanova et ai. 1996; Graves et ai. 1995;
Graves et ai. 1994b; Casanova et ai. 1992; Allen et ai. 1990). No DNA damage in livers and no
increases in gene mutations were observed in the livers of gpt delta mice after 4 weeks of
inhalation exposure to 800 ppm (Suzuki et ai. 2014). This was a lower exposure concentration
compared with the levels inducing DNA strand breaks (> 2000 ppm) or increased tumor
incidences. It is possible that CYP2E1 metabolism was not saturated at the lower concentrations,
limiting the formation of DNA-reactive GST metabolites.
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Fewer in vivo data are available for rats, but available information shows positive evidence for
DNA single strand breaks in rat liver after exposure to methylene chloride (Kitchin and Brown.
1989). Unlike mice, rats exposed via inhalation did not exhibit DNA SSBs in liver and lung cell
homogenates or hepatocytes at 2,000 ppm or higher (Graves et ai. 1995; Graves et at.. 1994b).
Similar to results for mice, methylene chloride did not induce unscheduled DNA synthesis
(UDS) in rat hepatocytes after inhalation (Trueman and Ashbv. 1987). An intraperitoneal UDS
study in rats was also negative (Mirsalis et at.. 1989). Also similar to the results in mice, rats
exposed to methylene chloride at a single 5 mg/kg intraperitoneal dose exhibited no DNA
adducts in liver or kidney cells (Watanabe et at.. 2007). Hamsters exposed to 4,000 ppm
methylene chloride via inhalation for 3 days did not exhibit DNA-protein cross links in liver or
lung cells (Casanova et at.. 1996).
In vitro testing in human cells and cell lines showed that methylene chloride induced micronuclei
(Doherty et at.. 1996) and sister-chromatid exchange (Olvera-Bello et at.. 20 i 0) and exhibited a
weak trend in DNA damage based on the comet assay (Land! et at.. 2.003). Methylene chloride
did not induce DNA single strand breaks (Graves et at... 1995) or DNA-protein cross-links
(Casanova et at.. 1997) in human cells.
Both mouse and rat hepatocytes showed DNA damage when incubated with methylene chloride
in vitro (Graves et a lb), and DNA-protein cross-links were observed in mouse (but not rat)
hepatocytes (Casanova et at... 1997). In mouse club lung cells tested in vitro, DNA damage was
induced by methylene chloride (Graves et at.. 1995). In vitro testing of hamster cells for forward
mutations, sister chromatid exchanges and DNA damage after methylene chloride exposure
generally showed negative results when testing was conducted without the addition of GST
activity from mice (Graves et at... 1995; Thitagar and Kumaroo. 1983; Jon gen et at.. 1981). When
GST activity was added in testing of hamster cells, positive results were seen for hprt mutation
(Graves et at.. 1996; Graves and Green. 1996). DNA damage (Hii et at.. 2.006; Graves and Green.
1996). and DNA-protein cross-links (Graves and Green. 1996; Graves et at.. 1994b).
Both forward and reverse mutagenicity testing of methylene chloride in bacteria (S. typhimurium
and E.coli) has yielded positive results both with and without exogenous metabolic activation,
generally in strains such as TA100 and TA98 that have higher GST activity (Demarini et at..
1997; Pegram et at.. 199 /; (>da et at... 1996; Graves et at.. 1994a; Roldan-Ariona and Puevo.
1993; Simula et at.. 1993; Thier et at.. 1993; Zi el en ska et at.. 1993; Dillon et; 2; Zeiger.
1990; Green. 1983; Osterman-Golkar et at.. 1983; Jon gen et at.. 1982; Gocke ^
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5595
5596
5597
5598
5599
5600
5601
5602
5603
5604
5605
5606
5607
5608
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5611
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Other Modes of Action
Limited data are available on other modes of action. Available data do not suggest that modes of
action other than genotoxicity are relevant. Kari et al. (1993) (cited in U.S. EPA (201IV) found
no evidence of cytotoxicity or proliferative non-neoplastic lesions preceding tumors in a series of
stop-exposure studies focused on the liver and lung. Also, sustained cell proliferation was not
observed in livers of female mice exposed to methylene chloride (Foley et al.. 1993) (cited in
U.S. EPA (2011)). There is no evidence of histologic changes or increased cell proliferation in
lung tissue of female B6C3F1 mice exposed to methylene chloride for up to 26 weeks (Kammo et
al.. 1993). Although acute exposure produced cell proliferation in bronchiolar epithelium, it was
not sustained with longer exposure; proliferation may have been a response to vacuolization of
club cells and may have involved a CYP metabolite (Foster et al.. 1994). Some cell proliferation
has been observed at higher concentrations (5250-14000 mg/m3) in lungs of mice but not at
lower concentrations (1750 mg/m3 and below) after acute exposure; data, however, are not
available after longer-term exposure (Casanova et al.. 1996). Finally, Aiso et al. ( )
identified significant increases in hyperplasia in terminal bronchioles in mice only at 14,000
mg/m3 whereas lung tumors were significantly increased at > 3510 mg/m3.
Data were not identified suggesting a receptor-mediated mode (e.g., peroxisome proliferation
resulting from PPAR-a activation; enzyme induction by constitutive androstane receptor (CAR),
pregnane X receptor (PXR), or aryl hydrocarbon receptor (AhR) activation).
3.2.3.2.2 Carcinogenicity
The potential carcinogenicity of methylene chloride has been evaluated in a number of human
epidemiological studies and animal cancer bioassays. These data are summarized by target tissue
(liver, lung, breast, hematopoietic, brain/CNS, and other neoplasms) below.
The human epidemiological data are inconclusive as to the association between liver and biliary
tract cancer and methylene chloride exposure (Table 3-5). Epidemiological data are limited to
four occupational cohort mortality studies of workers involved in CTA fiber (Gibbs et al.. 1996;
Lanes et al.. 1993) and film base production (Tomenson. 2011; Hearne and Pifer. 1999) with
contradictory findings, and a small cohort study of incident cholangiocarcinoma in Japanese
offset-proof print workers that did not show an association methylene chloride exposure
(Kumagai et al.. 2016).
Animal data (Also et al.. 2014a; NTP. 1986) provide clear and consistent evidence that
methylene chloride induces liver tumors in male and female mice (Tables 3-6 and 3-7).
Significant increases in the incidences of hepatocellular adenoma or carcinoma were observed in
male and female B6C3F1 and Crj:BDFl mice exposed via inhalation (Aiso et al.. 2014a; NTP.
1986). Male mice exposed by inhalation also exhibited a significant increase in the incidence of
hepatic hemangiomas in the study by Aiso (2014a). and both male and female mice in this study
showed significant exposure-related trends in the incidences of combined hemangiomas and
hemangiosarcomas. Increased incidences of hepatocellular adenoma or carcinoma were also
observed in male B6C3F1 mice exposed via drinking water (Serota et al.. 1986b; Hazleton
Laboratories. 1983). In rats there have been suggestive findings related to liver tumors, with a
significant increase in the incidence of hepatic neoplastic nodules or hepatocellular carcinomas
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5624 in female F344 rats after drinking water exposure (Serota et a 3a) and a significant dose-
5625 related trend in the incidence of hepatocellular adenoma or carcinoma in male F344/DuCrj rats
5626 after inhalation exposure (Also et al. 2014a).
5627
Table 3-5. Selected Effect Estimates for Epidemiological Studies of Liver Cancers
Reference
Type
S.MR/
IKK
95%
LCL
95%
I (1.
Study Quality
Evaluation
Liver and biliary tract
Lanes et al. (1993) (men and women)
SMR
2.98
0.81
7.63
Medium (1.8)
Lanes et al. (1993) (men and women: >10
yrs employment, > 20 yrs since first
employment)
SMR
5.83
1.59
14.92
Medium (1.8)
Hearne and Pifer ( )) (men)
SMR
0.42
0.01
2.36
High (1.6)
Gibbs et al. (1996) (men)
SMR
0.81
0.02
4.49
High (1.6)
Gibbs et al. (1996) (women)
SMR
(no exposed cases)
Tomenson et al. (2011) (men)
SMR
(no exposed cases)
Medium (1.7)
Cholangiocarcinoma
Kumagai et al. (2016)
IRR
0.45
0.11
1.77
Medium (1.7)
SMR = Standardized Mortality Ratio
IRR = incidence rate ratios
LCL = lower confidence limit
UCL = upper confidence limit
5628
Table 3-6. Summary of Significantly Increased Liver Tumor Incidences in Inhalation
Studies of Methylene Chloride
Male Mice
Concentration (nig/nr*)
0 1 35(H) 1 7000 1 14.000
Aiso et al. (2014a) (BDF1)
Hepatocellular adenoma
10/50A
13/50
14/50
15/50
Hepatocellular carcinoma
10/50A
9/50
14/50
20/50*
Hepatocellular adenoma or carcinoma
15/50A
20/50
25/50*
29/50*
Hepatic hemangioma
0/5 0A
4/50
3/50
5/50*
Hepatic hemangioma or hemangiosarcoma
1/50A
4/50
4/50
6/50
NT I' (1986) (B6C3F1)
Hepatocellular adenoma
10/50
NT
14/49
14/50
Hepatocellular carcinoma
13/50A
NT
15/49
26/50*
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Table 3-6. Summary of Significantly Increased Liver Tumor Incidences in Inhalation
Studies of Methylene Chloride
Hepatocellular adenoma or carcinoma
22/50A
NT
24/49
33/50*
I'cmalc Mice
( oneon)ration (mg/nr*)
0 1 35(H) 1 70(H) 1 14.000
Aiso et al. pi1' >oJ (F344/DuCrj)
Hepatocellular adenoma
1/50A
7/50*
4/49
16/50*
Hepatocellular carcinoma
1/50A
1/50
5/49
19/50*
Hepatocellular adenoma or carcinoma
2/5 0A
8/50*
9/49*
30/50*
Hepatic hemangioma or hemangiosarcoma
3/50A
2/50
0/49
7/50
NTP (1986) (F344)
Hepatocellular adenoma
2/5 0A
NT
6/48
22/48*
Hepatocellular carcinoma
1/50A
NT
11/48
32/48*
Hepatocellular adenoma or carcinoma
3/50A
NT
16/48*
40/48*
Male Kills
Concentration (mg/nr;)
0 1 3500 1 7000 1 14.000
Aiso et al. p^lSi) (F344/DuCrj)
Hepatocellular adenoma or carcinoma
1/50A
0/50
2/50
3/50
Study Quality Evaluation
Aiso et al. (2014a)
High (1.1)
NTP (1986)
High (1.3)
ASignificant dose-related trend (p<0.05)
*Significant pairwise comparison (p<0.05)
NT = not tested
5629
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5639
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5642
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Table 3-7. Summary of Significantly Increased Liver Tumor Incidences in Oral Studies of
Methylene Chloride
Hazleton Labs (1983); Serola el al., (1986b) (B6C3F1)
Dose (m«/k«-
dav)
Male Mice
0
61
124
177
234
Hepatocellular adenoma
10/125
20/200
14/100
14/99
15/125
Hepatocellular carcinoma
14/125
33/200
18/100
17/99
23/125*
Hepatocellular adenoma or carcinoma
24/125
51/200
30/100*
31/99*
35/125*
Serota et al. (1986a) (F344)
Dose (m«/k«-
dav)
I'cmalc Uals
0
6
58
136
263
Neoplastic nodules
0/135
1/85
2/85
1/85
3/85
Hepatocellular carcinoma
0/135
0/85
2/85
0/85
2/85
Neoplastic nodule or hepatocellular
carcinoma
0/135A
1/85
4/85*
1/85
5/85*
Study Quality Evaluation
Hazleton Labs (1983)
Serota et al. (1986b)
Medium (1.7)
Serota et al. (1986a)
High (1.3)
ASignificant dose-related trend (p<0.05)
*Significant pairwise comparison (p<0.05)
Most of the human data on lung cancer and methylene chloride exposure are not conclusive and
most do not show an association with methylene chloride (Table 3-8). Standardized mortality
rates for lung cancer were decreased (<1) in cohorts of CTA fiber or film workers (Tom en son.
2011; Heame and Pifer. 1999; Tom en son et at... 1997; Gibbs et at.. 1996; Lanes et at.. 1993). In
case-control studies, Vizcaya ( ) and Mattei (2014) found no excess risk of lung cancer
among men with occupational exposure to methylene chloride. Although Mattei (2014) observed
an increased risk of lung cancer among women, further analysis indicated that the increase was
largely attributable to perchloroethylene exposure.
Siemiatycki (1991). on the other hand, identified an increased risk (at significance level of p =
0.10) in a case-control study in males aged 35-70 in the Montreal area. Some studies that used
population mortality rates and that were conducted using employees of companies with no-
smoking policies may have been confounded by differences in smoking rates among the exposed
and non-exposed populations.
In animal studies, methylene chloride produced large, statistically significant increases in lung
tumor incidences in male and female mice exposed by inhalation (Also et at.. 2014a; NTP.
1986).
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There was also some evidence for production of lung tumors in mice by oral exposure to
methylene chloride (see Table 3-9). Maltoni (1988) reported a nonsignificant dose-related trend
for higher incidences of pulmonary adenomas in male, but not female, mice in an oral gavage
study that was, however, terminated at 64 weeks due to high mortality. A 2-year drinking water
study did not find any increase in lung tumor incidence in male or female mice (Serota et at..
1986b). Lung tumors were not increased by methylene chloride in rats or hamsters by inhalation
or oral exposure (Maltoni et at.. 1988; Nitschke et at... 1988a; NTP. 1986; Serota et at.. 1986a;
Burek et at.. 1984).
Table 3-8. Selected Effect Estimates for Epidemiological Studies of Lung Cancers
Reference
Type
SMR/
OK
95%
IX 1.
95%
1 CI.
Study
Quality
Kvaluation
Lanes et al. (1993) (men and women)
SMR
0.80
0.43
1.37
Medium (1.8)
Hearne and Pifer ( )) (men)
SMR
0.75
0.49
1.09
High (1.6)
Tom en son et al. (2011) (men)
SMR
0.48
0.31
0.69
Medium (1.7)
Gibbs et al. (1996) (men)
SMR
0.55
0.31
0.91
High (1.6)
Gibbs et al. (1996) (women)
SMR
2.29
0.28
8.29
High (1.6)
Vizcaya et al. (1 )
OR
1.1
0.6
1.9
Medium (1.9)
Mattei et al. (2014) (women)
OR
1.38
0.74
2.57
Medium (1.8)
Siemiatvcki et al. (1991) (all lung)
OR
3.8
1.2
12.0
Medium (1.7)
Siemiatvcki et al. (1991) (squamous cell)
OR
4.0
0.9
17.3
Medium (1.7)
AORs are for substantial exposure. Siemiatycki et al. (1991) also presents ORs for 'any' exposure, which are lower than for
substantial exposures. Also, the LCL and UCL are the 90%ile values, not 95%ile values.
Table 3-9. Summary of Significantly Increased Lung Tumor Incidences in Inhalation
Studies of Methylene Chloride
Male Mice
Concent rat ion (mg/iir*)
0 1 35(H) 1 7000 1 14.000
Aiso et al. (2014a) (BDF1)
Bronchoalveolar adenoma
7/50A
3/50
4/50
14/50
Bronchoalveolar carcinoma
1/50A
14/50*
22/50*
39/50*
Bronchoalveolar adenoma or carcinoma
8/5 0A
17/50*
26/50*
42/50*
NTP (1986) (B6C3F1)
Bronchoalveolar adenomas
3/50A
NT
19/50*
24/50**
Bronchoalveolar carcinomas
2/5 0A
NT
10/50*
28/50*
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5663
5664
5665
5666
5667
5668
5669
5670
5671
5672
5673
5674
5675
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5677
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Table 3-9. Summary of Significantly Increased Lung Tumor Incidences in Inhalation
Studies of Methylene Chloride
Bronchoalveolar adenomas or carcinomas
5/50A
NT
27/50*
40/50*
I'cmalc Mice
0
35(H)
7000
14.000
Aiso et al. (2014a) (BDF1)
Bronchoalveolar adenomas
2/5 0A
4/50
5/49
12/50*
Bronchoalveolar carcinomas
3/50A
1/50
8/49
20/50*
Bronchoalveolar adenomas or carcinomas
5/50A
5/50
12/49*
30/50*
Bronchoalveolar adenoma or carcinoma or
adenosquamous carcinoma
5/50A
5/50
12/49*
30/50*
NTP (1986) (B6C3F1)
Bronchoalveolar adenomas
2/5 0A
NT
23/48*
28/48*
Bronchoalveolar carcinomas
1/50A
NT
13/48*
29/48*
Bronchoalveolar adenomas or carcinomas
3/50A
NT
30/48*
41/48*
Study Quality Evaluation
Aiso et al. (2014a)
High (1.1)
NTP (1986)
High (1.3)
ASignificant dose-related trend (p<0.05)
*Significant pairwise comparison (p<0.05)
The available epidemiological data on breast cancer, including two occupational cohort mortality
studies, a prospective population cohort study and a case-control study, provide inconclusive
results (Table 3-10). The mortality rate for breast cancer was less than unity in a cohort of CTA
fiber production workers (Lanes et at.. 1993). but an elevated HR was reported among Air Force
base employees (Radiean et at.. 2008). Because exposure at the Air Force base was
predominantly trichloroethylene, the CTA cohort provides greater specificity for methylene
chloride. A case control study by Cantor (1995) showed increased ORs for breast cancer among
women with the highest exposure probability; however, this study estimated exposure based on
occupation reported on death certificates, instead of detailed job history obtained by in-person or
proxy interview. Garcia (2015) found no increased risk when using modeled outdoor air
concentrations from emissions (EPA NAT A). A summary measure of multiple pollutants also
did not yield an increased HR (HR = 1.05).
Animal data provide some evidence that methylene chloride induces mammary tumors in male
and female rats following inhalation exposure (Table 3-11). These incidences of mammary gland
fibroadenoma were significantly increased in male F344/DuCrj rats (Also et at.. 2.014a) and
female F344 rats (NTP. 1986) exposed to methylene chloride via inhalation. Exposure-related
trends were reported for both sexes. The incidence of this tumor was higher, and occurred at a
lower concentration, in female rats compared to males. Significant increases were also reported
in male rats for the combined incidences of mammary gland fibroadenoma or adenoma (Also et
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5681 at.. 2014a) and adenoma, fibroadenoma, or fibroma CNTP. 1986). In female rats, the combined
5682 incidence of adenoma, fibroadenoma, or adenocarcinoma was increased (K 16). A
5683 significant dose-related trend was observed in the incidence of benign mammary tumors in male
5684 Sprague-Dawley rats (Burek et a I j_2S4). Chronic inhalation studies in mice and chronic oral
5685 studies in rats and mice did not demonstrate an increased incidence of mammary tumors.
5686
Table 3-10. Selected Effect Estimates for Epidemiological Studies of Breast Cancers
Reference
Type
S.MR/
OK/
Ilk
95%
IX 1.
95%
1 CI.
Study
Quality
Kvaluation
Lanes et al. (1993)
SMR
0.54
0.11
1.57
Medium (1.8)
Radican et al. (2008)
HR
2.36
0.98
5.65
Medium (1.8)
Cantor et al. (1995) white women
OR
1.17
1.1
1.3
High (1.6)
Cantor et al. (1995) black women
OR
1.46
1.2
1.7
High (1.6)
Garcia et al. (2015)
HR
1.04
0.96
1.13
High (1.5)
5687
Table 3-11. Summary of Significantly Increased Mammary Tumor Incidences in
Inhalation Studies of Methylene Chloride
Male Uats
Concentration (ing/nr*)
0 1 35(H) 1 70(H) 1 14.000
Aiso et al. (2014a) (F344/DuCri)
Mammary gland fibroadenoma
1/50A
2/50
3/50
8/50*
Mammary gland fibroadenoma or
adenoma
2/5 0A
2/50
3/50
8/50*
Mammary gland fibroadenoma or
adenoma or adenocarcinoma @
3/50A
2/50
3/50
8/50
NTP (1986) (F344)
Mammary gland subcutaneous tissue
fibroma or sarcoma #
1/50A
1/50
2/50
5/50
Mammary gland fibroadenoma
0/5 0A
0/50
2/50
4/50
Mammary gland or subcutaneous
tissue adenoma, fibroadenoma, or
fibroma
1/50A
1/50
4/50
9/50*
Burek et al. (1984) (Sprague-Dawlev)
Concentration (ing/nr*)
0 | ISOO | 5300 | 12.000
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5690
5691
5692
5693
5694
5695
5696
5697
5698
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Table 3-11. Summary of Significantly Increased Mammary Tumor Incidences in
Inhalation Studies of Methylene Chloride
Benign mammary tumors
7/92A
3/95
7/95
14/97
l''emalc Uals
0
Concent ration (nig/nr*)
35(H) | 70(H)
14.000
Aiso et al. (2014a) (F344/DuCri)
Mammary gland fibroadenoma
7/50A
7/50
9/50
14/50
Mammary gland fibroadenoma or
adenoma
7/50A
8/50
10/50
14/50
Mammary gland fibroadenoma or
adenoma or adenocarcinoma @
7/50A
9/50
10/50
14/50
NTP (1986) (F344)
Mammary gland fibroadenoma
5/50A
11/50*
13/50*
22/50*
Mammary gland adenoma,
fibroadenoma, or adenocarcinoma #
6/5 0A
13/50
14/50*
23/50*
Nitschke et al. (1988a) (Spr ague-Daw lev)
Concent rat ion (ing/nr*)
0
ISO
700
IS00
Benign mammary tumors
52/70
58/70
61/70*
55/70
Study Quality Evaluations
Aiso et ai (2014a)
High (1.1)
Burek et ai (1984)
High (1.5)
Nitschke et ai (1988a)
High (1.3)
NTP (1986)
High (1.3)
ASignificant dose-related trend (p<0.05)
*Significant pairwise comparison (p<0.05)
@ Adenocarcinomas were observed in 0, 2, 1 and 0 female rats at 0, 3500, 7000 and 14,000 mg/m3; no malignant
tumors were seen in male rats
# Sarcoma incidence was observed in 1 male at the highest concentration (14,000 mg/m3); Adenocarcinomas/
carcinomas were observed in 1, 2, 2 and 0 female rats at 0, 3500, 7000 and 14,000 mg/m3
As presented in Table 3-12, the association between various hematopoietic cancers and exposure
to methylene chloride has been examined in occupational cohort mortality studies (Tomenson.
2011; Radican et ai. 2008; Heame and Pifer. 1999) and population-based case control studies
(Christensen et al. 201 J, VIorales-Suarez-Varela et ai. 2013; Barry et ai. 2011; Gold et ai.
2010; Wang et ai. 2009; Costantini et ai. 2008; Seidler et ai. 2007; Mitigi et ai. 2006).
Findings were inconsistent and inconclusive for most categories of hematopoietic cancers
(leukemia, multiple myeloma, Hodgkin lymphoma, non-Hodgkin lymphoma (NHL)). However,
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ORs for B-cell subtypes of NHL were consistently increased in three case-control studies that
evaluated this tumor type (Barry et ai. 2011; Seidler et at.. 2007; Miligi et at.. 2006). For
example, Miligi (2.006) identified an OR for B cell NHL of 3.2, which was higher than the ORs
for all other chemicals studied. Despite these more consistent results for B-cell NHL, the studies
did not control for other chemical exposures. In addition, there was evidence (e.g., for Miligi
(2.006) that some chemical exposures were highly correlated and other chemicals were also
associated with the outcomes of interest, making it difficult to attribute effects to methylene
chloride alone. NTP (1986). Mennear et al.(1988) (which is the published version of NTP
(1986)) and Aiso et al. (2014a) each reported an increased incidence of mononuclear cell
leukemia in female (but not male) rats (Table 3-13). However, the incidences did not exhibit
monotonic dose-response relationships.
Table 3-12. Selected Effect Estimates for Epidemiological Studies of Hematopoietic
Cancers
Reference
Type
SMR/
OR/
HR
95%
LCL
95%
UCL
Study Quality
Evaluation
Non-Hodgkin Lymphoma (NHL)
Hearne and Pifer (1999)
SMR
0.49
0.06
1.78
High (1.6)
Radican et al. (2008) (men)
(women)
HR
2.02
0.76
5.42
High (1.8)
No observed NHL
deaths
Miligi et al. (2006)
OR
1.7
0.7
4.3
High (1.6)
Wang et al. (2009)
OR
1.5
1.0
2.3
Medium (1.7)
Christensen et al. (2013)
OR
0.6
0.2
2.2
Medium (2.0)
B-cell NHL
Seidler et al. (2007)
OR
2.7
0.5
14.5
High (1.5)
Barrv et al. (2011)
(diffuse large B-cell lymphoma)
OR
2.10
1.15
3.85
High (1.6)
Miligi et al. (2006)
(small lymphocytic lymphoma*)
OR
3.2
1.0
10.1
High (1.6)
T-cell NHL (Mycosis Fungoides)
Morales-Suarez-Varela et al. ( ) (women)
OR
2.90
0.45
15.72
High (1.6)
Hodgkin Lymphoma
Hearne and Pifer (1999)
SMR
1.82
0.20
6.57
High (1.6)
Seidler et al. (2007)
OR
0.7
0.2
3.6
High (1.5)
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Table 3-12. Selected Effect Estimates for Epidemiological Studies of Hematopoietic
Cancers
Multiple Myeloma
Hearne and Pifer (1999)
SMR
0.68
0.01
3.79
High (1.6)
Radican et al. (2008) (men)
(women)
HR
2.58
0.86
7.72
No observed multiple
myeloma deaths
Gold et al. (2010)
OR
2.0
1.2
3.2
Mediuma
Leukemia
Hearne and Pifer ( ))
SMR
2.04
0.88
4.03
High (1.6)
Hoechst Celanese Corporation, (1992)b
(Maryland cohort)
SMR
1.9
0.51
4.8
Medium (1.9)
Hoechst Celanese Corporation.(1992 )h
(South Carolina cohort)
SMR
0.90
0.02
3.71
Medium (1.9)
Tomenson et al. (2011)
SMR
1.11
0.36
2.58
Medium (1.7)
Costantini et al. (2.008)
OR
0.5
0.1
2.3
Medium (1.7)
Costantini et al. (2.008)
(chronic lymphocytic leukemia*)
OR
1.6
0.3
8.6
Medium (1.7)
Infante-Rivard et al. (2005)
OR
3.22
0.88
11.7
High (1.5)
*These two diagnoses differ only in how they present (leukemia or lymphoma presentation).
a Downgraded from High (1.6)
b Also cited as Gibbs <19921 in U.S. EPA <2011).
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Table 3-13. Summary of Mononuclear Cell Leukemia Incidences in Inhalation Studies of
Methylene Chloride
Concent ration (nig/nr*)
Male Kills
0
3500
7000
14.000
Aiso et al. (2.014a) (F344/DuCri)
3/50
3/50
8/50
4/50
NTP (1986) (F344/N)
34/50
26/50
32/50
35/50
Concent ration (ing/nr')
I'einale Uals
0
3500
7000
14.000
Aiso et al. (2014a) (F344/DuCri)
2/5 0A
4/50
8/50*
7/50
NTP (1986) (F344/N)
17/50
17/50
23/50#
23/50#
Study Quality Evaluations
Aiso et al. (2014a)
High (1.1)
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Table 3-13. Summary of Mononuclear Cell Leukemia Incidences in Inhalation Studies of
Methylene Chloride
NTP (1986) High (1.3)
indicates statistically significant exposure-related trend
indicates statistically significant difference from concurrent control.
#¦
Statistically significant difference from concurrent control by life table test.
Epidemiological data on brain and CNS tumors after methylene chloride exposure are
inconclusive (see Table 3-14). Two occupational cohort studies ("Tom en son. 2011; Heame and
Pifer. 1999) reported non-significantly elevated SMRs for brain and CNS cancers. Two case-
control studies reported slightly increased ORs (Cocco et ai. 1999; Heineman etai. 1994). The
OR (1.2) reported by Cocco (1999) was statistically significantly increased. This study used an
imprecise exposure assessment based on occupation reported on each subject's death certificate,
and it is not known how the OR would change with more precise exposure information. Two
case-control studies with more robust exposure assessments (Ruder et al.. M \ Neta et ai.
2012.) did not show increases in the ORs for two of the most common brain cancers (gliomas and
meningiomas). The only animal evidence of brain or CNS tumors is the observation of low
incidences of rare astrocytomas in methylene chloride-exposed Sprague-Dawley rats with
incidences of 0, 1, 2, 1 (per 70 males/group) at 0, 50, 200, or 500 ppm (0, 175, 702, or 1755
mg/m3) (Nitsehke et al.. 1988a). No brain or CNS tumors were observed in F344 rats or in mice
exposed by inhalation to higher concentrations (Also et al.. iO I Jj; NT > Uhi)-
Table 3-14. Selected Effect Estimates for Epidemiological Studies of Brain and CNS
Cancers
Reference
Type
SMR/OR/
HR
95%
LCL
95%
UCL
Study
Quality
Evaluation
Tumor type not specified
Hearne and Pifer (1999) (New
York)
SMR
2.16
0.79
4.69
High (1.6)
Tomenson et al. (2011) (U.K.)
SMR
1.83
0.79
3.60
Medium (1.7)
Heineman et al. (1994) (U.S.)
OR
1.3
0.9
1.8
Medium (2.2)
Cocco etal. (1999) (U.S.)
OR
1.2
1.2
1.3
Medium (1.9)
Meningioma
Cocco etal. (1999) (U.S.)
OR
1.2
0.7
2.2
Medium (1.9)
Neta et al. (: )(U.S.)
OR
1.6
0.7
3.5
High (1.5)
Glioma
Neta et al. (! )(U.S.)
OR
0.8
0.6
1.1
High (1.5)
Ruder etal. (2013) (U.S.)
OR
0.8
0.66
0.97
High (1.6)
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Epidemiological studies provide limited data regarding other cancers. Carton et al. (20171
assigned a data quality score of medium (1.8), found no association between methylene chloride
exposure and risk of squamous cell carcinoma of the head and neck in a case-control study of
women in France. Dosemeci et al. (1999) found no increased risk of renal cell carcinoma in a
population case-control study in Minnesota from exposure to methylene chloride estimated based
on job matrices; this study was given a data quality rating of medium (1.9). Purdue et al. (2.016)
presents results of a sub-study within the population case-control U.S. Kidney Cancer Study and
did not identify a statistically significant increase in kidney cancer. The ORs in this study for
lower exposure probability groups were 1.2 (95% CLO.6-1.4 in the lowest group) and the OR for
the highest exposure probability group was 0.9 (95% CI: 0.6-1.6). Thus, no trend regarding
increased risk was identified for the higher likely exposure group. Purdue et al (2.016) received a
high (1.4) data quality rating. Siemiatycki (1991). in a case-control study, identified an increased
risk of rectal cancer (OR = 4.8; 90% CI: 1.7-13.8) among males aged 35-70 in the Montreal area
identified as having significant exposure to methylene chloride (using a significance level of p =
0.10). This study received a data quality rating of medium (1.7).
Studies of other cancers in mice or rats exposed by inhalation reported increased incidences or
dose-related trends in the incidences of adrenal gland pheochromocytomas, subcutaneous
fibromas or fibrosarcomas, and endometrial tumors (Also et al.. 2014a): mesotheliomas (Also et
al... 2014a: NTP. 1986): hemangiomas or hemangiosarcomas (NTP. 1986): or salivary gland
sarcomas (Burek et al.. 1984). In general, these tumors occurred at low frequency and were not
consistent across studies, species, or sexes, and the findings, therefore, are considered equivocal.
3.2.4 Weight of Scientific Evidence
The following sections describe the weight of the scientific evidence for both non-cancer and
cancer hazard endpoints. Factors considered in weighing the scientific evidence included
consistency and coherence among human and animal studies, quality of the studies (such as
whether studies exhibited design flaws that made them unacceptable) and biological plausibility.
Relevance of data was considered primarily during the screening process but may also have been
considered when weighing the evidence.
3.2.4.1 Non-Cancer Hazards
The following sections consider and describe the weight of the scientific evidence of health
hazard domains discussed in Section 3.2.3.1. These domains include: toxicity from acute/short-
term exposure; liver effects; nervous system effects; immune system effects; reproductive and
developmental effects; and irritation/burns.
3.2.4.1.1 Toxicity from Acute/Short-Term Exposure
Medium confidence human experimental studies of objective measures indicate that CNS
depression is a sensitive and common effect after acute exposure (e.g., (Putz et al.. 1979:
Winneke I' j J, Su'wart et al.. 1972)). Although Stewart et al. (1972) also evaluated subjective
symptoms, these results were given a low confidence rating due to lack of blinding. Information
from case reports of accidental or large exposures supports this conclusion (Nrc. 2008). Data
suggest that increased COHb levels result in CNS depression (Putz et al.. 1979) but also support
an independent and possible additive effect of methylene chloride with COHb levels based on a
weaker (or no) effect on the nervous system from exogenous CO compared with methylene
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chloride administration (Putz et al. 1979; Winneke. 1974). Although COHb can continue to rise
after exposure has ceased and thus COHb may still be relevant at longer time points, both Putz
(1979) and Winneke (1974) were conducted for 3.8 or 4 hrs, and EPA considers Putz (1979) to
still be relevant for an 8-hr duration.
The nervous system effects are supported by inhalation toxicity data in animals showing CNS
depression with decreased motor activity, changes in responses to sensory stimuli and some
impairment of memory ( ). Data from oral animal studies also identified nervous
system effects that include sensorimotor and neuromuscular changes after acute and short-term
exposure as well as excitability, autonomic effects, decreased activity and convulsions (one rat)
after short-term exposure (Moseretai. 1995; General Electric Co. 1976a).
Cardiotoxicity has been rarely reported as the sole cause of deaths or poisonings from methylene
chloride and is not identified as the most sensitive effect in available evidence (Nac/Aegl. 2008;
AT SDR. 2000).15 However, during exercise, cardiac patients have been identified as
experiencing angina more quickly after CO exposure and resulting increases in COHb
(Nac/Aegl. 2008). Based on this evidence and the limited data that does suggest some association
between methylene chloride and cardiac endpoints, EPA considers that increased COHb levels
resulting from inhalation exposure to methylene chloride may also result in adverse effects in
individual with cardiac disease, a sensitive subpopulation. Data are available from human
toxicokinetic studies that link increased methylene chloride exposure to increased COHb levels
in blood; many of these studies (Andersen et al.. 1991; Divincenzo and Kaplan. 1981; Peterson.
1978; Astrand et al.. 1975; Ratnev et al.. 1974) were used as the basis of the SMAC.
Although acute effects other than CNS effects have been reported in human and animal studies
(such as liver or lung effects), they are less often reported, based on inconclusive evidence or are
not as sensitive (e.g., reported in lethal or non-lethal case reports after exposure to high or
expected high methylene chloride concentrations) (Nac/Aegl. 2.008). Furthermore, although
NAC/AEGL (2008) report effects in lungs, liver and kidneys after acute high exposures,
methylene chloride concentrations are most often highest in the brain after acute lethal
concentrations.
Liver and lung effects were seen in an acute inhalation study in rodents but at higher
concentrations and lung effects appeared to be transient (Shell Oil. 1986). Immunosuppressive
effects were observed in rats after acute exposure to 100 ppm, a lower air concentration than the
levels associated with CNS effects observed in human studies (Aranyt et al.. 1986). However,
immune effects were not considered for dose-response analysis because data are sparse and
inconclusive when considered along with the human data on immune system effects (see Section
3.2.4.1.3).
Overall, there is evidence to support adverse effects following acute methylene chloride
exposure that include nervous system effects and the potential for adverse cardiac-related effects
15 Tomenson (2011). Lanes et al. (1993) and Hearne and Pifer (1999) did not identify an increased risk of mortality from
cerebrovascular disease or ischemic disease in three cohorts of workers producing cellulose triacetate film/fiber. These studies
received data quality scores of medium (1.7), medium (1.8) and high (1.6), respectively.
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from increased COHb in people with underlying cardiac conditions or heart disease. Therefore,
effects resulting from acute exposure were carried forward for dose-response analysis.
3.2.4.1.2 Liver Effects
Most human epidemiological studies did not investigate non-cancer liver effects. Of the
identified studies that measured changes in liver enzymes, two found evidence of increased
serum bilirubin (General Electric Co. 1990; Ott et at.. 1983a). General Electric Co. (1990)
received a data quality rating of medium (1.9).
Both inhalation and oral studies identified liver effects as sensitive non-cancer effect linked with
exposure to methylene chloride in animals. Vacuolization, necrosis, hemosiderosis and
hepatocellular degeneration have been identified in subchronic and chronic inhalation studies in
rats, mice, dogs and monkeys (Mennear et at.. 1988; Nitschke et at.. 1988a; NTP. 1986; Burek et
at.. 1984; Haun et at.. 1972; Haun ) A newer study (Also et at.. 2014a) identified
acidophilic and basophilic foci in rats but not mice after chronic inhalation exposure. An oral
study also identified altered liver foci (Serota et at.. 1986a). In both studies, liver foci were not
correlated with tumors, and thus, EPA considers them to be non-neoplastic. Chronic studies and
a couple newly identified studies received high data quality ratings.
Fatty liver, a more severe effect compared with vacuolization, was seen in rats and dogs (Haun et
at... 1972; Haun et at.. 1971); oral studies also identified fatty liver in mice and rats (Serota et at..
1986a. b). Based on these fatty liver changes that can be considered a more severe effect and
progression from vacuolization, U.S. EPA (2011) suggested that vacuolization should be
considered toxicologically adverse and not simply an adaptive change.
U.S. EPA (2.011) noted that limited MOA studies are available for methylene chloride regarding
non-cancer liver effects. Newer information is also limited and does not offer significant insight
into the MOA as it relates to non-cancer liver toxicity. The changes in gene and protein
expression measured in several studies (Park and Lee. 2.014; Kim, et at.. 2013; Kim et at.. 2.010)
do not easily suggest specific modes of action. Although Chen (2013) identified increased biliary
excretion of GSH and increased bile secretion, again, it is not clear how these changes inform the
vacuolization, necrosis and other apical effects observed in animal studies. Dzul-Caamal (2013)
identified lipid peroxidation and oxidation of proteins in livers of fish exposed to methylene
chloride. Lipid peroxidation affects lipids directly but can also produce electrophiles and free
radicals that can react with DNA and proteins (Gregus. 2008).
Overall, based on limited human evidence and evidence in multiple animal species from highly
rated studies, there is evidence to support non-cancer liver effects following methylene chloride
exposure. Therefore, this hazard was carried forward for dose-response analysis.
3.2.4.1.3 Immune System Effects
Overall, human, animal and mechanistic studies provide suggestive but inconclusive evidence of
methylene chloride's association with immune-related outcomes.
Among the epidemiological studies, which received medium to high confidence ratings, three
studies suggested an association between methylene chloride and immune-related, or possible
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immune-related, outcomes. Chaigne, et al. (2015) identified high-magnitude ORs spanning 9-11
(95% CI: 2.38-51.8) for methylene chloride's association with Sjogren's syndrome, an
autoimmune disorder. Radican et al. (2008) also identified a high magnitude HR of 9.21 (95%
CI: 1.03-82.7) for increased mortality from bronchitis, a less specific and not clearly immune-
related endpoint. Finally, Hoechst Celanese Corporation (1992) found some elevation of
mortality from flu and pneumonia associated with methylene chloride exposure (SMR 1.25 for
males and 4.36 for females) that was not statistically significant. Despite these suggested
associations, all studies had limited information on methylene chloride exposure, none controlled
for other chemicals and Radican et al. (2008) investigated a non-specific outcome and used
exposed and comparison populations with very different socioeconomic status.
Two additional epidemiological studies found no or decreased associations with methylene
chloride. Hearne and Pifer (1999) observed decreased mortality rates from infection or and Lanes
et al. (1993) found no increase in mortality from non-malignant respiratory disease. These two
studies used general population death rates and thus, the healthy worker effect may have resulted
in attenuation of any possible association with methylene chloride.
Although one animal study is suggestive for immune-related effects, the body of scientific
evidence from animals is also inconclusive. Aranyi (1986). a medium quality study, investigated
and identified increased mortality due to infection and impaired bacterial clearance and
bactericidal activity. In contrast, Warbrick et al. (2003). a high-quality study, found no
differences in IgM antibody responses among methylene chloride-exposed rats compared with
controls. Warbrick et al. (2003) reported decreased spleen weights in female rats, yet multiple
two-year studies found no histopathological changes in spleens, lymph nodes, or thymi of rats. In
addition, evidence is not available from other animal studies regarding changes in immune cell
populations. Although there is some evidence for immunosuppression from Aranyi (1986). EPA
cannot easily conclude from animal studies that methylene chloride results in immunotoxicity-
related effects due to a limited database and lack of association among other studies with
changes in immune cells or organs.
Data on modes of action are very limited. Methylene chloride may result in anti-inflammatory
effects (as evidenced by changes in specific cytokines demonstrated by Kubulus (2008)). but it
has also been associated with generation of ROA (Uraga-Tovar et al.. 2014). It is possible that
multiple mechanisms may be at work, but with such limited data, EPA cannot conclude on a
specific MOA for methylene chloride has a specific MOA.
Overall there is some evidence to support immune system effects following methylene chloride
exposure, but data are sparse and inconclusive. Therefore, this hazard was not carried forward
for dose-response analysis.
3.2.4.1.4 Nervous System Effects
CNS Depression and Spontaneous Activity
Based on the availability of multiple studies in humans and animals, CNS depression is a
primary neurotoxic effect associated with methylene chloride. Mechanism studies are not
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definitive for this endpoint. Increased dopamine in the medulla and increased GABA and
glutamate in the cerebellum by methylene chloride may be part of the MOA for these effects
(Kanada et ai. 1994); however, this study did not measure functional changes so firm
conclusions regarding the MOA for CNS depression and motor changes are not possible. Studies
have not been conducted to evaluate the neurochemical basis for changes in spontaneous activity
for methylene chloride (Bale et ai. 2011).
Lash et al. (1991) identified decreased attention and complex reaction tasks among retired
aircraft maintenance workers (data quality rating of medium, 1.8). Although this study suggests a
possible chronic nervous system effect, the effect was observed in only one study and was not
statistically significant and so it is difficult to make conclusions from this study.
Although the MOA is not clearly delineated, multiple human and animal studies indicate that
methylene chloride is associated with nervous system effects. Based on this evidence, EPA
determined that methylene chloride should be brought forward for dose-response modeling.
Specifically, CNS effects are brought forward for dose-response modeling of effects from
acute/short-term exposure.
Other Nervous System Effects
Five epidemiological studies have evaluated the association between measured and modeled
outdoor ambient air concentration estimates of many air pollutants (often starting with the 33-37
HAPs, although Roberts et al. (2013) investigated many more pollutants) and ASD for regions
across the U.S. (Talbott et al.. 201 von Ehren stein et al. 2014; Roberts et al.. 2013;
Kalkbretroer et al.. 2010; Windham et al.. 2006).
EPA has not advanced the ASD hazard to dose-response for several reasons. First, there are
uncertainties in the modeled estimates of air concentrations from NATA. Specifically, the NATA
data are annual average concentrations from the year of the pregnancy or within a few years of
the pregnancy. However, an etiologically relevant time period of exposure for ASD is thought to
be the perinatal period (Fetch et al.. 2.019; Kalkbrenner et al. 2010; Rice and Barone. 2.000) and
the lack of temporal specificity of the NATA data is a potential limitation. Further, a smaller
association was observed when considering average monthly measured outdoor air
concentrations within 3.5 miles of the pregnant women's residences (von Ehren stein et al.. 2014)
compared with using the annual NATA results (modeling of measured air emissions) in the other
four studies. The observation that the locally measured exposure data which was more precisely
matched to the perinatal period showed smaller effect sizes than the results based on the less
wellmatched NATA-based results somewhat decreases confidence in the overall association.
These studies do not provide exposure estimates for workers (e.g., nurses) or indoor exposure
estimates for consumer products or indoor exposure estimates for the general population. The
current studies all address multi-pollutant exposures either within the same regression models or
by correlations among chemicals and are hypothesis generating.
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3.2.4.1.5 Reproductive and Developmental Effects
Epidemiological studies sometimes identify reproductive/developmental effects, including oral
cleft defects in mothers older than 35 years and heart defects in mothers of all ages (Brender et
ai. 2014) and spontaneous abortions (Taskinen et at.. 1986). However, these studies didn't
directly consider co-exposures within the same model as methylene chloride. Brender et al.
(2014) ran independent analyses with other chemicals, which showed associations in mothers of
all ages or showed more positive associations. Taskinen et al. (1986) found that other chemicals
resulted in similar magnitude of spontaneous abortions and furthermore, received a low data
quality rating.
Some animal studies (Bornschein et al.. 1980; Hardin andManson. 1980; Schwetz et al.. 1975)
identified effects but these were observed at higher concentrations (1,250 or 4,500 ppm).
Although Raje et al (1988) identified reduced fertility at 144 ppm, results failed to reach
statistical significance in two of three statistical tests. Three oral reproductive/ developmental
studies (Narotsky and Kavlock. 1995; Nitschke et al.. 1988b; General Electric Company. 1976)
didn't identify reproductive and developmental toxicity. Also, multiple animal studies used only
a single concentration.
Therefore, although some studies identify reproductive and developmental effects,
epidemiological studies lacked controls for co-exposures, animal studies observed effects mostly
at higher methylene chloride concentrations in animals and EPA identified no relevant
mechanistic information. Thus, EPA did not carry reproductive/developmental effects forward
for dose-response.
3.2.4.1.6 Irritation/Burns
Data from case reports, an occupational study and animal data indicate that irritation is possible.
Based on direct contact from accidents or suicide attempts, methylene chloride has been shown
to result in burns to the eyes and skin (ATSDR. 2000; Hall and Rumac )). Gastrointestinal
tract irritation is also expected, and was suggested in a suicide case, assuming methylene
chloride was the causative agent (Hughes and Tracev. 1993). Irritation has been identified after
inhalation of methylene chloride vapor in some cases (Anundi et al.. 1993) but not others
(Stewart et al.. 1972.).
Documentation that supports the OSHA (1997a) standard notes that methylene chloride may lead
to a burning sensation if it remains on skin but notes that after short-term exposure, it is not
corrosive. OSHA (1997a) states that individuals should avoid skin contact based on its irritating
properties.
Based on data from humans and animals, there is evidence that methylene chloride is associated
with irritation and possible burning of skin, eyes and mucous membranes. A full elucidation of
the circumstances leading to irritation is not available because studies in humans are limited and
it is not easy to quantify these effects. For these reasons, irritation and burns will not be carried
forward for dose-response modeling.
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3.2.4.2 Genotoxicity and Carcinogenicity
There is sufficient evidence of methylene chloride carcinogenicity from animal studies.
Methylene chloride produced tumors at multiple sites, in males and females, in rats and mice, by
oral and inhalation exposure, and in multiple studies. The most prominent findings were
significant increases in liver (hepatocellular adenoma/carcinoma) and lung (bronchoalveolar
adenoma/carcinoma) tumor incidences in male and female B6C3F1 and Crj:BDFl mice by
inhalation exposure in two separate bioassays (Also et at.. 2014a; NTP. 1986). liver tumors in
male B6C3F1 mice exposed via drinking water (Serota et at.. 1986b; Hazleton Laboratories.
1983). and mammary gland tumors (adenoma/fibroadenoma) in male and female F344/N and
F344/DuCrj rats exposed by inhalation in two separate bioassays (Also et at... ; NTP.
1986). Other findings potentially related to treatment included increases in liver tumors in male
rats with inhalation exposure (Also et at.. 2014a) and female rats with drinking water exposure
(Serota et at.. 1986a; Hazleton Laboratories. 1983); hemangiomas/hemangiosarcomas in male
and female mice by inhalation exposure (Also et at.. 2014a); mononuclear cell leukemia in
female rats by inhalation exposure (Also et at.. 2014a; NTP. 1986); mesotheliomas,
subcutaneous fibromas/fibrosarcomas, and salivary gland sarcomas in male rats by inhalation
exposure (Also et at.. 2.014a; NTP. 1986; Burek et at.. 1984); and brain (glial cell) tumors in
male and female rats by inhalation exposure (Nitschke et at.. 1988a).
Although a number of relevant studies are available, findings were inconclusive for cancers of
the liver, lung, breast, brain and CNS, and most hematopoietic cancer types, due to weaknesses
of the individual studies and inconsistent results across studies. For these endpoints, the
epidemiological studies provide only limited support for a relationship between methylene
chloride exposure and tumor development.
While findings were also inconclusive for hematopoietic cancers (leukemia, multiple myeloma,
Hodgkin lymphoma), including NHL, ORs for B-cell subtypes of NHL were consistently
increased across all three case-control studies that evaluated this tumor type (Barry et at.. 2011;
Seidler et at.. 2007; Mitiei et at.. 2006). and ranged from 1.6 to 3.2 with marginal statistical
significance identified for two of the studies. Despite this greater consistency, the studies
evaluating the B-cell subtypes did not adjust for other chemical co-exposures, and there was
correlation among exposures for several chemicals. Furthermore, several chemicals showed
some association with B-cell NHL. Thus, firm conclusions regarding the specific association
between methylene chloride and the outcomes cannot be made.
Epidemiological studies inherently have limitations that decrease their ability to identify
associations between outcomes and exposures. Although not a complete or exhaustive list,
limitations regarding the epidemiological studies considered here and their ability to detect risks
associated with methylene chloride are described here:
1) It is preferred that cohort studies use comparison groups that are similar to the
exposed groups. Most of the cohort studies that evaluated risks by exposed workers to
methylene chloride (Tomenson. 2011; Heame and Pifer. 1999; Gibbs et at.. 1996;
Lanes et al.. 1993) used SMRs or standard incidence rates (SIRs), which use rates
from the full population - whether working or not - as comparison groups. The
characteristics of the general population are likely to differ from the population of
workers being evaluated. Often, morbidity and mortality rates are lower in workers
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than the full population (11 and Sung. 1999). The full population includes individuals
who are unable to work due to illness. According to Li and Sung (1999). some
authors suggest that the effect of these dissimilar groups (workers vs. full population)
may be mitigated when considering mortality from cancer as an endpoint and for
studies that included both active workers and retired individuals (Hearne and Pifer.
1999). However, it is possible that the effects of methylene chloride could be masked
in these cohorts that use dissimilar comparison groups.
2) Ability to classify individuals by degree of exposure information was limited. For
example, work histories were available for only 37% of the Lanes (1993) cohort, and
were not specific for 30% of the Tomenson ( ) cohort. One study characterized
methylene chloride exposure simply as yes/no (Radican et at.. 2008). If exposure is
misclassified, the results may be under or overpredicted. If misclassification is
random, it is likely to underestimate effects, but if it is not random, effects may be
under- or over-predicted (Hennekens and Burins. 1987).
3) For lung cancer studies, smoking restrictions at work (Tomenson. ; hoechst
celanese corp. 1992.) limits the ability to interpret the negative results because of the
potential for higher smoking rates in the general population. Lack of
information/adjustment regarding smoking (Lanes et at. 1993) also limits the ability
to interpret results.
4) Low numbers of deaths or cases in several studies made it difficult to detect an effect
or interpret results. Examples include Hearne and Pifer (1999). Tomenson (2011).
Radican (2008) and Christensen et al. (2013).
Some effects attributed to methylene chloride in epidemiological studies might instead be
associated with other chemicals. Methylene chloride has been shown to be correlated with other
chemicals (e.g., in the outdoor environment), particularly with other solvents. If epidemiological
studies did not control for exposures to other chemicals or did not report exposure information
for other chemicals that are both correlated with methylene chloride and cancer, positive results
with methylene chloride may be decreased or not be observed. For example, Miligi et al. (2006).
Barry et al. ( ) and Seidler et al. (2007) identified some association between methylene
chloride and B cell NHL but did not control for other chemical exposures. In addition, there was
evidence (e.g., for Miligi (2.006)) that some chemical exposures were highly correlated and other
chemicals, that were also associated with the outcomes of interest, making it difficult to attribute
effects to methylene chloride alone.
Mechanistic data show that methylene chloride has a mutagenic MOA involving DNA-reactive
metabolites produced via a metabolic pathway catalyzed by GSTT1 ( >011). There are
numerous genotoxicity tests showing positive results for methylene chloride, including assays for
mutagenicity in bacteria and mutagenicity, DNA damage, and clastogenicity in mammalian
tissues in vitro and in vivo (IARC. 2016; U.S. EPA. ). The most strongly positive results in
mammalian tissues in vivo and in vitro were found in mouse lung and liver, tissues with the
greatest rates of GST metabolism and the highest susceptibility to methylene chloride-induced
tumors. To further strengthen the case for the role of GST-mediated metabolism, studies have
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demonstrated increases in damage with the addition of GSTT1 to the test system and decreases
in damage by addition of a GSH depletory. The GSTT1 metabolic pathway has been measured in
human tissues with activities that are lower than rodents. Thus, the cancer results in animal
studies are relevant to humans, who do exhibit some GSTT1 activity (I .S In
particular, human cells have exhibited genotoxicity without exogenous addition of GSTT1 (U.S.
).
U.S. EPA (2011) evaluated sustained cell proliferation as an alternative MO A for methylene
chloride-induced lung and liver cancer. Enhanced cell proliferation was not observed in the liver
of female B6C3F1 mice exposed to 2000 ppm methylene chloride for up to 78 weeks (Foley et
at.. 1993) as cited in U.S. EPA (2011). Furthermore, acute and short-term inhalation studies
showed enhanced cell proliferation in the lung; however, this effect was not sustained for longer
exposure durations (83-93 days of exposure) (Casanova et at.. 1996; Foster et at.. 1992) as cited
in U.S. EPA (2.011). Based on these data, EPA doesn't expect sustained cell proliferation to be
important, especially in the development of liver and lung tumors. Also, data were not identified
suggesting a receptor-mediated mode (e.g., peroxisome proliferation resulting from PPAR-a
activation; enzyme induction by CAR, PXR, or AhR activation).
In accordance with U.S. EPA (2005a) Guidelines for Carcinogen Risk Assessment, methylene
chloride is considered "likely to be carcinogenic to humans" based on sufficient evidence in
animals, limited supporting evidence in humans, and mechanistic data showing a mutagenic
MO A relevant to humans. Therefore, this hazard was carried forward for dose-response analysis.
3.2.5 Dose-Response Assessment
3.2.5.1 Selection of Studies for Dose-Response Assessment
EPA evaluated data from studies described in Sections 3.2.3 and 3.2.4 to characterize the dose-
response relationships of methylene chloride and selected studies and endpoints to quantify risks
for specific exposure scenarios. The selected studies had adequate information to select PODs.
3.2.5.1.1 Toxicity from Acute/Short-Term Exposure
Based on the weight of scientific evidence evaluation, one health effect domain (CNS
depression) was selected for dose-response analysis for effects from acute/short-term exposure.
Information from human studies (controlled experiments) are available for this endpoint.
CNS Depression
As discussed in Section 3.2.3.1.1, several controlled experiments in humans are available that
support the relationship between methylene chloride exposure and CNS effects. Although data
quality evaluation criteria are not available for the types of human studies considered, EPA
qualitatively evaluated studies used as the basis for the American Conference of Government
Industrial Hygienists (ACGIH) Threshold Limit Value (TLV)-TWA, California REL, SMAC,
and other studies identified in backwards searching of these documents. Data are also available
from animal studies to support this health effect domain during acute exposure but the human
studies are considered adequate and are preferable to animal studies.
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A primary consideration for choosing studies for dose-response assessment includes use of
objective tests (such as visual evoked responses) that measure CNS effects, and not simply
subjective reports of symptoms, especially when it is not known whether the investigator and
participants are blinded to the use of methylene chloride vs. control. Another consideration is
appropriate generation of methylene chloride air concentrations. Finally, EPA determined that
the changes in CNS effects are likely to be related not only to hypoxia from increased COHb
levels but also from increased levels of methylene chloride concentrations in the brain; therefore,
EPA placed greater importance on studies that identified effects from direct methylene chloride
exposure, not effects modeled from COHb levels. Although COHb can continue to rise after
exposure has ceased and thus COHb may still be relevant at longer time points, both Putz (1979)
and Winneke (1974) were conducted for 3.8 or 4 hrs and identified greater effects from
methylene chloride compared to CO (and Winneke (1974) did not identify effects from CO).
Thus, EPA considers direct CNS effects from methylene chloride to still be relevant for an 8-hr
duration.
Based on these considerations, EPA chose Putz (1979) to estimate risks from acute/short-term
exposure. This study identified changes in visual peripheral response after 1.5 hrs (within a 4-hr
exposure) in a dual complex task, adequately generated methylene chloride exposures and used a
double-blind procedure. The study received a medium confidence rating. Although Winneke
( ) also identified similar effects from methylene chloride intake, the study did not test
concentrations lower than 300 ppm. Because Putz (1979) identified effects at a concentration not
evaluated in other similar studies (195 ppm) and because CNS effects are critical effects that lead
to more severe effects at higher concentrations and longer exposure durations, EPA chose Putz
( )) for dose-response modeling for this endpoint.
3.2.5.1.2 Toxicity from Chronic Exposure
Non-Cancer
Hepatic effects are the primary dose-dependent non-cancer effects observed in animals after
chronic and subchronic exposure to methylene chloride. Although a few other sensitive effects
are observed for other health domains (e.g., some persistent nervous system effects in humans
observed by Lash (1991). decreased fertility identified by Raje et al. (1988)). liver effects are
more consistently observed. The hazard identification and weight of evidence sections (3.2.3 and
3.2.4) both describe the evidence in more detail for each of these health domains.
EPA is relying on the dose-response modeling results presented in U.S. EPA (2011) from
Nitschke (1988a) for rats. This study is the most suited to dose-response modeling because it is
the chronic study with the lowest exposure concentrations and was rated high (1.3) for data
quality.
As a comparison, EPA also considered results from the recent study by Aiso et al. (2014a) in
rats. However, the concentrations used in Aiso et al. (2014a) are higher (0, 3500, 7000 and
14,000 mg/m3) than the concentrations in the Nitschke et al. (1988a) study (0, 180, 700 and 1800
mg/m3).
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6173 The effects used in the dose-response modeling from both the Nitschke (1988a) and Aiso et al.
6174 (2014a) studies are included in Table 3-15.
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Table 2
&-15. Candidate Non-Cancer Liver
effects for Dose-Response Modeling
Tsirsiel
Orgsin/
S\s(em
Sluclj
Tj pe
Species/
S(r;iin/Sc\
(Nil in hoi'/
Jil'Olip)
r.\i)(isuiT
Uoule
Doses/
('onccnlr;ilions
Dui'iilion
n().\i:i./i.()\i:i.
reported In
s 111«1 > iiulhors
NOAI'.I./
1.OA 111. img/m-'
or mii/kii-cl;i>)
(Se\)
r.lTeel
Rel'erenee
Diilii
Qu:ilil>
r.\ iiiuiiiion
Hepatic
Chronic
Rat, Sprague
Dawley, M/F
(n=180/group)
Inhalation,
vapor, whole
body
0, 176, 702 or
1755 mg/m3 (0,
50, 200 or 500
ppm)
6 hours/day,
5 days/week
for 2 years
NA
NOAEL= 702
(F)
Hepatic lipid
vacuolation and
multinucleated
hepatocytes
Nitschke
(1988a)
High (1.3)
Hepatic
Chronic
Rat,
F344/DuCij
Inhalation,
vapor, whole
body
0,3510, 7019 or
14,038 mg/m3 (0,
1000, 2000 or
4000 ppm)
6 hours/day,
5 days/week
for 2 years
NA
LOAEL = 3510
mg/m3 (F)
Increased
basophilic foci
and increased
abs/rel liver wt
(p<0.01)
Aiso et al.
High (1.1)
6176
6177
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Cancer
The epidemiological studies generally provide only limited support for the relationship between
methylene chloride exposure and tumor development. Therefore, EPA relied on inhalation rodent
cancer bioassays to model the dose-response relationship. EPA modeled both the tumor response
data from NTP (1986) and data from a recent publication (Also et at.. 2014a).
EPA modeled the same tumor response data from NTP (1986) chosen for the inhalation unit risk
(IUR) as was modeled by U.S. EPA (: _), (i.e., liver, lung and mammary gland tumors). EPA
also included modeling with the full set of dichotomous models available in benchmark dose
software (BMDS) to evaluate the sensitivity of the model output to the model choice.
EPA also modeled dose-response data for several tumor types from a study published subsequent
to the IRIS assessment (Also et at.. 2014a). The tumors modeled included those with positive
trend tests, significant pairwise differences from controls, the most sensitive tumors as well as
the clearest dose-response data. EPA modeled lung and liver tumors in male and female mice. In
rats, EPA modeled mammary and subcutis tumors.
NTP (1986) showed a clear dose-response with lung and liver cancer, and these data were chosen
for dose-response modeling (U.S. EPA. 2011). Furthermore, the study received a high data
quality rating using the criteria specified in Application of Systematic Review in TSCA Risk
Evaluations (U.S. EPA. 2018b). Of the inhalation studies and tumor types considered, these
tumors were most sensitive to methylene chloride exposure in mice, yielding responses of greater
magnitude and more positive association than most other tumor data, other than the mostly
benign mammary tumors results (see Section 3.2.3.2.2).
Table 3-16 presents tumor results from the NTP (1986) and Aiso et al. (2014a) studies that were
considered to be candidates for dose-response modeling.
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6205 Table 3-16. Candidate Tumor Data for Dose-Response Modeling
KiTciviiit
Sir;iin iind
Species
l'l\|)osiire
rou le
Sex
l'l\|)OMire le\els
"I'll 111(11" l>|)C
Si^nirieiinl
dose-reliiled
Ircml
Si^nirieiinl
|)iiir\\ ise
comparison'1
I'.xposurc lc\cl
\\ iili si^niriciinl
inciviiso'1
Diilii Qu;ili(\
l-'.\ iiliiiilimi
Hepatic Tumors
NTP (1.986)
B6C3F1 mouse
Inhalation
M
0, 2000, 4000 ppm
Hepatocellular adenoma
or carcinoma
y
y
4000 ppm
High (1.3)
F
Hepatocellular adenoma
or carcinoma
y
y
> 2000 ppm
Aiso et al.
("2014b")
BDF1 mouse
Inhalation
M
0, 1000,2000,
4000 ppm
Hepatocellular adenoma
or carcinoma
y
y
> 2000 ppm
High (1.1)
Hepatic hemangioma
y
y
4000 ppm
Hepatic hemangioma or
hemangiosarcoma
y
-
-
F
Hepatocellular adenoma
or carcinoma
y
y
> 1000 ppm
Hepatic hemangioma
y
-
-
Hepatic hemangioma or
hemangiosarcoma
y
-
-
Lung Tumors
NTP ("19861
B6C3F1 mouse
Inhalation
M
0, 2000,4000 ppm
Bronchoalveolar adenoma
or carcinoma
y
y
> 2000 ppm
High (1.3)
F
Bronchoalveolar adenoma
or carcinoma
y
y
> 2000 ppm
Aiso et al.
(2014b)
BDF1 mouse
Inhalation
M
0, 1000,2000,
4000 ppm
Bronchoalveolar adenoma
or carcinoma
y
y
> 1000 ppm
High (1.1)
F
Bronchoalveolar adenoma
or carcinoma
y
y
> 2000 ppm
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Reference
Sir;iin iiiul
Species
l'l\|)osiiiv
ion (e
Sox
r.\|)osurc le\ els
Tumor l\pe
Si^niriciinl
(Insc-rchilcd
(lend
Si^niriciinl
p;iir\\ ise
comparison'1
I'.xposnrc lc\cl
w illi si^niriciinl
incroiiso'1
Diilii Qu;ili(>
l-'.\ ;iln;ilion
Mammary Tumors
NTP ("19861
F344 rat
Inhalation
M
0, 1000,2000,
4000 ppm
Mammary or
subcutaneous tissue
adenoma, fibroadenoma,
or fibroma
y
y
4000 ppm
High (1.3)
F
Mammary adenoma,
fibroadenoma, or
adenocarcinoma
y
y
> 2000 ppm
Aiso et al.
C2014b1
F344/DuCij
Inhalation
M
0, 1000,2000,
4000 ppm
Mammary gland
fibroadenoma
y
y
4000 ppm
High (1.1)
Mammary gland
fibroadenoma or adenoma
y
y
4000 ppm
Mammary gland
fibroadenoma or adenoma
or adenocarcinoma
y
-
F
Mammary gland
fibroadenoma
y
-
Mammary gland
fibroadenoma or adenoma
y
-
Mammary gland
fibroadenoma or adenoma
or adenocarcinoma
y
-
Subcutaneous Tumors
Aiso et al.
("20141)1
F344/ DuCij
Inhalation
M
0, 1000,2000,
4000 ppm
Subcutaneous fibroma
y
y
> 2000 ppm
High (1.1)
Subcutaneous fibroma or
fibrosarcoma
y
y
> 2000 ppm
6206 aAs reported in the cited reference
6207
6208
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6211
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6214
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6217
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6220
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6223
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6227
6228
6229
6230
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3.2.5.2 Derivation of PODs and UFs for Benchmark Margins of Exposures (MOEs)
3.2.5.2.1 PODs for Acute/Short-term Inhalation Exposure
Workers and consumers can be exposed to a single acute exposure to methylene chloride under
various conditions of use via inhalation and dermal routes. EPA identified PODs for several
acute inhalation exposure durations based on both hazard and exposure considerations. A
duration of 8 hrs, a typical work shift, is used for occupational settings. For workers, EPA also
evaluated a 15-minute exposure, which matches the duration used to set the STEL. Furthermore,
some concentrations of methylene chloride in occupational settings are reported for 15 minutes
or similar durations.
A 1-hr value is used for consumer settings, which is similar to the length of time (1.5 hrs) after
which effects were observed by Putz et al., ( )).
Putz (1979) is a well-conducted study of 12 volunteers that identified decreased visual peripheral
performance after 1.5 hr of exposure to 195 ppm (200 ppm nominal). Results of EPA's
qualitative data quality evaluation indicate that this study is of medium quality and unlike other
key studies that have been evaluated, Putz (1979) conducted his study in a double-blind manner.
Because this study used a single concentration, it is not amenable to dose-response modeling so
EPA used the LOAEC of 195 ppm. Both OSHA and ACGIH cited the nominal value of 200 ppm
as a LOAEC for CNS effects.16 ACGIH used this study with a safety factor of 4 to account for
interindividual differences in sensitivity and use of a LOAEC rather than a NOAEC as the basis
of its 8-hr TLV-TWA of 50 ppm.
The Office of Environmental Health Hazard Assessment (OEHHA) from the state of California
uses Putz (1979) as the basis of their REL. OEHHA (2008a) used a simplified equation, Cnx T =
K with n = 2, to scale the LOAEC of 195 ppm (696 mg/m3) for 1.5 hrs to values of 240 ppm
(840 mg/m3) and 80 ppm (290 mg/m3) for 1 and 8 hrs, respectively. This equation is a
modification of Haber's rule, and n = 2 is based on an analysis by Ten Berge et al. (1986). of
concentration times time for lethality data from 20 acute inhalation studies of various compounds
that resulted in an average value of 1.8 for n. OEHHA (2008a) used a total UF of 60 based on an
intraspecies UF of 10 to account for human variability and a LOAEL-to-NOAEL UF of 6
(Oehha. 2008a).
The NAC/AEGL has used CnxT = K when setting AEGLs and has also used n = 2 when no
exposure-versus-time data are available (NASEM (National Academies of Sciences. 2000 2000.
5349306). Although there is uncertainty in using n=2 to extrapolate to longer time periods. Ten
Berge (1986) identified the value of n = 1.8 from LC50 studies, which typically are 4 hrs long.
Thus, it was considered appropriate to use this for an 8-hr period.
16 Some publications identify Putz as having a publication year of 1979 and others as 1976; however, the
publications are referring to the same citation.
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6256
6257
6258
6259
6260
6261
6262
6263
6264
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6273
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6275
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For methylene chloride, exposure-versus-time data are limited. Therefore, EPA considers the
Ten Berge equation using n = 2 as a valid method to convert the 1.5 hr POD value from Putz
(1979) to the 15-min, 1-hour and 8-hr PODs (see Table 3-17).
Table 3-17. Conversion of Acute POPs for Different Exposure Durations
Kxposure
Duration for
l i s for
Benchmark MOK
Value
POD
ii.ii
Kml point
References
15-min
478 ppm
UFh= 10
7% J, visual
CNS data from Putz
(1706 mg/m3)
UFl = 3
peripheral
(1979):
Conversion of
concentrations
1-hr
240 ppm (840
mg/m3)
Total UF = 30
performance at
1.5 hrs
among exposure
durations use ten
Berge et al. (1986)
equation Cn x T = K,
where n = 2
8-hr
80 ppm
(290 mg/m3)
a. Margin of Exposure (MOE) = Non-cancer POD / Human exposure
b. UFh= intraspecies uncertainty factor; UFL= LOAEL-to-NOAEL uncertainty factor
EPA applied a composite UF of 30 for the acute inhalation benchmark MOE, based on the
following considerations:
1) Interspecies uncertainty/variability factor (UFa) of 1
Accounting for differences between animals and humans is not needed because the POD
is based on data from humans
2) A default intraspecies uncertainty/variability factor (UFh) of 10
To account for variation in sensitivity within human populations due to limited
information regarding the degree to which human variability may impact the disposition
of or response to, methylene chloride.
a. Some of the specific variabilities/uncertainties for methylene chloride that can lead to
greater risk and are accounted for with this UFh include toxicokinetic differences:
Fetuses
Fetuses are at higher risk for CO toxicity and resulting CNS effects because of higher CO
affinity for hemoglobin and slower CO elimination (Nre. 2.010). There are no studies
reporting effects on the unborn after a single acute exposure resulting in lower COHb
levels fflrc. 2010: U.S. EPA. 2000).
Workers, consumers engaged in vigorous activity
It has been shown that greater metabolism to CO occurs in individuals who are exercising
(Nac/Aegl. 2008). The leads to increased COHb and subsequent effects that can may
exacerbate the CNS effects. Workers or consumers who are engaged in more vigorous
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activity would be expected to exhibit greater effects due to additional CNS effects of
increased COHb.
Individuals with higher CYP2E1 enzyme levels
Several other chemicals, including alcohol, can induce CYP 2E1 and lead to greater
metabolism that leads to increased CO and COHb levels. Thus, heavy drinkers may be at
greater risk.
Smokers
Smokers have higher levels of COHb and therefore, additional increases in COHb from
methylene chloride exposure may lead to increased CNS effects or increased angina in
individuals with heart disease.
b. Some of the specific variabilities/uncertainties related to toxicodynamic differences
based on potentially susceptible subpopulations are as follows:
Individuals with heart disease/cardiac patients
At COHb levels of 2 or 4%, patients with coronary artery disease may experience a
reduced time until onset of angina (chest pain) during physical exertion ( Allied et ai.
1991; Allred et ai. 1989a; Altred et ai. 1989b). Other studies have also confirmed a
reduced time to onset of exercise-induced chest pain at a COHb between 2.5 and 4.5
percent (Kleinman et ai. 1998; Kleinman et ai. 1989; Sheps et ai. 1987; Anderson et ai.
1973; Aronow c ). The SMAC (Nrc. 1996) identified a NOAEC of 100 ppm for
a 3% COHb level and because decreased time to angina may occur at even lower levels,
this UF is considered important to account for this susceptible subpopulation. These
values are lower than the value from Putz et ai (1979) used for the acute endpoint; the
COHb level was measured as 5.1%.
c. Furthermore, additional differences among individuals that may result from either
toxicokinetic or toxicodynamic differences may be of concern:
Bystanders of different ages
Residential bystanders for consumer uses are expected to be indirectly exposed to
methylene chloride and may be of any age. For example, elderly individuals who may
have other health concerns (e.g., those related to nervous system effects) may be more
susceptible to the effects of methylene chloride from acute exposure.
3) A LOAEC-to-NOAEC uncertainty factor (UFl) of 3
This factor was applied to account for the lack of NOAEC in the critical study. A value of 3
rather than a more conservative value of 10 is applied because the effects observed by Putz
et ai (1979) after 1.5 hrs. are of a small magnitude (decreased 7% in one measure - visual
peripheral changes).
3.2.5.2.2 PODs for Chronic Inhalation Exposure
Chronic exposure was defined for occupational settings as exposure reflecting a 40-hr work
week. A set of dichotomous dose-response models that are consistent with a variety of
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potentially underlying biological processes were applied to empirically model the dose-response
relationship in the range of the observed data. The models in EPA's BMDS were applied to
selected studies. Consistent with EPA's Benchmark Dose Technical Guidance Document (EPA.
2012a). the BMD and 95% lower confidence limit on the BMD (BMDL) were estimated using a
benchmark response (BMR) to represent a minimal, biologically significant level of change,
referred to as relative deviation (RD). In the absence of information regarding the level of change
that is considered biologically significant, a BMR of 10% extra risk (ER) for dichotomous data is
used to estimate the BMD and BMDL, and to facilitate a consistent basis of comparison across
endpoints and studies. The estimated BMDLs were used as PODs; the PODs are summarized in
Table 3-19 for non-cancer liver effects and in Table 3-20 for cancer endpoints. Details on
derivation of the IUR for cancer and the non-cancer HEC are included in Appendix I. More
information and the full suite of models and model outputs and graphical results for the model
selected for each endpoint can be found in Supplemental File: Methylene Chloride Benchmark
Dose andPBPKModeling Report (EPA. 2.019h).
Non-Cancer Liver Effects
U.S. EPA (2011) modeled the dose response relationships for liver vacuolation in female rats
using a modified PBPK model from Andersen et al. (1991). Female rats were used based on a
higher response and because data were available for the lower dose groups. The PBPK model
was used to calculate average daily internal liver doses.
U.S. EPA (1980) investigated four dose metrics (hepatic metabolism through the CYP pathway,
GST pathway or combined hepatic metabolism through both pathways, and the concentration
(AUC) of methylene chloride in the liver). Adequate model fits were observed for GST, CYP
and AUC for inhalation data. However, the GST and AUC metrics produced inconsistencies in
dose-response relationship depending on route of exposure. However, these inconsistencies were
not observed using the CYP metric. Therefore, EPA used the internal dose metric based on total
hepatic metabolism through the CYP2E1 pathway (as mg methylene chloride metabolized via
CYP pathway/L liver/day).
U.S. EPA (2011) used seven dichotomous dose-response models in EPA BMDS version 2.0 to
fit to liver lesions incidence and PBPK model-derived internal dose data to obtain rat internal
BMDio and BMDLio values. As noted above, a BMR of 10% was used given a lack of
information on the magnitude of change thought to be minimally biologically significant. The
log-probit model was the best fitting model. The comparison of BMDLios of internal doses from
all seven models are presented in Table 3-18. More details are provided in U.S. EPA (2019h).
Table 3-18. Results of BMD Modeling of Internal Doses Associated with Liver Lesions in
Female Rates from Nitschke et al. (1988a)
Model
l$M Dm
BMDLiu
\2
Goodness of fit
/rvalue
Al(
Gamma
622.10
227.29
0.48
367.24
Logistic
278.31
152.41
0.14
369.77
Log-logistic
706.50
506.84
0.94
365.90
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Model
IJMDm
liMDIm
\2
(,oo(lnoss of I'il
/J-V!llllC
AIC
Multistage (3)
513.50
155.06
0.25
368.54
Probit
279.23
154.52
0.14
369.76
Log-probit
737.93
531.82
0.98
365.82
Weibull
715.15
494.87
0.95
365.88
Source: U.S. EPA (20111. Table 5-6, pg. 193
AIC = Akaike information criterion
The human-equivalent internal BMDLio was then obtained by dividing the internal rat dose
metric by a pharmacokinetic scaling factor based on the ratio of BWs (scaling factor of 4.09). A
probabilistic PBPK model for methylene chloride in humans was adapted from David et al.
(2006) and used with Monte Carlo sampling to calculate distributions of chronic HECs (mg/m3)
associated with the internal BMDLio.
EPA used the 1st percentile to account for susceptibility from the toxicokinetic variability among
humans related to differences in metabolism. Using the 1st percentile, EPA reduced the
intraspecies uncertainty factor (UFH) from 10 to 3. The remaining UFH of 3 accounts for any
toxicodynamic differences among humans. EPA's use of the human toxicokinetics data
distribution is similar to using data-derived extrapolation factors (DDEFs) because it uses
information more specific to methylene chloride hazard. DDEFs are suggested by agency
guidance as preferable to default UFs (EPA, 2014b). The 5th percentile is very similar (21.3
mg/m3) to the 1st percentile (17.2 mg/m3). The mean is 48.5 mg/m3 (within an order of magnitude
of 3 times higher than the 1st percentile).
Although EPA chose to use the HEC value modeled from Nitschke et al. (1988a). the HEC
modeled from Aiso et al. (2014a) for basophilic cell foci is essentially the same as the value for
vacuolation from Nitschke et al. (1988a) using the same PBPK models and similar assumptions.
See Table 3-19 for the comparison of the modeled values.
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Table 3-19. BMD Modeling Results and HECs Determined for 10% Extra Risk, Liver Endpoints
from Two Studies
Internal
dose
metric11
Sex.
Species
Knd point
BMI)
model1'
Animal
liMDI.in"
II ii ma n
IJMDI.im"1
Resulting ///:('
Reference
Liver CYP
metabolism
Female
rat
Vacuolation
log-
probit
531.8
130.0
17.2 mg/m3
[First
percentile]f
Nitschke et al.
(1988a)g
Acidophilic
cell foci
gam-r
645.5
157.4
98.2 mg/m3
Aiso et al.
(2014a')
Basophilic
cell foci
log
114.2
27.85
17.3 mg/m3
11 mg methylene chloride metabolized via CYP pathway /Liter of liver tissue /day
b See BMD modeling report for model definitions and details.
0 Animal BMDLio refers to the BMD-model-predicted rat internal dose and its 95% lower confidence limit, associated
with a 10% ER for the incidence of tumors; units are those for the identified dose metric, described in footnote "a".
d When the dose metric is the rate of production of the presumed toxic metabolite (mg/kg/d or mg/L/day), allometric
scaling is applied to adjust for the fact that humans are expected to detoxify the metabolite more slowly than rats. A rat
BMDLio divided by (BWhuman/BWrat)°25 = 4.1. Units are the same as for the Animal BMDLio.
e HEC is the 1st percentile of a distribution obtained by determining the exposure concentration for each individual in a
simulated population that is predicted to yield an internal dose equal to the (internal) Human BMDLio; with use of the 1st
percentile the intra-human UF can be reduced from a standard value of 10 to 3, to account for remaining variability in
pharmacodynamic sensitivity.
f For comparison with 1st percentile the fifth percentile and mean values are 21.3 and 48.5 mg/m3, respectively.
gResults of BMD modeling for this study are presented in U.S. EPA (20.1.1').
EPA applied a composite UF of 10 for the chronic inhalation benchmark MOE, based on the
following considerations:
1) Interspecies uncertainty/variability factor (UFa) of 3
to account for species differences in animal to human extrapolation an interspecies
uncertainty/variability factor of 3 (UFa) was applied for toxicodynamic differences
between species. This UF is comprised of two separate areas of uncertainty to account for
differences in the toxicokinetics and toxicodynamics of animals and humans. In this
assessment, the toxicokinetic uncertainty was accounted for by the PBPK modeling. As
the toxicokinetic differences are thus accounted for, only the toxicodynamic uncertainties
in extrapolating from animals to humans remain, and an UFa of 3 is retained to account
for this uncertainty.
2) Intraspecies uncertainty/variability factor (UFh) of 3
to account for variation in sensitivity within human populations an intraspecies
uncertainty/variability factor of 3 (UFh) was applied for toxicodynamic differences in the
human population. This UF is comprised of two separate areas of uncertainty to account
for variation in the toxicokinetics and toxicodynamics of the human population due to
humans of varying gender, age, health status, or genetic makeup might vary in response
to methylene chloride. In this assessment, the toxicokinetic variation in humans was
accounted for by the probabilistic PBPK model using Monte Carlo sampling of
distributions for the following variables: physiological, tissue volume, partition
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coefficient and metabolism (including CYP 2E1) parameters. EPA selected the HEC
associated with the first percentile among humans. As the toxicokinetic differences are
thus accounted for, only the toxicodynamic variability in the human population remains,
and an UFa of 3 is retained to account for this variability.
3) A LOAEC-to-NOAEC uncertainty factor (UFl) of 1
A BMDL, considered to be equivalent to a NOAEL(C) was calculated from Nitschke et
al. (1988a) and therefore an UF of 1 is applied.
Cancer
EPA modeled dose-response relationships for tumor incidence in rodents observed in two
studies, Aiso et al. (2.014a) and NTP (1986). using the mouse PBPK model of Marino et al.
(2006). Because metabolites of methylene chloride produced by the GST pathway are primarily
responsible for methylene chloride carcinogenicity in mouse liver and lungs and based on the
assumption that metabolites are reactive enough that they don't have substantial distribution
outside the liver, the internal tissue-dose metrics used were daily mass of methylene chloride
metabolized via the GST pathway per unit volume of liver and lung, respectively. When lung
and liver tumors were combined, a whole-body GST metric was used that essentially combined
the lung and liver internal doses. Using species-specific information on GST activity in the
PBPK models accounts for differences in GST and GST Theta 1 activity between mice and
humans and among humans. Although the CYP pathway is considered important at lower
concentrations, EPA assumed that there is some non-zero GST Theta 1 activity even at low
concentrations because there is a possibility of reaction between methylene chloride and
GST/GSH when these molecules are present.
For other tissues (subcutis and mammary gland), there is too little information to determine the
relevant dose metric. For example, genotoxicity and mechanistic studies have not included
mammary tissues. Therefore, these tumors were modeled using the estimated area under the
curve (AUC) of methylene chloride from the Aiso (2014a) data.
U.S. EPA (2011) also modeled the dose response from mammary tumors observed in NTP
(1986) and details are presented in U.S. EPA (2011). Both NTP (1986) and Aiso (2014a)
observed mostly benign mammary tumors.
Table 3-20 presents the best model fits for several tumor types for multiple cancer endpoints
from Aiso et al. (2.014a) and for lung and liver tumors from NTP (1986). BMDLios of internal
doses are presented along with IURs. In addition, the HECs for terminal bronchiole hyperplasia
are also presented for context. Hyperplasia occurred at concentrations higher than lung tumors
and is not expected to be a precursor to the tumors observed. See U.S. EPA (2019h) for other
model results of the tumor types identified below.
Based on the results of these model fits, EPA chose to use the IUR from NTP (1986) in the
current risk evaluation because EPA determined that the combined liver and lung tumor response
is relevant for humans and it is the most sensitive of the best-fitting models for the malignant
tumors. Although mammary gland and subcutis tumors yielded higher IURs, there is less
certainty about these tumors.
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6456 Table 3-20. BMD Modeling Results and Tumor Risk Factors/HECs Determined for 10% Extra Risk, Various Endpoints From Aiso
6457 ( ) and M P ( )
Inloriiiil
dose
me( ric-'
Sox.
Species
r.nripoinl
(Asio s(ii(l\. unless
"(MIT)
mil)
model1'
Auiuiiil
liMDI.
Miiniiin
liMDI.In"1
1 llllllSlll
1 iimor risk
I'ilClf II'
Me.in liuin;
dose from
expos
Mixed
population
n inleniiil
1 usi/nr'
IIIV1
GST +/+
Resulting liu
or ///
Mixed
populiilion
niiin 11 K ifig/nr')1
:c (nifi in')1
GST +/+
Slowly
perfused
AUC
(methylene
chloride)
Male rat
Subcutis
lup-ui'
in
1.59 x 10"5
\nl
sigmlicandy
different
from mixed
population
5.76 x 10"8
Not significantly
different from
mixed population
nisi2-i'
mi.
mi.
in
1.49 x lO"8
Mammary Gland
(F/A)
k.u
:i.(. in.
:(.(.()(.
. -(. in
5.98 x 10"9
nisi |-r
:u5 ^5
:u5 ^5
4 S~ |o
7.74 x lO"9
Mammary Gland
(F/A/AC)
k.u
i(.
1(.
^ "4 lu
5.95 x 10"9
nisi |-r
:::
:::
4 5(1 lu
7.15 x lO"9
Subcutis or
Mammary Gland
(F/A)
multi-tumor
78.802
78.802
1.27 x 10"3
2.02 x 10"8
Subcutis or
Mammarv Gland
(F/A/AC)
mul li-tumor
81.265
81.265
1.23 x lO"3
1.96 x 10"8
Female
rat
Subcutis or
Mammarv Gland
(F/A/AC)
pro
166.68
166.68
6.00 x 10"4
9.54 x K)-"
mst 1 -r
123.7
123.7
8.08 x 10"4
1.29 x lO"'
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Inleriiiil
(lose
mel ric1
Sox.
Species
I'lmlpoini
(Asio s111«1 >. unless
"(MP)")
mil)
model1'
Auiuiiil
li.M 1)1.
Miiniiin
IJMDI.im"1
1 llllllSlll
1 iimor risk
I'iiclor
Mciin hum;
dose IVom
expos
Mixed
population
n inlcrn;il
1 usi/nr'
IIIV1
GST +/+
Resulting liu
or ///
Mixed
populiilion
niiin 11 K (psi/m')1
:c (nifi in')1
GST +/+
Liver GST
Male
mice
Liver tumor
lnl-r
413.06
59.01
1.70 x 10"3
6.65 x 10"7
1.17 x 10"6
1.13 x 10"9
1.98 x 10"9
msl2-r
593.21
84.74
1.18 x 10"3
7.58 x 10"10
1.38 x lO"9
Liver tumor (NTP)
lnl-r
740.82
105.8
9.45 x 10"4
6.28 x 10"10
1.11 x 10"9
msll-r
544.51
77.79
1.29 x 10-3
8.55 x lO"10
1.50 x lO"9
Female
mice
Liver tumor
pro
1332.8
190.40
5.25 x 10"4
3.49 x 10"10
6.14 x 10"10
msl2-r
762.31
108.90
9.18 x 10-4
6.11 x lO"10
1.07 x lO"9
Lung GST
Male
mice
Lung tumor
pro
115.93
16.56
6.04 x 10"3
4.39 x 10"8
7.75 x 10"8
2.65 x 10-'"
4.68 x 10"10
msll-r
55.91
7.987
1.25 x 10"2
5.50 x l()-i"
9.70 x 10"10
Lung tumor (NTP)
mstl-r
48.646
6.949
1.44 x 10"2
6.32 x 10"10
1.12 x 10"9
Female
mice
Lung tumor
mst2-r
223.47
31.92
3.13 x 10"3
4.39 x 10"8
7.75 x 10"8
1.38 x 10"10
2.43 x 10"10
TB hyperplasia
msl3-r
411.28
58.75
n/a
7.75 x 104
mg/m3
i
g>
*3"
o
!—1
X
R
Whole body
GST
Male
mice
Liver or lung tumor
multi-tumor
8.217
1.174
8.52 x 10"2
1.53 x 10"8
2.68 x 10"8
1.30 x 10"9
2.28 x 10"9
Liver or lung (NTP)
7.753
1.108
9.03 x 10"2
1.38 x 10""
2.42 x lO"9
Female
mice
Liver or lung tumor
25.302
3.615
2.77 x 10"2
4.23 x 10"10
7.41 x lO"10
"Tissue-specific dose-units = mg dichloro methane metabolized via GST pathway/L tissue (liver or lung)/day; whole-body dose units = mg dichloromethane
metabolized via GST pathway in lung and liver/kg-day; AUC(methylene chloride) = mg-h/L tissue; all metrics are daily averages given a - week exposure per
bioassay conditions (animal dosimetry) or 8 h/d, 5 d/w workplace exposure scenario (human dosimetry).
b See BMD modeling report for model definitions and details.
0 Animal BMDLio refers to the BMD-model-predicted mouse or rat internal dose and its 95% lower confidence limit, associated with a 10% ER for the incidence
of tumors; units are those for the identified dose metric, described in footnote "a".
d When the dose metric is the rate of production of the presumed toxic metabolite (mg/kg/d), allometric scaling is applied to adjust for the fact that humans are
expected to detoxify the metabolite more slowly than mice and rats. A mouse BMDLio is divided by (B Whuman/B Wmouse)a 25 = 7 and a rat BMDLio divided by
(B Whuman/B Wrat)°25 = 4.1. When the metric is the concentration (AUC) of a chemical, no adjustment is made. Units are the same as for the Animal BMDLio.
e Dichloromethane tumor risk factor (extra risk per unit internal dose) derived by dividing the BMR (0.1) by the allometric-scaled human BMDLio. Units are
l/(BMDLio units) for corresponding tissues/endpoints.
f Human inhalation risk is the product of the mean internal dose and the tumor risk factor. The HEC for the non-cancer response (hyperplasia) is the 1st percentile
of a distribution obtained by determining the exposure concentration for each individual in a simulated population that is predicted to yield an internal dose equal
to the (internal) Human BMDLio.
6458
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3.2.5.2.3 Route to Route Extrapolation for Dermal PODs
EPA did not identify toxicity studies by the dermal route that were adequate for dose-response
assessment. Dermal candidate values, therefore, were derived by route-to-route extrapolation
from the inhalation PODs as mentioned above. The inhalation PODs were extrapolated using a
POD based on either human data i.e., acute exposures or the BMDLhec a value from animals
adjusted to account for animal to human extrapolation using the PBPK model the preferred
approach because this incorporates methylene chloride specific toxicokinetic data. Therefore, the
equations for extrapolating from inhalation PODs to the dermal route account for human
inhalation and body weight, shown below, assume average exposure factors from the Exposure
Factors Handbook (EPA. 2 ).
For non-cancer effects:
dermal POD = inhalation POD [mg/m3] x inhaled volume (m3) ^ body weight (kg)
For cancer:
dermal slope factor = IUR [per mg/m3] ^ inhaled volume (m3) x body weight (kg)
where the inhaled volume was the ventilation rate 1.25 m3/hr (for light activity) times the
appropriate exposure duration (1.5 hours from Putz et al. (1979)) for acute endpoints, or 20 m3
per day for the chronic endpoint and a body weight of 80 kg. EPA assumes that activities
involving methylene chloride exposure involve some movement, and thus, assumed a ventilation
rate for light activity.
PODs were derived from Putz et al. (1979) for a range of inhalation exposure durations, the route
to route extrapolation for dermal used the duration of the experimental study (1.5 hrs) and the air
concentration in the study (a LOAEC of 195 ppm or 696 mg/m3) for extrapolation to the dermal
route.
There is uncertainty regarding the likelihood that dermal exposure will result in lung cancer, but
because humans may experience different cancers than rodents, EPA has assumed that the slope
factor of the combined tumor types can be considered generally representative of the potential
for cancers of other types and that this is relevant to model via the dermal route.
3.2.5.3 PODs for Human Health Hazard Endpoints and Confidence Levels
Table 3-21 summarizes the PODs derived for evaluating human health hazards from acute and
chronic inhalation scenarios. Table 3-22 summarizes the PODs extrapolated from inhalation
studies to evaluate human health hazards from acute and chronic dermal scenarios. EPA has also
determined confidence levels for the acute, non-cancer chronic and cancer chronic values used in
the risk evaluation. These confidence levels consider the data quality ratings of the study chosen
as the basis of dose-response modeling and also consider the strengths and limitations of the
body of evidence including the strengths and limitations of the human, animal and MOA
information to support the endpoint both qualitatively and quantitatively.
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6503
6504
6505
6506
6507
6508
6509
6510
6511
6512
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6514
6515
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6518
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6520
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Confidence Levels
For the acute inhalation endpoint, the value used for this risk evaluation is from Putz (1979). a
medium quality double-blind study. In addition, there is consistency in observing CNS effects in
humans, which is supported by several studies in animals. However, the study used a single
concentration and there is uncertainty in converting among exposure durations. Overall, there is
medium confidence in this endpoint.
For the chronic non-cancer endpoint, there is limited information in humans regarding liver
endpoints but a consistent and full set of studies of liver effects in animals. The dose-response
modeling is based on a chronic study given a high data quality rating with a chronic POD that is
supported by a second high quality study. Thus, EPA has medium confidence in the chronic non-
cancer endpoint based on liver effects.
For the chronic cancer endpoint, there are some inconsistencies in the epidemiological data and
uncertainty in concordance of cancers between animals and humans. However, there is good
consistency of results in animals across multiple studies and support from genotoxicity studies
that identify effects in the presence of GSTT1. Furthermore, use of PBPK models account for
differences in GST and GSTT1 activity between mice and humans and among humans.
Furthermore, a high-quality chronic cancer bioassay is used as the basis of the dose-response
modeling. Thus, EPA has medium confidence in the chronic cancer endpoint and dose-response
model used in this risk evaluation.
Table 3-21. Summary of PODs for Evaluating Human Health Hazards from Acute and
Chronic Inhalation Scenarios
l'A|)OMIIV
Dui'iiliun for
Risk \n;il> sis
llii/iii'd Value
r.fiVci
Tolill
I nccrl;iin(\
l";ic(or (I I") for
lieiichiiiiirk
moi:
Reference
( IIKONK
EXPOSURE
II k
40 hrs/wk:
1.38 x 10"6permg/m3
1 i\cr and Iiiiiu Illinois
\nl applicable
NTI'i i
1st percentile HEC i.e., the HEC99
24 hrs/day:
17.2 mg/m3
(4.8 ppm)
Liver effects
UFa=3;
UFh=3;
UFl=1
Total UF= 10
Nitschke CI988a)
ACUTE
EXPOSURE
15-min: 478 ppm (1706 mg/m3)
1-hr: 240 ppm (840 mg/m3)
8-hrs: 80 ppm (290 mg/m3)
Impairment of CNS
7% I visual peripheral
performance at 1.5 hrs
(p<0.01)
UFa=1;
UFh=10;
UFl=3
Total UF=30
CNS data from
Putz (1.979):
Conversion of
PODs based on Ten
Berse et al. CI986)
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6528 Table 3-22. Summary of PODs for Evaluating Human Health Hazards from Acute and
6529 Chronic Dermal Exposure Scenarios
l'l\|)OMIIV
Dui'iilion lor
Risk An;il\sis
llii/iii'd Yiiluc I sod in Risk Asscssiiionl
r.iTcci
loliil I nccr(;iin(\
l-iiclor (I I") for
lioiichiiiiirk MO I'.
CI IRONIC
EXPOSURE
Dermal Slope 1 actor
extrapolated from the IUR:
1.1 x 10"5 per mg/kg
l.i\crand lung minors
Vu applicable
1st percentile human equivalent dermal dose
(HEDD) i.e., the HEDD99 extrapolated from
inhalation:
2.15 mg/kg
Liver effects
UFa=3;
UFh=3;
UFl=1
Total UF= 10
ACUTE
EXPOSURE
Extrapolated from inhalation
POD =16 mg/kg
Impairment of the
CNS
UFa=1;
UFh=10;
UFl=3
Total UF=30
6530
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6531
6532
6533
6534
6535
6536
6537
6538
6539
6540
6541
6542
6543
6544
6545
6546
6547
6548
6549
6550
6551
6552
6553
6554
6555
6556
6557
6558
6559
6560
6561
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4
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
RISK CHARACTERIZATION
4.1 Environmental Risk
EPA took fate, exposure, and environmental hazard into consideration to characterize
environmental risk of methylene chloride. As stated in Section 2.1 Fate and Transport, methylene
chloride is not expected to bioconcentrate in biota or accumulate in wastewater biosolids, soil,
sediment, or biota. Releases of methylene chloride to the environment, are likely to volatilize to
the atmosphere, where it will slowly photooxidize. It may migrate to groundwater, where it will
slowly hydrolyze. Additionally, the bioconcentration potential of methylene chloride is low. EPA
modeled environmental exposure with surface water concentrations of methylene chloride
ranging from 3.48E-07 ppb to 17,000 ppb from facilities releasing the chemical to surface water.
Measured surface water concentrations in ambient water range from below the detection limit to
29 ppb. The modeled data represents estimated concentrations near facilities that are actively
releasing methylene chloride to surface water, while the reported measured concentrations
represent sampled ambient water concentrations of methylene chloride. Differences in magnitude
between modeled and measured concentrations may be due to measured concentrations not being
geographically or temporally close to known releasers of methylene chloride.
EPA concludes that methylene chloride poses a hazard to environmental aquatic receptors
(Section 3.1.5). Amphibians are the most sensitive taxa for both acute and chronic exposures. For
acute exposures, a hazard value of 26.35 mg/L was established for amphibians using data on
teratogenesis leading to lethality in frog embryos and larvae. For acute exposures, methylene
chloride also has toxicity values for fish as low as 99 mg/L and for freshwater aquatic
invertebrates as low as 135.81 mg/L. For chronic exposures, methylene chloride has a hazard
value for amphibians of 0.9 mg/L, based on teratogenesis and lethality in frog embryos and
larvae. For chronic exposures to fish, methylene chloride has hazard values as low as 1.5 mg/L.
For chronic exposure to aquatic invertebrates, methylene chloride has a toxicity value of 18
mg/L. In algal species, methylene chloride has toxicity values ranging from 33.09 mg/L to 242
mg/L (with the more sensitive value of 33.09 mg/L used to represent algal species as a whole).
A total of 14 acceptable aquatic environmental hazard studies were identified for methylene
chloride. EPA's evaluation of these studies was mostly high or medium during data quality
evaluation (see Table 3-1 in Section 3.1.2 and "Systematic Review Supplemental File: Data
Quality Evaluation of Environmental Hazard Studies CASRN: 75-09-2 "). The Methylene
Chloride (75-09-2) Systematic Review: Supplemental File for the TSCA Risk Evaluation
Document presents details of the data evaluations for each study, including scores for each
metric and the overall study score.
Given methylene chloride's conditions of use under TSCA outlined in problem formulation (U.S.
E 18c). EPA determined that environmental exposures are expected for aquatic species,
and risk estimation is discussed in Section 4.1.2.
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6601
6602
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4.1.1 Risk Estimation Approach
To assess environmental risk, EPA evaluates environmental hazard and exposure data. EPA used
modeled exposure data from E-FAST, as well as monitored data from the WQP
(www.waterqiialitvdata.iis). to characterize the exposure of methylene chloride to aquatic
species. Environmental risks are estimated by calculating a risk quotients (RQ). As stated
previously, modeled data was used to represent surface water concentrations near facilities
actively releasing methylene chloride to surface water, while the modeled concentrations were
used to represent ambient water concentrations of methylene chloride. RQs were calculated
using surface water concentrations and the COCs calculated in the hazard section of this
document (Section 3.1.4). The RQ is defined as:
RQ = Predicted Environmental Concentration / Effect Level or COC
RQs equal to 1 indicate that environmental exposures are the same as the COC. If the RQ is
above 1, the exposure is greater than the COC. If the RQ is below 1, the exposure is less than the
COC. The COCs for aquatic organisms shown in Table 3-2 and the environmental concentrations
described in Section 2.3.2 were used to calculate RQs (J ).
EPA considered the biological relevance of the species that the COCs were based on when
integrating the COCs with the location of surface water concentration data to produce RQs. For
example, certain biological factors affect the potential for adverse effects in aquatic organisms.
Life-history and the habitat of aquatic organisms influences the likelihood of exposure in an
aquatic environment. In general, amphibian distribution is limited to freshwater environments.
More specifically, those amphibian (Rana sp.) species evaluated for hazards resulting from
chronic exposure (see Section 3.1.2) generally occupy shallow, vegetated, low-flow, freshwater
habitats. In contrast, fish generally occupy a much wider breadth of water body types and
habitats. If hazard benchmarks are exceeded by both amphibians and fish from estimated chronic
exposures, it provides evidence that the site-specific releases could affect that specific aquatic
environment.
Frequency and duration of exposure also affects potential for adverse effects in aquatic
organisms. Therefore, the number of days that a COC was exceeded was also calculated using E-
FAST as described in Section 2.3.2. The days of exceedance modeled in E-FAST are not
necessarily consecutive and could occur sporadically throughout the year. For methylene
chloride, continuous aquatic exposures are more likely for the longer exposure scenarios (i.e.,
100-365 days/yr of exceedance of a COC), and more of an interval or pulse exposure for shorter
exposure scenarios (i.e., 1-99 days/yr of exceedances of a COC). Due to the volatile properties of
methylene chloride, it is more likely that a chronic exposure duration will occur when there are
long-term consecutive days of release versus an interval or pulse exposure which would more
likely result in an acute exposure duration.
4.1.2 Risk Estimation for Aquatic Environment
To characterize potential risk from exposures to methylene chloride, EPA calculated RQs based
on modeled data from E-FAST for sites that had surface water discharges of methylene chloride
according to DMR and TRI data (see Table 4-1 and Appendix H.2). EPA modeled surface water
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6628
6629
6630
6631
6632
6633
6634
6635
6636
6637
6638
6639
6640
6641
6642
6643
6644
6645
6646
6647
6648
6649
6650
6651
6652
6653
6654
6655
6656
6657
6658
6659
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
concentrations of methylene chloride for 123 releases from facilities that manufacture, import
and repackage, process, use, and dispose of methylene chloride. Direct releasing facilities
(releases from an active facility directly to surface water) were modeled with two scenarios
based on a high-end and low-end days of release. Indirect facilities (transfer of wastewater from
an active facility to a receiving POTW or non-POTW WWTP facility) were only modeled with a
high-end days of release scenario because it was assumed that the actual release to surface water
would mostly occur at receiving treatment facilities, which were assumed to typically operate greater
than 20 days/yr. As stated in Section 2.3.1.2.2, the maximum release frequency (250 to 365 days) is
based on estimates specific to the facility's condition of use and the low-end release frequency of 20
days of release per year is based on estimated releases that could lead to chronic risk.
All facilities were modeled in E-FAST and RQs are listed in Appendix H.2. Facilities with RQs
and days of exceedance that indicate risk for aquatic organisms (facilities with an acute RQ > 1,
or a chronic RQ > 1 and 20 days or more of exceedance for the chronic COC) are presented in
Table 4-1. There are four recycling and disposal facilities and one WWTP that indicate risk for
aquatic organisms. Faculties in other conditions of use had acute and chronic RQs < 1, indicating
they do not present acute or chronic risk to aquatic organisms. These conditions of use include
manufacturing, import and repackaging, processing as a reactant, processing and formulation,
use in polyurethane foam, use in plastics manufacturing, use in pharmaceuticals, CTA film
manufacturing, lithographic printer cleaning, spot cleaning, "other" unspecified conditions of
use, and Department of Defense.
Recycling and Disposal
Of the 16 recycling and disposal facilities, there were 4 sites with releases indicating risk to
aquatic organisms (either the acute RQ > 1, or the chronic RQ > 1 with 20 days or more of
exceedance for the chronic COC). One of these facilities had an acute RQ > 1, indicating acute
risk. This RQ was associated with indirect releases from a recycling and disposal facility, Veolia
ES Technical Solutions LLC. The facility transferred methylene chloride for the purpose of
wastewater treatment to Clean Harbors Baltimore. The acute RQ associated with this release was
6.46, indicating the surface water concentration was over six times higher than the acute COC.
Veolia ES Technical Solutions LLC also transferred methylene chloride to three other facilities;
however, those receiving facilities indicated no risk. Middlesex County Utilities Authority had
an acute RQ < 1 and after further analysis it was determined that Safety-Kleen Systems Inc and
Ross Incineration did not release methylene chloride to surface water.
Among the recycling and disposal facilities, there were 4 with releases indicating chronic risk
(where the chronic RQs > 1 and there were 20 days or more of exceedance). At these facilities, 3
of 10 evaluated indirect releases, and 1 out of 6 direct releases had chronic RQs > 1 and 20 days
or more of exceedance. One of the indirect releases with RQs > 1 was the result of transfers from
Veolia ES Technical Solutions LLC for wastewater treatment to: Clean Harbors Baltimore
(chronic RQ = 188.89) discussed above. Two other indirect releases were from Johnson Matthey
West and Clean Harbors Deer Park LLC and resulted in chronic RQ > 1 and involved transfers to
Clean Harbors Baltimore (chronic RQ = 1.53 and 1.29, respectively). The direct release from a
recycling and disposal facility with an RQ > 1, Clean Water of New York Inc, had a chronic RQ
of 3.92. The highest chronic RQ, 188.89 with 250 days of exceedance, was again associated with
indirect releases from a recycling and disposal site, Veolia ES Technical Solutions LLC, which
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6665
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6667
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6670
6671
6672
6673
6674
6675
6676
6677
6678
6679
6680
6681
6682
6683
6684
6685
6686
6687
6688
6689
6690
6691
6692
6693
6694
6695
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
transferred methylene chloride to Clean Harbors Baltimore for the purpose of wastewater
treatment. It is unclear whether this facility releases methylene chloride to freshwater or an
estuarian environment; however, chronic RQs are greater than or equal to one with 20 days or
more of exceedance for amphibians (RQ = 188.89 with 250 days of exceedance), fish (RQ =
112.58 with 250 days of exceedance), and invertebrates (RQ = 9.44 with 196 days of
exceedance).
As stated previously, the highest modeled release originated from Veolia ES Technical Solutions
LLC. The release was transferred to Clean Harbors of Baltimore (modeled concentration of
17,000 ppb). This concentration is 11 times higher than the next highest surface water
concentration modeled. The associated annual release amounts were similarly high, 13 times
higher than the next highest annual release amount. To calculate this surface water concentration,
EPA used TRI data indicating that methylene chloride was transferred to Clean Harbors
Baltimore for wastewater treatment. In the absence of information about how methylene chloride
waste was managed or possibly released at Clean Harbors Baltimore, EPA used a reasonable
default assumption for assessing releases to surface water. Because the TRI data indicate
methylene chloride was transferred to Clean Harbors Baltimore for wastewater treatment, EPA
assumed 57% removal of methylene chloride before it was released to surface water (the
assumption EPA uses for the POTW industry sector). Site-specific flow data was not available,
so instream flow information representative of industrialized POTWs was used to model
subsequent surface water concentrations. It was not indicated in the TRI data whether the
chemical was incinerated on-site or underwent some other treatment activity.
Waste Water Treatment Plant (WWTP)
For WWTPs, 1 facility, Long Beach (C) WPCP in Long Beach, NY, had an acute RQ > 1 at 2.78
from a direct release of methylene chloride to surface water. The acute RQ associated with the
high-end days of release scenario (365 days) for this site was 0.14, indicating no acute risk. A
WWTP is likely to be operating at greater than 20 days of release, therefore the RQ associated
with the high-end days of release scenario (365 days) is likely more representative of actual
conditions. However, this facility releases methylene chloride into an estuarian environment, and
the acute RQ is based on amphibian data. Because amphibians reside in freshwater
environments, acute risk to amphibians is unlikely at this facility. However, Long Beach (C)
WPCP also had direct releases with chronic RQs > 1 (fish RQ of 2.00) and 365 days of
exceedance. Again, because this facility releases methylene chloride into an estuarian
environment, the chronic fish RQ of 2.0 is more relevant than the chronic amphibian RQ.
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6701 Table 4-1. Modeled Facilities Showing Acute and/or Chronic Risk from the Release of Methylene Chloride; RQ Greater Than One
6702 are Shown in Bold
N;i mo.
l ocution, and
II) ul' Ac(i\c
Releaser
l-acililv1
Release
.Media1'
Modeled l acilil>
oi* Indusln
Sector in H-
IASIV
I.-I AST
\\ alcrhod.t
Tj pe'1
Annual
Release
UvJi)
Dajsof
release''
l)ail\
Release
(k&'daj/
¦'Qui
S\\(
tppbf
cot 1 > pe
COC (pph)
l)a\s of
I'Acecdancc
(da\ s/\ i\)h
RQ
OES: Recycling and Disposal
JOHNSON
Receiving
Facility: Clean
Harbors of
Baltimore, Inc;
POTW (Ind.)
Chronic
Amphib.
90
64
1.53
MATTHEY
WEST
Non-
POTW
WWT
Surface
620
250
2
137.42
Chronic
Fish
151
33
0.91
DEPTFORD, NJ
NPDES:
water
Chronic
Invert.
1,800
0
0.08
NJO115843
Acute
Amphib.
2,630
N/A
0.05
CLEAN
HARBORS
DEER PARK
LLC LA
PORTE, TX
NPDES:
TX0005941
Receiving
Facility: Clean
Harbors of
Baltimore, Inc;
POTW (Ind.)
Chronic
Amphib
90
52
1.29
Non-
POTW
WWT
Surface
522
250
2
115.81
Chronic
Fish
151
26
0.77
water
Chronic
Invert.
1,800
0
0.06
Acute
Amphib.
2,630
N/A
0.04
Receiving
Facility:
Chronic
Amphib.
90
0
5.36E-
05
VEOLIA ES
TECHNICAL
SOLUTIONS
LLC
MIDDLESEX,
NJ NPDES:
NJO127477
MIDDLESEX
COUNTY
Still body
4.40
250
0.018
0.00482
Chronic
Fish
151
0
3.19E-
05
Non-
POTW
WWT
UTILITIES
AUTHORITY;
Chronic
Invert.
1,800
0
2.68E-
06
NPDES:
NJ0020141
Acute
Amphib.
2,630
N/A
1.83E-
06
Receiving
Chronic
Amphib.
90
250
188.89
Facility: Clean
Harbors; POTW
Surface
water
76,451
250
306
17000
Chronic
Fish
151
250
112.58
(Ind.)
Chronic
Invert.
1,800
196
9.44
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N;i 1110.
l ocution, iiiul
Modeled l ;icili(\
II) ul' Ac(i\c
til' Indusln
l.-l AST
Aniiiiiil
l)nil\
¦'Qui
l)il\S (ll°
Uok'iisor
Release
Seelor in H-
\\ ;i(oiho(l\
Release
l);i\s of
Release
S\\(
llxm'diinco
hicililv'
Medi.i1'
l-ASP
Tj pe'1
(kii>
release''
(k^/da>)'
ippi))-
COC T\pe
( ()( (ppl>)
(d;i\sA r)h
RQ
Acute
Amphib.
2,630
N/A
6.46
Chronic
Receiving
Facility: ROSS
INCINERATION
SERVICES INC;
POTW (Ind.)
Amphib.
NA
NA
NA
NA
NA
Chronic
Fish
-
-
-
Chronic
Invert.
-
-
-
Acute
Amphib.
-
-
-
Chronic
Receiving
Facility:
SAFETY-KLEEN
SYSTEMS INC;
POTW (Ind.)
Amphib.
NA
NA
NA
NA
NA
Chronic
Fish
-
-
-
Chronic
Invert.
-
-
-
Acute
Amphib
-
-
-
Chronic
Amphib
90
250
0.31
250
0.01
27.94
Chronic
Fish
151
0
0.19
CLEAN
Chronic
Invert.
1,800
0
0.02
WATER OF
NEW YORK
INC STATEN
ISLAND, NY
NPDES:
NY0200484
Surface
Active Releaser
(Surrogate):
Still body
2
Acute
Amphib
2,630
N/A
0.01
Water
NPDES
NJ0000019
Chronic
Amphib
90
20
3.92
Chronic
Fish
151
20
2.34
20
0.12
352.94
Chronic
Invert.
1800
0
0.20
Acute
Amphib
2,630
N/A
0.13
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N;i mo.
l ocution, iiiul
II) ul' Ac(i\c
Uok'iisor
hicililv'
Kcloiiso
Med hi1'
Modeled l;icili(\
til' Indiisln
Sector in H-
l-ASP
l.-l AST
\\ ;ilcrl>od>
Tj |K'''
Aniiiiiil
Kclcsisc
(kii>
Dsijs of
rclciisc''
l);iil\
Kclcstsc
¦'Qui
S\\(
(l)l)l))-
COC Tjpe
( ()( (|)|>l>)
I);i\s of
ll\cccd;incc
(d;i\s/\ r)h
RQ
OES: WWTP
LONG BEACH
(C) WPCP
LONG BEACH,
NYNPDES:
NY0020567
Surface
Water
Active Releaser:
NPDES
NY0020567
Still water
2,730
365
7
301.46
Chronic
Amphib.
90
365
3.35
Chronic
Fish
151
365
2.00
Chronic
Invert.
1,800
0
0.17
Acute
Amphib
2,630
N/A
0.11
20
136.49
5878.12
Chronic
Amphib
-
-
-
Chronic
Fish
-
-
-
Chronic
Invert.
-
-
-
Acute
Amphib.
-
-
-
a. Facilities actively releasing methylene chloride were identified via DMR and TRI databases for the 2016 reporting year.
b. Release media are either direct (release from active facility directly to surface water) or indirect (transfer of wastewater from active facility to a receiving POTW or non-
POTW WWTP facility). A wastewater treatment removal rate of 57% is applied to all indirect releases, as well as direct releases from WWTPs.
c. If a valid NPDES of the direct or indirect releaser was not available in EFAST, the release was modeled using either a surrogate representative facility in EFAST (based on
location) or a representative generic industry sector. The name of the indirect releaser is provided, as reported in TRI.
d. EFAST uses ether the "surface water" model, for rivers and streams, or the "still water" model, for lakes, bays, and oceans.
e. Modeling was conducted with the maximum days of release per year expected. For direct releasing facilities, a minimum of 20 days was also modeled.
f. The daily release amount was calculated from the reported annual release amount divided by the number of release days per year.
g. For releases discharging to lakes, bays, estuaries, and oceans, the acute scenario mixing zone water concentration was reported in place of the 7Q10 SWC.
h. To determine the PDM days of exceedance for still bodies of water, the estimated number of release days should become the days of exceedance only if the predicted
surface water concentration exceeds the COC. Otherwise, the days of exceedance can be assumed to be zero.
6703
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6706
6707
6708
6709
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6716
6717
6718
6719
6720
6721
6722
6723
6724
6725
6726
6727
6728
6729
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EPA also used surface water monitoring data from the WQP and from the peer reviewed publicly
available literature and grey literature to characterize the risk of methylene chloride to aquatic
organisms in ambient water. From the WPQ, EPA's STORET data and USGS's NWIS data
show an average concentration of methylene chloride of 0.78 ±1.5 [j,g/L in surface water. These
data reflect 2,286 measurements taken throughout 10 U.S. states between 2013 and 2017. The
highest concentration recorded was 29 |ig/L, measured once in 2016. Very few monitors were
positioned downstream of facilities releasing methylene chloride to surface water, and the
monitors that were downstream were not close. As stated in Section 2.3.2, three of the
monitoring sites were 7.5 to 15.8 miles downstream of two facilities. The remaining monitoring
sites were not collocated with facilities. Therefore, the monitored data from these locations
reflect concentrations of methylene chloride in ambient water, rather than concentrations near
facilities. The monitored data generally show ambient concentrations much lower than the
concentrations modeled close to facilities releasing methylene chloride from the E-FAST results.
This indicates that risk to aquatic organisms from methylene chloride exposure is more likely
proximal to facilities, than in ambient water.
Table 4-2 shows acute and chronic RQs of 0.0 calculated using the mean surface water
concentration from monitoring data. It also shows an acute RQ of 0.0 and chronic RQs of 0.3,
0.2, and 0.0 calculated using the maximum surface water concentration from the monitored data.
These data indicate that no risks were identified in ambient water for amphibians, fish, and
aquatic invertebrates exposed to methylene chloride for a chronic duration.
Table 4-2. RQs Calculated using Monitored Environmental Concentrations from WQP
Monitored Surface \Yater
Concentrations (pph) from
2013-2017
UQ using
Acute COC of
2.630 pph
UQ using
Chronic COC
of 90 pph
UQ using
Chronic COC
of 151 pph
UQ using
Chronic COC of
1.800 pph
Mean (SD): 0.78 (1.5) ppb
0.0
0.0
0.0
0.0
Maximum: 29 ppb
0.0
0.3
0.2
0.0
To show where facilities releasing methylene chloride to surface water are in relation to
monitored data, EPA used the geospatial analysis outlined in Section 2.3 to conduct a watershed
analysis. This analysis combined predicted concentrations from modeled facility releases with
monitored data from WQP. Overall, there are 28 U.S. states/territories with either a measured
concentration (n=10) or a predicted concentration (n=23). At the watershed level, there are 127
HUC-8 areas and 198 HUC-12 areas with either measured or predicted concentrations
(TableApx E-l and TableApx E-2). The surface water concentrations were compared to the
COCs.
Figures 4-1 through 4-5 show where monitored and modeled surface water concentrations
exceeded the COCs for amphibians, fish, and invertebrates. Figures 4-1 and 4-2 show
exceedances for a maximum days of release scenario, and Figures 4-3 and 4-4 show exceedances
for a 20-days of release scenario. Figure 4-5 shows an area where some monitoring information
was co-located with facilities that release methylene chloride to surface water. However, the
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6742 monitoring samples were not down-stream of the facilities and did not detect methylene chloride
6743 in the ambient water.
6744
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Miles
Concentration Type
Modeled - Direct Release (250 - 365 days/yr)
A Modeled - Indirect Release (250 - 365 days/yr)
o Measured - NWIS/STORET Monitoring Sites
COCs) H A Days of exceedance s 20 days
States with no modeled or measured concentrations
Concentration Levels
¦ s 1800 |jg/L
151 - 1799 [jg/L
¦ 90 - 150 (jg/L
¦ <90 |jg/L (below all
¦ Not detected
6745
6746 Figure 4-1. Surface Water Concentrations of Methylene Chloride from Releasing Facilities
6747 (Maximum Days of Release Scenario) and WQX Monitoring Stations: Year 2016, East U.S.
6748 All indirect releases are mapped at the receiving facility unless the receiving facility is unknown.
6749
6750
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Concentration Levels Concentration Type
¦ > 1800 pg/L D Modeled - Direct Release (250 - 365 days/yr)
151 - 1799 ng/L A Modeled - Indirect Release (250 - 365 days/yr)
¦ 90 — 150 jjg/L ° Measured - NWIS/STORET Monitoring Sites
¦ < 90 ng/L (below all COCs) 0 A Days of exceedance > 20 days
Not detected X/// States with no modeled or measured concentrations
300
H Miles
6751
6752 Figure 4-2. Surface Water Concentrations of Methylene Chloride from Releasing Facilities
6753 (Maximum Days of Release Scenario) and WQX Monitoring Stations: Year 2016, West
6754 U.S.
6755 All indirect releases are mapped at the receiving facility unless the receiving facility is unknown.
6756
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Miles
Concentration Levels Concentration Type
¦ > 1800|jg/L ~ Modeled - Direct Release (20 days/yr)
151 - 1799 (jg/L o Measured - NWIS/STORET Monitoring Sites
¦ 90-150(jg/L 0 Days of exceedance > 20 days
< 90 (jg/L (below all C0Cs)r7^- States with no modeled or measured
¦ Not detected concentrations
6757
6758 Figure 4-3. Concentrations of Methylene Chloride from Releasing Facilities (20 Days of
6759 Release Scenario) and WQX Monitoring Stations: Year 2016, East U.S.
6760
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Concentration Levels Concentration Type
¦ > 1800 |jg/L ~ Modeled - Direct Release (20 days/yr)
151 - 1799 [jg/L o Measured - NWIS/STORET Monitoring Sites
¦ 90- 150 pg/L H Days of exceedance > 20 days
< 90 jjg/L (below all COCs) States with no modeled or measured
¦ Not detected concentrations
6761
6762 Figure 4-4. Concentrations of Methylene Chloride from Methylene Chloride-Releasing
6763 Facilities (20 Days of Release Scenario) and WQX Monitoring Stations: Year 2016, West
6764 U.S.
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U.S. Locations
Concentrations
Measured - NWIS/STORET Monitoring Sites
Not detected
Modeled - Direct Release (250 - 365 days/yr)
Below all COC
• Days of exceedance > 20 days
HUC-8 boundary
~ HUC-12 boundary*
Aqua Fria
15070102
Pleasant
AZ0020559
\Z0020001
Theodore
evelt
e
Apache-* I
Lower Salt
15060106
AZ(IU23y31
AZII020524
50
Miles
Only one HUC-12 contains both
a facility and a monitoring station
"
SGS The National Map: National Hydrography Dataset. Data refreshed October, 2018
Figure 4-5. Co-location of Methylene Chloride Releasing Facilities and WQX Monitoring
Stations at the IIUC 8 and HUC 12 Level
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4.1.3 Risk Estimation for Sediment
EPA did not quantitatively analyze exposure to sediment organisms. While no ecotoxicity
studies were available for sediment-dwelling organisms (e.g., Lumbriculus variegatus, Hyalella
azteca, Chironomus riparius), the toxicity of methylene chloride to sediment invertebrates is
expected to be similar to the toxicity to aquatic invertebrates. EPA calculated an acute aquatic
invertebrate COC of 36,000 ppb, and a chronic aquatic invertebrate COC of 1,800 to address
hazards to sediment organisms. Methylene chloride is not expected to partition to or be retained
in sediment and is expected to remain in aqueous phase due to its water solubility (13 g/L) and
low partitioning to organic matter (log Koc = 1.4). While limited sediment monitoring data for
methylene chloride suggest that it is present in sediments, the methylene chloride detected in
sediments is likely in the pore waters and not adsorbed to the sediment organic matter because
methylene chloride has low partitioning to organic matter. Thus, methylene
chloride concentrations in sediment pore water are expected to be similar to the concentrations in
the overlying water, and concentrations of methylene chloride in the deeper part of sediment,
where anaerobic conditions prevail, are expected to be lower. For both acute and chronic
exposures to methylene chloride, the RQs are 0.00 and 0.016, based on the highest ambient
surface water concentration of 29 ppb, indicating that there are no risks to sediment organisms
from acute or chronic exposures.
4.1.4 Risk Estimation for Terrestrial
EPA did not assess exposure to terrestrial organisms through soil, land-applied biosolids, or
ambient air. Methylene chloride is not expected to partition to or accumulate in soil; rather, it is
expected to volatilize to air or migrate through soil into groundwater, based on its physical-
chemical properties (log Koc = 1.4, Henry's Law constant = 0.00325 atm-m3/mole, vapor
pressure = 435 mmHg at 25°C). A screening of hazard data for terrestrial organisms shows
potential hazard; however, physical chemical properties do not support an exposure pathway
through water and soil pathways to terrestrial organisms.
Methylene chloride is not anticipated to partition to be retained in biosolids (processed sludge)
obtained through wastewater treatment. Any methylene chloride present in the water portion of
biosolids following wastewater treatment, processing, and land application would be expected to
rapidly volatilize into air. Furthermore, methylene chloride is not anticipated to remain in soil, as
it is expected to either volatilize into air or migrate through soil into groundwater. Therefore, the
land application of biosolids was not analyzed as a pathway for environmental exposure.
Methylene chloride is expected to volatilize to air, based on physical-chemical properties.
However, EPA did not include the emission pathways to ambient air from commercial and
industrial stationary sources or associated inhalation exposure of terrestrial species, because
stationary source releases of methylene chloride to ambient air are adequately assessed and any
risks effectively managed under the jurisdiction of the Clean Air Act (CAA).
4.2 Human Health Risk
Methylene chloride exposure is associated with a variety of cancer and non-cancer adverse
effects deemed relevant to humans for risk estimations for the scenarios and populations
addressed in this risk evaluation. Based on a weight-of-evidence analysis of the available toxicity
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studies from animals and humans, the non-cancer effects selected for risk estimation because of
their robustness and sensitivity were neurotoxicity (i.e. CNS depression) from acute exposure and
liver toxicity from chronic exposures. The evaluation of cancer includes estimates of risk of lung
and liver tumors.
4.2.1 Risk Estimation Approach
Tables 4-3, 4-4, and 4-5 show the use scenarios, populations of interest and toxicological
endpoints used for acute exposures for workers, acute exposure for consumers and chronic
exposure for workers, respectively.
Table 4-3. Use Scenarios, Populations of Interest and Toxicological Endpoints for Assessing
Occupational Risks Following Acute Exposures to Methylene Chloride
Popiilalions iiiid Toxicologic;!!
Approach
Occupational I se Scenarios of >lelh\ lene Chloride
Population of Interest and
Exposure Scenario:
Users:
Adults and youth of both sexes (>16 years old) exposed to methylene chloride during an 8-
hr workday 1 2
Occupational Non-user:
Adults and youth of both sexes (>16 years old) indirectly exposed to methylene chloride
while being in the same building during product use and further information when
available is included in section 2.4.1.2 listed by OES. Workers include 16 year olds
because of OSHA work permits.
Health Effects of Concern,
Concentration and Time
Duration
Non-Cancer Health Effects: Acute toxicity CNS degression.
Hazard Values (PODsj for Occupational Scenarios:3,4
• 15-min: 478 ppm (1706 mg/m3)
• 1-hr: 240 ppm (840 mg/m3)
• 8-hrs: 80 ppm (290 mg/m3)
Cancer Health Effects: Cancer risks following acute exposures were not estimated.
Relationship is not known between a single short-term exposure to methylene chloride
and the induction of cancer in humans.
Uncertainty Factors (UF)
used in Non-Cancer
Margin of Exposure (MOE)
calculations
Total UF = 30 (10X UFH * 3X UHL)5
Notes:
1 It is assumed no substantial buildup of methylene chloride in the body between exposure events due to methylene
chloride's short biological half-life (~40 min).
2 EPA believes that the users of these products are generally adults.
3 Exposure estimates were made for 8 hr TWAs for all the conditions of use and when exposure estimates for times shorter
than 8 hrs were made the additional PODs (identified above) were used.
4
In addition to the PODs identified, EPA also compared higher exposure values (> 4000 mg/m3) with the NIOSHIDLH
value of 7981 mg/m3, which is the value identified as immediately dangerous to life or health (NIOSH, 1994, 192295};
individuals should not be exposed to this level for any length of time.
5 UFH=intraspecies UF; UFL=LOAEL to NOAEL UF
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6824
6825 Table 4-4. Use Scenarios, Populations of Interest and Toxicological Endpoints for Assessing
6826 Consumer Risks Following Acute Exposures to Methylene Chloride
Use
Scenarios
Populations
and Toxicological^^
Approach
CONSl MI R I SI S
I'opulalion of InlcrcM
and llxposuiv Scenario:
I .SL't'S
Adults of both sexes (>16 years old) typically exposed to methylene chloride.
I'opulalion of InlcrcM
and llxposuiv Scenario:
liyshmdcr
Individuals of any age indirectly exposed to methylene chloride while being in the rest
of the house during product use see Section 2.4.2 for more information.
Non-Cancer Health Effects: CNS effects
llcallh I ITcclsor
( onccrn. ( onccnl ralion
and l ime Duration
Hazard Values (PODsj for Consumer Scenarios3:
• 15-min: 478 ppm (1706 mg/m3)
• 1-hr: 240 ppm (840 mg/m3)
• 8-hrs: 80 ppm (290 mg/m3)
Cancer Health Effects: Cancer risks following acute exposures were not estimated.
I nccrla in l> l-'aclorsil I )
used in \on-( anccr
Margin of l-lxposure
(MOT.) ca leu la I ions
Total UF = 30 (10X UFH * 3X UHL)4
Notes:
1 It is assumed no substantial buildup of methylene chloride in the body between exposure events due to methylene
chloride's short biological half-life (~40 min).
2 EPA believes that the users of these products are generally adults, but younger individuals may be users of
methylene chloride products
3In addition to the PODs identified, EPA also compared higher exposure values ( > 4000 mg/m3) with the NIOSH
IDLH value of 7981 mg/m3, which is the value identified as immediately dangerous to life or health (NIOSH,
1994, 192295}; individuals should not be exposed to this level for any length of time.
4 UFH= intraspecies UF; UFL=LOAEL to NOAEL UF
6827
6828
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6829
6830
Table 4-5. Use Scenarios, Populations of Interest and Toxicological Endpoints for Assessing
Use
Scenarios
Populations^^
And Toxicologic&k
Approach
OCCUPATIONAL USE
Population of Interest
and Exposure
Scenario:
Users
Adults of both sexes (>16 years old) exposed to methylene chloride during
an 8-hr workday for up to 250 days/yr for as many as 40 working years depending on
the occupational scenario 1 -23
Population of Interest
and Exposure
Scenario:
Non-user
Adults of both sexes (>16 years old) indirectly exposed to methylene chloride while
being in the same building during product use.3
Health Effects of
Concern,
Concentration and
Time Duration
Hazard Value (PODs) Hazard Value (PODs)
for Non-Cancer Effects for Cancer Effects
(liver effects): (liver and lung tumors):
1st percentile HEC i.e., the HEC99: IUR:
HEC i.e., the HEC99: 1.38 x 10~6 per mg/m3
17.2 mg/m3 for 40 lir work week
(4.8 ppm)
for 24 lir/day exposure
Uncertainty Factors
(UF) used in Non-
Cancer
Margin of Exposure
(MOE) calculations
UF for the HEC99 = 10 (3X UFA * 3X UHh)
UF is not applied for the cancer risk calculations.
Notes:
1 It is assumed no substantial buildup of methylene chloride in the body between exposure events due to
methylene chloride's short biological half-life (~40 min).
2 EPA believes that the users of these products are generally adults.
3 A range of working years were evaluated from 31 - 40 years, see Section 2.4.1.1.
4 Data sources did not often indicate whether exposure concentrations were for occupational users or non-users.
Therefore, EPA assumed that exposures were for a combination of users and non-users. Some non-users may
have lower exposures than users, especially when they are further away from the source of exposure.
6831
6832
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Acute or chronic MOEs (MOEaCute or MOEchronic) were used in this assessment to estimate non-
cancer risks using Eq. 4-1
(Eq. 4-1)
Equation to Calculate Non-Cancer Risks Following Acute or Chronic Exposures Using
MOEs
Non — cancer Hazard value (POD)
MOEacuteorchronlc = Human Exposure
Where:
MOE = Margin of exposure (unitless)
Hazard value (POD) = POD or HEC (mg/m3 or mg/kg/day)
Human Exposure = Exposure estimate (mg/m3 or mg/kg/day) from occupational or consumer
exposure assessment (see Section 2.4).
EPA used MOEs17 to estimate acute or chronic risks for non-cancer effects based on the
following:
1. the endpoint/study-specific UFs applied to the HECs per the EPA Guidance (EPA. 2002):
and
2. the exposure estimates calculated for methylene chloride uses examined in this risk
evaluation (see Section 2.4).
MOEs allow for the presentation of a range of risk estimates. The OES considered both acute and
chronic exposures. All consumer uses considered only acute exposure scenarios. Different adverse
endpoints were determined to be appropriate based on the expected exposure durations. For non-
cancer effects, risks for acute effects (neurotoxicity) were evaluated for acute (short-term)
exposures, whereas risks for liver toxicity were evaluated for repeated (chronic) exposures to
methylene chloride. For cancer, risks for chronic effects are based on lung and liver tumors.
For occupational exposure calculations, the 8 hr TWA was used to calculate MOEs for risk
estimates for acute and chronic exposures. When shorter duration exposure estimates were
available (e.g., 15 minutes or 1 hr), these were used to calculate MOEs for risk estimates for
acute exposures. EPA selected exposure durations of 15 mins and 1 hr, in addition to the 8-hr
duration to represent a reasonable range of acute exposure durations. Also, in one fatality case
report, the exposed individual was found dead 20-30 mins after the individual had been observed
alive (Nac/Aegl. 2008). Even though the individual may have been exposed for some time prior
to being still observed alive, additional information was not available and thus, the total exposure
time could have been limited. Finally, 15 mins matches the duration of the OSHA STEL. For
these reasons, EPA is presenting this range of acute durations when exposure data are available
to calculate such risks.
17 Margin of Exposure (MOE) = (Non-cancer hazard value, POD) (Human Exposure). Equation 4-1. The
benchmark MOE is used to interpret the MOEs and consists of the total UF shown in Table 4-3, Table 4-4 and Table
4-5.
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The total UF for each non-cancer POD was developed as the benchmark MOE used to interpret
the MOE risk estimates for each use scenario. The MOE estimate was interpreted as a human
health risk if the MOE estimate was less than the benchmark MOE (i.e., the total UF). On the
other hand, the MOE estimate indicated negligible concerns for adverse human health effects if
the MOE estimate was equal to or exceeded the benchmark MOE. Typically, the larger the MOE,
the more unlikely it is that a non-cancer adverse effect would occur.
Extra cancer risks for chronic exposures to methylene chloride were estimated using Eq 4-2.
Estimates of extra cancer risks should be interpreted as the incremental probability of an
individual developing cancer over a lifetime as a result of exposure to the potential carcinogen
(i.e., incremental or extra individual lifetime cancer risk).
(Eq. 4-2)
Equation to Calculate Extra Cancer Risks
Risk = Human Exposure x Slope Factor
Where:
Risk = Extra cancer risk (unitless)
Human exposure = Exposure estimate (mg/m3 ormg/kg/day) from occupational exposure
assessment
Slope Factor = Inhalation unit risk (1.38E-06 per mg/m3) or
Dermal slope factor (1.1 x 10"5 per mg/kg/day)
Exposures to methylene chloride were evaluated by inhalation and dermal routes separately.
Inhalation and dermal exposures are assumed to occur simultaneously for workers and
consumers. EPA chose not to employ simply additivity of exposure pathways at this time within
a condition of use because of the uncertainties present in the current exposure estimation
procedures and this may lead to an underestimate of exposure.
4.2.2 Risk Estimation for Inhalation and Dermal Exposures
The acute inhalation and dermal risk assessment used CNS effects to evaluate the acute risks for
consumer and occupational use of methylene chloride. Both non-cancer liver effects and cancer
liver and lung tumors were used to evaluate chronic risk. Non-cancer risk estimates were
calculated with equation 4-1 and cancer risks were calculated with equation 4-2.
4.2.2.1 Risk Estimation for Inhalation Exposures to Workers
4.2.2.1.1 Manufacturing
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for
manufacturing are presented in Tables 4-6, 4-7, and 4-8, respectively. For manufacturing
exposure estimates for TWAs of 15 mins, 1 hr and 8 hrs are available based on personal
monitoring data samples, including 136 data points from 2 sources (Halogenated Solvents
Industry Alliance. 2018). The 15 mins and 1 hr TWAs are useful for characterizing exposures
shorter than 8 hrs that could lead to adverse CNS effects. PODs specific to 15 mins and 1 hr
TWA exposures were used for characterization of the risk. EPA calculated 50th and 95th
percentiles to characterize the central tendency and high-end exposure estimates, respectively.
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EPA has not identified data on potential ONU inhalation exposures from methylene chloride
manufacturing. ONU inhalation exposures are expected to be lower than worker inhalation
exposures however the relative exposure of ONUs to workers cannot be quantified as described
in more detail above in Section 2.4.1.2.1. EPA calculated risk estimates assuming ONU
exposures could be as high as worker exposures as a high-end estimate and there is large
uncertainty in this assumption. Considering the overall strengths and limitations of the data,
EPA's overall confidence in the occupational inhalation estimates in this scenario is medium to
high. Section 2.4.1.2.1 describes the justification for this occupational scenario confidence
rating. The studies that support the health concerns of acute CNS effects, liver toxicity and
cancer and the hazard value and benchmark MOEs are described above in Section 4.2.1 Risk
Estimation Approach and overall EPA has medium confidence in the acute, chronic and cancer
endpoints. Section 3.2.5.3 describes the justification for these human health ratings.
Table 4-6. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for
Manufacturing
MIX l ime Period
l.ndpoinl = CNS HITccls1
Acme MIX
(inii/in1)
l'l\|)OMirc l.c\cl
MOIls for Aciilc l'.\|
Worker* ONI :
No rcspii'iilor
)osiircs
Worker
API- 25'
lienchniiirk
MOI.
(= locil I 1)
8-hr
290
High End
63
1575
30
Central Tendency
795
19878
15-minute
1706
High End
9.3
232
30
Central Tendency
182
4548
1-hr
840
High End
53
1314
30
Central Tendency
127
3182
1 Data from Putz et al. (1979)
2 Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. APF 50 not shown based on MOEs at APF 25 are all greater than the
benchmark MOE.
Table 4-7. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for
Manufacturing
IndpoiiH
Chronic
lll(
(niiVin')
l-'.\posiirc I .ex el
MOI'.s l'«r Chronic l-lxposnivs
Worker & OM :
No rcspimlor
\\ orkcr
API- 25'
licnchniiii'k
MOI.
(= locil I I )
Liver effects
High End
16
409
17.2
10
Central Tendency
207
5164
1 Data from Nitschke et al. (1988a")
9
Exposures to ONUs were not able to be estimated separately from workers
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6945
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6947
6948
6949
6950
6951
6952
6953
6954
6955
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3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. APF 50 not shown based on MOEs at APF 25 are all greater than the
benchmark MOE.
Table 4-8. Risk Estimation for Chronic, Cancer Inhalation Exposures for Manufacturing
l-lnripoinl. Tumor
Tjpes"
11 K
(risk per in^/nvM
I'ApoSIII'C I.C\cl
Cancer Risk l.slim;
Worker A <>M :
No respirator
lies
W orkcr
API 25'
licnchmark
Cancer Risk
Liver and lung tumors
1.38E-06
High End
3.26E-06
2.97E-08
104
Central Tendency
2.00E-07
1.83E-09
1 Data from NTP (.1.986)
9
Exposures to ONUs were not able to be estimated separately from workers
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. APF 50 not shown based on cancer risks at APF 25 are all less than the
cancer risk benchmark of 10~4.
For acute inhalation exposures, MOEs are greater than benchmark MOEs for workers when
respirators are not worn for all exposure scenarios except for the 15-minute estimate for high end
exposures and the consistency across multiple exposure durations adds further support to
identifying MOEs greater than benchmark MOEs. The OSHA STEL is 433 mg/m3 as a 15-min
TWA. In an alternative approach, EPA calculated central tendency and high end values for the
measurements lower than the STEL. Since, only one sample of 486 mg/m3 among the 148 15-
min samples exceeded the STEL, the high-end concentration values changed slightly, from 184
to 183 mg/m3 and risk estimate did not change for the 15-min exposure.
For chronic inhalation exposures, the MOEs are greater than benchmark MOEs for all exposure
scenarios.
For chronic inhalation exposures, cancer risks are less than 10"4 for all exposure scenarios.
Overall, there is medium confidence in the exposure and hazard estimates that make up the risk
estimates and the risk estimates for acute, chronic and cancer indicate negligible concerns for
adverse human health effects.
4.2.2.1.2 Processing as a Reactant
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for
processing as a reactant are presented in Tables 4-9, 4-10, and 4-11, respectively. For processing
as a reactant exposure estimates for TWAs of 15 minutes and 8 hrs are available based on
personal monitoring data samples, including 15 data points from 1 source (Halogenated Solvents
Industry Alliance. 2.018). The 1 hr TWAs are useful for characterizing exposures shorter than 8
hrs that could lead to adverse CNS effects. PODs specific to 15 mins TWA exposures were used
for characterization of the risk. EPA calculated 50th and 95fe percentiles to characterize the
central tendency and high-end exposure estimates, respectively. EPA has not identified data on
potential ONU inhalation exposures from methylene chloride processing as a reactant. ONU
inhalation exposures are expected to be lower than worker inhalation exposures however the
relative exposure of ONUs to workers cannot be quantified as described in more detail above in
Page 306 of 725
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6990
6991
6992
6993
6994
6995
6996
6997
6998
6999
7000
7001
7002
7003
7004
7005
7006
7007
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Section 2.4.1.2.2. EPA calculated risk estimates assuming ONU exposures could be as high as
worker exposures as a high-end estimate and there is large uncertainty in this assumption.
Considering the overall strengths and limitations of the data, EPA's overall confidence in the
occupational inhalation estimates in this scenario is medium to high. Section 2.4.1.2.2 describes
the justification for this occupational scenario confidence rating. The studies that support the
health concerns of acute CNS effects, liver toxicity and cancer and the hazard value and
benchmark MOEs are described above in Section 4.2.1 Risk Estimation Approach and overall
EPA has medium confidence in the acute, chronic and cancer endpoints. Section 3.2.5.3
describes the justification for these human health ratings.
Table 4-9. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Processing as a
Reactant
MIX lime Period
Fmlpoini = ( NS FITecIs1
Anile MIX
(iiiii/mM
F\poslll'e l.l'M'l
MOI-'.s lor Aeu
Worker & <>M :
No respir;ilor
(e r.xposures
Worker
API- 254
lienehniiirk
MOF.
(= loliil
I I)
8-hr
290
High End
28
698
30
Central Tendency
178
4441
15-min
1706
Point Estimate3
4.9
122
30
1 Data from Putz et al. (1979)
2 Exposures to ONUs were not able to be estimated separately from workers.
3 Exposure data were not available to characterize the central tendency and high-end exposures.
4 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. APF 50 not shown based on MOEs at APF 25 are all greater than the
benchmark MOE.
The MOEs are less than the benchmark MOE for high end exposures and the estimated 15-
minute exposure when respirators are not worn. The MOEs are greater than benchmark MOEs
when respirators APF 25 are worn.
Table 4-10. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Processing
as a Reactant
Fiiripoini1
('limine
MIX
(iiiii/nr1)
Fxposure l.c\ol
MOI-'.s for ( hron
Worker & ONI :
No respiriilor
ie Fxposure
Worker
API- 25'
lienehniiirk
MOF.
(= To(;il
I 1)
Liver Effects
17.2
High End
7.2
181
10
Central Tendency
46
1154
1 Data from Nitschke et al. (1988a)
2 Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. APF 50 not shown based on MOEs at APF 25 are all greater than the
benchmark MOE.
The MOEs are less than the benchmark MOE for high end exposures when respirators are not
worn. The MOEs are greater than benchmark MOEs when respirators APF 25 are worn.
Page 307 of 725
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7009
7010
7011
7012
7013
7014
7015
7016
7017
7018
7019
7020
7021
7022
7023
7024
7025
7026
7027
7028
7029
7030
7031
7032
7033
7034
7035
7036
7037
7038
7039
7040
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-11. Risk Estimation for Chronic, Cancer Inhalation Exposures for Processing as a
Reactant
I'lmlpoini. Tumor
T\ pes'
11 K
(risk per inii/in1)
I'ApoSIII'C I.C\cl
Cancel' Risk I'slimates
Worker & OM :
No respirator'
licnchmark
Cancer Risk
Liver and lung tumors
1.38E-06
High End
7.36E-06
104
Central Tendency
8.95E-07
1 Data from NTP (.1.986)
9
Exposures to ONUs were not able to be estimated separately from workers.
3 Cancer risks with respirators not shown based on cancer risks without respirators are less than the benchmark
cancer risk of 10"4.
Cancer risks are less than 10"4 for all exposure scenarios.
4.2.2.1.3 Processing - Incorporation into Formulation, Mixture, or Reaction
Product
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for
processing - incorporation into formulation, mixture, or reaction product are presented in Tables
4-12, 4-13, and 4-14, respectively. For processing - incorporation into formulation, mixture, or
reaction product exposure estimates for TWAs of 15 mins and 8 hrs are available based on
personal monitoring data samples, including a range of values for more than 14 samples from 3
sources (EPA. 1985). The 15 mins TWAs are useful for characterizing exposures shorter than 8
hrs that could lead to adverse CNS effects. PODs specific to 15 mins TWA exposures were used
for characterization of the risk. EPA calculated 50th and 95fe percentiles to characterize the
central tendency and high-end exposure estimates, respectively. EPA has not identified data on
potential ONU inhalation exposures from methylene chloride processing - incorporation into
formulation, mixture, or reaction product. ONU inhalation exposures are expected to be lower
than worker inhalation exposures however the relative exposure of ONUs to workers cannot be
quantified as described in more detail above in Section 2.4.1.2.3. EPA calculated risk estimates
assuming ONU exposures could be as high as worker exposures as a high-end estimate and there
is large uncertainty in this assumption. Considering the overall strengths and limitations of the
data, EPA's overall confidence in the occupational inhalation estimates in this scenario is
medium. Section 2.4.1.2.3 describes the justification for this occupational scenario confidence
rating. The studies that support the health concerns of acute CNS effects, liver toxicity and
cancer and the hazard value and benchmark MOEs are described above in Section 4.2.1 Risk
Estimation Approach and overall EPA has medium confidence in the acute, chronic and cancer
endpoints. Section 3.2.5.3 describes the justification for these human health ratings.
Page 308 of 725
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7042
7043
7044
7045
7046
7047
7048
7049
7050
7051
7052
7053
7054
7055
7056
7057
7058
7059
7060
7061
7062
7063
7064
7065
7066
7067
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-12. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Processing -
Incorporation into Formulation, Mixture, or Reaction Product i
lir.C lime Period
1'iitlpoint = ( NS
i-nwis1
Acme
MIX
(ing/m-')
r.\|)osiii"e l.c\cl
MOI-'.s lor
Worker A OM :
No rcs]>ir;ilor
Acule I'1\|)omii
\\ orkcr
API- 254
e
Worker
API- 504
licnchiiiiirk
MOI.
(= Tol;il
I 1)
8-hr
290
High End
0.13
3.3
6.5
30
Central
Tendency
1.61
40
81
15-min
1706
Point Estimate3
9.48
237
474
30
1 Data from Putz et al. (1979)
2 Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
3 Exposure data were not available to characterize the central tendency and high-end exposures.
4 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
The MOEs are less than the benchmark MOE for high end exposures and the estimated 15-
minute exposure when respirators are not worn. The MOEs are greater than benchmark MOEs
when respirators APF 25 are worn except for high end exposure estimates.
Table 4-13. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Processing
- Incorporation inl
o Formulation, Mixture, or E
Leaction Product
l.nripoinl1
Chronic lll'.(
(iiiiVnrM
l-lxpoMirc
1 .c\ el
MOI-'.s lor
Worker & OM :
No rcspimlor
C hronic l.\
Worker
API- 25'
)OSIIIT
W orkcr
API- 50*
licnchniiirk
MOI.
(= Tol;il
I 1)
Liver Effects
17.2
High End
0.034
0.85
1.7
10
Central
Tendency
0.42
10.5
20.9
1 Data from Nitschke et al. (1988a")
2 Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
The MOEs are less than the benchmark MOE when respirators are not worn and for high end
exposures when respirators APF 50 are worn. The MOE is greater than benchmark MOE for
central tendency exposures when respirators APF 50 are worn.
Table 4-14. Risk Estimation for Chronic, Cancer Inhalation Exposures for Processing -
Incorporation into Formulation, Mixture, or Reaction Product
l-'.mlpoinl. Tumor
Tjpes"
11 K
(risk per
mii/iii-4)
l-lxposiire l.c\cl
Ciinccr Risk I-
Worker & ONI :
No rcspiriilor
sliniiiles
Worker
API- 25*
licnchniiirk
1.38E-06
High End
1.57E-03
6.29E-05
104
Page 309 of 725
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7084
7085
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7093
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7095
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7101
7102
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Cancer Risk
Liver and lung tumors
Central Tendency
9.87E-05
3.95E-06
1 Data from NTP (.1.986)
9
Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. APF 50 not shown based on cancer risks at APF 25 are all less than the
cancer risk benchmark of 10~4
Cancer risks are greater than 10"4 when respirators are not worn for high end exposures. If
workers used respirators with APF 25 then the cancer risks are less than 10"4 for all scenarios.
4.2.2.1.4 Repackaging
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for
repackaging are presented in Tables 4-15, 4-16, and 4-17, respectively. For repackaging
exposure estimates for TWAs of 1 hr and 8 hrs are available based on personal monitoring data
samples, including 5 data points from 1 source (Unocal Corporation. 1986). The 1 hr TWAs are
useful for characterizing exposures shorter than 8 hrs that could lead to adverse CNS effects.
PODs specific to 1 hr TWA exposures were used for characterization of the risk. EPA assessed
the median value as the central tendency and the maximum reported value as the high-end
exposure estimate. EPA has not identified data on potential ONU inhalation exposures from
methylene chloride repackaging. ONU inhalation exposures are expected to be lower than
worker inhalation exposures however the relative exposure of ONUs to workers cannot be
quantified as described in more detail above in Section 2.4.1.2.4. EPA calculated risk estimates
assuming ONU exposures could be as high as worker exposures as a high-end estimate and there
is large uncertainty in this assumption. Considering the overall strengths and limitations of the
data, EPA's overall confidence in the occupational inhalation estimates in this scenario is
medium to low. Section 2.4.1.2.1 describes the justification for this occupational scenario
confidence rating. The studies that support the health concerns of acute CNS effects, liver
toxicity and cancer and the hazard value and benchmark MOEs are described above in Section
4.2.1 Risk Estimation Approach and overall EPA has medium confidence in the acute, chronic
and cancer endpoints. Section 3.2.5.3 describes the justification for these human health ratings.
Table 4-15. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Repackaging
MIX Time' Period
l.nripoim = ( NS
I'llccls1
Anile
MIX
(inii/iii"4)
l'l\posurc
l.c\cl
\ior.s r<
Worker* <)M :
No respirator
ii' Acute l-'.\pos
Worker
API- 25'
ii res
W orkcr
API- 50'
licnchmark
moi:
(= loial I 1)
8-hr
290
High End
2.1
53
105
30
Central
Tendency
33
822
1644
1-hr
840
High End
2.6
64
128
30
Central
Tendency
4.7
118
235
1 Data from Putz et al. (1979)
2Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
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7112
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7114
7115
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7119
7120
7121
7122
7123
7124
7125
7126
7127
7128
7129
7130
7131
7132
7133
7134
7135
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
The MOEs are less than benchmark MOEs when respirators are not worn, except for central
tendency exposures at the 8 hr TWA time point. The MOEs are greater than benchmark MOEs
when respirators APF 25 are worn for all exposure scenarios.
Table 4-16. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for
Repackaging
r.nripoinl1
Chronic
NIC
l-lxpoMirc
l.c\cl
MOI-'.s lo
Worker* OM :
No rcs]>ir;ilor
r Chronic l.\|
W orkcr
API- 25'
tosnrcs
W orkcr
API- 50'
licnchmark
MOI.
(= loliil
I 1)
Liver Effects
17.2
High End
0.55
14
27
10
Central
Tendency
8.54
213
427
1 Data from Nitschke et al. (1988a)
2 Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
The MOEs are less than benchmark MOEs when respirators are not worn. The MOEs are greater
than benchmark MOEs when respirators APF 25 are worn.
Table 4-17. Risk Estimation for Chronic. Cancer Inhalation Exposures for Repackaging
l-lnripoinl. Tumor
T\ pes'
11 K
(risk per mi;/iii\)
l'l\posiirc l.e\el
Cancel' Risk I'sliniates
Worker* OM :
No respirator'
licnchmark
Cancer Risk
Liver and lung tumors
1.38E-06
High End
9.74E-05
104
Central Tendency
4.84E-06
1 Data from NTP (1986)
9
Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. Cancer risks with respirators not shown based on cancer risks without
respirators are less than the cancer risk benchmark of 10~4.
Cancer risks are less than 10"4 for all exposure scenarios.
4.2.2.1.5 Waste Handling, Disposal, Treatment, and Recycling
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for waste
handling, disposal, treatment and recycling are presented in Tables 4-18, 4-19, and 4-20,
respectively. For waste handling, disposal, treatment and recycling exposure estimates for TWAs
of 8 hrs are available based on personal monitoring data samples, including 3 data points from 2
sources ( em.se Occupational and Environmental Health Readiness System - Industrial
Hygiene (DOEHRS-IHl 2018; EPA. 1985). EPA calculated 50th and 95th percentiles to
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7147
7148
7149
7150
7151
7152
7153
7154
7155
7156
7157
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7159
7160
7161
7162
7163
7164
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7166
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
characterize the central tendency and high-end exposure estimates, respectively. EPA has not
identified data on potential ONU inhalation exposures from methylene chloride waste handling,
disposal, treatment and recycling. ONU inhalation exposures are expected to be lower than
worker inhalation exposures however the relative exposure of ONUs to workers cannot be
quantified as described in more detail above in Section 2.4.1.2.21. EPA calculated risk estimates
assuming ONU exposures could be as high as worker exposures as a high-end estimate and there
is large uncertainty in this assumption. Considering the overall strengths and limitations of the
data, EPA's overall confidence in the occupational inhalation estimates in this scenario is
medium to low. Section 2.4.1.2.21 describes the justification for this occupational scenario
confidence rating. The studies that support the health concerns of acute CNS effects, liver
toxicity and cancer and the hazard value and benchmark MOEs are described above in Section
4.2.1 Risk Estimation Approach and overall EPA has medium confidence in the acute, chronic
and cancer endpoints. Section 3.2.5.3 describes the justification for these human health ratings.
Table 4-18. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Waste
Handling, Disposal, Treatment, and Recycling
II IK l ime Period
l.nripoinl = ( NS I'I'lVcl 1
Acule MIX
(iiiii/in1)
I'Aposlll'C I.C\cl
MOI-'.s lor Acu
Worker* OM :
No rcspii'iilor
le i:\posui-es
Worker
API- 25'
lienchniiirk
MOI.
(= loliil
I I)
8-hr
290
High End
15
378
30
Central Tendency
16
393
1 Data from Putz et al. (1979)
2 Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
not expect routine use of PPE that would mitigate risk (respirator APF 25) with this condition of use in part because
only supplied air respirators can be used (see section 2.4.1.1). APF 50 not shown based on MOEs at APF 25 are all
greater than the benchmark MOE.
The MOEs are less than the benchmark MOE when respirators are not worn. The MOEs are
greater than the benchmark MOEs when respirators APF 25 are worn.
Table 4-19. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Waste
Handling, Disposal, Treatment, and Recycling
r.nripoini1
Chronic
MIX
(ing/nr*)
l-l\posurc l.c\cl
MOI-'.s for ( hron
Worker* OM :
No respiriilor
c l-'.\posures
Workers
API- 25'
liciichniiirk
MOI.
(= loliil
I 1)
Liver Effects
17.2
High End
3.9
98
10
Central Tendency
4.08
102
1 Data from Nitschke et al. (1988a')
2 Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
not expect routine use of PPE that would mitigate risk (respirator APF 25) with this condition of use in part because
only supplied air respirators can be used (see section 2.4.1.1). APF 50 not shown based on MOEs at APF 25 are all
greater than the benchmark MOE.
Page 312 of 725
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7181
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7191
7192
7193
7194
7195
7196
7197
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7200
7201
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
The MOEs are less than the benchmark MOE when respirators are not worn. The MOEs are
greater than the benchmark MOEs when respirators APF 25 are worn.
Table 4-20. Risk Estimation for Chronic, Cancer Inhalation Exposures for Waste
Handling, Disposal, Treatment, and Recycling
I'lmlpoini. Tumor
Tjpes"
11 K
(risk per mii/iir1)
I'Aposlll'C I.C\cl
Cancel' Risk I'slimates
Worker* <)M :
No respirator
licnchmark
Cancer Risk
Liver and lung tumors
1.38E-06
High End
1.36E-05
104
Central Tendency
1.01E-05
1 Data from NTP (1986)
2 Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
not expect routine use of PPE with this condition of use. Cancer risks with APF 25 or APF 50 are not shown based
on cancer risks without respirators are less than the cancer risk benchmark of 10~4.
Cancer risks are less than 10"4 when respirators are not worn for all scenarios.
4.2.2.1.6 Batch Open-Top Vapor Degreasing
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for batch
open-top vapor degreasing are presented in Tables 4-21, 4-22, and 4-23, respectively. For batch
open-top vapor degreasing exposure estimates for TWAs of 8 hrs are available based on
modeling with a near-field and far-field approach. EPA calculated 50th and 95th percentiles to
characterize the central tendency and high-end exposure estimates, respectively. EPA used the
near-field air concentrations for worker exposures and the far-field air concentrations for
potential ONU inhalation exposures from methylene chloride batch open-top vapor degreasing as
described in more detail above in Section 2.4.1.2.5. Considering the overall strengths and
limitations of the data, EPA's overall confidence in the occupational inhalation estimates in this
scenario is medium to low. Section 2.4.1.2.5 describes the justification for this occupational
scenario confidence rating. The studies that support the health concerns of acute CNS effects,
liver toxicity and cancer and the hazard value and benchmark MOEs are described above in
Section 4.2.1 Risk Estimation Approach and overall EPA has medium confidence in the acute,
chronic and cancer endpoints. Section 3.2.5.3 describes the justification for these human health
ratings.
Table 4-21. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Batch Open-
Top Vapor Degreasing
IIl ( l ime Period
I'lmlpoini = CNS
r.lTccls1
Acnlc
MIX
(niii/mM
l-lxposiirc
1 .c\ el
No rcsp
W orkcrs
MO
iralor
ONl s
l-'.s for Aciil
API-
W orkcrs
I'lxposil
25:
ONI s
res
API-
Workers
*0-
ONl s
licnchmark
\ioi-:
(= Tolal I 1)
8-hr
290
High End
0.39
0.64
9.8
N/A
20
N/A
30
Page 313 of 725
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7202
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7205
7206
7207
7208
7209
7210
7211
7212
7213
7214
7215
7216
7217
7218
7219
7220
7221
7222
7223
7224
7225
7226
7227
7228
7229
7230
7231
7232
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Central
Tendency
1.7
3.4
43
N/A
86
N/A
1 Data from Putz et al. (1979)
2 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
N/A = not assessed because ONUs are not assumed to be wearing PPE
MOEs are less than benchmark MOEs for workers and ONUs when respirators are not worn. The
MOEs are greater than benchmark MOE for ONUs and central tendency exposures for workers
when respirators APF 50 are worn.
Table 4-22. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Batch
Open-Top Vapor Degreasing
r.mlpoinl1
Chronic
NIC
img/nr')
l'l\|)osiirc
1 .c\ el
Workers
No respirator
MOI
<>M s
No
rcspimlor
Is for Clii'oi
\\ or Iters
API 25:
tic l-'.xposiirc
ONI s
API- 25:
s
Workers
API- 50-
ONI s
API- 50-
licnchmark
MOI.
(= loliil
I 1)
Liver
Effects
17.2
High End
0.13
0.22
3.4
N/A
6.7
N/A
10
Central
Tendency
0.60
1.2
15
N/A
30
N/A
1 Data from Nitschke et al. (1988a")
2 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
N/A = not assessed because ONUs are not assumed to be wearing PPE
MOEs are less than benchmark MOEs for workers and ONUs when respirators are not worn. The
MOEs are greater than benchmark MOE for ONUs and central tendency exposures for workers
when respirators APF 50 are worn.
Table 4-23. Risk Estimation for Chronic, Cancer Inhalation Exposures for Batch Open-
Top Vapor Degreasing
I'lndpoini. Tumor
lApcs1
11 K
(risk per
mg/nr')
l'l\posurc
l.c\cl
W orkcrs
No respirator
"anccr Risk l-'.siii
ONI s
No rcspiralor
link's
W orkcrs
API- 25;
ONI s
API- 25:
benchmark
Cancer Risk
Liver and lung
tumors
1.38E-06
High End
3.97E-04
2.43E-04
1.59E-05
N/A
104
Central
Tendency
8.95E-05
4.61E-05
3.58E-06
N/A
1 Data from NTP (.1.986")
2 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. APF 50 not shown based on cancer risks at APF 25 are all less than the
cancer risk benchmark of 10~4.
N/A = not assessed because ONUs are not assumed to be wearing PPE
Cancer risks are greater than 10"4 for high end exposures for workers and ONUs when respirators
are not worn. If workers and ONUs used respirators with APF 25 then the cancer risks are less
than 10"4 for all scenarios.
Page 314 of 725
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7244
7245
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7247
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7249
7250
7251
7252
7253
7254
7255
7256
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7258
7259
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7263
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
4.2.2.1.7 Conveyorized Vapor Decreasing
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for
conveyorized vapor degreasing are presented in Tables 4-24, 4-25, and 4-26, respectively. For
conveyorized vapor degreasing exposure estimates for TWAs of 8 hrs are available based on
modeling with a near-field and far-field approach. EPA calculated 50th and 95th percentiles to
characterize the central tendency and high-end exposure estimates, respectively. EPA used the
near-field air concentrations for worker exposures and the far-field air concentrations for
potential ONU inhalation exposures from methylene chloride conveyorized vapor degreasing as
described in more detail above in Section 2.4.1.2.6. Considering the overall strengths and
limitations of the data, EPA's overall confidence in the occupational inhalation estimates in this
scenario is medium to low. Section 2.4.1.2.6 describes the justification for this occupational
scenario confidence rating. The studies that support the health concerns of acute CNS effects,
liver toxicity and cancer and the hazard value and benchmark MOEs are described above in
Section 4.2.1 Risk Estimation Approach and overall EPA has medium confidence in the acute,
chronic and cancer endpoints. Section 3.2.5.3 describes the justification for these human health
ratings.
Table 4-24. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Conveyorized
Vapor Degreasing
MIX Time
Period
l.nripoini = CNS
I'.ITccls1
Aculc
MIX
(insi/mM
l''.\poslll'C
l.c\cl
M
\\ orkcrs
No rcspii'iilor
Oils for Aculc I".
OM s
No rcspii'iilor
vposurcs
\\ orkcrs
API- 50-
ONI s
API- 50-
licnchniiirk
MOI.
(= Toliil I 1)
8-hr
290
High End
0.21
0.32
10.4
N/A
30
Central
Tendency
0.60
1
29.8
N/A
1 Data from Putz et al. (1979)
2 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
N/A = not assessed because ONUs are not assumed to be wearing PPE
MOEs are less than benchmark MOEs for workers and ONUs when respirators are not worn and
when respirators APF 50 are worn except for central tendency exposures to ONUs.
Table 4-25. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for
Conveyorized Vapor Degreasing
r.mlpoinl1
Chronic
MIX
(my/ill'¦')
l-lxposurc
1 .e\ cl
\1(]
Workers
No rcspii'iilor
Ms for Chronic 1
ONI s
No rcspii'iilor
.\posiircs
Workers
API- 50-
ONI s
API-
50;
licnchiiiiirk
MOI.
(= Toliil
I 1)
Liver Effects
17.2
High End
0.07
0.11
3.6
N/A
10
Central
Tendency
0.21
0.40
10.3
N/A
1 Data from Nitschke et al. (1988a)
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7275
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7277
7278
7279
7280
7281
7282
7283
7284
7285
7286
7287
7288
7289
7290
7291
7292
7293
7294
7295
7296
7297
7298
7299
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
2 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
N/A = not assessed because ONUs are not assumed to be wearing PPE
MOEs are less than benchmark MOEs for workers and ONUs when respirators are not worn and
when respirators APF 50 are worn for high end exposure scenarios.
Table 4-26. Risk Estimation for Chronic, Cancer Inhalation Exposures for Conveyorized
Vapor Degreasing
I'lnripuinl. Tumor
Tjpes"
11 R
(risk per
iiiii/m4)
l'l\posure
1 .e\ el
\\ orkers
No respirator
"aneer Risk l-'.slii
<)M s
No respirator
link's
\\ orkers
API- 25:
ONI s
API- 25;
lienchiiiark
Cancer Risk
Liver and lung
tumors
1.38E-06
High End
7.43E-04
4.80E-04
2.97E-05
N/A
104
Central
Tendency
2.59E-04
1.35E-04
1.04E-05
N/A
1 Data from NTP (1986)
2 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
N/A = not assessed because ONUs are not assumed to be wearing PPE
Cancer risks are greater than 10"4 for high end exposures when respirators are not worn. If
workers and ONUs used respirators with APF 25 then the cancer risks are less than 10"4 for all
scenarios.
4.2.2.1.8 Cold Cleaning
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for cold
cleaning are presented in Tables 4-27, 4-28, and 4-29, respectively. For cold cleaning exposure
estimates for TWAs of 8 hrs are available based on personal monitoring data samples, including
a range of values from 1 source ( ))• EPA calculated 50th and 95th percentiles to
characterize the central tendency and high-end exposure estimates, respectively. EPA has not
identified data on potential ONU inhalation exposures from methylene chloride cold cleaning.
ONU inhalation exposures are expected to be lower than worker inhalation exposures however
the relative exposure of ONUs to workers cannot be quantified as described in more detail above
in Section 2.4.1.2.7. EPA calculated risk estimates assuming ONU exposures could be as high as
worker exposures as a high-end estimate and there is large uncertainty in this assumption.
Considering the overall strengths and limitations of the data, EPA's overall confidence in the
occupational inhalation estimates in this scenario is medium to low. Section 2.4.1.2.7 describes
the justification for this occupational scenario confidence rating. The studies that support the
health concerns of acute CNS effects, liver toxicity and cancer and the hazard value and
benchmark MOEs are described above in Section 4.2.1 Risk Estimation Approach and overall
EPA has medium confidence in the acute, chronic and cancer endpoints. Section 3.2.5.3
describes the justification for these human health ratings.
Page 316 of 725
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7303
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7305
7306
7307
7308
7309
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7311
7312
7313
7314
7315
7316
7317
7318
7319
7320
7321
7322
7323
7324
7325
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-27. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Cold
Cleaning
MIX l ime Period
llnripoinl = ( NS
11 Heels'
Aeule
MIX
(iiiii/mM
l-lxposurc
l.e\el
MO Ms 1
Worker* OM :
No respirator
oi' Aeule M\po
W orker
API- 25'
<11 res
W orker
API- 50'
Benchmark
MOM
<= Tolal I 1)
8-hr
290
High End
0.29
7.3
15
30
Central
Tendency
1.04
26
52
1 Data from Putz et al. (1979)
2 Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
MOEs are less than benchmark MOEs for workers when respirators are not worn and when
respirators APF 50 are worn for high end exposure scenarios.
Table 4-28. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Cold
Cleaning
I'lnripoini1
Chronic
HEC
(iiiti/mM
I'lxposurc
Level
MOHs In
Worker* OM :
No respirator
r Chronic 11 \
Worker
API- 25'
)osurcs
Worker
API- 50'
Bench ma I'k
MOM
(= Total
1 1 )
Liver Effects
17.2
High End
0.08
1.9
3.8
10
Central
Tendency
0.27
7
13
1 Data from Nitschke et al. (1988a)
9
Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
MOEs are less than benchmark MOEs for workers when respirators are not worn and when
respirators APF 50 are worn for high end exposure scenarios.
Table 4-29. Risk Estimation for Chronic, Cancer Inhalation Exposures for Cold Cleaning
I'lnripoini. Tumor
Tjpes"
11 K
(risk per
ni!i/mi)
Exposure
1 .e\ el
Cancel
Worker* ONI :
No respirator
Risk llslima
Worker
API 25'
es
W orker
API- 50'
Benchmark
Cancer Risk
Liver and lung
tumors
1.38E-06
High End
7.08E-04
2.83E-05
1.4E-05
104
Central
Tendency
1.54E-04
6.14E-06
3.1E-06
1 Data from NTP (.1.986)
9
Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
Page 317 of 725
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7340
7341
7342
7343
7344
7345
7346
7347
7348
7349
7350
7351
7352
7353
7354
7355
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7357
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7359
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Cancer risks are greater than 10"4 when respirators are not worn. If workers used respirators with
APF 25 then the cancer risks are less than 10"4 for all scenarios.
4.2.2.1.9 Commercial Aerosol Products (Aerosol Degreasing, Aerosol
Lubricants, Automotive Care Products)
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for
commercial aerosol products are presented in Tables 4-30, 4-31, and 4-32, respectively. For
commercial aerosol products exposure estimates for TWAs of 1 hr and 8 hrs are available based
on modeling with a near-field and far-field approach. The 1 hr TWAs are useful for
characterizing exposures shorter than 8 hrs that could lead to adverse CNS effects. PODs specific
to 1 hr TWA exposures were used for characterization of the risk. EPA calculated 50th and 95th
percentiles to characterize the central tendency and high-end exposure estimates, respectively.
EPA used the near-field air concentrations for worker exposures and the far-field air
concentrations for potential ONU inhalation exposures from methylene chloride commercial
aerosol products as described in more detail above in Section2.4.1.2.8. Considering the overall
strengths and limitations of the data, EPA's overall confidence in the occupational inhalation
estimates in this scenario is medium. Section 2.4.1.2.8 describes the justification for this
occupational scenario confidence rating. The studies that support the health concerns of acute
CNS effects, liver toxicity and cancer and the hazard value and benchmark MOEs are described
above in Section 4.2.1 Risk Estimation Approach and overall EPA has medium confidence in the
acute, chronic and cancer endpoints. Section 3.2.5.3 describes the justification for these human
health ratings.
Table 4-30. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Commercial
Aerosol Products (Aerosol Degreasing. Aerosol Lubricants. Automotive Care Products)
11IX Time
Period
I'lnripoinl =
( \s i.nw-is1
Anile
lll(
( iiiii/iir1)
Kxposure
l.e\el
M
Workers
No respii'iilor
()l-'.s for Acme l-lxposu
OM s
No rcs]>ir;ilor
•es
Workers
API- 25;
lieiichniiirk
MOI.
(= loliil I I )
8-hr
290
High End
3.7
89
92
30
Central
Tendency
13
725
330
1-hr
840
High End
3.7
87
91
30
Central
Tendency
12
700
309
1 Data from Putz et al. (1979)
2 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
not expect routine use of PPE that would mitigate risk (respirator APF 25) with this condition of use in part because
only supplied air respirators can be used (see section 2.4.1.1). APF 50 not shown based on MOEs at APF 25 are all
greater than the benchmark MOE.
MOEs are less than benchmark MOEs for workers when respirators are not worn. The MOEs are
greater than benchmark MOE for ONUs without respirators and for workers when respirators
APF 25 are worn.
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7382
7383
7384
7385
7386
7387
7388
7389
7390
7391
7392
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-31. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for
Commercial Aerosol Products (Aerosol Degreasing, Aerosol Lubricants, Automotive Care
Products) i
linripoinl1
('limine
MIX
(111^/111 M
I'Aposlll'C
l.e\el
MOI
\\ orkers
No respirator
s lor Chronic I'xpo
OM s
No resj)ir;ilor
sii res
\\ orkers
API- 25:
lienchmark
MOI.
(= Tolal
I I)
Liver Effects
17.2
High End
1.3
31
32
10
Central
Tendency
4.53
246
113
1 Data from Nitschke et al. (1988a)
2 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
not expect routine use of PPE that would mitigate risk (respirator APF 25) with this condition of use in part because
only supplied air respirators can be used (see section 2.4.1.1). APF 50 not shown based on MOEs at APF 25 are all
greater than the benchmark MOE.
MOEs are less than benchmark MOEs for workers when respirators are not worn. The MOEs are
greater than benchmark MOE for ONUs without respirators and for workers when respirators
APF 25 are worn.
Table 4-32. Risk Estimation for Chronic, Cancer Inhalation Exposures for Commercial
Aerosol Products (Aerosol De
greasing. Aeroso
Lubricants. Automotive Care Products)
r.inlpoini. Tumor
Tjpes"
11 K
(risk per
mg/iir')
l-lxposiirc l.c\cl
Cancer Kisl
\\ orkers
No rcspiraloi"
; I'.sliniiiles
ONI s
No respirator
benchmark
Cancer Risk
Liver and lung
tumors
1.38E-06
High End
4.17E-05
1.75E-06
104
Central Tendency
1.15E-05
2.42E-07
1 Data from NTP (.1.986)
2 Cancer risk estimates with respirators not shown based on cancer risks without respirators are all less than the
cancer risk benchmark of 10~4.
Cancer risks are less than 10"4 for workers and ONUs when respirators are not worn for all
scenarios.
4.2.2.1.10 Adhesives and Sealants
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for
adhesives and sealants are presented in Tables 4-33, 4-34, and 4-35, respectively. For both spray
and non-spray industrial adhesive application exposure estimates for TWAs of 15 mins, and 8
hrs are available based on personal monitoring data samples, including 98 data points for non-
spray adhesive use (NIOSH. 1985); (EPA. 1985) and 16 data points for spray adhesive use from
multiple data sources (t \ > vt A < M s **.), (WH< > lr?%b): (EPA. 1985). The 15 mins TWAs
are useful for characterizing exposures shorter than 8 hrs that could lead to adverse CNS effects.
PODs specific to 15 mins TWA exposures were used for characterization of the risk. EPA
calculated 50th and 95th percentiles to characterize the central tendency and high-end exposure
Page 319 of 725
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7401
7402
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7407
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7409
7410
7411
7412
7413
7414
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
estimates, respectively. EPA has not identified data on potential ONU inhalation exposures from
methylene chloride adhesives and sealants. ONU inhalation exposures are expected to be lower
than worker inhalation exposures however the relative exposure of ONUs to workers cannot be
quantified as described in more detail above in Section 2.4.1.2.9. EPA calculated risk estimates
assuming ONU exposures could be as high as worker exposures as a high-end estimate and there
is large uncertainty in this assumption. Considering the overall strengths and limitations of the
data, EPA's overall confidence in the occupational inhalation estimates in this scenario is
medium. Section 2.4.1.2.9 describes the justification for this occupational scenario confidence
rating. The studies that support the health concerns of acute CNS effects, liver toxicity and
cancer, the respective hazard values and benchmark MOEs are described above in Section 4.2.1
Risk Estimation Approach. Overall EPA has medium confidence in the acute, chronic and cancer
hazard endpoints. Section 3.2.5.3 describes the justification for these human health ratings.
Table 4-33. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Adhesives
and Sealants
MIX Time Period
l.nripoinl = ( NS
r.lleels1
Acuk'
IIIX
(m^/m')
l'l\|)OMIIV
l.e\el
moi-'.s r<
Worker & OM :
No respimlor
i' Acuk' l-l\|)o
W orker
API- 25'
sii res
Worker
API- 50*
lienehniiii'k
MOI.
(= Tol;il
I 1)
SPRAY USES
8-hr
290
High End
0.52
13
26
30
Central
Tendency
7.4
186
372
15-min
1706
High End
2.6
64
129
30
Central
Tendency
6.0
150
299
NON-SPRAY USES
8-hr
290
High End
0.98
25
49
30
Central
Tendency
28
692
1385
15-min
1706
High End
3.0
86
150
30
Central
Tendency
3.4
75
172
1 Data from Putz et al. (1979)
2 Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. ONUs are not expected to wear respirators.
MOEs are less than benchmark MOEs when respirators are not worn for 8-hr TWA and 15
minute TWA exposure estimates. The OSHA STEL is 433 mg/m3 as a 15-min TWA. For
adhesives spray, 3 of 9 short-term concentration values shown in Table 2-48 were greater than
the STEL. In an alternative approach, EPA calculated central tendency and high end values for
the measurements lower than the STEL. The central tendency and high end concentrations went
from 285 to 151 mg/m3 and 662 to 342 mg/m3, respectively. The calculated risk estimates for
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7423
7424
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7428
7429
7430
7431
7432
7433
7434
7435
7436
7437
7438
7439
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
this approach are 4.99 (high end) and 11 (central tendency). These values are less than the
benchmark MOEs when respirators are not worn.
The non-spray use consisted of 98 monitoring samples and the spray use was 16 samples. If
workers used respirators with APF 50 then the MOEs are greater than the benchmark MOE for
all but the high end estimate and the 8-hr TWA exposure estimate. For adhesives non-spray, 1 of
2 short-term measured concentration values was greater than the STEL. EPA calculated a risk
estimate of 4 from the measured value of 420 mg/m3, which is less than the benchmark MOE
when respirators are not worn.
Table 4-34. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Adhesives
and Sealants
l-'.nd ixiiiil1
( hrunic
MIX
(iiiu/in')
l-lxposurc
1 .c\ el
MOI-'.s loi
Worker* OM :
No rcspirsilor
Chronic l'.\p
Worker
API- 25'
isii res
Worker
API- 50'
licnchmsirk
MOF.
(= Tolsil
I 1)
SPRAY USES
Liver Effects
17.2
High End
0.14
3.4
6.8
10
Central
Tendency
1.93
48
97
NON-SPRAY USES
Liver Effects
17.2
High End
0.25
6.4
13
10
Central
Tendency
7.2
180
360
1 Data from Nitschke et al. (1988a)
2 Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. ONUs are not expected to wear respirators.
MOEs are less than benchmark MOEs when respirators are not worn. If workers used respirators
with APF 50 then the MOEs are greater than the benchmark MOE for all except the high-end
exposure estimate.
Table 4-35. Risk Estimation for Chronic, Cancer Inhalation Exposures for Adhesives and
Sealants
l-lmlpoiiil. Tumor
Tjpes"
11 K
(risk per
mg/iir')
Exposure
1 .e\ el
('si lie
Worker* OM :
No rcspirsilor
it Risk l-'.slimsit
Worker
API- 25'
:s
W orker
API 50'
licnchmsirk
SPRAY
Cancer Risk
Liver and lung
tumors
1.38E-06
High End
3.95E-04
1.58E-05
7.9E-6
104
Central
Tendency
2.14E-05
8.56E-07
4.3E-7
Page 321 of 725
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7452
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7454
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7457
7458
7459
7460
7461
7462
7463
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7470
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7472
7473
7474
7475
7476
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
I'lmlpoinl. Tumor
Tapes'
11 K
(risk per
mu/ni"4)
l'l\posure
1 .e\ el
("sine
Worker & OM :
No respirator
it Risk l-'.sliinsit
Worker
API- 25'
:s
W orker
API- 50'
lienchmark
NON-SPRAY
Cancer Risk
Liver and lung
tumors
1.38E-06
High End
2.10E-04
8.39E-06
4.2E-6
104
Central
Tendency
5.74E-06
2.30E-07
1.2E-7
1 Data from NTP (1986)
9
Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. ONUs are not expected to wear respirators.
Cancer risks are greater than 10"4 for high end exposures when respirators are not worn. If
workers used respirators with APF 25 then the cancer risks are less than 10"4 for all scenarios.
4.2.2.1.11 Paints and Coatings
Risk estimates for methylene chloride-based paint and coating removers were assessed in EPA's
2014 Risk Assessment on Paint Stripping Use for Methylene Chloride (I. c H11 \ JO 14) and
those results are included in Appendix L. Risk estimates for use of methylene chloride-based
paints and coatings are described in this section.
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for paints
and coatings are presented in Tables 4-36, 4-37, and 4-38, respectively. For paints and coatings
exposure estimates for TWAs of 8 hrs are available based on personal monitoring data samples,
including 27 data points from 2 sources (OSHA. 2019); (EPA. 1985). For paint and coating
removers exposure estimates for TWAs of 8 hrs are available from EPA's 2014 Risk Assessment
on Paint Stripping Use for Methylene Chloride (U.S. EPA. 2014) and from DoD (Defense
Occupational and Environmental Health Readiness System - Industrial Hygiene tEHRS-IH).
2018). The DoD data also included 15-min TWAs and these 15 mins TWAs are useful for
characterizing exposures shorter than 8 hrs that could lead to adverse CNS effects. PODs specific
to 15 mins TWA exposures were used for characterization of the risk. EPA calculated 50th and
95th percentiles to characterize the central tendency and high-end exposure estimates,
respectively. EPA has not identified data on potential ONU inhalation exposures from methylene
chloride paints and coatings. ONU inhalation exposures are expected to be lower than worker
inhalation exposures however the relative exposure of ONUs to workers cannot be quantified as
described in more detail above in Section 2.4.1.2.10. EPA calculated risk estimates assuming
ONU exposures could be as high as worker exposures as a high-end estimate and there is large
uncertainty in this assumption. Considering the overall strengths and limitations of the data,
EPA's overall confidence in the occupational inhalation estimates in this scenario is medium to
high. Section 2.4.1.2.10 describes the justification for this occupational scenario confidence
rating. The studies that support the health concerns of acute CNS effects, liver toxicity and
cancer and the hazard value and benchmark MOEs are described above in Section 4.2.1 Risk
Estimation Approach and overall EPA has medium confidence in the acute, chronic and cancer
endpoints. Section 3.2.5.3 describes the justification for these human health ratings.
Page 322 of 725
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7480
7481
Table 4-36. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Paints and
MIX lime Period
l.ndpoinl = CNS
r.lTecls1 / l \|)(.suiv
Scenario
Acule
MIX
(nig/m M
l'l\posure
1 .e\ el
MOI-'.s lor
Worker & OM :
No respirator
Acule l.\po
\\ orker
API 25*
sii res
Worker
API- 50*
licnchmark
moi:
(= Toial I I )
Paints and Coatings
8-hr Paints and
Coatings
290
High End
0.80
20
40
30
Central
Tendency
4.15
104
208
Paint and Coating Removers 4
Professional
Contractors
290
High End5
0.1
2
5
306
Central
Tendency5
0.2
5
10
Automotive
Refinishing
290
High End5
0.7
17
35
306
Central
Tendency5
1
29
57
Furniture
Refinishing
290
High End5
0.1
3
6
306
Central
Tendency5
0.3
6
13
Art Restoration and
Conservation
290
Point estimate7
145
3625
7250
306
Aircraft Paint
Stripping
290
High End5
0.1
2
4
306
Central
Tendency5
0.2
4
7
Graffiti Removal
290
High End5
0.2
6
12
306
Central
Tendency5
0.5
12
24
Non-Specific
Workplace Settings
- Immersion
Stripping of Wood
290
High End5
0.04
1
2
306
Central
Tendency5
0.1
2
4
Non-Specific
Workplace Settings
- Immersion
Stripping of Wood
and Metal
290
High End5
0.3
7
14
306
Central
Tendency5
0.4
9
18
Non-Specific
Workplace Settings
- Unknown
290
High End5
0.7
17
34
306
Central
Tendency5
0.8
20
41
DoD Paint Removal
8-hr TWA
290
High End
6.2
154
308
30
Central
Tendency
58
1458
2916
1706
High End
5.9
147
295
30
Page 323 of 725
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7482
7483
7484
7485
7486
7487
7488
7489
7490
7491
7492
7493
7494
7495
7496
7497
7498
7499
7500
7501
7502
7503
7504
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
MIX lime Period
l.ndpoim = CNS
l-'.ITecls1 / I'.xposiirc
Sccnario
DoD Paint Removal
15-minute TWA
Anile
MIX
(ing/mM
l-lxposurc
l.c\cl
MOI'.s lor
Worker* OM :
No respirator
Aculc l.\po
W orkcr
API- 25'
sii res
Worker
API- 5111
Benchmark
MOI.
(= Tolal I 1")
Central
Tendency
62
1557
3113
1 Data from Putz et al. (1979)
2Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
not expect routine use of PPE that would mitigate risk (respirator APF 25 or 50) with this condition of use.
4 See Appendix L for the description of exposure and risk estimates
5 High-End is the "High" exposure estimate and central tendency is the "midpoint" exposure estimate as described in
the 2014 assessment there are not sufficient data to calculate a 50th and 95th percentile for more information see
Appendix L and Table L-6.
6 While the benchmark used in the 2014 assessment was 60 the benchmark shown here is 30 for consistency with
this current evaluation.
7 Exposure data were not available to characterize the central tendency and high-end exposures.
For paint and coatings uses MOEs are less than benchmark MOEs when respirators are not worn
for the 8-hr TWA. MOEs are greater than benchmark MOEs when respirators APF 50 are worn.
There are 27 monitoring samples for full-shift TWA.
There are short term exposure data that allow estimation of 30-min exposures (8 data points). For
1-hr exposures there are only 2 monitoring data points and were both non-detected therefore
risks were not estimated for 1-hr exposures. Monitoring data to estimate a 15-min TWA
exposure were not available.
Table 4-37. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Paints and
Coatings i
l.i\cr l-'.ITecls lliulpoini
/ l-lxpoMirc Scenario1
Chronic
MIX
(nig/m¦')
l-'.\posurc
1 .c\ el
Mor.s r<
Worker «Si
OM :
No respirator
i' Chronic l-'.\|
Worker
API- 25*
)osurcs
W orkcr
API 50'
Benchmark
moi:
(= Tolal
1 1 )
Paints and Coatings
Paints and Coatings
17.2
High End
0.21
5.2
10.3
10
Central
Tendency
1.08
27
54
Paint and Coating Removers 4
Professional
Contractors
17.2
High End5
0.025
1
2
10
Central
Tendency5
0.05
1
2
Automotive
Refinishing
17.2
High End5
0.2
5
10
10
Central
Tendency5
0.3
7
14
Furniture Refinishing
17.2
High End5
0.03
0.8
1.6
10
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7508
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7512
7513
7514
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7517
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
l.i\er l-'.ITecls l.nripoinl
/ r.\|)osiMV Scenario1
Chronic
NIC
(mg/m')
l''.\posuiv
1 .e\ el
MOI-'.s l<
Worker X
<)M :
No respiralor
i' Chronic l-'.\|
Worker
API- 25'
MIMirCN
W orker
API- 50'
Benchmark
moi:
(= Toial
1 1 )
Central
Tendency5
0.1
2
4
10
Art Restoration and
Conservation
17.2
Point estimate6
34
860
1720
10
Aircraft Paint
Stripping
17.2
High End5
0.02
0.5
1
10
Central
Tendency5
0.04
1
2
Graffiti Removal
17.2
High End5
0.1
2
4
10
Central
Tendency5
0.1
3
6
Non-Specific
Workplace Settings
- Immersion
Stripping of Wood
17.2
High End5
0.01
0.3
0.6
10
Central
Tendency5
0.02
0.5
1
Non-Specific
Workplace Settings -
Immersion Stripping
of Wood and Metal
17.2
High End5
0.07
2
4
10
Central
Tendency5
0.1
2
4
Non-Specific
Workplace Settings
- Unknown
17.2
High End5
0.18
4
8
10
Central
Tendency5
0.21
5
10
DoD Paint Removal
17.2
High End
1.6
40
80
10
Central
Tendency
15
379
757
1 Data from Nitschke et al. (1988a)
2 Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
not expect routine use of PPE that would mitigate risk (respirator APF 25) with this condition of use in part because
only supplied air respirators can be used (see secstion 2.4.1.1). ONUs are not expected to wear respirators.
4 See Appendix L for the description of exposure and risk estimates
5 High-End is the "High" exposure estimate and central tendency is the "midpoint" exposure estimate shown in
Appendix L Tables 3-21 through 3-29
6 Exposure data were not available to characterize the central tendency and high-end exposures.
MOEs are less than benchmark MOEs when respirators are not worn. MOEs are greater than
benchmark MOEs when respirators APF 50 are worn.
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7518 Table 4-38. Risk Estimation for Chronic, Cancer Inhalation Exposures for Paints and
7519 Coatings
Cancer Risk
l.i\er iind Inii^
(Minors1 / I'1\|)ommv
Scenario
11 K
(risk pei'
nig/in M
l'l\posure l.e\el
Cancer
Worker & OM :
No respiralor
iisk I'lslimales
\\ orker
API- 25'
Worker
API- 5111
benchmark
Paints and Coatings
Paints and
Coatings
1.38E-06
High End
2.58E-04
1.03E-05
5.2E-6
104
Central Tendency
3.83E-05
1.53E-06
7.7E-7
Paint and Coating Removers 4
Professional
Contractors
1E-05 5
High End6
3.9E-3
1.6E-4
8.0E-5
104
Central Tendency6
2.0E-3
7.9E-5
4.0E-5
Automotive
Refinishing
1E-05 5
High End6
5.4E-4
2.2E-5
1.1E-5
104
Central Tendency6
3.3E-4
1.3E-5
6.5E-6
Furniture
Refinishing
1E-05 5
High End6
2.9E-3
1.2E-4
6.0E-5
104
Central Tendency6
1.5E-3
5.9E-5
3.0E-5
104
Art Restoration
and Conservation
1E-05 5
Point estimate7
104
Aircraft Paint
Stripping
1E-05 5
High End6
5.0E-3
2.0E-4
1.0E-4
104
Central Tendency6
2.5E-3
1.0E-4
5.0E-5
Graffiti Removal
1E-05 5
High End6
1.6E-3
6.2E-5
3.1E-5
104
Central Tendency6
7.9E-4
3.2E-5
1.6E-5
Non-Specific
Workplace Settings
- Immersion
Stripping of Wood
1E-05 5
High End6
9.1E-3
3.7E-4
1.9E-4
104
Central Tendency6
4.6E-3
1.8E-4
9.0E-5
Non-Specific
Workplace Settings
- Immersion
Stripping of Wood
and Metal
1E-05 5
High End6
1.3E-3
5.3E-5
2.7E-5
104
Central Tendency6
1.1E-3
4.3E-5
2.2E-5
Non-Specific
Workplace Settings
- Unknown
1E-05 5
High End6
5.6E-4
2.2E-5
1.1E-5
104
Central Tendency6
4.7E-4
1.9E-5
1.0E-5
7520 1 Data from NTP (1986)
7521 2 Exposures to ONUs were not able to be estimated separately from workers.
7522 3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
7523 not expect routine use of PPE that would mitigate risk (respirator APF 25) with this condition of use in part because
7524 only supplied air respirators can be used (see section 2.4.1.1).
7525 4 See Appendix L for the description of exposure and risk estimates.
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7542
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5 The IUR used in the 2014 assessment was derived assuming 24 hr/day, 7 day/week exposure and the air
concentration exposure estimates were adjusted accordingly. The results of these calculations are shown in this table
and described in Appendix L. The IUR used in this evaluation was derived assuming worker exposures of 8 hrs/day,
5 days/week exposure and the air concentration exposure estimates were adjusted accordingly.
6 High-End is the "High" exposure estimate and central tendency is the "midpoint" exposure estimate shown in
Appendix L Tables 3-12 through 3-20
7 Exposure data were not available to characterize the central tendency and high-end exposures.
Cancer risks are greater than 10"4 for high end exposures when respirators are not worn. If
workers used respirators with APF 25 then the cancer risks are less than 10"4 for all scenarios.
4.2.2.1.12 Adhesive and Caulk Removers
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for
adhesive and caulk removers are presented in Tables 4-39, 4-40, and 4-41, respectively. EPA did
not find specific industry information exposure data for adhesive and caulk removers, based on
expected worker activities, EPA assumes that the use of adhesive and caulk removers is similar
to paint stripping by professional contractors and used the air concentration data from the 2014
Risk Assessment on Paint Stripping Use for Methylene Chloride ( 2.014) where
overall, four personal monitoring data samples were available. EPA calculated the 50th and 95th
percentile 8-hr TWA concentrations to represent a central tendency and high-end estimate of
potential occupational inhalation exposures, respectively. EPA has not identified data on
potential ONU inhalation exposures from methylene chloride adhesive and caulk removers.
ONU inhalation exposures are expected to be lower than worker inhalation exposures however
the relative exposure of ONUs to workers cannot be quantified as described in more detail above
in Section 2.4.1.2.11. EPA calculated risk estimates assuming ONU exposures could be as high
as worker exposures as a high-end estimate and there is large uncertainty in this assumption.
Considering the overall strengths and limitations of the data, EPA's overall confidence in the
occupational inhalation estimates in this scenario is medium. Section 2.4.1.2.11 describes the
justification for this occupational scenario confidence rating. The studies that support the health
concerns of acute CNS effects, liver toxicity and cancer and the hazard value and benchmark
MOEs are described above in Section 4.2.1 Risk Estimation Approach and overall EPA has
medium confidence in the acute, chronic and cancer endpoints. Section 3.2.5.3 describes the
justification for these human health ratings.
The high-end short-term exposure identified in Section 2.4.1.2.11 (14,000 mg/m3) exceeds the
NIOSH IDLH value of 7981 mg/m3 fNIOSH. 1994) described in Section 3.2.3.1.1. The short-
term value identified in Section 2.4.1.2.11 (7100 mg/m3) approaches the IDLH value. The
NIOSH IDLH value was set to avoid situations that are immediately dangerous and is a value
above which individuals should not be exposed for any length of time.
Table 4-39. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Adhesive and
Caulk Removers
MIX Time
Period
l.ndpoini = ( NS
r.riw-is1
Anile MIX
(iiiii/mM
Kxposure
1 .e\ el
moi-'.s
Worker* OM :
No respiriilor
lor Aeule l-lxpos
W orker
API 25'
ii res
W orker
API- 5111
lienehniiirk
MOI.
(= loliil
I I)
8-hr
290
High End
0.10
2.5
4.9
30
Page 327 of 725
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7568
7569
7570
7571
7572
7573
7574
7575
7576
7577
7578
7579
7580
7581
7582
7583
7584
7585
7586
7587
7588
7589
7590
7591
7592
7593
7594
7595
7596
7597
7598
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Central
0.19
4.8
9.5
Tendency
1 Data from Putz et al. (1979)
2 Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
Table 4-40. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Adhesive
and Caulk Removers
r.iHipuim'
Chronic
HEC
(inii/iir1)
l°'.\posiire
l.e\el
MOI-'.s l»
Worker & OM :
No respirator
i° Chronic K\po
Worker
API- 25*
¦in res
W orkcr
API- 50*
licnchniark
MOI.
(= Toial
I I)
Liver Effects
17.2
High End
0.025
0.63
1.3
10
Central
Tendency
0.050
1.3
2.5
1 Data from Nitschke et al. (1988a)
2 Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
Table 4-41. Risk Estimation for Chronic, Cancer Inhalation Exposures for Adhesive and
Caulk Removers
I'lmlpoini. Tumor
Tj pes4
11 R
(risk pei'
m g/nr')
l°'.\posiire
1 .e\ el
Cancer Risk
Worker & OM :
No rcspiralor
Islimales ( a
Worker
API 25s
iccr Risk
W orkcr
API- 50'
licnchniark
Cancer Risk
Liver and lung
tumors
1.38E-06
High End
2.11E-03
8.44E-05
4.2E-05
104
Central
Tendency
8.34E-04
3.33E-05
1.7E-05
1 Data from NTP (.1.986)
9
Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
For both acute and chronic inhalation exposures, MOEs are less than benchmark MOEs for
workers when respirators are not worn and when respirators APF 50 are worn for all exposure
scenarios.
For chronic inhalation exposures, cancer risks are greater than 10"4 when respirators are not
worn. If workers used respirators with APF 25 then the cancer risks are less than 10"4 for all
scenarios.
Overall, there is medium confidence in the exposure and hazard estimates that make up the risk
estimates and the risk estimates for acute, chronic and cancer all indicate human health hazard
concerns and acute and chronic non-cancer concerns even when an APF 50 respirator is used.
Page 328 of 725
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7600
7601
7602
7603
7604
7605
7606
7607
7608
7609
7610
7611
7612
7613
7614
7615
7616
7617
7618
7619
7620
7621
7622
7623
7624
7625
7626
7627
7628
7629
7630
7631
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4.2.2.1.13 Miscellaneous Non-Aerosol Commercial and Industrial Uses
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for
miscellaneous non-aerosol industrial and commercial settings are presented in Tables 4-42, 4-43,
and 4-44, respectively. For miscellaneous non-aerosol industrial and commercial settings
exposure estimates for TWAs of 8 hrs are available based on personal monitoring data samples,
including 108 data points from 1 source (EPA. 1985). EPA calculated 50th and 95th percentiles to
characterize the central tendency and high-end exposure estimates, respectively. EPA has not
identified data on potential ONU inhalation exposures from methylene chloride miscellaneous
non-aerosol industrial and commercial settings. ONU inhalation exposures are expected to be
lower than worker inhalation exposures however the relative exposure of ONUs to workers
cannot be quantified as described in more detail above in Section 2.4.1.2.20. EPA calculated risk
estimates assuming ONU exposures could be as high as worker exposures as a high-end estimate
and there is large uncertainty in this assumption. Considering the overall strengths and
limitations of the data, EPA's overall confidence in the occupational inhalation estimates in this
scenario is medium. Section 2.4.1.2.20 describes the justification for this occupational scenario
confidence rating. The studies that support the health concerns of acute CNS effects, liver
toxicity and cancer and the hazard value and benchmark MOEs are described above in Section
4.2.1 Risk Estimation Approach and overall EPA has medium confidence in the acute, chronic
and cancer endpoints. Section 3.2.5.3 describes the justification for these human health ratings.
Table 4-42. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Non-Aerosol
Commercial and Industrial Uses
lll.( l ime Period
l.nripoinl = ( NS
l-ffccls1
Anile
MIX
(iiiii/nr1)
l-'.\posiirc
1 .e\ el
MOI-'.s In
Worker & OM :
No respii'iilor
• Aeule l.\po
W orker
API- 25'
sii res
W orker
API- 50'
Bench m;irk
MOI.
(= lol;il
I 1)
8-hr
290
High End
0.31
7.8
16
30
Central
Tendency
5.1
128
256
1 Data from Putz et al. (1979)
2 Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
The MOEs are less than the benchmark MOE when respirators are not worn and when
respirators APF 50 are worn, except for central tendency exposure estimates.
Table 4-43. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Non-
Aerosol Commercial and Industrial Uses
r.nripoinl1
Chronic
MIX
(ing/iiv')
l-'.\posiirc
l.c\cl
MOI-'.s for (
Worker & OM :
No rcspimlor
lironic l-'.\|
Worker
API- 25'
xisnres
W orker
API- 51 r
Bench m;irk
MOI.
(= Tol;il
I 1)
Liver Effects
17.2
High End
0.08
2.0
4.0
10
Central
Tendency
1.3
33
66
1 Data from Nitschke et al. (1988a")
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7642
7643
7644
7645
7646
7647
7648
7649
7650
7651
7652
7653
7654
7655
7656
7657
7658
7659
7660
7661
7662
7663
7664
7665
7666
7667
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
2 Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
The MOEs are less than the benchmark MOE when respirators are not worn and when
respirators APF 50 are worn, except for central tendency exposure estimates.
Table 4-44. Risk Estimation for Chronic, Cancer Inhalation Exposures for Non-Aerosol
Commercial and Industrial Uses
I'lmlpoini. TniiKir
T\ pes'
11 K
(risk per
niii/iii-4)
l'l\pOMII'C I.C\cl
( .nicer Risk 1
Worker* OM :
No respii'iilor
slimales
Worker
API- 25'
licnchmark
Cancer Risk
Liver and lung tumors
1.38E-06
High End
6.58E-04
2.63E-05
104
Central Tendency
3.11E-05
1.24E-06
1 Data from NTP (1986)
9
Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. APF 50 not shown based on cancer risks at APF 25 are all less than the
cancer risk benchmark of 10~4.
Cancer risks are greater than 10"4 when respirators are not worn for high end exposures. If
workers used respirators with APF 25 then the cancer risks are less than 10"4 for all scenarios.
4.2.2.1.14 Fabric Finishing
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for fabric
finishing are presented in Tables 4-45, 4-46, and 4-47, respectively. For fabric finishing exposure
estimates for TWAs of 8 hrs are available based on personal monitoring data samples, including
15 data points from 2 sources (TNQ (CIVO). 1999); (Finkel. 2017). EPA calculated 50th and 95th
percentiles to characterize the central tendency and high-end exposure estimates, respectively.
EPA has not identified data on potential ONU inhalation exposures from methylene chloride
fabric finishing. ONU inhalation exposures are expected to be lower than worker inhalation
exposures however the relative exposure of ONUs to workers cannot be quantified as described
in more detail above in Section 2.4.1.2.12. EPA calculated risk estimates assuming ONU
exposures could be as high as worker exposures as a high-end estimate and there is large
uncertainty in this assumption. Considering the overall strengths and limitations of the data,
EPA's overall confidence in the occupational inhalation estimates in this scenario is medium to
low. Section 2.4.1.2.12 describes the justification for this occupational scenario confidence
rating. The studies that support the health concerns of acute CNS effects, liver toxicity and
cancer and the hazard value and benchmark MOEs are described above in Section 4.2.1 Risk
Estimation Approach and overall EPA has medium confidence in the acute, chronic and cancer
endpoints. Section 3.2.5.3 describes the justification for these human health ratings.
Page 330 of 725
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7672
7673
7674
7675
7676
7677
7678
7679
7680
7681
7682
7683
7684
7685
7686
7687
7688
7689
7690
7691
7692
7693
7694
7695
7696
7697
7698
7699
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-45. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Fabric
Finishing ^
II EC l ime Period
l.nripoinl = CNS I'l'lecls1
Acnle
MIX
(iiiii/in1)
I'Aposlirc 1 ,C\ el
MOI-'.s lor Acnlt
Worker & OM :
No respiralor
¦ Exposures
\\ orker
API- 25'
Benchmark MOI.
(= Toliil I I )
8-hr
290
High End
1.8
44
30
Central Tendency
3.3
83
1 Data from Putz et al. (1979)
2Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
not expect routine use of PPE that would mitigate risk (respirator APF 25) with this condition of use in part because
only supplied air respirators can be used (see section 2.4.1.1). APF 50 not shown based onMOEs at APF 25 are all
greater than the benchmark MOE.
The MOEs are less than the benchmark MOE when respirators are not worn. The MOEs are
greater than benchmark MOEs when respirators APF 25 are worn.
Table 4-46. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Fabric
Finishing
I'.nripoinl1
('limine
MIX
(lll!i/llli)
Exposure l.e\el
MOI-'.s for Cliroi
Worker & OM :
No respiralor
lie l''.\|)osures
Worker
API- 25'
Benchmark
MOI.
(= loliil
I 1)
Liver Effects
17.2
High End
0.46
12
10
Central Tendency
0.87
22
1 Data from Nitschke et al. (1.988a)
2 Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
not expect routine use of PPE that would mitigate risk (respirator APF 25) with this condition of use in part because
only supplied air respirators can be used (see section 2.4.1.1). APF 50 not shown based on MOEs at APF 25 are all
greater than the benchmark MOE.
The MOEs are less than the benchmark MOE when respirators are not worn. The MOEs are
greater than benchmark MOEs when respirators APF 25 are worn.
Table 4-47. Risk Estimation for Chronic, Cancer Inhalation Exposures for Fabric
Finishing
l-lnripoinl. Tumor
T> pes'
11 K
(risk per
niti/in1)
Exposure l.c\cl
Cancer Risk I-
Worker & ONI :
No respiralor
slimalcs
Worker
API- 25'
Benchmark
Cancer Risk
Liver and lung tumors
1.38E-06
High End
1.16E-04
4.62E-06
104
Central Tendency
4.76E-05
1.91E-06
1 Data from NTP (1986)
9
Exposures to ONUs were not able to be estimated separately from workers.
Page 331 of 725
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7702
7703
7704
7705
7706
7707
7708
7709
7710
7711
7712
7713
7714
7715
7716
7717
7718
7719
7720
7721
7722
7723
7724
7725
7726
7727
7728
7729
7730
7731
7732
7733
7734
7735
7736
7737
7738
7739
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
not expect routine use of PPE that would mitigate risk (respirator APF 25) with this condition of use in part because
only supplied air respirators can be used (see section 2.4.1.1). APF 50 not shown based on cancer risks at APF 25
are all less than the cancer risk benchmark of 10~4.
Cancer risks are greater than 10"4 when respirators are not worn for high end exposures. If
workers used respirators with APF 25 then the cancer risks are less than 10"4 for all scenarios.
4.2.2.1.15 Spot Cleaning
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for spot
cleaning are presented in Tables 4-48, 4-49, and 4-50, respectively. For spot cleaning exposure
estimates for TWAs of 8 hrs are available based on personal monitoring data samples, including
6 data points from 1 source (Finkel. 2017). EPA calculated 50th and 95th percentiles to
characterize the central tendency and high-end exposure estimates, respectively. EPA has not
identified data on potential ONU inhalation exposures from methylene chloride spot cleaning.
ONU inhalation exposures are expected to be lower than worker inhalation exposures however
the relative exposure of ONUs to workers cannot be quantified as described in more detail above
in Section 2.4.1.2.13. EPA calculated risk estimates assuming ONU exposures could be as high
as worker exposures as a high-end estimate and there is large uncertainty in this assumption.
Considering the overall strengths and limitations of the data, EPA's overall confidence in the
occupational inhalation estimates in this scenario is medium to low. Section 2.4.1.2.13 describes
the justification for this occupational scenario confidence rating. The studies that support the
health concerns of acute CNS effects, liver toxicity and cancer and the hazard value and
benchmark MOEs are described above in Section 4.2.1 Risk Estimation Approach and overall
EPA has medium confidence in the acute, chronic and cancer endpoints. Section 3.2.5.3
describes the justification for these human health ratings.
Table 4-48. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Spot
Cleaning
MIX lime Period
l.mlpoinl = ( NS l.nVds1
Anile
IIIX
(nig/nr*)
l'l\])OMIIV 1 ,e\ el
MOI'.s lor Aeult
Worker & OM :
No ivspii'iilor
¦ l-Aposiiivs
\\ orker
API- 25'
Bench msirk MOI.
(= lohil I I")
8-hr
290
High End
4.6
114
30
Central Tendency
114
2843
1 Data from Putz et al. (.1.979)
2 Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
not expect routine use of PPE that would mitigate risk (respirator APF 25) with this condition of use in part because
only supplied air respirators can be used (see section 2.4.1.1). APF 50 not shown based on MOEs at APF 25 are all
greater than the benchmark MOE.
MOEs are less than benchmark MOEs for workers when respirators APF 25 are worn and for
central tendency exposures when respirators are not worn.
Page 332 of 725
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7740
7741
7742
7743
7744
7745
7746
7747
7748
7749
7750
7751
7752
7753
7754
7755
7756
7757
7758
7759
7760
7761
7762
7763
7764
7765
7766
7767
7768
7769
7770
7771
7772
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-49. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Spot
Cleaning
linripoinl1
('limine
MIX
(iiiii/iii-4>
Exposure
1 .e\ el
MOEs for Chroi
Worker & <)M :
No respiralor
ie Exposures
Worker
API- 25'
lienchmark
MOI.
(= Tolal
I I)
Liver Effects
17.2
High End
1.2
30
10
Central
Tendency
30
739
1 Data from Nitschke et al. (1988a')
2 Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
not expect routine use of PPE that would mitigate risk (respirator APF 25) with this condition of use in part because
only supplied air respirators can be used (see section 2.4.1.1). APF 50 not shown based onMOEs at APF 25 are all
greater than the benchmark MOE.
MOEs are less than benchmark MOEs for workers when respirators APF 25 are worn and for
central tendency exposures when respirators are not worn.
Table 4-50. Risk Estimation for Chronic, Cancer Inhalation Exposures for Spot Cleaning
I'lmlpoinl. Tumor
Tjpes1
11 K
(risk per mg/nr'j
Exposure l.e\el
Cancer Risk Estimates
Worker ()\l : No respirator*
licnchmark
Cancer Risk
Liver and lung tumors
1.38E-06
High End
4.50E-05
104
Central Tendency
1.40E-06
1 Data from NTP (.1.986)
2 Exposures to ONUs were not able to be estimated separately from workers.
3 Cancer risk estimates with respirators not shown based on cancer risks without respirators are all less than the
cancer risk benchmark of 10~4.
Cancer risks are less than 10"4 when respirators are not worn for all scenarios.
4.2.2.1.16 Cellulose Triacetate Film Production
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for CTA
film production are presented in Tables 4-51, 4-52, and 4-53, respectively. For CTA film
production exposure estimates for TWAs of 8 hrs are available based on personal monitoring
data samples, including more than 100 data points from 6 studies compiled in 3 sources Dell et
al. (1999); T >); Ott et al. (1983a). EPA calculated 50th and 95th percentiles to
characterize the central tendency and high-end exposure estimates, respectively. EPA has not
identified data on potential ONU inhalation exposures from methylene chloride CTA film
production. ONU inhalation exposures are expected to be lower than worker inhalation
exposures however the relative exposure of ONUs to workers cannot be quantified as described
in more detail above in Section 2.4.1.2.14. EPA calculated risk estimates assuming ONU
exposures could be as high as worker exposures as a high-end estimate and there is large
uncertainty in this assumption. Considering the overall strengths and limitations of the data,
Page 333 of 725
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7774
7775
7776
7777
7778
7779
7780
7781
7782
7783
7784
7785
7786
7787
7788
7789
7790
7791
7792
7793
7794
7795
7796
7797
7798
7799
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
EPA's overall confidence in the occupational inhalation estimates in this scenario is medium.
Section 2.4.1.2.14 describes the justification for this occupational scenario confidence rating.
The studies that support the health concerns of acute CNS effects, liver toxicity and cancer and
the hazard value and benchmark MOEs are described above in Section 4.2.1 Risk Estimation
Approach and overall EPA has medium confidence in the acute, chronic and cancer endpoints.
Section 3.2.5.3 describes the justification for these human health ratings.
Table 4-51. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Cellulose
Triacetate Film Production
MIX lime Period
l.nripoini = ( NS
I! fleas'
AciUe
MIX
(ing/inM
l-'.\posurc
1 .c\ el
MOI-'.s lor A
Worker & OM :
No rcs]>ir;ilor
I'lllC I'ApOMII
\\ orkcr
API- 25'
es MOI.
\\ orkcr
API- 50'
licnchniiirk
MOI.
(= loliil
I 1)
8-hr
290
High End
0.21
5.3
10
30
Central
Tendency
0.28
7.0
14
1 Data from Putz et al. (1979)
2 Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
The MOEs are less than the benchmark MOE for workers when respirators are not worn and
when respirators APF 50 are worn.
Table 4-52. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Cellulose
Triacetate Film Production
r.nripoini1
Chronic
MIX
(nig/nr*)
l-'.\posurc
1 .c\ el
MOI-'.s for (
Worker & OM :
No rcspimlor
lironic I'.xj
Worker
API- 25*
)osurcs
W orkcr
API- 50*
licnchniiirk
MOI.
(= To(;il
I 1)
Liver Effects
17.2
High End
0.05
1.3
2.7
10
Central
Tendency
0.07
1.8
3.6
1 Data from Nitschke et al. (1988a")
2 Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
The MOEs are less than the benchmark MOE for workers when respirators are not worn and
when respirators APF 50 are worn.
Page 334 of 725
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7800
7801
7802
7803
7804
7805
7806
7807
7808
7809
7810
7811
7812
7813
7814
7815
7816
7817
7818
7819
7820
7821
7822
7823
7824
7825
7826
7827
7828
7829
7830
7831
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-53. Risk Estimation for Chronic, Cancer Inhalation Exposures for Cellulose
Triacetate Film Production
l-lnripoinl. Tumor
T\ pes'
11 K
(risk per
niti/m1)
Exposure l.c\cl
Cancer Risk I-
Worker* OM :
No respirator
slimalcs
Worker
API- 25'
licnchmark
Cancer Risk
Liver and lung tumors
1.38E-06
High End
7.67E-04
3.07E-05
104
Central Tendency
5.68E-04
2.27E-05
1 Data from NTP (1986)
9
Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. APF 50 not shown based on cancer risks at APF 25 are all less than the
cancer risk benchmark of 10~4.
Cancer risks are greater than 10"4 when respirators are not worn. If workers used respirators with
APF 25 then the cancer risks are less than 10"4 for all scenarios.
4.2.2.1.17 Plastic Product Manufacturing
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for plastic
product manufacturing are presented in Tables 4-54, 4-55, and 4-56, respectively. For plastic
product manufacturing exposure estimates for TWAs of 15 mins, and 8 hrs are available based
on personal monitoring data samples, including 30 data points from 5 sources OS 319);
Hatoeenated Solvents Industry Alliance (2018); Fairfax and Porter (2.006); WHO (1996b);
General Electric Co (1989). The 15 mins TWAs are useful for characterizing exposures shorter
than 8 hrs that could lead to adverse CNS effects. PODs specific to 15 mins TWA exposures
were used for characterization of the risk. EPA calculated 50th and 95fe percentiles to characterize
the central tendency and high-end exposure estimates, respectively. Based on these strengths and
limitations of the worker inhalation air concentration data, the overall confidence for these 8-hr
TWA data in this scenario is medium. EPA has identified 1 data point on potential ONU
inhalation exposures from methylene chloride plastic product manufacturing as described in
more detail above in Section 2.4.1.2.17. Considering the overall strengths and limitations of the
data, EPA's overall confidence in the occupational inhalation estimate in this scenario is low for
ONUs. Section 2.4.1.2.17 describes the justification for this occupational scenario confidence
rating. The studies that support the health concerns of acute CNS effects, liver toxicity and
cancer and the hazard value and benchmark MOEs are described above in Section 4.2.1 Risk
Estimation Approach and overall EPA has medium confidence in the acute, chronic and cancer
endpoints. Section 3.2.5.3 describes the justification for these human health ratings.
Page 335 of 725
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7832
7833
7834
7835
7836
7837
7838
7839
7840
7841
7842
7843
7844
7845
7846
7847
7848
7849
7850
7851
7852
7853
7854
7855
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-54. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Plastic
Product Manufacturing i
MIX
Time'
Period
l.mlpoinl
= CNS
i-nwis1
Acme
MIX
(niii/niM
l-lxposurc
l.c\cl
\\ orkcrs
No
rcspiriilor
MOI'.s lor Aci
OM s
No rcspimlor
(c r.xposurcs :
Workers
API-" 25'
\\ oi'kers
API- 50s
Benchmurk
MOI.
(= Tol;il
I I)
8-hr
290
High End
1.1
32
28
56
30
Central
Tendency
21
525
1045
15-
minute
1706
High End
13
--
327
654
30
Central
Tendency
21
525
1034
1 Data from Putz et al. (1979)
2 This scenario covers a broad range of industries and processes, which may result in significant differences between
central and high-end exposures for workers. For ONUs 15-minute TWA exposures were not able to be estimated
and data were not available to characterize the central tendency and high-end 8 hr TWA exposures for ONUs.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
The MOEs are less than the benchmark MOE for workers when respirators are not worn, not for
ONUs. The MOEs are greater than benchmark MOEs when respirators APF 50 are worn.
Table 4-55. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Plastic
I'lnri point1
Chronic
HEC
(nig/nr*)
l-lxposurc
1 .c\ el
\\ orkcrs
No
rcspimlor
MOI-'.s 1
ONI s
No
rcspimlor
or Chronic
\\ orkcrs
API- 25s
I'lxposurc
ONI s
API-
25'1
s 2
Workers
API- 50'
ONI s
API-
50'i
licnchniiii'k
MOI!
(= Tol;il
I 1)
Liver
Effects
17.2
High End
0.29
8.3
7.3
208
14
417
10
Central
Tendency
5.4
135
271
1 Data from Nitschke et al. (1988a)
2 Data were not available to characterize the central tendency and high-end exposures for ONUs; also, this scenario
covers a broad range of industries and processes, which may result in significant differences between central and
high-end exposures for workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
MOEs are less than benchmark MOEs for workers and ONUs when respirators are not worn.
MOEs are greater than benchmark MOEs when respirators APF 50 are worn.
Page 336 of 725
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7856
7857
7858
7859
7860
7861
7862
7863
7864
7865
7866
7867
7868
7869
7870
7871
7872
7873
7874
7875
7876
7877
7878
7879
7880
7881
7882
7883
7884
7885
7886
7887
7888
7889
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-56. Risk Estimation for Chronic, Cancer Inhalation Exposures for Plastic Product
Manufacturing
Kmlpoinl. Tumor
T\ pes'
11 K
(risk per
niti/m1)
Exposure l.c\cl
Cancer Risk I-
Worker* OM :
No respirator
slimalcs
Worker
API- 25'
licnchmark
Cancer Risk
Liver and lung tumors
1.38E-06
High End
1.85E-04
7.38E-06
104
Central Tendency
7.61E-06
3.04E-07
1 Data from NTP (1986)
9
Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. APF 50 not shown based on cancer risks at APF 25 are all less than the
cancer risk benchmark of 10~4.
Cancer risks are greater than 10"4 when respirators are not worn for high end exposures. If
workers used respirators with APF 25 then the cancer risks are less than 10"4 for all scenarios.
4.2.2.1.18 Flexible Polyurethane Foam Manufacturing
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for flexible
polyurethane foam manufacturing are presented in Tables 4-57, 4-58, and 4-59, respectively. For
flexible polyurethane foam manufacturing exposure estimates for TWAs of 8 hrs are available
based on personal monitoring data samples, including 82 data points from multiple sources
OARC. 2016; Tv I ; WHO. 1996b: Vulcan Chemical* i ' >. and Lusfaniak.
1990; \ I \ i c5; Cone Mills Corp. l''S 1 a. b, » Him Chemicals. 1977). EPA calculated 50th and
95th percentiles to characterize the central tendency and high-end exposure estimates,
respectively. EPA has not identified data on potential ONU inhalation exposures from methylene
chloride flexible polyurethane foam manufacturing. ONU inhalation exposures are expected to
be lower than worker inhalation exposures however the relative exposure of ONUs to workers
cannot be quantified as described in more detail above in Section 2.4.1.2.11. EPA calculated risk
estimates assuming ONU exposures could be as high as worker exposures as a high-end estimate
and there is large uncertainty in this assumption. Considering the overall strengths and
limitations of the data, EPA's overall confidence in the occupational inhalation estimates in this
scenario is medium. Section 2.4.1.2.11 describes the justification for this occupational scenario
confidence rating. The studies that support the health concerns of acute CNS effects, liver
toxicity and cancer and the hazard value and benchmark MOEs are described above in Section
4.2.1 Risk Estimation Approach and overall EPA has medium confidence in the acute, chronic
and cancer endpoints. Section 3.2.5.3 describes the justification for these human health ratings.
Table 4-57. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Flexible
Polyurethane Foam Manufacturing
lll.( l ime Period
I'.mlpoinl = CNS
r.lTccls1
Acule
MIX
(iiiii/iii-4)
I'lxposurc
l.c\cl
MOI-'.s 1
Worker* ONI -
No rcspiralor
oi' Acule l'l\j)o
W orkcr
API- 25'
<11 res
W orkcr
API- 50'
licnchmark
MOI.
(= loial I 1)
8-hr
290
High End
0.29
7.2
15
30
Page 337 of 725
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7890
7891
7892
7893
7894
7895
7896
7897
7898
7899
7900
7901
7902
7903
7904
7905
7906
7907
7908
7909
7910
7911
7912
7913
7914
7915
7916
7917
7918
7919
7920
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Central
1.4
34
68
Tendency
1 Data from Putz et al. (1979)
9
Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. ONUs are not expected to wear respirators.
MOEs are less than benchmark MOEs when respirators are not worn for the 8-hr TWA. The
MOE for central tendency exposure is greater than benchmark MOEs when respirator APF 50
are worn, but not for high end exposures.
There are short term exposure data that allow estimation of 30-minute exposures (7 data points)
and 4-hr exposures (1 data point). Monitoring data to estimate a 15-min or 1-hr TWA exposure
were not available.
Table 4-58. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for Flexible
Polyurethane Foam Manufacturing
r.nripoinl1
Chronic
NIX
(iiiii/m')
l-lxpuMirc
l.c\cl
MOI-'.s lor
Worker & <)M :
No rcspiralor
Chronic Taj
\\ orkcr
API- 25s
)osiircs
Worker
API- 50'
licnchmark
MOI.
(= Tolal
I 1)
Liver Effects
17.2
High End
0.08
1.9
3.8
10
Central
Tendency
0.35
8.9
18
1 Data from Nitschke et al. (1988a')
2 Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
MOEs are less than benchmark MOEs when respirators are not worn. The MOE for central
tendency exposures is greater than benchmark MOE when respirators APF 50 are worn, but the
MOE for high end exposures is less than the benchmark MOE.
Table 4-59. Risk Estimation for Chronic, Cancer Inhalation Exposures for Flexible
Polyurethane Foam Manufacturing
I'lnripoini. Tumor
T\ pes'
11 K
(risk per
ing/iiv¦')
l-lxposiirc
1 .c\ el
(a nee
Worker & OM :
No respirator
* Risk r.slimaU
Worker
API- 25'
:s
W orkcr
API- 50'
licnchmark
Cancer Risk
Liver and lung
tumors
1.38E-06
High End
7.08E-04
2.83E-05
1.4E-05
104
Central
Tendency
1.16E-04
4.66E-06
2.3E-06
1 Data from NTP (1986)
9
Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
Page 338 of 725
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7921
7922
7923
7924
7925
7926
7927
7928
7929
7930
7931
7932
7933
7934
7935
7936
7937
7938
7939
7940
7941
7942
7943
7944
7945
7946
7947
7948
7949
7950
7951
7952
7953
7954
7955
7956
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Cancer risks are greater than 10"4 when respirators are not worn. If workers used respirators with
APF 25 then the cancer risks are less than 10"4 for all scenarios.
4.2.2.1.19 Laboratory Use
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for
laboratory use are presented in Tables 4-60, 4-61, and 4-62, respectively. For laboratory use
exposure estimates for TWAs of 15 mins, and 8 hrs are available based on personal monitoring
data samples, including 10 data points from multiple sources Defense Occupational and
Environmental Health Readiness System - Industrial Hygiene (DOEHRS-IH) (2.018); Texaco Ine
(1993); Mccammon (1990). The 15 mins TWAs are useful for characterizing exposures shorter
than 8 hrs that could lead to adverse CNS effects. PODs specific to 15 mins TWA exposures
were used for characterization of the risk. EPA calculated 50th and 95th percentiles to
characterize the central tendency and high-end exposure estimates, respectively. EPA has not
identified data on potential ONU inhalation exposures from methylene chloride laboratory use.
ONU inhalation exposures are expected to be lower than worker inhalation exposures however
the relative exposure of ONUs to workers cannot be quantified as described in more detail above
in Section 2.4.1.2.16. EPA calculated risk estimates assuming ONU exposures could be as high
as worker exposures as a high-end estimate and there is large uncertainty in this assumption.
Considering the overall strengths and limitations of the data, EPA's overall confidence in the
occupational inhalation estimates in this scenario is medium to low. Section 2.4.1.2.16 describes
the justification for this occupational scenario confidence rating. The studies that support the
health concerns of acute CNS effects, liver toxicity and cancer and the hazard value and
benchmark MOEs are described above in Section 4.2.1 Risk Estimation Approach and overall
EPA has medium confidence in the acute, chronic and cancer endpoints. Section 3.2.5.3
describes the justification for these human health ratings.
Table 4-60. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Laboratory
Use
MIX l ime Period
l.nripoinl = ( NS I'I'lVcl 1
Acule lil t
(inii/in1)
I'!\|)omiiv l.e\el
MOI-'.s lor Aeu
Worker & OM :
No respiriilor
(e I'.xposures
Worker
API- 25'
lieneh niiii'k
moi:
(= Toliil
I I)
8-hr
290
High End
24
604
30
Central Tendency
83
2071
15-min
1706
High End
21
514
30
Central Tendency
255
6366
1 Data from Putz et al. (1979)
2 Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers abroad range
of industries and processes, which may result in significant differences between central and high-end exposures for
workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. APF 50 not shown based on MOEs at APF 25 are all greater than the
benchmark MOE.
Page 339 of 725
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7957
7958
7959
7960
7961
7962
7963
7964
7965
7966
7967
7968
7969
7970
7971
7972
7973
7974
7975
7976
7977
7978
7979
7980
7981
7982
7983
7984
7985
7986
7987
7988
7989
7990
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
The MOEs are less than the benchmark MOE for high end exposures and the estimated 15-
minute exposure when respirators are not worn. The MOEs are greater than benchmark MOEs
when respirators APF 25 are worn.
Table 4-61. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for
Laboratory Use
l-'udpt tinl1
('limine
MIX
(iiiii/nr1)
l''.\poslll'C I.C\cl
\l()l-'.s for ( limn
Worker* OM :
No respirator
e l-'.\posnrcs
Worker
API- 25'
licnchmark
MOF.
(= loliil
I I)
Liver Effects
17.2
High End
0.48
12
10
Central Tendency
18.6
465
1 Data from Nitschke et al. (1988a)
2 Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers abroad range
of industries and processes, which may result in significant differences between central and high-end exposures for
workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. APF 50 not shown based on MOEs at APF 25 are all greater than the
benchmark MOE.
The MOEs are less than the benchmark MOE when respirators are not worn for high end
exposures. The MOEs are greater than benchmark MOEs when respirators APF 25 are worn for
all scenarios.
Table 4-62. Risk Estimation for Chronic. Cancer Inhalation Exposures for Laboratory Use
l-lnripoinl. Tumor
'1 Apes'
11 K
(risk per
mg/m-'j
Exposure l.e\el
Cancer Risk I-
Worker* OM :
No rcspiralor
slimalcs
Worker
API- 25'
licnchmark
Cancer Risk
Liver and lung tumors
1.38E-06
High End
1.11E-04
4.45E-06
104
Central Tendency
2.22E-06
8.89E-08
1 Data from NTP (1986)
9
Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers abroad range
of industries and processes, which may result in significant differences between central and high-end exposures for
workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use. APF 50 not shown based on cancer risks at APF 25 are all less than the
cancer risk benchmark of 10~4.
Cancer risks are greater than 10"4 when respirators are not worn for high end exposures. If
workers used respirators with APF 25 then the cancer risks are less than 10"4 for all scenarios.
4.2.2.1.20 Pharmaceutical Production
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for
pharmaceutical production are presented in Tables 4-63, 4-64, and 4-65, respectively. For
pharmaceutical production exposure estimates for TWAs of 8 hrs are available based on personal
Page 340 of 725
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7991
7992
7993
7994
7995
7996
7997
7998
7999
8000
8001
8002
8003
8004
8005
8006
8007
8008
8009
8010
8011
8012
8013
8014
8015
8016
8017
8018
8019
8020
8021
8022
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
monitoring data samples, including 15 data points from 2 sources TNO b i «s *9); I P \
(1985). EPA calculated 50th and 95th percentiles to characterize the central tendency and high-
end exposure estimates, respectively. EPA has not identified data on potential ONU inhalation
exposures from methylene chloride pharmaceutical production. ONU inhalation exposures are
expected to be lower than worker inhalation exposures however the relative exposure of ONUs
to workers cannot be quantified as described in more detail above in Section 2.4.1.2.18. EPA
calculated risk estimates assuming ONU exposures could be as high as worker exposures as a
high-end estimate and there is large uncertainty in this assumption. Considering the overall
strengths and limitations of the data, EPA's overall confidence in the occupational inhalation
estimates in this scenario is medium. Section 2.4.1.2.18 describes the justification for this
occupational scenario confidence rating. The studies that support the health concerns of acute
CNS effects, liver toxicity and cancer and the hazard value and benchmark MOEs are described
above in Section 4.2.1 Risk Estimation Approach and overall EPA has medium confidence in the
acute, chronic and cancer endpoints. Section 3.2.5.3 describes the justification for these human
health ratings.
Table 4-63. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for
Pharmaceutical Production
MIX Time Period
l.nripoim = ( NS HITeels1
Anile MIX
(inii/in1)
l'l\])OMIIV l.l'\C'l
MOI-'.s lor Aeu
Worker* OM :
No respiriilor
le I'.xposures
Worker
API 51 r
lienehniiirk
MOI.
(= loliil
I I)
8-hr
290
High End
0.08
4.1
30
Central Tendency
1.3
63
1 Data from Putz et al. (1979)
2 Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
The MOEs are less than the benchmark MOE when respirators are not worn and when
respirators APF 50 are worn, except for central tendency exposure estimates.
Table 4-64. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for
Pharmaceutical Production
I'lnripoini1
Chronic MIX
(iiili/nr1)
l-lxposurc l.c\cl
MOI-'.s lor ( hron
Worker* OM :
No respiriilor
e l-'.xposurcs
Worker
API 5111
lieiichniiirk
MOI.
(= loliil
I I)
Liver Effects
17.2
High End
0.021
1.1
10
Central Tendency
0.33
16
1 Data from Nitschke et al. (1988a")
2 Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
Page 341 of 725
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8029
8030
8031
8032
8033
8034
8035
8036
8037
8038
8039
8040
8041
8042
8043
8044
8045
8046
8047
8048
8049
8050
8051
8052
8053
8054
8055
8056
8057
8058
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
The MOEs are less than the benchmark MOE when respirators are not worn and when
respirators APF 50 are worn, except for central tendency exposure estimates.
Table 4-65. Risk Estimation for Chronic, Cancer Inhalation Exposures for Pharmaceutical
Production
I'lmlpoini. Tumor
Tj pes'
11 K
(risk per
niti/m1)
Exposure l.c\cl
( .nicer Risk 1
Worker* OM :
No respirator
slimalcs
Worker
API 50'
licnchmark
Cancer Risk
Liver and lung tumors
1.38E-06
High End
2.53E-03
5.05E-05
104
Central Tendency
1.26E-04
2.52E-06
1 Data from NTP (1986)
9
Exposures to ONUs were not able to be estimated separately from workers.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride and are
considered plausible for respirator use.
Cancer risks are greater than 10"4 when respirators are not worn. If workers used respirators with
APF 50 then the cancer risks are less than 10"4 for all scenarios.
4.2.2.1.21 Lithographic Printing Plate Cleaning
Estimates of MOEs for acute and chronic exposures and cancer risks from inhalation for
lithographic printing plate cleaning are presented in Tables 4-66, 4-67, and 4-68, respectively.
For lithographic printing plate cleaning exposure estimates for TWAs of 8 hrs are available
based on personal monitoring data samples, including greater than 100 data points from 3
sources IJkai et i s °8); EPA. (1985); AhrenhcH s! HO). EPA calculated 50th and 95th
percentiles to characterize the central tendency and high-end exposure estimates, respectively.
EPA has not identified data on potential ONU inhalation exposures from methylene chloride
lithographic printing plate cleaning. ONU inhalation exposures are expected to be lower than
worker inhalation exposures however the relative exposure of ONUs to workers cannot be
quantified as described in more detail above in Section 2.4.1.2.19. EPA calculated risk estimates
assuming ONU exposures could be as high as worker exposures as a high-end estimate and there
is large uncertainty in this assumption. Considering the overall strengths and limitations of the
data, EPA's overall confidence in the occupational inhalation estimates in this scenario is
medium. Section 2.4.1.2.19 describes the justification for this occupational scenario confidence
rating. The studies that support the health concerns of acute CNS effects, liver toxicity and
cancer and the hazard value and benchmark MOEs are described above in Section 4.2.1 Risk
Estimation Approach and overall EPA has medium confidence in the acute, chronic and cancer
endpoints. Section 3.2.5.3 describes the justification for these human health ratings.
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8064
8065
8066
8067
8068
8069
8070
8071
8072
8073
8074
8075
8076
8077
8078
8079
8080
8081
8082
8083
8084
8085
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-66. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Lithographic
Printing Plate Cleaning ^
MIX lime Period
I'lnripoini = ( NS
llffecls1
Acnle
MIX
(niii/m')
l'l\poslll'C
l.e\el
MOIlslor A
Worker & OM :
No respirator
I'll|C l'l\J)OSIII
Worker
API 25'
es MOI.
W orker
API- 50'
lienchmark
MOM
(= Total
I I)
8-hr
290
High End
1.1
27
54
30
Central
Tendency
78
1950
3920
1 Data from Putz et al. (1979)
2 Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
not expect routine use of PPE that would mitigate risk (respirator APF 25 or 50) with this condition of use.
The MOEs are less than the benchmark MOE for workers with high end exposures when
respirators are not worn. MOEs are greater than the benchmark MOE for central tendency
exposures without a respirator and for high end exposures when respirators APF 50 are worn.
Table 4-67. Risk Estimation for Chronic, Non-Cancer Inhalation Exposures for
Lithographic Printing Plate Cleaning
I'lnripoini1
( hronic
MIX
(ing/nr*)
l-lxposnre
l.e\el
MOF.s for (
Worker & OM :
No respirator
lironic H\p»
Worker
API- 25'
isii res
Worker
API- 50'
lienchmark
MOM
(= Total
I 1)
Liver Effects
17.2
High End
0.28
7.0
14
10
Central
Tendency
20
509
1018
1 Data from Nitschke et al. (1988a)
2 Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
not expect routine use of PPE that would mitigate risk (respirator APF 25 or 50) with this condition of use.
The MOEs are less than the benchmark MOE for workers with high end exposures when
respirators are not worn. MOEs are greater than the benchmark MOE for central tendency
exposures without a respirator and for high end exposures when respirators APF 50 are worn.
Table 4-68. Risk Estimation for Chronic, Cancer Inhalation Exposures for Lithographic
Printing Plate Cleaning
I'lnripoini. Tumor
Tj pes'
II K
(risk per
niti/m1)
Exposure l.c\cl
Cancer Risk 1-
Worker & ONI :
No respirator
slimales
Worker
API- 25'
licnchmark
Cancer Risk
Liver and lung tumors
1.38E-06
High End
1.91E-04
7.65E-06
104
Central Tendency
2.03E-06
8.12E-08
1 Data from NTP (.1.986)
Page 343 of 725
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8089
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8091
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8093
8094
8095
8096
8097
8098
8099
8100
8101
8102
8103
8104
8105
8106
8107
8108
8109
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
9
Exposures to ONUs were not able to be estimated separately from workers; also, this scenario covers a broad range
of industries and processes, which may result in significant differences between central and high-end exposures.
3 APF 25 and APF 50 are the two lowest APF allowable under OSHA standards for methylene chloride. EPA does
not expect routine use of PPE that would mitigate risk (respirator APF 25) with this condition of use in part because
only supplied air respirators can be used (see section 2.4.1.1). APF 50 not shown based on cancer risks at APF 25
are all less than the cancer risk benchmark of 10~4.
Cancer risks are greater than 10"4 for high end exposures when respirators are not worn. If
workers used respirators with APF 25 then the cancer risks are less than 10"4 for all scenarios.
4.2.2.2 Risk Estimation for Dermal Exposures to Workers
Estimates of MOEs for acute and chronic exposures and cancer risks from dermal exposures for
workers for all of the OESs are presented in Table 4-69, Table 4-70 and Table 4-71, respectively.
EPA calculated exposure estimates as described in more detail above in Section 2.4.1.1.
Considering these primary strengths and limitations, the overall confidence of the dermal dose
results is medium. The studies that support the health concerns of acute CNS effects, liver
toxicity and cancer and the hazard value and benchmark MOEs are described above in Section
4.2.1 Risk Estimation Approach. EPA conducted route-to-route extrapolation to derive the
dermal PODs and uncertainty factors. Overall EPA has medium confidence in the acute, chronic
and cancer endpoints. Section 3.2.5.3 describes the justification for these human health ratings.
Table 4-69. MOEs for Acute Dermal Exposures to Workers, by Occupational Exposure
Scenario for CNS Effects PC
)D 16 mg/kg/day, Bene
imark MOE 2
10
Occii|);ilion:il Kxposmv
Scciiiirio
Selling
Kxposnrc
Le\el
KxpOSIIIT
(ni»/k»/il:iY)
N() (iloM'S
N
N() (iloM'S
lOKsu
PI 5
111 (il0M>
PI 10
Pis
PI 20
Manufacturing
industrial
Central
Tendency
0.75
21
H >7
NA
426
High-End
2.25
7.1
NA
142
Processing as a Reactant
industrial
Central
Tendency
0.75
21
H >7
NA
426
High-End
2.25
7.1
NA
142
Processing - Incorporation
into Formulation, Mixture, or
Reaction Product
industrial
Central
Tendency
0.75
21
11)7
NA
426
High-End
2.25
7.1
NA
142
Repackaging
industrial
Central
Tendency
0.75
21
11)7
NA
426
High-End
2.25
7.1
NA
142
Waste Handling, Disposal,
Treatment, and Recycling
industrial
Central
Tendency
0.75
21
11)7
NA
426
High-End
2.25
7.1
NA
142
Batch Open-Top Vapor
Degreasing
industrial
Central
Tendency
0.75
21
11)7
NA
426
High-End
2.25
7.1
NA
142
Conveyorized Vapor
Degreasing
industrial
Central
Tendency
0.75
21
11)7
NA
426
High-End
2.25
7.1
NA
142
Page 344 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
()cciip:ition:il Kxposnre
Scenario
Selling
Kxposnre
Le\el
Kxposnre
No (Jo\cs
N
No (Jo\cs
lOKsu
PI 5
111 (Jlo\e
PI 10
Pis
l»l 20
Cold Cleaning
industrial
CellU'al
Tendency
0.75
21
11)7
NA
426
High-End
2.25
7.1
NA
142
Commercial Aerosol Product
Uses
commercial
Central
Tendency
1.2
14
136
NA
High-End
3.5
4.5
23
45
NA
Adhesives and Sealants
industrial
Central
Tendency
0.75
21
11)7
NA
426
High-End
2.25
7.1
NA
142
Paints and Coatings
industrial
Central
Tendency
0.75
21
11)7
NA
426
High-End
2.25
7.1
NA
142
Paint and Coating Removers
commercial
Central
Tendency
1.2
14
136
NA
High-End
3.5
4.5
23
45
NA
Adhesive and Caulk
Removers
commercial
Central
Tendency
1.1
15
75
151
NA
High-End
3.2
5.0
25
50
NA
Miscellaneous Industrial
Non-Aerosol Use
industrial
Central
Tendency
0.75
21
11)7
NA
426
High-End
2.25
7.1
NA
142
Miscellaneous Commercial
Non-Aerosol Use
commercial
Central
Tendency
1.2
14
136
NA
High-End
3.5
4.5
23
45
NA
Fabric Finishing
commercial
Central
Tendency
1.1
14
71
143
NA
High-End
3.4
4.8
24
48
NA
Spot Cleaning
commercial
Central
Tendency
1.1
15
75
151
NA
High-End
3.2
5.0
25
50
NA
CTA Film Manufacturing
industrial
Central
Tendency
0.75
21
11)7
NA
426
High-End
2.25
7.1
NA
142
Plastic Product
Manufacturing
industrial
Central
Tendency
0.75
21
11)7
NA
426
High-End
2.25
7.1
NA
142
Flexible Polyurethane Foam
Manufacturing
industrial
Central
Tendency
0.75
21
11)7
NA
426
High-End
2.25
7.1
NA
142
Laboratory Use
industrial
Central
Tendency
1.18
14
NA
271
High-End
3.5
4.5
23
NA
90
Pharmaceutical Production
industrial
Central
Tendency
0.75
21
11)7
NA
426
High-End
2.25
7.1
NA
142
Page 345 of 725
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()cciip:ition:il Kxposnre
Scenario
Selling
Kxposnre
Le\el
Kxposnre
No (Jo\cs
N
No (Jo\cs
lOKsu
PI 5
111 (Jlo\e
PI 10
Pis
l»l 20
Lithographic Printing Plate
Cleaner
commercial
Central
Tendency
1.0
15
77
153
NA
High-End
3.1
5.1
26
51
NA
8110 NA not assessed because not all PFs are considered relevant to all conditions of use (COUs) and settings, see
8111 Section 2.4.1.1
8112
8113 MOEs are less than benchmark MOEs when gloves are not worn for all OESs. When gloves are
8114 used MOEs are greater than benchmark MOEs with PF 5 - 10 depending on the OES.
8115
8116 Table 4-70. MOEs for Chronic Dermal Exposures to Workers, by Occupational Exposure
Scenario for Liver Effects P<
3D 2.15 mg/kg/day, Benchmark MO
E = 10
Occiipnlioiiiil Kxposnre
Scenario
Selling
Kxposnre
l.e\el
Kxposnre
(ni»/k»/il:iv)
No (ilo\es
moi:
No (ilo\es
lor l)i
PI 5
Terenl P
PI 10
PI 20
Manufacturing
industrial
Coiiual
Tendency
0.75
3.0
15
Y\
Ml
High-End
2.25
1.0
5.0
NA
20
Processing as a Reactant
industrial
Central
Tendency
0.75
3.0
15
NA
60
High-End
2.25
1.0
5.0
NA
20
Processing - Incorporation
into Formulation, Mixture, or
Reaction Product
industrial
Central
Tendency
0.75
3.0
15
NA
60
High-End
2.25
1.0
5.0
NA
20
Repackaging
industrial
Central
Tendency
0.75
3.0
15
NA
60
High-End
2.25
1.0
5.0
NA
20
Waste Handling, Disposal,
Treatment, and Recycling
industrial
Central
Tendency
0.75
3.0
15
NA
60
High-End
2.25
1.0
5.0
NA
20
Batch Open-Top Vapor
Degreasing
industrial
Central
Tendency
0.75
3.0
15
NA
60
High-End
2.25
1.0
5.0
NA
20
Conveyorized Vapor
Degreasing
industrial
Central
Tendency
0.75
3.0
15
NA
60
High-End
2.25
1.0
5.0
NA
20
Cold Cleaning
industrial
Central
Tendency
0.75
3.0
15
NA
60
High-End
2.25
1.0
5.0
NA
20
Commercial Aerosol Product
Uses
commercial
Central
Tendency
1.2
2.7
13
27
NA
High-End
3.5
0.90
4.4
9.0
NA
Adhesives and Sealants
industrial
Central
Tendency
0.75
3.0
15
NA
60
High-End
2.25
1.0
5.0
NA
20
Paints and Coatings
industrial
Central
Tendency
0.75
3.0
15
NA
60
Page 346 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
()cciip:ition:il Kxposurc
SiTiiiirio
Soltiii"
Kxposurc
Le\el
Kxposuiv
N() (iloM'S
moi:
N() (iloM'S
< lor l)il
l»l 5
Tcivnl P
PI 10
PI 20
High-End
2.25
1.0
5.0
NA
2u
Paint and Coating Removers
commercial
Central
Tendency
1.2
2.7
13
27
NA
High-End
3.5
0.90
4.4
9.0
NA
Adhesive and Caulk
Removers
commercial
Central
Tendency
1.1
3.0
15
30
NA
High-End
3.2
0.98
4.8
9.7
NA
Miscellaneous Industrial
Non-Aerosol Use
industrial
Central
Tendency
0.75
3.0
15
NA
60
High-End
2.25
1.0
5.0
NA
20
Miscellaneous Commercial
Non-Aerosol Use
commercial
Central
Tendency
1.2
2.7
13
27
NA
High-End
3.5
0.90
4.4
9.0
NfA
Fabric Finishing
commercial
Central
Tendency
1.1
2.8
14
28
NA
High-End
3.4
0.93
4.7
9.3
NA
Spot Cleaning
commercial
Central
Tendency
1.1
3.0
15
3D
NA
High-End
3.2
0.97
4.8
9.7
NA
CTA Film Manufacturing
industrial
Central
Tendency
0.75
3.0
15
NA
60
High-End
2.25
1.0
5.0
NA
20
Plastic Product
Manufacturing
industrial
Central
Tendency
0.75
3.0
15
NA
60
High-End
2.25
1.0
5.0
NA
20
Flexible Polyurethane Foam
Manufacturing
industrial
Central
Tendency
0.75
3.0
15
NA
60
High-End
2.25
1.0
5.0
NA
20
Laboratory Use
industrial
Central
Tendency
1.2
2.7
13
27
NA
High-End
3.5
0.90
4.4
9.0
NA
Pharmaceutical Production
industrial
Central
Tendency
0.75
3.0
15
NA
60
High-End
2.25
1.0
5.0
NA
20
Lithographic Printing Plate
Cleaner
commercial
Central
Tendency
1.0
3.0
15
3ii
NA
High-End
3.1
1.0
5.0
In
NA
8118 NA not assessed because not all PFs are considered relevant to all COUs and settings, see Section 2.4.1.1
8119
8120 MOEs are less than benchmark MOEs when gloves are not worn for all OESs. When gloves are
8121 used MOEs are greater than benchmark MOEs for industrial uses with PF 20. MOEs are less
8122 than benchmark MOEs for commercial uses with PF 10.
8123
Page 347 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
8124
8125
Table 4-71. Cancer Risk for Chronic Dermal Exposures to Workers, by Occupational
FvnAcni
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
()eeiip;ilion;il Kxposnre
Seeniirio
Selling
Kxposnre
Le\el
Kxposnre
(m»/k»/d:iy)
No Cloxcs
('alie
No Cloxcs
it Risk l-'or
l»l 5
DilTerenl l>
l»l 10
Is
l»l 20
Miscellaneous
Commercial Non-
Aerosol Use
commercial
Central
Tendency
1.2
4.5E-06
9.0E-07
4.5E-07
NA
High-End
3.5
1.35E-05
2.70E-06
1.35E-06
NA
Fabric Finishing
commercial
Central
Tendency
1.1
4.2E-06
8.4E-07
4.2E-07
NA
High-End
3.4
1.30E-05
2.61E-06
1.30E-06
NA
Spot Cleaning
commercial
Central
Tendency
1.1
4.3E-06
7.3E-07
4.3E-07
NA
High-End
3.2
1.26E-05
2.51E-06
1.26E-06
NA
CTA Film
Manufacturing
industrial
Central
Tendency
0.75
2.9E-06
5.8E-07
NA
1.45E-07
High-End
2.25
8.69E-06
1.74E-06
NA
4.35E-07
Plastic Product
Manufacturing
industrial
Central
Tendency
0.75
2.9E-06
5.8E-07
NA
1.45E-07
High-End
2.25
8.69E-06
1.74E-06
NA
4.35E-07
Flexible Polyurethane
Foam Manufacturing
industrial
Central
Tendency
0.75
2.9E-06
5.8E-07
NA
1.45E-07
High-End
2.25
8.69E-06
1.74E-06
NA
4.35E-07
Laboratory Use
industrial
Central
Tendency
1.2
4.5E-06
9.0E-07
4.5E-07
NA
High-End
3.5
1.35E-05
2.70E-06
1.35E-06
NA
Pharmaceutical
Production
industrial
Central
Tendency
0.75
2.9E-06
5.8E-07
NA
1.45E-07
High-End
2.25
8.69E-06
1.74E-06
NA
4.35E-07
Lithographic Printing
Plate Cleaner
commercial
Central
Tendency
1.0
3.9E-06
7.8E-07
3.9E-07
NA
High-End
3.1
1.21E-05
2.41E-06
1.21E-06
NA
8126 NA not assessed because not all PFs are considered relevant to all COUs and settings, see Section 2.4.1.1
8127
8128 Cancer risks are less than 10"4 when gloves are not worn for all OESs.
8129 4.2.2.3 Risk Estimation for Inhalation and Dermal Exposures to Consumers
8130 Estimates of MOEs for consumers were calculated for consumers for acute inhalation and dermal
8131 exposures because the exposure frequencies were not considered sufficient to cause the health
8132 effects (i.e. liver effects and liver and lung tumors) that were observed in chronic animal studies
8133 typically defined as at least 10% of the animals lifetime.
8134 4.2.2.3.1 Brake Cleaner
8135 Estimates of MOEs for acute inhalation and dermal exposures for the brake cleaner consumer
8136 use are presented in Tables 4-72 and 4-73, respectively. Consumer inhalation and dermal
8137 exposures were modeled across a range of low, moderate and high user intensities as described in
8138 detail in Section 2.4.2. For inhalation, low, moderate and high intensity users are characterized
8139 by the 10th, 50th, and 95th percentile duration of use and mass of product used respectively and
8140 minimum, midpoint, and maximum reported weight fractions where possible respectively.
8141 Characterization of low intensity, moderate intensity and high intensity users for dermal
Page 349 of 725
-------
8142
8143
8144
8145
8146
8147
8148
8149
8150
8151
8152
8153
8154
8155
8156
8157
8158
8159
8160
8161
8162
8163
8164
8165
8166
8167
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
followed the same protocol as those described for the inhalation results, but only encompassing
the two varied duration of use and weight fraction parameters. Inhalation exposures are
presented for users and bystanders for TWAs of 1 hr and 8 hrs and dermal exposure results are
presented for users as acute ADRs in Section 2.4.2.4.5. Inhalation exposures were modeled for
27 different scenarios and dermal exposure was evaluated for nine scenarios (combinations of
the duration of use and weight fraction for receptors as adults and two youth age groups).
Considering the overall strengths and limitations of the data, EPA's overall confidence is high for
the consumer inhalation estimate and medium to high for the dermal estimate as discussed in
Section 2.4.2.6. The study that supports the CNS health concern is described above in Section
4.2.1. Overall, EPA has medium confidence in the acute endpoint, and Section 3.2.5.3 describes
the justification for this human health rating.
Table 4-72. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Brake
Cleaner Use
MIX Time Period
llmlpoini = ( NS KITeels'
Aeule
MIX
(111*4/111')
l-lxposure Seenario
I ser
MOI.
IVtMamler
MOI.
lieiiehmark
MOI.
(= Tolal
I I)
Low Intensity User
23.6
202.2
1-hr
840
Medium Intensity User
1.7
14.1
30
High Intensity User
0.4
2.3
Low Intensity User
50.2
218.0
8-hr
290
Medium Intensity User
3.6
15.0
30
High Intensity User
0.6
2.0
1 Data from Putz et al. (1979)
The MOEs are < benchmark MOE for the 1 hr and 8 hr value high end and medium exposure
scenarios. Most MOEs are > benchmark MOE for the low exposures.
Table 4-73. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Brake Cleaner
Use
Ariull I ser
lieiiehmark
MOI.
iiciiiih r.nvci
Aeule II111)
(jn*j/k*j/(lajj
l-lxposiire Seeiiiii'io
Aeule A 1)1)
un»/k*j/(lajj
MOI.
<= Tolal I I )
Impairment of
the CNS
Low Intensity User
0.062
258
16
Medium Intensity User
1.74
9.20
30
High Intensity User
3.80
4.21
For acute dermal exposures, MOEs are less than the benchmark MOE for consumer users for the
medium and high intensity user scenarios.
Page 350 of 725
-------
8168
8169
8170
8171
8172
8173
8174
8175
8176
8177
8178
8179
8180
8181
8182
8183
8184
8185
8186
8187
8188
8189
8190
8191
8192
8193
8194
8195
8196
8197
8198
8199
8200
8201
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
4.2.2.3.2 Carbon Remover
Estimates of MOEs for acute inhalation and dermal exposures for the carbon remover consumer
use are presented in Tables 4-74 and 4-75, respectively. Consumer inhalation and dermal
exposures were modeled across a range of low, moderate, and high user intensities as described
in detail in Section 2.4.2. For inhalation, low, moderate and high intensity users are characterized
by the 10th, 50th, and 95th percentile duration of use and mass of product used respectively and
minimum, midpoint, and maximum reported weight fractions where possible respectively.
Characterization of low intensity, moderate intensity and high intensity users for dermal
followed the same protocol as those described for the inhalation results, but only encompassing
the two varied duration of use and weight fraction parameters. Inhalation exposures are
presented for users and bystanders for TWAs of 1 hr and 8 hrs and dermal exposure results are
presented for users as acute ADRs in Section 2.4.2.4.7. Inhalation exposures were modeled for
18 different scenarios and dermal exposure evaluated for six scenarios (combinations of the
duration of use and weight fraction for receptors as adults and two youth age groups)
Considering the overall strengths and limitations of the data, EPA's overall confidence is high for
the consumer inhalation estimate and medium to high for the dermal estimate, as discussed in
Section 2.4.2.6. The study that supports the CNS health concern is described above in Section
4.2.1. Overall, EPA has medium confidence in the acute endpoint, and Section 3.2.5.3 describes
the justification for this human health rating.
Table 4-74. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Carbon
Remover Use
MIX Time Period
Imlpoinl = ( NS r.lTocls1
Anile
MIX
(nig/nr*)
I'1\])omiiv Scoiiiii'io
I ser
MOI.
IVtMiimler
MOI.
lienehm;irk
MOI.
(= loliil
I I)
Low Intensity User
9.5
102.9
1-hr
840
Medium Intensity User
0.9
9.7
30
High Intensity User
0.2
1.0
Low Intensity User
21.5
119.2
8-hr
290
Medium Intensity User
2.1
11.2
30
High Intensity User
0.2
0.9
1 Data from Putz et al. (1979)
The MOEs < benchmark MOE for both 1-hr and 8-hr exposures, except for the low exposure
bystanders.
The peak exposure value (4940 mg/m3) and the 1-hr maximum TWA (4750 mg/m3) for the high
intensity user identified in Section 2.4.2.4.7 do not exceed the NIOSH IDLH of 7981 mg/m3
(NIOSH. 1994) described in Section 3.2.3.1.1. but are greater than one half of the IDLH. The
NIOSH IDLH value was set to avoid situations that are immediately dangerous to life or health
and is a value above which individuals should not be exposed for any length of time.
Page 351 of 725
-------
8202
8203
8204
8205
8206
8207
8208
8209
8210
8211
8212
8213
8214
8215
8216
8217
8218
8219
8220
8221
8222
8223
8224
8225
8226
8227
8228
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-75. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Carbon
Remover Use
Arinll I ser
licnchmark
MOI.
lleallh l l'lccl
Acule III I)
(m^/k^/ria.t)
I'A])omii'c Scenario
Acme A 1)1)
(m^/k^/ria.t)
moi:
(= loial I I )
Impairment of
the CNS
Low Intensity User
0.360
44
16
Medium Intensity User
2.66
6.0
30
High Intensity User
3.38
4.7
For acute dermal exposures, MOEs are less than the benchmark MOE for consumer users for the
medium and high intensity user scenarios.
4.2.2.3.3 Carburetor Cleaner
Estimates of MOEs for acute inhalation and dermal exposures for the carburetor cleaner
consumer use are presented in Tables 4-76 and 4-77, respectively. Consumer inhalation and
dermal exposures were modeled across a range of low, moderate, and high user intensities as
described in detail in Section 2.4.2. For inhalation, low, moderate and high intensity users are
characterized by the 10th, 50th, and 95th percentile duration of use and mass of product used
respectively and minimum, midpoint, and maximum reported weight fractions where possible
respectively. Characterization of low intensity, moderate intensity and high intensity users for
dermal followed the same protocol as those described for the inhalation results, but only
encompassing the two varied duration of use and weight fraction parameters. Inhalation
exposures are presented for users and bystanders for TWAs of 1 hr and 8 hrs and dermal
exposure results are presented for users as acute ADRs in Section 2.4.2.4.8. Inhalation exposures
were modeled for 27 different scenarios and dermal exposure was evaluated for nine scenarios
(combinations of the duration of use and weight fraction for receptors as adults and two youth
age groups).
Considering the overall strengths and limitations of the data, EPA's overall confidence is high for
the consumer inhalation estimate and medium to high for the dermal estimate as discussed in
Section 2.4.2.6. The study that supports the CNS health concern is described above in Section
4.2.1. Overall, EPA has medium confidence in the acute endpoint, and Section 3.2.5.3 describes
the justification for this human health rating.
Page 352 of 725
-------
8229
8230
8231
8232
8233
8234
8235
8236
8237
8238
8239
8240
8241
8242
8243
8244
8245
8246
8247
8248
8249
8250
8251
8252
8253
8254
8255
8256
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-76. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Carburetor
Cleaner Use
IIF(' Time Period
Fmlpoinl = ( NS F.Heels'
Aeule
MFC
(niii/m')
Fxposure Seenario
I ser
MOF
IS> sliintler
MOF
lienehmark
MOF
(= Tolal
I F)
Low Intensity User
12.8
109.6
1-hr
840
Medium Intensity User
1.4
12.1
30
High Intensity User
0.3
2.0
Low Intensity User
27.2
118.3
8-hr
290
Medium Intensity User
3.0
12.9
30
High Intensity User
0.6
2.0
1 Data from Putz et al. (1979)
The MOEs < benchmark MOE for both 1-hr and 8-hr exposures, except for the low exposure
bystanders.
The peak exposure value (4420 mg/m3) for the high intensity user identified in Section 2.4.2.4.8
does not exceed the NIOSH IDLH of 7981 mg/m3 (NIOSH. 1994) described in Section 3.2.3.1.1.
but is greater than one half of the IDLH. The NIOSH IDLH value was set to avoid situations that
are immediately dangerous to life or health and is a value above which individuals should not be
exposed for any length of time.
Table 4-77. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Carburetor
Cleaner Use
Ariull I ser
lienehmark
MOF
lleiillh FITeeI
Aeule IIFI)
(mii/kii/din)
Fxposure Seenario
Aeule A 1)1)
(m^/k^/ria.t)
MOF
(= loial I I )
Impairment of
the CNS
Low Intensity User
0.091
175
16
Medium Intensity User
1.08
15
30
High Intensity User
3.23
4.9
For acute dermal exposures, MOEs are less than the benchmark MOE for consumer users for the
medium and high intensity user scenarios.
4.2.2.3.4 Coil Cleaner
Estimates of MOEs for acute inhalation and dermal exposures for the coil cleaner consumer use
are presented in Tables 4-78 and 4-79, respectively. Consumer inhalation and dermal exposures
were modeled across a range of low, moderate, and high user intensities as described in detail in
Section 2.4.2. For inhalation, low, moderate and high intensity users are characterized by the
10th, 50th, and 95th percentile duration of use and mass of product used respectively and
minimum, midpoint, and maximum reported weight fractions where possible respectively.
Characterization of low intensity, moderate intensity and high intensity users for dermal
followed the same protocol as those described for the inhalation results, but only encompassing
Page 353 of 725
-------
8257
8258
8259
8260
8261
8262
8263
8264
8265
8266
8267
8268
8269
8270
8271
8272
8273
8274
8275
8276
8277
8278
8279
8280
8281
8282
8283
8284
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
the two varied duration of use and weight fraction parameters. Inhalation exposures are
presented for users and bystanders for TWAs of 1 hr and 8 hrs and dermal exposure results are
presented for users as acute ADRs in Section 2.4.2.4.9. Inhalation exposures were modeled for
18 different scenarios and dermal exposure evaluated for six scenarios (combinations of the
duration of use and weight fraction for receptors as adults and two youth age groups).
Considering the overall strengths and limitations of the data, EPA's overall confidence is
medium to high for the consumer inhalation estimate and medium for the dermal estimate as
discussed in Section 2.4.2.6. The study that supports the CNS health concern is described above
in Section 4.2.1. Overall, EPA has medium confidence in the acute endpoint, and Section 3.2.5.3
describes the justification for this human health rating.
Table 4-78. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Coil Cleaner
Use
lli:(' Time Period
l.nripoini = ( NS I-;ITeels1
Aeule
MIX
(ing/nr*)
l-lxposure Seenario
I ser
MOI.
IS> sliintler
MOI.
Benehmark
MOI.
(= Tolal
I I)
Low Intensity User
5.5
59.9
1-hr
840
Medium Intensity User
0.6
5.9
30
High Intensity User
0.1
0.6
Low Intensity User
12.5
69.3
8-hr
290
Medium Intensity User
1.3
6.8
30
High Intensity User
0.1
0.6
1 Data from Putz et al. (1979
The MOEs < benchmark MOE for both 1-hr and 8-hr exposures, except for the low exposure
bystanders at 8 hrs.
The peak exposure value (8080 mg/m3) and the 1-hr maximum TWA (7770 mg/m3) for the high
intensity user identified in Section 2.4.2.4.9 exceed the NIOSH IDLH of 7981 mg/m3 (NIOSH.
1994) discussed in Section . The peak exposure value (4330 mg/m3) for the moderate intensity
user (Section 2.4.2.4.9) does not exceed the NIOSH IDLH but is greater than one half of the
IDLH. The NIOSH IDLH value was set to avoid situations that are immediately dangerous to life
or health and is a value above which individuals should not be exposed for any length of time.
Table 4-79. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Coil Cleaner
Use
Ariull I ser
Benehmark
MOI.
lleiillh KITeel
Aeule III I)
(inii/kii/din)
l-lxposure Seenario
Aeule A 1)1)
(m^/k^/ria.t)
MOI.
(= loial I I )
Impairment of
the CNS
Low Intensity User
0.617
26
16
Medium Intensity User
4.35
3.7
30
High Intensity User
5.55
2.9
Page 354 of 725
-------
8285
8286
8287
8288
8289
8290
8291
8292
8293
8294
8295
8296
8297
8298
8299
8300
8301
8302
8303
8304
8305
8306
8307
8308
8309
8310
8311
8312
8313
8314
8315
8316
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
For acute dermal exposures, MOEs are less than the benchmark MOE for consumer users for all
the exposure scenarios.
4.2.2.3.5 Electronics Cleaner
Estimates of MOEs for acute inhalation and dermal exposures for the electronics cleaner
consumer use are presented in Tables 4-80 and 4-81, respectively. Consumer inhalation and
dermal exposures were modeled across a range of low, moderate, and high user intensities as
described in detail in Section 2.4.2. For inhalation, low, moderate and high intensity users are
characterized by the 10th, 50th, and 95th percentile duration of use and mass of product used
respectively and minimum, midpoint, and maximum reported weight fractions where possible
respectively. Characterization of low intensity, moderate intensity and high intensity users for
dermal followed the same protocol as those described for the inhalation results, but only
encompassing the two varied duration of use and weight fraction parameters. Inhalation
exposures are presented for users and bystanders for TWAs of 1 hr and 8 hrs and dermal
exposure results are presented for users as acute ADRs in Section 2.4.2.4.11. Inhalation
exposures were modeled for nine different scenarios and dermal exposure evaluated for three
scenarios (combinations of the duration of use and a single identified weight fraction for
receptors as adults and two youth age groups)
Considering the overall strengths and limitations of the data, EPA's overall confidence is high for
the consumer inhalation estimate and medium to high for the dermal estimate as discussed in
Section 2.4.2.6. The study that supports the CNS health concern is described above in Section
4.2.1. Overall, EPA has medium confidence in the acute endpoint, and Section 3.2.5.3 describes
the justification for this human health rating.
Table 4-80. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Electronics
Cleaner Use
MIX Time Period
I'lmlpoini = ( NS r.lTocls'
Anile
MIX
(nig/nr*)
I'lxposuiv Scenario
I ser
MOI.
li>M;inrier
MOI.
lienehm;irk
MOI.
(= loliil
I I)
Low Intensity User
1171
8027
1-hr
840
Medium Intensity User
91
633
30
High Intensity User
6.5
31
Low Intensity User
2492
10794
8-hr
290
Medium Intensity User
195
854
30
High Intensity User
12.9
46
1 Data from Putz et al. (1979)
The MOEs < benchmark MOE for both 1-hr and 8-hr exposures for high intensity users and high
intensity bystanders at 1 hr.
Page 355 of 725
-------
8317
8318
8319
8320
8321
8322
8323
8324
8325
8326
8327
8328
8329
8330
8331
8332
8333
8334
8335
8336
8337
8338
8339
8340
8341
8342
8343
8344
8345
8346
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-81. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Electronics
Cleaner Use
Arinll I ser
licnchmark
MOI.
lleallh l l'lccl
Acule III I)
(m^/k^/da>)
I'A])omii'c Scenario
Acme A 1)1)
(m^/k^/da>)
moi:
(= loial I I )
Impairment of
the CNS
Low Intensity User
0.013
1208
16
Medium Intensity User
0.049
328
30
High Intensity User
0.25
64
For acute dermal exposures, MOEs are greater than the benchmark MOE for consumer users for
all the exposure scenarios.
4.2.2.3.6 Engine Cleaner
Estimates of MOEs for acute inhalation and dermal exposures for the engine cleaner consumer
use are presented in Tables 4-82 and 4-83, respectively. Consumer inhalation and dermal
exposures were modeled across a range of low, moderate, and high user intensities as described
in detail in Section 2.4.2. For inhalation, low, moderate and high intensity users are
characterized by the 10th, 50th, and 95th percentile duration of use and mass of product used
respectively and minimum, midpoint, and maximum reported weight fractions where possible
respectively. Characterization of low intensity, moderate intensity and high intensity users for
dermal followed the same protocol as those described for the inhalation results, but only
encompassing the two varied duration of use and weight fraction parameters. Inhalation
exposures are presented for users and bystanders for TWAs of 1 hr and 8 hrs and dermal
exposure results are presented for users as acute ADRs in Section 2.4.2.4.12. Inhalation
exposures were modeled for 27 different scenarios and dermal exposure evaluated for nine
scenarios (combinations of the duration of use and weight fraction for receptors as adults and
two youth age groups).
Considering the overall strengths and limitations of the data, EPA's overall confidence is high for
the consumer inhalation estimate and medium to high for the dermal estimate as discussed in
Section 2.4.2.6. The study that supports the CNS health concern is described above in Section
4.2.1. Overall, EPA has medium confidence in the acute endpoint, and Section 3.2.5.3 describes
the justification for this human health rating.
Table 4-82. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Engine
Cleaner Use
lienchmark
MIX l ime Period
Acnle
MOI.
MIX
I ser
IJ\ slander
(= Toial
l.ndpoinl = CNS F.ITecls"
(nig/nr*)
I'1\])omii'c Scenario
MOI.
MOI.
I I)
Low Intensity User
5.4
46.7
1-hr
840
Medium Intensity User
0.6
5.1
30
High Intensity User
0.2
0.9
8-hr
290
Low Intensity User
11.6
50.2
30
Page 356 of 725
-------
8347
8348
8349
8350
8351
8352
8353
8354
8355
8356
8357
8358
8359
8360
8361
8362
8363
8364
8365
8366
8367
8368
8369
8370
8371
8372
8373
8374
8375
8376
8377
8378
8379
8380
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Medium Intensity User
1.3
5.4
High Intensity User
0.2
0.8
1 Data from Putz et al. (1979)
The MOEs < benchmark MOE for both 1-hr and 8-hr exposures, except for the low exposure
bystanders.
Table 4-83. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Engine Cleaner
Use
Arinll I ser
licnchmark
MOI.
lleallh riled
Acule III I)
(niii/kii/daj)
I'1\|)omii'c Scenario
Acme A 1)1)
(m^/k^/(la>)
moi:
(= loial I I )
Impairment of
the CNS
Low Intensity User
0.376
43
16
Medium Intensity User
1.65
10
30
High Intensity User
3.27
4.9
For acute dermal exposures, MOEs are less than the benchmark MOE for consumer users for the
medium and high intensity user scenarios.
The peak exposure value (5480 mg/m3) and the 1-hr maximum TWA (5100 mg/m3) for the high
intensity user identified in Section 2.4.2.4.12 do not exceed the NIOSH IDLH of 7981 mg/m3
("NIOSH. 1994) described in Section 3.2.3.1.1. but are greater than one half of the IDLH. The
NIOSH IDLH value was set to avoid situations that are immediately dangerous to life or health
and is a value above which individuals should not be exposed for any length of time.
4.2.2.3.7 Gasket Remover
Estimates of MOEs for acute inhalation and dermal exposures for the gasket remover consumer
use are presented in Tables 4-84 and 4-85, respectively. Consumer inhalation and dermal
exposures were modeled across a range of low, moderate, and high user intensities as described
in detail in Section 2.4.2. For inhalation, low, moderate and high intensity users are characterized
by the 10th, 50th, and 95th percentile duration of use and mass of product used respectively and
minimum, midpoint, and maximum reported weight fractions where possible respectively.
Characterization of low intensity, moderate intensity and high intensity users for dermal
followed the same protocol as those described for the inhalation results, but only encompassing
the two varied duration of use and weight fraction parameters. Inhalation exposures are
presented for users and bystanders for TWAs of 1 hr and 8 hrs and dermal exposure results are
presented for users as acute ADRs in Section 2.4.2.4.13. Inhalation exposures were modeled for
18 different scenarios and dermal exposure was evaluated for six scenarios (combinations of the
duration of use and weight fraction for receptors as adults and two youth age groups).
Considering the overall strengths and limitations of the data, EPA's overall confidence is high for
the consumer inhalation estimate and medium to high for the dermal estimate, as discussed in
Section 2.4.2.6. The study that supports the CNS health concern is described above in Section
Page 357 of 725
-------
8381
8382
8383
8384
8385
8386
8387
8388
8389
8390
8391
8392
8393
8394
8395
8396
8397
8398
8399
8400
8401
8402
8403
8404
8405
8406
8407
8408
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
4.2.1. Overall, EPA has medium confidence in the acute endpoint, and Section 3.2.5.3 describes
the justification for this human health rating.
Table 4-84. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Gasket
Remover Use
MIX Time Period
llmlpoinl = ( NS KITccls1
Aculc
MIX
(jng/m-',)
l-lxposurc Scenario
I ser
MOI.
IVtManricr
MOI.
licnchmark
MOI.
(= Tolal
I I)
Low Intensity User
5.9
51.2
1-hr
840
Medium Intensity User
1.1
9.1
30
High Intensity User
0.2
1.4
Low Intensity User
12.6
55.1
8-hr
290
Medium Intensity User
2.3
9.7
30
High Intensity User
0.4
1.4
1 Data from Putz et al. (1979)
The MOEs < benchmark MOE for both 1-hr and 8-hr exposures, except for the low intensity
bystanders.
Table 4-85. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Gasket Remover
Use
Ariull I ser
licnchmark
MOI.
iiciiiih r.nvci
Acuk' II111)
(mji/kii/din)
l'l\|)OMire Seeiiiii'io
Acule A 1)1)
(mii/k*i/clii>)
MOI.
<= Tolal I I )
Impairment of
the CNS
Low 1 Ilk'llsIlN L sor
u 4~9
16
Medium Intensity User
2.70
5.9
30
High Intensity User
3.42
4.7
For acute dermal exposures, MOEs are less than the benchmark MOE for consumer users for the
medium and high intensity user scenarios.
The peak exposure value (5120 mg/m3) for the high intensity user identified in Section 2.4.2.4.13
does not exceed the NIOSH IDLH of 7981 mg/m3 (NIOSH. 1994) described in Section 3.2.3.1.1.
but is greater than one half of the IDLH. The NIOSH IDLH value was set to avoid situations that
are immediately dangerous to life or health and is a value above which individuals should not be
exposed for any length of time.
4.2.2.3.8 Adhesives
Estimates of MOEs for acute inhalation and dermal exposures for the adhesive consumer use are
presented in Tables 4-86 and 4-87, respectively. Consumer inhalation and dermal exposures were
modeled across a range of low, moderate, and high user intensities as described in detail in
Section 2.4.2. For inhalation, low, moderate and high intensity users are characterized by the
10th, 50th, and 95th percentile duration of use and mass of product used respectively and
Page 358 of 725
-------
8409
8410
8411
8412
8413
8414
8415
8416
8417
8418
8419
8420
8421
8422
8423
8424
8425
8426
8427
8428
8429
8430
8431
8432
8433
8434
8435
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
minimum, midpoint, and maximum reported weight fractions where possible respectively.
Characterization of low intensity, moderate intensity and high intensity users for dermal
followed the same protocol as those described for the inhalation results, but only encompassing
the two varied duration of use and weight fraction parameters. Inhalation exposures are
presented for users and bystanders for TWAs of 1 hr and 8 hrs and dermal exposure results are
presented for users as acute ADRs in Section 2.4.2.4.3. Inhalation exposures were modeled for
27 different scenarios and dermal exposure was evaluated for nine scenarios (combinations of
the duration of use and weight fraction for receptors as adults and two youth age groups).
Considering the overall strengths and limitations of the data, EPA's overall confidence is high for
the consumer inhalation estimate and moderate to high for the dermal estimate as discussed in
Section 2.4.2.6. The study that supports the CNS health concern is described above in Section
4.2.1. Overall, EPA has medium confidence in the acute endpoint, and Section 3.2.5.3 describes
the justification for this human health rating.
Table 4-86. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Adhesives
Use
MIX Time Period
llmlpoini = ( NS KITeels'
Aeule
MIX
(niii/m')
l-lxposure Scenario
I ser
MOI.
IVtManrier
MOI.
licnehmark
MOI.
(= Tolal
I I)
Low Intensity User
664.1
2187.6
1-hr
840
Medium Intensity User
28.8
129.5
30
High Intensity User
0.5
4.2
Low Intensity User
1066.2
2535.1
8-hr
290
Medium Intensity User
52.0
150.1
30
High Intensity User
1.1
4.7
1 Data from Putz et al. (1979)
The MOEs are < benchmark MOE for the 1 hr and 8 hr values high end exposure scenarios.
The MOEs are > benchmark MOE for most medium and low exposure scenarios.
Table 4-87. Risk
Estimation
ror Acute. Non-Cancer Dermal Exposures for Adhesives Fse
Ariull I ser
licnehmark
MOI!
ik;iiill i:iivci
Aeuie II111)
l''.\|)osiire Seeiiario
Acule ADD
(ill^/k^/(l;i> )
MOI.
<= Tolal I I )
Impairment of
the CNS
Low Intensity User
0.107
149
16
Medium Intensity User
1.51
11
30
High Intensity User
6.36
2.5
For acute dermal exposures, MOEs are less than the benchmark MOE for consumer users for the
medium and high intensity user scenarios.
Page 359 of 725
-------
8436
8437
8438
8439
8440
8441
8442
8443
8444
8445
8446
8447
8448
8449
8450
8451
8452
8453
8454
8455
8456
8457
8458
8459
8460
8461
8462
8463
8464
8465
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
4.2.2.3.9 Auto Leak Sealer
Estimates of MOEs for acute inhalation and dermal exposures for auto leak sealing consumer
uses are presented in Tables 4-88 and 4-89, respectively. Consumer inhalation and dermal
exposures were modeled across a range of low, moderate, and high user intensities as described
in detail in Section 2.4.2. For inhalation, low, moderate and high intensity users are characterized
by the 10th, 50th, and 95th percentile duration of use and mass of product used respectively and
minimum, midpoint, and maximum reported weight fractions where possible respectively.
Characterization of low intensity, moderate intensity and high intensity users for dermal
followed the same protocol as those described for the inhalation results, but only encompassing
the two varied duration of use and weight fraction parameters. Inhalation exposure for users and
bystanders for TWAs of 1 hr and 8 hrs and dermal exposure results for users as acute ADRs are
described in Section 2.4.2.4.1. Inhalation and dermal exposures were modeled for three different
scenarios respectively (combinations of the duration of use and a single value for weight fraction
for receptors as adults and two youth age groups)
Considering the overall strengths and limitations of the data, EPA's overall confidence is
medium to high for the consumer inhalation estimate and medium for the dermal estimate as
discussed in Section 2.4.2.6. The study that supports the CNS health concern is described above
in Section 4.2.1. Overall, EPA has medium confidence in the acute endpoint, and Section 3.2.5.3
describes the justification for this human health rating.
Table 4-88. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Auto Leak
Sealer Use
MIX Time Period
l.mlpoinl = ( NS HITeels1
Aeule
MIX
(nig/nr*)
l-lxposure Seenario
I ser
MOI.
IVtMamler
MOI.
lienehmark
MOI.
(= Tolal
I I)
Low Intensity User
1.2
10.3
1-hr
840
Medium Intensity User
1.2
10.1
30
High Intensity User
2.1
11.2
Low Intensity User
2.6
11.1
8-hr
290
Medium Intensity User
2.6
10.8
30
High Intensity User
2.7
9.8
1 Data from Putz et al. (1979)
For acute inhalation exposures, MOEs are less than the benchmark MOE for consumer users and
bystanders at 1-hr and 8-hr exposures for all the exposure scenarios.
Table 4-89. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Auto Leak
Sealer Use
lleallh l.llecl
Aeule III I)
dn»/k^/(la>)
l'l\|)OMire Seenario
Ariull
Aeule A 1)1)
(m^/k^/da>)
I ser
MOI.
lienehmark
MOI.
(= Tolal I I")
Impairment of
the CNS
16
Low Intensity User
1.65
10
30
Medium Intensity User
3.23
5.0
Page 360 of 725
-------
8466
8467
8468
8469
8470
8471
8472
8473
8474
8475
8476
8477
8478
8479
8480
8481
8482
8483
8484
8485
8486
8487
8488
8489
8490
8491
8492
8493
8494
8495
8496
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
High Intensity User
4.1
3.9
For acute dermal exposures, MOEs are less than the benchmark MOE for consumer users for all
the exposure scenarios.
4.2.2.3.10 Brush Cleaner
Estimates of MOEs for acute inhalation and dermal exposures for the brush cleaner consumer
use are presented in Tables 4-90 and 4-91, respectively. Consumer inhalation and dermal
exposures were modeled across a range of low, moderate, and high user intensities as described
in detail in Section 2.4.2. For inhalation, low, moderate and high intensity users are characterized
by the 10th, 50th, and 95th percentile duration of use and mass of product used respectively and
minimum, midpoint, and maximum reported weight fractions where possible respectively.
Characterization of low intensity, moderate intensity and high intensity users for dermal
followed the same protocol as those described for the inhalation results, but only encompassing
the two varied duration of use and weight fraction parameters. Inhalation exposures are
presented for users and bystanders for TWAs of 1 hr and 8 hrs and dermal exposure results are
presented for users as acute ADRs in Section 2.4.2.4.6. Inhalation exposures were modeled for
nine different scenarios and dermal exposure was evaluated for three scenarios (combinations of
the duration of use and a weight fraction for receptors as adults and two youth age groups).
Considering the overall strengths and limitations of the data, EPA's overall confidence is
medium to high for the consumer inhalation estimate and medium for the dermal estimate as
discussed in Section 2.4.2.6. The study that supports the CNS health concern is described above
in Section 4.2.1. Overall, EPA has medium confidence in the acute endpoint, and Section 3.2.5.3
describes the justification for this human health rating.
Table 4-90. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Brush
Cleaner Use
NIX Time Period
I'lmlpoini = ( NS r.lTocls'
Anile
MIX
(nig/nr*)
I'lxposuiv Scenario
I ser
MOI.
li>M;inrier
MOI.
lienehm;irk
MOI.
(= loliil
I I)
Low Intensity User
3956
44077
1-hr
840
Medium Intensity User
786
6209
30
High Intensity User
462
1293
Low Intensity User
8981
50216
8-hr
290
Medium Intensity User
1653
6916
30
High Intensity User
191
919
1 Data from Putz et al. (1979)
The MOEs > benchmark MOE for all the PODs.
Page 361 of 725
-------
8497
8498
8499
8500
8501
8502
8503
8504
8505
8506
8507
8508
8509
8510
8511
8512
8513
8514
8515
8516
8517
8518
8519
8520
8521
8522
8523
8524
8525
8526
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-91. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Brush Cleaner
Use
Arinll I ser
licnchmark
MOI.
Health l l'lccl
Acule III I)
(m^/k^/da>)
I'A])omii'c Scenario
Acme A 1)1)
(m^/k^/da>)
moi:
(= loial I I )
Impairment of
the CNS
Low Intensity User
0.0141
1135
16
Medium Intensity User
0.0350
457
30
High Intensity User
0.0351
456
For acute dermal exposures, MOEs are greater than the benchmark MOE for consumer users for
all the exposure scenarios.
4.2.2.3.11 Adhesive Remover
Estimates of MOEs for acute inhalation and dermal exposures for the adhesive remover
consumer uses are presented in Tables 4-92 and 4-93, respectively. Consumer inhalation and
dermal exposures were modeled across a range of low, moderate, and high user intensities as
described in detail in Section 2.4.2. For inhalation, low, moderate and high intensity users are
characterized by the 10th, 50th, and 95th percentile duration of use and mass of product used
respectively and minimum, midpoint, and maximum reported weight fractions where possible
respectively. Characterization of low intensity, moderate intensity and high intensity users for
dermal followed the same protocol as those described for the inhalation results, but only
encompassing the two varied duration of use and weight fraction parameters. Inhalation
exposures are presented for users and bystanders for TWAs of 1 hr and 8 hrs and dermal
exposure results are presented for users as acute ADRs in Section 2.4.2.4.4. Inhalation exposures
were modeled for 18 different scenarios and dermal exposure was evaluated for six scenarios
(combinations of the duration of use and weight fraction for receptors as adults and two youth
age groups).
Considering the overall strengths and limitations of the data, EPA's overall confidence is high for
the consumer inhalation estimate and medium to high for the dermal estimate as discussed in
Section 2.4.2.6. The study that supports the CNS health concern is described above in Section
4.2.1. Overall, EPA has medium confidence in the acute endpoint, and Section 3.2.5.3 describes
the justification for this human health rating.
Table 4-92. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Adhesive
Remover Use
NIX Time Period
l.ndpoinl = CNS KITccls1
Acnle
MIX
(niii/m')
l'l\|)osiirc Scenario
I ser
MOI.
li\ slander
MOI.
lienchmark
MOI.
(= Toial
I I)
1-hr
840
Low Intensity User
629.4
2869.4
30
Medium Intensity User
440.7
3482.0
High Intensity User
136.1
502.1
8-hr
290
Low Intensity User
1138.9
3288.6
30
Page 362 of 725
-------
8527
8528
8529
8530
8531
8532
8533
8534
8535
8536
8537
8538
8539
8540
8541
8542
8543
8544
8545
8546
8547
8548
8549
8550
8551
8552
8553
8554
8555
8556
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Medium Intensity User
928.3
3897.4
High Intensity User
51.5
279.2
1 Data from Putz et al. (1979)
The MOEs are > benchmark MOE.
Table 4-93. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Adhesive
Remover Use
Arinll I ser
licnchmark
MOI.
lleallh riled
Acule III I)
(niii/kii/daj)
I'1\|)omii'c Scenario
Acme A 1)1)
(m^/k^/(la>)
moi:
(= loial I I )
Impairment of
the CNS
Low Intensity User
3.055
5.2
16
Medium Intensity User
17.25
0.93
30
High Intensity User
17.25
0.93
For acute dermal exposures, MOEs are less than the benchmark MOE for consumer users for all
the exposure scenarios.
4.2.2.3.12 Auto AC Refrigerant
Estimates of MOEs for acute inhalation and dermal exposures for the auto AC refrigerant
consumer uses are presented in Tables 4-94 and 4-95, respectively. Consumer inhalation and
dermal exposures were modeled across a range of low, moderate, and high user intensities as
described in detail in Section 2.4.2. For inhalation, low, moderate and high intensity users are
characterized by the 10th, 50th, and 95th percentile duration of use and mass of product used
respectively and minimum, midpoint, and maximum reported weight fractions where possible
respectively. Characterization of low intensity, moderate intensity and high intensity users for
dermal followed the same protocol as those described for the inhalation results, but only
encompassing the two varied duration of use and weight fraction parameters. Inhalation
exposures are presented for users and bystanders for TWAs of 1 hr and 8 hrs and dermal
exposure results are presented for users as acute ADRs in Section 2.4.2.4.2. Inhalation exposures
were modeled for 18 different scenarios and dermal exposure was evaluated for six scenarios
(combinations of the duration of use and weight fraction for receptors as adults and two youth
age groups).
Considering the overall strengths and limitations of the data, EPA's overall confidence is
medium to high for the consumer inhalation estimate and medium for the dermal estimate as
discussed in Section 2.4.2.6. The study that supports the CNS health concern is described above
in Section 4.2.1. Overall, EPA has medium confidence in the acute endpoint, and Section 3.2.5.3
describes the justification for this human health rating.
Page 363 of 725
-------
8557
8558
8559
8560
8561
8562
8563
8564
8565
8566
8567
8568
8569
8570
8571
8572
8573
8574
8575
8576
8577
8578
8579
8580
8581
8582
8583
8584
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-94. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Auto AC
Refrigerant Use
NIX' Time Period
lienehmark
MOI.
l.ndpoinl = ( NS
r.lTeels"
Aeule MIX
(ing/nr*)
l'l\|)OMire Seenario
I ser
MOI.
li> slander
MOI.
(= Toial
I I)
Low Intensity User
101.7
874.6
1-hr
840
Medium Intensity User
8.8
72.0
30
High Intensity User
3.6
19.1
Low Intensity User
216.4
939.4
8-hr
290
Medium Intensity User
18.4
76.4
30
High Intensity User
4.7
16.8
1 Data from Putz et al. (1979)
The MOEs are < benchmark MOE for the 1-hr and 8-hr values for high end exposure scenarios
(user and bystander) and medium exposure scenarios for users.
Table 4-95. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Auto AC
Refrigerant Use i
Adull I ser
lienehmark
MOI.
lleidlh r.l'l'eel
Aeule III I)
(illii/kii/(l;i>)
l''.\|)osiire Seenario
Aeule A 1)1)
(mu/k^/da.t)
MOI.
(= Tolal I I")
Impairment of
the CNS
Low Intensity User
0.020
797
16
Medium Intensity User
0.12
136
30
High Intensity User
0.15
107
For acute dermal exposures, MOEs are greater than the benchmark MOE for consumer users for
all the exposure scenarios.
4.2.2.3.13 Cold Pipe Insulation Spray
Estimates of MOEs for acute inhalation and dermal exposures for the cold pipe insulation spray
consumer use are presented in Tables 4-96 and 4-97, respectively. Consumer inhalation and
dermal exposures were modeled across a range of low, moderate, and high user intensities as
described in detail in Section 2.4.2. For inhalation, low, moderate and high intensity users are
characterized by the 10th, 50th, and 95th percentile duration of use and mass of product used
respectively and minimum, midpoint, and maximum reported weight fractions where possible
respectively. Characterization of low intensity, moderate intensity and high intensity users for
dermal followed the same protocol as those described for the inhalation results, but only
encompassing the two varied duration of use and weight fraction parameters. Inhalation
exposures are presented for users and bystanders for TWAs of 1 hr and 8 hrs and dermal
exposure results are presented for users as acute ADRs in Section 2.4.2.4.10. Inhalation
exposures were modeled for 18 different scenarios and dermal exposure was evaluated for six
scenarios (combinations of the duration of use and weight fraction for receptors as adults and
two youth age groups).
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Considering the overall strengths and limitations of the data, EPA's overall confidence is
medium to high for the consumer inhalation estimate and medium for the dermal estimate as
discussed in Section 2.4.2.6. The study that supports the CNS health concern is described above
in Section 4.2.1. Overall, EPA has medium confidence in the acute endpoint, and Section 3.2.5.3
describes the justification for this human health rating.
Table 4-96. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Cold Pipe
Insulation Spray Use
lienehmark
lli:(' Time Period
Aeule
MOI.
MIX
I ser
li\ slander
(= Tolal
l.nripoini = ( NS WTeels1
(ing/nr*)
l'l\])OMire Seenario
MOI.
MOI.
1 1 )
Low Intensity User
15.7
167.3
1-hr
840
Medium Intensity User
1.6
17.1
30
High Intensity User
0.3
2.2
Low Intensity User
35.4
193.8
8-hr
290
Medium Intensity User
3.6
19.8
30
High Intensity User
0.6
2.4
1 Data from Putz et al. (1979)
The MOEs < benchmark MOE for both 1-hr and 8-hr exposures, except for the low exposure
bystanders and low exposure user at 8 hrs.
Table 4-97. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Cold Pipe
Insulation Spray Use
Ariull I ser
lienehmark
MOI.
lleiillh KITeel
Aeule lll'.l)
(mji/kii/din)
l'l\|)OMire Seeiiiii'io
Aeule A 1)1)
(mii/k*i/clii>)
MOI.
<= Tolal I I )
Impairment of
the CNS
Low Intensity User
0.049
325
16
Medium Intensity User
0.78
20
30
High Intensity User
1.95
8.2
For acute dermal exposures, MOEs are less than the benchmark MOE for consumer users for the
medium and high intensity user scenarios.
4.2.2.3.14 Sealants
Estimates of MOEs for acute inhalation and dermal exposures for the sealant consumer use are
presented in Tables 4-98 and 4-99, respectively. Consumer inhalation and dermal exposures were
modeled across a range of low, moderate and high user intensities as described in detail in
Section 2.4.2. For inhalation, low, moderate and high intensity users are characterized by the
10th, 50th, and 95th percentile duration of use and mass of product used respectively and
minimum, midpoint, and maximum reported weight fractions where possible respectively.
Characterization of low intensity, moderate intensity and high intensity users for dermal
followed the same protocol as those described for the inhalation results, but only encompassing
the two varied duration of use and weight fraction parameters. Inhalation exposures are
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presented for users and bystanders for TWAs of 1 hr and 8 hrs and dermal exposure results are
presented for users as acute ADRs in Section 2.4.2.4.14. Inhalation exposures were modeled for
18 different scenarios and dermal exposure was evaluated for six scenarios (combinations of the
duration of use and weight fraction for receptors as adults and two youth age groups)
Considering the overall strengths and limitations of the data, EPA's overall confidence is high for
the consumer inhalation estimate and medium to high for the dermal estimate as discussed in
Section 2.4.2.6. The study that supports the CNS health concern is described above in Section
4.2.1. Overall, EPA has medium confidence in the acute endpoint, and Section 3.2.5.3 describes
the justification for this human health rating.
Table 4-98. Risk Estimation for Acute. Non-Cancer Inhalation Exposures for Sealants Use
Benehmark
lli:(' Time Period
Aeule
MOI.
MIX
I ser
li\ slander
(= Tolal
l.nripoini = ( NS I-;ITeels1
(ing/nr*)
l'l\])OMire Seenario
MOI.
MOI.
I I)
Low Intensity User
35.1
303.5
1-hr
840
Medium Intensity User
2.9
24.0
30
High Intensity User
0.4
2.8
Low Intensity User
74.8
327.0
8-hr
290
Medium Intensity User
6.1
25.5
30
High Intensity User
0.7
3.1
1 Data from Putz et al. (1979)
The MOEs < benchmark MOE for both 1-hr and 8-hr exposures, except for the low intensity
users and bystanders.
Table 4-99. Ris
i Estimation for Acute. Non-Cancer Dermal Exposures for Sea
ants Use
Ariull I ser
lienehmark
MOI.
1 k;il111 KITeel
Aeule lll'.l)
(mji/kii/din)
l'l\|)OMire Seeiiiii'io
Aeule A 1)1)
(mii/k*i/clii>)
MOI.
(= Tolal I I )
Impairment of
the CNS
Low Intensity User
0.081
198
16
Medium Intensity User
1.02
16
30
High Intensity User
1.30
12
For acute dermal exposures, MOEs are less than the benchmark MOE for consumer users for the
medium and high intensity user scenarios.
4.2.2.3.15 Weld Spatter Protectant
Estimates of MOEs for acute inhalation and dermal exposures for the weld spatter protectant
consumer use are presented in Tables 4-100 and 4-101, respectively. Consumer inhalation and
dermal exposures were modeled across a range of low, moderate, and high user intensities as
described in detail in Section 2.4.2. For inhalation, low, moderate and high intensity users are
characterized by the 10th, 50th, and 95fe percentile duration of use and mass of product used
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respectively and minimum, midpoint, and maximum reported weight fractions where possible
respectively. Characterization of low intensity, moderate intensity and high intensity users for
dermal followed the same protocol as those described for the inhalation results, but only
encompassing the two varied duration of use and weight fraction parameters. Inhalation
exposures are presented for users and bystanders for TWAs of 1 hr and 8 hrs and dermal
exposure results are presented for users as acute ADRs in Section 2.4.2.4.15. Inhalation
exposures were modeled for nine different scenarios and dermal exposure was evaluated for six
scenarios (combinations of the duration of use and weight fraction for receptors as adults and
two youth age groups).
Considering the overall strengths and limitations of the data, EPA's overall confidence is
medium to high for the consumer inhalation estimate and medium for the dermal estimate as
discussed in Section 2.4.2.6. The study that supports the CNS health concern is described above
in Section 4.2.1. Overall, EPA has medium confidence in the acute endpoint, and Section 3.2.5.3
describes the justification for this human health rating.
Table 4-100. Risk Estimation for Acute, Non-Cancer Inhalation Exposures for Weld
Spatter Protectant Use i
Benehmark
lli:(' Time Period
Aeule
MOI.
MIX
I ser
li\ slander
(= Tolal
l.nripoini = ( NS WTeels1
(mg/nr')
l'l\])OMire Seenario
MOI.
MOI.
I I)
Low Intensity User
4.6
51.0
1-hr
840
Medium Intensity User
0.9
10.4
30
High Intensity User
0.2
1.3
Low Intensity User
10.5
59.2
8-hr
290
Medium Intensity User
2.1
12.1
30
High Intensity User
0.3
1.5
1 Data from Putz et al. (1979)
The MOEs < benchmark MOE for both 1-hr and 8-hr exposures, except for the low intensity
bystanders.
Table 4-101. Risk Estimation for Acute, Non-Cancer Dermal Exposures for Weld Spatter
Protectant Use
Ariull I ser
lienehmark
MOI.
lleiillh KITeel
Aeule lll'.l)
(mji/kii/din)
l'l\|)OMire Seeiiiii'io
Aeule A 1)1)
(mii/k*i/clii>)
MOI.
<= Tolal I I )
Impairment of
the CNS
Low Intensity User
0.161
99
16
Medium Intensity User
1.28
12
30
High Intensity User
3.19
5.0
For acute dermal exposures, MOEs are less than the benchmark MOE for consumer users for the
medium and high intensity user scenarios.
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The peak exposure values (6150, 5050 and 4130 mg/m3) for the high, moderate and low intensity
users as well as the 1-hr maximum TWA (5110 mg/m3) for the high intensity user identified in
Section 2.4.2.4.15 do not exceed the NIOSH IDLH of 7981 mg/m3 (NIPS 4) but are
greater than one half of the IDLH. The NIOSH IDLH value was set to avoid situations that are
immediately dangerous to life or health and is a value above which individuals should not be
exposed for any length of time.
4.3 Assumptions and Key Sources of Uncertainty
4.3.1 Key Assumptions and Uncertainties in the Environmental Exposure
Assessment
Modeled Surface Water Concentrations
Modeled releases using E-FAST 2014 used 2016 TRI and 2016 DMR data to estimate releases.
However, both data sources are self-reported and have reporting requirements that limit the
number of reporters. Due to these limitations, some sites that manufacture, process, or use
methylene chloride may not report to these datasets, are not included in this analysis and
therefore actual environmental exposures may be underestimated. Facilities are only required to
report to TRI if the facility has 10 or more full-time employees, is included in an applicable
NAICS code, and manufactures, processes, or uses the chemical in quantities greater than a
certain threshold (25,000 pounds for manufacturers and processors and 10,000 pounds for
users).DMR data are submitted by NPDES permit holders to states or directly to the EPA
according to the monitoring requirements of the facility's permit. States are only required to load
major discharger data into DMR and may or may not load minor discharger data. The definition
of major vs. minor discharger is set by each state and could be based on discharge volume or
facility size. Due to these limitations, some sites that discharge may not be included in the DMR
dataset.
Facilities are only required to report to TRI if the facility has 10 or more full-time employees, is
included in an applicable NAICS code, and manufactures, processes, or uses the chemical in
quantities greater than a certain threshold (25,000 pounds for manufacturers and processors and
10,000 pounds for users). DMR data are submitted by NPDES permit holders to states or directly
to the EPA according to the monitoring requirements of the facility's permit. States are only
required to load major discharger data into DMR and may or may not load minor discharger
data. The definition of major vs. minor discharger is set by each state and could be based on
discharge volume or facility size. Due to these limitations, some sites that discharge may not be
included in the DMR dataset.
Use of facility data to estimate environmental exposures is constrained by a number of
uncertainties including: the heterogeneity of processes and releases among facilities grouped
within a given sector; assumptions made regarding sector definitions used to select facilities
covered under the scope; and fluctuations in the level of production and associated
environmental releases incurred as a result of changes in standard operating procedures.
Uncertainty may also arise from omissions in the reporting data, such as sectors that are not
required to report, facilities that fall below the reporting threshold, or facilities for which forms
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simply are not filed. Additionally, some of the reported information reflects approximations
rather than actual measured emissions or release data potentially leading to mischaracterization
of actual releases. While these limitations are important, their impact on estimating exposure
potential may be less than that associated with the assumptions made regarding environmental
releases discussed below. Nevertheless, it is important to note that both TRI and DMR datasets
are based on the most comprehensive, best readily available data at a nationwide scale. TRI data
can include monitoring data, mass balances, emission factors, or engineering calculations. DMR
is based on representative pollutant monitoring data at facility outfalls and corresponding
wastewater discharge.
The days of release applied in modeling has a direct impact on predicting surface water
concentrations. The greater the number of release days assumed, the more the per-day release is
diluted (assuming the same overall annual loading estimate). For each condition of use, EPA
estimated the average daily releases and number of release days per year since actual facility
reporting of release days was not available as described in Section 2.2.1. EPA estimated a high
and low days of release frequency for all direct releasers and a high days of release frequency for
all indirect releasers. Actual release days may vary across and between industries and may not be
accurately represented by these assumed default values. There is some uncertainty regarding
which release frequency is more likely, but when both high and low days of release frequency
are evaluated it is expected to cover the range of possible releases to surface water bodies.
Another key parameter in modeling is the applied stream flow distribution, which provides for
the immediate dilution of the release estimate. The flow distributions are applied by selecting a
facility-specific NPDES code in E-FAST 2014. When site-specific or surrogate site-specific
stream flow data were not available, flow data based on a representative industry sector were
used in the assessment. This includes cases where a receiving facility for an indirect release
could not be determined. In such cases, it is likely that the stream concentration estimates are
higher than they would be if a facility-specific NPDES code was able to be applied, except in
certain cases (e.g., NPDES associated with low-flow or intermittent streams or bays).
Additionally, the stream flow data currently available in E-FAST 2014 are 15 to 30 years old and
may not represent current conditions at a particular location. Nevertheless, the used datasets
represent the most comprehensive and accurate nationwide datasets available for modeling
evaluation and analysis.
E-FAST 2014 does not take volatilization or other fate or hydrologic transport characteristics
into consideration when estimating surface water concentrations. Additionally, for static water
bodies, E-FAST 2014 may not take dilution into consideration. For a volatile chemical such as
methylene chloride, this may lead to overestimates in actual exposure concentrations. Estimated
concentrations evaluated here may best represent those found at the point of discharge.
Measured Surface Water Data and Watershed Analysis
The WQP Tools contains data from USGS-NWIS and STORET databases, and is one of the
largest environmental monitoring databases in the U.S.; however, comprehensive information
needed for data interpretation is not always readily available. In some instances, proprietary
information may be withheld, or specific details regarding analytical techniques may be unclear,
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or not reported at all. As a result, there are uncertainties in the reported data that are difficult to
quantify with regard to impacts on exposure estimates.
The quality of the data provided in the USGS-NWIS and STORET datasets varies, and some of
the information provided is non-quantitative. While a large number of individual sampling
results were obtained from these datasets, the monitoring studies used to collect the data were not
necessarily specifically designed to evaluate methylene chloride distribution across the U.S. The
available data represent a variety of discrete locations and time periods; therefore, it is uncertain
whether the reported data are representative of all possible nationwide conditions. Nevertheless,
these limitations do not diminish the overall findings reported in this assessment that exposure
data showed no instances where measured methylene chloride levels in the ambient environment
exceeded the identified hazard benchmarks for water or organisms. (Section 4.1.2)
It is also important to note that only a few USGS-NWIS and STORET monitoring stations
aligned with the watersheds of the methylene chloride-releasing facilities identified under the
scope of this assessment, and the co-located monitoring stations had samples with concentrations
below the detection limit; therefore, no direct correlation can be made between them.
Additionally, the evaluated databases represent the best-known available records of actual
methylene chloride concentrations in the environment.
With respect to the geospatial comparison of modeled estimates with ambient data obtained from
WQX, one limitation is the accuracy of the latitudes and longitudes. The geographic coordinates
for facilities were obtained from the FRS Interests geodatabase, which are assigned through
various methods including photo-interpretation, address matching, and GPS. These are
considered "Best Pick" coordinates. While EPA does assign accuracy values for each record
based on the method used, the true accuracy of any individual point is unknown. Also, in some
cases the receiving facilities for indirect releases could not be determined. In these cases, the
location of the active releaser was mapped. As such, the co-location of facilities and monitoring
sites may have been missed. As the number of unknown receiving facilities was small and most
monitoring sites had samples with concentrations below the detection limit, this would have
minimal impact on the watershed analysis.
4.3.2 Key Assumptions and Uncertainties in the Occupational Exposure
Assessment
Key uncertainties in the occupational exposure assessment arise from the following sources:
4.3.2.1 Occupational Inhalation Exposure Concentration Estimates
Air concentrations. In most scenarios where data were available, EPA did not find enough data
to determine complete statistical distributions of actual air concentrations for the workers
exposed to methylene chloride. Ideally, EPA would like to know 50th and 95th percentiles for
each exposed population. In the absence of percentile data for monitoring, the air concentration
means and medians (means are preferred over medians) of the data sets served as substitutes for
50th percentiles (central tendencies) of the actual distributions, whereas high ends of ranges
served as substitutes for 95th percentiles of the actual distributions. However, these substitutes
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are uncertain and are weak substitutes for the ideal percentiles. For instance, in the few cases
where enough data were found to determine statistical means and 95th percentiles, the associated
substitutes (i.e., medians and high ends of ranges) were shown to overestimate exposures,
sometimes significantly. While it is clear that most air concentration data represent real exposure
levels, EPA cannot determine whether these concentrations are representative of the statistical
distributions of actual air concentrations to which workers are exposed. It is unknown whether
these uncertainties overestimate or underestimate exposures.
Exposures for occupational non-users can vary substantially. Most data sources do not
sufficiently describe the proximity of these employees to the exposure source. As such, exposure
levels for the "occupational non-user" category will have high variability depending on the
specific work activity performed. It is possible that some employees categorized as
"occupational non-user" have exposures similar to those in the "worker" category depending on
their specific work activity pattern. It is unknown whether these uncertainties overestimate or
underestimate exposures. The available data and modeling approaches for assessing inhalation
exposures are shown in Table 4-102 for both workers and ONUs.
Table 4-102 Table of Occupationa
Exposure Assessment Approac
i for Inhalation
lAposure Scenario
Worker
PI3/ Monilonntj
IXiki (X-lir TWA)
Modeling
Deterministic
Worker *
Modeling
Probabilistic
Worker NF/ONU
FF
()\l s
Monitoring
da la
1 Manufacturing
X
2 Import/ Repackaging/ Distribution
X
X
3 Processing as a reactant
X
X
Area
monitoring A
4 Processing into a formulation
X
X
5 Batch vapor degreasing
X
6 Conveyorized vapor degreasing
X
7 Cold Cleaning
X
8 Commercial Aerosol Products
X
9 Adhesives and Sealants - spray
and non-spray
X
Area
monitoring A
10 Paints and coatings - paint
application - spray including:
Paints and coatings - paint removers
2014 EPA Risk Assessment
X
11 Adhesive and Caulk Removers
X
12 Fabric Finishing
X
13 Spot Cleaning
X
*
14 Cellulose Triacetate Film
Production
X
15 Flexible Polyurethane Foam
Manufacturing
X
16 Laboratory chemicals
X
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lAposure Scenario
Worker
PI}/ Monitoring
Data (X-lir TWA)
Modeling
Deterministic
Worker *
Modeling
Probabilistic
W orker \l ()\l
IT
ONUs
Momionn^
data
17 Plastic and rubber products
X*
ONU specific
PBZ
monitoring
18 Pharmaceutical Production
X
19 Lithographic Printing
X
20 Miscellaneous Non-Aerosol Uses
X
21 Waste Handling
X
X
A While area monitoring data were identified, there is some uncertainty about the representativeness of these data for
ONU exposures for these specific exposure scenarios because of the intended sample population and the selection of
the specific monitoring location.
* The deterministic modeling approach does not estimate exposures for ONUs
+ EPA has developed a model to evaluate potential worker and ONU exposures during spot cleaning for various
solvents; however, the specific methylene chloride use rate during spot cleaning was not reasonably available. This
is a critical data gap and other solvent use rates may not be applicable.
Additionally, some data sources may be inherently biased. For example, bias may be present if
exposure monitoring was conducted to address concerns regarding adverse human health effects
reported following exposures during use. These sources may cause exposures to be
overestimated.
Some air concentration data comes from sources pre-dating the most recent PEL update for
methylene chloride in 1997. PEL changes can drive improvements in engineering controls or
other efforts to reduce ambient exposure to meet the PEL. Use of pre-PEL data may overestimate
some exposures in some OESs.
Due to data limitations in most OESs, EPA combined inhalation data from two or more data sets
when metadata were not available to distinguish between OES subcategories. These
combinations introduce uncertainties as to whether data from disparate worker populations had
been combined into one OES or OES subcategory. This same uncertainty applies to mixing data
collected pre-PEL change with data collected post-PEL change.
Where data were not available, the modeling approaches used to estimate air concentrations also
have uncertainties. Parameter values used in models did not all have distributions known to
represent the modeled scenario. It is also uncertain whether the model equations generate results
that represent actual workplace air concentrations. It is unknown whether these uncertainties
overestimate or underestimate exposures. Additional model-specific uncertainties are included
below.
Averaging Times. EPA cannot determine how accurately the assumptions of exposure
frequencies (days/yr exposed) and exposed working years may represent actual exposure
frequencies and exposed working years. For example, tenure is used to represent exposed
working years, but many workers may not be exposed during their entire tenure. It is unknown
whether these uncertainties overestimate or underestimate exposures, although the high-end
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values may result in overestimates when used in combination with high-end values of other
parameters.
4.3.2.2 Near-Field/Far-Field Model Framework
The near-field/far-field approach is used as a framework to model inhalation exposure for many
conditions of use. The following describe uncertainties and simplifying assumptions generally
associated with this modeling approach:
• There is some degree of uncertainty associated with each model input parameter. In
general, the model inputs were determined based on review of available literature. Where
the distribution of the input parameter is known, a distribution is assigned to capture
uncertainty in the Monte Carlo analysis. Where the distribution is unknown, a uniform
distribution is often used. The use of a uniform distribution will capture the low-end and
high-end values but may not accurately reflect actual distribution of the input parameters.
• The model assumes the near-field and far-field are well mixed, such that each zone can
be approximated by a single, average concentration.
• All emissions from the facility are assumed to enter the near-field. This assumption will
overestimate exposures and risks in facilities where some emissions do not enter the
airspaces relevant to worker exposure modeling.
• The exposure models estimate airborne concentrations. Exposures are calculated by
assuming workers spend the entire activity duration in their respective exposure zones
(i.e., the worker in the near-field and the occupational non-user in the far-field). Since
vapor degreasing and cold cleaning involve automated processes, a worker may actually
walk away from the near-field during part of the process and return when it is time to
unload the degreaser. As such, assuming the worker is exposed at the near-field
concentration for the entire activity duration may overestimate exposure. The assumption
that ONUs are present only in the far-field could result in underestimates for ONUs
present in the near-field.
• For certain applications (e.g., vapor degreasing), methylene chloride vapor is assumed to
emit continuously while the equipment operates (i.e., constant vapor generation rate).
Actual vapor generation rate may vary with time. However, small time variability in
vapor generation is unlikely to have a large impact in the exposure estimates as exposures
are calculated as a time-weighted average.
• The exposure models represent model workplace settings for each methylene chloride
condition of use. The models have not been regressed or fitted with monitoring data.
• Beyond the exceptions noted, it is unknown whether these uncertainties overestimate or
underestimate exposures.
Each subsequent section below discusses uncertainties associated with the individual model.
4.3.2.2.1 Vapor Degreasing Models
The OTVD and conveyorized vapor degreasing assessments use a near-field/far-field approach
to model worker exposure. In addition to the uncertainties described above, the vapor degreasing
models have the following uncertainties:
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• To estimate vapor generation rate for each equipment type, EPA used a distribution of the
emission rates reported in the 2014 NEI for each degreasing equipment type. NEI only
contains information on major sources not area sources. Therefore, the emission rate
distribution used in modeling may not be representative of degreasing equipment
emission rates at area sources.
• The emission rate for conveyorized vapor degreasing is based on equipment at a single
site and the emission rates for web degreasing are based on equipment from two sites. It
is uncertain how representative these data are of a "typical" site.
• EPA assumes workers and occupational non-users remove themselves from the
contaminated near- and far-field zones at the conclusion of the task, such that they are no
longer exposed to any residual methylene chloride in air, which may underestimate
exposures.
• Beyond the exceptions noted, it is unknown whether these uncertainties overestimate or
underestimate exposures.
4.3.2.2.2 Brake Servicing Model
The aerosol degreasing assessment also uses a near-field/far-field approach to model worker
exposure. Specific uncertainties associated with the aerosol degreasing scenario are presented
below:
• The model references a CARB study ( )00) on brake servicing to estimate use
rate and application frequency of the degreasing product. The brake servicing scenario
may not be representative of the use rates for other aerosol degreasing applications
involving methylene chloride.
• Because market penetration data were not available for methylene chloride-containing
products, EPA assumed the market penetration for perchloroethylene as an upper bound
because perchloroethylene comprises the majority of the chlorinated solvent-based
degreaser volume ( )0).
• EPA found 10 different aerosol degreasing formulations containing methylene chloride.
For each Monte Carlo iteration, the model determines the methylene chloride
concentration in product by selecting one of 10 possible formulations, assuming the
distribution for each formulation is equal. It is uncertain if this distribution is
representative of all sites in the U.S.
• Aerosol formulations were taken from available safety data sheets, and most were
provided as ranges. For each Monte Carlo iteration, the model selects a methylene
chloride concentration within the range of concentrations using a uniform distribution. In
reality, the methylene chloride concentration in the formulation may be more consistent
than the range provided.
• It is unknown whether these uncertainties overestimate or underestimate exposures.
4.3.2.3 Occupational Dermal Exposure Dose Estimates
The Dermal Exposure to Volatile Liquids Model used for modeling occupational dermal
exposures accounts for the effect of evaporation on dermal absorption for volatile chemicals and
the potential exposure reduction due to glove use. The model does not account for the transient
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exposure and exposure duration effect, which likely overestimates exposures. The model
assumes one exposure event per day, which likely underestimates exposure as workers often
come into repeat contact with the chemical throughout their work day. Surface areas of skin
exposure are based on skin surface area of hands from EPA's Exposure Factors Handbook, but
actual surface areas with liquid contact are unknown and uncertain for all OESs. For many
OESs, the high end assumption of contact over the full area of two hands likely overestimates
exposures. Weight fractions are usually reported to CDR and shown in other literature sources as
ranges, and EPA assessed only upper ends of ranges. The glove protection factors, based on the
ECETOC TRA model as described in Section 2.4.1.1, are "what-if' assumptions and are
uncertain. EPA does not know the actual frequency, type, and effectiveness of glove use in
specific workplaces of the OESs. Except where specified above, it is unknown whether most of
these uncertainties overestimate or underestimate exposures. The representativeness of the
modeling results toward the true distribution of dermal doses for the OESs is uncertain.
4.3.3 Key Assumptions and Uncertainties in the Consumer Exposure
Assessment
Systematic review was conducted to identify chemical- and product-specific monitoring and use
data for assessing consumer exposures. As no product-specific monitoring data were identified,
exposure scenarios were assessed using a modeling approach that requires the input of various
chemical parameters and exposure factors. When possible, default model input parameters were
modified based on chemical and product specific inputs available in literature and product
databases. Uncertainties and assumptions related to these inputs are discussed below.
Product & Market Profile
The products and articles assessed in this risk evaluation are largely based on EPA's 2016-2017
Use and Market Profile for Methylene Chloride, as well as EPA's Use Report and Preliminary
Information on Manufacturing, Processing, Distribution, Use, and Disposal: Methylene Chloride,
which provide information on commercial and consumer products available in the U.S.
marketplace at that time. While it is possible that some products may have changed since 2017,
EPA believes that the timeframe is recent enough to still represent the current market.
Information on products from the Use and Market Profile was augmented with other sources
such as the NIH Household Product Survey and EPA's CPDat, as well as available product
labels and SDSs. However, it is still possible that the entire universe of products may not have
been identified, due to market changes or research limitations.
U.S. EPA (1387) Consumer Use Survey
A number of product labels and/or technical fact sheets were identified for use in assessing
consumer exposure. The identified information often did not contain product-specific use data,
and/or represented only a small fraction of the product brands containing the chemical of
interest. A comprehensive survey of consumer use patterns in the U.S., the Household Solvent
Product: A National Usage Survey ( ')> was used to parameterize critical
consumer modeling inputs, based on applicable product and use categories. This large survey of
over 4,920 completed questionnaires, obtained through a randomized sampling technique, is
highly relevant because the primary purpose was to provide statistics on the use of solvent-
containing consumer products for the calculation of exposure estimates. The survey focused on
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32 different common household product categories, generally associated with cleaning, painting,
lubricating, and automotive care. Although there is uncertainty due to the age of the use pattern
data, as specific products in the household product categories have likely changed over time,
EPA assumes that the use pattern data presented in U.S. EPA (1987) reflects reasonable
estimates for current use patterns of similar product type. These estimates were deemed to be
reasonable due to the range of use patterns evaluated (e.g., ranging from 10th to 95th percentile)
and that this dataset represents the most recent, relevant and nationally-representative data
available for use pattern data in most cases. U.S. EPA (1987) aimed to answer the following key
questions for each product category, some of which were used as key model inputs in this
consumer assessment:
• room of product use (key input: environment of use),
• how much time was spent using the product (key input: duration of product use per
event),
• how much of the product was used (key input: mass of product used per event),
• how often the products were used,
• when the product was last used,
• product formulation,
• brand names used, and
• degree of ventilation or other protective measures undertaken during product use.
The strengths and weakness of the Westat survey are discussed in more detail below with an
emphasis on the key modeling inputs.
Product Use Category
A crosswalk was completed to assign consumer products in the current risk evaluation to one of
the product or article scenarios in the CEM model, and then to an appropriate survey category.
Although detailed product descriptions were not provided in U.S. EPA (1987). a list of product
brands and formulation type in each category was useful in pairing the survey product categories
to the scenarios being assessed. In most cases, the product categories in U.S. EPA (1987) aligned
reasonably well with the products being assessed. For product scenarios without an obvious
survey scenario match, professional judgment was used to make an assignment. For a limited
number of scenarios, technical fact sheets or labels with information on product use amounts
were available, and this information was used in the assessment as needed.
Another limitation of the U.S. EPA (1987) data is that while the overall respondent size of the
survey was large, the number of users in each product category was varied, with some product
categories having a much smaller pool of respondents than others. Product categories such as
spot removers, cleaning fluids, glues and adhesives, lubricants, paints, paint strippers, fabric
water repellents, wood stains, tire cleaners, engine degreasers, carburetor cleaners, and
specialized electronic cleaners had sample sizes ranging from roughly 500 to 2,000 users;
whereas, categories such as shoe polish, adhesive removers, rust removers, primers, outdoor
water repellents, gasket removers and brake cleaners had sample sizes of less than 500 users.
The survey was conducted for adults ages 18 and older. Most consumer products are targeted to
this age category, and thus the respondent answers reflect the most representative age group.
However, youth may also be direct users of some consumer products. It is unknown how the
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usage patterns compare between adult and youth users, but it is assumed that the product use
patterns for adults will be very similar to, or more conservative (i.e., longer use duration, higher
frequency of use) than use patterns for youth.
Room of Use
The CEM model requires specification of a room of use, which results in the following default
model assumptions (relevant for inhalation exposure only): ventilation rates, room volume, and
the amount of time per day that a person resides in the room of use. The U.S. EPA (1987) survey
provided the location of last product use for the following room categories: basement, living
room, other inside room, garage, and outside. The room with the highest percentage was selected
as the room to model in CEM. For some specific product scenarios, however, professional
judgement was used to assign the room of use; these selections are documented in the input
section. For many scenarios in which "other inside room" was the highest percentage, the utility
room was selected as the default room of use. The utility room is a smaller room, and therefore
may provide a more conservative assumption for peak concentrations. In cases where outside
was identified as the "room of use," but it was deemed reasonable to assume the product could
be used inside (such as for auto care products), the garage was typically selected as the room of
use.
Amount of Product Used and Duration of Product Use
The U.S. EPA (1987) survey reported ounces per use, derived from the ounces of product used
per year (based on can size and number of cans used), divided by the number of reported uses
per year. The duration of use (in minutes) reported in U.S. EPA (1987) was a direct survey
question. An advantage to these parameters is that the results are reported in percentile rankings
and were used to develop profiles of high intensity, moderate intensity, and low intensity users of
the products (95th, 50th, and 10th percentile values, respectively). In cases where a product was
not crosswalked to a CEM scenario, the amount of product used was tailored to those specific
products instead of depending on U.S. EPA (1987)data.
Ventilation and Protection
For most scenarios, the CEM model was run using median air exchange rates from EPA's
Exposure Factors Handbook (201 la), and interzone ventilation rates derived from the air
exchange rates and the default median building volume from EPA's Exposure Factors Handbook
(201 la). These inputs do not incorporate any measures that would serve to increase air exchange.
The U.S. EPA (1987) survey questions indicated that most respondents did not have an exhaust
fan on when using these products, most respondents kept the door to the room open when using
these products, and most people reported reading the directions on the label. The modeling
conducted by EPA did not account for specific product instructions or warning labels. For
example, some product labels might indicate that protective equipment (chemical resistant gloves
or respirator) should be worn, which would lower estimated exposures
Other Parameters and Data Sources
Activity Patterns: EPA assumed that a consumer product would be used only once per day. This
is a realistic assumption for most scenarios, but a high-intensity user could use the same product
multiple times in one day. Additionally, CEM allows for selection of activity patterns based on a
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"stay-at-home" resident or a part-time or full-time "out-of-the home" resident. The activity
patterns were developed based on CHAD data of activity patterns, which is an EPA database that
includes more than 54,000 individual study days of detailed human behavior (Isaacs. 2014). It
was assumed that the user followed a "stay-at-home" activity pattern that would place them in
the home and room of use for more time than a part-time or full-time "out-of-the home" resident.
Applying an "out-of-the home" resident activity pattern would reduce estimated exposures.
Product Density: If available, product-specific densities were obtained from SDS information,
and used to convert the ounces of the product used from U.S. EPA (1987). to grams of product
used. If product-specific densities were not available, default product densities from the CEM
User Guide (EPA. 2017) were used.
Amount Retained on Skin: For estimation of dermal exposure using the Fraction Absorbed
Method within CEM as outlined in Section 2.4.2.3.1.2 (P_DER2a), the amount retained on skin
parameter (AR) was assumed to equal the amount absorbed in the top of the stratum corneum
(SC). In practice, a portion of the amount of chemical applied on top of the SC at the beginning
of exposure (AR term) will evaporate and another portion will enter into the top layer of the SC.
That portion entering the SC is then subject to potential further-evaporation from the SC or
further penetration into the dermis layer.
4.3.4 Key Assumptions and Uncertainties in Environmental Hazards
While EPA determined that there was sufficient environmental hazard data to characterize
environmental hazards of methylene chloride, uncertainties exist.
EPA used sub-chronic data, measuring a developmental effect in embryo and larvae, to calculate
the amphibian chronic COC, which introduces some uncertainty about whether we are
overestimating or underestimating chronic risk. Assessment factors (AFs) were used to calculate
the acute and chronic COCs for methylene chloride. AFs account for the uncertainty in the
differences in inter- and intra-species variability, as well as laboratory-to-field variability and are
routinely used within TSCA for assessing the hazard of new industrial chemicals (with very
limited environmental test data). However, there is no way of knowing exactly how much
uncertainty to account for in the AFs. Therefore, there is uncertainty associated with the use of
the specific AFs used in the hazard assessment. For example, a standard UF has not been
established for amphibians by the EPA under TSCA, because there are few amphibian studies for
industrial chemicals. It is unclear whether using an assessment factor of 10 to calculate the acute
COC value for amphibians using the sub-chronic embryo-larvae test data is sufficiently
protective or is overly protective of amphibian exposures to methylene chloride.
There are additional factors that affect the potential for adverse effects in aquatic organisms.
Life-history factors and the habitat of aquatic organisms influences the likelihood of exposure
above the hazard benchmark in an aquatic environment.
4.3.5 Key Assumptions and Uncertainties in the Human Health Hazards
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Effects from Acute and Short-term Exposure - CNS Depression
There is uncertainty in converting the POD value from 1.5 hrs to PODs appropriate for the 15-
minute, 1-hr and 8-hr exposure durations used in the risk evaluation. EPA used a default
approach (Ten Berge et at.. 1986). which is a modification of Haber's rule, to convert the POD to
other exposure durations. Other methods to convert among exposure durations have been used by
other programs. For instance, the AEGL program used a PBPK model that estimated methylene
chloride concentrations in the brain for different exposure durations for the percent of the
population who did and did not conjugate GSTT1, which affects the level of COHb in blood. The
PBPK model may be slightly more precise, but when NAC/AEGL (2008) compared values using
the PBPK model to default values for shorter time frames, the values were similar.18 Therefore,
EPA used the simpler method to convert POD values among exposure durations.
The AEGL program estimated AEGL values using other studies. Stewart et al. (1972) formed the
basis of AEGL 1 values (thresholds for discomfort), but the study did not describe whether
blinding was used. Because the authors reported subjective symptoms did not describe whether
blinding was used, EPA has lower confidence in this value. Winneke (1974). used for AEGL 2
values (thresholds for disabling effects), suggested that the volunteers were blinded to the study
design but acknowledged that the subjects may have detected the methylene chloride's odor.
Winneke (1974) also tested higher concentrations than Putz (1979). and AEGL 2 values were set
using the highest concentration evaluated in the study. Based on these study considerations and
because AEGL values are meant to be used for emergency situations, EPA did not use these
studies or the AEGL values in this risk evaluation.
Gamberale (1975). DiVincenzo et al. (1972) and Kozena et al. (1990) did not find significant
CNS-related effects. However, all three studies received low confidence ratings. Gamberale
01211) and Kozena et al. (1990) used non-standard methods of f methylene chloride exposure
generation that made it difficult to compare with air concentrations. DiVincenzo et al. (1972)
lacked information on results and did not describe whether controls were used. Furthermore, the
current risk evaluation uses changes in a complex task (as measured by Putz et al. (1979)). which
might not be identified in a study such as Gamberale (1975) that measured only simple reaction
tasks. DiVincenzo et al. (1972.) did use a dual task but only reported on one aspect of the task.
EPA used an effect of limited severity (7% decreased visual performance) observed in a complex
task leading to uncertainty about the adversity of the effect. However, to account for the limited
severity, EPA applied a smaller UF for LOAEL to NOAEL (3 vs. 10) when setting the
benchmark MOE.
The 15-minute STEL (OSU i i) is 433 mg/m3 and is expected to prevent a significant risk
of material impairment to the CNS. OSHA, however, did not specify how they chose this value.
They do acknowledge that it was chosen as a feasible value for the workplace and acknowledge
uncertainty as to whether the value would adequately protect physically active workers (OSHA...
1997a). EPA noted how the STEL compares with the occupational exposure in section 2.4.1,
human health hazard values in section 3.2.5 and in the risk characterization of human health
section 4.2.2. Because the derivation of the STEL considered issues of feasibility and not strictly
18 PBPK vs. Default: 290 vs. 310 ppm (10 min); 230 vs. 210 ppm (30 min); 200 vs. 170 ppm (1 hr)
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hazard and may not be protective of physically active workers, EPA did not use the 15-minute
STEL as a basis to evaluate risk from acute exposure. EPA also determined that it is important to
consider less severe effects rather than quantifying only more severe effects, in part, due to the
possibility of serious harm and death as concentrations and exposure durations increase.
Immune System Effects
EPA did not carry immune system effects forward for dose-response because epidemiological,
animal and mechanistic data are limited and inconclusive for several reasons. The
epidemiological studies that identified associations had limited information on methylene
chloride exposure, none controlled for other chemicals and Radican et al. (2.008) investigated a
non-specific outcome and used exposed and comparison populations with very different
socioeconomic status and other studies did not identify an association between immune effects
and methylene chloride. Although there is some evidence for immunosuppression from Aranyi
(19861 EPA cannot easily conclude from animal studies that methylene chloride results in
immunotoxicity-related effects due to a limited database and lack of association among other
studies with changes in immune cells or organs.
Nervous System Effects
EPA has not advanced the ASD hazard to dose-response for several reasons. First, there are
uncertainties in the modeled estimates of air concentrations from NATA. Specifically, the NATA
data are annual average concentrations from the year of the pregnancy or within a few years of
the pregnancy. However, an etiologically relevant time period of exposure for ASD is thought to
be the perinatal period (Pelch et al.. 2019; Kalkbrenner et al.. 2010; Rice and Barone. 2000) and
the lack of temporal specificity of the NATA data is a potential limitation. Further, a smaller
association was observed when considering average monthly measured outdoor air
concentrations within 3.5 miles of the pregnant women's residences (von Ehren stein et al.. 2014)
compared with using the annual NATA results (modeling of measured air emissions) in the other
four studies. The observation that the locally measured exposure data which was more precisely
matched to the perinatal period showed smaller effect sizes than the results based on the less
wellmatched NATA-based results somewhat decreases confidence in the overall association.
These studies do not provide exposure estimates for workers (e.g., nurses) or indoor exposure
estimates for consumer products or indoor exposure estimates for the general population. The
current studies all address multi-pollutant exposures either within the same regression models or
by correlations among chemicals and are hypothesis generating.
Liver Effects
In the evaluation of liver effects from chronic methylene chloride exposure, EPA used a
probabilistic PBPK model to address the toxicokinetic variability among humans related to
differences in metabolism based on information specific to methylene chloride hazard. EPA
chose the 1st percentile to account for sensitive individuals in the population. Alternative
percentiles are similar to the 1st percentile 17.2 mg/m3, the 5th percentile 21.3 mg/m3 and the
mean 48.5 mg/m3 a difference of less than 3-fold between the mean and 1st percentile values.
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Reproductive/Developmental Effects
EPA did not carry reproductive/developmental effects forward for dose-response modeling
because data are inconclusive. However, there is uncertainty about such effects given endpoints
identified within epidemiological studies and effects observed in animal studies.
Cancer
Although EPA chose to model the combination of liver and lung tumor results from a cancer
bioassay using mice, there is uncertainty regarding modeling these tumor types for humans.
The majority of epidemiology studies did not identify an association between methylene chloride
and liver cancer, although these studies compared the exposed workers mortality rates against the
general population control mortality rates, and worker cohorts have often been shown to be
healthier in general than the full population. Likewise, the majority of epidemiology studies have
not identified an association between methylene chloride and lung cancer in humans. However,
as noted in Section 3.2.4.2, there may have been differences between the exposed and control
groups regarding smoking status, limiting the utility of these lung cancer studies. In addition,
increases in genotoxicity have been shown to be correlated with increases in GSTT1 activity in
many test systems and mice lung and liver tissues have higher levels of GSTT1 compared with
these tissues in humans. EPA was able, however, to address this uncertainty by using a PBPK
model to account for differences in GST activity between mice and humans and among humans.
In the PBPK model EPA used the mean value to address the toxicokinetic variability among
humans related to differences in metabolism based on information specific to methylene chloride
hazard.
Methylene chloride may lead to other types of tumors in humans. Humans have a class Theta
transferase related to GSTT1 that is expressed in erythrocytes (Sherratt et al. 1997). Also,
workers exposed to methylene chloride had increased frequencies of micronuclei and DNA
damage in peripheral blood lymphocytes. Furthermore, hematopoietic tumors have been
observed in some epidemiology studies and these results are more consistently positive than
other tumor types. Thus, even though this type of tumor was not modeled in the current risk
evaluation it may be of concern for humans.
Animal studies consistently identify methylene chloride exposure as associated with mammary
tumors, and the IURs for mammary tumors are of greater magnitude than the combined liver and
lung tumor IURs. Furthermore, breast cancer has been identified in one human epidemiology
study (see Section 3.2.4.2). Thus, there is uncertainty in not using IURs for these tumor
responses in the current evaluation. However, very few tumors from the animal studies are
malignant, the dose metric for breast cancer is not certain and data on mutagenicity in these
tissues is lacking. In addition, a small fraction 0.1% of fibroadenomas lead to carcinomas (Russo.
2015). Thus, EPA chose not to use the animal mammary tumor data in this risk evaluation.
Another uncertainty is the lack of positive genotoxicity results in the liver of mice exposed via
inhalation of 800 ppm methylene chloride for four weeks (Suzuki et al.. 2014). Therefore, there
is uncertainty regarding whether there may be methylene chloride concentrations at which
carcinogenicity may not be observed.
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4.3.6 Key Assumptions and Uncertainties in the Environmental Risk Estimation
There was uncertainty related to environmental risk for methylene chloride. EPA used both E-
FAST and monitored data to characterize acute and chronic exposures of methylene chloride to
aquatic organisms.
E-FAST: In some ways the E-FAST estimates are underestimating exposure, because data used
in E-FAST include TRI and DMR data. TRI does not include smaller facilities with fewer than
10 full time employees, nor does it cover certain sectors, which may lead to underestimates in
total methylene chloride releases to the environment. In other ways the E-FAST estimates are
overestimating exposure, because methylene chloride is a volatile chemical, and E-FAST doesn't
take volatilization into consideration; and, for static water bodies, E-FAST doesn't take dilution
into consideration.
Specifically, there is some uncertainty around modeled releases that have surface water
concentrations greater than the highest COC for fish (7,581 ppb). As stated in Section 4.1.2, both
of the releases originated from the same indirect discharging facility, VEOLIA ES TECHNICAL
SOLUTIONS LLC (MIDDLESEX, NJ), which is categorized in the recycling and disposal OES.
The releases were transferred to separate receiving facilities for treatment: Clean Harbors of
Baltimore (modeled concentration of 17,000 ppb). These concentrations are 5 to 11 times higher
than the next highest surface water concentration modeled. A NPDES or surrogate NPDES code
of the receiving facilities could not be identified in E-FAST 2014; therefore, the model runs were
made using the POTW industry sector as a surrogate, as described in Section 4.1.2. Site-specific
flows would improve the accuracy of the estimates, but due to the large release amounts it is
likely that even site-specific flows would result in concentrations that would exceed one or more
COC. Better understanding of how the methylene chloride transferred to these facilities was
handled or treated is likely to lead to better estimated releases and exposure concentrations from
these facilities. The remaining facilities with 7Q10 SWCs that exceeded a COC also generally
had high annual release amounts. Some facilities with lower release amounts, such as LONG
BEACH (C) WPCP LONG BEACH discharged to a still waterbody which utilized a dilution
factor of 1.
Monitored data: The available monitored data was limited temporally and geographically.
Aquatic environmental conditions such as temperature and composition (i.e., total organic
carbon, water hardness, dissolve oxygen, and pH) can fluctuate with the seasons, which could
affect methylene chloride concentrations in water and sediment pore water. In addition,
methylene chloride monitoring data was collected only in certain areas, and within a limited
number of states in the U.S. There were no measurements available immediately downstream
from facilities releasing methylene chloride to surface water; these data are only a limited
representation of ambient water.
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4.3.7 Key Assumptions and Uncertainties in the Human Health Risk Estimation
Occupational Exposure
Air concentrations. In most scenarios where data were available, EPA did not find enough data
to determine complete statistical distributions of actual air concentrations for the workers
exposed to methylene chloride. Ideally, EPA would like to know 50th and 95th percentiles for
each exposed population. In the absence of percentile data for monitoring, the air concentration
means and medians (means are preferred over medians) of the data sets served as substitutes for
50th percentiles (central tendencies) of the actual distributions, whereas high ends of ranges
served as substitutes for 95th percentiles of the actual distributions. However, these substitutes
are uncertain and are weak substitutes for the ideal percentiles. For instance, in the few cases
where enough data were found to determine statistical means and 95th percentiles, the associated
substitutes (i.e., medians and high ends of ranges) were shown to overestimate exposures,
sometimes significantly. While it is clear that most air concentration data represent real exposure
levels, EPA cannot determine whether these concentrations are representative of the statistical
distributions of actual air concentrations to which workers are exposed. It is unknown whether
these uncertainties overestimate or underestimate exposures. The range of air concentration
estimates from central tendency to high-end was generally not large (e.g., less than 20-fold for
most OESs). Because of this the results of risk characterization were generally not sensitive to
the individual estimates of the central tendency and high-end separately but rather were based on
considering both central tendency and high-end exposure estimates which increase the overall
confidence in the risk characterization.
Exposures for ONUs can vary substantially. Most data sources do not sufficiently describe the
proximity of these employees to the exposure source. As such, exposure levels for the
"occupational non-user" category will have high variability depending on the specific work
activity performed. It is possible that some employees categorized as "occupational non-user"
have exposures similar to those in the "worker" category depending on their specific work
activity pattern. It is unknown whether these uncertainties overestimate or underestimate
exposures.
Additionally, some data sources may be inherently biased. For example, bias may be present if
exposure monitoring was conducted to address concerns regarding adverse human health effects
reported following exposures during use. These sources may cause exposures to be
overestimated.
Where data were not available, the modeling approaches used to estimate air concentrations also
have uncertainties. Parameter values used in models did not all have distributions known to
represent the modeled scenario. It is also uncertain whether the model equations generate results
that represent actual workplace air concentrations. It is unknown whether these uncertainties
overestimate or underestimate exposures. Additional model-specific uncertainties are included
below.
Averaging Times. EPA cannot determine how accurately the assumptions of exposure
frequencies (days/yr exposed) and exposed working years may represent actual exposure
frequencies and exposed working years. For example, tenure is used to represent exposed
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working years, but many workers may not be exposed during their entire tenure. It is unknown
whether these uncertainties overestimate or underestimate exposures, although the high-end
values may result in overestimates when used in combination with high-end values of other
parameters.
Consumer Exposure
EPA's approach recognizes the need to include uncertainty analysis. An important distinction for
such an analysis concerns variability versus sensitivity - both aspects need to be addressed.
Variability refers to the inherent heterogeneity or diversity of data in an assessment19 It is "a
quantitative description of the range or spread of a set of values"20 and is often expressed through
statistical metrics, such as variance or standard deviation, that reflect the underlying variability
of the data. Sensitivity refers to an analysis of the predictability of a response variable, whereby a
change in a given parameter or assumption affects a response variable. For a full discussion of
the sensitivity analysis please refer to the Supplemental Information on Consumer Exposure
Assessment, Section 2.1. Uncertainty refers to a lack of data or an incomplete understanding of
the context of the risk assessment decision.
Variability cannot be reduced, but it can be better characterized. Uncertainty can be reduced by
collecting more or better data. Quantitative methods to address uncertainty include non-
probabilistic approaches such as sensitivity analysis and probabilistic methods such as Monte
Carlo analysis. Uncertainty can also be addressed qualitatively, by including a discussion of
factors such as data gaps and subjective decisions or instances where professional judgment was
used.
With these approaches, the output of the model is fully determined by the choices of parameter
values and initial conditions. Stochastic approaches feature inherent randomness, such that a
given set of parameter values and initial conditions can lead to an ensemble of different model
outputs. Because EPA's largely deterministic approach involves choices regarding low, medium,
and high values for highly influential factors such as chemical mass and frequency/duration of
product use, it likely captures the range of potential exposure levels although it does not
necessarily enable characterization of the full probabilistic distribution of all possible outcomes.
Certain inputs to which model outputs are sensitive, such as zone volumes and airflow rates,
were not varied across product-use scenarios. As a result, model outcomes for extreme
circumstances such as a relatively large chemical mass in a relatively low-volume environment
likely are not represented among the model outcomes. Such extreme outcomes are believed to lie
near the upper end (e.g., at or above the 90th percentile) of the exposure distribution.
Human Health Hazards
Effects resulting from acute exposure. There is uncertainty in converting the POD value from
1.5 hrs to PODs appropriate for the 15-min, 1-hr and 8-hr exposure durations used in the risk
evaluation. EPA used a default approach (Ten Berge et at.. 1986). which is a modification of
19 https://www.epa. gov/expobox/uncertaintv-and-variabilitv
20 https://www.epa.gov/expobi3x/exposnre-6ictors-haiidbook-chapter-2
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Haber's rule, to convert the POD to other exposure durations. Although there are acute PBPK
models, there were little differences between the ten Berge and acute PBPK approaches.
The adverse effect used in this risk evaluation was related to changes in a complex task as
measured by Putz et al. (1979). which might not be identified in a study that measured simple
reaction tasks. However, EPA applied a smaller UF for LOAEL to NOAEL (3 vs. 10) when
setting the benchmark MOE based on the severity of changes identified by Putz et al. (1979).
EPA determined that it is important to consider less severe effects rather than quantifying only
more severe effects, in part, due to the possibility of serious harm and death as concentrations
and exposure durations increase.
Liver (non-cancer) effects from chronic exposure. Liver effects were chosen for evaluation of
chronic effects because they are a sensitive endpoint for methylene chloride after chronic
exposure. However, there is uncertainty regarding whether CNS effects, may be as sensitive.
Limited data preclude using this endpoint for chronic effects.
Cancer. Epidemiology studies are inconclusive for the lung and liver tumors modeled in the
current assessment. Also, there are some mixed results in genotoxicity studies including negative
results at certain concentrations. EPA did, however, address uncertainties in the enzyme
considered to be associated with genotoxicity by using a PBPK model to account for differences
between species and among humans.
There is uncertainty in the type of tumors modeled. First, epidemiological studies appear to be
more consistent for the association between methylene chloride and hematopoietic-related
cancers. Humans do have increased frequencies of micronuclei and DNA damage in peripheral
blood lymphocytes.
Second, animal studies consistently identify methylene chloride exposure as associated with
mammary tumors, and the IURs for mammary tumors are of greater magnitude than the
combined liver and lung tumor IURs. However, very few tumors from the animal studies are
malignant. In addition, a small fraction 0.1% of fibroadenomas lead to carcinomas (Russo.
2015). Thus, EPA chose not to use the animal mammary tumor data in this risk evaluation.
Exposures to methylene chloride were evaluated by inhalation and dermal routes separately.
Inhalation and dermal exposures are assumed to occur simultaneously for workers and
consumers. EPA chose not to employ simply additivity of exposure pathways at this time within
a condition of use because of the uncertainties present in the current exposure estimation
procedures and this may lead to an underestimate of exposure.
4.4 Potentially Exposed or Susceptible Subpopulations
TSCA requires that the determination of whether a chemical substance presents an unreasonable
risk include consideration of unreasonable risk to "a potentially exposed or susceptible
subpopulation identified as relevant to the risk evaluation" by EPA. TSCA § 3(12) states that
"the term 'potentially exposed or susceptible subpopulation' means a group of individuals within
the general population identified by the Administrator who, due to either greater susceptibility or
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greater exposure, may be at greater risk than the general population of adverse health effects
from exposure to a chemical substance or mixture, such as infants, children, pregnant women,
workers, or the elderly."
EPA identified groups of individuals with greater exposure as workers in occupational scenarios
and in consumer exposure scenarios considered multiple age groups. EPA examined worker
exposures in this risk evaluation for several occupational scenarios (see Section 2.4.1 for these
exposure scenarios).
For the evaluation of consumer exposures, inhalation and dermal exposures of various age
groups were incorporated into the modeling framework. As described in Section 2.4.2.3.2,
dermal exposure results are presented for users of three possible age groups: adults and two
youth age groups (16-20 years and 11-15 years). Inhalation exposures are presented as
concentrations encountered for users and non-user bystander populations and are independent of
age group. In developing the hazard assessment, EPA evaluated available data to ascertain
whether some human subpopulations may have greater susceptibility than the general population
to the chemical's hazard(s). Consideration of possible PESS, including age group specific
evaluation of modeled inhalation exposures are incorporated within the risk characterization
section 4.2 and discussed below.
EPA identified certain human subpopulations may be more susceptible to exposure to methylene
chloride than others. Variability of susceptibility to methylene chloride may be correlated with
genetic polymorphism in its metabolizing enzymes. Genetic polymorphisms have been identified
for both GSTT1 and CYP2E1 (Parte and Crosti. 1999). In the U.S. population, the calculated
U.S. average distributions of GSTT1 are 32% +/+, 48% +/-, and 20% -/- (Haber et ai. 2002). as
cited in U.S. EPA (2011). Higher COHb levels are observed in the GSTT1 -/- individuals
(Nac/Aeet. 2.008). In contrast, the GSTT1 +/+ individuals are expected to be more susceptible to
cancer endpoints (Section 3.2.4.2).
Factors other than polymorphisms that regulate CYP2E1 may have greater influence on the
formation of COHb, a metabolic product of methylene chloride exposure. The CYP2E1 enzyme
is easily inducible by many substances, resulting in increased metabolism. For example, alcohol
drinkers would have increased CO and COHb (Nac/Aegt. 2008). Simultaneous exposure with
these other substances, however, can also decrease the metabolic rate based on competitive
inhibition. Any net effect of increased CO and COHb formation is not easily understood because
increased CO/COHb leads to decreased methylene chloride levels in tissues (Nac/Aeel. 2008).
and both methylene chloride and COHb are expected to result in the acute effects observed.
The COHb generated from methylene chloride is expected to be additive to COHb from other
sources. Populations of particular concern are smokers who maintain significant constant levels
of COHb and persons with existing cardiovascular disease (ATSDR. 2000).
Individuals with cardiac disease are a potentially susceptible subpopulation. During exercise,
cardiac patients have experienced angina more quickly after CO exposure, which is associated
with increased COHb levels (Nac/Aeal 2008). EPA considers that increased COHb levels
resulting from methylene chloride exposure may also result in similar adverse effects in
individuals with cardiac disease.
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Fetuses, infants and toddlers are also potentially susceptible to methylene chloride exposure.
Hemoglobin in the fetus has a higher affinity for CO than does adult hemoglobin. Thus, the
neurotoxic and cardiovascular effects may be exacerbated in fetuses and in infants with higher
residual levels of fetal hemoglobin when exposed to high concentrations of methylene chloride
(PERHA, 2008b). Alexeeff and Kilgore (1983) identified an age-related difference in nervous
system responses among mice as well. In a passive-avoidance conditioning task, the percentage
of three-week old mice recalling the task was statistically significantly lower than controls at day
3, whereas 5- and 8-week old mice did not show significant differences from controls.
To account for variation in sensitivity within human populations intraspecies UFs were applied
for non-cancer effects. The UF values selected are described in section 3.2.5.2.
4.5 Aggregate and Sentinel Exposures
Section 2605(b)(4)(F)(ii) of TSCA requires the EPA, as a part of the risk evaluation, to describe
whether aggregate or sentinel exposures under the conditions of use were considered and the
basis for their consideration. The EPA has defined aggregate exposure as "the combined
exposures to an individual from a single chemical substance across multiple routes and across
multiple pathways (40 CFR § 702.33)." In this risk evaluation aggregate exposure was evaluated
first by determining both the exposure to methylene inhalation and dermal contact separately.
Time profiles of each type of exposure were estimated for a variety of occupational categories
and household consumer uses, behaviors, and activity profiles. Inhalation exposure is specified
by the air concentration encountered as a function of time during the work-day or for 24 hr from
the start of a household application. Dermal contact is characterized by the weight fraction of
methylene chloride in the product being used, the surface area of skin (hands) exposed, and the
duration of the dermal exposure. For workplace exposures inhalation and dermal exposures are
assumed to occur simultaneous i.e. both occur at the start of the task and continue through the
end of the task, shift, or work day. For household exposures inhalation and dermal exposures
occur at the start of the task and continue through the end of the task. EPA Consumer inhalation
exposures typically continue for some time after the task is complete, although at a lower
concentration, while the individual remains in the rest of house. The available PBPK models lack
a dermal compartment and therefore a PBPK model for aggregating inhalation and dermal
exposures is not reasonably available. Aggregating inhalation and dermal exposures without the
use of a PBPK model would introduce additional uncertainties and was not included here. EPA
chose not to employ simply additivity of exposure pathways at this time within a condition of use
because of the uncertainties present in the current exposure estimation procedures. This lack of
aggregation may lead to an underestimate of exposure, but based on physical chemical properties
the majority of the exposure pathway is believed to be from inhalation exposures.
The EPA defines sentinel exposure as "the exposure to a single chemical substance that
represents the plausible upper bound of exposure relative to all other exposures within a broad
category of similar or related exposures (40 CFR § 702.33)." In terms of this risk evaluation, the
EPA considered sentinel exposure the highest exposure given the details of the conditions of use
and the potential exposure scenarios. Sentinel exposures for workers are the high-end no gloves
scenario within each OES.
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4.6 Risk Conclusions
4.6.1 Summary of Environmental Risk
Risks to aquatic organisms were identified near four recycling and disposal facilities and one
WWTP. Facilities presenting risk to aquatic organisms (facilities with an acute RQ > 1, or a
chronic RQ > 1 and 20 days or more of exceedance for the chronic COC) are presented in Table
4-103. No risks were identified for facilities in other conditions of use including manufacturing,
import and repackaging, processing as a reactant, processing and formulation, use in
polyurethane foam, use in plastics manufacturing, use in pharmaceuticals, CTA film
manufacturing, lithographic printer cleaning, spot cleaning, "other" unspecified conditions of
use, and Department of Defense.
No acute or chronic risks to aquatic organisms were identified in ambient water; therefore, the
risks identified for the five facilities mentioned above are likely localized to surface water near
the facility.
Recycling and Disposal
Four out of 16 recycling and disposal facilities had releases of methylene chloride to surface
water that indicate risk to aquatic organisms. Veolia es Technical Solutions, which transfers
methylene chloride to Clean Harbors Baltimore, had an indirect release to surface water
indicating acute risk with an acute RQ of 6.46. Veolia es Technical Solutions also had chronic
risks for multiple taxonomic groups, with a chronic RQ for amphibians of 188.89 with 250 days
of exceedance, for fish of 112.58 with 250 days of exceedance, and for aquatic invertebrates of
9.44 with 196 days of exceedance, respectively. Johnson Matthey West Deptford and Clean
Harbors Deer Park both had indirect releases to Clean Harbors Baltimore with chronic RQs for
amphibians of 1.53 with 64 days of exceedance and 1.29 with 52 days of exceedance,
respectively. Clean Water of New York Inc Staten Island, which may be releasing methylene
chloride into an estuarian environment, had chronic RQs for amphibians of 3.92 and for fish of
2.34, both with 20 days of exceedance.
Waste Water Treatment Plants (WWTP)
One out of 29 WWTPs had a release of methylene chloride to surface water that indicated risk to
aquatic organisms. Long Beach WPCP Long Beach had a direct release to an estuarian
environment that indicated chronic risk for fish and amphibians, with RQs of 2 and 3.35, both
with 365 days of exceedance.
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9558 Table 4-103. Modeled Facilities Showing Acute and/or Chronic Risk from the Release of Methylene Chloride; RQ Greater Than One
9559 are Shown in Bold
N;i mo.
l ocution, and
II) ul' Ae(i\e
Releaser
l-acililv1
Release
Media1'
Modeled l acilil>
or Indusln
Sector in I-'.-
i-vs r
I'.-l-AST
\\ alerhod>
Tj pe'1
Annual
Release
Dajsof
release"'
l)ail\
Release
(k&'daj/
¦'Qui
S\\(
tppbf
cot 1 > pe
COC (pph)
l)a\s of
H\ceedance
(da\ s/\ i\)h
RQ
OES: Recycling and Disposal
JOHNSON
Receiving
Facility: Clean
Harbors of
Baltimore, Inc;
POTW (Ind.)
Chronic
Amphib.
90
64
1.53
MATTHEY
WEST
Non-
POTW
WWT
Surface
620
250
2
137.42
Chronic
Fish
151
33
0.91
DEPTFORD, NJ
NPDES:
water
Chronic
Invert.
1,800
0
0.08
NJO115843
Acute
Amphib.
2,630
N/A
0.05
CLEAN
HARBORS
DEER PARK
LLC LA
PORTE, TX
NPDES:
TX0005941
Receiving
Facility: Clean
Harbors of
Baltimore, Inc;
POTW (Ind.)
Chronic
Amphib
90
52
1.29
Non-
POTW
WWT
Surface
522
250
2
115.81
Chronic
Fish
151
26
0.77
water
Chronic
Invert.
1,800
0
0.06
Acute
Amphib.
2,630
N/A
0.04
Receiving
Facility:
Chronic
Amphib.
90
0
5.36E-
05
VEOLIA ES
TECHNICAL
SOLUTIONS
LLC
MIDDLESEX,
NJ NPDES:
NJO127477
MIDDLESEX
COUNTY
Still body
4.40
250
0.018
0.00482
Chronic
Fish
151
0
3.19E-
05
Non-
POTW
WWT
UTILITIES
AUTHORITY;
Chronic
Invert.
1,800
0
2.68E-
06
NPDES:
NJ0020141
Acute
Amphib.
2,630
N/A
1.83E-
06
Receiving
Chronic
Amphib.
90
250
188.89
Facility: Clean
Harbors; POTW
Surface
water
76,451
250
306
17000
Chronic
Fish
151
250
112.58
(Ind.)
Chronic
Invert.
1,800
196
9.44
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N;i 1110.
l ocution, iiiul
II) ul' Ac(i\c
Uok'iisor
l-iicililv'
Release
Media1'
Modeled l ;icili(>
or Indiisin
Seelor in 1-'.-
1-'AST*'
r.-i as i
\\ ;ik'rbod\
Tj pe'1
Anniiiil
Release
(kji)
Dsijs of
release''
l)ail\
Release
(k^/da>)'
¦'Qui
S\\(
(|)|)h)-
COC l> |»0
( ()( (|)|>l>)
l)il\S of
llxm'diinco
(d;i\sA r)h
RQ
Acute
Amphib.
2,630
N/A
6.46
Receiving
Facility: ROSS
INCINERATION
SERVICES INC;
POTW (Ind.)
NA
NA
NA
NA
NA
Chronic
Amphib.
-
-
-
Chronic
Fish
-
-
-
Chronic
Invert.
-
-
-
Acute
Amphib.
-
-
-
Receiving
Facility:
SAFETY-
KLEEN
SYSTEMS INC;
POTW (Ind.)
NA
NA
NA
NA
NA
Chronic
Amphib.
-
-
-
Chronic
Fish
-
-
-
Chronic
Invert.
-
-
-
Acute
Amphib
-
-
-
CLEAN
WATER OF
NEW YORK
INC STATEN
ISLAND, NY
NPDES:
NY0200484
Surface
Water
Active Releaser
(Surrogate):
NPDES
NJ0000019
Still body
2
250
0.01
27.94
Chronic
Amphib
90
250
0.31
Chronic
Fish
151
0
0.19
Chronic
Invert.
1,800
0
0.02
Acute
Amphib
2,630
N/A
0.01
20
0.12
352.94
Chronic
Amphib
90
20
3.92
Chronic
Fish
151
20
2.34
Chronic
Invert.
1800
0
0.20
Acute
Amphib
2,630
N/A
0.13
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N;i mo.
l ocution, iiiul
II) ul' Ac(i\c
Uok'iisor
l-'iicililv'
Kcloiisc
Moiliii1'
Modeled l ;icili(>
or Indiisin
Sector in ti-
l-AST
t:-i-as i
\\ od>
Tj pc'1
Anniiiil
Rclc;isc
diji)
Dsijs of
release''
l);iil\
Release
(kii/d;i\)'
¦'Qui
S\\(
(ppl))-
COC Tjpe
( ()( (ppl>)
I);i\s of
tl\cccdancc
(da\s/\ r)1'
RQ
OES: WWTP
LONG BEACH
(C) WPCP
LONG BEACH,
NYNPDES:
NY0020567
Surface
Water
Active Releaser:
NPDES
NY0020567
Still water
2,730
365
7
301.46
Chronic
Amphib.
90
365
3.35
Chronic
Fish
151
365
2.00
Chronic
Invert.
1,800
0
0.17
Acute
Amphib
2,630
N/A
0.11
20
136.49
5878.12
Chronic
Amphib
-
-
-
Chronic
Fish
-
-
-
Chronic
Invert.
-
-
-
Acute
Amphib.
-
-
-
i. Facilities actively releasing methylene chloride were identified via DMR and TRI databases for the 2016 reporting year.
j. Release media are either direct (release from active facility directly to surface water) or indirect (transfer of wastewater from active facility to a receiving POTW or non-
POTW WWTP facility). A wastewater treatment removal rate of 57% is applied to all indirect releases, as well as direct releases from WWTPs.
k. If a valid NPDES of the direct or indirect releaser was not available in EFAST, the release was modeled using either a surrogate representative facility in EFAST (based on
location) or a representative generic industry sector. The name of the indirect releaser is provided, as reported in TRI.
1. EFAST uses ether the "surface water" model, for rivers and streams, or the "still water" model, for lakes, bays, and oceans.
m. Modeling was conducted with the maximum days of release per year expected. For direct releasing facilities, a minimum of 20 days was also modeled,
n. The daily release amount was calculated from the reported annual release amount divided by the number of release days per year,
o. For releases discharging to lakes, bays, estuaries, and oceans, the acute scenario mixing zone water concentration was reported in place of the 7Q10 SWC.
p. To determine the PDM days of exceedance for still bodies of water, the estimated number of release days should become the days of exceedance only if the predicted
surface water concentration exceeds the COC. Otherwise, the days of exceedance can be assumed to be zero.
9560
Page 392 of 725
-------
9561
9562
9563
9564
9565
9566
9567
9568
9569
9570
9571
9572
9573
9574
9575
9576
9577
9578
9579
9580
9581
9582
9583
9584
9585
9586
9587
9588
9589
9590
9591
9592
9593
9594
9595
9596
9597
9598
9599
9600
9601
9602
9603
9604
9605
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
4.6.2 Summary of Risk Estimates for Inhalation and Dermal Exposures to
Workers
Table 4-104 summarizes the risk estimates for inhalation and dermal exposures for all
occupational exposure scenarios. Risk estimates that exceed the benchmark (i.e. MOEs less than
the benchmark MOE or cancer risks greater than the cancer risk benchmark) are highlighted by
bolding the number and shading the cell. U.S. EPA shaded the cells for risk estimates that are not
calculated i.e. short-term exposures estimates for chronic endpoints and that are not assessed i.e.
PPE use for ONUs. The risk characterization is described in more detail in sections 2.4.1 and
4.2.2 and specific links to the exposure and risk characterization sections are listed in Table
4-104 in the column headed Occupational Exposure Scenario.
For acute and chronic exposures via inhalation without PPE (i.e. no respirators) there are risks
for workers relative to the benchmarks for all the COUs. When respirators are worn (either APF
25 or 50) there are risks relative to the benchmarks for non-cancer effects from both acute and
chronic exposure durations (i.e. CNS effects and liver effects) but not for cancer for the two life
cycle stages with many subcategories:
• Processing - incorporation into formulation, mixture, or reaction product and all other chemical
product and preparation manufacturing which includes:
• Solvents (for cleaning or degreasing), including manufacturing of:
All other basic organic chemical
Soap, cleaning compound and toilet preparation
• Solvents (which become part of product formulation or mixture), including manufacturing of:
All other chemical product and preparation
Paints and coatings
• Propellants and blowing agents for all other chemical product and preparation manufacturing
• Propellants and blowing agents for plastics product manufacturing
• Paint additives and coating additives not described by other codes
• Laboratory chemicals for all other chemical product and preparation manufacturing
• Laboratory chemicals
• Processing aid, not otherwise listed for petrochemical manufacturing
• Adhesive and sealant chemicals in adhesive manufacturing
• Oil and gas drilling, extraction, and support activities
• Industrial and commercial uses:
• Solvents (for cleaning or degreasing) including:
o Batch vapor degreaser (e.g., open-top, closed-loop)
o In-line vapor degreaser (e.g., conveyorized, web cleaner)
o Cold cleaner
• Adhesives and sealants
• Paints and coatings including commercial paint and coating removers
o Paint and Coating Removers
o Adhesive/caulk removers
• Metal products not covered elsewhere
• Automotive care products
• Lubricants and greases
Page 393 of 725
-------
9606
9607
9608
9609
9610
9611
9612
9613
9614
9615
9616
9617
9618
9619
9620
9621
9622
9623
9624
9625
9626
9627
9628
9629
9630
9631
9632
9633
9634
9635
9636
9637
9638
9639
9640
9641
9642
9643
9644
9645
9646
9647
9648
9649
9650
9651
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
• Degreasers - aerosol and non-aerosol degreasers and cleaners
• Solvents (which become part of product formulation or mixture)
• Processing aid not otherwise listed in multiple manufacturing sectors
• Propellants and blowing agents
• Other Uses:
o Electrical equipment, appliance, and component manufacturing
o Plastic and rubber products
o Oil and gas drilling, extraction, and support activities
o Functional fluids (closed systems) in
o Pharmaceutical and medicine manufacturing
o Toys, playground, and sporting equipment - including novelty articles (toys, gifts,
etc.)
o Wood floor cleaner
When respirators are worn (either APF 25 or 50) there are not risks relative to the benchmarks
for non-cancer effects from both acute and chronic exposure durations (i.e. CNS effects and liver
effects) but not for cancer for the following life cycle stages:
• Manufacturing / Domestic manufacturing
• Manufacturing / Import
• Processing / Processing as a reactant
• Processing/ Repackaging
• Processing/ Recycling
• Distribution in commerce
• Industrial and commercial uses
o Aerosol spray degreaser/cleaner
o Paints and coatings use
o Fabric, textile and leather products not covered elsewhere
o Interior car care - spot remover
o Degreasers: gasket remover, transmission cleaners, carburetor cleaner, brake
quieter/cleaner
o Apparel and footwear care products for Post-market waxes and polishes applied to
footwear (e.g., shoe polish)
o Laundry and dishwashing products for Spot remover for apparel and textiles
o Building/ construction materials not covered elsewhere for cold pipe insulation
o Other Uses
¦ Laboratory chemicals - all other chemical product and preparation manufacturing
¦ Anti-adhesive agent - anti-spatter welding aerosol
¦ Carbon remover, lithographic printing cleaner, brush cleaner
• Disposal
For acute and chronic exposures via dermal contact without PPE (i.e. no gloves) there are risks
for workers (ONUs are assumed to not have direct dermal contact with methylene chloride)
relative to the benchmarks for all the COUs. When gloves are worn (either PF 10 or 20) there
either are not risks relative to the benchmarks for non-cancer effects from both acute and chronic
exposure durations (i.e. CNS effects and liver effects) and cancer or the risks are very nearly at
the benchmarks (i.e. MOE of 9 for benchmark MOE of 10) for all of the COUs.
Page 394 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table 4-104 Summary of Risk Estimates for Inhalation and Dermal Exposures to Workers by Condition of Use
Risk 1 !siimales lor \o 1*1*1!
Risk 1 !siimales u nli 1*1*1!
\cute
Chrome
\cuie
( limine
l.ilc ( >ele
Si;i>ze ( ;ileuni'\
Subcategory
()ccupatioual
1 Aposure Scenario
Population
1 Aposure
Route and
1 )ui'aliou
1 Aposure
I.CNCl
Non-
cancer
i he uc li-
ma rk
\ou-
caucer
i he lie li-
ma rk
(a uce r
(bench-
mark
in )
Noil-
cancer
(bench-
mark
\ou-
caucer
(bench-
mark
Cancer
(bench-
mark
in )
\1( )l:
\1( )l:
\1()L
\I()L
'Hi
Id)
'<>)
Hi)
Manufacturing
Manufacturing
Section 2 4 12 1 and
Central
7y5
2u7
2.UUE-U7
l'JS"S
51(4
1 X'l :-()'>
Domestic
4.2.2.1.1 -
Worker
Inhalation
Tendency
(APF 25)
(APF 25)
(APF 25)
manufacturing
Manufacturing
Exposure
8-hr TWA
High-
End
63
l(.
; 2(>L-iK>
1575
(APF 25)
409
(APF 25)
2.97E-08
(APF 25)
Worker
lhalation
5-min
'WA*
Central
Tendency
IS2
\ (
\ (
454S
( \l*l 25)
\ (
\ (
High-
End
\ (
\ (
2 '2
( \l*l 25)
\ (
\ (
Worker
Dermal
High-
End
" 1
1 4
x<.<>i :-u(,
< 1*1
2S
(1*1 2d)
i "4i :-(>«.
( i*i .*>
ONU
Inhalation
Central
Tendency
"<>5
2(1"
2 noi -<)-
\ \
\ \
\ \
8-hr TWA
High-
End
l(>
' 2(.i :-<)(¦
\ \
\ \
\ \
ONU
Inhalation
15-min
TWA*
Central
Tendency
IS2
\ (
\ (
\ \
\ \
\ \
Manufacturing/
Import
Import
Section 2.4.1.2.4 and
4.2.2.1.4 -
Worker
Inhalation
Central
Tendency
33
X.54
4S4L-U(,
822
(APF 25)
213
(APF 25)
-
Repackaging
8-hr TWA
High-
End
2 1
(i 55
"4L-U5
53
(APF 25)
14
(APF 25)
-
Vorker
Inhalation
1-hr
TWA*
Central
Tendency
4 "
\ (
\ (
118
(APF 25)
\ (
\ (
High-
End
2 (¦
\ (
\ (
64
(APF 25)
\ (
\ (
Worker
Dermal
High-
End
"1
1.4
xi.'ji :-u(,
356
(PF5)
28
(PF 20)
1.74E-06
(PF 5)
Page 395 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Risk 1 !siiinales lor \o 1*1*1
Risk 1 !siiniales w illi 1*1*1
Life (>ele
Seme ( aleuors
Siihealeuor\
()eeiipalioiial
1 \poMire Scenario
Kipulalion
1 \posiire
konle and
1 )iii;iIiom
1 Aposiire
l.e\el
\enie
\oii-
c: nicer
i he nc li-
ma rk
\I()L
'i)i
( limine
\oii-
c; nicer
i he lie li-
ma rk
\1( )l:
10)
( aileer
(heneli-
n i; ilk
Id i
\enie
\oii-
eaneer
(heneli-
mnrk
\1( )l:
30)
('limine
Noii-
eaneer
(heiicli-
m;irk
\k )i:
10)
Cancer
i he lie li-
ma rk
l<> i
ONU
Inhalation
Ceiiual
Tendency
y y
X 54
4 X4I :-()(>
N/A
\ \
\ \
8-hr TWA
High-
End
: i
u 55
"41: -() 5
N/A
\ \
\ \
ONU
Inhalation
1-hr
TWA*
Central
Tendency
4 "
\ (
\ (
N/A
\ \
\ \
Processing/
Processing as a
reactant
Intermediate in industrial gas
manufacturing (e.g., manufacture of
fluorinated gases used as refrigerants)
Section 2.4.1.2.2 and
4.2.2.1.2 - Processing
as a Reactant
Worker
Inhalation
8-hr TWA
Central
Tendency
178
46
8.95E-07
4441
(APF 25)
1154
(APF 25)
-
High-
End
2X
7.2
" .(.I:-()(.
698
(APF 25)
181
( \l*i :5i
-
Worker
Inhalation
15-min
TWA*
Point
Estimate
4.')
\ (
\ (
122
(APF 25)
\ (
\ (
Intermediate for pesticide, fertilizer, and
other agricultural chemical
Worker
Dermal
High-
End
"1
1.4
x (.')i :-()(>
356
< 1*1
28
< 1*1 :ui
1.74E-06
< 1*1
manufacturing
ONU
Inhalation
Central
Tendency
rx
4<>
x ')5i:-u-
N/A
\ \
\ \
8-hr TWA
High-
End
:x
":
- .(.I:-()(.
N/A
\ \
\ \
Petrochemical manufacturing
ONU
Inhalation
15-min
TWA*
Point
Estimate
4 <>
\ (
\ (
N/A
\ \
\ \
Processing/
Incorporated
Solvents (for cleaning or degreasing),
including manufacturing of:
Section 2.4.1.2.3 and
4.2.2.1.3 - Processing
Worker
Inhalation
Central
Tendency
1 (.1
0 4:
X'R-05
81
( \ 1 * 1" 5()i
20.9
( \ 1 * 1" 5()i
3.95E-06
( \I*F 25)
into formulation,
mixture, or
• All other basic organic chemical
• Soap, cleaning compound and toilet
- Incorporation into
Formulation, Mixture,
8-hr TWA
High-
End
0 1'
ii I)'4
15"i ¦:-()'
6.5
( \l*l 50)
1 "
( \ 1 * 1" 5()i
(. :i®-05
( \I*F 25)
reaction product
preparation
or Reaction Product
Worker
Inhalation
15-min
TWA*
Point
Estimate
') 4X
\ (
\ (
237
( \l*l 25)
\ (
N'/C
Worker
Dermal
High-
End
"1
1.4
x (.')i:-()(.
356
< 1*1 -s)
:x
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Life C\clc
Seme Caleuors
Siihealeuiii\
()ccnpalional
1 ApoMiie Scenario
I'opnlalioii
1 \poMirc
konle and
1 )iiralioii
1 Aposiire
l.e\el
Risk 1 !siiinales lor \o 1*1*1
Risk 1 !siiniales w illi 1*1*1
\cnie
Noil-
cancer
i he nc li-
ma rk
\I()L
'i)i
( limine
\on-
cancer
i he nc li-
ma rk
\1( )l:
10)
(a nee r
(heiicli-
n i; ilk
Id i
\cnie
\on-
cancer
(hencli-
mark
\1( )l:
30)
( limine
Noil-
cancer
(bench-
mark
\1( )l:
10)
Cancel"
i he nc li-
ma rk
In i
Sol\ enis (\\ Inch become pari of product
formulation or mixture), including
manufacturing of:
• All other chemical product and
preparation
• Paints and coatings
Propellants and blowing agents for all
other chemical product and preparation
manufacturing
Propellants and blowing agents for
plastics product manufacturing
Paint additives and coating additives not
described by other codes
Laboratory chemicals for all other
chemical product and preparation
manufacturing
Laboratory chemicals
Processing aid, not otherwise listed for
petrochemical manufacturing
Adhesive and sealant chemicals in
adhesive manufacturing
Oil and gas drilling, extraction, and
support activities
ONU
Inhalation
8-hr TWA
Ceiiiral
Tendency
1.61
0 4:
') S~l:-()5
N/A
\ \
\ \
High-
End
u 1 '
ii I)'4
1 5"L:-i)'
N/A
\ \
\ \
ONU
Inhalation
15-min
TWA*
Point
Estimate
') 48
\ (
\ (
N/A
\ \
\ \
See the rows above for risk estimates
Processing/
Repackaging
Solvents (which become part of product
formulation or mixture) for all other
chemical product and preparation
manufacturing
Section 2.4.1.2.4 and
4.2.2.1.4 -
Repackaging
Worker
Inhalation
8-hr TWA
Central
Tendency
y y
8.54
4 841:-()(,
822
(APF 25)
213
(APF 25)
-
High-
End
: i
() 55
~4i: -() 5
53
(APF 25)
14
(APF 25)
-
Worker
Inhalation
1-hr
TWA*
Central
Tendency
4 "
\ (
\ (
118
(APF 25)
\ (
\ (
High-
End
: (.
\ (
\ (
64
(APF 25)
\ (
\ (
Page 397 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Risk 1 !siiinales lor \o 1*1*1
Risk 1 !siiniales w illi 1*1*1
Life ( \cle
Seme (aleuors
Suhcalcuor\
()ccupalioiial
1 \poMire Scenario
l*opulalioii
1 Aposlll'C
koule and
1 )uralioii
1 Aposure
I.CNCl
\cule
Noil-
cancer
i he nc li-
ma rk
\I()L
'i)i
( limine
\oii-
cancer
i he nc li-
ma rk
\1( )l:
10)
(a nee r
(bench-
mark
in i
\cuie
\oii-
cancer
(hencli-
n i; ilk
\I()L
'Oi
( lironic
Noii-
cancer
(bench-
mark
\I()L
10)
Cancer
(he nc li-
ma rk
l<> i
All oilier chemical product and
preparation manufacturing
Worker
Dermal
High-
End
" 1
1 4
8 (.')| :-<)(.
'5(>
< 1*1
28
(1*1 2()i
1 "41 :-()(¦
(1*1 ¦*)
ONU
Inhalation
Central
Tendency
33
8 54
4 841:-()(,
\ \
\ \
\ \
8-hr TWA
High-
End
: i
() 55
~4i: -() 5
\ \
\ \
\ \
ONU
Inhalation
1-hr
TWA*
Central
Tendency
4 "
\ (
\ (
\ \
\ \
\ \
Processing/
Recycling
Recycling
Section 2.4.1.2.5 and
4.2.2.1.5 - Waste
Worker
Inhalation
Central
Tendency
15 "u
4.08
1 nil -0 5
vr,
( \l*l 251
102
( \l*l 25)
Handling, Disposal,
Treatment, and
8-hr TWA
High-
End
15 11
1 '(>1 :-()5
'"8
( \l*l 251
l)S
( \l*l 25)
Recycling
Worker
Dermal
High-
End
"1
1.4
8 (.')i:-()(.
'5(>
< 1*1
28
(1*1 2()i
i "4i :-o(.
( i*i -si
ONU
Inhalation
Central
Tendency
15. "D
4 US
1 nil -0 5
\ \
\ \
\ \
8-hr TWA
High-
End
15 11
1 '(>1: -n 5
\ \
\ \
\ \
Distribution in
commerce
Distribution
Section 2.4.1.2.4 and
4.2.2.1.4 -
Worker
Inhalation
Central
Tendency
-> ¦*>
•) •)
8 54
4 841:-()(,
822
( \l*l 25)
21'
( \l*l 25)
Repackaging
8-hr TWA
High-
End
: i
u 55
"41: -n 5
53
( \l*l 25)
14
( \l*l 25)
Worker
Inhalation
1-hr
TWA*
Central
Tendency
4 "
\ (
\ (
1 18
( \l*l 25)
\ (
\ (
High-
End
: (.
\ (
\ (
(4
( \l*l 25)
\ (
\ (
Worker
Dermal
High-
End
"i
1.4
8(.')i:-o(>
'5(>
< 1*1
28
(1*1 2()i
i "4i :-o(.
( i*i -si
ONU
Inhalation
Central
Tendency
33
8.54
4 841:-()(,
\ \
\ \
\ \
8-hr TWA
High-
End
: i
I) 55
"41: -n 5
\ \
\ \
\ \
Page 398 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Risk 1 Simmies lor \o 1*1*1
Risk 1 !siiniales u illi 1*1*1
\enie
( limine
\enie
( limine
Life (>ele
Seme ( nleuors
()eeiipnlioiial
1 \poMire Scenario
1 \posiire
1 Aposiire
l.e\el
\on-
c: nicer
i he nc li-
ma rk
\oii-
c; nicer
i he lie li-
ma rk
( aileer
\on-
eaneer
(heneli-
mark
\oii-
eaneer
(heneli-
iikiiL
Cancer
SuhealeuoiA
I'opiilalioii
konle and
1 )iii;iIiom
(heneli-
n i; ilk
Id i
i he lie li-
ma rk
|0 |
\I()L
\1( )l:
\I()L
\k )i:
'i)i
10)
'Oi
10)
Inhalation
Central
ONU
1-hr
TWA*
Tendency
4.7
\ (
N/C
\ \
\ \
\ \
Industrial and
commercial use/
Batch vapor degreaser (e.g., open-top,
closed-loop)
Section 2.4.1.2.6 and
4.2.2.1.6 - Batch
Worker
Inhalation
Central
Tendency
i
().(>()
S <>5L-o5
4'
( \ 1 * 1" 25)
15
( \ 1 * 1" 25s)
3.58E-06
(^PF25,1
Solvents (for
cleaning or
Open-Top Vapor
Degreasing
8-hr TWA
High-
End
(1 v;
«). 1
' ,)"L-04
2()
( \l*L50i
(. "
( \ 1 * 1 ¦" 50)
1 5')L-o5
( \ 1 * 1" 251
degreasing)
Worker
Dermal
High-
End
"1
1.4
S(.')L-()(>
'5(.
< 1*1 -s)
2S
(1*1 2oi
1 "4L-0(,
11*1' 5)
ONU
Inhalation
Central
Tendency
' 4
Ll(.
4 (> 11: -<) 5
\ \
\ \
\ \
8-hr TWA
High-
End
u.(4
().::
: 4-i :-D4
\ \
\ \
\ \
In-line vapor degreaser (e.g.,
conveyorized, web cleaner)
Section 2.4.1.2.7 and
4.2.2.1.7 -
Worker
Inhalation
Central
Tendency
().(.()
1)2
: 5,)i:-o4
y> s
( \ 1 * 1 ¦" 5oi
lo ;
( \ 1 * 1" 5oi
1 04L-05
( \ 1 * 1" 251
Conveyorized Vapor
Degreasing
8-hr TWA
High-
End
u 21
mr
"4.'i:-()4
In 4
( \l*l 51)1
- (.
( \ 1 * 1" 5oi
2
DOS
"USL-04
15
( \ 1*1" 50)
- S
( \ 1 * 1 ¦" 50)
2 S'L-o5
( \ 1 * 1" 251
Worker
Dermal
High-
End
"1
1.4
S(.')R-06
356
< 1*1 -s)
28
(1*1 2oi
1.74E-06
< 1*1 -s)
ONU
Inhalation
Central
Tendency
I.D4
u.:-
1 54L-U4
\ \
\ \
\ \
8-hr TWA
High-
End
i).2l)
DOS
"USL-04
\ \
\ \
\ \
Page 399 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Risk 1 !siiinales lor \o 1*1*1
Risk 1 !siiniales w illi 1*1*1
Life (>cle
Seme (nlcuor>
SuhealeuoiA
()cciipnlioiial
1 \posiirc Scenario
I'opnlalioii
1 ApoMII'C
konle and
1 )iiralioii
1 Aposnre
Lc\el
\cule
\oii-
caiicer
(bench-
mark
\1( )l:
'i)i
( limine
\oii-
eaneer
i he lie li-
ma rk
\1( )l:
10)
( aileer
(bench-
mark
in i
\enle
\oii-
eaneer
(heneli-
mark
\I()L
'Oi
('limine
\on-
eaneer
(heiicli-
mark
\1( )l:
10)
Cancer
(he lie li-
ma rk
|o )
Aerosol spra\ deyeas>er. cleaner
Seclion 2.4.1.2.9 and
4.2.2.1.9 -
Worker
Inhalation
Ceniral
Tendency
13
4 5'
1 I5E-05
330
(APF 25)
113
(APF 25)
-
Commercial Aerosol
Products (Aerosol
8-hr TWA
High-
End
3.7
1 '
4 1 "E-05
92
(APF 25)
32
(APF 25)
-
Degreasing, Aerosol
Lubricants,
Worker
Dermal
High-
End
4.<>
o.1)
1 '51: -() 5
46
(1*1 10)
') 0
(1*1 10)
2 "'OF-06
(1*1
Automotive Care
Products)
ONU
Inhalation
Central
Tendency
"25
'1
2 42L-U-
\ \
\ \
\ \
8-hr TWA
High-
End
S<>
24(>
1 "51:-()(,
\ \
\ \
\ \
Industrial and
commercial use/
Single component glues and adhesives
and sealants and caulks
Section 2.4.1.2.10
and 4.2.2.1.10-
Worker
Inhalation
Central
Tendency
"4'
I.1)'
2 141: -() 5
1 S(i
( \l*l 25)
4S
( \l*l 25)
s 5(.i :-o"
( \l*l 25)
Adhesives and
sealants
Adhesives and
Sealants (spray)
8-hr TWA
High-
End
u 52
D.I4
' ,)5L-()4
25 W
( \l*l 50)
(. S
( \ 1 * 1" 50)
1 5SL-05
( \l*l 25)
Worker
Dermal
High-
End
"1
1.4
S (.')| :-()(>
'(.
< 1*1 -s)
2S
(1*1 20)
1 "41 :-()(¦
(1*1
ONU
Inhalation
Central
Tendency
~ 4'
1 «r.
2 141: -() 5
\ \
\ \
\ \
8-hr TWA
High-
End
U52
u 14
' i)5i:-u4
\ \
\ \
\ \
Section 2.4.1.2.10
and 4.2.2.1.10-
Worker
Inhalation
Central
Tendency
2" "
" 2
5 "4i:-()(,
(il>2
( \l*l 25)
ISO
( \l*l 25)
2 'OL-o"
( \l*l 25)
Adhesives and
Sealants (non-spray)
8-hr TWA
High-
End
0
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Risk 1 !siiinales lor \o 1*1*1
Risk 1 !siiniales w illi 1*1*1
Life (>cle
Seme ( nlcuors
Siihcnleuor\
()eciipnlioiial
1 \poMire Scenario
Kipulalion
1 Aposiire
konle and
1 )iii;iIiom
1 Aposiire
l.e\el
\cnie
\oii-
c: nicer
i he nc li-
ma rk
\I()L
'i)i
( limine
\oii-
c; nicer
i he lie li-
ma rk
\1( )l:
10)
( aileer
(bench-
mark
10 )
\enie
\oii-
eaneer
(heneli-
mark
\I()L
'0)
('limine
Noii-
ca i icer
(bench-
mark
\I()L
10)
Cancer
(he lie li-
ma rk
|0 )
Painis and
coatings
lligh-
End
0.80
() 21
2 5SL-04
4o
i \ 1 * 1 ¦" 50)
10 '
( \ 1 * 1" 50)
1 () i|; -() 5
( \l*l" 25)
including
commercial
Paints and coatings use and paints and
coating removers, including furniture
refinisher
Section 2.4.1.2.11
and 4.2.2.1.11 -
Paints and Coatings
Worker
Dermal
High-
End
" 1
1 4
S(.')L-0(>
< 1*1 5)
:s
"
(1*1 10)
2 5 11 :-()(>
(1*1 5)
ONU
Inhalation
Central
Tendency
() :
i)i)5
s ui :-o4
\ \
\ \
\ \
8-hr TWA
High-
End
ii III
mi!
: i il-o;
\ \
\ \
\ \
Industrial and
commercial use/
Degreasers - aerosol and non-aerosol
degreasers and cleaners (e.g., coil
Section 2.4.1.2.9 and
4.2.2.1.9 -
Worker
Inhalation
Central
Tendency
1 '
4 5'
1 I5E-05
330
(APF 25)
113
(APF 25)
-
Metal products
not covered
cleaners)
Commercial Aerosol
Products (Aerosol
8-hr TWA
High-
End
3.7
1 '
4 1 "E-05
92
(APF 25)
32
(APF 25)
-
elsewhere
Degreasing, Aerosol
Lubricants,
Worker
Dermal
High-
End
4 6
0 ')
1 '5 E-05
46
(1*1 10)
0
(1*1 10)
2.70E-06
(1*1 5)
Automotive Care
Products)
ONU
Inhalation
Central
Tendency
725
31
2.421 :-o"
\ \
\ \
\ \
8-hr TWA
High-
End
89
246
1.75E-0I.
\ \
\ \
\ \
Section 2.4.1.2.13
and 4.2.2.1.13 -
Worker
Inhalation
8-hr TWA
Central
Tendency
5 12
1 V,
3.11E-05
128
(APF 25)
33
(APF 25)
1.24E-06
(APF 25)
Page 401 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Risk 1 !siiiii;iies fin' \o 1*1*1
Risk 1 !siiniales w nli 1*1*1!
\cule
( limine
\cuie
('limine
Life ( \cle
Seme Caleuors
Siihcaleuor\
()cciipalional
1 \posurc Scenario
l*opulalioii
1 Aposlll'C
koule and
1 )uraliou
1 Aposlll'C
Le\cl
\on-
c: nicer
i he lie li-
\on-
eaueer
(he lie li-
Cancel'
(bench-
mark
in i
\on-
caueer
(heucli-
Noil-
cancer
(bench-
Cancer
(he lie li-
ma rk
l<> i
ma i'k
ma ik
mark
mark
\1( )l:
\1( )l:
\I()L
\I()L
'i)i
10)
'Oi
10)
Miscellaneous Non-
lligh-
0.31
(1 (IS
(. 5SL-U4
l(.
4
2 (¦'1:-(15
Aerosol Industrial
End
( \l*l 5()i
( \l*l 50)
( \ 1 * 1" 251
and Commercial Uses
Worker
Dermal
High-
End
4 (>
(i <;n
1 '51: -() 5
4(>
(1*1 Id)
'HI
(1*1 Id)
2 "o| :-()(¦
(1*1 -s)
ONU
Inhalation
Central
Tendency
5 12
1 v.
' 1 11: -()5
\ \
\ \
\ \
8-hr TWA
High-
End
u '1
DOS
(. 5SL-D4
\ \
\ \
\ \
Industrial and
commercial use/
Textile finishing and
impregnating/surface treatment products
Section 2.4.1.2.14
and 4.2.2.1.14-
Worker
Inhalation
Central
Tendency
' U
1) S"
4 ~(>l:-()5
S'
( \l*l 251
22
( \ 1 * 1" 251
i ii:-()(.
( \ 1 * 1 ¦" 251
Fabric, textile
and leather
(e.g., water repellant)
Fabric Finishing
8-hr TWA
High-
End
1 "S
o.4(>
LI(.L-i)4
44
( \l*l 251
12
( \ 1 * 1" 251
4 (.21:-()(.
( \ 1 * 1 ¦" 251
products not
covered
Worker
Dermal
High-
End
4 "
(1 T,
i 'Oi:-()5
4"
(1*1 Id)
'¦> '
(1*1 Hi)
2 oil:-()(.
(1*1 .*)
elsewhere
ONU
Inhalation
Central
Tendency
' U
I) S"
4 ~<>i: -() 5
\ \
\ \
\ \
8-hr TWA
High-
End
1 "S
0 4(>
i u.i:-()4
\ \
\ \
\ \
Industrial and
Function fluids for air conditioners:
Section 2.4.1.2.13
Central
5 i:
1.''
' 111: -() 5
i:s
*> ->
1241:-()(.
commercial use/
refrigerant, treatment, leak sealer
and 4.2.2.1.13 -
Worker
Inhalation
Tendency
( \l*l 25)
( \ 1 * 1" 251
( \ 1 * 1 ¦" 251
Automotive care
Miscellaneous Non-
8-hr TWA
High-
u '1
(MIS
<, 5SI :-(>4
l(.
4
2 <>'i: -() 5
products
Aerosol Industrial
End
( \l*l 5(1)
( \l*l 50)
( \ 1 * 1 ¦" 251
and Commercial Uses
Worker
Dermal
High-
End
4 (>
(1
i '5i:-()5
4<>
(1*1 Id)
'HI
(1*1 Id)
2 "oi:-()(.
(1*1" 5)
ONU
Inhalation
Central
Tendency
51:
1.''
' 111: -(15
\ \
\ \
\ \
8-hr TWA
High-
End
II '1
(IDS
(. 5SL-II4
\ \
\ \
\ \
Interior car care - spot remover
Section 2.4.1.2.9 and
4.2.2.1.9 -
Worker
Inhalation
Central
Tendency
1'
4 5'
1 I5L-05
v,(i
( \l*l 25)
1 1 '
( \ 1 * 1" 251
Commercial Aerosol
Products (Aerosol
8-hr TWA
High-
End
3.7
1. '
4 1 "I -05
')2
UVl*L25j
'2
UVI*L25;
Page 402 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Risk 1 !siiiii;iies fin' \o 1*1*1
Risk 1 !s|iiii;iies u nli 1*1*1\
Life (>ele
Seme (nleuors
()eeiipnlioiinl
1 \posiire Scenario
1 \posiire
1 Aposiire
l.e\el
\enie
\oii-
eniieer
i he lie li-
( limine
\oii-
cancer
(he lie li-
( a i ieer
\eule
\oii-
eaneer
(heneli-
( limine
Noii-
eaueer
(heneli-
Cnneer
Siihenleuor\
l*opiilnlioii
koule and
1 )iii;iIiom
(heneli-
mark
in i
(he lie li-
mn rk
l<> i
ma i'k
\ioi:
'i)i
ma ik
\I()L
10)
mark
\I()L
'Oi
ii in rk
\I()L
10)
Decreasing, Aerosol
Lubricants,
Worker
Dermal
lligh-
End
4 (.
(i')
1 '5L-U5
4(>
(1*1 |ui
v ii
(1*1 lui
2 "ol:-()(.
(1*15)
Automotive Care
Products)
ONU
Inhalation
Central
Tendency
725
31
2.421
\ \
\ \
\ \
8-hr TWA
High-
End
89
246
1.75L-IK.
\ \
\ \
\ \
Degreasers: gasket remover, transmission
cleaners, carburetor cleaner, brake
Section 2.4.1.2.9 and
4.2.2.1.9 -
Worker
Inhalation
Central
Tendency
1 '
4 5'
1.15E-05
330
(APF 25)
113
(APF 25)
-
quieter/cleaner
Commercial Aerosol
Products (Aerosol
8-hr TWA
High-
End
3.7
1.'
4.17E-05
92
(APF 25)
32
(APF 25)
-
Degreasing, Aerosol
Lubricants,
Worker
Dermal
High-
End
4.<>
().'>
1.35E-05
4<>
(PF 10)
'J ()
(1*1 ID)
: "oi:-()(.
< 1*1" 5)
Automotive Care
Products)
ONU
Inhalation
Central
Tendency
725
31
2.42E-D"
\ \
\ \
\ \
8-hr TWA
High-
End
89
246
1.75E-IK.
\ \
\ \
\ \
Industrial and
commercial use/
Post-market waxes and polishes applied
to footwear (e.g., shoe polish)
Section 2.4.1.2.9 and
4.2.2.1.9 -
Worker
Inhalation
Central
Tendency
1 '
4 5'
1.15E-05
330
(APF 25)
113
(APF 25)
-
Apparel and
footwear care
Commercial Aerosol
Products (Aerosol
8-hr TWA
High-
End
3.7
1 '
4.17E-05
92
(APF 25)
32
(APF 25)
-
products
Degreasing, Aerosol
Lubricants,
Worker
Dermal
High-
End
4 (>
(i 'J
1.35E-05
46
(1*1 |ui
9.0
(1*1" lui
2 7np-n6
(1*1 ¦*)
Automotive Care
Products)
ONU
Inhalation
Central
Tendency
725
31
2.42E-07
N \
\ \
\ \
8-hr TWA
High-
End
89
246
1.75E-06
\i/^
\ \
\ \
Industrial and
commercial use/
Spot remover for apparel and textiles
Section 2.4.1.2.15
and 4.2.2.1.15 - Spot
Worker
Inhalation
Central
Tendency
114
30
1.40E-06
2843
(APF 25)
"39
(APF 25)
-
Laundry and
dishwashing
Cleaning
8-hr TWA
High-
End
4 5(>
i.:
4.50E-05
114
(APF 25)
30
(APF 25)
-
products
Worker
Dermal
High-
End
4.')
(1 T
1.26E-05
49
(PF 10)
K) ~
(1*1 ID)
2.51E-06
(PF 5)
Page 403 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Life (>ele
Seme (nleuors
Siihenleuor\
()eeiipnlioiial
1 \poMire Scenario
I'opiilalioii
1 \posiire
konle and
1 )iii;iIiom
1 Aposiire
l.e\el
Risk 1 Simmies lor \o 1*1*1
Risk 1 !siiniales u illi 1*1*1
\enie
\oii-
c: nicer
i he lie li-
ma rk
\I()L
'i)i
( limine
\oii-
c; nicer
i he lie li-
ma rk
\ioi:
10)
( aileer
(heneli-
n i; ilk
Id i
\enie
\oii-
eaneer
(heneli-
mnrk
\k >i:
'0|
( limine
Noii-
eaneer
(heneli-
m;irk
\ioi:
10)
Cancer
i he lie li-
ma rk
l<> i
ONU
Inhalation
8-hr TWA
Ceniral
Tendency
114
30
L40E-0(.
\ \
\ \
\ \
High-
End
4 5<>
i:
4 50E-05
\ \
\ \
\ \
Industrial and
commercial use/
Lubricants and
greases
Liquid and spray lubricants and greases
Section 2.4.1.2.9 and
4.2.2.1.9 -
Commercial Aerosol
Products (Aerosol
Degreasing, Aerosol
Lubricants,
Automotive Care
Products)
Worker
Inhalation
8-hr TWA
Central
Tendency
1 '
4 5'
1 I5E-05
330
(APF 25)
113
(APF 25)
-
High-
End
3.7
1.'
4 1 "E-05
92
(APF 25)
32
(APF 25)
-
Worker
Dermal
High-
End
4.<>
().'>
1 '5 E-05
46
(1*1 |ui
K) 0
(1*1 loi
2.70E-06
< 1*1 -s)
ONU
Inhalation
8-hr TWA
Central
Tendency
725
31
2.42E-07
\ \
\ \
\ \
High-
End
X')
:4(.
L.75E-06
N/A
\ \
\ \
Section 2.4.1.2.13
and 4.2.2.1.13 -
Miscellaneous Non-
Aerosol
Industrial and
Commercial Uses
Worker
Inhalation
8-hr TWA
Central
Tendency
5 1
1 ''
' 1 li:-()5
i:s
( \l*l 251
i \i*i :5i
i :4i:-()(,
( \ 1 * 1 ¦" 251
High-
End
u '1
(MIS
(. 5SI -<)4
l(.
( \l*l 5()|
4
( \l*l 50)
2 (.'L-U5
( \ 1 * 1" 251
Worker
Dermal
High-
End
" 1
(1 <;<>
1 '51: -() 5
4<>
(1*1 |ui
'HI
(1*1 loi
2 "oi :-()(¦
< 1*1 .*)
ONU
Inhalation
8-hr TWA
Central
Tendency
5 1
1.''
' i ii:-u5
\ \
\ \
\ \
High-
End
u '1
DOS
(. 5SI :-<)4
\ \
\ \
\ \
Degreasers - aerosol and non-aerosol
degreasers and cleaners
Section 2.4.1.2.9 and
4.2.2.1.9 -
Commercial Aerosol
Products (Aerosol
Degreasing, Aerosol
Lubricants,
Automotive Care
Products)
Worker
Inhalation
8-hr TWA
Central
Tendency
1 '
4 5'
i 15i: -<) 5
v,ii
( \l*l 251
1 1 '
i \i*i :5i
High-
End
3.7
1.'
4 n:-<)5
( \l*l 251
'2
i \i*i :5i
Worker
Dermal
High-
End
4.<>
().'>
1 '5 E-05
4(>
(1*1 |ui
K) 0
(1*1 loi
2 "0L-0O
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Risk 1 !siiinales lor \o 1*1*1
Risk 1 !siiniales w illi 1*1*1
Life (>ele
Seme (aleuors
Siihealeuor\
()cciipalional
1 \poMire Scenario
I'opiilalioii
1 \posiire
konle and
1 )iii;iIiom
1 Aposiire
l.e\el
\enie
\oii-
c: nicer
i he nc li-
ma rk
\I()L
'i)i
( limine
\oii-
c; nicer
i he lie li-
ma rk
\1( )l:
10)
( aileer
(bench-
mark
10 1
\enie
\oii-
eaneer
(heneli-
mark
\1( )l:
'0|
( 'limine
Noii-
eaneer
(hencli-
n i; ilk
\1( )l:
10)
Cancer
i he lie li-
ma rk
|0 |
lligh-
End
89
246
1.751 :-oi,
\ \
\ \
\ \
Section 2.4.1.2.13
and 4.2.2.1.13 -
Worker
Inhalation
Central
Tendency
5 i:
1. -
' 1 1E-05
128
( \l*l 25)
33
( \ 1 * 1" 251
1.24E-06
( \ 1 * 1" 251
Miscellaneous Non-
Aerosol Industrial
8-hr TWA
High-
End
u '1
1)08
(. 58L-04
l(.
( \l*l 50i
4
( \ 1 * 1" 5oi
2 (.'L-05
( \ 1 * 1" 251
and Commercial Uses
Worker
Dermal
High-
End
4.<>
(1 'JO
1 '5L-05
4(>
(1*1 10)
l) o
(1*1 10)
2 "oL-oi,
< 1*1 -s)
ONU
Inhalation
Central
Tendency
5 12
1 V,
' 1 IL-05
\ \
\ \
\ \
8-hr TWA
High-
End
u '1
0.08
(. 58L-04
\ \
\ \
\ \
Industrial and
commercial use/
Cold pipe insulation
Section 2.4.1.2.9 and
4.2.2.1.9 -
Worker
Inhalation
Central
Tendency
1 '
4 5'
1 I5L-05
V,()
( \l*l 25)
11'
( \ 1 * 1 ¦" 251
Building/
construction
Commercial Aerosol
Products (Aerosol
8-hr TWA
High-
End
3.7
1. '
4 l"L-05
<>:
( \l*l 25)
'2
( \ 1 * 1" 251
materials not
covered
Degreasing, Aerosol
Lubricants,
Worker
Dermal
High-
End
4 (>
o ')
1 '5L-05
4<>
(1*1 10)
o
(1*1 |0|
: "oL-oi,
(1*1" 5)
elsewhere
Automotive Care
Products)
ONU
Inhalation
Central
Tendency
"25
'1
: 421 :-o~
\ \
\ \
\ \
8-hr TWA
High-
End
X')
24(.
1 "5L-0(,
\ \
\ \
\ \
Industrial and
commercial use/
All other chemical product and
preparation manufacturing
Section 2.4.1.2.3 and
4.2.2.1.3 - Processing
Worker
Inhalation
Central
Tendency
1 (.1
0 42
'i 8"E-05
4o
( \l*l 25)
10 5
( \ 1 * 1" 251
' ')5L-0(>
( \ 1 * 1" 251
Solvents (which
become part of
- Incorporation into
Formulation, Mixture,
8-hr TWA
High-
End
u 1 '
o o'4
1 5~L-o'
(. 5
< \l*l 5oi
1 "
( \ 1 * 1" 5oi
(. 2')L-o5
( \ 1 * 1" 251
product
formulation or
mixture)
or Reaction Product
Worker
Inhalation
15-min
TWA*
Point
Estimate
') 48
\ (
\ (
2'"
( \l*l 25)
\ (
\ (
Worker
Dermal
High-
End
"1
1.4
8(.')i:-o(>
'5<>
< 1*1 -s)
28
(1*1 2oi
1 "4L-0(,
< 1*1 -s)
ONU
Inhalation
15-min
TWA*
Point
Estimate
') 48
\ (
\ (
\ \
\ \
\ \
Page 405 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Risk 1 Simmies lor \o 1*1*1
Risk 1 !siiniales w illi 1*1*1
Life (>ele
Seme (nleuors
(leciipalioiial
1 \poMire Scenario
1 \posiire
1 Aposiire
l.e\el
\enie
\oii-
c: nicer
i he nc li-
ma rk
\I()L
'i)i
( limine
\oii-
c; nicer
i he lie li-
ma rk
\1( )l:
KM
( aileer
\enie
\oii-
eaneer
(heneli-
mnrk
\1( )l:
30)
( limine
Noii-
eaneer
(bench-
mark
\1( )l:
KM
Cancer
Siihcaleuor\
I'opiilalioii
konle and
1 )iii;iIiom
(heneli-
n i; ilk
Id i
(he lie li-
ma rk
|o )
ONU
Inhalation
Central
Tendency
1.61
0 42
') S"l:-(15
N/A
\ \
\ \
8-hr TWA
High-
End
u 1 '
(MIU
1 5 "1:-()'
N/A
\ \
\ \
Industrial and
commercial use/
In multiple manufacturing sectors
Section 2.4.1.2.16
and 4.2.2.1.16-
Worker
Inhalation
Central
Tendency
().2S
ii.ii"
5 (.SL-H4
14
( \l*l 5(1)
' (.
( \ 1 * 1" 5(1)
2 2~l:-()5
( \l*l 25)
Processing aid
not otherwise
Cellulose Triacetate
Film Production
8-hr TWA
High-
End
U.2I
(1.(15
- (>"i:-(14
10
( \l*l 50)
2 "
( \ 1 * 1 ¦" 50)
' o"L-()5
( \l*l 25)
listed
Worker
Dermal
High-
End
"1
1.4
si.'ji :-(K.
36
(PF 5)
2S
(1*1 20)
1 "41 :-()(¦
(1*1
ONU
Inhalation
Central
Tendency
u.:x
(i.ii"
5 (.SI -04
N/A
\ \
\ \
8-hr TWA
High-
End
D.2
(i.(i5
-(."L-II4
N/A
\ \
\ \
Industrial and
commercial use/
Flexible polyurethane foam
manufacturing
Section 2.4.1.2.18
and 4.2.2.1.18-
Worker
Inhalation
Central
Tendency
1.4
() '5
LI(.L-04
34
( \l*l 25)
IS
( \l*l 50)
4 (.(.i :-o(.
( \l*l 25)
Propellants and
blowing agents
Flexible Polyurethane
Foam Manufacturing
8-hr TWA
High-
End
(i 2<>
(MIS
- osi :-(i4
15
( \l*l 50)
' S
( \l*l 50)
2 S'1: -() 5
( \l*l 25)
Worker
Dermal
High-
End
" 1
1 4
S(.'JE-06
356
(PF 5)
28
(PF 20)
1.74E-0O
(PF 5)
ONU
Inhalation
Central
Tendency
1 4
() '5
i ici:-(14
N/A
\ \
\ \
8-hr TWA
High-
End
(i 2<>
(MIS
- osi :-o4
N/A
\ \
\ \
Industrial and
commercial use/
Laboratory chemicals - all other chemical
product and preparation manufacturing
Section 2.4.1.2.19
and 4.2.2.1.19-
Worker
Inhalation
Central
Tendency
83
18.6
2.22E-06
2071
(APF 25)
465
(APF 25)
8.89E-08
(APF 25)
Other Uses
Laboratory Use
8-hr TWA
High-
End
24
H.4S
1.1 IL-II4
604
(APF 25)
12
( \l*l 25)
4.45E-06
( \l*l 25)
Worker
Inhalation
15-min
TWA*
Central
Tendency
255
\ (
\ (
6366
(APF 25)
\ (
\ (
High-
End
21
\ (
\ (
514
(APF 25)
\ (
\ (
Page 406 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Risk 1 Simmies lor \o 1*1*1
Risk 1 !siiniales u illi 1*1*1
Life (>ele
Seme (nleuors
Siihenleuor\
()eeiipnlioiinl
1 \poMire Scenario
I'opnlnlioii
1 \posiire
konle and
1 )iii;iIiom
1 Aposiire
l.e\el
\enie
Non-
em icer
i he lie li-
ma rk
\I()L
'i)i
( limine
\oii-
enneer
i he lie li-
ma rk
\1( )l:
10)
( aileer
(heneli-
n i; ilk
It) i
\enie
\on-
eaneer
(heneli-
mark
\1( )l:
'Oi
( lll'OIIIC
Noii-
en i icer
(heneli-
mnrk
\1( )l:
10)
Cnneer
i he lie li-
mn rk
l<> i
Worker
Dermal
lligh-
End
4 (>
(i 'J
1 '51: -() 5
<>l
(1*1 2()i
18
(1*1 2()i
2 "o|:-()(.
< 1*1 ¦*)
ONU
Inhalation
Central
Tendency
8^
186
2 221:-()(,
\ \
\ \
\ \
8-hr TWA
High-
End
24
D.4S
1.1 IL-04
\ \
\ \
\ \
ONU
Inhalation
15-min
TWA*
Central
Tendency
255
\ (
\ (
\ \
\ (
\ (
High-
End
21
\ (
\ (
\ \
\ (
\ (
Electrical equipment, appliance, and
component manufacturing
Section 2.4.1.2.13
and 4.2.2.1.13 -
Worker
Inhalation
Central
Tendency
5 12
1 V,
' 1 IL-U5
128
( \l*l 25)
"> ->
( \l*l 25)
1241:-()(,
( \l*l 25)
Miscellaneous Non-
Aerosol Industrial
8-hr TWA
High-
End
u '1
1)08
(. 58L-04
l(.
( \1 * 1" 51) i
4
( \l*l 5()i
2 (>'1:-()5
( \l*l 25)
and Commercial Uses
Worker
Dermal
High-
End
4.<>
(1 <>(>
1 '5L-U5
4(>
(1*1 |ui
'HI
(1*1 Id)
2 "oi :-()(¦
< 1*1 .*)
ONU
Inhalation
Central
Tendency
5 12
1. ' '
' 1 IL-U5
\ \
\ \
\ \
8-hr TWA
High-
End
u '1
mis
(. 581 -<)4
\ \
\ \
\ \
Plastic and rubber products
Section 2.4.1.2.17
and 4.2.2.1.17 -
Worker
Inhalation
Central
Tendency
21
5 4
" (.11 :-()(¦
525
( \l*l 25)
1 '5
( \l*l 25)
' (>4i :-<)-
( \l*l 25)
Plastic Product
Manufacturing
8-hr TWA
High-
End
1 1
(i 2<>
1 851 :-(>4
5<>
( \ 1 * 1" 5()i
14
( \ 1 * 1" 5()i
- '8i :-()(¦
( \l*l 25)
Worker
Inhalation
15-min
TWA*
Central
Tendency
21
\ (
\ (
525
( \l*l 25)
\ (
\ (
High-
End
1 '
\ (
\ (
327
(APF 25)
N/C
N/C
Worker
Dermal
High-
End
"1
1.4
8 <.<>i:-()(.
36
(1*1 51
28
(1*1 2<))
1.74E-06
(1*1 5)
ONU
Inhalation
8-hr TWA
Point
Estimate
32
8. i
"7.6ii:-()(,
\ \
\ \
\ \
Page 407 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Risk 1 !siiinales lor \o 1*1*1
Risk 1 !siiniales u illi 1*1*1
Life ( \cle
Seme Caleuors
Siihcaleuor\
()cciipalional
1 \poMire Scenario
l*opnlalioii
1 Aposlll'C
konle and
1 )iiralion
1 Aposnre
Lc\el
\cule
\on-
caiicer
i he lie li-
ma rk
\I()L
'i)i
( limine
\on-
eaneer
i he lie li-
ma rk
\1( )l:
KM
( aileer
(bench-
mark
in i
\enie
Noil-
cancer
(bench-
mark
\1( )l:
'())
( limine
Noil-
cancer
(bench-
mark
\1( )l:
10)
Cancer
(he lie li-
ma rk
l<> i
Section 2.4.1.2. lo
and 4.2.2.1.16-
Worker
Inhalation
Central
Tendency
o 2s
(1 0"
5(.si:-(i4
14
( \l*l 5()i
' (i
( \1 * 1" 5()i
2 2"I:-()5
( \l*l 25)
Cellulose Triacetate
Film Production
8-hr TWA
High-
End
u 21
mi5
- (,-| ;-(>4
in
( \l*l 5()i
2.7
( \ 1 * 1" 5()i
' ()~l:-()5
( \l*l 25)
Worker
Dermal
High-
End
"1
1.4
si.'^i :-(K.
'(.
(1*1 -s)
:s
(i*i :oi
1 "41 :-()(¦
(1*1 -s)
ONU
Inhalation
Central
Tendency
u.:x
tin"
5 (.SL-04
\ \
\ \
\ \
8-hr TWA
High-
End
D.2
(1.(15
"(."L-04
\ \
\ \
\ \
Anti-adhesive agent - anti-spatter
welding aerosol
Section 2.4.1.2.9 and
4.2.2.1.9 -
Worker
Inhalation
Central
Tendency
1 '
4 5'
1 I5L-05
v,(i
( \l*l 251
11'
( \l*l 25)
Commercial Aerosol
Products (Aerosol
8-hr TWA
High-
End
3.7
1.'
4 1 "E-05
92
(APF 25)
32
(APF 25)
-
Degreasing,
Aerosol Lubricants,
Worker
Dermal
High-
End
4.<>
o:>
1 '5 E-05
46
(1*1 Id)
9.0
(1*1 Id)
2.70E-06
(1*1 -s)
Automotive Care
Products)
ONU
Inhalation
Central
Tendency
725
31
2.42E-07
\ \
\ \
\ \
8-hr TWA
High-
End
89
246
1.75E-06
\ \
\ \
\ \
Oil and gas drilling, extraction, and
support activities
Section 2.4.1.2.13
and 4.2.2.1.13 -
Worker
Inhalation
Central
Tendency
5 1
1 '
' 1 11: -(15
i:s
( \l*l 251
33
( \l*l 25)
1241:-()(.
( \l*l 25)
Miscellaneous Non-
Aerosol Industrial
8-hr TWA
High-
End
u '1
(MIS
(. 5SL-U4
l(.
( \l*l 5(1)
4
( \ 1 * 1" 50)
2 (>'1:-()5
( \l*l 25)
and Commercial Uses
Worker
Dermal
High-
End
4 (>
(i <;n
1 '51: -(15
4(>
(1*1 Id)
'HI
(1*1 Id)
2 "oi:-()(.
(1*1 .*)
ONU
Inhalation
Central
Tendency
5 1
1.'
' 1 11: -(15
\ \
\ \
\ \
8-hr TWA
High-
End
u '1
(i.( IS
(. 5SL-04
\ \
\ \
\ \
Functional fluids (closed systems) in
Section 2.4.1.2.20
and 4.2.2.1.20-
Worker
Inhalation
8-hr TWA
Central
Tendency
1 2(>
(1 V,
12(.i :-(i4
63
(APF 50)
16.38
(APF 50)
2.52E-06
(APF 50)
Page 408 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Life (>ele
Seme (nleuors
Siihenleuor\
pharniaeeiilieal and medicine
manufacturing
()eeiipnlioiinl
1 \poMire Scenario
Pharniaee u lieal
Production
Kipulalion
1 \posiire
konle and
1 )iii;iIiom
1 Aposiire
l.e\el
Risk 1 Simmies lor \o 1*1*1
Risk 1 !siiniales w illi 1*1*1
\enie
\oii-
c: nicer
i he nc li-
ma rk
\I()L
'i)i
( limine
\oii-
c; nicer
(he lie li-
ma rk
\1( )l:
10)
( aileer
(heneli-
n i; ilk
10 1
\enie
\oii-
eaneer
(heneli-
mark
\1( )l:
'Oi
( lll'OIIIC
Noii-
eaneer
(heiicli-
mark
\1( )l:
loi
Cancer
(he lie li-
ma rk
|0 )
lligh-
End
(MIS
0 021
2 5 '1:-()'
4.0(>
( \l*l 5(>i
1 1
( \l*l 50)
5 05L-05
( YPF 50)
Worker
Dermal
High-
End
7.1
1 4
S(.')R-06
36
(1*1
28
(1*1 2oi
1.74E-06
< 1*1
ONU
Inhalation
8-hr TWA
Central
Tendency
l.2(.
0 V,
L2(.L-04
\ \
\ \
\ \
High-
End
o.os
0 021
: 5'L-O'
\ \
\ \
\ \
Toys, playground, and sporting
equipment - including novelty articles
(toys, gifts, etc.)
Section 2.4.1.2.20
and 4.2.2.1.20 -
Miscellaneous Non-
Aerosol Industrial
and Commercial Uses
Worker
Inhalation
8-hr TWA
Central
Tendency
5 12
1 v.
' 1 IL-05
128
( \l*l 251
33
( \ 1 * 1 ¦" 251
1241 :-o(.
( \l*l 25)
High-
End
0 '1
0.08
(. 58L-04
l<>
( \l*l 50i
4
( \ 1 * 1" 5o i
2 (.'L-05
( \l*l 25)
Worker
Dermal
High-
End
4.<>
0 <>o
1 '5L-05
4(>
(1*1 loi
'HI
(1*1 10)
2 "o| :-()(¦
< 1*1
ONU
Inhalation
8-hr TWA
Central
Tendency
5 1
1.'
' 1 IL-05
\ \
\ \
\ \
High-
End
0 '1
(MIS
(. 58L-04
\ \
\ \
\ \
Carbon remover, lithographic
printing cleaner, brush cleaner
Section 2.4.1.2.21
and 4.2.2.1.21 -
Lithographic Printing
Plate Cleaning
Worker
Inhalation
8-hr TWA
Central
Tendency
78
20
2.03E-06
1950
(APF 25)
509
(APF 25)
8.12E-08
(APF 25)
High-
End
1 1
o 28
1 'Jli:-o4
54
( \ 1 * 1" 5oi
14
(APF 50)
7.65E-06
(APF 25)
Worker
Dermal
High-
End
5 1
1 o
1 :ii:-o5
5 1
(1*1 loi
10
CPF ini
2.41E-06
fPF 5 s)
ONU
Inhalation
8-hr TWA
Central
Tendency
-?8
20
2.031:-()(.
\ \
\ \
\ \
High-
End
1.1
0.28
i.i)ii:-o4
\ \
\ \
\ \
Wood floor cleaner
Section 2.4.1.2.13
and 4.2.2.1.13 -
Miscellaneous Non-
Worker
Inhalation
8-hr TWA
Central
Tendency
5 12
1.'
' 1 IL-05
128
( \l*l 25)
( \l*l 25)
1 24L-OI,
( \l*l 25)
High-
End
0 '1
DOS
(. 58L-04
l(.
( \l*l 50)
4
( \l*l 50)
2 <¦ i| :-()5
( \l*l 25)
Page 409 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Life (>ele
Seme CaleuniA
Siihealeuor\
()ceiipalioual
1 \posure Scenario
Aerosol Industrial
and Commercial Uses
l*opulalioii
1 \posiire
koule and
1 )uraliou
1 Aposiire
l.e\el
Risk 1 !siiiii;iies lor \o 1*1*1
Risk 1 !siiniales w nli 1*1*1!
\eule
\oii-
eaneer
i he lie li-
ma rk
\1()L
'i)i
( limine
\ou-
eaueer
i he lie li-
ma rk
\1( )l:
10)
( aileer
(bench-
mark
in i
\euie
\ou-
eaueer
(heueli-
mark
\I()L
'())
( 'limine
Noii-
eaueer
(heneli-
n i; ilk
\1( )l:
10)
Cancer
i he lie li-
ma rk
In i
Worker
Dermal
lligh-
End
4.6
(i <;<>
1 '51: -() 5
4(>
(1*1 |ui
ii
(1*1 liii
2 "(il :-<><¦
(1*1 51
ONU
Inhalation
8-hr TWA
Central
Tendency
5 1
1 '
' 111-05
\ \
\ \
\ \
High-
End
u '1
DOS
(. 58L-U4
\ \
\ \
\ \
Disposal/
Disposal
Industrial pre-treatment
Industrial wastewater treatment
Section 2.4.1.2.5 and
4.2.2.1.5 - Waste
Handling, Disposal,
Treatment, and
Recycling
Worker
Inhalation
8-hr TWA
Central
Tendency
l(>
4 us
1 01E-05
393
(APF 25)
102
(APF 25)
-
Publicly owned treatment works (POTW)
Underground injection
High-
End
15
1 '6E-05
378
(APF 25)
98
(APF 25)
-
Municipal landfill
Hazardous landfill
Worker
Dermal
High-
End
"1
1.4
SI.9E-06
356
< 1*1
28
< 1*1 :in
1.74E-06
11*1' 51
Other land disposal
Municipal waste incinerator
ONU
Inhalation
8-hr TWA
Central
Tendency
l<>
4.US
1 01E-05
N/A
\ \
\ \
Off-site waste transfer
High-
End
15
1 '6E-05
\ \
\ \
\ \
653 N/C = not calculated because 15-min TWAs are not used for assessing chronic non-cancer or cancer risks
654 * risk estimates for the 15-min TWA are shown for COUs that had available exposure data and when acute risks indicated were different from 8-hr TWA, see Section 4.2.2.1 for
655 details of 15-min TWAs for each OES.
656 N/A = not assessed because ONUs are not assumed to be wearing PPE
657 - = cancer risks assuming PPE are not shown when the cancer risk without PPE was above the cancer risk benchmark of 10~4
Page 410 of 725
-------
9658
9659
9660
9661
9662
9663
9664
9665
9666
9667
9668
9669
9670
9671
9672
9673
9674
9675
9676
9677
9678
9679
9680
9681
9682
9683
9684
9685
9686
9687
9688
9689
9690
9691
9692
9693
9694
9695
9696
9697
9698
9699
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
4.6.3 Summary of Risk Estimates for Inhalation and Dermal Exposures to
Consumers and Bystanders
Table 4-105 summarizes the risk estimates for CNS effects from acute inhalation and dermal
exposures for all consumer exposure scenarios. Risk estimates that exceed the benchmark (i.e.
MOEs less than the benchmark MOE) are highlighted by bolding the number and shading the
cell. The risk characterization is described in more detail in sections 2.4.2 and 4.2.2.3 and
specific links to the exposure and risk characterization sections are listed in Table 4-105 in the
column headed Consumer Condition of Use Scenario.
For acute inhalation exposures there are risks for consumers and bystanders relative to the
benchmarks for all the COUs for medium and high intensity except for:
• solvents (for cleaning and degreasing) as aerosol spray degreaser / cleaner for electronics
cleaner where MOEs exceed benchmark only for high intensity users
• adhesives and sealants as single component glues and adhesives and sealants and caulk
where MOEs exceed benchmark for medium and high intensity only for users and only at
1 hr TWA.
• Paints and coatings including paint and coating removers
o Paint and Coating Removers for brush cleaners where MOEs do not exceed the
benchmark MOE in any scenario
o Adhesive/caulk remover where MOEs do not exceed the benchmark MOE in any
scenario
• Metal products not covered elsewhere as Degreasers - aerosol and non-aerosol degreasers
for electronics cleaner where MOEs exceed benchmark only for high intensity users
• Other Uses as Brush Cleaner where MOEs do not exceed the benchmark MOE in any
scenario
For acute dermal exposures there are risks for consumers (bystanders are assumed to not have
direct dermal contact) relative to the benchmarks for all the COUs for medium and high intensity
except for:
• solvents (for cleaning and degreasing) as aerosol spray degreaser / cleaner for electronics
cleaner where MOEs do not exceed the benchmark MOE in any scenario
• adhesives and sealants as single component glues and adhesives and sealants and caulk
where MOEs exceed benchmark for medium and high intensity only for users and only at
1 hr TWA).
• Paints and coatings including paint and coating removers as Paint and Coating Removers
for brush cleaners where MOEs do not exceed the benchmark MOE in any scenario
• Metal products not covered elsewhere as Degreasers - aerosol and non-aerosol degreasers
for electronics cleaner where MOEs exceed benchmark only for high intensity users)
• Automotive care products as Function fluids for air conditioners: refrigerant, treatment,
leak sealer for Automotive AC Refrigerant where MOEs do not exceed the benchmark
MOE in any scenario
Page 411 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
9700 • Other Uses as Brush Cleaner where MOEs do not exceed the benchmark MOE in any
9701 scenario
9702
Page 412 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
9703 Table 4-105 Summary of Risk Estimates for CNS effects from Acute Inhalation and Dermal Exposures to Consumers by
9704 Conditions of Use
(OIISIIIIHT
Condition of
I so Scenario
i scr moi:
(bench ni;uk
MOI. = 30)
|}\s(;iii(kr
Ciileiion
Siih Csiicgon
Mxposiiiv Kniilc
iiml Dumlinn
Scciiiirio Description
MOI.
(hcnchiiiiirk
MOI.=30)
Low Intensity User
24
:o:
Inhalation 1-hr
Medium Intensity User
1 "
14
High Intensity User
o 4(1
: ^
Section 2.4.2.4.5
and Section
4 ? ? 3 1 - Rrake
Low Intensity User
5"
:ix
Inhalation 8-hr
Medium Intensity User
. (.
15
Cleaner
High Intensity User
().(>()
: 0
Low Intensity User
25X
\ \
Dermal
Medium Intensity User
9.2
\ \
High Intensity User
42
\ \
Low Intensity User
5
in'
Inhalation 1-hr
Medium Intensity User
I) 'JO
'j.~
Solvents (for cleaning and degreasing
Aerosol spray
High Intensity User
0 :d
i n
degreaser/cleaner
Section 2.4.2.4.7
Low Intensity User
::
i i'j
and Section
4.2.2.3.2 -
Carbon Remover
Inhalation 8-hr
Medium Intensity User
2.1
11
High Intensity User
0 :i)
(I'M
Low Intensity User
44
iN/A
Dermal
Medium Intensity User
(> I)
\ \
High Intensity User
4."
\ \
Low Intensity User
1 ^
1 in
Section 2.4.2.4.8
Inhalation 1-hr
Medium Intensity User
1 4
i:
and Section
4.2.2.3.3 -
Carburetor
High Intensity User
0 M)
: ii
Low Intensity User
:~
1 IS
Cleaner
Inhalation 8-hr
Medium Intensity User
vll
n
High Intensity User
I) (.0
: ii
Page 413 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Consumer
Condition of
I so Scenario
i scr moi:
(bench ni;irk
MOI. = 30)
|}\s(;iii(kr
Ciileiion
Siih Csiicgon
Mxpnsuiv Roiilc
iiml Dumlinn
Scciiiirin Description
MOI.
(hcnchiiiiirk
MOI.=30)
Low Intensity User
175
N/A
Dermal
Medium Intensity User
15
N/A
High Intensity User
4<>
N/A
Low Intensity User
5 5
60
Inhalation 1-hr
Medium Intensity User
0 (.0
5 'J
High Intensity User
u. |i)
I) (.0
Section 2.4.2.4.9
Low Intensity User
n
(,')
and Section
4.2.2.3.4 - Coil
Cleaner
Inhalation 8-hr
Medium Intensity User
i ^
<..x
High Intensity User
0 in
I) (.0
Low Intensity User
:<¦
\ \
Dermal
Medium Intensity User
3.7
\ \
High Intensity User
2 'J
\ \
Low Intensity User
1171
8027
Inhalation 1-hr
Medium Intensity User
91
633
Section
2.4.2.4.11 and
High Intensity User
(> 5
31
Low Intensity User
2492
10794
Section 4.2.2.3.5
Inhalation 8-hr
Medium Intensity User
195
854
- Electronics
Cleaner
High Intensity User
1 ^
46
Low Intensity User
1208
N/A
Dermal
Medium Intensity User
328
N/A
High Intensity User
64
N/A
Low Intensity User
5 4
4n
Section
Inhalation 1-hr
Medium Intensity User
I) (.0
5 1
2.4.2.4.12 and
Section 4.2.2.3.6
- Engine Cleaner
High Intensity User
o :<)
0 'JO
Inhalation 8-hr
Low Intensity User
i:
5()
Medium Intensity User
1 '
5 4
Page 414 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
('onsunior
Condition of
I so Scenario
i scr moi:
(bench ni;uk
MOI. = 30)
IS\sl;imkT
Ciileiion
Siih Csiicgon
Mxposiiiv Kniilc
iiml Dumlinn
Scciiiirio Description
MOI.
(hcnchiiiiirk
MOI.=30)
High Intensit\ 1 ser
0 20
I) SO
Low Intensity User
4^
\ \
Dermal
Medium Intensity User
lu
\ \
High Intensity User
4.<>
\ \
Low Intensity User
5 'J
51
Inhalation 1-hr
Medium Intensity User
1 1
'1 1
Section
2 4 2 4.13 and
High Intensity User
o 2d
1 4
Low Intensity User
11
55
Section 4.2.2.3.7
Inhalation 8-hr
Medium Intensity User
: i
'1 ~
- Gasket
Remover
High Intensity User
(I 4(1
1 4
Low Intensity User
-> *>
\ \
Dermal
Medium Intensity User
5.y
N/A
High Intensity User
4 "
N/A
Low Intensity User
(¦(¦4
2188
Inhalation 1-hr
Medium Intensity User
1
High Intensity User
(I 5(1
42
Section 2.4.2.4.3
Low Intensity User
1066
2535
and Section
4.2.2.3.8 -
Adhesives
Inhalation 8-hr
Medium Intensity User
52
150
Single component
glues and adhesives
High Intensity User
1 1
4."
Adhesives and Sealants
Low Intensity User
14')
\ \
and sealants and caulk
Dermal
Medium Intensity User
1 1
N/A
High Intensity User
2 5
X'\
Section
Low Intensity User
35
'i>4
2.4.2.4.14 and
Section
4.2.2.3.14 -
Inhalation 1-hr
Medium Intensity User
: 'j
24
High Intensity User
o 4(1
: s
Sealant
Inhalation 8-hr
Low Intensity User
75
327
Page 415 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Ciileiion
Siih Csiicgon
('onsunior
Condition of
I so Scenario
Mxposiiiv Kniilc
iiml Dumlinn
SiTiiiirio Description
i scr moi:
(bench ni;uk
MOI. = 30)
IVtshimliT
MOI.
(hcnchiiiiirk
MOI.=30)
Medium Intensils I ser
(. 1
2(>
High Intensit\ I ser
I) "0
^ 1
Dermal
Low Intensity User
198
N/A
Medium Intensity User
l(.
N/A
High Intensity User
12
N/A
Paints and coatings including paint and
coating removers
Paint and Coating
Removers
Section 2.4.2.4.6
and Section
4.2.2.3.10 -
Brush Cleaner
Inhalation 1-hr
Low Intensity User
3956
44077
Medium Intensity User
786
6209
High Intensity User
462
1293
Inhalation 8-hr
Low Intensity User
8981
50216
Medium Intensity User
1653
6916
High Intensity User
191
919
Dermal
Low Intensity User
1135
N/A
Medium Intensity User
457
N/A
High Intensity User
456
N/A
Adhesive/caulk
removers
Section 2.4.2.4.4
and Section
4.2.2.3.11 -
Adhesives
Remover
Inhalation 1-hr
Low Intensity User
629
2869
Medium Intensity User
441
3482
High Intensity User
136
502
Inhalation 8-hr
Low Intensity User
1139
3289
Medium Intensity User
928
3897
High Intensity User
52
279
Dermal
Low Intensity User
5 2
N/A
Medium Intensity User
() "
N/A
High Intensity User
() •)?
N/A
Metal products not covered elsewhere
Degreasers - aerosol
and non-aerosol
degreasers
Section 2.4.2.4.7
and Section
4.2.2.3.2 -
Carbon Remover
Inhalation 1-hr
Low Intensity User
K> 5
|Ui
Medium Intensity User
0 'JO
"
High Intensity User
0 :
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Consumer
Condition of
I so Scenario
i sit moi:
(bench ni;irk
MOI. = 30)
IS\sl;imkT
Ciileiion
Siih Csiicgon
Mxpnsuiv Roiilc
iiml Dumlinn
Scciiiirin Description
MOI.
(hcnchiiiiirk
MOI.=30)
Low Intensity User
119
Inhalation 8-hr
Medium Intensity User
: i
1 1
High Intensity User
0.20
n.'ju
Low Intensity User
44
N/A
Dermal
Medium Intensity User
(> ()
N/A
High Intensity User
4 "
N/A
Low Intensity User
5.5
(.0
Inhalation 1-hr
Medium Intensity User
<).<><)
5 'J
High Intensity User
i) |n
0 (.0
Section 2.4.2.4.9
Low Intensity User
1 ^
(,')
and Section
4.2.2.3.4 - Coil
Cleaner
Inhalation 8-hr
Medium Intensity User
1 ^
(. S
High Intensity User
0. |o
I) (.0
Low Intensity User
2(>
N/A
Dermal
Medium Intensity User
}. /
N/A
High Intensity User
2 'J
N/A
Low Intensity User
1171
8027
Inhalation 1-hr
Medium Intensity User
91
633
Section
2.4.2.4.11 and
High Intensity User
(> 5
31
Low Intensity User
2492
10794
Section 4.2.2.3.5
Inhalation 8-hr
Medium Intensity User
195
854
- Electronics
Cleaner
High Intensity User
1 ^
46
Low Intensity User
1208
N/A
Dermal
Medium Intensity User
328
N/A
High Intensity User
64
N/A
Page 417 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Ciileiion
Siih Csiicgon
(oilSlllllCr
Condition of
I so Scenario
Mxposiiiv Kniilc
iiml Dumlinn
SiTiiiirio Description
i scr moi:
(bench ni;uk
MOI. = 30)
IVtshimliT
MOI.
(hcnchiiiiirk
MOI.=30)
Automotive care products
Function fluids for air
conditioners:
refrigerant, treatment,
leak sealer
Section 2.4.2.4.1
and Section
4.2.2.3.9 -
Automotive AC
Leak Sealer
Inhalation 1-hr
Low Intensity I ser
i:
lu
Medium Intensils I scr
i:
It)
High Intensit\ I scr
: i
11
Inhalation 8-hr
Low Intensity I ser
: (.
1 1
Medium Intensils I scr
2.<>
1 1
High Intensit\ I scr
:"
s
Dermal
Low Intensity User
lu
N/A
Medium Intensity User
5.U
N/A
High Intensity User
N/A
Section 2.4.2.4.2
and Section
4.2.2.3.12 -
Automotive AC
Refrigerant
Inhalation 1-hr
Low Intensity User
iu:
875
Medium Intensity User
x.x
High Intensity User
. (.
i'j
Inhalation 8-hr
Low Intensity User
:i(.
939
Medium Intensity User
IS
76
High Intensity User
4 "
r
Dermal
Low Intensity User
797
N/A
Medium Intensity User
136
N/A
High Intensity User
107
N/A
Degreasers: gasket
remover, transmission
cleaners, carburetor
cleaner, brake
quieter/cleaner
Section 2.4.2.4.5
and Section
4.2.2.3.1 - Brake
Cleaner
Inhalation 1-hr
Low Intensity User
24
:u:
Medium Intensity User
1 "
14
High Intensity User
o 40
: ^
Inhalation 8-hr
Low Intensity User
5(1
:ix
Medium Intensity User
. (.
15
High Intensity User
().(>()
: 0
Dermal
Low Intensity User
258
N/A
Medium Intensity User
'j:
N/A
Page 418 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Consumer
Condition of
I so Scenario
i sit moi:
(bench ni;irk
MOI. = 30)
IS\sl;imkT
Ciileiion
Siih Csiicgon
Mxpnsuiv Roiilc
iiml Dumlinn
Scciiiirin Description
MOI.
(hcnchiiiiirk
MOI.=30)
High Intensity User
4.2
\ \
Low Intensity User
1 ^
llu
Inhalation 1-hr
Medium Intensity User
1.4
i:
Section 2.4.2.4.8
and Section
High Intensity User
0 M)
:.o
Low Intensity User
:~
1 IS
4.2.2.3.3 -
Inhalation 8-hr
Medium Intensity User
vll
n
Carburetor
Cleaner
High Intensity User
<).<>()
: 0
Low Intensity User
1"
\ \
Dermal
Medium Intensity User
15
\ \
High Intensity User
4<>
N.A
Low Intensity User
5 4
4"
Inhalation 1-hr
Medium Intensity User
<).<><)
5 1
High Intensity User
o 20
I) 'JO
Section
Low Intensity User
i:
5(1
2.4.2.4.12 and
Section 4.2.2.3.6
- Engine Cleaner
Inhalation 8-hr
Medium Intensity User
1 ^
5 4
High Intensity User
0 2d
I) so
Low Intensity User
4'
N/A
Dermal
Medium Intensity User
lu
\ \
High Intensity User
4'J
\ \
Low Intensity User
5
51
Section
2 4 2 4 13 and
Inhalation 1-hr
Medium Intensity User
1 1
•J 1
High Intensity User
o :<)
1 4
Section 4.2.2.3.7
Low Intensity User
1 ^
55
- Gasket
Remover
Inhalation 8-hr
Medium Intensity User
2.3
"
High Intensity User
(1.4(1
1 4
Dermal
Low Intensity User
33
N/A
Page 419 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Ciileiion
Siih Csiicgon
('onsunior
Condition of
I so Scenario
Mxposiiiv Kniilc
iiml Dumlinn
Scciiiirio Description
i scr moi:
(bench ni;uk
MOI. = 30)
IVtshimliT
MOI.
(hcnchiiiiirk
MOI.=30)
Medium Intensity User
5.9
\ \
High Intensity User
4."
\"\
Lubricants and greases
Degreasers - Aerosol
and non-aerosol
degreasers and
cleaners
Section 2.4.2.4.5
and Section
4.2.2.3.1 - Brake
Cleaner
Inhalation 1-hr
Low Intensity User
24
:u:
Medium Intensity User
1 "
14
High Intensity User
o 4(1
2 ^
Inhalation 8-hr
Low Intensity User
5(1
:ix
Medium Intensity User
. (.
15
High Intensity User
I) (.0
: u
Dermal
Low Intensity User
258
N,A
Medium Intensity User
1>.2
\ \
High Intensity User
4 :
\ \
Section 2.4.2.4.8
and Section
4.2.2.3.3 -
Carburetor
Cleaner
Inhalation 1-hr
Low Intensity User
1 ^
i in
Medium Intensity User
1 4
i:
High Intensity User
0 M)
2 0
Inhalation 8-hr
Low Intensity User
2~
1 IS
Medium Intensity User
vll
n
High Intensity User
I) (.1)
2 u
Dermal
Low Intensity User
1 "5
\ \
Medium Intensity User
15
\ \
High Intensity User
4<>
\ \
Section
2.4.2.4.12 and
Section 4.2.2.3.6
- Engine Cleaner
Inhalation 1-hr
Low Intensity User
5 4
4"
Medium Intensity User
I) (.0
5 1
High Intensity User
0 :<)
0 <>()
Inhalation 8-hr
Low Intensity User
12
50
Medium Intensity User
n
5 4
High Intensity User
0 :
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Ciileiion
Siih Csiicgon
(OIISIIIIHT
Condition of
I so Scenario
Mxposiiiv Kniilc
iiml Dumlinn
SiTiiiirio IK'scriplion
i scr moi:
(benchmurk
MOI. = 30)
IVtshimliT
MOI.
(hcnchiiiiirk
MOI.=30)
Dermal
Low Intensity User
43
N/A
Medium Intensity User
lu
N/A
High Intensity User
4<>
N/A
Section
2.4.2.4.13 and
Section 4.2.2.3.7
- Gasket
Remover
Inhalation 1-hr
Low Intensity User
5 <>
51
Medium Intensity User
1 1
y I
High Intensity User
o :
l(."
Medium Intensity User
I (.
r
High Intensity User
0
::
Inhalation 8-hr
Low Intensity User
35
I'U
Medium Intensity User
. (.
:u
High Intensity User
I) (.0
: 4
Dermal
Low Intensity User
N,A
Medium Intensity User
:n
N/A
High Intensity User
S 2
N/A
Arts, crafts, and hobby materials
Crafting glue and
cement/concrete
Section 2.4.2.4.3
and Section
4.2.2.3.8 -
Adhesives
Inhalation 1-hr
Low Intensity User
(¦(¦4
2188
Medium Intensity User
:y
1
High Intensity User
o 5(1
42
Inhalation 8-hr
Low Intensity User
1066
2535
Medium Intensity User
52
150
Page 421 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Ciileiion
Siih Csiicgon
('onsunior
Condition of
I so Scenario
Mxposiiiv Kniilc
iiml Dumlinn
SiTiiiirio IK'scriplion
i scr moi:
(benchmurk
MOI. = 30)
IVtshimliT
MOI.
(hcnchiiiiirk
MOI.=30)
High I ute nsit\ L scr
1 1
4 "
Dermal
Low Intensity User
I4<>
\ \
Medium Intensity User
11
\ \
High Intensity User
: 5
\ \
Other Uses
Anti-adhesive agent -
anti-spatter welding
aerosol
Section
2.4.2.4.15 and
Section
4.2.2.3.15 - Weld
Spatter
Protectant
Inhalation 1-hr
Low Intensity User
4 (>
51
Medium Intensity User
<).<;<)
in
High Intensity User
o :
Medium Intensity User
: i
i:
High Intensity User
0 M)
1 5
Dermal
Low Intensity User
<><>
\ \
Medium Intensity User
12
N/A
High Intensity User
5 (1
N/A
Brush Cleaner
Section 2.4.2.4.6
and Section
4.2.2.3.10 -
Brush Cleaner
Inhalation 1-hr
Low Intensity User
3956
44077
Medium Intensity User
786
6209
High Intensity User
462
1293
Inhalation 8-hr
Low Intensity User
8981
50216
Medium Intensity User
1653
6916
High Intensity User
191
919
Dermal
Low Intensity User
1135
N/A
Medium Intensity User
457
N/A
High Intensity User
456
N/A
Carbon Remover
Section 2.4.2.4.7
and Section
4.2.2.3.2 -
Carbon Remover
Inhalation 1-hr
Low Intensity User
'J 5
|Ui
Medium Intensity User
0 'JO
>> ~
High Intensity User
0 :
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Consumer
Condition of
I so Scenario
i scr moi:
(bench ni;irk
MOI. = 30)
|}\s(;mdcr
Ciileiion
Siih Csiicgon
Mxpnsuiv Roiilc
iind Diimlinn
Scciiiirin Description
MOI.
(hcnchiiiiirk
MOI.=30)
Medium Intensils I ser
: i
1 1
High Intensit\ I scr
0 2d
I) 'JO
Low Intensity User
44
N/A
Dermal
Medium Intensity User
(> ()
N/A
High Intensity User
4."
N/A
9705
9706
Page 423 of 725
-------
9707
9708
9709
9710
9711
9712
9713
9714
9715
9716
9717
9718
9719
9720
9721
9722
9723
9724
9725
9726
9727
9728
9729
9730
9731
9732
9733
9734
9735
9736
9737
9738
9739
9740
9741
9742
9743
9744
9745
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
5 Risk Determination
5.1 Unreasonable Risk
5.1.1 Overview
In each risk evaluation under TSCA section 6(b), EPA determines whether a chemical substance
presents an unreasonable risk of injury to health or the environment, under the conditions of use.
These determinations do not consider costs or other non-risk factors. In making these
determinations, EPA considers relevant risk-related factors, including, but not limited to: the
effects of the chemical substance on health and human exposure to such substance under the
conditions of use (including cancer and non-cancer risks); the effects of the chemical substance
on the environment and environmental exposure under the conditions of use; the population
exposed (including any potentially exposed or susceptible subpopulations (PESS)); the severity
of hazard (including the nature of the hazard, the irreversibility of the hazard); and uncertainties.
EPA also takes into consideration the Agency's confidence in the data used in the risk estimate.
This includes an evaluation of the strengths, limitations and uncertainties associated with the
information used to inform the risk estimate and the risk characterization. This approach is in
keeping with the Agency's final rule, Procedures for Chemical Risk Evaluation Under the
Amended Toxic Substances Control Act (82 FR 33726).21
Under TSCA, conditions of use are defined as the circumstances, as determined by the
Administrator, under which the substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed of. TSCA §3(4).
An unreasonable risk may be indicated when health risks under the conditions of use are
identified by comparing the estimated risks with the risk benchmarks and where the risks affect
the general population or PESS, identified as relevant. For workers (which are one example of
PESS), an unreasonable risk may be indicated when risks are not adequately addressed through
expected use of workplace practices and exposure controls, including engineering controls or use
of personal protective equipment (PPE). An unreasonable risk may also be indicated when
environmental risks under the conditions of use are greater than environmental risk benchmarks.
The risk estimates contribute to the evidence EPA uses to determine unreasonable risk.
EPA uses the term "indicates unreasonable risk" to indicate EPA concern for potential
unreasonable risk. For non-cancer endpoints, "less than MOE benchmark" is used to indicate
potential unreasonable risk; this occurs if an MOE value is less than the benchmark MOE (e.g.,
MOE 0.3 < benchmark MOE 30). For cancer endpoints, EPA uses the term "greater than risk
benchmark" to indicate potential unreasonable risk; this occurs, for example, if the lifetime
21 This risk determination is being issued under TSCA section 6(b) and the terms used, such as unreasonable risk,
and the considerations discussed are specific to TSCA. Other statutes have different authorities and mandates and
may involve risk considerations other than those discussed here.
Page 424 of 725
-------
9746
9747
9748
9749
9750
9751
9752
9753
9754
9755
9756
9757
9758
9759
9760
9761
9762
9763
9764
9765
9766
9767
9768
9769
9770
9771
9772
9773
9774
9775
9776
9777
9778
9779
9780
9781
9782
9783
9784
9785
9786
9787
9788
9789
9790
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
cancer risk value is greater than 1 in 10,000 (e.g., cancer risk value is 5xl0"2 which is greater
than the standard range of acceptable cancer risk benchmarks of lxlO"4 to lxlO"6). For
environmental endpoints, to indicate potential unreasonable risk EPA uses a risk quotient (RQ)
value "greater than 1" (i.e., RQ >1). Conversely, EPA uses the term "does not indicate
unreasonable risk" to indicate that it is unlikely that EPA has a concern for potential
unreasonable risk. More details are described below.
The degree of uncertainty surrounding the MOEs, cancer risk or RQs is a factor in determining
whether or not unreasonable risk is present. Where uncertainty is low, and EPA has high
confidence in the hazard and exposure characterizations (for example, the basis for the
characterizations is measured or monitoring data or a robust model and the hazards identified for
risk estimation are relevant for conditions of use), the Agency has a higher degree of confidence
in its risk determination. EPA may also consider other risk factors, such as severity of endpoint,
reversibility of effect, or exposure-related considerations, such as magnitude or number of
exposures, in determining that the risks are unreasonable under the conditions of use. Where
EPA has made assumptions in the scientific evaluation, whether or not those assumptions are
protective will also be a consideration. Additionally, EPA considers the central tendency and
high-end scenarios when determining the unreasonable risk. High-end risk estimates (i.e., 95th
percentile) are generally intended to cover individuals or sub-populations with greater exposure
(PESS) and central tendency risk estimates are generally estimates of average or typical
exposure.
EPA may make a no unreasonable risk determination for conditions of use where the substance's
hazard and exposure potential, or where the risk-related factors described previously, lead EPA
to determine that the risks are not unreasonable.
5.1.2 Risks to Human Health
5.1.2.1 Determining Non-Cancer Risks
Margins of exposure (MOEs) are used in EPA's risk evaluations as a starting point to estimate
non-cancer risks for acute and chronic exposures. The non-cancer evaluation refers to potential
adverse health effects associated with health endpoints other than cancer, including to the body's
organ systems, such as reproductive/developmental effects, cardiac and lung effects, and kidney
and liver effects. The MOE is the point of departure (POD) (an approximation of the no-
observed adverse effect level (NOAEL) or benchmark dose level (BMDL)) for a specific health
endpoint divided by the exposure concentration for the specific scenario of concern. The
benchmark for the MOE that is used accounts for the total uncertainty in a POD, including, as
appropriate: (1) the variation in sensitivity among the members of the human population (i.e.,
intrahuman/intraspecies variability); (2) the uncertainty in extrapolating animal data to humans
(i.e., interspecies variability); (3) the uncertainty in extrapolating from data obtained in a study
with less-than-lifetime exposure to lifetime exposure (i.e., extrapolating from subchronic to
chronic exposure); and (4) the uncertainty in extrapolating from a lowest observed adverse effect
level (LOAEL) rather than from a NOAEL. MOEs can provide a non-cancer risk profile by
presenting a range of estimates for different non-cancer health effects for different exposure
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scenarios and are a widely recognized point estimate method for evaluating a range of potential
non-cancer health risks from exposure to a chemical.
A calculated MOE that is less than the benchmark MOE indicates the possibility of risk to
human health. Whether those risks are unreasonable will depend upon other risk-related factors,
such as severity of endpoint, reversibility of effect, exposure-related considerations (e.g.,
duration, magnitude, frequency of exposure, population exposed), and the confidence in the
information used to inform the hazard and exposure values. If the calculated MOE is greater than
the benchmark MOE, generally it is less likely that there is risk.
Uncertainty factors (UFs) also play an important role in the risk estimation approach and in
determining unreasonable risk. A lower benchmark MOE (e.g., 30) indicates greater certainty in
the data (because fewer of the default UFs relevant to a given POD as described above were
applied). A higher benchmark MOE (e.g., 1000) would indicate more uncertainty in risk
estimation and extrapolation for the MOE for specific endpoints and scenarios. However, these
are often not the only uncertainties in a risk evaluation.
5.1.2.2 Determining Cancer Risks
EPA estimates cancer risks by determining the incremental increase in probability of an
individual in an exposed population developing cancer over a lifetime (excess lifetime cancer
risk (ELCR)) following exposure to the chemical under specified use scenarios. Standard cancer
benchmarks used by EPA and other regulatory agencies are an increased cancer risk above
benchmarks ranging from 1 in 1,000,000 to 1 in 10,000 (i.e., lxlO"6 to lxlO"4) depending on the
subpopulation exposed. Generally, EPA considers 1 x 10"6 to lx 10"4 as the appropriate
benchmark for the general population, consumer users, and non-occupational PESS.22
For methylene chloride, the EPA, consistent with case law and 2017 NIOSH guidance,23 used 1 x
10"4 as the benchmark for the purposes of this risk determination for individuals in industrial and
commercial work environments subject to Occupational Safety and Health Act (OSHA)
requirements. It is important to note that lxlO"4 is not a bright line and EPA has discretion to
make risk determinations based on other benchmarks as appropriate. It is important to note that
22 As an example, whenEPA's Office of Water in 2017 updated the Human Health Benchmarks for Pesticides, the
benchmark for a "theoretical upper-bound excess lifetime cancer risk" from pesticides in drinking water was
identified as 1 in 1,000,000 to 1 in 10,000 over a lifetime of exposure (EPA. Human Health Benchmarks for
Pesticides: Updated 2017 Technical Document. January 2017. https://www.epa.gov/sites/production/files/2015-
10/documents/hh-benchmarks-techdoc.pdf). Similarly, EPA's approach under the Clean Air Act to evaluate residual
risk and to develop standards is a two-step approach that includes a "presumptive limit on maximum individual
lifetime [cancer] risk (MIR) of approximately 1 in 10 thousand" and consideration of whether emissions standards
provide an ample margin of safety to protect public health "in consideration of all health information, including the
number of persons at risk levels higher than approximately 1 in 1 million, as well as other relevant factors" (54 FR
38044, 38045, September 14, 1989).
23 International Union, UAW v. Pendergrass, 878 F.2d 389 (D.C. Cir. 1989), citing Industrial Union Department,
AFL-CIO v. American Petroleum Institute, 448 U.S. 607 (1980) ("Benzene decision"), in which it was found that a
lifetime cancer risk of 1 in 1,000 was found to be clearly significant; and NIOSH (20.1.6). Current intelligence
bulletin 68: NIOSH chemical carcinogen policy, available at https://www.cdc.gov/niosh/docs/2017-100/pdf/2017-
100.pdf.
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exposure-related considerations (duration, magnitude, population exposed) can affect EPA's
estimates of the ELCR.
5.1.3 Determining Environmental Risk
To assess environmental risk, EPA identifies and evaluates environmental hazard data for
aquatic, sediment-dwelling, and terrestrial organisms exposed under acute and chronic exposure
conditions. The environmental risk includes any risks that exceed benchmarks to the aquatic
environment from levels of the evaluated chemical released to the environment (e.g., surface
water, sediment, soil, biota) under the conditions of use, based on the fate properties, release
potential, and reasonably available environmental monitoring and hazard data.
Environmental risks are estimated by calculating a RQ. The RQ is defined as:
RQ = Environmental Concentration / Effect Level
An RQ equal to 1 indicates that the exposures are the same as the concentration that causes
effects. If the RQ is greater than 1, the exposure is greater than the effect concentration and there
is potential for risk presumed. If the RQ is less than 1, the exposure is less than the effect
concentration and unreasonable risk is not likely. The Concentrations of Concern (COC) or
hazard value for certain aquatic organisms are used to calculate RQs for acute and chronic
exposures. For environmental risk, EPA is more likely to determine that there is unreasonable
risk if the RQ exceeds 1 for the conditions of use being evaluated. Consistent with EPA's human
health evaluations, the RQ is not treated as a bright line and other risk-based factors may be
considered (e.g., exposure scenario, uncertainty, severity of effect) for purposes of making a risk
determination.
5.2 Risk Determination for Methylene Chloride
EPA's determination of unreasonable risk for specific conditions of use of methylene chloride
listed below are based on health risks to workers, occupational non-users (ONUs), consumers,
bystanders, and to the environment (aquatic organisms) during occupational and consumer
exposures. As described below, risks to general population either were not relevant for these
conditions of use or were evaluated and not found to be unreasonable. For the conditions of use
where EPA found no unreasonable risk, EPA describes the estimated risks in Section 4.6 (Table
4-104 and Table 4-105).
• Environmental risks: EPA determined that environmental exposures are expected for
aquatic species for the conditions of use under TSCA. All but two conditions of use
(recycling and disposal) had RQs < 1, indicating no unreasonable risk. An acute RQ that
exceeds 1 indicates that releases resulted in acute risks. A chronic RQ that exceeds 1
indicates that facility modeled releases had an instream concentration above or equal to
the COC. Chronic risk was identified for those facilities where RQ exceeds 1 and
threshold days of exceedance were surpassed. In general, the majority of releases of
methylene chloride to the aquatic environment do not exceed the aquatic benchmark.
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However, there are specific facilities where estimate releases result in modeled surface
water concentrations that exceed the aquatic benchmark. Given the uncertainties in the
data for the limited number of data points above the RQ, EPA does not consider these
risks unreasonable (see Section 4.1.2).
• Occupational Non-Users (ONUs): While the difference between ONU exposures and
workers directly handling the chemical generally cannot be quantified, EPA assumed
that, in most cases, ONU inhalation exposures are expected to be lower than inhalation
exposures for workers directly handling the chemical substance. To account for those
instances where monitoring data or modeling did not distinguish between worker and
ONU inhalation exposure estimates, EPA considered the central tendency risk estimate
when determining ONU risk. For dermal exposures, because ONUs are not expected to
be dermally exposed to methylene chloride, dermal risks to ONUs generally were not
identified. For inhalation exposures, EPA, where possible, estimated ONU exposures and
described the risks separately from workers directly exposed.
• Dermal risks: EPA determined that occupational dermal exposures were expected. For
acute and chronic cancer dermal exposures, risk estimates for these pathways do not
indicate risk when expected PPE was considered (gloves PF = 10 or PF = 20). For
chronic non-cancer dermal exposures, while some risks are indicated with gloves PF =
10, EPA has determined that these risks are not unreasonable.
• General population: As part of the problem formulation for methylene chloride, EPA
identified exposure pathways under other environmental statutes, administered by EPA,
which adequately assess and effectively manage exposures and for which long-standing
regulatory and analytical processes already exist, i.e., the Clean Air Act (CAA), the Safe
Drinking Water Act (SDWA), the Clean Water Act (CWA) and the Resource
Conservation and Recovery Act (RCRA). The Office of Chemical Safety and Pollution
Prevention works closely with EPA offices that administer and implement the regulatory
programs under these statutes. In some cases, EPA has determined that chemicals present
in various media pathways (i.e., air, water, land) fall under the jurisdiction of existing
regulatory programs and associated analytical processes carried out under other EPA-
administered statutes and have been assessed and effectively managed under those
programs. EPA believes that the TSCA risk evaluation should focus on those exposure
pathways associated with TSCA uses that are not subject to the regulatory regimes
discussed above because these pathways are likely to represent the greatest areas of
concern to EPA. Exposures to methylene chloride by receptors (i.e., general population)
may occur from industrial and/or commercial uses; industrial releases to air, water or
land; and other conditions of use. As described above, other environmental statutes
administered by EPA adequately assess and effectively manage these exposures.
Therefore, EPA did not evaluate hazards or exposures to the general population in this
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9908 risk evaluation, and there is no risk determination for the general population (
9909 2018cY
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9910 Table 5-1 Unreasonable Risk Determinations by Condition of Use
Condition of I
se
Life Cycle
Stsi«e
C:ite«iorv
Sub Csilegorv
I nrciisoiiiihlc Risk Dclcrmiiuilion
Manufacturing
Domestic
Manufacturing
Section 6(b)(4)(A) unreasonable risk determination for
manufacturing
domestic manufacture of methylene chloride:
- Does not present an unreasonable risk of injury to health
(workers, occupational non-users1).
Exposure scenario with the highest risk estimate: CNS
adverse effects resulting from acute inhalation exposure.
Benchmark - workers and ONUs: Acute inhalation CNS
effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10. Chronic,
cancer inhalation lung and liver tumors: Benchmark = lxlO"4
Risk estimate - workers:
CNS effects: Acute inhalation 15-minute MOE 4548
and 232 (central tendency and high end) with PPE
(respirator APF 25) (Table 4-6).
Liver effects: Chronic inhalation MOE 5164 and 409
(central tendency and high end) with PPE (respirator
APF 25) (Table 4-7)
Cancer risks: Chronic inhalation 1.83E-09 and 2.97E-
08 (central tendency and high end) with PPE
(respirator APF 25) (Table 4-8)
Risk estimate - ONUs:
CNS effects: Acute inhalation 15-minute MOE 182
and 9.3 (central tendency and high end) (Table 4-6).
Liver effects: Chronic inhalation MOE 207 and 16
(central tendency and high end) (Table 4-7)
Cancer risks: Chronic inhalation 2.00E-07 and 3.26E-
06 (central tendency and high end) (Table 4-8)
Systematic Review confidence ratine (hazard): Medium.
Systematic Review confidence ratine (inhalation exposure):
Medium to high.
Risk Considerations: Risk estimates for workers and ONUs
for acute and chronic inhalation do not indicate risk. While
risk estimates for some pathways of occupational exposure
for this condition of use (such as acute non-cancer inhalation
15-minute exposures (high end)) indicate risk in the absence
of PPE, risk estimates for these pathways do not indicate risk
when expected use of PPE (respirator APF 25 and gloves PF
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Condition of I se
Life Cycle
St:i»e
Ciileiiorv
Sub C:ile«iorv
I nre:isoiiiihle Risk Delermiinilion
= 20) was considered for workers (Table 4-6, Table 4-7,
Table 4-8, Table 4-69, Table 4-70, Table 4-71). Additionally,
EPA calculated risk estimates using personal breathing zone
monitoring data and assumed ONU exposures could be as
high as worker exposures as a high-end estimate. There is
uncertainty in this assumption since the data did not
distinguish between worker and ONU inhalation
exposure estimates. ONU inhalation exposures are expected
to be lower than inhalation exposures for workers directly
handling the chemical substance. To account for this
uncertainty, EPA considered the central tendency estimate
when determining ONU risk.
Estimated exposed worker population: 1.200 workers and
occupational non-users2 (Table 2-27).
Import
Import
Section 6(b)(4)(A) unreasonable risk determination for
import of methylene chloride:
- Presents an unreasonable risk of injury to health
(occupational non-users1).
- Does not present an unreasonable risk of injury to health
(workers).
Unreasonable risk driver - occupational non-users: CNS
adverse effects resulting from acute inhalation exposure (1-
hr).
Driver benchmark: Acute inhalation CNS effects: Benchmark
MOE = 30.
Risk estimate - ONUs:
CNS effects: Acute (1-hr) inhalation MOEs 4.7 and
2.6 (central tendency and high end) (Table 4-15).
Systematic Review confidence ratine (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.3).
Risk Considerations: ONU unreasonable risk determination
reflects the severity of the effect (neurotoxicity including loss
of consciousness and fatality) associated with exposure to
methylene chloride and the expected absence of PPE. While
risk estimates for other pathways of occupational exposure
for this condition of use (such as acute non-cancer inhalation
(8-hrs, high end exposures and 1-hr, central tendency and
high end exposures) and chronic non-cancer inhalation
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Life Cycle
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Condition of I
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Sub C:ile«iorv
I nre:isoiiiihle Risk Delermiiuilion
exposures (central tendency and high end)) indicate risk in
the absence of PPE, risk estimates for these pathways do not
indicate risk when expected use of PPE (respirator APF 25
and gloves PF = 20) was considered for workers (Table 4-15,
Table 4-16, Table 4-69, Table 4-70, Table 4-71).
Additionally, EPA calculated risk estimates using personal
breathing zone monitoring data, and assumed ONU exposures
could be as high as worker exposures as a high-end estimate.
There is uncertainty in this assumption since the data did
not distinguish between worker and ONU inhalation
exposure estimates. ONU inhalation exposures are expected
to be lower than inhalation exposures for workers directly
handling the chemical substance. To account for this
uncertainty, EPA considered the central tendency estimate
when determining ONU risk. The high volatility of
methylene chloride and potentially severe effects from short
term (1-hr) exposure are factors when weighing uncertainties.
As discussed in section 2.4.1.1, the OSHA Methylene
Chloride Standard was updated in 1997. The incremental
general exposure reduction due to the PEL update indicates
that exposure data from before the update are adequate for
EPA's risk evaluation purposes. Use of pre-PEL data may
overestimate some exposures in some occupational exposure
scenarios. In consideration of the uncertainties in the
exposures for ONUs for this COU, EPA has determined the
non-cancer risks presented by chronic inhalation are not
unreasonable, though unreasonable risk remains from acute
inhalation.
Estimated exposed worker population: 2.300 workers and
occupational non-users2 (Table 2-27).
Processing
Processing as
a reactant
Intermediate in
industrial gas
manufacturing
Section 6(b)(4)(A) unreasonable risk determination for
processing of methylene chloride as a reactant:
- Does not present an unreasonable risk of injury to health
(workers, occupational non-users1).
Exposure scenario with the highest risk estimate: Liver
Intermediate for
pesticide,
fertilizer, and
other agricultural
chemical
manufacturing
adverse effects resulting from chronic non-cancer inhalation
exposure.
Benchmark — workers and ONUs' Acute inhalation CNS
Intermediate for
petrochemical
manufacturing
effects: Benchmark MOE = 30. Chronic, non-cancer
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Life Cycle
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Condition of I
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se
Sub C:ile«i<>r\
I nre:isoiiiihle Risk Detenu in :il ion
inhalation liver effects: Benchmark MOE =10. Chronic,
cancer inhalation lung and liver tumors: Benchmark = lxlO"4
Risk estimate - workers:
CNS effects: Acute inhalation MOEs 4441 and 698
(central tendency and high end) with PPE (respirator
APF 25) (Table 4-9).
Liver effects: Chronic inhalation MOEs 1154 and
181 (central tendency and high end) with PPE
(respirator APF 25) (Table 4-10).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 178 and 28
(central tendency and high end) (Table 4-9).
Liver effects: Chronic inhalation MOEs 46 and 7.2
(central tendency and high end) (Table 4-10).
Cancer risks: Chronic inhalation 8.95E-07 and 7.36E-
06 (central tendency and high end) (Table 4-11)
Svstematic Review confidence ratine (hazard): Medium.
Intermediate for
other chemicals
Systematic Review confidence ratine (inhalation exposure):
Medium to high.
Risk Considerations: Risk estimates for workers and ONUs
for acute and chronic inhalation do not indicate risk. While
risk estimates for some pathways of occupational exposure
for this condition of use (such as acute non-cancer inhalation
exposures (8-hr (high end) and 15-min point estimate) and
chronic non-cancer inhalation exposures (high end)) indicate
risk in the absence of PPE, risk estimates for these pathways
do not indicate risk when expected use of PPE (APF 25 and
gloves PF = 20) was considered for workers (Table 4-9,
Table 4-10, Table 4-11, Table 4-69, Table 4-70, Table 4-71).
Additionally, EPA calculated risk estimates using personal
breathing zone monitoring data and assumed ONU exposures
could be as high as worker exposures as a high-end estimate.
There is uncertainty in this assumption since the data did not
distinguish between worker and ONU inhalation exposure
estimates. ONU inhalation exposures are expected to be
lower than inhalation exposures for workers directly handling
the chemical substance. To account for this uncertainty, EPA
considered the central tendency estimate when determining
ONU risk.
Estimated exposed worker population: 460 workers and 120
occupational non-users2 (Table 2-27).
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Condition of I se
Life Cycle
St:i»e
Ciileiiorv
Sub C:ile«iorv
I nreasonahle Risk Determination
Incorporated
into a
formulation,
mixture, or
reaction
product
Solvents (for
cleaning or
degreasing)
Solvents (which
become part of
product
formulation or
mixture)
Propellants and
blowing agents
for all other
chemical product
and preparation
manufacturing
Propellants and
blowing agents
for plastics
product
manufacturing
Paint additives
and coating
additives not
described by
other codes
Laboratory
chemicals for all
other chemical
product and
preparation
manufacturing
Laboratory
chemicals
Processing aid,
not otherwise
listed for
petrochemical
manufacturing
Adhesive and
sealant
chemicals in
Section 6(b)(4)(A) unreasonable risk determination for
incorporation of methylene chloride into a formulation,
mixture, or reaction product:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, liver adverse
effects resulting from chronic non-cancer inhalation exposure
for ONUs.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10.
Risk estimate - workers:
CNS effects: Acute inhalation MOEs 81 and 6.5
(central tendency and high end) with PPE (respirator
APF 50) (Table 4-12).
Liver effects: Chronic inhalation MOEs 20.9 and 1.7
(central tendency and high end) with PPE (respirator
APF 50) (Table 4-13).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 1.61 and 0.13
(central tendency and high end) (Table 4-12).
Liver effects: Chronic inhalation MOEs 0.42 and
0.034 (central tendency and high end) (Table 4-13).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium.
Risk Considerations: For workers, risks are indicated even
when expected PPE (APF 50) was considered for high end
acute and chronic non-cancer inhalation scenarios for this
condition of use. While risk estimates for other occupational
exposure scenarios for this condition of use (such as acute
non-cancer inhalation (central tendency), chronic non-cancer
inhalation (central tendency), and chronic cancer inhalation
exposures (high end)) indicate risk in the absence of PPE,
risk estimates for these pathways do not indicate risk when
expected use of PPE was considered (Table 4-12, Table 4-13,
Table 4-14). ONU unreasonable risk determination reflects
the severity of the effects associated with acute exposures to
methylene chloride and the expected absence of PPE.
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Life Cycle
St:i»e
Condition of I
Ciileiiorv
se
Sub C:ile«i<>r\
I nreasonahle Risk Detenu in :il ion
Estimated exposed worker population: 4.500 workers and
adhesive
manufacturing
Unknown
function for oil
and gas drilling,
extraction, and
support activities
occupational non-users2 (Table 2-27).
Repackaging
Solvents (which
become part of
product
formulation or
mixture) for all
other chemical
product and
preparation
manufacturing
All other
chemical product
and preparation
manufacturing
Section 6(b)(4)(A) unreasonable risk determination for
repackaging of methvlene chloride:
- Presents an unreasonable risk of injury to health
(occupational non-users1).
- Does not present an unreasonable risk of injury to health
(workers).
Unreasonable risk driver - occupational non-users: CNS
adverse effects resulting from acute inhalation exposure (1-
hr).
Driver benchmark: Acute inhalation CNS effects: Benchmark
MOE = 30.
Risk estimate - ONUs:
CNS effects: Acute (1-hr) inhalation MOEs 4.7 and
2.6 (central tendency and high end) (Table 4-15).
Svstematic Review confidence ratine (hazard): Medium.
Svstematic Review confidence ratine (inhalation exposure):
Medium to low (see Section 2.4.1.3).
Risk Considerations: ONU unreasonable risk determination
reflects the severity of the effect (neurotoxicity including loss
of consciousness and fatality) associated with exposure to
methylene chloride and the expected absence of PPE. While
risk estimates for other pathways of occupational exposure
for this condition of use (such as acute non-cancer inhalation
(8-hrs, high end exposures and 1-hr, central tendency and
high end exposures) and chronic non-cancer inhalation
exposures (central tendency and high end)) indicate risk in
the absence of PPE, risk estimates for these pathways do not
indicate risk when expected use of PPE (respirator APF 25
and gloves PF = 20) was considered for workers (Table 4-15,
Table 4-16, Table 4-69, Table 4-70, Table 4-71).
Additionally, EPA calculated risk estimates using personal
breathing zone monitoring data, and assumed ONU exposures
could be as high as worker exposures as a high-end estimate.
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Condition of I se
Life Cycle
St:i»e
Ciileiiorv
Sub C:ile«iorv
I nreasonahle Risk Determination
There is uncertainty in this assumption since the data did not
distinguish between worker and ONU inhalation exposure
estimates. ONU inhalation exposures are expected to be
lower than inhalation exposures for workers directly handling
the chemical substance. To account for this uncertainty, EPA
considered the central tendency estimate when determining
ONU risk. The high volatility of methylene chloride and
potentially severe effects from short term (1-hr) exposure are
factors when weighing uncertainties. As discussed in section
2.4.1.1, the OSHA Methylene Chloride Standard was updated
in 1997. The incremental general exposure reduction due to
the PEL update indicates that exposure data from before the
update are adequate for EPA's risk evaluation purposes. Use
of pre-PEL data may overestimate some exposures in some
occupational exposure scenarios. In consideration of the
uncertainties in the exposures for ONUs for this COU, EPA
has determined the non-cancer risks presented by chronic
inhalation are not unreasonable, though unreasonable risk
remains from acute inhalation.
Recycling
Recycling
Section 6(b)(4)(A) unreasonable risk determination for
recycling of methylene chloride:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and occupational non-
users: CNS adverse effects resulting from acute inhalation
exposure, and liver adverse effects from chronic, non-cancer
inhalation exposure.
Driver benchmark - workers and occupational non-users:
Acute inhalation CNS effects: Benchmark MOE = 30.
Chronic, non-cancer inhalation liver effects: Benchmark
MOE = 10.
Risk estimate - workers:
CNS effects: Acute inhalation MOEs 15.70 and
15.11 (central tendency and high end) (Table 4-18).
Liver effects: Chronic inhalation MOEs 4.08 and 3.9
(central tendency and high end) (Table 4-19).
Risk estimate - occupational non-users:
CNS effects: Acute inhalation MOEs 15.70 and
15.11 (central tendency and high end) (Table 4-18).
Liver effects: Chronic inhalation MOEs 4.08 and 3.9
(central tendency and high end) (Table 4-19).
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Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.2.21).
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (respirator APF 25)
for workers with this condition of use (Table 4-18, Table
4-19). ONU unreasonable risk determination reflects the
severity of the effects associated with exposures to methylene
chloride and the expected absence of PPE.
Estimated exposed worker population: 12,000 workers and
7,600 occupational non-users2 (Table 2-27).
Distribution in
commerce
Distribution
Distribution
Section 6(b)(4)(A) unreasonable risk determination for
distribution of methylene chloride:
- Does not present an unreasonable risk of injury to health
(workers and occupational non-users).
Risk Considerations: A quantitative evaluation of the
distribution of methylene chloride was not included in the
risk evaluation because exposures and releases from
distribution were considered within each condition of use.
Industrial and
commercial
use
Solvents (for
cleaning or
degreasing)
Batch vapor
degreaser (e.g.,
open-top, closed-
loop)
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as a
solvent for batch vapor degreasing:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, liver effects
resulting from chronic, non-cancer inhalation exposure, and
cancer effects (liver and lung tumors) from chronic inhalation
exposure for ONUs.
Driver benchmark - workers: Acute inhalation CNS effects:
Benchmark MOE = 30. Chronic, non-cancer inhalation liver
effects: Benchmark MOE =10.
Driver benchmark - ONUs: Acute inhalation CNS effects:
Benchmark MOE = 30. Chronic, non-cancer inhalation liver
effects: Benchmark MOE =10. Chronic, cancer inhalation
lung and liver tumors: Benchmark = lxlO 4
Risk estimate - workers:
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CNS effects: Acute inhalation MOE 20 (high end)
with PPE (respirator APF 50) (Table 4-21).
Liver effects: Chronic inhalation MOE 6.7 (high end)
with PPE (respirator APF 50) (Table 4-22).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 3.4 and 0.64
(central tendency and high end) (Table 4-21).
Liver effects: Chronic inhalation MOEs 1.16 and
0.22 (central tendency and high end) (Table 4-22).
Cancer risks: 2.43E-04 (high end) (Table 4-23).
Systematic Review confidence rating (hazard):
Medium.
Systematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.3).
Risk Considerations: For workers, unreasonable risks are
indicated even when expected PPE (APF 50) was considered
for high end acute and chronic non-cancer inhalation
scenarios for this condition of use While risk estimates for
other occupational exposure scenarios for this condition of
use (such as acute non-cancer inhalation (8-hrs, central
tendency) and chronic non-cancer inhalation exposures
(central tendency) and cancer (high end exposures)) indicate
risk in the absence of PPE, risk estimates for these pathways
do not indicate risk when expected use of PPE was
considered (Table 4-21, Table 4-22,Table 4-23). ONU
unreasonable risk determination reflects the severity of the
effects associated with exposures to methylene chloride and
the expected absence of PPE.
Estimated exposed worker population: 270 workers and
occupational non-users2 (Table 2-27).
In-line vapor
degreaser (e.g.,
conveyorized,
web cleaner)
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as a
solvent for in-line vapor degreasing:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, and liver
adverse effects from chronic, non-cancer inhalation exposure,
and cancer effects (liver and lung tumors) from chronic
inhalation exposure for ONUs.
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Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10. Chronic,
cancer inhalation lung and liver tumors: Benchmark = lxlO 4
Risk estimate - workers:
CNS effects: Acute inhalation MOEs 29.8 and 10.4
(central tendency and high end) with PPE (respirator
APF 50) (Table 4-24).
Liver effects: Chronic inhalation MOE 3.6 (high end)
with PPE (respirator APF 50) (Table 4-25).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 1 and 0.32
(central tendency and high end) (Table 4-24).
Liver effects: Chronic inhalation MOEs 0.40 and
0.11 (central tendency and high end) (Table 4-25).
Cancer risks: Chronic inhalation 1.35E-04 and 4.80
E-04 (central tendency and high end) (Table 4-26).
Svstematic Review confidence ratine (hazard):
Medium.
Svstematic Review confidence ratine (inhalation exposure):
Medium to low (see Section 2.4.1.3).
Risk Considerations: For workers, unreasonable risks are
indicated even when expected PPE (APF 50) was considered
for high end acute and chronic non-cancer inhalation
scenarios for this condition of use While risk estimates for
other occupational exposure scenarios for this condition of
use (such as chronic non-cancer inhalation exposures (central
tendency) and cancer (central tendency and high end
exposures)) indicate risk in the absence of PPE, risk estimates
for these pathways do not indicate risk when expected use of
PPE was considered (Table 4-24, Table 4-25,Table 4-26).
ONU unreasonable risk determination reflects the severity of
the effects associated with exposures to methylene chloride
and the expected absence of PPE.
Estimated exposed worker population: 180 workers and
occupational non-users2 (Table 2-27).
Cold cleaner
Section 6(b)(4¥A) unreasonable risk determination for
industrial and commercial use of methvlene chloride as a
solvent for cold cleanine:
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- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, liver adverse
effects from chronic, non-cancer inhalation exposure, and
cancer effects (liver and lung tumors) from chronic inhalation
exposure for ONUs.
Driver benchmarks - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10. Chronic,
cancer inhalation (liver and lung effects): Benchmark = 1x10"
4.
Risk estimate - workers:
CNS effects: Acute inhalation MOE 15 (high end)
with PPE (respirator APF 50) (Table 4-27).
Liver effects: Chronic inhalation MOE 3.8 (high end)
with PPE (respirator APF 50) (Table 4-28).
Risk estimate -ONUs:
CNS effects: Acute inhalation MOEs 1.04 and 0.29
(central tendency and high end) (Table 4-27).
Liver effects: Chronic inhalation MOEs 0.27 and
0.08 (central tendency and high end) (Table 4-28).
Cancer risks: Chronic inhalation 1.54E-04 and 7.08E-
04 (central tendency and high end) (Table 4-29).
Svstematic Review confidence rating (hazard):
Medium.
Svstematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.3).
Risk Considerations: For workers, unreasonable risks are
indicated even when expected PPE (APF 50) was considered
for high end acute and chronic non-cancer inhalation
scenarios for this condition of use While risk estimates for
other occupational exposure scenarios for this condition of
use (such as acute non-cancer inhalation (8-hours, central
tendency) and chronic non-cancer inhalation exposures
(central tendency) and cancer (central tendency and high end
exposures)) indicate risk in the absence of PPE, risk estimates
for these pathways do not indicate risk when expected use of
PPE (respirator APF 50) was considered (Table 4-27, Table
4-28,Table 4-29). ONU unreasonable risk determination
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reflects the severity of the effects associated with exposures
to methylene chloride and the expected absence of PPE.
Estimated exposed worker population: 95,000 workers and
occupational non-users2 (Table 2-27).
Aerosol spray
degreaser/cleaner
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as a
solvent for aerosol spray degreaser/cleaner:
- Presents unreasonable risk of injury to health (workers)
- Does not present an unreasonable risk of injury to health
(occupational non-users).
Unreasonable risk driver - workers: CNS adverse effects
resulting from acute inhalation exposure and liver adverse
effects resulting from chronic, non-cancer inhalation
exposure.
Driver benchmarks: Acute inhalation CNS effects:
Benchmark MOE = 30. Chronic, non-cancer inhalation liver
effects: Benchmark MOE =10.
Risk estimate - Workers:
CNS effects: Acute inhalation MOEs 13 and 3.7
(central tendency and high end) (Table 4-30)
Liver effects: Chronic inhalation MOEs 4.53 and 1.3
(central tendency and high end) (Table 4-31).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.3).
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (respirator APF 25)
with this condition of use (Table 4-30,Table 4-31).
Estimated exposed worker population: 250,000 workers and
29,000 occupational non-users2 (Table 2-27).
Adhesives
and sealants
Single
component glues
and adhesives
and sealants and
caulks
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride in single
component glues and adhesives and sealants and caulks:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
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Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure and liver
adverse effects from chronic, non-cancer inhalation exposure.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10.
Risk estimate - workers:
CNS effects: Acute inhalation MOE 25.99 (high end)
with PPE for spray uses (respirator APF 50) (Table
4-33).
Liver effects: Chronic inhalation MOE 6.8 (high end)
with PPE for spray uses (respirator APF 50) and
MOE 13 (high end) with PPE for non-spray uses
(respirator APF 50) (Table 4-34).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 7.43 and 0.52
(central tendency and high end) for spray uses, and
MOEs 27.7 and 0.98 (central tendency and high end)
for non-spray uses (Table 4-33).
Liver effects: Chronic inhalation MOEs 1.93 and
0.14 (central tendency and high end) for spray uses
and MOEs 7.20 and 0.25 (central tendency and high
end) for non-spray uses (Table 4-34).
Svstematic Review confidence ratine (hazard): Medium.
Svstematic Review confidence rating (inhalation exposure):
Medium.
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (for central
tendency, respirator APF 25) for this condition of use. In
addition, unreasonable risks are indicated even when
respirator APF 50 was considered for high end acute and
chronic non-cancer inhalation scenarios for this condition of
use (Table 4-33, Table 4-34, Table 4-35). Additionally, EPA
calculated risk estimates using personal breathing zone
monitoring data and assumed ONU exposures could be as
high as worker exposures as a high-end estimate. There is
uncertainty in this assumption since the data did not
distinguish between worker and ONU inhalation exposure
estimates. ONU inhalation exposures are expected to be
lower than inhalation exposures for workers directly handling
the chemical substance. To account for this uncertainty, EPA
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considered the central tendency estimate when determining
ONU risk. ONU unreasonable risk determination reflects the
severity of the effects associated with exposures to methylene
chloride and the expected absence of PPE.
Estimated exposed worker population: 2,700,000 workers and
810 occupational non-users2 (Table 2-27).
Paints and
coatings
including
paint and
coating
removers
Paints and
coatings
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene for paints and
coatings:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, liver adverse
effects from chronic, non-cancer inhalation exposure, and
cancer effects (liver and lung tumors) from chronic inhalation
exposure.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10. Cancer
effects (liver and lung tumors): Benchmark = lxlO"4.
Risk estimate - workers:
CNS effects: Acute inhalation MOEs 4.15 and 0.80
(central tendency and high end) (Table 4-36).
Liver effects: Chronic inhalation MOEs 1.08 and
0.21 (central tendency and high end) (Table 4-37).
Cancer effects: 2.58E-04 (high end) (Table 4-38).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 4.15 and 0.80
(central tendency and high end) (Table 4-36).
Liver effects: Chronic inhalation MOEs 1.08 and
0.21 (central tendency and high end) (Table 4-37).
Cancer effects: 2.58E-04 (high end) (Table 4-38).
Systematic Review confidence rating (hazard):
Medium.
Systematic Review confidence rating (inhalation exposure):
Medium to high.
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (respirator APF 50)
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with this condition of use. ONU unreasonable risk
determination reflects the severity of the effects associated
with exposures to methylene chloride and the expected
absence of PPE.
Estimated exposed worker population: 1.700.000 workers and
810,000 occupational non-users for paints and coatings (not
remover)2 (Table 2-27).
Paints and
coating
removers,
including
furniture
refinisher
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methvlene for paints and
coatings remover:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, liver adverse
effects from chronic, non-cancer inhalation exposure, and
cancer effects (liver and lung tumors) from chronic inhalation
exposure.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 303. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10. Chronic,
cancer inhalation (liver and lung effects): Benchmark = 1x10"
4
Risk estimate - workers:
Professional contractors: CNS effects: Acute
inhalation MOEs 10 and 5 (central tendency and high
end) with PPE (respirator APF 50) (Table 4-36).
Automotive refinishing: CNS effects: Acute
inhalation MOEs 29 and 17 (central tendency and
high end) with PPE (respirator APF 25) (Table 4-36).
Furniture refinishing: CNS effects: Acute inhalation
MOEs 13 and 6 (central tendency and high end) with
PPE (respirator APF 50) (Table 4-36).
Art restoration and conservation: CNS effects: Acute
inhalation MOE 145 (point estimate) with no PPE
(Table 4-36).
Aircraft paint stripping: CNS effects: Acute
inhalation MOEs 7 and 4 (central tendency and high
end) with PPE (respirator APF 50) (Table 4-36).
Graffiti removal: CNS effects: Acute inhalation
MOEs 24 and 12 (central tendency and high end)
with PPE (respirator APF 50) (Table 4-36).
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Non-Specific workplace settings - immersion
stripping of wood: CNS effects: Acute inhalation
MOEs 4 and 2 (central tendency and high end) with
PPE (respirator APF 50) (Table 4-36).
Non-Specific workplace settings - immersion
stripping of wood and metal: CNS effects: Acute
inhalation MOEs 18 and 14 (central tendency and
high end) with PPE (respirator APF 50) (Table 4-36).
Non-Specific workplace settings - unknown: CNS
effects: Acute inhalation MOEs 20 and 17 (central
tendency and high end) with PPE (respirator APF 25)
(Table 4-36).
In addition, see Table 4-37 and Table 4-38 for risk
estimates for chronic, non-cancer liver effects and
cancer effects.
Risk estimate - ONUs:
Professional contractors: CNS effects: Acute
inhalation MOEs 0.2 and 0.1 (central tendency and
high end) (Table 4-36).
Automotive refinishing: CNS effects: Acute
inhalation MOEs 1 and 0.7 (central tendency and
high end) (Table 4-36).
Furniture refinishing: CNS effects: Acute inhalation
MOEs 0.3 and 0.1 (central tendency and high end)
(Table 4-36).
Art restoration and conservation: CNS effects: Acute
inhalation MOE 145 (point estimate) (Table 4-36).
Aircraft paint stripping: CNS effects: Acute
inhalation MOEs 0.2 and 0.1 (central tendency and
high end) (Table 4-36).
Graffiti removal: CNS effects: Acute inhalation
MOEs 0.5 and 0.2 (central tendency and high end)
(Table 4-36).
Non-specific workplace settings - immersion
stripping of wood: CNS effects: Acute inhalation
MOEs 0.1 and 0.04 (central tendency and high end)
(Table 4-36).
Non-specific workplace settings - immersion
stripping of wood and metal: CNS effects: Acute
inhalation MOEs 0.4 and 0.3 (central tendency and
high end) (Table 4-36).
Non-specific workplace settings - unknown: CNS
effects: Acute inhalation MOEs 0.8 and 0.7 (central
tendency and high end) (Table 4-36).
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In addition, see Table 4-37 and Table 4-38 for risk
estimates for chronic, non-cancer liver effects and
cancer effects.
Systematic Review confidence rating (hazard):
Medium.
Systematic Review confidence rating (inhalation exposure):
See Appendix L.
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk with this condition
of use. In addition, unreasonable risks for chronic inhalation
are indicated even with PPE use at APF 50 for central
tendency and high end scenarios for professional contractors,
furniture refinishing, aircraft paint stripping, graffiti removal,
non-specific workplace settings - immersion stripping of
wood, non-specific workplace settings - immersion stripping
of wood and metal, and non-specific workplace settings -
unknown. For automotive refinishing, unreasonable risks for
chronic inhalation are indicated even with PPE use at APF 50
for high end scenarios. Unreasonable risks for cancer effects
are indicated even with PPE use at APF 50 for high end
scenarios for non-specific workplace settings - immersion
stripping of wood and metal. Unreasonable risks for cancer
effects are indicated even with PPE use at APF 25 for high
end scenarios for professional contractors, furniture
refinishing, and aircraft paint stripping. Unreasonable risks
were not indicated for art restoration and conservation (Table
4-36, Table 4-37, Table 4-38). ONU unreasonable risk
determination reflects the severity of the effect associated
with exposures to methylene chloride (neurotoxicity
including loss of consciousness and fatality) and the expected
absence of PPE.
Estimated exposed worker population: 230,000 workers. EPA
is not able to estimate occupational non-users for this use
(Appendix L, Section 3.1.1).
Adhesive/caulk
removers
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride for
adhesive/caulk removers:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, liver adverse
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effects from chronic, non-cancer inhalation exposure, and
cancer effects (liver and lung tumors) from chronic inhalation
exposure for ONUs.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10. Chronic,
cancer inhalation (ONUs): Benchmark = lxlO 4.
Risk estimate - workers:
CNS effects: Acute inhalation MOEs 9.5 and 4.9
(central tendency and high end) with PPE (respirator
APF 50) (Table 4-39).
Liver effects: Chronic inhalation MOEs 2.5 and 1.3
(central tendency and high end) with PPE (respirator
APF 50) (Table 4-40)
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 0.19 and 0.10
(central tendency and high end) (Table 4-39).
Liver effects: Chronic inhalation MOEs 0.05 and
0.025 (central tendency and high end) (Table 4-40).
Cancer Risks: Chronic inhalation 8.34E-04 and 2.11
E-03 (central tendency and high end) (Table 4-41).
Systematic Review confidence rating (hazard):
Medium.
Systematic Review confidence rating (inhalation exposure):
Medium.
Risk Considerations: For workers, unreasonable risks are
indicated even when expected PPE (APF 50) was considered
for high end acute and chronic non-cancer inhalation
scenarios for this condition of use. (Table 4-39 and Table
4-40). While use of PPE (respirators APF 25) would mitigate
cancer risks, non-cancer risks remain (Table 4-41). ONU
unreasonable risk determination reflects the severity of the
effects associated with exposures to methylene chloride and
the expected absence of PPE.
Estimated exposed worker population: 190,000 workers and
18,000 occupational non-users2 (Table 2-27).
Metal
products not
Degreasers -
aerosol
degreasers and
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as a
metal products aerosol spray degreaser/cleaner:
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covered
elsewhere
cleaners e.g., coil
cleaners
- Presents unreasonable risk of injury to health (workers)
- Does not present an unreasonable risk of injury to health
(occupational non-users).
Unreasonable risk driver - workers: CNS adverse effects
resulting from acute inhalation exposure and liver adverse
effects resulting from chronic, non-cancer inhalation
exposure.
Driver benchmarks: Acute inhalation CNS effects:
Benchmark MOE = 30. Chronic, non-cancer inhalation liver
effects: Benchmark MOE =10.
Risk estimate - Workers:
CNS effects: Acute inhalation MOEs 13 and 3.7
(central tendency and high end) (Table 4-30)
Liver effects: Chronic inhalation MOEs 4.53 and 1.3
(central tendency and high end) (Table 4-31).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.3).
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (respirator APF 25)
with this condition of use (Table 4-30, Table 4-31).
Estimated exposed worker population: 250,000 workers and
29,000 occupational non-users2 (Table 2-27).
Metal
products not
covered
elsewhere
Degreasers -
non-aerosol
degreasers and
cleaners e.g., coil
cleaners
Section 6(b¥4XA) unreasonable risk determination for
industrial and commercial use of methylene chloride for
metal products not covered elsewhere for non-aerosol
degreases:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, and liver
adverse effects from chronic, non-cancer inhalation exposure.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10.
Risk estimate - workers:
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CNS effects: Acute inhalation MOE 16 (high end)
with PPE (respirator APF 50) (Table 4-42).
Liver effects: Chronic inhalation MOE 4 (high end)
with PPE (respirator APF 50) (Table 4-43).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 5.12 and 0.31
(central tendency and high end) (Table 4-42).
Liver effects: Chronic inhalation MOEs 1.33 and
0.08 (central tendency and high end) (Table 4-43).
Svstematic Review confidence rating (hazard):
Medium.
Svstematic Review confidence ratine (inhalation exposure):
Medium.
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (for central
tendency, respirator APF 25) for this condition of use. In
addition, for both acute and chronic non-cancer inhalation
scenarios for workers (high end), unreasonable risks are
indicated even when a respirator APF 50 was considered
(Table 4-42, Table 4-43). While risk estimates for other
occupational exposure scenarios for this condition of use
(such as acute non-cancer inhalation (8-hrs, central tendency)
and chronic non-cancer inhalation exposures (central
tendency) and chronic cancer (high end)) indicate risk in the
absence of PPE, risk estimates for these pathways do not
indicate risk when expected use of PPE was considered
(Table 4-42, Table 4-43, Table 4-44). Additionally, EPA
calculated risk estimates using personal breathing zone
monitoring data and assumed ONU exposures could be as
high as worker exposures as a high-end estimate. There is
uncertainty in this assumption since the data did not
distinguish between worker and ONU inhalation exposure
estimates. ONU inhalation exposures are expected to be
lower than inhalation exposures for workers directly handling
the chemical substance. To account for this uncertainty, EPA
considered the central tendency estimate when determining
ONU risk. ONU unreasonable risk determination reflects the
severity of the effects associated with exposures to methylene
chloride and the expected absence of PPE.
Estimated exposed worker population: Not identified2.
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Fabric, textile
and leather
products not
covered
elsewhere
Textile finishing
and
impregnating/
surface treatment
products e.g.,
water repellant
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as a
fabric, textile, and leather product not covered elsewhere:
- Present an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and occupational non-
users: CNS adverse effects resulting from acute inhalation
exposure, and liver adverse effects from chronic, non-cancer
inhalation exposure.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10.
Risk estimate - workers:
CNS effects: Acute inhalation MOEs 3.34 and 1.78
(central tendency and high end) (Table 4-45).
Liver effects: Chronic inhalation MOEs 0.87 and
0.46 (central tendency and high end) (Table 4-46).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 3.34 and 1.78
(central tendency and high end) (Table 4-45).
Liver effects: Chronic inhalation MOEs 0.87 and
0.46 (central tendency and high end) (Table 4-46).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.3).
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (respirator APF 25)
with this condition of use (Table 4-45, Table 4-46, Table
4-47). ONU unreasonable risk determination reflects the
severity of the effects associated with exposures to methylene
chloride and the expected absence of PPE.
Estimated exposed worker population: 19,000 workers and
12,000 occupational non-users2 (Table 2-27).
Automotive
care products
Function fluids
for air
conditioners:
refrigerant,
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as
automotive care products for function fluids for air
conditioners:
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treatment, leak
sealer
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, liver adverse
effects from chronic, non-cancer inhalation exposure.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE = 10.
Risk estimate - workers:
CNS effects: Acute inhalation MOE 16 (high end)
with PPE (respirator APF 50) (Table 4-42).
Liver effects: Chronic inhalation MOE 4 (high end)
with PPE (respirator APF 50) (Table 4-43).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 5.12 and 0.31
(central tendency and high end) (Table 4-42).
Liver effects: Chronic inhalation MOEs 1.33 and
0.08 (central tendency and high end) (Table 4-43).
Systematic Review confidence rating (hazard):
Medium.
Systematic Review confidence rating (inhalation exposure):
Medium.
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (for central
tendency, respirator APF 25) for this condition of use. In
addition, for both acute and chronic non-cancer inhalation
scenarios for workers (high end), unreasonable risks are
indicated even when a respirator with APF 50 was
considered. (Table 4-42, Table 4-43). While risk estimates for
other occupational exposure scenarios for this condition of
use (such as acute non-cancer inhalation (8-hrs, central
tendency) and chronic non-cancer inhalation exposures
(central tendency) and chronic cancer (high end)) indicate
risk in the absence of PPE, risk estimates for these pathways
do not indicate risk when expected use of PPE was
considered (Table 4-42, Table 4-43, Table 4-44).
Additionally, EPA calculated risk estimates using personal
breathing zone monitoring data and assumed ONU exposures
could be as high as worker exposures as a high-end estimate.
There is uncertainty in this assumption since the data did not
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distinguish between worker and ONU inhalation exposure
estimates. ONU inhalation exposures are expected to be
lower than inhalation exposures for workers directly handling
the chemical substance. To account for this uncertainty, EPA
considered the central tendency estimate when determining
ONU risk. ONU unreasonable risk determination reflects the
severity of the effects associated with exposures to methylene
chloride and the expected absence of PPE.
Estimated exposed worker population: Not identified2.
Automotive
care products
Interior car care
- spot remover
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as an
automotive care product for interior car care:
- Presents unreasonable risk of injury to health (workers)
- Does not present an unreasonable risk of injury to health
(occupational non-users).
Unreasonable risk driver - workers: CNS adverse effects
resulting from acute inhalation exposure and liver adverse
effects resulting from chronic, non-cancer inhalation
exposure.
Driver benchmarks: Acute inhalation CNS effects:
Benchmark MOE = 30. Chronic, non-cancer inhalation liver
effects: Benchmark MOE =10.
Risk estimate - Workers:
CNS effects: Acute inhalation MOEs 13 and 3.7
(central tendency and high end) (Table 4-30)
Liver effects: Chronic inhalation MOEs 4.53 and 1.3
(central tendency and high end) (Table 4-31).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.3).
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (respirator APF 25)
with this condition of use (Table 4-30, Table 4-31).
Estimated exposed worker population: 250,000 workers and
29,000 occupational non-users2 (Table 2-27).
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Automotive
care products
Degreasers:
gasket remover,
transmission
cleaners,
carburetor
cleaner, brake
quieter/cleaner
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as an
automotive care product for degreasers:
- Presents unreasonable risk of injury to health (workers)
- Does not present an unreasonable risk of injury to health
(occupational non-users).
Unreasonable risk driver - workers: CNS adverse effects
resulting from acute inhalation exposure and liver adverse
effects resulting from chronic, non-cancer inhalation
exposure.
Driver benchmarks: Acute inhalation CNS effects:
Benchmark MOE = 30. Chronic, non-cancer inhalation liver
effects: Benchmark MOE =10.
Risk estimate - Workers:
CNS effects: Acute inhalation MOEs 13 and 3.7
(central tendency and high end) (Table 4-30)
Liver effects: Chronic inhalation MOEs 4.53 and 1.3
(central tendency and high end) (Table 4-31).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.3).
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (respirator APF 25)
with this condition of use (Table 4-30, Table 4-31).
Estimated exposed worker population: 250,000 workers and
29,000 occupational non-users2 (Table 2-27).
Apparel and
footwear care
products
Post-market
waxes and
polishes applied
to footwear e.g.,
shoe polish
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as an
apparel and footwear care product for post market waxes and
polishes:
- Presents unreasonable risk of injury to health (workers)
- Does not present an unreasonable risk of injury to health
(occupational non-users).
Unreasonable risk driver - workers: CNS adverse effects
resulting from acute inhalation exposure and liver adverse
effects resulting from chronic, non-cancer inhalation
exposure.
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Driver benchmarks: Acute inhalation CNS effects:
Benchmark MOE = 30. Chronic, non-cancer inhalation liver
effects: Benchmark MOE =10.
Risk estimate - Workers:
CNS effects: Acute inhalation MOEs 13 and 3.7
(central tendency and high end) (Table 4-30)
Liver effects: Chronic inhalation MOEs 4.53 and 1.3
(central tendency and high end) (Table 4-31).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.3).
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (respirator APF 25)
with this condition of use (Table 4-30, Table 4-31).
Estimated exposed worker population: 250,000 workers and
29,000 occupational non-users2 (Table 2-27).
Laundry and
dishwashing
products
Spot remover for
apparel and
textiles
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as a
laundry and dishwashing product:
- Presents an unreasonable risk of injury to health
(workers).
- Does not present an unreasonable risk of injury to health
(occupational non-users1).
Unreasonable risk driver - workers: CNS adverse effects
resulting from acute inhalation exposure, and liver adverse
effects from chronic, non-cancer inhalation exposure.
Driver benchmark - workers: Acute inhalation CNS effects:
Benchmark MOE = 30. Chronic, non-cancer inhalation liver
effects: Benchmark MOE =10.
Risk estimate -workers:
CNS effects: Acute inhalation MOE 4.56 (high end)
(Table 4-48).
Liver effects: Chronic inhalation MOE 1.2 (high end)
(Table 4-49).
Systematic Review confidence rating (hazard): Medium.
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Systematic Review confidence rating (inhalation exposure):
Medium.
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (respirator APF 25)
for high end exposures with this condition of use.
Additionally, EPA calculated risk estimates using personal
breathing zone monitoring data and assumed ONU exposures
could be as high as worker exposures as a high-end estimate.
There is uncertainty in this assumption since the data did not
distinguish between worker and ONU inhalation exposure
estimates. ONU inhalation exposures are expected to be
lower than inhalation exposures for workers directly handling
the chemical substance. To account for this uncertainty, EPA
considered the central tendency estimate when determining
ONU risk.
Estimated exposed worker population: 76,000 workers and
7,900 occupational non-users2 (Table 2-27).
Lubricants
and greases
Spray lubricants
and greases
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as a
lubricant and grease in spray lubricants and greases:
- Presents unreasonable risk of injury to health (workers)
- Does not present an unreasonable risk of injury to health
(occupational non-users).
Unreasonable risk driver - workers: CNS adverse effects
resulting from acute inhalation exposure and liver adverse
effects resulting from chronic, non-cancer inhalation
exposure.
Driver benchmarks: Acute inhalation CNS effects:
Benchmark MOE = 30. Chronic, non-cancer inhalation liver
effects: Benchmark MOE =10.
Risk estimate - Workers:
CNS effects: Acute inhalation MOEs 13 and 3.7
(central tendency and high end) (Table 4-30).
Liver effects: Chronic inhalation MOEs 4.53 and 1.3
(central tendency and high end) (Table 4-31).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.3).
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Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (respirator APF 25)
with this condition of use (Table 4-30, Table 4-31).
Estimated exposed worker population: 250,000 workers and
29,000 occupational non-users2 (Table 2-27).
Lubricants
and greases
Liquid lubricants
and greases
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as a
lubricant and grease in liquid lubricants and greases:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, liver adverse
effects from chronic, non-cancer inhalation exposure.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10.
Risk estimate - workers:
CNS effects: Acute inhalation MOE 16 (high end)
with PPE (respirator APF 50) (Table 4-42).
Liver effects: Chronic inhalation MOE 4 (high end)
with PPE (respirator APF 50) (Table 4-43).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 5.12 and 0.31
(central tendency and high end) (Table 4-42).
Liver effects: Chronic inhalation MOEs 1.33 and
0.08 (central tendency and high end) (Table 4-43).
Systematic Review confidence rating (hazard):
Medium.
Systematic Review confidence rating (inhalation exposure):
Medium.
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (for central
tendency, respirator APF 25) for this condition of use. In
addition, for both acute and chronic non-cancer inhalation
scenarios for workers (high end), unreasonable risks are
indicated even when a respirator APF 50 was considered
(Table 4-42, Table 4-43). While risk estimates for other
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occupational exposure scenarios for this condition of use
(such as acute non-cancer inhalation (8-hrs, central tendency)
and chronic non-cancer inhalation exposures (central
tendency) and chronic cancer (high end)) indicate risk in the
absence of PPE, risk estimates for these pathways do not
indicate risk when expected use of PPE was considered
(Table 4-42, Table 4-43, Table 4-44). Additionally, EPA
calculated risk estimates using personal breathing zone
monitoring data and assumed ONU exposures could be as
high as worker exposures as a high-end estimate. There is
uncertainty in this assumption since the data did not
distinguish between worker and ONU inhalation exposure
estimates. ONU inhalation exposures are expected to be
lower than inhalation exposures for workers directly handling
the chemical substance. To account for this uncertainty, EPA
considered the central tendency estimate when determining
ONU risk. ONU unreasonable risk determination reflects the
severity of the effects associated with exposures to methylene
chloride and the expected absence of PPE.
Estimated exposed worker population: Not identified2.
Lubricants
and greases
Degreasers -
aerosol
degreasers and
cleaners
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as a
lubricant and grease in aerosol degreasers and cleaners:
- Presents unreasonable risk of injury to health (workers)
- Does not present an unreasonable risk of injury to health
(occupational non-users).
Unreasonable risk driver - workers: CNS adverse effects
resulting from acute inhalation exposure and liver adverse
effects resulting from chronic, non-cancer inhalation
exposure.
Driver benchmarks: Acute inhalation CNS effects:
Benchmark MOE = 30. Chronic, non-cancer inhalation liver
effects: Benchmark MOE =10.
Risk estimate - Workers:
CNS effects: Acute inhalation MOEs 13 and 3.7
(central tendency and high end) (Table 4-30)
Liver effects: Chronic inhalation MOEs 4.53 and 1.3
(central tendency and high end) (Table 4-31).
Systematic Review confidence ratine (hazard): Medium.
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Systematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.3).
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (respirator APF 25)
with this condition of use (Table 4-30,Table 4-31).
Estimated exposed worker population: 250,000 workers and
29,000 occupational non-users2 (Table 2-27).
Lubricants
and greases
Degreasers -
non-aerosol
degreasers and
cleaners
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as a
lubricant and grease in non-aerosol degreasers and cleaners:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, liver adverse
effects from chronic, non-cancer inhalation exposure.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10.
Risk estimate - workers:
CNS effects: Acute inhalation MOE 16 (high end)
with PPE (respirator APF 50) (Table 4-42).
Liver effects: Chronic inhalation MOE 4 (high end)
with PPE (respirator APF 50) (Table 4-43).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 5.12 and 0.31
(central tendency and high end) (Table 4-42).
Liver effects: Chronic inhalation MOEs 1.33 and
0.08 (central tendency and high end) (Table 4-43).
Systematic Review confidence rating (hazard):
Medium.
Systematic Review confidence rating (inhalation exposure):
Medium.
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (for central
tendency, respirator APF 25) for this condition of use. In
addition, for both acute and chronic non-cancer inhalation
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scenarios for workers (high end), unreasonable risks are
indicated even when a respirator APF 50 was considered
(Table 4-42, Table 4-43). While risk estimates for other
occupational exposure scenarios for this condition of use
(such as acute non-cancer inhalation (8-hrs, central tendency)
and chronic non-cancer inhalation exposures (central
tendency) and chronic cancer (high end)) indicate risk in the
absence of PPE, risk estimates for these pathways do not
indicate risk when expected use of PPE was considered
(Table 4-42, Table 4-43, Table 4-44). Additionally, EPA
calculated risk estimates using personal breathing zone
monitoring data, and assumed ONU exposures could be as
high as worker exposures as a high-end estimate. There is
uncertainty in this assumption since the data did not
distinguish between worker and ONU inhalation exposure
estimates. ONU inhalation exposures are expected to be
lower than inhalation exposures for workers directly handling
the chemical substance. To account for this uncertainty, EPA
considered the central tendency estimate when determining
ONU risk. ONU unreasonable risk determination reflects the
severity of the effects associated with exposures to methylene
chloride and the expected absence of PPE.
Estimated exposed worker population: Not identified2.
Building/
construction
materials not
covered
elsewhere
Cold pipe
insulation
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methvlene chloride as a
building construction material not covered elsewhere for cold
pipe insulations:
- Presents unreasonable risk of injury to health (workers)
- Does not present an unreasonable risk of injury to health
(occupational non-users).
Unreasonable risk driver - workers: CNS adverse effects
resulting from acute inhalation exposure and liver adverse
effects resulting from chronic, non-cancer inhalation
exposure.
Driver benchmarks: Acute inhalation CNS effects:
Benchmark MOE = 30. Chronic, non-cancer inhalation liver
effects: Benchmark MOE =10.
Risk estimate - Workers:
CNS effects: Acute inhalation MOEs 13 and 3.7
(central tendency and high end) (Table 4-30)
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Liver effects: Chronic inhalation MOEs 4.53 and 1.3
(central tendency and high end) (Table 4-31).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.3).
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (respirator APF 25)
with this condition of use (Table 4-30, Table 4-31).
Estimated exposed worker population: 250,000 workers and
29,000 occupational non-users2 (Table 2-27).
Solvents
(which
become part
of product
formulation or
mixture)
All other
chemical product
and preparation
manufacturing
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as a
solvent for all other chemical product and preparation
manufacturing:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS_effects
resulting from acute inhalation exposure, and liver effects
resulting from chronic inhalation exposure for ONUs.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE = 10.
Risk estimate - workers:
CNS effects: Acute inhalation MOE 6.5 (high end)
with PPE (respirator APF 50) (Table 4-12).
Liver effects: Chronic inhalation MOE 1.7 (high end)
with PPE (respirator APF 50) (Table 4-13).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 1.61 and 0.13
(central tendency and high end) (Table 4-12).
Liver effects: Chronic inhalation MOEs 0.42 and
0.034 (central tendency and high end) (Table 4-13).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium.
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Risk Considerations: For workers, unreasonable risks are
indicated even when expected PPE (APF 50) was considered
for high end acute and chronic non-cancer inhalation
scenarios for this condition of use. While risk estimates for
other occupational exposure scenarios for this condition of
use (such as acute non-cancer inhalation (central tendency),
chronic non-cancer inhalation (central tendency), and chronic
cancer inhalation exposures (high end)) indicate risk in the
absence of PPE, risk estimates for these pathways do not
indicate risk when expected use of PPE was considered
(Table 4-12, Table 4-13, Table 4-14). ONU unreasonable risk
determination reflects the severity of the effects associated
with acute exposures to methylene chloride and the expected
absence of PPE.
Estimated exposed worker population: 4,500 workers and
occupational non-users2 (Table 2-27).
Processing aid
not otherwise
listed
In multiple
manufacturing
sectors
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as a
processing aid not otherwise listed for multiple
manufacturing sectors:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and occupational non-
users: CNS adverse effects resulting from acute inhalation
exposure, liver adverse effects from chronic, non-cancer
inhalation exposure, and cancer effects (liver and lung
tumors) from chronic, inhalation exposure for ONUs.
Driver benchmark - workers and occupational non-users:
Acute inhalation CNS effects: Benchmark MOE = 30.
Chronic, non-cancer inhalation liver effects: Benchmark
MOE =10. Cancer effects (liver and lung tumors):
Benchmark = lxlO4.
Risk estimate - workers:
CNS effects: Acute inhalation MOEs 14 and 10
(central tendency and high end) with PPE (respirator
APF 50) (Table 4-51).
Liver effects: Chronic inhalation MOEs 3.6 and 2.7
(central tendency and high end) with PPE (respirator
APF 50) (Table 4-52).
Risk estimate - ONUs:
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CNS effects: Acute inhalation MOEs 0.28 and 0.21
(central tendency and high end) (Table 4-51).
Liver effects: Chronic inhalation MOEs 0.07 and
0.05 (central tendency and high end) (Table 4-52).
Cancer effects: Chronic inhalation 5.68E-04 and
7.67E-04 (central tendency and high end) (Table
4-53).
Systematic Review confidence rating (hazard):
Medium.
Systematic Review confidence rating (inhalation exposure):
Medium.
Risk Considerations: For workers, unreasonable risks are
indicated even when expected PPE (APF 50) was considered
for high end acute and chronic non-cancer inhalation
scenarios for this condition of use (Table 4-51, Table 4-52).
While risk estimates for other occupational exposure
scenarios for this condition of use (such as chronic cancer
inhalation (central tendency and high end) indicate risk in the
absence of PPE, risk estimates for these pathways do not
indicate risk when expected use of PPE was considered.
However, PPE sufficient to address cancer risks is not
sufficient to address non-cancer risks (Table 4-51, Table
4-52, Table 4-53). ONU unreasonable risk determination
reflects the severity of the effects associated with exposures
to methylene chloride and the expected absence of PPE.
Estimated exposed worker population: 700 workers and
occupational non-users2 (Table 2-27).
Propellants
and blowing
agents
Flexible
polyurethane
foam
manufacturing
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as a
propellant and blowing agent for flexible polyurethane foam
manufacturing:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, liver adverse
effects from chronic, non-cancer inhalation exposure, and
cancer effects (liver and lung tumors) from chronic inhalation
exposure for ONUs.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
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inhalation liver effects: Benchmark MOE =10. Chronic,
cancer inhalation effects: Benchmark = lxlO 4
Risk estimate - workers:
CNS effects: CNS effects: Acute inhalation MOE 15
(high end) with PPE (respirator APF 50) (Table
4-57).
Liver effects: Chronic inhalation MOE 3.8 (high end)
with PPE (respirator APF 50) (Table 4-58).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 1.4 and 0.29
(central tendency and high end) (Table 4-57).
Liver effects: Chronic inhalation MOEs 0.35 and
0.08 (central tendency and high end) (Table 4-58).
Cancer risks: Chronic inhalation 1.16E-04 and 7.08E-
04 (central tendency and high end) (Table 4-59).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium.
Risk Considerations: For workers, unreasonable risks are
indicated even when expected PPE (APF 50) was considered
for high end acute and chronic non-cancer inhalation
scenarios for this condition of use. While risk estimates for
other occupational exposure scenarios for this condition of
use (such as acute non-cancer inhalation (8-hrs, central
tendency) and chronic non-cancer inhalation exposures
(central tendency) and chronic cancer (central tendency and
high end)) indicate risk in the absence of PPE, risk estimates
for these pathways do not indicate risk when expected use of
PPE was considered (Table 4-57, Table 4-58, Table 4-59).
ONU unreasonable risk determination reflects the severity of
the effects associated with exposures to methylene chloride
and the expected absence of PPE.
Estimated exposed worker population: 9,600 workers and
2,700 occupational non-users2 (Table 2-27).
Other Uses
Laboratory
chemicals - all
other chemical
product and
preparation
manufacturing
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as a
laboratory chemical for all other chemical product and
preparation manufacturing:
- Does not present an unreasonable risk of injury to health
(workers, occupational non-users1).
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Exposure scenario with the highest risk estimate: Liver
adverse effects resulting from chronic non-cancer inhalation
exposure.
Benchmark - Workers and ONUs: Acute inhalation CNS
effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10. Chronic,
cancer inhalation effects: Benchmark = lxlO 4
Risk estimate - Workers:
CNS effects: Acute inhalation MOEs 2071 and 604
(central tendency and high end) for 8-hr and 6366
and 514 (central tendency and high end) for 15-
minute exposure estimates with PPE (respirator APF
25) (Table 4-60).
Liver effects: Chronic inhalation MOEs 465 and 12
(central tendency and high end) with PPE (respirator
APF 25) (Table 4-61).
Cancer risks: Chronic inhalation 8.89E-08 and 4.45E-
06 (central tendency and high end) with PPE
(respirator APF 25) (Table 4-62).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 83 and 24
(central tendency and high end) for 8-hr and 255 and
21 (central tendency and high end) for 15-minute
exposure estimates (Table 4-60).
Liver effects: Chronic inhalation MOEs 18.6 and
0.48 (central tendency and high end) (Table 4-61).
Cancer risks: Chronic inhalation 2.22E-06 and 1.11E-
04 (central tendency and high end) (Table 4-62).
Svstematic Review confidence ratine (hazard): Medium.
Svstematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.2.16).
Risk Considerations: Risk estimates for workers and ONUs
for acute and chronic inhalation do not indicate risk. While
risk estimates for some pathways of occupational exposure
for this condition of use (such as acute non-cancer inhalation
(8-hrs, high end and 15-minutes exposures) and chronic non-
cancer inhalation exposures (high end) and chronic cancer
(high end)) indicate risk in the absence of PPE, risk estimates
for these pathways do not indicate risk when expected use of
PPE (respirator APF 25 and gloves PF = 20) was considered
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for workers. Additionally, EPA calculated risk estimates
using personal breathing zone monitoring data, and assumed
ONU exposures could be as high as worker exposures as a
high-end estimate. There is large uncertainty in this
assumption since the data did not distinguish between worker
and ONU inhalation exposure estimates. ONU inhalation
exposures are expected to be lower than inhalation exposures
for workers directly handling the chemical substance. To
account for this uncertainty, EPA considered the central
tendency estimate when determining ONU risk.
Estimated exposed worker population: 17,000 workers and
150,000 occupational non-users2 (Table 2-27).
Electrical
equipment,
appliance, and
component
manufacturing
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as other
uses for electrical equipment, appliance, and component
manufacturing:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, liver adverse
effects from chronic, non-cancer inhalation exposure.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10.
Risk estimate - workers:
CNS effects: Acute inhalation MOE 16 (high end)
with PPE (respirator APF 50) (Table 4-42).
Liver effects: Chronic inhalation MOE 4 (high end)
with PPE (respirator APF 50) (Table 4-43).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOE 5.12 and 0.31
(central tendency and high end) (Table 4-42).
Liver effects: Chronic inhalation MOEs 1.33 and
0.08 (central tendency and high end) (Table 4-43).
Systematic Review confidence rating (hazard):
Medium.
Systematic Review confidence rating (inhalation exposure):
Medium.
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Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (for central
tendency, respirator APF 25) for this condition of use. In
addition, unreasonable risks are indicated even when a
respirator APF 50 was considered for high end acute and
chronic non-cancer inhalation scenarios for this condition of
use (Table 4-42, Table 4-43). While risk estimates for other
occupational exposure scenarios for this condition of use (8-
hrs, central tendency) and chronic non-cancer inhalation
exposures (central tendency) and chronic cancer (high end))
indicate risk in the absence of PPE, risk estimates for these
pathways do not indicate risk when expected use of PPE was
considered (Table 4-42, Table 4-43, Table 4-44).
Additionally, EPA calculated risk estimates using personal
breathing zone monitoring data, and assumed ONU exposures
could be as high as worker exposures as a high-end estimate.
There is uncertainty in this assumption since the data did not
distinguish between worker and ONU inhalation exposure
estimates. ONU inhalation exposures are expected to be
lower than inhalation exposures for workers directly handling
the chemical substance. To account for this uncertainty, EPA
considered the central tendency estimate when determining
ONU risk. ONU unreasonable risk determination reflects the
severity of the effects associated with exposures to methylene
chloride and the expected absence of PPE.
Estimated exposed worker population: Not identified2.
Plastic and
rubber products
(plastic
manufacturing)
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methvlene chloride for
plastic and rubber products (plastic manufacturing):
- Presents an unreasonable risk of injury to health
(occupational non-users).
- Does not present an unreasonable risk of injury to health
(workers).
Unreasonable risk driver - ONUs: Cancer effects (liver and
lung tumors) from chronic inhalation exposure.
Driver benchmark - ONUs: Chronic, cancer inhalation
effects: Benchmark =lxl0~4
Risk estimate - ONUs:
Cancer effects: chronic inhalation 7.61E-06 and
1.85E-04 (central tendency and high end) (Table
4-56).
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Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence ratine (inhalation exposure):
Low (see Section 2.4.1.2.17).
Risk Considerations: ONU unreasonable risk determination
reflects the severity of the effect (liver and lung cancer)
associated with exposure to methylene chloride and the
expected absence of PPE. While risk estimates for other
pathways of occupational exposure for this condition of use
(such as acute non-cancer inhalation (8-hrs and 15 minutes,
central tendency and high end) and chronic non-cancer
inhalation exposures (central tendency and high end) and
chronic cancer (high end exposures)) indicate risk in the
absence of PPE, risk estimates for these pathways do not
indicate risk when expected use of PPE (respirator APF 50
and gloves PF = 20) was considered for workers (Table 4-54,
Table 4-55, Table 4-56, Table 4-69, Table 4-70, Table 4-71).
While the point estimate for the chronic non-cancer
inhalation scenario estimate for ONUs indicates risk, in
consideration of the uncertainties in the exposures for ONUs
for this COU and the single data point for ONU exposure,
EPA has determined these risks are not unreasonable. For
chronic cancer risks, EPA considers both the central tendency
and the high end, because in this instance monitoring data
was available to distinguish between workers and ONUs.
Estimated exposed worker population: 210.000 workers and
90,000 occupational non-users2 (Table 2-27).
Plastic and
rubber products
(cellulose
triacetate film
production).
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as other
uses for plastic and rubber products (cellulose triacetate film
production):
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and occupational non-
users: CNS adverse effects resulting from acute inhalation
exposure, liver adverse effects from chronic, non-cancer
inhalation exposure, and cancer effects (liver and lung
tumors) from chronic, inhalation exposure for ONUs.
Driver benchmark - workers and occupational non-users:
Acute inhalation CNS effects: Benchmark MOE = 30.
Chronic, non-cancer inhalation liver effects: Benchmark
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MOE =10. Cancer effects (liver and lung tumors):
Benchmark = lxlO"4.
Risk estimate - workers:
CNS effects: Acute inhalation MOEs 14 and 10
(central tendency and high end) with PPE (respirator
APF 50)) (Table 4-51).
Liver effects: Chronic inhalation MOEs 3.6 and 2.7
(central tendency and high end) with PPE (respirator
APF 50) (Table 4-52).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 0.28 and 0.21
(central tendency and high end) (Table 4-51).
Liver effects: Chronic inhalation MOEs 0.07 and
0.05 (central tendency and high end) (Table 4-52).
Cancer effects: Chronic inhalation 5.68E-04 and
7.67E-04 (central tendency and high end) (Table
4-53).
Svstematic Review confidence ratine (hazard):
Medium.
Svstematic Review confidence ratine (inhalation exposure):
Medium.
Risk Considerations: For workers, unreasonable risks are
indicated even when expected PPE (APF 50) was considered
for high end acute and chronic non-cancer inhalation
scenarios for this condition of use (Table 4-51, Table 4-52).
While risk estimates for other occupational exposure
scenarios for this condition of use (such as chronic cancer
inhalation (central tendency and high end) indicate risk in the
absence of PPE, risk estimates for these pathways do not
indicate risk when expected use of PPE was considered.
However, PPE sufficient to address cancer risks is not
sufficient to address non-cancer risks (Table 4-51, Table
4-52, Table 4-53). ONU unreasonable risk determination
reflects the severity of the effects associated with exposures
to methylene chloride and the expected absence of PPE.
Estimated exposed worker population: 700 workers and
occupational non-users2 (Table 2-27).
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Anti-adhesive
agent - anti-
spatter welding
aerosol
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride for other
uses as an anti-spatter welding aerosol:
- Presents unreasonable risk of injury to health (workers)
- Does not present an unreasonable risk of injury to health
(occupational non-users).
Unreasonable risk driver - workers: CNS adverse effects
resulting from acute inhalation exposure and liver adverse
effects resulting from chronic, non-cancer inhalation
exposure.
Driver benchmarks: Acute inhalation CNS effects:
Benchmark MOE = 30. Chronic, non-cancer inhalation liver
effects: Benchmark MOE =10.
Risk estimate - Workers:
CNS effects: Acute inhalation MOEs 13 and 3.7
(central tendency and high end) (Table 4-30)
Liver effects: Chronic inhalation MOEs 4.53 and 1.3
(central tendency and high end) (Table 4-31).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.3).
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (respirator APF 25)
with this condition of use (Table 4-30, Table 4-31).
Estimated exposed worker population: 250,000 workers and
29,000 occupational non-users2 (Table 2-27).
Oil and gas
drilling,
extraction, and
support activities
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as other
uses for oil and gas drilling, extraction, and support activities:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, liver adverse
effects from chronic, non-cancer inhalation exposure.
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Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10.
Risk estimate - workers:
CNS effects: Acute inhalation MOE 16 (high end)
with PPE (respirator APF 50) (Table 4-42).
Liver effects: Chronic inhalation MOE 4 (high end)
with PPE (respirator APF 50) (Table 4-43).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 5.12 and 0.31
(central tendency and high end) (Table 4-42).
Liver effects: Chronic inhalation MOEs 1.33 and
0.08 (central tendency and high end) (Table 4-43).
Svstematic Review confidence rating (hazard):
Medium.
Svstematic Review confidence rating (inhalation exposure):
Medium.
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (for central
tendency, respirator APF 25) for this condition of use In
addition, unreasonable risks are indicated even when a
respirator APF 50 was considered for high end acute and
chronic non-cancer inhalation scenarios for this condition of
use (Table 4-42, Table 4-43). While risk estimates for other
occupational exposure scenarios for this condition of use
(such as acute non-cancer inhalation (8-hours, central
tendency) and chronic non-cancer inhalation exposures
(central tendency) and chronic cancer (high end)) indicate
risk in the absence of PPE, risk estimates for these pathways
do not indicate risk when expected use of PPE was
considered (Table 4-42, Table 4-43, Table 4-44).
Additionally, EPA calculated risk estimates using personal
breathing zone monitoring data, and assumed ONU exposures
could be as high as worker exposures as a high-end estimate.
There is uncertainty in this assumption since the data did not
distinguish between worker and ONU inhalation exposure
estimates. ONU inhalation exposures are expected to be
lower than inhalation exposures for workers directly handling
the chemical substance. To account for this uncertainty, EPA
considered the central tendency estimate when determining
ONU risk. ONU unreasonable risk determination reflects the
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severity of the effects associated with exposures to methylene
chloride and the expected absence of PPE.
Estimated exposed worker population: Not identified2.
Functional fluids
(closed systems)
in
pharmaceutical
and medicine
manufacturing
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride for
functional fluids in pharmaceutical and medicine
manufacturing:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, liver adverse
effects from chronic, non-cancer inhalation exposure, and
cancer effects (liver and lung tumors) from chronic inhalation
exposure for ONUs.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10. Chronic,
cancer inhalation: Benchmark = lxlO"4
Risk estimate - Workers:
CNS effects: Acute inhalation MOE 4.06 (high end)
with PPE (respirator APF 50) (Table 4-63).
Liver effects: Chronic inhalation MOE 1.1 (high end)
with PPE (respirator APF 50) (Table 4-64).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 1.26 and 0.08
(central tendency and high end) (Table 4-63).
Liver effects: Chronic inhalation MOEs 0.33 and
0.021 (central tendency and high end) (Table 4-64).
Cancer Risks: Chronic inhalation 1.26E-04 and
2.53E-03 (central tendency and high end (Table
4-65).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium.
Risk Considerations: For workers, unreasonable risks are
indicated even when expected PPE (APF 50) was considered
for high end acute and chronic non-cancer inhalation
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scenarios for this condition of use. While risk estimates for
other occupational exposure scenarios for this condition of
use (such as acute non-cancer inhalation (8-hrs, central
tendency) and chronic non-cancer inhalation exposures
(central tendency) and chronic cancer (central tendency and
high end)) indicate risk in the absence of PPE, risk estimates
for these pathways do not indicate risk when expected use of
PPE (respirator APF 50) was considered (Table 4-63, Table
4-64, Table 4-65). ONU unreasonable risk determination
reflects the severity of the effects associated with exposures
to methylene chloride and the expected absence of PPE.
Estimated exposed worker population: 77,000 workers and
47,000 occupational non-users2 (Table 2-27).
Toys,
playground, and
sporting
equipment -
including
novelty articles
(toys, gifts, etc.)
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as other
uses for toys, playground, and sporting equipment including
novelty articles:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, liver adverse
effects from chronic, non-cancer inhalation exposure.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10.
Risk estimate - workers:
CNS effects: Acute inhalation MOE 16 (high end)
with PPE (respirator APF 50) (Table 4-42).
Liver effects: Chronic inhalation MOE 4 (high end)
with PPE (respirator APF 50) (Table 4-43).
Risk estimate - ONUs:
CNS effects: Acute inhalation MOEs 5.12 and 0.31
(central tendency and high end) (Table 4-42).
Liver effects: Chronic inhalation MOEs 1.33 and
0.08 (central tendency and high end) (Table 4-43).
Systematic Review confidence rating (hazard):
Medium.
Systematic Review confidence rating (inhalation exposure):
Medium.
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Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (for central
tendency, respirator APF 25) for this condition of use. In
addition, unreasonable risks are indicated even when a
respirator APF 50 was considered for high end acute and
chronic non-cancer inhalation scenarios for this condition of
use (Table 4-42, Table 4-43). While risk estimates for other
occupational exposure scenarios for this condition of use
(such as acute non-cancer inhalation (8-hrs, central tendency)
and chronic non-cancer inhalation exposures (central
tendency) and chronic cancer (high end)) indicate risk in the
absence of PPE, risk estimates for these pathways do not
indicate risk when expected use of PPE was considered
(Table 4-42, Table 4-43, Table 4-44). Additionally, EPA
calculated risk estimates using personal breathing zone
monitoring data, and assumed ONU exposures could be as
high as worker exposures as a high-end estimate. There is
uncertainty in this assumption since the data did not
distinguish between worker and ONU inhalation exposure
estimates. ONU inhalation exposures are expected to be
lower than inhalation exposures for workers directly handling
the chemical substance. To account for this uncertainty, EPA
considered the central tendency estimate when determining
ONU risk. ONU unreasonable risk determination reflects the
severity of the effects associated with exposures to methylene
chloride and the expected absence of PPE.
Estimated exposed worker population: Not identified2.
Lithographic
printing cleaner
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride as a
lithoaraphic printing cleaner:
- Presents unreasonable risk of injury to health
(workers).
- Does not present an unreasonable risk of injury to health
(occupational non-users1).
Unreasonable risk driver - workers: Liver adverse effects
from chronic, non-cancer inhalation exposure.
Driver benchmark - workers: Chronic, non-cancer inhalation
liver effects: Benchmark MOE = 10.
Risk estimate - workers:
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Liver effects: Chronic inhalation MOE 7 (high end)
with PPE (APF 25) (Table 4-67).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Medium.
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (respirator APF 50)
with this condition of use (Table 4-66, Table 4-67, Table
4-68). Additionally, EPA calculated risk estimates using
personal breathing zone monitoring data, and assumed ONU
exposures could be as high as worker exposures as a high-end
estimate. There is uncertainty in this assumption since the
data did not distinguish between worker and ONU inhalation
exposure estimates. ONU inhalation exposures are expected
to be lower than inhalation exposures for workers directly
handling the chemical substance. To account for this
uncertainty, EPA considered the central tendency estimate
when determining ONU risk.
Estimated exposed worker population: 40,000 workers and
19,000 occupational non-users2 (Table 2-27).
Other Uses
Carbon remover,
wood floor
cleaner, brush
cleaner
Section 6(b)(4)(A) unreasonable risk determination for
industrial and commercial use of methylene chloride in other
uses for carbon remover, wood floor cleaner, and brush
cleaner:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and ONUs: CNS adverse
effects resulting from acute inhalation exposure, liver adverse
effects from chronic, non-cancer inhalation exposure.
Driver benchmark - workers and ONUs: Acute inhalation
CNS effects: Benchmark MOE = 30. Chronic, non-cancer
inhalation liver effects: Benchmark MOE =10.
Risk estimate - workers:
CNS effects: Acute inhalation MOE 16 (high end)
with PPE (respirator APF 50) (Table 4-42).
Liver effects: Chronic inhalation MOE 4 (high end)
with PPE (respirator APF 50) (Table 4-43).
Risk estimate - ONUs:
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CNS effects: Acute inhalation MOEs 5.12 and 0.31
(central tendency and high end) (Table 4-42).
Liver effects: Chronic inhalation MOEs 1.33 and
0.08 (central tendency and high end) (Table 4-43).
Svstematic Review confidence rating (hazard):
Medium.
Svstematic Review confidence rating (inhalation exposure):
Medium.
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (for central
tendency, respirator APF 25) for this condition of use. In
addition, unreasonable risks are indicated even when a
respirator APF 50 was considered for high end acute and
chronic non-cancer inhalation scenarios for this condition of
use (Table 4-42, Table 4-43). While risk estimates for other
occupational exposure scenarios for this condition of use
(such as acute non-cancer inhalation (8-hrs, central tendency)
and chronic non-cancer inhalation exposures (central
tendency) and chronic cancer (high end)) indicate risk in the
absence of PPE, risk estimates for these pathways do not
indicate risk when expected use of PPE was considered
(Table 4-42, Table 4-43, Table 4-44). Additionally, EPA
calculated risk estimates using personal breathing zone
monitoring data, and assumed ONU exposures could be as
high as worker exposures as a high-end estimate. There is
uncertainty in this assumption since the data did not
distinguish between worker and ONU inhalation exposure
estimates. ONU inhalation exposures are expected to be
lower than inhalation exposures for workers directly handling
the chemical substance. To account for this uncertainty, EPA
considered the central tendency estimate when determining
ONU risk. ONU unreasonable risk determination reflects the
severity of the effect (neurotoxicity including loss of
consciousness and fatality) associated with exposures to
methylene chloride and the expected absence of PPE.
Estimated exposed worker population: Not identified2
Consumer Use
solvents (for
cleaning or
degreasing)
Aerosol spray
degreaser/cleaner
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methvlene chloride as a solvent in an aerosol
sprav dcercascr/clcaner (brake cleaner):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
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Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bvstander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bvstanders: Acute CNS
effects: Benchmark MOE = 30. Acute dermal CNS effects:
Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 1.7
(medium intensity user) (Table 4-72).
CNS adverse effects: Acute dermal MOE 9.2
(medium intensity user) (Table 4-73).
Risk estimate - bvstanders:
CNS adverse effects: acute inhalation MOE 14.1
(medium intensity user) (Table 4-72).
Svstematic Review confidence ratine (hazard): Medium.
Svstematic Review confidence ratine (inhalation exposure):
High.
Svstematic Review confidence ratine (dermal exposure):
High to medium.
Risk Considerations: Consumer and bvstander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-72, Table 4-73).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified.
Estimated exposed populations: There is some eeneral
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
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Consumer Use
Solvents (for
cleaning or
degreasing)
Aerosol spray
degreaser/cleaner
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as a solvent in an aerosol
spray degreaser/cleaner (carbon remover):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bystander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 0.9
(medium intensity user, 1 hr) (Table 4-74).
CNS adverse effects: Acute dermal MOE 6.0
(medium intensity user) (Table 4-75).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 9.7
(medium intensity user, 1 hr) (Table 4-74).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-74, Table 4-75).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
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use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Solvents (for
cleaning or
degreasing)
Aerosol spray
degreaser/cleaner
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as a solvent in an aerosol
spray degreaser/cleaner (carburetor cleaner):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bystander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 1.4
(medium intensity user, 1 hr) (Table 4-76).
CNS adverse effects: Acute dermal MOE 15
(medium intensity user) (Table 4-77).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 12.1
(medium intensity user, 1 hr) (Table 4-76).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-76, Table 4-77).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified
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Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Solvents (for
cleaning or
degreasing)
Aerosol spray
degreaser/cleaner
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as a solvent in an aerosol
spray degreaser/cleaner (coil cleaner):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bystander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 0.6
(medium intensity user, 1 hr) (Table 4-78).
CNS adverse effects: Acute dermal MOE 3.7
(medium intensity user) (Table 4-79).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 5.9
(medium intensity user, 1 hr) (Table 4-78).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High to medium.
Systematic Review confidence rating (dermal exposure):
Medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-78, Table 4-79).
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Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Solvents (for
cleaning or
degreasing)
Aerosol spray
degreaser/cleaner
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as a solvent in an aerosol
spray degreaser/cleaner (electronics cleaner):
- Presents an unreasonable risk of injury to health
(consumers).
- Does not present an unreasonable risk of injury to health
(bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation.
Driver benchmark - consumers: Acute inhalation CNS
effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOEs 6.5
(high intensity user, 1 hr) and 12.9 (high intensity
user, 8 hr) (Table 4-80).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Risk Considerations: Consumer unreasonable risk
determinations reflect the severity of the effects associated
with acute exposures. Risk estimates for consumer users at
the high intensity use scenarios of acute inhalation exposures
indicate risk (Table 4-80).
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Solvents (for
cleaning or
degreasing)
Aerosol spray
degreaser/cleaner
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as a solvent in an aerosol
spray degreaser/cleaner (engine cleaner):
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- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bvstander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bvstanders: Acute.
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 0.6
(medium intensity user, 1 hr) (Table 4-82).
CNS adverse effects: Acute dermal MOE 10
(medium intensity user) (Table 4-83).
Risk estimate - bvstanders:
CNS adverse effects: Acute inhalation MOE 5.1
(medium intensity user, 1 hr) (Table 4-82).
Svstematic Review confidence ratine (hazard): Medium.
Svstematic Review confidence rating (inhalation exposure):
High.
Svstematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bvstander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk. Because bystanders are not
expected to be dermally exposed to methylene chloride,
dermal non-cancer risks to bystanders were not identified.
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
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Consumer Use
Solvents (for
cleaning or
degreasing)
Aerosol spray
degreaser/cleaner
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as a solvent in an aerosol
spray degreaser/cleaner (gasket remover):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bystander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 1.1
(medium intensity user, 1 hr) (Table 4-84).
CNS adverse effects: Acute dermal MOE 5.9
(medium intensity user) (Table 4-85).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 9.1
(medium intensity user, 1 hr) (Table 4-84).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-84, Table 4-85).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified.
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
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use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Adhesives
and sealants
Single
component glues
and adhesives
and sealants and
caulks
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as an adhesive and
sealant for single component glues and adhesives and sealants
and caulks (adhesives):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bystanders: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 28.8
(medium intensity user) (Table 4-86).
CNS adverse effects: Acute dermal MOE 11
(medium intensity user) (Table 4-87).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 4.2
(high intensity user) (Table 4-86).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the high intensity use scenario of acute
inhalation indicate risk (Table 4-86, Table 4-87). Because
bystanders are not expected to be dermally exposed to
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methylene chloride, dermal non-cancer risks to bystanders
were not identified.
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Adhesives
and sealants
Single
component glues
and adhesives
and sealants and
caulks
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as an adhesive and
sealant for single component glues and adhesives and sealants
and caulks (sealants):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bystanders: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 2.9
(medium intensity user, 1 hr) (Table 4-98).
CNS adverse effects: Acute dermal MOE 16
(medium intensity user) (Table 4-99).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 24 (high
intensity user, 1 hr) (Table 4-98).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
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inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the high intensity use scenario of acute
inhalation indicate risk (Table 4-98, Table 4-99). Because
bystanders are not expected to be dermally exposed to
methylene chloride, dermal non-cancer risks to bystanders
were not identified.
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Paints and
coatings
including
paint and
coating
removers
Brush cleaner for
paints and
coatings
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as a brush cleaner for
paints and coatings:
- Does not present an unreasonable risk of injury to health
(consumers, bystanders).
Exposure scenario with highest risk estimate: CNS adverse
effects resulting from acute dermal exposure.
Benchmark - consumers: Acute inhalation CNS effects:
Benchmark MOE = 30. Acute inhalation and dermal CNS
effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 462
(high intensity user) (Table 4-90).
CNS adverse effects: Acute dermal MOE 456 (high
intensity user) (Table 4-91).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High to medium.
Systematic Review confidence rating (dermal exposure):
Medium.
Risk Considerations: Risk estimates for consumer users at the
high intensity use scenarios of acute inhalation and dermal
exposures do not indicate risk. For bystanders the risk
estimates for the high intensity use scenario of acute
inhalation do not indicate risk (Table 4-90, Table 4-91).
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Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Paints and
coatings
including
paint and
coating
removers
Adhesive/caulk
removers
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as an adhesive/caulk
remover:
- Presents an unreasonable risk of injury to health
(consumers).
-Does not present unreasonable risk of injury to health
(bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute dermal exposure.
Driver benchmark - consumers: Acute dermal CNS effects:
Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute dermal MOE 0.93
(medium intensity user) (Table 4-93).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer unreasonable risk
determinations reflect the severity of the effects associated
with acute exposures. Risk estimates for consumer users at
the medium intensity use scenarios of acute dermal exposures
indicate risk (Table 4-93).
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Metal
products not
covered
elsewhere
Degreasers -
aerosol and non-
aerosol
degreasers
(carbon remover)
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as a metal product not
covered elsewhere in aerosol and non-aerosol degreasers
(carbon remover):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
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Unreasonable risk driver - bystander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 0.9
(medium intensity user, 1 hr) (Table 4-74).
CNS adverse effects: Acute dermal MOE 6.0
(medium intensity user) (Table 4-75).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 9.7
(medium intensity user, 1 hr) (Table 4-74).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-74, Table 4-75).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Metal
products not
covered
elsewhere
Degreasers -
aerosol and non-
aerosol
degreasers (coil
cleaner)
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as a metal product not
covered elsewhere in aerosol and non-aerosol degreasers (coil
cleaner):
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- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bvstander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bvstanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 0.6
(medium intensity user, 1 hr) (Table 4-78).
CNS adverse effects: Acute dermal MOE 3.7
(medium intensity user) (Table 4-79).
Risk estimate - bvstanders:
CNS adverse effects: Acute inhalation MOE 5.9
(medium intensity user, 1 hr) (Table 4-78).
Svstematic Review confidence ratine (hazard): Medium.
Svstematic Review confidence rating (inhalation exposure):
High to medium.
Svstematic Review confidence rating (dermal exposure):
Medium.
Risk Considerations: Consumer and bvstander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-78, Table 4-79).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
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Metal
products not
covered
elsewhere
Degreasers -
aerosol and non-
aerosol
degreasers
(electronics
cleaner)
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as a metal product not
covered elsewhere in aerosol and non-aerosol degreaser
(electronics cleaner):
- Presents an unreasonable risk of injury to health
(consumers).
- Does not present an unreasonable risk of injury to health
(bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation.
Driver benchmark - consumers: Acute inhalation CNS
effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOEs 6.5
(high intensity user, 1 hr) and 12.9 (high intensity
user, 8 hr) (Table 4-80).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Risk Considerations: Consumer unreasonable risk
determinations reflect the severity of the effects associated
with acute exposures. Risk estimates for consumer users at
the high intensity use scenarios of acute inhalation exposures
indicate risk (Table 4-80).
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Automotive
care products
Function fluids
for air
conditioners:
refrigerant,
treatment, leak
sealer
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as an automotive care
product for functional fluids for air conditioners: refrigerant,
treatment, leak sealer (automotive air conditioning leak
sealer):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
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Unreasonable risk driver - bystander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 1.2
(medium intensity user, 1 hr) (Table 4-88).
CNS adverse effects: Acute dermal MOE 5 (medium
intensity user) (Table 4-89).
Risk estimate - bystanders:
CNS adverse effects: acute inhalation MOE 10.1
(medium intensity user, 1 hr) (Table 4-88).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High to medium.
Systematic Review confidence rating (dermal exposure):
Medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-88, Table 4-89).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified.
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Automotive
care products
Function fluids
for air
conditioners:
refrigerant,
treatment, leak
sealer
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as an automotive care
product for functional fluids for air conditioners: refrigerant-
treatment. leak sealer (automotive air conditioning
refrigerant):
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- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation exposure.
Unreasonable risk driver - bystanders: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 8.8
(medium intensity user, 1 hr) (Table 4-94).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 19.1
(high intensity user, 1 hr) (Table 4-94).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
Moderate to high.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation exposures indicate risk. For bystanders the risk
estimates for the high intensity use scenario of acute
inhalation indicate risk (Table 4-94). Because bystanders are
not expected to be dermally exposed to methylene chloride,
dermal non-cancer risks to bystanders were not identified.
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Automotive
care products
Degreasers:
gasket remover,
transmission
cleaners,
carburetor
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as an automotive care
product in degreasers (brake cleaner):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
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cleaner, brake
quieter/cleaner
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bystander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 1.7
(medium intensity user) (Table 4-72).
CNS adverse effects: Acute dermal MOE 9.2
(medium intensity user) (Table 4-73).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 14.1
(medium intensity user) (Table 4-72).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-72, Table 4-73).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified.
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
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Consumer Use
Automotive
care products
Degreasers:
gasket remover,
transmission
cleaners,
carburetor
cleaner, brake
quieter/cleaner
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as an automotive care
product in degreasers (carburetor cleaner):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bystander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 1.4
(medium intensity user, 1 hr) (Table 4-76).
CNS adverse effects: Acute dermal MOE 15
(medium intensity user) (Table 4-77).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 12.1
(medium intensity user, 1 hr) (Table 4-76).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-76, Table 4-77).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
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use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Automotive
care products
Degreasers:
gasket remover,
transmission
cleaners,
carburetor
cleaner, brake
quieter/cleaner
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as an automotive care
product in degreasers (engine cleaner):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bystander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 0.6
(medium intensity user, 1 hr) (Table 4-82).
CNS adverse effects: Acute dermal MOE 10
(medium intensity user) (Table 4-83).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 5.1
(medium intensity user, 1 hr) (Table 4-82).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-82, Table 4-83).
Because bystanders are not expected to be dermally exposed
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to methylene chloride, dermal non-cancer risks to bystanders
were not identified.
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Automotive
care products
Degreasers:
gasket remover,
transmission
cleaners,
carburetor
cleaner, brake
quieter/cleaner
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as an automotive care
product in degreasers (gasket remover):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bystander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 1.1
(medium intensity user, 1 hr) (Table 4-84).
CNS adverse effects: Acute dermal MOE 5.9
(medium intensity user) (Table 4-85).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 9.1
(medium intensity user, 1 hr) (Table 4-84).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
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inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-84, Table 4-85).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified.
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Lubricants
Degreasers -
Section 6(b)(4)(A) unreasonable risk determination for
and greases
Aerosol and non-
consumer use of methylene chloride as lubricant and erease
aerosol
in degreasers (brake cleaner):
degreasers and
cleaners (Break
Cleaner)
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bvstander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bvstanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 1.7
(medium intensity user) (Table 4-72).
CNS adverse effects: Acute dermal MOE 9.2
(medium intensity user) (Table 4-73).
Risk estimate - bvstanders:
CNS adverse effects: Acute inhalation MOE 14.1
(medium intensity user) (Table 4-72).
Systematic Review confidence ratine (hazard): Medium.
Systematic Review confidence ratine (inhalation exposure):
High.
Systematic Review confidence ratine (dermal exposure):
High to medium.
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Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-72, Table 4-73).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified.
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Lubricants
and greases
Degreasers -
aerosol and non-
aerosol
degreasers and
cleaners
(Carburetor
Cleaner)
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as a lubricant and grease
in degreasers (carburetor cleaner):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bystander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 1.4
(medium intensity user, 1 hr) (Table 4-76).
CNS adverse effects: Acute dermal MOE 15
(medium intensity user) (Table 4-77).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 12.1
(medium intensity user, 1 hr) (Table 4-76).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
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Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-76, Table 4-77).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Lubricants
and greases
Degreasers -
aerosol and non-
aerosol
degreasers and
cleaners (Engine
Cleaner)
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as an automotive care
product in degreasers (engine cleaner):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bystander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 0.6
(medium intensity user, 1 hr) (Table 4-82).
CNS adverse effects: Acute dermal MOE 10
(medium intensity user) (Table 4-83).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 5.1
(medium intensity user, 1 hr) (Table 4-82).
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Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-82, Table 4-83).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified.
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Lubricants
and greases
Degreasers -
aerosol and non-
aerosol
degreasers and
cleaners (Gasket
Remover)
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as a lubricant and grease
in degreasers (gasket remover):
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bystander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 1.1
(medium intensity user, 1 hr) (Table 4-84).
CNS adverse effects: Acute dermal MOE 5.9
(medium intensity user) (Table 4-85).
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Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 9.1
(medium intensity user, 1 hr) (Table 4-84).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-84, Table 4-85).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified.
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Building/
construction
materials not
covered
elsewhere
Cold pipe
insulation
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as a building
construction material not covered elsewhere for cold pipe
insulation:
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bystander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
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CNS adverse effects: Acute inhalation MOE 1.6
(medium intensity user, 1 hr) (Table 4-96).
CNS adverse effects: Acute dermal MOE 20
(medium intensity user) (Table 4-97).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 17.1
(medium intensity user, 1 hr) (Table 4-96).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High to medium.
Systematic Review confidence rating (dermal exposure):
Medium.
Risk Considerations: Consumer and bystander unreasonable
risk determination reflects the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-96, Table 4-97).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified.
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Arts, crafts
and hobby
materials
Crafting glue
and
cement/concrete
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as an arts, crafts, and
hobby materials for crafting glue and cement/concrete:
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bystanders: CNS adverse effects
resulting from acute inhalation exposure.
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Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 0.5
(high intensity user) (Table 4-86).
CNS adverse effects: Acute dermal MOE 11
(medium intensity user) (Table 4-87).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 4.2
(high intensity user) (Table 4-86).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the high intensity use scenario of acute
inhalation indicate risk (Table 4-86, Table 4-87). Because
bystanders are not expected to be dermally exposed to
methylene chloride, dermal non-cancer risks to bystanders
were not identified.
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Other Uses
Anti-adhesive
agent - anti-
spatter welding
aerosol
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as other uses for anti-
adhesive agent - anti-spatter welding aerosol:
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
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Unreasonable risk driver - bystander: CNS adverse effects
resulting from acute inhalation exposure.
Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 0.9
(medium intensity user, 1 hr) (Table 4-100).
CNS adverse effects: Acute dermal MOE 12
(medium intensity user) (Table 4-101).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 10.4
(medium intensity user, 1 hr) (Table 4-100).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High to medium.
Systematic Review confidence rating (dermal exposure):
Medium.
Risk Considerations: Consumer and bystander unreasonable
risk determination reflects the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-100, Table 4-101).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified.
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Other Uses
Brush cleaner
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as brush cleaner for
other uses:
- Does not present an unreasonable risk of injury to health
(consumers, bystanders).
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Exposure scenario with highest risk estimate: CNS adverse
effects resulting from acute dermal exposure to consumers.
Benchmarks: Acute inhalation CNS effects: Benchmark
MOE = 30. Acute inhalation and dermal CNS effects:
Benchmark MOE = 30.
Risk estimate:
CNS adverse effects: Acute inhalation MOE 462
(high intensity user) (Table 4-90).
CNS adverse effects: Acute dermal MOE 456 (high
intensity user) (Table 4-91).
Svstematic Review confidence ratine (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High to medium.
Svstematic Review confidence rating (dermal exposure):
Medium.
Risk Considerations: Risk estimates for consumer users at the
high intensity use scenarios of acute inhalation and dermal
exposures do not indicate risk. For bystanders the risk
estimates for the high intensity use scenario of acute
inhalation do not indicate risk (Table 4-90, Table 4-91).
Estimated exposed populations: There is some aeneral
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Consumer Use
Other Uses
Carbon remover
Section 6(b)(4)(A) unreasonable risk determination for
consumer use of methylene chloride as other uses for carbon
remover:
- Presents an unreasonable risk of injury to health
(consumers and bystanders).
Unreasonable risk driver - consumers: CNS adverse effects
resulting from acute inhalation and dermal exposure.
Unreasonable risk driver - bvstander: CNS adverse effects
resulting from acute inhalation exposure.
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Driver benchmark - consumers and bystanders: Acute
inhalation CNS effects: Benchmark MOE = 30. Acute dermal
CNS effects: Benchmark MOE = 30.
Risk estimate - consumers:
CNS adverse effects: Acute inhalation MOE 0.9
(medium intensity user, 1 hr) (Table 4-74).
CNS adverse effects: Acute dermal MOE 6.0
(medium intensity user) (Table 4-75).
Risk estimate - bystanders:
CNS adverse effects: Acute inhalation MOE 9.7
(medium intensity user, 1 hr) (Table 4-74).
Systematic Review confidence rating (hazard): Medium.
Systematic Review confidence rating (inhalation exposure):
High.
Systematic Review confidence rating (dermal exposure):
High to medium.
Risk Considerations: Consumer and bystander unreasonable
risk determinations reflect the severity of the effects
associated with acute exposures. Risk estimates for consumer
users at the medium intensity use scenarios of acute
inhalation and dermal exposures indicate risk. For bystanders
the risk estimates for the medium intensity use scenario of
acute inhalation indicate risk (Table 4-74, Table 4-75).
Because bystanders are not expected to be dermally exposed
to methylene chloride, dermal non-cancer risks to bystanders
were not identified
Estimated exposed populations: There is some general
uncertainty regarding the nature and extent of the consumer
use of methylene chloride for the products within the scope of
this assessment.
Disposal
Disposal
Industrial pre-
treatment
Industrial
wastewater
treatment
Publicly owned
treatment works
(POTW)
Section 6(b)(4)(A) unreasonable risk determination for
disposal of methylene chloride:
- Presents an unreasonable risk of injury to health
(workers and occupational non-users1).
Unreasonable risk driver - workers and occupational non-
users: CNS adverse effects resulting from acute inhalation
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exposure and liver adverse effects from chronic, non-cancer
inhalation exposure.
Driver benchmark - workers and occupational non-users:
Underground
injection
Municipal
landfill
Hazardous
landfill
Other land
disposal
Acute inhalation CNS effects: Benchmark MOE - 30.
Chronic, non-cancer inhalation liver effects: Benchmark
MOE = 10.
Risk estimate - workers:
Municipal waste
incinerator
Hazardous waste
incinerator
Off-site waste
transfer
CNS effects: Acute inhalation MOEs 15.70 and
15.11 (central tendency and high end) (Table 4-18).
Liver effects: Chronic inhalation MOEs 4.08 and 3.9
(central tendency and high end) (Table 4-19).
Risk estimate - occupational non-users:
CNS effects: Acute inhalation MOEs 15.70 and
15.11 (central tendency and high end) (Table 4-18).
Liver effects: Chronic inhalation MOEs 4.08 and 3.9
(central tendency and high end) (Table 4-19).
Svstematic Review confidence ratine (hazard): Medium.
Svstematic Review confidence rating (inhalation exposure):
Medium to low (see Section 2.4.1.2.21).
Risk Considerations: EPA does not expect routine use of
respiratory PPE sufficient to mitigate risk (respirator APF 25)
for workers with this condition of use (Table 4-18, Table
4-19). ONU unreasonable risk determination reflects the
severity of the effects associated with exposures to methylene
chloride and the expected absence of PPE.
Estimated exposed worker population: 12.000 workers and
7,600 occupational non-users2 (Table 2-27).
9911
9912 1 Data do not distinguish between workers and ONUs.
9913 2 Estimated exposed worker populations apply to each occupational exposure scenario. For a crosswalk of
9914 occupational and consumer exposure scenarios to the conditions of use, see Table 2-24.
9915 3 While the benchmark used in the 2014 assessment was 60, the benchmark shown here is 30 for consistency with
9916 this current evaluation.
9917
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9918
9919
9920
9921
9922
9923
9924
9925
9926
9927
9928
9929
9930
9931
9932
9933
9934
9935
9936
9937
9938
9939
9940
9941
9942
9943
9944
9945
9946
9947
9948
9949
9950
9951
9952
9953
9954
9955
9956
9957
9958
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http://dx.doi.ors >890-623 8(89190025-7
Whittaker. C; RK ^ t , VIcKernan. L; Danko\ > .1' 1 ^ntz. T; Macmahon. K; Kuempel. E;
Zumwalde. R; Schulte. P. (2016). Current Intelligence Bulletin 68: NIOSH Chemical
Carcinogen Policy. Whittaker, C; Rice, F; Mckernan, L; Dankovic, D; Lentz, T;
Macmahon, K; Kuempel, E; Zumwalde, R; Schulte, P.
WHO. (1996a). Environmental health criteria 164: Methylene chloride, 2nd ed. Geneva,
Switzerland.
WHO. (1996b). Methylene chloride (second edition).
WHO. (2000). Air quality guidelines for Europe (2nd ed.). Copenhagen, Denmark: World Health
Organization, Regional Office for Europe, http://www.euro, who.int/en/health-
topics/environment-and-health/air-qualitv/publications/pre2009/air-qualitv-guidelines-
for-europe
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Toxicants. 60-75.
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in relation to distribution of hazardous air pollutants in the San Francisco Bay area.
Environ Health Perspect 114: 1438-1444.
Winneke. G (1974). Behavioral effects of methylene chloride and carbon monoxide as assessed
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Behavioral toxicology: Early detection of occupational hazards (pp. 130-144). Cincinnati,
OH: U.S. Department of Health, Education, and Welfare, National Institute for
Occupational Safety and Health.
Winneke dor. GG. (1976). Dichloromethane produces narcotic effect. Occup Health Saf
45: 34-35.
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Wu. S; Zhang. H; Yu. X; Qiu. L. (2014). Toxicological Responses of Chlorella vulgaris to
Dichloromethane and Dichloroethane. Environ Eng Sci 31: 9-17.
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Yamamoto. K; Fukushima. M; Kakutani. N: Kuroda. K. (1997). Volatile organic compounds in
urban rivers and their estuaries in Osaka, Japan. Environ Pollut 95: 135-143.
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Y mg. I; Chu. W: Yin. D; Templeton. MR. (2014). Haloactamides versus
halomethanes formation and toxicity in chloraminated drinking water. J Hazard Mater
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Zeiger. E. (1990). Mutagenicity of 42 chemicals in Salmonella. Environ Mol Mutagen 16: 32-54.
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Zeliezic. D; Mladinic. M; Kopjar. N; Radulovic. AH. (2016). Evaluation of genome damage in
subjects occupationally exposed to possible carcinogens. Toxicol Ind Health 32: 1570-
1580. http://dx.doi.org/tO I I ' 07481' t H ( >478
Zi el en ska. M; Ahmi kowska. M; Anderson. M; Glickman. BW. (1993). Mutational
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11126 APPENDICES
11127
11128 Appendix A REGULATORY HISTORY
11129
11130 A.l Federal Laws and Regulations
11131 Table Apx A-l. Federal Laws and Regulations
Maliilcs/Ucgulalions
Description of
Authority/Regulation
Description of Regulation
EPA Regulations
TSCA - Section 6(a)
If EPA evaluates the risk of
a chemical substance, in
accordance with TSCA
Section 6(b)(A), and
concludes that the
manufacture (including
import), processing,
distribution in commerce,
disposal of such chemical
substance, or any
combination of these
activities, presents an
unreasonable risk of injury
to human health or the
environment, then EPA
shall, by rule, take one or
more of the actions
described in TSCA Section
6(a)(l)-(7) to ensure the
chemical substance no
longer presents an
unreasonable risk.
Prohibits the manufacture
(including import), processing,
and distribution in commerce of
methylene chloride for consumer
paint and coating removal,
including distribution to and by
retailers; requiring
manufacturers (including
importers), processors, and
distributors, except for retailers,
of methylene chloride for any
use to provide downstream
notification of these
prohibitions; and requiring
recordkeeping 40 CFR 751.1,
effective as of May 28, 2019.
TSCA - Section 6(b)
Directs EPA to promulgate
regulations to establish
processes for prioritizing
chemical substances and
conducting risk evaluations
on priority chemicals
substances. In the meantime,
EPA was required to identify
and begin risk evaluations on
Methylene chloride is one of the
10 chemical substances on the
initial list to be evaluated for
unreasonable risk of injury to
health or the environment (§1
FR 91927. December 19. 20161
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10 chemical substances
drawn from the 2014 update
of the TSCA Work Plan for
Chemical Assessments.
TSCA - Section 8(a)
The TSCA section 8(a) CDR
Rule requires manufacturers
(including importers) to give
EPA basic exposure-related
information on the types,
quantities and uses of
chemical substances
produced domestically and
imported into the U.S.
Methylene chloride
manufacturing (including
importing), processing, and use
information is reported under the
CDR rule ( 316. Aueust
16, 2011).
TSCA - Section 8(b)
EPA must compile, keep
current and publish a list (the
TSCA Inventory) of each
chemical substance
manufactured, processed or
imported in the U.S..
Methylene chloride was on the
initial TSCA Inventory and
therefore was not subject to
EPA's new chemicals review
process under TSCA section 5
(60 FR 16309. March 29. 1995V
TSCA - Section 8(d)
Provides EPA with authority
to issue rules requiring
producers, importers, and (if
specified) processors of a
chemical substance or
mixture to submit lists
and/or copies of ongoing and
completed, unpublished
health and safety studies.
One submission received in
2001 (U.S. EPA, Chemical Data
Access Tool. Accessed April 24,
2017).
TSCA - Section 8(e)
Manufacturers (including
importers), processors, and
distributors must
immediately notify EPA if
they obtain information that
supports the conclusion that
a chemical substance or
mixture presents a
substantial risk of injury to
health or the environment.
Sixteen submissions received
1992-1994 (U.S. EPA,
ChemView. Accessed April 24,
2017).
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TSCA - Section 4
Provides EPA with authority
to issue rules and orders
requiring manufacturers
(including importers) and
processors to test chemical
substances and mixtures.
Five chemical data from test
rules (Section 4) from 1974 and
(U.S. EPA, ChemView.
Accessed April 24, 2017).
Emergency Planning
and Community Right-
to-Know Act (EPCRA)
- Section 313
Requires annual reporting
from facilities in specific
industry sectors that employ
10 or more full-time
equivalent employees and
that manufacture, process or
otherwise use a TRI-listed
chemical in quantities above
threshold levels. A facility
that meets reporting
requirements must submit a
reporting form for each
chemical for which it
triggered reporting,
providing data across a
variety of categories,
including activities and uses
of the chemical, releases and
other waste management
(e.g., quantities recycled,
treated, combusted) and
pollution prevention
activities (under section
6607 of the Pollution
Prevention Act). These data
include on- and off-site data
as well as multimedia data
(i.e., air, land and water).
Methylene chloride is a listed
substance subject to reporting
requirements under 40 CFR
372.65 effective as of January
01, 1987.
Federal Food, Drug,
and Cosmetic Act
(FFDCA) -Section 408
FFDCA governs the
allowable residues of
pesticides in food. Section
408 of the FFDCA provides
EPA with the authority to set
tolerances (rules that
establish maximum
allowable residue limits), or
Methylene chloride was
registered as an antimicrobial,
conventional chemical in 1974.
In 1998, EPA removed
methylene chloride from its list
of pesticide product inert
ingredients that are currently
used in pesticide products (63
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exemptions from the
requirement of a tolerance,
for pesticide residues
(including inert ingredients)
on food. Prior to issuing a
tolerance or exemption from
tolerance, EPA must
determine that the pesticide
residues permitted under the
action are "safe." Section
408(b) of the FFDCA
defines "safe" to mean a
reasonable certainty that no
harm will result from
aggregate, nonoccupational
exposures to the pesticide.
Pesticide tolerances or
exemptions from tolerance
that do not meet the FFDCA
safety standard are subject to
revocation under FFDCA
section 408(d) or (e). In the
absence of a tolerance or an
exemption from tolerance, a
food containing a pesticide
residue is considered
adulterated and may not be
distributed in interstate
commerce.
FR 343841 The tolerance
exemptions for methylene
chloride were revoked in 2002
( • \\< 1 027. April 4. 2002).
CAA- Section 112(b)
Defines the original list of
189 HAPs. Under 112(c) of
the CAA, EPA must identify
and list source categories
that emit HAP and then set
emission standards for those
listed source categories
under CAA section 112(d).
CAA section 112(b)(3)(A)
specifies that any person
may petition the
Administrator to modify the
list of HAP by adding or
Methylene chloride is listed as a
HAP (42 U.S. Code section
7412), and is considered an
"urban air toxic" (CAA Section
112(k)).
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deleting a substance. Since
1990, EPA has removed two
pollutants from the original
list leaving 187 at present.
CAA- Section 112(d)
Directs EPA to establish, by
rule, National Emission
Standards for Hazardous Air
Pollutants (NESHAPs) for
each category or subcategory
of listed major sources and
area sources of HAPs (listed
pursuant to Section 112(c)).
The standards must require
the maximum degree of
emission reduction that the
EPA determines is
achievable by each particular
source category. This is
generally referred to as
maximum achievable control
technology (MACT).
There are a number of source-
specific NESHAPs for
methylene chloride, including:
• Foam production and
fabrication process (68 FR
18062. April 14. 2003; 72 FR
38864. Julv 16. 20027; 73 FR
15923, March 26, 2008; 79
FR 48073. August 15, 2014).
• Aerospace (60 FR 45948,
September 1, 1995).
• Boat manufacturing (
44218, August 22, 2001).
• Chemical manufacturing
industry (agricultural
chemicals and pesticides,
cyclic crude and intermediate
production, industrial
inorganic chemicals,
industrial and miscellaneous
organic chemicals, inorganic
pigments, plastic materials
and resins, pharmaceutical
production, synthetic rubber)
( 008. October 29.
2009).
• Fabric printing, coating and
dveina (68 FR . Mav
29, 2003).
• Halogenated Solvent
Cleaning ( , May
3, 2007).
• Miscellaneous organic
chemical production and
processes (MON) (68 FR
63852, November 10, 2003).
• Paint and allied products
manufacturing (area sources)
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( 504. December 3.
2009).
• Paint stripping and
miscellaneous surface
coating operations (area
sources) (73 FR 1738,
January 9, 2008).
• Paper and other web surface
coating (61 FR 72330.
December 4, 2002).
• Pesticide active ingredient
production (64 FR 33550.
June 23. 1999. . R ^200.
June 3, 2002).
• Pharmaceutical production
(63 FR 502.80. September 21.
1998).
• POTW ( 1,
October 26, 1999).
• Reciprocating Internal
Combustion Engines (RICE)
( , August 20,
2010).
• Reinforced plastic
composites production (68
, April 21, 2003).
• Wood preserving (area
sources) (12 FR 38864. Julv
16, 2007).)
CAA sections 112(d)
and 112(f)
Risk and technology review
(RTR) of section 112(d)
MACT standards. Section
112(f)(2) requires EPA to
conduct risk assessments for
each source category subject
to section 112(d) MACT
standards, and to determine
if additional standards are
needed to reduce remaining
risks. Section 112(d)(6)
requires EPA to review and
revise the MACT standards,
EPA has promulgated a number
of RTR NESHAP (e.g., the RTR
NESHAP for Halogenated
Solvent Cleaning (12 FR 2.5138;
May 3, 2007) and will do so, as
required, for the remaining
source categories with
NESHAP.
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as necessary, taking into
account developments in
practices, processes and
control technologies.
CAA - Section 612
Under Section 612 of the
CAA, EPA's Significant
New Alternatives Policy
(SNAP) program reviews
substitutes for ozone-
depleting substances within a
comparative risk framework.
EPA publishes lists of
acceptable and unacceptable
alternatives. A determination
that an alternative is
unacceptable, or acceptable
only with conditions, is
made through rulemaking.
Under the SNAP program, EPA
listed methylene chloride as an
acceptable substitute in multiple
industrial end-uses, including as
a blowing agent in polyurethane
foam, in cleaning solvents, in
aerosol solvents and in adhesives
and coatings (59 FR 13044,
March 18, 1994). In 2016,
methylene chloride was listed as
an unacceptable substitute for
use as a blowing agent in the
production of flexible
polyurethane foam (81 FR
86778, December 1, 2016).
CWA - Section 301(b),
304(b), 306, and 307(b)
Requires establishment of
Effluent Limitations
Guidelines and Standards for
conventional, toxic, and
nonconventional pollutants.
For toxic and non-
conventional pollutants, EPA
identifies the best available
technology that is
economically achievable for
that industry after
considering statutorily
prescribed factors and sets
regulatory requirements
based on the performance of
that technology.
Methylene chloride is designated
as a toxic pollutant under section
307(a)(1) of the CWA and as
such is subject to effluent
limitations. Under CWA section
304, methylene chloride is
included in the list of total toxic
organics (TTO) (40 CFR
413.02(i)).
CWA - Section 307(a)
Establishes a list of toxic
pollutants or combination of
pollutants under the CWA.
The statue specifies a list of
families of toxic pollutants
also listed in the CFR at 40
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CFRPart401.15. The
"priority pollutants"
specified by those families
are listed in 40 CFR Part 423
Appendix A. These are
pollutants for which best
available technology effluent
limitations must be
established on either a
national basis through rules
(Sections 301(b), 304(b),
307(b), 306) or on a case-by-
case best professional
judgement basis in NPDES
permits, see Section
402(a)(1)(B).
SDWA- Section 1412
Requires EPA to publish
non-enforceable maximum
contaminant level goals
(MCLGs) for contaminants
which 1. may have an
adverse effect on the health
of persons; 2. are known to
occur or there is a substantial
likelihood that the
contaminant will occur in
public water systems with a
frequency and at levels of
public health concern; and 3.
in the sole judgement of the
Administrator, regulation of
the contaminant presents a
meaningful opportunity for
health risk reductions for
persons served by public
water systems. When EPA
publishes an MCLG, EPA
must also promulgate a
National Primary Drinking
Water Regulation (NPDWR)
which includes either an
enforceable maximum
Methylene chloride is subject to
NPDWR under the SDWA with
a MCLG of zero and an
enforceable MCL of 0.005 mg/L
or 5 ppb (Section 1412).
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contaminant level (MCL), or
a required treatment
technique. Public water
systems are required to
comply with NPDWRs.
Comprehensive
Environmental
Response,
Compensation, and
Liability Act
(CERCLA) - Sections
102(a) and 103
Authorizes EPA to
promulgate regulations
designating as hazardous
substances those substances
which, when released into
the environment, may
present substantial danger to
the public health or welfare
or the environment. EPA
must also promulgate
regulations establishing the
quantity of any hazardous
substance the release of
which must be reported
under Section 103.
Section 103 requires persons
in charge of vessels or
facilities to report to the
National Response Center if
they have knowledge of a
release of a hazardous
substance above the
reportable quantity
threshold.
Methylene chloride is a
hazardous substance under
CERCLA. Releases of
methylene chloride in excess of
1,000 pounds must be reported
(40 CFR 302.4).
RCRA- Section 3001
Directs EPA to develop and
promulgate criteria for
identifying the
characteristics of hazardous
waste, and for listing
hazardous waste, taking into
account toxicity, persistence,
and degradability in nature,
potential for accumulation in
tissue and other related
factors such as flammability,
corrosiveness, and other
hazardous characteristics.
Methylene chloride is included
on the list of hazardous wastes
pursuant to RCRA 3001.
RCRA Hazardous Waste Code:
F001, F002, U080; see 40 CFR
261.31, 261.32.
In 2013, EPA modified its
hazardous waste management
regulations to conditionally
exclude solvent-contaminated
wipes that have been cleaned
and reused from the definition of
solid waste under RCRA and to
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Description of Regulation
conditionally exclude solvent-
contaminated wipes that are
disposed from the definition of
hazardous waste (78 FR 46448,
July 31, 2013, 40 CFR
261.4(a)(26)).
Other Federal Regulations
Federal Hazardous
Substance Act (FHSA)
Requires precautionary
labeling on the immediate
container of hazardous
household products and
allows the Consumer
Product Safety Commission
(CPSC) to ban certain
products that are so
dangerous or the nature of
the hazard is such
that labeling is not adequate
to protect consumers.
Certain household products that
contain methylene chloride are
hazardous substances required to
be labelled under the FHSA (52
FR 34698. September 14. 1987V
In 2016, the Halogenated
Solvents Industry Alliance
petitioned the CPSC to amend
the CPSC's labeling
interpretation and policy on
those products (81 FR 60298,
September 1, 2016). In 2018,
CPSC updated the labelling
policy for paint strippers
containing methylene chloride
(83 FR 122.54. March 21. 2018
and 83 FR 18219. April 26.
2018)
Hazardous Materials
Transportation Act
(HMTA)
Section 5103 of the Act
directs the Secretary of
Transportation to:
• Designate material
(including an explosive,
radioactive material,
infectious substance,
flammable or
combustible liquid, solid
or gas, toxic, oxidizing or
corrosive material, and
compressed gas) as
hazardous when the
Secretary determines that
transporting the material
in commerce may pose an
Methylene chloride is listed as a
hazardous material with regard
to transportation and is subject
to regulations prescribing
requirements applicable to the
shipment and transportation of
listed hazardous materials (70
FR 34381. June 14 2005V
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unreasonable risk to
health and safety or
property.
• Issue regulations for the
safe transportation,
including security, of
hazardous material in
intrastate, interstate and
foreign commerce.
FFDCA
Provides the Food and Drug
Administration (FDA) with
authority to oversee the
safety of food, drugs and
cosmetics.
Methylene chloride is banned
by the FDA as an ingredient in
all cosmetic products (54 FR
27328. June 29, 1989).
Occupational Safety
and Health Act
Requires employers to
provide their workers with a
place of employment free
from recognized hazards to
safety and health, such as
exposure to toxic chemicals,
excessive noise levels,
mechanical dangers, heat or
cold stress or unsanitary
conditions (29 U.S.C.
section 651 et seq.).
In 1997, OSHA revised an
existing occupational safety and
health standards for methylene
chloride, to include an 8-hr
TWA PEL of 25 ppm TWA,
exposure monitoring, control
measures and respiratory
protection (29 CFR 1910.1052
App. A).
11132
11133 A.2 State Laws and Regulations
11134 Table Apx A-2. State Laws and Regulations
State Actions
Description of Action
State PELs
California (PEL of 25 ppm and a STEL of 100) (Cal Code Regs, title
8, section 5155)
State Right-to-
Know Acts
Massachusetts (454 Code Mass. Regs, section 21.00), New Jersey
(8:59 N.J. Admin. Code section 9.1) and Pennsylvania (34 Pa. Code
section 323).
State Drinking
Water Standards
and Guidelines
Arizona (14 Ariz. Admin. Register 2978, August 1, 2008), California
(Cal Code Regs. Title 26, section 22-64444), Delaware (Del. Admin.
Code Title 16, section 4462), Connecticut (Conn. Agencies Regs.
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Stsilo Actions
Description of Action
section 19-13-B102), Florida (Fla. Admin. CodeR. Chap. 62-550),
Maine (10 144 Me. Code R. Chap. 231), Massachusetts (310 Code
Mass. Regs, section 22.00), Minnesota (Minn R. Chap. 4720), New
Jersey (7:10 N.J Admin. Code section 5.2), Pennsylvania (25 Pa.
Code section 109.202), Rhode Island (14 R.I. Code R. section 180-
003), Texas (30 Tex. Admin. Code section 290.104).
Chemicals of
High Concern to
Children
Several states have adopted reporting laws for chemicals in children's
products that include methylene chloride, including Maine (38
MRSA Chapter 16-D), Minnesota (Minnesota Statutes 116.9401 to
116.9407), Oregon (Toxic-Free Kids Act, Senate Bill 478, 2015),
Vermont (18 V.S.A section 1776) and Washington State (WAC 173-
334-130).
voc
Regulations for
Consumer
Products
Many states regulate methylene chloride as a VOC. These regulations
may set VOC limits for consumer products and/or ban the sale of
certain consumer products as an ingredient and/or impurity.
Regulated products vary from state to state, and could include contact
and aerosol adhesives, aerosols, electronic cleaners, footwear or
leather care products and general degreasers, among other products.
California (Title 17, California Code of Regulations, Division 3,
Chapter 1, Subchapter 8.5, Articles 1, 2, 3 and 4), Connecticut
(R.C.S.A Sections 22a-174-40, 22a-174-41, and 22a-174-44),
Delaware (Adm. Code Title 7, 1141), District of Columbia (Rules 20-
720, 20-721, 20-735, 20-736, 20-737), Illinois (35 Adm Code 223),
Indiana ( 326 IAC 8-15), Maine (Chapter 152 of the Maine
Department of Environmental Protection Regulations), Maryland
(COMAR 26.11.32.00 to 26.11.32.26), Michigan (R 336.1660 and R
336. 1661), New Hampshire (Env-A 4100) New Jersey (Title 7,
Chapter 27, Subchapter 24), New York (6 CRR-NY III A 235),
Rhode Island (Air Pollution Control Regulation No. 31) and Virginia
(9VAC5 CHAPTER 45) all have VOC regulations or limits for
consumer products. Some of these states also require emissions
reporting.
Other
California listed methylene chloride on Proposition 65 (Cal Code
Regs, title 27, section 27001)
Massachusetts designated methylene chloride as a Higher Hazard
Substance which will require reporting starting in 2014 (301 CMR
41.00).
11135
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11136 A.3 International Laws and Regulations
11137 Table Apx A-3. Regulatory Actions by other Governments and Tribes
Country/
Organization
Requirements and Restrictions
Canada
Methylene chloride is on the Canadian List of Toxic Substances
(CEPA 1999 Schedule 1). Canada required pollution prevention
plan implementation for methylene chloride in 2003 for aircraft
paint stripping; flexible polyurethane foam blowing;
pharmaceuticals and chemical intermediates manufacturing and
tablet coating; industrial cleaning; and adhesive formulations. The
overall reduction objective of 85% was exceeded (Canada Gazette,
Part I, Saturday, February 28, 2004; Vol. 138, No. 9, p. 409).
European Union
In 2010, a restriction of sale and use of paint removers containing
0.1% or more methylene chloride was added to Annex XVII of
regulation (EC) No 1907/2006 - REACH (Registration, Evaluation,
Authorization and Restriction of Chemicals). The restriction
included provisions for individual member states to issue a
derogation for professional uses if they have completed proper
training and demonstrate they are capable of safely use the paint
removers containing methylene chloride (European Chemicals
Agency (ECHA) database. Accessed April 18, 2017).
Australia
Methylene chloride was assessed under Human Health Tier II of the
Inventory Multi-Tiered Assessment and Prioritisation (EVIAP). Uses
reported include solvent in paint removers, adhesives, detergents,
print developing, aerosol propellants (products not specified), cold
tank degreasing and metal cleaning, as well as uses in waterproof
membranes, in urethane foam and plastic manufacturing, and as an
extraction solvent for spices, caffeine and hops (NICNAS, 2017,
Human Health Tier II assessment for Methane, dichloro-. Accessed
April 18 2017;.
Japan
Methylene chloride is regulated in Japan under the following
legislation:
Act on the Evaluation of Chemical Substances and Regulation of
Their Manufacture, etc. (Chemical Substances Control Law; CSCL)
• Act on Confirmation, etc. of Release Amounts of Specific
Chemical Substances in the Environment and Promotion of
Improvements to the Management Thereof
• Industrial Safety and Health Act (ISHA)
• Air Pollution Control Law
• Water Pollution Control Law
• Soil Contamination Countermeasures Act
Page 546 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Country/
Requirements siml Restrictions
Orgsini/iilion
(National Institute of Technology and Evaluation [NITE] Chemical
Risk Information Platform [CHIRP]. Accessed April 17, 2017).
Basel Convention
Halogenated organic solvents (Y41) are listed as a category of waste
under the Basel Convention. Although the U.S. is not currently a
party to the Basel Convention, this treaty still affects U.S. importers
and exporters.
OECD Control of
Transboundary
Movements of
Wastes Destined
for Recovery
Operations
Halogenated organic solvents (A3150) are listed as a category of
waste subject to The Amber Control Procedure under Council
Decision C (2001) 107/Final.
Australia, Austria,
Belgium, Canada,
Denmark, EU,
Finland, France,
Germany,
Hungary, Ireland,
Israel, Japan,
Latvia New
Zealand, People's
Republic of
China, Poland,
Singapore, South
Korea, Spain,
Sweden,
Switzerland, U.K.
OES for methylene chloride (GESTIS International limit values for
chemical agents (Occupational exposure limits, OELs) database.
Accessed April 18, 2017).
11138
Page 547 of 725
-------
1139
1140
1141
1142
1143
1144
1145
1146
1147
1148
1149
1150
1151
1152
1153
1154
1155
1156
1157
1158
1159
1160
1161
1162
1163
1164
1165
1166
1167
1168
1169
1170
1171
1172
1173
1174
1175
1176
1177
1178
1179
1180
1181
1182
1183
1184
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Appendix B LIST OF SUPPLEMENTAL DOCUMENTS
List of supplemental documents:
1. Associated Systematic Review Data Quality Evaluation and Data Extraction
Documents - Provides additional detail and information on individual study evaluations
and data extractions including criteria and scoring results.
a. Risk Evaluation for Methylene Chloride, Systematic Review Supplemental File:
Data Extraction Tables for Environmental Fate and Transport Studies (EPA.
2019e).
b. Risk Evaluation for Methylene Chloride, Systematic Review Supplemental File:
Data Quality Evaluation of Physical Chemical Properties Studies (EPA. 2019D
c. Risk Evaluation for Methylene Chloride, Systematic Review Supplemental File:
Data Quality Evaluation of Environmental Releases and Occupational Exposure
Data (EPA. 20I9d)
d. Risk Evaluation for Methylene Chloride, Systematic Review Supplemental File:
Data Quality Evaluation of Environmental Releases and Occupational Exposure
Common Sources (EPA. 2019c)
e. Risk Evaluation for Methylene Chloride, Systematic Review Supplemental File:
Data Quality Evaluation for Data Sources on Consumer and Environmental
Exposure (EPA. 2019q)
f Risk Evaluation for Methylene Chloride, Systematic Review Supplemental File:
Data Extraction Tables for Consumer and Environmental Exposure Studies (EPA.
2019p)
g. Risk Evaluation for Methylene Chloride, Systematic Review Supplemental File:
Data Quality Evaluation of Environmental Hazard Studies (EPA. )
h. Risk Evaluation for Methylene Chloride, Systematic Review Supplemental File:
Data Quality Evaluation of Human Health Hazard Studies - Animal Studies
(EPA. 2019u)
i. Risk Evaluation for Methylene Chloride, Systematic Review Supplemental File:
Data Quality Evaluation of Human Health Hazard Studies - Epidemiological
Studies (EPA. 2019s)
j. Risk Evaluation for Methylene Chloride, Systematic Review Supplemental File:
Data Quality Evaluation of Human Health Hazard Studies - Human Controlled
Experiments ( 19f)
Page 548 of 725
-------
11185
11186
11187
11188
11189
11190
11191
11192
11193
11194
11195
11196
11197
11198
11199
11200
11201
11202
11203
11204
11205
11206
11207
11208
11209
11210
11211
11212
11213
11214
11215
11216
11217
11218
11219
11220
11221
11222
11223
11224
11225
11226
11227
11228
11229
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
k Risk Evaluation for Methylene Chloride, Systematic Review Supplemental File:
Updates to the Data Quality Criteria for Epidemiological Studies (EPA. 2019a)
I. Risk Evaluation for Methylene Chloride, Systematic Review Supplemental File:
Data Extraction Tables for Human Health Hazard Studies (EPA. 2019o)
2. Associated Supplemental Information Documents - Provides additional details and
information on exposure, hazard and risk assessments.
a. Risk Evaluation for Methylene Chloride, Supplemental Information on Consumer
Exposure Assessment (EPA. 2019e)
This document provides additional details and information on the exposure
assessment and analyses including modeling inputs and outputs.
b. Risk Evaluation for Methylene Chloride, Supplemental Information on Consumer
Exposure Assessment Model Input Parameters ( 0191)
c. Risk Evaluation for Methylene Chloride, Supplemental Information on Consumer
Exposure Assessment Model Outputs (EPA. 2019i)
d. Risk Evaluation for Methylene Chloride, Supplemental Information on Surface
Water Exposure Assessment (EPA. 2019k)
e. Risk Evaluation for Methylene Chloride (Dichloromethane, DCM) CASRN: 75-
09-2, Supplemental Information on Releases and Occupational Exposure
Assessment (EPA. 2019b)
This document provides additional details and information on the environmental
release and occupational exposure assessment, including process information,
estimates of number of sites and workers, summary of monitoring data, and
exposure modeling equations, inputs and outputs.
f. Risk Evaluation for Methylene Chloride, Supplemental File: Methylene Chloride
Benchmark Dose and PBPKModeling (EPA. 2019h)
This document provides details on the modeling used to estimate the PODs for the
human health chronic non-cancer and cancer endpoints.
g. Risk Evaluation for Methylene Chloride, Supplemental Information Risk
Calculator for Occupational Exposures (EPA. 2019n)
h. Risk Evaluation for Methylene Chloride, Supplemental Information Risk
Calculator for Consumer Inhalation Exposures (EPA. 2019m)
i. Risk Evaluation for Methylene Chloride, Supplemental Information Risk
Calculator for Consumer Dermal Exposures (EPA. )
Page 549 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
11230 Appendix C FATE AND TRANSPORT
11231
11232 EPISuite™ Model Inputs
11233
11234 To set up EPI Suite™ for estimating fate properties of methylene chloride, methylene chloride
11235 was identified using the "Name Lookup" function. The physical-chemical properties were input
11236 based on the values in Table 1-1. EPI Suite™ was run using default settings (i.e., no other
1123 7 parameters were changed or input).
11238
PhysProp
Input CAS ff
Input Smiles:
MPBPVP
Show
Structure
Output
Fugacity
Help
EPI Suite - Welcome Screen
Clear Input Fields
Output
Full
Summary
Input Chem Name: [Methane, dichloro-
Name Lookup |
3
atm-m /mole
Henry LC: | 0.00325
Water Solubility: |
13000
mg/L
Melting Point: |
-95
Celsius
Vapor Pressure: j
435
mm Hg
Boiling Point:
39.7
Celsius
Log Kow:
1.25
River
Lake
Water Depth: |
1
1 i
meters
Wind Velocity:
5
0.5
meters/sec
Current Velocity:
1
0.05
meters/sec
CI
CI
EPI Links
lL
The Estimation Programs Interface (EPI) SuiteTM was developed by the US Environmental Protection Agency's Office of Pollution Prevention
and Toxics and Syracuse Research Corporation (SRC). It is a screening-level tool, intended for use in applications such as to quickly screen
chemicals for release potential and "bin" chemicals by priority for future work. Estimated values should not be used when experimental
(measured) values are available.
EPI SuiteTM cannot be used for all chemical substances. The intended application domain is organic chemicals. Inorganic and organometallic
chemicals generally are outside the domain.
Important information on the performance, development and application of EPI SuiteTM and the individual programs within it can be
found under the Help tab. Copyright 2000-2012 United States Environmental Protection Agency for EPI SuiteTM and all component
programs except BioHCWIN and KOAWIN.
_l!
~J
FigureApx C-l. EPI Suite Model Inputs for Estimating Methylene Chloride Fate
Transport Properties
and
11243
Page 550 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
11244 Appendix D RELEASES TO THE ENVIRONMENT
11245
11246 TableApx D-l presents a summary of all information on releases to water available for the
11247 assessed scenarios.
11248
11249 Table Apx D-l. Water Releases Reported in 2016 TRI or DMR for Occupational Exposure
11250 Scenarios
Silo Iricnlilt
( il>
Siale
Annual
Release
(kii/sile-
>n
Annual
Release
l);i\ s
(da\s/> n
l)ail\
Release
(kji/sile-
da>)
Release
Media
Sources-' «K:
Noles
OES: Polyurethane Foam
PREGIS
INNOVATIVE
PACKAGING INC
WURTLAND
KY
2
250
0.01
Surface
Water
2016 TRI
OES: Spot Cleaner
BOISE STATE
UNIVERSITY
BOISE
ID
0.1
250
0.0002
Surface
Water
2016 DMR
OES: Manufacturing
COVESTRO LLC
BAYTOWN
TX
1
350
0.004
Surface
Water
2016 TRI
EMERALD
PERFORMANCE
MATERIALS LLC
HENRY
IL
0.5
350
0.001
Surface
Water
2016 TRI
FISHER SCIENTIFIC
CO LLC
FAIR LAWN
NJ
2
350
0.01
POTW
2016 TRI
FISHER SCIENTIFIC
CO LLC
BRIDGEWATER
NJ
2
350
0.01
POTW
2016 TRI
OLIN BLUE CUBE
FREEPORT TX
FREEPORT
TX
58
350
0.2
Non-
POTW
WWT
2016 TRI
REGIS
TECHNOLOGIES
INC
MORTON GROVE
IL
2
350
0.01
POTW
2016 TRI
SIGMA-ALDRICH
MANUFACTURING
LLC
SAINT LOUIS
MO
2
350
0.01
POTW
2016 TRI
VANDERBILT
CHEMICALS LLC-
MURRAY DIV
MURRAY
KY
0.5
350
0.00
Non-
POTW
WWT
2016 TRI
E IDUPONT DE
NEMOURS -
CHAMBERS WORKS
DEEPWATER
NJ
76
350
0.2
Surface
Water
2016 DMR
BAYER
MATERIALSCIENCE
BAYTOWN
BAYTOWN
TX
10
350
0.03
Surface
Water
2016 DMR
INSTITUTE PLANT
INSTITUTE
WV
3
350
0.01
Surface
Water
2016 DMR
Page 551 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Silc l(kii(i(\
Cil>
Siale
Annual
Release
(kg/sile-
>n
Annual
Release
l)a j s
(da\s/>r)
Dail>
Release
(kg/sile-
da\)
Release
Media
Sources-1 &
Noles
MPM SILICONES
LLC
FRIENDLY
WV
2
350
0.005
Surface
Water
2016 DMR
BASF
CORPORATION
WEST MEMPHIS
AR
1
350
0.003
Surface
Water
2016 DMR
ARKEMA INC
PIFFARD
NY
0.3
350
0.001
Surface
Water
2016 DMR
EAGLE US 2 LLC -
LAKE CHARLES
COMPLEX
LAKE CHARLES
LA
0.2
350
0.001
Surface
Water
2016 DMR
BAYER
MATERIALSCIENCE
NEW
MARTINSVILLE
WV
0.2
350
0.001
Surface
Water
2016 DMR
ICL-IP AMERICA
INC
GALLIPOLIS
FERRY
WV
0.1
350
0.0004
Surface
Water
2016 DMR
KEESHAN AND
BOST CHEMICAL
CO., INC.
MANVEL
TX
0.02
350
0.00005
Surface
Water
2016 DMR
INDORAMA
VENTURES
OLEFINS, LLC
SULPHUR
LA
0.01
350
0.00003
Surface
Water
2016 DMR
CHEMTURA NORTH
AND SOUTH
PLANTS
MORGANTOWN
WV
0.01
350
0.00002
Surface
Water
2016 DMR
OES: Repackaging
CHEMISPHERE
CORP
SAINT LOUIS
MO
2
250
0.01
POTW
2016 TRI
HUBBARD-HALL
INC
WATERBURY
CT
144
250
1
Non-
POTW
WWT
2016 TRI
WEBB CHEMICAL
SERVICE CORP
MUSKEGON
HEIGHTS
MI
98
250
0.4
POTW
2016 TRI
RESEARCH
SOLUTIONS GROUP
INC
PELHAM
AL
0.09
250
0.0003
Surface
Water
2016 DMR
EMD MILLIPORE
CORP
CINCINNATI
OH
0.03
250
0.0001
Surface
Water
2016 DMR
OES: Processing as a Reactant
AMVAC CHEMICAL
CO
AXIS
AL
213
350
0.6
Non-
POTW
WWT
2016 TRI
THE DOW
CHEMICAL CO
MIDLAND
MI
25
350
0.1
Surface
Water
2016 TRI
FMC
CORPORATION
MIDDLEPORT
NY
0.1
350
0.0003
Surface
Water
2016 DMR
OES: Processing: Formulation
ARKEMA INC
CALVERT CITY
KY
31
300
0.1
Surface
Water
2016 TRI
Page 552 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Silc l(kii(i(\
Cil>
Siale
Annual
Release
(kg/sile-
>n
Annual
Release
l)a j s
(da\s/>r)
l)ail>
Release
(kg/sile-
da\)
Release
Media
Sources'1 &
Noles
MCGE AN -ROHCO
INC
LIVONIA
MI
113
300
0.4
POTW
2016 TRI
WM BARR & CO
INC
MEMPHIS
TN
0.5
300
0.002
POTW
2016 TRI
BUCKMAN
LABORATORIES
INC
MEMPHIS
TN
254
300
1
POTW
2016 TRI
EUROFINS MWG
OPERON LLC
LOUISVILLE
KY
5,785
300
19
POTW
2016 TRI
SOLVAY-
HOUSTON PLANT
HOUSTON
TX
12
300
0.04
Surface
Water
2016 DMR
HONEYWELL
INTERNATIONAL
INC - GEISMAR
COMPLEX
GEISMAR
LA
4
300
0.01
Surface
Water
2016 DMR
STEP AN CO
MILLSDALE ROAD
EL WOOD
IL
2
300
0.01
Surface
Water
2016 DMR
ELEMENTIS
SPECIALTIES, INC.
CHARLESTON
WV
0.2
300
0.001
Surface
Water
2016 DMR
OES: Plastics Manufacturing
SABIC
INNOVATIVE
PLASTICS US LLC
BURKVILLE
AL
8
250
0.03
Surface
Water
2016 TRI
SABIC
INNOVATIVE
PLASTICS MT.
VERNON, LLC
MOUNT VERNON
IN
28
250
0.1
Surface
Water
2016 DMR
SABIC
INNOVATIVE
PLASTICS US LLC
SELKIRK
NY
9
250
0.03
Surface
Water
2016 DMR
EQUISTAR
CHEMICALS LP
LA PORTE
TX
9
250
0.03
Surface
Water
2016 DMR
CHEMOURS
COMPANY FC LLC
WASHINGTON
WV
7
250
0.03
Surface
Water
2016 DMR
SHINTECH ADDIS
PLANT A
ADDIS
LA
3
250
0.01
Surface
Water
2016 DMR
STYROLUTION
AMERICA LLC
CHANNAHON
IL
0.2
250
0.001
Surface
Water
2016 DMR
DOW CHEMICAL
CO DALTON PLANT
DALTON
GA
0.3
250
0.001
Surface
Water
2016 DMR
PREGIS
INNOVATIVE
PACKAGING INC
WURTLAND
KY
0.02
250
0.0001
Surface
Water
2016 DMR
OES: CTA Film Manufacturing
KODAK PARK
DIVISION
ROCHESTER
NY
29
250
0.1
Surface
Water
2016 DMR
Page 553 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Silc lden(i(\
Cil>
Siale
Annual
Release
(kg/sile-
>n
Annual
Release
l)a j s
(da\s/>n
Dail>
Release
(kg/sile-
da\)
Release
Media
Sources-1 «Si
Noles
OES: Lithographic Printer Cleaner
FORMER REXON
FACILITY AKA
ENJEMS
MILLWORKS
WAYNE TWP
NJ
0.001
250
0.000004
Surface
Water
2016 DMR
OES: Pharmaceutical
ABB VIE-NORTH CH
ICAGO FACILITY
NORTH CHICAGO
IL
2
300
0.01
POTW
2016 TRI
EUTICALS INC
SPRINGFIELD
MO
0.5
300
0.002
POTW
2016 TRI
MALLIN CKRODT
LLC
SAINT LOUIS
MO
7
300
0.02
POTW
2016 TRI
NORAMCO INC
WILMINGTON
DE
2
300
0.01
POTW
2016 TRI
AMRI RENSSELAER
INC
RENSSELAER
NY
340
300
1
POTW
2016 TRI
E R SQUIBB & SONS
LLC
NORTH
BRUNSWICK
NJ
113
300
0.4
POTW
2016 TRI
EVONIK CORP
TIPPECANOE
LABORATORIES
LAFAYETTE
IN
2
300
0.01
Surface
Water
2016 TRI
PACIRA
PHARMACEUTICAL
SINC
SAN DIEGO
CA
40
300
0.1
POTW
2016 TRI
PCI SYNTHESIS
NEWBURYPORT
MA
0.5
300
0.002
POTW
2016 TRI
PFIZER
PHARMACEUTICAL
S LLC
BARCELONETA
PR
20
300
0.1
POTW
2016 TRI
PHARMACIA &
UPJOHN CO LLC A
SUBSIDIARY OF
PFIZER INC
PORTAGE
MI
2,588
300
9
99.9%
POTW
0.1%
Surface
Water
2016 TRI
SI GROUP INC
ORANGEBURG
SC
42
300
0.1
Surface
Water
2016 TRI
TEVA
PHARMACEUTICAL
SUSA
MEXICO
MO
10
300
0.03
POTW
2016 TRI
EVONIK DEGUSSA
CORP TIPPECANOE
LABORATORIES
LAFAYETTE
IN
3
300
0.01
Surface
Water
2016 DMR
OES: Recycling and Disposal
JOHNSON
MATTHEY
WEST DEPTFORD
NJ
620
250
2
Non-
POTW
WWT
2016 TRI
CLEAN HARBORS
DEER PARK LLC
LA PORTE
TX
522
250
2
Non-
POTW
WWT
2016 TRI
Page 554 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Silc l(kii(i(\
Cil>
Si iiie
Anniiiil
Kck'iiso
(kii/sik1-
> r)
Anniiiil
Kck'sisi*
l);i\ s
(d;i\s/\ r)
l);iil\
Kck'iisi'
(kg/sik*-
d;i\)
Kck'sisi*
Modiii
Sources'1 «Si
Soles
CLEAN HARBORS
EL DORADO LLC
EL DORADO
AR
113
250
0.5
Non-
POTW
WWT
2016 TRI
TRADEBE
TREATMENT &
RECYCLING LLC
EAST CHICAGO
IN
19
250
0.1
Non-
POTW
WWT
2016 TRI
VEOLIA ES
TECHNICAL
SOLUTIONS LLC
WEST
CARROLLTON
OH
2
250
0.01
POTW
2016 TRI
VEOLIA ES
TECHNICAL
SOLUTIONS LLC
AZUSA
CA
0.5
250
0.002
POTW
2016 TRI
VEOLIA ES
TECHNICAL
SOLUTIONS LLC
MIDDLESEX
NJ
115,059
250
460
99.996%
Non-
POTW
WWT
0.004%
POTW
2016 TRI
CHEMICAL WASTE
MANAGEMENT
EMELLE
AL
4
250
0.01
Surface
Water
2016 DMR
OILTANKING
HOUSTON INC
HOUSTON
TX
1
250
0.003
Surface
Water
2016 DMR
HOWARD CO ALFA
RIDGE LANDFILL
MARRIOTTSVILL
E
MD
0.1
250
0.0002
Surface
Water
2016 DMR
CLIFFORD G
HIGGINS DISPOSAL
SERVICE INC SLF
KINGSTON
NJ
0.02
250
0.0001
Surface
Water
2016 DMR
CLEAN WATER OF
NEW YORK INC
STATEN ISLAND
NY
2
250
0.01
Surface
Water
2016 DMR
FORMER
CARBORUNDUM
COMPLEX
SANBORN
NY
0.2
250
0.001
Surface
Water
2016 DMR
OES: Other
APPLIED
BIOSYSTEMS LLC
PLEASANTON
CA
42
250
0.2
Non-
POTW
WWT
2016 TRI
EMD MILLIPORE
CORP
JAFFREY
NH
2
250
0.01
POTW
2016 TRI
GBC METALS LLC
SOMERS THIN
STRIP
WATERBURY
CT
0.2
250
0.001
Surface
Water
2016 DMR
HYSTER-YALE
GROUP, INC
SULLIGENT
AL
0.0002
250
0.000001
Surface
Water
2016 DMR
AVNET INC
(FORMER
IMPERIAL
SCHRADE)
ELLENVILLE
NY
0.005
250
0.00002
Surface
Water
2016 DMR
Page 555 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Silc l(kii(i(\
Cil>
Si iiie
Anniiiil
Kck'iiso
(kii/silc-
> r)
Anniiiil
Kck'sisi*
l);i\ s
(d;i\s/\ r)
l);iil\
Kck'iisi'
(kg/sik*-
d;i\)
Kck'sisi*
Modiii
Sources'1 «Si
Soles
BARGE CLEANING
AND REPAIR
CHANNEL VIEW
TX
0.1
250
0.0003
Surface
Water
2016 DMR
AC & S INC
NITRO
WV
0.01
250
0.00005
Surface
Water
2016 DMR
MOOG INC - MOOG
IN-SPACE
PROPULSION ISP
NIAGARA FALLS
NY
0.003
250
0.00001
Surface
Water
2016 DMR
OILTANKING
JOLIET
CHANNAHON
IL
1
250
0.003
Surface
Water
2016 DMR
NIPPON
DYNAWAVE
PACKAGING
COMPANY
LONGVIEW
WA
22
250
0.1
Surface
Water
2016 DMR
TREE TOP INC
WENATCHEE
PLANT
WENATCHEE
WA
0.01
250
0.00003
Surface
Water
2016 DMR
CAROUSEL
CENTER
SYRACUSE
NY
0.001
250
0.000002
Surface
Water
2016 DMR
11251 a Sources: 2016 TRI (U.S. EPA. 2017ft: 2016 DMR (EPA. 2016^)
11252
Page 556 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
11253 Appendix E ENVIRONMENTAL EXPOSURES
11254
11255 TableApx E-l. Occurrence of Methylene Dichloride Releases (Facilities) and Monitoring
11256 Sites By HUC-8
III ( X
III ( Name
Area
(Acres)
Area
(kill")
Stales
\o. or
Facilities
No. or
Moil.
Sites
No. or
Samples
HUCs with Co-located Methylene Dichloride Releases (Facilities) and Monitoring Sites (n = 2)
15060106
Lower Salt
666211.2
2696.1
AZ
1
5
12
15070102
Aqua Fria
1758350.5
7115.8
AZ
3
7
11
HUCs with Methylene Dichloride Releases (Facilities) Only (n = 83)
01070003
Contoocook
488993.1
1978.9
NH
1
0
0
02030103
Hackensack-Passaic
725724.6
2936.9
NJ,NY
1
0
0
02030104
Sandy Hook-Staten
Island
454261.8
1838.3
NJ,NY
2
0
0
02030105
Raritan
707463.2
2863.0
NJ
3
0
0
02040206
Cohansey-Maurice
764587.9
3094.2
DE,NJ
1
0
0
02020007
Rondout
760490.1
3077.6
NJ,NY
1
0
0
02040202
Lower Delaware
736887.9
2982.1
DE,NJ,PA
1
0
0
02020006
Middle Hudson
1554773.3
6291.9
MA,NY
2
0
0
02030102
Bronx
120544.9
487.8
CT,NY
1
0
0
02030202
Southern Long Island
1255171.2
5079.5
NJ,NY,RI
2
0
0
04130001
Oak Orchard-
Twelvemile
685684.0
2774.9
CN,NY
1
0
0
04130003
Lower Genesee
682891.3
2763.6
NY
2
0
0
04140201
Seneca
2214337.6
8961.1
NY
1
0
0
04110001
Black-Rocky
572567.0
2317.1
OH
1
0
0
05060002
Lower Scioto
1392040.5
5633.4
KY,OH
1
0
0
05090202
Little Miami
1125043.6
4552.9
OH
1
0
0
05080002
Lower Great Miami,
Indiana, Ohio
883871.2
3576.9
IN,OH
2
0
0
21010002
Cibuco -Guaj ataca
781263.4
3161.7
PR
1
0
0
03150201
Upper Alabama
1530362.5
6193.2
AL
1
0
0
03150202
Cahaba
1167292.7
4723.9
AL
1
0
0
03160204
Mobile-Tensaw
583840.0
2362.7
AL
1
0
0
06030002
Wheeler Lake
1851599.9
7493.2
AL,TN
1
0
0
03160108
Noxubee
907700.0
3673.3
AL,MS
1
0
0
03050203
North Fork Edisto
486443.1
1968.6
SC
1
0
0
Page 557 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
III ( X
III ( Niiim-
AiVii
(Acivs)
AiVii
(km-)
S(;iles
No. or
l-'iicililios
No. or
Moil.
Silcs
No. or
Siimplos
08010211
Horn Lake-Nonconnah
178697.3
723.2
MS,TN
1
0
0
08010100
Lower Mississippi-
Memphis
702312.8
2842.2
AR,IL,KY
,MO,MS,T
N
2
0
0
15020016
Lower Little Colorado
1532516.1
6201.9
AZ
1
0
0
15050301
Upper Santa Cruz
1680515.5
6800.8
AZ,MX
1
0
0
12040104
Buffalo-San Jacinto
756769.3
3062.5
TX
4
0
0
12040203
North Galveston Bay
228393.2
924.3
TX
1
0
0
12040204
West Galveston Bay
776232.4
3141.3
TX
1
0
0
12070104
Lower Brazos
1051241.4
4254.2
TX
1
0
0
18010102
Mad-Redwood
910412.8
3684.3
CA
1
0
0
18020155
Paynes Creek-
Sacramento River
271113.3
1097.2
CA
1
0
0
18020163
Lower Sacramento
786286.3
3182.0
CA
1
0
0
18060006
Central Coastal
1231592.2
4984.1
CA
1
0
0
18060015
Monterey Bay
484626.6
1961.2
CA
1
0
0
05050008
Lower Kanawha
591554.2
2393.9
WV
3
0
0
18070103
Calleguas
280115.7
1133.6
CA
1
0
0
18070104
Santa Monica Bay
430957.7
1744.0
CA
1
0
0
18070105
Los Angeles
531817.9
2152.2
CA
1
0
0
18070106
San Gabriel
579966.3
2347.0
CA
4
0
0
18070203
Santa Ana
1084241.9
4387.8
CA
1
0
0
18070303
San Luis Rey-Escondido
531675.9
2151.6
CA
1
0
0
18070304
San Diego
993894.7
4022.2
CA,MX
1
0
0
01100006
Saugatuck
287476.3
1163.4
CT,NY
1
0
0
01100005
Housatonic
1248786.3
5053.7
CT,MA,N
Y
2
0
0
05030201
Little Muskingum-
Middle Island
1161545.0
4700.6
OH,WV
2
0
0
05030202
Upper Ohio-Shade
906812.9
3669.7
OH,WV
1
0
0
05090101
Raccoon-Symmes
933778.8
3778.9
KY,OH,W
V
1
0
0
05020003
Upper Monongahela
296728.7
1200.8
PA,WV
1
0
0
17110011
Snohomish
189946.6
768.7
WA
1
0
0
03070103
Upper Ocmulgee
1902869.0
7700.6
GA
1
0
0
03150101
Conasauga
465346.3
1883.2
GA,TN
1
0
0
Page 558 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
III ( X
III ( N;um>
AiVii
(Acivs)
AiVii
(km-)
S(;iles
No. or
l-'iicililios
No. or
Moil.
Silcs
No. or
Siimplos
07130001
Lower Illinois-
Senachwine Lake
1254288.3
5075.9
IL
1
0
0
17050114
Lower Boise
850233.1
3440.8
ID
1
0
0
07120003
Chicago
419754.7
1698.7
IL,IN
1
0
0
07140101
Cahokia-Joachim
1053340.7
4262.7
IL,MO
1
0
0
07120004
Des Plaines
931517.4
3769.7
IL,WI
0
0
04040001
Little Calumet-Galien
440799.0
1783.8
IL,IN,MI
1
0
0
05120108
Middle Wabash-Little
Vermilion
1455976.0
5892.1
IL,IN
1
0
0
05140101
Silver-Little Kentucky
807385.6
3267.4
IN,KY
1
0
0
17080003
Lower Columbia-
Clatskanie
732479.8
2964.2
OR,WA
1
0
0
17020010
Upper Columbia-Entiat
958508.9
3878.9
WA
1
0
0
17020011
Wenatchee
850266.6
3440.9
WA
1
0
0
17030003
Lower Yakima
1860149.0
7527.8
WA
0
0
06040006
Lower Tennessee
446630.3
1807.5
KY,TN
1
0
0
05140202
Highland-Pigeon
663290.7
2684.2
IL,IN,KY
1
0
0
05090103
Little Scioto-Tygarts
644954.4
2610.0
KY,OH,W
V
1
0
0
08070204
Lake Maurepas
456253.8
1846.4
LA
1
0
0
08070300
Lower Grand
508704.3
2058.7
LA
1
0
0
08080206
Lower Calcasieu
812177.5
3286.8
LA
0
0
01070006
Merrimack River
1152204.3
4662.8
MA,NH
1
0
0
02060003
Gunpowder-Patapsco
907202.4
3671.3
MD,PA
1
0
0
02060006
Patuxent
593323.7
2401.1
MD
1
0
0
04050003
Kalamazoo
1300194.9
5261.7
MI
0
0
04090004
Detroit
567874.0
2298.1
CN,MI
1
0
0
07110006
South Fork Salt
776800.5
3143.6
MO
1
0
0
11010002
James
932247.2
3772.7
MO
1
0
0
03160103
Buttahatchee
553396.1
2239.5
AL,MS
1
0
0
04120104
Niagara
871679.6
3527.6
CN,NY
0
0
04060102
Muskegon
1745075.3
7062.1
MI
1
0
0
04080201
Tittabawassee
926364.9
3748.9
MI
1
0
0
HUCs with Monitoring Sites Only (n = 42)
03030003
Deep
928079.2
3755.8
NC
0
1
9
Page 559 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
III ( X
III ( Niiim-
AiVii
(Acivs)
AiVii
(km-)
S(;iles
No. or
l-'iicililios
No. or
Moil.
Silcs
No. or
Siimplos
03030004
Upper Cape Fear
1043179.5
4221.6
NC
0
1
1
03030005
Lower Cape Fear
706736.1
2860.1
NC
0
3
14
03030006
Black
1007357.4
4076.6
NC
0
3
37
03030007
Northeast Cape Fear
1114550.1
4510.4
NC
0
4
28
03040101
Upper Yadkin
1571033.4
6357.8
NC,VA
0
2
21
03040103
Lower Yadkin
761498.9
3081.7
NC
0
1
9
03040105
Rocky
907088.6
3670.9
NC,SC
0
1
11
03050101
Upper Catawba
1508875.2
6106.2
NC,SC
0
4
47
06010105
Upper French Broad
1202906.3
4868.0
NC,SC,T
N
0
3
33
06010108
Nolichucky
1125185.5
4553.5
NC,TN
0
1
12
03010103
Upper Dan
1315517.1
5323.7
NC,VA
0
1
10
03010106
Roanoke Rapids
378781.5
1532.9
NC,VA
0
1
13
02040105
Middle Delaware-
Musconetcong
869995.3
3520.8
NJ,PA
0
1
3
11080001
Canadian Headwaters
1104144.6
4468.3
CO,NM
0
12
13
11080002
Cimarron
671679.8
2718.2
NM
0
5
5
11080003
Upper Canadian
1314676.9
5320.3
NM
0
3
3
11080004
Mora
932568.3
3774.0
NM
0
6
6
11080006
Upper Canadian-Ute
Reservoir
1432680.7
5797.9
NM,TX
0
5
6
11080008
Revuelto
515805.1
2087.4
NM
0
1
1
13020201
Rio Grande-Santa Fe
1197851.1
4847.5
NM
0
1
3
13020203
Rio Grande-
Albuquerque
2057935.0
8328.2
NM
0
1
3
11040001
Cimarron Headwaters
1073779.5
4345.4
CO,NM,0
K
0
1
1
11100101
Upper Beaver
1748464.8
7075.8
NM,OK,T
X
0
1
1
03040202
Lynches
904417.1
3660.1
NC,SC
0
1
11
03040203
Lumber
1121797.1
4539.8
NC,SC
0
3
27
06030003
Upper Elk
821468.2
3324.4
AL,TN
0
4
8
12100303
Lower San Antonio
950344.1
3845.9
TX
0
1
1
03010107
Lower Roanoke
838200.5
3392.1
NC
0
1
2
03020202
Middle Neuse
681738.1
2758.9
NC
0
3
15
02070004
Conococheague-
Opequon
1457399.0
5897.9
MD,PA,V
A,WV
0
1
3
Page 560 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
III ( X
III ( Name
Area
(Acres)
Area
(km-)
Slales
No. or
l-'acililies
No. or
Moil.
Silcs
No. or
Samples
11030012
Little Arkansas
910452.3
3684.5
KS
0
5
14
07140102
Meramec
1375977.1
5568.4
MO
0
4
7
03020101
Upper Tar
835088.1
3379.5
NC
0
1
2
03020102
Fishing
572188.7
2315.6
NC
0
1
13
03020103
Lower Tar
614561.4
2487.0
NC
0
1
1
03020104
Pamlico
836270.2
3384.3
NC
0
1
2
03020201
Upper Neuse
1539933.1
6231.9
NC
0
1
13
03020204
Lower Neuse
1013224.6
4100.4
NC
0
2
14
03020302
New River
554324.3
2243.3
NC
0
1
2
03030002
Haw
1092854.1
4422.6
NC
0
2
21
09030008
Lower Rainy
982352.5
3975.4
CN,MN
0
1
2
11257
11258 TableApx E-2. Occurrence of Methylene Dichloride Releases (Facilities) and Monitoring
11259 Sites By HUC-12
III (12
III ( Name
Area
(Acres)
Area
(knr)
Sisiics
No. or
l-'acililio
No. of
Mon.
Sites
No. or
Samples
HUCs with Methylene Dichloride Releases (Facilities) and Monitoring Sites (n = 1)
150601060306
City of Phoenix-Salt River
87618.1
354.6
AZ
2
2
4
HUCs with Methylene Dichloride Releases (Facilities) Only (n = KM))
031602040401
Gunnison Creek
28009.6
113.3
AL
1
0
0
060300020501
Upper Indian Creek
24626.8
99.7
AL
1
0
0
031601081005
Bodka Creek-Caney Creek
33649.7
136.2
AL,MS
2
0
0
031502010407
Lower Pintlala Creek
15550.7
62.9
AL
2
0
0
031502020202
Cahaba Valley Creek
17492.0
70.8
AL
2
0
0
031601030202
Cannon Mill Creek-Beaver Creek
28263.4
114.4
AL
2
0
0
080101000703
Loosahatchie Bar-Mississippi
River
37253.2
150.8
AR,TN
3
0
0
150200160807
Janus Spring-Little Colorado
River
27894.8
112.9
AZ
2
0
0
180201550405
Sevenmile Creek-Sacramento
River
17275.5
69.9
CA
2
0
0
180701060606
Coyote Creek-San Gabriel River
37975.6
153.7
CA
3
0
0
180701060701
Long Beach Harbor
33394.5
135.1
CA
2
0
0
180702030804
East Etiwanda Creek-Santa Ana
River
138518.
8
560.6
CA
2
0
0
180703030504
Loma Alta Creek-Frontal Gulf of
Santa Catalina
52326.8
211.8
CA
2
0
0
Page 561 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
III (12
III ( Niimo
Aivsi
(Acres)
Aivsi
(km-)
SliiU's
No. <.r
lucililkv
No. of
Moil.
Sites
No. or
Siinipk-s
180201630403
Laguna Creek
30785.5
124.6
CA
2
0
0
150701020605
Lookout Mountain-Cave Creek
22632.2
91.6
AZ
4
0
0
150701020907
White Tank Number Three Wash
44741.3
181.1
AZ
2
0
0
180101020408
Mill Creek-Mad River
19798.6
80.1
CA
2
0
0
180600060106
Potrero Canyon-Carmel River
19786.8
80.1
CA
2
0
0
180703041300
Mission Beach-Frontal Pacific
Ocean
107314.
7
434.3
CA,M
X
3
0
0
180600150305
Monterey Bay
224556.
6
908.8
CA
2
0
0
180701030102
Lower Simi Arroyo
39214.2
158.7
CA
2
0
0
180701040500
Manhattan Beach-Frontal Santa
Monica Bay
74377.4
301.0
CA
2
0
0
180701050401
Chavez Ravine-Los Angeles
River
39431.4
159.6
CA
1
0
0
180701060102
Lower Dominguez Channel
36125.6
146.2
CA
4
0
0
030701031605
Stone Creek-Ocmulgee River
63787.5
258.1
GA
2
0
0
040400010603
Calumet River-Frontal Lake
Michigan
34563.8
139.9
IL,IN
1
0
0
071200030104
North Shore Channel
14685.7
59.4
IL
1
0
0
071200040302
Bull Creek-Des Plaines River
32350.9
130.9
IL
1
0
0
071200040905
Des Plaines River
23822.3
96.4
IL
6
0
0
071401010401
Maline Creek-Mississippi River
60447.7
244.6
IL,MO
3
0
0
031501010504
Jobs Creek-Conasauga River
32865.9
133.0
GA
2
0
0
071300011004
Senachwine Lake-Illinois River
24040.8
97.3
IL
2
0
0
080702040103
Grand Goudine Bayou-New
River
17644.3
71.4
LA
2
0
0
080703000207
Bayou Bourbeaux
16521.5
66.9
LA
2
0
0
051401010101
Headwaters Little Kentucky
River
16767.0
67.8
KY
1
0
0
051402020605
Beaverdam Creek-Ohio River
30633.3
124.0
IN,KY
2
0
0
080802060301
Maple Fork-Bayou d'Inde
22308.4
90.3
LA
2
0
0
080802060303
Prien Lake-Calcasieu River
29606.9
119.8
LA
2
0
0
020600030902
Dead Run-Gywnns Falls
31450.3
127.3
MD
4
0
0
060400060502
Guess Creek-Tennessee River
20398.5
82.5
KY
2
0
0
050901030105
Pond Run-Ohio River
28165.0
114.0
KY,0
H
4
0
0
040500030604
Davis Creek-Kalamazoo River
15942.8
64.5
MI
2
0
0
040500030606
Averill Lake-Kalamazoo River
25885.2
104.8
MI
1
0
0
Page 562 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
III (12
III ( Niimo
AiVii
(Acres)
AiVii
(km-)
SliiU's
No. or
lucililkv
No. of
IMon.
Sites
No. or
Siiinpk's
020600060202
Dorsey Run-Little Patuxent River
42440.5
171.8
MD
2
0
0
051201080203
Cedar Hollow-Wabash River
14697.6
59.5
IN
4
0
0
080102110302
Horn Lake-Horn Lake Pass
18306.6
74.1
MS,TN
1
0
0
071100060503
Long Branch-South Fork Salt
River
19143.3
77.5
MO
1
0
0
040900040503
Huntington Creek-Frontal Lake
Erie
37521.8
151.8
MI
1
0
0
110100020303
Wilsons Creek
16314.3
66.0
MO
1
0
0
041402011509
Onondaga Lake
26522.2
107.3
NY
0
0
041100010403
Willow Creek
14437.9
58.4
OH
1
0
0
020402020606
Raccoon Creek
29214.5
118.2
NJ
1
0
0
020402060103
Whooping John Creek-Frontal
Delaware River
10235.8
41.4
DE,NJ
2
0
0
020301040204
Morses Creek-Arthur Kill
18931.5
76.6
NJ,NY
2
0
0
050600020105
Oak Run
17133.2
69.3
OH
2
0
0
020200060302
Rensselaer Lake-Hudson River
31510.6
127.5
NY
1
0
0
020200060402
Onesquethaw Creek
35841.4
145.1
NY
2
0
0
050800020106
Opossum Creek-Great Miami
River
12167.1
49.2
OH
2
0
0
041201040603
Cayuga Creek
22754.1
92.1
NY
4
0
0
041300010501
Jeddo Creek
20039.9
81.1
NY
2
0
0
020200070504
Sandburg Creek
37947.4
153.6
NY
2
0
0
020301020203
East Creek-Frontal Long Island
Sound
11252.5
45.5
NY
2
0
0
020301030801
Preakness Brook-Passaic River
14523.7
58.8
NJ
2
0
0
020301040203
Newark Bay
17761.8
71.9
NJ
1
0
0
020302020206
Reynolds Channel-East
Rockaway Inlet
10571.6
42.8
NY
2
0
0
041300030502
Jaycox Creek-Genesee River
25635.1
103.7
NY
2
0
0
041300030704
Genesee River
14336.9
58.0
NY
2
0
0
050902021404
Duck Creek
9891.1
40.0
OH
2
0
0
020301050312
Lower Millstone River
31839.8
128.8
NJ
2
0
0
020302020406
Santapogue Creek-Great South
Bay
17890.8
72.4
NY
2
0
0
050302011004
Haynes Run-Ohio River
19386.4
78.5
OH,W
V
2
0
0
050302011006
Mill Creek-Ohio River
27702.4
112.1
OH,W
V
2
0
0
Page 563 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
III (12
III ( Niimo
Aivsi
(Acres)
Aivsi
(km-)
SliiU's
No. <.r
lucililkv
No. of
Moil.
Sites
No. or
Siinipk-s
050302020106
Sandy Creek-Ohio River
25650.1
103.8
OH,W
V
2
0
0
050901010103
Long Run-Ohio River
16607.3
67.2
OH,W
V
2
0
0
020301050501
Peters Brook-Raritan River
15666.0
63.4
NJ
1
0
0
020301050507
Mill Brook-Raritan River
17892.2
72.4
NJ
4
0
0
210100020302
Cano Tiburones
25880.0
104.7
PR
1
0
0
030502030308
Whirlwind Creek-North Fork
Edisto River
35350.5
143.1
SC
2
0
0
120701040505
Outlet Barzos River
35803.4
144.9
TX
1
0
0
120401040703
Vince Bayou-Buffalo Bayou
38130.8
154.3
TX
4
0
0
120401040705
Highlands Reservoir-San Jacinto
River
18115.0
73.3
TX
2
0
0
120401040706
Goose Creek-Frontal Galveston
Bay
37289.7
150.9
TX
2
0
0
120402030106
Cedar Point Lateral-Cedar Bayou
31473.7
127.4
TX
4
0
0
120402040400
Mustang Bayou
183973.
7
744.5
TX
2
0
0
050200030307
Cobun Creek-Monongahela River
21730.5
87.9
WV
2
0
0
050500080303
Tyler Creek-Kanawha River
21033.5
85.1
WV
4
0
0
050500080304
Scary Creek-Kanawha River
20472.1
82.8
WV
2
0
0
170200100307
Rainey Spring-Columbia River
21142.9
85.6
WA
2
0
0
170200110708
Nahahum Canyon-Wenatchee
River
30271.1
122.5
WA
1
0
0
170300030906
Sulphur Creek Waste way
19187.2
77.7
WA
4
0
0
170501140403
Crane Creek-Boise River
18624.7
75.4
ID
2
0
0
171100110203
Snohomish River-Frontal
Possession Sound
45483.4
184.1
WA
2
0
0
170800030602
City of Longview-Frontal
Columbia River
25007.4
101.2
WA
2
0
0
040601021002
Mosquito Creek-Muskegon River
31043.0
125.6
MI
1
0
0
150503010906
Arroyo Chico-Santa Cruz River
43989.0
178.0
AZ
2
0
0
010700061404
Outlet Merrimack River
32546.2
131.7
MA,N
H
1
0
0
010700030101
Town Farm Brook-Contoocook
River
27145.4
109.8
NH
1
0
0
040802010604
Prairie Creek-Tittabawassee
River
25251.7
102.2
MI
2
0
0
011000051205
Long Meadow Pond Brook-
Naugatuck River
18242.3
73.8
CT
3
0
0
Page 564 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
III (12
III ( VlllK-
Area
(Acres)
Aivsi
(km-)
SliiU's
No. or
l-';icililie>
No. of
Moil.
Sites
No. or
Samples
011000060405
Horseneck Brook-Frontal Long
Island Sound
23419.3
94.8
CT,NY
2
0
0
HUCs with Monitoring Sites Only (n = 97)
150601060202
Upper Indian Bend Wash
27058.2
109.5
AZ
0
1
3
150601060307
Town of Santa Maria-Salt River
34122.5
138.1
AZ
0
5
150701020606
Upper Arizona Canal Diversion
Channel
15465.9
62.6
AZ
0
1
3
150701020607
Lower Arizona Canal Diversion
Channel
19739.1
79.9
AZ
0
1
1
150701020806
Middle Skunk Creek
28304.4
114.5
AZ
0
1
3
150701020807
Lower Skunk Creek
24449.6
98.9
AZ
0
2
150701020809
City of Peoria-New River
38282.5
154.9
AZ
0
2
110400011005
Miller Canyon-Dry Cimarron
River
36341.5
147.1
CO,N
M
0
1
1
110800010101
Upper Chicorica Creek
36590.1
148.1
CO,N
M
0
1
1
110800010104
Raton Creek
28802.5
116.6
CO,N
M
0
1
1
110800010304
Bernal Creek-Vermejo River
17284.0
70.0
CO,N
M
0
1
1
110300120303
110300120303-Little Arkansas
River
23920.3
96.8
KS
0
1
4
110300120408
City of Sedgwick-Little Arkansas
River
27404.6
110.9
KS
0
10
071401020703
Stater Creek-Meramec River
28521.9
115.4
MO
0
1
2
071401021001
Hamilton Creek-Meramec River
34956.9
141.5
MO
0
1
2
071401021002
Grand Glaize Creek-Meramec
River
29896.0
121.0
MO
0
1
2
071401021004
Meramec River
27977.7
113.2
MO
0
1
1
030402030103
Naked Creek
25026.5
101.3
NC
0
1
12
030300020301
Upper Big Alamance Creek
23563.4
95.4
NC
0
1
11
030300020506
Marys Creek-Haw River
18499.4
74.9
NC
0
1
10
030300030104
Bull Run-Deep River
11364.4
46.0
NC
0
1
9
030402030402
Bear Swamp
18155.9
73.5
NC
0
1
13
030202011501
Headwaters Little River
27575.7
111.6
NC
0
1
13
030202020103
Seymour Johnson Air Force
Base-Neuse River
10050.8
40.7
NC
0
1
1
030402031005
River Swamp-Lumber River
13009.7
52.6
NC
0
1
2
030202020303
Yadkin Branch-Neuse River
11135.9
45.1
NC
0
1
1
Page 565 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
III (12
III ( Niimo
Aivsi
(Acres)
Aivsi
(km-)
SliiU's
No. <.r
lucililkv
No. of
Moil.
Sites
No. or
Siinipk-s
030300040706
City of Fayetteville-Cape Fear
River
18506.3
74.9
NC
0
1
1
030300050206
White Lake-Cape Fear River
19631.2
79.4
NC
0
1
2
030300050302
Middle Livingston Creek
17637.8
71.4
NC
0
1
11
030202020404
Clayroot Swamp
31573.4
127.8
NC
0
1
13
030300050501
Indian Creek-Cape Fear River
18164.0
73.5
NC
0
1
1
030300060301
Caesar Swamp-Little Coharie
Creek
30510.3
123.5
NC
0
1
12
030300060303
Bearskin Swamp
16148.0
65.3
NC
0
1
13
030300060805
Rowan Creek-Black River
26201.3
106.0
NC
0
1
12
030501010106
Toms Creek-Catawba River
17337.3
70.2
NC
0
1
11
030501010401
Upper Warrior Fork
23781.8
96.2
NC
0
1
12
030501010501
Upper Johns River
26796.4
108.4
NC
0
1
12
030501010504
Lower Wilson Creek
18305.8
74.1
NC
0
1
12
030201010903
Buck Swamp-Tar River
20652.5
83.6
NC
0
1
2
030201020204
Bear Swamp
28720.3
116.2
NC
0
1
13
030300070201
Lewis Branch-Northeast Cape
Fear River
19845.8
80.3
NC
0
1
13
030202040204
Town of Trenton-Trent River
43012.8
174.1
NC
0
1
12
030202040401
City of New Bern-Neuse River
14210.7
57.5
NC
0
1
2
030101030109
Flat Shoals Creek-Dan River
28246.1
114.3
NC
0
1
10
030201030202
Town Creek-Tar River
19716.5
79.8
NC
0
1
1
060101050302
Clear Creek
28811.3
116.6
NC
0
1
10
060101050403
Mills River
20437.8
82.7
NC
0
1
11
060101050503
Lower Hominy Creek
15416.6
62.4
NC
0
1
12
030101070509
City of Williamston-Roanoke
River
15369.3
62.2
NC
0
1
2
030201040103
Hills Creek-Pamlico River
20821.4
84.3
NC
0
1
2
030300070611
Lewis Creek-Northeast Cape Fear
River
34873.9
141.1
NC
0
1
1
030300070802
Pike Creek-Northeast Cape Fear
River
34936.3
141.4
NC
0
1
13
060101080206
Jacks Creek
13392.1
54.2
NC
0
1
12
030300070809
Ness Creek-Northeast Cape Fear
River
17715.3
71.7
NC
0
1
1
030401010306
Mulberry Creek
31521.5
127.6
NC
0
1
10
030402020102
Headwaters Lynches River
32657.2
132.2
NC,SC
0
1
11
Page 566 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
III (12
III ( Niimo
AiVii
(Acres)
AiVii
(km-)
SliiU's
No. or
lucililkv
No. of
IMon.
Sites
No. or
Siiinpk's
030401011005
Little Yadkin River
18870.5
76.4
NC
0
1
11
030203020103
Cowhorn Swamp-New River
18267.5
73.9
NC
0
1
2
030401030601
Lick Creek
21942.3
88.8
NC
0
1
9
030401050203
Irish Buffalo Creek
29616.8
119.8
NC
0
1
11
030101060205
Blue Mud Creek-Smith Creek
23151.8
93.7
NC,VA
0
1
13
020401050911
Buck Creek-Delaware River
15442.9
62.5
NJ,PA
0
1
110800010107
Outlet Una de Gato Creek
18883.6
76.4
NM
0
1
1
110800010305
York Canyon
19318.4
78.2
NM
0
1
1
110800010306
Griffin Canyon-Vermejo River
31314.3
126.7
NM
0
1
110800010309
Bracket Canyon-Vermejo River
27060.4
109.5
NM
0
1
1
110800010401
Rail Canyon-Vermejo River
28467.1
115.2
NM
0
110800010406
Stubblefield Arroyo-Vermejo
River
28101.0
113.7
NM
0
1
1
110800010510
Maxwell National Wildlife
Refuge
22719.1
91.9
NM
0
1
1
110800010606
110800010606-Canadian River
28344.2
114.7
NM
0
1
1
110800020104
Outlet Cieneguilla Creek
13369.9
54.1
NM
0
1
1
110800020105
Eagle Nest Lake
18531.5
75.0
NM
0
1
1
110800020109
Turkey Creek Canyon-Cimarron
River
29455.4
119.2
NM
0
1
1
110800020401
Springer Lake
15355.0
62.1
NM
0
1
1
110800020404
Outlet Cimarron River
26894.7
108.8
NM
0
1
1
110800030107
Charette Lake-Ocate Creek
38051.9
154.0
NM
0
1
1
110800030505
Canon Vercere-Canadian River
17450.2
70.6
NM
0
1
1
130202010209
Canada de Cochiti-Rio Grande
20418.4
82.6
NM
0
1
130202030107
Town of Corrales-Rio Grande
26313.8
106.5
NM
0
1
110800030610
Canon Negro-Canadian River
25106.6
101.6
NM
0
1
1
110800040106
Lower Coyote Creek
29881.2
120.9
NM
0
1
1
110800040208
Phoenix Lake-Sapello River
14850.8
60.1
NM
0
1
1
110800040305
Encinal Creek-Mora River
15092.1
61.1
NM
0
1
1
110800040306
Santiago Creek
19713.5
79.8
NM
0
1
1
110800040308
Eagle Creek-Mora River
38784.0
156.9
NM
0
1
1
110800040605
Canon Vegocito-Mora River
29443.0
119.2
NM
0
1
1
110800060909
Martin Draw-Canadian River
20893.7
84.5
NM,T
X
0
1
1
110800060409
Carpenter Creek-Canadian River
36596.2
148.1
NM
0
1
2
Page 567 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
III (12
III ( Niimo
AiVii
(Acres)
AiVii
(km-)
SliiU's
No. or
lucililio
No. of
IMon.
Sites
No. or
Siiinpk's
110800060606
Outlet Pajarito Creek
34811.1
140.9
NM
0
1
1
110800060801
Hudson Lake-Ute Reservoir
32050.3
129.7
NM
0
1
1
110800060805
Town of Logan-Canadian River
25798.5
104.4
NM
0
1
1
110800080504
Lower Revuelto Creek
25500.0
103.2
NM
0
1
1
111001010204
Clayton Lake-Seneca Creek
21142.1
85.6
NM
0
1
1
020700040702
Dennis Creek-Back Creek
32533.8
131.7
PA
0
1
3
060300030201
Bradley Creek
30268.8
122.5
TN
0
4
8
121003030306
Salt Creek-Ecleto Creek
18817.5
76.2
TX
0
1
1
090300080501
City of International Falls-Rainy
River
36508.3
147.7
CN,M
N
0
1
2
11260
Page 568 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx E-3. Sample Information for WQX Surface Water Observations With Concentrations Above the Reported
Detection Limit: 2013-2017"
Miiiiiiuriii^ Siii- II) ;iihI
()rn
Miuiiliirin^ Sili- 1 nIV>riii:ilion
\\ ;ili'i'l)ii(l\ T\ pi- ;iikI
l.oi.ilion
I.;iI/I.iiiili- II)
liilV>rin;iii(>ii
l);ili' ;ill(l
Tillli-
C "
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Miiiiiiuriii^ Siii- II) ;iihI
()rn
Miuiiliirin^ Sili- 1 nIV>riii:ilion
\\ ;ili'i'l)ii(l\ T\ pi- ;iiul
1 .million
I.;iI/I.iiiili- II)
lnr
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Miiiiiiuriii^ Siii- II) ;iihI
()rn
Miuiiliirin^ Sili- 1 nIV>riii:ilion
\\ ;ili'i'l)ii(l\ T\ pi- ;iiul
1 .million
l.;il/l.nnli- II)
liilV>rin;iii(>ii
l);ili' ;ill(l
Tillli-
C "
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
11269 Table Apx E-4. E-FAST Modeling Results for Known Direct and Indirect Releasing Facilities for 2016
Name, Location, and ID of
Active Releaser Facility"
Release
Media1*
Modeled Facility or
Industry Sector in E-FAST'
E-FAST
Waterbody
Type'1
Days of
release'
Release
(kg/day)f
7Q10 SWC
(ppb)s
coc
(|)|)b)
Days of
Evcccdancc
(days/yr)h
OES: Manufacturing
COVESTRO LLC
BAYTOWN, TQX FRS:
110000463098
Surface
Water
Active Releaser: NPDES
TX0002798
Surface
water
350
0.004
0.44
90.0
4
151
4
1800
4
20
0.068
7.510
90.0
1
151
1
1800
0
EMERALD
PERFORMANCE
MATERIALS LLC HENRY,
ILNPDES: IL0001392
Surface
Water
Active Releaser: NPDES
IL0001392
Still water
350
0.001
0.370
90.0
0
151
0
1800
0
20
0.023
8.42
90.0
0
151
0
1800
0
FISHER SCIENTIFIC CO
LL C FAIR LAWN, NJ
NPDES:NJ0110281
POTW
Receiving Facility:
PASSAIC VALLEY
SEWER COMM; NPDES
NJ0021016
Still water
350
0.01
0.000637
90.0
0
151
0
1800
0
FISHER SCIENTIFIC CO
LLC BRIDGEWATER, NJ
NPDES: NJ0119245
POTW
Receiving Facility:
SOMERSET RARITIAN
VALLEY SEWERAGE;
NPDES NJ0024864
Surface
water
350
0.01
0.10
90.0
0
151
0
1800
0
OLIN BLUE CUBE
FREEPORT TX
FREEPORT, TX TRI:
7754WBLCBP231NB
Non-
POTW
WWT
Receiving Facility: DOW
CHEMICAL-FREEPORT,
TX; NPDES TX0006483
Surface
water
350
0.2
0.033
90.0
0
151
0
1800
0
REGIS TECHNOLOGIES
INC MORTON GROVE, IL
FRS:110000429661
POTW
Receiving Facility:
MWRDGC TERRENCE J
O'BRIEN WTR
RECLAMATION PLANT;
NPDES IL0028088
Still water
350
0.01
0.00389
90.0
0
151
0
1800
0
SIGMA-ALDRICH
MANUFACTURING LLC
SAINT LOUIS, MO FRS:
POTW
Receiving Facility: BISSEL
POINT WWTP ST LOUIS
MSD; NPDES M00025178
Surface
water
350
0.01
0.0000528
90.0
0
151
0
1800
0
Page 572 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
110000743125
VANDERBILT
CHEMICALS LLC-
MURRAY DIV MURRAY,
KYNPDES: KY0003433
Non-
POTW
WWT
Receiving Facility:
VALICOR
ENVIRONMENTAL
SERVICES; Organic
Chemicals Manufacturing
Surface
water
350
0.0013
0.100
90.0
0
151
0
1800
0
EI DUPONT DE
NEMOURS - CHAMBERS
WORKS DEEPWATER, NJ
NPDES: NJ0005100
Surface
Water
Active Releaser: NPDES
NJ0005100
Surface
water
350
0.2
0.0297
90.0
0
151
0
1800
0
20
3.8
0.56
90.0
0
151
0
1800
0
BAYER
MATERIALSCIENCE
BAYTOWN, TX NPDES:
TX0002798
Surface
Water
Active Releaser: NPDES
TX0002798
Surface
water
350
0.03
3.31
90.0
11
151
7
1800
4
20
0.50
55.19
90.0
3
151
2
1800
1
INSTITUTE PLANT
INSTITUTE, WV NPDES:
WV0000086
Surface
Water
Active Releaser: NPDES
WV0000086
Surface
water
350
0.01
0.00299
90.0
0
151
0
1800
0
20
0.16
0.0479
90.0
0
151
0
1800
0
MPM SILICONES LLC
FRIENDLY, WV NPDES:
WV0000094
Surface
Water
Active Releaser: NPDES
WV0000094
Surface
water
350
0.005
0.000594
90.0
0
151
0
1800
0
20
0.082
0.00974
90.0
0
151
0
1800
0
BASF CORPORATION
WEST MEMPHIS, AR
NPDES: AR0037770
Surface
Water
Active Releaser: NPDES
AR0037770
Surface
water
350
0.003
0.0000120
90.0
0
151
0
1800
0
20
0.059
0.000235
90.0
0
151
0
Page 573 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
1800
0
ARKEMA INC PIFFARD,
NY NPDES: NY0068225
Surface
Water
Active Releaser: NPDES
NY0068225
Surface
water
350
0.001
0.00479
90.0
0
151
0
1800
0
20
0.013
0.0622
90.0
0
151
0
1800
0
EAGLE US 2 LLC - LAKE
CHARLES COMPLEX
LAKE CHARLES, LA
NPDES: LA0000761
Surface
Water
Active Releaser: NPDES
LA0000761
Surface
water
350
0.001
0.00113
90.0
0
151
0
1800
0
20
0.012
0.0136
90.0
0
151
0
1800
0
BAYER
MATERIALSCIENCE NEW
MARTINSVILLE, WV
NPDES: WV0005169
Surface
Water
Active Releaser: NPDES
WV0005169
Surface
water
350
0.001
0.000119
90.0
0
151
0
1800
0
20
0.012
0.00143
90.0
0
151
0
1800
0
ICL-IP AMERICA INC
GALLIPOLIS FERRY, WV
NPDES: WV0002496
Surface
Water
Active Releaser: NPDES
WV0002496
Surface
water
350
0.0004
0.0000281
90.0
0
151
0
1800
0
20
0.0065
0.000457
90.0
0
151
0
1800
0
KEESHAN AND BOST
CHEMICAL CO., INC.
MANVEL, TX NPDES:
TX0072168
Surface
Water
Active Releaser: NPDES
TX0072168
Still water
350
0.00005
5.00
90.0
0
151
0
1800
0
20
0.00083
83.00
90.0
0
151
0
1800
0
INDORAMA VENTURES
OLEFINS, LLC SULPHUR,
LA NPDES: LA0069850
Surface
Water
Active Releaser (Surrogate):
NPDES LA0000761
Surface
water
350
0.00003
0.0000339
90.0
0
151
0
1800
0
20
0.00047
0.000531
90.0
0
Page 574 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
151
0
1800
0
CHEMTURA NORTH AND
SOUTH PLANTS
MORGANTOWN, WV
NPDES: WV0004740
Surface
Water
Active Releaser: NPDES
WV0004740
Surface
water
350
0.00002
0.0000290
90.0
0
151
0
1800
0
20
0.00041
0.000595
90.0
0
151
0
1800
0
OES: Import and Repackaging
CHEMISPHERE CORP
SAINT LOUIS, MO FRS:
110000852943
POTW
Receiving Facility: BISSEL
POINT WWTP ST LOUIS
MSD; NPDES M00025178
Surface
water
250
0.01
0.0000528
90.0
0
151.0
0
1800.0
0
HUBBARD-HALL INC
WATERBURY, CT FRS:
110000317194
Non-
POTW
WWT
Receiving Facility:
RECYCLE INC.; POTW
(Ind.)
Surface
water
250
0.58
32.14
90.0
7
151.0
2
1800.0
0
WEBB CHEMICAL
SERVICE CORP
MUSKEGON HEIGHTS, MI
NPDES: MI0049719
POTW
Receiving Facility:
MUSKEGON CO WWMS
METRO WWTP; NPDES
MI0027391
Surface
water
250
0.4
0.0998
90.0
0
151.0
0
1800.0
0
RESEARCH SOLUTIONS
GROUP INC PELHAM, AL
NPDES: AL0074276
Surface
Water
Active Releaser (Surrogate):
POTW (Ind.)
Surface
water
250
0.0003
0.0387
90.0
0
151.0
0
1800.0
0
20
0.0043
0.55
90.0
0
151.0
0
1800.0
0
EMD MILLIPORE CORP
CINCINNATI, OH NPDES:
OH0047759
Surface
Water
Active Releaser (Surrogate):
POTW (Ind.)
Surface
water
250
0.0001
0.0129
90.0
0
151.0
0
1800.0
0
20
0.0014
0.18
90.0
0
151.0
0
1800.0
0
OES: Processing as a Rcactant
AMVAC CHEMICAL CO
AXIS, AL FRS:
110015634866
Non-
POTW
WWT
Receiving Facility: DUPONT
AGRICULTURAL
PRODUCTS; NPDES
AL0001597
Surface
water
350
0.6
0.0140
90.0
0
151.0
0
1800.0
0
Page 575 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
THE DOW CHEMICAL CO
MIDLAND, MI NPDES:
MI0000868
Surface
Water
Active Releaser: NPDES
MI0000868
Surface
water
350
0.1
0.16
90.0
0
151.0
0
1800.0
0
20
1.2
1.90
90.0
0
151.0
0
1800.0
0
FMC CORPORATION
MIDDLEPORT, NY
NPDES: NY0000345
Surface
Water
Active Releaser: NPDES
NY0000345
Surface
water
350
0.0003
0.24
90.0
0
151.0
0
1800.0
0
20
0.0057
4.52
90.0
0
151.0
0
1800.0
0
OES: Processing - Formulation
ARKEMA INC CALVERT
CITY, KY NPDES:
KY0003603
Surface
Water
Active Releaser: NPDES
KY0003603
Surface
water
300
0.1
0.00434
90.0
0
151.0
0
1800.0
0
20
1.5
0.0650
90.0
0
151.0
0
1800.0
0
MCGE AN -ROHCO INC
LIVONIA, MI FRS:
110000405801
POTW
Receiving Facility:
DETROIT WWTP-
CHLORINATION/DECHLO
RINATION FACILITY;
NPDES MI0022802
Surface
water
300
0.4
0.00216
90.0
0
151.0
0
1800.0
0
WM BARR & CO INC
MEMPHIS, TN FRS:
110000374265
POTW
Receiving Facility:
MEMPHIS CITY MAXSON
WASTEWATER
TREATMENT; NPDES
TN0020729
Surface
water
300
0.002
0.00000343
90.0
0
151.0
0
1800.0
0
BUCKMAN
LABORATORIES INC
MEMPHIS, TN NPDES:
TN0040606
POTW
Receiving Facility: MC
STILES TREATMENT
PLANT; NPDES
TN0020711
Surface
water
300
0.8
0.00138
90.0
0
151.0
0
1800.0
0
EUROFINS MWG
OPERON LLC
POTW
Receiving Facility: VEOLIA
ENVIRONMENTAL
Surface
water
300
19
1527.10
90.0
215
151.0
174
Page 576 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
LOUISVILLE, KY TRI:
4029WRFNSM1271P
SERVICES TECH
SOLUTIONS LLC;
Inorganic Chemicals Manuf.
1800.0
19
SOLVAY - HOUSTON
PLANT HOUSTON, TX
NPDES: TX0007072
Surface
Water
Active Releaser: NPDES
TX0007072
Surface
water
300
0.04
7.41
90.0
0
151.0
0
1800.0
0
20
0.58
107.41
90.0
0
151.0
0
1800.0
0
HONEYWELL
INTERNATIONAL INC -
GEISMAR COMPLEX
GEISMAR, LA NPDES:
LA0006181
Surface
Water
Active Releaser: NPDES
LA0006181
Surface
water
300
0.01
0.0000405
90.0
0
151.0
0
1800.0
0
20
0.22
0.000890
90.0
0
151.0
0
1800.0
0
STEP AN CO MILLSDALE
ROAD EL WOOD, IL
NPDES: IL0002453
Surface
Water
Active Releaser: NPDES
IL0002453
Surface
water
300
0.01
1.24000
90.0
0
151.0
0
1800.0
0
20
0.12
0.0503
90.0
0
151.0
0
1800.0
0
ELEMENTIS
SPECIALTIES, INC.
CHARLESTON, WV
NPDES: WV0051560
Surface
Water
Active Releaser: NPDES
WV0051560
Surface
water
300
0.001
0.000627
90.0
0
151.0
0
1800.0
0
20
0.011
0.00690
90.0
0
151.0
0
1800.0
0
OES: Polvurcthanc Foam
PREGIS INNOVATIVE
PACKAGING INC
WURTLAND, KY NPDES:
KY0094005
Surface
Water
Active Releaser (Surrogate):
Plastic Resins and Synthetic
Fiber Manuf.
Surface
water
250
0.01
1.25
90.0
0
151.0
0
1800.0
0
20
0.11
13.72
90.0
0
151.0
0
1800.0
0
OES: Plastics Manufacturing
Page 577 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
90.0
0
SABIC INNOVATIVE
Active Releaser (Surrogate):
Plastic Resins and Synthetic
Fiber Manuf.
250
0.03
3.74
151.0
0
PLASTICS US LLC
Surface
Surface
1800.0
0
BURKVILLE, AL NPDES:
Water
water
90.0
1
ALR16ECGK
20
0.41
51.12
151.0
1
1800.0
0
90.0
0
SABIC INNOVATIVE
250
0.1
0.00446
151.0
0
PLASTICS MT. VERNON,
Surface
Active Releaser: NPDES
Surface
1800.0
0
LLC MOUNT VERNON, IN
Water
IN0002101
water
90.0
0
NPDES: IN0002101
20
1.40
0.0624
151.0
0
1800.0
0
90.0
0
SABIC INNOVATIVE
250
0.03
0.00437
151.0
0
PLASTICS US LLC
Surface
Active Releaser: NPDES
Surface
1800.0
0
SELKIRK, NY NPDES:
Water
NY0007072
water
90.0
0
NY0007072
20
0.44
0.0641
151.0
0
1800.0
0
90.0
0
EQUISTAR CHEMICALS
LP LA PORTE, TX NPDES:
TXO119792
Active Releaser (Surrogate):
Plastic Resins and Synthetic
Fiber Manuf.
250
0.03
3.74
151.0
0
Surface
Surface
1800.0
0
Water
water
90.0
1
20
0.43
53.62
151.0
1
1800.0
0
90.0
0
CHEMOURS COMPANY
FC LLC WASHINGTON,
WV NPDES: WV0001279
250
0.03
0.00301
151.0
0
Surface
Active Releaser: NPDES
Surface
1800.0
0
Water
WV0001279
water
90.0
0
20
0.37
0.0371
151.0
0
1800.0
0
90.0
0
SHINTECH ADDIS
Surface
Water
Active Releaser: NPDES
LA0055794
Surface
water
250
0.01
0.0000405
151.0
0
PLANT A ADDIS, LA
1800.0
0
NPDES: LAO 111023
20
0.13
0.000526
90.0
0
151.0
0
Page 578 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
1800.0
0
STYROLUTION AMERICA
LLC CHANNAHON, IL
NPDES: IL0001619
Surface
Water
Active Releaser: NPDES
IL0001619
Surface
water
250
0.001
0.000347
90.0
0
151.0
0
1800.0
0
20
0.01
0.00347
90.0
0
151.0
0
1800.0
0
DOW CHEMICAL CO
DALTON PLANT
DALTON, GA NPDES:
GA0000426
Surface
Water
Active Releaser: NPDES
GA0000426
Surface
water
250
0.001
0.00495
90.0
0
151.0
0
1800.0
0
20
0.02
0.0989
90.0
0
151.0
0
1800.0
0
PREGIS INNOVATIVE
PACKAGING INC
WURTLAND, KY NPDES:
KY0094005
Surface
Water
Active Releaser (Surrogate):
Plastic Resins and Synthetic
Fiber Manuf.
Surface
water
250
0.0001
0.0125
90.0
0
151.0
0
1800.0
0
20
0.0012
0.15
90.0
0
151.0
0
1800.0
0
OES: Pharmaceutical
ABB VIE-NORTH CH
ICAGO FACILITY NORTH
CHICAGO, IL NPDES:
ILR006192
POTW
Receiving Facility: NORTH
SHORE WATER
RECLAMATION DIST;
NPDES IL0035092
Surface
water
300
0.01
0.10
90.0
0
151.0
0
1800.0
0
EUTICALS INC
SPRINGFIELD, MO
NPDES: MOOOO1970
POTW
Receiving Facility:
SPRINGFIELD SW WWTP;
NPDES M00049522
Surface
water
300
0.002
0.00874
90.0
0
151.0
0
1800.0
0
MALLINCKRODT LLC
SAINT LOUIS, MO FRS:
110000494796
POTW
Receiving Facility: BISSEL
POINT WWTP ST LOUIS
MSD; NPDES M00025178
Surface
water
300
0.02
0.000106
90.0
0
151.0
0
1800.0
0
NORAMCO INC
WILMINGTON, DE FRS:
110000338741
POTW
Receiving Facility:
WILMINGTON
WASTEWATER
TREATMENT PLANT-
12TH ST & HAY RD,
Surface
water
300
0.01
0.000639
90.0
0
151.0
0
1800.0
0
Page 579 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
WILMINGTON; NPDES
DE0020320
AMRI RENSSELAER INC
RENSSELAER, NY
NPDES: NY0241148
POTW
Receiving Facility:
RENSSELAER COUNTY
SD#1 WWTP; NPDES
NY0087971
Surface
water
300
1.1
0.0691
90.0
0
151.0
0
1800.0
0
E R SQUIBB & SONS LLC
NORTH BRUNSWICK, NJ
NPDES: NJ0123722
POTW
Receiving Facility:
MIDDLESEX COUNTY
UTILITIES AUTHORITY;
NPDES NJ0020141
Still water
300
0.4
0.11
90.0
0
151.0
0
1800.0
0
EVONIK CORP
TIPPECANOE
LABORATORIES
LAFAYETTE, IN NPDES:
IN0002861
Surface
Water
Active Releaser: NPDES
IN0002861
Surface
water
300
0.01
0.00865
90
0
151
0
1800
0
20
0.11
0.0951
90
0
151
0
1800
0
PACIRA
PHARMACEUTICALS INC
SAN DIEGO, CA NPDES:
unknown
POTW
Receiving Facility: SD CITY
PT LOMA WASTEWATER
TREATMENT; NPDES
CA0107409
Still water
300
0.1
0.10
90.0
0
151.0
0
1800.0
0
PCI SYNTHESIS
NEWBURYPORT, MA
NPDES: MAR05B262
POTW
Receiving Facility:
NEWBURYPORT
WASTEWATER
TREATMENT FACILITY;
NPDES MAO 101427
Surface
water
300
0.002
0.000339
90.0
0
151.0
0
1800.0
0
PFIZER
PHARMACEUTICALS LLC
BARCELONETA, PR FRS:
110008472063
POTW
Receiving Facility: PRASA
BARCELONETA STP;
NPDES PR0021237
Still water
300
0.1
0.00365
90.0
0
151.0
0
1800.0
0
PHARMACIA & UPJOHN
CO LLC A SUBSIDIARY
OF PFIZER INC
PORTAGE, MI NPDES:
unknown
Surface
Water
Active Releaser: NPDES
MI0002941
Surface
water
300
0.007
0.10
90.0
0
151.0
0
1800.0
0
20
0.11
1.60
90.0
0
151.0
0
1800.0
0
POTW
Receiving Facility:
KALAMAZOO WWTP;
NPDES MI0023299
Surface
water
300
7.6
5.80
90.0
0
151.0
0
1800.0
0
Page 580 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
90.0
0
SI GROUP INC
ORANGEBURG, SC
NPDES: SCR002882
300
0.1
0.89
151.0
0
Surface
Active Releaser: NPDES
Surface
1800.0
0
Water
SC0001180
water
90.0
0
20
2.1
18.66
151.0
0
1800.0
0
TEVA
Receiving Facility: MEXICO
WWTP; NPDES
90.0
2
PHARMACEUTICALS
USA MEXICO, MO
NPDES: MOR23A013
POTW
Surface
water
300
0.03
1.70
151.0
0
M00036242
1800.0
0
90.0
0
EVONIK DEGUSSA CORP
TIPPECANOE
LABORATORIES
LAFAYETTE, IN NPDES:
IN0002861
300
0.01
0.00865
151.0
0
Surface
Active Releaser: NPDES
Surface
1800.0
0
Water
IN0002861
water
90.0
0
20
0.13
0.11
151.0
0
1800.0
0
OES: CTA Film Manufacturing
90.0
0
KODAK PARK DIVISION
ROCHESTER, NY NPDES:
NY0001643
250
0.1
0.0949
151.0
0
Surface
Active Releaser: NPDES
Surface
1800.0
0
Water
NY0001643
water
90.0
0
20
1.4
1.33
151.0
0
1800.0
0
OES: Lithographic Printer
90.0
0
FORMER REXON
FACILITY AKA ENJEMS
MILL WORKS WAYNE
TWP,NJ NPDES:
NJG218316
250
0.000004
0.0000583
151.0
0
Surface
Active Releaser (Surrogate):
Surface
1800.0
0
Water
Printing
water
90.0
0
20
0.000046
0.000671
151.0
0
1800.0
0
OES: Spot Cleaner
BOISE STATE
UNIVERSITY BOISE, ID
NPDES: IDG911006
90.0
0
Surface
Active Releaser (Surrogate):
Surface
250
0.0002
0.00502
151.0
0
Water
NPDES ID0020443
water
1800.0
0
20
0.0030
0.0753
90.0
0
Page 581 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
151.0
0
1800.0
0
OES: Recycling and Disposal
JOHNSON MATTHEY
WEST DEPTFORD, NJ
NPDES:NJ0115843
Non-
POTW
WWT
Receiving Facility: Clean
Harbors of Baltimore, Inc;
POTW (Ind.)
Surface
water
250
2
137.42
90.0
64
151.0
33
1800.0
0
CLEAN HARBORS DEER
PARK LLC LA PORTE, TX
NPDES: TX0005941
Non-
POTW
WWT
Receiving Facility: Clean
Harbors of Baltimore, Inc;
POTW (Ind.)
Surface
water
250
2
115.81
90.0
52
151.0
26
1800.0
0
CLEAN HARBORS EL
DORADO LLC EL
DORADO, AR NPDES:
AR0037800
Non-
POTW
WWT
Receiving Facility: Clean
Harbors of Baltimore, Inc;
POTW (Ind.)
Surface
water
250
0.5
24.94
90.0
4
151.0
1
1800.0
0
TRADEBE TREATMENT &
RECYCLING LLC EAST
CHICAGO, IN FRS:
110000397874
Non-
POTW
WWT
Receiving Facility:
ADVANCED WASTE
SERVICES OF INDIANA
LLC and BEAVER OIL
TREATMENT AND
RECYCLING; POTW (Ind.)
Surface
water
250
0.1
4.43
90.0
0
151.0
0
1800.0
0
VEOLIA ES TECHNICAL
SOLUTIONS LLC WEST
CARROLLTON, OH FRS:
110000394920
POTW
Receiving Facility:
WESTERN REGIONAL
WRF; NPDES OH0026638
Surface
water
250
0.01
0.00809
90.0
0
151.0
0
1800.0
0
VEOLIA ES TECHNICAL
SOLUTIONS LLC AZUSA,
CAFRS: 110000477261
POTW
Receiving Facility: SAN
JOSE CREEK WATER
RECLAMATION PLANT;
NPDES CA0053911
Surface
water
250
0.002
0.00402
90.0
20
151.0
20
1800.0
20
VEOLIA ES TECHNICAL
SOLUTIONS LLC
MIDDLESEX, NJ NPDES:
NJ0127477
Non-
POTW
WWT
Receiving Facility:
MIDDLESEX COUNTY
UTILITIES AUTHORITY;
NPDES: NJ0020141
Still body
250
0.018
0.00482
90.0
0
151.0
0
1800.0
0
Receiving Facility: Clean
Harbors; POTW (Ind.)
Surface
water
250
306
17000
90.0
250
151.0
250
1800.0
196
Receiving Facility: ROSS
INCINERATION
SERVICES INC; POTW
(Ind.)
Surface
water
250
147
8146
90.0
249
151.0
247
1800.0
146
Page 582 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Receiving Facility:
SAFETY-KLEEN
SYSTEMS INC; POTW
(Ind.)
Surface
water
250
8
443
90.0
151
151.0
111
1800.0
3
CHEMICAL WASTE
MANAGEMENT EMELLE,
ALNPDES: AL0050580
Surface
Water
Active Releaser (Surrogate):
POTW (Ind.)
Surface
water
250
0.01
1.29
90.0
0
151.0
0
1800.0
0
20
0.18
23.20
90.0
0
151.0
0
1800.0
0
OILTANKING HOUSTON
INC HOUSTON, TX
NPDES: TX0091855
Surface
Water
Active Releaser (Surrogate):
NPDES TX0065943
Surface
water
250
0.003
6.52
90.0
0
151.0
0
1800.0
0
20
0.041
89.13
90.0
0
151.0
0
1800.0
0
HOWARD CO ALFA
RIDGE LANDFILL
MARRIOTTSVILLE, MD
NPDES: MD0067865
Surface
Water
Active Releaser (Surrogate):
POTW (Ind.)
Surface
water
250
0.0002
0.0258
90.0
0
151.0
0
1800.0
0
20
0.0030
0.39
90.0
0
151.0
0
1800.0
0
CLIFFORD G HIGGINS
DISPOSAL SERVICE INC
SLF KINGSTON, NJ
NPDES: NJG160946
Surface
Water
Active Releaser (Surrogate):
POTW (Ind.)
Surface
water
250
0.0001
0.0129
90.0
0
151.0
0
1800.0
0
20
0.0012
0.15
90.0
0
151.0
0
1800.0
0
CLEAN WATER OF NEW
YORK INC STATEN
ISLAND, NY NPDES:
NY0200484
Surface
Water
Active Releaser (Surrogate):
NPDES NJ0000019
Still body
250
0.01
27.94
90.0
250
151.0
0
1800.0
0
20
0.12
352.94
90.0
20
151.0
20
1800.0
0
250
0.001
0.13
90.0
0
Page 583 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
FORMER
CARBORUNDUM
COMPLEX SANBORN, NY
NPDES: NY0001988
Surface
Water
Active Releaser (Surrogate):
POTW (Ind.)
Surface
water
151.0
0
1800.0
0
20
0.012
1.55
90.0
0
151.0
0
1800.0
0
OES: Other
APPLIED BIOSYSTEMS
LLC PLEASANTON, CA
FRS:110020517010
Non-
POTW
WWT
Receiving Facility: Evoqua
Water Technologies; POTW
(Ind.)
Surface
water
250
0.2
11.08
90.0
0
151.0
0
1800.0
0
EMD MILLIPORE CORP
JAFFREY, NH NPDES:
NHR05C584
POTW
Receiving Facility:
JAFFREY WASTEWATER
TREATMENT FACILITY;
NPDES NH0100595
Surface
water
250
0.01
0.19
90.0
0
151.0
0
1800.0
0
GBC METALS LLC
SOMERS THIN STRIP
WATERBURY, CT NPDES:
CT0021873
Surface
Water
Active Releaser: NPDES
CT0021873
Surface
water
250
0.001
0.00689
90.0
0
151.0
0
1800.0
0
20
0.009
0.0620
90.0
0
151.0
0
1800.0
0
HYSTER-YALE GROUP,
INC SULLIGENT, AL
NPDES: AL0069787
Surface
Water
Active Releaser: Motor
Vehicle Manuf.
Surface
water
250
0.000001
0.000200
90.0
0
151.0
0
1800.0
0
20
0.000012
0.00240
90.0
0
151.0
0
1800.0
0
AVNET INC (FORMER
IMPERIAL SCHRADE)
ELLENVILLE, NY NPDES:
NY0008087
Surface
Water
Active Releaser: Electronic
Components Manuf.
Surface
water
250
0.00002
0.0426
90.0
0
151.0
0
1800.0
0
20
0.0002
0.43
90.0
0
151.0
0
1800.0
0
BARGE CLEANING AND
REPAIR CHANNEL VIEW,
TX NPDES :TX0092282
Surface
Water
Active Releaser: Metal
Finishing
Surface
water
250
0.0003
0.11
90.0
0
151.0
0
1800.0
0
20
0.003
1.140
90.0
0
Page 584 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
151.0
0
1800.0
0
AC & S INC NITRO, WV
NPDES: WV0075621
Surface
Water
Active Releaser: Metal
Finishing
Surface
water
250
0.00005
0.0189
90.0
0
151.0
0
1800.0
0
20
0.001
0.38
90.0
0
151.0
0
1800.0
0
MOOG INC - MOOGIN-
SPACE PROPULSION ISP
NIAGARA FALLS, NY
NPDES: NY0203700
Surface
Water
Active Releaser: Metal
Finishing
Surface
water
250
0.00001
0.00379
90.0
0
151.0
0
1800.0
0
20
0.0002
0.0758
90.0
0
151.0
0
1800.0
0
OILTANKING JOLIET
CHANNAHON, IL NPDES:
IL0079103
Surface
Water
Active Releaser (Surrogate):
NPDES IL0001619
Surface
water
250
0.003
0.00104
90.0
0
151.0
0
1800.0
0
20
0.032
0.0111
90.0
0
151.0
0
1800.0
0
NIPPON DYNAWAVE
PACKAGING COMPANY
LONG VIEW, WA NPDES:
WA0000124
Surface
Water
Active Releaser: NPDES
WA0000124
Surface
water
250
0.1
0.000726
90.0
0
151.0
0
1800.0
0
20
1.090
0.00879
90.0
0
151.0
0
1800.0
0
TREE TOP INC
WENATCHEE PLANT
WENATCHEE, WA
NPDES: WA0051527
Surface
Water
Active Releaser (Surrogate):
NPDES WA0023949
Surface
water
250
0.00003
0.000000348
90.0
0
151.0
0
1800.0
0
20
0.0004
0.00000440
90.0
0
151.0
0
1800.0
0
CAROUSEL CENTER
SYRACUSE, NY NPDES:
NY0232386
Surface
Water
Active Releaser: POTW
(Ind.)
Surface
water
250
0.000002
0.000258
90.0
0
151.0
0
1800.0
0
Page 585 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
90.0
0
20
0.000031
0.00399
151.0
0
1800.0
0
OES: DoD
90.0
0
250
0.002
0.00201
151.0
0
US DOD USAF ROBINS
AFB ROBINS AFB, GA
NPDES: GA0002852
Surface
Active Releaser (Surrogate):
Surface
1800.0
0
Water
NPDES GA0024538
water
90.0
0
20
0.023
0.0231
151.0
0
1800.0
0
OES: N/A (WWTP)
90.0
0
EDWARD C. LITTLE WRP
EL SEGUNDO, CA NPDES:
CA0063401
365
0.01
0.00601
151.0
0
Surface
Active Releaser (Surrogate):
Still water
1800.0
0
Water
NPDES CA0000337
90.0
0
20
0.19
0.11
151.0
0
1800.0
0
90.0
0
JU ANITA MILLENDER-
MCDONALD CARSON
REGIONAL WRP
CARSON, CA NPDES:
CA0064246
365
0.002
0.00117
151.0
0
Surface
Active Releaser (Surrogate):
Still water
1800.0
0
Water
NPDES CA0000337
90.0
0
20
0.04
0.0233
151.0
0
1800.0
0
90.0
0
365
0.001
0.19
151.0
0
LONDON WTP LONDON,
Surface
Active Releaser (Surrogate):
Surface
1800.0
0
OH NPDES: OH0041734
Water
NPDES OH0023779
water
90.0
0
20
0.02
3.78
151.0
0
1800.0
0
LONG BEACH (C) WPCP
LONG BEACH, NY
NPDES: NY0020567
90.0
365
Surface
Active Releaser: NPDES
Still water
365
7
301.46
151.0
365
Water
NY0020567
1800.0
0
20
136.49
5878.12
90.0
20
Page 586 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
151.0
20
1800.0
20
MIDDLESEX COUNTY
UTILITIES AUTHORITY
SAYREVILLE, NJ NPDES:
NJ0020141
Surface
Water
Active Releaser: NPDES
NJ0020141
Still water
365
4
2.49
90.0
0
151.0
0
1800.0
0
20
81.68
50.89
90.0
0
151.0
0
1800.0
0
JOINT WATER
POLLUTION CONTROL
PLANT CARSON, CA
NPDES: CA0053813
Surface
Water
Active Releaser: NPDES
CA0053813
Still water
365
1.7
0.00685
90.0
0
151.0
0
1800.0
0
20
30.18
0.12
90.0
0
151.0
0
1800.0
0
HYPERION TREATMENT
PLANT PLAYA DEL REY,
CA NPDES: CA0109991
Surface
Water
Active Releaser: NPDES
CA0109991
Still water
365
0.5
0.00399
90.0
0
151.0
0
1800.0
0
20
8.22
0.0656
90.0
0
151.0
0
1800.0
0
SD CITY PT LOMA
WASTEWATER
TREATMENT SAN DIEGO,
CA NPDES: CA0107409
Surface
Water
Active Releaser: NPDES
CAO107409
Still water
365
0.5
1.20
90.0
0
151.0
0
1800.0
0
20
8.22
19.74
90.0
0
151.0
0
1800.0
0
REGIONAL SANITATION
DISTRICT ELK GROVE,
CA NPDES: CA0077682
Surface
Water
Active Releaser: NPDES
CA0077682
Surface
water
365
0.2
0.0126
90.0
0
151.0
0
1800.0
0
20
4.31
0.27
90.0
0
151.0
0
1800.0
0
BERGEN POINT STP &
BERGEN AVE DOCK W
Surface
Water
Active Releaser: NPDES
NYO104809
Still water
365
0.2
4.06
90.0
0
151.0
0
1800.0
0
Page 587 of 725
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BABYLON, NY NPDES:
NYO104809
20
3.27
66.40
90.0
0
151.0
0
1800.0
0
NEW ROCHELLE STP
NEW ROCHELLE, NY
NPDES: NY0026697
Surface
Water
Active Releaser: NPDES
NY0026697
Still water
365
0.04
0.65
90.0
0
151.0
0
1800.0
0
20
0.77
12.47
90.0
0
151.0
0
1800.0
0
SIMI VLY CNTY
SANITATION SIMI
VALLEY, CA NPDES:
CA0055221
Surface
Water
Active Releaser: NPDES
CA0055221
Surface
water
365
0.02
0.90
90.0
142
151.0
142
1800.0
91
20
0.330
14.88
90.0
10
151.0
9
1800.0
8
OCEANSIDE OCEAN
OUTFALL OCEANSIDE,
CA NPDES: CA0107433
Surface
Water
Active Releaser: NPDES
CAO107433
Still water
365
0.01
0.63
90.0
0
151.0
0
1800.0
0
20
0.19
12.00
90.0
0
151.0
0
1800.0
0
SANTA CRUZ
WASTEWATER
TREATMENT PLANT
SANTA CRUZ, CA NPDES:
CA0048194
Surface
Water
Active Releaser: NPDES
CA0048194
Still water
365
0.01
0.17
90.0
0
151.0
0
1800.0
0
20
0.12
2.07
90.0
0
151.0
0
1800.0
0
CORONA WWTP 1
CORONA, CA NPDES:
CA8000383
Surface
Water
Active Releaser: POTW
(Ind.)
Surface
water
365
0.005
0.64
90.0
0
151.0
0
1800.0
0
20
0.09
11.60
90.0
0
151.0
0
1800.0
0
Surface
Water
Active Releaser: NPDES
NY0026719
Still water
365
0.003
0.16
90.0
0
151.0
0
Page 588 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
BLIND BROOK SD WWTP
RYE, NY NPDES:
NY0026719
1800.0
0
20
0.06
3.14
90.0
0
151.0
0
1800.0
0
MCKINLEYVILLE CSD -
WASTEWATER
TREATMENT PLANT
MCKINLEYVILLE, CA
NPDES: CA0024490
Surface
Water
Active Releaser: NPDES
CA0024490
Surface
water
365
0.003
0.15
90.0
0
151.0
0
1800.0
0
20
0.05
2.54
90.0
0
151.0
0
1800.0
0
SAN JOSE CREEK WATER
RECLAMATION PLANT
WHITTIER, CA NPDES:
CA0053911
Surface
Water
Active Releaser: NPDES
CA0053911
Surface
water
365
0.001
0.00467
90.0
29
151.0
29
1800.0
29
20
0.02
0.0934
90.0
2
151.0
2
1800.0
2
CARMEL AREA
WASTEWATER DISTRICT
TREATMENT FACILITY
CARMEL, CA NPDES:
CA0047996
Surface
Water
Active Releaser: NPDES
CA0047996
Still water
365
0.001
0.11
90.0
0
151.0
0
1800.0
0
20
0.01
1.15
90.0
0
151.0
0
1800.0
0
CAMERON TRADING
POST WWTP CAMERON,
AZ NPDES: NN0021610
Surface
Water
Active Releaser: POTW
(Ind.)
Surface
water
365
0.001
0.13
90.0
0
151.0
0
1800.0
0
20
0.01
1.29
90.0
0
151.0
0
1800.0
0
CITY OF RED BLUFF
WASTEWATER
RECLAMATION PLANT
RED BLUFF, CA NPDES:
CA0078891
Surface
Water
Active Releaser: NPDES
CA0078891
Surface
water
365
0.001
0.000147
90.0
0
151.0
0
1800.0
0
20
0.01
0.00147
90.0
0
151.0
0
1800.0
0
365
0.1
0.29
90.0
0
Page 589 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
91ST AVE WASTEWATER
TREATMENT PLANT
TOLLESON, AZ NPDES:
AZ0020524
Surface
Water
Active Releaser: NPDES
AZ0020524
Surface
water
151.0
0
1800.0
0
20
1.54
4.52
90.0
0
151.0
0
1800.0
0
EVERETT WATER
POLLUTION CONTROL
FACILITY EVERETT, WA
NPDES: WA0024490
Surface
Water
Active Releaser: NPDES
WA0024490
Surface
water
365
0.1
1.04
90.0
0
151.0
0
1800.0
0
20
1.50
15.54
90.0
0
151.0
0
1800.0
0
PIMA COUNTY - INA
ROAD WWTP TUCSON,
AZ NPDES: AZ0020001
Surface
Water
Active Releaser: NPDES
AZ0020001
Surface
water
365
0.1
1.36
90.0
314
151.0
310
1800.0
303
20
1.37
18.59
90.0
18
151.0
18
1800.0
17
23RD AVENUE
WASTEWATER
TREATMENT PLANT
PHOENIX, AZ NPDES:
AZ0020559
Surface
Water
Active Releaser: NPDES
AZ0020559
Surface
water
365
0.1
0.26
90.0
0
151.0
0
1800.0
0
20
0.95
2.49
90.0
0
151.0
0
1800.0
0
SUNNYSIDE STP
SUNNYSIDE, WA NPDES:
WA0020991
Surface
Water
Active Releaser: NPDES
WA0020991
Surface
water
365
0.005
0.00673
90.0
0
151.0
0
1800.0
0
20
0.08
0.11
90.0
0
151.0
0
1800.0
0
AGUA NUEVA WRF
TUCSON, AZ NPDES:
AZ0020923
Surface
Water
Active Releaser: NPDES
AZ0020923
Surface
water
365
0.003
0.0273
90.0
303
151.0
303
1800.0
303
20
0.06
0.55
90.0
17
151.0
17
1800.0
17
Page 590 of 725
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11270
11271
11272
11273
11274
11275
11276
11277
11278
11279
11280
11281
11282
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
90.0
0
PORT OF SUNNYSIDE
365
0.002
0.26
151.0
0
INDUSTRIAL WWTF
Surface
Active Releaser: POTW
Surface
1800.0
0
SUNNYSIDE, WA NPDES:
Water
(Ind.)
water
90.0
0
WA0052426
20
0.03
3.87
151.0
0
1800.0
0
90.0
0
APACHE JUNCTION
WWTP APACHE
365
0.0003
0.04
151.0
0
Surface
Active Releaser: POTW
Surface
1800.0
0
JUNCTION, AZ NPDES:
Water
(Ind.)
water
90.0
0
AZ0023931
20
0.0056
0.72
151.0
0
1800.0
0
a. Facilities actively releasing dichloromethane were identified via DMR and TRI databases for the 2016 reporting year.
b. Facilities actively releasing dichloromethane were identified via DMR and TRI databases for the 2016 reporting year.
c. Release media are either direct (release from active facility directly to surface water) or indirect (transfer of wastewater from active facility to a receiving
POTW or non-POTW WWTP facility). A wastewater treatment removal rate of 57% is applied to all indirect releases.
d. If a valid NPDES of the direct or indirect releaser was not available in E-FAST, the release was modeled using either a surrogate representative facility in E-
FAST (based on location) or a representative generic industry sector. The name of the indirect releaser is provided, as reported in TRI.
e. E-FAST uses ether the "surface water" model, for rivers and streams, or the "still water" model, for lakes, bays, and oceans.
f. Modeling was conducted with the maximum days of release per year expected. For direct releasing facilities, a minimum of 20 days was also modeled.
g. The daily release amount was calculated from the reported annual release amount divided by the number of release days/yr.
h. For releases discharging to lakes, bays, estuaries, and oceans, the acute scenario mixing zone water concentration was reported in place of the 7Q10 SWC.
i. To determine the PDM days of exceedance for still bodies of water, the estimated number of release days should become the days of exceedance only if the
predicted surface water concentration exceeds the COC. Otherwise, the days of exceedance can be assumed to be zero.
Page 591 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
11283 Table Apx E-5. States with Monitoring Sites or Facilities in 2016
Stale Name
Methylene
Dichloride
Releasing l-'acility
.Methylene
Dichloride
Monitoring Site
Methylene
Dichloride l-'acility
or Monitoring Site
Alabama
X
X
Arizona
X
X
X
California
X
X
Connecticut
X
X
Georgia
X
X
Idaho
X
X
Illinois
X
X
Indiana
X
X
Kansas
X
X
Kentucky
X
X
Louisiana
X
X
Maryland
X
X
Michigan
X
X
Minnesota
X
X
Missouri
X
X
X
New Hampshire
X
X
New Jersey
X
X
X
New Mexico
X
X
New York
X
X
North Carolina
X
X
Ohio
X
X
Pennsylvania
X
X
Puerto Rico
X
X
South Carolina
X
X
Tennessee
X
X
X
Texas
X
X
X
Washington
X
X
West Virginia
X
X
Total
23
10
28
11284
11285
11286
Page 592 of 725
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11287
11288
11289
11290
11291
11292
11293
11294
11295
11296
11297
11298
11299
11300
11301
11302
11303
11304
11305
11306
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Appendix F OCCUPATIONAL EXPOSURES
Appendix F.l contains information gathered by EPA in support of understanding glove use for
pure methylene chloride and for paint and coatings removal using methylene chloride
formulations (https://www.regulations.gov/documer PA-HQ-OPPT-2016-0231 -0255).
This information may be generally useful for a broader range of uses of methylene chloride and
is presented for illustrative purposes. Appendix F.2 contains a summary of information on gloves
from Safety Data Sheets (SDS) for methylene chloride and formulations containing methylene
chloride.
F.l Information on Respirators and Gloves for Methylene
Chloride including Paint and Coating Removal
Respirator Specifications
TableApx F-l shows the specifications for respirators required to achieve the APFs shown in
tables in Section 4.2 Human Health Risk. Assigned Protection Factors for Respirators in OSHA
Standard 29 CFR 1910.134 a. Only respirators that meet OSHA requirements for routine
exposures to methylene chloride are included in this table.
Table Apx F-l. Respirator Specifications by APF for Use in Paint and Coating Removal
Scenarios with Methylene Chloride Exposure
Assigned
Protect ion
I'siclor
(API )
Type of Respirator
10
No respirators with this APF meet OSHA requirements for routine exposures to
methylene chloride.
Any respirator listed in Table Apx F-l with APF greater than 10.
25
Any NIOSH-certified continuous flow supplied-air respirator equipped with a
loose fitting facepiece, hood, or helmet.
Any respirator listed in Table Apx F-l with APF greater than 25.
50
Any NIOSH-certified negative pressure (demand) supplied-air respirator
equipped with a full facepiece.
Any NIOSH-certified negative pressure (demand) self-contained breathing
apparatus (SCBA) equipped with a hood, helmet, or a full facepiece.
Any respirator listed in Table Apx F-l with APF greater than 50.
1,000
Any NIOSH-certified continuous flow supplied-air respirator equipped with a
full facepiece.
Page 593 of 725
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11307
11308
11309
11310
11311
11312
11313
11314
11315
11316
11317
11318
11319
11320
11321
11322
11323
11324
11325
11326
11327
11328
11329
11330
11331
11332
11333
11334
11335
11336
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Assigned
Protect ion
I'sictor
(API )
Type of Respirator
Any NIOSH-certified continuous flow supplied-air respirator equipped with a
hood or helmet with evidence demonstrating protection level of1,000 or greater.
[See important note below]*
Any NIOSH-certified pressure-demand or other positive pressure mode
supplied-air respirator equipped with a full facepiece.
Any respirator listed in Table Apx F-l with APF greater than 1,000.
10,000
Any NIOSH-certified pressure-demand or other positive-pressure mode (e.g.,
open/closed circuit) self-contained breathing apparatus (SCBA) equipped with
a hood or helmet or a full facepiece.
Adapted from "OFFICE OF POLLUTION PREVENTION AND TOXIC'S (OPPT'S)
DECISION LOGIC FOR SELECTION OF RESPIRATORS FOR PMN SUBSTANCES", May
2012.
OSHA has assigned APFs of 1000 for certain types of hoods and helmets with supplied air
respirators (SARs) where the manufacturer can demonstrate adequate air flows to maintain
positive pressure inside the hood or helmet in normal working conditions. However, the
employer must have evidence provided by the respirator manufacturer that the testing of these
respirators demonstrates performance at a level of protection of 1,000 or greater to receive an
APF of 1,000. This level of performance can best be demonstrated by performing a Workplace
Protection Factor or Simulated Workplace Protection Factor study or equivalent testing. Without
testing data that demonstrates a level of protection of 1,000 or greater, all SARs with
helmets/hoods are to be treated as loose-fitting facepiece respirators, and receive an APF of
25.
Dermal Protection
OSHA indicates that dermal protection for workers exposed to methylene chloride is important.
The information below provides information on glove protection when using pure methylene
chloride or formulations containing methylene chloride.
Summary of Suitable Gloves for Pure Methylene Chloride and in Formulations
Several studies specified below indicate that gloves should be tested to determine whether they
are protective against solvents when present in formulated products. According to these studies,
the two best types of glove materials to protect against dermal exposure to pure methylene
chloride are Silver Shield and Polyvinyl Alcohol (PVA), followed by Viton. Silver Shield gloves
provide the best protection against methylene chloride whether it is in pure form or as part of a
formulation. Detailed information on these and other glove types which were evaluated for their
permeation characteristics against methylene chloride are provided below. The cited studies'
results may be a good starting point for determining glove types to consider for glove testing.
Page 594 of 725
-------
11337
11338
11339
11340
11341
11342
11343
11344
11345
11346
11347
11348
11349
11350
11351
11352
11353
11354
11355
11356
11357
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Glove Information for Pure Methylene Chloride and for Methylene Chloride in Paint and
Coating Removal Formulations
There are many factors that determine proper chemical-resistant glove selection. In addition to
the specific chemical(s) used, the most important factors include duration, frequency, and
severity of chemical exposure. The degree of dexterity required for the task and associated
physical stress to the glove are also significant considerations. The manner in which employees
are able to doff the various glove types to best prevent skin contamination is also important but
sometimes overlooked.
Generally, dermal exposures to the solvents in paint and coating removal formulations may be
assumed to be frequent or lengthy and may result in significant exposure. These assumptions
affect the proper choice of glove type and also errs on the side of caution, which is advised for
any personal protective equipment (PPE) decision since PPE is the last line of defense against
exposure in an industrial hygienist's hierarchy of controls.
Table Apx F-2 summarizes commonly used industrial hygiene literature (e.g., glove selection
guides, manufacturer publications, etc.) and capture the highest rated glove types from each
reference. Consideration of all factors (breakthrough time, qualitative indicator (QI), and other
issues raised in the comments field) allow an overall determination of effectiveness.
Table_Apx F-2. Glove Types Evaluated for Pure Methylene Chloride
Reference
(•love type
Breakthrough
Time
Qualitative
Indicator
Com incuts
Polyvinyl Alcohol
(PVA)
>360 mins
Very well suited
Degradation rate: Good
Permeation rate:
Excellent
1
Viton/Butyl
29 mins
Suitable under
careful control of
use
Degradation rate:
Excellent
Permeation rate: Good
Ansell Barrier
(Laminate Film)
Glove
20 mins
Suitable under
careful control of
use
Degradation rate:
Excellent
Permeation rate: Very
Good
2
Viton
113 mins
Satisfactory
Change soon after
exposure. Product is
Best Viton 890
PVA
Not Provided
Recommended
Extended contact
Viton
Not Provided
Recommended
Extended contact
3
Nitrile
Not Provided
See Comment
Double-gloved 8-mil
Nitrile gloves are only
acceptable for
"incidental contact".
Change immediately
Page 595 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Uol'orciuT
(•love type
l$rc;i kill rough
lime
Qusililsilivc
Imliciilor
Com incuts
4
Silver Shield
>8 hrs
Good for total
immersion
Degradation Rate:
Excellent
Viton
1 hr
Good for
accidental splash
protection and
intermittent
contact
Degradation Rate: Fair
5
PVA
Not Provided
Best protection
*Detailed comments
provided in footnote
Viton
Not Provided
Recommended
Nitrile
< 4 mins (thin)
Poor
Latex
Seconds
Very Poor
6
Latex
Not Provided
NOT
recommended
This source only
evaluates latex and
nitrile gloves
Nitrile
Not Provided
NOT
recommended
7
Viton
"Generally
greater than 4
hrs"
Good
Silver Shield and PVA
are not evaluated by
this source
Nitrile
"Generally
greater than 1
hr"
Fair
8
Fluoroelastomer
(Viton)
64 mins
Use for high
chemical
exposure
Specific glove
evaluated is Fluonit 468
9
Silver Shield (North)
>6 hrs
Excellent
Degradation rate:
Excellent
PVA
>6 hrs
Good
Degradation rate: Good
10
Silver Shield (North)
Not Provided
Not Provided
Silver Shield and PVA
gloves are the only two
glove types
recommended by this
source
PVA
Not Provided
Not Provided
11358 * Detailed comments from Cornell University Hand Protection and Glove Selection Guide: "Double glove
11359 with heavier weight (8 mil) nitrile gloves (incidental contact). Methylene chloride will permeate through
11360 thin (3-4 mil) nitrile gloves in four minutes or less. If you are double gloved, as recommended, and you
11361 splash or spill methylene chloride on your gloves, stop what you are doing and change the outer glove
11362 immediately. If you allow methylene chloride to remain on the outer nitrile glove for more than two to
11363 four minutes you must discard both sets of gloves and re-double glove. Methylene chloride permeates
Page 596 of 725
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11364
11365
11366
11367
11368
11369
11370
11371
11372
11373
11374
11375
11376
11377
11378
11379
11380
11381
11382
11383
11384
11385
11386
11387
11388
11389
11390
11391
11392
11393
11394
11395
11396
11397
11398
11399
11400
11401
11402
11403
11404
11405
11406
11407
11408
11409
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
disposable latex exam gloves in a matter of seconds and latex gloves should never be used to handle this
material. For use of methylene chloride where contact with the glove is anticipated, such as stripping
paint or gluing plastics, only polyvinyl acetate (PVA) or Viton gloves are recommended. These
gloves come in .28-.33 mm thickness. PVA offers the best protection" (Cornell University).
Based on the information from Table Apx F-2, the two best types of glove materials to protect
against pure methylene chloride dermal exposure are Silver Shield and PVA (highlighted green
above), followed by Viton (highlighted yellow above). Silver Shield is a trade name and is
generally regarded as the most protective glove type for the majority of chemicals. They are
composed of laminate-layered polyethylene (PE)/ethylene vinyl alcohol (EVOH) materials.
However, Silver Shield gloves do not provide much dexterity and because of this are commonly
used in conjunction with a second tight-fitting glove of a different type over the top.
Alternatively, PVA gloves could be worn and would provide significant protection. These
conclusions are in agreement with OSHA's recommendation from a Hazard Alert published in
January of 2013 entitled "Methylene Chloride Hazards for Bathtub Refinishers," where
methylene chloride is used for paint/ coating removal (OSHA; NIOSH. 2.013). The Hazard Alert
states that "gloves made of PE)/ EVOH or other laminate materials that are resistant to
methylene chloride are recommended to meet the requirements of the standard" (OSHA Hazard
Alert).
Key Points and Examples for Paint and Coating Removal Formulations
The U.S. EPA's Safety, Health and Environmental Management Division's (SHEMD) Guideline
44 (Personal Protective Equipment) states that when working with mixtures and formulated
products, the chemical component with the shortest break-through time must be considered when
determining the appropriate glove type for protection against chemical hazards unless specific
test data are available (Enander et ai. 2004). Additionally, an industrial hygienist will consider
the formulation's chemical properties as a whole, the highest hazard component of the
formulation, and whether individual components produce synergistic degradation effects.
Typically, specific test data for formulations are not available and best judgment based on the
aforementioned considerations provides the basis for glove type selection. However, in this case
there are a few publications that specifically address glove types for use with methylene chloride
and N-Methylpyrrolidone (NMP) as part of paint and coating removal formulations.
In early 2002, an article entitled "A Comparative Analysis of Glove Permeation Resistance to
Paint Stripping Formulations" (Stull et ai. 2002) specifically examined which glove types
provide the best protection to users of commercial paint and coating removal products. Twenty
different glove types were evaluated for degradation and resistance to permeation under
continuous and/or intermittent contact with seven different paint and coating removal
formulations in a multiple-phase experiment. Paint and coating removal formulations included
some that were methylene chloride-based and others that were NMP-based. The study found that
gloves made of Plastic Laminate (e.g., Silver Shield) resisted permeation by the majority of paint
and coating removal while Butyl Rubber provided the next best level of permeation resistance
against the majority of formulations. However, Butyl Rubber gloves did show rapid permeation
for methylene chloride-based formulations and would not be recommended for methylene
chloride. It should be noted that PVA gloves, shown to be effective against pure methylene
chloride, were not evaluated. Interestingly, more glove types resisted permeation of NMP-based
formulations than conventional solvent-based products such as methylene chloride. The results
Page 597 of 725
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11410
11411
11412
11413
11414
11415
11416
11417
11418
11419
11420
11421
11422
11423
11424
11425
11426
11427
11428
11429
11430
11431
11432
11433
11434
11435
11436
11437
11438
11439
11440
11441
11442
11443
11444
11445
11446
11447
11448
11449
11450
11451
11452
11453
11454
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
showed that relatively small-molecule, volatile, chemical-based solvents cause somewhat more
degradation and considerably more permeation of glove types as compared with NMP-based
formulations against the same gloves. Key conclusions include the following: "However, paint
stripper formulations represent varying multichemical mixtures and, ultimately, commercial
paint strippers must be individually evaluated for permeation resistance against selected gloves"
(Stull et al. 2002.). and, "because of several potential synergistic effects well established in the
literature and in this study for mixture permeation, it is highly recommended that glove selection
decisions be based on testing of the commercial paint stripper against the specific glove in
question'YStuH et al.. 2002).
Another study from in 2007 entitled "Protective Glove Selection for Workers using NMP-
Containing Products: Graffiti Removal" essentially came to the same conclusion; of the gloves
studied Silver Shield gloves provide the best protection against NMP-based paint and coating
removal formulations (HSL. 2007). The study states that "Butyl gloves, used with caution would
be a second choice" (H.SL. 2007). The increased dexterity and robustness of Butyl gloves were
noted as an advantage of Butyl over Silver Shield. Key recommendations include that gloves
should be "tested against all relevant chemical formulations as a matter of routine in order to
inform glove selection" (HSL. 2007) and "assumptions of glove choice based on the use of
model compounds or similar formulations should be made with extreme caution (HSL. 2007)."
Additionally, Crook recommended that "The BS EN 374-3 continuous contact test and its
successors should remain the benchmark for chemically protective glove type decisions" (HSL.
2007).
In summary, these studies indicate that glove permeation continuous contact testing of each
formulation is necessary to provide proper protection. These studies' results may be a good
starting point for determining glove types to consider for permeation testing. The studies found
that among gloves tested Silver Shield provide the best protection against both methylene
chloride and NMP, whether they are in pure form or as part of a formulation. The best alternative
for protection against methylene chloride would be PVA gloves, while the best alternative for
NMP protection would be Butyl Rubber gloves. There are other glove type materials with varied
effectiveness that could potentially be appropriate for use with incidental contact. However,
these conclusions are based on lengthy, often, and significant exposure. A more task-specific
decision on appropriate glove type selection could be made through employee interviews and
observation of tasks using methylene chloride- or NMP-containing products.
References for Appendix F.l
All Safety Products: http://www.allsafetvproducts.com/asp~glove~selection~chart~chemical~
break-through-times.html, accessed 3/14/15.
Ansell Healthcare, LLC:
http://www.ansellpro.com/download/Ansell SthEditionChemi calResistanceGuide.pdf. accessed
3/14/15.
California Dept. of Public Health:
http://www.cdph.ca.gov/programs/ohb/Documents/PPEChart.pdf. accessed 3/14/15.
Page 598 of 725
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11455
11456
11457
11458
11459
11460
11461
11462
11463
11464
11465
11466
11467
11468
11469
11470
11471
11472
11473
11474
11475
11476
11477
11478
11479
11480
11481
11482
11483
11484
11485
11486
11487
11488
11489
11490
11491
11492
11493
11494
11495
11496
11497
11498
11499
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Cornell University Hand Protection and Glove Selection Guide:
http://collum.chem.cornell.edu/documents/Hand Protection and Glove Selection.pdf. accessed
3/14/15.
Cornell University Lab Safety Manual: http://sp.ehs.comell.edu/lab-research-safetv/laboratory-
safetv-manual/Pages/Appendix-F.aspx. accessed 3/14/15.
Crook V, Simpson A (2007). Protective Glove Selection for Workers using NMP-Containing
Products: Graffiti Removal. Buxton: Health and Safety Laboratory.
Microflex Corporation:
http://www.microflex.eom/Prodiicts/~/media/Files/Literatiire/Domestic%20Reference%20Mateii
als/DOM Reference Chemical%20Resistance.ashx. accessed 3/14/15.
MAPA Professional: http://www.mapa-pro.com/hand-protection-selection-
guide/protections/chemical-protection.html, accessed 3/14/15.
North by Honeywell: Chemical Resistance Guide:
http://www.honevwellsafetv.com/Prodiicts/Gloves/SilverShield -
SSG29.aspx?site=/usa.%20Document%202948 pdf. accessed 3/14/15.
Northwestern University:
http://www.northwestern.edu/uservices/docs/labs/SafetyTrainer gloveselection.pdf. accessed
3/14/15.
Occupational Health and Safety Administration (OSHA) Hazard Alert. Methylene Chloride
Hazards for Bathtub Refinishers. January 2013.
https ://www. osha. gov/dts/hazardalerts/m ethyl ene chloride hazard alert.pdf
Showa Best Glove: http://www.showabestglove.com/site/chemrest/default.aspx. accessed
3/14/15.
Stull JO, Thomas RW, James LE (2002). A Comparative Analysis of Glove Permeation
Resistance to Paint Stripping Formulations, AIHA Journal, 63:1, 62-71.
U.S. EPA Safety, Health and Environmental Management Division (SHEMD). Guideline 44,
Personal Protective Equipment. October 2004.
F.2 Summary of Information on Gloves from SDS for
Methylene Chloride and Formulations containing
Methylene Chloride
EPA reviewed SDSs for neat methylene chloride and products containing methylene chloride for
information on glove and respiratory protection. Specifically, EPA reviewed SDSs for each
occupational scenario assessed in Section 2.4.1.2. EPA compiled the recommended glove
Page 599 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
11500 materials and respiratory protection for each scenario from the reviewed SDSs (total of 18 SDSs
11501 were reviewed) in Table Apx F-2. For neat methylene chloride and methylene chloride-
11502 containing products, the SDSs recommend a variety of glove materials, including fluorinated
11503 rubbers (7 SDSs), PVA(6 SDSs), nitrile rubber (5 SDSs), neoprene (4 SDSs), polyvinyl chloride
11504 (3 SDSs), and various laminates. Note that many of the reviewed SDSs included multiple glove
11505 material recommendations.
Page 600 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Table Apx F-3. Recommended
Glove Materials Methylene Chloride and Methylene Chloride-Containing Products from SDSs
Applicable OES
Methylene
Chloride
wt.%
Recommended Glove Material
Source
Commercial Aerosol Products
(Aerosol Degreasing, Aerosol
Lubricants, Automotive Care
Products), Cold Cleaning
30-40%
EVAL, neoprene, nitrile/Buna-N, PVC,
or Viton
https://www.berrvmanproducts.com/assets/2AA-E-
0901-0905-0955-SDS-l.pdf
Manufacturing
99.9%
PVA, ethyl vinyl alcohol laminate,
Viton, butyl rubber
http://208.112.58.204/pridesol/documents/sds/Met
hvlene%20Chloride%20Tech%20-%20Dow%20-
%202015-03-04.pdf
Batch Open-Top Vapor
Degreasing; Conveyorized Vapor
Degreasing; Manufacturing
99.5%
Chemical-resistant gloves
http://208.112.58.204/pridesol/documents/sds/Met
hvlene%20Chloride%20VDG%20-%20Dow%20-
%202015 -04-01 .pdf
Paints and Coatings; Flexible
Polyurethane Foam Manufacturing;
Commercial Aerosol Products
(Aerosol Degreasing, Aerosol
Lubricants, Automotive Care
Products)
99.97-100%
Chemical-resistant gloves
http://www.silverfernchemical.eom/media/42759/S
FC-Methvlene-Chloride-SDS-siened.pdf
Manufacturing; Laboratory Use
90-100%
Fluorinated rubber
https://www.nwmissouri.edu/naturalsciences/sds/d/
Dichloromethane .pdf
Adhesives and Sealants; Processing
- Incorporation into Formulation,
Mixture, or Reaction Product
60-85%
Fluoroelastomer polymer laminate
https://multimedia.3m.com/mws/mediawebserver?
mwsId=SSSSSuUn zu8100xM82SNY Bnv70kl7z
Hvu91xtD7SSSSSS—
Adhesives and Sealants
80-90%
Chemical-resistant gloves
http: //www .camie. com/sites/default/file s/msds/cam
ie-sds313B.pdf
Commercial Aerosol Products
(Aerosol Degreasing, Aerosol
Lubricants, Automotive Care
Products)
25-35%
Suitable gloves
https://www.dodeepackaeine.net/msds/B-
00002.PDF
Spot Cleaning
35-45%
Butyl rubber, chlorinated polyethylene,
polyethylene, ethyl vinyl alcohol
laminate, PVA, natural rubber, neoprene,
nitrile/butadiene rubber, PVC, Viton
https://www.msdsdieital.com/sites/default/files/ms
ds record database/1005 .pdf
Page 601 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Applicable OES
Methylene
Chloride
wt.%
Recommended Glove Material
Source
Fabric Finishing; Spot Cleaning
70 - < 90%
PVA
https://www.davisint.com/Imaees/document/TS-
VLR-Ene-US-SDS-GHS.pdf
Spot Cleaning
40-50%
Impervious gloves
http://www.allopar.com/wp-
content/uploads/2015/05/spot-lifter-2.pdf
Paints and Coatings; Non-Aerosol
Industrial and Commercial Uses
60-100%
Laminate film, nitrile rubber, neoprene,
and PVC
https: //eoofoffproducts. com/wp -
content/uploads/2017/08/SpravableStripperMSDS.
pdf
Laboratory Use
>25 - <49%
Chemical-resistant gloves
https: //www .aailent .com/cs/librarv/msds/5190-
0487 NAEnslish.pdf
Paints and Coatings; Non-Aerosol
Industrial and Commercial Uses
44-78%
Rubber or nitrile
https://www.antiseize.com/PDFs/ml7052.pdf
Lithographic Printing Plate
Cleaning
30-60%
PVA, Viton rubber (fluoro rubber)
http: //www .lehmaninc .com/customer/leinco/pdf 11 /
MSDS/Allied/msds-al-10034.pdf
Paints and Coatings; Flexible
Polyurethane Foam Manufacturing;
Commercial Aerosol Products
(Aerosol Degreasing, Aerosol
Lubricants, Automotive Care
Products); Laboratory Use; Plastic
Product Manufacturing; CTA Film
Production
100%
Ansell laminate film (Barrier), or
supported PVA
https: //www .chemsupplv. com. au/documents/MAO
121CH2L.pdf
Adhesive and Caulk Removers
60-100%
Laminate film, nitrile rubber, neoprene,
and PVC
http: //www .kleanstrip.com/uploads/documents/GK
AS94326 SDS-4015.34.pdf
Processing as a Reactant
0-0.5%
PVA, Viton
http: //www .certifiedacpro. com/datasheets/msds/34
5 MSDS.pdf
11507
Page 602 of 725
-------
11508
11509
11510
11511
11512
11513
11514
11515
11516
11517
11518
11519
11520
11521
Appendix G
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
CONSUMER EXPOSURES
See the following supplemental documents:
• Risk Evaluation for Methylene Chloride, Supplemental Information on Consumer Exposure
Assessment ("EPA. 20.19g)
This document provides additional details and information on the exposure
assessment and analyses including modeling inputs and outputs.
• Risk Evaluation for Methylene Chloride, Supplemental Information on Consumer
Exposure Assessment Model Input Parameters (EPA. 20191)
• Risk Evaluation for Methylene Chloride, Supplemental Information on Consumer
Exposure Assessment Model Outputs (EPA. 2019D
Page 603 of 725
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11522 Appendix H ENVIRONMENTAL HAZARDS
11523
11524 H.l Aquatic Toxicity Data Extraction Table for Methylene
11525 Chloride
1 1526
TableApx H-l. Aquatic Toxicity Data Extraction Table for Methylene Chloride
Tesl Species
Ircsli /
Siili
\\ .Her
Dunilio
it
IikI-
poinl
(inii/l.)
('oiiceiili'iilioii(s)
(lll!i/l.)
Tesl
An;il\sis
I.ITi'Cdsl
References
Diilii Qu;ili(>
l-'.\ iiliiiilion
Fish
Rainbow trout
(Oncorhynchu
s mykiss)
Fresh
23-day
LC50 -
13.51
0, 0.008, 0.042,
0.41,5.55,23.1,
36.5
Flow-
through,
Measured
Mortality
(Black et
al. 1982)
High
Rainbow trout
(iOncorhynchu
s mykiss)
Fresh
27-day
LC50 =
13.16
0, 0.008, 0.042,
0.41,5.55,23.1,
36.5
Flow-
through,
Measured
Mortality
(Black et
al. 1982)
High
Rainbow trout
(iOncorhynchu
s mykiss)
Fresh
27-day
NOEC =
0.41
LOEC =
5.55
0, 0.008, 0.042,
0.41,5.55,23.1,
36.5
Flow-
through,
Measured
Teratic larvae
(Black et
al. 1982)
High
Bluegill
(Lepomis
macrochirus)
Fresh
24-hr
LC50 =
230
Not reported
Static,
Nominal
Mortality
(Buccafusc
0 et al.
1981)
Unacceptable
Bluegill
(Lepomis
macrochirus)
Fresh
96-hr
LC50 =
220
Not reported
Static,
Nominal
Mortality
(Buccafusc
0 et al.
1.98.1.)
Unacceptable
Fathead
minnow
(Pimephales
promelas)
Fresh
96-hr
LC90 =
722.1
Not reported
Flow-
through,
Measured
Mortality
(Alexander
et al. .1.978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
96-hr
LC50 =
193
Not reported
Flow-
through,
Measured
Mortality
(Alexander
et al... .1.978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
96-hr
LC10 =
51.2
Not reported
Flow-
through,
Measured
Mortality
(Alexander
et al. .1.978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
72-hr
LC90 =
802
Not reported
Flow-
through,
Measured
Mortality
(Alexander
et al. .1.978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
72-hr
LC50 =
232.4
Not reported
Flow-
through,
Measured
Mortality
(Alexander
et al. .1.978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
72-hr
LC10 =
67.3
Not reported
Flow-
through,
Measured
Mortality
(Alexander
et al. .1.978)
Medium
Page 604 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx H-l. Aquatic Toxicity Data Extraction Table for Methylene Chloride
Tesl Species
Ircsli /
Siili
\\ .Her
Dunilio
it
IikI-
poinl
(inii/l.)
('oiiceiili'iilioii(s)
(lll!i/l.)
lesl
An;il\sis
I.ITi'Cdsl
References
Diilii Qu;ili(>
l-'.\ iiliiiilion
lalhcad
minnow
{Pimephales
promelas)
liesli
4S-ln
I.(
746.3
\nl ivpoi'lcd
I'low-
through,
Measured
Moilalils
(Alexander
et aL 1978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
48-hr
LC50 =
265
Not reported
Flow-
through,
Measured
Mortality
(Alexander
et aL 1978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
48-hr
LC10 = 94
mg AI/L
Not reported
Flow-
through,
Measured
Mortality
(Alexander
et aL. 1978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
24-hr
LC90=
589
Not reported
Flow-
through,
Measured
Mortality
(Alexander
et aL. 1978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
24-hr
LC50 =
268
Not reported
Flow-
through,
Measured
Mortality
(Alexander
et aL. 1978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
24-hr
LC10 =
122
Not reported
Flow-
through,
Measured
Mortality
(Alexander
et aL. 1978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
96-hr
LC50 =
310
Not reported
Static,
Nominal
Mortality
(Alexander
et aL. 1978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
24-hr
ec90 =
220.1
Not reported
Flow-
through,
Measured
Immobilizati
on
(Alexander
et aL. 1978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
24-hr
ec50 =
112.8
Not reported
Flow-
through,
Measured
Immobilizati
on
(Alexander
et aL. 1978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
24-hr
EC10 =
68.5 L
Not reported
Flow-
through,
Measured
Immobilizati
on
(Alexander
et aL. 1978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
48-hr
ec90 =
147.6
Not reported
Flow-
through,
Measured
Immobilizati
on
(Alexander
et aL. 1978)
Medium
Fathead
minnow
{Pimephales
promelas)
Fresh
48-hr
EC50 = 99
Not reported
Flow-
through,
Measured
Immobilizati
on
(Alexander
et aL. 1978)
Medium
Page 605 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx H-l. Aquatic Toxicity Data Extraction Table for Methylene Chloride
Ircsli /
IikI-
Siili
Dunilio
poinl
('oiiceiili'iilioii(s)
lesl
Diilii Qu;ili(>
Tesl Species
\\ .Her
it
(inii/l.)
An;il\sis
I.ITi'Cdsl
References
l-'.\ iiliiiilion
l a I head
liesli
4S-ln
i:c
\nl icpoi'lcd
I'low-
Imiikihili/aii
(Alexander
Medium
minnow
66.3
through,
on
et aL 1978)
{Pimephales
promelas)
Measured
Fathead
Fresh
72-hr
ec90 =
Not reported
Flow-
Immobilizati
(Alexander
Medium
minnow
147.6
through,
on
et aL 1978)
{Pimephales
promelas)
Measured
Fathead
Fresh
72-hr
W
O
o
II
VO
VO
Not reported
Flow-
Immobilizati
(Alexander
Medium
minnow
through,
on
et aL. 1978)
{Pimephales
promelas)
Measured
Fathead
Fresh
72-hr
m
p
o
II
Not reported
Flow-
Immobilizati
(Alexander
Medium
minnow
66.3
through,
on
et aL. 1978)
{Pimephales
promelas)
Measured
Fathead
Fresh
96-hr
ec90 =
Not reported
Flow-
Immobilizati
(Alexander
Medium
minnow
147.6
through,
on
et aL. 1978)
{Pimephales
promelas)
Measured
Fathead
Fresh
96-hr
ECso = 99
Not reported
Flow-
Immobilizati
(Alexander
Medium
minnow
through,
on
et aL. 1978)
{Pimephales
promelas)
Measured
Fathead
Fresh
96-hr
m
p
o
II
Not reported
Flow-
Immobilizati
(Alexander
Medium
minnow
66.3
through,
on
et aL. 1978)
{Pimephales
promelas)
Measured
Fathead
Fresh
5-day
LCso >34
0,0.003,0.11,
Flow-
Mortality
(Black et
High
minnow
0.80,6.77,21.3,
through,
at. 1.982)
{Pimephales
promelas)
34.3
Nominal
Fathead
Fresh
9-day
r
p
o
II
0,0.003,0.11,
Flow-
Mortality
(Black et
High
minnow
-34
0.80,6.77,21.3,
through,
at. 1.982)
{Pimephales
promelas)
34.3
Nominal
Fathead
Fresh
24-hr
EC50 =
0,21,42, 63,84,
In vitro,
Inhibition of
(Dierickx,
Unacceptable
minnow
49,400
105
Nominal
total protein
.1.993)
{Pimephales
promelas)
content
Fathead
Fresh
96-hr
LCso =
79, 135, 207, 357,
Flow-
Mortality
(Dill et al..
High
minnow
502
527, 855
through,
.1.987)
{Pimephales
promelas)
Measured
Fathead
Fresh
192-hr
LC50 =
79, 135, 207, 357,
Flow-
Mortality
(Dill et aL.
High
minnow
{Pimephales
promelas)
471
527, 855
through,
Measured
1.987)
Page 606 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx H-l. Aquatic Toxicity Data Extraction Table for Methylene Chloride
Ircsli /
IikI-
Siili
Dunilio
poinl
('oiiceiili'iilioii(s)
lesl
Diilii Qu;ili(>
Tesl Species
\\ .Her
it
(inii/l.)
(ni!i/l.)
An;il\sis
I.ITi'Cdsl
References
l-'.\ iiliiiilion
lallicad
liesli
^:-da\
\l \T(
"»> SS s"" 14""
I'low-
( MOW ill
(Dill et aL
1 huh
minnow
{Pimephales
promelas)
108
NOEC =
82.5
LOEC =
142
209, 321
through,
Measured
body weight
1987)
Fathead
minnow
{Pimephales
promelas)
Fresh
32-day
NOEC =
142
LOEC =
209
29, 55, 82, 142,
209, 321
Flow-
through,
Measured
Mortality
(Dill et aL.
1987)
High
Rainbow trout
Fresh
96-hr
r
p
o
II
29,39, 78, 111,
Flow-
Mortality
CEI Diroont
High
(Oncorhynchu
s mykiss) cited
108
146, 240
through,
Measured
Denemours
& Co Inc,
as Salmo
1987b)
gairdneri
Fathead
Fresh
96-hr
r
p
o
II
6.42, 78.4, 169,
Flow-
Mortality
CGeieer et
High
minnow
{Pimephales
promelas)
330
212, 288, 485
through,
Measured
aL 1986)
Fathead
Fresh
96-hr
m
p
o
II
6.42, 78.4, 169,
Flow-
Hypo-and
CGeieer et
High
minnow
{Pimephales
promelas)
330
212, 288, 485
through,
Measured
hyperactivity
aL 1986)
Sheepshead
minnow
Salt
24-hr
LC50 =
370
Not reported
Static,
Nominal
Mortality
(Heitmuller
et aL. 1981)
Unacceptable
{Cyprinodon
variegatus)
Sheepshead
minnow
Salt
48-hr
LC50 =
360
Not reported
Static,
Nominal
Mortality
CHeitmuller
et aL. 1981)
Unacceptable
{Cyprinodon
variegatus)
Sheepshead
minnow
Salt
72hr
LC50 =
360
Not reported
Static,
Nominal
Mortality
CHeitmuller
et aL. 1981)
Unacceptable
{Cyprinodon
variegatus)
Sheepshead
minnow
Salt
96-hr
LC50 =
330
Not reported
Static,
Nominal
Mortality
(Heitmuller
et aL. 1981)
Unacceptable
{Cyprinodon
variegatus)
Sheepshead
minnow
Salt
96-hr
NOEC =
130
Not reported
Static,
Nominal
Mortality
(Heitmuller
et aL. 1981)
Unacceptable
{Cyprinodon
variegatus)
Aquatic Invertebrates
Water flea
Fresh
48-hr
m
p
0
II
Not reported
Static,
Immobilizati
(Abernethy
Medium
{Daphnia
135.8077
Nominal
on
et aL. 1986)
magna)
071
Page 607 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx H-l. Aquatic Toxicity Data Extraction Table for Methylene Chloride
Ircsli /
IikI-
Siili
Dunilio
poim
(oiicciilr;ilioii(s)
lesl
Diilii Qu;ilil>
Tesl Species
\\ ;i lor
it
(inii/l.)
(lll!i/l.)
An;il\sis
i.nwiisi
References
l-'.\ iiliiiilion
Wilier lien
I'resli
24-hr
i:c
\nl reported
Sialic.
Imiikihili/ali
i
1 .OH
(Daphnia
1,447
Nominal
on
a.L 1989)
magna)
Water flea
Fresh
24-hr
EC50 =
Not reported
Static,
Immobilizati
(K11J111 et
Low
(Daphnia
1,959
Nominal
on
a.L 1989)
magna)
Water flea
Fresh
24-hr
ECioo =
Not reported
Static,
Immobilizati
(Kiihn et
Low
(Daphnia
2,500
Nominal
on
at. .1.989)
magna)
Water flea
Fresh
48-hr
EC0 =
Not reported
Static,
Immobilizati
(Kiihn et
Low
(Daphnia
1,005
Nominal
on
at. .1.989)
magna)
Water flea
Fresh
48-hr
ec50 =
Not reported
Static,
Immobilizati
(Kiihn et
Low
(Daphnia
1,682
Nominal
on
at. .1.989)
magna)
Water flea
Fresh
48-hr
ECioo =
Not reported
Static,
Immobilizati
(Kiihn et
Low
(Daphnia
2,500
Nominal
on
at. .1.989)
magna)
Water flea
Fresh
24-hr
r
p
o
II
Not reported
Static,
Mortality
(Leblanc,
High
(Daphnia
310
Nominal
.1.980)
magna)
Water flea
Fresh
48-hr
LC50 =
Not reported
Static,
Mortality
(Leblanc,
High
(Daphnia
220
Nominal
.1.980)
magna)
Water flea
Fresh
48-hr
NOEC =
Not reported
Static,
Mortality
(Leblanc.
High
(.Daphnia
68
Nominal
.1.980)
magna)
Water flea
Fresh
12-15-
BCF = <
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
(.Daphnia
day
1
0.7559028
Measured
whole body
et at. .1.994)
magna)
Water flea
Fresh
48-hr
ec50=
23, 34, 60, 106,
Static,
Immobilizati
(EI Direont
High
(.Daphnia
177
180, 253
Measured
on
Denemours
magna)
& Co Inc.
1987a)
Bladder snail
Fresh
12-15-
BCF = 5
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
(Physa
day
(Expt. 1)
0.7559028
Measured
whole body
et at. .1.994)
fontinalis)
Bladder snail
Fresh
12-15-
BCF = 7
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
(Physa
day
(Expt. 2)
0.7559028
Measured
whole body
et at. .1.994)
fontinalis)
Bladder snail
Fresh
12-15-
BCF = 8
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
(.Physa
day
(Expt. 3)
0.7559028
Measured
whole body
et at. .1.994)
fontinalis)
Bladder snail
Fresh
12-15-
BCF = <
0.11890606-
Static,
Residue, egg
(Thiebaud
Unacceptable
(Physa
day
1
0.7559028
Measured
et at. .1.994)
fontinalis)
(Expt. 1)
Bladder snail
Fresh
12-15-
BCF = <1
0.11890606-
Static,
Residue, egg
(Thiebaud
Unacceptable
(Physa
day
(Expt. 2)
0.7559028
Measured
et at. .1.994)
fontinalis)
Page 608 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx H-l. Aquatic Toxicity Data Extraction Table for Methylene Chloride
Tesl Species
Ircsli /
Siili
\\ .Her
Dunilio
it
IikI-
poim
(inii/l.)
('oiiceiili'iilioii(s)
Tesl
An;il\sis
r.l'fccl(s)
References
Diilii Qu;ili(>
l-'.\ iiliiiilion
1 !nno shrimp
(Arte mi a
salina)
Sail
24-hr
I.(
122.3033
76
\nl icpoi'lcd
Sialic.
Nominal
Moilalils.
24-hr age
class
(
Fortun et
a.L 1997)
I iiao-vpiahlc
Brine shrimp
(Arte mi a
salina)
Salt
24-hr
LC50 =
96.82350
6
Not reported
Static,
Nominal
Mortality,
48-hr age
class
(Sanchez-
Fortun et
a.L 1997)
Unacceptable
Brine shrimp
(Arte mi a
salina)
Salt
24-hr
LC50 =
87.48088
7
Not reported
Static,
Nominal
Mortality,
72-hr age
class
Fortun et
at. .1.997)
Unacceptable
Daggerblade
grass shrimp
(Palaemonetes
pugio)
Salt
4-day
LC50 =
1170
(Expt. 1)
Not reported
Static,
Nominal
Mortality
(Ravburn
and Fisher.
1999)
Unacceptable
Daggerblade
grass shrimp
(Palaemonetes
pugio)
Salt
4-day
LC50 =
758
(Expt. 2)
Not reported
Static, Not
reported
Mortality
(Ravburn
and Fisher.
.1.999)
Unacceptable
Daggerblade
grass shrimp
(Palaemonetes
pugio)
Salt
4-day
LC50 =
891
(Expt. 3)
Not reported
Static,
Nominal
Mortality
(Ravburn
and Fisher.
.1.999)
Unacceptable
Daggerblade
grass shrimp
(Palaemonetes
pugio)
Salt
12-day
LC50 =
319
(Expt. 1)
Not reported
Static,
Nominal
Mortality
(Ravburn
and Fisher.
.1.999)
Unacceptable
Daggerblade
grass shrimp
(Palaemonetes
pugio)
Salt
12-day
LC50 =
452
(Expt. 2)
Not reported
Static,
Nominal
Mortality
(Ravburn
and Fisher.
1999)
Unacceptable
Daggerblade
grass shrimp
(Palaemonetes
pugio)
Salt
12-day
LC50 =
479
(Expt. 3)
Not reported
Static,
Nominal
Mortality
(Ravburn
and Fisher.
1999)
Unacceptable
Daggerblade
grass shrimp
(Palaemonetes
pugio)
Salt
7-day
NOAEL =
930
(Expt. 1)
0, 130, 400, 670,
930
Static,
Nominal
Growth:
Length
(Ravburn
and Fisher,
.1.999)
Unacceptable
Daggerblade
grass shrimp
(Palaemonetes
pugio)
Salt
7-day
NOAEL=
930
(Expt. 2)
0, 130, 400, 670,
930
Static,
Nominal
Growth:
Length
(Ravburn
and Fisher,
.1.999)
Unacceptable
Daggerblade
grass shrimp
(Palaemonetes
pugio)
Salt
4-day
LC100 =
0.5%v/v
(if 100%
purity =
6,700)
0,0.01,0.05,0.1,
0.5, 1% v/v (if
100% purity = 0,
130, 670, 1,300,
6,700, 13,000)
Static,
Nominal,
Embryonic
stage 3
Mortality
(Wilson.
.1.998)
High
Page 609 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx H-l. Aquatic Toxicity Data Extraction Table for Methylene Chloride
Tesl Species
Ircsli /
Siili
\\ .Her
Dunilio
it
IikI-
poim
(inii/l.)
('oiiceiili'iilioii(s)
(lll!i/l.)
Tesl
An;il\sis
r.l'fccl(s)
References
Diilii Qu;ili(\
l-'.\ iiliiiilion
Dauuci'hladc
grass shrimp
{Palaemonetes
pugio)
Sail
4-da>
I.(
1% v/v (if
100%
purity =
13,000)
0. 0 01. 0 o5. u 1.
0.5, 1% v/v (if
100% purity = 0,
130, 670, 1,300,
6,700, 13,000)
Sialic.
Nominal,
Embryonic
stage 4
Miiiialils
(Wilson.
1998)
1 huh
Daggerblade
grass shrimp
{Palaemonetes
pugio)
Salt
4-day
LCioo =
0.5% v/v
(if 100%
purity =
6,700)
0,0.01,0.05,0.1,
0.5, 1% v/v (if
100% purity = 0,
130, 670, 1,300,
6,700, 13,000)
Static,
Nominal,
Embryonic
stage 6
Mortality
(Wilson.
1998)
High
Daggerblade
grass shrimp
{Palaemonetes
pugio)
Salt
4-day
NOEC =
0.05% v/v
(if 100%
purity
=670
LOEC =
0.1% v/v
(if 100%
purity =
1,300)
0,0.01,0.05,0.1,
0.5, 1% v/v (if
100% purity = 0,
130, 670, 1,300,
6,700, 13,000)
Static,
Nominal
Development
al delay
(Wilson.
1.998)
High
Daggerblade
grass shrimp
{Palaemonetes
pugio)
Salt
4-day
NOEC =
670
LOEC =
1,300
0,0.01,0.05,0.1,
0.5, 1% v/v (if
100% purity = 0,
130, 670, 1,300,
6,700, 13,000)
Static,
Nominal
Mortality
(Wilson.
1998)
High
Algae
Green algae
{Chlamydomo
nas
reinhardtii)
Fresh
72-hr
ECio =
115
Not reported
Static,
Measured
Biomass
(Brack and
Rottler.
.1.994)
High
Green algae
{Chlamydomo
nas
reinhardtii)
Fresh
72-hr
ec50 =
242
Not reported
Static,
Measured
Biomass
(Brack and
Rottler.
1.994)
High
Green algae
{Chlorella
vulgaris)
Fresh
10-day
NOAEL =
2
0, 0.002, 0.02,
0.2,2
Static,
Nominal
Growth
(chlorophyll
A
concentration
)
aL 2003)
Medium
Green algae
{Pseudokirchn
eriella
subcapitata)
Fresh
10-day
NOAEL=
2
0, 0.002, 0.02,
0.2,2
Static,
Nominal
Growth
(chlorophyll
A
concentration
)
(Ando et
al. 2003)
Medium
Green algae
{Volvulina
steinii)
Fresh
10-day
LOAEL =
0.002
0, 0.002, 0.02,
0.2,
Static,
Nominal
Growth
(chlorophyll
A
concentration
)
(Ando et
al. 2003)
Medium
Page 610 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx H-l. Aquatic Toxicity Data Extraction Table for Methylene Chloride
Ircsli /
IikI-
Siili
Dunilio
poinl
('oiicenlriilioii(s)
Tesl
Diilii Qu;ili(>
Tesl Species
\\ .Her
it
(inii/l.)
(lll!i/l.)
An;il\sis
r.l'fccl(s)
References
l-'.\ iiliiiilion
(liven aluac
liesli
4S-ln
i:c
\nl ivpoi'lcd
Sialic.
Cell dcilsllS
(Tsai and
1 huh
(Pseudokirchn
33.09
Nominal
Chen.
eriella
2007s)
subcapitata)
Green algae
(Chlorella
Fresh
96-hr
EC50 =
0.98
0, 221, 299, 403,
550, 735, 992
Static,
Nominal
Growth
rWu et al..
2014)
Unacceptable
vulgaris)
Green algae
0Chlorella
vulgaris)
Fresh
96-hr
LOAEL =
221
0, 221,299, 403,
550, 735, 992
Static,
Nominal
Catalase
activity
fWii et at
20.1.4)
Unacceptable
Green algae
0Chlorella
Fresh
96-hr
LOAEL=
221
0, 221, 299, 403,
550, 735, 992
Static,
Nominal
Malondialde
hyde content
fWii et at
20.1.4)
Unacceptable
vulgaris)
Green algae
(iChlorella
Fresh
96-hr
NOAEL =
221
0, 221, 299, 403,
550, 735,992
Static,
Nominal
Superoxide
dismutase
fWii et al.
20.1.4)
Unacceptable
vulgaris)
LOAEL=
299
(SOD)
enzyme
activity
Green algae
(iChlorella
Fresh
96-hr
NOAEL=
221
0, 221, 299, 403,
550, 735, 992
Static,
Nominal
Cell density
fWu et at
20.1.4)
Unacceptable
vulgaris)
LOAEL=
299
Green algae
(iChlorella
Fresh
96-hr
NOAEL=
299
0, 221, 299, 403,
550, 735,992
Static,
Nominal
Total protein
content
fWu et at
20.1.4)
Unacceptable
vulgaris)
LOAEL=
403
Green algae
(iChlorella
Fresh
96-hr
LOAEL=
221
0, 221, 299, 403,
550, 735,992
Static,
Nominal
Chlorophyll
A
fWu et at
20.1.4)
Unacceptable
vulgaris)
concentration
Green algae
(iChlorella
vulgaris)
Fresh
6-hr
LOAEL=
0.98
0, 0.98
Static,
Nominal
Transcription
of
photosystem
I reaction
center protein
subunit B
gene
fWu et at
20.1.4)
Unacceptable
Green algae
(iChlorella
Fresh
12-hr
LOAEL=
0.98
0, 0.98
Static,
Nominal
Transcription
of
fWu et at
20.1.4)
Unacceptable
vulgaris)
photosystem
I reaction
center protein
subunit B
gene
Green algae
(Chlorella
vulgaris)
Fresh
48-hr
LOAEL=
0.98
0, 0.98
Static,
Nominal
Transcription
of
photosystem
I reaction
center protein
subunit B
gene
fWu et at
20.1.4)
Unacceptable
Page 611 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx H-l. Aquatic Toxicity Data Extraction Table for Methylene Chloride
Tesl Species
Ircsli /
Siili
\\ alcr
Dunilio
it
IikI-
poim
(inii/l.)
('onccnlralion(s)
(lll»/l.)
Tesl
Analysis
r.l'fccl(s)
References
Diilii Qn;ili(>
l-'.\ iiliiiilion
(iiven ;ilu;ie
(Chlorella
vulgaris)
llVsh
(4-hr
i.o \i:i.
0.98
II. II <)X
Sialic.
Nominal
1 laiisci'ipiKin
of
photosystem
I reaction
center protein
subunit B
gene
(Wu et al,
2014)
I nacccpiahlc
Green algae
0Chlorella
vulgaris)
Fresh
64-hr
LOAEL =
0.98
0, 0.98
Static,
Nominal
Transcription
of gene for
photosystem
II membrane
protein
component
fWii et at
2014)
Unacceptable
Green algae
0Chlorella
vulgaris)
Fresh
48-hr
LOAEL=
0.98
0, 0.98
Static,
Nominal
Transcription
of gene for
photosystem
II membrane
protein
component
fWii et at
20.1.4)
Unacceptable
Green algae
(iChlorella
vulgaris)
Fresh
24-hr
LOAEL=
0.98
0, 0.98
Static,
Nominal
Transcription
of gene for
photosystem
II membrane
protein
component
fWu et at
20.1.4)
Unacceptable
Green algae
(iChlorella
vulgaris)
Fresh
12-hr
LOAEL=
0.98
0, 0.98
Static,
Nominal
Transcription
of gene for
photosystem
II membrane
protein
component
fWu et at
20.1.4)
Unacceptable
Green algae
(iChlorella
vulgaris)
Fresh
6-hr
LOAEL=
0.98
0, 0.98
Static,
Nominal
Transcription
of gene for
photosystem
II membrane
protein
component
(Wu et al.
20.1.4)
Unacceptable
Aquatic Plants
Duckweed
(Lemna
minor)
Fresh
12-15-
day
BCF = 39
(Expt. 1)
0.11890606-
0.7559028
Static,
Measured
Residue,
colonies
(Thiebaud
et al. .1.994)
Unacceptable
Duckweed
{Lemna
minor)
Fresh
12-15-
day
BCF = 4
(Expt. 2)
0.11890606-
0.7559028
Static,
Measured
Residue,
colonies
(Thiebaud
et al. .1.994)
Unacceptable
Duckweed
{Lemna
minor)
Fresh
12-15-
day
BCF = 54
(Expt. 1)
0.11890606-
0.7559028
Static,
Measured
Residue,
young fronds
(Thiebaud
et al. .1.994)
Unacceptable
Duckweed
{Lemna
minor)
Fresh
12-15-
day
BCF = <1
(Expt. 2)
0.11890606-
0.7559028
Static,
Measured
Residue,
young fronds
(Thiebaud
et al. .1.994)
Unacceptable
Page 612 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx H-l. Aquatic Toxicity Data Extraction Table for Methylene Chloride
livsli /
IikI-
Siili
Dursilio
poini
("onceii I r;i 1 ioiK s)
Tcsl
Dsilsi Qusili(>
Tcsl Species
\> siler
11
UiiU/l ¦)
(m»/l.)
\nsil\sis
I.ITccl(s)
Kcfereiices
l .> si In si 1 ion
Duckweed
Fresh
12-15-
BCF = 15
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
(Lemna
day
(Expt. 3)
0.7559028
Measured
young fronds
et al.. 19941
minor)
Duckweed
Fresh
12-15-
BCF = 13
0.11890606-
Static,
Residue, old
(Thiebaud
Unacceptable
{Lemna
day
(Expt. 1)
0.7559028
Measured
fronds
et al. 19941
minor)
Duckweed
Fresh
12-15-
BCF = 4
0.11890606-
Static,
Residue, old
(Thiebaud
Unacceptable
{Lemna
day
(Expt. 2)
0.7559028
Measured
fronds
et al. 19941
minor)
Duckweed
Fresh
12-15-
BCF = 7
0.11890606-
Static,
Residue, old
(Thiebaud
Unacceptable
{Lemna
day
(Expt. 3)
0.7559028
Measured
fronds
et al. 19941
minor)
Duckweed
Fresh
12-15-
BCF =
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
{Lemna
day
112
0.7559028
Measured
roots
et al. 19941
minor)
(Expt. 1)
Duckweed
Fresh
12-15-
BCF = <1
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
{Lemna
day
(Expt. 2)
0.7559028
Measured
roots
et al. 19941
minor)
Duckweed
Fresh
12-15-
BCF = 28
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
{Lemna
day
(Expt. 3)
0.7559028
Measured
roots
et al. 19941
minor)
Pondweed
Fresh
12-15-
BCF = 74
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
{Groenlandia
day
(Expt. 1)
0.7559028
Measured
leaves
et al. 19941
densa)
Pondweed
Fresh
12-15-
BCF = 9
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
{Groenlandia
day
(Expt. 2)
0.7559028
Measured
leaves
et al. 19941
densa)
Pondweed
Fresh
12-15-
BCF = 5
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
{Groenlandia
day
(Expt. 3)
0.7559028
Measured
leaves
et al. 19941
densa)
Pondweed
Fresh
12-15-
BCF = 34
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
{Groenlandia
day
(Expt. 1)
0.7559028
Measured
stems
et al. 19941
densa)
Pondweed
Fresh
12-15-
BCF = 5
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
{Groenlandia
day
(Expt. 2)
0.7559028
Measured
stems
et al. 19941
densa)
Pondweed
Fresh
12-15-
BCF = 10
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
{Groenlandia
day
(Expt. 3)
0.7559028
Measured
stems
et al. 19941
densa)
Pondweed
Fresh
12-15-
BCF = 10
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
{Groenlandia
day
(Expt. 1)
0.7559028
Measured
roots
et al.. 19941
densa)
Pondweed
Fresh
12-15-
BCF = 1
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
{Groenlandia
day
(Expt. 2)
0.7559028
Measured
roots
et al.. 19941
densa)
Pondweed
Fresh
12-15-
BCF = 15
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
{Groenlandia
day
(Expt. 3)
0.7559028
Measured
roots
et al.. 19941
densa)
Page 613 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx H-l. Aquatic Toxicity Data Extraction Table for Methylene Chloride
livsli /
IikI-
Siili
Dursilio
poini
('oiKTiilrsilioii(s)
Tcsl
Dsilsi Qusili(>
Tcsl Species
\> siler
11
UiiU/l ¦)
(m»/l.)
\nsil\sis
I.ITccl(s)
Kcfereiices
l .> si In si 1 ion
Walerweed
Fresh
12-15-
BCF = 5
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
(Elodea
day
0.7559028
Measured
leaves
et al.. 19941
canadensis)
Waterweed
Fresh
12-15-
BCF = 3
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
{Elodea
day
0.7559028
Measured
stems
et al. 19941
canadensis)
Moss
Fresh
12-15-
BCF =
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
(Fontinalis
day
577
0.7559028
Measured
whole plant
et al. 19941
antipyretica)
(Expt. 1)
Moss
Fresh
12-15-
BCF = 9
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
(.Fontinalis
day
(Expt. 2)
0.7559028
Measured
whole plant
et al. 19941
antipyretica)
Moss
Fresh
12-15-
BCF = 41
0.11890606-
Static,
Residue,
(Thiebaud
Unacceptable
(Fontinalis
day
(Expt. 3)
0.7559028
Measured
whole plant
et al. 19941
antipyretica)
Amphibians
Bullfrog
(Rana
catesbeiana)
Fresh
4-day
LC50 -
30.61
0,0.017,0.071,
0.66,6.73,46.8
Flow-
through,
Measured
Teratogenesi
s and
Mortality
(Birge et
al. 19801
High
Bullfrog
(Rana
catesbeiana)
Fresh
8-day
LC50 =
17.78
0,0.017,0.071,
0.66,6.73,46.8
Flow-
through,
Measured
Teratogenesi
s and
Mortality
(Birge et
al. 19801
High
Fowler's toad
(Anaxyrus
woodhousei
Fresh
3-day
LC50 >32
0,0.022,0.13,
1.42, 10.1, 32.1
Flow-
through,
Measured
Teratogenesi
s and
Mortality
(Birge et
at. 1.9801
High
ssp.) cited as
Bufo fowleri
Fowler's toad
Fresh
7-day
LC50 >32
0,0.022,0.13,
Flow-
Teratogenesi
(Birge et
High
(Anaxyrus
woodhousei
1.42, 10.1, 32.1
through,
Measured
s and
Mortality
at. 1.9801
ssp.) cited as
Bufo fowleri
Pickerel frog
(Lithobates
palustris)
cited as Rana
Fresh
4-day
LC50 >32
0,0.022,0.13,
1.42, 10.1, 32.1
Flow-
through,
Measured
Teratogenesi
s and
Mortality
(Birge et
al. .1.9801
High
palustris
Pickerel frog
(Lithobates
palustris)
cited as Rana
Fresh
8-day
LC50 >32
0,0.022,0.13,
1.42, 10.1, 32.1
Flow-
through,
Measured
Mortality
(Birge et
al. .1.9801
High
palustris
Bullfrog
(Rana
catesbeiana)
Fresh
8-day
LC10 =
0.981
0,0.017,0.071,
0.66,6.73,46.8
Flow-
through,
Measured
Mortality
(Birge et
al. .1.9801
High
Bullfrog
(Rana
catesbeiana)
Fresh
8-day
LC01 =
0.0925
0,0.017,0.071,
0.66,6.73,46.8
Flow-
through,
Measured
Mortality
(Birge et
al. .1.9801
High
Page 614 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx H-l. Aquatic Toxicity Data Extraction Table for Methylene Chloride
Ircsli /
IikI-
Siili
Dunilio
poinl
('oiiceiili'iilioii(s)
Tesl
Diilii Qu;ili(>
Tesl Species
\\ .Her
it
(inii/l.)
An;il\sis
r.l'fccl(s)
References
l-'.\ iiliiiilion
1 >uliri\29
0,0.003,0.18,
Flow-
Mortality
(Black et
High
clawed frog
(Xenopus
laevis)
0.65,7.61, 18.6,
29.3
through,
Measured
at. 1.982)
African
Fresh
6-day
LC50 >29
0,0.003,0.18,
Flow-
Mortality
(Black et
High
clawed frog
(Xenopus
laevis)
0.65,7.61, 18.6,
29.3 mg/L
through,
Nominal
at. 1.982)
Leopard frog
(Lithobates
pipiens)
Fresh
5-day
LC50 >48
0,0.010,0.077,
1.17, 28.7, 47.8
mg/L
Flow-
through,
Nominal
Mortality
(Black: et
at. .1.982)
High
Leopard frog
(Lithobates
pipiens)
Fresh
9-day
LC50 >48
0,0.010,0.077,
1.17, 28.7, 47.8
mg/L
Flow-
through,
Nominal
Mortality
(Black: et
at. .1.982)
High
European
Fresh
48-hr
NOAEL =
0,0.001,0.1
Static,
Mortality
(Martinis et
Unacceptable
Common Frog
0.1 mL/L
mL/L
Nominal,
at. 2006)
(Rana
temporaria)
Eggs
without
jelly coat
Page 615 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx H-l. Aquatic Toxicity Data Extraction Table for Methylene Chloride
Tesl Species
Ircsli /
Siili
\\ .Her
Dunilio
it
IikI-
poinl
(inii/l.)
('oiiceiili'iilioii(s)
(lll!i/l.)
Tesl
An;il\sis
r.l'fccl(s)
References
Diilii Qu;ili(>
l-'.\ iiliiiilion
1 limpcan
Common Frog
(Rana
temporaria)
liesli
4S-ln
i.o \i:i.
0.1 mL/L
u. 0 I ml. 1.
Sialic.
Nominal,
Eggs with
jelly coat
Moilalils
(Marquis et
al. 2006)
I iiao-vpiahlc
European
Common Frog
(Rana
temporaria)
Fresh
48-hr
NOAEL =
0.1 mL/L
0, 0.1 mL/L
Static,
Nominal,
Tadpoles
Mortality
(Martinis et
al. 2006)
Unacceptable
Fungi
Fungus
(Aspergillus
versicolor)
Vapor
exposu
re
32-hr
lt50 =
11.5 hours
0, 2,400 mg AI/L
air
Static, Not
reported
Mortality
Mufer
Unacceptable
Fungus
(Aspergillus
cejpii,
formerly
Dichotomomy
ces ceipii))
Vapor
exposu
re
32-hr
lt50 =
~30 hours
0, 2,400 mg AI/L
air
Static, Not
reported
Mortality
(l[Z|995r
Unacceptable
Fungus
(Coniothrium
sp.)
Vapor
exposu
re
32-hr
LT50 = ~5
hours
0, 2,400 mg AI/L
air
Static, Not
reported
Mortality
(Steiman et
al. 1995)
Unacceptable
Fungus
(Acremonium
tubakii)
Vapor
exposu
re
32-hr
LT50 = ~4
hours
0, 2,400 mg AI/L
air
Static, Not
reported
Mortality
(Steiman et
al. 1995)
Unacceptable
Fungus
(Phoma
putaminum)
Vapor
exposu
re
32-hr
LTso = 2.8
hours
0, 2,400 mg AI/L
air
Static, Not
reported
Mortality
ki^ir
Unacceptable
Fungus
(Unidentified
Basidiomycete
s)
Vapor
exposu
re
32-hr
LT50 = 1.9
hours
0, 2,400 mg AI/L
air
Static, Not
reported
Mortality
(Steiman et
al.. 1.995)
Unacceptable
Fungus
(Unidentified
Basidiomycete
s)
Vapor
exposu
re
32-hr
LT50 = 1.4
hours
0, 2,400 mg AI/L
air
Static, Not
reported
Mortality
(Steiman et
al.. 1.995)
Unacceptable
Insects
Yellow fever
mosquito
(Aedes
aegypti)
Fresh
4-hr
LCso -
6,920
Not reported
Static,
Nominal
Mortality
(Kramer et
al. .1.983)
Unacceptable
Terrestrial Invertebrates
Beer
nematode
(Panagrellus
redivivus)
Cultur
e
mediu
m
96-hr
LOAEL =
0.00085
0, 0.00085,
0.0085, 0.085,
0.85,8.5, 85
Static,
Nominal
Growth:
slowed,
retarded,
delayed, or
non-
development
al delay
(Samoiloff
et al. 1.980)
Unacceptable
11527
Page 616 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
11528 H.2 Risk Quotients for All Facilities Modeled in E-FAST
11529
11530 Table Apx H-2. Risk Quotients for All Facilities Modeled in E-FAST
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
ppb)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
OES: Manufacturing
350
0.44
0.00
0.00
0.00
0.00
COVESTRO LLC
BAYTOWN, TQX FRS:
110000463098
Surface Water
Active Releaser: NPDES TX0002798
Surface
water
20
7.51
0.00
0.08
0.05
0.00
350
0.37
0.00
0.00
0.00
0.00
EMERALD
PERFORMANCE
Surface Water
Active Releaser: NPDES IL0001392
Still water
MATERIALS LLC HENRY,
ILNPDES: IL0001392
20
8.42
0.00
0.09
0.06
0.00
Page 617 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
FISHER SCIENTIFIC CO
LL C FAIR LAWN, NJ
NPDES:NJ0110281
POTW
Receiving Facility: PASSAIC VALLEY
SEWER COMM; NPDES NJ0021016
Still water
350
0.000637
0.00
0.00
0.00
0.00
FISHER SCIENTIFIC CO
LLC BRIDGEWATER, NJ
NPDES: NJ0119245
POTW
Receiving Facility: SOMERSET
RARITIAN VALLEY SEWERAGE;
NPDES NJ0024864
Surface
water
350
0.1
0.00
0.00
0.00
0.00
OLIN BLUE CUBE
FREEPORT TX
FREEPORT, TX TRI:
7754WBLCBP231NB
Non-POTW
WWT
Receiving Facility: DOW CHEMICAL-
FREEPORT, TX; NPDES TX0006483
Surface
water
350
0.033
0.00
0.00
0.00
0.00
REGIS TECHNOLOGIES
INC MORTON GROVE, IL
FRS:110000429661
POTW
Receiving Facility: MWRDGC
TERRENCE J O'BRIEN WTR
RECLAMATION PLANT; NPDES
IL0028088
Still water
350
0.00389
0.00
0.00
0.00
0.00
SIGMA-ALDRICH
MANUFACTURING LLC
SAINT LOUIS, MO FRS:
110000743125
POTW
Receiving Facility: BISSEL POINT
WWTP ST LOUIS MSD; NPDES
M00025178
Surface
water
350
0.0000528
0.00
0.00
0.00
0.00
Page 618 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
VANDERBILT
CHEMICALS LLC-
MURRAY DIV MURRAY,
KYNPDES: KY0003433
Non-POTW
WWT
Receiving Facility: VALICOR
ENVIRONMENTAL SERVICES;
Organic Chemicals Manufacturing
Surface
water
350
0.1
0.00
0.00
0.00
0.00
EI DUPONT DE
NEMOURS - CHAMBERS
WORKS DEEPWATER, NJ
NPDES: NJ0005100
Surface Water
Active Releaser: NPDES NJ0005100
Surface
water
350
0.0297
0.00
0.00
0.00
0.00
20
0.56
0.00
0.01
0.00
0.00
BAYER
MATERIALSCIENCE
BAYTOWN BAYTOWN,
TX NPDES: TX0002798
Surface Water
Active Releaser: NPDES TX0002798
Surface
water
350
3.31
0.00
0.04
0.02
0.00
20
55.19
0.02
0.61
0.37
0.03
Page 619 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
INSTITUTE PLANT
INSTITUTE, WVNPDES:
WV0000086
Surface Water
Active Releaser: NPDES WV0000086
Surface
water
350
0.00299
0.00
0.00
0.00
0.00
20
0.0479
0.00
0.00
0.00
0.00
MPM SILICONES LLC
FRIENDLY, WVNPDES:
WV0000094
Surface Water
Active Releaser: NPDES WV0000094
Surface
water
350
0.000594
0.00
0.00
0.00
0.00
20
0.00974
0.00
0.00
0.00
0.00
BASF CORPORATION
WEST MEMPHIS, AR
NPDES: AR0037770
Surface Water
Active Releaser: NPDES AR0037770
Surface
water
350
0.000012
0.00
0.00
0.00
0.00
20
0.000235
0.00
0.00
0.00
0.00
Page 620 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Release Media1*
Modeled Facilitv or Industry Sector in
EFAST
Waterbody
Type'1
Davs of
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
Active Releaser Facility"
EFASTC
release1
(using
fish COC
of 151)
350
0.00479
0.00
0.00
0.00
0.00
ARKEMA INC PIFFARD,
Surface Water
Active Releaser: NPDES NY0068225
Surface
NY NPDES: NY0068225
water
20
0.0622
0.00
0.00
0.00
0.00
350
0.00113
0.00
0.00
0.00
0.00
EAGLE US 2 LLC - LAKE
CHARLES COMPLEX
Surface Water
Active Releaser: NPDES LA0000761
Surface
LAKE CHARLES, LA
water
NPDES: LA0000761
20
0.0136
0.00
0.00
0.00
0.00
BAYER
MATERIALSCIENCE NEW
MARTINSVILLE, WV
Surface Water
Active Releaser: NPDES WV0005169
Surface
water
350
0.000119
0.00
0.00
0.00
0.00
NPDES: WV0005169
Page 621 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Release Media1*
Modeled Facilitv or Industry Sector in
EFAST
Waterbody
Type'1
Davs of
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
Active Releaser Facility"
EFASTC
release1
(using
fish COC
of 151)
20
0.00143
0.00
0.00
0.00
0.00
350
0.0000281
0.00
0.00
0.00
0.00
ICL-IP AMERICA INC
Surface
GALLIPOLIS FERRY, WV
Surface Water
Active Releaser: NPDES WV0002496
water
NPDES: WV0002496
20
0.000457
0.00
0.00
0.00
0.00
350
5
0.00
0.06
0.03
0.00
KEESHAN AND BOST
CHEMICAL CO., INC.
Surface Water
Active Releaser: NPDES TX0072168
Still water
MANVEL, TX NPDES:
TX0072168
20
83
0.03
0.92
0.55
0.05
Page 622 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
PPb)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
INDORAMA VENTURES
OLEFINS, LLC SULPHUR,
LANPDES: LA0069850
Surface Water
Active Releaser (Surrogate): NPDES
LA0000761
Surface
water
350
0.0000339
0.00
0.00
0.00
0.00
20
0.000531
0.00
0.00
0.00
0.00
CHEMTURA NORTH AND
SOUTH PLANTS
MORGANTOWN, WV
NPDES: WV0004740
Surface Water
Active Releaser: NPDES WV0004740
Surface
water
350
0.000029
0.00
0.00
0.00
0.00
20
0.000595
0.00
0.00
0.00
0.00
OES: Import and Repackaging
CHEMISPHERE CORP
SAINT LOUIS, MO FRS:
110000852943
POTW
Receiving Facility: BISSEL POINT
WWTP ST LOUIS MSD; NPDES
M00025178
Surface
water
250
0.0000528
0.00
0.00
0.00
0.00
250
32.14
0.01
0.36
0.21
0.02
Page 623 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of .1.51)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
HUBBARD-HALL INC
WATERBURY, CT FRS:
110000317194
Non-POTW
WWT
Receiving Facility: RECYCLE INC.;
POTW (Ind.)
Surface
water
WEBB CHEMICAL
SERVICE CORP
MUSKEGON HEIGHTS, MI
NPDES: MI0049719
POTW
Receiving Facility: MUSKEGON CO
WWMS METRO WWTP; NPDES
MI0027391
Surface
water
250
0.0998
0.00
0.00
0.00
0.00
250
0.0387
0.00
0.00
0.00
0.00
RESEARCH SOLUTIONS
GROUP INC PELHAM, AL
NPDES: AL0074276
Surface Water
Active Releaser (Surrogate): POTW
Surface
(Ind.)
water
20
0.55
0.00
0.01
0.00
0.00
EMD MILLIPORE CORP
CINCINNATI, OH NPDES:
OH0047759
Surface Water
Active Releaser (Surrogate): POTW
(Ind.)
Surface
water
250
0.0129
0.00
0.00
0.00
0.00
20
0.18
0.00
0.00
0.00
0.00
Page 624 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Release Media1*
Modeled Facilitv or Industry Sector in
EFAST
Waterbody
Type'1
Davs of
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
Active Releaser Facility"
EFASTC
release1
(using
fish COC
of 151)
OES: Processing as a Reactant
AMVAC CHEMICAL CO
AXIS, AL FRS:
Non-POTW
WWT
Receiving Facility: DUPONT
AGRICULTURAL PRODUCTS;
Surface
water
350
0.014
0.00
0.00
0.00
0.00
110015634866
NPDES AL0001597
350
0.16
0.00
0.00
0.00
0.00
THE DOW CHEMICAL CO
Surface
MIDLAND, MI NPDES:
Surface Water
Active Releaser: NPDES MI0000868
water
MI0000868
20
1.9
0.00
0.02
0.01
0.00
350
0.24
0.00
0.00
0.00
0.00
FMC CORPORATION
Surface
MIDDLEPORT, NY
Surface Water
Active Releaser: NPDES NY0000345
water
NPDES: NY0000345
20
4.52
0.00
0.05
0.03
0.00
Page 625 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
OES: Processing - Formulation
ARKEMA INC CALVERT
CITY, KY NPDES:
KY0003603
Surface Water
Active Releaser: NPDES KY0003603
Surface
water
300
0.00434
0.00
0.00
0.00
0.00
20
0.065
0.00
0.00
0.00
0.00
MCGEAN -ROHCO INC
LIVONIA, MI FRS:
110000405801
POTW
Receiving Facility: DETROIT WWTP-
CHLORINATION/DECHLORINATION
FACILITY; NPDES MI0022802
Surface
water
300
0.00216
0.00
0.00
0.00
0.00
WM BARR & CO INC
MEMPHIS, TN FRS:
110000374265
POTW
Receiving Facility: MEMPHIS CITY
MAXSON WASTEWATER
TREATMENT; NPDES TN0020729
Surface
water
300
3.43E-06
0.00
0.00
0.00
0.00
BUCKMAN
LABORATORIES INC
MEMPHIS, TN NPDES:
TN0040606
POTW
Receiving Facility: MC STILES
TREATMENT PLANT; NPDES
TN0020711
Surface
water
300
0.00138
0.00
0.00
0.00
0.00
POTW
300
1527.1
0.58
16.97
10.11
0.85
Page 626 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
EUROFINS MWG
OPERON LLC
LOUISVILLE, KY TRI:
4029WRFNSM1271P
Receiving Facility: VEOLIA
ENVIRONMENTAL SERVICES TECH
SOLUTIONS LLC; Inorganic Chemicals
Manuf.
Surface
water
SOLVAY - HOUSTON
PLANT HOUSTON, TX
NPDES: TX0007072
Surface Water
Active Releaser: NPDES TX0007072
Surface
water
300
7.41
0.00
0.08
0.05
0.00
20
107.41
0.04
1.19
0.71
0.06
HONEYWELL
INTERNATIONAL INC -
GEISMAR COMPLEX
GEISMAR, LA NPDES:
LA0006181
Surface Water
Active Releaser: NPDES LA0006181
Surface
water
300
0.0000405
0.00
0.00
0.00
0.00
20
0.00089
0.00
0.00
0.00
0.00
STEP AN CO MILLSDALE
ROAD EL WOOD, IL
NPDES: IL0002453
Surface Water
Active Releaser: NPDES IL0002453
Surface
water
300
1.24
0.00
0.01
0.01
0.00
Page 627 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Release Media1*
Modeled Facilitv or Industry Sector in
EFAST
Waterbody
Type'1
Davs of
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
Active Releaser Facility"
EFASTC
release1
(using
fish COC
of 151)
20
0.0503
0.00
0.00
0.00
0.00
300
0.000627
0.00
0.00
0.00
0.00
ELEMENTIS
SPECIALTIES, INC.
Surface Water
Active Releaser: NPDES WV0051560
Surface
CHARLESTON, WV
water
NPDES: WV0051560
20
0.0069
0.00
0.00
0.00
0.00
OES: Polyurethane Foam
250
1.25
0.00
0.01
0.01
0.00
PREGIS INNOVATIVE
PACKAGING INC
Surface Water
Active Releaser (Surrogate): Plastic
Surface
WURTLAND, KY NPDES:
Resins and Synthetic Fiber Manuf.
water
KY0094005
20
13.72
0.01
0.15
0.09
0.01
Page 628 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
OES: Plastics Manufacturing
250
3.74
0.00
0.04
0.02
0.00
SABIC INNOVATIVE
PLASTICS US LLC
Surface Water
Active Releaser (Surrogate): Plastic
Surface
BURKVILLE, AL NPDES:
ALR16ECGK
Resins and Synthetic Fiber Manuf.
water
20
51.12
0.02
0.57
0.34
0.03
250
0.00446
0.00
0.00
0.00
0.00
SABIC INNOVATIVE
PLASTICS MT. VERNON,
Surface Water
Active Releaser: NPDES IN0002101
Surface
LLC MOUNT VERNON, IN
NPDES: IN0002101
water
20
0.0624
0.00
0.00
0.00
0.00
SABIC INNOVATIVE
PLASTICS US LLC
SELKIRK, NY NPDES:
NY0007072
Surface Water
Active Releaser: NPDES NY0007072
Surface
water
250
0.00437
0.00
0.00
0.00
0.00
20
0.0641
0.00
0.00
0.00
0.00
Page 629 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Release Media1*
Modeled Facilitv or Industry Sector in
EFAST
Waterbody
Type'1
Davs of
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
Active Releaser Facility"
EFASTC
release1
(using
fish COC
of 151)
250
3.74
0.00
0.04
0.02
0.00
EQUISTAR CHEMICALS
LP LA PORTE, TX NPDES:
TXO119792
Surface Water
Active Releaser (Surrogate): Plastic
Surface
Resins and Synthetic Fiber Manuf.
water
20
53.62
0.02
0.60
0.36
0.03
250
0.00301
0.00
0.00
0.00
0.00
CHEMOURS COMPANY
Surface
FC LLC WASHINGTON,
Surface Water
Active Releaser: NPDES WV0001279
water
WV NPDES: WV0001279
20
0.0371
0.00
0.00
0.00
0.00
SHINTECH ADDIS
Surface
water
PLANT A ADDIS, LA
Surface Water
Active Releaser: NPDES LA0055794
250
0.0000405
0.00
0.00
0.00
0.00
NPDES: LA0111023
Page 630 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Release Media1*
Modeled Facilitv or Industry Sector in
EFAST
Waterbody
Type'1
Davs of
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
Active Releaser Facility"
EFASTC
release1
(using
fish COC
of 151)
20
0.000526
0.00
0.00
0.00
0.00
250
0.000347
0.00
0.00
0.00
0.00
STYROLUTION AMERICA
Surface
LLC CHANNAHON, IL
Surface Water
Active Releaser: NPDES IL0001619
water
NPDES: IL0001619
20
0.00347
0.00
0.00
0.00
0.00
250
0.00495
0.00
0.00
0.00
0.00
DOW CHEMICAL CO
DALTON PLANT
Surface Water
Active Releaser: NPDES GA0000426
Surface
DALTON, GA NPDES:
water
GA0000426
20
0.0989
0.00
0.00
0.00
0.00
Page 631 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
PREGIS INNOVATIVE
PACKAGING INC
WURTLAND, KY NPDES:
KY0094005
Surface Water
Active Releaser (Surrogate): Plastic
Resins and Synthetic Fiber Manuf.
Surface
water
250
0.0125
0.00
0.00
0.00
0.00
20
0.15
0.00
0.00
0.00
0.00
OES: Pharmaceutical
ABB VIE-NORTH CH
ICAGO FACILITY NORTH
CHICAGO, IL NPDES:
ILR006192
POTW
Receiving Facility: NORTH SHORE
WATER RECLAMATION DIST;
NPDES IL0035092
Surface
water
300
0.1
0.00
0.00
0.00
0.00
EUTICALS INC
SPRINGFIELD, MO
NPDES: M00001970
POTW
Receiving Facility: SPRINGFIELD SW
WWTP; NPDES M00049522
Surface
water
300
0.00874
0.00
0.00
0.00
0.00
MALLINCKRODT LLC
SAINT LOUIS, MO FRS:
110000494796
POTW
Receiving Facility: BISSEL POINT
WWTP ST LOUIS MSD; NPDES
M00025178
Surface
water
300
0.000106
0.00
0.00
0.00
0.00
POTW
300
0.000639
0.00
0.00
0.00
0.00
Page 632 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
NORAMCO INC
WILMINGTON, DE FRS:
110000338741
Receiving Facility: WILMINGTON
WASTEWATER TREATMENT
PLANT- 12TH ST & HAY RD,
WILMINGTON; NPDES DE0020320
Surface
water
AMRI RENSSELAER INC
RENSSELAER, NY
NPDES: NY0241148
POTW
Receiving Facility: RENSSELAER
COUNTY SD#1 WWTP; NPDES
NY0087971
Surface
water
300
0.0691
0.00
0.00
0.00
0.00
E R SQUIBB & SONS LLC
NORTH BRUNSWICK, NJ
NPDES: NJ0123722
POTW
Receiving Facility: MIDDLESEX
COUNTY UTILITIES AUTHORITY;
NPDES NJ0020141
Still water
300
0.11
0.00
0.00
0.00
0.00
EVONIK CORP
TIPPECANOE
LABORATORIES
LAFAYETTE, IN NPDES:
IN0002861
Surface Water
Active Releaser: NPDES IN0002861
Surface
water
300
0.00865
0.00
0.00
0.00
0.00
20
0.0951
0.00
0.00
0.00
0.00
PACIRA
PHARMACEUTICALS INC
SAN DIEGO, CA NPDES:
unknown
POTW
Receiving Facility: SD CITY PT LOMA
WASTEWATER TREATMENT;
NPDES CAO107409
Still water
300
0.1
0.00
0.00
0.00
0.00
Page 633 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
PCI SYNTHESIS
NEWBURYPORT, MA
NPDES: MAR05B262
POTW
Receiving Facility: NEWBURYPORT
WASTEWATER TREATMENT
FACILITY; NPDES MAO 101427
Surface
water
300
0.000339
0.00
0.00
0.00
0.00
PFIZER
PHARMACEUTICALS LLC
BARCELONETA, PR FRS:
110008472063
POTW
Receiving Facility: PRASA
BARCELONETA STP; NPDES
PR0021237
Still water
300
0.00365
0.00
0.00
0.00
0.00
PHARMACIA & UPJOHN
CO LLC A SUBSIDIARY
OF PFIZER INC
PORTAGE, MI NPDES:
unknown
Surface Water
Active Releaser: NPDES MI0002941
Surface
water
300
0.1
0.00
0.00
0.00
0.00
20
1.6
0.00
0.02
0.01
0.00
POTW
Receiving Facility: KALAMAZOO
WWTP; NPDES MI0023299
Surface
water
300
5.8
0.00
0.06
0.04
0.00
Page 634 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
SI GROUP INC
ORANGEBURG, SC
NPDES: SCR002882
Surface Water
Active Releaser: NPDES SC0001180
Surface
water
300
0.89
0.00
0.01
0.01
0.00
20
18.66
0.01
0.21
0.12
0.01
TEVA
PHARMACEUTICALS
USA MEXICO, MO
NPDES: MOR23A013
POTW
Receiving Facility: MEXICO WWTP;
NPDES M00036242
Surface
water
300
1.7
0.00
0.02
0.01
0.00
EVONIK DEGUSSA CORP
TIPPECANOE
LABORATORIES
LAFAYETTE, IN NPDES:
IN0002861
Surface Water
Active Releaser: NPDES IN0002861
Surface
water
300
0.00865
0.00
0.00
0.00
0.00
20
0.11
0.00
0.00
0.00
0.00
OES: CTA Film Manufacturing
Surface Water
Active Releaser: NPDES NY0001643
250
0.0949
0.00
0.00
0.00
0.00
Page 635 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
PPb)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
KODAK PARK DIVISION
ROCHESTER, NY NPDES:
NY0001643
Surface
water
20
1.33
0.00
0.01
0.01
0.00
OES: Lithographic Printer
FORMER REXON
FACILITY AKA ENJEMS
MILL WORKS WAYNE
TWP,NJ NPDES:
NJG218316
Surface Water
Active Releaser (Surrogate): Printing
Surface
water
250
0.0000583
0.00
0.00
0.00
0.00
20
0.000671
0.00
0.00
0.00
0.00
OES: Spot Cleaner
BOISE STATE
UNIVERSITY BOISE, ID
NPDES: IDG911006
Surface Water
Active Releaser (Surrogate): NPDES
ID0020443
Surface
water
250
0.00502
0.00
0.00
0.00
0.00
20
0.0753
0.00
0.00
0.00
0.00
Page 636 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
PPb)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
OES: Recycling and Disposal
JOHNSON MATTHEY
WEST DEPTFORD, NJ
NPDES:NJ0115843
Non-POTW
WWT
Receiving Facility: Clean Harbors of
Baltimore, Inc; POTW (Ind.)
Surface
water
250
137.42
0.05
1.53
0.91
0.08
CLEAN HARBORS DEER
PARK LLC LA PORTE, TX
NPDES: TX0005941
Non-POTW
WWT
Receiving Facility: Clean Harbors of
Baltimore, Inc; POTW (Ind.)
Surface
water
250
115.81
0.04
1.29
0.77
0.06
CLEAN HARBORS EL
DORADO LLC EL
DORADO, AR NPDES:
AR0037800
Non-POTW
WWT
Receiving Facility: Clean Harbors of
Baltimore, Inc; POTW (Ind.)
Surface
water
250
24.94
0.01
0.28
0.17
0.01
TRADEBE TREATMENT &
RECYCLING LLC EAST
CHICAGO, IN FRS:
110000397874
Non-POTW
WWT
Receiving Facility: ADVANCED
WASTE SERVICES OF INDIANA LLC
and BEAVER OIL TREATMENT AND
RECYCLING; POTW (Ind.)
Surface
water
250
4.43
0.00
0.05
0.03
0.00
VEOLIA ES TECHNICAL
SOLUTIONS LLC WEST
CARROLLTON, OH FRS:
110000394920
POTW
Receiving Facility: WESTERN
REGIONAL WRF; NPDES OH0026638
Surface
water
250
0.00809
0.00
0.00
0.00
0.00
Page 637 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbodv
Days of
release1
7Q10
swe
Acute
Risk
Quotients
(using
Chronic
Risk
Quotients
(using
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
Type'1
(ppb)g
COC of
2,630
ppb)
amphibian
COC of
90)
invertebrate
COC of
1,800)
VEOLIA ES TECHNICAL
SOLUTIONS LLC AZUSA,
CAFRS: 110000477261
POTW
Receiving Facility: SAN JOSE CREEK
WATER RECLAMATION PLANT;
NPDES CA0053911
Surface
water
250
0.00402
0.00
0.00
0.00
0.00
Receiving Facility: MIDDLESEX
COUNTY UTILITIES AUTHORITY;
NPDES: NJ0020141
Still body
250
0.00482
0.00
0.00
0.00
0.00
VEOLIA ES TECHNICAL
SOLUTIONS LLC
Non-POTW
Receiving Facility: Clean Harbors;
POTW (Ind.)
Surface
water
250
17000
6.46
188.89
112.58
9.44
MIDDLESEX, NJ NPDES:
NJO127477
WWT
Receiving Facility: ROSS
INCINERATION SERVICES INC;
POTW (Ind.)
Surface
water
250
8146
3.10
90.51
53.95
4.53
Receiving Facility: SAFETY-KLEEN
SYSTEMS INC; POTW (Ind.)
Surface
water
250
443
0.17
4.92
2.93
0.25
Page 638 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of .1.51)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
250
1.29
0.00
0.01
0.01
0.00
CHEMICAL WASTE
MANAGEMENT EMELLE,
AL NPDES: AL0050580
Surface Water
Active Releaser (Surrogate): POTW
Surface
(Ind.)
water
20
23.2
0.01
0.26
0.15
0.01
250
6.52
0.00
0.07
0.04
0.00
OILTANKING HOUSTON
INC HOUSTON, TX
NPDES: TX0091855
Surface Water
Active Releaser (Surrogate): NPDES
Surface
TX0065943
water
20
89.13
0.03
0.99
0.59
0.05
HOWARD CO ALFA
RIDGE LANDFILL
MARRIOTTSVILLE, MD
NPDES: MD0067865
Surface Water
Active Releaser (Surrogate): POTW
(Ind.)
Surface
water
250
0.0258
0.00
0.00
0.00
0.00
20
0.39
0.00
0.00
0.00
0.00
Page 639 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Release Media1*
Modeled Facilitv or Industry Sector in
EFAST
Waterbody
Type'1
Davs of
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
Active Releaser Facility"
EFASTC
release1
(using
fish COC
of .1.51)
250
0.0129
0.00
0.00
0.00
0.00
CLIFFORD G HIGGINS
DISPOSAL SERVICE INC
Surface Water
Active Releaser (Surrogate): POTW
Surface
SLF KINGSTON, NJ
(Ind.)
water
NPDES: NJG160946
20
0.15
0.00
0.00
0.00
0.00
250
27.94
0.01
0.31
0.19
0.02
CLEAN WATER OF NEW
YORK INC STATEN
Surface Water
Active Releaser (Surrogate): NPDES
Still body
ISLAND, NY NPDES:
NJ0000019
NY0200484
20
352.94
0.13
3.92
2.34
0.20
FORMER
CARBORUNDUM
COMPLEX SANBORN, NY
Surface Water
Active Releaser (Surrogate): POTW
(Ind.)
Surface
water
250
0.13
0.00
0.00
0.00
0.00
NPDES: NY0001988
Page 640 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
20
1.55
0.00
0.02
0.01
0.00
OES: Other
APPLIED BIOSYSTEMS
LLC PLEASANTON, CA
FRS:110020517010
Non-POTW
WWT
Receiving Facility: Evoqua Water
Technologies; POTW (Ind.)
Surface
water
250
11.08
0.00
0.12
0.07
0.01
EMD MILLIPORE CORP
JAFFREY, NH NPDES:
NHR05C584
POTW
Receiving Facility: JAFFREY
WASTEWATER TREATMENT
FACILITY; NPDES NH0100595
Surface
water
250
0.19
0.00
0.00
0.00
0.00
GBC METALS LLC
SOMERS THIN STRIP
WATERBURY, CT NPDES:
CT0021873
Surface Water
Active Releaser: NPDES CT0021873
Surface
water
250
0.00689
0.00
0.00
0.00
0.00
20
0.062
0.00
0.00
0.00
0.00
Page 641 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
HYSTER-YALE GROUP,
INC SULLIGENT, AL
NPDES: AL0069787
Surface Water
Active Releaser: Motor Vehicle Manuf.
Surface
water
250
0.0002
0.00
0.00
0.00
0.00
20
0.0024
0.00
0.00
0.00
0.00
AVNET INC (FORMER
IMPERIAL SCHRADE)
ELLENVILLE, NY NPDES:
NY0008087
Surface Water
Active Releaser: Electronic Components
Manuf.
Surface
water
250
0.0426
0.00
0.00
0.00
0.00
20
0.43
0.00
0.00
0.00
0.00
BARGE CLEANING AND
REPAIR CHANNEL VIEW,
TX NPDES: TX0092282
Surface Water
Active Releaser: Metal Finishing
Surface
water
250
0.11
0.00
0.00
0.00
0.00
20
1.14
0.00
0.01
0.01
0.00
Page 642 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
250
0.0189
0.00
0.00
0.00
0.00
AC & S INC NITRO, WV
Surface Water
Active Releaser: Metal Finishing
Surface
NPDES: WV0075621
water
20
0.38
0.00
0.00
0.00
0.00
250
0.00379
0.00
0.00
0.00
0.00
MOOG INC - MOOGIN-
SPACE PROPULSION ISP
Surface Water
Active Releaser: Metal Finishing
Surface
NIAGARA FALLS, NY
NPDES: NY0203700
water
20
0.0758
0.00
0.00
0.00
0.00
OILTANKING JOLIET
CHANNAHON, IL NPDES:
IL0079103
Surface Water
Active Releaser (Surrogate): NPDES
IL0001619
Surface
water
250
0.00104
0.00
0.00
0.00
0.00
Page 643 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Release Media1*
Modeled Facilitv or Industry Sector in
EFAST
Waterbody
Type'1
Davs of
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
Active Releaser Facility"
EFASTC
release1
(using
fish COC
of 151)
20
0.0111
0.00
0.00
0.00
0.00
250
0.000726
0.00
0.00
0.00
0.00
NIPPON DYNAWAVE
PACKAGING COMPANY
Surface Water
Active Releaser: NPDES WA0000124
Surface
LONG VIEW, WANPDES:
water
WA0000124
20
0.00879
0.00
0.00
0.00
0.00
250
3.48E-07
0.00
0.00
0.00
0.00
TREE TOP INC
WENATCHEE PLANT
Surface Water
Active Releaser (Surrogate): NPDES
Surface
WENATCHEE, WA
WA0023949
water
NPDES: WA0051527
20
0.0000044
0.00
0.00
0.00
0.00
Page 644 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
CAROUSEL CENTER
SYRACUSE, NY NPDES:
NY0232386
Surface Water
Active Releaser: POTW (Ind.)
Surface
water
250
0.000258
0.00
0.00
0.00
0.00
20
0.00399
0.00
0.00
0.00
0.00
OES: DoD
US DOD USAF ROBINS
AFB ROBINS AFB, GA
NPDES: GA0002852
Surface Water
Active Releaser (Surrogate): NPDES
GA0024538
Surface
water
250
0.00201
0.00
0.00
0.00
0.00
20
0.0231
0.00
0.00
0.00
0.00
OES: N/A (WWTP)
EDWARD C. LITTLE WRP
EL SEGUNDO, CA NPDES:
CA0063401
Surface Water
Active Releaser (Surrogate): NPDES
CA0000337
Still water
365
0.00601
0.00
0.00
0.00
0.00
Page 645 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
20
0.11
0.00
0.00
0.00
0.00
JU ANITA MILLENDER-
MCDONALD CARSON
REGIONAL WRP
CARSON, CANPDES:
CA0064246
Surface Water
Active Releaser (Surrogate): NPDES
CA0000337
Still water
365
0.00117
0.00
0.00
0.00
0.00
20
0.0233
0.00
0.00
0.00
0.00
LONDON WTP LONDON,
OHNPDES: OH0041734
Surface Water
Active Releaser (Surrogate): NPDES
OH0023779
Surface
water
365
0.19
0.00
0.00
0.00
0.00
20
3.78
0.00
0.04
0.03
0.00
Surface Water
Active Releaser: NPDES NY0020567
Still water
365
301.46
0.11
3.35
2.00
0.17
Page 646 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
LONG BEACH (C) WPCP
LONG BEACH, NY
NPDES: NY0020567
20
5878.12
2.24
65.31
38.93
3.27
MIDDLESEX COUNTY
UTILITIES AUTHORITY
SAYREVILLE, NJ NPDES:
NJ0020141
Surface Water
Active Releaser: NPDES NJ0020141
Still water
365
2.49
0.00
0.03
0.02
0.00
20
50.89
0.02
0.57
0.34
0.03
JOINT WATER
POLLUTION CONTROL
PLANT CARSON, CA
NPDES: CA0053813
Surface Water
Active Releaser: NPDES CA0053813
Still water
365
0.00685
0.00
0.00
0.00
0.00
20
0.12
0.00
0.00
0.00
0.00
Page 647 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Release Media1*
Modeled Facilitv or Industry Sector in
EFAST
Waterbody
Type'1
Davs of
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
Active Releaser Facility"
EFASTC
release1
(using
fish COC
of 151)
365
0.00399
0.00
0.00
0.00
0.00
HYPERION TREATMENT
PLANT PLAYA DEL REY,
Surface Water
Active Releaser: NPDES CAO109991
Still water
CANPDES: CA0109991
20
0.0656
0.00
0.00
0.00
0.00
365
1.2
0.00
0.01
0.01
0.00
SD CITY PT LOMA
WASTEWATER
Surface Water
Active Releaser: NPDES CAO 107409
Still water
TREATMENT SAN DIEGO,
CANPDES: CA0107409
20
19.74
0.01
0.22
0.13
0.01
REGIONAL SANITATION
Surface
water
DISTRICT ELK GROVE,
Surface Water
Active Releaser: NPDES CA0077682
365
0.0126
0.00
0.00
0.00
0.00
CANPDES: CA0077682
Page 648 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
20
0.27
0.00
0.00
0.00
0.00
BERGEN POINT STP &
BERGEN AVE DOCK W
BABYLON, NY NPDES:
NYO104809
Surface Water
Active Releaser: NPDES NYO 104809
Still water
365
4.06
0.00
0.05
0.03
0.00
20
66.4
0.03
0.74
0.44
0.04
NEW ROCHELLE STP
NEW ROCHELLE, NY
NPDES: NY0026697
Surface Water
Active Releaser: NPDES NY0026697
Still water
365
0.65
0.00
0.01
0.00
0.00
20
12.47
0.00
0.14
0.08
0.01
Surface Water
Active Releaser: NPDES CA0055221
365
0.9
0.00
0.01
0.01
0.00
Page 649 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
SIMI VLY CNTY
SANITATION SIMI
VALLEY, CANPDES:
CA0055221
Surface
water
20
14.88
0.01
0.17
0.10
0.01
OCEANSIDE OCEAN
OUTFALL OCEANSIDE,
CANPDES: CA0107433
Surface Water
Active Releaser: NPDES CAO107433
Still water
365
0.63
0.00
0.01
0.00
0.00
20
12
0.00
0.13
0.08
0.01
SANTA CRUZ
WASTEWATER
TREATMENT PLANT
SANTA CRUZ, CA NPDES:
CA0048194
Surface Water
Active Releaser: NPDES CA0048194
Still water
365
0.17
0.00
0.00
0.00
0.00
20
2.07
0.00
0.02
0.01
0.00
Page 650 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
365
0.64
0.00
0.01
0.00
0.00
CORONA WWTP 1
CORONA, CANPDES:
CA8000383
Surface Water
Active Releaser: POTW (Ind.)
Surface
water
20
11.6
0.00
0.13
0.08
0.01
365
0.16
0.00
0.00
0.00
0.00
BLIND BROOK SD WWTP
RYE, NY NPDES:
NY0026719
Surface Water
Active Releaser: NPDES NY0026719
Still water
20
3.14
0.00
0.03
0.02
0.00
MCKINLEYVILLE CSD -
WASTEWATER
TREATMENT PLANT
MCKINLEYVILLE, CA
NPDES: CA0024490
Surface Water
Active Releaser: NPDES CA0024490
Surface
water
365
0.15
0.00
0.00
0.00
0.00
Page 651 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
20
2.54
0.00
0.03
0.02
0.00
SAN JOSE CREEK WATER
RECLAMATION PLANT
WHITTIER, CANPDES:
CA0053911
Surface Water
Active Releaser: NPDES CA0053911
Surface
water
365
0.00467
0.00
0.00
0.00
0.00
20
0.0934
0.00
0.00
0.00
0.00
CARMEL AREA
WASTEWATER DISTRICT
TREATMENT FACILITY
CARMEL, CANPDES:
CA0047996
Surface Water
Active Releaser: NPDES CA0047996
Still water
365
0.11
0.00
0.00
0.00
0.00
20
1.15
0.00
0.01
0.01
0.00
Surface Water
Active Releaser: POTW (Ind.)
365
0.13
0.00
0.00
0.00
0.00
Page 652 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
CAMERON TRADING
POST WWTP CAMERON,
AZNPDES: NN0021610
Surface
water
20
1.29
0.00
0.01
0.01
0.00
CITY OF RED BLUFF
WASTEWATER
RECLAMATION PLANT
RED BLUFF, CA NPDES:
CA0078891
Surface Water
Active Releaser: NPDES CA0078891
Surface
water
365
0.000147
0.00
0.00
0.00
0.00
20
0.00147
0.00
0.00
0.00
0.00
91ST AVE WASTEWATER
TREATMENT PLANT
TOLLESON, AZ NPDES:
AZ0020524
Surface Water
Active Releaser: NPDES AZ0020524
Surface
water
365
0.29
0.00
0.00
0.00
0.00
20
4.52
0.00
0.05
0.03
0.00
Page 653 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Release Media1*
Modeled Facilitv or Industry Sector in
EFAST
Waterbody
Type'1
Davs of
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
Active Releaser Facility"
EFASTC
release1
(using
fish COC
of 151)
365
1.04
0.00
0.01
0.01
0.00
EVERETT WATER
POLLUTION CONTROL
Surface Water
Active Releaser: NPDES WA0024490
Surface
FACILITY EVERETT, WA
water
NPDES: WA0024490
20
15.54
0.01
0.17
0.10
0.01
365
1.36
0.00
0.02
0.01
0.00
PIMA COUNTY - INA
Surface
ROAD WWTP TUCSON,
Surface Water
Active Releaser: NPDES AZ0020001
water
AZ NPDES: AZ0020001
20
18.59
0.01
0.21
0.12
0.01
23RD AVENUE
WASTEWATER
Surface
water
TREATMENT PLANT
Surface Water
Active Releaser: NPDES AZ0020559
365
0.26
0.00
0.00
0.00
0.00
PHOENIX, AZ NPDES:
AZ0020559
Page 654 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
swe
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
20
2.49
0.00
0.03
0.02
0.00
SUNNYSIDE STP
SUNNYSIDE, WA NPDES:
WA0020991
Surface Water
Active Releaser: NPDES WA0020991
Surface
water
365
0.00673
0.00
0.00
0.00
0.00
20
0.11
0.00
0.00
0.00
0.00
AGUA NUEVA WRF
TUCSON, AZ NPDES:
AZ0020923
Surface Water
Active Releaser: NPDES AZ0020923
Surface
water
365
0.0273
0.00
0.00
0.00
0.00
20
0.55
0.00
0.01
0.00
0.00
Surface Water
Active Releaser: POTW (Ind.)
365
0.26
0.00
0.00
0.00
0.00
Page 655 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Name, Location, and ID of
Active Releaser Facility"
Release Media1*
Modeled Facility or Industry Sector in
EFASTC
EFAST
Waterbody
Type'1
Days of
release1
7Q10
SWC
(ppb)g
Acute
Risk
Quotients
(using
COC of
2,630
|)|)b)
Chronic
Risk
Quotients
(using
amphibian
COC of
90)
Chronic
Risk
Quotients
(using
fish COC
of 151)
Chronic
Risk
Quotients
(using
invertebrate
COC of
1,800)
PORT OF SUNNYSIDE
INDUSTRIAL WWTF
SUNNYSIDE, WA NPDES:
WA0052426
Surface
water
20
3.87
0.00
0.04
0.03
0.00
APACHE JUNCTION
WWTP APACHE
JUNCTION, AZ NPDES:
AZ0023931
Surface Water
Active Releaser: POTW (Ind.)
Surface
water
365
0.04
0.00
0.00
0.00
0.00
20
0.72
0.00
0.01
0.00
0.00
11531 a. Facilities actively releasing methylene chloride were identified via DMR and TRI databases for the 2016 reporting year.
11532 b. Release media are either direct (release from active facility directly to surface water) or indirect (transfer of wastewater from active facility to a receiving
11533 POTW or non-POTW WWTP facility). A wastewater treatment removal rate of 57% is applied to all indirect releases, as well as direct releases from WWTPs.
11534 c.Ifa valid NPDES of the direct or indirect releaser was not available in EFAST, the release was modeled using either a surrogate representative facility in
11535 EFAST (based on location) or a representative generic industry sector. The name of the indirect releaser is provided, as reported in TRI.
11536 d. EFAST uses ether the "surface water" model, for rivers and streams, or the "still water" model, for lakes, bays, and oceans.
11537 e. Modeling was conducted with the maximum days of release per year expected. For direct releasing facilities, a minimum of 20 days was also modeled.
11538 f. The daily release amount was calculated from the reported annual release amount divided by the number of release days per year.
11539 g. For releases discharging to lakes, bays, estuaries, and oceans, the acute scenario mixing zone water concentration was reported in place of the 7Q10 SWC.
Page 656 of 725
-------
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
11540 h. To determine the PDM days of exceedance for still bodies of water, the estimated number of release days should become the days of exceedance only if the
11541 predicted surface water concentration exceeds the COC. Otherwise, the days of exceedance can be assumed to be zero.
Page 657 of 725
-------
11542
11543
11544
11545
11546
11547
11548
11549
11550
11551
11552
11553
11554
11555
11556
11557
11558
11559
11560
11561
11562
11563
11564
11565
11566
11567
11568
11569
11570
11571
11572
11573
11574
11575
11576
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Appendix I DERIVATION OF IUR AND NON-CANCER
HUMAN EQUIVALENT CONCENTRATION FOR CHRONIC
EXPOSURES
The reader is referred to Risk Evaluation for Methylene Chloride, Supplemental File - Methylene
Chloride Benchmark Dose and PBPK Modeling Report (EPA. 2019h) for additional details on
dose metrics, models used to derive the IUR as well as individual model outputs.
1.1 Cancer Inhalation Unit Risk
Methylene chloride's cancer IUR of 1.38 x 10"6 per mg/m3 <24> was derived from mouse liver and
lung tumor incidence data (Mennear et at.. 1988; NTP. 1986). Figure Apx 1-1 describes the steps
used to derive the methylene chloride IUR using PBPK modeling. Because this modeling is
updated from the model used for the methylene chloride IRIS assessment, additional details on
aspects of IUR derivation are included in the IRIS assessment (U.S. EPA. 2011).
The derivation steps are the following:
1. Dose conversion: A deterministic mouse PBPK model (Marino et al. 2006) was used to
convert the mouse inhalation exposures to long-term daily average internal doses in the liver
or lung. The selected internal dose-metric was long-term average daily mass of methylene
chloride metabolized via the GST pathway per unit volume of liver or lung tissue. The choice
of the dose metric was based on evidence related to the involvement of the GST metabolites
in methylene chloride-induced carcinogenicity (x % I \* \ JO I I).
2. Dose-response modeling and extrapolation: All dichotomous models that use likelihood
optimization and profile likelihood-base CIs from BMDS version 3.1 were used to fit the
mouse liver and lung tumor incidence and PBPK-derived internal doses and derive a mouse
internal BMDio and BMDLio25 associated with 10% ER (U.S. EPA. 2011). Several tumors
using multiple models were evaluated. The chosen model was the multi-tumor (MSCombo)
model, which uses individual Multistage models fit to the individual (liver and lung) tumors
to estimate the risk of getting one or more of the tumors being analyzed (EPA. 2019h).
Standard and non-standard forms of these models were run separately in BMDS 3.1 so that
auto-generated model selection recommendations accurately reflect current EPA model
selection procedures (EPA. 2.012. EPA. 2014). BMDS 3.1 models that use Bayesian fitting
procedures and Bayesian model averaging were not applied in this work.
The mouse internal BMDLio (0.1/BMDL10) were used to derive inhalation risk factors for
lung and liver tumors by linear extrapolation. Consistent with EPA Guidelines for
24 The inhalation unit risk for methylene chloride should not be used with exposures exceeding the point of
departure (BMDLio = 7,700 mg/m3 or 2,200 ppm), because above this level the fitted dose-response model better
characterizes what is known about the carcinogenicity of methylene chloride.
25 The benchmark dose (BMD) is a dose or concentration that produces a predetermined change in response rate of
an adverse effect (called the benchmark response or BMR) compared to background (U.S. EPA. 20.1.1').
BMD io- benchmark dose at the 10% response
BMDLio=lower confidence limit of the benchmark dose at the 10% response
Page 658 of 725
-------
11577
11578
11579
11580
11581
11582
11583
11584
11585
11586
11587
11588
11589
11590
11591
11592
11593
11594
11595
11596
11597
11598
11599
11600
11601
11602
11603
11604
11605
11606
11607
11608
11609
11610
11611
11612
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Carcinogen Risk Assessment, a linear low-dose extrapolation approach is used for chemicals
with DNA-reactive and mutagenic properties (EPA. 2005b).
3. Application of allometric scaling factor: The chosen dose metric is a rate of metabolism
rather than the concentration of putative toxic metabolites. Currently, there are no data
pertaining to the reactivity or clearance rate of the relevant metabolite(s). A scaling factor
was used to address the possibility that the rate of clearance for the metabolite is limited by
processes that are known to scale allometrically. The human BMDLio was derived by
applying a mouse:human dose-rate scaling factor of 7 [i.e., (Body Weight human/Body
Weight mouse)0 25 = 7] to adjust the mouse-based BMDLio values downward based on the
potential slower clearance per volume tissue in the human compared with the mouse (EPA.
2019h: U.S. EPA. 20111
4. Linear extrapolation: A linear extrapolation approach using the internal human BMDLio
for liver and lung tumors was used to calculate human tumor risk factors by dividing the
BMR of 0.1 by the human BMDL for each tumor type for adults aged 18-65. Currently, there
are no data from chronic inhalation cancer bioassays in mice or rats providing support for a
nonlinear dose-response relationship at low doses. ; (EPA. 2019h; U.S. EPA. ).
5. Calculation of the IUR: A probabilistic human PBPK model (adapted from David (2006))
with Monte Carlo sampling was used to determine a distribution of human internal doses -
lung, liver, or blood - associated with chronic unit inhalation (1 (J,g/m3) exposures. The
distribution of IURs was derived by multiplying the human inhalation tumor risk factors by
the respective distributions of human average daily internal doses resulting from chronic, unit
inhalation exposures of one |ig/m3 methylene chloride. Sampling of the full distribution of
GSTT genotypes in the human population (GSTT1+/+, GSTT1+/- and GSTT1 -/-) was done to
derive the IUR for liver and lung tumors.
The slope of the linear extrapolation from the lower 95 percent bound estimate BMDLio is
1.38 x 10"6 per mg/m3, which represents an upper-bound estimate for exposure for adult
workers 18-65 years old, 8 hrs/day, 5 days/week without consideration of increased early-life
susceptibility due to methylene chloride's mutagenic MOA because the IUR is used for
scenarios in occupational settings where only adults are expected to be exposed. Use of the
upper-bound estimate for the full population distribution of the GSTT1 genotypes is
considered sufficiently protective of sensitive sub-populations.
Page 659 of 725
-------
11613
11614
11615
11616
11617
11618
11619
11620
11621
11622
11623
11624
11625
11626
11627
11628
11629
11630
11631
11632
11633
11634
11635
11636
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Rodent Dose
Response Data
Rodent
PBPK Model
Estimates of Rodent
Internal Dose
BMD
Modeling
O
I
0.5
0.4
0.3
0.2
0.1
0
Human Tumor Risk Factor
(internal dose)-1
Scaling
Factor
lXi
Rodent Tumor Risk Factor
(internal dose)"1
(0.1/Rodent BMDL10)
Benchmark Dose Analysis
Rodent Internal BMDLn
95% Lower Bound Estimate of Internal
Dose Associated with a 10% response
Multiply Human Tumor Risk Factor
By Distribution of Human Internal
Unit Doses
95* 99*
Distribution of Human Cancer
Oral Slope Factors or
Inhalatior^Unit Risks
Recommend mean value
Apply Age-De pen dent Adjustment Factors
(AD AFs) for early life exposure
Probabilistic
Human PBPK
Model
A.
Distribution of Human Internal
Doses from Unit Oral Doses
(1 mg/kg) or Inhalation
Concentrations (1ug/m3)
Monte Carlo
Sampling from
Distributions of
Human PBPK
Model Parameters
FigureApx 1-1. Process of Deriving the Cancer Inhalation Unit Risk for Methylene
Chloride
Source: U.S. EPA (2011)
1.2 Non-Cancer Hazard Value
The non-cancer hazard value for methylene chloride is based on liver effects. These effects were
reported in female rats exposed to methylene chloride for 6 hrs/day, 5 days/week for 2 years
(Nitschke et al., 1988a). The rat data were suitable for non-cancer dose-response analysis.
Because the study was suitable for dose-response analysis, EPA used a PBPK model (Andersen
et al.. 1991) to estimate rat internal doses from the Nitschke (1988a) study. BMD modeling used
the rat internal doses and their corresponding incidence data (i.e., hepatic vacuolation) to
estimate the rat internal BMDLio for hepatic effects. In other words, the BMDLio is the lower
95% confidence limit of the BMD at the 10% BMR (EPA, 2012a). A BMR of 10% was selected
because, in the absence of information regarding the magnitude of change in a response that is
thought to be minimally biologically significant, a BMR of 10% is generally recommended since
it provides a consistent basis of comparison across assessments. Moreover, there were no
additional data to suggest that the severity of the critical effect or the power of the study would
warrant a lower BMR ( J.S. EPA. 2011).
The rat internal BMDLio was allometrically adjusted because the dose-metric is a rate of
metabolism and the clearance of these metabolites may be slower per volume tissue in the human
BMDL
0 10 20 30 40 SO 60
Dose
4
M jIi ista ge
BMD
Page 660 of 725
-------
11637
11638
11639
11640
11641
11642
11643
11644
11645
11646
11647
11648
11649
11650
11651
11652
11653
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
compared with the rat. This adjustment consisted of dividing the rat internal BMDLio by
4.09 [(BWhuman)/(BWrat)0'25 ~ 4.09)]26 to obtain a human equivalent internal BMDLio of
130.03 mg methylene dichloride metabolized via CYP27 pathway/litter liver tissue/day (EPA.
2019h).
A probabilistic PBPK model for methylene chloride in humans (adapted from David (2.006)) was
then used with Monte Carlo sampling to calculate distributions of chronic hHEC (in units of
mg/m3) associated with the internal BMDLio based on the responses in female Sprague-Dawley
rats. Estimated HECs corresponding to the mean, 1st, and 5th percentiles of the distribution were
48.5, 17.2 and 21.3 mg/m3, respectively. The 1st percentile of the distribution of HECs i.e., the
HEC99 the concentration at which there is 99% likelihood an individual would have an internal
dose less than or equal to the internal dose of hazard, 17.2 mg/m3, was chosen as the POD28 for
the non-cancer hazard value because it would protect toxicokinetically sensitive individuals.
EPA's use of the human toxicokinetics data distribution is similar to using data-derived
extrapolation factors (DDEFs) because it uses information more specific to methylene chloride
hazard. DDEFs are suggested by agency guidance as preferable to default UFs (EPA. 2014b).
26 BW=body weight
27 CYP=cytochrome P450
28 A POD is a dose or concentration that can be considered to be in the range of observed responses, without
significant extrapolation. A POD is used to mark the beginning of extrapolation to determine risk associated with
lower environmentally relevant human exposures (U.S. EPA. 20.1.1').
Page 661 of 725
-------
11654
11655
11656
11657
11658
11659
11660
11661
11662
11663
11664
11665
11666
11667
11668
11669
11670
11671
11672
11673
11674
11675
11676
11677
11678
11679
11680
11681
11682
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Appendix J CASE REPORTS OF FATALITIES ASSOCIATED
WITH METHYLENE CHLORIDE EXPOSURE
The main cause of death from high level of inhalation of methylene chloride is related to CNS
effects. This includes loss of consciousness and -respiratory depression leading to irreversible
coma, hypoxia and death (Nac/Aegl. 2008). The organ most often affected in fatal accidents is
the brain, followed by the lungs and heart. Changes in these organs include congestion and
edema. Lung and heart also showed petechiae in a few cases. Cardiotoxic effects are observed in
a few cases (Nac/Aegl. 2008).
CDC (2012.) reported 13 deaths from methylene chloride from bathtub refinishing between 2000
to 2011; these 13 deaths represent 75% of the deaths from methylene chloride that were
investigated by OSHA. Ages of the 13 deaths ranged from 23 years to 57 years old. Twelve were
male, and the percent of methylene chloride was 60-100% in the paint strippers. Methylene
blood concentrations ranged from 18 to 223 mg/L for the six decedents for which blood levels
were recorded. Among 5 decedents with COHb measurements, levels ranged from undetected to
5%>, indicating CO was unlikely to be the primary cause of death. Methylene chloride had only
been recognized as potentially fatal to furniture strippers and factory workers up to that time, and
from 1976-1999, only 2 (8%) of all methylene chloride deaths investigated by OSHA were
linked to bathtub refinishing. There are 9 state Fatality Assessment and Control Evaluation
(FACE) programs funded by NIOSH to investigate deaths to workers. U.S. EPA (2014)
presented information on 15 reported worker deaths associated with 10 different methylene
chloride paint stripping products.
NIOSH lists a value of 2300 ppm (7981 mg/m3) as IDLH (NIOSH. 1994). Individuals should not
be exposed to methylene chloride at this level for any length of time. The IDLH is based on
acute inhalation toxicity data in humans. The AEGL-3 value for death ranges from 12,000 ppm
(42,000 mg/m3) to 2100 ppm (7400 mg/m3) for a 10-min to 8-hr value, respectively. The value is
based on mortality from CNS effects in rats and COHb formation in humans (Nac/Aegl. 2008).
Page 662 of 725
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11683 Table Apx J-l. Examples of Fatalities
Subject (s)
I so
C ire ii in si Jin cos of
C\|)()SII IV
C'iiiisc of ile.ilh, symptoms,
milopsv
Possible methylene chloride
:iir concenlriilion
(in i \ lu re i den I i I'i c;i lion)
Reference
27-year old male
Paint stripping
(occupational)
Found dead 20-30 min
after being alive; slumped
over tank with paint
stripper; head and trunk in
tank, arms in solvent
Cause of death: asphyxia
secondary to inhalation of fumes
Transported to hospital in cardio-
respiratory arrest;
Lungs: congestion/edema; micro-
hemorrhagic changes; significant
fin pigmented macrophages in
alveoli/bronchioles;
Liver: f consistency/size, mild
portal inflammation, dilated
centrilobular veins, acute
congestion
Methylene chloride:
0.14 mg/mL (blood),
0.54 mg/mL (pulmonary exudate)
COHb: 3%
Samples taken after the accident:
>140,000 mg/m3 (>39,200 ppm)
(5-10 cm from solvent)
89,474 mg/m3 (25,053 ppm)
(25 cm above solvent)
4789 mg/m3 (1341 ppm)
(75 cm from solvent)
243 mg/m3 (68 ppm) and 390
mg/m3 (109 ppm) at level of upper
airways of standing worker
(resting/stirring)
[colleagues suggest the worker had
been very close to the solvent
surface with his head]
(77% methylene chloride; 18%
methanol)
Zarrabeitia et al.
(2001) cited in
NAC/AEGL (2008)
19-year old male
Paint stripping
of furniture
(occupational)
Found slumped over
immersion tank; arms and
forehead submerged
Cause of death: suffocation due
to inhalation of toxic solvents
Methylene chloride:
0.4 mg/mL (blood)
Methanol: 2.4 mg/mL (blood)
COHb: none found
Air concentrations: n/a
(methylene chloride; methanol)
Novak and Hain
(1990) cited in
NAC/AEGL (2008)
21-year old male
Paint stripping
of furniture
(occupational)
Found unconscious with
head and shoulders
submerged in solvent;
man was resuscitated,
remained comatose and
died 7 days later
Methylene chloride: n/a
Methanol: 0.2 mg/mL
COHb: 3.6%
Re-enactment air samples:
1711, 89, and > 771 ppm of
methylene chloride, toluene and
methanol, respectively at 10 cm
above surface.
64, 6, and > 44 ppm, respectively at
top of tank (76 cm above surface)
Novak and Hain
(1990) cited in
NAC/AEGL (2008)
Page 663 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Subject (s)
I se
(ircumstiinccs of
exposure
C'iiuse of ilc.ith, symptoms,
iiutopsv
Possible methylene chloride
:iir concent nil ion
(mixture identiI'icntion)
Reference
100, 3, and > 124 ppm (55-min
samples) and
313, 13 ppm and NA (10-min
samples) (76 cm away from tank at
breathing zone)
(65-85% methylene chloride, 6-
12% methanol, 6-12% toluene,
monoethanolamine)
50 and 55-year old
men
Burying waste
barrels
(occupational)
Burying barrels of mixed
solvent and solid waste
from nearby plant for a
few hours (in well 2
meters below ground level
in a building); found dead
in evening; death
estimated as early
afternoon
Cause of death: narcosis, loss of
consciousness, respiratory
depression and irreversible coma,
hypoxia and death
Besides respiratory depression,
levels of formaldehyde, formic
acid and carbon dioxide may have
led to hypoxia, cardio-respiratory
failure, and death.
Methylene chloride:
0.572 and 0.601 mg/mL (blood)
COHb: 30%
Air concentrations:
Near well, soon after discovery of
bodies:
1,800 and 10,700 mg/m3 (504 and
2996 ppm) -
Bottom of well, next day:
582,500 mg/m3 (163,100 ppm)
Near bodies, next day:
72,900 mg/m3 (20,412 ppm)
Concentrations of other solvents
(1,2-dichloroethane, 1,1,1-
trichloroethane, and styrene) were
much lower
Manno et al. (1989,
1992) cited in
NAC/AEGL (2008)
20- and 40-year
olds
Paint stripping
(occupational)
Removing original surface
of squash court, found
dead at 2 hrs and 20 min
after starting; not known
whether they stayed in the
room or left and returned
N/A
Air concentrations:
53,000 ppm (estimated from
amount of stripper used, room size,
etc.)
(> 80% methylene chloride)
Fairfax (1996) cited
in NAC/AEGL
(2008)
Page 664 of 725
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Subject (s)
I se
(ircumstiinccs of
exposure
C'iiuse of ilc.ith, symptoms,
iiutopsv
Possible methylene chloride
:iir concent nil ion
(mixture identiI'icntion)
Reference
N/A
Paint stripping
(occupational)
Occupational poisoning in
a plant where the
employee was using a
paint stripper
N/A
Air concentration:
< 100,000 ppm (estimated)
(75% methylene chloride)
Tay etal. (1995)
cited in NAC/AEGL
13-year old male
Paint stripping
(consumer)
N/A
Cause of death:
Narcosis
Methylene chloride:
0.510 mg/mL (blood)
0.248 mg/g (brain)
COHb: 3.0
Air concentrations: n/a
(methylene chloride, toluene,
methanol, ethanol, mineral spirit,
methyl ethyl ketone, and n-
methylpyrimidol
tetraethylammonium phosphate)
Bonventre et al.
(1977) cited in
NAC/AEGL (2008)
66-year old
Furniture
stripping
(consumer)
Working in basement for
3 hrs; 1-hroutof
basement, had chest pains
(diagnosed as myocardial
infarction); no prior
history of heart disease;
2 wks later, after 3 hrs in
basement using varnish
remover (had myocardial
infarction, cardiogenic
shock, dysrhythmia, heart
failure); 6 months later
went to basement and
after 2 hrs, had chest
pains, collapsed and died.
Cause of death:
Myocardial infarction (no signs of
CNS depression)
Air concentrations: n/a
(80% methylene chloride)
Steward and Hake
(1976) cited in
NAC/AEGL (2008)
37-yr old female
Bathtub
refinishing
(occupational)
Found unresponsive;
slumped over the bathtub;
No respiratory protection
or ventilation controls
Cause of death: Inhalation
exposure of paint remover
pulmonary edema and congestion;
congestion of the conjunctivae;
hyperemia of the small bowel and
Air concentrations:
23,000 ppm (estimate based on
volume removed from can)
Iowa FACE (20.1.2b)
Page 665 of 725
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Subject (s)
I se
(ircumstiinccs of
exposure
C'iiuse of ilc.ith, symptoms,
iiutopsv
Possible methylene chloride
:iir concentriition
(mixture identiI'icntion)
Reference
gastric mucosa; and dilated right
ventricle.
Methylene chloride:
0.12 mg/mL (blood)
Methanol: 7 mg/dL (blood)
(80-90% methylene chloride, 5-
10% methanol)
24-yr old male, no
known health
problems
Paint stripping
(occupational)
Stripping baptismal font
in small enclosed room;
found unresponsive 6.5
hrs later
Cause of death:
Intoxication by methylene
chloride resulting in hypoxia,
dysrhythmia, death.
Autopsy: identified underlying
cardiopulmonary disease (found
cardiomegaly with 4-chamber
dilation, artherosclerosis - 50% in
left anterior descending artery)
Methylene chloride:
37.8 mg/dL (blood)
Other chems (methanol, ethanol,
isopropyl alcohol) undetectable in
blood
COHb: 10%
Air concentrations: n/a
(70-85% methylene chloride,
smaller amounts of methanol,
isopropyl alcohol, 2-butoxy-
ethanol, and ethanol)
Maclsaac et al.
(2013); CaFACE
(2012a)
65-yr old male,
history of diabetes
and chronic
neuropathic pain;
medications
metformin and
gabapentin
Paint stripping
(occupational)
Entered empty paint-
mixing tank through small
opening in top; applied
paint stripper to inside
walls to remove paint;
wore organic vapor
cartridge respirator; fan
and hose used for exhaust
but positioned only
halfway between tank
opening and tank floor;
found unconscious 2.5 hrs
after entering tank
Cause of death: asphyxia due to
inhalation of methylene chloride
Found in state of asystole;
congestion in lungs and
myocardium
Methylene chloride:
220 mg/dL (blood)
COHb: < 5%
Air concentrations: n/a
(60-100% methylene chloride, 10-
30% methanol, 1-5% Stoddard
solvent)
Maclsaac et al.
Page 666 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Subject (s)
I se
(ircumstiinccs of
exposure
C'iiuse of ilc.ith, symptoms,
iiutopsv
Possible methylene chloride
:iir concent nil ion
(mixture identiI'icntion)
Reference
52-yr old male, no
history of heart
attack or asthma;
medication for
cholesterol
Bathtub
stripping
(occupational)
Found slumped over
bathtub with face on
bottom of tub; found ~2
hrs later
Cause of death:
Sudden cardio-respiratory arrest
due to inhalation of toxic fumes;
Autopsy: mild artherosclerosic
cardiovascular disease; heavy
congested lungs with mucous
plugging
Methylene chloride:
50 mg/L
COHb: negative
Air concentrations:
637-1062 ppm in room (estimated
1-hr TWA from volume used - 6
oz. - and room size)
11,618-19,364 ppm in tub
(estimated 1-hrTWA)
But average (assuming 80% mc) in
tub estimated to be 123,933 ppm in
tub
(60-100% methylene chloride, 3-
7% ethyl alcohol, smaller percent
of other chemicals)
MiFACE, (20.1.1a)
11684
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Appendix K SUMMARY OF METHYLENE CHLORIDE
GENOTOXICITY DATA
This appendix provides a high-level summary of genotoxicity studies available for methylene
chloride. The appendix first summarizes recent studies and presents study findings in Table Apx
K-l. The appendix also includes a summary of the conclusions from EPA's 2011 IRIS
assessment (U.S. EPA Q0j |)) and reproduces Tables 4-20 through 4-25 from U.S. EPA (2011).
Recent Studies
In peripheral blood lymphocyte/leukocyte samples of an occupational cohort exposed to
methylene chloride and other possible/probable carcinogens, Zeljezic et al. (2016) found
increased frequencies of micronuclei, nuclear buds and nucleoplasmic bridges as well as DNA
damage in exposed subjects when compared with unexposed individuals. After implementing
strict use of personal protective equipment (PPE), workers exhibited less genotoxicity than
before strict use of PPE (Zeljezic et al.. 2016).
Suzuki et al. (2014) found no increases in micronuclei in reticulocytes or normochromatic
erythrocytes or gene mutations (using Pig-a assay) in total red blood cells of B6C3F1 mice
exposed by inhalation to methylene chloride concentrations up to 1600 ppm (5615 mg/m3) for 6
weeks. In addition, Suzuki et al. (2.014) did not identify an increase in gene mutations or DNA
damage in the liver in transgenic gpt delta mice exposed to 800 ppm (2808 mg/m3) for 4 weeks.
A study by this group also showed no evidence of mutagenicity in the livers of gpt delta rats
orally exposed to methylene chloride alone (up to 500 mg/kg) or with up to 200 mg/kg-day 1,2-
dichloropropane for 4 weeks (Hirata et al.. 2016). Other recent studies reported positive results.
In an in vitro study of normal rat kidney (NRK) cells, Yang et al. (2014) identified increased
DNA damage (via the comet/SCGE assay) in the absence of cytotoxicity, apoptosis or G1 cell
cycle arrest. Mimaki et al. (2016) evaluated mutagenicity of methylene chloride in S.
typhimurium TA100 and found increased revertants/plate and an increased mutation rate in the
absence of metabolic activation, similar to previous studies.
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11715 Table Apx K-l Methylene Chloride Genotoxicity Studies Published After the 2011 IRIS Assessment
Species
Methylene Chloride Kxposure
Outcome
Comments
Reference
Route
Dose/iliinition
I Iumans: workers
in pharmaceutical
industry
Inhalation/
dermal most
likely
8 hrs/day lor > 8 months of
irregular PPE use followed
by
8 months of strict PPE use
(same 16 worker volunteers
for both phases)
Irregular PPE: Micronnclei. nuclear
buds and nucleoplasms bridges
were higher in blood lymphocytes of
workers exposed to multiple
chemicals than controls. Tail length
and percent DNA in tail of comet
assay did not significantly differ
from controls in blood leukocytes.
Workers were exposed to other
possible carcinogens in addition to
methylene chloride: phenylhydrazine,
ethylene oxide, 1,2-dichlorethane;
Strict PPE: some effects significantly
decreased compared with irregular
PPE after the strict use of PPE was
implemented
/elje/ic et al. ( ;]j; )
Mice: B6C3F1
males
Inhalation
0,400, 800, 1600 ppm; 6
hrs/day, 5 days/week for 6
weeks
Total red blood cells - no increase in
pig-A mutant frequencies
Reticulocytes or normochromatic
erythrocytes - no increase in
micronuclei
Authors note that the results are
indicative of lack of mutagenic
potential in hematopoietic stem cells,
and lack of clastogenicity/
aneugenicity in bone marrow of mice
Suzuki et al. (2014)
Mice: gpt Delta
C57BL/6J males
0, 800 ppm; 6 hrs/day, 5
days/week for 4 weeks
Liver - no increase in DNA damage
via comet assay or gpt mutations
DNA damage and gpt mutations were
increased after co-exposure of
methylene chloride and 1,2-
dichloropropane, suggesting that the
mutagenic potential of
1,2-dichloropropance may be
enhanced by methylene chloride
Rats: F344 gpt
delta
Gavage
0,250 or 500 mg/kg-bw via
gavage in corn oil every day
for 4 weeks
No increase in Gpt and Spi-
mutation frequencies; no changes in
gene or protein expression of GST-
T1 or CYP2E1
The gpt delta rats carry approximately
10 copies of the transgene lambda
EG10 per haploid genome
Hirata et al. (2016)
Rats: Normal rat
kidney (NRK)
52E cell line
In vitro assay
50 to 5000 mg/L (comet
assay); 10 to -10,000 mg/L
(cytotoxicity - MTT -
viability); 10 to 1000 mg/L
(apoptosis assay); 5000 mg/L
(cell cycle analysis)
DNA damage at 5 x 103 mg/L (p <
0.05) via comet (SCGE) assay; no
increased cytotoxicity (MTT/cell
viability or apoptotic cells); no
changes in cell cycle
None
Yang et al. (201.4)
S. typhimurium
TA100
In vitro reverse
mutation assay
Up to 3500 ppm vapor
concentration
Increased revertants/plate and
increased mutation rate
No metabolic activation used; method
modified for evaluation of volatile
compounds
Mimaki et al. (2016)
11716
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Genotoxicity Studies Summarized in the 2011 Methylene Chloride IRIS Assessment
Some overall conclusions from the genotoxicity data on methylene chloride identified by U.S.
EPA (2011) are as follows:
• In vitro assays in nonmammalian organisms (bacteria, yeast, fungi) (U.S. EPA (2011) Table
4-20)
o In bacteria, methylene chloride mutagenicity is enhanced in the presence of GSH.
o In bacteria, consistent induction in TA100 and TA 98 that is not markedly influenced
by exogenous mammalian liver fractions. Thus, U.S. EPA (2011) suggested that
endogenous metabolism in these strains was sufficient to activate methylene chloride,
o A glutathione-deficient strain variant of TA100 (NG-11) produced 2 times fewer
base-pair substitution mutations vs. TA100 that produces normal levels of GSH.
However, adding 1 mM GSH to NG-11 did not induce fewer substitutions compared
with NG-11 alone (thus, the result was more similar to results using normal TA100).
o TA1535, TA1537, TA1538 that are deficient in GST did not develop base-pair
mutations
o TA1535 transfected with rat GST-T1 showed base-pair substitution mutations at a
DCM concentration 60x lower than that needed to induce mutations in TA100.
o Based on these results, U.S. EPA (2011) notes that there is a likelihood that this
involves GST-T1 metabolic pathway, which produces formaldehyde and S-
(chloromethyl)glutathione.
o Fungal assays resulted in some positive results - for mitotic segregation (only seen at
4000 ppm but not 8000 ppm).
o A yeast assay was positive for gene conversion and recombination at concentrations
up to 209 mM.
• In vitro assays in mammalian systems (U.S. EPA (2011) Table 4-21)
o In human cell lines, methylene chloride exposure yielded positive results in
chromosomal aberrations, micronucleus and sister chromatid exchange assays,
o Human cell lines exposed to methylene chloride were negative for unscheduled DNA
synthesis, DNA SSBs.
o At methylene chloride concentrations from 0.5 to 5 mM, DNA protein cross links
exhibited a dose-response in mouse hepatocytes but rat, hamster and human
hepatocytes showed no cross links,
o DNA single strand breaks (SSBs) were induced by methylene chloride in mouse
hepatocytes and club (Clara) cells and SSBs were decreased after addition of a GSH
depleter.
o DNA SSBs were induced at lower concentrations in mouse hepatocytes than in rat
hepatocytes.
o Chinese hamster ovary cells incubated with GST-competent mouse liver cytosol
induced gene mutations, DNA-protein cross-links and DNA SSBs.
o Rat and hamster cells without addition of exogenous GST/GSH generally exhibited
negative genotoxicity results.
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o Calf thymus DNA in the presence of 1) methylene chloride dehalogenase/GST from
bacteria and GSH 2) human GST-T1, 3) rat GST5-5 or 4) bacterial GST (from
DM11) formed DNA adducts. However, calf thymus DNA with methylene chloride
in the presence of formaldehyde and GSH did not result in detectable DNA adducts.
o In human lung epithelial cells that showed no GST-T1 activity, DNA damage via the
comet assay exhibited a weak trend after methylene chloride exposure,
o In human peripheral blood mononuclear cells from 20 volunteers that had low,
medium or high GST-T1 activity, methylene chloride exposure induced genotoxicity
and cytotoxicity at relatively low methylene chloride concentrations (sometimes
starting at 30 ppm) that was stronger in the high GST-T1 activity cells. Outcomes
included increased sister chromatid exchange, decreased mitotic indices and changes
in cell proliferation kinetics,
o Results of several experiments suggest that the S-(chloromethyl)glutathione
intermediate is primarily responsible for methylene chloride's genotoxicity although
there is evidence of DNA damage resulting from the formation of formaldehyde.
• In vivo assays in insects (U.S. EPA (2011) Table 4-22)
o In Drosophila, two oral methylene chloride studies (sex-linked recessive, somatic
w/w+) resulted in positive findings whereas an inhalation study did not identify gene
mutations.
• In vivo assays in mice (U.S. EPA (2011) Table 4-23)
o Mice exposed to methylene chloride via inhalation:
¦ exhibited chromosomal aberrations, DNA SSBs and sister chromatid
exchange in liver and lung cells at 2,000 ppm or higher (multiple studies).
¦ exhibited DNA-protein cross links in hepatocytes but not in lung cells from
500 to 5,000 ppm for 3 days.
¦ exhibited micronuclei in peripheral red blood cells at 2,000 ppm for 12 weeks
and 4,000 and 8,000 ppm for 2 weeks.
¦ exhibited sister chromatid exchange in peripheral lymphocytes at 8,000 ppm
for 2 weeks.
o Mice exposed to methylene chloride via gavage (single dose of 1,720 mg/kg-bw/day)
exhibited DNA damage via the comet assay in liver and lung cells but not stomach,
urinary bladder, kidney, brain or bone marrow cells,
o Mice exposed to methylene chloride at a single 5 mg/kg intraperitoneal dose
exhibited no DNA adducts in liver or kidney cells,
o Chromosomal micronuclei, chromosomal aberrations or sister chromatid exchange
were not consistently positive in bone marrow of mice after oral or parenteral
exposure; however, GST-activity is minimal in bone marrow and Crebelli et al.
(1999) indicates that halogenated hydrocarbons are not very effective in inducing
micronucleus formation in mouse bone marrow. Thus, negative findings in bone
marrow shouldn't negate positive in vitro findings (Crebelli et al.. 1999).
o The H-ra.s oncogene mutation profile did not differ significantly among
spontaneously or methylene chloride induced liver tumors in mice. Other studies of
tumor oncogenes and tumor suppressors were not clearly conclusive.
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o Unscheduled DNA synthesis was not induced in mice hepatocytes after inhalation of
2,000 or 4,000 ppm methylene chloride for 2 or 6 hrs.
• In vivo assays in rats and hamsters (U.S. EPA (2011) Table 4-24)
o Unlike mice, rats exposed via inhalation did not exhibit DNA SSBs in liver and lung
cell homogenates or hepatocytes at 2,000 ppm or higher,
o Rats exhibited DNA SSBs in a liver homogenate via gavage dose of 1,275 mg/kg but
not 425 mg/kg methylene chloride,
o Similar to mice, unscheduled DNA synthesis was not induced in rat hepatocytes after
inhalation.
o In rats, unscheduled DNA synthesis was not induced after intraperitoneal
administration of 400 mg/kg or gavage administration up to 1,000 mg/kg.
o Similar to mice, rats exposed to methylene chloride at a single 5 mg/kg
intraperitoneal dose exhibited no DNA adducts in liver or kidney cells,
o Unlike mice, hamsters exposed to 4,000 ppm methylene chloride via inhalation for 3
days did not exhibit DNA-protein cross links in liver or lung cells
• Comparison of in vivo assays targeting lung or liver cells (U.S. EPA ( ) Table 4-25)
o This table lists similar studies that use different species (mice, rats, hamster) on the
same row if they used comparable methods,
o The table lists studies with no comparable studies in a second species on separate
rows.
o All studies described in Table 4-25 were presented in previous tables.
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Table 4-20. Results fi oiu in vitro geuotoxiritv assnvs of (lichlcirametbane in nonmamm.ili.TH svsrems
D o se ¦¦ ronce n tra tion
Results"
Endpoint
Test system
aud dm ation
-S9
-so
Comments
Reference
Reverse
imitation
Sahncmdki
typhiwwfhw
TAPS. TA100
48-hr exposure to 0. 5.70t).
11.400,17.100. 22.800. and
57.000 ppm
(DR)
.. t
(DRt
Vapor phase exposure in enclosed 37 3C
system. Tosc at highest dose only.
loneenetal i' 1P7.8>
Reverse
mutation.
S nvhimwhmi
TA9S. TA100
TA1535. TA1537.
7Al::yi
8-hr exposure up to 750 pL'plate
(DRi
, . z
(BR)
Exposures tn airtight desiccator.
Gocke et al. (1981)
Reverse
mutation
S. nphimw iimi
IA100
5-hr exposure to 0, 3,500, 7.000,
and 14.000 ppm
(DR)
(DRi
Vapor phase exposure in enclosed 37°C
system.
Jongen et al (1982)
Reverse
mutation
,S' hint
7A100
3-day exposure, up to 84.000
ppm
+e
Vapor phase exposure in sealed jars.
Peak response at 12 h. E\oeenou> GST
or GSH had no effect.
Green 11SS3;
Reverse
S. nphmwmn
10 |iL/plate
-s-
ND
•>pot test.
O stemian-Golkar
mutation
TAlOi.l TA1P50:
E. coil WU3olOS9
S. t)'phmmrnpn
TA1535
-
ND
et al i 1S33^
TA100
2-hr exposures; 0, 20,40, and 80
mM
(DRI
ND
Standard plate incubation assay: no
toxicity observed
Reverse
imitation
S tipiumu'rihm
TA10Q, TAPS
24-hr exposure to (i. 0 01. 0.05,
0.1. 0.25. 0.5. and 1 0
niL chamber
(DRi
, t
!DR(
'Vapor phase exposure in sealed
desiccator jars requited for positive
result Toxicity at lushest dose only
Zeiger (19901
Reverie
mutation
,S'. .yphimurmm
TA100
2- and o-lii exposi:re> to 0.
2.500. 5.000. 7.5001.
10.000 ppm; 6- and 48-hr
exposures up to 50.000 ppm
(DR)
o-§
(DR i
Vapor phase exposure in sealed jars.
NG54-TA100 with 4-fold lower GSH
levels. Exogenous GSH slightly
increased mutation frequency. Peak
Dilloa et al 11992;
S". nphimmn/m
TA100. NG54
6-hr exposure to 0. 2.500. 5.000.
7.500. 10.000. 20.000. 40.000
ppm
(DR)
+
;DR>
respoase at 6 h
E. coh WP2 iv.tA
6- aad 43-hr exposures to 6.300.
-
+
pKMlOl
12.500. 25.000 and 50.000 ppm
(DRi
,DRt
Reverse
,S nvhimiuimi
0, SO1. 100, and 200 pL plate
-
ND
Mutaseutci?'- m TA100 not enhanced by
Simula et al (1PP3 ?
mutation
TA100 (-GSTA1-1
and &STP1-1)
(DR,*
traasfection with human GSTA1-1 or
GSTPI-1.
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Table 4-20. Results from in vitro genofoxicity assays of dicbtloromethane in nonmammalian systems
Dose coucefttr.ition
Resmits1
Endpoint
Test system
and dm ntion
-St
-SS»
C oinmeurs
Reference
Reverse
mutation
S rfphmiurmm
TA1535 f^C-STS-5)
TA1535
0-2 0 <>iM plate
i i
Q
ND
ND
5 mm preincubation. Trans fee ted with
fat GST5-5. Negative with exogenous S-
(1 -aeetoxymethy!>GSH or HC HO
Parental strain negative with exogenous
GSH or &SX.
Tt:er et ?1 (1 -?P ^ i
Reverse
mutation
5 typhftmirmm
TA100
NG-11
3-day exposure, tip to 100,000
ppm
i DR i
(DRj
ND
ND
Vapor phase exposure m sealed jars
NG-11-TA100 without GSH: adding
GSH incre.ved mutagenicity of NG-11.
Toxic at highest dose.
Graves et al.
f J oci4h)
Reverse
mutation
S nphimwrsm
TA1>3^ (+GST5-5}
TA1535
0. 200. 400. 800. and loOO ppm
;0. 0 03.0.06. 0 13. and0.26
mM m meimms
(DR)
-iX)
ND
ND
Plate mcorpoTation assay 24 h exposure
in sealed Tedlar bap Transfected with
rat &ST5-5. Toxic at highest dose.
Peg! a m et al.
11PP7i
Reverse
mutation
S. t)'phimmrmn
TA10H RSJ100
TA1>35. IPX 100
Up to 24.000 ppm
-CD
ND
ND
Pbte incorporation assay: 24 h exposure
in sealed Xedlar bags.
RSJ100=TA 153 5-transfec ted rat
GSTX1-1. XPT100= nonfunctional
GSXX1-1 gene. Toxic at highest dose.
DeMarim et al
tIP07 h
Forward
inutatiiMi
S nphimw turn
BAi3
0. S. 20. 40. and S5 juiiol/plate
_i_C
Preincubation assay for L-arabmose
resistance lAra1'test;. Toxic _S5 liiioL
Roldan-Arjona and
Puevc t IP$3 >
Forward
mutation
£ t ii7 K12 (Wild!
type)
E. colt U*tA
2-hi exposures to 0, 30, 60, and
130 mM plate t.rtqurous
concentrations)
+"
Vapor phase exposure in sealed jars " +"
with mouse liver Si? only not rat No
cell death m these strains snd doses
Graves et al
119?4b>
Forward
mutation
E. co !i Uvr*
E col' UvrS"
20.000 ppm
ND
ND
Excision repair-proficient strain
indicated toy tacl gene expression.
Excision repair-absent strain..
Zielenska et a]
119P31
DNA repair
S np/tkmniian
TA1535 pSK.1002
S nplmiwiinn
NM5004
0, 2.5, 5.0, 10, and 20 mM
(DR1
ND
ND
SOS response in.iic.atei by uinu gene
expression,
TA1535 pSKI002 transfected with rat
GST5-5 Toxic at highest dose
0>ii et al i 19961
Prophage
induction
E. colt K-3P (?¦.']
10 j.tL plate
\D
Spot test.
Osterrnan-Golkn
etal (1P?3)
11826
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Table 4-20, Results from in vitro genoroxioitv assay* of dichlorouietliane in no«nammaHaii systems
Dose concentration
Results1
Endpoint
Test system
and dwation
-S§
+S9
Comments
Reference
Fungi and yeasts
Mitotic
segregation
-diploid -tram ?!
0. 800, 2.000. 4.000, 6.000, and
8.000 ppir..
-(Tt
ND
Positive only at 4.000 ppm.
Crebellt et al.
ilPSSi
Gene
conversion
k-,cch?j tm'c.j
ccr*xKw?
0, 104. 157. and 20? iilW
- fTi
ND
Totel eel! death Jt 20P m.M Positive at
157 mM only with 5S°o cell death
C alien et ai ilPSOi
Mitotic
reconciliation
-5.tr Jin D7
-m
ND
Reverse
mutation
-at
i.DR;
ND
Pontive dose-response at 104 .and 157
niM
*+-> positive, - = negative, (T) = toxicity, ND = not determined, DR = dose-respanse observed.
* S9 liver fraction isolated from male Wistar rats induced wifli pheaobarbital.
CS§ liver fraction isolated from rats induced with Aroclor 1254.
11S5> Brer fraction isolated from mate Wistar rats induced with Aroclor 1254 and pheoobaibital and separated into aiicrosomal and cyto solic frictions.,
* 89 liver fraction isolated from male Sprague-Dawley rats induced with Aroclor 1254 and separated into microsomal and cytosolic fractions.
f S9 fiver fraction isolated from male Spragne-Dawley rats induced with .Aroclor 1254.
*SS> liver fraction isolated from .male Fischer F344 rats induced 'with Arocloi and separated into microsomal .and cytosolic fractions.
hS9 liver fractions isolated from male B6C3Fi mice or male AlpkAPfSD (AP) rats.
11827
11828 Source: U.S. EPA (20111 pp. 104-106
11829
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Table 4-21, Results from in vitro genotaxicity assays of diclilorometUnue with mammalian systems, bv type of test
Assar
Test svstem
C oucenn ations
Re-suits
Reference
Forward mutation (hgprf
lOCUS)
Chinese hamster epithelial
cells
10.000. 20.000.
30.000, 40.1)1)0 ppm
Negative
loiigenetal > l^Sl i
DNA SSBs by alkaline
elution
¦Syrian golden hamster
hepatoevtes
0.4-90 mM
Negative Cytotoxicity at P0 mM as measured by Trypan
blue exclusion assay.
Graves et al : Ni'J i
Sister chromatid
extha«iee
Chinese hamster V79 cells
10.000. 20.00-0.
30.000. 40.000 ppm
Weak positive with or without rat-liver microsomal system
Joagen et al ; 1PS11
Sister chromatid
exchange
CHO cells
Not prov ided
Negative with or without rat liver S9
Thilagar and Kumaroo
{19S?j
DNA and protein
synthesis
CHG cells
1.000 iis mL
Negative
Garrett uid Le-vtas
Unscheduled DNA
synthesis
Chinese hamster epithelial
cells
5.000. 10.000.
30.000, 50,000 ppm
Negative
Jongen et al. (1981*1
Calf
DNA adducts
Calf thymus DNA
50 rnM
Positive m the presence ofbacteii.il GST DM11 and
Aeliloroiiietliane deSwlogenase; adducts priniarih formed
with tlie guanine residues
Kayser and Vuiileiiniier
12001)
DNA adducts
Calf thymus DNA
Up to 60 nM
Positive tn the presence ofbacteri.il GST DM11. rat GST5-
5. and Iranian GSTTtl: adducts primarily formed with the
guanine residues
Marsett et al i'2nu41
Human
Micronucleus test
Human AHH-1. MCL-5,
h2El cell lir.ei
Up to 10 mM
Positive ui MCL-5. h2£l cell lines, increasing with
increasing concentrations from 2 to 10 mM
Doherty et ai i H'Po1
DNA damage by comet
ctsssy
Primary Iranian lung
epithelial cells.
10. 100. 1.000 ;.M
Weak trend, 'ndepeadent of GST activity (GST enzymatic
activity not present in the cultured cells)
Landx et al. (2003 i
DNA SSBs by alkaline
elation
Human hepatoevtes
5-120 mM
Negative Cytotoxicity' -90 mM as measured by Trypan blue
exclusion assay.
Graves et al. {1995>
Sister chromatid
exchange
Primary human peripheral
blood mononuclear ceils
0. 15. 30. 60. 125.
250, 500 ppm
Sister cliromatid exchanges significantly increased at
exposures of 00 ppm and higher, most strongly in the high
GST-T1 activity group
GJvera-Bello et al 120101
DNA-proteai cross-links
Human hepatoevtes
0 f-5 itiM
Negative
Casanova et al. :
Unscheduled DNA
synthesis
Human peripheral
lymphocytes
250. 50C 1,000 ppm
Negative with or without rat liver 59
Perocco and Prodi 11.:'81>
11830
11831
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Table 4-21. Results from in vitro aenotoxicity assays of clichlorometliaiie with mammalian systems, by type of test
Assay
Test system
C oucentrafkms
Results
Reference
Moose
DNA breaks by alkaline
elation
Mouse hepatocytes
|B(?C3F;t
0, 0,4. 3 0. 5.5 niM
Positive with dose-response. No toxicity at these doses as
measured by trypan blue exclusion assay.
Graves et si. (1994a I
DNA SSBby alkaline
elation
Mouse C lara cells
•B6C3F:"i
0. 5. 10. 30. 60 mM
Positive with dose-response; DNA damage reduced by
addition of GSH depletor No toxicity at these doses as
measured by trypan blue exclusion assay.
Graves et al. t IPPi")
DNA-protem cross-links
Mouse liepitocvtes
|36C3F; i
0.5-5 mM
Positive
Casanova et al. {l?'P7'i
Rat
DNA SSBs by alkaline
elution
Rat kepatocvtes
; Alpk APfSD [AP] i
0, 30. 60, 90 mM
Positive ".villi dose-response. Cytotoxicity at 90 mM as
measured by trypan blue exclusion assay.
Graves et al f 1994a)
DNA-protem cross-links
Rat hepatocvte» iFischer-
34-Ti
0.5-5 mM
Negative
Casanova et al , 1P97i
Unscheduled DNA
synthesis
Sat hepalocytes
Up to 16 mM
(measured)
Negative
Andrae and Wolff: 1 - S3 >
Hamster with GST activity from mouse
hprt mutauon analysis
CHO cells
3.000 and 5.000 ppiu
Positive with mouse liver cytowl
Graves and Green lj£% >'
hprt mutation analysis
CHQ eels
2.500 ppm3
Mutation spectrum supports role of glutathione conjugate
Graves et al. U9P6)
DNA SSBs and DNA-
protem cros-.-hnks
CHO cells
3.000 and 5.000 ppai
Positive at concentration of 0.5° o i v>v; for SSBs m presence
of mouse liver cytosol. but increase m DNA-protein cross-
links marginal. formaldehyde nil absence of mouse liver
cytosol; was positive ar 0.5 iixM for both DNA SSBs and
DNA-protem cross-links. CHO ceil cultures were suspended
Graves and Green #2226)
Comet assay
Chinese iiauv-ter V7£> king
fibroblast cells tranifected
with mouse GST-Tl
2 s ; 10 niM
A Significant, dose-dependeat increase m DNA damage
resulting from DNA-proteia cross-links 111V7P cells
tran:fected with mouse GST-Tl compared to parental cells
Hu et ?1
DNA-proteia cross-links
Svnan golden hamster
bepatoevtes
0,5-5 mM
Negative
Casanova et al (1997)
DNA-protem cross-links
CHO cells iKl)
60 mM
Positive only with mouse liver S9 added: formaldehyde
positive at lower conceatrationi (0.5-4 mM)
Graves et al i
Hamster without GST activity from mouse
Chromosomal
aberrations
CHO cells
Not provided
Positive, independent of rat liver S9
i kilaear and Kumaroo
ll:?831
11832
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Table 4-21, Results from In vitro genotoxicitv assay? of diclilornmethane with mammalian systems, by type of test
Assay
Test system
C ouceiin .uioiis
Results
Reference
Unscheduled DNA
synthesis
Primary human fibroblast
5.000. 10.000.
30.000. 50.000 ppm
Negative
longen et al :'i~'Sl)
CHO = Chinese hamster ovary; hprt = hjpoxantliiiie-gaaiiiae pliosphofibosyl transferase
1 Methods section described concentration as 3,000ppm (0.3%v/v) but Table 1 describes it as 2,500 ppm • 0 25'# v vi
11833
11834 Source: U.S. EPA (20111 pp. 108-110
11835
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Table 4-22, Results from, in tit© graotoxicity assays of dKhloromethane in
insects
Assay
T»:i ttkis
Doses
Result
Reference
Gene mntatMHi (sex-
linked recessive isthal)
Dit rophii a
Positive (fading
exposure)
Gocke rr a] 119SI)
Gene mutation (ui-
liokei wmhi leilal,
somatic nutation and
rEcombimtio^l
Drosopbila
6 b.—1 S5G. 5.5CC'ppio
1 avV.—25 (SO. 4.660 ppm
2 mi«—I,3~0. 2.360 ppm
(all JC-p:o:;icui:» >
(miubtfton
exposure)
Krimtn et aL ("19911
Somatic w.
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T tl le 4-23. Results from in vii o senotoxidty assay? of dichlororaethaue in mice
Assay
lest system
Route Mid dose
Duration
Results
Reference
Kias and Hras oncogenes
Mouse liver aad lung
tumors (BtSC 3Fl"i
0, 2.TOO ppm
Up to 104 wks
No difference in mutation profile
between control and
dieliloronietliaae-induced liver
tu mors; number of spontaneous lung
tumors (n = 7) limits comparison at
this site
Devereux et al
(199}\
p53 tumor suppressor gene
Mouse liver aad tone
tumors (B6C3Fi'i
0, 2.000 ppr.i
Up to 104 wks
Loss of heterozygosity infrequently
seen m hver trailers from exposed or
controls; number of spontaneous
lime rasnofs (a = ¦?) limits
comparison at tins site
He?: ft al il°P3i
Micranucleus test
Mou* bone marrow
iNMRT-
425, 850. or 1.700 mg/kg
Two closes
Negative at all doses
Gocke et al :i9Sl)
Micromideus test
Mouse bone marrow
IC57BL SJ -Upk)
Gavaee 1.250. 2.500, and
4,000 mg.tg
Single dose
Negative at .ill doses
Sheldon et al. (1987)
Mttronitcieiis test
Mouse peripheral red
blood cells iB6C3F>s
Inhalation 6 far d 5 d wit,
0 4.000. S 000 ppin
2 wk
Positive at 4 000 and S 000 ppm
Allen etal i IPPC0
Micromicleus test
Mouse peripheral red
blood ceils i B6C3F; '•
Iiihalatioii, 6 M6, 5 d 'wk.
i). 2.000 ppm
12 wks
Positive at 2.000 ppm
Allen et al i l°°0i
Chromosome aberrations
Mouse bone marrow
IC57BL 6Jt
Intraperitoneal 100. 1.000,
1.5,00. 2.000 mz kg
Single dose
Negative
Wfstbrook-C'ollios et
al. tlPftui
Chromosome aberrations
Mouse borne marrow
t"B6C3F-j
Subcutaneous. 0. 2.500.
5.000 mg-kg
Single dose
Negative
Allen et al. 1ISPOi
Chromosome aberrations
Mouse lime and bone
marrow cells :B6C3Fi)
Inhalation. 6 hr-d. 5 d wk.
0, 4.000. S.000 ppm
2 wis
Increase beginning at 4.000 ppm m
Line cells; increase only at S.000
ppm in bone marrow cells
Allen et al. tlPPOt
DNA SSBs by alkaline elution
Mouse hepatoeytes
(B(?C3Fij
Inhalation 2 000 and
4,000 ppm
3 or 6 hrs
Positive at 4.000 ppm at 3 and 6 hrs
Graves et aL fi9P4al
DXA SSBs. by alkaline elution.
Mouse liver and lung
homogenate (B<5C3Fi)
Liver: inhalation. 2.000.
4.000, 6.000. S.000 ppsi
Lunr inhalation. 1.000.
2.000. 4.000. 6.000 ppai
3 hrs
3 hrs
Liver positive at 4 (00-8,000 ppm
Lung: positive at 2.000-4,000 ppm
Graves et al. f 1995)
(Table 4-13. page 1 of 2)
11839
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Table 4-23. Results from in vivo genotoxicify assays of dichloromethaiie in mice
Assay
Test system
Route and dose
Dm alioli
Results
Reference
DNA damage by comet assav
Mouse stomach, urxary
bladder, kidnev. brain,
bone marrow (CD-I}
Garage, 1.720 nig ke;
organs harvested at 0
(controls. 3. and 24 iirs
Single dose
Negative 3 or 24 hr after dosing
S?.sai"i et al > 1 ''-'S i
DNA damage by comet assay
Mouse liver and tone
cells {CD-l'i
Garage. 1.720 mg'kg:
organs harvested at 0
(controls. 3. and 24 Sirs
Single dose
Positive only at 24 hrs after dosing
Sasaki et al 09981
DNA adducts
Mouse liver and kidney
cells !.36C3F; i
Intraperitoneal. 5 mg kg
Single dose
Negative
Watanabe et al.
tiSi)
DNA-proteia cross-links
Mouse liver and ling
jcelk (B6C'3F;l
Inhalation. 6 hr d. 3 d.
4.000 ppm
3d
Positive in mouse liver cell: at 4.000
ppm. negative :n mouse lima cells
Casanova et al.
i 1902)
DMA-protein. cross-links
Mouse liver aacl tang
cells {B6C3F-J
Inhalation. 6 br'd. 150.
500. 1.500. 3.000.
4.000 ppm
3d
PosiM* n; mouse liver cells at 500-
4.00(i ppm. negative m mouse lung
cells
Casanova et ?1
tl5rX'6)
Sister chromatid exchange
Moose bone marrow
iC'STBL <5J>
Intraperitoneal. 100. 1.000,
1.500. 2.000 m&ke
Single dose
Negative
Westbrook-Collins et
al 11 PPG i
Sister chroma'id exchange
Mouse bone marrow
[B6C3F,)
Subcutaneous. 0. 2.500.
5,00-0 mg.kg
Single dose
Negative at all doses
Allen et al ilPPQi
Sister chromatid exchange
Mouse lung cells and
peripteral lymphocytes
(3«5C3FO
Inhalation 6 lir d. 5 d wk.
0,4.000. S.000 ppm
2 wks
Positive at 4.000 and S.000 ppm for
mouse lung cells and at 8.000 ppm
for peripheral lymphocytes
Allen et al. 11i
Sister chromatid exchange
Mouse lung cells
t'B6C3F>)
Inhalation c hr d 5 d'wfc
0. 2.000 ppm
12 iris
Positive at 2.000 ppm
Allen et al. i
DNA synthes::
Mouse liver (BtOFi i
Garage. 1.000 mg kg:
inhalation. 4.000 ppm
Single dose:
2hn
Negative in both oral and inhalation
studies
Lefevre and Ashby
11983)
Unscheduled DNA synthesis
Mouse hep.itoc-.ies
fB6C3F>.}
Inhalation. 2.000 mi
4.000 ppm
2 or 6 hrs
Negative
Tiueman and Ashby
i ¦)
(Table 4-23; page 2 of 2)
11840
11841 Source: U.S. EPA (20111 pp. 115-116
11842
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Table 4-2-1. Result* from in vivo geuotoxiciry assays of dichloromethane in rats and hamsters
Assay
Test system
Route and dow
Duration
Results
Reference
DNA SSBs by alkaline ehmen
Rat hepatocytes
Inhalation. 3 or 6 hrs.
2.000 and 4.000 ppm
3 or 6 lirs
Negative at all concentrations
and rune points
Graves et al
ilgP4ai
DNA SSBs by alkaline etotion
Rat liver homogenate
Gavage. 2 do;es. 425 r.ig'kg
and 1.275 me kg,
administered 4 and 2'. his
before liver harvesting
4 or 21 ins (tune
between do sine and
hver harvesting)
Positive at 1.275 Kig/kg
Kitclim and
Brown! 19SS11
DNA SSBs by alkaline elution
Rat liver and lung
homogenate
Liver: inhalation. 4.000,
5.000 ppm
Lxaig inhalation. 4.000 ppm
3 las
3 Ins
Negative for both liver and
lung at all concentrations
Graves et al.
t' 1 ^ P ;
DNA adchKts
Rat Ever and kidney
cells
Intraperitoneal. 5 mg'kg
Single dose
Negative
YVatanabe et al
¦:200?j
DMA-protein cross-lints
Hamster liver and lung
cells
Inhalation. 5 hr d. 500. 1,500.
4.000 ppm
3 d
Negative at all concentrations
Casanova et al
>• lgpot
Unscheduled DNA synthesis
Rst liepatocytes
Gavage. 100. 500.
1.000 me kg
Liver harvested 4 and
12 hrs after dosing
Negative 4 or 12 lirs alter
dosing
Tiueman and
Ashby 11 PS 71
L'nscheduled DNA synthesis.
Rat hepatocytes
Inhalation. 2 or 6 lir;.
2.000 and 4.0CH] ppm
2 or 6 lirs
Negative at both
concentrations and exposure
durations
Trueman and
Ashby 11P87I
Unscheduled DNA synthesis
Rat hepatocytes
Intraperitoneal single dose.
40-0 me kg
Single dose
Negative 4S lirs after dosing
Mirsalis et al.
11843
11844 Source: U.S. EPA (20111 p. 120
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Table 4-25. C'ompaiison of In vivo dichioromethane genotoxicicy assay? targeted to tang oi In er cells, by species
Assay
Srudie? in B6C3F mice
Studies in rats
Test system
Route. dose (duration1)
Results
Refei Mice
Test system
Route, dose (duration)
Results
Reference
Chromosome
aberrations
Lung cells
Inhalation. 6 hr d. 5 d wk. 0.
4,000, 8,000 ppm \2 wks)
Positive at
8,000 ppm
Allen et al.
flupOi
No studies
DNA SSBs
by alkaline
etaton
Hepatocytes
Inhalation. 2.000 and
4.000 ppm i,3 or 6 hrs)
Positive at
4.000 ppm
Graves et al.
1 lPP4if
Hepatocytes
Inhalation. 3 or 6 hrs.
2.000 and 4.000 ppm
Negative at all
concentrations
and time
points
Graves et al.
(l»4a)
DNA SSBs
by alkaline
eltilioii
Liver and
lung
homogenate
Liver: inhalation, 1.000,
4.00(1, 6.0(Ci. S.000 ppm
(3 lira, i
Luag: inhalation. 1,000.
2,000. 4.000. 6.000 ppm
(3 hrs)
Liver. Positive at
4.000-8.000 ppm
Liiag: Positive at
2.000-4.00-0 ppm
Graves ef al
11PP5)
Liver and Sung
homogenate
Liver: mhalation.
4.000. 5,000ppm
Lung inhalation.
4.000 ppm
Negative in
liver and lung
at all
concentrations
and time
points
Graves et at.
i1PP5)
DNA SSBs
bv alkaline
elat;oa
No studies
Liver
homogenate
Gavage, 425 me'kg and
1.275 me kg
Positive at
1.275 mg kg
Kitchrn and
Brown i 1)
DNA damage
by cociet
assay
Liver and
hang cells
Gavage. 1.720 me kg.
organs harvested at 0
f control:. 3. and 24 tars
Positive only at
24 fcrs after dosing
Sasaki et al..
d£i£i
No studies
DNA-protein
crosslinks
Liver and
lung cells
Inhalation. 6 tar d. 3 d. 4.000
ppm. (3 d J
Inhalation. 6 hr d. 150. 500,
1.500. 3.000.4.000 ppm (3
A)
Positive :n liver
4.000 ppm
Positive in liver at
500-4.000 ppm;
both studies
negative in iung
C asrnova et
ai
No studies
DNA adducts
Liver and
kidney cells
Intraperitoneal, 5 mg/kg
Negative
Watambe ef
al i200T>
Liver and
kidney cells
Intraperitoneal, 5
mg kg
Negative
Wafaaabe et
al f2007)
Sister
chromatid
fXCtlllgf
Lung cells
Inhalation 6 lir- d. 5 d v/k. 0.
4,000. 8.000 ppm (2 wks)
Inhalation i> hr d. 5 d wk. 0.
2.000 ppm (12 wks)
Positive at
8.000 ppm
Positive at
2.000 ppm
Allen et al.
(1°P0i
No stiwies
DNA
synthesis
Liver
Gavage. 1,000 me kg.
inhalation 4.000 ppm
(2 lir -1
Negative ir oral and
Mialation studies
Lefevre aid
Ashby (19S9\
No studies
liable4-25 page 1 of2)
11845
Page 683 of 725
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T f le 4-25. C ompniisou of in vivo (licliloi oineflmne genotoxicity assays mi get
-------
11848
11849
11850
11851
11852
11853
11854
11855
11856
11857
11858
11859
11860
11861
11862
11863
11864
11865
11866
11867
11868
11869
11870
11871
11872
11873
11874
11875
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
Appendix L SUMMARY OF OCCUPATIONAL EXPOSURES
AND RISKS FOR PAINT AND COATING REMOVERS
Use of methylene chloride for commercial paint and coating removal were assessed in the TSCA
Work Plan Chemical Risk Assessment Methylene Chloride: Paint Stripping Use CASRN: 75-09-
2 (U.S. EPA. 2014). This appendix summarizes the occupational exposures and risk estimates for
this use. The majority of this appendix is pulled directly from the 2014 risk assessment in
addition to relevant data provided to EPA as described below. This appendix provides detailed
analysis of the paint and coating removal scenario and similarly detailed information on other
occupational exposure scenarios is provided in the supplemental document titled "Risk
Evaluation for Methylene Chloride (Dichloromethane, DCM) CASRN: 75-09-2, Supplemental
Information on Releases and Occupational Exposure Assessment"(EPA. 2019b).
Additional occupational exposure monitoring data for paint and coating removal have been
provided by DoD (Defense Occupational and Environmental Health Readiness System -
Industrial Hygiene (DOEHRS-IH). 2018). The raw data for DoD are summarized in Table Apx
L-l. For estimating risks, samples with exactly 15 mins of sampling time were grouped for acute
risks, and samples between >4 and 8 hrs were proportionately scaled to generate 8-hr TWA data
for chronic risks; these acute and chronic estimates are shown in Table Apx L-2.
TableApx L-l. Raw Air Sampling Data for Methylene Chloride During DoD Uses in Paint
and Coating Removers
Sample Duration Ranges
# of Samples
Exposure Concentrations (mg/m3)
50th Percentile
95th Percentile
0 to 15 mins
377
28.7
285
> 15 to 30 mins
184
5.7
151
> 0.5 to 1 lir
101
16.2
230
> 1 to 4 lir
84
9.9
378
> 4 to 8 lir
11
7.7
54
Table Apx L-2. Acute and Chronic Exposures for Methylene Chloride During DoD Uses in
Paint and Coating Removers
TWA Duration
# of Samples
Exposure Concentrations (mg/m3)
50th Percentile
95th Percentile
15-minute TWA
324
27.4
289
8-lir TWA Exposure
Concentration
11
5.0
47.1
Average Daily Concentration
(ADC)
1.1
10.8
Lifetime Average Daily
Concentration (LADC)
2.0
24.2
Table Apx L-3 presents modeled dermal exposures during paint and coatings removal uses.
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TableApx L-3. Summary of Dermal Exposure Doses to Methylene Chloride for Paint and
Coatings Removal Uses
()ccii|);ilion;il
Kxposnre
Scenario
I so Selling
(Industrial \s.
Commercial)
Miixiniiini
Wei «hl
Iraclion, V.!,.,-,!!1'
Dermal Kxnosure Dose
(iiii>/cl:iv) and (ilo\e
Protection l iiclor (PI-)
C'nlciiliitecl
Iraclion
Absorbed. I'.,i>s
Paint and Coatings
Removal
Industrial
1
180 (PF = 1)
36 (PF = 5)
18 (PF= 10)
9 (PF = 20)
0.08
Paint and Coatings
Removal
Commercial
1
280 (PF = 1)
57 (PF = 5)
28 (PF = 10)
0.13
a - The 2016 CDR includes a submission that reports >90% concentration during commercial and consumer use
(U.S. EPA. 20.1.6'). EPA assumes up to 100% concentration, and that similar concentrations will be used for
industrial paints and coatings removers.
Note on Protection Factors (PFs): All PF values are what-if type values where use of protection factors above 1 is
valid only for glove materials that have been tested for permeation against the methylene chloride-containing liquids
associated with the condition of use. For scenarios with only industrial sites, EPA assumes that workers are likely to
wear protective gloves and have training on the proper usage of these gloves, which assumes a protection factor of
20. For scenarios covering a broader variety of commercial and industrial sites, EPA assumes either the use of
gloves with minimal to no employee training, which assumes a protection factor of 5, or the use of gloves with basic
training, which assumes a protection factor of 10. If less-protective gloves are used, a protection factor of 1 may be
assumed.
The remainder of this appendix is an unedited excerpt of Chapter 3 sections covering the
occupational exposures (Section L.l) and risk estimates (Section 3.4) of the 2014 risk
assessment. Table L-6 below summarizes the results of the exposures for the highest exposed
population from the risk assessment. Section L.l refers to appendices in the 2014 risk
assessment, which may be accessed for more details.
L.l OCCUPATIONAL EXPOSURE ASSESSMENT FOR THE USE
OF DCM IN PAINT STRIPPING
Section L. 1.1 summarizes the approach and methodology used for estimating occupational
inhalation exposures to DCM for the use of DCM-based paint strippers. Section L. 1.1.3 lists the
occupational exposure estimates for the highest exposed worker population. Additional
information is found in Appendices F and G [from the 2014 risk assessment].
Appendix F describes the industries that may use DCM-based paint strippers, worker activities,
processes, numbers of sites, and numbers of exposed workers. Appendix G provides details
about the air concentrations and associated worker Average Daily Concentrations (ADCs) and
Lifetime Average Daily Concentrations (LADCs) presented in this section.
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L.l.l Approach and Methodology for Estimating Occupational Exposures
L. 1.1.1 Identification of Relevant Industries
Because a variety of industries include paint stripping among their business activities, EPA made
the effort to determine and characterize these industries, with a special interest in small
commercial shops. EPA's interest in small shops for this assessment is due to the possibility that
these shops may have fewer resources or less expertise and awareness of hazards, exposures, or
controls as compared to large shops.
There is no standard or universal definition for the term "small shop". The various meanings of
this term can depend upon the industry sector (e.g., metal finishing, furniture repair, foam
production, chemical manufacturing) or governmental jurisdiction (e.g., OSHA, EPA, other
countries). For the purpose of risk assessment of work plan chemicals, EPA generally refers to
entities, businesses, operators, plants, sites, facilities, or shops interchangeably and considers a
number of factors to categorize these as small. The factors that have been usually considered
include revenue, capacity, throughput, production, use rate of materials, or number of employees.
Further characterization to determine which factors best distinguish small shops for all the
various industries that perform paint stripping would require more research.
EPA reviewed the published literature and evaluated the 2007 North American Industry
Classification System (NAICS) codes to determine industries that likely include paint stripping
activities (see Appendix F, Table F-l) [2014 risk assessment].
The following industries were identified:
• Professional contractors;
• Bathtub refinishing;
• Automotive refinishing;
• Furniture refinishing;
• Art restoration and conservation;
• Aircraft paint stripping;
• Ship paint stripping; and
• Graffiti removal
By identifying these industries, EPA identified corresponding worker subpopulations that may be
exposed to DCM due to the use of these paint strippers. Appendix F details the industries
identified, processes and worker activities that may contribute to workplace exposures. Section
L.l.l.2 and Appendix F [2014 risk assessment] provide the estimated number of workers
exposed nationwide and average numbers of employees per facility for these industries.
L.1.1.2Estimation of Potential Workplace Exposures for Paint Stripping Facilities
Workplace exposures based on monitoring data: EPA used air concentration data and
estimates found in literature sources to serve as exposure concentrations for occupational
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inhalation exposures to DCM. These air concentrations were used to estimate the exposure levels
for workers exposed to DCM as a result of the use of DCM-based paint strippers.
EPA did not find enough monitoring data to determine complete statistical distributions of actual
exposure concentrations for the exposed population of workers in each of the industries. Ideally,
EPA would like to know 50th and 95th percentiles for each population, which are considered to be
the most important parts of complete statistical exposure distributions. The air concentration
means and midpoints (means are preferred over midpoints) served as substitutes for 50111
percentiles, and high ends of ranges served as substitutes for 95th percentiles.
Data sources often did not indicate whether monitored exposure concentrations were for
occupational users or bystanders. Therefore, EPA assumed that these exposure concentrations
were for a combination of users and bystanders. Some bystanders may have lower exposures
than users, especially when they are further away from the source of exposure.
Additionally, inhalation exposure data from OSHA and state health inspections were obtained
from the OSHA's Integrated Management Information System (IMIS) database. However,
OSHA IMIS data were not used to estimate workplace exposures, except where noted, because
of the high degree of uncertainty and questionable relevancy of these data to stripping with
DCM-containing products. Refer to Appendix G for a detailed discussion of the OSHA IMIS
data.
Workplace exposure scenarios evaluated in this assessment: Workers performing DCM-
based paint stripping might or might not use a respirator and may be exposed to DCM at
different exposure frequencies (days per year) or working years. Thus, EPA assessed acute risks
for 4 occupational scenarios and chronic risks for 16 occupational scenarios based on 8-hr time-
weighted average (TWA) exposure concentrations and different variations in exposure
conditions. These scenarios were constructed within each industry evaluated in the assessment.
To estimate acute exposure, EPA defined 4 scenarios to reflect a combination of the following
(Table Apx L-4):
• No use of a respirator (APF = zero);
• Use of a respirator with an APF of 10, 25, or 50, which would reduce the personal breathing
concentration by 10-, 25- or 50-fold (i.e., 0.1, 0.04, 0.02), respectively.
Table_ApxL-4. Acute Occupational Exposure Scenarios for the Use of DCM-Based Paint
Strippers
Acute
Scenario
Respirator APF a
8-hr TWA Concentration
Multiplier b
Scenario Description
1
0
1
No respirator
2
10
0.1
Respirator APF 10
3
25
0.04
Respirator APF 25
4
50
0.02
Respirator APF 50
Notes:
a APF= assigned protection factor. APFs of 10, 25 or 50 mean that the respirator reduced the personal breathing
concentration by 10-, 25- or 50-fold (i.e., 0.1, 0.04, 0.02).
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b As indicated in equation 3-2, these multipliers are applied to the 8-hr time-weighted average (TWA) acute
exposure concentrations.
To estimate chronic exposure, EPA defined 16 scenarios to reflect a combination of the
following (Table Apx L-5):
• No use of a respirator (APF = zero)29;
• Use of a respirator with an APF of 10, 25, or 50;
• An exposure frequency (EF) of the assumed Scenario 1 value of 250 days per year or half of
the assumed Scenario 1 value (the midpoint between the assumed Scenario 1 value and zero:
125 days per year); and
• Exposed working years (WY) of the assumed Scenario 1 value of 40 years or half of the
assumed Scenario 1 value (the midpoint between the assumed Scenario 1 value and zero: 20
years).
The multipliers in Tables Apx L-4 and L-5 were used to adjust the exposure estimates of acute
and chronic Scenario 1, respectively, to obtain the exposure estimates for the other exposure
scenarios. Additional information is presented below about the estimation approach to calculate
the acute and chronic exposure estimates.
29 APF assumptions are the same for both acute and chronic
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TableApx L-5. Chronic Occupational Exposure Scenarios for the Use of DCM-Based Paint
Strippers
Chronic
Scenario
Respirator
APF a
Exposure
Frequency
(EF) (days/yr)
Working
Years
(WY)
(years)
ADC/LAD
C
Multiplier
b
Scenario Description
1
0
250
40
1
No respirator, high ends of
ranges for EF and WY
2
10
250
40
0.1
Respirator APF 10, high ends
of ranges for EF and WY
3
25
250
40
0.04
Respirator APF 25, high ends
of ranges for EF and WY
4
50
250
40
0.02
Respirator APF 50, high ends
of ranges for EF and WY
5/9
0
250/125
20/ 40
0.5
No respirator, one midpoint
and one high end of range for
EF and WY
6/10
10
250/125
20/ 40
0.05
Respirator APF 10, one
midpoint and one high end of
range for EF and WY
7/11
25
250/125
20/ 40
0.02
Respirator APF 25, one
midpoint and one high end of
range for EF and WY
8/12
50
250/125
20/ 40
0.01
Respirator APF 50, one
midpoint and one high end of
range for EF and WY
13
0
125
20
0.25
No respirator, midpoints of
ranges for EF and WY
14
10
125
20
0.025
Respirator APF 10, midpoints
of ranges for EF and WY
15
25
125
20
0.01
Respirator APF 25, midpoints
of ranges for EF and WY
16
50
125
20
0.005
Respirator APF 50, midpoints
of ranges for EF and WY
Notes:
a APF= assigned protection factor. APFs of 10, 25 or 50 mean that the respirator reduced the personal breathing
concentration by 10-, 25- or 50-fold, respectively.
b As indicated in equation 3-4, these multipliers are applied to the chronic average daily concentrations (ADCs)
and lifetime average daily concentrations (LADCs).
3PA evaluated scenarios both with and without respirator use and a range of respirator APFs
because no data were found about the overall prevalence of the use of respirators to reduce DCM
exposures and it was not possible to estimate the numbers of workers who have reduced
exposures due to the use of respirators (as described by the data and information sources
presented in Appendices F and G [2014 risk assessment]).
Likewise, EPA made assumptions about the exposure frequencies and working years because
data were not found to characterize these parameters. Thus, EPA evaluated occupational risks by
developing hypothetical scenarios under varying exposure conditions (i.e., use of respirators with
different respiratory protection factors, and different exposure frequencies and working years).
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Approach for calculating acute and chronic workplace exposures: To facilitate the exposure
calculations for the occupational scenarios, EPA first estimated the acute and chronic exposure
estimates for Scenario 1 (highest exposure group). Equations are described below.
The exposure estimates for Acute Scenarios 2 to 4 and Chronic Scenarios 2 to 16 were obtained
by adjusting scenario 1 (highest exposure group) with various multipliers (Tables 3-1 and 3-2 for
acute and chronic, respectively). The acute multipliers reflected the numerical reduction in
exposure levels when respirators were used. The chronic multipliers reflected the numerical
reduction in exposure levels when respirators were used and/or other EF and WY values were
used. Although 16 chronic scenarios were possible, scenarios 5 through 8 and 9 through 12
resulted in the same multiplier regardless of whether the scenario used an EF of 250 days/yr and
a WY of 20 yrs, or an EF of 125 days/yr and a WY of 40 years.
Acute occupational exposure estimates
For single (acute) workplace exposure estimates, the DCM single (acute) exposure concentration
was set to the 8-hr TWA air concentration in mg/m3 reported for the various relevant industries.
EPA assumed that some workers could be rotating tasks and not necessarily using DCM-based
paint strippers on a daily basis. This type of exposure was characterized as acute in this
assessment as the worker would clear DCM and its metabolites before the next encounter with
the DCM-containing paint stripper.
Equation L-l was used to estimate the single (acute) exposure estimates for acute scenario 1
(EPA. 2009V
(Eq. L-l)
EC scenario 1 — C
where:
EC scenario i = exposure concentration for a single 8-hr exposure to DCM (mg/m3) for
scenario 1
C = contaminant concentration in air for relevant industry (central tendency,
low- or high-end 8-hr TWA in mg/m3 from Appendix G, Table G-2 or
G-5);
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Equation L-2 was used to calculate the acute exposure estimates for scenarios 2 through 4.
(Eq. L-2)
EC scenario 2—~ 4 = EC scenario 1
X M acute
where:
EC scenario 2^4 = exposure concentration for a single 8-hr exposure to DCM
(mg/m3) for acute scenarios 2, 3, or 4;
EC scenario i = single (acute) exposure concentration for relevant industry (8-hr
TWA in mg/m3 from Appendix G, Table G-2 or G-5);
M acute Scenario-specific acute exposure multiplier (unit less) for relevant
industry (see Table 3-1)
Acute exposure estimates for scenario 1 are presented in Table 3-3. Acute exposure estimates for
scenarios 2 through 4 were integrated into the risk calculations by applying the scenario-specific
multipliers. Thus, separate tables listing the acute exposure estimates for scenarios 2 through 4
are not provided in this section, but are available in a supplemental Excel spreadsheet
documenting the risk calculations for this assessment (DCM Exposure and Risk
Estimates 081114.xlsx).
Chronic occupational exposure estimates
The worker exposure estimates for the non-cancer and cancer risk calculations were estimated as
ADCs and LADCs, respectively. Both ADC and LADC calculations for Scenario 1 were based
on the 8-hr TWA air concentration in mg/m3 reported for the various relevant industries
(Appendix G, Table G-5). EPA assumed that the worker would be doing paint stripping activities
during the entire 8-hr work shift on a daily basis. Equation 3-3 was used to estimate the chronic
ADCs and LADCs for Scenario 1 (EPA. 20091
(Eq. L-3)
^ _ C x ED x EF x WY
scenario 1 — ~
/l 1
where:
EC scenario i = exposure concentration (mg/m3) for Scenario 1 = ADC for chronic non-
cancer risks or LADC for chronic cancer risks for Scenario 1;
C = contaminant concentration in air for relevant industry (central tendency,
low- or high-end 8-hr TWA in mg/m3 from Appendix G, Table G-2);
ED = exposure duration (hrs/day) = 8 hrs/day;
EF = exposure frequency (days/yr) = 250 days/yr for high-end of range
for both ADC and LADC calculations:
WY = working years per lifetime (yrs) = 40 yrs for high end of range
for both ADC and LADC calculations; and
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AT = averaging time (years x 365 days/years x 24 hrs/day) = 40 yrs for high
end of range for ADC calculations; 70 yrs for LADC calculations, which is used
to match the years used to calculate EPA's cancer inhalation unit risk (IUR).
Equation L-4 was used to estimate the chronic ADCs and LADCs for scenarios 2 through 16.
(Eq L-4)
EC scenario 2-^> 16 = EC scenario 1 x M chronic
where:
EC scenario 2 —>• 16 = exposure concentration for chronic exposure concentration (ADC
or LADC) to DCM (mg/m3) for chronic scenarios 2 through 16
EC scenario 1 = chronic exposure concentration (ADC or LADC) for relevant
industry, chronic scenario 1 (in mg/m3 from Table 3-3);
M chronic = scenario-specific ADC/LADC chronic multiplier for relevant
industry (see Table 3-2)
Non-cancer and cancer exposure estimates (i.e., ADC and LADC, respectively) for scenario 1
are presented in Table 3-3. The estimates for scenarios 2 through 16 were integrated into the risk
calculations by applying the scenario-specific ADC/LADC multipliers. Thus, separate tables
listing the chronic exposure estimates for scenarios 2 through 16 are not provided in this section,
but are available in a supplemental Excel spreadsheet documenting the risk calculations for this
assessment (DCM Exposure and Risk Estimates 081114.xlsx).
Numbers of exposed workers and shop sizes: Knowing the sizes of exposed populations
provides perspective on the prevalence of the health effects. Thus, EPA estimated the current
total number of workers in the potentially exposed populations.
EPA found limited data on numbers of workers exposed to DCM in shops that use DCM-based
paint strippers. EPA relied on an estimation approach to estimate the total number of exposed
workers from the technical support document for the National Emission Standards for Hazardous
Air Pollutants (NESHAP) Paint Stripping Operations at Area Sources proposed rule (U.S. EPA.
2007).
Based on the NESHAP data and analyses, EPA estimates that over 230,000 workers nationwide
are directly exposed to DCM from DCM-based paint strippers. This estimate only accounts for
workers performing the paint stripping using DCM and does not include other workers
("occupational bystanders") within the facility who are indirectly exposed. EPA cannot estimate
the numbers of workers exposed in each of the individual industries that may use DCM-based
strippers. EPA also cannot estimate the numbers of workers exposed in small shops. Appendix E
details the literature search, data found, and assumptions for worker population exposed
nationwide.
EPA estimated the average number of employees per facility which can be a factor in
determining shop sizes. These estimates were derived by combining the facility and population
data obtained from the U.S. Census data, as described in Appendix F. The average number of
employees for the identified industries based on U.S. Census data were the following:
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• Professional contractors (likely to include Bathtub refinishing): 5 workers/facility;
• Automotive refinishing: 6 workers/facility;
• Furniture refinishing: 3 workers/facility;
• Art restoration and conservation (not estimated);
• Aircraft paint stripping: 320 workers/facility (for aircraft manufacturing only);
• Ship paint stripping: 100 workers/facility; and
• Graffiti removal: 8 workers/facility.
These averages give some perspective on shop size but are simple generalizations.
L.l. 1.3 Summary of Occupational DCM Exposure Estimates
Table Apx L-6 shows the DCM air concentrations used in this assessment for estimating acute
and chronic risks for the highest exposed worker scenario group (Scenario 1) within each
industry. The statistical issues of these estimates are briefly discussed in section L.5.1.
Acute and chronic DCM exposure estimates for Acute Scenarios 2 through 4 and Chronic
Scenarios 2 through 16 were integrated into the risk calculations by applying multipliers to
Scenario 1. Separate tables listing the acute and chronic exposure estimates are not provided in
this section, but can be found in the supplemental Excel spreadsheet - DCM Exposure and Risk
Estimates 081114.xlsx. Also, Table ES-1 provides a summary of the ranges of acute, ADC and
LADC estimates for the various occupational scenarios.
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TableApx L-6. DCM Acm
Scenario Grou
e and Chronic Exposure Concentrations (ADCs and LADCs) for Workers - Scenario 1 - Highest Exposed
p
Industry /
Activity
Time
Range of
Studies
ACUTE EXPOSURE ESTIMATES
Single 8-hr Concentration (mg/m3)a
CHRONIC EXPOSURE
ESTIMATES USED IN THE NON-
CANCER RISK ESTIMATES
ADC (mg/m3)b
CHRONIC EXPOSURE
ESTIMATES USED IN THE
CANCER RISK ESTIMATES
LADC (mg/m3)b
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Professional
Contractors
1981-2004
--
2,980
1,520
60
--
680
347
14
--
389
198
7.8
Bathtub
Refinishing
--
--
--
--
--
--
--
--
--
--
--
--
Automotive
Refinishing
2003
253
416
253
90
58
95
58
21
33
54
33
12
Furniture
Refinishing
1989-2007
499
2,245
(1,266)c
1,125
4.0
114
513
(289)c
257
0.9
65
293
(165)
C
147
0.5
Art
Restoration
and
Conservation
2005
2.0
0.5
0.3
Aircraft Paint
Stripping
1977-2006
--
3,802
1,944
86
--
868
444
20
--
496
254
11
Ship Paint
Stripping
1980
--
--
--
--
--
--
--
--
--
--
--
--
Graffiti
Removal
1993
260
1,188
603
18
59
271
138
4.1
34
155
79
2.3
Non-Specific
Workplace
Settings -
Immersion
Stripping of
Wood
1980-1994
--
7,000
3,518
35
--
1,598
803
8.0
--
913
459
4.6
12154
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TableApx L-6. DCM Acute and Chronic Exposure Concentrations (ADCs and LADCs) for Workers - Scenario 1 - Highest
Exposed Scenario Group
Industry /
Activity
Time
Range of
Studies
ACUTE EXPOSURE ESTIMATES
Single 8-hr Concentration (mg/m3)a
CHRONIC EXPOSURE
ESTIMATES USED IN THE NON-
CANCER RISK ESTIMATES
ADC (mg/m3)b
CHRONIC EXPOSURE
ESTIMATES USED IN THE
CANCER RISK ESTIMATES
LADC (mg/m3)b
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Non-Specific
Workplace
Settings -
Immersion
Stripping of
Wood and
Metal
1980
--
1,017
825
633
--
232
188
145
--
133
108
83
Non-Specific
Workplace
Settings -
Immersion
Stripping of
Metal
--
--
--
--
--
--
--
--
--
--
--
--
Non-Specific
Workplace
Settings -
Unknown
1997-
2004
357
428
357
285
81
98
81
65
47
56
47
37
Notes:
Sources are reported in Table G-2 and discussed in section G-3.
a Calculated acute single 8-hr concentrations are only estimated from 8-hr TWA exposures; see Equation 3-1. Airborne concentration conversion factor for DCM is 3.47 mg/m3
per ppm CNiosh. 201 lb\
b Calculated ADCs and LADCs are only calculated from 8-hr TWA exposures; see Equation 3-3.
c The values in parentheses are the 95th percentiles of the calculated acute single 8-hr concentrations and the calculated ADCs and LADCs.
— Indicates no data found.
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L.1.1.4Worker Exposure Limits for DCM
Both regulatory and non-regulatory worker exposure limits have been established for DCM by
OSHA, NIOSH, and the American Conference of Government Industrial Hygienists (ACGIH).
EPA analysis showed that the OSHA permissible exposure limit (PEL) and Action Level values
were exceeded for some industries using DCM-based strippers when the OSHA values were
compared to the air concentrations.
Table Apx L-7 provides a summary of the current occupational exposure values established by
OSHA, NIOSH, and ACGIH. Appendix F [2014 risk assessment] presents additional background
on processes, respiratory protection, facilities and worker populations.
OSHA's amended regulatory occupational exposure limits for DCM were effective April 10,
1997. The amendments included reducing the PEL, reducing and changing the averaging time of
the short-term exposure limit (STEL), adding an Action Level, and removing the ceiling limit
(OSHA. 1997a). See Appendix G, section G-2-3, for more details [2014 risk assessment].
Table Apx L-7. Occupationa
Exposure Limits for DCMa
Source
Limit Type
Exposure Limit
OSHA PEL
PEL (8-hr TWA) b
25 ppm c
STEL (15-minute TWA)
125 ppm
Action Level (8-hr TWA)
12.5 ppm
NIOSH exposure limits
IDLH d
2,300 ppm
Recommended Exposure Limite
Ca
ACGIH TLVf
8-hr TWA
50 ppm
Notes:
a Source: (OSHA. 1997a")
bPEL= Permissible exposure limit; TWA= Time-weighted average
0 Airborne concentration conversion factor for DCM is 3.47 mg/m3 per ppm (Niosli, 201 lb").
dIDLH = Immediately dangerous to life or health. IDLH values are based on effects that might occur from a 30-
minute exposure.
e The Recommended Exposure Limit notation "Ca" is for a potential occupational carcinogen. The NIOSH
Pocket Guide website has detailed oolicv recommendations for chemicals with "Ca" notations (Niosli.
2011b).
f TLV = Threshold limit value
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L.4 HUMAN HEALTH RISK CHARACTERIZATION
Exposure to DCM is associated with adverse effects on the nervous system, liver and lung. These
non-cancer adverse effects are deemed important for acute and chronic risk estimation for the
scenarios and populations addressed in this risk assessment.
DCM is likely to be carcinogenic to humans. The cancer risk assessment uses the IUR derived in
the 2011 DCM IRIS assessment based on liver and lung tumors in rodents. The weight-of-
evidence analysis for the cancer endpoint was sufficient to conclude that DCM-induced tumor
development operates through a mutagenic mode of action ( ).
L.4.1 Risk Estimation Approach for Acute and Repeated Exposures
Tables Apx L-8 and L-9 show the use scenarios, populations of interest and toxicological
endpoints that were used for estimating acute or chronic risks, respectively.
Table Apx L-8. Use Scenarios, Populations of Interest and Toxicological Endpoints for Assessing
Acute Risks to DCM-containing Paint Strippers
Use
Scenarios
Populations^.
And Toxicolojjicstk
Approach
OCCUPATIONAL USE
RESIDENTIAL USE
Population of Interest
and Exposure
Scenario:
Users
Adults of both sexes (>16 years old)
exposed to DCM during
an 8-hr workday 1 2
Adults of both sexes (>16 years old)
typically exposed to DCM for 1 lir. Other
shorter (10-min, 30-min) or longer
exposure times (4-hr, 8-hr) were also
assumed when comparing DCM air
concentrations with AEGLs.
Population of Interest
and Exposure
Scenario:
Bystander
Adults of both sexes (>16 years old)
indirectly exposed to DCM while being
in the same building during product use.
Individuals of any age indirectly exposed
to DCM while being in the rest of the
house during product use.
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TableApx L-8. Use Scenarios, Populations of Interest and Toxicological Endpoints for Assessing
Acute Risks to DCM-containing Paint Strippers
Use
Scenarios
Populations^^
And Toxicologic^^
Approach
OCCUPATIONAL USE
RESIDENTIAL USE
Health Effects of
Concern,
Concentration and
Time Duration
Non-Cancer Health Effects: CNS effects and COHb formation in the blood (see Table
3-10).
Hazard Values (PODs) for Occupational Hazard Values (PODs) for Residential
Scenarios:3 Scenarios:
8-hr California REL POD= 290 mg/m3 1-hr SMAC POD= 350 mg/m3
8-hr AEGL-2 POD = 210 mg/m3 1-hr California REL POD= 840 mg/m3
10-min AEGL-1 POD= 3,000 mg/m3
30-min AEGL-1 POD = 2,400 mg/m3
1-hr AEGL-1 POD = 2,130 mg/m3
10-min AEGL-2 POD = 6,000 mg/m3
30-min AEGL-2 POD = 4,200 mg/m3
1-hr AEGL-2 POD = 2,000 mg/m3
4-hr AEGL-2 POD = 350 mg/m3
8-hr AEGL-2 POD = 210 mg/m3
Cancer Health Effects: Acute cancer risks were not estimated. Relationship is not
known between a single short-term exposure to DCM and the induction of cancer in
humans.
Uncertainty Factors
(UF) used in Non-
Cancer
Margin of Exposure
(MOE) calculations
UF for SMAC PODs= 10
UF for California REL POD= 60
UF for AEGL-1 PODs= 3
UF for AEGL-2 PODs= 1
Notes:
1 It is assumed no substantial buildup of DCM in the body between exposure events due to DCM's short
biological half-life (~40 min).
2 EPA believes that the users of these products are generally adults, but younger individuals may be users of
DCM-based paint strippers.
3 AEGL-1 POD for 8-hr is not available since the DCM AEGL technical support document did not derive AEGL-
1 values for 8-hrs.
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TableApx L-9. Use Scenarios, Populations of Interest and Toxicological Endpoints for Assessing
Chronic Risks to DCM-containing Paint Strippers
Use
Scenarios
Populations^^
And Toxicologic^^
Approach
OCCUPATIONAL USE
Population of Interest
and Exposure
Scenario:
Users
Adults of both sexes (>16 years old) exposed lo DCM during
an 8-hr workday for up to 250 days per year for 40 working years depending on the
occupational scenario 1 2
Population of Interest
and Exposure
Scenario:
Bystander
Adults of both sexes (>16 years old) indirectly exposed to DCM while being in the
same building during product use.3
Health Effects of
Concern,
Concentration and
Time Du ration
Hazard Value (PODs) Hazard Value (PODs)
for Non-Cancer Effects for Cancer Effects
(liver effects): (liver and lung tumors):
1st percentile human equivalent Inhalation Unit Risk (IUR):
concentration (HEC) i.e. the HEC99: 4 x 10 5 per ppm
17.2 mg/m3 0 x 10"5 Per mg/m3)
(4.8 ppm)
Uncertainty Factors
(UF) used in Non-
Cancer
Margin of Exposure
(MOE) calculations
UF for the HEC99 = 10
UF is not applied for the cancer risk calculations.
Notes:
1 It is assumed no substantial buildup of DCM in the body between exposure events due to DCM's short
biological half-life (~40 min).
2 EPA believes that the users of these products are generally adults, but younger individuals may be users of
DCM-based paint strippers.
3 Data sources did not often indicate whether exposure concentrations were for occupational users or bystanders.
Therefore, EPA assumed that exposures were for a combination of users and bystanders. Some bystanders may
have lower exposures than users, especially when they are further away from the source of exposure.
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Acute or chronic MOEs (MOEaCute or MOEchronic) were used in this assessment to estimate non-
cancer risks (TableApx L-10).
Table Apx L-10. Margin of Exposure (MOE) Equation to Estimate Non-Cancer Risks Following
Acute or Chronic Exposures to DCM
MOE acute or chronic = Non-cancer Hazard value (POD)
Human Exposure
MOE =
Hazard value (POD)
Human Exposure =
Margin of exposure (unitless)
derived from various toxicological documents (see Tables 3-10, 3-11, 3-12)
Exposure estimate (in ppm) from occupational or consumer exposure
assessment. ADCs were used for non-cancer risks associated with chronic
exposures to DCM. Acute concentrations as expressed as 8-hr TWA DCM air
concentrations were used for acute risks.
Study-specific UFs were identified for each hazard value (i.e., POD). These UFs accounted for
(1) the variation in susceptibility among the members of the human population (i.e., inter-
individual or intraspecies variability); (2) the uncertainty in extrapolating animal data to humans
(i.e., interspecies uncertainty); and (3) the uncertainty in extrapolating from a LOAEL rather than
from a NOAEL.
The total UF for each non-cancer hazard value was the benchmark MOE used to interpret the
MOE risk estimates for each use scenario. The MOE estimate was interpreted as human health
risk if the MOE estimate was less than the benchmark MOE (i.e. the total UF). On the other
hand, the MOE estimate indicated negligible concerns for adverse human health effects if the
MOE estimate exceeded the benchmark MOE. Typically, the larger the MOE, the more unlikely
it is that a non-cancer adverse effect would occur.
Cancer risks for repeated exposures to DCM were estimated using the equation in Table Apx L-
11. Estimates of cancer risks should be interpreted as the incremental probability of an individual
developing cancer over a lifetime as a result of exposure to the potential carcinogen (i.e.,
incremental or excess individual lifetime cancer risk).
Table Apx L-ll. Equation to Calculate Cancer Risks
Risk= Human Exposure x IUR
Risk = Cancer risk (unitless)
Human exposure = Exposure estimate (LADC in ppm) from occupational exposure assessment
IUR = Inhalation unit risk 4 x 10 5 per ppm (1 x 10 5 per mg/m3) (U.S. EPA, )
L.4.1 Acute Non-Cancer Risk Estimates for Inhalation Exposures to DCM
The acute inhalation risk assessment used CNS effects to evaluate the acute risks for consumer
and occupational use of DCM-containing paint strippers. Health hazard values were derived
from the SMAC and the California acute REL hazard/dose-response assessments. This
assessment gives preferences to those acute risk estimates derived from the SMAC hazard/dose-
response assessment because the SMAC POD was based on multiple human observations
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reporting increased COHb levels after DCM exposure, coupled with the knowledge of what
would be considered a NOAEL COHb level based on the extensive CO database (Nrc. 1996).
Hazard values based on the AEGL hazard/dose-response assessment were also included in the
acute risk assessment. As discussed in section 3.3.1.3.3, AEGL PODs for the respective tiers
(discomfort/non-disabling effects = AEGL-1 threshold; disability = AEGL-2 threshold; and
death = AEGL-3 threshold) are selected to represent an estimated point of transition between one
defined set of symptoms or adverse effects in one tier and another defined set of symptoms or
adverse effects in the next tier (NRC. 2001). Although the AEGL PODs and total UFs do not
have the degree of conservatism that other values have, EPA used them in this assessment to
gauge how far the acute consumer and occupational exposure are from the thresholds for
discomfort/non-disabling effects (AEGL-1) and disability (AEGL-2). These comparisons
provide an indicator of whether the exposure estimates would be expected to produce human
adverse effects following DCM exposure.
L.4.1.1 Acute Risks for Consumer Exposure Scenarios
Acute inhalation risks for CNS effects were reported for all of the consumer exposure scenarios
when risks were evaluated with the SMAC and the California acute REL PODs and respective
benchmark MOEs. There risks were reported for both the product user and the residential
bystanders exposed to DCM, irrespective of the type of product used (i.e., brush-on vs. spray-on
paint stripper) (TableApx L-12).
Consumers using DCM-based paint strippers reported risk concerns for non-disabling effects
(AEGL-1) during the first hour of product use (i.e., 10-min, 30-min or 1-hr exposure). For
instance, MOEs based on the AEGL-1 PODs were lower than the benchmark MOE for users
using brush-on and spray-on products in those scenarios constructed with upper-end estimates
for either the user or the user and bystanders (Scenarios 2, 3, 5 and 6) (Table Apx L-13).
Likewise, risk concerns for incapacitating effects (AEGL-2) in product users were observed in
Scenarios 2, 3, 5 and 6 at longer exposure times (i.e., 4-hr or 8-hrs). Interestingly, these risks
were also reported for residential bystanders in Scenarios 3 and 6, where upper end user and
bystander parameters were used to construct the scenarios (Table Apx L-13).
The bathroom scenario (#7) was constructed to simulate a human fatality case during a bathtub
refinishing project. It was included in the assessment to estimate the DCM air concentrations to
residential occupants outside the use zone (i.e., bystanders) under conditions of high product use
in the room of use. As expected, risk concerns for incapacitating effects (AEGL-2) were seen in
users exposed to DCM for 4- and 8-hrs. Similarly, the users showed risks for non-disabling
effects (AEGL-1) during the first hour of product use (i.e., 10-min, 30-min or 1-hr). Bystanders
did not show risk concerns for non-disabling (AEGL-1) and incapacitating (AEGL-2) effects at
any of the exposure durations (i.e., 10-min, 30-min, 1-hr, 4-hr or 8-hr) (Table Apx L-13).
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TableApx L-12. Acute Risk Estimates for Residential Exposures to DCM-Based Paint Strippers:
SMAC and California's REL PODs. MOEs below benchmark MOE indicate potential health
risks and are denoted in bold text
Exposure
Scenario
Individual
Maximum
Value for
1-hr
Averaging
Period
(mg/m3)
Margin of Exposure (MOE)
1-hr SMAC POD
Total UF or
Benchmark
M O E=10 * Prefer red
Approach
1-hr California REL
POD
Total UF or
Benchmark MOE=60
Scenario #1
Brush application in
workshop,
central parameter values
User
220
1.6
3.8
Bystander
120
2.9
7.0
Scenario #2
Brush application in
workshop,
upper-end values for user
User
1,100
0.3
0.8
Bystander
210
1.7
4.0
Scenario #3
Brush application in
workshop, upper-end
values for user and
bystander estimates
User
760
0.5
1.1
Bystander
460
0.8
1.8
Scenario #4
Spray application in
workshop, central
parameter values
User
490
0.7
1.7
Bystander
280
1.3
3.0
Scenario #5
Spray application in
workshop, upper-end
values for user
User
1,600
0.2
0.5
Bystander
310
1.1
2.7
Scenario #6
Spray application in
workshop, upper-end
values for user and
bystander estimates
User
1,100
0.3
0.8
Bystander
700
0.5
1.2
Scenario #7
Brush application in
bathroom, simulation
User
799
0.4
1.1
Bystander
218
1.6
3.9
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TableApx L-13. Acute Risk E
Exposure Durations. MOEs be
stimates for Residential Exposures to DCM-Based Paint Strippers: AEGL-1 and AEGL-2 PODs for Various
ow benchmark MOE indicate potential health risks and are denoted in bold text
Consumer
Scenario
Individual
Maximum Values for Averaging
Period, mg/m3
Margin of Exposure (MOE)
10-min
30-min
1-hr
4-hr
8-hr
AEGL-1 PODs
Total UF or Benchmark
MOE =3
AEGL-2 PODs
Total UF or Benchmark MOE =1
10-min
(3,000
mg/m3)
30-min
(2,400
mg/m3)
1-hr
(2,130
mg/m3)
10-min
(6,000
mg/m3)
30-min
(4,200
mg/m3)
1-hr
(2,000
mg/m3)
4-hr (350
mg/m3)
8-hr (210
mg/m3)
Scenario # 1: Brush
application in
workshop, central
parameter
estimates
User
380
270
220
120
69
7.9
8.9
9.7
15.8
15.6
9.1
2.9
3.0
Bystander
130
130
120
82
49
23.1
18.5
17.8
46.2
32.3
16.7
4.3
4.3
Scenario #2: Brush
application in
workshop, upper-
end user estimates
User
1,300
1,100
1,100
420
220
2.3
2.2
1.9
4.6
3.8
1.8
0.8
1.0
Bystander
220
220
210
140
82
13.6
10.9
10.1
27.3
19.1
9.5
2.5
2.6
Scenario #3: Brush
application in
workshop, upper-
end user and
bystander
estimates
User
1,200
900
760
560
400
2.5
2.7
2.8
5.0
4.7
2.6
0.6
0.5
Bystander
470
470
460
380
290
6.4
5.1
4.6
12.8
8.9
4.3
0.9
0.7
Scenario #4: Spray
application in
workshop, central
parameter
estimates
User
780
600
490
270
150
3.8
4.0
4.3
7.7
7.0
4.1
1.3
1.4
Bystander
300
300
280
190
110
10.0
8.0
7.6
20.0
14.0
7.1
1.8
1.9
Scenario #5: Spray
application in
workshop, upper-
end user estimates
User
1,900
1,800
1,600
620
330
1.6
1.3
1.3
3.2
2.3
1.3
0.6
0.6
Bystander
330
320
310
200
120
9.1
7.5
6.9
18.2
13.1
6.5
1.8
1.8
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TableApx L-13. Acute Risk E
Exposure Durations. MOEs be
stimates for Residential Exposures to DCM-Based Paint Strippers: AEGL-1 and AEGL-2 PODs for Various
ow benchmark MOE indicate potential health risks and are denoted in bold text
Consumer
Scenario
Individual
Maximum Values for Averaging
Period, mg/m3
Margin of Exposure (MOE)
10-min
30-min
1-hr
4-hr
8-hr
AEGL-1 PODs
Total UF or Benchmark
MOE =3
AEGL-2 PODs
Total UF or Benchmark MOE =1
10-min
(3,000
mg/m3)
30-min
(2,400
mg/m3)
1-hr
(2,130
mg/m3)
10-min
(6,000
mg/m3)
30-min
(4,200
mg/m3)
1-hr
(2,000
mg/m3)
4-hr (350
mg/m3)
8-hr (210
mg/m3)
Scenario #6: Spray
application in
workshop, upper-
end user and
bystander
estimates
User
1,600
1,300
1,100
810
580
1.9
1.8
1.9
3.8
3.2
1.8
0.4
0.4
Bystander
710
710
700
580
430
4.2
3.4
3.0
8.5
5.9
2.9
0.6
0.5
Scenario #7: Brush
application in
bathroom,
simulation
User
1,455
887
799
536
340
2.1
2.7
2.7
4.1
4.7
2.5
0.7
0.6
Bystander
224
222
218
187
150
13.4
10.8
9.8
26.8
18.9
9.2
1.9
1.4
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L.4.1.1 Acute Risks for Occupational Exposure Scenarios
Acute inhalation risks for CNS effects were reported for most of the relevant industries when
occupational risks were evaluated with the California acute REL POD and respective benchmark
MOE. These risks were irrespective of the absence or presence of respirators and were observed
with central tendency or high-end DCM air concentrations. No risks were found for workers
handling DCM-based strippers in the art restoration and conservation industry (TableApx L-
14).
Workers handling DCM-containing paint strippers with no respirator showed risks for
incapacitating effects (AEGL-2) when employed in all of the relevant industries, except the art
restoration and conservation industry (Table Apx L-14). These risks were present with either
central tendency or high-end DCM air concentrations of DCM.
Workers employed in industries with high exposure to DCM [i.e., professional contractors,
furniture refinishing, aircraft paint stripping, and immersion stripping of wood (non-specific
workplace settings)] typically showed risks for incapacitating (AEGL-2) effects when using APF
10 respirators (Scenario 2) during high exposure conditions. The use of APF 25 respirators
(Scenario 3) was not protective for workers employed in the immersion stripping of wood (non-
specific workplace settings when DCM air concentrations were as high as 7,000 mg/m3.
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TableApx L-14. Acute Risk Estimates for Occupational Exposures to DCM-Based Paint Strippers: AEGL-1 and AEGL-2 PODs for
Various Exposure Durations. MOEs below benchmark MOE indicate potential health risks and are denoted in bold text
Professional
Contractors
Acute 8-hr concentration (mg/m3)
Acute MOE (8hr-REL POD=290 mg/m3)
Total UF or Benchmark MOE=60
Acute MOE (8hr-AEGL-2 POD=210 mg/m3)
Total UF or Benchmark MOE=l
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Scenario 1 (No
respirator, APF=0)
2,980
1,520
60
0.1
0.2
5
0.07
0.1
4
Scenario 2
(Respirator, APF 10)
298
152
6
1
2
48
0.7
1.4
35
Scenario 3
(Respirator, APF 25)
119
61
2
2
5
121
1.8
4
88
Scenario 4
(Respirator, APF 50)
60
30
1
5
10
242
4
7
175
Automotive
Refinishing
Acute 8-hr concentration (mg/m3)
Acute MOE (8hr-REL POD=290 mg/m3)
Total UF or Benchmark MOE=60
Acute MOE (8hr-AEGL-2 POD=210 mg/m3)
Total UF or Benchmark MOE=l
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Scenario 1 (No
respirator, APF=0)
253
416
253
90
1
0.7
1
3
0.8
0.5
0.8
2
Scenario 2
(Respirator, APF 10)
25
42
25.3
9
12
7
12
32
8
5
8
23
Scenario 3
(Respirator, APF 25)
10
17
10
4
29
17
29
81
21
13
21
58
Scenario 4
(Respirator, APF 50)
5
8
5
2
57
35
57
161
42
25
42
117
Furniture
Refinishing
Acute 8-hr concentration (mg/m3)
Acute MOE (8hr-REL POD=290 mg/m3)
Total UF or Benchmark MOE=60
Acute MOE (8hr-AEGL-2 POD=210 mg/m3)
Total UF or Benchmark MOE=l
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Scenario 1 (No
respirator, APF=0)
499
2,245
1,125
4
0.6
0.1
0.3
73
0.4
0.1
0.2
53
Scenario 2
(Respirator, APF 10)
49.9
225
113
0.4
6
1.3
2.6
725
4
0.9
2
525
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TableApx L-14. Acute Risk Estimates for Occupational Exposures to DCM-Based Paint Strippers: AEGL-1 and AEGL-2 PODs for
Various Exposure Durations. MOEs below benchmark MOE indicate potential health risks and are denoted in bold text
Scenario 3
(Respirator, APF 25)
20
90
45
0.2
15
3
6
1813
11
2
5
1312
Scenario 4
(Respirator, APF 50)
10
45
23
0.1
29
6
13
3625
21
5
9
2625
Art Restoration
and
Conservation
Acute 8-hr concentration (mg/m3)
Acute MOE (8hr-REL POD=290 mg/m3)
Total UF or Benchmark MOE=60
Acute MOE (8hr-AEGL-2 POD=210 mg/m3)
Total UF or Benchmark MOE=l
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Scenario 1 (No
respirator, APF=0)
2
145
105
Scenario 2
(Respirator, APF 10)
0.2
1450
1050
Scenario 3
(Respirator, APF 25)
0.1
3625
2625
Scenario 4
(Respirator, APF 50)
0.04
7250
5250
Aircraft Paint
Stripping
Acute 8-hr concentration (mg/m3)
Acute MOE (8hr-REL POD=290 mg/m3)
Total UF or Benchmark MOE=60
Acute MOE (8hr-AEGL-2 POD=210 mg/m3)
Total UF or Benchmark MOE=l
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Scenario 1 (No
respirator, APF=0)
3,802
1,944
86
0.1
0.2
3
0.1
0.1
2
Scenario 2
(Respirator, APF 10)
380
194
9
1
1.5
34
0.6
1
24
Scenario 3
(Respirator, APF 25)
152
78
3
2
4
84
1
3
61
Scenario 4
(Respirator, APF 50)
76
39
2
4
7
167
3
5
122
Graffitti
Removal
Acute 8-hr concentration (mg/m3)
Acute MOE (8hr-REL POD=290 mg/m3)
Total UF or Benchmark MOE=60
Acute MOE (8hr-AEGL-2 POD=210 mg/m3)
Total UF or Benchmark MOE=l
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Page 708 of 725
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TableApx L-14. Acute Risk Estimates for Occupational Exposures to DCM-Based Paint Strippers: AEGL-1 and AEGL-2 PODs for
Various Exposure Durations. MOEs below benchmark MOE indicate potential health risks and are denoted in bold text
Scenario 1 (No
respirator, APF=0)
260
1,188
603
18
1
0.2
0.5
16
0.8
0.2
0.4
12
Scenario 2
(Respirator, APF 10)
26
118.8
60.3
1.8
11
2
5
161
8
2
3
117
Scenario 3
(Respirator, APF 25)
10
48
24
0.7
28
6
12
403
20
4
9
292
Scenario 4
(Respirator, APF 50)
5
24
12
0.4
56
12
24
806
40
9
17
583
Non-Specific
Workplace Settings
- Immersion
Stripping of Wood
Acute 8-hr concentration (mg/m3)
Acute MOE (8hr-REL POD=290 mg/m3)
Total UF or Benchmark MOE=60
Acute MOE (8hr-AEGL-2 POD=210 mg/m3)
Total UF or Benchmark MOE=l
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Scenario 1 (No
respirator, APF=0)
7,000
3,518
35
0.04
0.1
8
0.03
0.1
6
Scenario 2
(Respirator, APF 10)
700
352
4
0.4
0.8
83
0.3
0.6
60
Scenario 3
(Respirator, APF 25)
280
141
1
1
2
207
0.8
1.5
150
Scenario 4
(Respirator, APF 50)
140
70
0.7
2
4
414
2
3
300
Non-Specific
Workplace Settings
- Immersion
Stripping of Wood
and Metal
Acute 8-hr concentration (mg/m3)
Acute MOE (8hr-REL POD=290 mg/m3)
Total UF or Benchmark MOE=60
Acute MOE (8hr-AEGL-2 POD=210 mg/m3)
Total UF or Benchmark MOE=l
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Scenario 1 (No
respirator, APF=0)
1,017
825
633
0.3
0.4
0.5
0.2
0.3
0.3
Scenario 2
(Respirator, APF 10)
101.7
83
63
3
4
5
2
3
3
Scenario 3
(Respirator, APF 25)
41
33
25
7
9
11
5
6
8
Page 709 of 725
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TableApx L-14. Acute Risk Estimates for Occupational Exposures to DCM-Based Paint Strippers: AEGL-1 and AEGL-2 PODs for
Various Exposure Durations. MOEs below benchmark MOE indicate potential health risks and are denoted in bold text
Scenario 4
(Respirator, APF 50)
20
17
13
14
18
23
10
13
17
Non-Specific
Workplace Settings
- Unknown
Acute 8-hr concentration (mg/m3)
Acute MOE (8hr-REL POD=290 mg/m3)
Total UF or Benchmark MOE=60
Acute MOE (8hr-AEGL-2 POD=210 mg/m3)
Total UF or Benchmark MOE=l
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Scenario 1 (No
respirator, APF=0)
357
428
357
285
0.8
0.7
0.8
1
0.6
0.5
0.6
0.7
Scenario 2
(Respirator, APF 10)
36
43
36
29
8
7
8
10
6
5
6
7
Scenario 3
(Respirator, APF 25)
14
17
14
11
20
17
20
25
15
12
15
18
Scenario 4
(Respirator, APF 50)
7
9
7
6
41
34
41
51
29
25
29
37
Page 710 of 725
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12287
12288
12289
12290
12291
12292
12293
12294
12295
12296
12297
12298
12299
12300
12301
12302
12303
12304
12305
12306
12307
12308
12309
12310
12311
12312
12313
12314
12315
12316
12317
12318
12319
12320
12321
12322
12323
12324
12325
12326
12327
12328
12329
12330
12331
12332
12333
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
L.4.1 Non-Cancer and Cancer Risk Estimates for Chronic Inhalation Exposures to DCM
Non-cancer and cancer risk estimates for inhalation exposures to DCM were only derived for
occupational scenarios since the exposures for consumer uses were not considered chronic in
nature. Hazard values were obtained from the EPA IRIS Toxicological Review of Methylene
Chloride (U.S. EPA. 20111
L.4.1.1 Cancer Risks for Occupational Exposure Scenarios
The cancer risk assessment evaluated the incremental individual lifetime cancer risks for
continuous exposures to DCM occurring during the use of paint stripping products. Excess
cancer risks were calculated by multiplying the EPA inhalation unit risk for DCM (U.S. EPA.
2011) by the exposure estimate (i.e., LADC). Cancer risks were expressed as number of cancer
cases per million.
Occupational scenarios assumed that the exposure frequency (i.e., the number of days per year
workers or bystanders are exposed to DCM) was either 125 or 250 days per year for an
occupational exposure duration of 20 or 40 years over a 70-yr lifespan. It is recognized that the
combination of these assumptions may yield conservative cancer risk estimates for some of the
occupational scenarios evaluated in this assessment. Nevertheless, EPA does not have additional
information for further refinement of the exposure assumptions.
EPA typically uses a benchmark cancer risk level between lxlO"4 and lxlO"6 for determining the
acceptability of the cancer risk in a population. Since the benchmark cancer risk level will be
determined during risk management, the occupational cancer risk estimates were compared to
three benchmark levels within EPA's acceptability range. The benchmark levels were:
1. lxlO"6: the probability of 1 chance in 1 million of an individual developing cancer;
2. lxlO"5: the probability of 1 chance in 100,000 of an individual developing cancer, which is
equivalent to 10 cancer cases in 1 million;
3. lxlO 4: the probability of 1 chance in 10,000 of an individual developing cancer, which is
equivalent to 100 cancer cases in 1 million.
Tables Apx L-15 to L-23 show the excess cancer risks calculated for workers of different
industries handling DCM-based paint strippers. Selected scenarios ranging from the highest
exposure scenario (i.e., no respiratory protection and high end values for EF and WY—i.e.,
Scenario 1) to the lowest exposure scenario (e.g., respiratory protection APF 50 and midpoints
for EF and WY—Scenario 16) were included in the tables. Calculations of cancer risks for the
full set of industries and scenarios are provided in the supplemental Excel spreadsheet, DCM
Exposure and Risk Estimates 081114. xlsx.
Workers showed excess cancer risks for all of the industries evaluated when working with DCM-
based paint strippers for 250 days/year for 40 years with no respiratory protection (Scenario 1).
Generally, Scenario 1 exceeded the three target cancer levels with the exception of art restoration
and conservation that only exceeded the lxlO"6 target level.
On the other hand, workers showed a reduction in cancer risks when working for 125 days/year
for 20 years with adequate respiratory protection (Scenario 16). That reduction in excess cancer
Page 711 of 725
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12334 risk was one or two orders of magnitude depending on the industry involved in paint stripping
12335 activities when compared with Scenario 1.
12336
12337 For Scenarios 3 and 15, occupational cancer risks for the different industries fell between the
12338 risks calculated for Scenario 1 and 16, and generally exceeded one or more benchmark cancer
12339 levels when workers were exposed to high or midpoint DCM air concentrations.
12340
Table Apx L-15. Occupational Cancer Risks for Professional Contractors (Scenarios 1,3,15 and
16)
Lowest Exposure Highest Exposure
Professional
Contractors
LADC (mg/m3) ** LADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Excess Cancer Risk (Inhalation
Unit Risk =
1x105 per mg/m3)
High
Midpoint
Low
High
Midpoint
Low
Scenario 1
[No respirator, high ends
of ranges for exposure
frequency (EF) and
working years (WY)]
389
198
8
3.9E-03
2.0E-03
7.8E-05
Scenario 3
(Respirator APF 25, high
ends of ranges for EF and
WY)
16
8
0.31
1.6E-04
7.9E-05
3.1E-06
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
4
2
0.08
3.9E-05
2.0E-05
7.8E-07
Scenario 16
(Respirator APF 50,
midpoints of ranges for
EF and WY)
2
1
0.04
1.9E-05
9.9E-06
3.9E-07
12341
12342
Page 712 of 725
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Table Apx L-16. Occupational Cancer Risks for Automotive Refinishing (Scenarios 1, 3,15 and
16)
Lowest Exposure Highest Exposure
Automotive Refinishing
LADC (mg/m3) ** LADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Excess Cancer Risk (Inhalation
Unit Risk =
1x105 per mg/m3)
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Scenario 1
[No respirator, high ends
of ranges for exposure
frequency (EF) and
working years (WY)]
33
54
33
12
3.3E-04
5.4E-04
3.3E-04
1.2E-04
Scenario 3
(Respirator APF 25, high
ends of ranges for EF
and WY)
1
2
1
0.48
1.3E-05
2.2E-05
1.3E-05
4.8E-06
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
0.3
1
0.33
0.12
3.3E-06
5.4E-06
3.3E-06
1.2E-06
Scenario 16
(Respirator APF 50,
midpoints of ranges for
EF and WY)
0.2
0.3
0.2
0.1
1.7E-06
2.7E-06
1.7E-06
6.0E-07
12343
Table Apx L-17. Occupational Cancer Risks for Furniture Refinishing (Scenarios 1, 3,15 and 16)
Lowest Exposure Highest Exposure
Furniture Refinishing
LADC (mg/m3) ** LADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Excess Cancer Risk (Inhalation
Unit Risk =
1x105 per mg/m3)
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Scenario 1
[No respirator, high ends
of ranges for exposure
frequency (EF) and
working years (WY)]
65
293
147
0.5
6.5E-04
2.9E-03
1.5E-03
5.0E-06
Scenario 3
(Respirator APF 25, high
ends of ranges for EF
and WY)
3
12
6
0.02
2.6E-05
1.2E-04
5.9E-05
2.0E-07
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
1
3
1
0.01
6.5E-06
2.9E-05
1.5E-05
5.0E-08
Scenario 16
(Respirator APF 50,
midpoints of ranges for
EF and WY)
0.3
1.5
0.7
0.003
3.3E-06
1.5E-05
7.4E-06
2.5E-08
12344
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TableApx L-18. Occupational Cancer Risks for Aircraft Stripping (Scenarios 1, 3,15 and 16)
Lowest Exposure Highest Exposure
Aircraft Paint
Stripping
LADC (mg/m3) ** LADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Excess Cancer Risk (Inhalation
Unit Risk =
1x105 per mg/m3)
High
Midpoint
Low
High
Midpoint
Low
Scenario 1
[No respirator, high ends
of ranges for exposure
frequency (EF) and
working years (WY)]
496
254
11
5.0E-03
2.5E-03
1.1E-04
Scenario 3
(Respirator APF 25, high
ends of ranges for EF
and WY)
20
10
0.44
2.0E-04
1.0E-04
4.4E-06
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
5
3
0.11
5.0E-05
2.5E-05
1.1E-06
Scenario 16
(Respirator APF 50,
midpoints of ranges for
EF and WY)
2
1
0.06
2.5E-05
1.3E-05
5.5E-07
12345
Table Apx L-19. Occupational Cancer Risks for Graffiti Removal (Scenarios 1, 3,15 and 16)
Lowest Exposure Highest Exposure
Graffiti Removal
LADC (mg/m3) ** LADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Excess Cancer Risk (Inhalation
Unit Risk =
1x105 per mg/m3)
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Scenario 1
[No respirator, high ends
of ranges for exposure
frequency (EF) and
working years (WY)]
34
155
79
2.3
3.4E-04
1.6E-03
7.9E-04
2.3E-05
Scenario 3
(Respirator APF 25, high
ends of ranges for EF
and WY)
1
6
3
0.092
1.4E-05
6.2E-05
3.2E-05
9.2E-07
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
0.340
2
1
0.023
3.4E-06
1.6E-05
7.9E-06
2.3E-07
Scenario 16
(Respirator APF 50,
midpoints of ranges for
EF and WY)
0.2
0.8
0.4
0.012
1.7E-06
7.8E-06
4.0E-06
1.2E-07
12346
Page 714 of 725
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Table Apx L-20. Occupational Cancer Risks for Non-Specific Workplace Settings—Immersion
Stripping of Wood (Scenarios 1, 3,15 and 16)
Lowest Exposure Highest Exposure
Non-Specific
Workplace Settings -
Immersion Stripping of
Wood
LADC (mg/m3) ** LADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Excess Cancer Risk (Inhalation
Unit Risk =
1x105 per mg/m3)
High
Midpoint
Low
High
Midpoint
Low
Scenario 1
[No respirator, high ends
of ranges for exposure
frequency (EF) and
working years (WY)]
913
459
4.6
9.1E-03
4.6E-03
4.6E-05
Scenario 3
(Respirator APF 25, high
ends of ranges for EF
and WY)
37
18
0.184
3.7E-04
1.8E-04
1.8E-06
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
9
5
0.046
9.1E-05
4.6E-05
4.6E-07
Scenario 16
(Respirator APF 50,
midpoints of ranges for
EF and WY)
5
2
0.023
4.6E-05
2.3E-05
2.3E-07
12347
12348
Page 715 of 725
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TableApx L-21. Occupational Cancer Risks for Non-Specific Workplace Settings—Immersion
Stripping of Wood and Metal (Scenarios 1,3,15 and 16)
Lowest Exposure Highest Exposure
Non-Specific
Workplace Settings -
Immersion Stripping of
Wood and Metal
LADC (mg/m3) ** LADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Excess Cancer Risk (Inhalation
Unit Risk =
1x105 per mg/m3)
High
Midpoint
Low
High
Midpoint
Low
Scenario 1
[No respirator, high ends
of ranges for exposure
frequency (EF) and
working years (WY)]
133
108
83
1.3E-03
1.1E-03
8.3E-04
Scenario 3
(Respirator APF 25, high
ends of ranges for EF
and WY)
5
4
3
5.3E-05
4.3E-05
3.3E-05
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
1
1
1
1.3E-05
1.1E-05
8.3E-06
Scenario 16
(Respirator APF 50,
midpoints of ranges for
EF and WY)
1
1
0.415
6.7E-06
5.4E-06
4.2E-06
12349
Table Apx L-22. Occupational Cancer Risks for Non-Specific Workplace Settings—Unknown
(Scenarios 1, 3,15 and 16)
Lowest Exposure Highest Exposure
Non-Specific
Workplace Settings -
Unknown
LADC (mg/m3) ** LADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Excess Cancer Risk (Inhalation
Unit Risk =
1x105 per mg/m3)
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Scenario 1
[No respirator, high
ends of ranges for
exposure frequency
(EF) and working years
(WY)]
47
56
47
37
4.7E-04
5.6E-04
4.7E-04
3.7E-04
Scenario 3
(Respirator APF 25,
high ends of ranges for
EF and WY)
2
2
2
1
1.9E-05
2.2E-05
1.9E-05
1.5E-05
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
0.5
1
0.5
0.4
4.7E-06
5.6E-06
4.7E-06
3.7E-06
Scenario 16
(Respirator APF 50,
midpoints of ranges for
EF and WY)
0.2
0.3
0.2
0.2
2.4E-06
2.8E-06
2.4E-06
1.9E-06
Page 716 of 725
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12350
12351
12352
12353
12354
12355
12356
12357
12358
12359
12360
12361
12362
12363
12364
12365
12366
12367
12368
12369
12370
12371
12372
12373
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Table Apx L-23. Occupational Cancer Risks for Art Restoration and Conservation (Scenarios 1,
3,15 and 16)
Lowest Exposure Highest Exposure
Art Restoration and
Conservation
LADC (mg/m3) ** LADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Excess Cancer Risk (Inhalation
Unit Risk =
1x105 per mg/m3)
Mean High Midpoint Low
Mean High Midpoint Low
Scenario 1
[No respirator, high
ends of ranges for
exposure frequency
(EF) and working years
(WY)]
0.3
3.0E-06
Scenario 3
(Respirator APF 25,
high ends of ranges for
EF and WY)
0.012
1.2E-07
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
0.003
3.0E-08
Scenario 16
(Respirator APF 50,
midpoints of ranges for
EF and WY)
0.0015
1.5E-08
L.4.1.1 Non-Cancer Risks for Occupational Exposure Scenarios Following Chronic Exposure to
DCM
EPA estimated non-cancer risks for the occupational use of DCM-containing paint strippers. Chronic
exposure to DCM has been associated with liver effects. As previously discussed, the DCM IRIS
assessment developed a non-cancer hazard value (i.e., POD) based on hepatic effects. EPA used the
PBPK-derived 1st percentile HEC i.e. the HEC99 the concentration at which there is 99% likelihood an
individual would have an internal dose less than or equal to the internal dose of hazard reported in the
DCM IRIS assessment ( :1Y) to calculate non-cancer risks associated with the repeated use
of DCM-based strippers at different workplace settings.
Tables Apx 3-24 to 3-32 show the non-cancer MOE estimates calculated for workers of different
industries handling DCM-based paint strippers on a repeated basis. Selected scenarios ranging from the
highest exposure scenario (i.e., no respiratory protection and high end values for EF and WY—i.e.,
Scenario 1) to the lowest exposure scenario (e.g., respiratory protection APF 50 and midpoints for EF
and WY—Scenario 16) were included in the tables. Calculations of non-cancer risks for the full set of
industries and scenarios are provided in the supplemental Excel spreadsheet, DCM Exposure and Risk
Estimates 081114. xlsx.
Most workers using DCM-based paint strippers showed non-cancer risks for liver effects, with the
exception of workers employed in the art renovation and conservation industry (Table Apx L-33). For
instance, risk concerns for liver effects were reported for most workers handling DCM-based paint
Page 717 of 725
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strippers. These risk findings were reported with or without respiratory protection and using the product
in a repeated nature at facilities usually reporting central tendency or high-end DCM air levels. Among
all of the occupational scenarios, the greatest risk concern is for workers engaging in long-term use of
the product (i.e., 250 days/year for 40 years) with no respiratory protection.
Non-cancer risks were not observed for workers that reduce their exposure to DCM-based strippers by
doing all of the following: (1) wearing adequate respiratory protection (i.e., APF 50 respirator), (2)
limiting exposure to central tendency exposure conditions (i.e., 125 days/year for 20 years) and (3)
working in facilities with low-end DCM air concentrations. This observation was reported in all of the
relevant industries.
TableApx L-24. Occupational Non-Cancer Risks for Professional Contractors Following Chronic
Exposure to DCM (Scenarios 1, 3,15 and 16)
Professional
Contractors
ADC (mg/m3) ** ADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
High
Midpoint
Low
Chronic MOE (24hr HEC99 =
17.2 mg/m3)
Total UF or Benchmark MOE=10
High
Midpoint
Low
Scenario 1
[No respirator, high ends
of ranges for exposure
frequency (EF) and
working years (WY)]
680
347
14
0.025
0.050
o
s.
H
W
0>
JS
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx L-25. Occupational Non-Cancer Risks for Automotive Refinishing Following Chronic
Exposure to DCM (Scenarios 1, 3,15 and 16)
Scenario 3
(Respirator APF 25, high
ends of ranges for EF
and WY)
2
4
2
1
7
5
7
20
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
1
1
1
0.2
30
18
30
82
Scenario 16
(Respirator APF 50,
midpoints of ranges for
EF and WY)
0.3
0.5
0.3
0.1
59
36
59
164
12387 Note: MOEs below benchmark MOE indicating risk are denoted in bold text.
12388
Table Apx L-26. Occupational Non-Cancer Risks for Furniture Refinishing Following Chronic
Exposure to DCM (Scenarios 1, 3,15 and 16)
Lowest Exposure Highest Exposure
Furniture Refinishing
ADC (mg/m3) ** ADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Chronic MOE (24hr HEC99 =
17.2 mg/m3)
Total UF or Benchmark MOE=10
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Scenario 1
[No respirator, high ends
of ranges for exposure
frequency (EF) and
working years (WY)]
114
513
257
0.9
0.2
0.03
0.1
19
Scenario 3
(Respirator APF 25, high
ends of ranges for EF
and WY)
5
21
10
0.04
4
0.8
2
478
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
1
5
3
0.01
15
3
7
1911
Scenario 16
(Respirator APF 50,
midpoints of ranges for
EF and WY)
0.6
3
1
0.005
30
7
13
3822
12389
12390
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TableApx L-27. Occupational Non-Cancer Risks for Art Restoration and Conservation
Following Chronic Exposure to DCM (Scenarios 1, 3,15 and 16)
Lowest Exposure Highest Exposure
Art Restoration/
Conservation
ADC (mg/m3) ** ADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Chronic MOE (24hr HEC99 =
17.2 mg/m3)
Total UF or Benchmark MOE=10
Mean a
Mean3
Scenario 1
[No respirator, high ends
of ranges for exposure
frequency (EF) and
working years (WY)]
0.5
34
Scenario 3
(Respirator APF 25,
high ends of ranges for
EF and WY)
0.02
860
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
0.005
3440
Scenario 16
(Respirator APF 50,
midpoints of ranges for
EF and WY)
0.0025
6880
Note:
a Based on one 8-hr TWA data point reported in the OSHA IMtS database.
12391 Note: MOEs below benchmark MOE indicating risk are denoted in bold text.
12392
Table Apx L-28. Occupational Non-Cancer Risks for Aircraft Stripping Following Chronic
Exposure to DCM (Scenarios 1, 3,15 and 16)
Lowest Exposure Highest Exposure
Aircraft Paint
Stripping
ADC (mg/m3) ** ADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Chronic MOE (24hr HEC99 =
17.2 mg/m3)
Total UF or Benchmark MOE=10
High
Midpoint
Low
High
Midpoint
Low
Scenario 1
[No respirator, high ends
of ranges for exposure
frequency (EF) and
working years (WY)]
868
444
20
0.02
0.04
0.9
Scenario 3
(Respirator APF 25, high
ends of ranges for EF
and WY)
35
18
1
0.5
1
22
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
9
4
0.2
2
4
86
Scenario 16
4
2
0.1
4
8
172
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TableApx L-28. Occupational Non-Cancer Risks for Aircraft Stripping Following Chronic
Exposure to DCM (Scenarios 1, 3,15 and 16)
(Respirator APF 50,
midpoints of ranges for
EF and WY)
12393
Table Apx L-29. Occupational Non-Cancer Risks for Graffiti Removal Following Chronic
Exposure to DCM (Scenarios 1, 3,15 and 16)
Lowest Exposure Highest Exposure
Graffiti Removal
ADC (mg/m3) ** ADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Chronic MOE (24hr HEC99 =
17.2 mg/m3)
Total UF or Benchmark MOE=10
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Scenario 1
[No respirator, high
ends of ranges for
exposure frequency
(EF) and working years
(WY)]
59
271
138
4
0.3
0.1
0.1
4
Scenario 3
(Respirator APF 25,
high ends of ranges for
EF and WY)
2
11
6
0.2
7
2
3
105
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
1
3
1
0.04
29
6
12
420
Scenario 16
(Respirator APF 50,
midpoints of ranges for
EF and WY)
0.3
1
0.7
0.02
58
13
25
839
12394 Note: MOEs below benchmark MOE indicating risk are denoted in bold text.
Page 721 of 725
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PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx L-30. Occupational Non-Cancer Risks for Non-Specific Workplace Settings
(Immersion Stripping of Wood) Following Chronic Exposure to DCM (Scenarios 1, 3,15 and 16)
Lowest Exposure Highest Exposure
Non-Specific
Workplace Settings -
Immersion Stripping of
Wood
ADC (mg/m3) ** ADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Chronic MOE (24hr HEC99 =
17.2 mg/m3)
Total UF or Benchmark MOE=10
High
Midpoint
Low
High
Midpoint
Low
Scenario 1
[No respirator, high ends
of ranges for exposure
frequency (EF) and
working years (WY)]
1,598
803
8
0.01
0.02
2
Scenario 3
(Respirator APF 25, high
ends of ranges for EF
and WY)
64
32
0.3
0.3
0.5
54
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
16
8
0.08
1
2
215
Scenario 16
(Respirator APF 50,
midpoints of ranges for
EF and WY)
8
4
0.04
2
4
430
12395
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TableApx L-31. Occupational Non-Cancer Risks for Non-Specific Workplace Settings
(Immersion Stripping of Wood and Metal) Following Chronic Exposure to DCM (Scenarios 1, 3,
15 and 16)
Non-Specific
Workplace Settings -
Immersion Stripping of
Wood and Metal
ADC (mg/m3) ** ADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Chronic MOE (24hr HEC99 =
17.2 mg/m3)
Total UF or Benchmark MOE=10
High
Midpoint
Low
High
Midpoint
Low
-------
12398
12399
12400
12401
12402
12403
12404
12405
12406
12407
12408
12409
12410
12411
12412
12413
12414
12415
12416
12417
12418
12419
12420
12421
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
TableApx L-32. Occupational Non-Cancer Risks for Non-Specific Workplace Settings
(Unknown) Following Chronic Exposure to DCM (Scenarios 1, 3,15 and 16)
Lowest Exposure Highest Exposure
Non-Specific
Workplace Settings -
Unknown
ADC (mg/m3) ** ADCs for
scenarios 2 to 16 have been
adjusted with the multiplier
Chronic MOE (24hr HEC99 =
17.2 mg/m3)
Total UF or Benchmark MOE=10
Mean
High
Midpoint
Low
Mean
High
Midpoint
Low
Scenario 1
[No respirator, high
ends of ranges for
exposure frequency (EF)
and working years
(WY)]
81
98
81
65
0.21
0.18
0.21
0.27
Scenario 3
(Respirator APF 25,
high ends of ranges for
EF and WY)
3
4
3
3
5
4
5
7
Scenario 15
(Respirator APF 25,
midpoints of ranges for
EF and WY)
1
1
1
0.65
21
18
21
26
Scenario 16
(Respirator APF 50,
midpoints of ranges for
EF and WY)
0.41
0.49
0.41
0.33
42
35
42
53
L.4.1 Human Health Risk Characterization Summary
This risk assessment focused on the occupational and consumer uses of DCM-containing paint strippers.
The population of interest consisted of workers and consumers with direct (users) or indirect (bystander)
exposure to DCM. Only the inhalation route of exposure was considered in this risk assessment.
The occupational and consumer exposure assessments generated the DCM exposure levels required to
derive non-cancer risk estimates associated with acute and chronic exposures to DCM. In addition,
cancer risks were estimated for occupational scenarios and expressed as lifetime risks, meaning the risk
of developing cancer as a result of the occupational exposure over a normal lifetime of 70 yrs. Lifetime
cancer risks from DCM exposure were compared to benchmark cancer risks ranging from 10"6 to 10"4.
Many of the occupational scenarios exceeded the target cancer risks of 10"6, 10"5 and 10"4 when workers
employed at various industries handled DCM-paint strippers for 250 days/year for 40 years with no
respiratory protection. Adequate respiratory protection and reduced exposure conditions (e.g., exposure
to 125 day/year for 20 years) resulted in reduced cancer risks for workers when compared to conditions
of no respiratory protection while working with paint strippers for a 250 days/year for a working lifetime
(i.e., 40 years).
To characterize the risks of adverse health effects other than cancer, MOEs were used to evaluate non-
cancer risks for both acute and chronic exposures using hazard values derived from peer-reviewed
hazard/dose-response assessments. Health protective hazard values were derived from the SMAC and
the California acute REL hazard/dose-response assessments, whereas hazard values for non-disabling
Page 724 of 725
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12422
12423
12424
12425
12426
12427
12428
12429
12430
12431
12432
12433
12434
12435
12436
12437
12438
12439
12440
12441
12442
12443
12444
12445
12446
12447
12448
12449
12450
12451
12452
12453
12454
12455
12456
12457
12458
12459
12460
12461
12462
12463
12464
12465
12466
12467
12468
PEER REVIEW DRAFT, DO NOT CITE OR QUOTE
(AEGL-1) and incapacitating (AEGL-2) effects were obtained from the AEGL hazard/dose-response
assessment for DCM.
Workers employed at most industries showed non-cancer risks for liver effects when using DCM-based
strippers on a repeated basis. The exception was the art renovation and conservation industry which did
not show non-cancer risks for the different scenarios evaluated in the assessment.
Most workers handling DCM-based paint strippers are at risk of developing non-cancer effects when
they handle the product on a repeated basis with or without wearing respiratory protection. These
observations were seen under various exposure conditions (i.e., exposure frequency and working years)
in facilities reporting central tendency or high-end DCM air levels. Of special interest are workers using
DCM-containing paint strippers engaging in long-term use of the product (i.e., 250 days/year for 40
years) with no respiratory protection as they showed the greatest risk concern for non-cancer risks.
On the contrary, non-cancer risks were not observed in workers that reduced their chronic exposure to
DCM by doing all of the following: (1) wearing adequate respiratory protection (i.e., APF 50 respirator),
(2) limiting exposure to central tendency exposure conditions (i.e., 125 days/year for 20 years), and (3)
working in facilities with low-end DCM air concentrations.
Most occupational and residential users of DCM-based paint strippers reported acute risks for CNS
effects when the SMAC and California's acute REL hazard values were used for risk estimation. These
risks were observed in workers with or without respiratory protection and residential bystanders
indirectly exposed to DCM.
There were concerns for discomfort/non-disabling (AEGL-1) and incapacitating (AEGL-2) effects for
residential users exposed to DCM for shorter (10-min, 30-min, 1-hr) or longer exposure durations (4-hr,
8-hr) while doing the product application or staying in the residence after completion of the stripping
task. These concerns were present for upper-end exposure conditions in the residential scenario as well
as some of the upper-end exposure scenarios for affected bystanders.
Moreover, there were concerns for incapacitating effects (AEGL-2 effects) in workers handing DCM-
containing paint strippers on an acute/short-term basis with no respiratory protection while employed in
most industries involved in paint stripping. Concerns for incapacitating effects (AEGL-2 effects) were
also observed for workers wearing respirators (i.e., APF 10 or APF 25) while performing paint stripping
activities in industries with high DCM air concentrations [i.e., professional contractors, furniture
refinishing, aircraft paint stripping, and immersion stripping of wood (non-specific workplace settings)].
The bathroom consumer modeling indicated that application of DCM-based paint strippers in a
bathroom generate unsafe exposure conditions for the user of the product. Risk concerns for
discomfort/non-disabling (AEGL-1) and incapacitating effects (AEGL-2) were seen in users exposed to
DCM for shorter (10-min, 30-min, 1-hr) or longer exposure durations (4-hr, 8-hr) while doing the
product application or staying in the residence after completion of the stripping task. However,
residential bystanders did not report risk concerns for AEGL-1 and AEGL-2 effects.
Page 725 of 725
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