United States
LhiI Environmental Protection Agency
EPA Document# EPA 740-R1-7016
May 2018
Office of Chemical Safety and
Pollution Prevention
Problem Formulation of the Risk Evaluation for
Methylene Chloride
(Dichloromethane, DCM)
CASRN: 75-09-2
H
011CI
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May 2018
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 7
ABBREVIATIONS 8
EXECUTIVE SUMMARY 11
1 INTRODUCTION 13
1.1 Regulatory Hi story 15
1.2 Assessment History 15
1.3 Data and Information Collection 17
1.4 Data Screening During Problem Formulation 18
2 PROBLEM FORMULATION 19
2.1 Physical and Chemical Properties 19
2.2 Conditions of Use 20
2.2.1 Data and Information Sources 20
2.2.2 Identification of Conditions of Use 20
2.2.2.1 Categories and Subcategories Determined Not to be Conditions of Use or Otherwise
Excluded During Problem Formulation 21
2.2.2.2 Categories and Subcategories of Conditions of Use Included In the Scope of Risk
Evaluation 22
2.2.2.3 Overview of Conditions of Use and Lifecycle Diagram 28
2.3 Exposures 32
2.3.1 Fate and Transport 32
2.3.2 Releases to the Environment 33
2.3.3 Presence in the Environment and Biota 35
2.3.4 Environmental Exposures 36
2.3.5 Human Exposures 37
2.3.5.1 Occupational Exposures 37
2.3.5.2 Consumer Exposures 38
2.3.5.3 General Population Exposures 39
2.3.5.4 Potentially Exposed or Susceptible Subpopulations 40
2.4 Hazards (Effects) 41
2.4.1 Environmental Hazards 41
2.4.2 Human Health Hazards 44
2.4.2.1 Non-Cancer Hazards 45
2.4.2.2 Genotoxicity and Cancer Hazards 45
2.4.2.3 Potentially Exposed or Susceptible Subpopulations 46
2.5 Conceptual Models 46
2.5.1 Conceptual Model for Industrial and Commercial Activities and Uses: Potential Exposures
and Hazards 47
2.5.2 Conceptual Model for Consumer Activities and Uses: Potential Exposures and Hazards.... 50
2.5.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards 53
2.5.3.1 Pathways That EPA Expects to Include and Further Analyze in Risk Evaluation 53
2.5.3.2 Pathways That EPA Expects to Include in Risk Evaluation But Not Further Analyze . 53
2.5.3.3 Pathways That EPA Does Not Expect to Include in the Risk Evaluation 54
2.6 Analysis Plan 59
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2.6.1 Exposure 59
2.6.1.1 Environmental Releases 59
2.6.1.2 Environmental Fate 61
2.6.1.3 Environmental Exposures 62
2.6.1.4 Occupational Exposures 63
2.6.1.5 Consumer Exposures 64
2.6.1.6 General Population 65
2.6.2 Hazards (Effects) 66
2.6.2.1 Environmental Hazards 66
2.6.2.2 Human Health Hazards 67
2.6.3 Risk Characterization 69
REFERENCES 70
APPENDICES 76
Appendix A REGULATORY HISTORY 76
A.1 Federal Laws and Regulations , . 76
A.2 Slate Laws and Regulations 84
A3 International Law* and Regulations...,,. ...86
Appendix B PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION ... 88
B.l Process Infoimation............ . 88
B. 1.1 Manufacturing (Including Import) 88
B.l. 1.1 Domestic Manufacturing 88
B.l. 1.2 Import 88
B.1.2 Processing 89
B. 1.2.1 Reactant or Intermediate 89
B. 1.2.2 Incorporating into Formulation, Mixture, or Reaction Product 89
B.1.2.3 Repackaging 89
B. 1.2.4 Recycling 89
B.1.3 Uses 89
B. 1.3.1 Solvents for Cleaning or Degreasing 90
B.1.3.2 Adhesives and Sealants 91
B.1.3.3 Paints and Coatings 91
B. 1.3.4 Laundry and Di shwashing Products 91
B.1.3.5 Lubricants and Greases 92
B. 1.3.6 Other Uses 92
B.1.4 Disposal 92
B.2 Occupational Exposure Data 92
B.3 Sources Containing Potentially Relevant Data or Information ,...,,...97
Appendix C SUPPORTING TABLE FOR INDUSTRIAL AND COMMERCIAL ACTIVITIES
AND USES CONCEPTUAL MODEL 112
Appendix D SUPPORTING TABLE FOR CONSUMER ACTIVITIES AND USES
CONCEPTUAL MODEL 125
Appendix E SUPPORTING TABLE FOR ENVIRONMENTAL RELEASES AND WASTES
CONCEPTUAL MODEL 139
Appendix F INCLUSION AND EXCLUSION CRITERIA FOR FULL TEXT SCREENING.. 141
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FJ. Inclusion Criteria for Data Sources Reporting Environmental Fate Data 141
F.2 Inclusion Criteria for Data Sources Reporting Release and Occupational Exposure Data 144
F.3 Inclusion Criteria for Data Sources Reporting Exposure Data on Consumers and Ecological
Receptors.... 146
F.4 Inclusion Criteria for Data Sources Reporting Human Health Hazards 147
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LIST OF TABLES
Table 1-1. Assessment History of Methylene Chloride 15
Table 2-1. Physical and Chemical Properties of Methylene Chloride 19
Table 2-2. Categories and Subcategories Determined Not to be Conditions of Use or Otherwise
Excluded During Problem Formulation 21
Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 22
Table 2-4. Production Volume of Methylene Chloride in CDR Reporting Period (2012 to 2015) a 29
Table 2-5. Environmental Fate Characteristics of Methylene Chloride 33
Table 2-6. Summary of Methylene Chloride TRI Production-Related Waste Managed in 2015 (lbs) .... 34
Table 2-7. Summary of Methylene Chloride TRI Releases to the Environment in 2015 (lbs) 34
Table 2-8. Summary of Ecological Hazard Information for Methylene Chloride 42
Table 2-9. Potential Sources of Environmental Release Data 60
Table 2-10. Potential Sources of Occupational Exposure Data 63
LIST OF FIGURES
Figure 2-1. Methylene Chloride Life Cycle Diagram 31
Figure 2-2. Methylene Chloride Conceptual Model for Industrial and Commercial Activities and Uses:
Potential Exposures and Hazards 49
Figure 2-3. Methylene Chloride Conceptual Model for Consumer Activities and Uses: Potential
Exposures and Hazards 52
Figure 2-4. Methylene Chloride Conceptual Model for Environmental Releases and Wastes: Potential
Exposures and Hazards 58
LIST OF APPENDIX TABLES
Table_Apx A-l. Federal Laws and Regulations 76
Table_Apx A-2. State Laws and Regulations 84
Table_Apx A-3. Regulatory Actions by other Governments and Tribes 86
TableApx B-l Mapping of Scenarios to Industry Sectors with Methylene Chloride Personal Monitoring
Air Samples Obtained from OSHA Inspections Conducted Between 2002 and 2016 92
Table Apx B-2 Mapping of Scenarios to Industry Sectors with Methylene Chloride Area Monitoring
Air Samples Obtained from OSHA Inspections Conducted Between 2013 and 2016 95
Table Apx B-3 Summary of NIOSH III Ills Since 2000 97
Table Apx B-4 Potentially Relevant Data Sources for Information Related to Process Description 98
Table Apx B-5 Potentially Relevant Data Sources for Measured or Estimated Release Data 102
Table Apx B-6 Potentially Relevant Data Sources for Personal Exposure Monitoring and Area
Monitoring Data 104
Table Apx B-7 Potentially Relevant Data Sources for Engineering Controls and Personal Protective
Equipment 108
Table Apx C-l Industrial and Commercial Activities and Uses Conceptual Model Supporting Table 112
Table Apx D-l Consumer Activities and Uses Conceptual Model Supporting Table 125
Table Apx E-l Environmental Releases and Wastes Conceptual Model Supporting Table 139
Table Apx F-l. Inclusion Criteria for Data Sources Reporting Environmental Fate Data 142
Table Apx F-2. Fate Endpoints and Associated Processes, Media and Exposure Pathways Considered in
the Development of the Environmental Fate Assessment 143
Table Apx F-3. Inclusion Criteria for Data Sources Reporting Engineering and Occupational Exposure
Data 144
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TableApx F-4. Engineering, Environmental Release and Occupational Data Necessary to Develop the
Environmental Release and Occupational Exposure Assessments 145
Table Apx F-5. Inclusion Criteria for the Data Sources Reporting Methylene Chloride Exposure Data
on Consumers and Ecological Receptors 146
Table Apx F-6. Inclusion Criteria for Data Sources Reporting Human Health Hazards Related to
Methylene Chloride a 147
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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: EPA-HQ-QPPT-2016-0742.
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
ACGIH
American Conference of Government Industrial Hygienists
AEGL
Acute Exposure Guideline Level
atm
Atmosphere(s)
AT SDR
Agency for Toxic Substances and Disease Registry
BAF
Bioaccumulation Factor
BCF
Bioconcentration Factor
CAA
Clean Air Act
CASRN
Chemical Abstracts Service Registry Number
CBI
Confidential Business Information
CDR
Chemical Data Reporting
CEHD
Chemical Exposure Health Data
CEPA
Canadian List of Toxic Substances
CERCLA
Comprehensive Environmental Response, Compensation and Liability Act
CFR
Code of Federal Regulations
CHIRP
Chemical Risk Information Platform
cm3
Cubic Centimeter(s)
CNS
Central Nervous System
coc
Concentration of Concern
CoCAP
Cooperative Chemicals Assessment Program
COHb
Carboxyhemoglobin
CPS A
Consumer Product Safety Act
CPSC
Consumer Product Safety Commission
CSCL
Chemical Substances Control Law
CSHO
Certified Safety and Health Official
CWA
Clean Water Act
DCM
Dichloromethane (Methylene Chloride)
DIY
Do it yourself
DMR
Discharge Monitoring Report
DOT
Department of Transportation
ECso
Effect concentration at which 50% of test organisms exhibit an effect
ECHA
European Chemicals Agency
EG
Effluent Guidelines
EHC
Environmental Health Criteria
EPA
Environmental Protection Agency
EPCRA
Emergency Planning and Community Right-to-Know Act
ESD
Emission Scenario Document
EU
European Union
FDA
Food and Drug Administration
FFDCA
Federal Food, Drug, and Cosmetic Act
FSHA
Federal Hazardous Substance Act
g
Gram(s)
HAP
Hazardous Air Pollutant
HFC
Hydrofluorocarbon
HHE
Health Hazard Evaluation
HMTA
Hazardous Materials Transportation Act
HPV
High Production Volume
Hr
Hour
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IARC International Agency for Research on Cancer
ICIS Integrated Compliance Information System
IDLH Immediately Dangerous to Life and Health
IMAP Inventory Multi-Tiered Assessment and Prioritisation
IRIS Integrated Risk Information System
ISHA Industrial Safety and Health Act
Koc Soil Organic Carbon-Water Partitioning Coefficient
Kow Octanol/Water Partition Coefficient
kg Kilogram(s)
L Liter(s)
lb Pound(s)
LCso Lethal Concentration at which 50% of test organisms die
LD50 Lethal Dose at which 50% of test organisms die
LOD Limit of detection
Log Koc Logarithmic Organic Carbon:Water Partition Coefficient
Log Kow Logarithmic Octanol: Water Partition Coefficient
m3 Cubic Meter(s)
MACT Maximum Achievable Control Technology
MCL Maximum Contaminant Level
MCLG Maximum Contaminant Level Goal
mg Milligram(s)
mmHg Millimeter(s) of Mercury
MO A Mode of Action
mPas Millipascal(s)-Second
MSW Municipal Solid Waste
NAC National Advisory Committee
NAICS North American Industry Classification System
NATA National Scale Air-Toxics Assessment
NAWQA National Water Quality Assessment Program
ND Non-detect
NEI National Emissions Inventory
NESHAP National Emission Standards for Hazardous Air Pollutants
NHANES National Health and Nutrition Examination Survey
NICNAS National Industrial Chemicals Notification and Assessment Scheme
NIH National Institutes of Health
NIOSH National Institute of Occupational Safety and Health
NITE National Institute of Technology and Evaluation
NOAA National Oceanic and Atmospheric Administration
NPDES National Pollutant Discharge Elimination System
NPDWR National Primary Drinking Water Regulation
NRC National Research Council
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
ONU Occupational Non-User
OPPT Office of Pollution Prevention and Toxics
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OSHA
Occupational Safety and Health Administration
OTVD
Open-Top Vapor Degreaser
PBPK
Physiologically-Based Pharmacokinetic
PBZ
Personal Breathing Zone
PECO
Population, Exposure, Comparator, and Outcome
PEL
Permissible Exposure Limit
PESS
Potentially Exposed or Susceptible Subpopulations
POD
Point of Departure
POTW
Publicly Owned Treatment Works
ppb
Part(s) per Billion
PPE
Personal Protective Equipment
ppm
Part(s) per Million
PSD
Particle Size Distribution
PV
Production Volume
QC
Quality Control
RCRA
Resource Conservation and Recovery Act
REACH
Registration, Evaluation, Authorisation and Restriction of Chemicals
REL
Recommended Exposure Limit
RICE
Reciprocating Internal Combustion Engines
RTR
Risk and Technology Review
SDS
Safety Data Sheets
SDWA
Safe Drinking Water Act
SIDS
Screening Information Data Set
SMAC
Spacecraft Maximum Allowable Concentrations
SNAP
Significant New Alternatives Policy
SpERC
Specific Environmental Release Categories
STEL
Short-Term Exposure Limit
STORET
STOrage and RETrieval and Water Quality exchange
TCCR
Transparent, clear, consistent, and reasonable
TLV
Threshold Limit Value
TRI
Toxics Release Inventory
TSCA
Toxic Substances Control Act
TTO
Total Toxic Organics
TWA
Time-Weighted Average
U.S.
United States
USGS
United States Geological Survey
VOC
Volatile Organic Compound
VP
Vapor Pressure
WHO
World Health Organization
Yr
Year(s)
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EXECUTIVE SUMMARY
TSCA § 6(b)(4) requires the U.S. Environmental Protection Agency (EPA) to establish a risk evaluation
process. In performing risk evaluations for existing chemicals, EPA is directed to "determine whether a
chemical substance presents an unreasonable risk of injury to health or the environment, without
consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed
or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator under the
conditions of use." In December of 2016, EPA published a list of 10 chemical substances that are the
subject of the Agency's initial chemical risk evaluations ( 7), as required by TSCA §
6(b)(2)(A). Methylene chloride was one of these chemicals.
TSCA § 6(b)(4)(D) requires that EPA publish the scope of the risk evaluation to be conducted, including
the hazards, exposures, conditions of use and potentially exposed or susceptible subpopulations that the
Administrator expects to consider. In June 2017, EPA published the Scope of the Risk Evaluation for
methylene chloride. As explained in the scope document, because there was insufficient time for EPA to
provide an opportunity for comment on a draft of the scope, as EPA intends to do for future scope
documents, EPA is publishing and taking public comment on a problem formulation document to refine
the current scope, as an additional interim step prior to publication of the draft risk evaluation for
methylene chloride. Comments received on this problem formulation document will inform
development of the draft risk evaluation.
This problem formulation document refines the conditions of use, exposures and hazards presented in
the scope of the risk evaluation for methylene chloride and presents refined conceptual models and
analysis plans that describe how EPA expects to evaluate the risk for methylene chloride.
Methylene chloride, also known as dichloromethane and DCM, is a volatile and high production volume
(HPV) chemical that is used as a solvent in a wide range of industrial, commercial and consumer
applications. Methylene chloride is subject to a number of federal and state regulations and reporting
requirements. Methylene chloride has been a reportable 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), a hazardous waste under
the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), a drinking
water contaminant subject to national primary drinking water regulations under the Safe Drinking Water
Act (SDWA), and certain household products containing methylene chloride are hazardous substances
required to be labeled under the Federal Hazardous Substances Act (FHSA) by the Consumer Product
Safety Commission (CPSC) including a recent update to the labelling for paint removers (83 FR 12254.
March 21, 2018 and 83 FR 18219. April 26, 2018).
Information on domestic manufacture, processing and use of methylene chloride is available to EPA
through its Chemical Data Reporting (CDR) Rule, issued under TSCA. In 2015, more than
260 million lbs of methylene chloride was reported to be manufactured (including imported) in the U.S.
According to the ICIS (2007) chemical profile in 2005, the primary uses for methylene chloride are
paint stripping and removal (30%), adhesives (22%), pharmaceuticals (11%), metal cleaning (8%),
aerosols (8%), chemical processing (8%), flexible polyurethane foam (5%) and miscellaneous (8%).
This document presents the potential exposures that may result from the conditions of use of methylene
chloride. Exposures may occur to workers and occupational non-users (workers who do not directly
handle the chemical but perform work in an area where the chemical is used), consumers and bystanders
(non-product users that are incidentally exposed to the product) and the general population through
inhalation, dermal and oral pathways. Workers and occupational non-users may be exposed to
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methylene chloride during a variety of conditions of use, such as manufacturing, processing and
industrial and commercial uses, including uses in paint removal, adhesives and degreasing. EPA expects
that the highest exposures to methylene chloride generally involve workers in industrial and commercial
settings. Methylene chloride can be found in numerous products and can, therefore, result in exposures
to commercial and consumer users in indoor or outdoor environments. For methylene chloride, EPA
considers workers, occupational non-users, consumers, bystanders, and certain other groups of
individuals who may experience greater exposures than the general population due to proximity to
conditions of use to be potentially exposed or susceptible subpopulations. Exposures to the general
population may occur from industrial and/or commercial uses; industrial releases to air, water or land;
and other conditions of use. EPA will evaluate whether groups of individuals within the general
population may be exposed via pathways that are distinct from the general population due to unique
characteristics (e.g., life stage, behaviors, activities, duration) that increase exposure and whether groups
of individuals have heightened susceptibility, and should therefore be considered potentially exposed or
susceptible subpopulations for purposes of the risk evaluation. EPA plans to further analyze inhalation
exposures to vapors and mists for workers and occupational non-users (workers who do not directly
handle the chemical but perform work in an area where the chemical is present) and dermal exposures
for skin contact with liquids in occluded situations for workers in the risk evaluation. EPA plans to
further analyze inhalation exposures to vapors and mists for consumers and bystanders and dermal
exposures for skin contact with liquids in the risk evaluation. For environmental release pathways, EPA
plans to further analyze surface water exposure to aquatic invertebrates and aquatic plants in the risk
evaluation.
Methylene chloride has been the subject of numerous human health reviews including EPA's Integrated
Risk Information System (IRIS) Toxicological Review and Agency for Toxic Substances and Disease
Registry's (ATSDR's) Toxicological Profile. A number of targets of toxicity from exposures to
methylene chloride have been identified in animal and human studies for both oral and inhalation
exposures. EPA plans to evaluate all potential hazards for methylene chloride, using these previous
analyses as a starting point for identifying key and supporting studies and including any found in recent
literature. The relevant studies will be evaluated using the data quality criteria in the Application of
Systematic Review in TSCA Risk Evaluations document (U.S. EPA. 2018). Hazard endpoints identified
in previous assessments include: acute toxicity (via central nervous system [CNS] depression which can
result in death), irritation, liver toxicity and neurotoxicity. Methylene chloride is also likely carcinogenic
in humans. If additional hazard concerns are identified during the systematic review of the literature,
these will also be considered. These hazards will be evaluated based on the specific exposure scenarios
identified.
The revised conceptual models presented in this problem formulation identify conditions of use;
exposure pathways (e.g., media); exposure routes (e.g., inhalation, dermal, oral); potentially exposed or
susceptible subpopulations; and hazards EPA expects to consider in the risk evaluation. The initial
conceptual models provided in the scope document were revised during problem formulation based on
evaluation of reasonably available information for physical and chemical properties, fate, exposures,
hazards, and conditions of use and based upon consideration of other statutory and regulatory
authorities. In each problem formulation document for the first 10 chemical substances, EPA also
refined the activities, hazards and exposure pathways that will be included in and excluded from the risk
evaluation.
EPA's overall objectives in the risk evaluation process are to conduct timely, relevant, high-quality, and
scientifically credible risk evaluations within the statutory deadlines, and to evaluate the conditions of
use that raise greatest potential for risk 82 FR 3372.6. 33728 (July 20, 2017).
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1 INTRODUCTION
This document presents for comment the problem formulation of the risk evaluation to be conducted 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, on June 22, 2016. The new law includes
statutory requirements and deadlines for actions related to conducting risk evaluations of existing
chemicals.
In December of 2016, EPA published a list of 10 chemical substances that are the subject of the
Agency's initial chemical risk evaluations (81 R\ f> I '"C ), as required by TSCA § 6(b)(2)(A). These
10 chemical substances were drawn from the 2014 update of EPA's TSCA Work Plan for Chemical
Assessments, a list of chemicals that EPA identified in 2012 and updated in 2014 (currently totaling
90 chemicals) for further assessment under TSCA. EPA's designation of the first 10 chemical
substances constituted the initiation of the risk evaluation process for each of these chemical substances,
pursuant to the requirements of TSCA § 6(b)(4).
TSCA § 6(b)(4)(D) requires that EPA publish the scope of the risk evaluation to be conducted, including
the hazards, exposures, conditions of use and potentially exposed or susceptible subpopulations that the
Administrator expects to consider, within 6 months after the initiation of a risk evaluation. The scope
documents for all first 10 chemical substances were issued on June 22, 2017. The first 10 problem
formulation documents are a refinement of what was presented in the first 10 scope documents. TSCA §
6(b)(4)(D) does not distinguish between scoping and problem formulation, and requires EPA to issue
scope documents that include information about the chemical substance, including the hazards,
exposures, conditions of use, and the potentially exposed or susceptible subpopulations that the
Administrator expects to consider in the risk evaluation. In the future, EPA expects scoping and problem
formulation to be completed prior to the issuance of scope documents and intends to issue scope
documents that include problem formulation.
As explained in the scope document, because there was insufficient time for EPA to provide an
opportunity for comment on a draft of the scope, as EPA intends to do for future scope documents, EPA
is publishing and taking public comment on a problem formulation document to refine the current scope,
as an additional interim step prior to publication of the draft risk evaluation for methylene chloride.
Comments received on this problem formulation document will inform development of the draft risk
evaluation.
The Agency defines problem formulation as the analytical phase of the risk assessment in which "the
purpose for the assessment is articulated, the problem is defined and a plan for analyzing and
characterizing risk is determined" (see Section 2.2 of the Framework for Human Health Risk
Assessment to Inform Decision Making). The outcome of problem formulation is a conceptual model(s)
and an analysis plan. The conceptual model describes the linkages between stressors and adverse human
health effects, including the stressor(s), exposure pathway(s), exposed life stage(s) and population(s),
and endpoint(s) that will be addressed in the risk evaluation (U.S. EPA. 2014a). The analysis plan
follows the development of the conceptual model(s) and is intended to describe the approach for
conducting the risk evaluation, including its design, methods and key inputs and intended outputs as
described in the EPA Human Health Risk Assessment Framework (U.S. EPA, 2014a). The problem
formulation documents refine the initial conceptual models and analysis plans that were provided in the
scope documents.
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First, EPA has removed from the risk evaluation any activities and exposure pathways that EPA has
concluded do not warrant inclusion in the risk evaluation. For example, for some activities which were
listed as "conditions of use" in the scope document, EPA has insufficient information following the
further investigations during problem formulation to find they are circumstances under which the
chemical is actually "intended, known, or reasonably foreseen to be manufactured, processed,
distributed in commerce, used, or disposed of."
Second, EPA also identified certain exposure pathways that are under the jurisdiction of regulatory
programs and associated analytical processes carried out under other EPA-administered environmental
statutes - namely, the Clean Air Act (CAA), the Safe Drinking Water Act (SDWA), the Clean Water
Act (CWA), and the Resource Conservation and Recovery Act (RCRA) - and which EPA does not
expect to include in the risk evaluation.
As a general matter, EPA believes that certain programs under other Federal environmental laws
adequately assess and effectively manage the risks for the covered exposure pathways. To use Agency
resources efficiently under the TSCA program, to avoid duplicating efforts taken pursuant to other
Agency programs, to maximize scientific and analytical efforts, and to meet the three-year statutory
deadline, EPA is planning to exercise its discretion under TSCA 6(b)(4)(D) to focus its analytical efforts
on exposures that are likely to present the greatest concern and consequently merit a risk evaluation
under TSCA, by excluding, on a case-by-case basis, certain exposure pathways that fall under the
jurisdiction of other EPA-administered statutes.1 EPA does not expect to include any such excluded
pathways as further explained below in the risk evaluation. The provisions of various EPA-administered
environmental statutes and their implementing regulations represent the judgment of Congress and the
Administrator, respectively, as to the degree of health and environmental risk reduction that is sufficient
under the various environmental statutes.
Third, EPA identified any conditions of use, hazards, or exposure pathways which were included in the
scope document and that EPA expects to include in the risk evaluation but which EPA does not expect
to further analyze in the risk evaluation. EPA expects to be able to reach conclusions about particular
conditions of use, hazards or exposure pathways without further analysis and therefore expects to
conduct no further analysis on those conditions of use, hazards or exposure pathways in order to focus
the Agency's resources on more extensive or quantitative analyses. Each risk evaluation will be "fit-for-
purpose," meaning not all conditions of use will warrant the same level of evaluation and the Agency
may be able to reach some conclusions without comprehensive or quantitative risk evaluations
33726. 33734, 33739 (July 20, 2017).
EPA received comments on the published scope document for methylene chloride and has considered
the comments specific to methylene chloride in this problem formulation document. EPA is soliciting
public comment on this problem formulation document and when the draft risk evaluation is issued the
Agency intends to respond to comments that are submitted. In its draft risk evaluation, EPA may revise
the conclusions and approaches contained in this problem formulations, including the conditions of use
and pathways covered and the conceptual models and analysis plans, based on comments received.
1 As explained in the final rule for chemical risk evaluation procedures, "EPA may, on a case-by case basis, exclude certain
activities that EPA has determined to be conditions of use in order to focus its analytical efforts on those exposures that are
likely to present the greatest concern, and consequently merit an unreasonable risk determination." [82 FR 33726. 33729
(July 20, 2017)]
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1.1 Regulatory History
EPA conducted a search of existing domestic and international laws, regulations and assessments
pertaining to methylene chloride. EPA compiled this summary from data available from federal, state,
international and other government sources, as cited in Appendix A. EPA evaluated and considered the
impact of existing laws and regulations (e.g., regulations on landfill disposal, design, and operations) in
the problem formulation step to determine what, if any future analysis might be necessary as part of the
risk evaluation. Consideration of the nexus between these existing regulations and TSCA conditions of
use may additionally be made as detailed/specific conditions of use and exposure scenarios are
developed in conducting the analysis phase of the risk evaluation.
Federal Laws and Regulations
Methylene chloride is subject to federal statutes or regulations, other than TSCA, 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.
State Laws and Regulations
Methylene chloride is subject to state statutes or 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 or regulations in countries other than the United States and/or
international treaties and/or agreements. A summary of these laws, regulations, treaties and/or
agreements is provided in Appendix A.3.
1.2 Assessment History
EPA has identified assessments conducted by other EPA Programs and other organizations (see Table
1-1). Depending on the source, these assessments may include information on conditions of use,
hazards, exposures and potentially exposed or susceptible subpopulations. Table 1-1 shows the
assessments that have been conducted. EPA found no additional assessments beyond those listed in the
Scope document, but the WHO IPCS Environmental Health Criteria (EHC) document which was cited
in the Scope document was added to the assessment history table.
In addition to using this information, EPA intends to conduct a full review of the relevant data and
information collected in the initial comprehensive search [see Methylene Chloride (CASRN 75-09-2)
Bibliography: Supplemental File for the TSCA Scope Document 3742-0059 (U.S.
EPA. 2017a)1 using the literature search and screening strategies documented in the Strategy for
Conducting Literature Searches for Methylene Chloride: Supplemental File for the TSCA Scope
Document EPA-HQ-QPPT-2016-0742-0060 (US. EPA. 2017cY This will ensure that EPA considers
data and information that has been made available since these assessments were conducted.
Table 1-1. 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 Striooi : CASRN:
75~0'
Page 15 of 148
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Authoring Organization
Assessment
U.S. EPA, Integrated Risk Information System
(IRIS)
Toxicological Review of Dichloromethane
(Methylene Chloride) (CAS No. 75-09-2)
EPA. (201 lb)
U.S. EPA, Office of Water (OW)
Ambient Water Quality Criteria for tlv Pi election
of Human. Health U.S. EPA. (2.015)
Other U.S.-Based Organizations
Agency for Toxic Substances and Disease Registry
(AT SDR)
Toxicological Profile for Methylene Chloride
A ; (2000) and ATSDk , addendum
National Advisory Committee for Acute Exposure
Guideline Levels for Hazardous Substances
(NAC/AEGL Committee)
Interim. Acute Exposure Guideline Level
for Methylene Chloride \ \( V , >1 < _0<«»1
U.S. National Academies, National Research
Council (NRC)
Spacecraft Maximum Allowable Concentrations
(SMA.C) for Selected Airborne Contaminants:
Methylene chloride (Volume 2) NRC (1996a)
National Toxicology Program (NTP), National
Institutes of Health (NIH)
Report on. Carcinogens. Twelfth Edition.
Dich 1 orom ethane NIH (2016)
Occupational Safety and Health Administration
(OSHA)
Occupational Exposure to Methylene Chloride
California Environmental Protection Agency,
Office of Environmental Health Hazard
Assessment (OEHHA)
Acute Reference Exposure Level (RED and
Toxicity Summary for Methylene Chloride
OEHHA. (2008)
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 Assessrne lie
OECD (:
International Agency for Research on Cancer
(IARC)
IARC Monographs on the Evaluation of
Carcinogenic Risks to Humans Volui
World Health Organization (WHO)
Air Oualm Guidelines for Europe WHO (2000)
WHO International Programme on Chemical
Safety (IPCS)
Environmental Health Criteria 164 Methylene
Chlo
Government of Canada, Environment Canada,
Health Canada
Dichloromethane. Priority substances list
assessment report. Health and Environment
Page 16 of 148
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Authoring Or»;miz;ilion
Assessment
National Industrial Chemicals Notification and
Assessment Scheme (NICNAS), Australian
Government
Human Health. Tiei essment for Methane.
dicMoro- CAS Numbe
1.3 Data and Information Collection
EPA/OPPT generally applies a systematic review process and workflow that includes: (1) data
collection; (2) data evaluation; and (3) data integration of the scientific data used in risk evaluations
developed under TSCA. Scientific analysis is often iterative in nature as new knowledge is obtained.
Hence, EPA/OPPT expects that multiple refinements regarding data collection will occur during the
process of risk evaluation. Additional information that may be considered and was not part of the initial
comprehensive bibliographies will be documented in the Draft Risk Evaluation for methylene chloride.
Data Collection: Data Search
EPA/OPPT conducted chemical-specific searches for information on: physical and chemical properties;
environmental fate and transport; conditions of use information; environmental and human exposures,
including potentially exposed or susceptible subpopulations; ecological and human health hazard,
including potentially exposed or susceptible subpopulations.
EPA/OPPT designed its initial data search to be broad enough to capture a comprehensive set of sources
containing information potentially relevant to the risk evaluation. For most disciplines, the search was
not limited by date and was conducted on a wide range of data sources, including but not limited to:
peer-reviewed literature and gray literature (e.g., publicly-available industry reports, trade association
resources, government reports). For human health hazard, EPA/OPPT relied on the search strategies
from recent assessments, such as the 2011 EPA Integrated Risk Information System (IRIS) assessment
to identify relevant information published after the end date of the previous search to capture more
recent literature. The Strategy for Conducting Literature Searches for Methylene Chloride:
Supplemental File for the TSCA Scope Document EP A-HO-OPPT-201.6-0742-0060 (U.S. EPA. 2017c)
provides details about the data and information sources and search terms that were used in the literature
search.
Data Collection: Data Screening
Following the data search, references were screened and categorized using selection criteria outlined in
the Strategy for Conducting Literature Searches for Methylene Chloride: Supplemental File for the
TSCA Scope Document I r • I h * 1 'l'PT-2016 0742-0060 (U.S. EPA. 2017c). Titles and abstracts were
screened against the criteria as a first step with the goal of identifying a smaller subset of the relevant
data to move into the subsequent data extraction and data evaluation steps. Prior to full-text review,
EPA/OPPT anticipates refinements to the search and screening strategies, as informed by an evaluation
of the performance of the initial title/abstract screening and categorization process.
The categorization scheme (or tagging structure) used for data screening varies by scientific discipline
(i.e., physical and chemical properties; environmental fate and transport; chemical use/conditions of use
information; human and environmental exposures, including potentially exposed or susceptible
subpopulations identified by virtue of greater exposure; human health hazard, including potentially
exposed or susceptible subpopulations identified by virtue of greater susceptibility; and ecological
hazard). However, within each data set, there are two broad categories or data tags: (1) on-topic
references or (2) off-topic references. On-topic references are those that may contain data and/or
Page 17 of 148
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information relevant to the risk evaluation. Off-topic references are those that do not appear to contain
data or information relevant to the risk evaluation. The supplemental document, Strategy for Conducting
Literature Searches for Methylene Chloride: Supplemental File for the TSCA Scope Document EPA-
HQ-OPPT-2.016-0742-0060 (U.S. EPA. 2017c). discusses the inclusion and exclusion criteria that
EPA/OPPT used to categorize references as on-topic or off-topic.
Additional data screening using sub-categories (or sub-tags) was also performed to facilitate further
sorting of data/information - for example, identifying references by source type (e.g., published peer-
reviewed journal article, government report); data type (e.g., primary data, review article); human health
hazard (e.g., liver toxicity, cancer, reproductive toxicity); or chemical-specific and use-specific data or
information. These sub-categories are described in the supplemental document, Strategy for Conducting
Literature Searches for Methylene Chloride: Supplemental File for the TSCA Scope Document EPA-
HO-OPPT-2016 0742-006 1 (' SJ }\\ 2017c), and will be used to organize the different streams of
data during the stages of data evaluation and data integration steps of systematic review.
Results of the initial search and categorization can be found in the Methylene Chloride (CASRN 75-09-
2) Bibliography: Supplemental File for the TSCA Scope Document EPA-HQ-OPPT 2016-0742 0059
(U.S. EPA.! ). This document provides a comprehensive list (bibliography) of the sources of data
identified by the initial search and the initial categorization for on-topic and off-topic references.
Because systematic review is an iterative process, EPA/OPPT expects that some references may move
from the on-topic to the off-topic categories, and vice versa. Moreover, targeted supplemental searches
may also be conducted to address specific needs for the analysis phase (e.g., to locate specific data
needed for modeling); hence, additional on-topic references not initially identified in the initial search
may be identified as the systematic review process proceeds.
1.4 Data Screening During Problem Formulation
EPA/OPPT is in the process of completing the full text screening of the on-topic references identified in
the Methylene Chloride (CASRN 75-09-2) Bibliography: Supplemental File for the TSCA Scope
Document EPA-HQ-QPPT-2016-0742-0059 (U.S. EPA. 2017a). The screening process at the full-text
level is described in the Application of Systematic Review in TSCA Risk Evaluations ( )18).
Appendix F provides the inclusion and exclusion criteria applied at the full text screening. The eligibility
criteria are guided by the analytical considerations in the revised conceptual models and analysis plan, as
discussed in the problem formulation document. Thus, it is expected that the number of data/information
sources entering evaluation is reduced to those that are relevant to address the technical approach and
issues described in the analysis plan of this document.
Following the screening process, the quality of the included data/information sources will be assessed
using the evaluation strategies that are described in the Application of Systematic Review in TSCA Risk
Evaluations (U.S. EPA. 2018).
Page 18 of 148
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2 PROBLEM FORMULATION
As required by TSCA, the scope of the risk evaluation identifies the conditions of use, hazards,
exposures and potentially exposed or susceptible subpopulations that the Administrator expects to
consider. To communicate and visually convey the relationships between these components, EPA
included in the scope document a life cycle diagram and conceptual models that describe the actual or
potential relationships between methylene chloride and human and ecological receptors. During the
problem formulation, EPA revised the conceptual models based on further data gathering and analysis,
as presented in this problem formulation document. An updated analysis plan is also included which
identifies, to the extent feasible, the approaches and methods that EPA may use to assess exposures,
effects (hazards) and risks under the conditions of use for methylene chloride.
2.1 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 intends to consider. For scope development, EPA considered the measured or estimated
physical-chemical properties set forth in Table 2-1; EPA found no additional information during
problem formulation that would change these values.
Table 2-1. Physical and Chemical Properties of Methylene Chloride
Properly
Vill lie
References
Molecular formula
CH2CI2
Molecular weight
84.93 g/mol
Physical form
Colorless liquid; sweet, pleasant
odor resembling chloroform
U. S. Coast Gui 14)
Melting point
-95°C
O'Neil C
Boiling point
39.7°C
O'Neil C
Density
1.33 g/cm3 at 20°C
O'Neil C
Vapor pressure
435 mmHg at 25°C
Boublik et a 4)
Vapor density
2.93 (relative to air)
Holbrook (2003)
Water solubility
13 g/L at 25°C
Horvath (1982)
Octanol/water partition
coefficient (log KoW)
1.25
Hansch et al. (1995)
Henry's Law constant
0.00325 atm-m3/mole
Leighton an 81)
Flash point
Not readily available
Autoflammability
Not readily available
Viscosity
0.437 mPa-s at 20°C
Rossberg et al. (2011)
Refractive index
1.4244 at 20°C
O'Neil C
Dielectric constant
9.02 at 20°C
Laurence et al. (1994)
a Measured unless otherwise noted.
Page 19 of 148
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2.2 Conditions of Use
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."
2.2.1 Data and Information Sources
In the scope documents, EPA identified, based on reasonably available information, the conditions of
use for the subject chemicals. EPA searched a number of available data sources (e.g., Use and Market
Profile for Methylene Chloride, EPA-HQ-OPPT-2016-0742). Based on this search, EPA published a
preliminary list of information and sources related to chemical conditions of use (see Preliminary
Information on Manufacturing, Processing, Distribution, Use, and Disposal: Methylene Chloride, EPA-
HO-OPPT-2 f42-0003) prior to a February 2017 public meeting on scoping efforts for risk
evaluation convened to solicit comment and input from the public. EPA also convened meetings with
companies, industry groups, chemical users and other stakeholders to aid in identifying conditions of use
and verifying conditions of use identified by EPA. The information and input received from the public
and stakeholder meetings was incorporated into this problem formulation document to the extent
appropriate. Thus, EPA believes the manufacture, processing, distribution, use and disposal activities
constitute the intended, known, and reasonably foreseeable activities associated with the subject
chemical, based on reasonably available information.
2.2.2 Identification of Conditions of Use
To determine the current conditions of use of methylene chloride and inversely, activities that do not
qualify as conditions of use, EPA conducted extensive research and outreach. This included EPA's
review of published literature and online databases including the most recent data available from EPA's
Chemical Data Reporting program (CDR) and Safety Data Sheets (SDSs). EPA also conducted online
research by reviewing company websites of potential manufacturers, importers, distributors, retailers, or
other users of methylene chloride and queried government and commercial trade databases. EPA also
received comments on the Scope of the Risk Evaluation for Methylene Chloride (EPA-HQ-OPPT-2016-
0742) that were used to determine the conditions of use. In addition, EPA convened meetings with
companies, industry groups, chemical users, states, environmental groups, and other stakeholders to aid
in identifying conditions of use and verifying conditions of use identified by EPA. Those meetings
included a February 14, 2017 public meeting with such entities ("EPA-HQ-OI ).
EPA has removed from the risk evaluation any activities that EPA concluded do not constitute
conditions of use - for example because EPA has insufficient information to find certain activities are
circumstances under which the chemical is actually "intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used or disposed of." EPA has also identified any
conditions of use that EPA does not expect to include in the risk evaluation. As explained in the final
rule for Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act,
TSCA section 6(b)(4)(D) requires EPA to identify "the hazards, exposures, conditions of use, and the
potentially exposed or susceptible subpopulations the Administrator expects to consider" in a risk
evaluation, suggesting that EPA may exclude certain activities that EPA has determined to be
conditions of use on a case-by-case basis. (K 5, 33729; July 20, 2017). For example, EPA may
exclude conditions of use that the Agency has sufficient basis to conclude would present only de
minimis exposures or otherwise insignificant risks (such as use in a closed system that effectively
precludes exposure or use as an intermediate).
Page 20 of 148
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The activities that EPA no longer believes are conditions of use or were otherwise excluded during
problem formulation are described in Section 2.2.2.1. The conditions of use included in the scope of the
risk evaluation are summarized in Section 2.2.2.2.
2.2.2.1 Categories and Subcategories Determined Not to be Conditions of Use or
Otherwise Excluded During Problem Formulation
For methylene chloride, EPA has conducted public outreach and literature searches to collect
information about methylene chloride's conditions of use and has reviewed reasonably available
information obtained or possessed by EPA concerning activities associated with methylene chloride.
Based on this research and outreach, other than the category and subcategory described in Section
2.2.2.1, EPA does not have reason to believe that any conditions of use identified in the methylene
chloride scope should be excluded from risk evaluation. Therefore, all the conditions of use for
methylene chloride will be included in the risk evaluation.
During problem formulation, EPA determined that methylene chloride-based extraction solvents for oils,
waxes, fats, spices, and hops meet the definition of food additive in section 201 of the Federal Food,
Drug, and Cosmetic Act, 21 U.S.C. § 321, and are therefore excluded from the definition of "chemical
substance" in TSCA § 3(2)(B)(vi). Activities and releases associated with such extraction solvents are
therefore not "conditions of use" (defined as circumstances associated with "a chemical substance,"
TSCA § 3(4)) and will not be evaluated during risk evaluation. In particular, the use of methylene
chloride-based extraction solvent for oils, waxes, fats, spices, and hops in agricultural chemical
manufacturing and food processing was identified as a condition of use in the methylene chloride scope
document but is no longer considered a condition of use and will not be evaluated in the risk evaluation.
In its 2014 risk evaluation, EPA assessed the risk from methylene chloride in consumer and commercial
paint removal ( 2014b). The Agency determined that those risks were unreasonable and, on
January 19, 2017, proposed restrictions under TSCA section 6 to address the risks from methylene
chloride in paint and coating removal by consumers and most commercial users except for commercial
furniture stripping (Si /_k*J, January 19, 2017). While paint and coating removal falls under the
conditions of use for methylene chloride, based on the intention to finalize the rulemaking the scenarios
already assessed in the 2014 risk assessment these uses will not be re-evaluated and EPA will rely on the
2014 risk evaluation (https://www.epa.gov/newsreleases/epa-announces-action-methylene-chloridey
Table 2-2. Categories and Subcategories Determined Not to be Conditions of Use or Otherwise
Excluded During Problem Formulation
l.ife Cycle Stage
Category 11
Subcategory h
References
Industrial,
commercial and
consumer uses
Other Uses
Extraction solvent for oils,
waxes, fats, spices and hops in
agricultural chemical
manufacturing and food
processing
2016b) Market
profile EPA-HQ-OPPT-
2016-0742
Paints and
coatings
Paints and coating removers
except for commercial furniture
stripping
proposed restrictions
under TSCA section 6 (82
, January 19,
2017).
Page 21 of 148
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2.2.2.2 Categories and Subcategories of Conditions of Use Included In the Scope of
Risk Evaluation
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.
According to the ICIS (2007) chemical profile, 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%).
Table 2-3 summarizes each life cycle stage and the corresponding categories and subcategories of
conditions of use for methylene chloride that EPA expects to consider in the risk evaluation. Using the
2016 CDR (U.S. EPA. 2016b). EPA identified industrial processing or use activities, industrial function
categories and commercial and consumer use product categories. EPA identified the subcategories by
supplementing CDR data with other published literature and information obtained through stakeholder
consultations. For risk evaluations, EPA intends to consider each life cycle stage (and corresponding use
categories and subcategories) and assess certain relevant potential sources of release and human
exposure associated with that life cycle stage.
Beyond the uses identified in the Scope of the Risk Evaluation for Methylene Chloride, EPA has
received no additional information identifying additional current conditions of use for methylene
chloride from public comment and stakeholder meetings.
Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
l.ife Cycle Stage
Category 11
Subcategory h
References
Manufacturing
Domestic
manufacturing
Manufacturing
JO16b)
Import
Import
JO16b)
Processing
Processing as a
reactant
Intermediate in industrial gas
manufacturing (e.g., manufacture
of fluorinated gases used as
refrigerants)
JO 16b); U.S.
EPA. (2014b) Market
profile EPA-HQ-OPPT-
2016-0742 Public
Comments EPA-HQ-
OPPT-2016-0742-0016.
-'J'Olo-
M'42"0MI ' . LilV.-llO-
OPPT-2016-0742-0019
Intermediate for pesticide,
fertilizer, and other agricultural
chemical manufacturing
JO16b)
CBI function for petrochemical
manufacturing
JO16b)
Page 22 of 148
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l.ili' ( vole S(:i«o
Ciitcgorv 11
Siihcsilcgorv h
UcfomuTs
Processing
Processing as a
reactant
Intermediate for other chemicals
Public Comment EPA-HC
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
>016b)
Incorporated into
formulation,
mixture, or
reaction product
Solvents (which become part of
product formulation or mixture),
including manufacturing of:
• All other chemical product
and preparation
• Paints and coatings
>016b)
Propellants and blowing agents
for all other chemical product and
preparation manufacturing;
>016b)
Propellants and blowing agents
for plastics product
manufacturing
Use document EPA-HO-
OPPT-2016-0742-0003.
Market profile
Paint additives and coating
additives not described by other
codes for CBI industrial sector
>016b)
Laboratory chemicals for all other
chemical product and preparation
manufacturing
>016b). EPA-
II"' - <1 'II 1 -"hi " J -
fLPMiO-OPPT-
Laboratory chemicals for CBI
industrial sectors
>016b)
Processing aid, not otherwise
listed for petrochemical
manufacturing
>016b)
Adhesive and sealant chemicals
in adhesive manufacturing
Use document EPA-HO-
OPPT-2016-0742-0003;
>016b)
Unknown function for oil and gas
drilling, extraction, and support
activities
Use document EPA-HO-
OPPT-2016-0742-0003;
>016b)
Page 23 of 148
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l.ili' ( vole S(:i«o
Ciitcgorv 11
Siihcsilcgorv h
UcfomuTs
Processing
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;
CBI functions for all other
chemical product and preparation
manufacturing
Use document EPA-HO-
OPPT-2016-0742-0003;
>016b)
Recycling
Recycling
1, S MP \ d
Distribution in
commerce
Distribution
Distribution
Use document EPA-HO-
OPPT-2016-0742-0003
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. (2016b); Public
comment EP A-HO-OPPT-
2
In-line vapor degreaser (e.g.,
conveyorized, web cleaner)
Use document EPA-HO-
OPPT-2016-0742-0003;
I. S H1 \ lam--b); Public
comment »PT-
2
Cold cleaner
Use document EPA-HO-
OPPT-2016-0742-0003;
1 < i V \,i0iob. 2014b)
Aerosol spray degreaser/cleaner
>016b. 2014b)
EP A-HO-OPPT-2016-
v«" , Market profile
EP A-HO-OPPT-2016-0742
Page 24 of 148
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l.ili' ( vole S(:i«o
Ciitcgorv 11
Siihcsilcgorv h
UcfomuTs
Industrial,
commercial and
consumer uses
Adhesives and
sealants
Single component glues and
adhesives and sealants and caulks
Use document EPA-HO-
OPPT-2016-0742-0003:
1 t l> \ t i. Public
comments EPA-HO-GPPT-
2<>i 'i: 000>, \ 1- \
HO-OPPT-20 i 6-0742-
00i \ XV \ HO-OPPT-
:016b. 2014b);
Market profile
OPPT-2016-0742 Public
Comments EPA-HO-
OPPT-2016-0742-0005.
EPA-HO-OPPT-2016-
0742-000''. I PA;iIQi
OPPI-20 i 6-0742-0014.
EPA-HO-OPPT-2016-
¦ r-ll:-«'»«jT'. NV\-HO-
1 1 ¦' -! |U
EPA-HO-OPPT-2016-
0742-0025
Adhesive/caulk removers
Use document EPA-HQ-
OPPT-2016-0742-0003.
Market profile
Metal products not
covered elsewhere
Degreasers - aerosol and non-
aerosol degreasers and cleaners
e.g., coil cleaners
Market profile
EPA. (2016b)
Fabric, textile and
leather products
not covered
elsewhere
Textile finishing and
impregnating/ surface treatment
products e.g. water repellant
Market profile
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 (2016b)
Page 25 of 148
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l.ili' ( vole S(:i«o
Ciitcgorv 11
Siihcsilcgorv h
UcfomuTs
Industrial,
commercial and
consumer uses
Automotive care
products
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
i IT I 11 . i , 1 \
EPA. (2016b)
Apparel and
footwear care
products
Post-market waxes and polishes
applied to footwear e.g. shoe
polish
Market profile EPA-HQ-
OPPT-2016-0742
Laundry and
dishwashing
products
Spot remover for apparel and
textiles
Use document EPA-HQ-
OPPT-2016-0742-0003
Lubricants and
greases
Liquid and spray lubricants and
greases
JO 16b): EPA-
HO-<
0003; Market profile EPA-
HO-OPI . ;
Public Comment EPA-HQ-
OPPT-2016-0742-0021
Degreasers - aerosol and non-
aerosol degreasers and cleaners
>016b); EPA-
HO-OPPT-2016-0742-
0003; Market profile EPA-
HO-OPPT-2016 0742;
Public Comments EPA-
j i" , [J , ,[•[ |
2016-0'"-!! 2-0".» i -!
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
>016b)
Page 26 of 148
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l.ili' ( vole S(:i«o
Ciitcgorv 11
Siihcsilcgorv h
UcfomuTs
Industrial,
commercial and
consumer uses
Processing aid not
otherwise listed
In multiple manufacturing
sectors'1
Use document EPA-HO-
OPPT-2016-0742-0003:
Market profile
,
EPA. (2016b)
Propellants and
blowing agents
Flexible polyurethane foam
manufacturing
Market profile
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-2' 3;
Market profile
•'1 'I' 1 .( - Public
Comment: EPA-HQ-
OPPT-2' 5
Electrical equipment, appliance,
and component manufacturing
>016b). Public
Comment EPA-HO-OPPT-
2
Plastic and rubber products
>016b)
Anti-adhesive agent - anti-spatter
welding aerosol
Use document EPA-HO-
OPPT-21 3;
Market profile
^'111 •!,. '¦ " , Public
Comment EPA-HO-OPPT-
20116 0742-0005
Oil and gas drilling, extraction,
and support activities
Use document EPA-HO-
OPPT-2016-0742-0003:
Functional fluids (closed systems)
in pharmaceutical and medicine
manufacturing
>016b)
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;
Page 27 of 148
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l.ife ('vole Stage
Category 11
Subcategory h
References
Industrial,
commercial and
consumer uses
Other Uses
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. (2016b)
Disposal
Disposal
Industrial pre-treatment
I S ,1)
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.
0 Reported for the following sectors in the 2016 CDR for manufacturing of: plastic materials and resins, plastics products,
miscellaneous, all other chemical product and nreraration (IIS. EPA. 2016b).
d Reported for the following sectors in the 2016 CDR for manufacturing of: petrochemicals, plastic materials and resins,
plastics products, miscellaneous, all other chemical product and CBI (U.S. EPA. 2016b) also including as a chemical
processor for polycarbonate resins and cellulose triacetate (photographic film).
2.2.2.3 Overview of Conditions of Use and Lifecycle Diagram
The life cycle diagram provided in Figure 2-1 depicts the conditions of use that are considered within
the scope of the risk evaluation during various life cycle stages including manufacturing, processing,
distribution, use (industrial, commercial, consumer; when distinguishable) and disposal. Additions or
changes to conditions of use based on additional information gathered or analyzed during problem
formulation were described in Section 2.2.2.1 and 2.2.2.2. The activities that EPA determined are out of
scope during problem formulation are not included in the life cycle diagram. The information is grouped
according to Chemical Data Reporting (CDR) processing codes and use categories (including functional
use codes for industrial uses and product categories for commercial and consumer uses), in combination
with other data sources (e.g., published literature and consultation with stakeholders), to provide an
overview of conditions of use. EPA notes that some subcategories may be grouped under multiple CDR
categories.
Use categories include the following: "industrial use" means use at a site at which one or more
chemicals or mixtures are manufactured (including imported) or processed. "Commercial use" means
the use of a chemical or a mixture containing a chemical (including as part of an article) in a commercial
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enterprise providing saleable goods or services. "Consumer use" means the use of a chemical or a
mixture containing a chemical (including as part of an article, such as furniture or clothing) when sold to
or made available to consumers for their use (U.S. EPA. 2016b).
To understand conditions of use relative to one another and associated potential exposures under those
conditions of use, the life cycle diagram includes the production volume associated with each stage of
the life cycle, as reported in the 2016 CDR reporting ( 016b). when the volume was not
claimed confidential business information (CBI).
The 2016 CDR reporting data for methylene chloride are provided in Table 2-4 from EPA's CDR
database. This information has not changed during problem formulation from that provided in the scope
document.
Table 2-4. Production Volume of Methylene Chloride in CDR Reporting Period (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
•' The CDR data for the 2016 rcDortinu period is available via ChemView (httDs://iava.eDa.gov/chemview") ("U.S. EPA.
2016b). Because of an onsoins CBI substantiation process required bv amended TSCA. the CDR data available in the scope
document is more specific than currently in ChemView.
Descriptions of the industrial, commercial and consumer use categories identified from the 2016 CDR
( 2016b) and included in the life cycle diagram (Figure 2-1) are summarized below. The
descriptions provide a brief overview of the use category; Appendix B contains more detailed
descriptions (e.g., process descriptions and worker activities) for each manufacturing, processing, use
and disposal category. The descriptions provided below are primarily based on the corresponding
industrial function category and/or commercial and consumer product category descriptions from the
2016 CDR and can be found in EPA's Instructions for Reporting 2016 TŁ iernical Data Reporting
( 2016a).
The "Solvents for Cleaning and Degreasing" category encompasses chemical substances used to
dissolve oils, greases and similar materials from a variety of substrates including metal surfaces,
glassware and textiles. This category includes the use of methylene chloride in vapor degreasers and
cold cleaners and in industrial, commercial and consumer aerosol degreasing products. Methylene
chloride degreasers are often designed to clean electronic parts, electric motors and other water-sensitive
parts in industrial and commercial settings. Methylene chloride is also found in products available to
consumers such as brush cleaners or products designed to remove oil and grease from electronic or
mechanical parts.
The "Adhesives and Sealants" category encompasses chemical substances contained in adhesive and
sealant products used to fasten other materials together. The adhesives and sealants are found in both
liquid and aerosol forms. Examples include adhesives for bonding laminate to particle board or other
surfaces, foam to textiles, fiberglass to metal ductwork, carpet installation and cement for bonding
acrylic.
The "Paints and Coatings" category encompasses chemical substances used in a variety of paints,
varnishes, lacquers or other types of coatings used on a variety of substrates including wood and metal.
This category also covers paints and coatings removal uses, which include uses addressed in a previous
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risk assessment. Both of these categories have industrial, commercial and consumer uses with products
used in liquid, aerosol and paste forms.
The "Metal Products Not Covered Elsewhere" category encompasses chemical substances contained
in metal products not covered elsewhere that are intended for consumer or commercial use. Examples of
metal products not covered elsewhere include metal products produced by forging, stamping, plating,
turning, and other processes; hand tools; metal tubing/pipes/duct work; wire fencing; tableware; and
small appliances and cookware.
The "Fabric, Textile, and Leather Products Not Covered Elsewhere" category encompasses
chemical substances used to clean and treat a variety of textiles including upholstery and leather. This
category is primarily industrial and commercial users and the products are generally in liquid
formulations.
The "Automotive Care Products" category encompasses chemical substances contained in products
used to seal leaks in car air conditioners or used in auto air conditioner refrigerants. These products are
generally used in aerosol form and used in both commercial and consumer settings.
The "Apparel and Footwear Care Products" category encompasses chemical substances contained in
apparel and footwear care products that are applied post-market. Examples of apparel and footwear care
products include footwear polishes/waxes, garment waterproofing sprays, and stain repellents. These
products are primarily consumer or commercial uses.
The "Laundry and Dishwashing Products" category encompasses chemical substances contained in
laundry and dishwashing products and aids. Examples of laundry and dishwashing products include
detergents, fabric softeners, pre-soaks and prewashes to remove soil and stains, dryer sheets, bleach,
rinse aids, and film, lime and rust removers. These products are generally used as liquids, granular,
powders, gels, cakes, and flakes and used in both consumer and commercial settings.
The "Lubricants and Greases" category encompasses chemical substances contained in products used
in lubricants for cables, chains, metal parts, doors and dry film. These are primarily commercial or
industrial uses with both liquid and aerosol formulations.
Other uses of methylene chloride include uses in building/construction materials not covered elsewhere;
solvents (which become part of product formation or mixture); processing aids not otherwise listed;
propellants and blowing agents; arts, crafts and hobby materials (e.g., crafting glue and cement);
functional fluids (closed systems); laboratory chemicals; novelty items (e.g., Red Retro Happy Dippy
Drinking Bird).
Figure 2-1 depicts the life cycle diagram of methylene chloride from manufacture to the point of
disposal. Activities related to the distribution (e.g., loading, unloading) will be considered throughout
the methylene chloride life cycle rather, than using a single distribution scenario.
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MFG/IMPORT PROCESSING INDUSTRIAL, COMMERCIAL, CONSUMER USESa RELEASES and WASTE DISPOSAL
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 2-4 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 2-1. 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 (J.S. EPA. 2016b). Activities related to distribution (e.g., loading and unloading)
will be considered throughout the methylene chloride life cycle, rather than using a single distribution scenario.
a See Table 2-3 for additional uses not mentioned specifically in this diagram.
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2.3 Exposures
For TSCA exposure assessments, EPA expects to evaluate exposures and releases to the environment
resulting from the conditions of use applicable to methylene chloride. Post-release pathways and routes
will be described to characterize the relationship or connection between the conditions of use for
methylene chloride and the exposure to human receptors, including potentially exposed or susceptible
subpopulations and ecological receptors. EPA will take into account, where relevant, the duration,
intensity (concentration), frequency and number of exposures in characterizing exposures to methylene
chloride.
2.3.1 Fate and Transport
Environmental fate includes both 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 with other species in the environment. Hence, knowledge of the
environmental fate of the chemical informs the determination of the specific exposure pathways and
potential human and environmental receptors EPA expects to consider in the risk evaluation. Table 2-5
provides environmental fate data that EPA identified and considered in developing the scope for
methylene chloride. This information has not changed from that provided in the scope document.
Fate data including volatilization during wastewater treatment, volatilization from lakes and rivers,
biodegradation rates, and organic carbon:water partition coefficient (log Koc) were used when
considering changes to the conceptual models. Model results and basic principles were used to support
the fate data used in problem formulation while the literature review is currently underway through the
systematic review process.
EPI Suite™ (U.S. EPA. 2012b) modules were used to estimate volatilization of methylene chloride from
wastewater treatment plants, lakes, and rivers and to confirm the data showing slow biodegradation. The
EPI Suite™ module that estimates chemical removal in sewage treatment plants ("STP" module) was
run using default settings to evaluate the potential for methylene chloride to volatilize to air or adsorb to
sludge during wastewater treatment. The STP module estimates that 56% of methylene chloride in
wastewater will be removed by volatilization while < 1% of methylene chloride will be removed by
adsorption.
The EPI Suite™ module that estimates volatilization from lakes and rivers ("Volatilization" module)
was run using default settings to evaluate the volatilization half-life of methylene chloride in surface
water. The parameters required for volatilization (evaporation) rate of an organic chemical from the
water body are water depth, wind and current velocity of the river or lake. The volatilization module
estimates 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 3.7 days.
The EPI Suite™ module that predicts biodegradation rates ("BIOWIN" module) was run using default
settings to estimate biodegradation rates of methylene chloride in soil and sediment. The aerobic
biodegradation models (BIOWIN 1-6) estimate that methylene chloride is not readily biodegradable in
aerobic environments, which supports the biodegradation data presented in the methylene chloride
scoping document demonstrating slow biodegradation under aerobic conditions. The anaerobic
biodegradation model (BIOWIN 7) predicts that methylene chloride will rapidly biodegrade under
anaerobic conditions. Previous assessments of methylene chloride reported moderate aerobic
biodegradation, particularly following an acclimation period, and evidence of anaerobic biodegradation
(0< K :< M, > > ;r \ :« 111,, \ i SDR. 2010. 2000; Health and Environment Canada 1993V
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The organic carbon:water partition coefficient (log Koc) reported in the methylene chloride scoping
document was predicted using EPI Suite™. That value (1.4) is supported by the basic principles of
environmental chemistry which states that the Koc is typically within one order of magnitude (one log
unit) of the octanol: water partition coefficient (Kow). Indeed, the log Kow reported for methylene
chloride in the scoping document was 1.25, which is within the expected range. The log Koc reported in
previous assessments of methylene chloride were in the range of 1.27 - 1.4 (ATSDR. 2000; Health and
Environment Canada. 1993).
Table 2-5. Environmental Fate Characteristics of Methylene Chloride
Property or Endpoint
Value a
References
Indirect photodegradation
107 days (estimated)
OECD (2011)
Hydrolysis half-life
18 months
OECD (2011)
Biodegradation
13% in 28 days (not readily
biodegradable) (aerobic sludge)
NITE (2002)
Bioconcentration factor
(BCF)
2.0 to 5.4 (carp)
<6.4 to 40 (carp)
NITE (2002)
Bioaccumulation factor
(BAF)
2.6 (estimated)
U.S. EPA (2012b)
Organic carbon:water
partition coefficient (log Koc)
1.4 (estimated)
U.S. EPA (2012b)
"¦Measured unless otherwise noted. Data retrieved from the 2014 EPA risk assessment on methylene chloride (U.S. EPA.
2014b).
Releases of methylene chloride to the air and water are likely to evaporate to the atmosphere, or if
released to soil, migrate to ground water. Methylene chloride is expected to undergo photooxidation in
the atmosphere but considering its photodegradation half-life (107 days) it is moderately persistent and
is expected to be subject to atmospheric transport.
Methylene chloride is not readily biodegradable but has been shown to biodegrade over a range of rates
under aerobic and anaerobic conditions. Measured BCFs for methylene chloride considered in the 2014
EPA risk assessment on methylene chloride (U.S. EPA. 2014b) are 40 (log BCF 1.60) or below. The
estimated bioaccumulation factor for methylene chloride is 2.6 (log BAF 0.4). Therefore, methylene
chloride is not considered to be bioaccumulative.
2.3.2 Releases to the Environment
Releases to the environment from conditions of use (e.g., industrial and commercial processes,
commercial or consumer uses resulting in down-the-drain releases) are one component of potential
exposure and may be derived from reported data that are obtained through direct measurement,
calculations based on empirical data and/or assumptions and models.
A source of information that EPA considered in evaluating exposure are data reported under the Toxics
Release Inventory (TRI) program. Under the Emergency Planning and Community Right-to-Know Act
(EPCRA) Section 313 rule, methylene chloride is a TRI-reportable substance effective January 1, 1987.
During problem formulation EPA further analyzed the TRI data and examined the definitions of
elements in the TRI data to determine the level of confidence that a release would result from certain
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types of disposal to land (e.g. RCRA Subtitle C hazardous landfill and Class I underground Injection
wells) and incineration. EPA also examined how methylene chloride is treated at industrial facilities.
Table 2-6 provides production-related waste managed data (also referred to as waste managed) for
methylene chloride reported by industrial facilities to the TRI program for 2015. Table 2-7 provides
more detailed information on the quantities released to air or water or disposed of on land.
Table 2-6. Summary of Methylene Chloride TRI Production-Related Waste Managed in 2015 (lbs)
Number of
Facilities
Recycling
Energy
Recovery
Treatment
Releases a-b-c
Total Production
Related Waste
271
96,865,223
15,619,010
37,832,075
3,390,985
153,707,292
Data source: 2015 TRI Data (undated March 2017) (U.S. EPA. 2017d)
a Terminology used in these columns may not match the more detailed data element names used in the TRI public data and
analysis access points.
b Does not include releases due to one-time event not associated with production such as remedial actions or earthquakes.
0 Counts all releases including release quantities transferred and release quantities disposed of by a receiving facility
reporting to TRI.
In 2015, 271 facilities reported a total of about 153.7 million pounds of methylene chloride waste
managed. Of this total, about 96.9 million pounds were recycled, 15.6 million pounds were recovered
for energy, 37.8 million pounds were treated, and 3.4 million pounds were released into the
environment.
Table 2-7. Summary of Methylene Chloride TRI Releases to the Environment in 2015 (lbs)
Number of
Facilities
Air Releases
Stack Air
Releases
Fugitive
Air
Releases
Land Disposal
Water
Releases
Class I
Under-
ground
Injection
RCRA
Subtitle
C
Landfills
All other
Land
Disposala
Other
Releases'
Total On-
and Off-
site
Disposal or
Other
Releases b
Subtotal
1,279,661 1,262,485
59,711
36,091
18,199
Totals
271
2,542,146
2,366
114,001
713,241
3,371,754
Data source: 2015 TRI Data (updated March 2017) (U.S. EPA. 2017d)
3 Terminology used in these columns may not match the more detailed data element names used in the TRI public data and analysis access points.
b These release quantities do include releases due to one-time events not associated with production such as remedial actions or earthquakes.
0 Counts release quantities once at final disposition, accounting for transfers to other TRI reporting facilities that ultimately dispose of the chemical waste.
Of these releases, 75%, or 2.5 million pounds, were released to air (stack and fugitive air emissions),
2,366 pounds were released to water (surface water discharges), 114,000 pounds were released to land
(of which Class I Underground Injection and Resource Conservation and Recovery Act (RCRA) Subtitle
C landfills were the primary disposal methods) and 713,000 pounds were released in other forms such as
to waste brokers. For stack releases, multiple types of facilities reported on incineration destruction,
including hazardous waste facilities and facilities that perform other industrial activities and may be
privately or publicly (i.e., federal, state or municipality) owned or operated. Off-site transfers for
incineration (energy recovery, incineration/thermal treatment, incineration/insignificant fuel value)2 of
methylene chloride from TRI facilities nearly all go to RCRA Subtitle C facilities. Of the 14.9 million
2 Quantities reported as managed on-site or off-site through incineration are within the energy recovery category and a
portion of treatment category in Table 2-6.
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lbs transferred for incineration, only 89,000 lbs were instead sent to facilities in Canada. The 713
thousand pounds released in other forms were transfers off-site for disposal. The majority were to waste
brokers (662 thousand pounds), 39 thousand pounds were for disposal by other techniques, 8 thousand
pounds were for off-site storage and 3 thousand pounds for unknown disposal.
Of the methylene chloride that went to on-site land disposal in 2015, most was disposed of in Class I
underground injection wells (about 59,700 lbs) or RCRA Subtitle C Landfills (about 30,800 lbs). An
additional 250 lbs were disposed of in landfills other than RCRA Subtitle C. No methylene chloride was
reported to be disposed of in on-site Class II-V underground injection wells, on-site land treatment, or
on-site surface impoundments. Of the off-site land disposal, about 5,300 lbs went to RCRA Subtitle C
Landfills and about 8,200 lbs went to landfills other than RCRA Subtitle C. Almost negligible amounts
were transferred off-site to land treatment, and Class I underground injection wells.
While production-related waste managed shown in Table 2-6 excludes any quantities reported as
catastrophic or one-time releases (TRI section 8 data), release quantities shown in Table 2-7 include
both production-related and non-routine quantities (TRI section 5 and 6 data). As a result, release
quantities may differ slightly and may further reflect differences in TRI calculation methods for reported
release range estimates ( ).
Other sources of information provide evidence of releases of methylene chloride, including EPA effluent
guidelines (EGs) promulgated under the Clean Water Act (CWA), National Emission Standards for
Hazardous Air Pollutants (NESHAPs) promulgated under the Clean Air Act (CAA), or other EPA
standards and regulations that set legal limits on the amount of methylene chloride that can be emitted to
a particular media. EPA is aware of additional agency resources for methylene chloride emissions data,
including National Emissions Inventory (NEI) and the Discharge Monitoring Report (DMR) Pollutant
Loading Tool, which provide additional release data specific to air and surface water, respectively. NEI
provides comprehensive and detailed estimates of air emissions for criteria pollutants, criteria precursors
and Hazardous Air Pollutants (HAPs) on a 3-year cycle. The DMR loading tool calculates pollutant
loadings from permit and DMR data from EPA's Integrated Compliance Information System for the
National Pollutant Discharge Elimination System (ICIS-NPDES). EPA expects to consider these data in
conducting the exposure assessment component of the risk evaluation for methylene chloride.
2.3.3 Presence in the Environment and Biota
Monitoring studies or a collection of relevant and reliable monitoring studies provide(s) information that
can be used in an exposure assessment. Monitoring studies that measure environmental concentrations
or concentrations of chemical substances in biota provide evidence of exposure. Monitoring and
biomonitoring data were identified in EPA's data search for methylene chloride.
Due to its variety of uses and subsequent release to the environment, methylene chloride is present and
measurable through monitoring in a variety of environmental media including ambient and indoor air,
surface water and ground water, including sources used for drinking water supplies, sediment, soil and
food products.
Ambient air samples worldwide have shown measured levels of methylene chloride, with background
levels usually around 50 parts per trillion (ATSDR. 2.000). National Oceanic and Atmospheric
Administration (NOAA) monitoring data between 1994 and 2016 show mid-latitude northern
hemisphere atmospheric concentrations to decrease slightly from 1994 to the early 2000s, and then
increase thereafter to present day, with monthly mean concentrations ranging from approximately 30-80
parts per trillion (Hossaini et at.. 2015). Similarly, air concentrations in the continental U.S. between
2003 and 2014 showed either no trend or increasing levels of methylene chloride (U.S. EPA, 2016b).
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The 2011 National Air Toxics Assessment (NATA) modeled concentrations for various air toxics
nationwide at a census tract level. This screening level tool modeled a maximum total methylene
chloride concentration of 5,000 parts per trillion (18 |ig/m3). Greater than 94% of all modeled tracts
were less than 100 parts per trillion. While available indoor air measurements for methylene chloride are
less prevalent, it may be present in this environment due to its variety of uses including consumer uses.
Methylene chloride has been detected in ground water and surface water, including finished drinking
water, through varied national monitoring efforts and water quality databases such as U.S. EPA's
STOrage and RETrieval and Water Quality exchange (STORET) and U.S. Geological Survey's National
Water Quality Assessment Program (NAWQA) (U.S. EPA. 2009; ATSDR. 2000). As part of its 6-year
review of drinking water regulations, U.S. EPA (U.S. EPA, 2009) compiled a nationwide dataset of over
372,000 samples of ground water and surface water used for drinking water. Methylene chloride was
detected approximately 1% of the time, with median concentrations similar for ground water and surface
water. Other monitoring efforts have shown that with volatilization being limited in a ground water
environment and the ability of methylene chloride to readily transport to ground water, concentrations
are often higher in ground water as compared to surface water. Data compiled between 1992 and 2001
from NAWQA showed methylene chloride to be found in 6% of all ground water and surface water
samples, with occurrences more common in surface water (U.S. EPA. 2009). Methylene chloride was
detected in 20% of sediment samples in the STORET database (ATSDR. 2000).
Methylene chloride and its metabolites have been measured in expired air, blood, urine and breast milk
however methylene chloride measurements in human milk have not been quantified and there are no
animal studies testing to what extent methylene chloride can pass into milk (ATSDR. 2000). Elimination
of methylene chloride from the body is rapid and therefore, is only representative of recent exposures.
Blood concentrations of methylene chloride were below the level of detection in 1,165 individuals who
participated in the National Health and Nutrition Examination Survey (NHANES) 2003-2004 subsample
of the U.S. population (CDC. 2009). The methylene chloride metabolite, carboxy hemogl obi n (COHb),
has also been measured in blood and used as a biomarker; however, COHb results from exposure to
carbon monoxide (such as in tobacco smoke and automobile exhaust) is not specific to methylene
chloride (ATSDR. 2000).
2.3.4 Environmental Exposures
The manufacturing, processing, distribution, use and disposal of methylene chloride can result in
releases to the environment. In this section, EPA presents exposures to aquatic and terrestrial organisms.
Aquatic Environmental Exposures
Based on national-scale monitoring data from EPA's STORET and U.S.G.S.'s NAWQA, methylene
chloride is detected in surface and ground water. In an evaluation of the STORET database containing
nearly 9,000 samples, methylene chloride was detected 30% of the time at a median concentration of
0.1 ppb (ATSDR. 2000; Staples et at.. 1985). In an evaluation of USGS NAWQA data from 1992-2001,
methylene chloride was found above the reporting limit in both groundwater and surface water at 2.9%
and 14.6%) of all samples respectively and 5.6% overall. When calculated as a percentage of sampled
sites, 3.2%) of all groundwater sites, 31.9% of all surface water sites and 4.4% of all sites overall
recorded a detectable result ( ,009). Methylene chloride was detected in groundwater with a
median value of 0.05 |ig/L and ranged from 0.008 to 25.8 |ig/L (99th percentile = 21.6 |ig/L) and in
surface water samples with a median of 0.035 |ig/L and ranged from 0.0055 to 34 |ig/L (99th percentile
= 1-55 ng/L).
A recent review of the multi-agency Water Quality Portal which includes data from the National Water
Information System (NWIS), STORET, and USDA STEWARDS databases also shows hundreds of
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measures of methylene chloride in soil and sediment. In a literature review of various VOC
concentrations found in landfill leachates, Klett et al. (2005) found methylene chloride ranged in
concentration from 1.0 - 58,200 |ig/L. Staples et al. (1985) reported that methylene chloride was found
in 20% of sediment samples in the STORET database. Methylene chloride concentrations in soil and
sediment pore water are expected to be similar to the concentrations in groundwater (in soil) or
overlying water (in sediment) because methylene chloride does not partition to organic matter (estimated
log Koc = 1.4) and biodegrades slowly (13% biodegradation in 28 days; (NITE, 2002)). Thus, the
methylene chloride detected in soil and sediments is likely from the pore water and not methylene
chloride that was adsorbed to the soil or sediment solids.
Terrestrial Environmental Exposures
Terrestrial species populations living near industrial and commercial facilities using methylene chloride
may be exposed via multiple routes such as ingestion of surface waters and inhalation of outdoor air. As
described in Section 2.3.3 methylene chloride is present and measurable through monitoring in a variety
of environmental media including ambient and indoor air, surface water and ground water.
2.3.5 Human Exposures
In this section, EPA presents occupational, consumer and general population exposures. Subpopulations,
including potentially exposed and susceptible subpopulations, within these exposure categories are also
presented.
2.3.5.1 Occupational Exposures
Exposure pathways and exposure routes are listed below for worker activities under the various
conditions of use (industrial or commercial) described in Section 2.2. In addition, exposures to
occupational non-users (ONU), who do not directly handle the chemical but perform work in an area
where the chemical is present are listed. Engineering controls and/or personal protective equipment may
impact the occupational exposure levels.
In the previous 2014 risk assessments ( 314b). EPA assessed inhalation exposures to
methylene chloride for occupational use in paint and coating removal, which will be considered in the
methylene chloride risk evaluation.
Workers and occupational non-users may be exposed to methylene chloride when performing activities
associated with the conditions of use described in Section 2.2, including, but not limited to:
• Unloading and transferring methylene chloride to and from storage containers to process vessels;
• Using methylene chloride in process equipment (e.g., vapor degreasing machine, process
equipment used to manufacture refrigerants);
• Applying formulations and products containing methylene chloride onto substrates (e.g.,
applying adhesive removers containing methylene chloride onto substrates requiring adhesive
removal);
• Cleaning and maintaining equipment;
• Sampling chemical, formulations or products containing methylene chloride for quality control
(QC);
• Repackaging chemical, formulations or products containing methylene chloride;
• Handling, transporting and disposing waste containing methylene chloride;
• Performing other work activities in or near areas where methylene chloride is used.
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Key Data
Key data that inform occupational exposure assessment include: the OSHA Chemical Exposure Health
Data (CEHD) and NIOSH Health Hazard Evaluation (HHE) program data. OSHA data are workplace
monitoring data from OSHA inspections. OSHA data can be obtained through CEHD
https://www.osha.gov/opengov/healthsamples.html. TableApx B-l and TableApx B-2 in Appendix B
provides a summary of industry sectors with methylene chloride personal monitoring air samples
obtained from OSHA inspections conducted between 2011 and 2016. NIOSH HHEs are conducted at
the request of employees, union officials, or employers and help inform potential hazards at the
workplace. HHEs can be downloaded at https://www.cdc.gov/ niosh/hhe/. EPA identified several HHEs
during the problem formulation; these HHEs are listed in Table Apx B-3 in Appendix B. EPA also
identified additional sources of potentially relevant occupational exposure data. These sources are listed
in Table Apx B-4 through Table Apx B-7 in Appendix B, and EPA will review these data and evaluate
their utility in the risk evaluation.
Inhalation
Based on these occupational exposure scenarios, inhalation exposure to vapor is expected. EPA
anticipates this is the most important methylene chloride exposure pathway for workers and
occupational nonusers based on the high volatility of methylene chloride. Based on the potential for
spray application of some products containing methylene chloride exposures to mists are also expected
for workers and ONU and will be incorporated into the occupational inhalation exposure estimates.
The United States has several regulatory and non-regulatory exposure limits for methylene chloride: an
Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (PEL) of 25 ppm
8-hour time-weighted average (TWA) and Short-Term Exposure Limit (STEL) of 125 ppm 15-minute
TWA (C 7), and an American Conference of Government Industrial Hygienists (ACGIH)
Threshold Limit Value (TLV) of 50 ppm 8-hour TWA (ACGIH, 2001). Also, the National Institute for
Occupational Safety and Health (NIOSH) indicates that methylene chloride has an immediately
dangerous to life and health (IDLH) value of 2,300 ppm based on effects that might occur from a
30-minute exposure, and NIOSH provides a notation that methylene chloride is a potential occupational
carcinogen (NIOSH. 2011).
Dermal
Based on the conditions of use EPA expects workers to have potential for skin contact with liquids and
vapors. Where workers may be exposed to methylene chloride, the OSHA standard requires that workers
are protected from contact (e.g. gloves) (29 CFR 1910.1052). Occupational non-users are not directly
handling methylene chloride; therefore, skin contact with liquid methylene chloride is not expected for
occupational non-users but skin contact with vapors is expected for occupational nonusers.
Oral
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 will be considered as an inhalation exposure.
2.3.5.2 Consumer Exposures
Methylene chloride can be found in consumer products and/or commercial products that are readily
available for public purchase at common retailers CEPA-HQ-OPPT-2016-0742.-0003. Sections 3 and 4
and Table 2-3) and can therefore result in exposures to consumers and bystanders (non-product users
that are incidentally exposed to the product).
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In EPA's 2014 risk assessment for methylene chloride paint stripping use, consumer inhalation
exposures in residential settings were assessed using a variety of indoor exposure scenarios (U.S. EPA,
2.014b). Scenarios differed in their type of application (i.e., brush vs. spray), location of product
application (workshop vs. bathroom), mass of methylene chloride emitted, user's location during the
wait period and air exchange rate between the rest of the house with outdoor air.
Inhalation
EPA expects that inhalation exposure to vapor will be the most significant route of exposure for
consumer and bystander exposure scenarios, in line with EPA's 2014 risk assessment of methylene
chloride paint stripping use, which assumed that inhalation is the main exposure pathway based on the
physical-chemical properties of methylene chloride (e.g. high vapor pressure) ( 014b). Based
on the potential for spray application of some products containing methylene chloride exposures to mists
are also expected. These exposures to consumers and bystanders through mists may deposit in the upper
respiratory tract; EPA assumes these are absorbed via inhalation
Dermal
There is a potential for dermal exposures to methylene chloride in consumer uses. Dermal exposure may
occur via contact with vapor or mist deposition onto the skin or via direct liquid contact during use.
Exposures to skin would be expected to evaporate fairly quickly based on physical chemical properties
including vapor pressure, water solubility and log Kow but some methylene chloride would also be
dermally absorbed. When evaporation of methylene chloride is reduced such as in occluded scenarios
(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 however there may be exceptions for the occluded scenarios. Overall, dermal exposures to
consumers in occluded and non-occluded scenarios are expected. Bystanders will not have dermal
contact with liquid methylene chloride but will have dermal exposures to methylene chloride vapor.
Oral
Consumers may be exposed to methylene chloride via transfer of methylene chloride from hand to
mouth. This exposure pathway will be limited by a combination of dermal absorption and volatilization.
Exposures from Disposal
EPA does not expect exposure to consumers from disposal of consumer products. It is anticipated that
most products will be disposed of in original containers, particularly those products that are purchased as
aerosol cans. Liquid products may be recaptured in an alternate container following use (e.g. paint
scrapings after paint removal as was done in EPA's 2014 risk assessment for methylene chloride paint
stripping use).
2.3.5.3 General Population Exposures
Wastewater/liquid wastes, solid wastes or air emissions of methylene chloride could result in potential
pathways for oral, dermal or inhalation exposure to the general population.
Inhalation
Inhalation serves as the expected primary route of exposure for the general population due to both its
high volatility and propensity to be released to air from ongoing commercial and industrial activities
0 r * ^ 2.014b. 200 . \ I r DR. 2000). Between 1998 and 2006, >90% of all reported TRI releases of
methylene chloride were air releases (U.S. EPA. 2.014b) and levels of methylene chloride in the ambient
air are widespread and shown to be increasing (Section 2.3.2). The 20 \ \ \\ I'A modeled concentrations
at a census tract level found a maximum total methylene chloride concentration of 5,000 parts per
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trillion (18 |ig/m3) and maximum human inhalation exposure concentrations of 3,900 parts per trillion
(14 |ig/m3). Greater than 94% of all modeled tracts were less than 100 parts per trillion. While available
indoor air measurements for methylene chloride are less prevalent, it may be present in this environment
due to its variety of uses including consumer uses.
Oral
The general population may ingest methylene chloride via contaminated drinking water, ground water,
and/or surface water. Ingestion of contaminated drinking water is expected to be the primary route of
oral exposure. Oral ingestion may include exposure to contaminated breast milk or incidental ingestion
of methylene chloride residue on the hand/body. Based on the presence of methylene chloride in water
used for bathing or recreation, the oral ingestion of contaminated water could contribute, to a lesser
degree, to oral exposures.
Dermal
General population exposures to methylene chloride through the dermal route may occur through
contact with water such as while bathing in household water that has residual methylene chloride or
public recreation in contaminated waterways. Methylene chloride can be absorbed through the skin;
however, based on its physical and chemical properties, once exposed to air most of the amount on skin
would be expected to volatize before being absorbed.
2.3.5.4 Potentially Exposed or Susceptible Subpopulations
TSCA requires the determination of whether a chemical substance presents an 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 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." General population is "the total of individuals inhabiting an area or making up a
whole group" and refers here to the U.S. general population (I _ \_i_ *; \_ I ).
As part of the Problem Formulation, EPA identified potentially exposed and susceptible subpopulations
for further analysis during the development and refinement of the life cycle, conceptual models,
exposure scenarios, and analysis plan. In this section, EPA addresses the potentially exposed or
susceptible subpopulations identified as relevant based on greater exposure. EPA will address the
subpopulations identified as relevant based on greater susceptibility in the hazard section.
EPA identifies the following as potentially exposed or susceptible subpopulations that EPA expects to
consider in the risk evaluation due to their greater exposure:
• Workers and occupational non-users.
• Consumers and bystanders associated with consumer use. Methylene chloride has been identified
in products available to consumers; however, only some individuals within the general
population may use these products. Therefore, those who do use these products are a potentially
exposed or susceptible subpopulation due to greater exposure.
• Other groups of individuals within the general population who may experience greater exposures
due to their proximity to conditions of use identified in Section 2.2 that result in releases to the
environment and subsequent exposures (e.g., individuals who live or work near manufacturing,
processing, use or disposal sites).
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In developing exposure scenarios, EPA will analyze available data to ascertain whether some human
receptor groups may be exposed via exposure pathways that may be distinct to a particular
subpopulation or lifestage and whether some human receptor groups may have higher exposure via
identified pathways of exposure due to unique characteristics (e.g., activities, duration or location of
exposure) when compared with the general population (U.S. EPA. 2006a).
In summary, in the risk evaluation for methylene chloride, EPA expects to analyze the following
potentially exposed groups of human receptors: workers, occupational non-users, consumers, bystanders
associated with consumer use, and other groups of individuals within the general population who may
experience greater exposure. EPA may also identify additional potentially exposed or susceptible
subpopulations that will be considered based on greater exposure.
2.4 Hazards (Effects)
For scoping, EPA conducted comprehensive searches for data on hazards of methylene chloride, as
described in Strategy for Conducting Literature Searches for Methylene Chloride: Supplemental File for
the TSCA Scope Document EPA-HQ-OPPT-2016-0742-00> » ^ \ ^ i ). Based on initial
screening, EPA expects to analyze the hazards of methylene chloride identified in this problem
formulation document. However, when conducting the risk evaluation, the relevance of each hazard
within the context of a specific exposure scenario will be judged for appropriateness. For example,
hazards that occur only as a result of chronic exposures may not be applicable for acute exposure
scenarios. This means that it is unlikely that every hazard identified will be analyzed for every exposure
scenario.
2.4.1 Environmental Hazards
EPA identified the following sources of environmental hazard data for methylene chloride: (U.S. EPA.
2.014b: OECD.. -11, WHO. 1996: Health and Environment Canar> ¦ s ( 3). Only the on-topic
references listed in the Ecological Hazard Literature Search Results were considered as potentially
relevant data/information sources for the risk evaluation. Inclusion criteria were used to screen the
results of the ECOTOX literature search (as explained in the Strategy for Conducting Literature
Searches for Methylene Chloride: Supplemental Document to the TSCA Scope Document, CASRN:79-
09-2). Data from the screened literature are summarized below (Table 2-8) as ranges (min-max). EPA
expects to review these 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 ( 08).
Toxicity to Aquatic Organisms
Fish exposed to methylene chloride between 24 hours and 9 days had LCso concentrations ranging from
34 mg/L to 1,100 mg/T/U.S. EPA. 2014b: OECD. 2011; Health and Environment Canada. 1993). In a
24-hour cytotoxicity test in cultured fish cells, protein content decreased 50% at a calculated in vitro
concentration of 49,000 mg/L ((Dierickx. 1993). Amphibians exposed to methylene chloride from 48
hours to 9.5 days had EC so concentrations ranging from 16.92 mg/L to > 48 mg/L for mortality and
teratogenicity and a no observed effect concentration range of 0.017 mg/L to 0.1 mg/L. Aquatic
invertebrates exposed to methylene chloride between 4 hours to 12 days had EC so concentrations
ranging from 27 mg/L to 69,160 mg/L (as needed, units were converted to mg/L based on the methylene
chloride MW of 84.93 g/mol and density of 1.33 g/cm3) and there was a 96-hour LOEC for
developmental and teratogenic effects between concentrations of 0.0008 and 0.0009 mg/L. Aquatic
plants exposed between 3 to 96 hours to methylene chloride had various effects, including biomass and
growth inhibition and population-level effects, at concentrations ranging from 0.98 to 2,292 mg/L.
Mortality to freshwater fungi was observed when exposed to methylene chloride at concentrations of
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2400 mg/L for 2 to 30 hours. There were no available acute sediment toxicity studies, however, toxicity
is expected to be similar to that of aquatic invertebrates when exposed to methylene chloride in sediment
pore water.
For chronic exposures to methylene chloride, there was one fish study with 23 to 27-day LCso
concentrations between 13.16 mg/L and 13.51 mg/L, respectively. Developmental and other effects in
fish were observed at LOECs ranging from 5.5 mg/L to 209 mg/L. Aquatic plants had a 10-day LOEC
of 0.002 mg/L for reduction in Chlorophyll A.
Toxicity to Soil and Terrestrial Organisms
Terrestrial mammals exposed to methylene chloride, by injection for 0.25 hours, had physiological
effects with an EC so of 326.3 mg/kg-body weight. Mammals exposed via oral administration for up to
30 days had LOAELs ranging from 115 to 1720 mg/kg-body weight per day. In two studies, bird eggs
injected with methylene chloride for 14 days had LDso concentration of > 8.5 and 14.1 mg/egg,
respectively, but teratogenicity was not observed. Terrestrial invertebrates fumigated with methylene
chloride for 24 hours had LDsos ranging from 81.28 - 129.9 mg/L. Soil invertebrates had a 48-hr LCso
of 0.304 mg/cm2 after topical exposures to methylene chloride. The 48-hr LCso was >1.0 mg/cm2 for
invertebrates exposed to methylene chloride in soil. Fungi exposed in an assay to methylene chloride
demonstrated cellular effects at LOECs ranging from 5.3-11.5 mg/L (converted from 62.4 to 135.7
mM).
Mammals with oral exposures to methylene chloride for 18-weeks to 31-weeks had a NOAEC of 225
mg/kg body weight per day with no mortality or reproductive effects at the highest concentrations tested.
Mammals with inhalation exposures to methylene chloride over a two-year period had a NOAEC of 695
mg/m3 and a LOAEC of 1737 mg/m3. Terrestrial plants exposed to methylene chloride for 14-days had
no growth effects.
Table 2-8. Summary oi
' Ecological Hazard Information for Methylene C
lloride
Duration
Test
Organism
Endpoint
Hazard
Values*
Units
Effect
Endpoint
References
Aquatic Organisms and Amphibians
Acute
Fish
LCso
34-1,100
mg/L
Mortality/
Immobility
U.S. EPA (2014b);
OECD (2011); Health
and Environment
Canada (1993); Tsuii et
al. (1986)
ECso
(assay)
49,000
mg/L
Biochemical/
Protein Content
Dierickx (1993)
Amphibians
ECso
16.93->48
mg/L
Mortality/
Teratogenicity
Marauis et al. (2006);
WHO (1996); Health and
Environment Canada
NOEC
0.017-0.1
LOEC
0.822-0.981
(1993)
Aquatic
invertebrates
ECso
27-69,160
mg/L
Mortality/
Immobility
U.S. EPA (2014b);
OECD (2011);
Ravburn and Fisher
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Duration
Test
Organism
Endpoint
Hazard
Values*
Units
Effect
Endpoint
References
Acute
Aquatic
invertebrates
NOEC
68- 133,000
mg/L
Mortality/
Immobility/
Development
(1999); Wilson 0998);
Sanchez-Fortun et al.
0997); WHO 0996);
Health and
Environment Canada
0993)
LOEC
0.0008 -
0.0009
mg/L
Development/
Teratogenicity
Aquatic
Plants
ECso
0.98 - 2,292
mg/L
Growth Rate/
Biomass/
Cellular/
Biochemical
U.S. EPA (2014b); Wu et
al. (2014); OECD (2011);
Tsai and Chen (2007);
Ando et al. (2003); WHO
(1996); Brack and Rottler
(1994)
NOEC
0.98 -221
mg/L
Population/
Cellular/
Biochemical
Wuetal. (2014); Tsai
and Chen (2007); Ando
et al. (2003); Brack and
Rottler (1994)
LOEC
0.98 -403
Fungi
LTso
2400
mg/L
Mortality
Steiman et al. (1995)
Chronic
Fish
LCso
13.16 —
13.51
mg/L
Mortality
WHO (1996); Health and
Environment Canada
(1993)
LOEC
5.5-209
mg/L
Mortality/Develo
pment/Body
Weight
U.S. EPA (2014b);
OECD (2011); WHO
(1996); Health and
Environment Canada
(1993)
MATC
108
mg/L
Body Weight
U.S. EPA (2014b); WHO
(1996)
Aquatic
Plants
NOEC
2
mg/L
Population/
Cellular
Wuetal. (2014); Tsai
and Chen (2007); Ando
et al. (2003); Brack and
Rottler (1994)
LOEC
0.002
Terrestrial Organisms
Acute
Mammals
ECso
326.3
mg/kg
bdwt/d
Mortality/Growth
/Physiological
Sasaki et al. (1998);
Herr and Boves (1997)
NOAEC
25 - 600
LOAEC
75 - 1720
Avian
LD50
>8.5- 14.1
mg/egg
Mortality
Health and Environment
Canada(1993)
Terrestrial
Invertebrates
LD50
81.28- 129.9
mg/L
Mortality
Health and Environment
Canada(1993)
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Duration
Test
Organism
Endpoint
Hazard
Values*
Units
Effect
Endpoint
References
Acute
Soil
Invertebrates
LC50
0.304->1.0
mg/cm2
Mortality
OECD (2011): WHO
(1996)
Fungi
LOEC
5300- 11,525
mg/L
Cellular/Genetic
Crebelli et al. (1995)
Chronic
Mammals
NOAEC
225 - 695
mg/m3
Mortality/Liver/
CNS
OECD (2011); U.S.
EPA (2011b); WHO
(1996)
* Values in the tables are presented as reported by the study authors, unless units were converted for
consistency.
Based on the information listed in Table 2-8, fish and aquatic invertebrates with acute exposures to
methylene chloride resulted in mortality or immobilization. Mortality and other adverse effects were
observed to amphibians with acute exposures. When algae were exposed to methylene chloride, adverse
effects to biomass, growth rate, and cellular effects were observed. There was mortality and/or
developmental effects in fish, aquatic invertebrates and amphibians with acute and chronic exposures.
The most sensitive taxa in the dataset were:
• aquatic invertebrates, including insect larvae, had ECsos as low as 27 mg/L and developmental
effects with a 96-h LOEC of 0.0008 mg/L
• amphibians had ECsos as low as 16.93 mg/L and LOECs from 0.822 mg/L to 0.981 mg/L
• aquatic plants had a LOEC of 0.002 mg/L for reduction in Chlorophyll A
Based on the studies listed in Table 2-8, acute toxicity to terrestrial species was observed, including
cellular effects in mammals, mortality in soil and terrestrial invertebrates, growth and cellular effects in
terrestrial plants and cellular effects in fungi. There was mortality in mammals and bird embryos with
acute exposures to methylene chloride and effects chronic exposures had growth effects. The most
sensitive taxa in the dataset were:
• soil invertebrates had a LCso of 0.304 mg/cm2 from topical application of methylene chloride
• terrestrial mammals with an oral LOAEC of 115 mg/kg bdwt/day and a NOAEC of 25 mg/kg
bdwt/day and an inhalation LOAEC of 1737 mg/m3 and NOAEC of 695 mg/m3
• terrestrial invertebrates with a LDso of 81.28 mg/L
Environmental hazard data will be further reviewed for overall data quality confidence and integrated
during the risk evaluation phase. The lowest values were used for hazard levels of concern to estimate
lower bound effect levels that would likely encompass more sensitive species not specifically
represented by the available experimental data. It should be noted that these hazard levels of concern do
not account for differences in inter- and intra-species variability, as well as laboratory-to-field variability
and are dependent upon the availability of datasets that can be used to characterize relative sensitivities
across multiple species within a given taxa or species group, since the data available for most industrial
chemicals are limited.
2.4.2 Human Health Hazards
Methylene chloride has an existing EPA IRIS Assessment (U.S. EPA 2011b). an ATSDR Toxicological
Profile (ATSDR. 2010. 2000). and assessments of the effects of acute exposures in the AEGL
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( L. 2008). Spacecraft Maximum Allowable Concentrations (SMAC) for Methylene Chloride
(NR€, 1996a) and an acute Recommended Exposure Limit (REL) published by the Office of
Environmental Health Hazard Assessment (OEHHA) (OEHHA. 2008); hence, many of the hazards of
methylene chloride have been previously compiled and reviewed. EPA expects to use these previous
analyses as a starting point for identifying key and supporting studies to inform the human health hazard
assessment, including dose-response analysis. The relevant studies will be evaluated using the data
quality criteria in the Application of Systematic Review in TSCA Risk Evaluations document (
2018). EPA also expects to consider other studies (e.g., more recently published, alternative test data)
that have been published since these reviews, as identified in the literature search conducted by the
Agency for methylene chloride [Methylene Chloride (CASRN 75-09-2) Bibliography: Supplemental File
for the TSCA Scope Document ( 17a)]. Based on
reasonably available information, the following sections describe the potential hazards associated with
methylene chloride.
2.4.2.1 Non-Cancer Hazards
Acute Toxicity
Neurotoxicity indicative of CNS depression is a primary effect of methylene chloride in humans
following acute oral and inhalation exposures Q ^ ^* \ 201 I b). CNS depressive effects may be a
result of methylene chloride or its metabolite carbon monoxide and will be evaluated. Identified CNS
depressive symptoms include drowsiness, confusion, headache, dizziness and neurobehavioral deficits
when performing various tasks. Acute and/or short-term inhalation and oral exposure by animals to
methylene chloride has also resulted in CNS depressant effects; decreased motor activity; impaired
learning and memory; and changes in responses to sensory stimuli. CNS depressant effects can result in
loss of consciousness and respiratory depression, resulting in irreversible coma, hypoxia and eventual
death (NAC/AEGL. 2008).
Liver Toxicity
The liver is a sensitive target organ for inhalation and oral exposure (U.S. EPA., ). Based on
studies of workers there is limited evidence of liver effects. Following chronic repeated inhalation and
oral exposures to methylene chloride, rats and mice exhibited hepatocyte vacuolation, necrosis and
degeneration (1 _ S j "p V 201 lb).
Neurotoxicity
The brain is often affected by exposures to methylene chloride (U.S. EPA. 201 lb). As noted above,
acute non-lethal effects in humans include general CNS depressive symptoms. There is some limited
evidence of increased prevalence of neurological symptoms among workers and possible detriments in
attention and reaction time in complex tasks in retired workers after longer-term exposures (U.S. EPA,
2 ).
Irritation
Following exposures to methylene chloride vapors, irritation has been observed in the respiratory tract
and eyes (ATSDR. 2000). Direct contact with liquid methylene chloride on the skin has caused chemical
burns in workers and gastrointestinal irritation in individuals who ingested methylene chloride (U.S.
I \\ \ ,0ljh, \ 1'SOR. 2000).
2.4.2.2 Genotoxicity and Cancer Hazards
Methylene chloride and some of its key metabolites have been extensively evaluated in carcinogenicity,
genotoxicity and other MOA studies. Most of these studies have been thoroughly reviewed in the EPA
IRIS Assessment (U.S. EPA.: ). Studies in humans provide evidence for an association between
occupational exposure to methylene chloride and increased risk for some specific cancers, including
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brain cancer, liver cancer, non-Hodgkin's lymphoma and multiple myeloma (U.S. EPA. 201 lb). In
addition, several cancer bioassays in animals have identified the liver and lung as the most sensitive
target organs for methylene chloride-induced tumor development ( 1 lb). In the IRIS
assessment, EPA hypothesized that methylene chloride induced lung and liver tumors through a
mutagenic mode of carcinogenic action. A weight-of-evidence analysis of in vivo and in vitro data
provide support to the proposed mutagenicity of methylene chloride Q r U> \ iO I I h).
In the 2011 IRIS assessment, following U.S. EPA (2005) Guidelines for Carcinogen Risk Assessment
(U.S. EPA. 2005) using a weight-of-evidence judgment of the likelihood that methylene chloride is a
human carcinogen, EPA concluded that methylene chloride is "likely to be carcinogenic in humans by
all routes of exposure" (U.S. EPA, 2.01 lb).
2.4.2.3 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 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." In developing the hazard
assessment, EPA will evaluate available data to ascertain whether some human receptor groups may
have greater susceptibility than the general population to the chemical's hazard(s).
2.5 Conceptual Models
EPA risk assessment guidance ( , ), defines Problem Formulation as the part of the
risk assessment framework that identifies the major factors to be considered in the assessment. It draws
from the regulatory, decision-making and policy context of the assessment and informs the assessment's
technical approach.
A conceptual model describes the actual or predicted relationships between the chemical substance and
receptors, either human or environmental. These conceptual models are integrated depictions of the
conditions of use, exposures (pathways and routes), hazards and receptors. The initial conceptual models
describing the scope of the assessment for methylene chloride, have been refined during problem
formulation. The changes to the conceptual models in this problem formulation are described along with
the rationales.
In this section, EPA outlines those pathways that will be included and further analyzed in the risk
evaluation; will be included but will not be further analyzed in risk evaluation; and will not be included
in the TSCA risk evaluation; and the underlying rationale for these decisions.
EPA determined as part of problem formulation that it is not necessary to conduct further analysis on
certain exposure pathways that were identified in the methylene chloride scope document and that
remain in the risk evaluation. Each risk evaluation will be "fit-for-purpose," meaning not all conditions
of use will warrant the same level of evaluation and the Agency may be able to reach some conclusions
without comprehensive or quantitative risk evaluations 26, 33734, 33739 (July 20, 2017).
As part of this problem formulation, EPA also identified exposure pathways under regulatory programs
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., the Clean
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Air Act (CAA), the Safe Drinking Water Act (SDWA), the Clean Water Act (CWA) and the Resource
Conservation and Recovery Act (RCRA). OPPT worked closely with the offices within EPA 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 generally focus on those exposure pathways associated
with TSCA conditions of use that are not adequately assessed and effectively managed under the
regulatory regimes discussed above because these pathways are likely to represent the greatest areas of
risk concern. As a result, EPA does not expect to include in the risk evaluation certain exposure
pathways identified in the methylene chloride scope document.
2.5.1 Conceptual Model for Industrial and Commercial Activities and Uses: Potential
Exposures and Hazards
The revised conceptual model (Figure 2-2) describes the pathways of exposure from industrial and
commercial activities and uses of methylene chloride that EPA expects to include in the risk evaluation.
There are exposures to workers and/or occupational non-users via inhalation routes and/or exposures to
workers via dermal routes for all conditions of use identified in this problem formulation. In the (U.S.
EPA. 2014b) risk assessment, inhalation exposures to vapor were assessed as the most likely exposure
route; however, there are potential dermal exposures for some conditions of use, such as maintenance of
industrial degreasing tanks and manual handling of metal parts removed from industrial degreasing
tanks. In addition to the pathways illustrated in the figure, EPA will evaluate activities resulting in
exposures associated with distribution in commerce (e.g. loading, unloading) throughout the various
lifecycle stages and conditions of use (e.g. manufacturing, processing, industrial use, commercial use,
disposal) rather than a single distribution scenario.
Inhalation
EPA/OPPT's 2014 risk assessment of methylene chloride paint stripping use assumed that inhalation is
the main exposure pathway based on the physical-chemical properties of methylene chloride (e.g. high
vapor pressure) ( )). Inhalation exposures for workers are regulated by OSHA's
occupational safety and health standards for methylene chloride which include a PEL of 25 ppm TWA,
exposure monitoring, control measures and respiratory protection (29 CFR 1910.1052 App. A). EPA
expects that for workers and occupational non-users exposure via inhalation will be the most significant
route of exposure for most exposure scenarios. EPA expects to further analyze inhalation exposures to
vapors and mists for workers and occupational non-users in the risk evaluation.
Dermal
There is the potential for dermal exposures to methylene chloride in many worker scenarios. Where
workers may be exposed to methylene chloride, the OSHA standard requires that workers are protected
from contact (e.g. gloves) (29 CFR 1910.1052). EPA's 2014 risk assessment of methylene chloride paint
stripping use included the potential dermal exposures to methylene chloride as an area of uncertainty
that may underestimate the total exposures ( 2014b). These dermal exposures would be
concurrent with inhalation exposures and the overall contribution of dermal exposure to the total
exposure is expected to be small however there may be exceptions for occluded scenarios. Occupational
non-users are not directly handling methylene chloride; therefore, skin contact with liquid methylene
chloride is not expected for occupational non-users and EPA does not expect to further analyze this
pathway in the risk evaluation. EPA expects to further analyze dermal exposures for skin contact with
liquids in occluded situations for workers.
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Workers and occupational non-users can have skin contact with methylene chloride vapor concurrently
with inhalation exposures. The parameters determining the absorption of methylene chloride vapor are
based on the concentration of the vapor, the duration of exposure and absorption. The concentration of
the vapor and the duration of exposure are the same for concurrent dermal and inhalation exposures.
Therefore, the differences between dermal and inhalation exposures depend on the absorption. The
dermal absorption can be estimated from the skin permeation coefficient (0.28 cm/hr for methylene
chloride vapor (ATSDR. 2010. 2000)) and exposed skin surface area (on the order of 0.2 nr (
201 la)). The absorption of inhaled vapors can be estimated from the volumetric inhalation rate
(approximately 1.25 nrVhr for a person performing light activity ( 201 la) adjusted by a
retention factor such as 0.75. Based on these parameters the absorption of methylene chloride vapor via
skin will be orders of magnitude lower than via inhalation and will not be further analyzed.
Waste Handling, Treatment and Disposal
Figure 2-2 shows that waste handling, treatment and disposal is expected to lead to the same pathways
as other industrial and commercial activities and uses. The path leading from the "Waste Handling,
Treatment and Disposal" box to the "Hazards Potentially Associated with Acute and/or Chronic
Exposures See Section 2.4.2" box was re-routed to accurately reflect the expected exposure pathways,
routes, and receptors associated with these conditions of use of methylene chloride.
For each condition of use identified in Table 2-3, a determination was made as to whether or not each
unique combination of exposure pathway, route, and receptor will be further analyzed in the risk
evaluation. The results of that analysis along with the supporting rationale are presented in Appendix C
and Appendix E.
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INDUSTRIAL AND COMMERCIAL EXPOSURE PATHWAY EXPOSURE ROUTE RECEPTORSd HAZARDS
ACTIVITIES/USES
Manufacturing
Processing:
• As Reactant
• Incorporated into
Formulation, Mixture, or
Reaction Product
• Repackaging
Recycling
Workerse
Solvents for Cleaning or
Degreasing
Occupational
Non-Users
Adhesives and Sealants
Paints and Coatings
including Paints and
Coatings Removers for
furniture stripping
Metal Products
Fabric, Textile, and
Leather Products
Automotive Care Products
Apparel and Footwear
Care Products
Laundry and Dishwashing
Products
Lubricants and Greases
Other Uses3
Fugitive
Emissions b
Dermal
Liquid Contact
Vapor/Mist
Inhalationc
Waste Handling,
Treatment and Disposal
KEY:
~ Pathways that will be further analyzed
— Pathways that will not be further analyzed
Hazards Potentially Associated
with Acute and/or Chronic
Exposures:
See Section 2.4.2
I ^ Wastewater or Liquid Wastes
(See Figure 2-4)
Figure 2-2. Methylene Chloride Conceptual Model for Industrial and Commercial Activities and Uses: Potential Exposures and
Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human receptors from industrial and commercial
activities and uses of methylene chloride.
a Some products are used in both commercial and consumer applications such adhesives and sealants. Additional uses of methylene chloride are included in Table 2-3.
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 will be considered as an inhalation exposure.
d Receptors include potentially exposed or susceptible subpopulations.
e When data and information are available to support the analysis, EPA also considers the effect that engineering controls and/or personal protective equipment have on
occupational exposure levels.
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2,5,2 Conceptual Model for Consumer Activities and Uses: Potential Exposures and
Hazards
The revised conceptual model (Figure 2-3) illustrates the pathways of exposure from consumer uses of
methylene chloride that EPA expects to include in the risk evaluation. In the ( ) risk
assessment, inhalation exposures to vapor and mist were assessed as the most likely exposure route;
however, there are potential dermal exposures for some conditions of use. It should be noted that some
consumers may purchase and use products primarily intended for commercial use.
Inhalation
As mentioned above, EPA/OPPT's 2014 risk assessment of methylene chloride paint stripping use
assumed that inhalation of methylene chloride vapor is the main exposure pathway based on the
physical-chemical properties of methylene chloride (e.g. high vapor pressure) ( 014b). EPA
expects inhalation to be the primary route of exposure and expects to further analyze inhalation
exposures to methylene chloride vapor and mist for consumers and bystanders.
Dermal
There is potential for dermal exposures to methylene chloride from consumer uses. Dermal exposure
may occur via contact with vapor or mist deposition onto the skin or via direct liquid contact during use.
Direct contact with liquid methylene chloride would be concurrent with inhalation exposures and dermal
exposures to consumers in occluded and non-occluded scenarios are expected. Bystanders will not have
direct dermal contact with liquid methylene chloride. EPA expects to further analyze direct dermal
contact with liquid methylene chloride for consumers.
Consumers and bystanders can have skin contact with methylene chloride vapor concurrently with
inhalation exposures. Similar to workers (see Section 2.5.1) the parameters determining the absorption
of methylene chloride vapor are based on the concentration of the vapor, the duration of exposure and
absorption. The concentration of the vapor and the duration of exposure are the same for concurrent
dermal and inhalation exposures. Therefore, the differences between dermal and inhalation exposures
depend on the absorption. The dermal absorption can be estimated from the skin permeation coefficient
(0.28 cm/hr for methylene chloride vapor (ATSI , 2000)) and exposed skin surface area (on the
order of 0.2 nr ( 1 la)). The absorption of inhaled vapors can be estimated from the
volumetric inhalation rate (approximately 1.25 nrVhr for a person performing light activity (U.S. EPA.
201 la) adjusted by a retention factor such as 0.75. Based on these parameters the absorption of
methylene chloride vapor via skin will be orders of magnitude lower than via inhalation and will not be
further analyzed.
Oral
Consumers may be exposed to methylene chloride via transfer of methylene chloride from hand to
mouth. This exposure pathway will be limited by a combination of dermal absorption and volatilization;
therefore, this pathway will not be further evaluated.
Furthermore, based on available toxicological data, EPA does not expect that considering separate oral
routes of exposure for incidental ingestion would have significantly different toxicity, rather skin contact
will be included as part of consumer dermal exposures. Bystanders are not directly handling methylene
chloride; therefore, incidental ingestion via contact with methylene chloride is not expected for
bystanders. Therefore, this pathway will not be further evaluated for consumers or bystanders.
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Disposal
EPA does not expect to further analyze exposure to consumers from disposal of consumer products. It is
anticipated that most products will be disposed of in original containers, particularly those products that
are purchased as aerosol cans. Liquid products may be recaptured in an alternate container following use
(e.g. paint scrapings after paint removal as was done in EPA's 2014 risk assessment for methylene
chloride paint stripping use) (U.S. EPA. 2014b).
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CONSUMER ACTIVITIES / USES EXPOSURE PATHWAY EXPOSURE ROUTE RECEPTORSb HAZARDS
Solvents for Cleaning or
Degreasing
Dermal
Liquid Contact
Adhesives and Sealants
Hazards Potentially
Associated with Acute
and/or Chronic
Exposures:
See Section 2.4.2
Consumers
Paints and Coatings
Metal Products
Bystanders
Fabric, Textile, and
Leather Products
Vapor/Mist
Inhalation
Automotive Care Products
Apparel and Footwear
Care Products
Laundry and Dishwashing
Products
Lubricants and Greases
KEY:
Gray Text: Use or route that will not be further
analyzed
—*¦ Pathways that will be further analyzed
— Pathways that will not be further analyzed
Other Uses3
Consumer Handling of [_
; Disposal and Waste |
Figure 2-3. Methylene Chloride Conceptual Model for Consumer Activities and Uses: Potential Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human receptors from consumer activities and uses of
methylene chloride.
a Some products are used in both commercial and consumer applications. Additional uses of methylene chloride are included in Table 2-3.
b Receptors include potentially exposed or susceptible subpopulations.
c 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
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2,5,3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures
and Hazards
The revised conceptual model (Figure 2-4) illustrates the expected exposure pathways to human and
ecological receptors from environmental releases and waste streams associated with industrial and
commercial activities for methylene chloride that EPA expects to include in the risk evaluation. The
pathway that EPA expects to include and analyze further in the risk evaluation is described in Section
2.5.3.1 and shown in the conceptual model Figure 2-4. The pathways that EPA expects to include but
not further analyze in risk evaluation are described in Section 2.5.3.2 and shown in the conceptual model
Figure 2-4. The pathways that EPA does not expect to include in risk evaluation are described in Section
2.5.3.3.
2.5.3.1 Pathways That EPA Expects to Include and Further Analyze in Risk
Evaluation
EPA expects to analyze aquatic invertebrates and aquatic plants exposed via contaminated surface water.
There are no national recommended water quality criteria for the protection of aquatic life for methylene
chloride and as a result EPA does not believe that methylene chloride exposure to aquatic organisms in
surface water has been adequately assessed or effectively managed under other EPA statutory authorities
(see Section 2.5.3.3). Based on the national-scale environmental monitoring data for methylene chloride
described in Section 2.3.4 methylene chloride was detected in 14.6% of all surface water samples with a
median of 0.035 |ig/L and ranged from 0.0055 to 34 |ig/L (99th percentile = 1.55 |ig/L). As summarized
in Section 2.4.1 methylene chloride demonstrated hazard at concentrations as low as 0.9 |ig/L for
aquatic invertebrate developmental delays/non-development and 2 |ig/L for aquatic plant reduction in
Chlorophyll A. These hazard levels are not sufficiently below the range of monitored concentrations to
eliminate risk concerns. Therefore, EPA expects to evaluate risks to aquatic invertebrates and aquatic
plants from exposures to methylene chloride in surface waters.
2.5.3.2 Pathways That EPA Expects to Include in Risk Evaluation But Not Further
Analyze
Species in the environment including aquatic organisms, amphibians and terrestrial organisms may
come into contact with methylene chloride-contaminated biosolids and soil pore water when the
biosolids are land applied. Methylene chloride is not expected to adsorb to soil and sediment due to its
low partitioning to organic matter (estimated log Koc = 1.4), so methylene chloride detected in biosolids
is in the aqueous phase associated with the biosolids, not adsorbed to the organic matter. Thus,
methylene chloride concentrations in surface waters and soil pore water are representative of exposures
to amphibians and terrestrial organisms since only limited amounts of methylene chloride will be
adsorbed to the organic matter in associated sediments and soils. Based on methylene chloride
concentrations in surface waters and soil pore water described in Section 2.3.4 and hazard information
summarized in Section 2.4.1, the exposures are orders of magnitude below levels observed to cause
effects in amphibians and terrestrial organisms, including mammals, soil invertebrates and birds.
If methylene chloride-contaminated biosolids are released to the environment, including when the
biosolids are land applied, methylene chloride will be present mainly in aqueous compartments based on
its physical-chemical properties (water solubility, organic carbon:water partition coefficient [log Koc],
Henry's Law constant, vapor pressure). Overall, methylene chloride in land-applied biosolids is
expected to be mobile in soil, volatilizing to air or migrating into surface and groundwater in the
aqueous phase. However, methylene chloride concentrations in biosolids-associated water are expected
to be no greater than the concentrations in the WWTP effluent, which represents a much larger fraction
of the water released from WWTP (the volume of water removed with biosolids represents < 2% of
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wastewater treatment plant influent volume (U.S. EPA. 1974). and is < 1% of influent volume when the
sludge is dewatered and the excess water is returned to treatment, a process that is commonly used
CNRC. 1996b)). Concentrations of methylene chloride in biosolids-associated water will further decrease
through volatilization to air during transport, processing (including dewatering), handling, and
application to soil (which may include spraying, which increases surface area and can enhance
volatilization). Overall, the exposures to surface water from biosolids will be negligible compared to the
direct release of WWTP effluent to surface water, and therefore exposures of aquatic organisms to
methylene chloride from surface water due to land-applied biosolids will not be further analyzed.
2.5.3.3 Pathways That EPA Does Not Expect to Include in the Risk Evaluation
Exposures to receptors (i.e. general population, terrestrial species) may occur from industrial and/or
commercial uses; industrial releases to air, water or land; and other conditions of use. As described in
section 2.5, EPA does not expect to include in the risk evaluation pathways under programs 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. These
pathways are described below.
Ambient Air Pathway
The Clean Air Act (CAA) contains a list of hazardous air pollutants (HAP) and provides EPA with the
authority to add to that list pollutants that present, or may present, a threat of adverse human health
effects or adverse environmental effects. For stationary source categories emitting HAP, the CAA
requires issuance of technology-based standards and, if necessary, additions or revisions to address
developments in practices, processes, and control technologies, and to ensure the standards adequately
protect public health and the environment. The CAA thereby provides EPA with comprehensive
authority to regulate emissions to ambient air of any hazardous air pollutant.
Methylene chloride is a HAP. EPA has issued a number of technology-based standards for source
categories that emit perchloroethylene to ambient air and, as appropriate, has reviewed, or is in the
process of reviewing remaining risks. Because stationary source releases of methylene chloride to
ambient air are adequately assessed and any risks effectively managed when under the jurisdiction of the
CAA, EPA does not expect to evaluate emission pathways to ambient air from commercial and
industrial stationary sources or associated inhalation exposure of the general population or terrestrial
species in this TSCA evaluation.
Drinking Water Pathway
EPA has regular analytical processes to identify and evaluate drinking water contaminants of potential
regulatory concern for public water systems under the Safe Drinking Water Act (SDWA). Under
SDWA, EPA must also review and revise "as appropriate" existing drinking water regulations every 6
years.
EPA has promulgated National Primary Drinking Water Regulations (NPDWRs) for methylene chloride
under the Safe Drinking Water Act. EPA has set an enforceable Maximum Contaminant Level (MCL) as
close as feasible to a health based, non-enforceable Maximum Contaminant Level Goal (MCLG).
Feasibility refers to both the ability to treat water to meet the MCL and the ability to monitor water
quality at the MCL, SDWA Section 1412(b)(4)(D), and public water systems are required to monitor for
the regulated chemical based on a standardized monitoring schedule to ensure compliance with the
maximum contaminant level (MCL).
Hence, because the drinking water exposure pathway for methylene chloride is currently addressed in
the SDWA regulatory analytical process for public water systems, EPA does not expect to include this
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pathway in the risk evaluation for methylene chloride under TSCA. EPA's Office of Water and Office
of Pollution Prevention and Toxics will continue to work together providing understanding and analysis
of the SDWA regulatory analytical processes and to exchange information related to toxicity and
occurrence data on chemicals undergoing risk evaluation under TSCA.
Ambient Water Pathways
EPA develops recommended water quality criteria under section 304(a) of the CWA for pollutants in
surface water that are protective of aquatic life or human health designated uses. EPA develops and
publishes water quality criteria based on priorities of states and others that reflect the latest scientific
knowledge. A subset of these chemicals are identified as "priority pollutants" (103 human health and 27
aquatic life). The CWA requires states adopt numeric criteria for priority pollutants for which EPA has
published recommended criteria under section 304(a), the discharge or presence of which in the affected
waters could reasonably be expected to interfere with designated uses adopted the state. When states
adopt criteria that EPA approves as part of state's regulatory water quality standards, exposure is
considered when state permit writers determine if permit limits are needed and at what level for a
specific discharger of a pollutant to ensure protection of the designated uses of the receiving water. Once
states adopt criteria as water quality standards, the CWA requires National Pollutant Discharge
Elimination System (NPDES) discharge permits include effluent limits as stringent as necessary to meet
standards. CWA section 301(b)(1)(C). This is the process used under the CWA to address risk to human
health and aquatic life from exposure to a pollutant in ambient waters.
EPA has identified methylene chloride as a priority pollutant and EPA has developed recommended
water quality criteria for protection of human health for methylene chloride which are available for
adoption into state water quality standards for the protection of human health and are available for use
by NPDES permitting authorities in deriving effluent limits to meet state narrative criteria. As such,
EPA does not expect to include this pathway in the risk evaluation under TSCA. EPA's Office of Water
and Office of Pollution Prevention and Toxics will continue to work together providing understanding
and analysis of the CWA water quality criteria development process and to exchange information related
to toxicity of chemicals undergoing risk evaluation under TSCA. EPA may update its CWA section
304(a) water quality criteria for methylene chloride in the future under the CWA.
EPA has not developed CWA section 304(a) recommended water quality criteria for the protection of
aquatic life for methylene chloride, so there are no national recommended criteria for this use available
for adoption into state water quality standards and available for use in NPDES permits. As a result, this
pathway will undergo aquatic life risk evaluation under TSCA (see Section 2.5.3.1). EPA may publish
CWA section 304(a) aquatic life criteria for methylene chloride in the future if it is identified as a
priority under the CWA.
Disposal Pathways
Methylene chloride is included on the list of hazardous wastes pursuant to RCRA 3001 (40 CFR §§
261.33) as a listed waste on the F, K, and U lists. The general standard in section RCRA 3004(a) for the
technical criteria that govern the management (treatment, storage, and disposal) of hazardous waste are
those "necessary to protect human health and the environment," RCRA 3004(a). The regulatory criteria
for identifying "characteristic" hazardous wastes and for "listing" a waste as hazardous also relate solely
to the potential risks to human health or the environment. 40 C.F.R. §§ 261.11, 261.21-261.24. RCRA
statutory criteria for identifying hazardous wastes require EPA to "tak[e] 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." Subtitle C controls cover not
only hazardous wastes that are landfilled, but also hazardous wastes that are incinerated (subject to joint
control under RCRA Subtitle C and the Clean Air Act (CAA) hazardous waste combustion MACT) or
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injected into UIC Class I hazardous waste wells (subject to joint control under Subtitle C and the Safe
Drinking Water Act (SDWA)).
EPA does not expect to include emissions to ambient air from municipal and industrial waste
incineration and energy recovery units in the risk evaluation, as they are regulated under section 129 of
the Clean Air Act. CAA section 129 requires EPA to review and, if necessary, add provisions to ensure
the standards adequately protect public health and the environment. Thus, combustion by-products from
incineration treatment of methylene chloride wastes (the majority of the 37.8 million lbs identified as
treated in Table 2-6) would be subject to these regulations, as would methylene chloride burned for
energy recovery (15.6 million lbs).
EPA does not expect to include on-site releases to land that go to underground injection in its risk
evaluation. TRI reporting in 2016 indicated 59,711 pounds released to underground injection to a Class I
well and no releases to underground injection wells of Classes II-VI. Environmental disposal of
methylene chloride injected into Class I well types are managed and prevented from further
environmental release by RCRA and SDWA regulations. Therefore, disposal of methylene chloride via
underground injection is not likely to result in environmental and general population exposures.
EPA does not expect to include on-site releases to land from RCRA Subtitle C hazardous waste landfills
or exposures of the general population or terrestrial species from such releases in the TSCA evaluation.
Based on 2015 reporting to TRI, the majority of the land disposals occur in Subtitle C landfills (30,757
lbs on-site and 5,334 lbs off site). Design standards for Subtitle C landfills require double liner, double
leachate collection and removal systems, leak detection system, run on, runoff, and wind dispersal
controls, and a construction quality assurance program. They are also subject to closure and post-closure
care requirements including installing and maintaining a final cover, continuing operation of the leachate
collection and removal system until leachate is no longer detected, maintaining and monitoring the leak
detection and groundwater monitoring system. Bulk liquids may not be disposed in Subtitle C landfills.
Subtitle C landfill operators are required to implement an analysis and testing program to ensure
adequate knowledge of waste being managed, and to train personnel on routine and emergency
operations at the facility. Hazardous waste being disposed in Subtitle C landfills must also meet RCRA
waste treatment standards before disposal. Given these controls, general population exposure to
methylene chloride in groundwater from Subtitle C landfill leachate is not expected to be a significant
pathway.
EPA does not expect to include on-site releases to land from RCRA Subtitle D municipal solid waste
(MSW) landfills or exposures of the general population (including susceptible populations) or terrestrial
species from such releases in the TSCA evaluation. While permitted and managed by the individual
states, municipal solid waste landfills are required by federal regulations to implement some of the same
requirements as Subtitle C landfills. MSW landfills generally must have a liner system with leachate
collection and conduct groundwater monitoring and corrective action when releases are detected. MSW
landfills are also subject to closure and post-closure care requirements, and must have financial
assurance for funding of any needed corrective actions. MSW landfills have also been designed to allow
for the small amounts of hazardous waste generated by households and very small quantity waste
generators (less than 220 lbs per month). Bulk liquids, such as free solvent, may not be disposed of at
MSW landfills.
EPA does not expect to include on-site releases to land from industrial non-hazardous waste and
construction/demolition waste landfills in the methylene chloride risk evaluation. Industrial non-
hazardous and construction/demolition waste landfills are primarily regulated under state regulatory
programs. States must also implement limited federal regulatory requirements for siting, groundwater
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monitoring and corrective action and a prohibition on open dumping and disposal of bulk liquids. States
may also establish additional requirements such as for liners, post-closure and financial assurance, but
are not required to do so. Therefore, EPA does not expect to include this pathway in the risk evaluation.
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RELEASES AND WASTES FROM
INDUSTRIAL / COMMERCIAL USES
EXPOSURE PATHWAY
RECEPTORS
HAZARDS
Direct
discharge
Aquatic
Species
Water,
Sediment
Indirect discharge
Terrestrial
Species
Biosolids
Soil
POTW
Wastewater or
Liquid Wastes a
Industrial Pre-
Treatment or
Industrial WWT
Hazards Potentially Associated with
Acute and Chronic Exposures:
See Section 2.4.1
KEY:
Gray Text: Receptors that will not be further
analyzed
—~ Pathways that will be further analyzed
—~ Pathways that will not be further analyzed
Figure 2-4. Methylene Chloride Conceptual Model for Environmental Releases and Wastes: Potential Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human and environmental receptors from
environmental releases and wastes of methylene chloride.
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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2.6 Analysis Plan
The analysis plan presented in the problem formulation is a refinement of the initial analysis plan that
was published in the Scope of the Risk Evaluation for Methylene Chloride (Dichlor ome thane).
The analysis plan outlined here is based on the conditions of use for methylene chloride, as described in
Section 2.2 of this problem formulation. EPA is implementing systematic review approaches to identify,
select, assess, integrate and summarize the findings of studies supporting the TSCA risk evaluation. The
analytical approaches and considerations in the analysis plan are used to frame the scope of the
systematic review activities for this assessment. The supplemental document, Application of Systematic
Review in TSCA Risk Evaluations ( )18). provides additional information about criteria and
methods that have been and will be applied to the first 10 chemical risk evaluations.
While EPA has conducted a comprehensive search for reasonably available data as described in the
Scope of the Risk Evaluation for Methylene Chloride, EPA encourages submission of additional existing
data, such as full study reports or workplace monitoring from industry sources, that may be relevant for
refining conditions of use, exposures, hazards and potentially exposed or susceptible subpopulations
during the risk evaluation. EPA will continue to consider new information submitted by the public.
During risk evaluation, EPA will rely on the comprehensive literature results [Methylene Chloride
(CASRN 75-09-2) Bibliography: Supplemental File for the TSCA Scope Document EPA-HO-OPPT-
201.6-0742-0059 (U.S. EPA. 2017aYl or supplemental literature searches to address specific questions.
Further, EPA may consider any relevant confidential business information (CBI) in the risk evaluation
in a manner that protects the confidentiality of the information from public disclosure. The analysis plan
is based on EPA's knowledge of methylene chloride to date, which includes partial, but not complete
review of identified literature. If additional data or approaches become available, EPA may refine its
analysis plan based on this information.
2.6,1 Exposure
Based on their physical-chemical properties, expected sources, and transport and transformation within
the outdoor and indoor environment chemical substances are more likely to be present in some media
and less likely to be present in others. Media-specific levels will vary based on the chemical substance
of interest. For most chemical substances level(s) can be characterized through a combination of
available monitoring data and modeling approaches.
2.6.1.1 Environmental Releases
EPA expects to consider and analyze releases to relevant environmental media as follows:
1) Review reasonably available published literature or information on processes and activities
associated with the conditions of use to evaluate the types of releases and wastes generated. EPA
has reviewed some key data sources containing information on processes and activities resulting
in releases, and the information found is shown in Appendix B.l. EPA will continue to review
potentially relevant data sources identified in Table Apx B-4 in Appendix B during risk
evaluation.
EPA plans to review the following key data sources in Table 2-9 for additional information on
activities resulting in environmental releases. The evaluation strategy for engineering and
occupational data sources discussed in the Application of Systematic Review in TSCA Risk
Evaluations ( ) describes how data, information, and studies will be reviewed.
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Table 2-9. Potential Sources of Environmental Release Data
U.S. EPA TRI Data (Reporting Year 2016 only)
U.S. EPA Generic Scenarios
OECD Emission Scenario Documents
EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Specific
Environmental Release Categories (SpERC) factsheets
Discharge Monitoring Report (DMR) surface water discharge data for methylene chloride
from NPDES-permitted facilities
2) Review reasonably available chemical-specific release data, including measured or estimated
release data (e.g., data collected under the TRI program). EPA has reviewed key release data
sources including the Toxics Release Inventory (TRI), and the data from this source is summarized
in Section 2.3.2 above and also in Appendix B. EPA will continue to review relevant data sources
as identified in Table Apx B-5 in Appendix B during risk evaluation. EPA will match identified
data to applicable conditions of use and identify data gaps where no data are found for particular
conditions of use. EPA will attempt to address data gaps identified as described in steps 3 and 4
below by considering potential surrogate data and models.
3) Review reasonably available measured or estimated release data for surrogate chemicals that have
similar uses and chemical and physical properties. Data for solvents that are used in the same types
of applications may be considered as surrogate data for methylene chloride. As with methylene
chloride, trichloroethylene is used in paints and coatings, in adhesives and sealants, and as solvents
for cleaning and degreasing. EPA will evaluate the use of data for solvents such as trichloroethylene
as surrogates to fill data gaps where uses of methylene chloride and other solvents align. If
surrogate data are used, EPA normally converts air concentrations using the ratio of the vapor
pressures of the two chemicals. EPA will review literature sources identified and if surrogate data
are found, EPA will match these data to applicable conditions of use for potentially filling data
gaps.
4) Understand and consider regulatory limits that may inform estimation of environmental releases.
EPA has identified information from various EPA statutes (including, for example, regulatory
limits, reporting thresholds or disposal requirements) that may be relevant to release estimation.
Some of the information has informed revision of the conceptual models during problem
formulation. EPA will further consider relevant regulatory requirements in estimating releases
during risk evaluation.
5) Review and determine applicability of OECD Emission Scenario Documents (ESDs) and EPA
Generic Scenarios to estimation of environmental releases. Potentially relevant OECD Emission
Scenario Documents (ESDs) and EPA Generic Scenarios (GS) have been identified that correspond
to some conditions of use. For example, the ESD on Industrial Use of Adhesives for Substrate
Bonding, the ESD on the Coating Industry (Paints, Lacquers and Varnishes), and the GS on the Use
of Vapor Degreasers are some of the ESDs and GSs that EPA may use to assess potential releases.
EPA will need to critically review these generic scenarios and ESDs to determine their applicability
to the conditions of use assessed. EPA was not able to identify ESDs or GSs corresponding to
several conditions of use, including manufacture and import of methylene chloride, use of
methylene chloride as an anti-spatter welding aerosol, and use of methylene chloride in
pharmaceutical manufacturing. EPA will perform additional targeted research to understand those
conditions of use which may inform identification of release scenarios. EPA may also need to
perform targeted research for applicable models and associated parameters that EPA may use to
estimate releases for certain conditions of use. If ESDs and GSs are not available, other methods
may be considered. Additionally, for conditions of use where no measured data on releases are
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available, EPA may use a variety of methods including the application of default assumptions such
as standard loss fractions associated with drum cleaning (3%) or single process vessel cleanout
(1%).
6) Map or group each condition(s) of use to a release assessment scenario. EPA has identified release
scenarios and mapped them to some conditions of use. For example, some scenario groupings
include Contractor Adhesive Removal and Industrial In-line Vapor Degreasing. EPA grouped
similar conditions of use (based on factors including process equipment and handling, release
sources and usage rates of methylene chloride and formulations containing methylene chloride, or
professional judgment) into scenario groupings but may further refine these groupings as additional
information becomes available during risk evaluation.
EPA was not able to identify release scenarios corresponding to several conditions of use due to a
lack of general knowledge of those conditions of use. EPA will perform additional targeted research
to understand those uses which may inform identification of release scenarios.
7) Complete the weight of the evidence of environmental release data.
EPA will rely on the weight of the scientific evidence when evaluating and integrating
environmental release data. The data integration strategy will be designed to be fit-for-purpose in
which EPA will use systematic review methods to assemble the relevant data, evaluate the data for
quality and relevance, including strengths and limitations, followed by synthesis and integration of
the evidence.
2.6.1.2 Environmental Fate
EPA expects to consider and analyze fate and transport in environmental media as follows:
1) Review reasonably available measured or estimated environmental fate endpoint data collected
through the literature search.
A general overview of persistence and bioaccumulation was presented in the TSCA Work Plan
Chemical Risk Assessment Methylene Chloride: Paint Stripping Use ( 1Mb)- Key
environmental fate characteristics were included in the TSCA Scope for Methylene Chloride (U.S.
EPA. 2017b) and in previous assessments of methylene chloride, including those conducted by the
EPA Integrated Risk Information System (l__S FP \ _ 20 j I b), EPA Office of Water (OW, 2015),
US Agency for Toxic Substances and Disease Registry (A 1 SDR. 2010. 2000). Environment
Canada (Health and Environment Canada. 1()°3). and Organization for Economic Cooperation and
Development Cooperative Chemicals Assessment Program (OECD. 2011). These information
sources will be used as a starting point for the environmental fate assessment. Other sources that
will be consulted include those that are identified through the systematic review process. Studies
will be evaluated using the evaluation strategies laid out in Application of Systematic Review in
TSCA Risk Evaluations ( Ł018).
If measured values resulting from sufficiently high-quality studies are not available (to be
determined through the systematic review process), chemical properties will be estimated using EPI
Suite, SPARC, and other chemical parameter estimation models. Estimated fate properties will be
reviewed for applicability and quality.
2) Using measured environmental fate data and/or environmental fate modeling, determine the
influence of environmental fate endpoints (e.g., persistence, bioaccumulation, partitioning,
transport) on exposure pathways and routes of exposure to environmental receptors.
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Measured fate data including volatilization from water, sorption to organic matter in soil and
sediments, aqueous and atmospheric photolysis rates, and aerobic and anaerobic biodegradation
rates, along with physical-chemical properties and models such as the EPI Suite™ STP model
(which estimates removal in wastewater treatment due to adsorption to sludge and volatilization to
air) and volatility model (which estimates half-life from volatilization from a model river and model
lake), will be used to characterize the movement of methylene chloride within and among
environmental media and the persistence of methylene chloride in media.
3) Evaluate the weight of the evidence of environmental fate data.
EPA will rely on the weight of the scientific evidence when evaluating and integrating
environmental fate data. The data integration strategy will be designed to be fit-for-purpose in
which EPA will use systematic review methods to assemble the relevant data, evaluate the data for
quality and relevance, including strengths and limitations, followed by synthesis and integration of
the evidence.
2.6.1.3 Environmental Exposures
EPA expects to consider the following in developing its environmental exposure assessment of
methylene chloride:
1) Refine and finalize exposure scenarios for environmental receptors by considering unique
combinations of sources (use descriptors), exposure pathways, exposure settings, populations
exposed, and exposure routes. For methylene chloride, exposure scenarios for environmental
receptors include exposures from surface water.
2) Review reasonably available environmental and biological monitoring data for environmental
exposure to surface water. EPA will rely on databases (see examples below) and literature obtained
during systematic review to include ranges and trends of chemical in surface water, including any
trends seen in concentrations and spatial trends.
• STORET and NWIS (USGS/EPS): httj3s ://www.epa.gov/waterdata/storage-and-retrieval-and-water-
qual itv-exchange#portal
• OPPT monitoring database
3) Review reasonably available information on releases to determine how modeled estimates of
concentrations near industrial point sources compare with available monitoring data. Available
exposure models that estimate surface water (e.g. E-FAST) will be evaluated and considered
alongside available surface water data to characterize environmental exposures. Modeling
approaches to estimate surface water concentrations generally consider the following inputs: direct
release into surface water and transport (partitioning within media) and characteristics of the
environment (river flow, volume of pond, meteorological data).
4) Determine applicability of existing additional contextualizing information for any monitored data or
modeled estimates during risk evaluation. For example, site/location, time period, and conditions
under which monitored data were collected will be evaluated to determine relevance and
applicability to wider scenario development. Any studies which relate levels of methylene chloride
in the environment or biota with specific sources or groups of sources will be evaluated.
5) Evaluate the weight of evidence of environmental occurrence data and modeled estimates.
EPA will rely on the weight of the scientific evidence when evaluating and integrating
environmental exposure data. The data integration strategy will be designed to be fit-for-purpose in
which EPA will use systematic review methods to assemble the relevant data, evaluate the data for
quality and relevance, including strengths and limitations, followed by synthesis and integration of
the evidence.
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2.6.1.4 Occupational Exposures
EPA expects to consider and analyze both worker and occupational nonuser exposures as follows:
1) Review reasonably available exposure monitoring data for specific condition(s) of use. Exposure
data to be reviewed may include workplace monitoring data collected by government agencies such
as OSHA and NIOSH, and monitoring data found in published literature (e.g., personal exposure
monitoring data (direct measurements) and area monitoring data (indirect measurements)). Data,
information, and studies will be evaluated using the evaluation strategies laid out in Application of
Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2018). For some OSHA data, NAICS
codes included with the data will be matched with potentially applicable conditions of use, and data
gaps will be identified where no data are found for particular conditions of use. EPA will attempt to
address data gaps identified as described in steps 2 and 3 below. Where possible, job descriptions
may be useful in distinguishing exposures to different subpopulations within a particular condition
of use. EPA has also identified additional data sources that may contain relevant monitoring data
for the various conditions of use. EPA will review these sources, identified in Table 2-10 and in
Table Apx B-6 in Appendix B, and will extract relevant data for consideration and analysis during
risk evaluation.
Table 2-10. Potential Sources of Occupational Exposure Data
2014 TSCA Work Plan Chemical Risk Assessment Report for Methylene Chloride (Paint
Stripping use)
U.S. NIOSH Health Hazard Evaluation (HHE) Program reports
U.S. OSHA Chemical Exposure Health Data (CEHD) program data
U.S. EPA Generic Scenarios
OECD Emission Scenario Documents
Sector-specific Worker Exposure Descriptions (SWEDs)
2000 AT SDR Tox Profile
2) Review reasonably available exposure data for surrogate chemicals that have uses and chemical and
physical properties similar to methylene chloride. If surrogate data are identified, these data will be
matched with applicable conditions of use for potentially filling data gaps. For several uses
including use of adhesives, cleaners, and laundry and dishwashing products, EPA believes that
trichloroethylene and other similar solvents may share the same or similar conditions of use and
may be considered as surrogates for methylene chloride.
3) For conditions of use where data are limited or not available, review existing exposure models that
may be applicable in estimating exposure levels. Models may be generic, broadly applicable models
or may be specific to conditions of use (e.g., some OECD Emission Scenario Documents and US
EPA Generic Scenarios may be identified as potentially mapping to some conditions of use). EPA
has identified potentially relevant OECD ESDs and EPA GSs corresponding to some conditions of
use. For example, the ESD on Industrial Use of Adhesives for Substrate Bonding, the ESD on the
Industrial Use of Industrial Cleaners, and the GS on Textile Finishing are some of the ESDs and
GSs that EPA may use to estimate occupational exposures. Where mappings are identified, the
scenario documents will be reviewed for whether they contain exposure models that may apply to
the conditions of use. An example of a generic model that has been used in addressing data gaps in
some conditions of use is the Near-Field/ Far-Field (NF/FF) model e.g. in the recent
trichloroethylene risk evaluation (U.S. EPA. ). This or other models, including the
assumption of compliance with the OSHA PEL for methylene chloride, may be explored where
models specific to conditions of use are not found. If any models are identified as applicable, EPA
will search for appropriate model parameter data. If parameter data can be located or assumed,
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exposure estimates generated from these models may be used for potentially filling data gaps. EPA
was not able to identify ESDs or GSs corresponding to several conditions of use, including
recycling of methylene chloride and solvent mixtures containing methylene chloride, and
processing and formulation of methylene chloride into industrial, commercial and consumer
products. EPA will perform additional targeted research to understand those conditions of use,
which may inform identification of exposure scenarios. EPA may also need to perform targeted
research to identify applicable models that EPA may use to estimate exposures for certain
conditions of use.
4) Review reasonably available data that may be used in developing, adapting or applying exposure
models to the particular risk evaluation. This step will be performed after Steps #2 and #3 above.
Based on information developed from Step #2 and Step #3, EPA will evaluate relevant data to
determine whether the data can be used to develop, adapt, or apply models for specific conditions of
use (and corresponding exposure scenarios).
5) Consider and incorporate applicable engineering controls and/or personal protective equipment into
exposure scenarios. EPA will review potentially relevant data sources on engineering controls and
personal protective equipment as identified in Table 2-10 and in Table Apx B-7 in Appendix B and
determine their applicability for incorporation into exposure scenarios during risk evaluation.
6) Map or group each condition of use to occupational exposure assessment scenario(s). For scenarios
and worker exposure estimates, some key information and data to consider for grouping include
per-site throughput or use rates of methylene chloride and formulations containing methylene
chloride, process equipment and handling, and worker exposure activities and factors impacting
exposures/ doses (routes, exposure factors or modeling). These main drivers must be similar enough
between uses to allow for uses to be grouped for worker exposure. EPA has identified occupational
exposure scenarios and mapped them to conditions of use. For example, one scenario grouping is
commercial aerosol degreasing, where cleaning products containing methylene chloride are applied
to substrates via spraying methods in a commercial setting. EPA grouped similar conditions of use
(based on factors including process equipment and handling, usage rates of methylene chloride and
formulations containing methylene chloride, exposure/release sources, or professional judgment)
into scenario groupings but may further refine these groupings as additional information is
identified during risk evaluation.
7) EPA was not able to identify occupational exposure scenarios corresponding to several conditions
of use due to a lack of understanding of those conditions of use. EPA will perform targeted research
to understand those uses which may inform identification of occupational exposure scenarios. If no
data are available EPA may use appropriate conservative default assumptions in assessing
occupational exposure.
8) Evaluate the weight of the evidence of occupational exposure data. EPA will rely on the weight of
the scientific evidence when evaluating and integrating occupational exposure data. The data
integration strategy will be designed to be fit-for-purpose in which EPA will use systematic review
methods to assemble the relevant data, evaluate the data for quality and relevance, including
strengths and limitations, followed by synthesis and integration of the evidence.
2.6.1.5 Consumer Exposures
EPA expects to consider and analyze both consumers using a consumer product and bystanders
associated with the consumer using the product as follows:
1) Refine and finalize exposure scenarios for consumers by mapping sources of exposure (i.e.,
consumer products), exposure pathways, exposure settings, exposure routes, and populations
exposed. Considerations for constructing exposure scenarios for consumers:
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• Reasonably available data on consumer products or products available for consumer use
including the weight fraction of methylene chloride in products;
• Information characterizing the use patterns of consumer products containing methylene
chloride including the following: intended or likely consumer activity, method of application
(e.g., spray-applied, brush-applied, dip), formulation type, amount of product used, frequency
and duration of individual use events, and room or setting of use;
• The associated route of exposure for consumers; and
• Populations who may be exposed to products as users or bystanders in the home, including
potentially exposed and susceptible subpopulations such as children or women of child bearing
age and subsets of consumers who may use commercially-available products or those who may
use products more frequently than typical consumers.
During consumer exposure modeling, these factors determine the resulting exposure route and
magnitude. For example, while the product with the highest weight fraction in a given consumer
product scenario could be run early on to indicate preliminary levels of exposure, that product may
not actually result in the highest potential exposure due to having a lower frequency of use.
2) Evaluate the relative potential and magnitude of exposure routes based on available data. For
methylene chloride, inhalation of vapor is expected to result in higher exposure to consumers and
bystanders as compared to other pathways due to fate and exposure properties. We expect to
comprehensively evaluate the data sources to effectively evaluate these pathways moving forward,
but quantitative comparisons across exposure pathways or in relation to toxicity thresholds are not
yet possible.
3) Review and use existing indoor exposure models that may be applicable in estimating indoor air
(vapor). For example, U.S. EPA (2014b) used the Multi-Chamber Concentration and Exposure
Model (MCCEM) to estimate and evaluate indoor exposures to methylene chloride-based paint
strippers. EPA anticipates using similar models and approaches to evaluate indoor exposures
moving forward.
9) Review reasonably available empirical data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation. For example, existing models developed for a
chemical assessment may be applicable to another chemical assessment if model parameter data are
available. For methylene chloride, existing scenarios and data parameters associated with modeling
exposure from the use of methylene chloride-based paint strippers have already been developed
(U.S. EPA. 2014b). EPA anticipates using this and other developed models for evaluation moving
forward.
10) Review reasonably available consumer product-specific sources to determine how those exposure
estimates compare with each other and with indoor monitoring data reporting methylene chloride in
dust or indoor air.
11) Review reasonably available population- or subpopulation-specific exposure factors and activity
patterns to determine if potentially exposed or susceptible subpopulations need to be further refined.
12) Evaluate the weight of the evidence of consumer exposure estimates based on different approaches.
EPA will rely on the weight of the scientific evidence when evaluating and integrating consumer
exposure data. The data integration strategy will be designed to be fit-for-purpose in which EPA
will use systematic review methods to assemble the relevant data, evaluate the data for quality and
relevance, including strengths and limitations, followed by synthesis and integration of the
evidence.
2.6.1.6 General Population
EPA does not expect to include general population exposures in the risk evaluation for methylene
chloride. EPA has determined that the existing regulatory programs and associated analytical processes
adequately assess and effectively manage the risks of methylene chloride that may be present in various
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media pathways (e.g., air, water, land) for the general population. For these cases, EPA believes that the
TSCA risk evaluation should focus not on those exposure pathways, but rather on exposure pathways
associated with TSCA conditions of use that are not subject to those regulatory processes, because the
latter pathways are likely to represent the greatest areas of concern to EPA.
2,6,2 Hazards (Effects)
2.6.2.1 Environmental Hazards
EPA will conduct an environmental hazard assessment of methylene chloride as follows:
1) Review reasonably available environmental hazard data, including data from alternative test
methods (e.g., computational toxicology and bioinformatics; high-throughput screening methods;
data on categories and read-across; in vitro studies).
Environmental hazard data will be evaluated using the ecological toxicity data quality criteria
outlined in the Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2.018). The
study evaluation results will be documented in the risk evaluation phase and data from suitable
studies will be extracted and integrated in the risk evaluation process.
Conduct hazard identification (the qualitative process of identifying acute and chronic endpoints)
and concentration-response assessment (the quantitative relationship between hazard and exposure)
for all identified environmental hazard endpoints. Suitable environmental hazard data will be
reviewed for acute and chronic endpoints for mortality and other effects (e.g. growth, immobility,
reproduction, etc.). EPA will evaluate the character of the concentration-response relationship {i.e.
positive, negative or no response) as part of the review.
Sufficient environmental hazard studies are available to assess the hazards of environmental
concentrations of methylene chloride to terrestrial and aquatic species. EPA did not find suitable
sediment invertebrate hazard data, but will use hazard information from aquatic invertebrates to
infer hazards to sediment invertebrates from exposures to methylene chloride in sediment pore
water.
2) Derive aquatic and terrestrial concentrations of concern (COC) for acute and, where possible,
chronic endpoints.
The aquatic environmental hazard studies may be used to derive acute and chronic concentrations
of concern (COC) for mortality, behavioral, developmental and reproductive or other endpoints
determined to be detrimental to environmental populations. Depending on the robustness of the
evaluated data for a particular organism (e.g. aquatic invertebrates), environmental hazard values
(e.g. ECx/LCx/NOEC/LOEC, etc.) may be derived and used to further understand the hazard
characteristics of methylene chloride to aquatic species.
3) Evaluate the weight of the evidence of environmental hazard data.
EPA will rely on the weight of the scientific evidence when evaluating and integrating
environmental hazard data. The data integration strategy will be designed to be fit-for-purpose.
EPA will use systematic review methods to assemble the relevant data, evaluate the data for quality
and relevance, including strengths and limitations, followed by synthesis and integration of the
evidence.
4) Consider the route(s) of exposure, available biomonitoring data and available approaches to
integrate exposure and hazard assessments.
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EPA believes there is sufficient information to evaluate the potential risks to aquatic invertebrates,
aquatic plants and amphibians from exposures to methylene chloride in ground water and surface
water.
2.6.2.2 Human Health Hazards
EPA expects to consider and analyze human health hazards as follows:
1) Review reasonably available human health hazard data, including data from alternative test methods
as needed (e.g., computational toxicology and bioinformatics; high-throughput screening methods;
data on categories and read-across; in vitro studies; systems biology).
For the methylene chloride risk evaluation, EPA will evaluate information in the IRIS assessment
and human health studies using OPPT's structured process described in the document, Application
of Systematic Review in TSCA Risk Evaluations (U. S. EPA. 2018). Human and animal data will be
identified and included as described in the inclusion and exclusion criteria in Appendix F. EPA
plans to prioritize the evaluation of mechanistic evidence. Specifically, EPA does not plan to
evaluate mechanistic studies unless needed to clarify questions about associations between
methylene chloride and health effects and its relevance to humans. The Applications of Systematic
Review document (U.S. EPA. 2018) describes the process of how studies will be evaluated using
specific data evaluation criteria and a predetermined approach. Study results will be extracted and
presented in evidence tables by hazard endpoint. EPA plans to evaluate relevant studies identified
in the Integrated Risk Information System (IRIS) Toxicological Review of Dichloromethane
(Methylene Chloride) (U.S. EPA. 201 lb) and the TSCA Work Plan Chemical Risk Assessment -
Methylene Chloride: Paint Striping Use ( )14b). In addition for identifying human and
animal data, EPA intends to review studies published after the most recent of the multiple acute
reference values were published (e.g. AEGLs). These studies were published from January 1, 2008
to March 2, 2017 and are captured in the comprehensive literature search conducted by the Agency
for methylene chloride (see Methylene Chloride (CASRN 75-09-2) Bibliography: Supplemental File
for the TSCA Scope Document EPA-HO-OI T I ¦ ¦ I-0742-0-' • 0 EPA. 2017a)) using the
approaches described in Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA.
2018). To more fully understand circumstances related to deaths by individuals using methylene
chloride, EPA/OPPT will review case reports, case series and ecological studies related to deaths
and effects that may imminently lead to death (respiratory distress). EPA/OPPT will not be
evaluating case reports and series or ecological studies for endpoints that appear to be less severe
endpoints (e.g., nausea).
2) In evaluating reasonably available data, determine whether particular human receptor groups may
have greater susceptibility to the chemical's hazard(s) than the general population.
Reasonably available human health hazard data will be evaluated to ascertain whether some human
receptor groups may have greater susceptibility than the general population to methylene chloride
hazard(s).
3) Conduct hazard identification (the qualitative process of identifying non-cancer and cancer
endpoints) and dose-response assessment (the quantitative relationship between hazard and
exposure) for all identified human health hazard endpoints.
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Human health hazards from acute and chronic exposures will be identified by evaluating the human
and animal data that meet the data quality criteria described in Application of Systematic Review in
TSCA Risk Evaluations ( 318). Data quality evaluation will be performed on relevant
studies identified in the IRIS assessment ( ), the TSCA work plan risk assessment
(U.S. EPA. 2014b). and assessments of the effects of acute exposures in the (\
-------
6) Evaluate the weight of the evidence of human health hazard data.
EPA will rely on the weight of the scientific evidence when evaluating and integrating human health
hazard data. The strategy will be designed to be fit-for-purpose. EPA will use systematic review
methods to assemble the relevant data, evaluate the data for quality and relevance, including
strengths and limitations, followed by synthesis and integration of the evidence.
2.6.3 Risk Characterization
Risk characterization is an integral component of the risk assessment process for both ecological and
human health risks. EPA will derive the risk characterization in accordance with EPA's Risk
Characterization Handbook (U.S. EPA. 2000). As defined in EPA's Risk Characterization Policy. "the
risk characterization integrates information from the preceding components of the risk evaluation and
synthesizes an overall conclusion about risk that is complete, informative and useful for decision
makers." Risk characterization is considered to be a conscious and deliberate process to bring all
important considerations about risk, not only the likelihood of the risk but also the strengths and
limitations of the assessment, and a description of how others have assessed the risk into an integrated
picture.
Risk characterization at EPA assumes different levels of complexity depending on the nature of the risk
assessment being characterized. The level of information contained in each risk characterization varies
according to the type of assessment for which the characterization is written. Regardless of the level of
complexity or information, the risk characterization for TSCA risk evaluations will be prepared in a
manner that is transparent, clear, consistent, and reasonable (TCCR) (U.S. EPA. 2000). EPA will also
present information in this section consistent with approaches described in the Procedures for Chemical
Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726). For instance, in the
risk characterization summary, EPA will further carry out the obligations under TSCA section 26; for
example, by identifying and assessing uncertainty and variability in each step of the risk evaluation,
discussing considerations of data quality such as the reliability, relevance and whether the methods
utilized were reasonable and consistent, explaining any assumptions used, and discussing information
generated from independent peer review. EPA will also be guided by EPA's Information Quality
Guidelines (U.S. EPA. 2002) as it provides guidance for presenting risk information. Consistent with
those guidelines, in the risk characterization, EPA will also identify: (1) Each population addressed by
an estimate of applicable risk effects; (2) the expected risk or central estimate of risk for the potentially
exposed or susceptible subpopulations affected; (3) each appropriate upper-bound or lower bound
estimate of risk; (4) each significant uncertainty identified in the process of the assessment of risk effects
and the studies that would assist in resolving the uncertainty; and (5) peer reviewed studies known to the
Agency that support, are directly relevant to, or fail to support any estimate of risk effects and the
methodology used to reconcile inconsistencies in the scientific information.
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APPENDICES
Appendix A REGULATORY HISTORY
A.l Federal Laws and Regulations
Table Apx A-l. Federal Laws and Regulations
Maliilcs/Ucgulalions
Description of
Aiilhorilv/Uegulalion
Description of Regulation
EPA Regulations
TSCA - Section 6(a)
Provides EPA with the authority to
prohibit or limit the manufacture
(including import), processing,
distribution in commerce, use or
disposal of a chemical if EPA
evaluates the risk and concludes
that the chemical presents an
unreasonable risk to human health
or the environment.
Proposed rule ( , January 19,
2017) regulating certain uses of
methylene chloride and N-
methylpyrrolidone in paint and coating
removal.
EPA intends to finalize the methylene
chloride rule
(httos://www.eDa.80v/newsreleases/eoa-
announces-action-methvlene-chloride)
TSCA - Section 6(b)
Directs EPA to promulgate
regulations to establish processes
for prioritizing chemicals and
conducting risk evaluations on
priority chemicals. In the
meantime, EPA directed to
identify and begin risk evaluations
on 10 chemical substances drawn
from the 2014 update of the TSCA
Work Plan for Chemical
Assessments.
Methylene chloride is on the initial list
of chemicals to be evaluated for
unreasonable risk under TSCA (
91927. December 19, 2016).
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
United States.
Methylene chloride manufacturing
(including importing), processing, and
use information is reported under the
CDR rule ( 316. August 16.
2011).
TSCA - Section 8(b)
EPA must compile, keep current
and publish a list (the TSCA
Inventory) of each chemical
Methylene chloride was on the initial
TSCA Inventory and therefore was not
subject to EPA's new chemicals review
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Miiliik's/Ucgiihilions
Description of
Aiilhorhy/Ucgiihilion
Description of Ucgiihilion
substance manufactured, processed
or imported in the United States.
process under TSCA section 5 (
16309, March 29, 1995).
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).
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).
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
Methylene chloride is a listed substance
subject to reporting requirements under
40 CFR 372.65 effective as of January
01, 1987.
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Miiliik's/Ucgiihilions
Description of
Aiilhorhy/Ucgiihilion
Description of Ucgiihilion
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).
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 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.
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
I R 34384). The tolerance exemptions
for methylene chloride were revoked in
2002 ( 27, 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
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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Miiliik's/Ucgiihilions
Description of
Aiilhorhy/Ucgiihilion
Description of Ucgiihilion
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 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,
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 (
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) (74 FR
56008, October 29, 2009).
• Fabric printing, coating and dyeing
(68 FR 32172. Mav 29. 2003).
• Halogenated Solvent Cleaning (72
FR 25138. May 3, 2007).
• Miscellaneous organic chemical
production and processes (MON)
(68 FR 63852. November 10, 2003).
• Paint and allied products
manufacturing (area sources) (
63504. December 3, 2009).
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Miiliik's/Ucgiihilions
Description of
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Description of Ucgiihilion
• Paint stripping and miscellaneous
surface coating operations (area
sources) (73 FR 1738. January 9.
2008).
• Paper and other web surface coating
(67 FR 72.330. December 4. 2002).
• Pesticide active ingredient
production ( ), June 23,
1999; 1 UvJK-OO, June 3, 2002).
• Pharmaceutical production (63 FR
50280, September 21, 1998).
• Publicly Owned Treatment Works
(64 FR 57572. October 26, 1999).
• Reciprocating Internal Combustion
Engines (RICE) (
August 20, 2010).
• Reinforced plastic composites
production (68 FR 19375. April 21.
2003).
• Wood preserving (area sources) (72
FR 38864. Julv 16. 2007V}
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, as
necessary, taking into account
developments in practices,
processes and control
technologies.
EPA has promulgated a number of RTR
NESHAP (e.g., the RTR NESHAP for
Halogenated Solvent Cleaning (
25138; May 3, 2007) and will do so, as
required, for the remaining source
categories with NESHAP.
CAA - Section 612
Under Section 612 of the CAA,
EPA's Significant New
Alternatives Policy (SNAP)
program reviews substitutes for
ozone-depleting substances within
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
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Description of Ucgiihilion
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.
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
Code of Federal Regulations at 40
CFR Part 401.15. 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).
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Description of
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Description of Ucgiihilion
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 contaminant level
(MCL), or a required treatment
technique. Public water systems
are required to comply with
NPDWRs.
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).
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
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).
Page 82 of 148
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Maliilcs/Ucgulalions
Description of
Aiilhorilv/Uegulalion
Description of Regulation
report to the National Response
Center if they have knowledge of a
release of a hazardous substance
above the reportable quantity
threshold.
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
conditionally exclude solvent-
contaminated wipes that are disposed
from the definition of hazardous waste
(78 FR 46448, Julv 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 ( 698. September 14.
1987). 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 12254. March 21. 2018 and 83
, April 26, 2018)
Hazardous Materials
Transportation Act
(HMTA)
Section 5103 of the Act directs the
Secretary of Transportation to:
Methylene chloride is listed as a
hazardous material with regard to
transportation and is subject to
Page 83 of 148
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Miiliilcs/Ucgiihilions
Description of
Aiilhorhy/Ucgiihilion
Description of Ucgiihilion
• 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 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.
regulations prescribing requirements
applicable to the shipment and
transportation of listed hazardous
materials (70 FR 34381, June 14
2005).
FFDCA
Provides the 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 ( 28, 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-hour TWA PEL of 25 ppm
TWA, exposure monitoring, control
measures and respiratory protection (29
CFR 1910.1052 App. A).
A.2 State Laws and Regulations
Tsihle_Apx A-2. Stsitc l.siws sinri Ucgiihitions
Sliilc 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).
Page 84 of 148
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Stsito Actions
Description of Action
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, section 19-13-
B102), Florida (Fla. Admin. Code R. 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 MRS A
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).
Volatile Organic
Compound (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).
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A.3 International Laws and Regulations
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 (IMAP). 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
(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 United States is not currently
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Country/
Orgsiniziilion
Requirements sinri Restrictions
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, European
Union, Finland,
France, Germany,
Hungary, Ireland,
Israel, Japan, Latvia
New Zealand,
People's Republic
of China, Poland,
Singapore, South
Korea, Spain,
Sweden,
Switzerland, United
Kingdom
Occupational exposure limits for methylene chloride (GESTIS
International limit values for chemical agents (Occupational exposure
limits, OELs) database. Accessed April 18, 2017).
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Appendix B PROCESS, RELEASE AND OCCUPATIONAL
EXPOSURE INFORMATION
This appendix provides information and data found in preliminary data gathering for methylene
chloride.
B.l Process Information
Process-related information potentially relevant to the risk evaluation may include process diagrams,
descriptions and equipment. Such information may inform potential release sources and worker
exposure activities.
Note that the processing information below is representative of methylene chloride, but not inclusive of
all uses. EPA will consider this information and data in combination with other data and methods for use
in the risk evaluation.
B.l.l Manufacturing (Including Import)
According to 2016 public CDR data, methylene chloride is both manufactured in and imported into the
United States ( >016b).
B.l.1.1 Domestic Manufacturing
Methylene chloride is primarily manufactured through the gas-phase reaction of hydrogen chloride with
methanol to produce methyl chloride, which is then reacted with chlorine to produce methylene chloride,
along with chloroform and carbon tetrachloride as coproducts. This reaction is typically driven by high
temperature, but may also be driven through catalysis or photolysis. This reaction may alternatively be
conducted in the liquid phase at low temperatures and high pressures, which can yield high selectivities
of methylene chloride (Holbrook. 2003).
An antiquated production method of methylene chloride is the reaction of excess methane with chlorine
at temperatures of approximately 400 to 500°C. Lower reaction temperatures are possible through the
use of catalysis or photolysis. This reaction produces methylene chloride with methyl chloride,
chloroform and carbon tetrachloride as coproducts and unreacted methane with hydrogen chloride as
byproducts. The unreacted methane and hydrogen chloride are removed through a water wash, dried,
and recycled. The liquid stream of chlorinated organic products is washed, alkali scrubbed, dried and
fractionated (Holbrook. 2003).
Other minor production methods of methylene chloride exist, such as: the reduction of chloroform or
carbon tetrachloride with hydrogen over a platinum catalyst; the molten salt oxychlorination of methane;
the reaction of phosgene and formaldehyde over an activated carbon catalyst; and the reduction of
carbon tetrachloride with ferrous hydroxide in the presence of alkaline hydroxides or carbonates
(Holbrook. 2003).
B.l.1.2 Import
Based on EPA's knowledge of the chemical industry, typical import activities include storage in
warehouses prior to distribution for further processing and use and QC sampling.
Methylene chloride may be transported in drums, trucks, railcars, barges and oceangoing ships. Storage
contains should be constructed of galvanized or otherwise suitably lined mild or plain steel. Bulk storage
tanks should include a vent equipped with a desiccant-packed dryer, such as calcium chloride, or an inert
gas pad with pressure/vacuum relief valve (Holbrook. 2003).
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B.1.2 Processing
B.l.2.1 Reactant or Intermediate
Processing as a reactant or intermediate is the use of methylene chloride as a feedstock in the production
of another chemical product via a chemical reaction in which methylene chloride is consumed to form
the product. Methylene chloride is used as an intermediate for the production of difluoromethane, also
known as HFC-32, which is used in fluorocarbon blends for refrigerants (Marshall and Pottenger. ^ ).
Methylene chloride is also a feedstock in the production of bromochloromethane. Bromochloromethane
is produced through a halogen exchange reaction with methylene chloride and either bromine or
hydrogen bromide with an aluminum or aluminum trihalide catalyst. Alternative processes include the
gas-phase bromination of methylene chloride with hydrogen bromide and the liquid-phase displacement
reaction of methylene chloride with inorganic bromides (Ioffe and Frim. 2011).
B.l.2.2 Incorporating into Formulation, Mixture, or Reaction Product
Incorporation into a formulation, mixture or reaction product refers to the process of mixing or blending
of several raw materials to obtain a single product or preparation. The uses of methylene chloride that
may require incorporation into a formulation include paint removers; adhesives and sealants; paints and
coatings; degreasers, cleaners, and spot removers; and lubricants. Methylene chloride-specific
formulation processes were not identified; however, several ESDs published by the OECD have been
identified that provide general process descriptions for some of these types of products. The formulation
of paints and coatings typically involves dispersion, milling, finishing and filling into final packages
(OECD. 2009b). Adhesive formulation involves mixing together volatile and non-volatile chemical
components in sealed, unsealed or heated processes (OECD. 2009a). Sealed processes are most common
for adhesive formulation because many adhesives are designed to set or react when exposed to ambient
conditions (OECD, 2009a). Lubricant formulation typically involves the blending of two or more
components, including liquid and solid additives, together in a blending vessel (OECD. 2004).
B. 1.2.3 Repackaging
Based on EPA's knowledge of the chemical industry, typical repackaging sites receive the chemical in
bulk containers and transfer the chemical from the bulk container into another smaller container in
preparation for distribution in commerce.
B.1.2.4 Recycling
TRI data from 2015 indicate that many sites ship methylene chloride for off-site recycling. A general
description of waste solvent recovery processes was identified. Waste solvents are generated when it
becomes contaminated with suspended and dissolved solids, organics, water, or other substance (U.S.
80). Waste solvents can be restored to a condition that permits reuse via solvent
reel am ati on/recy cl i ng (U.S. EPA, 1980). The recovery process involves an initial vapor recovery (e.g.,
condensation, adsorption, and absorption) or mechanical separation (e.g., decanting, filtering, draining,
setline, and centrifuging) step followed by distillation, purification, and final packaging (U.S. EPA.
1980).
B.1.3 Uses
In this scope document, EPA has grouped uses based on CDR categories and identified examples within
these categories as subcategories. Note that some subcategories may be grouped under multiple CDR
categories. The differences between these uses will be further investigated and defined during risk
evaluation.
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B. 1.3.1 Solvents for Cleaning or Decreasing
EPA has gathered information on different types of cleaning and degreasing systems from recent
trichloroethylene risk evaluation (U.S. EPA. 2014c) and risk management (8! , January 19,
2017, , December 16, 2016) activities and 1 -Bromopropane Draft Risk Assessment (U.S.
) activities. Provided below are descriptions of three cleaning and degreasing uses of
methylene chloride.
Vapor Degreasers
Vapor degreasing is a process used to remove dirt, grease and surface contaminants in a variety of metal
cleaning industries. Vapor degreasing may take place in batches or as part of an in-line (i.e., continuous)
system. Vapor degreasing equipment can generally be categorized into one of three degreaser types
described below:
1) Batch vapor degreasers - In batch machines, each load (parts or baskets of parts) is loaded into the
machine after the previous load is completed. Individual organizations, regulations and academic
studies have classified batch vapor degreasers differently. For the purposes of the scope document,
EPA categories the batch vapor degreasers into five types: open-top vapor degreasers (OTVDs);
OTVDs with enclosures; closed-loop degreasing systems (airtight); airless degreasing systems
(vacuum drying); and airless vacuum-to-vacuum degreasing systems.
2) Conveyorized vapor degreasers - In conveyorized systems, an automated parts handling system,
typically a conveyor, continuously loads parts into and through the vapor degreasing equipment and
the subsequent drying steps. Conveyorized degreasing systems are usually fully enclosed except for
the conveyor inlet and outlet portals. Conveyorized degreasers are likely used in shops where there
are a large number of parts being cleaned. There are seven major types of conveyorized degreasers:
monorail degreasers; cross-rod degreasers; vibra degreasers; ferris wheel degreasers; belt
degreasers; strip degreasers; and circuit board degreasers ( 77).
3) Continuous web vapor degreasers - Continuous web cleaning machines are a subset of in-line
degreasers but differ in that they are specifically designed for cleaning parts that are coiled or on
spools such as films, wires and metal strips (Kamegsberg and Kamegsberg, 2011; U.S. EPA, 2.006b).
In continuous web degreasers, parts are uncoiled and loaded onto rollers that transport the parts
through the cleaning and drying zones at speeds >11 feet/minute (U.S. EPA. 2006b). The parts are
then recoiled or cut after exiting the cleaning machine (Kamegsberg and Kanegsberg. 2011: U.S.
EPA. 2006b).
Cold Cleaners
Methylene chloride can also be used as a solvent in cold cleaners, which are non-boiling solvent
degreasing units. Cold cleaning operations include spraying, brushing, flushing and immersion; the use
process and worker activities associated with cold cleaning have been previously described in (U.S.
) 1-Bromopropane Draft Risk Assessment.
Aerosol Spray Degreasers and Cleaners
Aerosol degreasing is a process that uses an aerosolized solvent spray, typically applied from a
pressurized can, to remove residual contaminants from fabricated parts. Products containing methylene
chloride may be used in aerosol degreasing applications such as brake cleaning, engine degreasing and
metal product cleaning (see thq Preliminary Information on Manufacturing, Processing, Distribution,
Use and Disposal for Methylene Chloride EPA-HQ-OP iQ3). This use has been
previously described in ( 016c) 1-Bromopropane Draft Risk Assessment. Aerosol degreasing
may occur at either industrial facilities or at commercial repair shops to remove contaminants on items
being serviced. Aerosol degreasing products may also be purchased and used by consumers for various
applications.
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B.l.3.2 Adhesives and Sealants
Based on products identified in EP A's Preliminary Information on Manufacturing, Processing,
Distribution, Use, and Disposal for Methylene Chloride (EP A-HQ-QPPT-2016-0742-0003) and 2016
CDR reporting ( 16b). methylene chloride may be used in adhesives and sealants for
industrial, commercial and consumer applications. Thq Preliminary Information on Manufacturing,
Processing, Distribution, Use and Disposal for Methylene Chloride (EPA-HQ-OPPT-2016-0742-0003)
identifies aerosol and canister adhesive products that contain methylene chloride. In these applications,
the methylene chloride likely serves as a propellant or solvent and evaporates during adhesive drying.
These adhesive products are identified for use on substrates such as metal, foam, plastic, rubber, fabric,
leather, wood and fiberglass. The types of adhesives identified in thq Preliminary Information on
Manufacturing, Processing, Distribution, Use and Disposal for Methylene Chloride (EP A-HQ-QPPT -
2016-0742-0003) include contact adhesives, crosslinking adhesives, pressure sensitive adhesives, sealers
and cements.
The QECD (2013) ESD for Use of Adhesives provides general process descriptions and worker
activities for industrial adhesive uses. Given the identified applications of methylene chloride in aerosol
and canister adhesives, EPA anticipates workers spray apply the adhesive to substrates. The adhesives
are likely sold and used in sealed containers such as spray cans or canister tanks.
B.l.3.3 Paints and Coatings
Based onthq Preliminary Information on Manufacturing, Processing, Distribution, Use, and Disposal:
Methylene Chloride and Use and Market Profile for Methylene Chloride, both available in the public
docket (EPA-HQ-QPPT-2016-0742). methylene chloride may be used in various paints and coatings for
industrial, commercial and consumer applications. Typical process descriptions and worker activities for
industrial and commercial uses in coating applications include manual application with roller or brush,
air spray systems, airless and air-assisted airless spray systems, electrostatic spray systems,
electrodeposition/electrocoating and autodeposition, dip coating, curtain coating systems, roll coating
systems and supercritical carbon dioxide systems (QECD. 2009b). After application, solvent-based
coatings typically undergo a drying stage in which the solvent evaporates from the coating (QECD.
2009b).
Methylene chloride is used for paint removal in a variety of industries, such as the automotive, aircraft,
construction and refinishing industries. Application methods include manual or automated application,
with techniques such as spray application, pouring, wiping and rolling. Additional details on this use of
methylene chloride can be found in EPA's 2014 TSCA Work Plan Chemical Risk Assessment for the
use of methylene chloride as a paint remover ( 014b). The Agency proposed restrictions
under TSCA section 6 to address the risks from methylene chloride in paint and coating removal by
consumers and most commercial users except for commercial furniture stripping (82 FR 7464. January
19, 2017). While paint and coating removal falls under the conditions of use for methylene chloride,
based on the intention to finalize the rulemaking the scenarios already assessed in the 2014 risk
assessment these uses will not be re-evaluated and EPA will rely on the 2014 risk evaluation
(https://www.epa.gov/newsreleases/epa-aimoimces-action-methylene-chloride) see Section 2.2.2.1.
B.l.3.4 Laundry and Dishwashing Products
Spot Cleaner
Methylene chloride is found in products used to spot clean garments (EPA.-HQ-OPPT-2 3).
Spot cleaning products can be applied to the garment either before or after the garment is dry cleaned.
Page 91 of 148
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The process and worker activities associated with commercial dry cleaning and spot cleaning have been
previously described in ( 016c) 1 -Bromopropane Draft Risk Assessment.
B.l.3.5 Lubricants and Greases
EPA identified several commercial and consumer lubricant products that contain methylene chloride.
These lubricants are used to reduce friction and wear and prevent seizing where metal-to-metal contact
is possible and inhibit rusting and corrosion by displacing water in a wide variety of applications,
including machinery, hardware, cables, and chains. The majority of these lubricant products are aerosol
lubricants (available in aerosol cans), although one liquid-based lubricant product (available in pails and
drums) was also identified. Aerosol lubricants are sprayed directly onto metal substrates, while liquid
lubricants may be brushed or spray applied to metal substrates. The methylene chloride is anticipated to
completely evaporate during the drying phase, leaving behind a lubricating film {Use and Market Profile
for Methylene Chloride EP A-HQ-QPPT-2016-0742-0003)
B.l.3.6 Other Uses
Methylene chloride is a I ."-listed hazardous waste under RCRA code U080 (40 CFR § 261.33(f)).
Additionally, methylene chloride is included in multiple waste codes under the F-list of non-specific
source wastes (40 CFR § 261.31(a)).
B.1.4 Disposal
Methylene chloride is a U-listed hazardous waste under code U080 under RCRA; therefore, discarded,
unused pure and commercial grades of methylene chloride are regulated as a hazardous waste under
RCRA (40 CFR § 261.33(f)). Additionally, methylene chloride is included in multiple waste codes
under the F-list of non-specific source wastes (40 CFR § 261.31(a)).
B.2 Occupational Exposure Data
EPA presents below examples of occupational exposure-related information from the preliminary data
gathering. EPA will consider this information and data in combination with other data and methods for
use in the risk evaluation.
TableApx B-land TableApx B-2 show mappings of release and worker exposure scenarios to industry
sectors with available OSHA data for methylene chloride, obtained from OSHA inspections between
2002 and 2016 for personal monitoring data and area monitoring data, respectively. EPA attempted to
group industry sectors according to possible release/exposure scenarios, but there is a great degree of
uncertainty where and how methylene chloride may be used in these industries. The industry sectors in
Table Apx B-land Table Apx B-2 were extracted from the OSHA CEHD (OSHA.. 2017).
EPA also found some NIOSH HHE data since 2000 that are summarized and included in Table Apx
B-3.
Table Apx B-l Mapping of Scenarios to Industry Sectors with Methylene Chloride Personal
Monitoring Air Samples Obtained from OSHA Inspections Conducted Between 2002 and 2016
Possible Kck'iiso/ l-lxposmv Scciiiii'ios
NAICS
NAICS Description (Job l idos from OSIIA)
Manufacture of methylene chloride; Processing
as a Reactant;
Incorporated into Formulation, Mixture or
Reaction Product
325199
All Other Basic Organic Chemical Manufacturing (Operator)
325998
All Other Miscellaneous Chemical Product and Preparation
Manufacturing (Technician)
Page 92 of 148
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TableApx B-l Mapping of Scenarios to Industry Sectors with Methylene Chloride Personal
Monitoring Air Samples Obtained from OSHA Inspections Conducted Between 2002 and 2016
I'nssihk* Kck'iiso / I'xpcisure Sivniirios
NAICS
NAICS Description i.loh l ilies I'min OSIIA)
Solvents (for cleaning and degreasing); Metal
products not covered elsewhere
331316
Aluminum Extruded Product Manufacturing (2007 NAICS -
2012 is 331318 Other Aluminum Rolling, Drawing, and
Extruding) (Poly-Pour Setup)
331513
Steel Foundries (except Investment) (Machine Operator,
Industrial Hygienist)
332710
Machine Shops (Shipping and Receiving)
332811
Metal Heat Treating (Controller)
332999
All Other Miscellaneous Fabricated Metal Product
Manufacturing (Welder)
333132
Oil and Gas Field Machinery and Equipment Manufacturing
(Laborer)
336211
Motor Vehicle Body Manufacturing (Welder)
334416
Capacitor, Resistor, Coil, Transformer, and Other Inductor
Manufacturing (Operator)
327390
Other Concrete Product Manufacturing (Rspecta Machine
Cleaner, Rspecta Machine Operator)
Application of Adhesives; Solvents (for
cleaning and degreasing); Metal products not
covered elsewhere
332321
Metal Window and Door Manufacturing (Adhesive Sprayer)
335121
Residential Electric Lighting Fixture Manufacturing (Glue
Application)
333921
Elevator and Moving Stairway Manufacturing (Carpenter,
Adhesive Sprayer)
Paint and Coating Application; Solvents (for
cleaning and degreasing); Metal products not
covered elsewhere
332312
Fabricated Structural Metal Manufacturing (Painter)
Paint and Coating Application
238320
Painting and Wall Covering Contractors (apprentice painter
employee)
238390
Other Building Finishing Contractors (laborer)
713110
Amusement and Theme Parks (Painter)
811420
Reupholstery and Furniture Repair (Owner, Refinisher,
Laborer, Stripper)
448190
Other Clothing Stores (Screen Printer)
451110
Sporting Goods Stores (Screen Printing)
323113
Commercial Screen Printing (Quality Control,
Production/Sprayer, Screen Print Lead)
Fabric Finishing
313312
Textile and Fabric Finishing (except Broadwoven Fabric)
Mills (2007 NAICS - 2012 is 313310 Textile and Fabric
Finishing Mills) (Production specialist)
315240
Women's, Girls', and Infants' Cut and Sew Apparel
Manufacturing (Presser, Supervisor - Finishing Dept)
316998
All Other Leather Good and Allied Product Manufacturing
(Spray Finishing, Sprayer of Methylene Chloride, Press
Operator, Miscellaneous)
Plastic product manufacturing (converting)
325211
Plastics Material and Resin Manufacturing (Plastic
Fabricator, CSHO, Assistant Supervisor, Extruder Operator)
326199
All Other Plastics Product Manufacturing (ADA Area, Hop
Area Operator, Injection Molding Operator, Assembler)
325991
Custom Compounding of Purchased Resins (Fabricator)
Rubber product manufacturing (converting);
Solvents (for cleaning and degreasing)
325212
Synthetic Rubber Manufacturing (Insert Prep / Degreaser
Operator, Compliance Officer)
Page 93 of 148
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TableApx B-l Mapping of Scenarios to Industry Sectors with Methylene Chloride Personal
Monitoring Air Samples Obtained from OSHA Inspections Conducted Between 2002 and 2016
I'nssihk* Kck'iiso / I'xpcisure Sivniirios
NAICS
NAICS Description i.loh l ilies I'min OSIIA)
Pharmaceutical product manufacturing;
Processing aid, not otherwise listed; Laboratory
use
325412
Pharmaceutical Preparation Manufacturing (Laboratory
Technician)
Polyurethane foam blowing; Application of
Adhesives
326150
Urethane and Other Foam Product (except Polystyrene)
Manufacturing (Molder/Painter, Mold Machine Operator,
Blue Zone, Adhesive Application)
Paint and Coating Application; Automotive
care products (Functional fluids for air
conditioners: refrigerant, treatment, leak sealer,
Interior car care - spot remover, degreasers)
811111
General Automotive Repair (Paint, Production)
Automotive care products (Functional fluids for
air conditioners: refrigerant, treatment, leak
sealer, Interior car care - spot remover,
degreasers); Aerosol degreasing/ cleaning by
contractors
811310
Commercial and Industrial Machinery and Equipment
(except Automotive and Electronic) Repair and Maintenance
(Mechanic)
811121
Automotive Body, Paint, and Interior Repair and
Maintenance (Manager)
Laboratory use
541380
Testing Laboratories (Analyst, Lab Tech)
621511
Medical Laboratories (Lab Tech)
Paint and Coating Application; Application of
Adhesives
339950
Sign Manufacturing (Gluer, Floor Manager, Painter,
Laminator, OSHA CSHO, Acrylic Production, Production,
Industrial Hygienist, Sign Maker, Lettering)
Unknown / Other Uses
327991
Cut Stone and Stone Product Manufacturing (Carpenter,
Postform)
321211
Hardwood Veneer and Plywood Manufacturing (Lamination,
Operator, CSHO)
321911
Wood Window and Door Manufacturing (stripper)
321999
All Other Miscellaneous Wood Product Manufacturing
(Floater: stripper and refinisher, Fabricator)
337110
Wood Kitchen Cabinet and Countertop Manufacturing (Glue
Sprayer, CSHO, Cabinet Assembler, Spray Painter,
Fabricator)
337212
Custom Architectural Woodwork and Millwork
Manufacturing (Shop worker)
423930
Recyclable Material Merchant Wholesalers (Fingers)
339999
All Other Miscellaneous Manufacturing (Glass decorator)
423810
Construction and Mining (except Oil Well) Machinery and
Equipment Merchant Wholesalers (Technician)
424610
Plastics Materials and Basic Forms and Shapes Merchant
Wholesalers (Fabricator)
424990
Other Miscellaneous Nondurable Goods Merchant
Wholesalers (Plant Worker)
443112
Radio, Television, and Other Electronics Stores (2007
NAICS - 2012 is 443142 Electronic Stores) (Press Operator)
443141
Household Appliance Stores (Metal Shop Worker)
322121
Paper (except Newsprint) Mills (Operators, Mechanics)
485410
School and Employee Bus Transportation (Service Worker)
532299
All Other Consumer Goods Rental (Warehouse Help,
Industrial Hygienist)
811490
Other Personal and Household Goods Repair and
Maintenance (Laborer)
Page 94 of 148
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TableApx B-l Mapping of Scenarios to Industry Sectors with Methylene Chloride Personal
Monitoring Air Samples Obtained from OSHA Inspections Conducted Between 2002 and 2016
1'ossihk* Kck'iiso / I'xpcisure Scciiiirios
NAICS
NAICS Description (Joh l ilies from OSIIA)
N/A
926150
Regulation, Licensing, and Inspection of Miscellaneous
Commercial Sectors (Compliance Officer, Industrial
Hygienist, CSHO)
Table Apx B-2 Mapping of Scenarios to Industry Sectors with Methylene Chloride Area
Monitoring Air Samples Obtained from OSHA Inspections Conducted Between 2013 and 2016
I'ossihk* Kek'iisc / I'xposure Scenarios
NAICS
NAICS Description
I'ols u iel ha lie loam blow mg
326150
L ivilunie and Oilier 1 oam I'roducl (e\cepi I'ols sl\ rcnc;
Manufacturing (Blue Zone, Adhesive Application)
Paint and Coating Application; Application of
Adhesives
339950
Sign Manufacturing (Production Area)
NIOSHHHEs
EPA found a total of 122 HHEs that contained methylene chloride on NIOSH's website. Limiting the
search to reports done since 2000 (-16 years) resulted in three HHEs. The following subsections provide
summaries of the facilities inspected, the findings of the inspection, and any recommendations for using
the data.
Federal Crime Lab, Unidentified Location (2016) (2012-0238-3257)
The Health Hazard Evaluation Program received a request from the health and safety director at a
Federal Bureau of Investigation (FBI) crime laboratory (lab) to evaluate workplace health hazards.
Inspectors sampled employees in the Operational Projects Unit, which builds crime scene models to
display in court hearings. Activities included woodcutting, spray painting, laser cutting of plastics,
assembling plastics parts, and 3-dimensional printing. The inspectors used Drager direct-reading
colorimetric detector tubes to evaluate employee exposures to methylene chloride during the following
tasks:
1. Manually transferring methylene chloride from a 1-quart container to a 30-mL squeeze bottle in
the paint spray booth. This task took approximately 2 minutes and was done 1-2 times per month.
2. Hand assembling Plexiglas® parts without local exhaust ventilation. A small amount of
methylene chloride was squeezed from a 30-mL container onto the parts. The employee then held the
pieces together for a few seconds.
Employees voluntarily wore lab coats, Sperian® N95 filtering facepiece respirators, ear plugs or
earmuffs, and nitrile gloves. No methylene chloride was detected during sampling activities (< 20 ppm).
EPA notes that these exposure data may be compared with alternative data that are available for the risk
evaluation before use. The methodology and results for this study are limited, and/or may not be
representative of typical occupational use.
Page 95 of 148
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Woodworking Studio, Brooklyn College, Brooklyn, New York (2009) (HETA 2007-0167-3078)
NIOSH received a confidential employee request for an HHE at Brooklyn College in Brooklyn, New
York, to investigate health and safety concerns in the sculpture studios, including the ceramic,
woodworking, and metalworking studios. In the woodworking studio, the inspectors observed methylene
chloride being used as an adhesive for plexiglass bonding and being applied using a 4-ounce squeeze
bottle. The inspectors performed PBZ air sampling for VOCs, but methylene chloride was not
measurable at quantifiable levels (LOD unknown). The inspectors recommended that the college
substitute a less toxic plastics adhesive for methylene chloride.
EPA notes that these exposure data be compared with alternative data that are available for the risk
evaluation before use. The methodology and results for this study are limited, and/or may not be
representative of typical occupational use.
Human Performance International, Inc., Charlotte, North Carolina (2001) (HETA 2000-0110-2849)
The Hazard Evaluation and Technical Assistance Branch (HETAB) of the National Institute for
Occupational Safety and Health (NIOSH) collaborated with the Division of Applied Research and
Technology (DART) within NIOSH to conduct a pilot research study evaluating occupational exposure
to noise and potential ototoxic agents, such as solvents, metals, and asphyxiants, among a stock car
racing team.
Methylene chloride was present in the lacquer thinner used to clean the paint guns. In between each coat
of primer, sealer, or paint that is applied, the painter leaves the paint booth to clean the paint gun in a
lacquer thinner bath that is located directly adjacent to the paint booth. After cleaning, the primer or
paint is mixed and poured into the paint gun. Coveralls and an organic vapor cartridge half-face
respirator are worn inside the paint booth. The respirator is removed when the painter exits the paint
booth, and is not worn while the paint gun is cleaned, or while the paint is mixed. The painter reported
that the respirator filters are changed every two months and the respirator is discarded when it gets dirty.
It was not cleaned on a daily basis after use. A chemical solutions glove was occasionally worn while
cleaning the paint gun in the lacquer thinner bath and while mixing paint.
Full-shift area samples were taken in the paint booth, outside the paint booth door, in the paint storage
and mixing area, and the body shop area. Concentrations of methylene chloride were non-detectable
(LOD = 0.045 ppm).
This use of methylene chloride as a paint thinner used to clean paint guns may be a previously
unidentified activity that occurs in automotive refinishing shops. Paint stripping in automotive
refinishing shops was previously assessed in EPA's 2014 risk assessment.
Table Apx B-3 summarizes information from the NIOSH HHEs described above.
Page 96 of 148
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Table Apx B-3 Summary of NIOSH HHEs Since 2000
Kxposiirc/Uclcasc
Scenario
l-'acililv
Description
.Number
of
Kxposurc
Sam pies
.Minimum
of
Kxposurc
Values
(ppm)
.Maximum
of
Kxposurc
Values
(ppm)
Coiiimenls
Data Source
Manual adhesive
application
Model
Building
Shop
I nknou n
M)
M)
\>HZ
samples;
LOD = 20
ppm
( )
Manual adhesive
application
Woodworking
Studio
Unknown
ND
ND
PBZ
samples;
LOD
unknown
(NIOSH. 2009)
Paint and coating
(use of paint
thinner to clean
paint guns may
be a not-
previously
identified activity
in auto refinish
shops)
Race Shop -
Paint Booth,
Paint Mixing,
Body Shop
Unknown
ND
ND
Area
samples;
LOD =
0.045 ppm
(Gwin et al..
2001)
B.3 Sources Containing Potentially Relevant Data or Information
Some sources of information and data related to releases and worker exposure were found during the
systematic review literature search. Sources of data or information identified in the Analysis Plan
Sections 2.6.1.1 Environmental Releases and 2.6.1.5 Occupational Exposures are shown in the four
tables below. The data sources identified are based on preliminary results to date of the full-text
screening step of the systematic review process. Further screening and quality evaluation are on-going.
These sources will be reviewed to determine the utility of the data and information in the Risk
Evaluation.
Page 97 of 148
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Table Apx B-4 Potentially Relevant Data Sources for Information Related to Process Description
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ference id/3982131
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ference id/3982144
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ference id/3982337
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ference id/3982372
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https ://hero. epa. gov/heronet/index. cfm/reference/download/ref
County. Florida: EPA facility ID: FLD004100152. Part 2. Atlanta. GA.
erence id/3982212
OEHHA (2007s). Occupational health hazard risk assessment proiect for California: Identification of
https ://hero. epa. gov/heronet/index. cfm/reference/download/ref
chemicals of concern, possible risk assessment methods, and examples of health protective
occupational air concentrations. Sacramento. CA.
erence id/3982225
NIH (2016s). Report on carcinogens: Dichloromethane. Report on carcinogens: Fourteenth Edition.
https ://hero. epa. gov/heronet/index. cfm/reference/download/ref
Washington. DC. National Toxicology Program.
erence id/3982330
ATSDR (2000s). Toxicological profile for methylene chloride. Atlanta. GA
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erence id/3982337
TNO (1999s). Methylene chloride: Advantages and Drawbacks of Possible Market Restrictions in the
https ://hero. epa. gov/heronet/index. cfm/reference/download/ref
EU. Methylene chloride: Advantages and drawbacks of possible market restrictions in the EU. STB-
99-53 Final. Brussels. Belgium. European Commision. TNO-STB.
erence id/3982348
EC (2009s). Recommendation from the scientific committee on occupational exposure limits from
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methylene chloride (dichloromethane). Brussels. Belgium.
erence id/3982443
Page 107 of 148
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CalEPA (2005). Appendix D.3 Chronic RELS and toxicity summaries usins the previous version of
https ://hero. epa. sov/heronet/index. cfm/reference/download/ref
Hot Soots Risk Assessment guidelines (OEHHA 1999). Sacramento. CA. Office of Environmental
Health Hazard Assessment.
erence id/3982628
Finkel (2017). Comment submitted bv A. M. Finkel on the Environmental Protection Asencv (EPA)
https://www.re sulations.sov/document?D=EPA-HO-OPPT-
Proposed Rule: Regulation of Certain Uses under Toxic Substances Control Act: Methylene Chloride
and N - Mc th v 1 d v rro 1 i do nc.
2016-0231-0536
DHHS (1992). In- Depth Survev Reoort: The Control of Methylene Chloride in Furniture Strippins at
https ://hero. epa. eov/heronet/index. cfm/reference/download/ref
The JM Murray Center. Inc. Atlanta. GA. CDC.
erence id/3986433
Table Apx B-7 Potentially Relevant Data Sources for Engineering Controls and Personal Protective Equipment
liihliogranhv
nrl
Gliittori. S.. el nl ("\1elh\ lene chloride e\nosure in industrial workers " \ 111 \ Journal 54( 1)
lilins hero ena so\ lie rone I iiidcvcfni re Terence dow uload re
27-31.
ference id/13832
Hein. M. J., et al. (2010). "Statistical modelins of occupational chlorinated solvent exposures for case-
https://hero.epa.sov/heronet/index.cfm/reference/download/re
control studies usins a literature-based database." Annals of Occupational Hvsiene 54(4): 459-472.
ference id/729521
Hearne. F. T.. et al. (1987). "Methylene chloride mortality study: Dosc-rcsoonsc characterization and
https://hero.epa.sov/heronet/index.cfm/reference/download/re
animal model comparison." Journal of Occupational Medicine 29(3): 217-228.
ference id/730524
Mahmud. M. and S. N. Kales (1999). "Methylene chloride poisonins in a cabinet worker."
https://hero.epa.sov/heronet/index.cfm/reference/download/re
Environmental Health Perspectives 107(9): 769-772.
ference id/730564
Mccammon. C. S. (1990). Health Hazard Evaluation Report HETA 89-199-2033. Enseco. Inc.. Rocky
https://hero.epa.sov/heronet/index.cfm/reference/download/re
Mountain Analytical Laboratory. Arvada. Colorado. Mccammon. CS.
ference id/2531033
Macisaac. J., et al. (2013). "Fatalities due to dichloromethane in paint strippers: a continuing
https://hero.epa.sov/heronet/index.cfm/reference/download/re
problem." American Journal of Industrial Medicine 56(8): 907-910.
ference id/2554527
Tsukahara. T.. et al. (2016). "Control bandins assessment of exposure of offset printins workers to
https://hero.epa.sov/heronet/index.cfm/reference/download/re
orsanic solvents." Journal of Occupational Health 58(3): 314-319.
ference id/3419932
Beaucham. C. C.. etal. (2016). Hazard Evaluation Report: HHE-2012-0238-3257. Ausust2016:
https://hero.epa.sov/heronet/index.cfm/reference/download/re
Evaluation of forensic crime lab employees' chemical exposures, iob stress, and work-related health
concerns. U.S. Department of Health and Human Services: Centers for Disease Control and
Prevention; National Institute for Occupational Safety and Health.
ference id/3520311
Lewis. F. A. (1980). Health Hazard Evaluation Determination. Report No. HHE-79-141-711. Fischer
https://hero.epa.sov/heronet/index.cfm/reference/download/re
and Porter Company. Warminster. Pennsylvania. Lewis. FA. NIOSH: 79-141.
ference id/3653519
Love. J. R. and M. Kern (1981). Health hazard evaluation report no. HETA-81-065-938. METRO Bus
https://hero.epa.sov/heronet/index.cfm/reference/download/re
Maintenance Shop. Washington. DC. Cincinnati. OH. National Institute for Occupational Safety and
Health.
ference id/3859376
White. D. L. and J. A. Bardole (2004). Paint and finish removers.
https://hero.epa.sov/heronet/index.cfm/reference/download/re
ference id/3859417
Page 108 of 148
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U.S. EPA (1996). Hazardous air do Mutant emissions from the dinduction of flexible Dolvurcthanc
https://hero.epa.sov/heronet/index.cfm/reference/download/re
foam ~ Basis and purpose document for proposed standards. Research Triansle Park. NC. U.S.
Environmental Protection Asencv. Office of Air and Radiation. Office of Air Oualitv Plannins and
Standards.
ference id/3970122
Pubchem (2017). PubChem: Dichloromethane. Bethesda. MD. National Institute of Health. U.S.
https://hero.epa.sov/heronet/index.cfm/reference/download/re
National Library of Medicine.
ference id/3970248
ToxNet Hazardous Substances Data Bank (2017). HSDB: Methylene chloride. Bethesda. MD.
https://hero.epa.sov/heronet/index.cfm/reference/download/re
National Institute of Health. U.S. National Library of Medicine.
ference id/3970276
Kanwal. R. and R. J. Bovlstein (2006s). Health hazard evaluation rcoort no. HETA 2006-0059-3009.
https://hero.epa.sov/heronet/index.cfm/reference/download/re
DaimlerChrvsler Jefferson North Assembly Plant. Detroit Michisan. Cincinnati. OH. National
Institute for Occupational Safety and Health.
ference id/3970547
McCammon. C. (1990s). Health hazard evaluation rcoort no.HETA 89-199-2033. Enesco. Inc.. Rocky
https://hero.epa.sov/heronet/index.cfm/reference/download/re
Mountain Analytical Laboratory. Arvada. Colorado. Cincinnati. OH. National Institute for
Occupational Safety and Health.
ference id/3970566
Burr. G. A. and F. D. Richardson (1988s). Health hazard evaluation rcoort no. HETA 87-250-1888.
https://hero.epa.sov/heronet/index.cfm/reference/download/re
GTE Products Corporation. WilliamsDort. Pennsylvania. Cincinnati. OH. National Institute for
Occupational Safety and Health.
ference id/3970567
Kiefer. M. and R. J. Driscoll (1998s). Health hazard evaluation rcoort no. HETA 97-0185-2675.
https://hero.epa.sov/heronet/index.cfm/reference/download/re
McGresor Loudspeaker Manufacturing Company. Prarie du Chiea Wisconsia Part 2. Cincinnati.
OH. National Institute for Occupational Safety and Health.
ference id/3970568
Reh. C. M.. et al. (2002s). Health hazard evaluation rcoort no. HETA 98-0153-2883. Custom Products.
https://hero.epa.sov/heronet/index.cfm/reference/download/re
Inc.. Moorsville. North Carolina. Cincinnati. OH. National Institute for Occupational Safety and
Health.
ference id/3970569
Reh. C. M. and B. D. Lushniak (1990s). Health hazard evaluation report no. HETA 87-350-2084.
https://hero.epa.sov/heronet/index.cfm/reference/download/re
Trailmobile. Inc.. Charleston. Illinois. Cincinnati. OH. National Institute for Occupational Safety and
Health.
ference id/3970570
Kiefer. M.. et al. (1993s). Health hazard evaluation report no. HETA 92-0101-2341. Robins Air Force
https://hero.epa.sov/heronet/index.cfm/reference/download/re
Base. Warner Robins. Georsia. Cincinnati. OH. National Institute for Occupational Safety and Health.
ference id/3970572
Harnev. J. M.. et al. (2002s). Health hazard evaluation report no. HETA 2000-0410-2891. STN Cusion
https://hero.epa.sov/heronet/index.cfm/reference/download/re
company. Thomasville. North Carolina. Cincinnati. OH. National Institute for Occupational Safety
and Health.
ference id/3970574
Bicknell. R.. et al. (1989s). Health hazard evaluation report no. HETA 87-075-1988. American
https://hero.epa.sov/heronet/index.cfm/reference/download/re
cvanamid. Wallinsford. Connecticut. Cincinnati. OH. National Institute for Occupational Safety and
Health.
ference id/3970576
Ahrenholz. S. H. (1980s). Health hazard evaluation report no. HHE 80-18-691. Looart Press
https://hero.epa.sov/heronet/index.cfm/reference/download/re
Incorporate. Colorado Sprinss. Colorado. Cincinnati. OH. National Institute for Occupational Safety
and Health.
ference id/3970580
Sussell. A. L. and B. D. Lushniak (1990s). Health hazard evaluation report no. HETA 90-172-2076.
https://hero.epa.sov/heronet/index.cfm/reference/download/re
Bussman/Cooper Industries. MPH. Elizabethtowa Kentucky. Cincinnati. OH. National Institute for
Occupational Safety and Health.
ference id/3970589
Page 109 of 148
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Ruhe. R. L.. et al. (1981). Health hazard evaluation report no. HHE 80-49-808. Superior Tube
https://hero.epa.gov/heronet/index.cfm/reference/download/re
Company. Colleseville. Pennsylvania. Cincinnati. OH. National Institute for Occupational Safety and
Health.
ference id/3970617
ECHA (2017). Guidance on safe use: Diehloromethane. Helsinki. Finland.
https://hero.epa.gov/heronet/index.cfm/reference/download/re
ference id/3970725
NIOSH (2004). In-dcDth survey report: Assisting furniture strippers in reducing the risk from
https://hero.epa.gov/heronet/index.cfm/reference/download/re
methylene chloride stripping fomulations at The Strip Joint. Inc. CDC.
ference id/3974904
NIOSH (1985s). Health hazard evaluation report no. HETA-84-214-1633. Sheldahl. Inc.. Northfield.
https://hero.epa.gov/heronet/index.cfm/reference/download/re
Minnesota. Cincinnati. OH.
ference id/3974905
Roper. P.. et al. (1987). Health hazard evaluation report no. HETA 86-130-1775. Owens-Illinois Glass
https://hero.epa.gov/heronet/index.cfm/reference/download/re
Container Divisions. Hapeville. Georgia. Cincinnati. OH. National Institute for Occupational Safety
and Health.
ference id/3974906
Koketsu. M. (1978s). Celanese Fibers Company. Celriver Plant. Rock Hill. South Carolina. CDC.
https://hero.epa.gov/heronet/index.cfm/reference/download/re
Center for Occupational and Environmental Safety and Health.
ference id/3974907
NIOSH (2014s). Health hazard evaluation report no. HHE-2012-0176-3215. evaluation of exposure to
https://hero.epa.gov/heronet/index.cfm/reference/download/re
chemicals at a polymer additive manufacturing facility. Cincinnati. OH.
ference id/3974908
Sussell. A. L. and B. D. Lushniak (1990s). Health hazard evaluation report no. HETA 90-172-2076.
https://hero.epa.gov/heronet/index.cfm/reference/download/re
Bussman/Cooper Industries. MPH. Elizabethtowa Kentucky. Cincinnati. OH. National Institute for
Occupational Safety and Health.
ference id/3974938
NIOSH (2016s). "Methylene chloride. Part 2." from httos://www.cdc.gov/niosh/npg/npgd0414.html.
https://hero.epa.gov/heronet/index.cfm/reference/download/re
ference id/3978130
NIOSH (2014s). International chemical safety cards (ICDC): Dichloromethane. Atlanta. GA.
https://hero.epa.gov/heronet/index.cfm/reference/download/re
ference id/3978152
OSHA (2003s). Methylene chloride. Washington. DC. U.S. Department of Labor. Occupational Safety
https://hero.epa.gov/heronet/index.cfm/reference/download/re
and Health Administration.
ference id/3978265
OSHA (1998s). Small entity compliance guide fact sheets: Methylene chloride facts No. 7: Suggested
https://hero.epa.gov/heronet/index.cfm/reference/download/re
work practices for flexible polvurethane foam manufacturers. Washington. DC. U.S. Department of
Labor. Occupational Safety and Health Administration.
ference id/3978270
OSHA (1998s). Small entity compliance guide fact sheets: Methylene chloride facts No. 6: Suggested
https://hero.epa.gov/heronet/index.cfm/reference/download/re
engineering controls for flexible polvurethane foam manufacturers. Washington. DC. U.S.
Department of Labor. Occupational Safety and Health Administration.
ference id/3978273
OSHA (1998s). Small entity compliance guide fact sheets: Methylene chloride facts No. 10: Suggested
https://hero.epa.gov/heronet/index.cfm/reference/download/re
engineering controls for vapor degreasing operations. Washington. DC. U.S. Department of Labor.
Occupational Safety and Health Administration.
ference id/3978278
OSHA (2012s). Occupational safety and health standards: Toxic and hazardous substances: Methylene
https://hero.epa.gov/heronet/index.cfm/reference/download/re
chloride. Washington. DC. U.S. Department of Labor. Occupational Safety and Health
Administration.
ference id/3978279
OSHA (2010s). Regulatory review of 29 CFR 1910.1052: Methylene chloride. Washington. DC. U.S.
https://hero.epa.gov/heronet/index.cfm/reference/download/re
Department of Labor. Occupational Safety and Health Administration.
ference id/3978282
Page 110 of 148
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OSHA (1991). Final rules: Occupational exposure to methylene chloride. Washington. DC. U.S.
https://hero.epa.gov/heronet/index.cfm/reference/download/re
Department of Labor. Occupational Safety and Health Administration.
ference id/3978298
OSHA (1997). Occupational exposure to methylene chloride: Section 8 - VIII. Summary of the final
https://hero.epa.gov/heronet/index.cfm/reference/download/re
economic analysis. Washington. DC. U.S. Department of Labor. Occupational Safety and Health
Administration.
ference id/3978300
OSHA (1997). Occupational exposure to methylene chloride: Section 10 - X. Summary and
https://hero.epa.gov/heronet/index.cfm/reference/download/re
explanation of the final standard. Washington. DC. U.S. Department of Labor. Occupational Safety
and Health Administration.
ference id/3978301
OSHA (1998). Respiratory protection: Section 7 - VII. Summary and explanation. Washington. DC.
https://hero.epa.gov/heronet/index.cfm/reference/download/re
U.S. Department of Labor. Occupational Safety and Health Administration.
ference id/3978302
OSHA (2015). OSHA regional news brief - Region 1: Follow up OSHA inspections identify new and
https://hero.epa.gov/heronet/index.cfm/reference/download/re
recurring hazards for employees at New Hampshire sign manufacturer. Washington. DC. U.S.
Department of Labor. Occupational Safety and Health Administration.
ference id/3978306
OSHA (2013). Occupational safety and health standards: Toxic and hazardous substances: Substance
https://hero.epa.gov/heronet/index.cfm/reference/download/re
safety data sheet and technical guidelines for methylene chloride. Washington. DC. U.S. Department
of Labor. Occupational Safety and Health Administration.
ference id/3978324
European Chlorinated Solvents Association (ECSA) (2016). Guidance on storage and handling of
https://hero.epa.gov/heronet/index.cfm/reference/download/re
chlorinated solvents.
ference id/3982131
HSIA (2008). Chlorinated solvents - The kev to surface cleaning performance.
https://hero.epa.gov/heronet/index.cfm/reference/download/re
ference id/3982144
HESIS (2006). Methylene chloride: How to find out if vou are working with methylene chloride: Fact
https://hero.epa.gov/heronet/index.cfm/reference/download/re
sheet. Richmond. CA.
ference id/3982224
CalEPA (2005). Appendix D.3 Chronic RELS and toxicity summaries using the previous version of
https://hero.epa.gov/heronet/index.cfm/reference/download/re
Hot Spots Risk Assessment guidelines (OEHHA 1999). Sacramento. CA. Office of Environmental
Health Hazard Assessment.
ference id/3982628
DHHS (1992). In- Depth Survey Report: The Control of Methylene Chloride in Furniture Stripping at
https://hero.epa.gov/heronet/index.cfm/reference/download/re
The JM Murray Center. Inc. Atlanta. GA. CDC.
ference id/3986433
Page 111 of 148
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Appendix C SUPPORTING TABLE FOR INDUSTRIAL AND COMMERCIAL ACTIVITIES
AND USES CONCEPTUAL MODEL
TableApx C-l Industrial and Commercial Activities and Uses Conceptual Model Supporting Table
l.ik ( \ik-
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I'ApiiMir
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l';illl\\;i\
l!\|)iisuiv
Ron li s
Ri'ivpliir /
Population
Proposi-d
lor I'uiiIkt
Aiisil\sis
K;ilion;ik- 1'nr I'lii llu i' Aii;il\sis / mi I'lirllK-r Aiisil\sis
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29 CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Conlacl
] )ermal
ONIJ
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Manufacturing
Domestic
Manufacture
Domestic
Manufacture
Manufacture of
methylene chloride
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility (VP = 435 mmHg) at room
temperature, inhalation pathway will be further
analyzed.
Vapor
] )ennal
W orkers.
ONU
No
Based on OSIIA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures lor workers and ONU
Mist
])ennal/ln
halation
W orkers.
ONLJ
No
Mist generation not expected
Liquid
Contact
Dermal
Workers
Yes
Based on OSIIA standard (29C1R 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Manufacturing
Import
Import
Repackaging of
Import Containers
Liquid
Conlacl
I )ermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility (VP = 435 mmHg) at room
temperature, inhalation pathway will be further
analyzed.
Page 112 of 148
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l.ilV ( >i k-
Shim-
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l;.\|)iisur
i-
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l!\|)iisu iv
Ron li s
Ki'i'i'pliir /
Popii hit >il
PmpuM-d
1'nr l-'urlluT
All;il\sis
K;ilii>n;ik- 1'nr l-'urlluT Ansil\ sis / n<> I'unIkt Anal> sis
Vapor
I )ermal
W orkers.
ONI J
No
Based on OSIIA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
coneurrent inhalation exposures for workers and ONU
Mist
I )ermal/In
halation
W orkers.
ONI J
No
Mist generation not expected
Intermediate in
industrial gas
manufacturing
(e.g. manufacture
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
of fluorinated
gases used as
refrigerants);
Intermediate for
pesticide,
fertilizer, and
other agricultural
chemical
manufacturing;
CBI function for
petrochemical
manufacturing;
Intermediate for
other chemicals
Industrial gas
manufacturing;
Liquid
Contact
] )ermal
ONI J
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Processing
Processing
as a reactant
Agricultural
chemical
manufacturing;
Vapor
Inhalation
W orkers,
ONU
Yes
Due to high volatility (VP = 435 mml Ig) at room
temperature, inhalation pathway will be further
analyzed.
Petrochemical
manufacturing;
Chemical
manufacturing
Vapor
I )ermal
W orkers.
ONU
No
Based on OSI IA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures for workers and ()NI J
Mist
Dormul/In
halation
W orkers,
ONU
No
Mist generation not expected
Processing
Incorporated
into
formulation,
mixture, or
reaction
Solvents3;
Propellants and
blowing agents;
Paint additives
and coating
additives;
Laboratory
chemicals;
Processing aid,
Formulation of:
• chemical
mixtures;
• cleaning fluids;
• Paints and
Coatings;
Liquid
Contact
Dermal
Workers
Yes
Based on OSF1A standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
product
• laboratory
chemicals;
Liquid
Contact
I )ermal
0\T'
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
3 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; and Propellants and blowing agents for plastics product manufacturing; Paint additives and coating additives; Laboratory chemicals for all other chemical product and
preparation manufacturing; Processing aid, not otherwise listed for petrochemical manufacturing; Adhesive and sealant chemicals in adhesive manufacturing; Unknown function for oil and
gas drilling, extraction, and support
Page 113 of 148
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l.ilV ( >i k-
Shim-
(';ik-»or\
F.\|>IISIIIV
Si'iii;irin
l;.\|)iisur
i-
l';illl\\;i\
l!\|)iisu iv
Ron li s
Ki'i'i'pliir /
Popii hit >11
PmpuM-d
1'nr l-'urlluT
All;il\sis
K;ilii>n;ik- 1'nr l-'urlluT Aiiiil\sis / mi I'iiiiIkt An.iKsis
not otherwise
listed; Adhesive
and sealant
chemicals in
adhesive
manufacturing;
Unknown
function for oil
and gas drilling,
extraction, and
support activities
• petrochemical
products;
• adhesives;
• oil and gas
drilling and
extraction
products;
Use of blowing
agents in chemical
product
manufacturing and
plastics product
manufacturing;
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility (VP = 435 mmllg) at room
temperature, inhalation pathway will be further
analyzed.
Vapor
I )ermal
W orkers.
ONU
No
Based on OSIIA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures lor workers and ONU
Mist
Dermal/In
halation
W orkers.
ONU
No
Mist generation not expected
Processing
Repackaging
Solvents (which
become part of
product
formulation or
mixture) for all
other chemical
product and
preparation
manufacturing;
Laboratory
chemicals; CBI
functions for all
other chemical
product and
preparation
manufacturing;
Repackaging
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Contact
] )ermal
ONU
No
Dennal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
Workers.
ONU
Yes
Due to high volatility (VP = 435 mmHg) at room
temperature, inhalation pathway will be further
analv/ed.
Vapor
I )ermal
W orkers.
ONU
No
Based on OSI IA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dennal
exposures are expected to be much smaller than
concurrent inhalation exposures for workers and ONU
Mist
])ermal/In
halation
Workers,
ONU
No
Mist generation not expected
Processing
Recycling
Recycling
Process solvent
recycling
Liquid
Contact
Dermal
Workers
Yes
Based on OSILA. standard (29C1R 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Contact
I )ermal
ONU
No
Dennal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility (VP = 435 mmHg) at room
temperature, inhalation pathway will be further
analyzed.
Page 114 of 148
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l.ilc ( >ck-
Shim-
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F.\|>IISIIIV
Si'iii;irin
l;.\|)iisur
i-
l';illl\\;i\
l!\|)iisu iv
Ron li s
Ki'i'i'pliir /
Popii hit >11
PmpuM-d
1'nr l-'urlluT
All;il\sis
K;ilii>n;ik- 1'nr l-'urlluT Ansil\ sis / mi I'iii'IIkt An;il> sis
Vapor
I )ermal
W orkers.
ONI J
No
Based on OSIIA standard (29CTR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures lor workers and ONU
Mist
I )ermal/In
halation
W orkers.
ONI J
No
Mist generation not expected
Distribution in
commerce
Distribution
Distribution
Distribution of bulk
shipments of
methylene chloride;
Distribution of
formulated
products
Liquid
Contact,
Vapor
Dermal/
Inhalation
Workers,
ONU
No
Activities related to distribution (e.g., loading and
unloading) will be considered throughout the methylene
chloride life cycle, rather than using a single distribution
scenario.
Open top vapor
degreasing
(OTVD); OTVD
with enclosures;
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Batch vapor
degreaser (e.g.,
open-top, closed-
loop)
Airtight closed-
loop degreasing
system; Airless
vacuum drying
degreasing system;
Airless vacuum-to-
vacuum degreasing
system
Conveyorized
vapor degreasing;
Cross-rod and
ferris wheel vapor
degreasing; Web
vapor degreasing
Liquid
Contact
] )ermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Industrial,
commercial
Solvents (for
cleaning or
degreasing)
Vapor
Inhalation
W orkers,
ONU
Yes
Due to high volatility (VP = 435 mmHg) at room
temperature, inhalation pathway will be further
analv/ed.
and consumer
uses
In-line vapor
degreaser (e.g.,
conveyorized,
web cleaner)
Vapor
I )ermal
W orkers.
ONU
No
Based on OSI IA standard (29C1'R 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded, furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures for workers and ()NIJ
Mist
l)ermal/In
halation
W orkers.
ONU
No
Mist generation not expected
Industrial,
commercial
and consumer
uses
Solvents (for
cleaning or
degreasing)
Cold cleaner;
Spray use in cold
cleaning -
maintenance
(manual spray;
spray sink; dip
tank); Aerosol
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Aerosol spray
degreaser/ cleaner
Liquid
Contact
I )ermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
degreasing/
cleaning by
contractors
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility (VP = 435 mmHg) at room
temperature, inhalation pathway will be further
analyzed.
Page 115 of 148
-------
l.ilV ( >i k-
Shim-
(';ik-»or\
F.\|>IISIIIV
Si'iil;irin
l;.\|)iisur
i-
l';illl\\;i\
l!\|)iisu iv
Ron li s
Ki'i'i'pliir /
Popii hit >il
PmpuM-d
1'nr I 'ui iIk i'
All;il\sis
K;ilii>n;ik- 1'nr l-'urlluT Aiiiil\sis / mi Furl Ik-r An.iKsis
Vapor
I )ermal
W orkers.
ONI J
No
leased on OSIIA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures lor workers and ONU
Mist
Dermal/In
halation
Workers,
ONU
Yes
EPA will further analyze to determine whether mist
generation is applicable.
Industrial,
commercial
and consumer
uses
Adhesives
and sealants
Single component
glues and
adhesives and
sealants and
caulks
Manual non-spray
(paste/roller/brush)
application
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Contact
] )ermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
W orkers,
ONU
Yes
Due to high volatility (VP = 435 mml Ig) at room
temperature, inhalation pathway will be further
analyzed.
Vapor
I )ermal
W orkers.
ONU
No
Based on OSI IA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures for workers and ()NI J
Mist
l)ermal/In
halation
W orkers,
ONU
No
Mist generation not expected
Industrial,
commercial
and consumer
uses
Adhesives
and sealants
Single component
glues and
adhesives and
sealants and
caulks
Manual spray
application
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Contact
I )ermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
Workers.
ONU
Yes
Due to high volatility (VP = 435 mmHg) at room
temperature, inhalation pathway will be further
analv/ed.
Vapor
1 )ermal
W orkers.
ONU
No
Based on OSI IA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures for workers and ONU
Mist
Dermal/In
halation
Workers,
ONU
Yes
Public comments indicate aerosol spray application
occurs.
Page 116 of 148
-------
1 .i I V ( \i k-
Sla»i-
(';ik-»or\
F.\|>IISIIIV
Sii-iiariii
l;.\|)iisur
i-
l';illi\\;i\
l!\|)iisu iv
Ron li s
Ki'i'i'pliir /
Popii hit >il
PropuM-d
1'nr I'ui llu'i-
All;il\sis
Kalimiak- lor I'lirllu r Ansil\ sis / n<> I'iii'IIkt Anal> sis
Industrial,
commercial
and consumer
uses
Paints and
coalings
including
paint and
coaling
removers lor
furniture
stripping
Paints and
coatings removers
for furniture
stripping
Paint and coating
remover
application and
removal
Liquid
Contact
Vapor
Mist
Dermal
Inhalation
W orkers
ONIJ
No
LPA intends to finalize the methylene chloride
rulemaking addressing paint stripping uses of methylene
chloride, scenarios already assessed in the 2014 risk
assessment will not be re-evaluated and will rely on the
in the 2014 risk evaluation i ; " . •)
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Industrial,
commercial
and consumer
uses
Liquid
Contact
Dermal
ONIJ
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Paints and
coatings
Paints and
coatings use
Manual spray
application
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility (VP = 435 mmHg) at room
temperature, inhalation pathway will be further
analyzed.
Vapor
1 )ermal
W orkers.
ON'I'
No
Based on OS1IA standard (29CTR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded.
Mist
Dermal/In
halation
Workers,
ONU
Yes
EPA will further analyze to determine whether mist
generation is applicable.
Industrial,
commercial
Paints and
Paints and
Manual non-spray
(paste/roller/brush)
application
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
and consumer
uses
coatings
coatings use
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility (VP = 435 mmHg) at room
temperature, inhalation pathway will be further
analyzed.
Page 117 of 148
-------
l.ilV ( >i k-
Shim-
(';ik-»or\
F.\|>IISIIIV
Si'iii;irin
l;.\|)iisur
i-
l';illl\\;i\
l!\|)iisu iv
Ron li s
Ki'i'i'pliir /
Popii hit >11
Pnipusi-d
liir FiiiiIkt
All;il\sis
K;ilii>n;ik- 1'nr l-'urlluT Ansil\ sis / n<> I'iii'IIkt An;il> sis
Vapor
Dermal
Workers.
ONI J
No
Based on OS11A standard (29CTR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures lor workers and ()NI J
Misl
Dormal/In
halation
W orkers.
ONI J
No
Mist generation not expected
Industrial,
commercial
and consumer
uses
Adhesives
and sealants
including
adhesives
and sealants
removers
Adhesive/caulk
removers
Adhesive/caulk
removal by
contractors
Liquid
Contact
Dermal
Workers
Yes
Based on OSILA standard (29C1R 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Contact
Dermal
ONI J
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility (VP = 435 mmllg) at room
temperature, inhalation pathway will be further
analyzed.
Vapor
I )ermal
W orkers.
ONU
No
Based on OSIIA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures lor workers and ONU
Mist
Dermal/In
halation
Workers,
ONU
Yes
EPA will further analyze to determine whether mist
generation is applicable.
Industrial,
commercial
and consumer
uses
Metal
products not
covered
elsewhere
Degreasers -
aerosol and non-
aerosol degreasers
and cleaners e.g.,
coil cleaners
Spray use in cold
cleaning -
maintenance
(manual spray;
spray sink)
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Contact
] )ermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
W orkers.
ONU
Yes
Due to high volatility (VP = 435 mml Ig) at room
temperature, inhalation pathway will be further
analyzed.
Vapor
I )ermal
W orkers,
ONU
No
Based on OSI IA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures for workers and ()NI J
Page 118 of 148
-------
l.ilV ( >i k-
Shim-
(';ik-»or\
F.\|>IISIIIV
Si'iii;irin
l;.\|)iisur
i-
l!\|)iisu iv
Ron li s
Ki'i'i'pliir /
Popii hit >11
PmpuM-d
1'nr l-'urlluT
All;il\sis
K;ilii>n;ik- 1'nr l-'urlluT Ansil\ sis / mi I'iii'IIkt An;il> sis
Mist
Dermal/In
halation
Workers,
ONU
Yes
EPA will further analyze to determine whether mist
generation is applicable.
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Degreasers -
aerosol and non-
aerosol degreasers
and cleaners e.g.,
coil cleaners
Liquid
Contact
] )ermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Industrial,
commercial
and consumer
Metal
products not
covered
Dip tank use in
cold cleaning -
manufacturing (dip
Vapor
Inhalation
W orkers.
ONU
Yes
Due to high volatility (VP = 435 mmHg) at room
temperature, inhalation pathway will be further
analyzed.
uses
elsewhere
tank)
Vapor
I )ermal
W orkers.
ONU
No
1 Sased on ()SI IA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures for workers and ONI J
Mist
l)ermal/In
halation
W orkers.
ONU
No
Mist generation not expected
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Fabric,
Textile finishing
and impregnating/
surface treatment
products e.g.
water repellant
Liquid
Contact
I )ermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Industrial,
commercial
and consumer
textile and
leather
products not
Fabric finishing
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility (VP = 435 mmHg) at room
temperature, inhalation pathway will be further
analyzed.
uses
covered
elsewhere
Vapor
I )ermal
W orkers.
ONU
No
Based oil OSI IA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures for workers and ONI J
Mist
Dermal/In
halation
Workers,
ONU
Yes
EPA will further analyze to determine whether mist
generation is applicable.
Industrial,
commercial
and consumer
uses
Automotive
care
products
Functional fluids
for air
conditioners:
refrigerant,
Charging air
conditioners during
automotive original
equipment
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Page 119 of 148
-------
l.ilV ( >i k-
Shim-
(';ik-»or\
F.\|>IISIIIV
Si'iii;irin
l;.\|)iisur
i-
l';illl\\;i\
l!\|)iisu iv
Ron li s
Ki'i'i'pliir /
Popii hit >11
PmpuM-d
1'nr l-'urlluT
All;il\sis
K;ilii>n;ik- 1'nr l-'urlluT Ansil\ sis / n<> I'iii'IIkt An;il> sis
treatment, leak
sealer; Interior car
care - spot
remover;
Degreasers:
gasket remover,
transmission
cleaners,
carburetor
cleaner, brake
quieter/cleaner;
Degreasers:
gasket remover,
transmission
cleaners,
carburetor
cleaner, brake
quieter/cleaner
manufacture;
Servicing
automotive air
conditioners
(refrigerant, leak
sealer);
Commercial
interior car care;
Commercial
automotive
servicing;
Commercial brake
servicing
Liquid
Contact
I )ermal
ONI J
No
Dennal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility (VP = 435 mmHg) at room
temperature, inhalation pathway will be further
analyzed.
Vapor
I )ermal
W orkers.
ONU
No
Based 011 OSIIA standard (29CTR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded, furthermore, vapor dermal
exposures are expected to be much smaller than
coneurrent inhalation exposures for workers and ONU
Mist
Dermal/In
halation
Workers,
ONU
Yes
Automotive Care Products are generally used in aerosol
form.
Industrial,
commercial
and consumer
uses
Apparel and
footwear
care
products
Post-market
waxes and
polishes applied
to footwear e.g.
shoe polish
Commercial shoe
care
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Contact
] )ermal
ONU
No
Dennal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
W orkers.
ONU
Yes
Due to high volatility (VP = 435 mmHg) at room
temperature, inhalation pathway will be further
analv/ed.
Vapor
I )ermal
W orkers,
ONU
No
Based on OSI IA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded.
Mist
Dermal/In
halation
Workers,
ONU
Yes
EPA will further analyze to determine whether mist
generation is applicable.
Industrial,
commercial
and consumer
uses
Laundry and
dishwashing
products
Spot remover for
apparel and
textiles
Spot cleaning at
commercial dry
cleaners
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Contact
I )ermal
n\'T'
No
Dennal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility (VP = 435 111mlIg) at room
temperature, inhalation pathway will be further
analyzed.
Page 120 of 148
-------
l.ilV ( >i k-
Shim-
(ak-»IISIIIV
Sii-iiariii
l;.\|)iisur
i-
l!\|)iisu iv
Ron li s
Ki'i'i'pliir /
Popii hit >11
PmpuM-d
1'nr I 'ui iIk i'
All;il\sis
Kalimiak- 1'nr l-'urlluT Aiiiil\sis / mi I'iiiiIkt Analysis
Vapor
I )ermal
W orkers.
ONI J
No
Based on OSIIA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures lor workers and ONU
Mist
Dermal/In
halation
Workers,
ONU
Yes
EPA will further analyze to determine whether mist
generation is applicable.
Industrial,
commercial
and consumer
uses
Lubricants
and greases
Liquid and spray
lubricants and
greases;
Degreasers -
aerosol and non-
aerosol degreasers
and cleaners
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Contact
] )ermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
W orkers,
ONU
Yes
Due to high volatility (VP = 435 mml Ig) at room
temperature, inhalation pathway will be further
analyzed.
Vapor
I )ermal
Workers.
ONU
No
Based on OSI IA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded.
Mist
Dermal/In
halation
Workers,
ONU
Yes
EPA will further analyze to determine whether mist
generation is applicable.
Industrial,
commercial
and consumer
uses
Building/
construction
materials not
covered
elsewhere
Cold pipe
insulation
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Contact
I )ermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility (VP = 435 mmHg) at room
temperature, inhalation pathway will be further
analyzed.
Vapor
I )ermal
W orkers.
ONU
No
Based on OSI IA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures for workers and ONU
Mist
Dermal/In
halation
Workers,
ONU
Yes
EPA will further analyze to determine whether mist
generation is applicable.
Page 121 of 148
-------
l.ilV ( >i k-
Shim-
(ak-»IISIIIV
Sii-iiariii
l;.\|)iisur
i-
l';illl\\;i\
l!\|)iisu iv
Ron li s
Ki'i'i'pliir /
Popii hit >11
PmpuM-d
1'nr l-'urlluT
All;il\sis
Kalimiak- 1'nr l-'urlluT Ansil\ sis / mi I'iii'IIkt An;il> sis
Industrial,
commercial
and consumer
uses
Solvents
(which
become part
of product
formulation
or mixture)
All other
chemical product
and preparation
manufacturing
Unspecified
chemical product
manufacturing
Liquid
Contact
Dermal
Workers
Yes
Based 011OSILA standard (29C1R 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Contact
] )ermal
ONI J
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility (VP = 435 mnillg) at room
temperature, inhalation pathway will be further
analyzed.
Vapor
I )ermal
W orkers.
ONU
No
Based 011 OSIIA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
coneurrent inhalation exposures for workers and ONU
Mist
l)ermal/In
halation
Workers.
ONU
No
Mist generation not expected
Industrial,
commercial
and consumer
uses
Processing
aid not
otherwise
listed
In multiple
manufacturing
sectors
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Contact
] )ermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
W orkers,
ONU
Yes
Due to high volatility (VP = 435 111ml Ig) at room
temperature, inhalation pathway will be further
analyzed.
Vapor
I )ermal
W orkers.
ONU
No
Based on OSI IA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures for workers and ()NU
Mist
l)ermal/In
halation
W orkers,
ONU
No
Mist generation not expected
Industrial,
commercial
and consumer
uses
Propellants
and blowing
agents
Flexible
polyurethane
foam
manufacturing
Polyurethane foam
blowing
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Page 122 of 148
-------
l.ilV ( >i k-
Shim-
(';ik-»or\
F.\|>IISIIIV
Si'iii;irin
l;.\|)iisur
i-
l';illl\\;i\
l!\|)iisu iv
Ron li s
Ki'i'i'pliir /
Popii hit >11
PnipiiM-d
1'nr l-'urlluT
All;il\sis
Kalimiuk- 1'nr l-'urlluT Ansil\ sis / mi I'unIkt Anal> sis
Vapor
Inhalation
Workers,
ONU
Yes
Dlic to high volatility (VP = 435 111mlIg) at room
temperature, inhalation pathway will be further
analyzed.
Vapor
I )ermal
W orkers.
ONU
No
Based 011 OSIIA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures for workers and ONU
Mist
])ermal/In
halation
W orkers.
ONU
No
Mist generation not expected
Industrial,
commercial
and consumer
uses
Other Uses
Other non-aerosol
uses, e.g.
Laboratory
chemicals - all
other chemical
product and
preparation
manufacturing;
Electrical
equipment,
appliance, and
component
manufacturing;
Plastic and rubber
products; Oil and
gas drilling,
extraction, and
support activities;
Functional fluids
(closed systems)
in pharmaceutical
and medicine
manufacturing;
Carbon remover,
lithographic
printing cleaner,
wood floor
cleaner, brush
cleaner
Laboratory use;
Electrical
equipment,
appliance, and
component
manufacturing;
Plastic product
manufacturing
(compounding and
converting); Use in
oil and gas drilling,
extraction, and
support activities;
Pharmaceutical
product
manufacturing; Use
as carbon remover,
lithographic
printing cleaner,
wood floor cleaner,
brush cleaner
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Contact
I )ermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility (VP = 435 mmHg) at room
temperature, inhalation pathway will be further
analyzed.
Vapor
I )ermal
W orkers.
ONU
No
Based 011 OSI 1A standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures for workers and ()NU
Mist
l)ermul/In
halation
W orkers,
o\r
No
Mist generation not expected
Page 123 of 148
-------
l.ilV ( >i k-
Shim-
(';ik-»or\
F.\|>IISIIIV
Si'iii;irin
l;.\|)iisur
i-
l';illl\\;i\
l!\|)iisu iv
Ron li s
Ki'i'i'pliir /
Popii hit >11
PmpuM-d
liir I'ui'IIk i'
All;il\sis
K;ilii>n;ik- 1'nr l-'urlluT Ansil\ sis / mi I'iii'IIkt An;il> sis
Liquid
Contact
Dermal
Workers
Yes
Based 011OSILA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Other aerosol
uses, e.g. Anti-
adhesive agent -
anti-spatter
welding aerosol
Liquid
Contact
] )ermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Industrial,
commercial
and consumer
Other Uses
Use as anti-
adhesive agent -
anti-spatter welding
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility (VP = 435 mmllg) at room
temperature, inhalation pathway will be further
analyzed.
uses
aerosol
Vapor
I )ermal
W orkers.
ONU
No
Based 011 OSIIA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures lor workers and ONU
Mist
Dermal/In
halation
Workers,
ONU
Yes
EPA will further analyze to determine whether mist
generation is applicable.
Liquid
Contact
Dermal
Workers
Yes
Based on OSHA standard (29CFR 1910.1052) workers
are required to be protected however occluded
exposures may significantly contribute to total
exposure. Occluded exposures will be further analyzed.
Liquid
Contact
] )ermal
ONU
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
Disposal
Waste
Handling,
Treatment
Disposal of
methylene
chloride wastes
Worker handling of
wastes
Vapor
Inhalation
W orkers,
ONU
Yes
Due to high volatility (VP = 435 111ml Ig) at room
temperature, inhalation pathway will be further
analyzed.
and Disposal
Vapor
I )ermal
W orkers.
ONU
No
Based on OSI IA standard (29CFR 1910.1052) workers
are required to be protected and exposure to vapors are
not expected to be occluded. Furthermore, vapor dermal
exposures are expected to be much smaller than
concurrent inhalation exposures for workers and ONU
Mist
l)ermal/In
halation
W orkers,
ONU
No
Mist generation not expected
Page 124 of 148
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Appendix D SUPPORTING TABLE FOR CONSUMER ACTIVITIES AND USES
CONCEPTUAL MODEL
TableApx D-l Consumer Activities and Uses Conceptual Model Supporting Table
K;iliiill;ili- In I'
C;ili'»iir\
Sul>i;ik'»iir\
l"n rm
I!\|)iisuiv
l';illl\\;i\ /
r.\i>HMiiv
S (.111:1 liii
l'A|>HMIIV
Kiuik-s
ki-ivpiiir /
I'lipilhlliiill
Pnipiisi-d fur
I'll rllu-r
I'll li Ik-r
Aii;il\ sis /1111
\k'ili;i
An
-------
K;iliiill;ili- In I'
C;ili'»iir\
Sul>i;ik'»iir\
l"n rm
I!\|)iisuiv
l';illl\\;i\ /
r.\i>HMiiv
S (.111:1 liii
l'A|>HMIIV
Kiuik-s
ki-ivpiiir /
I'lipilhlliiill
Pnipusi-d I'm-
I'll rllu-r
I'll li Ik-r
Aii;il\ sis /1111
\li'ili;i
An
-------
k;iliun;ik' fur
C;ili'»iir\
Sul>i;ik'»iir\
l"n rm
I!\|)iisuiv
l';illl\\;i\ /
l'A|)HMIIV
Si'i'ii;irii>
l'A|>HMIIV
Knilk-s
ki-ivpiiir /
Piipuhiiiiin
Pnipusi-d I'm-
I'll rllu-r
I'll li Ik-r
Aii;il\ sis / mi
\li'ili;i
An
-------
K;iliiui;ili- fur
C;iU-»iir\
Sul>i;ik-»nr\
l"n rm
I!\|)iisuiv
l';illl\\;i\ /
I'A|>IISIIIV
Sii'iiiiriii
I'A|>IISIIIV
Knilk-s
ki-ivpiiir /
Piipuhiiiiin
Pnipiisi-d fur
I'll rlliiT
I'll rl Ik-r
Aii;il\ sis / nil
\k'ili;i
An
-------
C;ili'»iir\
Sul>i;ik'»iir\
l"n rm
I!\|)iisuiv
l';illl\\;i\ /
Mi-di;i
r.\i>HMiiv
S (.111:1 liii
l'A|>HMIIV
Kiuik-s
Ki-ivpliir /
I'lipilhlliiill
Pnipusi-d I'm-
I'll i'IIut
An
-------
C;ili'»iir\
Sul>i;ik'»iir\
l"n rm
I!\|)iisuiv
I'.ilhw ;i\ /
Mi-di;i
I'A|>IISIIIV
Si'i'ii;irii>
l'A|>HMIIV
Kiillk-s
ki-ivpiiir /
Piipuhiiiiin
Pnipiisi-d I'm-
I'll i'IIut
An
No
None of the uses
are lor consumers
Automotive
care products
Function fluids
for air
conditioners:
refrigerant,
Aerosol
Liquid Contact
Dermal contact
with liquid
product on skin
Dermal
Consumer
Yes
Based on
conditions of use,
consumers may
have direct
dermal contact
with methylene
Page 130 of 148
-------
C;ili'»iir\
Sul>i;ik'»iir\
l"n rm
I!\|)iisuiv
l';illl\\;i\ /
Mi-di;i
l'l\|)IISUIV
Sii'iiiiriii
l'A|>HMIIV
Kiillk-s
ki-ivpiiir /
Piipuhiiiiin
Pnipusi-d I'm-
I'll rllu-r
An
-------
C;iU-»iir\
Sul>i;ik-»nr\
l"n rm
I!\|)iisuiv
l>;illl\\;i\ /
\k'ili;i
I'A|)IISIIIV
S (.111:1 liii
I'A|>IISIIIV
Kmik-s
ki-ivpiiir /
I'lipilhlliiill
Pnipusi-d I'm-
I'll illur
An
-------
K;iliiill;ili- In I'
C;ili'»iir\
Sul>i;ik'»iir\
l"n rm
I!\|)iisuiv
l';illl\\;i\ /
r.\i>HMiiv
S (.111:1 liii
l'A|>HMIIV
Kiuik-s
ki-ivpiiir /
I'lipilhlliiill
Pnipusi-d I'm-
I'll illur
I'll li Ik-r
Aii;il\ sis /1111
\li'ili;i
An
-------
K;iliiui;ili- fur
C;iU-»iir\
Sul>i;ik-»nr\
l"n rm
I!\|)iisuiv
l';illl\\;i\ /
I'A|)IISIIIV
Sii'iiiiriii
I'A|>IISIIIV
Knilk-s
ki-ivpiiir /
Piipuhiiiiin
Pnipiisi-d fur
I'll illur
I'll rl Ik-r
Aii;il\ sis / nil
\k'ili;i
An
-------
K;iliiui;ili- liir
C;iU-»iir\
Sul>i;ik-»nr\
l"n rm
I!\|)iisuiv
l';illl\\;i\ /
I'A|>IISIIIV
Sii'iiiiriii
I'A|>IISIIIV
Knilk-s
ki-ivpiiir /
Piipuhiiiiin
Pnipiisi-d fur
I'll rlliiT
I'll rl Ik-r
Aii;il\ sis / nil
\k-ili;i
An
-------
C;iU-»iir\
Sul>i;ik-»nr\
l"n rm
I!\|)iisiiiv
I'.ilhw ;i\ /
\k'ili;i
I'A|)IISIIIV
S (.111:1 liii
I'A|>IISIIIV
Kmik-s
ki-ivpiiir /
Piipilhlliiill
Pnipiisi-d fur
I'll illur
An slander
Evaporation
from the
surface
Inhalation
Consumer
Yes
Due to high
volatility (VP =
435 mmHg) at
room
temperature,
inhalation
pathway will be
further analv/.ed.
Bystander
\pparel and
I\ki|wc;ii( are
hoducls
TeMlle
1 iv;iliiicnl
\o
None ol" the listed
products are
consumer
products
Laundry and
Dishuashiim
I'mdiicls
\o
None of the listed
products are
consumer
products
Liihricaiils ;nid
(i reuses
l.iihi'icaiil
\emsnl nr
Liquid
\ll
None of the listed
products are
Page 136 of 148
-------
k;iliun;ik' fur
C;ili'»iir\
Sul>i;ik'»iir\
l"n rm
I!\|)iisuiv
l';illl\\;i\ /
r.\i>HMiiv
S (.111:1 liii
l'A|>HMIIV
Kiuik-s
ki-ivpiiir /
I'lipilhlliiill
Pnipusi-d I'm-
I'll i'IIut
I'll li Ik-r
Aii;il\ sis /1111
\li'ili;i
An
-------
C;ili'»iir\
Sul>i;ik'»iir\
l"n rm
I!\|)iisuiv
l';illl\\;i\ /
Mi-di;i
l'.\|)IISUIV
S (.111:1 liii
l'A|>HMIIV
Kiuik-s
ki-ivpiiir /
I'lipilhlliiill
Pnipusi-d I'm-
I'll i'IIut
An
-------
C;ili'»iir\
Sul>i;ik'»iir\
l"n rm
I!\|)iisuiv
l';illl\\;i\ /
Mi-di;i
l'A|)HMIIV
Si'i'ii;irii>
l'A|>HMIIV
Kiillk-s
ki-ivpiiir /
Piipuhiiiiin
Pnipiisi-d fur
I'll rllu-r
An cle
Siaue
I se
( aleuors
(alcuor\
Release
1 Aposlll'C
Ralhwas
Receptor
I 'm it her
\nal> sis''
Rationale lor I'lirllier \ii;il\ sis iri 1'iiriher \n;il\sis
Disposal
Disposal
Wastewater
or Liquid
Wastes
Industrial WWT
operations
Water,
Sediment
Aquatic
Species
Yes
Aquatic species may be exposed to MC in water and sediment pore water
at hazardous concentrations.
1 erresirial
Species
\o
1 erresirial species exposures lo M(' in waler are orders of mamiiliide
helow ha/ardoiis coiieeiiiralions
Industrial
wastewater pre
treatment
operations, then
transfer to POTW
Water,
Sediment
Aquatic
Species
Yes
EPI Suite STP model estimates 43% of MC in wastewater will not be
removed during treatment and will be present in the WWTP effluent. The
Henry's Law constant of MC (3.25E-3 atm-m3/mol) indicates that MC
will volatilize from water. Aquatic species may be exposed to MC in
water and sediment pore water at hazardous concentrations.
1 erresirial
Species
\o
1 erresirial species exposures lo \1C in waler are orders of mauiiiliide
helow hazardous coiieeiiiralions
Publicly owned
treatment works
(POTW)
Water,
Sediment
Aquatic
Species
Yes
EPI Suite STP model estimates 43% of MC in wastewater will not be
removed during treatment and will be present in the WWTP effluent.
Aquatic species may be exposed to MC in water and sediment pore water
at hazardous concentrations.
Page 139 of 148
-------
Life
( > ele
Si;me
I se
( ;ileuor\
(;ileuor\
kele;ise
1 \posure
P;illi\\ ;i>
keeepior
\u;il\ sis''
k;iliou;ile for I'urlher \u;il\sis no
"urilier -\n;il\ sis
1 ei'iesiii;il
\o
Terresiml speeies exposures in \l(
in \x;iler ;ire orders of iii;muiiude
Speeies
IvIom h;i/;irdous eoiieeiiimiious.
Mmnilioii
IJiosolids ;iik.| |;nid
from
hiosollds
\ i;i soil
deposllloll
1 eiresiiuil
\o
1 "erresiri;i 1 speeies exposures io \l(
in wilier ;ire orders of ui;imiiiude
disposal U) soil
Speeies
IvIom h;i/;irdous eoiieeiiir;ilious
Page 140 of 148
-------
Appendix F INCLUSION AND EXCLUSION CRITERIA FOR FULL
TEXT SCREENING
Appendix F contains the eligibility criteria for various data streams informing the TSCA risk evaluation:
environmental fate; engineering and occupational exposure; exposure to consumers; and human health
hazard. The criteria are applied to the on-topic references that were identified following title and abstract
screening of the comprehensive search results published on June 22, 2017.
Systematic reviews typically describe the study eligibility criteria in the form of PECO statements or a
modified framework. PECO stands for Population, Exposure, Comparator and Outcome and the approach is
used to formulate explicit and detailed criteria about those characteristics in the publication that should be
present in order to be eligible for inclusion in the review. EPA/OPPT adopted the PECO approach to guide
the inclusion/exclusion decisions during full text screening.
Inclusion and exclusion criteria were also used during the title and abstract screening, and documentation
about the criteria can be found in the Strategy for Conducting Literature Searches document published in
June 2017 along with each of the TSCA Scope documents. The list of on-topic references resulting from the
title and abstract screening is undergoing full text screening using the criteria in the PECO statements. The
overall objective of the screening process is to select the most relevant evidence for the TSCA risk
evaluation. As a general rule, EPA is excluding non-English data/information sources and will translate on
a case by case basis.
The inclusion and exclusion criteria for ecotoxicological data have been documented in the ECOTOX
SOPs. The criteria can be found at https://cfpub.epa.gov/ecotox/help.cfm?helptabs=tab4) and in the
Strategy for Conducting Literature Searches document published along with each of the TSCA Scope
documents.
F.l Inclusion Criteria for Data Sources Reporting Environmental Fate
Data
EPA/OPPT developed a generic PESO statement to guide the full text screening of environmental fate data
sources. PESO stands for Pathways and Processes, Exposure, Setting or Scenario, and Outcomes.
Subsequent versions of the PESO statement may be produced throughout the process of screening and
evaluating data for the chemicals undergoing TSCA risk evaluation. Studies that comply with the inclusion
criteria in the PESO statement are eligible for inclusion, considered for evaluation, and possibly included in
the environmental fate assessment. On the other hand, data sources are excluded if they do not meet the
criteria in the PESO statement.
Assessors seek information on various chemical-specific fate endpoints and associated fate processes,
environmental media and exposure pathways as part of the process of developing the environmental fate
assessment (TableApx F-2). Those that will be the focus of the environmental fate assessment for
methylene chloride have been indicated in Table Apx F-2. The PESO statement and information in
TableApx F-l will be used when screening the fate data sources to ensure complete coverage of the
processes, pathways and data relevant to the fate of the chemical substance of interest.
Page 141 of 148
-------
TsihleApx l -l. Inclusion (rhcrin lor l):il:i Sources Reporting Knvironnienlsil I'sile l);il;i
PI. SO
Klenienl
r.vidcncc
Pathways
and
Processes
• Environmental fate, transport, partitioning and degradation behavior across
environmental media to inform exposure pathways of the chemical
substance of interest
• Media of interest may include:
- Surface water
Please refer to the conceptual models for more information about the
exposure pathways included in the TSCA risk evaluation.
Exposure
• Environmental exposure of ecological receptors (i.e., aquatic organisms) to
the chemical substance of interest and/or its degradation products and
metabolites
Please refer to the conceptual models for more information about the ecological
and human receptors included in the TSCA risk evaluation.
Setting or
Scenario
Any setting or scenario resulting in releases of the chemical substance of
interest into the natural or built environment (e.g., wastewater treatment
facilities) that would expose ecological receptors (i.e., aquatic organisms)
Outcomes
• Fate properties which allow assessments of exposure pathways:
o Abiotic and biotic degradation rates, mechanisms, pathways, and
products
o Bioaccumulation magnitude and metabolism rates
o Partitioning within and between environmental media (see
Pathways and Processes)
Page 142 of 148
-------
Table Apx 1-2. l-'ale V. ml points and Associated Processes. Media and Kxposure Pathways
Considered in (lie Development of Hie Knvironnienlsil Kate Assessment
Fate Data Endpoint
Associated Process(es)
Associated Media/Exposure
Pathways
Surface water, Sediment
Abiotic reduction rates or half-lives
Abiotic reduction, Abiotic
dehalogenation
X
Aerobic biodegradation rates or half-
lives
Aerobic biodegradation
X
Anaerobic biodegradation rates or
half-lives
Anaerobic biodegradation
X
Aqueous photolysis (direct and
indirect) rates or half-lives
Aqueous photolysis (direct and
indirect)
X
Bioconcentration factor (BCF),
Bioaccumulation factor (BAF)
B i oconcentrati on,
Bioaccumulation
X
Hydrolysis rates or half-lives
Hydrolysis
X
Kaw, Henry's Law constant, and
other volatilization information
Volatilization
X
Koc and other sorption information
Sorption, Mobility
X
Abiotic transformation products
Hydrolysis, Photolysis
X
Aerobic biotransformation products
Aerobic biodegradation
X
Anaerobic biotransformation
products
Anaerobic biodegradation
X
Biomagnification and related
information
Trophic magnification
X
Desorption information
Sorption, Mobility
X
Wastewater treatment removal
information
Wastewater treatment
X
Page 143 of 148
-------
F.2 Inclusion Criteria for Data Sources Reporting Release and
Occupational Exposure Data
EPA/OPPT developed a generic RESO statement to guide the full text screening of release and
occupational exposure literature (TableApx F-3). RESO stands for Receptors, Exposure, Setting or
Scenario, and Outcomes. Subsequent versions of the RESO statement may be produced throughout the
process of screening and evaluating data for the chemicals undergoing TSCA risk evaluation. Studies
that comply with the inclusion criteria specified in the RESO statement will be eligible for inclusion,
considered for evaluation, and possibly included in the environmental release and occupational exposure
assessments, while those that do not meet these criteria will be excluded.
The RESO statement should be used along with the engineering and occupational exposure data needs
table (Table Apx F-4) when screening the literature.
Table Apx I -
Occupul iomil
KI-'.SO lilcmenl
3. Inclusion Criteria lor Data Sources Reporting Knginccring ami
Kxposurc Data
l.\ idcncc
Receptors
• Humans:
Workers, including occupational non-users
• Environment:
Aquatic ecological receptors (relevant release estimates input to Exposure)
Please refer to the conceptual models for more information about the ecological and human
receptors included in the TSCA risk evaluation.
Exposure
• Worker exposure to and relevant occupational environmental releases of the chemical
substance of interest
o Dermal and inhalation exposure routes (as indicated in the conceptual model)
o Surface water (as indicated in the conceptual model)
Please refer to the conceptual models for more information about the routes and media/pathways
included in the TSCA risk evaluation.
Setting or
Scenario
• Any occupational setting or scenario resulting in worker exposure and relevant environmental
releases (includes all manufacturing, processing, use, disposal indicated in Table Apx F-4
below.
Outcomes
• Quantitative estimates* of worker exposures and of relevant environmental releases from
occupational settings
• General information and data related and relevant to the occupational estimates*
* Metrics (e.g., mg/kg/day or mg/m3 for worker exposures, kg/site/day for releases) are determined
by toxicologists for worker exposures and by exposure assessors for releases; also, the
Engineering, Release and Occupational Exposure Data Needs (Table Apx F-4) provides a list of
related and relevant general information.
Page 144 of 148
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TsihleApx l-"-4.
Kiivironiiicnlsil
K11 «ineeriii«. Kiivironnicnlsil Uelesise mid Occnp:ilionnl Necessary 1» Develop (lie
Kelcsise and Occupational Kxposure Assessments
Ohjiiiitc
Dckriiiincd
during Scoping
l \|)o ol' l);il:i
1. Description of the life cycle of the chemical(s) of interest, from manufacture to end-of-life (e.g., each
manufacturing, processing, or use step), and material flow between the industrial and commercial life cycle
stages. {Tags: Life cycle description, Life cycle diagram}3
2. The total annual U.S. volume (lb/yr or kg/yr) of the chemical(s) of interest manufactured, imported,
processed, and used; and the share of total annual manufacturing and import volume that is processed or
used in each life cycle step. {Tags: Production volume (PV), Import volume, Use volume, Percent PV}a
3. Description of processes, equipment, unit operations, and material flows and frequencies (lb/site-day or
kg/site-day and days/yr; lb/site-batch and batches/yr) of the chemical(s) of interest during each industrial/
commercial life cycle step. Note: if available, include weight fractions of the chemicals (s) of interest and
material flows of all associated primary chemicals (especially water). {Tags: Process description, Process
material flow rate, Annual operating days, Annual batches, Weight fractions (for each of above,
manufacture, import, processing, use)}a
4. Basic chemical properties relevant for assessing exposures and releases, e.g., molecular weight, normal
boiling point, melting point, physical forms, and room temperature vapor pressure. {Tags: Molecular
weight, Boiling point, Melting point, Physical form, Vapor pressure, Water solubility}a
5. Number of sites that manufacture, process, or use the chemical(s) of interest for each industrial/
commercial life cycle step and site locations. {Tags: Numbers of sites (manufacture, import, processing,
use), Site locations}a
General
Engineering
Assessment (may
apply for either
or both
Occupational
Exposures and /
or Environmental
Releases)
Occupational
Exposures
6.
7.
9.
Description of worker activities with exposure potential during the manufacture, processing, or use of the
chemical(s) of interest in each industrial/commercial life cycle stage. {Tags: Worker activities
(manufacture, import, processing, use)}a
Potential routes of exposure (e.g., inhalation, dermal). {Tags: Routes of exposure (manufacture, import,
processing, use)}a
Physical form of the chemical(s) of interest for each exposure route (e.g., liquid, vapor, mist) and activity.
{Tags: Physical form during worker activities (manufacture, import, processing, use)}a
Breathing zone (personal sample) measurements of occupational exposures to the chemical(s) of interest,
measured as time-weighted averages (TWAs), short-term exposures, or peak exposures in each
occupational life cycle stage (or in a workplace scenario similar to an occupational life cycle stage). {Tags:
Personal Breathing Zone (PBZ) measurements (manufacture, import, processing, use)}a
10. Area or stationary measurements of airborne concentrations of the chemical(s) of interest in each
occupational setting and life cycle stage (or in a workplace scenario similar to the life cycle stage of
interest). {Tags: Area measurements (manufacture, import, processing, use)}a
11. For solids, bulk and dust particle size characterization data. {Tags: Particle Size Distribution (PSD)
measurements (manufacture, import, processing, use)}a
12. Dermal exposure data. {Tags: Dermal measurements (manufacture, import, processing, use)}
13. Data needs associated with mathematical modeling (will be determined on a case-by-case basis). {Tags:
Worker exposure modeling data needs (manufacture, import, processing, use)}a
14. Exposure duration (hr/day). {Tags: Worker exposure durations (manufacture, import, processing, use)}a
15. Exposure frequency (days/yr). {Tags: Worker exposure frequencies (manufacture, import, processing,
use)}a
16. Number of workers who potentially handle or have exposure to the chemical(s) of interest in each
occupational life cycle stage. {Tags: Numbers of workers exposed (manufacture, import, processing, use)}
a
17. Personal protective equipment (PPE) types employed by the industries within scope. {Tags: Worker PPE
(manufacture, import, processing, use)}a
18. Engineering controls employed to reduce occupational exposures in each occupational life cycle stage (or
in a workplace scenario similar to the life cycle stage of interest), and associated data or estimates of
exposure reductions. {Tags: Engineering controls (manufacture, import, processing, use), Engineering
control effectiveness data}a
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Tsihle Apx 1-4. Kngincering. Kiivironnicnlsil Uclcsise mid Occnp:ilionnl Necessary lo Develop (lie
Knvironiiienlsil Uelcsise and Occupational Kxposure Assessments
Ol>.joc(i\e
Dclcrmineri
during Scoping
Tjpe or l);il:i
Environmental
Releases (to
relevant
environmental
media)
19. Description of sources of potential environmental releases, including cleaning of residues from process
equipment and transport containers, involved during the manufacture, processing, or use of the
chemical(s) of interest in each life cycle stage. {Tags: Release sources (manufacture, import, processing,
use)}a
20. Estimated mass (lb or kg) of the chemical(s) of interest released from industrial and commercial sites to
each environmental medium (water) and treatment and disposal methods (POTW), including releases per
site and aggregated over all sites (annual release rates, daily release rates) {Tags: Release rates
(manufacture, import, processing, use)}a
21. Release or emission factors. {Tags: Emission factors (manufacture, import, processing, use)}a
22. Number of release days per year. {Tags: Release frequencies (manufacture, import, processing, use)}"
23. Data needs associated with mathematical modeling (will be determined on a case-by-case basis). {Tags:
Release modeling data needs (manufacture, import, processing, use)}a
24. Waste treatment methods and pollution control devices employed by the industries within scope and
associated data on release/emission reductions. {Tags: Treatment/ emission controls (manufacture, import,
processing, use), Treatment/ emission controls removal/ effectiveness data}a
Note:
" These are the tags included in the full text screening form. The screener makes a selection from these specific tags, which
describe more specific types of data or information.
,r
Inclusion Criteria for Data Sources Reporting Exposure Data on
Consumers and Ecological Receptors
EPA/OPPT developed PECO statements to guide the full text screening of exposure data/information for
human (i.e., consumers, potentially exposed or susceptible subpopulations) and ecological receptors.
Subsequent versions of the PECO statements may be produced throughout the process of screening and
evaluating data for the chemicals undergoing TSCA risk evaluation. Studies that comply with the
inclusion criteria in the PECO statement are eligible for inclusion, considered for evaluation, and
possibly included in the exposure assessment. On the other hand, data sources are excluded if they do
not meet the criteria in the PECO statement. The methylene chloride-specific PECO is provided in
TableApx F-5.
T:ihle_Apx 1-5. Inclusion Criteria lor (lie Sources Reporting Methylene Chloride
Kxposure l>;i 1 :i on Consumers and Kcological Ueceptors
PI CO I!lemonl
11 \ irience
Population
Human: Consumers (i.e.. receptors who use a product directlv) and bvstanders in the home (i.e..
receptors who are non-product users that are incidentally exposed to the product or article);
including PESS such as children; infants; pregnant women; lactating women, do it yourself
(DIY) or consumers with high-end exposure.
Ecological: Aquatic biota.
Exposure
Exucctcd Primarv Exposure Sources. Pathwavs. Routes:
• Sources: Consumer uses in the home producing releases lo air and dermal contact: industrial
and commercial activities involving non-closed systems producing releases to surface water
• Pathwavs: Indoor air and dermal contact in consumer products: surface water
• Routes of Exposure: Inhalation exposure via indoor air (consumer and bvstander
populations) and dermal exposure via direct contact with consumer products containing
methylene chloride including occluded exposures: exposure lo aquatic species via surface
water
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TsihleApx 1-5. Inclusion Crilerisi lor (lie Dnlsi Sources Reporting Methylene Chloride
Kxposure l):il;i on Consumers siml Kcologicsil Ueceplors
PI'.CO r. lemon i
l.\ idcncc
Comparator
(Scenario)
Human: Consumer and bystander exposure via use of methylene chloride containing consumer
products in the home.
Ecological: Aauatic soecies exposure via contact with surface water
Outcomes for
Exposure
Concentration or Dose
Human: Acute, subchronic. and/or chronic external dose estimates (ms>/ks>/dav): acute,
subchronic. and/or chronic air and water concentration estimates (mg/nf' or mg/L). Both external
potential dose and internal dose based on biomonitoring and reverse dosimetry mg/kg/day will
be considered.
Ecological: A ransje of ecological rcccotors will be considered (range dependent on available
ccoloxicily data) using surface water concentrations.
F.4 Inclusion Criteria for Data Sources Reporting Human Health
Hazards
EPA/OPPT developed a methylene chloride-specific PECO statement (Table Apx F-6) to guide the full
text screening of the human health hazard literature. Subsequent versions of the PECOs may be
produced throughout the process of screening and evaluating data for the chemicals undergoing TSCA
risk evaluation. Studies that comply with the criteria specified in the PECO statement will be eligible for
inclusion, considered for evaluation, and possibly included in the human health hazard assessment,
while those that do not meet these criteria will be excluded according to the exclusion criteria.
In general, the PECO statements were based on (1) information accompanying the TSCA Scope
document, and (2) preliminary review of the health effects literature from authoritative sources cited in
the TSCA Scope documents. When applicable, these authoritative sources (e.g., IRIS assessments,
EPA/OPPT's Work Plan Problem Formulations or risk assessments) will serve as starting points to
identify PECO-relevant studies.
Table Apx 1-6. Inclusion Criteria lor Data Sources Reporting lluniiin llciillh lla/arris Related to
.Methylene Chloride 11
PI'.CO
l.lcilK'iH
l .\ idcncc Si ream
Papcrs/I-Valuivs Included
Papcrs/IValuivs llxcludcd
Population b
Human
• Any population
• All lifestages
• Study designs:
o Controlled exposure, cohort, case-control, cross-
sectional, case-crossover for all endpoints
o Case studies and case series only related to
deaths and respiratory distress from acute
exposure
• Case studies and case series for all
endnoints other than death and
respiratory distress from acute exposure
Animal
• All non-human whole-organism mammalian species
• All lifestages
• Non-mammalian species
Exposure
Human
• Exposure based on administered dose or
concentration of methylene chloride, biomonitoring
data (e.g., urine, blood or other specimens),
environmental or occupational-setting monitoring
data (e.g., air, water levels), job title or residence
• Primary metabolites of interest (e.g., COHb) as
identified in biomonitoring studies
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TableApx F-6. Inclusion Criteria for Data Sources Reporting Human Health Hazards Related to
Methylene Chloride"
• Exposure identified as or presumed to be from oral,
dermal, inhalation routes
• Any number of exposure groups
• Quantitative, semi-quantitative or qualitative
estimates of exposure
• Exposures to multiple chemicals/mixtures only if
methylene chloride or related metabolites were
independently measured and analyzed
• Route of exposure not by inhalation,
oral or dermal type (e.g.,
intraperitoneal, injection)
• Multiple chemical/mixture exposures
with no independent measurement of or
exposure to methylene chloride (or
related metabolite)
Animal
• A minimum of 2 quantitative dose or concentration
levels of methylene chloride plus a negative control
groupa
• Acute, subchronic, chronic exposure from oral,
dermal, inhalation routes
• Exposure to methylene chloride only (no chemical
mixtures)
• Only 1 quantitative dose or
concentration level in addition to the
control
• Route of exposure not by inhalation,
oral or dermal type (e.g.,
intraperitoneal, injection)
• No duration of exposure stated
• Exposure to methylene chloride in a
chemical mixture
Comparator
Human
• A comparison population [not exposed, exposed to
lower levels, exposed below detection] for
endpoints other than death or respiratory distress
Any or no comparison for exposures associated
with death or respiratory distress
• No comparison population for
endpoints other than death or
respiratory distress from acute
exposure
Animal
• Negative controls that are vehicle-only treatment
and/or no treatment
• Neaative controls other than vehicle-
only treatment or no treatment
Outcome
Human
• Endpoints described in the methylene chloride scope
document0:
o Acute toxicity (neurotoxicity and lethality)
o Liver toxicity
o Neurotoxicity
o Irritation
o Cancer
• Other endpoints (e.g., immunotoxicity,
reproductive/developmental toxicity) d
Animal
General Considerations
Pa pers/Featu res I n cl u ded
Papers/Features Excluded
• Written in Englishe
• Reports primary data
• Full text available
• Reports both methylene chloride exposure and a
health outcome
• Not written in English
• Reports secondary data (e.g., review
papers)
• No full text available (e.g., only a study
description/abstract, out-of-print text)
• Reports a methylene chloride-related
exposure or a health outcome, but not
both (e.g. incidence, prevalence report)
a Some of the studies that are excluded based on the PECO statement may be considered later during the systematic review process. For methylene chloride,
EPA will evaluate studies related to susceptibility and may evaluate, toxicokinetics and physiologically based pharmacokinetic models after other data (e.g.,
human and animal data identifying adverse health outcomes) are reviewed. EPA may need to evaluate mechanistic data (especially related to
immunotoxicity, CNS depression, lethality) depending on the review of health effects data. Finally, EPA may also review other data as needed (e.g., animal
studies using one concentration, review papers) when analyzing evidence during the data integration phase of the systematic review process.
b Mechanistic data are excluded during the full text screening phase of the systematic review process but may be considered later (see footnote a).
c EPA will review key and supporting studies in the IRIS assessment (U.S. EPA. 2011b) that were considered in the dose-response assessment for non-
cancer and cancer endpoints as well as studies published after the IRIS assessment (U.S. EPA. 2011b).
d EPA may screen for hazards other than those listed in the scope document if they were identified in the updated literature search that accompanied the
scope document.
e EPA may translate studies as needed.
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