Problem Formulation of the Risk Evaluation for Trichloroethylene


EPA Document# EPA-740-R1-7014
May 2018
United States	Office of Chemical Safety and
Environmental Protection Agency	Pollution Prevention
Problem Formulation of the Risk Evaluation for
T richloroethylene
CASRN: 79-01-6
May 2018

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TABLE OF CONTENTS
ACKNOWLEDGEMENTS	5
ABBREVIATIONS	6
EXECUTIVE SUMMARY	10
1	INTRODUCTION	12
1.1	Regul atory Hi story	13
1.2	Assessment History	14
1.3	Data and Information Collection	16
1.4	Data Screening During Problem Formulation	17
2	PROBLEM FORMULATION	17
2.1	Physical and Chemical Properties	18
2.2	Conditions of Use	19
2.2.1	Data and Information Sources	19
2.2.2	Identification of Conditions of Use	19
2.2.2.1	Categories and Subcategories Determined Not to Be Conditions of Use During Problem
Formulation	20
2.2.2.2	Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation	20
2.2.2.3	Overview of Conditions of Use and Lifecycle Diagram	25
2.3	Exposures	29
2.3.1	Fate and Transport	29
2.3.2	Releases to the Environment	31
2.3.3	Presence in the Environment and Biota	33
2.3.4	Environmental Exposures	34
2.3.5	Human Exposures	35
2.3.5.1	Occupational Exposures	35
2.3.5.2	Consumer Exposures	36
2.3.5.3	General Population Exposures	37
2.3.5.4	Potentially Exposed or Susceptible Subpopulations	38
2.4	Hazards (Effects)	39
2.4.1	Environmental Hazards	39
2.4.2	Human Health Hazards	44
2.4.2.1	Non-Cancer Hazards	44
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 Plans to Include and Further Analyze in Risk Evaluation	53
2.5.3.2	Pathways that EPA Plans to Include But Not Further Analyze	53
2.5.3.3	Pathways that EPA Does Not Plan to Include in the Risk Evaluation	54
2.6	Analysis Plan	58
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2.6.1	Exposure	58
2.6.1.1	Environmental Releases	58
2.6.1.2	Environmental Fate	61
2.6.1.3	Environmental Exposures	61
2.6.1.4	General Population	62
2.6.1.5	Occupational Exposures	62
2.6.1.6	Consumer Exposures	65
2.6.2	Hazards (Effects)	67
2.6.2.5	Environmental Hazards	67
2.6.2.6	Human Health Hazards	68
2.6.3	Risk Characterization	70
REFERENCES	72
APPENDICES	87
Appendix A REGULATORY HISTORY	87
A. 1 Federal Laws and Regulations	87
A.2 State Laws and Regulations	93
A.3	International Laws and Regulations	94
Appendix B PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION	96
B.	1 Process Information	96
B,2 Occupational Exposure Data	108
B.3 References Related to Risk Evaluation - Environmental Release and Occupational Exposure
	112
Appendix C SUPPORTING TABLES FOR INDUSTRIAL AND COMMERCIAL ACTIVITIES
CONCEPTUAL MODEL	145
Appendix D SUPPORTING TABLE FOR CONSUMER ACTIVITIES AND USES
CONCEPTUAL MODEL	174
Appendix E SUPPORTING TABLE FOR ENVIRONMENTAL RELEASES AND WASTES
CONCEPTUAL MODEL	202
Appendix F INCLUSION AND EXCLUSION CRITERIA FOR FULL TEXT SCREENING	203
F. 1 Inclusion Criteria for Data Sources Reporting Environmental Fate Data	203
F.2 Inclusion Criteria for Data Sources Reporting Engineering and Occupational Exposure Data
	204
F.3 Inclusion Criteria for Data Sources Reporting Exposure Data on Consumers and Ecological
Receptors	206
F.4 Inclusion Criteria for Data Sources Reporting Human Health Hazards	207
Appendix G List of Retracted Papers	209
LIST OF TABLES
Table 1-1. Assessment History of TCE	14
Table 2-1. Physical and Chemical Properties of TCE	18
Table 2-2. Categories and Subcategories Determined Not to Be Conditions of Use During Problem
Formulation	20
Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation	21
Table 2-4. Production Volume of TCE in CDRReporting Period (2012 to 2015) a	26
Table 2-5. Environmental Fate Characteristic of TCE	30
Table 2-6. Summary of TCE TRI Production-Related Waste Managed in 2015 (lbs)	31
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Table 2-7. Summary of TCE TRI Releases to the Environment in 2015 (lbs) 31
Table 2-8. Ecological Hazard Characterization of TCE 42
LIST OF FIGURES
Figure 2-1. TCE Life Cycle Diagram 28
Figure 2-2. TCE Conceptual Model for Industrial and Commercial Activities and Uses: Potential
Exposures and Hazards 49
Figure 2-3. TCE Conceptual Model for Consumer Activities and Uses: Potential Exposures and Hazards
52
Figure 2-4. TCE Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards 57
LIST OF APPENDIX TABLES
Table_Apx A-l. Federal Laws and Regulations 87
Table_Apx A-2. State Laws and Regulations 93
Table_Apx A-3. Regulatory Actions by Other Governments and Tribes 94
TableApx B-l. Mapping of Scenarios to Industry Sectors with TCE Personal Monitoring Air Samples
Obtained from OSHA Inspections Conducted Between 2002 and 2017 109
TableApx B-2. Summary of Exposure Data from NIOSH HHEs a Ill
Table Apx B-3. Potentially Relevant Data Sources for Process Description Related Information for TCE
112
Table Apx B-4. Potentially Relevant Data Sources for Estimated or Measured Release Data for TCE121
Table Apx B-5. Potentially Relevant Data Sources for Personal Exposure Monitoring and Area
Monitoring Data for TCE 126
Table Apx B-6. Potentially Relevant Data Sources for Engineering Controls and Personal Protective
Equipment Information for TCE 137
Table Apx C-l. Supporting Table for Industrial and Commercial Activities Conceptual Model 145
Table Apx D-l. Consumer Activities and Uses Conceptual Model Supporting Table 174
Table Apx E-l. Environmental Releases and Wastes Conceptual Model Supporting Table 202
Table Apx F-l. Inclusion Criteria for Data Sources Reporting Engineering and Occupational Exposure
Data 204
Table Apx F-2. Engineering, Environmental Release and Occupational Data Necessary to Develop the
Environmental Release and Occupational Exposure Assessments 205
Table Apx F-3. Inclusion Criteria for the Data Sources Reporting Trichloroethylene Exposure Data on
Consumers and Ecological Receptors 206
Table Apx F-4. Inclusion and Exclusion Criteria for the Data Sources Reporting Human Health Hazards
Related to TCE Exposure21 208
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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 (Docket: EPA-HQ-OPPT-2016-0737).
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
£0
Vacuum Permittivity
ACGIH
American Conference of Industrial Hygienists
AEGL
Acute Exposure Guideline Level
AF
Assessment Factor
AQS
Air Quality System
ATCM
Airborne Toxic Control Measure
atm
Atmosphere(s)
AT SDR
Agency for Toxic Substances and Disease Registries
BAF
Bioaccumulation Factor
BCF
Bioconcentration Factor
BIOWIN
The EPI Suite™ module that predicts biodegradation rates
BW34
body weight374
CAA
Clean Air Act
CARB
California Air Resources Board
CASRN
Chemical Abstracts Service Registry Number
CBI
Confidential Business Information
CCR
California Code of Regulations
CDC
Centers for Disease Control and Prevention
CDR
Chemical Data Reporting
CEHD
Chemical Exposure Health Data
CEM
Consumer Exposure Model
CEPA
Canadian Environmental Protection Act
CERCLA
Comprehensive Environmental Response, Compensation, and Liability Act
CFC
Chi orofluorocarb on
CFR
Code of Federal Regulations
ChemSTEER Chemical Screening Tool for Exposure and Environmental Releases
CHIRP
Chemical Risk Information Platform
ChV
Chronic Value
cm3
Cubic Centimeter(s)
CNS
Central Nervous System
coc
Concentration of Concern
cou
Conditions of Use
CPCat
Chemical and Product Categories
CSCL
Chemical Substances Control Law
CWA
Clean Water Act
CYP2E1
Cytochrome P450 2E1
DMR
Discharge Monitoring Report
ECso
Effect concentration at which 50% of test organisms exhibit an effect
ECCC
Environment and Climate Change Canada
ECHA
European Chemicals Agency
EDC
Ethylene Dichloride
E-FAST
Exposure and Fate Assessment Screening Tool
EG
Effluent Guidelines
EPA
Environmental Protection Agency
EPCRA
Emergency Planning and Community Right-to-Know Act
EPI Suite™ Estimation Program Interface Suite™
ESD
Emission Scenario Document
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EU	European Union
FDA	Food and Drug Administration
FFDCA	Federal Food, Drug, and Cosmetic Act
FIFRA	Federal Insecticide, Fungicide, and Rodenticide Act
FR	Federal Register
g	Gram(s)
GACT	Generally Available Control Technology
GST	Glutathione-S-transferase
HAP	Hazardous Air Pollutant
HCFC	Hydrochlorofluorocarbon
HC1	Hydrochloric Acid
HEC	Human Equivalent Concentration
HFC	Hydrofluorocarbon
HHE	Health Hazard Evaluation
HPV	High Production Volume
Hr	Hour
IARC	International Agency for Research on Cancer
ICIS	Integrated Compliance Information System
IDLH	Immediately Dangerous to Life and Health
IMIS	Integrated Management Information System
IRIS	Integrated Risk Information System
ISHA	Industrial Safety and Health Act
ISOR	Initial Statement of Reasons
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
LOAEL	Lowest-ob served-adverse-effect-level
LOEC	Lowest-observable-effect Concentration
m3	Cubic Meter(s)
MACT	Maximum Achievable Control Technology
MATC	Maximum Acceptable Toxicant Concentration
MCCEM	Multi-Chamber Concentration and Exposure Model
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
MSDS	Material Safety Data Sheet
MSW	Municipal Solid Waste
NAICS	North American Industry Classification System
NATA	National Scale Air-Toxics Assessment
NCEA	National Center for Environmental Assessment
NICNAS	Australia National Industrial Chemicals Notification and Assessment Scheme
NCP	National Contingency Plan
NEI	National Emissions Inventory
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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 Institute of Health
NICNAS
National Industrial Chemicals Notification and Assessment Scheme
NIOSH
National Institute for Occupational Safety and Health
NITE
National Institute of Technology and Evaluation
NOAEL
No-Observed-Adverse-Effect-Level
NOEC
No-observable-effect Concentration
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
Organization 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
OSHA
Occupational Safety and Health Administration
OST
Office of Science and Technology
OTVD
Open-Top Vapor Degreaser
OW
Office of Water
PBPK
Phy si ol ogi cally-B ased Pharmacokineti c
PBZ
Personal Breathing Zone
PCE
T etrachl oroethy 1 ene
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
QSAR
Quantitative Structure Activity Relationship
RCRA
Resource Conservation and Recovery Act
REACH
Registration, Evaluation, Authorisation and Restriction of Chemicals
REL
Relative Exposure Limit
RTR
Risk and Technology Review
SDS
Safety Data Sheet
SDWA
Safe Drinking Water Act
SIDS
Screening Information Dataset
SNUN
Significant New Use Notice
SNUR
Significant New Use Rule
SOCMI
Synthetic Organic Chemical Manufacturing Industry
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SPARC
SPARC Performs Automated Reasoning in Chemistry
SpERC
Specific Environmental Release Categories
STEL
Short-Term Exposure Limit
STP model
Sewage Treatment Plant model
STORET
STOrage and RETrieval
TCCR
Transparent, clear, consistent, and reasonable
TCE
T ri chl oroethy 1 ene
TLV
Threshold Limit Value
TRI
Toxics Release Inventory
TSCA
Toxic Substances Control Act
TWA
Time Weighted Average
UIC
Underground Injection Control
U.S.
United States
UV
Ultraviolet
USGS
United States Geological Survey
VOC
Volatile Organic Compound
VP
Vapor Pressure
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). Trichloroethylene 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
trichloroethylene (EPA-H.O-OPPT-2016-0737-0 , ). 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 trichloroethylene. 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 trichloroethylene and presents refined conceptual models and
analysis plans that describe how EPA expects to evaluate the risk for trichloroethylene.
Trichloroethylene, also known as TCE, is a volatile organic liquid that is classified as a human
carcinogen. TCE is subject to numerous federal and state regulations and reporting requirements. In the
2014 TCE risk assessment (U.S. EPA. 2014c). EPA assessed inhalation risks from TCE in vapor and
aerosol degreasing, spot cleaning at dry cleaning facilities and arts and craft uses and also completed
four supplemental analyses. Based on these analyses, EPA published two proposed rules to address the
risks presented by TCE use in vapor degreasing and in commercial and consumer aerosol degreasing
and for spot cleaning at dry cleaning facilities. TCE is designated as a Hazardous Air Pollutant (HAP)
under the Clean Air Act (CAA), a regulated drinking water contaminant under the Safe Drinking Water
Act (SDWA), and a toxic pollutant under the Clean Water Act (CWA). TCE is widely used in industrial
and commercial processes.
Information on domestic manufacture, processing, use, and disposal of TCE is available to EPA through
its Chemical Data Reporting (CDR) Rule, issued under the TSCA, as well as through the Toxics Release
Inventory (TRI). In 2015, approximately 172 million pounds of TCE was manufactured or imported in
the US. An estimated 83.6% of TCE's annual production volume is used as an intermediate in the
manufacture of hydrofluorocarbon (HFC-134a - an alternative to the refrigerant CFC-12). Another
14.7% of TCE production volume is used as a degreasing solvent, leaving approximately 1.7% for other
uses, including consumer uses. Based on 2015 TRI data, most reported environmental releases of TCE
are to air, with much lower volumes disposed to land or released to water. It is expected to be
moderately persistent in the environment and has a low bioaccumulation potential.
This document presents the potential exposures that may result from the conditions of use of TCE.
Exposure may occur through inhalation, oral and dermal pathways, due to trichloroethylene's
widespread presence in a variety of environmental media. Exposures to the general population may
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occur from industrial and/or commercial uses; industrial releases to air, water or land; and other
conditions of use. Workers and occupational non-users may be exposed to trichloroethylene during a
variety of conditions of use, such as manufacturing, processing and industrial and commercial uses,
including uses in paint and coatings, adhesives and degreasing. EPA expects that the highest exposures
to trichloroethylene generally involve workers in industrial and commercial settings. Trichloroethylene
can be found in numerous products and can, therefore, result in exposures to commercial and consumer
users in indoor or outdoor environments. For trichloroethylene, 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. 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. For environmental release
pathways, EPA plans to further analyze surface water exposure to aquatic species (i.e. aquatic plants) in
the risk evaluation.
TCE has been the subject of numerous health hazard and risk assessments. TCE toxicity was assessed in
2011 under the EPA Integrated Risk Information System (IRIS) Toxicological Review of
Trichloroethylene_(1 v \ 201 Id which served as the toxicological basis for the 2014 final TCE
risk assessment (U.S. EPA. 2.014c). For non-cancer effects, TCE exposure has been associated with
acute toxicity, liver toxicity, kidney toxicity, reproductive/developmental toxicity, neurotoxicity,
immunotoxicity, and sensitization. TCE is also carcinogenic to humans by all routes of exposures, as
documented in the TCE IRIS assessment, through both genotoxic and non-genotoxic mechanisms. 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 analyze further 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 33726. 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
TCE 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 ( ), 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, such as 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 TCE. 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" ( )). 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
lifestage(s) and population(s), and endpoint(s) that will be addressed in the risk evaluation (U.S. EPA.
2.014b). 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 (
2014b). The problem formulation documents refine the initial conceptual models and analysis plans that
were provided in the scope documents.
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
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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 plan 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 plans 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. 82 FR
33726. 33734. 33739 (July 20, 2017).
EPA received comments on the published scope document for trichloroethylene and has considered the
comments specific to trichloroethylene 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.
1.1 Regulatory History
EPA conducted a search of existing domestic and international laws, regulations and assessments
pertaining to TCE. 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
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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existing laws and regulations (e.g., regulations on landfill disposal, design, and operations) in the
problem formulation step to determine what, if any, further analysis might be necessary as part of the
risk evaluation. Consideration of the nexus between these existing regulations and TSCA uses 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
TCE 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
TCE 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
TCE 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.
In addition to using this information, EPA intends to conduct a full review of the data collected [see
Trichloroethylene (CASRN 79-01-6) Bibliography: Supplemental File for the TSCA Scope Document
(EPA-HQ-OPPT-21' * 1 r .^1 using the literature search strategy (see Strategy for
Conducting Literature Searches for Trichloroethylene (TCE): Supplemental Document to the TSCA
Scope Document, CASRN: 79-01-6. EPA-HQ-OPPT-2016-0737)1 to ensure that EPA is considering
information that has been made available since these assessments were conducted.
The final Work Plan Chemical Risk Assessment of TCE was used to support two proposed rules under
TSCA section 6 ( ;; December 16, 2016; , January 19, 2017) to address risks
from commercial and consumer solvent degreasing (aerosol and vapor), consumer use as a spray-applied
protective coating for arts and crafts and commercial use as a spot remover at dry-cleaning facilities. It
was also considered in development of a Significant New Use Rule (SNUR) for TCE ( 0535;
April 8, 2016).
Table 1-1. Assessment History of TCE
Authoring Organization
Assessment
EPA Assessments
Office of Chemical Safety and Pollution
Prevention (OCSPP)/ Office of Pollution
Prevention and Toxics (OPPT)
TSCA. Work Plan Chemical Risk Assessment
Tvidiloroethvleiv I >cgreasing„ Soot Cleaning and
CraftsI'cO > ' J \ _0i \c)
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Authoring Organization
Assessment
OCSPP/OPPT
Supplemental Occupational Exposure and Risk
Reduction Technical Report in Support of Risk
Management Options 1 Moroethylene (TCE)

Use in Aerosol Decreasing (U.S. EPA. 2016d)
OCSPP/OPPT
Supplemental Exposure and Risk Reduction
Technical Report in Support of Risk Management
Options for Trichloroethylene (TCE) Use in
Consumer Aerosol Degreasing ( ,016c)
OCSPP/OPPT
Supplemental Occupational Exposure and Risk
Reduction Technical Report in Support of Risk
Management Options 1 Moroethylene (TCE)
Use in Spot Cleanii ( )
OCSPP/OPPT
Supplemental Occupational Exposure and Risk
Reduction Technical Report in Support of Risk
Management Options i hloroethylene (TCE)
Use in Vapor Degreasi
( )
Integrated Risk Information System (IRIS)
Toxicological Review of Trichloroethylene (U.S.
)
National Center for Environmental Assessment
(NCEA)
Sources. Emission and Exposure for
iloroethylene (TCE) and Related Chemicals
( )
Office of Water (OW)/ Office of Science and
Technology (OST)
Update of Human Health Ambient Water Oualitv
Criteria: Trichloroethylene (T -01-6 (U.S.
15)
Other U.S.-Based Organizations
Agency for Toxic Substances and Disease
Registries (ATSDR)
Draft Toxicological Profile for Trichloroethylene
( SDR. 2014a)
National Research Council (NRC)
Assessing the Human Health Risks of
iloroethylene: Key Scientific Issues (NRC.
2006)
Office of Environmental Health Hazard
Assessment (OEHHA), Pesticide and
Environmental Toxicology Section
Public Heath Goal for Trichloroethylene in
Drinkim ( )
International
Institute for Health and Consumer Protection,
European Chemicals Bureau
European Union Risk Assessment Report,
iloroethylene (EC. 2.004)
Australia National Industrial Chemicals
Notification and Assessment Scheme (NICNAS)
Trichloroethylene: Priority Existing Chemical
Assessment Report No. 8 (NICNAS. 2000)
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Authoring Organization
Assessment
Environment and Climate Change Canada (ECCC)
Canadian Environmental Protection Act Priority
Substances List Assessment Report:
iloroethylene (Environment Canada. 1993).
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 TCE.
Data Collection: Data Search
EPA/OPPT conducted chemical-specific searches for data and information on: physical and chemical
properties; environmental fate and transport; conditions of use information; environmental exposures,
human exposures, including potentially exposed or susceptible subpopulations; ecological hazard,
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 data and/or information potentially relevant to the risk evaluation. Generally, 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). When available, EPA/OPPT relied on the search strategies from recent
assessments, such as EPA Integrated Risk Information System (IRIS) assessments and the NTP Report
on Carcinogens, to identify relevant references and supplemented these searches to identify relevant
information published after the end date of the previous search to capture more recent literature. Strategy
for Conducting Literature Searches f hloroethylene (TCE): Supplemental Document to the TSCA
Scope Pom	(	) provides details about the data 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 Trichloroethylene (TCE): Supplemental Document
to the TSCA Scope Document, CASH	_(	). 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; environmental exposures, human 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), but 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 information relevant
to the risk evaluation. Off-topic references are those that do not appear to contain data or information
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relevant to the risk evaluation. The Strategy for Conducting Literature Searches for Trichloroethylene
(ICE): Supplemental Document to the JSC A Scope Document, CASH _( ;
0737) 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 Trichloroethylene (TCE): Supplemental Document to the JSC A Scope
Dock _( ) 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 results can be found in the Tricholoroethylene (79-01-6)
Bibliography: Supplemental File for the TSCA Scope Document (EP A-HQ-QPP'T-2016-0737; U.S.
). 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 Trichloroethylene fCASRN 79-01-6) '.Bibliography: Supplemental File for the TSCA Scope Document
( , ), The screening process at the full-text level is described
in the Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA... 2018). 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).
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 TCE 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
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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 of TCE.
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 and EPA found no additional information during
problem formulation that would change these values.
TCE is a colorless liquid with a pleasant, sweet odor resembling that of chloroform. It is considered a
volatile organic compound (VOC) because of its moderate boiling point, 87.2°C, and high vapor
pressure, 73.46 mm Hg at 25°C. TCE is moderately water soluble (1.280 g/L at 25°C), and has a log
octanol/water partition coefficient (Kow) of 2.42. The density of TCE, 1.46 g/m3 at 20°C, is greater than
that of water.
Table 2-1. Physical and Chemical
'roperties of TCE
Property
Value a
References
Molecular Formula
C2HCI3

Molecular Weight
131.39 g/mole

Physical Form
Colorless, liquid, sweet,
pleasant odor, resembles
chloroform
O'Neil et al. (2006)
Melting Point
-84.7°C
Lide(2007)
Boiling Point
87.2°C
Lide(2007)
Density
1.46 g/cm3 at 20°C
EC (2000)
Vapor Pressure
73.46 mmHg at 25°C
Daubert and Danner
0989)
Vapor Density
4.53
O'Neil et al. (2006)
Water Solubility
1,280 mg/L at 25°C
Horvath et al. (1999)
Octanol/W ater Partition
Coefficient (Log K0W)
2.42 (Estimated)
U.S. EPA (2012a)
Henry's Law Constant
9.85E-03 atm-m3/mole
Leishton and Calo
(1981)
Flash Point
90°C (closed cup)
EC (2000)
Auto Flammability
410°C (Estimated)
U.S. EPA (2012a)
Viscosity
0.53 mPas at 25°C
Weast and Selbv (1966)
Refractive Index
1.4775 at 20°C
O'Neil et al. (2001)
Dielectric Constant
3.4 so at 16°C
Weast and Selbv (1966)
a Measured unless otherwise noted
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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. Based on this
search, EPA published a preliminary list of information and sources related to chemical conditions of
use (e.g., Use and Market Profile for TCE and Preliminary Information on Manufacturing. Processing,
Distribution, Use, and Disposal: TCEPreliminary Information on Manufacturing, Processing,
Distribution, Use, and Disposal: TCE: EP A-HQ-OPPT-2016-073 7-0056) 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 has been incorporated into
this problem formulation document to the extent appropriate Thus, EPA believes the identified
manufacture, processing, distribution, use and disposal activities identified in these documents 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 TCE, 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 TCE and queried government and commercial trade databases. EPA also received comments on the
Scope of the Risk Evaluation for TCE ffiPA-H.O-QPPT-2016-073 7-005 7: U.S. EPA. 2017d) that were
used to determine the current conditions of use. Scope of the Risk Evaluation for TCE Scope of the Risk
Evaluation for TCE (EP A-HQ-OPPT-2016-073 7) that were used to determine the current 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.
EPA has removed from the risk evaluation certain activities that EPA has concluded to not constitute
conditions of use - for example, 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 plan 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 that the Agency 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. (82 J J<. ' Jo -.9; July 20, 2017). For example, EPA may
exclude conditions of use that the Agency has sufficient basis to conclude would present only de
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minimis exposures or otherwise insignificant risks (such as some uses in a closed system that effectively
preclude exposure or use as an intermediate).
The activities that EPA no longer believes are conditions of use or that 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
During Problem Formulation
EPA has conducted public outreach and literature searches to collect information about TCE's
conditions of use and has reviewed reasonably available information obtained or possessed by EPA
concerning activities associated with TCE. As a result of that analysis during problem formulation, EPA
determined there is insufficient information to support a finding that certain activities which were listed
as conditions of use in the Scope Document (EPA-HO-OPPT-l'i * I < < 737-0057; U.S. EPA. ^ 01 '• I) for
TCE actually constitute "circumstances.. .under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of."
Consequently, EPA intends to exclude these activities not considered conditions of use from the scope
of the evaluation.
As shown in Table 2-22, these activities consist of paints and coatings for consumer use. EPA no longer
believes that paints and coatings for consumer use contain TCE, as evidenced by SNUR on TCE for
Certain Consumer Products (81 FR 20535). Consequently, EPA intends to exclude consumer uses of
paints and coatings from the scope of the evaluation.
Table 2-2. Categories and Subcategories Determined Not to Be Conditions of Use During Problem
Formulation
Life Cycle Stage
Category a
Subcategory
References
Consumer use
Paints and Coatings
Diluent in solvent-based
paints and coatings
TCE SNUR on
consumer products (81.
FR 20535)
" These categories are no longer shown in the Life Cycle Diagram.
2.2.2.2 Categories and Subcategories of Conditions of Use Included in the Scope of
the Risk Evaluation
EPA has conducted public outreach and literature searches to collect information about
trichloroethylene's conditions of use and has reviewed reasonably available information obtained or
possessed by EPA concerning activities associated with trichloroethylene. Based on this research and
outreach, other than the category and subcategory described above in Section 2.2.2.1, EPA does not
have reason to believe that any conditions of use identified in the trichloroethylene scope should be
excluded from risk evaluation. Therefore, all the conditions of use for TCE will be included in the risk
evaluation.
Table 2-33 summarizes each life cycle stage and the corresponding categories and subcategories of
conditions of use for TCE that EPA plans to evaluate 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
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and subcategories) and assess certain potential sources of release and human exposure associated with
that life cycle stage. In addition, activities related to distribution (e.g., loading, unloading) will be
considered throughout the life cycle, rather than using a single distribution scenario.
Beyond the uses identified in the Scope of the Risk Evaluation for TCE, EPA has received no additional
information identifying additional current conditions of use for TCE from public comment and
stakeholder meetings.
Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
Life Cycle Stage
Category a
Subcategory b
References
Manufacture
Domestic
manufacture
Domestic manufacture
U.S. EPA (2016b)

Import
Import
U.S. EPA (2016b)
Processing
Processing as a
reactant/
intermediate
Intermediate in industrial gas
manufacturing (e.g.,
manufacture of fluorinated
gases used as refrigerants,
foam blowing agents and
solvents)
U.S. EPA (2016b);
EP A-HO-OPPT-2016-
0737-0013; EPA-HO-
OPPT-2016-0737-0013;
EP A-HO-OPPT-2016-
0737-0026; EPA-HO-
OPPT-2016-073 7-0027

Processing -
Incorporation into
formulation, mixture
or reaction product
Solvents (for cleaning or
degreasing)
U.S. EPA (2016b)

Processing -
Incorporation into
formulation, mixture
or reaction product
Adhesives and sealant
chemicals
U.S. EPA (2016b)


Solvents (which become part
of product formulation or
mixture) (e.g., lubricants and
greases, paints and coatings,
other uses)
U.S. EPA (2016b);
EP A-HO-OPPT-2016-
0737-0003; EPA-HO-
OPPT-2016-073 7-0056

Processing -
incorporated into
articles
Solvents (becomes an
integral components of
articles)
U.S. EPA (2016b)

Repackaging
Solvents (for cleaning or
degreasing)
U.S. EPA (2016b)

Recycling
Recycling
U.S. EPA (2017e)
Distribution in
commerce
Distribution
Distribution
EP A-HO-OPPT-2016-
0737-0003
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Life Cycle Stage
Category a
Subcategory b
References
Industrial/commercial/
consumer use
Solvents (for
cleaning or
degreasing)
Batch vapor degreaser (e.g.,
open-top, closed-loop)c
EP A-HO-OPPT-2016-
0737-0003. U.S. EPA
(2014c). U.S. EPA
(2016a EPA-HO-
OPPT-2016-073 7-0056


In-line vapor degreaser (e.g.,
conveyorized, web cleaner)c
EP A-HO-OPPT-2016-
0737-0003. U.S. EPA
(2014c). U.S. EPA
(2016a EPA-HO-
OPPT-2016-073 7-0056


Cold cleaner
EP A-HO-OPPT-2016-
0737-0003; U.S. EPA
(2017a EPA-HO-
OPPT-2016-073 7-0056

Solvents (for
cleaning or
degreasing)
Aerosol spray
degreaser/cleanerc
EP A-HO-OPPT-2016-
0737-0003. U.S. EPA
(2014c). U.S. EPA
(2016d). U.S. EPA
(2016c). EPA-HO-
OPPT-2016-073 7-0056


Mold release
EP A-HO-OPPT-2016-
0737-0003; EPA-HO-
OPPT-2016-073 7-0056

Lubricants and
greases/lubricants
and lubricant
additives
Tap and die fluid
U.S. EPA (2016b);
EP A-HO-OPPT-2016-
0737-0003; EPA-HO-
OPPT-2016-073 7-0028.
EP A-HO-OPPT-2016-
0737-0056


Penetrating lubricant
U.S. EPA (2016b).
EP A-HO-OPPT-2016-
0737-0056; EPA-HO-
OPPT-2016-073 7-0003;
EP A-HO-OPPT-2016-
0737-0028

Adhesives and
sealants
Solvent-based adhesives and
sealants
U.S. EPA (2016b).
EP A-HO-OPPT-2016-
0737-0056; EPA-HO-
OPPT-2016-073 7-0003


Tire repair cement/sealer
U.S. EPA (2016b).
EP A-HO-OPPT-2016-
0737-0056; EPA-HO-
OPPT-2016-073 7-0003
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Life Cycle Stage
Category a
Subcategory b
References

Adhesives and
sealants
Mirror edge sealant
EP A-HO-OPPT-2016-
0737-0003; U.S. EPA
(2014c\ EPA-HO-
OPPT-2016-073 7-0056

Functional fluids
(closed systems)
Heat exchange fluid
U.S. EPA f2017f>

Paints and coatings d
Diluent in solvent-based
paints and coatings
U.S. EPA (2016b\
EP A-HO-OPPT-2016-
0737-0056; EPA-HO-
OPPT-2016-073 7-0003;
EP A-HO-OPPT-2016-
0737-0010; EPA-HO-
OPPT-2016-0737-0015;
EP A-HO-OPPT-2016-
0737-0027

Cleaning and
furniture care
products
Carpet cleaner
EP A-HO-OPPT-2016-
0737-0056; EPA-HO-
OPPT-2016-073 7-0003


Cleaning wipes
EP A-HO-OPPT-2016-
0737-0056; EPA-HO-
OPPT-2016-073 7-0003

Laundry and
dishwashing
products
Spot removerc
EP A-HO-OPPT-2016-
0737-0003. U.S. EPA
(2014c\ U.S. EPA
(2016e\ EPA-HO-
OPPT-2016-073 7-0056

Arts, crafts and
hobby materials
Fixatives and finishing spray
coatings c
U.S. EPA (2014c)

Corrosion inhibitors
and anti-scaling
agents
Corrosion inhibitors and anti-
scaling agents
U.S. EPA (2016b)

Processing aids
Process solvent used in
battery manufacture
U.S. EPA f2017f>


Process solvent used in
polymer fiber spinning,
fluoroelastomer manufacture
and Alcantara manufacture
U.S. EPA f2017f>


Extraction solvent used in
caprolactam manufacture
U.S. EPA f2017f>


Precipitant used in beta-
cyclodextrin manufacture
U.S. EPA f2017f>
Page 23 of 209

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Life Cycle Stage
Category a
Subcategory b
References

Ink, toner and
colorant products
Toner aid
EP A-HO-OPPT-2016-
0737-0056; EPA-HO-
OPPT-2016-073 7-0003
Automotive care
products
Brake and parts cleaner
EP A-HO-OPPT-2016-
0737-0056; EPA-HO-
OPPT-2016-073 7-0003
Apparel and
footwear care
products
Shoe polish
U.S. EPA f2017f>
Other uses
Hoof polishes
EP A-HO-OPPT-2016-
0737-0056; EPA-HO-
OPPT-2016-073 7-0003
Pepper spray
EP A-HO-OPPT-2016-
0737-0056; EPA-HO-
OPPT-2016-073 7-0003
Lace wig and hair extension
glues
EP A-HO-OPPT-2016-
0737-0056; EPA-HO-
OPPT-2016-073 7-0003
Gun scrubber
EP A-HO-OPPT-2016-
0737-0056; EPA-HO-
OPPT-2016-073 7-0003
Other miscellaneous
industrial, commercial and
consumer uses
U.S. EPA f2017f>
Disposal
Disposal
Industrial pre-treatment
Industrial wastewater
treatment
Publicly owned treatment
works (POTW)
U.S. EPA (2017e)
a These categories of conditions of use appear in the Life Cycle Diagram, reflect CDR codes, and broadly represent
conditions of use of TCE in industrial and/or commercial settings.
b These subcategories reflect more specific uses of TCE.
0 This includes uses assessed in the U.S. EPA. 2014c risk assessment.
d Paints and coatings only applies to industrial and commercial uses and not consumer uses.
Although EPA indicated in the TCE scope document that EPA did not expect to evaluate the uses
assessed in the 2014 risk assessment in the TCE risk evaluation, EPA has decided to evaluate these
conditions of use in the risk evaluation as described in this problem formulation. EPA is including these
conditions of use so that they are part of EPA's determination of whether TCE presents an unreasonable
risk "under the conditions of use," TSCA 6(b)(4)(A). EPA has concluded that the Agency's assessment
of the potential risks from this widely used chemical will be more robust if the potential risks from these
conditions of use are evaluated by applying standards and guidance under amended TSCA. In particular,
this includes ensuring the evaluation is consistent with the scientific standards in Section 26 of TSCA,
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the Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act (40
CFR Part 702) and EPA's supplemental document, Application of Systematic Review in TSCA Risk
Evaluations (U.S. EPA. 2018) EPA also expects to consider other available hazard and exposure data to
ensure that all reasonably available information is taken into consideration. It is important to note that
conducting these evaluations does not preclude EPA from finalizing the proposed TCE regulation (82
, January 19, 2017; I; December 16, 2016).
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 for TCE 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.
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
industrial, 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 of use 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
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).
Descriptions of the industrial, commercial and consumer use categories identified from the 2016 CDR
and included in the life cycle diagram are summarized below ( 2016b). The descriptions
provide a brief overview of the use category; Appendix B contains more detailed descriptions (e.g.
process descriptions, worker activities, process flow diagrams, equipment illustrations) for each
manufacture, processing, distribution, 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 TSCA Chemical Data Reporting (U.S. EPA. 2.016b).
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 TCE in vapor degreasing, cold cleaning and in
industrial and commercial aerosol degreasing products.
The "Lubricants and Greases" category encompasses chemical substances contained in products used
to reduce friction, heat generation and wear between solid surfaces. This category includes the use of
TCE in penetrating lubricants, and tap and die fluids for industrial, commercial and consumer uses.
The "Adhesives and Sealants" category encompasses chemical substances contained in adhesive and
sealant products used to fasten other materials together. This category includes the use of TCE in mirror-
edge sealants, lace wig and hair extension glues and other adhesive products.
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The "Functional Fluids (closed system)" category encompasses liquid or gaseous chemical substances
used for one or more operational properties in a closed system. Examples are heat transfer agents (e.g.,
coolants and refrigerants).
The "Paints and Coatings" category encompasses chemical substances contained in paints, lacquers,
varnishes and other coating products that are applied as a thin continuous layer to a surface. Coating
may provide protection to surfaces from a variety of effects such as corrosion and ultraviolet (UV)
degradation; may be purely decorative; or may provide other functions. EPA anticipates that the primary
subcategory to be the use of TCE in solvent-based coatings. EPA no longer believes that paints and
coatings for consumer use contain TCE, as evidenced by the SNUR on TCE in Certain Consumer
Products SNUR (81 FR 20535). Therefore, EPA is only including paints and coatings from industrial
and commercial uses as a condition of use for TCE.
The "Cleaning and Furniture Care Products" category encompasses chemical substances contained
in products that are used to remove dirt, grease, stains and foreign matter from furniture and furnishings,
or to cleanse, sanitize, bleach, scour, polish, protect or improve the appearance of surfaces. This
category includes the use of TCE for spot cleaning and carpet cleaning.
The "Laundry and Dishwashing Products" category encompasses chemical substances contained in
laundry and dishwashing products and aids formulated as a liquid, granular, powder, gel, cakes, and
flakes that are intended for consumer or commercial use.
The "Arts, Crafts and Hobby Materials" category encompasses chemical substances contained in arts,
crafts, and hobby materials that are intended for consumer or commercial use.
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 TCE are provided in Table 2-4 for TCE from EPA's CDR database
( 2016b). For the 2016 CDR period, non-confidential data indicate a total of 13 manufacturers
and importers of TCE in the United States. This information has not changed during problem
formulation from that provided in the scope document.
Table 2-4. Production Volume of TCE in CDR Reporting Period (2012 to 2015)a
Reporting Year
2012
2013
2014
2015
Total Aggregate
Production Volume (lbs)
220,536,812
198,987,532
191,996,578
171,929,400
aThe CDR data for the 2016 reoortine ocriod is available via ChemView (lUtDs://iava.cDa.aov/chcmvic\v). Because of an
ongoing CBI substantiation process required by amended TSCA. the CDR data available in the scope document (Scope
Documeni) is more specific than currently in ChemView.
As seen in Figure 2-1, most information on the production volume associated with the various uses is
shown as "Volume CBI" in the life cycle diagram, based on CBI claims in the 2016 CDR (U.S. EPA.
2016b). The production volumes shown are for reporting year 2015 from the 2016 CDR reporting
period. As reported in the Use Document [EPA-HO-OP* I _ < * I * ouo, (» \ I v \ <17c)], as well
as in the 2014 TCE risk assessment (i v < T \ TO I 4c), an estimated 83.6% of TCE's annual production
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volume is used as an intermediate in the manufacture of the hydrofluorocarbon, HFC-134a, an
alternative to the refrigerant chlorofluorocarbon, CFC-12. Another 14.7% of TCE production volume is
used as a degreasing solvent, leaving approximately 1.7% for other uses. Also reflected in the life cycle
diagram is the fact that TCE, as a widely used solvent, has numerous applications across industrial,
commercial and consumer settings.
Figure 2-1 depicts the life cycle diagram of trichloroethylene from manufacture to the point of disposal.
Activities related to the distribution (e.g., loading, unloading) will be considered throughout the TCE life
cycle rather, than using a single distribution scenario.
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MFG / IMPORT
PROCESSING
INDUSTRIAL, COMMERCIAL, CONSUMER USES a
WASTE DISPOSAL
Manufacture
(Includes Import)
(171.9 million lbs.)
Processing as a
React ant/Intermediate
(Volume CBI)
e.g., intermediate for
refrigerant manufacture
Incorporated into
Formulation, Mixture,
or Reaction Products
(Volume CBI)
Repackaging
(Volume CBI)

Recycling
Manufacture (Includes import)
Processing
Solvents for Cleaning and Degreasing
(Volume CBI)
e.g., vapor degreasing, cold cleaning,
aerosol degreasing, mold release
Lubricants and Greases
(185,000 lbs.)
e.g., lubricant, tap and diefluid
Adhesive* and Sealants
(Volume CBI)
e.g., mirror-edge sealant
Functional Fluids (closed system)
(Volume CBI)
e.g., refrigerant
Paints and Coatings b
(Volume CBI)
Cleaning and Furniture Care Products
(Volume CBI)
e.g., carpet cleaner
Laundry and Dishwashing Products
e.g., spot remover
Arts, Crafts, and Hobby Materials
e.g., spray-applied protective coating
Other Uses, Incl.
Corrosion Inhibitors and Anti-Scaling
Agents (Volume CBI); Processing Aids;
Ink, Toner and Colorant Products;
Automotive Care Products;
Miscellaneous (e.g., hoof polish, pepper
spray)
Disposal
See Figure 2-4 for Environmental
Releases and Wastes
Uses. At the scope level of detail in the Iifecycle diagram we are not distinguishing between industrial/commercial/
consumer uses.The differences between these uses will be further investigated and defined during risk evaluation.
Figure 2-1. TCE 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 M.S. EPA. 2016b). Activities related to distribution (e.g., loading and unloading)
will be considered throughout the TCE life cycle, rather than using a single distribution scenario.
a See Table 2-3 for additional uses not mentioned specifically in this diagram.
b Paints and coatings only applies to industrial and commercial uses and not consumer uses.
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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 TCE. Post-release pathways and routes will be
described to characterize the relationship or connection between the conditions of use for TCE 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 TCE.
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 TCE.
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) and bioaccumulation
potential were used when considering changes to the conceptual models. Model results and basic
principles were used to support the fate data in problem formulation while literature review is currently
underway through the systematic review process.
The Estimation Program Interface Suite™ (EPI Suite™) ( HOI2a) modules were used to
predict volatilization of TCE 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 (set biodegradation half-life to 10,000
hours) to evaluate the potential for TCE to volatilize to air or adsorb to sludge during wastewater
treatment. The STP module estimates that 74% of TCE in wastewater will be removed by volatilization
while 1% of TCE 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 TCE in surface water. The
volatilization module estimates that the half-life of TCE in a model river will be 1.2 hours and the half-
life in a model lake will be 110 hours.
The EPI Suite™ module that predicts biodegradation rates ("BIOWIN" module) was run using default
settings to estimate biodegradation rates of TCE in soil and sediment. Three of the models built into the
BIOWIN module (BIOWIN 1, 2, and 5) estimate that TCE will not rapidly biodegrade in aerobic
environments, while a fourth (BIOWIN 6) estimates that TCE will rapidly biodegrade in aerobic
environments. These results support the biodegradation data presented in the TCE scope document,
which demonstrate slow biodegradation under aerobic conditions. The model that estimates anaerobic
biodegradation (BIOWIN 7) predicts that TCE will biodegrade under anaerobic conditions. Further,
previous assessments of TCE found that biodegradation was slow or negligible.
The log Koc reported in the TCE scoping document was predicted using EPI Suite™ as 1.8 and
extracted from measured values which ranged from 1.86 to 2.17 with different soils. That range of
values (1.8-2.17) is supported by the basic principles of environmental chemistry which states that the
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Koc is typically within one order of magnitude (one log unit) of the octanol: water partition coefficient
(Kow). The log Koc values reported in previous assessments of TCE were in the range of 1.8-2.17,
suggesting low sorption to soil and sediment and is mobile in soil and sediment.
Table 2-5. Environmental Fate Characteristic of TCE
Property or Endpoint
Value a
References
Indirect photodegradation
5.5-8 days (atmospheric degradation based on
measured hydroxyl radical degradation)
1-11 days (atmospheric degradation based on
measured hydroxyl radical degradation)
ECB (2004). U.S.
EPA. (2014c)
Hydrolysis half-life
Does not undergo hydrolysis at pH 7
EC (2000)
Biodegradation
19% in 28 days (aerobic in water, OECD 301D)
2.4% in 14 days (aerobic in water, OECD
301C)
25% degradation after 10 days, 95%
degradation after 30 days (anaerobic
biodegradation in subsurface sediment with
methanol)
65% degradation after 10 days, 99%
degradation after 30 days (anaerobic
biodegradation in subsurface sediment with
glucose)
TCE removed slowly with a reduction of 40%
after 8 weeks (TCE (200 (J,g/L) incubated with
batch bacterial cultures under methanogenic
conditions)
ECB (2004}
Bioconcentration factor
(BCF)
4-17 (carp)
U.S. EPA. c
Bioaccumulation factor
(BAF)
23.7 (estimated)
I > M \ i >01 ID
Organic carbon:water
partition coefficient (Log Koc)
2.17 (measured in silty clay Nebraska loam);
1.94 (measured in silty clay Nevada loam);
1.86 (measured in a forest soil)
1.8 (estimated)
1 4 n* \ 12014c)
"Measured unless otherwise noted
If released to the air, TCE does not absorb radiation well at wavelengths that are present in the lower
atmosphere (>290 nm) so direct photolysis is not a main degradation process. Degradation by reactants
in the atmosphere has a half-life of several days meaning that long range transport is possible.
If released to water, sediment or soil, the fate of TCE is influenced by volatilization from the water
surface or from moist soil as indicated by its physical chemical properties (e.g. Henry's law constant)
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and by microbial biodegradation under some conditions. The biodegradation of TCE in the environment
is dependent on a variety of factors and thus, a wide range of degradation rates have been reported
(ranging from days to years). TCE is not expected to accumulate in aquatic organisms due to low
measured BCFs and estimated BAF.
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 expects to consider 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, TCE 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
types of disposal to land (e.g. Resource Conservation and Recovery Act (RCRA) Subtitle C hazardous
landfill and Class I underground Injection wells) and incineration. EPA also examined how
trichloroethylene is treated at industrial facilities.
Table 2-66 provides production-related waste managed data (also referred to as waste managed) for TCE
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. Release quantities in Table
2-7 are more representative of actual releases during the year. Production-related waste managed shown
in Table 2-6 excludes any quantities reported as catastrophic or one-time releases (TRI section 8 data),
while release quantities shown in Table 2-7 include both production-related and non-routine quantities
(TRI section 5 and 6 data).
Table 2-6. Summary of TCE TRI Production-Related Waste Managed in 2015 (lbs)
Number of
Facilities
Recycling
Energy
Recovery
Treatment
Releases a'b'c
Total
Production
Related Waste
172
76,090,421
2,585,262
10,540,042
1,967,576
91,183,301
Data source: 2015 TRI Data (updated March 2017).
11 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.
Table 2-7. Summary of TCE TRI Releases to the Environment in 2015 (lbs)

-------

Number
of
Facilities
Air Releases
Water
Releases
Land Disposal
Other
Releases a
Total On-
and Off-
site
Disposal
or Other
Releases b'
c
Stack Air
Releases
Fugitive
Air
Releases
Class I
Under-
ground
Injection
RCRA
Subtitle C
Landfills
All other
Land
Disposala
Totals
1,880,569
50,027
Data source: 2015 TRI Data (updated March 2017).
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 These release quantities do include releases due to one-time events not associated with production such as remedial actions or earthquakes.
c Counts release quantities once at final disposition, accounting for transfers to other TRI reporting facilities that ultimately dispose of the chemical waste.
Facilities are required to report if they manufacture (including import) or process more than 25,000
pounds of TCE, or if they otherwise use more than 10,000 pounds of TCE. In 2015, 172 facilities
reported a total of 91 million pounds of TCE waste managed. Of this total, 76 million pounds were
recycled, 2.5 million pounds were recovered for energy, 10.5 million pounds were treated, and nearly
2 million pounds were released into the environment (Table 2-6).
Of the nearly 2 million pounds of total disposal or other releases, there were stack and fugitive air
releases, water releases, Class I underground injection, releases to Resource Conservation and Recovery
Act (RCRA) Subtitle C landfills and other land disposal, and other releases. Of these releases, 96% were
released to air. For stack releases, multiple types of facilities report 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. Approximately 690,000
pounds of TCE releases were reported to TRI as on-site stack releases, and account for any incineration
destruction. Stack releases reported to TRI represent the total amount of TCE being released to the air at
the facility from stacks, confined vents, ducts, pipes, or other confined air streams.
In 2015, 1,928,867 pounds of TCE were disposed of or otherwise released on-site, and 38,671 pounds
were disposed of or otherwise released off-site. Of the on-site releases, 97.496% (1,880,569 pounds)
were released to air, including both stack and fugitive releases, 2.501% (48,245 pounds) went to land
disposal, and 0.003% (52 pounds) were released to water. Of the on-site land disposal, nearly all went to
RCRA Subtitle C landfills. Just 3 pounds went to on-site landfills other than RCRA Subtitle C, and none
was disposed of in on-site underground injection wells, on-site land treatment, or on-site surface
impoundments. Of the off-site releases, 46.1% (17,815 pounds) was transferred for other off-site
management, 31.3% (12,105 pounds) was transferred to a waste broker for disposal, 16.1% (6,246
pounds) was transferred for storage only, 3.3% (1,263 pounds) was transferred to a RCRA Subtitle C
landfill, 1% (397 pounds) was transferred to a non-RCRA Subtitle C landfill, 1.9% (722 pounds) was
transferred for unknown disposal, and 0.3% (122 pounds) was transferred to an off-site underground
injection Class I well.
While most TCE going to land disposal went to Subtitle C Hazardous Waste Landfills in 2015, in past
years, the TRI data show TCE going to other types of land disposal as well. In 2014, 12,600 pounds was
transferred for off-site land treatment, and in both 2013 and 2014 over 11,000 pounds were transferred
to off-site landfills other than RCRA subtitle C landfills. From 2012 through 2014, 24,000 pounds to
over 100,000 pounds of TCE were released on-site to other land disposal. That volume decreased to only
5 pounds in 2015.
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While the volume of 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
includes both production-related and non-routine quantities (TRI section 5 and 6 data). As a result,
release quantities may differ slightly and may reflect differences in TRI calculation methods for reported
release range estimates (U.S. EPA. 2017e). In addition, Table 2-6 counts all release quantities reported
to TRI, while Table 2-7 counts releases once at final disposition, accounting for transfers of chemical
waste from one TRI reporting facility and received by another TRI reporting facility for final
disposition. As a result, release quantities may differ slightly and may further reflect differences in TRI
calculation methods for reported release range estimates (I 3
Other sources of information provide evidence of releases of TCE, 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 TCE that can be emitted to a particular media. There
are additional sources of TCE emissions data, including National Emissions Inventory (NEI) (
2.017h) and the Discharge Monitoring Report (OMR) Pollutant Loading Tool (U.S. EPA. 2010). 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,
Hazardous Air Pollutants (HAPs) on a 3-year cycle. Another source is EPA's AP-42, Compilation of Air
Pollutant Emission Factors. AP-42 sections provide general process and emission information for a
variety of industry sectors. AP-42 sections relevant to the conditions of use of TCE include: 4.2 on
surface coating, 4.6 on solvent degreasing, 4.7 on waste solvent reclamation, 4.8 on tanks and drum
cleaning, 4.10 on commercial/consumer solvent use, and 6.7 on printing inks. 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 TCE.
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 TCE.
Environment
TCE is widely detected in a number of environmental media. While the primary fate of TCE released to
surface waters or surface soils is volatilization, TCE is more persistent in air and ground water, where it
is commonly detected through national and state-level monitoring efforts. TCE is frequently found at
Superfund sites as a contaminant in soil and ground water.
TCE has been detected in ambient air across the United States, though ambient levels vary by location
and proximity to industrial activities. EPA's Air Quality System (AQS) is EPA's repository of Criteria
Pollutant and Hazardous Air Pollutant (HAP) monitoring data. A summary of the ambient air
monitoring data for TCE (i.e., measured data) in the United States from 1999 to 2006 suggests that TCE
levels in ambient air have remained fairly constant in ambient air for the United States since 1999, with
an approximate mean value of 0.23 (.ig/m3 (U.S. EPA. 2^1 h\ 2007). EPA also compiles modeled air
concentrations in its National-scale Air Toxics Assessments (NATA) using NEI data for the Criteria
Pollutants and HAPs, like TCE. Recent ambient air concentration data from both sources, as well as
those identified in open literature, will be reviewed and considered for risk evaluation.
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The presence of TCE in indoor air may result from ambient air releases from industrial and commercial
activities, volatilization from tap water and household uses of TCE-containing consumer products.
Additionally, TCE in ground water may volatilize through soil and into indoor environments of
overlying buildings in a process called vapor intrusion. There are a number of studies that have reported
indoor air levels of TCE in residences, schools and stores, and recent indoor air data from open
literature, agency databases (e.g., )or Intrusion Database) and other authoritative documents
addressing vapor intrusion.
TCE is one of the most frequently detected organic solvents in U.S. ground water. The U.S. Geological
Survey (USGS) conducted a national assessment of VOCs in ground water, including TCE. Between
1985 and 2001, the detection frequency of TCE was 2.6%, with a median concentration of 0.15 |ig/m3
(U.S. EPA. 201 I c; Zogorski et at... 2006). Recent sources of national and state-level )
groundwater monitoring data will be reviewed and considered for risk evaluation.
TCE has been detected in drinking water systems through national and state-wide monitoring efforts.
EPA's second and third Six-Year Review (Six-Year Review 2 and 3) contains a compilation of state
drinking water monitoring data from 1998-2005 and 2006-2011, which are available through EPA's Six-
Year Review 2 Contaminant Occurrence Data site and Six-Year Review 3 Contaminant
Occurrence Data site. These sources, as well as additional drinking water monitoring data from states
and/or the open literature, will be used to inform the magnitude and extent of TCE's presence in
drinking water.
EPA's STOrage and RETrieval (STORET) is an electronic data system for water quality monitoring
data. Based on a recent search of STORET surface water monitoring data covering the past ten years,
there are detections with a maximum of 50 ppb and average of 4.5 ppb. Data from other sources will
also be reviewed for a better understanding of current levels of TCE in surface water. EPA's STORET
database will also be examined for recent data on TCE levels in sediment.
Compared with other environmental media, there is a relative lack of nationally representative
monitoring data on levels of TCE in ambient soil.
Biota
Biological studies have detected TCE in human blood and urine in the United States and several other
countries, with those exposed through occupational degreasing activities reporting the highest frequency
of positive detections (U.S. EPA. 201 lo; lARC. 1995). The Third National Health and Nutrition
Examination Survey (NHANES III) analyzed blood concentrations of TCE in non-occupationally
exposed individuals in the United States and found that 10% of those sampled had TCE levels in whole
blood at or above the detection limit of 0.01 ppb ( )11c).
2.3.4 Environmental Exposures
The manufacturing, processing, use and disposal of TCE can result in releases to the environment. In
this section, EPA presents exposures to aquatic and terrestrial organisms.
Aquatic Environmental Exposures
TCE is released to surface water from ongoing industrial and/or commercial activities, as reported in
recent TRI and DMR release and loading data. TRI reporting from 2015 indicates direct releases to
surface water of 52 pounds/ year. In 2016, the top ten DMR dischargers reported site-specific loadings
to surface water of 17.5 to 1,564 lbs/yr. Within the past ten years of surface water monitoring data from
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STORET, there are detections (e.g., maximum of 50 ppb and average of 4.5 ppb), that do not exceed the
preliminary acute concentration of concern (COC) for TCE (acute COC = 340 ppb), but do exceed the
preliminary chronic COC (chronic COC = 3 ppb).
Terrestrial Environmental Exposures
Exposure to terrestrial organisms is expected to be low since physical chemical properties do not support
an exposure pathway through water and soil pathways to these organisms. The partition of TCE into
sediments is very low. Furthermore, the primary fate of TCE released to surface waters or surface soils
is volatilization.
2.3.5 Human Exposures
In this section, EPA presents occupational exposures, consumer exposures 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 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 affect the occupational exposure levels.
In the previous 2014 risk assessment (U.S. EPA. 2014c). EPA assessed inhalation exposures to TCE for
occupational use in vapor degreasing, aerosol degreasing, and spot cleaning in dry cleaning facilities,
which will be considered in the TCE risk evaluation. Based on information identified during scoping, as
described in Section 2.3, additional conditions of use resulting in occupational exposure will be
considered during the risk evaluation.
Worker Activities
Workers and occupational non-users may be exposed to TCE when performing activities associated with
the conditions of use described in Section 2.2, including but not limited to:
• Unloading and transferring TCE to and from storage containers to process vessels;
• Cleaning and maintaining equipment;
• Sampling chemicals, formulations or products containing TCE for quality control;
• Repackaging chemicals, formulations or products containing TCE;
• Using TCE in process equipment (e.g., vapor degreasing machine);
• Applying formulations and products containing TCE onto substrates (e.g., spray applying
coatings or adhesives containing TCE);
• Handling, transporting and disposing waste containing TCE; and
• Performing other work activities in or near areas where TCE is used.
Inhalation
Based on these occupational exposure scenarios, inhalation exposure to vapor is expected. EPA
anticipates this is the most important TCE exposure pathway for workers and occupational non-users
based on high volatility. Based on the potential for spray application of some products containing TCE
exposures to mists are also expected for workers and ONU and will be incorporated into the worker
inhalation exposure.
The United States has several regulatory and non-regulatory exposure limits for trichloroethylene: an
Occupational Safety and Health Administration (OSHA) permissible exposure limit (PEL) of 100 ppm
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8-hour time-weighted average (TWA), an acceptable ceiling concentration of 200 ppm provided the
8-hour PEL is not exceeded, and an acceptable maximum peak of 300 ppm for a maximum duration of
5 minutes in any 2 hours (OSHA. 1997). and an American Conference of Government Industrial
Hygienists (ACGIH) Threshold Limit Value (TLV) of lOppm 8-hour TWA and a short-term exposure
level (STEL) of 25ppm (ACGIH. ). (ACGIH. 20IQ)The National Institute for Occupational Safety
and Health (NIOSH) has classified trichloroethylene as a potential occupational carcinogen and
established an immediately dangerous to life or health (IDLH) value of 1,000 ppm. NIOSH has a
recommended exposure limit of 2 ppm (as a 60-minute ceiling) during the usage of TCE as an anesthetic
agent and 25 ppm (as a 10-hour TWA) during all other exposures (NIOSH. 2016).
Dermal
Based on the conditions of use EPA expects dermal exposures for workers, who are expected to have
skin contact with liquids and vapors. Occupational non-users are not directly handling TCE; therefore,
skin contact with liquid TCE is not expected for occupational non-users but skin contact with vapors is
expected for occupational non-users.
Oral
Worker exposure via the oral route is not expected. Exposure may occur through mists that deposit in
the upper respiratory tract however, based on physical chemical properties, mists of TCE will likely be
rapidly absorbed in the respiratory tract and will be considered as an inhalation exposure.
Key Data
Key data that inform occupational exposure assessment include: OSHA Integrated Management
Information System (IMIS) and NIOSH Health Hazard Evaluation (HHE) program data. OSHA data are
workplace monitoring data from OSHA inspections. The inspections can be random or targeted, or can
be the result of a worker complaint. OSHA data can be obtained through the OSHA Chemical Exposure
Health Data (CEHD) at https://www.osha.eov/oshstats/ index.html. TableApx B-l provides a mapping
of scenarios to industry sectors with trichloroethylene personal monitoring air samples obtained from
OSHA inspections conducted between 2003 and 2017.
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/.
Table Apx B-2 provides a summary of personal and area monitoring air samples obtained from NIOSH
HHEs occurring after 1990.
2.3.5.2 Consumer Exposures
TCE can be found in consumer products and commercial products that are readily available for public
purchase at common retailers rEPA-HQ-OPPT-lV 1 • 0737-003. Sections 3 and 4, (l\8 ~^L'.f)]
and can therefore result in exposures to consumers/product users (i.e., receptors who use a product
directly) and bystanders (i.e., receptors who are a non-product users that are incidentally exposed to the
product or article) (U.S. EPA. ).
Inhalation
EPA expects that exposure via inhalation will be the most significant route of exposure for consumer
exposure scenarios, including those involving users and bystanders. This assumption is in line with
EPA/OPPT's 2014 inhalation risk assessment of TCE, which evaluated inhalation exposure to
consumers and bystanders from degreasing and arts & crafts uses.
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Dermal
There is potential for dermal exposures to TCE from consumer uses. Exposures to skin that are
instantaneous would be expected to evaporate before significant dermal absorption could occur based on
the physical chemical properties including the vapor pressure, water solubility and log Kow (the estimate
from IHSkinPerm, a mathematical tool for estimating dermal absorption, is 0.8% absorption and 99.2%
volatilization). Exposure that occurs as a deposition over time or a repeated exposure that maintains a
thin layer of liquid TCE would have greater absorption (the estimate from IHSkinPerm for an 8-hr
exposure is 1.6% absorption and 98.4% volatilization). Furthermore, dermal exposures to liquid TCE are
expected to be concurrent with inhalation exposures, which reflect the preponderance of overall
exposure from a particular use or activity for most consumer exposure scenarios. This is in agreement
with the NIOSH skin notation profile for TCE, which estimates a low hazard potential by dermal
absorption for systemic effects when inhalation and dermal exposures are concurrent (NIOSH. ).
There may also be certain scenarios with a higher dermal exposure potential, for example, an occluded
scenario where liquid TCE is not able to evaporate readily such as a user holding a rag soaked with
liquid TCE against their palm during a cleaning activity.
Generally, individuals that have contact with liquid TCE would be users and not bystanders. Therefore,
dermal exposures to liquid TCE are not expected and inhalation is the primary route of exposure for
bystanders. There is potential for bystanders or users to have indirect dermal contact via contact with a
surface upon which TCE has been applied (e.g., counter, floor). Based on the expectation that TCE
would evaporate from the surface rapidly, with <1% dermal absorption predicted from instantaneous
contact, this route is unlikely to contribute significantly to overall exposure.
Oral
Oral exposure to TCE may occur through incidental ingestion of TCE mists that deposit in the upper
respiratory tract. EPA initially assumed that mists may be swallowed. However, based on physical
chemical properties, mists of TCE are expected to be rapidly absorbed in the respiratory tract or
evaporate upon being introduced into the respiratory tract, thus contributing to the amount of TCE vapor
in the air available for inhalation exposure. Furthermore, based on available toxicological data, EPA
does not expect inhalation and oral routes of exposure to differ significantly in the toxicity of
trichloroethylene. Oral exposures may also occur through hand-to-mouth patterns following dermal
contact with TCE. As described, dermal contact would not be expected for bystanders, and any TCE
present on surfaces of the home or skin surfaces is expected to volatilize rapidly - making it available
for inhalation as a vapor before oral ingestion may occur through such patterns.
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 (refrigerant
flush or coin cleaning).
2.3.5.3 General Population Exposures
Wastewater/liquid wastes, solid wastes or air emissions of TCE could result in potential pathways for
oral, dermal or inhalation exposure to the general population.
Inhalation
Based on TRI data and TCE physical-chemistry and fate properties, it is expected that inhalation
represents the primary route of exposure for the general population from ongoing industrial and/or
commercial activities. As noted in Section 2.3.3, Presence in the Environment and Biota, levels of TCE
in ambient air vary based on proximity to industrial and commercial activities and urban environments
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and there are a number of possible sources that may contribute to TCE levels in indoor air. Like other
VOCs, TCE in drinking water can also contribute to general population inhalation exposures from
volatilization from water during activities such as showering, bathing or washing (McKone and
Knezovich. 1991)
Oral
The general population may ingest TCE via contaminated drinking water and other ingested media. It is
anticipated that ingestion of drinking water containing TCE, for on-going TSCA uses, represents the
primary route of oral exposure for this chemical. TCE has been detected in national-scale drinking water
monitoring datasets (i.e., EPA's Six-Year Review 3) and is released to surface water from ongoing
TSCA uses and activities. The primary oral exposure route for TCE is expected to be via drinking water.
TCE's presence in drinking water may also contribute, to a lesser degree, to oral ingestion through
showering or other non-drinking activities.
Dermal
General population dermal exposures are expected to primarily result from dermal contact with TCE-
containing tap water during showering, bathing and/or washing. TCE has been detected in national-scale
drinking water monitoring datasets (i.e., EPA's Six-Year Review 3) and is released to surface water
from ongoing TSCA uses and activities. While instantaneous contact with TCE is expected to result
primarily in inhalation exposures (see Section 2.3.5.2), activities such as bathing or showering involve
longer durations, large surface area for exposure, and a different exposure medium (i.e., a more dilute
solution).
2.3.5.4 Potentially Exposed or Susceptible Subpopulations
TSCA requires that 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 (U.S. EPA. 201 la).
As part of the Problem Formulation, EPA identified potentially exposed and susceptible subpopulations
during the development and refinement of the life cycle, conceptual models, the development of the
exposure scenarios and the development of the analysis plan. In this section, EPA addresses the
potentially exposed or subpopulations identified as relevant based on greater exposure. EPA will address
the subpopulation identified as relevant based on greater susceptibility in the hazard section.
EPA identifies the following as potentially exposed or susceptible subpopulations due to their greater
exposure:
• Workers and occupational non-users.
• Populations in buildings co-located with facilities using TCE.
• Consumers and bystanders associated with consumer use. TCE has been identified as being used
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 that result in releases to the environment and
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subsequent exposures (e.g., individuals who live or work near manufacturing, processing, use or
disposal sites).
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 (e.g., children's crawling, mouthing or hand-to-mouth behaviors) 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. 2006V
In summary, in the risk evaluation for TCE, EPA plans to analyze the following potentially exposed
groups of human receptors: workers, occupational non-users, consumers, bystanders associated with
consumer use and other groups 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 TCE, as described in
Strategy for Conducting Literature Searches for Trichloroethylene (TCE): Supplemental Document to
the ISC A Scope Document CASRN: 79-01-6 (EPA-HQ-QPPT-2016-073 7). Based on initial screening,
EPA plans to analyze the hazards of TCE identified in the scope 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
in the scope document will be considered for every exposure scenario.
2.4.1 Environmental Hazards
EPA identified the following sources of environmental hazard data for TCE: European Chemicals
Agent \ tatabase (ECHA. 2017a). EPA. Chemical TestRul'' Rita (f jf.l j\Wo7\i), and
Ecological Hazard Literature Search Results in Trichloroethylene (CASRN 7! biography:
Supplemental File for the TSCA Scope Document (EPA-HQ-0 ; v>) 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 Trichloroethylene (ICE): Supplemental Document to the TSCA Scope
Document, CASRN: 79 ) ( , )JData from the screened literature are
summarized below (Table 2-8) as ranges (min-max). EPA plans 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 ( 18).
EPA also evaluated studies previously reviewed in the 2004 European Union (EU) environmental risk
assessment on TCE (ECHA. 2004) and in the ECHA Database on TCE that supplements the 2004 EU
environmental risk assessment.
The EPA TSCA 2014 TCE Risk Assessment ( . 314c) did not analyze aquatic risk from TCE
exposures due to low hazard for aquatic toxicity. The low hazard was based on moderate persistence,
low bioaccumulation, and physical-chemical properties of TCE. The assessment concluded that the
potential environmental impacts, i.e., risk, is expected to be low from environmental releases.
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Additionally, TCE meets the criteria under Section 64 of the Canadian Environmental Protection Act
(CEPA), 1999 and is therefore on the List of Toxic Substances (Schet ). Under Section 64 of
CEP A, TCE is a substance that is determined to be toxic since it is entering or may enter the
environment in a quantity or concentration or under conditions that have or may have an immediate or
long-term harmful effect on the environment or its biological diversity. A risk assessment was
completed by the Environment and Climate Change Canada (ECCC) under Schedule 1 concluded that
TCE has the potential to cause harm to the environment (Environment Canac 3). Specifically,
ECCC concluded that TCE is not expected to cause adverse effects to aquatic biota or terrestrial wildlife
but may cause adverse effects to terrestrial plants from atmospheric concentrations of TCE.
Toxicity to Aquatic Organisms
Aquatic toxicity data were identified for fish, aquatic invertebrates, algae, and amphibians. Acute and
chronic aquatic toxicity studies considered in this assessment are summarized in Table 2-8 (below). Fish
acute 96-hour lethal concentration at which 50% of test organisms die (LCso) values ranged from 1.9
mg/L to 66.8 mg/L. For aquatic invertebrates, the acute effect concentration at which 50% of test
organisms exhibit an effect (ECso) values ranged from 7.8 mg/L (a 48-hour EC so in Daphnia magna) to
22 mg/L (a 24-hour EC so in Daphnia magna). For aquatic plants, acute EC so values range from 26.24
mg/L to 820 mg/L. For amphibians, acute 96-hour LCso values range from 412.0 mg/L to 490.0 mg/L,
and acute 96-hr EC so values range from 22 mg/L to more than 85 mg/L. For planarian (Dugesia
japonica), an LCso of 1.7 mg/L was reported over 7 days.
For chronic fish toxicity, a no-observable-effect concentration (NOEC) of 10.568 mg/L and a lowest-
observable-effect concentration (LOEC) of 20.915 mg/L were reported for mortality, resulting in a
chronic value (ChV) for fish of 14.850 mg/L. For aquatic invertebrates, a NOEC of 7.1 mg/L and a
LOEC of 12 mg/L was reported for reproduction, resulting in a ChV of 9.2 mg/L. For aquatic plants, a
NOEC of 0.02 mg/L and a LOEC of 0.05 mg/L were reported for growth, resulting in a ChV of 0.03
mg/L.
As stated in Section 2.3.1, TCE is not expected to accumulate in aquatic organisms. The COCs
calculated later in this section show an acute COC of 340 ppb and a chronic COC of 3 ppb. As stated in
Section 2.3.4, surface water monitoring data show detection concentrations for TCE below the acute
COC but above the chronic COC.
Toxicity to Terrestrial Organisms
Terrestrial toxicity data were identified for terrestrial invertebrates, plants, avian, fungi, and mammals
(Table 2-8) (U.S. EPA. 2017e). For terrestrial invertebrates, an acute value was reported in earthworms
(Eisenia fetida) with a 48-hour LCso of 105 |ig/cm2. Acute toxicity was observed in terrestrial plants
exposed through hydroponic root exposure at 118 mg/L for two weeks, and in terrestrial plants exposed
through the air at 10.8 |ig/m3 for five hours. Another study reported an ECso of greater than 1,000 mg/L
for oat and turnip plants exposed to TCE through the soil for two weeks. Limited relevant data was
available for avian and fungi. Acute toxicity values for mammals exposed to TCE ranged from 457
mg/kg bd wt to 2,190 mg/kg bd wt (LOEC).
For chronic values in terrestrial invertebrates, a NOEC of 1 mg/L and a LOEC of 30 mg/L were reported
in nematodes over 28 days, resulting in a ChV of 5 mg/L. Chronic toxicity values were reported for
terrestrial plants exposed to TCE through soil with a NOEC of 50 mg/L, a LOEC of 150 mg/L, and a
ChV of 87 mg/L over two months. Chronic toxicity was also observed in terrestrial plants exposed
through the air with concentrations of TCE as low as 2.7-10.8 |ig/m3 over a 6-month time-period.
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As stated in Section 2.3.1, TCE is not expected to partition to soil but is expected to volatilize to air,
based on its physical chemical properties. Review of hazard data for terrestrial organisms shows
potential hazard; however, physical chemical properties do not support an exposure pathway through
water and soil pathways to these organisms.
Toxicity to Sediment Organisms
No data on the toxicity to sediment organisms (e.g. Lumbriculus variegatus, Hyalella azteca,
Chironomus riparius) were found; however, as stated in Section 2.3.1, TCE is not expected to partition
to sediment, based on physical chemical properties.
Toxicity to Microorganisms
Toxicity values for microorganisms, including microorganisms in activated sludge and ciliates, were
found during EPA's review. Values range from a 3-hour ECso of 260 mg/L for inhibition of respiration
in activated sludge to a 24-hour ECso of 410 mg/L for growth inhibition in the ciliate Tetrahymena
pyriformis.
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Table 2-8. Ecological Hazard Characterization of TCE
Duration
Test organism
Endpoint
Hazard
value*
Units
Effect
Endpoint
Citation
Aquatic Organisms
Acute
Fish
LCso
1.9-
66.8
mg/L
Mortality
Yoshioka (1986);
Alexander(1978)
Aquatic
invertebrates
ECso
7.8-22
mg/L
Mortality
Abernethv 0986);
Leblanc (1980)
Algae
ECso
26.24-
820
mg/L
Growth
Tsai (2007);
Lukavskv et al.
(2011)
Amphibian
LCso
412.0-
490.0
mg/L
Mortality
Fort (2001)
ECso
22 - >85
mg/L
Deformities
McDaniel et al.
(2004)
Planarian
LCso
1.7
mg/L
Mortality
Yoshioka (1986)
Acute COC
0.34
mg/L


Chronic
Fish
NOEC
LOEC
ChV
10.568
20.915
14.850
mg/L
Mortality
Smith (1991)
Aquatic
invertebrates
NOEC
LOEC
ChV
7.1
12
9.2
mg/L
Reproduction
Niederlehner et al.
(1998)
Algae
NOEC
LOEC
ChV
0.02
0.05
0.03
mg/L
Growth
Labra et al. (2010)
Chronic COC
0.003
mg/L


Terrestrial Organisms
Acute
Earthworm
LCso
105
|ig/cm2
Mortality
Neuhauser (1985);
Neuhauser (1986)
Terrestrial plant
(Hydroponic or
soil exposure)
LOEC/ECso
118 -
>1,000
mg/L
Zero growth;
growth
Dietz and Schnoor
(2001); Ballhorn
(1984)
Terrestrial plant
(air exposure)
LOEC
10.8
|ig/m3
Reduction in
Photosynthetic
Pigment
Environment
Canada(1993)
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Mammalian
LOEC
457-
2,190
mg/kg
bdwt
Ratio of
polychromatic
cells to
micronucleated
in bone
marrow;
survival
Hrelia et al. (1994);
Hoffmann (1987)
Chronic
Nematode
NOEC
LOEC
ChV
1
30
5
mg/L
Abundance
Fuller et al. (1997)

Terrestrial plant
(soil exposure)
NOEC
LOEC
ChV
50
150
87
mg/L
Growth
Strvcharz and
Newman (2009)
Terrestrial plant
(air exposure)
LOEC
2.7-
10.8
|ig/m3
Reduction in
Photosynthetic
Pigment
Environment
Cana
Microorganisms
Acute
Microorganisms
ECso
260-
410
mg/L
Respiration
inhibition;
population
growth rate
ECHA (2.017a);
Yoshioka (1985)
* Values in the table are presented in the number of significant figures reported by the study authors.
Concentrations of Concern
The concentrations of concern (COCs) for aquatic ecological endpoints were derived based on the
ecological hazard data for TCE. The information below describes how the acute and chronic COCs were
calculated for aquatic toxicity.
The acute COC is derived by dividing the planarian 7-day LCso of 1.7 mg/L (the lowest acute value in
the dataset for aquatic organisms) by an assessment factor (AF) of 5 as described in (	):
•	Lowest value for the 7-day planarian LCso (1.7 mg/L) / AF of 5 = 0.34 mg/L; 0.34 x 1,000 = 340
Hg/L-
The acute COC of 340 ppb, derived from the acute planarian endpoint, will be used for TCE.
The chronic COC is derived by dividing the algae ChV of 0.03 mg/L (the lowest chronic value in the
dataset for aquatic organisms) by an assessment factor of 10 as described in (U.S. EPA. ):
•	Lowest value for algae ChV (0.03 mg/L) / AF of 10 = 0.003 mg/L; 0.003 x 1,000 = 3 |ig/L.
The chronic COC of 3 ppb, derived from the chronic algal endpoint, will be used for TCE.
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The application of assessment factors is based on established EPA/OPPT methods ( 2012b).
(U.S. EPA. 20 i 3) and were used in this hazard assessment to calculate lower bound effect levels
(referred to as the concentration of concern or COC) that would likely encompass more sensitive species
not specifically represented by the available experimental data. Also, assessment factors are included in
the COC calculation to account for differences in inter- and intra-species variability, as well as
laboratory-to-field variability. It should be noted that these assessment factors 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, but are often standardized in risk assessments conducted under
TSCA, since the data available for most industrial chemicals are limited.
In conclusion, the hazard of TCE to aquatic organisms from acute exposures is moderate, and the hazard
from chronic exposures is high based on available data. The hazard of TCE is expected to be low for
sediment-dwelling organisms and terrestrial organisms based on physical and chemical properties of
TCE.
2.4.2 Human Health Hazards
TCE has an existing EPA IRIS Assessment ( ! i; j _>j ) and an ATSDR Toxicological Profile
("AT SDR. 2014a); hence, many of the hazards of TCE have been previously compiled and systematically
reviewed. Furthermore, EPA previously reviewed data/information on health effects endpoints,
identified hazards and conducted dose-response analysis in the TSCA Work Plan Chemical Risk
Assessment of TCE (TJ.S. EPA. 2014c). EPA has relied heavily on these comprehensive reviews in
preparing this problem formulation. 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 ( ). 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 TCE
\Trichloroethylene (CASRN 79-01-6) Bibliography: Supplemental File for the TSCA Scope Document)
(EPA-HQ-QPPT-2016-0737; U.S. EPA. 2017e)l. Based on reasonably available information, the
following sections describe the potential hazards associated with TCE.
2.4.2.1 Non-Cancer Hazards
Acute Toxicity
Human volunteers reported mild nose and throat irritation in TCE inhalation studies (U.S. EPA. 2014c)
and laboratory studies have also demonstrated acute effects of TCE on the respiratory tract in the form
of both localized irritation and broad fibrosis as well as labored breathing ( ). Acute
exposures to TCE have additionally shown to cause central nervous system depression and cardiac
arrhythmias while there are also reports of deaths following accidental exposure ( )9).
An Acute Exposure Guideline Level (AEGL) has been derived for TCE (NA.C/AEGL. 2.009).
Liver toxicity
Several available human studies have reported clinical and functional evidence of TCE-induced liver
toxicity. The primary effect of TCE on liver in laboratory rodents is hepatomegaly (which has also been
observed in humans), with only mild effects seen in other indicators of toxicity such as necrosis and
enzyme changes (' jj'A lo).
Kidney toxicity
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Multiple lines of evidence in human and animal studies support the conclusion that TCE induces toxic
nephropathy. Visible effects resulting from TCE exposure include both histopathological and weight
changes in the kidney ( ).
Reproductive/developmental toxicity
Human studies have reported TCE exposure to be associated with increased sperm density and
decreased sperm quality, altered sexual drive or function, and altered serum endocrine levels. Male
reproductive effects have been corroborated by several laboratory animal studies reporting effects on
sperm, libido/copulatory behavior and serum hormone levels, while histopathological lesions in testis or
epididymis, altered sperm-oocyte binding and reduced fertilization have also been observed. Evidence
for female reproductive toxicity is more limited, however delayed parturition (giving birth) was
identified as an adverse effect (U.S. EPA. 201 le). Additionally, epidemiological and/or experimental
animal studies of TCE have reported increases in total birth defects, central nervous system (CNS)
defects, oral cleft defects, eye/ear defects, kidney/urinary tract disorders, musculoskeletal birth
anomalies, lung/respiratory tract disorders, skeletal defects, developmental immunotoxicity, and cardiac
defects (U.S. EPA. ). Increased incidence of fetal cardiac malformations was identified as the most
sensitive health endpoint within the developmental toxicity domain in the TSCA Work Plan Chemical
Risk Assessment of TCE (U.S. EPA. 2014c).
Neurotoxicity
Both epidemiologic and animal studies have reported abnormalities in trigeminal nerve function and
psychomotor effects in association with TCE exposure. Laboratory animal studies have demonstrated
additional critical effects from TCE exposure including auditory impairment and decreased wakefulness
(U.S. EPA.: ).
Immunotoxicity
TCE promotes both immunosuppressive and auto-immune effects in humans and animals. Sensitive
markers of immunosuppression that have been observed include decreased thymus weight and
cellularity as well as reduced immune cell response. Auto-immune effects include hypersensitivity
(discussed in sensitization section) and increased anti dsDNA/ssDNA antibodies ( )1 le).
Sensitization
Limited epidemiological data do not support an association between TCE exposure and allergic
respiratory sensitization or asthma; however, there is strong human evidence for severe skin
sensitization resulting in dermatitis, mucosal lesions and often systemic effects such as hepatitis. Skin
sensitization tests on rodents corroborate the contact allergenicity potential of TCE and its metabolites
along with the resulting immune-mediated hepatitis (U.S. EPA. 201le).
2.4.2.2 Genotoxicity and Cancer Hazards
Studies in humans have shown convincing evidence of a causal association between TCE exposure in
humans and kidney cancer as well as human evidence of TCE carcinogenicity in the liver and lymphoid
tissues. Further support for TCE's carcinogenic characterization comes from positive results in multiple
rodent cancer bioassays in rats and mice of both sexes, similar toxicokinetics between rodents and
humans, mechanistic data supporting a mutagenic mode of action for kidney tumors, and the lack of
mechanistic data supporting the conclusion that any of the mode(s) of action for TCE-induced rodent
tumors are irrelevant to humans (t S < <'P 201 ic). TCE is considered to have both genotoxic and non-
genotoxic mechanisms. Following EPA's Guidelines for Carcinogen Risk Assessment (
2005). including a weight of evidence judgement, TCE is considered "carcinogenic to humans" by all
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routes of exposure and calculated quantitative estimates of risk from oral and inhalation exposures (U.S.
EPA. 201 lcV
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 ( , j, defines Problem Formulation as the part of the
risk assessment framework that identifies the 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 trichoroethylene, 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 trichloroethylene 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 extensive or quantitative risk evaluations. 8_ 5. K < .(> 33 /.'«4. 33739 (July 20. 2017).
As part of this problem formulation, EPA also identified exposure pathways under other environmental
statutes, administered by EPA, which adequately assess and effectively manage exposures and for which
long-standing regulatory and analytical processes already exist, i.e., the Clean Air Act (CAA), the Safe
Drinking Water Act (SDWA), the Clean Water Act (CWA) and the Resource Conservation and
Recovery Act (RCRA). EPA 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 focus on those exposure pathways associated with TSCA uses that are not subject to
the regulatory regimes discuss above because these pathways are likely to represent the greatest areas of
concern to EPA. As a result, EPA does not plan to include in the risk evaluation certain exposure
pathways identified in the TCE scope document.
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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 trichloroethylene that EPA plans 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 EPA's 2014
risk assessment (U.S. EPA. 2.014c). 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
There is potential for inhalation exposures to TCE in worker scenarios. EPA's 2014 risk assessment
0. "l. 11A ,-.9J J.O of TCE in degreasing, spot cleaning and arts & crafts uses assumed that inhalation as
the primary exposure route based on the physical-chemical properties of TCE (e.g., high vapor
pressure). Inhalation exposures for workers are regulated by OSHA's occupational safety and health
standards for TCE, which include a PEL of 100 ppm TWA, exposure monitoring, control measures and
respiratory protection. EPA expects that exposure via inhalation will be the most significant route of
exposure for occupational exposure scenarios, including those involving workers and occupational non-
users and will be further analyzed.
Dermal
There is potential for dermal exposures to TCE in many worker scenarios. Exposures to skin that are
instantaneous would be expected to evaporate before significant dermal absorption could occur based on
the physical chemical properties including the vapor pressure, water solubility and log Kow (the estimate
from IHSkinPerm, a mathematical tool for estimating dermal absorption, is 0.8% absorption and 99.2%
volatilization). Exposure that occurs as a deposition over time or a repeated exposure that maintains a
thin layer of liquid TCE would have greater absorption (the estimate from IHSkinPerm for an 8-hr
exposure is 1.6% absorption and 98.4% volatilization). In both instantaneous or repeated exposure
scenarios, the dermal exposures to liquid TCE would be concurrent with inhalation exposures and
overall the contribution of dermal exposure to the total exposure is relatively small. This is in agreement
with the NIOSH skin notation profile for TCE, which estimates a low hazard potential by dermal
absorption for systemic effects when inhalation and dermal exposures are concurrent (NIOSH. ).
Therefore, it is not anticipated that dermal absorption will be significant for the majority of occupational
exposure scenarios; thus, non-occluded dermal exposure scenarios will not be analyzed for workers.
Based on the 2017 NIOSH Skin Notation Profile for TCE, TCE is associated with systemic and direct
(i.e., irritation) effects, as well as sensitization. An occluded exposure scenario, wherein liquid TCE is
not able to evaporate readily, may have dermal exposures that significantly contribute to the total
exposure or effects on the skin (e.g., dermal sensitization). An example of such an occluded scenario
includes TCE being trapped under a worker's glove during occupational activities, thus preventing the
rapid volatilization that generally inhibits dermal absorption. Therefore, occluded dermal exposure
scenarios will be analyzed for workers.
Generally, occupational non-users would not be expected to have dermal contact with liquid TCE;
therefore, dermal exposure for these receptors will not be analyzed.
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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 TCE.
For each condition of use identified in Figure 2-2, 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
ACTIVITIES / USES EXPOSURE PATHWAY EXPOSURE ROUTE RECEPTORSc HAZARDS
Manufacturing
Processing:
Processing as a
rea eta nt/i nter med i ate
Incorporated into
formulations, mixtures, or
reaction products
Repackaging
Non-incorporative
activities
Recycling
Solvents for Cleaning and
Degreasing
Lubricants and Greases
Adhesivesand Sealants
Functional Fluids
Paints and Coatings
Cleaning and Furniture Care
Products
Other Industrial or
Commercial Uses®
Laundry and Dishwashing
Products
Waste Handling,
Treatment and Disposal
. Wastewater and Liquid Wastes
(See Figure 2-4)
Workers d
Liquid Contact
Dermal
Hazards Potentially Associated
with Acute and/or Chronic
Exposures
See Section 2.4.2
Occupational
Non-Users
Vapor/ Mist
inhalation
Fugitive
Emissions b
KEY:

Grey Text
Pathways and receptors that will not be

further analyzed
~
Pathways that will be further analyzed.
~
Pathways that will not be further analyzed.
Figure 2-2. TCE 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 TCE.
a Some products are used in both commercial and consumer applications. Additional uses of TCE 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.
c Receptors include potentially exposed or susceptible subpopulations.
d 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
TCE that EPA plans to include in the risk evaluation. In the ( EPA. 2014c) 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
There is potential for inhalation exposures to TCE from consumer uses. As mentioned above,
EPA/OPPT's 2014 risk assessment ( ) of TCE in degreasing, spot cleaning and arts &
crafts uses assumed that inhalation is the main exposure pathway based on the physical-chemical
properties of TCE (e.g., high vapor pressure). EPA expects that exposure via inhalation will be the
primary route of exposure for consumer exposures to consumers and bystanders and will be evaluated.
Dermal
There is potential for dermal exposures to TCE from consumer uses. As described in section 2.5.1, TCE
in direct contact with skin would be expected to evaporate before significant dermal absorption could
occur. Based on TCE's physical chemical properties, including the vapor pressure, water solubility and
log Kow, only 0.8% is expected to be absorbed dermally after instantaneous exposure and only 1.6% of
TCE is expected to be absorbed dermally after an 8-hour duration of continual deposition. Furthermore,
dermal exposures to liquid TCE are expected to be concurrent with inhalation exposures, which reflect
the preponderance of overall exposure from a particular use or activity for most consumer exposure
scenarios. Therefore, non-occluded dermal exposure scenarios will not be analyzed for systemic effects
for users. However, dermal sensitization will still be considered for these scenarios. There may also be
certain scenarios with a higher dermal exposure potential, for example, an occluded scenario where
liquid TCE is not able to evaporate readily such as a user holding a rag soaked with liquid TCE against
their palm during a cleaning activity. Therefore, occluded dermal exposure scenarios will be evaluated
for both systemic effects and sensitization and non-occluded scenarios will only be evaluated for
sensitization. In scenarios involving exposure to TCE vapor, inhalation and dermal exposures would
also be concurrent, with predominate exposure from inhalation. A dermal to inhalation uptake ratio of
around 0.1% for vapor to skin scenarios is predicted using IHSkinPerm. Therefore, only the inhalation
exposures will be analyzed in these cases.
Generally, individuals that have contact with liquid TCE would be users and not bystanders. Therefore,
dermal exposures to liquid TCE are not expected and inhalation is the primary route of exposure for
bystanders. There is potential for bystanders or users to have indirect dermal contact via contact with a
surface upon which TCE has been applied (e.g., counter, floor). Based on the expectation that TCE
would evaporate from the surface rapidly, with <1% dermal absorption predicted from instantaneous
contact, this route is unlikely to contribute significantly to overall exposure. Therefore, dermal exposure
scenarios will not be analyzed for bystanders.
Oral
Oral exposure to TCE may occur through incidental ingestion of TCE mists that deposit in the upper
respiratory tract. EPA initially assumed that mists may be swallowed. However, based on physical
chemical properties, mists of TCE are expected to be rapidly absorbed in the respiratory tract or
evaporate being introduced into the respiratory tract, thus contributing to the amount of TCE vapor in
the air available for inhalation exposure. Furthermore, based on available toxicological data, EPA does
not expect inhalation and oral routes of exposure to differ significantly in the toxicity of TCE. Therefore,
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EPA will not analyze oral exposures to mists and instead will assume mists will be absorbed in the
lungs.
Oral exposures could also occur through hand-to-mouth patterns following dermal contact with TCE. As
described, dermal contact would not be expected for bystanders, and any TCE present on surfaces of the
home or skin surfaces is expected to volatilize rapidly - making it available for inhalation as a vapor
before oral ingestion may occur through such patterns. Therefore, EPA will not analyze oral exposures
for users or bystanders and instead assume any mists present are absorbed in the lungs and any TCE
present on surfaces are inhaled as vapors.
Disposal
EPA does not plan 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. There may be some consumer exposure (dermal or inhalation) during
clean up following use (e.g., spills, drips) leading to transient dermal exposure or inhalation exposure.
Disposal of spent products are expected to be taken to municipal landfill sites and collected and disposed
of as part of their waste handling practices.
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CONSUMER
ACTIVITIES / USES
EXPOSURE PATHWAY
EXPOSURE ROUTE
RECEPTORS c
HAZARDS
Solvents for Cleaning and
Degreasing
Lubricants and Greases
Adhesives and Sealants
Cleaning and Furniture Care
Products
Laundry and Dishwashing
Products
Arts, Crafts, and Hobby
Materials
Other Consumer Uses3
Vapor/Mist
I Consumer Handling and
Disposal of Waste
i :
Dermal b
Consumers
Liquid Contact
Inha at:on
( Bystanders J—
KEY:
Grey Text

Hazards Potentially

Associated

with Acute and/or

Chronic

Exposures
\ fc
See Section 2.4.2
) *
Pathways and receptors that will not be
further analyzed
Pathways th at wi 11 be f u rther ana lyzed.
Pathways that will not be further analyzed.
Figure 2-3. TCE 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
TCE.
a Some products are used in both commercial and consumer applications. Additional uses of TCE are included in Table 2-3.
b Exposure may occur through mists that deposit in the upper respiratory tract however, based on physical chemical properties, mists of TCE will likely be rapidly
absorbed in the respiratory tract or evaporate and not result in an oral exposure. Although less likely given the physical-chemical properties, oral exposure may also occur
from incidental ingestion of residue on hand/body.
0 Receptors include potentially exposed or susceptible subpopulations.
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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 TCE. The pathways that EPA plans to include and analyze further in risk
evaluation are described in Section 2.5.3.1 and shown in the conceptual model. The pathways that EPA
plans to include but not further analyze in risk evaluation are described in Section 2.5.3.2 and shown in
the conceptual model. The pathways that EPA does not plan to include in risk evaluation are described
in Section 2.5.3.3.
2.5.3.1 Pathways That EPA Plans to Include and Further Analyze in Risk
Evaluation
EPA expects to analyze aquatic species (i.e. aquatic plants) exposed via contaminated surface water.
There are no national recommended water quality criteria for the protection of aquatic life for TCE and
as a result EPA does not believe that TCE exposure to aquatic organisms in surface water has been
adequately assessed or effectively managed under other EPA statutory authorities. Trichloroethylene is
released to surface water from ongoing industrial and/or commercial activities, as reported in recent TRI
and DMR release and loading data. TRI reporting from 2015 indicates direct releases to surface water of
52 lbs/yr and indirect releases to surface water (i.e., sent off-site to a publically owned treatment works
(POTW)) of 28 lbs/yr. In 2016, the top ten DMR dischargers reported site-specific loadings to surface
water of 17.5 to 1,564 lbs/yr. Within the past ten years of surface water monitoring data from STORET,
there are detections (e.g., maximum of 50 ppb and average of 4.5 ppb), that do not exceed the
preliminary acute COCs (acute COC = 340 ppb, based on an acute planarian endpoint), but did exceed
the preliminary chronic COC (chronic COC = 3 ppb, based on a chronic algal endpoint). EPA has not
developed CWA section 304(a) recommended water quality criteria for the protection of aquatic life for
trichloroethylene, and there are no national recommended criteria for this use available for adoption into
state water quality standards and available for use in NPDES permits (see Section 2.5.3.3). Due to the
rational above, EPA will further analyze aquatic life risk evaluation.
2.5.3.2 Pathways that EPA Plans to Include But Not Further Analyze
Based on TCE's fate properties, it is not anticipated to partition to biosolids during wastewater
treatment. TCE has a predicted 81% wastewater treatment removal efficiency, predominately due to
volatilization during aeration. Any TCE present in the water portion of biosolids following wastewater
treatment and land application would be expected to rapidly volatilize into air. Furthermore, TCE is not
anticipated to remain in soil, as it is expected to either volatilize into air or migrate through soil into
groundwater. Therefore, the land application of biosolids will not be analyzed as a pathway for human
or ecological exposure.
Based on TCE's fate properties, it is anticipated to primarily volatilize following discharge to surface
water; thus, it is not expected that a significant portion of TCE would be available to enter the sediment
compartment.
Review of hazard data for terrestrial organisms shows potential hazard; however, physical chemical
properties do not support an exposure pathway through water and soil pathways to these organisms.
Therefore, exposure to terrestrial organisms will not be analyzed.
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2.5.3.3 Pathways that EPA Does Not Plan 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.
TCE is a HAP. EPA has issued a number of technology-based standards for source categories that emit
TCE to ambient air and, as appropriate, has reviewed, or is in the process of reviewing remaining risks.
Because stationary source releases of TCE to ambient air are adequately assessed and any risks
effectively managed when under the jurisdiction of the CAA, EPA does not plan 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) under the Safe
Drinking Water Act for trichloroethylene. 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 MCL.
Hence, because the drinking water exposure pathway for trichloroethylene is currently addressed in the
SDWA regulatory analytical process for public water systems, EPA does not plan to include this
pathway in the risk evaluation for trichloroethylene 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 Pathway
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. A criterion is a hazard
assessment only; i.e., there is no exposure assessment or risk estimation. When states adopt criteria that
EPA approves as part of state's regulatory water quality standards, exposure is considered when state
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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. 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 developed CWA section 304(a) recommended human health criteria for 122 chemicals and
aquatic life criteria for 47 chemicals. A subset of these chemicals is identified as "priority pollutants"
(103 human health and 27 aquatic life), including trichloroethylene. The CWA requires that 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. For other pollutants with recommended human health
criteria, EPA regulations require that state criteria contain sufficient parameters and constituents to
protect designated uses. Once states adopt criteria as water quality standards, the CWA requires that
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 permit issuance process
accounts for risk in accordance with the applicable ambient water exposure pathway (human health or
aquatic life as applicable) for the designated water use and, therefore, can the risk from the pathway can
be considered assessed and managed. If numeric water quality criteria are not available for a pollutant
for permit writers to develop permit limits, the risk associated with the ambient water exposure pathway
cannot be considered assessed and managed.
EPA has developed recommended water quality criteria for protection of human health for
trichloroethylene which are available for possible adoption into state water quality standards and are
available for possible use by NPDES permitting authorities in deriving effluent limits to meet state
narrative criteria. As such, this pathway will not be included 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 trichloroethylene in the future under the CWA.
Disposal, Sediment and Soil Pathways
TCE is included on the list of hazardous wastes under the Resource Conservation and Recovery Act
(RCRA) (40 CFR §§ 261.22. 261.31. 261.32, 2.61.24; Appendi f 40 CFR 261V The general RCRA
standard in section 3004(a) for the technical (regulatory) criteria that govern the management (treatment,
storage, and disposal) of hazardous waste (i.e., Subtitle C) 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 CFR <	). 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 Maximum Achievable Control Technology (MACT)) or
injected into Underground Injection Control (UIC) Class I hazardous waste wells (subject to joint
control under Subtitle C and the Safe Drinking Water Act (SDWA)).
Emissions to ambient air from municipal and industrial waste incineration and energy recovery units
will not be included in the risk evaluation, as they are regulated under section 129 of the Clean Air Act.
CAA section 129 also requires EPA to review and, if necessary, add provisions to ensure the standards
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adequately protect public health and the environment. Thus, combustion by-products from incineration
treatment of TCE wastes ((< 2 million lbs identified in Table 2-6) would be subject to these regulations,
as would TCE burned for energy recovery (2.6 million lbs).
EPA does not plan to include on-site releases to land that go to underground injection in the risk
evaluation. TRI reporting in 2015 indicated 122 pounds released to underground injection to a Class I
well and no releases to underground injection wells of Classes II-VI. Environmental disposal of
trichloroethylene injected into Class I well types are presumed to be managed and prevented from
further environmental release by RCRA and SDWA regulations. Therefore, disposal of trichloroethylene
via underground injection is not likely to result in environmental and general population exposures.
EPA does not plan to include releases to land that go to RCRA Subtitle C hazardous waste landfills in
the risk evaluation. Based on 2015 reporting, the majority of TRI land disposal includes Subtitle C
landfills (49,501 pounds) with a much smaller amount transferred to "other landfills" both on-site and
off-site (400 pounds reported in 2015). TCE is present in commercial and consumer products that may
be disposed of in landfills, such as Municipal Solid Waste landfills. 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 in groundwater from Subtitle C landfill leachate is not expected to be a significant
pathway.
EPA does not plan to include on-site releases to land from RCRA Subtitle D municipal solid waste
landfills or exposures of the general population (including susceptible populations) or terrestrial species
from such releases in this TSCA evaluation. While permitted and managed by the individual states,
municipal solid waste (MSW) 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 and
construction/demolition waste landfills. 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 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	EXPOSURE PATHWAY	RECEPTORS	HAZARDS
INDUSTRIAL / COMMERCIAL / CONSUMER USES
Direct
Discharge
Aquatic
Species
Water
Sediment
Indirect
Discharge
iiosolids
Terrestrial
Species
POTW
Wastewater or
Liquid Wastesa
Industrial Pre-
Treatment or
Industrial WWT
Hazards Potentially Associated with Acute
and/or Chronic Exposures:
See Section 2.4.1
£
* .1c
I Q
-a
! e
~
Soil
KEY:


Pathways and receptors that will not be

further analyzed
	~
Pathways that will be further analyzed.

Pathways that will not be further analyzed.
Figure 2-4. TCE 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 TCE.
a Industrial wastewater or liquid wastes 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 here is a refinement of the initial analysis plan that was published in the
Scope of the Risk Evaluation for Trichloroethylene (EP A-HQ-QPPT-2016-073 7-0057; U.S. EPA.
20m).
The analysis plan outlined here is based on the conditions of use for trichloroethylene, 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 for TCE (EPA-HQ-QPPT-20[o-0V *..1005 ,\ i \ V \l), 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 Trichloroethylene (CASRN
79-01-6) Bibliography: Supplemental File for the TSCA Scope Document (EPA-HQ-OPPT-2016-0737;
U.S. EPA, 2017g) 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 trichloroethylene 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 exposure levels will vary based on the chemical
substance of interest. For most high-priority chemical substances, non-zero background level(s) can be
characterized through a combination of available monitoring data and modeling approaches.
2.6.1.1 Environmental Releases
EPA plans to further analyze releases to water, based on information described in Section 2.5. For the
purposes of developing estimates of occupational exposure, EPA may use release related data in selected
data sources such as the Toxics Release Inventory (TRI) and National Emissions Inventory (NEI)
programs.
EPA expects to consider and analyze releases to water as follows:
1) Review reasonably available published literature or information on processes and activities
associated with TCE conditions of use to evaluate the types of releases and wastes
generated.
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EPA plans to evaluate other sources of information such as the EPA Effluent Guidelines and
may use these data in conducting the exposure assessment component of the risk evaluation.
EPA has reviewed some key data sources containing information on processes and activities
resulting in releases, and the information found is shown below as well as in Appendix B.3. EPA
will continue to review data sources identified in Appendix B.3 during risk evaluation. The
evaluation strategy for engineering and occupational data sources discussed in the Application of
Systematic Review in TSCA Risk Evaluations document (U.S. EPA. 2.018) describes how studies
will be reviewed.
2014 Draft ATSDR Toxicological Profile for TCE
U.S. EPA TRI Data (Reporting Year 2016 only)
U.S. EPA Generic Scenarios
OECD Emission Scenario Documents
U.S. EPA NEI Data
EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)
Specific Environmental Release Categories (SpERC) factsheets
Discharge Monitoring Report (DMR) surface water discharge data from NPDES-
permitted facilities
EPA AP-42 Air Emission Factors
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). EPA
will continue to review relevant data sources as identified in Table Apx B-4 during risk
evaluation. EPA will match identified data to applicable conditions of use and identify data gaps
when no data are found.
Additionally, for conditions of use where no published release data are available, EPA may use a
variety of methods including the application of conservative release estimation approaches and
assumptions in the Chemical Screening Tool for Exposures and Environmental Releases
(Chero STEER).
3) Review measured or estimated release data for surrogate chemicals that have similar uses
and physical-chemical properties.
Data for similar solvents that are used in the same applications, such as 1-bromopropane or
perchloroethylene, may be used as surrogate for TCE. 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
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formulation. EPA will further consider relevant regulatory requirements and their potential
impact on environmental releases during risk evaluation.
For example, TCE is a hazardous air pollutant (HAP) regulated under the Clean Air Act (CAA),
and both a priority pollutant and toxic pollutant regulated under the Clean Water Act (CWA).
EPA has identified several regulations under the CAA and CWA that regulate the release of TCE
into the environment, including the National Emission Standards for Hazardous Air Pollutants
(NESHAP) for Halogenated Solvent Cleaning (40 CFR Part 63, Subpart T), the NESHAP for the
Synthetic Organic Chemical Manufacturing Industry (SOCMI) (40 CFR Part 63, Subparts F, G,
H, and I), and the Industrial Effluent Guidelines for Organic Chemicals, Plastics, and Synthetic
Fibers (40 CFR Part 414).
5) Review and determine applicability of Organisation for Economic Co-operation and
Development (OECD) Emission Scenario Documents (ESDs) and EPA Generic Scenarios
(GS) to the estimation of environmental releases.
EPA has identified OECD Emission Scenario Documents (ESDs) and EPA Generic Scenarios
that correspond to some conditions of use; for example, the ESD on Industrial Use of Industrial
Cleaners and the ESD on Industrial Use of Adhesives for Substrate Bonding may be useful. 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 release scenarios corresponding to
several conditions of use, including recycling of TCE, commercial carpet cleaning, and as an
industrial process solvent. 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.
6) Map or group condition(s) of use to a release assessment scenario(s).
EPA has identified release scenarios and mapped (i.e., grouped) them to relevant conditions of
use as shown in Appendix C. As presented in the fourth column in Table Apx C-l, EPA has
grouped the scenarios into seventeen representative release/exposure scenarios, of which five
scenarios will be further analyzed. For example, some scenario groupings include Industrial
Batch Cold Cleaning and Industrial Roll Applications of paints/coatings and adhesives/sealants.
EPA was not able to identify release scenarios corresponding to several conditions of use (e.g.
recycling, commercial carpet cleaning, and use as an industrial process solvent) due generally to
a lack of knowledge of those conditions of use. EPA will perform additional targeted research to
understand those uses which may inform identification of release scenarios. EPA will group
similar conditions of use (based on factors including process equipment and handling, release
sources, and usage rates of TCE and formulations containing TCE) into scenario groupings but
may further refine these groupings as additional information becomes available during risk
evaluation.
7) Evaluate the weight of evidence for environmental release scenarios.
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
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integration of the evidence. Refer to the Application of Systematic Review in TSCA Risk
Evaluations (	)18) document for more information on the general process for data
integration.
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.
Data on measured concentrations in water will be collected and used along with chemical and
physical properties to evaluate exposures in surface water groundwater wastewater treatment
systems, landfill leachate and other aqueous systems. Measured data on the chemical behavior of
TCE in aqueous systems will be collected via systematic review. When not available chemical
and biological fate parameters will be estimated using Estimation Program Interface Suite™
(EPI Suite™), SPARC and other estimation models.
2)	Using measured data and/or modeling, determine the influence of environmental fate
endpoints (e.g., persistence, bioaccumulation, partitioning, transport) on exposure
pathways and routes of exposure to human and environmental receptors.
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 and persistence of trichloroethylene in
environmental 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
tri chl oroethy 1 ene:
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 trichloroethylene, exposure scenarios for environmental receptors include exposures from
surface water.
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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.
• STORE! and NWI jS/EPS)
• 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 trichloroethylene 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. Refer to the supplemental document, Application of Systematic
Review in TSCA Risk Evaluations, for more information on the general process for data
evaluation.
2.6.1.4 General Population
EPA does not plan to consider and analyze general population exposures in the risk evaluation for TCE.
EPA has determined that the existing regulatory programs and associated analytical processes have
addressed or are in the process of addressing potential risks of TCE that may be present in various 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 uses that are not subject to those regulatory processes.
2.6.1.5 Occupational Exposures
EPA will analyze exposures to workers and occupational non-users as follows:
1) Review reasonably available exposure monitoring data for specific condition(s) of use.
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EPA expects to review exposure data including workplace monitoring data collected by
government agencies such as the Occupational Safety and Health Administration (OSHA) and
the National Institute for Occupational Safety and Health (NIOSH), and monitoring data
found in published literature (including both personal exposure monitoring data (direct
exposures) and area monitoring data (indirect exposures)). EPA has reviewed available
monitoring data collected by OSHA and NIOSH and matched them to applicable conditions
of use. EPA has also identified data sources that may contain relevant monitoring data for the
various conditions of use. EPA will review these sources (identified in Table Apx B-5) and
other data sources to extract relevant data for consideration and analysis during risk
evaluation.
2) Review reasonably available exposure data for surrogate chemicals that have uses and
chemical and physical properties similar to TCE.
EPA will review literature sources identified and if surrogate data are found, these data will be
matched to applicable conditions of use for potentially filling data gaps. For several conditions
of use (e.g., cold cleaning, coating applications, adhesive applications), EPA may consider other
similar solvents that share the same conditions of use as possible surrogates for TCE.
3) For conditions of use where data are limited or not available, review existing exposure
models that may be applicable in estimating exposure levels.
EPA has identified Emission Scenario Documents (ESDs) from the Organization for Economic
Co-operation and Development (OECD) and EPA Generic Scenarios (GS's) corresponding to
some conditions of use. For example, the ESD on Industrial Use of Adhesives for Substrate
Bonding, the ESD on Metalworking Fluids, and the GS for textile finishing are some of the
ESDs and GS's that EPA may use to estimate occupational exposures. 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 and GSs corresponding to
several conditions of use, including manufacture of TCE, use of TCE as an intermediate,
recycling of TCE, and commercial carpet cleaning. EPA may conduct industry outreach efforts
or perform supplemental, targeted research to understand those conditions of use, which may
inform identification of exposure scenarios. EPA will consider inhalation exposure to vapor and
mist models in the Chemical Screening Tool for Exposure and Environmental Releases
(Chem.STEER) Tool that are routinely used for assessing new chemicals. EPA may also need to
perform targeted research to identify applicable models that EPA could 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 scenario.
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). EPA may utilize existing, peer-reviewed exposure models developed by EPA/OPPT,
other government agencies, or available in the scientific literature, or EPA may elect to develop
additional models to assess specific condition(s) of use. Inhalation exposure models may be
simple box models or two-zone (near-field/far-field) models. In two-zone models, the near-field
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exposure represents potential inhalation exposures to workers, and the far-field exposure
represents potential inhalation exposures to occupational non-users.
As part of the 2014 RA and subsequent Section 6 rulemaking, EPA developed models to assess
inhalation exposures to workers and occupational non-users during the use of TCE in spot
cleaning, vapor degreasing, and aerosol degreasing. The results of the RA and Section 6
analyses resulted in proposed rules banning the use of TCE in these scenarios. Scenarios
previously examined in the 2014 publication will be considered in this risk evaluation to ensure
previous assessments are in alignment with the Procedures for Chemical Risk Evaluation under
the Amended Toxic Substances Control Act (40 CFR Part 702). During risk evaluation, EPA
will evaluate the applicability of the models to other conditions of use and adapt and refine
these models as necessary for evaluating exposure to TCE in scenarios not covered by the
proposed rules.
EPA will consider the effect of evaporation when evaluating options for dermal exposure
assessment. In addition, EPA will consider the impact of occluded exposure or repeated dermal
contacts. EPA anticipates that existing EPA/OPPT dermal exposure models would not be
suitable for quantifying dermal exposure to highly volatile chemicals such as TCE.
5) Consider and incorporate applicable engineering controls and/or personal protective
equipment into exposure scenarios.
EPA will review data sources on engineering controls and personal protective equipment as
identified in TableApx B-6 and to determine their applicability and incorporation into
exposure scenarios during risk evaluation. Studies will be evaluated using the evaluation
strategies laid out in the Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA.
2018V
6) Evaluate the weight of the evidence of occupational exposure data, which may include
qualitative and quantitative sources of information.
EPA will rely on the weight of the scientific evidence when evaluating and integrating
occupational 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. Refer to the Application of Systematic Review in TSCA Risk Evaluations (U.S.
EPA. 2018) document for more information on the general process for data evaluation.
7) Map or group each condition of use to occupational exposure assessment scenario(s).
EPA has identified occupational exposure scenarios and mapped them to relevant conditions of
use as shown in Appendix C. As presented in the fourth column in Table Apx C-l, EPA has
grouped the scenarios into 17 representative release/exposure scenarios, of which five scenarios
will be further analyzed. For example, one scenario grouping is the aerosol application of mold
release and lubricant products to substrates, where mold release and lubricant products
containing TCE are applied to substrates via aerosol cans. EPA was not able to identify
occupational exposure scenarios corresponding to several conditions of use due generally to a
lack of understanding of those conditions of use. EPA will perform targeted research to
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understand those uses which may inform identification of occupational exposure scenarios and
analyze those uses identified. EPA may refine the mapping/grouping of occupational exposures
scenarios based on factors (e.g. process equipment and handling, usage rates of TCE and
formulations containing TCE, exposure/release sources) corresponding to conditions of use as
additional information is identified during risk evaluation.
2.6.1.6 Consumer Exposures
EPA will analyze consumer exposures as follows:
1) Review reasonably available consumer product-specific exposure data related to
consumer uses/exposures.
The availability of TCE concentrations in consumer products will be evaluated. These data
provide the source term for any subsequent consumer modeling. Additional product-specific
data will be reviewed and considered, including formulation type, application method,
percentage of TCE in product, and likely use patterns (e.g., frequency of use, duration of
activity, room of use).
2) Evaluate the weight of the evidence for consumer exposures.
EPA will rely on the weight of the scientific evidence when evaluating and integrating data
related to consumer exposure. The weight of the evidence may include qualitative and
quantitative sources of information. 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. Refer to the Application of Systematic Review in
TSCA Risk Evaluations ( 2018) document for more information on the general
process for data integration.
3) Review existing exposure models that may be applicable in estimating exposure levels for
exposure pathways where data are not available.
EPA will review existing consumer exposure models that may be applicable in estimating
indoor air concentrations (near field and far field) for the user and bystander, and in estimating
dermal exposure to the consumer in transient exposures (e.g., typical consumer activities) and
longer term (e.g., occluded) exposure scenarios. Determine the applicability of the identified
models for use in a quantitative exposure assessment. Review reasonably available data that
may be used in developing, adapting or applying exposure models to the particulars of this risk
evaluation.
4) Review reasonably available 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.
EPA will review reasonably available empirical data that may be used in developing, adapting
or applying exposure models to the exposure assessment of TCE. For example, existing models
developed for a chemical assessment may be applicable to another chemical evaluation if model
parameter data are available.
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5) Review reasonably available consumer product-specific sources to determine how those
exposure estimates compare with those reported in monitoring data.
EPA will evaluate the relative potential and magnitude of exposure routes based on available
data. For TCE, inhalation of vapor is expected to result in relatively higher exposure to
consumers and bystanders in the home compared with dermal absorption through direct contact
and ingestion of mists. The data sources associated with these respective pathways have not
been comprehensively evaluated, therefore quantitative comparisons across exposure pathways
or in relation to toxicity thresholds are not yet possible.
6) Review reasonably available population- or subpopulation-specific exposure factors and
activity patterns to determine if potentially exposed or susceptible subpopulations need be
further refined.
Based on hazard concerns, certain subpopulations such as pregnant women may be included for
any consumer use scenarios, as a user or bystander. Children and/or infants are generally not
considered "users," but may be assessed as bystanders of consumer uses in the home. Other
subpopulations may be subject to greater exposure, such as DIY users or those in the business
of arts and crafts.
Considerations will include:
• Age-specific differences (exposure factors and activity patterns) for populations defined in
the exposure scenarios. Exposure factors and activities patterns will be sourced from
EPA's 2011 Exposure Factors Handbook.
• Characteristics of the user of the consumer product and the bystander in the room,
including for example, women of child bearing age and children.
• Subpopulations that may have greater exposure due to magnitude, frequency or duration
of exposure as they apply to specific consumer products.
7) Map or group each condition of use to consumer exposure assessment scenario(s).
EPA has identified consumer exposure scenarios that include sources of exposure (i.e.,
consumer products), exposure pathways, exposure settings, exposure routes, and populations
exposed and mapped them to relevant conditions of use, as shown in Appendix C. As presented
in the fourth column in Table Apx D-l, EPA has grouped the scenarios into 141 representative
release/exposure scenarios, of which 38 scenarios will be analyzed during risk evaluation. These
scenarios are associated with different receptor groups (i.e., consumers and bystanders) and
different subcategories of use (e.g., liquid / non-spray applications of penetrating lubricant).
EPA may refine the mapping/grouping of consumer exposures scenarios as product use patterns
and are further characterized.
EPA will further refine and finalize exposure scenarios for consumers with the following
considerations:
• Reasonably available data on consumer products or products available for consumer use
including the weight fraction of TCE in products;
• Information characterizing the use patterns of consumer products containing TCE
including the following: intended or likely consumer activity, method of application (e.g.,
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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.
2.6.2 Hazards (Effects)
2.6.2.5 Environmental Hazards
EPA will conduct an environmental hazard assessment of TCE 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 ( 18)
document. 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 TCE to aquatic species (i.e. aquatic plants).
2) Derive aquatic concentrations of concern (COC) for acute and chronic endpoints.
The aquatic environmental hazard studies may be used to derive acute and chronic
concentrations of concern (COC) for mortality, growth 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 plants), environmental hazard values (e.g.
ECx/LCx/NOEC/LOEC, etc.) may be derived and used to further understand the hazard
characteristics of TCE to aquatic species.
3) Evaluate the weight of the evidence of environmental hazard data.
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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. Refer to the supplemental document, Application of Systematic Review in TSCA
Risk Evaluations (U.S. EPA. 2.018), for more information on the general process for data
evaluation.
4) Consider the route(s) of exposure, available biomonitoring data and available approaches
to integrate exposure and hazard assessments.
EPA believes there is sufficient information to evaluate the potential risks to aquatic species
(i.e. aquatic plants) from exposures to TCE in surface water.
2.6.2.6 Human Health Hazards
EPA expects to analyze human health hazards as follows:
1) Review reasonably available human health 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; systems biology).
Human health studies will be evaluated using the evaluation strategies laid out in the
Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2018). Human, animal
and mechanistic data will be identified and included as described in the Population, Exposure,
Comparator, and Outcome (PECO) statement for TCE (see Appendix F.4). The protocol
describes how studies will be evaluated using specific data evaluation criteria and a
predetermined systematic approach. Study results will be extracted and presented in evidence
tables by hazard endpoint. For the TCE risk evaluation, EPA will evaluate information in the
IRIS assessment (U.S. EPA. ), the final TSCA Work Plan Chemical Risk Assessment of
TCE (1 r U \ jQ 14c) and studies published after 2010 that were captured in the
comprehensive literature search conducted by the Agency for TCE \Tricholoroethylene (79-01-
6) Bibliography: Supplemental File for the TSCA Scope Document; (EPA-HQ-OPPT-2016-
0737; U.S. EPA, 2017g)] using OPPT's structured process described in the document,
Application of Systematic Review in TSCA Risk Evaluations ( 2018). EPA intends to
review studies published after the IRIS assessment to ensure that EPA is considering
information that has been made available since these assessments were conducted. Evidence for
each health outcome will be integrated by synthesizing the lines of human epidemiology and
animal experimental evidence. The final TSCA Work Plan Chemical Risk Assessment of TCE
(U.S. EPA. 2014c) included an assessment of fetal cardiac malformations. EPA will use the
systematic review approach (U.S. EPA. 2018) to re-evaluate key studies in this assessment as
well as more recent information on this endpoint. of mechanistic data as part of EPA's
reevaluation of key studies. Mechanistic data related to all other endpoints will be identified as
"Supplemental Information."
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.
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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 TCE
hazard(s). Susceptibility of particular human receptor groups to TCE will be determined by
evaluating information on factors that influence susceptibility.
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.
Human health hazards from acute and chronic exposures will be identified by evaluating the
human and animal data that meet the systematic review data quality criteria described in the
Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2018) document. Data
quality evaluation will be performed on key studies identified from the Integrated Risk
Information System (IRIS) Toxicological Review of TCE (U.S. EPA. 201lc). the final TSCA
Work Plan Chemical Risk Assessment of TCE (U.S. EPA. 2014c) and studies published after
2010 that were captured in the comprehensive literature search conducted by the Agency for
TCE \Tricholoroethylene (79-01-6) Bibliography: Supplemental File for the TSCA Scope
Document; (EPA-HQ-OPPT-2016-0737; U.S. EPA, 2017g)]. Hazards identified by studies
meeting data quality criteria will be grouped by routes of exposure relevant to humans (oral,
dermal, inhalation) and by cancer and noncancer endpoints.
Dose-response assessment will be performed in accordance with EPA guidance (U.S. EPA.
2 , j). Dose-response analyses performed for the IRIS oral and
inhalation reference dose determinations may be used if the data meet data quality criteria and if
additional information on the identified hazard endpoints are not available or would not alter the
analysis.
The cancer mode of action (MOA) determines how cancer risks can be quantitatively evaluated.
EPA will evaluate information on genotoxicity and the mode of action for all cancer endpoints
to determine the appropriate approach for quantitative cancer assessment in accordance with the
U.S. EPA Guidelines for Carcinogen Risk Assessment (U.S. EPA. 2.005).
4) Derive points of departure (PODs) where appropriate; conduct benchmark dose modeling
depending on the available data. Adjust the PODs as appropriate to conform (e.g., adjust
for duration of exposure) to the specific exposure scenarios evaluated.
Hazard data will be evaluated to determine the type of dose-response modeling that is
applicable. Where modeling is feasible, a set of dose-response models that are consistent with a
variety of potentially underlying biological processes will be applied to empirically model the
dose-response relationships in the range of the observed data consistent with the EPA
Benchmark Dose Technical Guidance Document. Where dose-response modeling is not
feasible, no-observed-adverse-effect-levels (NOAELs) or lowest-observed-adverse-effect-
levels (LOAELs) will be identified. Non-quantitative data will also be evaluated for
contribution to weight of evidence or for evaluation of qualitative endpoints that are not
appropriate for dose-response assessment.
EPA will evaluate whether the available physiologically-based pharmacokinetic (PBPK) and
empirical kinetic models are adequate for route-to-route and interspecies extrapolation of the
POD, or for extrapolation of the POD to standard exposure durations (e.g., lifetime continuous
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exposure). If application of the PBPK model is not possible, oral PODs may be adjusted by
body weight374 (BW3 4) scaling in accordance with ( lib), and inhalation PODs
may be adjusted by exposure duration and chemical properties in accordance with (U.S. EPA.
1994V
5) Evaluate the weight of the evidence for human health hazards.
EPA will rely on the weight of the scientific evidence when evaluating and integrating human
health hazard 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 including strengths and limitations, followed by
synthesis and integration of the evidence. Refer to the Application of Systematic Review in
TSCA Risk Evaluations (U.S. EPA. 2018) document for more information on the general
process for data evaluation.
6) Consider the route(s) of exposure (oral, inhalation, dermal), available route-to-route
extrapolation approaches, available biomonitoring data and available approaches to
correlate internal and external exposures to integrate exposure and hazard assessment.
EPA believes there will be sufficient data to conduct dose-response analysis and/or benchmark
dose modeling for both inhalation and oral routes of exposure.
If sufficient dermal toxicity studies are not identified in the literature search to assess risks from
dermal exposures, then a route-to-route extrapolation from the inhalation and oral toxicity
studies would be needed to assess systemic risks from dermal exposures. Without an adequate
PBPK model for the dermal route of exposure, the approaches described in the EPA guidance
document Risk Assessment Guidance for Superfund Volume I: Human Health Evaluation
Manual (Part E, Supplemental Guidance for Dermal Risk Assessment) could be applied. These
approaches may be able to further inform the relative importance of dermal exposures compared
with other routes of exposure.
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 Risk Evaluation Framework Rule
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(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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L J"!!.!* (U.S. Environmental Protection Agency). (2016d). Supplemental occupational exposure and
risk reduction technical report in support of risk management options for trichloroethylene (TCE)
use in aerosol degreasing. (RENT 2070-AK03). Washington D.C.: Office of Chemical Safety and
Pollution Prevention. https://www.regulations.gov/document'?D=EPA-HO>	.'A'tll
0021
(U.S. Environmental Protection Agency). (2016e). Supplemental occupational exposure and
risk reduction technical report in support of risk management options for trichloroethylene (TCE)
use in spot cleaning. (RIN 2070-AK03). Washington D.C.: Office of Chemical Safety and
Pollution Prevention, http s: //www .regulations, gov/docum e IP A-HQ-OPPT-2016-0163 -
0024
L ^ EPA (U.S. Environmental Protection Agency). (2016f). Supplemental occupational exposure and
risk reduction technical report in support of risk management options for trichloroethylene (TCE)
use in vapor degreasing. (RIN 2070-AK11). Washington D.C.: Office of Chemical Safety and
Pollution Prevention, http s: //www .regulations, gov/docum. e IP A-HQ-OPPT-2016-0387-
0126
11 ^ EPA (U.S. Environmental Protection Agency). (2016g). TSCA work plan chemical risk
assessment: Peer review draft 1-bromopropane: (n-Propyl bromide) spray adhesives, dry
cleaning, and degreasing uses CASRN: 106-94-5 [EPA Report], (EPA 740-R1-5001).
Washington, DC. https://www.epa.gov/sites/production/files/2016-03/documents/l-
bp report and appendices final.pdf
(2017a). Chemical test rule data: Trichloroethylene. Washington, DC. Retrieved from
http ://i ava.epa. gov/chemview
(U.S. Environmental Protection Agency). (2017b). Consumer Exposure Model (CEM) version
2.0: User guide. U.S. Environmental Protection Agency, Office of Pollution Prevention and
Toxics. https://www.epa.gOv/sites/production/files/l:01 ' 06/documents/ctH^ J ^ i^er guide.pdf
(U.S. Environmental Protection Agency). (2017c). Preliminary information on manufacturing,
processing, distribution, use, and disposal: Trichloroethylene. (EPA-HQ-OPPT-2016-0737).
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Washington, DC: Office of Chemical Safety and Pollution Prevention.
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(U.S. Environmental Protection Agency). (2017d). Scope of the risk evaluation for
trichloroethy 1 ene. CASRN: 79-01-6 [EPA Report], (EPA-740-R1-7004).
https://www.epa.gOv/sites/production/files/2 /documents/toe scope 06-22-17.pdf
(U.S. Environmental Protection Agency). (2017e). Toxics Release Inventory (TRI). Retrieved
from https://www.epa.gov/toxics-release-inventorv4ri-proeram/tri-data-and4ools
(U.S. Environmental Protection Agency). (2017f). Trichloroethylene market and use report.
Washington, DC: Office of Chemical Safety and Pollution Prevention, Chemistry, Economics,
and Sustainable Strategies Division.
(U.S. Environmental Protection Agency). (2017g). Tricholoroethylene (79-01-6)
bibliography: Supplemental file for the TSCA Scope Document [EPA Report],
https://www.epa.gOv/sites/prodiiction/files/2 /documents/tce comp bib.pdf
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https://www.epa.gov/vaporintmsion/vapor-intmsion.-database
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Ulander. A; Selden. A; Ahlborg. G. Jr. (1992). Assessment of intermittent trichloroethylene exposure in
vapor degreasing. AIHA J 53: 742-743. http://dx.doi.org/10.1080/15298669291360454
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the removal and recovery of resin from dyed cloth. Ispra, Italy: European Commission Joint
Research Centre, Institute for Health and Consumer Protection, European Chemicals Bureau.
Weast. RC: Selbv. SM. (1966). CRC handbook of chemistry and physics Ethene, trichloro. Cleaveland,
OH: The Chemical Rubber Co.
Wu. C; Schaum. J. (2000). Exposure assessment of trichloroethylene. Environ Health Perspect 108: 359-
363.
Xu. X: Yang. R; Wu. N: Zhong. P; Ke. Y: Zhou. L; Yuan, J; Li Huang. H; Wu K (2009). Severe
hypersensitivity dermatitis and liver dysfunction induced by occupational exposure to
trichloroethylene. Ind Health 47: 107-112.
Yang. WB; Chen. WH; Yuan. CS; Yaii^ JC ,'ltao. QL. (2012). Comparative assessments of VOC
emission rates and associated health risks from wastewater treatment processes. J Environ Monit
14: 2464-2474. http://dx.doi.org/10.1039/c2em30138e
Yoshioka. YO. Y. Sato. T. (1985). Testing for the toxicity of chemicals with Tetrahymena pyriformis.
Sci Total Environ 43: 149-157.
Yoshioka. YO. Y. Sato. T. (1986). Correlation of the Five Test Methods to Assess Chemical Toxicity
and Relation to Physical Properties. 12: 15-21.
Zogorsld. JS; Carter. JM; Ivahnenko. T; Lapham. WW; Moran. MI; Rows' «'! Squillacc * 1 11 calino.
PL. (2006). Volatile organic compounds in the nation's ground water and drinking-water supply
wells. (Circular 1292). Reston, VA: U.S. Department of the Interior, U.S. Geological Survey.
http://pubs.usgs. gov/circ/circ 1292/pdf/circularl 292.pdf
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APPENDICES
Appendix A REGULATORY HISTORY
A.l Federal Laws and Regulations
Table Apx A-l. Federa
Laws and Regulations
Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
EPA Regulations
Toxics Substances
Control Act (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 under section 6 of
TSCA to address the unreasonable
risks presented by TCE use in
vapor degreasing (i I;
January 19, 2017).
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 under section 6 of
TSCA to address the unreasonable
risks presented by TCE use in
commercial and consumer aerosol
degreasing and for spot cleaning at
dry cleaning facilities (
>2; December 16, 2016).
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 is directed to identify
and begin risk evaluations on
10 chemical substances drawn from the
2014 update of the TSCA Work Plan for
Chemical Assessments.
TCE is on the initial list of
chemicals to be evaluated for
unreasonable risks under TSCA
(Si Hx i".' , December 19,
2016).
TSCA - Section 5(a)
Once EPA determines that a use of a
chemical substance is a significant new
use under TSCA section 5(a), persons are
required to submit a significant new use
notice (SNUN) to EPA at least 90 days
before they manufacture (including
import) or process the chemical
substance for that use.
Significant New Use Rule (SNUR)
( 10535: April 8. 2016V
TCE is subject to reporting under
the SNUR for manufacture
(including import) or processing of
TCE for use in a consumer product
except for use in cleaners and
solvent degreasers, film cleaners,
hoof polishes, lubricants, mirror
edge sealants and pepper spray.
This SNUR ensures that EPA will
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation


have the opportunity to review any
new consumer uses of TCE and, if
appropriate, take action to prohibit
or limit those uses.
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.
TCE manufacturing (including
importing), processing and use
information is reported under the
CDR rule (76 FR 50816. Auaust
16, 2011).
TSCA - Section 8(b)
EPA must compile, keep current and
publish a list (the TSCA Inventory) of
each chemical substance manufactured,
processed or imported in the United
States.
TCE was on the initial TSCA
Inventory and was therefore not
subject to EPA's new chemicals
review process (60 FR 16309,
March 29, 1995).
TSCA - Section 8(e)
Manufacturers (including imports),
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.
28 substantial risk notifications
received for TCE (U.S. EPA,
ChemView. Accessed April 13,
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.
Seven studies received for TCE
(U.S. EPA, ChemView. Accessed
April 13, 2017).
Emergency Planning
and Community Right-
to-Know Act (EPCRA)
- Section 313
Requires annual reporting from facilities
in specific industry sectors that employ
10 or more full time equivalent
employees and that manufacture, process,
or otherwise use a TRI-listed chemical in
quantities above threshold levels. A
facility that meets reporting requirements
must submit a reporting form for each
chemical for which it triggered reporting,
providing data across a variety of
categories, including activities and uses
of the chemical, releases and other waste
management (e.g., quantities recycled,
treated, combusted) and pollution
prevention activities (under section 6607
of the Pollution Prevention Act). These
data include on- and off-site data as well
TCE is a listed substance subject
to reporting requirements under
40 CFR 372.65 effective as of
January 1, 1987.
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation

as multimedia data (i.e., air, land and
water).

Federal Insecticide,
Fungicide, and
Rodenticide Act
(FIFRA) - Section 6
FIFRA governs the sale, distribution and
use of pesticides. Section 3 of FIFRA
generally requires that pesticide products
be registered by EPA prior to distribution
or sale. Pesticides may only be registered
if, among other things, they do not cause
"unreasonable adverse effects on the
environment." Section 6 of FIFRA
provides EPA with the authority to
cancel pesticide registrations if either: (1)
the pesticide, labeling, or other material
does not comply with FIFRA or (2) when
used in accordance with widespread and
commonly recognized practice, the
pesticide generally causes unreasonable
adverse effects on the environment.
TCE is no longer used as an inert
ingredient in pesticide products.
Clean Air Act (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 HAPs and then set emission
standards for those listed source
categories under CAA section 112(d).
CAA section 112(b)(3)(A) specifies that
any person may petition the
Administrator to modify the list of HAPs
by adding or deleting a substance. Since
1990, EPA has removed two pollutants
from the original list, leaving 187 at
present.
Lists TCE as a HAP (42 U.S.C.
7412(b)(1)).
CAA - Section 112(d)
Section 112(d) states that the EPA must
establish a National Emission Standards
for Hazardous Air Pollutants (NESHAP)
for each category or subcategory of
major sources and area sources of HAPs
(listed pursuant to Section 112(c)). The
standards must require the maximum
degree of emission reduction that EPA
determines to be achievable by each
particular source category. Different
criteria for maximum achievable control
technology (MACT) apply for new and
existing sources. Less stringent
standards, known as generally available
control technology (GACT) standards,
EPA has promulgated a number of
NESHAP regulating industrial
source categories that emit
trichloroethylene and other HAP
httos://www. eoa. gov/ stationary-
sources-air-Dollution/halogenated-
solvent-cleaning-national-
emission-standards-hazardou-0 .
These include, for example, the
NESHAP for Halogenated Solvent
Cleaning (59 FR 61801; December
2, 1994), among others.
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation

are allowed at the Administrator's
discretion for area sources.

CAA - Sections 112(d)
and 112 (f)
Risk and technology review (RTR) of
section 112(d) MACT standards. Section
1 12(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 1 12(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 (12 FR 25138; Mav 3.
2007) and will do so, as required,
for the remaining source
categories with NESHAP.
CWA - Sections
301(b), 304(b), 306,
and 307(b)
Requires establishment of Effluent
Limitations Guidelines and Standards for
conventional, toxic, and
non-conventional 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. Regulations apply to
existing and new sources.
TCE is designated as a toxic
pollutant under section 307(a)(1)
of the CWA and as such, is subject
to effluent limitations.
CWA - Section 307(a)
Establishes a list of toxic pollutants or
combination of pollutants under the to
the CWA. The statute specifies a list of
families of toxic pollutants also listed in
40 CFR 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, or on a case-by-case best
professional judgement basis in National
Pollutant Discharge Elimination System
(NPDES) permits.

Safe Drinking Water
Act (SDWA) - Section
1412
Requires EPA to publish a 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
EPA issued drinking water
standards for TCE pursuant to
section 1412 of the SDWA. EPA
promulgated the NPDWR for TCE
in 1987 with a MCLG of zero an
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation

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
enforceable MCL of 0.005 mg/L
(52 FR 25690, July 8, 1987).
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.
TCE is included on the list of
commercial chemical products,
manufacturing chemical
intermediates or off-specification
commercial chemical products or
manufacturing chemical
intermediates that, when disposed
(or when formulations containing
any one of these as a sole active
ingredient are disposed) unused,
become hazardous wastes pursuant
to RCRA 3001. RCRA Hazardous
Waste Status: D040 at 0.5 mg/L;
F001, F002; U228
Comprehensive
Environmental
Response,
Compensation and
Liability Act
(CERCLA) - Section
102(a)
Authorizes EPA to promulgate
regulations designating as hazardous
substances those substances which, when
released into the environment, may
present substantial danger to the public
health or welfare or the environment.
EPA must also promulgate regulations
establishing the quantity of any
hazardous substance the release of which
must be reported under Section 103.
Section 103 requires persons in charge of
vessels or facilities to report to the
National Response Center if they have
knowledge of a release of a hazardous
TCE is a hazardous substance with
a reportable quantity pursuant to
section 102(a) of CERCLA (40
CFR 302.4) and EPA is actively
overseeing cleanup of sites
contaminated with TCE pursuant
to the National Contingency Plan
(NCP) (40 CFR 751).
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation

substance above the reportable quantity
threshold.

Other Federal Regulations
OSHA
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.
In 1971, OSHA issued
occupational safety and health
standards for TCE that included a
Permissible Exposure Limit (PEL)
of 100 ppm TWA, exposure
monitoring, control measures and
respiratory protection (29 CFR
1910.1000).
While OSHA has established a
PEL for TCE, OSHA has
recognized that many of its
permissible exposure limits (PELs)
are outdated and inadequate for
ensuring protection of worker
health. Most of OSHA's PELs
were issued shortly after adoption
of the Occupational Safety and
Health (OSH) Act in 1970, and
have not been updated since that
time. Section 6(a) of the OSH Act
granted the Agency the authority
to adopt existing Federal standards
or national consensus standards as
enforceable OSHA standards. For
TCE, OSHA recommends the use
of the NIOSH REL of 2 ppm (as a
60-minute ceiling) during the
usage of TCE as an anesthetic
agent and 25 ppm (as a 10-hour
TWA) during all other exposures.
Atomic Energy Act
The Atomic Energy Act authorizes the
Department of Energy to regulate the
health and safety of its contractor
employees
10 CFR 851.23, Worker Safety
and Health Program, requires the
use of the 2005 ACGM TLVs if
they are more protective than the
OSHA PEL. The 2005 TLV for
TCE is 50 ppm.
Federal Food, Drug,
and Cosmetic Act
(FFDCA)
Provides the FDA with authority to
oversee the safety of food, drugs and
cosmetics.
Tolerances are established for
residues of TCE resulting from its
use as a solvent in the manufacture
of decaffeinated coffee and spice
oleoresins (21 CFR 173.290).
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A.2 State Laws and Regulations
Table Apx A-2. State Laws and Regulations
State Actions
Description of Action
California Code of
Regulations (CCR), Title 17,
Section 94509(a)
Lists standards for VOCs for consumer products sold, supplied, offered
for sale or manufactured for use in California. As part of that
regulation, use of consumer general purpose degreaser products that
contain TCE are banned in California and safer substitutes are in use
(17 CCR, Section 94509(a).
State Permissible Exposure
Limits (PELs)
Most states have set PELs identical to the OSHA 100 ppm 8-hour
TWA PEL. Nine states have PELs of 50 ppm. California's PEL of
25 ppm is the most stringent (CCR, Title 8, Table AC-1).
VOC regulations for
consumer products
Many states regulate TCE 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
TCE is on California Proposition 65 List of chemicals known to cause
cancer in 1988 or birth defects or other reproductive harm in 2014
(CCR Title 27, section 27001). TCE is on California's Safer Consumer
Products Regulations Candidate List of chemicals that exhibit a hazard
trait and are on an authoritative list (CCR Title 22, Chapter 55).
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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
TCE is on the Canadian List of Toxic Substances (CEPA
1999 Schedule 1). TCE is also regulated for use and sale
for solvent degreasing under Solvent Degreasing
Regulations (SOR/2003-283) (Canada Gazette, Part II on
August 13, 2003). The purpose of the regulation is to
reduce releases of TCE into the environment from solvent
degreasing facilities using more than 1000 kilograms of
TCE per year. The regulation includes a market
intervention by establishing tradable allowances for the
use of TCE in solvent degreasing operations that exceed
the 1000 kilograms threshold per year.
European Union
In 2011, TCE was added to Annex XIV (Authorisation
list) of regulation (EC) No 1907/2006 - REACH
(Registration, Evaluation, Authorization and Restriction
of Chemicals). Entities that would like to use TCE needed
to apply for authorization by October 2014, and those
entities without an authorization must stop using TCE by
April 2016. The European Chemicals Agency (ECHA)
received 19 applications for authorization from entities
interested in using TCE beyond April 2016.
TCE is classified as a carcinogen category IB, and was
added to the EU REACH restriction of substances
classified as carcinogen category 1A or IB under the EU
Classification and Labeling regulation (among other
characteristics) in 2009. The restriction bans the placing
on the market or use of TCE as substance, as constituent
of other substances, or, in mixtures for supply to the
general public when the individual concentration in the
substance or mixture is equal to or greater than 0.1 % w/w
(Regulation (EC) No 1907/2006 - REACH (Registration,
Evaluation, Authorization and Restriction of Chemicals)).
Previous regulations, such as the Solvent Emissions
Directive (Directive 1999/13/EC) introduced stringent
emission controls of TCE.
Australia
In 2000, TCE was assessed (National Industrial Chemicals
Notification and Assessment Scheme, NICNAS (2000).
Trichloroethylene. Accessed April, 18 2017).
Japan Chemical Substances
Control Law
TCE 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)
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•	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
•	Law for the Control of Household Products Containing
Harmful Substances
(National Institute of Technology and Evaluation (NITE)
Chemical Risk Information Platform (CHIRP), Accessed
April 18, 2017).
Australia, Austria, Belgium,
Canada, Denmark, 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 TCE (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 TCE.
B.l Process Information
Process-related information to the risk evaluation may include process diagrams, descriptions and
equipment. Such information may inform potential release sources and worker exposure activities for
consideration.
B.l.l Manufacture (including Import)
B.l.1.1 Import
EPA has also not identified specific activities related to the import of TCE. EPA expects imported
chemicals are stored in warehouses prior to distribution for further processing and use. In some cases,
the chemicals may be repackaged into differently sized containers, depending on customer demand, and
quality control (QC) samples may be taken for analyses.
According to Snedecor et al. (2004b). TCE is typically shipped by truck or rail car or in 55-galIon
drums. TCE may be stored in mild steel tanks equipped with vents and vent dryers to prevent water
accumulation (Snedecor et al.. 2004b).
B.l.1.2 Manufacturing
TCE was previously produced through chlorination of acetylene to 1,1,2,2-tetrachloroethane, then
dehydrochlorination to TCE in an aqueous base or by thermal cracking (Snedecor et al... 2004b). Due to
rising costs of acetylene, this process has largely been phased-out (ATSDR. 2014a; Snedecor et al..
2004b). Currently, most TCE is manufactured via chlorination or oxychlorination of ethylene,
dichloroethane or ethylene dichloride (EDC) (ATSDR. 2014a; Snedecor et al.. 2004b).
• Chlorination - The chlorination process involves a catalytic reaction of chlorine and ethylene,
dichloroethane or EDC to form TCE and perchloroethylene (PCE) as co-products and
hydrochloric acid (HC1) as a byproduct (ATSDR. 2014; Snedecor et al.. 2004; (U.S. EPA. 1985).
Typical catalysts include potassium chloride, aluminum chloride, Fuller's earth, graphite,
activated carbon and activated charcoal (Snedecor et al.. 2004b).
• Oxychlorination - The oxychlorination process involves the reaction of either chlorine or HC1
and oxygen with ethylene, dichloroethane or EDC in the presence of a catalyst to produce TCE
and PCE as co-products ( DR. 2014a; Snedecor et al.. 2004b). The process usually occurs in
a fluidized-bed reactor (Snedecor et al.. 2004b). Common catalysts are mixtures of potassium
and cupric chlorides (Snedecor et al.. 2004b).
In either process the product ratio of TCE to PCE products are controlled by adjusting the reactant
rations (Snedecor et al.. 2004b).
B.1.2 Processing
B.l.2.1 Reactant or Intermediate
Processing as a reactant or intermediate is the use of TCE as a feedstock in the production of another
chemical product via a chemical reaction in which TCE is consumed to form the product. TCE is used as
a feedstock in the production of HFCs alternatives to CFCs, specifically the HFC-134a alternative to
CFC-12 (ATSDR. 2014a; Elsheikh et al.. 2005; Snedecor et al.. 2004b). The production of HFC-134a
from TCE can be carried out in one of two processes (Elsheikh et al.. 2005). In the first process, TCE is
Page 96 of 209

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fluorinated in either a gas- or liquid-phase reaction with hydrofluoric acid using a Lewis acid catalyst to
produce the hydrochlorofluorocarbon, HCFC-133a, which is then subsequently fluorinated to produce
HFC-134a by reaction with hydrofluoric acid using a catalyst (Elsheikh et ai. 2005) (Smart and
Fernandez. 2000). The second process involves fluorination of TCE using a chromium-based catalyst to
form HCFC-133a as the major product and HFC-134a as the minor product (Elsheikh et at.. 2005). The
HFC-134a is then separated out using distillation and the HCFC-133a is recycled back through the
reactor (Elsheikh et at.. 2005).
B. 1.2.2 Incorporating into a 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 TCE that may require
incorporation into a formulation include adhesives, sealants, coatings and lubricants. TCE-specific
formulation processes were not identified; however, several Emission Scenario Documents (ESDs)
published by the OECD have been identified that provide general process descriptions for these types of
products. The formulation of coatings typically involves dispersion, milling, finishing and filling into
final packages (OE< 09b). Adhesive formulation involves mixing together volatile and non-volatile
chemical components in sealed, unsealed or heated processes (OB 09a). 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
EPA has not identified specific information for the repackaging of TCE. EPA expects 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.l.2.4 Recycling
TRI data from 2015 indicate that some sites ship TCE for off-site recycling. EPA did not identify TCE-
specific information for recycling; however, a general description of waste solvent recovery processes
was identified. Waste solvents are generated when the solvent stream becomes contaminated with
suspended and dissolved solids, organics, water or other substance (U.S. EPA. 1980a). Waste solvents
can be restored to a condition that permits reuse via solvent reclamation/recycling ( )a).
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 ( 80a). Figure Apx B-l illustrates a typical
solvent recovery process flow diagram ( 3a).
Page 97 of 209

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Storage
Tank
Venl
Fugitive
Emissions
Fugitive
Emissions
Fugitive
Emissions
Fugitive
Emissions
Waste
Solvent
Incinerator Stack
* Fugitive Emissions
Storage
and
Handling
Storage
and
Handling
Waste
Disposal
Purification
FigureApx B-l. General Process Flow Diagram for Solvent Recovery Processes
Page 98 of 209

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B.1.3 Uses
EPA assessed inhalation risks from TCE in vapor and aerosol degreasing, spot cleaning at dry cleaning
facilities and arts and craft uses (U.S. EPA, z ) and also completed four supplemental analyses as
identified in Section 1.2. Based on these analyses, EPA published two proposed rules to address the
unreasonable risks presented by TCE use in vapor degreasing and in commercial and consumer aerosol
degreasing and for spot cleaning at dry cleaning facilities (82 FR 7432. January 19, 2017; 2,
December 16, 2016). Scenarios previously examined in the 2014 publication will be considered in this
risk evaluation to ensure previous assessments are in alignment with the Procedures for Chemical Risk
Evaluation under the Amended Toxic Substances Control Act (40 CFR Part 702).
B.l.3.1 Solvent for Cleaning or Degreasing
Vapor Degreasing
This scenario was previously assessed in the 2014 risk assessment (U.S. EPA. 2014c). 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:
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 (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.
• Open top vapor degreasers (OTVD) - In OTVDs, a vapor cleaning zone is created by heating the
liquid solvent in the OTVD causing it to volatilize. Workers manually load or unload fabricated
parts directly into or out of the vapor cleaning zone. The tank usually has chillers along the side
of the tank to prevent losses of the solvent to the air. However, these chillers are not able to
eliminate emissions, and throughout the degreasing process significant air emissions of the
solvent can occur. These air emissions can cause issues with both worker health and safety as
well as environmental issues. Additionally, the cost of replacing solvent lost to emissions can be
expensive (NEWM >01). Figure_Apx B-2 illustrates a standard OTVD.
Page 99 of 209

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:§
Boiling sump-
Vapor Zone
]
.Condensing Coils
^^Water Jacket
]^/Water Separator
Heat Source
FigureApx B-2. Open Top Vapor Degreaser
OTVD with enclosure - OTVDs with enclosures operate the same as standard OTVDs except
that the OTVD is enclosed on all sides during degreasing. The enclosure is opened and closed to
add or remove parts to/from the machine, and solvent is exposed to the air when the cover is
open. Enclosed OTVDs may be vented directly to the atmosphere or first vented to an external
carbon filter and then to the atmosphere (EPA, 2004). Figure Apx B-3 illustrates an OTVD with
an enclosure. The dotted lines in Figure Apx B-3 represent the optional carbon filter that may or
may not be used with an enclosed OTVD.
—I
->I Carbon Filter
•vent
Loading/
unloading
lock
[
Boiling su
Heat Sou
np-
ce-

Vapor Zone
O
-8
1
Wate
1/W,
J
Condensing Coils
Jacket
er Separator
Figure Apx B-3. Open Top Vapor Degreaser with Enclosure
• Closed-loop degreasing system (Airtight) - In closed-loop degreasers, parts are placed into a
basket, which is then placed into an airtight work chamber. The door is closed and solvent vapors
are sprayed onto the parts. Solvent can also be introduced to the parts as a liquid spray or liquid
Page 100 of 209

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immersion. When cleaning is complete, vapors are exhausted from the chamber and circulated
over a cooling coil where the vapors are condensed and recovered. The parts are dried by forced
hot air. Air is circulated through the chamber and residual solvent vapors are captured by carbon
adsorption. The door is opened when the residual solvent vapor concentration has reached a
specified level (Kanegsberg and Kanegsberg. 2011). FigureApx B-4 illustrates a standard
closed-loop vapor degreasing system.
Vent
Solvent Abatement Loop
Refrigeration
Distillation
Solvent Sump
Electric Heat
Solvent Tank(s)
Working Chamber
Workload
Figure Apx B-4. Closed-loop/Vacuum Vapor Degreaser
• Airless degreasing system (vacuum drying) - Airless degreasing systems are also sealed, closed-
loop systems, but remove air at some point of the degreasing process. Removing air typically
takes the form of drawing vacuum, but could also include purging air with nitrogen at some point
of the process (in contrast to drawing vacuum, a nitrogen purge operates at a slightly positive
pressure). In airless degreasing systems with vacuum drying only, the cleaning stage works
similarly as with the airtight closed-loop degreaser. However, a vacuum is generated during the
drying stage, typically below 5 torr (5 mmHg). The vacuum dries the parts and a vapor recovery
system captures the vapors (EPA, 2001; (Kanegsberg and Kanegsberg. 2011); (NEWMOA
2001).
• Airless vacuum-to-vacuum degreasing system - Airless vacuum-to-vacuum degreasers are true
"airless" systems because the entire cycle is operated under vacuum. Typically, parts are placed
into the chamber, the chamber sealed, and then vacuum drawn within the chamber. The typical
solvent cleaning process is a hot solvent vapor spray. The introduction of vapors in the vacuum
chamber raises the pressure in the chamber. The parts are dried by again drawing vacuum in the
chamber. Solvent vapors are recovered through compression and cooling. An air purge then
purges residual vapors over an optional carbon adsorber and through a vent. Air is then
introduced in the chamber to return the chamber to atmospheric pressure before the chamber is
opened (Durkee. 2014; NEWMOA 2001).
The general design of vacuum vapor degreasers and airless vacuum degreasers is similar as illustrated in
Figure Apx B-7 for closed-loop systems except that the work chamber is under vacuum during various
stages of the cleaning process.
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Conveyorized Vapor Degreasers
Conveyorized vapor degreasing systems are solvent cleaning machines that use an automated parts
handling system, typically a conveyor, to automatically provide a continuous supply of parts to be
cleaned. Conveyorized degreasing systems are usually fully enclosed except for the conveyor inlet and
outlet portals. Conveyorized degreasers are likely used in similar shop types as batch vapor degreasers
except for repair shops, where the number of parts being cleaned is likely not large enough to warrant
the use of a conveyorized system. 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 (U.S. EPA. 1977).
• Monorail Degreasers - Monorail degreasing systems are typically used when parts are already
being transported throughout the manufacturing areas by a conveyor ( J.S. EPA, 1977). They use
a straight-line conveyor to transport parts into and out of the cleaning zone. The parts may enter
one side and exit and the other or may make a 180° turn and exit through a tunnel parallel to the
entrance ( J.S. EPA, 1977). Figure_Apx B-5 illustrates atypical monorail degreaser (J.S. EPA.
1977).
Monora i1
Conveyop^ —
BoiTTfig-
Chamber
Water
Jacket
FigureApx B-5. Monorail Conveyorized Vapor Degreasing System (U.S. EPA, 1977)
• Cross-rod Degreasers - Cross-rod degreasing systems utilize two parallel chains connected by a
rod that support the parts throughout the cleaning process. The parts are usually loaded into
perforated baskets or cylinders and then transported through the machine by the chain support
system. The baskets and cylinders are typically manually loaded and unloaded ( '.S. EPA. 1977).
Cylinders are used for small parts or parts that need enhanced solvent drainage because of
crevices and cavities. The cylinders allow the parts to be tumbled during cleaning and drying and
thus increase cleaning and drying efficiency. Figure Apx B-6 illustrates a typical cross-rod
degreaser (U.S. EPA. 1977).
Page 102 of 209

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Conveyor Path
Chain Support
Water
Jacket
Boiling Chamber
FigureApx B-6. Cross-Rod Conveyorized Vapor Degreasing System ( l.S, EPA, 1977)
• Vibra Degreasers - In vibra degreasing systems, parts are fed by conveyor through a chute that
leads to a pan flooded with solvent in the cleaning zone. The pan and the connected spiral
elevator are continuously vibrated throughout the process causing the parts to move from the pan
and up a spiral elevator to the exit chute. As the parts travel up the elevator, the solvent
condenses and the parts are dried before exiting the machine ( J.S. EPA. 1977). Figure_Apx B-7
illustrates a typical vibra degreaser ( J.S. EPA. 1977).
Workload Discharger Chute
Ascending
Vibrating
Trough —
Condensers
Distillate
Trough
Workload
Entry Chute
Distillate Return
For Counter-
flow Wash
Steam Coils
Figure Apx B-7. Vibra Conveyorized Vapor Degreasing System ( J.S. EPA, 1977)
Page 103 of 209

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• Ferris wheel degreasers - Ferris wheel degreasing systems are generally the smallest of all the
conveyorized degreasers (J.S. EPA. 1977). In these systems, parts are manually loaded into
perforated baskets or cylinders and then rotated vertically through the cleaning zone and back
out. FigureApx B-8 illustrates a typical ferris wheel degreaser ( J.S. EPA. 1977).
tumble
Figure Apx B-8. Ferris Wheel Conveyorized Vapor Degreasing System ( J.S. EPA, 1977)
• Belt degreasers - Belt degreasing systems (similar to strip degreasers; see next bullet) are used
when simple and rapid loading and unloading of parts is desired ( S. EPA. 1977). Parts are
loaded onto a mesh conveyor belt that transports them through the cleaning zone and out the
other side. Figure_Apx B-9 illustrates a typical belt or strip degreaser ( J.S. EPA. 1977).
Conveyor.
Path
Boiling
Chamber
Figure Apx B-9. Belt/Strip Conveyorized Vapor Degreasing System (U.S. EPA, 1977)
Page 104 of 209
Basket
Boiling
Chamber
Work
Sear to
baskets

-------
• Strip degreasers - Strip degreasing systems operate similar to belt degreasers except that the belt
itself is being cleaned rather than parts being loaded onto the belt for cleaning. FigureApx B-9
illustrates a typical belt or strip degreaser (U.S. EPA. 1977).
• Circuit board cleaners - Circuit board degreasers use any of the conveyorized designs. However,
in circuit board degreasing, parts are cleaned in three different steps due to the manufacturing
processes involved in circuit board production (U.S. EPA. 1977).
Continuous web vapor degreasers: Continuous web cleaning machines are a subset of conveyorized
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 (Kanegsberg and Kanegsberg. 2011); U.S. EPA, 2006b). In
continuous web degreasers, parts are uncoiled and loaded onto rollers that transport the parts through the
cleaning and drying zones at speeds greater than 11 feet per minute (U.S. EPA, 2006c). The parts are
then recoiled or cut after exiting the cleaning machine (Kanegsberg and Kanegsberg. 2011). Figure Apx
B-10 illustrates a typical continuous web cleaning machine.
Figure Apx B-10. Continuous Web Vapor Degreasing System
Cold Cleaners
TCE 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 EPA's TCE Risk Assessment
(U.S. EPA 2014a).
Aerosol Spray Degreasers and Cleaners
EPA assessed inhalation risks from TCE in vapor and aerosol degreasing, spot cleaning at dry cleaning
facilities and arts and craft uses (U.S. EPA. 2014a)) and completed four supplemental analyses Table
1-11. Based on these analyses, EPA published two proposed rules to address the unreasonable risks
presented by TCE use in vapor degreasing and in commercial and consumer aerosol degreasing and for
Page 105 of 209

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spot cleaning at dry cleaning facilities (8! , January 19, 2017; , December 16,
2016).
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 TCE may
be used in aerosol degreasing applications such as brake cleaning, engine degreasing and metal product
cleaning. This use has been previously described in EPA's 1-BP Draft Risk Assessment (
2016g). 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.
Non-Aerosol Degreasing and Cleaning
TCE can also be used as a solvent in non-aerosol degreasing and cleaning products. Non-aerosol
cleaning products typically involve dabbing or soaking a rag with cleaning solution and then using the
rag to wipe down surfaces or parts to remove contamination ( ^014a). The cleaning solvent is
usually applied in excess and allowed to air-dry (U.S. EPA. 2.014a). Parts may be cleaned in place or
removed from the service item for more thorough cleaning (U.S. EPA. 2014a).
B.l.3.2 Lubricants and Greases
The Use Document for TCE [: r -* >;r i - -v-; (; S U';, )| identified TCE in
penetrating lubricants and tap and die fluids. EPA has not identified process information specific to tap
and die fluids; however, the OECD ESD on Use of Metalworking Fluids provides a general process
description for metalworking fluids. Metalworking fluids are unloaded, either diluted with water and
transferred to the trough or directly transferred to the trough without dilution (OECD. 2011). The fluid is
then pumped from the trough and applied to the metal parts, as needed, during shaping ( 11).
Parts are then allowed to drip dry and the fluids are collected and treated with other process fluids
(( ). Parts may be rinsed down or wiped and then cleaned via alkaline cleaning or degreasing
prior to the final finishing operations (OECD. 2011). Any metalworking fluid residue remaining on the
part is removed during the cleaning or degreasing operation (OECD. 2011).
EPA has not identified process-specific information regarding the use of TCE in penetrating lubricants.
More information on this use will be gathered through expanded literature searches in subsequent phases
of the risk evaluation process.
B.l.3.3 Adhesive and Sealants
Based on products identified in EPA's Use Document, [;
2017c)], TCE may be used in adhesive and sealants for industrial, commercial and consumer
applications. EPA did not identify TCE-specific information for adhesive and sealant use; however, the
OECD ESD for Use of Adhesives provides general process descriptions and worker activities for
industrial adhesive uses. Liquid adhesives are unloaded from containers into the coating reservoir,
applied to a flat or three-dimensional substrate and the substrates are then joined and allowed to cure
(( ). The majority of adhesive applications include spray, roll, curtain, syringe or bead
application (OECD. 2013). For solvent-based adhesives, the volatile solvent (in this case TCE)
evaporates during the curing stage (OECD. 2013). Based on EPA's knowledge of the industry, overlap
in process descriptions, worker activities and application methods are expected for sealant products.
EPA's Use Document, [EPA-HO-OPr 1' ;0k-0737-0003 (U.S. EPA. 2017c)l indicates that adhesives
and sealants containing TCE may be used in both commercial and consumer applications. EPA did not
identify process information for commercial and consumer use of adhesives and sealants; EPA
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anticipates that the application methods for commercial and consumer uses may include spray, brush,
syringe, eyedropper, roller and bead applications.
B.l.3.4 Functional Fluids (Closed Systems)
indicates TCE may be used as a heat transfer agent in industrial and commercial
applications. EPA will further evaluate the use of TCE as a heat exchange fluid during the risk
evaluation process.
B.l.3.5 Cleaning and Furniture Care Products
EPA interprets this reported commercial/consumer use category in CDR "Cleaning and Furniture Care
Products" to include the use of TCE in spot cleaning and carpet cleaning applications. This use includes
both professional spot cleaning (dry cleaning) and carpet cleaning activities as well as use in consumer
purchased spot cleaning and carpet cleaning products.
Professional spot cleaning was previously assessed in the 2014 risk assessment (I .S .LT j> 2014c). Spot
cleaning products can be applied to the garment either before or after the garment is dry cleaned. The
process and worker activities associated with commercial dry cleaning and spot cleaning have been
previously described in the 2014 risk assessment ( ).
B.l.3.6 Paints and Coatings
Based on products identified in EPA's Use Document, [ (
2017c)l. TCE may be used in various paints and coatings for industrial, commercial and consumer
applications. EPA did not identify TCE specific information for paints and coating use; however, several
OECD ESDs and EPA generic scenarios provide general process descriptions and worker activities for
industrial and commercial uses. Typical 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 (OECD. 2009b). After application, solvent-based
coatings typically undergo a drying stage in which the solvent evaporates from the coating (OE
2009b).
B.l.3.7 Corrosion Inhibitors and Anti-Scaling Agents
In the 2016 CDR (U.S. EPA. 2016a). one submitter reported the use of TCE in corrosion inhibitors and
anti-scaling agents in soap, cleaning compound, and toilet preparation manufacturing. The U.S. EPA
Trichloroethylene Market and Use Report ( ,01 If) identified TCE as a component in
commercial and consumer battery coat products. Battery coat products form a coating that protects
against corrosion on battery terminals, cables, clamps, and hold-downs (U.S. EPA. 2017f).
B.l.3.8 Processing Aid
The U.S. EPA Trichloroethylene Market and Use Report ( ) identified uses of TCE as a
process solvent in lithium ion battery manufacture, polymer fiber spinning, fluoroelastomer
manufacture, Alacantara manufacture, and pulverized sulfur production; as a extractant in caprolactam
manufacture, in the recovery of fat-free glues in tanneries, in wood resin extraction, in the recovery of
wax and paraffin from refuse, for tin recovery from scrap metal, and phenol extraction from wastewater;
and as a precipitant for beta-cyclodextrin manufacture (Baumann et at.. 2008a) indicates TCE is used in
the manufacture of microporous polyethylene battery separator material to remove excess oil from the
extruded polyethylene sheets.
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B.l.3.9 Ink, Toner and Colorant Products
Based on products identified in EPA's Use Document, (
2017c)l and the U.S. EPA Trichloroethylene Market and Use Report ( ), TCE may be
used as a component in a toner aid to improve image opacity, develop higher resolutions, and enhance
detail clarity. The GS for Use of PMN Component in Toner Used in Photocopiers (1992) provides
general process description for the use of toner. Toners are received in plastic cartridges and workers
remove seal on the cartridge and place it into the photocopier (U.S. EPA, 1992). Toner is applied to the
image area of the paper through electrostatic transfer (U.S. EPA, 1992). Waste toner is disposed to
municipal landfills and spent cartridges are sent back to the manufacturer or distributor for reuse (U.S.,
1992).
B.l.3.10 Other Uses
Based on products identified in EPA's Use Document, [ " (
2017c)], a variety of other uses may exist for TCE, including use in hoof polish, pepper spray and as a
toner aide. It is unclear at this time the total volume of TCE used in any of these applications. EPA has
not identified any information to further refine the use of TCE in these products at this time; more
information on these uses will be gathered through expanded literature searches in subsequent phases of
the risk evaluation process.
B.1.4 Disposal
Federal regulations prevent land disposal of various chlorinated solvents (including TCE) (ATSDR.
2.014a). The recommended disposal method is mixing with a combustible fuel followed by incineration
(ATSDR. 2014a). In incineration, complete combustion is necessary to prevent phosgene or other toxic
byproduct formation (ATSDR. 2014a).
J?!? Occupational Exposure Data
EPA presents below an example 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-l summarizes the TCE OSHA CEHD data by NAICS code and TableApx B-2
summarizes NIOSH HHE data.
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TableApx B-l. Mapping of Scenarios to Industry Sectors with TCE Personal Monitoring Air
	Samples Obtained from OSHA Inspections Conducted Between 2002 and 2017	
Release/ Exposure Scenario
NAICS
Code
NAICS Description
Unknown, company inspected is an
excavation contractor, possibly from
contact with soil contaminated with TCE
236220
Commercial and Institutional Building Construction
Textile pre-treatment, textile dyeing, or
textile finishing
313312
Textile and Fabric Finishing (except Broadwoven Fabric) Mills
Textile pre-treatment or textile finishing
313320
Fabric Coating Mills
Textile pre-treatment, textile dyeing, or
textile finishing
314999
All Other Miscellaneous Textile Product Mills
Manufacture of large, rigid plastic products
(as vapor degreaser)
325212
Synthetic Rubber Manufacturing
Formulation of aerosol and non-aerosol
products
325520
Adhesive Manufacturing
Aerosol use of mold release or other
miscellaneous industrial, commercial, and
consumer uses (Foam Blowing Agent)
326150
Urethane and Other Foam Product (except Polystyrene)
Manufacturing
Manufacture of large, rigid plastic products
(likely as adhesive or vapor degreaser) or
Aerosol use of mold release
326199
All Other Plastics Product Manufacturing
Manufacture of large, rigid plastic products
326211
Tire Manufacturing (except Retreading)
Manufacture of large, rigid plastic products
(as a vapor degreaser or paint/coating)
326299
All Other Rubber Product Manufacturing
Vapor degreasing or cold cleaning
331210
Iron and Steel Pipe and Tube Manufacturing from Purchased
Steel
Vapor degreasing or cold cleaning
331491
Nonferrous Metal (except Copper and Aluminum) Rolling,
Drawing, and Extruding
Vapor degreasing or cold cleaning
331512
Steel Investment Foundries
Vapor degreasing or cold cleaning
331528
Beryllium castings (except die-castings), unfinished
manufacturing
Vapor degreasing or cold cleaning
332116
Metal stampings (except automotive, cans, cooking, closures,
crowns), unfinished, manufacturing
Vapor degreasing or cold cleaning
332439
Other Metal Container Manufacturing
Vapor degreasing or cold cleaning or
metalworking fluids
332710
Machine Shops
Vapor degreasing or cold cleaning
332721
Precision Turned Product Manufacturing
Vapor degreasing or cold cleaning
332722
Bolt, Nut, Screw, Rivet, and Washer Manufacturing
Vapor degreasing or cold cleaning
332811
Metal Heat Treating
Vapor degreasing or cold cleaning
332813
Electroplating, Plating, Polishing, Anodizing, and Coloring
Vapor degreasing or cold cleaning
332991
Ball and Roller Bearing Manufacturing
Vapor degreasing or cold cleaning
332994
Small Arms, Ordnance, and Ordnance Accessories
Manufacturing
Vapor degreasing or cold cleaning
332996
Fabricated Pipe and Pipe Fitting Manufacturing
Vapor degreasing or cold cleaning
332999
All Other Miscellaneous Fabricated Metal Product
Manufacturing
Vapor degreasing or cold cleaning
333111
Farm Machinery and Equipment Manufacturing
Vapor degreasing or cold cleaning
333513
Arbor presses, metalworking, manufacturing
Vapor degreasing or cold cleaning
334412
Bare Printed Circuit Board Manufacturing
Vapor degreasing or cold cleaning
334419
Other Electronic Component Manufacturing
Page 109 of 209

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Release/ Exposure Scenario
NAICS
Code
NAICS Description
Vapor degreasing or cold cleaning
334513
Instruments and Related Products Manufacturing for Measuring,
Displaying, and Controlling Industrial Process Variables
Vapor degreasing or cold cleaning
335311
Power, Distribution, and Specialty Transformer Manufacturing
Vapor degreasing or cold cleaning
336370
Motor Vehicle Metal Stamping
Vapor degreasing or cold cleaning
339114
Dental Equipment and Supplies Manufacturing
Industrial adhesive (unknown application
type)
339950
Sign Manufacturing
Vapor degreasing or cold cleaning
339991
Gasket, Packing, and Sealing Device Manufacturing
Paints and Coatings (application method
unknown)
423830
Industrial Machinery and Equipment Merchant Wholesalers
Commercial automotive repair/servicing
424610
Plastics Materials and Basic Forms and Shapes Merchant
Wholesalers
Spot cleaning
812320
Drycleaning and Laundry Services (except Coin-Operated)
Spot cleaning
812332
Industrial Launderers
Unknown - this seems to be for OSHA
inspectors which could have been collected
during site inspections
926150
Regulation, Licensing, and Inspection of Miscellaneous
Commercial Sectors
Other miscellaneous industrial,
commercial, and consumer uses
(atmospheric chamber cleaner)
927110
Space Research and Technology
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Table Apx B-2. Summary of Exposure Data from NIOSH H
EEs a
Data
Source
Report
Number
Exposure/Release
Scenario
Facility
Description
Number of
Exposure
Samples
Minimum of
Exposure
Values
(ppm)
Maximum
of Exposure
Values
(ppm)
Comments
NIOSH,
1991
HETA-
1990-
0344-2159
Vapor degreasing
Brass and
stainless steel
valve
manufacture
7
1.1
5.3
Two PBZ full-
shift samples
and five area
full-shift
samples
NIOSH,
1992a
HETA-
1990-
0029-2212
Adhesive
application
Automotive
headliner
production
4
2.7
21.4
PBZ samples
NIOSH,
1992b
HETA-
1990-
0223-2211
Vapor degreasing
Television
picture tubes
(i.e., cathode
ray tubes)
11
ND
50
Partial shift
PBZ and area
samples
NIOSH,
1995
HETA-
1994-
0298-2499
Rubber stock
mixing
Automotive
vibration
control and
vibration
sealing
manufacture
Unknown
Trace
Exact use of
TCE is not
specified and is
only detected at
trace levels.
NIOSH,
1998
HETA-
1997-
0214-2689
Vapor degreasing
Hydraulic door
closer
manufacturing
2
0.71
3.5
Partial shift
PBZ samples
NIOSH,
2003
HETA-
2002-
0184-2888
Vapor degreasing
Aluminum oil
coolers (for use
in army battle
tank)
manufacture
2
7.1
7.6
TCE vapor
degreaser was
not in operation
at time of site
visit. PBZ full-
shift samples
taken of
welders;
exposure likely
residual TCE
on parts that
vaporized
during welding.
NIOSH,
2004
HETA-
2003-
0029-2923
Wipe cleaning
Musical
instrument
repair
6
Trace
(>0.0143 and
<0.0477)
0.99
Two PBZ and
four area
samples.
NIOSH,
2005
HETA-
2003-
0203-2952
Wipe cleaning
Printing press
operations
26
ND
(<0.00005)
25
20 full-shift
PBZ and six
task-based PBZ
samples.
NIOSH,
2008
HETA-
2004-
0372-3054
Battery
manufacturing
Oil extraction
during battery
separator
manufacturing
274
1.7
130
Full shift PBZ
samples
ND = not detected
PBZ = personal breathing zone
a Table includes HHEs identified to date
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80-49-808, Superior Tube Company, Collegeville, Pennsylvania.
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Health.
(Ruhe et al.. 1981)
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74-51, Western Electric Company, Dublic, California. Cincinnati,
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\ (2016a)
Page 144 of 209

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Appendix C SUPPORTING TABLES FOR INDUSTRIAL AND COMMERCIAL ACTIVITIES
CONCEPTUAL MODEL
TableApx C-l. Supporting Table for Industrial and Commercial Activities Conceptual Model
'Note that rows shaded in gray are not proposed for further analysis) 		i	
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Manufacture
Domestic
Manufacture
Domestic
Manufacture
Manufacture of
TCE via
chlorination,
oxychlorination
and as a
byproduct
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization).
Vapor
Inhalation
Workers
Yes
Due to high volatility (VP = 73.46
mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Due to high volatility (VP = 73.46
mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
No
Mist generation not expected during
Manufacturing
Page 145 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Manufacture
Import
Import
Repackaging of
import
containers
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Exposure will only
occur in the event the imported
material is repackaged.
Vapor
Inhalation
Workers
Yes
Exposure expected only in the event
the imported material is repackaged
into different sized containers.
Exposure frequency may be low.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Exposure expected only in the event
the imported material is repackaged
into different sized containers.
Exposure frequency may be low.
Mist
Dermal/
Inhalation
Workers,
ONU
No
Mist generation not expected during
import
Page 146 of 209

-------



Release /
Exposure
Scenario



Proposed

Life Cycle
Stage
Category
Subcategory
Exposure
Pathway
Exposure
Route
Receptor /
Population
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation


Intermediate in
industrial gas

Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization).
Processing
Processing
as a reactant
manufacturing;
all other basic
inorganic
chemical
manufacturing;
and all other
basic organic
Manufacture of
HFCs, HC1 and
muriatic acid
Vapor
Inhalation
Workers
Yes
Due to high volatility (VP = 73.46
mmHg) at room temperature,
inhalation pathway should be further
analyzed. However, potential for
exposure may be low in scenarios
where TCE is consumed as a
chemical intermediate.


chemical
manufacturing

Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical




Vapor
Inhalation
ONU
Yes
Due to high volatility (VP = 73.46
mmHg) at room temperature,
inhalation pathway should be further
analyzed. However, potential for
exposure may be low in scenarios
where TCE is consumed as a
chemical intermediate.




Mist
Dermal/
Inhalation
Workers,
ONU
No
Mist generation not expected during
processing as an intermediate
Page 147 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Processing
Incorporated
into
formulation,
mixture or
reaction
product
Solvent for
cleaning or
degreasing;
adhesive and
sealant
chemicals; and
solvents which
become part of
product
formulation or
mixture (e.g.,
lubricants and
greases, paints
and coatings,
other uses)
Formulation of
aerosol and
non-aerosol
products
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization).
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected at
processing sites that formulate
products containing TCE. Due to
high volatility (VP = 73.46 mmHg) at
room temperature, inhalation
pathway should be further analyzed.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected at
processing sites that formulate
products containing TCE. Due to
high volatility (VP = 73.46 mmHg) at
room temperature, inhalation
pathway should be further analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
No
Mist generation not expected during
processing/formulation operations.
Page 148 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Processing
Incorporated
into articles
Solvents
(becomes an
integral
components of
articles)
Manufacture of
large, rigid
plastic products;
industrial textile
dyeing; and
industrial textile
finishing
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization).
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected at
processing sites that incorporate TCE
into articles. Due to high volatility
(VP = 73.46 mmHg) at room
temperature, inhalation pathway
should be further analyzed.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected at
processing sites that incorporate TCE
into articles. Due to high volatility
(VP = 73.46 mmHg) at room
temperature, inhalation pathway
should be further analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
No
Mist generation not expected during
processing operations.
Page 149 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Processing
Repackaging
Solvent for
cleaning or
degreasing
Repackaging
into large and
small containers
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization).
Vapor
Inhalation
Workers
Yes
Exposure frequency may be low;
however, the number of workers
exposed may be high per CDR (1
submission reporting 10-25 workers,
2 submissions reporting 50-100
workers, 4 submissions reporting
100-500 workers, 2 submissions
reporting 500-1,000 workers, and 2
submissions reporting NKRA).
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Exposure frequency may be low;
however, the number of workers
exposed may be high per CDR (1
submission reporting 10-25 workers,
2 submissions reporting 50-100
workers, 4 submissions reporting
100-500 workers, 2 submissions
reporting 500-1,000 workers, and 2
submissions reporting NKRA).
Mist
Dermal/
Inhalation
Workers,
ONU
No
Mist generation not expected during
repackaging.
Page 150 of 209

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Release /
Exposure
Scenario



Proposed

Life Cycle
Stage
Category
Subcategory
Exposure
Pathway
Exposure
Route
Receptor /
Population
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation



Recycling of
process solvents
containing TCE
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization).
Processing
Recycling
Recycling
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected at
recycling sites. Due to high volatility
(VP = 73.46 mmHg) at room
temperature, inhalation pathway
should be further analyzed.




Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical




Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected at
recycling sites. Due to high volatility
(VP = 73.46 mmHg) at room
temperature, inhalation pathway
should be further analyzed.




Mist
Dermal/
Inhalation
Workers,
ONU
No
Mist generation not expected during
recycling.
Distribution in
commerce
Distribution
Distribution
Distribution of
bulk shipment
of TCE; and
distribution of
formulated
products
Liquid
Contact,
Vapor
Dermal/
Inhalation
Workers,
ONU
No
These exposures will be assessed
during other life-cycle stages such as
loading/unloading.
Page 151 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Industrial /
commercial /
consumer use
Solvents (for
cleaning or
degreasing)
Batch vapor
degreaser (e.g.,
open-top,
closed-loop);
and In-line
vapor
degreaser (e.g.,
conveyorized,
web cleaner)
Open top vapor
degreasing
(OTVD);
OTVD with
enclosures;
Conveyorized
vapor
degreasing;
Cross-rod and
ferris wheel
vapor
degreasing;
Web vapor
degreasing;
Airtight closed-
loop degreasing
system; Airless
vacuum-to-
vacuum
degreasing
system; Airless
vacuum drying
degreasing
system
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, repeat
contact or dermal immersion may
occur, especially while cleaning and
maintaining degreasing equipment.
Note: EPA proposed a rule to ban the
use of TCE in vapor degreasing and
will consider the proposed rule when
evaluating this scenario.
Vapor
Inhalation
Workers
Yes
EPA has previously assessed OTVD
in the 2014 RA and conveyorized
degreasing in the subsequent Section
6 rulemaking and has a proposed rule
to ban the use of TCE in vapor
degreasing. EPA will forward the
past assessments for this risk
evaluation.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Page 152 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation




Vapor
Inhalation
ONU
Yes
EPA has previously assessed OTVD
in the 2014 RA and conveyorized
degreasing in the subsequent Section
6 rulemaking and has a proposed rule
to ban the use of TCE in vapor
degreasing. EPA will forward the
past assessments for this risk
evaluation.
Mist
Dermal/
Inhalation
Workers,
ONU
No
Mist generation not expected during
this use scenario.
Page 153 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Industrial /
commercial /
consumer use
Solvents (for
cleaning or
degreasing)
Cold cleaner
Cold cleaning -
maintenance
(manual spray;
spray sink; dip
tank)
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, repeat
contact or dermal immersion may
occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
cold cleaning operations. Due to high
volatility (VP = 73.46 mrnHg) at
room temperature, inhalation
pathway should be further analyzed.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected from
cold cleaning operations. Due to high
volatility (VP = 73.46 mrnHg) at
room temperature, inhalation
pathway should be further analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
EPA will further evaluate to
determine if mist generation is
applicable.
Page 154 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Industrial /
commercial /
consumer use
Solvents (for
cleaning or
degreasing)
Aerosol spray
degreaser/
cleaner
Aerosol use in
degreasing/
cleaning
Liquid
Contact
Dermal
Workers
No
Contact time with skin is expected to
be <3 min due to rapid volatilization.
However, repeat contact may occur.
Note: EPA proposed a rule to ban the
use of TCE in aerosol degreasing and
will consider the proposed rule when
evaluating this scenario.
Vapor
Inhalation
Workers
Yes
As a result of the 2014 RA, EPA
previously assessed inhalation
exposure from aerosol degreasing
during the Section 6 rulemaking and
has a proposed rule to ban the use of
TCE in aerosol degreasing. EPA will
forward the past assessments for this
risk evaluation.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
As a result of the 2014 RA, EPA
previously assessed inhalation
exposure from aerosol degreasing
during the Section 6 rulemaking and
has a proposed rule to ban the use of
TCE in aerosol degreasing. EPA will
forward the past assessments for this
risk evaluation.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
Mist generation expected for aerosol
applications.
Page 155 of 209

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Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Industrial /
commercial /
consumer use
Solvents (for
cleaning or
degreasing)
Mold release
Aerosol use of
mold release
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, repeat
contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
use of aerosols. Due to high volatility
(VP = 73.46 mmHg) at room
temperature, inhalation pathway
should be further analyzed.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected from
use of aerosols. Due to high volatility
(VP = 73.46 mmHg) at room
temperature, inhalation pathway
should be further analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
Mist generation expected for aerosol
applications.
Page 156 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Industrial /
commercial /
consumer use
Lubricants
and greases/
lubricants
and
lubricant
additives
Tap and die
fluid
Use of
metalworking
fluids (tap and
die)
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, repeat
contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
use of metalworking fluids. Due to
high volatility (VP = 73.46 mmHg) at
room temperature, inhalation
pathway should be further analyzed.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected from
use of metalworking fluids. Due to
high volatility (VP = 73.46 mmHg) at
room temperature, inhalation
pathway should be further analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
Mist generation expected from use of
metalworking fluids.
Page 157 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Industrial /
commercial /
consumer use
Lubricants
and greases/
lubricants
and
lubricant
additives
Penetrating
lubricant
Aerosol
application of
lubricants to
substrates
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, repeat
contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
use of aerosols. Due to high volatility
(VP = 73.46 mmHg) at room
temperature, inhalation pathway
should be further analyzed.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected from
use of aerosols. Due to high volatility
(VP = 73.46 mmHg) at room
temperature, inhalation pathway
should be further analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
Mist generation expected for aerosol
applications.
Page 158 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Industrial /
commercial /
consumer use
Adhesives
and sealants
Solvent-based
adhesives and
sealants; and
mirror edge
sealants
Industrial spray
adhesive
application; and
other adhesive
and sealant
applications
(e.g. roll)
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, repeat
contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
use of adhesives and sealants. Due to
high volatility (VP = 73.46 mmHg) at
room temperature, inhalation
pathway should be further analyzed.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected from
use of adhesives and sealants. Due to
high volatility (VP = 73.46 mmHg) at
room temperature, inhalation
pathway should be further analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
Mist generation expected for spray
and roll applications. EPA will
further evaluate to determine if mist
generation is applicable for each
adhesive/sealant product.
Page 159 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Industrial /
commercial /
consumer use
Adhesives
and sealants
Tire repair
cement/sealer
Commercial
automotive
repair/servicing
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, repeat
contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
use of adhesives and sealants. Due to
high volatility (VP = 73.46 mmHg) at
room temperature, inhalation
pathway should be further analyzed.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected from
use of adhesives and sealants. Due to
high volatility (VP = 73.46 mmHg) at
room temperature, inhalation
pathway should be further analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
Products identified in marker report
show brush application; generation of
mists not expected from brush
applications. EPA will further
evaluate if other application methods
resulting in mist generation are
applicable to this scenario
Page 160 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Industrial /
commercial /
consumer use
Functional
fluids
(closed
systems)
Heat exchange
fluid
Refrigerant in
air-conditioning
installations;
and low
temperature
heat transfer
agent
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, repeat
contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
initial charging and
servicing/recharging of heat
exchange fluid. Due to high volatility
(VP = 73.46 mmHg) at room
temperature, inhalation pathway
should be further analyzed. However
exposure frequency may be low.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected from
initial charging and
servicing/recharging of heat
exchange fluid. Due to high volatility
(VP = 73.46 mmHg) at room
temperature, inhalation pathway
should be further analyzed. However
exposure frequency may be low.
Mist
Dermal/
Inhalation
Workers,
ONU
No
Mist generation not expected during
use of heat exchange fluid.
Page 161 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Industrial /
commercial
Paints and
coatings
Diluent in
solvent-based
paints and
coatings
Industrial spray
coating
application; and
other paint and
coating
applications
(e.g. roll)
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, repeat
contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
use of paints and coatings. Due to
high volatility (VP = 73.46 mmHg) at
room temperature, inhalation
pathway should be further analyzed.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected from
use of paints and coatings. Due to
high volatility (VP = 73.46 mmHg) at
room temperature, inhalation
pathway should be further analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
Mist generation expected for spray
and roll applications. EPA will
further evaluate to determine if mist
generation is applicable for each
paint/coating product.
Page 162 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Industrial /
commercial /
consumer use
Cleaning
and furniture
care
products
Carpet cleaner
Commercial
carpet spotting
and stain
removers
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, repeat
contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
carpet cleaning. Due to high volatility
(VP = 73.46 mmHg) at room
temperature, inhalation pathway
should be further analyzed.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected from
carpet cleaning. Due to high volatility
(VP = 73.46 mmHg) at room
temperature, inhalation pathway
should be further analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
EPA will further evaluate to
determine if mist generation is
applicable.
Page 163 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Industrial /
commercial /
consumer use
Cleaning
and furniture
care
products
Cleaning
wipes

Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, repeat
contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
wipe cleaning. Due to high volatility
(VP = 73.46 mmHg) at room
temperature, inhalation pathway
should be further analyzed.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected from
wipe cleaning. Due to high volatility
(VP = 73.46 mmHg) at room
temperature, inhalation pathway
should be further analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
No
Mist generation not expected during
wipe cleaning.
Page 164 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Industrial /
commercial /
consumer use
Laundry and
dishwashing
products
Spot cleaner
Spot cleaning at
dry cleaners
Liquid
Contact
Dermal
Workers
No
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, repeat
contact may occur. Note: EPA
proposed a rule to ban the use of TCE
in spot cleaning and will consider the
proposed rule when evaluating this
scenario.
Vapor
Inhalation
Workers
Yes
EPA has previously assessed spot
cleaning in the 2014 RA and in the
subsequent Section 6 rulemaking and
has a proposed rule to ban the use of
TCE in spot cleaners. EPA will
forward the past assessments for this
risk evaluation.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
EPA has previously assessed OTVD
in the 2014 RA and conveyorized
degreasing in the subsequent Section
6 rulemaking and has a proposed rule
to ban the use of TCE in vapor
degreasing. EPA will forward the
past assessments for this risk
evaluation.
Page 165 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation




Mist
Dermal/
Inhalation
Workers,
ONU
Yes
Mist generation expected for spot
cleaning. Note: EPA proposed a rule
to ban the use of TCE in spot
cleaning and will consider the
proposed rule when evaluating this
scenario.
Industrial /
commercial /
consumer use
Corrosion
inhibitors
and anti-
scaling
agents
Battery coat;
and soap,
cleaning
compound,
and toilet
preparation
manufacturing
Battery coat;
and soap,
cleaning
compound, and
toilet
preparation
manufacturing
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, EPA will
need additional information to fully
understand the use of TCE in this
scenario to determine potential for
dermal exposure.
Vapor
Inhalation
Workers
Yes
Due to high volatility (VP = 73.46
mmHg) at room temperature,
inhalation pathway should be further
analyzed. However, EPA will need
additional information to fully
understand the use of TCE in this
scenario to determine potential for
inhalation exposure.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Page 166 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation




Vapor
Inhalation
ONU
Yes
Due to high volatility (VP = 73.46
mmHg) at room temperature,
inhalation pathway should be further
analyzed. However, EPA will need
additional information to fully
understand the use of TCE in this
scenario to determine potential for
inhalation exposure.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
EPA will further evaluate to
determine if mist generation is
applicable.
Industrial /
commercial /
consumer use
Processing
aids
Industrial
process
solvent;
industrial
extraction
solvent; and
industrial
precipitant
Process solvent
for lithium ion
battery
manufacture;
polymer fiber
spinning;
fluoroelastomer
manufacture;
Alcantara
manufacture;
pulverized
sulfur
production; and
sulfur chloride
and cellulose
esters and
ethers
Extraction
solvent for
caprolactam
manufacture;
recovery of fat-
free glues in
tanneries; wood
resin extraction;
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPerm) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, EPA will
need additional information to fully
understand the use of TCE in this
scenario to determine potential for
dermal exposure.
Vapor
Inhalation
Workers
Yes
Due to high volatility (VP = 73.46
mmHg) at room temperature,
inhalation pathway should be further
analyzed. However, EPA will need
additional information to fully
understand the use of TCE in this
scenario to determine potential for
inhalation exposure.
Page 167 of 209

-------



Release /
Exposure
Scenario



Proposed

Life Cycle
Stage
Category
Subcategory
Exposure
Pathway
Exposure
Route
Receptor /
Population
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation



recovery of wax
and paraffin
from refuse; tin
recovery from
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical



scrap metal; and
phenol
extraction from
wastewater
Precipitant for
beta-
cyclodextrin
Vapor
Inhalation
ONU
Yes
Due to high volatility (VP = 73.46
mmHg) at room temperature,
inhalation pathway should be further
analyzed. However, EPA will need
additional information to fully
understand the use of TCE in this
scenario to determine potential for
inhalation exposure.



manufacture
Mist
Dermal/
Inhalation
Workers,
ONU
No
Mist generation not expected during
use of industrial processing aid.




Liquid
Contact
Dermal
Workers

Contact time with skin is expected to
be <3 min due to rapid volatilization.
Additionally, toner expected to be
contained in cartridges thus reducing
the potential for dermal exposures.




Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
toner use. Due to high volatility (VP
= 73.46 mmHg) at room temperature,
inhalation pathway should be further
Industrial /
commercial /
consumer use
Ink, toner
and colorant
products

Commercial
printing and
copying




analyzed.
Toner aid
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical




Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected from
toner use. Due to high volatility (VP
= 73.46 mmHg) at room temperature,
inhalation pathway should be further
analyzed.




Mist
Dermal/
Inhalation
Workers,
ONU
Yes
EPA will further evaluate to
determine if mist generation is
expected.
Page 168 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation
Industrial /
commercial /
consumer use
Automotive
care
products
Brake and
parts cleaner
Aerosol
degreasing use
in commercial
automotive
servicing and
brake servicing
Liquid
Contact
Dermal
Workers
No
Contact time with skin is expected to
be <3 min due to rapid volatilization.
However, repeat contact may occur.
Additionally, EPA may need to
evaluate total exposure to TCE from
multiple conditions of use in
automotive servicing (degreasing and
tire repair). Note: EPA proposed a
rule to ban the use of TCE in aerosol
degreasing and will consider the
proposed rule when evaluating this
scenario.
Vapor
Inhalation
Workers
Yes
As a result of the 2014 RA, EPA
previously assessed inhalation
exposure from aerosol degreasing
during the Section 6 rulemaking and
has a proposed rule to ban the use of
TCE in aerosol degreasing. EPA will
forward the past assessments for this
risk evaluation. Additionally, EPA
may need to evaluate total exposure
to TCE from multiple conditions of
use in automotive servicing
(degreasing and tire repair).
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Page 169 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation




Vapor
Inhalation
ONU
Yes
As a result of the 2014 RA, EPA
previously assessed inhalation
exposure from aerosol degreasing
during the Section 6 rulemaking and
has a proposed rule to ban the use of
TCE in aerosol degreasing. EPA will
forward the past assessments for this
risk evaluation. Additionally, EPA
may need to evaluate total exposure
to TCE from multiple conditions of
use in automotive servicing
(degreasing and tire repair).
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
Mist generation expected for aerosol
applications. Additionally, EPA may
need to evaluate total exposure to
TCE from multiple conditions of use
in automotive servicing (degreasing
and tire repair). Note: EPA proposed
a rule to ban the use of TCE in
aerosol degreasing and will consider
the proposed rule when evaluating
this scenario.
Industrial /
commercial /
consumer use
Apparel and
footwear
care
products
Shoe polish
Commercial
shoe polishing
and repair
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPerm) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, repeat
contact may occur.
Page 170 of 209

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Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation




Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
shoe polish use. Due to high
volatility (VP = 73.46 mrnHg) at
room temperature, inhalation
pathway should be further analyzed.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected from
shoe polish use. Due to high
volatility (VP = 73.46 mrnHg) at
room temperature, inhalation
pathway should be further analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
EPA will further evaluate to
determine if mist generation is
applicable.
Industrial /
commercial /
consumer use
Other uses
Other
miscellaneous
industrial,
commercial,
and consumer
uses
See Table XX
for specific
scenario
corresponding
to the condition
of use.
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, repeat
contact may occur for some
miscellaneous conditions of use.
Vapor
Inhalation
Workers
Yes
Due to high volatility (VP = 73.46
mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Page 171 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation




Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical
Vapor
Inhalation
ONU
Yes
Due to high volatility (VP = 73.46
mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
EPA will further evaluate to
determine if mist generation is
applicable to specific conditions of
use in this scenario.
Disposal
Waste
Handling,
Treatment
and Disposal
Disposal of
TCE wastes
Worker
handling of
wastes
Liquid
Contact
Dermal
Workers
Yes
Although the potential for dermal
exposure exists, EPA expects the
relative contribution of dermal to
overall exposure to be relatively
small (0.8% absorption and 99.2%
volatilization based on modeling
from IHSKinPenn) for non-occluded
conditions. An occluded scenario,
wherein liquid TCE is not able to
readily evaporate, may result in
higher dermal exposures and a larger
contribution to the overall exposure
or effects on the skin (e.g. dermal
sensitization). Additionally, the
frequency of exposure and the
potential for dermal immersion needs
to be further analyzed.
Vapor
Inhalation
Workers
Yes
Due to high volatility (VP = 73.46
mmHg) at room temperature,
inhalation pathway should 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 172 of 209

-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Rationale for Further Evaluation /
No Further Evaluation




Vapor
Inhalation
ONU
Yes
Due to high volatility (VP = 73.46
mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Page 173 of 209

-------
Appendix D SUPPORTING TABLE FOR CONSUMER ACTIVITIES AND USES
CONCEPTUAL MODEL
TableApx D-l. Consumer Activities and Uses Conceptual Model Supporting Table
(Note that rows shaded in gray are not proposed for further ana
ysis)
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation
Use
Solvents (for
cleaning or
degreasing)
Liquid / non-
spray application:
Cold cleaner
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Liquid
Contact
Dermal
Consumers
Yes
CEM
TCE in direct contact with skin would be
expected to evaporate before significant
dermal absorption could occur. However,
there may be effects on the skin (e.g.,
dermal sensitization), or certain scenarios
with a higher dermal exposure potential,
for example, an occluded scenario,
wherein liquid TCE is not able to
evaporate readily. Therefore, occluded
scenarios will be evaluated for systemic
and sensitization effects, whereas, non-
occluded scenarios will be evaluated for
sensitization effects alone.



Dermal contact
with liquid
product on the
skin per event -
shorter duration


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct dermal
exposures to liquid TCE are not expected
and inhalation is the primary route of



(direct)





exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Oral exposures may also occur through
hand-to-mouth patterns following dermal
contact with TCE. As described, any TCE
present on surfaces of the home or skin
surfaces is expected to volatilize rapidly -
making it available for inhalation as a
vapor before oral ingestion may occur
through such patterns.



Oral swallowing
the product
directly


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct oral
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.
Page 174 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Dermal vapor to
skin
Vapor
Dermal
Consumers
No
NA
Mist not expected from this use pattern. In
scenarios involving exposure to TCE
vapor, inhalation and dermal exposures
are concurrent, with predominate exposure
from inhalation. A dermal to inhalation
uptake ratio of around 0.1% for vapor to
skin scenarios is predicted using
IHSkinPenn. Therefore, only the
inhalation exposures will be evaluated in
these cases.



Dermal vapor to
skin


Bystanders
No
NA
Mist not expected from this use pattern. In
scenarios involving exposure to TCE
vapor, inhalation and dermal exposures
are concurrent, with predominate exposure
from inhalation. A dermal to inhalation
uptake ratio of around 0.1% for vapor to
skin scenarios is predicted using
IHSkinPenn. Therefore, only the
inhalation exposures will be evaluated in
these cases.



Evaporation from
the surface (quick
decay)

Inhalation
Consumers
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for users.



Evaporation from
the surface (quick
decay)


Bystanders
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Mist not expected from this use pattern.



Oral swallowing
the product
directly


Bystanders
No
NA
Mist not expected from this use pattern.
Use
Solvents (for
cleaning or
degreasing)
Spray / aerosol
application:
Aerosol spray
degreaser/cleaner,
electronic
degreaser, gun
scrubber
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Liquid
Contact
Dermal
Consumers
Yes
CEM
This use assessed in the U.S. EPA (2014c)
risk assessment will be considered in this
evaluation to ensure previous assessments
are in alignment with the Procedures for
Chemical Risk Evaluation under the
Amended Toxic Substances Control Act
(40 CFR Part 702). TCE in direct contact
with skin would be expected to evaporate
before significant dermal absorption could
occur. However, there may be effects on
the skin (e.g., dermal sensitization), or
Page 175 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation









certain scenarios with a higher dermal
exposure potential, for example, an
occluded scenario, wherein liquid TCE is
not able to evaporate readily. Therefore,
occluded scenarios will be evaluated for
systemic and sensitization effects,
whereas, non-occluded scenarios will be
evaluated for sensitization effects alone.
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct dermal
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.
Oral swallowing
the product
directly
Oral
Consumers
No
NA
Oral exposures may also occur through
hand-to-mouth patterns following dermal
contact with TCE. As described, any TCE
present on surfaces of the home or skin
surfaces is expected to volatilize rapidly -
making it available for inhalation as a
vapor before oral ingestion may occur
through such patterns.
Oral swallowing
the product
directly
Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct oral
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct);
Dermal vapor to
skin
Vapor /
Mist
Dermal
Consumers
No
NA
Based on physical chemical properties,
mists of TCE are expected to rapidly
evaporate before being deposited on skin,
thus contributing to the amount of TCE
vapor in the air available for inhalation
exposure. In scenarios involving exposure
to TCE vapor, inhalation and dermal
exposures are concurrent, with
predominate exposure from inhalation. A
dermal to inhalation uptake ratio of
around 0.1% for vapor to skin scenarios is
predicted using IHSkinPerm. Therefore,
only the inhalation exposures will be
evaluated in these cases.
Page 176 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct);
Dermal vapor to
skin


Bystanders
No
NA
Based on physical chemical properties,
mists of TCE are expected to rapidly
evaporate before being deposited on skin,
thus contributing to the amount of TCE
vapor in the air available for inhalation
exposure. In scenarios involving exposure
to TCE vapor, inhalation and dermal
exposures are concurrent, with
predominate exposure from inhalation. A
dermal to inhalation uptake ratio of
around 0.1% for vapor to skin scenarios is
predicted using IHSkinPerm. Therefore,
only the inhalation exposures will be
evaluated in these cases.



Spray application
(stationary)

Inhalation
Consumers
Yes
MCCEM,
CEM
This use assessed in the U.S. EPA (2014c)
risk assessment will be considered in this
evaluation to ensure previous assessments
are in alignment with the Procedures for
Chemical Risk Evaluation under the
Amended Toxic Substances Control Act
(40 CFR Part 702). Inhalation is expected
to be the primary route of exposure for
users.



Spray application
(stationary)


Bystanders
Yes
MCCEM,
CEM
This use assessed in the U.S. EPA (2014c)
risk assessment will be considered in this
evaluation to ensure previous assessments
are in alignment with the Procedures for
Chemical Risk Evaluation under the
Amended Toxic Substances Control Act
(40 CFR Part 702). Inhalation is expected
to be the primary route of exposure for
bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Based on physical chemical properties,
mists of TCE are expected to be rapidly
absorbed in the respiratory tract or
evaporate before being introduced into the
respiratory tract, thus contributing to the
amount of TCE vapor in the air available
for inhalation exposure.



Oral swallowing
the product
directly


Bystanders
No
NA
Based on physical chemical properties,
mists of TCE are expected to be rapidly
absorbed in the respiratory tract or
evaporate before being introduced into the
Page 177 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation









respiratory tract, thus contributing to the
amount of TCE vapor in the air available
for inhalation exposure.
Use
Lubricants
and greases/
lubricants
and lubricant
additives
Liquid / non-
spray application:
Penetrating
lubricant
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Liquid
Contact
Dermal
Consumers
Yes
CEM
TCE in direct contact with skin would be
expected to evaporate before significant
dermal absorption could occur. However,
there may be effects on the skin (e.g.,
dermal sensitization), or certain scenarios
with a higher dermal exposure potential,
for example, an occluded scenario,
wherein liquid TCE is not able to
evaporate readily. Therefore, occluded
scenarios will be evaluated for systemic
and sensitization effects, whereas, non-
occluded scenarios will be evaluated for
sensitization effects alone.
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct dermal
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.
Oral swallowing
the product
directly
Oral
Consumers
No
NA
Oral exposures may also occur through
hand-to-mouth patterns following dermal
contact with TCE. As described, any TCE
present on surfaces of the home or skin
surfaces is expected to volatilize rapidly -
making it available for inhalation as a
vapor before oral ingestion may occur
through such patterns.
Oral swallowing
the product
directly
Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct oral
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.
Dermal vapor to
skin
Vapor
Dermal
Consumers
No
NA
Mist not expected from this use pattern. In
scenarios involving exposure to TCE
vapor, inhalation and dermal exposures
are concurrent, with predominate exposure
from inhalation. A dermal to inhalation
uptake ratio of around 0.1% for vapor to
skin scenarios is predicted using
Page 178 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation









IHSkinPerm. Therefore, only the
inhalation exposures will be evaluated in
these cases.



Dermal vapor to
skin


Bystanders
No
NA
Mist not expected from this use pattern. In
scenarios involving exposure to TCE
vapor, inhalation and dermal exposures
are concurrent, with predominate exposure
from inhalation. A dermal to inhalation
uptake ratio of around 0.1% for vapor to
skin scenarios is predicted using
IHSkinPerm. Therefore, only the
inhalation exposures will be evaluated in
these cases.



Evaporation from
the surface (quick
decay)

Inhalation
Consumers
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for users.



Evaporation from
the surface (quick
decay)


Bystanders
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Mist not expected from this use pattern.



Oral swallowing
the product
directly


Bystanders
No
NA
Mist not expected from this use pattern.
Use
Lubricants
and greases/
lubricants
and lubricant
additives
Spray / aerosol
application:
Penetrating
lubricant
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Liquid
Contact
Dermal
Consumers
Yes
CEM
TCE in direct contact with skin would be
expected to evaporate before significant
dermal absorption could occur. However,
there may be effects on the skin (e.g.,
dermal sensitization), or certain scenarios
with a higher dermal exposure potential,
for example, an occluded scenario,
wherein liquid TCE is not able to
evaporate readily. Therefore, occluded
scenarios will be evaluated for systemic
and sensitization effects, whereas, non-
occluded scenarios will be evaluated for
sensitization effects alone.
Page 179 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct dermal
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.
Oral swallowing
the product
directly
Oral
Consumers
No
NA
Oral exposures may also occur through
hand-to-mouth patterns following dermal
contact with TCE. As described, any TCE
present on surfaces of the home or skin
surfaces is expected to volatilize rapidly -
making it available for inhalation as a
vapor before oral ingestion may occur
through such patterns.
Oral swallowing
the product
directly
Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct oral
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct);
Dermal vapor to
skin
Vapor /
Mist
Dermal
Consumers
No
NA
Based on physical chemical properties,
mists of TCE are expected to rapidly
evaporate before being deposited on skin,
thus contributing to the amount of TCE
vapor in the air available for inhalation
exposure. In scenarios involving exposure
to TCE vapor, inhalation and dermal
exposures are concurrent, with
predominate exposure from inhalation. A
dermal to inhalation uptake ratio of
around 0.1% for vapor to skin scenarios is
predicted using IHSkinPerm. Therefore,
only the inhalation exposures will be
evaluated in these cases.
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct);
Dermal vapor to
skin
Bystanders
No
NA
Based on physical chemical properties,
mists of TCE are expected to rapidly
evaporate before being deposited on skin,
thus contributing to the amount of TCE
vapor in the air available for inhalation
exposure. In scenarios involving exposure
to TCE vapor, inhalation and dermal
exposures are concurrent, with
predominate exposure from inhalation. A
Page 180 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation









dermal to inhalation uptake ratio of
around 0.1% for vapor to skin scenarios is
predicted using IHSkinPerm. Therefore,
only the inhalation exposures will be
evaluated in these cases.



Spray application
(stationary)

Inhalation
Consumers
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for users.



Spray application
(stationary)


Bystanders
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Based on physical chemical properties,
mists of TCE are expected to be rapidly
absorbed in the respiratory tract or
evaporate before being introduced into the
respiratory tract, thus contributing to the
amount of TCE vapor in the air available
for inhalation exposure.



Oral swallowing
the product
directly


Bystanders
No
NA
Based on physical chemical properties,
mists of TCE are expected to be rapidly
absorbed in the respiratory tract or
evaporate before being introduced into the
respiratory tract, thus contributing to the
amount of TCE vapor in the air available
for inhalation exposure.
Use
Adhesives
and sealants
Liquid / non-
spray application:
Mirror edge
sealant
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Liquid
Contact
Dermal
Consumers
Yes
CEM
TCE in direct contact with skin would be
expected to evaporate before significant
dermal absorption could occur. However,
there may be effects on the skin (e.g.,
dermal sensitization), or certain scenarios
with a higher dermal exposure potential,
for example, an occluded scenario,
wherein liquid TCE is not able to
evaporate readily. Therefore, occluded
scenarios will be evaluated for systemic
and sensitization effects, whereas, non-
occluded scenarios will be evaluated for
sensitization effects alone.
Page 181 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Dermal contact
with liquid
product on the
skin per event -
shorter duration


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct dermal
exposures to liquid TCE are not expected
and inhalation is the primary route of



(direct)





exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Oral exposures may also occur through
hand-to-mouth patterns following dermal
contact with TCE. As described, any TCE
present on surfaces of the home or skin
surfaces is expected to volatilize rapidly -
making it available for inhalation as a
vapor before oral ingestion may occur
through such patterns.



Oral swallowing
the product
directly


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct oral
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.



Dermal vapor to
skin
Vapor
Dermal
Consumers
No
NA
Mist not expected from this use pattern. In
scenarios involving exposure to TCE
vapor, inhalation and dermal exposures
are concurrent, with predominate exposure
from inhalation. A dermal to inhalation
uptake ratio of around 0.1% for vapor to
skin scenarios is predicted using
IHSkinPerm. Therefore, only the
inhalation exposures will be evaluated in
these cases.



Dermal vapor to
skin


Bystanders
No
NA
Mist not expected from this use pattern. In
scenarios involving exposure to TCE
vapor, inhalation and dermal exposures
are concurrent, with predominate exposure
from inhalation. A dermal to inhalation
uptake ratio of around 0.1% for vapor to
skin scenarios is predicted using
IHSkinPerm. Therefore, only the
inhalation exposures will be evaluated in
these cases.



Evaporation from
the surface (slow
decay)

Inhalation
Consumers
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for users.
Page 182 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Evaporation from
the surface (slow
decay)


Bystanders
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Mist not expected from this use pattern.



Oral swallowing
the product
directly


Bystanders
No
NA
Mist not expected from this use pattern.
Use
Adhesives
and sealants
Spray / aerosol
application:
Mirror edge
sealant
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Liquid
Contact
Dermal
Consumers
Yes
CEM
TCE in direct contact with skin would be
expected to evaporate before significant
dermal absorption could occur. However,
there may be effects on the skin (e.g.,
dermal sensitization), or certain scenarios
with a higher dermal exposure potential,
for example, an occluded scenario,
wherein liquid TCE is not able to
evaporate readily. Therefore, occluded
scenarios will be evaluated for systemic
and sensitization effects, whereas, non-
occluded scenarios will be evaluated for
sensitization effects alone.



Dermal contact
with liquid
product on the
skin per event -
shorter duration


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct dermal
exposures to liquid TCE are not expected
and inhalation is the primary route of



(direct)





exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Oral exposures may also occur through
hand-to-mouth patterns following dermal
contact with TCE. As described, any TCE
present on surfaces of the home or skin
surfaces is expected to volatilize rapidly -
making it available for inhalation as a
vapor before oral ingestion may occur
through such patterns.



Oral swallowing
the product
directly


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct oral
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.
Page 183 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct);
Dermal vapor to
skin
Vapor /
Mist
Dermal
Consumers
No
NA
Based on physical chemical properties,
mists of TCE are expected to rapidly
evaporate before being deposited on skin,
thus contributing to the amount of TCE
vapor in the air available for inhalation
exposure. In scenarios involving exposure
to TCE vapor, inhalation and dermal
exposures are concurrent, with
predominate exposure from inhalation. A
dermal to inhalation uptake ratio of
around 0.1% for vapor to skin scenarios is
predicted using IHSkinPerm. Therefore,
only the inhalation exposures will be
evaluated in these cases.



Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct);
Dermal vapor to
skin


Bystanders
No
NA
Based on physical chemical properties,
mists of TCE are expected to rapidly
evaporate before being deposited on skin,
thus contributing to the amount of TCE
vapor in the air available for inhalation
exposure. In scenarios involving exposure
to TCE vapor, inhalation and dermal
exposures are concurrent, with
predominate exposure from inhalation. A
dermal to inhalation uptake ratio of
around 0.1% for vapor to skin scenarios is
predicted using IHSkinPerm. Therefore,
only the inhalation exposures will be
evaluated in these cases.



Spray application
(stationary)

Inhalation
Consumers
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for users.



Spray application
(stationary)


Bystanders
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Based on physical chemical properties,
mists of TCE are expected to be rapidly
absorbed in the respiratory tract or
evaporate before being introduced into the
respiratory tract, thus contributing to the
amount of TCE vapor in the air available
for inhalation exposure.
Page 184 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Oral swallowing
the product
directly


Bystanders
No
NA
Based on physical chemical properties,
mists of TCE are expected to be rapidly
absorbed in the respiratory tract or
evaporate before being introduced into the
respiratory tract, thus contributing to the
amount of TCE vapor in the air available
for inhalation exposure.
Use
Cleaning
and furniture
care
products
Liquid / non-
spray application:
Carpet cleaner,
cleaning wipes,
spot remover
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Liquid
Contact
Dermal
Consumers
Yes
CEM
TCE in direct contact with skin would be
expected to evaporate before significant
dermal absorption could occur. However,
there may be effects on the skin (e.g.,
dermal sensitization), or certain scenarios
with a higher dermal exposure potential,
for example, an occluded scenario,
wherein liquid TCE is not able to
evaporate readily. Therefore, occluded
scenarios will be evaluated for systemic
and sensitization effects, whereas, non-
occluded scenarios will be evaluated for
sensitization effects alone.



Dermal contact
with liquid
product on the
skin per event -
shorter duration


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct dermal
exposures to liquid TCE are not expected
and inhalation is the primary route of



(direct)





exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Oral exposures may also occur through
hand-to-mouth patterns following dermal
contact with TCE. As described, any TCE
present on surfaces of the home or skin
surfaces is expected to volatilize rapidly -
making it available for inhalation as a
vapor before oral ingestion may occur
through such patterns.



Oral swallowing
the product
directly


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct oral
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.



Dermal vapor to
skin
Vapor
Dermal
Consumers
No
NA
Mist not expected from this use pattern.
Page 185 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Dermal vapor to
skill


Bystanders
No
NA
Mist not expected from this use pattern.



Evaporation from
the surface (quick
decay)

Inhalation
Consumers
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for users.



Evaporation from
the surface (quick
decay)


Bystanders
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Mist not expected from this use pattern. In
scenarios involving exposure to TCE
vapor, inhalation and dermal exposures
are concurrent, with predominate exposure
from inhalation. A dermal to inhalation
uptake ratio of around 0.1% for vapor to
skin scenarios is predicted using
IHSkinPenn. Therefore, only the
inhalation exposures will be evaluated in
these cases.



Oral swallowing
the product
directly


Bystanders
No
NA
Mist not expected from this use pattern. In
scenarios involving exposure to TCE
vapor, inhalation and dermal exposures
are concurrent, with predominate exposure
from inhalation. A dermal to inhalation
uptake ratio of around 0.1% for vapor to
skin scenarios is predicted using
IHSkinPenn. Therefore, only the
inhalation exposures will be evaluated in
these cases.



Dermal contact
with liquid
Contact
with

Bystanders
No
NA
There is potential for bystanders to have
indirect dermal contact via contact with a



product on the
skin (direct)
treated
surface
Dermal



surface upon which TCE has been applied
(e.g., counter, floor). Based on the
expectation that TCE would evaporate
from a surface rapidly (i.e., likely before
such indirect contact occurs), this route is
unlikely to contribute significantly to
overall exposure to bystanders.



Oral swallowing
the product
directly

Oral
Bystanders
No
NA
Oral exposures may also occur through
hand-to-mouth patterns following dermal
contact with TCE. As described, dermal








contact would not be expected for
bystanders, and any TCE present on
surfaces of the home or skin surfaces is
Page 186 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation









expected to volatilize rapidly - making it
available for inhalation as a vapor before
oral ingestion may occur through such
patterns.
Use
Cleaning
and furniture
care
products
Spray / aerosol
application:
Carpet cleaner,
spot remover
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Liquid
Contact
Dermal
Consumers
Yes
CEM
TCE in direct contact with skin would be
expected to evaporate before significant
dermal absorption could occur. However,
there may be effects on the skin (e.g.,
dermal sensitization), or certain scenarios
with a higher dermal exposure potential,
for example, an occluded scenario,
wherein liquid TCE is not able to
evaporate readily. Therefore, occluded
scenarios will be evaluated for systemic
and sensitization effects, whereas, non-
occluded scenarios will be evaluated for
sensitization effects alone.



Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct dermal
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Oral exposures may also occur through
hand-to-mouth patterns following dermal
contact with TCE. As described, any TCE
present on surfaces of the home or skin
surfaces is expected to volatilize rapidly -
making it available for inhalation as a
vapor before oral ingestion may occur
through such patterns.



Oral swallowing
the product
directly


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct oral
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.
Page 187 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct);
Dermal vapor to
skin
Vapor /
Mist
Dermal
Consumers
No
NA
Based on physical chemical properties,
mists of TCE are expected to rapidly
evaporate before being deposited on skin,
thus contributing to the amount of TCE
vapor in the air available for inhalation
exposure. In scenarios involving exposure
to TCE vapor, inhalation and dermal
exposures are concurrent, with
predominate exposure from inhalation. A
dermal to inhalation uptake ratio of
around 0.1% for vapor to skin scenarios is
predicted using IHSkinPerm. Therefore,
only the inhalation exposures will be
evaluated in these cases.



Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct);
Dermal vapor to
skin


Bystanders
No
NA
Based on physical chemical properties,
mists of TCE are expected to rapidly
evaporate before being deposited on skin,
thus contributing to the amount of TCE
vapor in the air available for inhalation
exposure. In scenarios involving exposure
to TCE vapor, inhalation and dermal
exposures are concurrent, with
predominate exposure from inhalation. A
dermal to inhalation uptake ratio of
around 0.1% for vapor to skin scenarios is
predicted using IHSkinPerm. Therefore,
only the inhalation exposures will be
evaluated in these cases.



Spray application
(stationary)

Inhalation
Consumers
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for users.



Spray application
(stationary)


Bystanders
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Based on physical chemical properties,
mists of TCE are expected to be rapidly
absorbed in the respiratory tract or
evaporate before being introduced into the
respiratory tract, thus contributing to the
amount of TCE vapor in the air available
for inhalation exposure.
Page 188 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Oral swallowing
the product
directly


Bystanders
No
NA
Based on physical chemical properties,
mists of TCE are expected to be rapidly
absorbed in the respiratory tract or
evaporate before being introduced into the
respiratory tract, thus contributing to the
amount of TCE vapor in the air available
for inhalation exposure.
Dermal contact
with liquid
product on the
skin (direct)
Contact
with
treated
surface
Dermal
Bystanders
No
NA
There is potential for bystanders to have
indirect dermal contact via contact with a
surface upon which TCE has been applied
(e.g., counter, floor). Based on the
expectation that TCE would evaporate
from a surface rapidly (i.e., likely before
such indirect contact occurs), this route is
unlikely to contribute significantly to
overall exposure to bystanders.
Oral swallowing
the product
directly
Oral
Bystanders
No
NA
Oral exposures may also occur through
hand-to-mouth patterns following dermal
contact with TCE. As described, dermal
contact would not be expected for
bystanders, and any TCE present on
surfaces of the home or skin surfaces is
expected to volatilize rapidly - making it
available for inhalation as a vapor before
oral ingestion may occur through such
patterns.
Use
Arts, crafts
and hobby
materials
Spray / aerosol
application:
Fixatives and
coatings
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Liquid
Contact
Dermal
Consumers
Yes
CEM
This use assessed in the U.S. EPA (U.S.
EPA, 2014c) risk assessment will be
considered in this evaluation to ensure
previous assessments are in alignment
with the Procedures for Chemical Risk
Evaluation under the Amended Toxic
Substances Control Act (40 CFR Part
702). TCE in direct contact with skin
would be expected to evaporate before
significant dermal absorption could occur.
However, there may be effects on the skin
(e.g., dermal sensitization), or certain
scenarios with a higher dermal exposure
potential, for example, an occluded
scenario, wherein liquid TCE is not able
to evaporate readily. Therefore, occluded
scenarios will be evaluated for systemic
Page 189 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation









and sensitization effects, whereas, non-
occluded scenarios will be evaluated for
sensitization effects alone.



Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct dermal
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Oral exposures may also occur through
hand-to-mouth patterns following dermal
contact with TCE. As described, any TCE
present on surfaces of the home or skin
surfaces is expected to volatilize rapidly -
making it available for inhalation as a
vapor before oral ingestion may occur
through such patterns.



Oral swallowing
the product
directly


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct oral
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.



Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct);
Dermal vapor to
skin
Vapor /
Mist
Dermal
Consumers
No
NA
Based on physical chemical properties,
mists of TCE are expected to rapidly
evaporate before being deposited on skin,
thus contributing to the amount of TCE
vapor in the air available for inhalation
exposure. In scenarios involving exposure
to TCE vapor, inhalation and dermal
exposures are concurrent, with
predominate exposure from inhalation. A
dermal to inhalation uptake ratio of
around 0.1% for vapor to skin scenarios is
predicted using IHSkinPerm. Therefore,
only the inhalation exposures will be
evaluated in these cases.
Page 190 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct);
Dermal vapor to
skin


Bystanders
No
NA
Based on physical chemical properties,
mists of TCE are expected to rapidly
evaporate before being deposited on skin,
thus contributing to the amount of TCE
vapor in the air available for inhalation
exposure. In scenarios involving exposure
to TCE vapor, inhalation and dermal
exposures are concurrent, with
predominate exposure from inhalation. A
dermal to inhalation uptake ratio of
around 0.1% for vapor to skin scenarios is
predicted using IHSkinPerm. Therefore,
only the inhalation exposures will be
evaluated in these cases.



Spray application
(stationary)

Inhalation
Consumers
Yes
MCCEM,
CEM
This use assessed in the U.S. EPA (2014c)
risk assessment will be considered in this
evaluation to ensure previous assessments
are in alignment with the Procedures for
Chemical Risk Evaluation under the
Amended Toxic Substances Control Act
(40 CFR Part 702). Inhalation is expected
to be the primary route of exposure for
users.



Spray application
(stationary)


Bystanders
Yes
MCCEM,
CEM
This use assessed in the U.S. EPA (2014c)
risk assessment will be considered in this
evaluation to ensure previous assessments
are in alignment with the Procedures for
Chemical Risk Evaluation under the
Amended Toxic Substances Control Act
(40 CFR Part 702). Inhalation is expected
to be the primary route of exposure for
bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Based on physical chemical properties,
mists of TCE are expected to be rapidly
absorbed in the respiratory tract or
evaporate before being introduced into the
respiratory tract, thus contributing to the
amount of TCE vapor in the air available
for inhalation exposure.



Oral swallowing
the product
directly


Bystanders
No
NA
Based on physical chemical properties,
mists of TCE are expected to be rapidly
absorbed in the respiratory tract or
evaporate before being introduced into the
Page 191 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation









respiratory tract, thus contributing to the
amount of TCE vapor in the air available
for inhalation exposure.
Use
Automotive
care
products
Liquid / non-
spray application:
Brake and parts
cleaner
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Liquid
Contact
Dermal
Consumers
Yes
CEM
TCE in direct contact with skin would be
expected to evaporate before significant
dermal absorption could occur. However,
there may be effects on the skin (e.g.,
dermal sensitization), or certain scenarios
with a higher dermal exposure potential,
for example, an occluded scenario,
wherein liquid TCE is not able to
evaporate readily. Therefore, occluded
scenarios will be evaluated for systemic
and sensitization effects, whereas, non-
occluded scenarios will be evaluated for
sensitization effects alone.
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct dermal
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.
Oral swallowing
the product
directly
Oral
Consumers
No
NA
Oral exposures may also occur through
hand-to-mouth patterns following dermal
contact with TCE. As described, any TCE
present on surfaces of the home or skin
surfaces is expected to volatilize rapidly -
making it available for inhalation as a
vapor before oral ingestion may occur
through such patterns.
Oral swallowing
the product
directly
Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct oral
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.
Dermal vapor to
skin
Vapor
Dermal
Consumers
No
NA
Mist not expected from this use pattern. In
scenarios involving exposure to TCE
vapor, inhalation and dermal exposures
are concurrent, with predominate exposure
from inhalation. A dermal to inhalation
uptake ratio of around 0.1% for vapor to
skin scenarios is predicted using
Page 192 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation









IHSkinPerm. Therefore, only the
inhalation exposures will be evaluated in
these cases.



Dermal vapor to
skin


Bystanders
No
NA
Mist not expected from this use pattern. In
scenarios involving exposure to TCE
vapor, inhalation and dermal exposures
are concurrent, with predominate exposure
from inhalation. A dermal to inhalation
uptake ratio of around 0.1% for vapor to
skin scenarios is predicted using
IHSkinPerm. Therefore, only the
inhalation exposures will be evaluated in
these cases.



Evaporation from
the surface (quick
decay)

Inhalation
Consumers
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for users.



Evaporation from
the surface (quick
decay)


Bystanders
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Mist not expected from this use pattern.



Oral swallowing
the product
directly


Bystanders
No
NA
Mist not expected from this use pattern.
Use
Automotive
care
products
Spray / aerosol
application:
Brake and parts
cleaner
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Liquid
Contact
Dermal
Consumers
Yes
CEM
TCE in direct contact with skin would be
expected to evaporate before significant
dermal absorption could occur. However,
there may be effects on the skin (e.g.,
dermal sensitization), or certain scenarios
with a higher dermal exposure potential,
for example, an occluded scenario,
wherein liquid TCE is not able to
evaporate readily. Therefore, occluded
scenarios will be evaluated for systemic
and sensitization effects, whereas, non-
occluded scenarios will be evaluated for
sensitization effects alone.
Page 193 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct dermal
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.
Oral swallowing
the product
directly
Oral
Consumers
No
NA
Oral exposures may also occur through
hand-to-mouth patterns following dermal
contact with TCE. As described, any TCE
present on surfaces of the home or skin
surfaces is expected to volatilize rapidly -
making it available for inhalation as a
vapor before oral ingestion may occur
through such patterns.
Oral swallowing
the product
directly
Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct oral
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct);
Dermal vapor to
skin
Vapor /
Mist
Dermal
Consumers
No
NA
Based on physical chemical properties,
mists of TCE are expected to rapidly
evaporate before being deposited on skin,
thus contributing to the amount of TCE
vapor in the air available for inhalation
exposure. In scenarios involving exposure
to TCE vapor, inhalation and dermal
exposures are concurrent, with
predominate exposure from inhalation. A
dermal to inhalation uptake ratio of
around 0.1% for vapor to skin scenarios is
predicted using IHSkinPerm. Therefore,
only the inhalation exposures will be
evaluated in these cases.
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct);
Dermal vapor to
skin
Bystanders
No
NA
Based on physical chemical properties,
mists of TCE are expected to rapidly
evaporate before being deposited on skin,
thus contributing to the amount of TCE
vapor in the air available for inhalation
exposure. In scenarios involving exposure
to TCE vapor, inhalation and dermal
exposures are concurrent, with
predominate exposure from inhalation. A
Page 194 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation









dermal to inhalation uptake ratio of
around 0.1% for vapor to skin scenarios is
predicted using IHSkinPerm. Therefore,
only the inhalation exposures will be
evaluated in these cases.



Spray application
(stationary)

Inhalation
Consumers
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for users.



Spray application
(stationary)


Bystanders
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Based on physical chemical properties,
mists of TCE are expected to be rapidly
absorbed in the respiratory tract or
evaporate before being introduced into the
respiratory tract, thus contributing to the
amount of TCE vapor in the air available
for inhalation exposure.



Oral swallowing
the product
directly


Bystanders
No
NA
Based on physical chemical properties,
mists of TCE are expected to be rapidly
absorbed in the respiratory tract or
evaporate before being introduced into the
respiratory tract, thus contributing to the
amount of TCE vapor in the air available
for inhalation exposure.
Use
Other uses
Liquid / non-
spray application:
Hoof polish, film
cleaner
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Liquid
Contact
Dermal
Consumers
Yes
CEM
TCE in direct contact with skin would be
expected to evaporate before significant
dermal absorption could occur. However,
there may be effects on the skin (e.g.,
dermal sensitization), or certain scenarios
with a higher dermal exposure potential,
for example, an occluded scenario,
wherein liquid TCE is not able to
evaporate readily. Therefore, occluded
scenarios will be evaluated for systemic
and sensitization effects, whereas, non-
occluded scenarios will be evaluated for
sensitization effects alone.
Page 195 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Dermal contact
with liquid
product on the
skin per event -
shorter duration


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct dermal
exposures to liquid TCE are not expected
and inhalation is the primary route of



(direct)





exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Oral exposures may also occur through
hand-to-mouth patterns following dermal
contact with TCE. As described, any TCE
present on surfaces of the home or skin
surfaces is expected to volatilize rapidly -
making it available for inhalation as a
vapor before oral ingestion may occur
through such patterns.



Oral swallowing
the product
directly


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct oral
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.



Dermal vapor to
skin
Vapor
Dermal
Consumers
No
NA
Mist not expected from this use pattern. In
scenarios involving exposure to TCE
vapor, inhalation and dermal exposures
are concurrent, with predominate exposure
from inhalation. A dermal to inhalation
uptake ratio of around 0.1% for vapor to
skin scenarios is predicted using
IHSkinPerm. Therefore, only the
inhalation exposures will be evaluated in
these cases.



Dermal vapor to
skin


Bystanders
No
NA
Mist not expected from this use pattern. In
scenarios involving exposure to TCE
vapor, inhalation and dermal exposures
are concurrent, with predominate exposure
from inhalation. A dermal to inhalation
uptake ratio of around 0.1% for vapor to
skin scenarios is predicted using
IHSkinPerm. Therefore, only the
inhalation exposures will be evaluated in
these cases.



Evaporation from
the surface (quick
decay)

Inhalation
Consumers
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for users.
Page 196 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Evaporation from
the surface (quick
decay)


Bystanders
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Mist not expected from this use pattern.



Oral swallowing
the product
directly


Bystanders
No
NA
Mist not expected from this use pattern.
Use
Other uses
Spray / aerosol
application:
Pepper spray,
film cleaner
Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct)
Liquid
Contact
Dermal
Consumers
Yes
CEM
TCE in direct contact with skin would be
expected to evaporate before significant
dermal absorption could occur. However,
there may be effects on the skin (e.g.,
dermal sensitization), or certain scenarios
with a higher dermal exposure potential,
for example, an occluded scenario,
wherein liquid TCE is not able to
evaporate readily. Therefore, occluded
scenarios will be evaluated for systemic
and sensitization effects, whereas, non-
occluded scenarios will be evaluated for
sensitization effects alone.



Dermal contact
with liquid
product on the
skin per event -
shorter duration


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct dermal
exposures to liquid TCE are not expected
and inhalation is the primary route of



(direct)





exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Oral exposures may also occur through
hand-to-mouth patterns following dermal
contact with TCE. As described, any TCE
present on surfaces of the home or skin
surfaces is expected to volatilize rapidly -
making it available for inhalation as a
vapor before oral ingestion may occur
through such patterns.



Oral swallowing
the product
directly


Bystanders
No
NA
Generally, individuals that have contact
with liquid TCE would be users and not
bystanders. Therefore, direct oral
exposures to liquid TCE are not expected
and inhalation is the primary route of
exposure for bystanders.
Page 197 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct);
Dermal vapor to
skin
Vapor /
Mist
Dermal
Consumers
No
NA
Based on physical chemical properties,
mists of TCE are expected to rapidly
evaporate before being deposited on skin,
thus contributing to the amount of TCE
vapor in the air available for inhalation
exposure. In scenarios involving exposure
to TCE vapor, inhalation and dermal
exposures are concurrent, with
predominate exposure from inhalation. A
dermal to inhalation uptake ratio of
around 0.1% for vapor to skin scenarios is
predicted using IHSkinPerm. Therefore,
only the inhalation exposures will be
evaluated in these cases.



Dermal contact
with liquid
product on the
skin per event -
shorter duration
(direct);
Dermal vapor to
skin


Bystanders
No
NA
Based on physical chemical properties,
mists of TCE are expected to rapidly
evaporate before being deposited on skin,
thus contributing to the amount of TCE
vapor in the air available for inhalation
exposure. In scenarios involving exposure
to TCE vapor, inhalation and dermal
exposures are concurrent, with
predominate exposure from inhalation. A
dermal to inhalation uptake ratio of
around 0.1% for vapor to skin scenarios is
predicted using IHSkinPerm. Therefore,
only the inhalation exposures will be
evaluated in these cases.



Spray application
(stationary)

Inhalation
Consumers
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for users.



Spray application
(stationary)


Bystanders
Yes
MCCEM,
CEM
Inhalation is expected to be the primary
route of exposure for bystanders.



Oral swallowing
the product
directly

Oral
Consumers
No
NA
Based on physical chemical properties,
mists of TCE are expected to be rapidly
absorbed in the respiratory tract or
evaporate before being introduced into the
respiratory tract, thus contributing to the
amount of TCE vapor in the air available
for inhalation exposure.
Page 198 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation



Oral swallowing
the product
directly


Bystanders
No
NA
Based on physical chemical properties,
mists of TCE are expected to be rapidly
absorbed in the respiratory tract or
evaporate before being introduced into the
respiratory tract, thus contributing to the
amount of TCE vapor in the air available
for inhalation exposure.
Disposal
Consumer
Handling
and Disposal
of Waste
Disposal of TCE
wastes
Consumer
handling of spent
consumer
products
Liquid
Contact
Dermal /
Oral
Consumers
No
NA
Consumer products containing TCE are
expected to be primarily disposed of in
original containers, thus limiting direct
exposures to TCE during disposal or
handling. Disposal of spent products are
expected to be taken to municipal landfill
sites and collected and disposed of as part
of their waste handling practices. Any
exposures associated with TCE-containing
consumer products are expected to be
significantly higher during use than during
disposal or handling. Therefore,
evaluation of the use-associated exposures
is anticipated to reflect the worst-case
exposure scenario for a specific product.
Bystanders
No
NA
Consumer products containing TCE are
expected to be primarily disposed of in
original containers, thus limiting direct
exposures to TCE during disposal or
handling. Disposal of spent products are
expected to be taken to municipal landfill
sites and collected and disposed of as part
of their waste handling practices. Any
exposures associated with TCE-containing
consumer products are expected to be
significantly higher during use than during
disposal or handling. Therefore,
evaluation of the use-associated exposures
is anticipated to reflect the worst-case
exposure scenario for a specific product.
Vapor
Dermal /
Oral
Consumers
No
NA
Consumer products containing TCE are
expected to be primarily disposed of in
original containers, thus limiting direct
exposures to TCE during disposal or
handling. Disposal of spent products are
expected to be taken to municipal landfill
Page 199 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation









sites and collected and disposed of as part
of their waste handling practices. Any
exposures associated with TCE-containing
consumer products are expected to be
significantly higher during use than during
disposal or handling. Therefore,
evaluation of the use-associated exposures
is anticipated to reflect the worst-case
exposure scenario for a specific product.
Bystanders
No
NA
Consumer products containing TCE are
expected to be primarily disposed of in
original containers, thus limiting direct
exposures to TCE during disposal or
handling. Disposal of spent products are
expected to be taken to municipal landfill
sites and collected and disposed of as part
of their waste handling practices. Any
exposures associated with TCE-containing
consumer products are expected to be
significantly higher during use than during
disposal or handling. Therefore,
evaluation of the use-associated exposures
is anticipated to reflect the worst-case
exposure scenario for a specific product.
Inhalation
Consumers
No
NA
Consumer products containing TCE are
expected to be primarily disposed of in
original containers, thus limiting direct
exposures to TCE during disposal or
handling. Disposal of spent products are
expected to be taken to municipal landfill
sites and collected and disposed of as part
of their waste handling practices. Any
exposures associated with TCE-containing
consumer products are expected to be
significantly higher during use than during
disposal or handling. Therefore,
evaluation of the use-associated exposures
is anticipated to reflect the worst-case
exposure scenario for a specific product.
Page 200 of 209

-------
Life
Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor /
Population
Proposed
for
Further
Risk
Evaluation
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation






Bystanders
No
NA
Consumer products containing TCE are
expected to be primarily disposed of in
original containers, thus limiting direct
exposures to TCE during disposal or
handling. Disposal of spent products are
expected to be taken to municipal landfill
sites and collected and disposed of as part
of their waste handling practices. Any
exposures associated with TCE-containing
consumer products are expected to be
significantly higher during use than during
disposal or handling. Therefore,
evaluation of the use-associated exposures
is anticipated to reflect the worst-case
exposure scenario for a specific product.
Page 201 of 209

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Appendix E SUPPORTING TABLE FOR ENVIRONMENTAL RELEASES AND WASTES
CONCEPTUAL MODEL
TableApx E-l. Environmental Releases and Wastes Conceptual Model Supporting Table
(Note that rows shaded in gray are not proposec
for further analysis)
Life Cycle
Stage
Releases and Wastes
from Industrial /
Commercial /
Consumer Uses
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Route
Receptor
Proposed
for
Further
Analysis
Applicable
Modeling
Approach
Rationale for Further Evaluation / no
Further Evaluation
Manufacturing,
Processing,
Use, and/or
Disposal
Wastewater
or Liquid
Wastes
Industrial
pre-
treatment
or indirect
discharge
to POTW
Direct
discharge to
surface
water
Surface
water
Not
applicable
to
ecological
receptors
Aquatic
Species
Yes
E-FAST,
VVWM
Within the past ten years of surface water
monitoring data from STORET, there are
detections (e.g., maximum of 50 ppb and
average of 4.5 ppb), that do not exceed the
acute COC for TCE, 340 ppb, but do exceed the
chronic COC, 3 ppb.
Manufacturing,
Processing,
Use, and/or
Disposal
Wastewater
or Liquid
Wastes
Industrial
pre-
treatment
or indirect
discharge
to POTW
Direct
discharge to
surface
water
Surface
water
Not
applicable
to
ecological
receptors
Terrestrial
Species
No
NA
Review of hazard data for terrestrial organisms
shows that there is likely to be hazard; however,
physical chemical properties do not support an
exposure pathway through water and soil
pathways to these organisms. TCE has a
predicted 81% wastewater treatment removal
efficiency, predominately due to volatilization
during aeration.
Manufacturing,
Processing,
Use, and/or
Disposal
Wastewater
or Liquid
Wastes
Industrial
pre-
treatment
or indirect
discharge
to POTW
Direct
discharge to
surface
water
Sediment:
surface
water to
sediment
Not
applicable
to
ecological
receptors
Aquatic
Species
No
NA
TCE is released to surface water from ongoing
industrial and/or commercial activities, as
reported in recent TRI and DMR release and
loading data. However, TCE released to surface
water is expected to primarily volatilize; thus, it
is not expected that a significant portion of TCE
would be available to enter the sediment
compartment.
Manufacturing,
Processing,
Use, and/or
Disposal
Wastewater
or Liquid
Wastes
Industrial
pre-
treatment
or indirect
discharge
to POTW
Partitioning
to biosolids
Soil:
biosolids to
soil
Not
applicable
to
ecological
receptors
Terrestrial
Species
No
NA
Based on TCE's fate properties, it is not
anticipated to partition to biosolids during
wastewater treatment. TCE has a predicted 81%
wastewater treatment removal efficiency,
predominately due to volatilization during
aeration. Any TCE present in the water portion
of biosolids following wastewater treatment
and land application would be expected to
rapidly volatilize into air. Beyond these fate-
based considerations, TCE is subject to RCRA
land disposal restrictions under (40 CFR 268)
and is considered a prohibited waste (organics
toxicity characteristic) with land disposal
restriction treatment standards that must be met
prior to land disposal.
Page 202 of 209

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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.efm?helptabs=tab4) and in the
Strategy for Conducting Literature Searches document published along with each of the TSCA Scope
documents.
F.I 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.
EPA describes the expected exposure pathways to human receptors from consumer uses of
trichloroethylene that EPA plans to include in the risk evaluation in Section 2.5.2. EPA expects that the
primary route of exposure for consumers will be via inhalation. There may also be dermal exposure.
Environmental fate data will not be used to further assess these exposure pathways as they are expected
to occur in the indoor environment.
During problem formulation, exposure pathways to human and ecological receptors from environmental
releases and waste stream associated with industrial and commercial activities will not be further
analyzed in risk evaluation. For a description of the rationale behind this conclusion, see Section 2.5.3.2
and Section 2.5.3.3 . In the absence of exposure pathways for further analysis, environmental fate data
will not be further evaluated. Therefore, PESO statements describing fate endpoints, associated
Page 203 of 209

-------
processes, media and exposure pathways that were considered in the development of the environmental
fate assessment for trichloroethylene will not be presented.
F.2 Inclusion Criteria for Data Sources Reporting Engineering and
Occupational Exposure Data
EPA/OPPT developed a generic RESO statement to guide the full text screening of engineering and
occupational exposure literature (TableApx F-l). 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-2) when screening the literature.
Table Apx F-l. Inclusion Criteria for Data Sources Reporting Engineering and
Occupational Exposure Data
RESO Element
Evidence

• Humans:
Workers, including occupational non-users
Receptors
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 Any relevant media/pathway [list included: water, land, air, incineration, and
other(s)] 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 A-3 below
except (state none excluded or list excluded uses)
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 Data Needs (Table Apx F-2) provides
a list of related and relevant general information.
TSCA=Toxic Substances Control Act
Page 204 of 209

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TableApx F-2
Environmenta
. Engineering, Environmental Release and Occupational Data Necessary to Develop the
Release and Occupational Exposure Assessments
Objective
Determined
during Scoping
Type of Data
General
Engineering
Assessment (may
apply for either
or both
Occupational
Exposures and /
or Environmental
Releases)
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, 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}"
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
Occupational
Exposures
6.	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)}11
7.	Potential routes of exposure (e.g., inhalation, dermal). {Tags: Routes of exposure (manufacture, import,
processing, use)}a
8.	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
9.	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:
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: 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
Page 205 of 209

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Table Apx F-2
Environmenta
. Engineering, Environmental Release and Occupational Data Necessary to Develop the
Release and Occupational Exposure Assessments
Objective
Determined
during Scoping
Type of Data
Environmental
Releases
19.	Description of relevant 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
relevant 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.	Relevant 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)}a
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
Notes:
a 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.
Abbreviations:
hr=Hour
kg=Kilogram(s)
lb=Pound(s)
yr=Year
PV=Production Volume
PBZ= Personal Breathing Zone
POTW=Publicly Owned Treatment Works
PPE=Personal Protective Equipment
PSD=Particle Size Distribution
TWA=Time-Weighted Average
F.3 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 exposure 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 TCE-specific PECO is provided in TableApx F-3.
Table Apx F-3. Inclusion Criteria for the Data Sources Reporting Trichloroethylene
Exposure Data on Consumers and Ecological Receptors
PECO Element
Evidence
Population
Human: Consumers (i.e.. rcccotors who use a oroduct directly) and bystanders (i.e.. rcccotors
who are non-product users that are incidentally exposed to the product or article), including
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PESS such as infants, children, pregnant women, lactating women, women of child bearing
age, and high-end consumers
Ecological: Aauatic soecies. aauatic olants
Exposure
Expected Primary Exposure Sources, Pathways, Routes: See Figures 2-3 and 2-4
•	Sources: Consumer uses in the home oroducine releases of TCE to air and dermal contact:
industrial and commercial activities producing releases to surface water
•	Pathwavs: Indoor air and dermal contact with TCE in consumer Droducts: surface water
•	Routes of Exposure: Inhalation via indoor air (consumer and bvstander DODulations) and
dermal exposure via direct contact with consumer products containing TCE; surface water
Comparator
(Scenario)
Human: Consumer and bvstander exposure via use of TCE-containine consumer Droducts in
the home
Ecological: Aauatic soecies and olants cxooscd via releases to or presence in surface water
Outcomes for
Exposure
Concentration or
Dose
Human: Acute, subchronic. and/or chronic external dose estimates (mu/ku/dav): acute,
subchronic, and/or chronic air concentration estimates (|ig/m;l mg/m3). Both external potential
dose and internal dose based on biomonitoring and reverse dosimetry mg/kg/day will be
considered.
Ecological: A wide ranee of ecolosical rcccotors will be considered (ranee deoendine on
available ecotoxicity data) using surface water concentration^) (ng/1, mg/L)
Abbreviations:
Kg=Kilogram(s)
Mg=Milligram(s)
M3=Cubic meter
L=Liter(s)
F.4 Inclusion Criteria for Data Sources Reporting Human Health Hazards
EPA/OPPT developed a TCE-specific PECO statement 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.
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TableApx F-4. Inclusion and Exclusion Criteria for the Data Sources Reporting Human Health
Hazards Related to TCE Exposure3
PECO Element
Evidence Stream
Papers/Features Included
Papers/Features Excluded
Population
Human
•	Any population
•	All lifestages
•	Study designs:
o Controlled exposure, cohort, case-control,
cross-sectional, case-crossover for all
endpoints
o Case studies, case series and ecological
studies only related to deaths and respiratory
distress
• Case studies, case series and ecological
studies for all endDoints other than
death and respiratory distress

Animal
•	All non-human whole-organism mammalian
species
•	All lifestages
• Non-mammalian species

Mechanistic/
Alternative Methods
• Human or animal cells (including
nonmammalian model systems), tissues, or
biochemical reactions (e.g., ligand binding
assays) with in vitro exposure regimens;
bioinformatics pathways of disease analysis; or
high throughput screening data.

Exposure
Human
•	Exposure based on administered dose or
concentration of TCE, 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.,
trichloroacetic acid) as identified in
biomonitoring studies
•	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 TCE 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 TCE (or related metabolite)

Animal
•	A minimum of 2 quantitative dose or
concentration levels of TCE plus a negative
control group a
•	Acute, subchronic, chronic exposure from oral,
dermal, inhalation routes
•	Exposure to TCE only (no chemical mixtures)
•	Quantitative and/or qualitative relative/rank-
order estimates of exposure
•	Only 1 quantitative dose or
concentration level in addition to the
controla
•	Route of exposure not by inhalation,
oral or dermal type (e.g.,
intraperitoneal, injection)
•	No duration of exposure stated
•	Exposure to TCE in a chemical mixture

Mechanistic/
Alternative Methods
•	A minimum of 2 quantitative concentrations of
TCE plus a negative control group a
•	Exposure to TCE only (no chemical mixtures)
•	Only 1 quantitative dose or
concentration level in addition to the
controla
•	Exposure to TCE in a chemical mixture
Comparator
Human
• A comparison population [not exposed,
• No comparison population for
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TableApx F-4. Inclusion and Exclusion Criteria for the Data Sources Reporting Human Health
Hazards Related to TCE Exposure3


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
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
Mechanistic/
Alternative Methods
• 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 documentb:
o Acute toxicity
o Liver toxicity
o Kidney toxicity
o Reproductive/developmental Toxicity
o Neurotoxicity
o Immunotoxicity
o Sensitization
o Cancer
•	Other endpoints c

Animal
Mechanistic/
Alternative Methods
• All data that may inform mechanisms of
developmental toxicity
• Data that inform mechanisms of
toxicity for enduoints other than
developmental toxicity
General Considerations
Papers/Features Included
Papers/Features Excluded

•	Written in English d
•	Reports primary data or meta-analysis a
•	Full-text available
•	Reports both TCE exposure and a health
outcome or mechanism of action
•	Not written in English d
•	Reports secondary data (e.g., review
papers)a
•	No full-text available (e.g., only a
study description/abstract, out-of-print
text)
•	Reports a TCE-related exposure or a
health outcome/mechanism of action,
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
TCE, 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 also review other data as
needed (e.g., animal studies using one concentration, review papers).
b EPA will review key and supporting studies in the IRIS assessment that were considered in the dose-response assessment for non-cancer
and cancer endpoints as well as studies published after the IRIS assessment.
c 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.
d EPA may translate studies as needed.
Appendix G List of Retracted Papers
The following reference was retracted by the journal:
HERO ID: 647007
Zhao, B; Zhu, L. (2006). Solubilization of DNAPLs by mixed surfactant: synergism and solubilization
capacity. J Hazard Mater 136: 513-519. http://dx.doi.or;	i jhazMat2005.08.03
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