EPA Document# EPA-740-R1-7017
May 2018
States Office of Chemical Safety and
Environmental Protection Agency Pollution Prevention
Problem Formulation of the Risk Evaluation for
Perchloroethylene
(Ethene, l,l»2,2-Tetrachloro)
CASRN: 127-18-4
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TABLE OF CONTENTS
ABBREVIATIONS 8
EXECUTIVE SUMMARY 11
1 INTRODUCTION 14
1.1 Regulatory History 16
1.2 Assessment History 16
1.3 Data and Information Collection 18
1.4 Data Screening During Problem Formulation 19
2 PROBLEM FORMULATION 20
2.1 Physical and Chemical Properties 20
2.2 Conditions of Use 21
2.2.1 Data and Information Sources 21
2.2.2 Identification of Conditions of Use 21
2.2.2.1 Categories and Subcategories Determined Not to be Conditions of Use During Problem
Formulation 22
2.2.2.2 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 22
2.2.2.3 Overview of Conditions of Use and Lifecycle Diagram 32
2.3 Exposures 35
2.3.1 Fate and Transport 35
2.3.2 Releases to the Environment 37
2.3.3 Presence in the Environment and Biota 40
2.3.4 Environmental Exposures 43
2.3.5 Human Exposures 43
2.3.5.1 Occupational Exposures 43
2.3.5.2 Consumer Exposures 44
2.3.5.3 General Population Exposures 46
2.3.5.4 Potentially Exposed or Susceptible Subpopulations 47
2.4 Hazards 48
2.4.1 Environmental Hazards 48
2.4.2 Human Health Hazards 51
2.4.2.1 Non-Cancer Hazards 51
2.4.2.2 Genotoxicity and Cancer Hazards 53
2.4.2.3 Potentially Exposed or Susceptible Subpopulations 53
2.5 Conceptual Models 53
2.5.1 Conceptual Model for Industrial and Commercial Activities and Uses: Potential Exposures
and Hazards 54
2.5.2 Conceptual Model for Consumer Activities and Uses: Potential Exposures and Hazards.... 57
2.5.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards 59
2.5.3.1 Pathways That EPA Expects to Include and Further Analyze in the Risk Evaluation... 59
2.5.3.2 Pathways That EPA Does Not Expect to Include in the Risk Evaluation 59
2.6 Analysis Plan 65
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2.6.1 Exposure 65
2.6.1.1 Environmental Releases 65
2.6.1.2 Environmental Fate 67
2.6.1.3 Environmental Exposures 68
2.6.1.4 Occupational Exposures 69
2.6.1.5 Consumer Exposures 71
2.6.1.6 General Population 73
2.6.2 Hazards (Effects) 73
2.6.2.1 Environmental Hazards 73
2.6.2.2 Human Health Hazards 74
2.6.3 Risk Characterization 76
REFERENCES 77
APPENDICES 93
Appendix A REGULATORY HISTORY 93
A. 1 Federal Laws and Regulations 93
A.2 State Laws and Regulations 99
A.3 International Laws and Regulations.... 100
Appendix B PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION 102
B.l Process Information. 102
B. 1.1 Manufacture (Including Import) 102
B. 1.1.1 Domestic Manufacture 102
B.l. 1.2 Import 107
B. 1.2 Processing and Distribution 107
B. 1.2.1 Reactant or Intermediate 107
B. 1.2.2 Incorporating into a Formulation, Mixture or Reaction Product 108
B. 1.2.3 Incorporating into an Article 108
B. 1.2.4 Repackaging 109
B. 1.2.5 Recycling 109
B.1.3 Uses Ill
B. 1.3.1 Cleaning and Furniture Care Products Ill
B. 1.3.2 Solvents for Cleaning and Degreasing Ill
B. 1.3.3 Lubricant and Greases 119
B. 1.3.4 Adhesives and Sealants 119
B.1.3.5 Paints and Coatings 120
B. 1.3.6 Processing Aid for Pesticide, Fertilizer and Other Agricultural Manufacturing 120
B. 1.3.7 Processing Aid, Specific to Petroleum Production 120
B.1.3 .8 Other Uses 120
B.1.4 Disposal 120
B.2 Occupational Exposure Data....,.,.. 121
B.3 References related to Risk Evaluation - Environmental Release and Occupational Exposure 125
Appendix C SUPPORTING TABLE FOR INDUSTRIAL AND COMMERCIAL ACTIVITIES
AND USES CONCEPTUAL MODEL 143
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Appendix D SUPPORTING TABLE FOR CONSUMER ACTIVITIES AND USES
CONCEPTUAL MODEL 157
Appendix E SUPPORTING TABLE FOR ENVIRONMENTAL RELEASES AND WASTES
CONCEPTUAL MODEL 158
Appendix F INCLUSION AND EXCLUSION CRITERIA FOR FULL TEXT SCREENING. 159
F. 1 Inclusion Criteria for Data Sources Reporting Environmental Fate Data. 159
F.2 Inclusion Criteria for Data Sources Reporting Engineering and Occupational Exposure
Data 161
F.3 Inclusion Criteria for Data Sources Reporting Exposure Data on Consumers and Ecological.
Receptors,.,......,..,, .......... 163
F.4 Inclusion Criteria for Data Sources Reporting Ecological Hazards 165
F.5 Inclusion Criteria for Data Sources Reporting Human Health Hazards 165
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LIST OF TABLES
Table 1-1. Assessment History of Perchloroethylene 16
Table 2-1. Physical and Chemical Properties of Perchloroethylene 20
Table 2-2. Categories and Subcategories Determined Not to be Conditions of Use During Problem
Formulation 22
Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 25
Table 2-4. Production Volume of Perchloroethylene in CDR Reporting Period (2012 to 2015) a 32
Table 2-5. Environmental Fate Characteristics of Perchloroethylene 36
Table 2-6. Summary of Perchloroethylene TRI Production-Related Waste Managed in 2015 (lbs) 37
Table 2-7. Summary of Perchloroethylene TRI Releases to the Environment in 2015 (lbs) 38
Table 2-8. Summary of 2015 TRI Releases for Perchloroethylene (CASRN 127-18-4) 39
Table 2-9: Ecological Hazard Characterization of Perchloroethylene 50
Table 2-10. Potential Sources of Environmental Release Data 66
Table 2-11. Potential Sources of Occupational Exposure Data 69
LIST OF FIGURES
Figure 2-1. Perchloroethylene Life Cycle Diagram 34
Figure 2-2. Perchloroethylene Conceptual Model for Industrial and Commercial Activities and Uses:
Potential Exposures and Hazards 56
Figure 2-3. Perchloroethylene Conceptual Model for Consumer Activities and Uses: Potential Exposures
and Hazards 58
Figure 2-4. Perchloroethylene Conceptual Model for Environmental Releases and Wastes: Potential
Exposures and Hazards 64
LIST OF APPENDIX TABLES
TableApx A-l. Federal Laws and Regulations 93
TableApx A-2. State Laws and Regulations 99
Table Apx A-3. Regulatory Actions by Other Governments and Tribes 100
Table Apx B-l. Summary of Perchloroethylene Personal Monitoring Air Samples Obtained from
OSHA Inspections Conducted Between 2011 and 2016 122
Table Apx B-2. Summary of Monitoring Data from NIOSH Health Hazard Evaluations Conducted
since 1990 124
Table Apx B-3. Potentially Relevant Data Sources for Process Description Related Information for
Perchloroethylene 125
Table Apx B-4. Potentially Relevant Data Sources for Estimated or Measured Release Data for
Perchloroethylene 130
Table Apx B-5. Potentially Relevant Data Sources for Personal Exposure Monitoring and Area
Monitoring Data for Perchloroethylene 132
Table Apx B-6. Potentially Relevant Data Sources for Engineering Controls and Personal Protective
Equipment Information for Perchloroethylene 138
Table Apx C-l. Industrial and Commercial Activities and Uses Conceptual Model Supporting Tablel43
Table Apx D-l. Consumer Activities and Uses Conceptual Model Supporting Table 157
Table Apx E-l. Environmental Releases and Wastes Conceptual Model Supporting Table 158
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TableApx F-l. Inclusion Criteria for Data Sources Reporting Engineering and Occupational Exposure
Data 161
Table Apx F-2. Engineering, Environmental Release and Occupational Data Necessary to Develop the
Environmental Release and Occupational Exposure Assessments 162
Table Apx F-3. Inclusion Criteria for the Data Sources Reporting Perchloroethylene Exposure Data on
Consumers and Ecological Receptors 164
Table Apx F-4. Ecological Hazard PECO (Populations, Exposures, Comparators, Outcomes) Statement
for Perchloroethylene 165
Table Apx F-5. Inclusion and Exclusion Criteria for Data Sources Reporting Human Health Hazards
Related to Perchloroethylene (PERC)a 166
LIST OF APPENDIX FIGURES
FigureApx B-l. Process Flow Diagram for the Manufacture of Perchloroethylene via Chlorination of
EDC (EPA, 1985) 104
Figure Apx B-2. Process Flow Diagram for the Manufacture of Perchloroethylene via Chlorination of
Hydrocarbons (EPA, 1985) 105
Figure Apx B-3. Process Flow Diagram for the Manufacture of Perchloroethylene via Oxychlorination
of C2 Chlorinated Hydrocarbons (EPA, 1985) 106
FigureApx B-4. Process Flow Diagram of Perchloroethylene Solvent Recovery (U.S. EPA, 1985b) 110
Figure Apx B-5. Open Top Vapor Degreaser 112
Figure Apx B-6. Open Top Vapor Degreaser with Enclosure 113
Figure Apx B-7. Closed-loop/Vacuum Vapor Degreaser 114
Figure Apx B-8. Monorail Conveyorized Vapor Degreasing System (EPA, 1977a) 115
Figure Apx B-9. Cross-Rod Conveyorized Vapor Degreasing System (EPA, 1977a) 116
Figure Apx B-10. Vibra Conveyorized Vapor Degreasing System (U.S. EPA, 1977) 116
Figure Apx B-l 1. Ferris Wheel Conveyorized Vapor Degreasing System (EPA, 1977a) 117
Figure Apx B-12. Belt/Strip Conveyorized Vapor Degreasing System (U.S. EPA, 1977) 117
Figure Apx B-13. Continuous Web Vapor Degreasing System 118
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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: | <_ \ JjO » UTT-2016-0732
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
1-BP
1-Bromopropane
ACGIH
American Conference of Government Industrial Hygienists
AEGL
Acute Exposure Guideline Level
AT SDR
Agency for Toxic Substances and Disease Registries
atm
Atmosphere(s)
BAF
Bioaccumulation Factor
BCF
Bioconcentration Factor
CAA
Clean Air Act
CASRN
Chemical Abstracts Service Registry Number
CBI
Confidential Business Information
ecu
Carbon Tetrachloride
CDC
Centers for Disease Control
CDR
Chemical Data Reporting
CEHD
Chemical Exposure Health Data
CEPA
Canadian List of Toxic Substances
CERCLA
Comprehensive Environmental Response, Compensation and Liability Act
CFC
Chi orofluorocarb on
CHIRP
Chemical Risk Information Platform
cm3
Cubic Centimeter(s)
coc
Concentration of Concern
CoRAP
Community Rolling Action Plan
CP
Centipoise
CPCat
Chemical and Product Categories
CPSC
Consumer Product Safety Commission
CSCL
Chemical Substances Control Law
CWA
Clean Water Act
DNAPL
Dense Non-Aqueous Phase Liquid
ECHA
European Chemicals Agency
EDC
Ethylene Dichloride
EG
Effluent Guidelines
EPA
Environmental Protection Agency
EPCRA
Emergency Planning and Community Right-to-Know Act
ESD
Emission Scenario Documents
EU
European Union
FDA
Food and Drug Administration
FFDCA
Federal Food, Drug and Cosmetic Act
FHSA
Federal Hazardous Substance Act
FIFRA
Federal Insecticide, Fungicide and Rodenticide Act
g
Gram(s)
GACT
Generally Available Control Technology
HAP
Hazardous Air Pollutant
HCFC
Hy drochl orofluorocarb on
HC1
Hydrochloric Acid
HFC
Hydrofluorocarbon
HSIA
Halogenated Solvents Industry Association
HPV
High Production Volume
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Hr Hour
IARC International Agency for Research on Cancer
IDLH Immediately Dangerous to Life and Health
i.p. Intraperitoneal
IRIS Integrated Risk Information System
ISHA Industrial Safety and Health Act
kg Kilogram(s)
L Liter(s)
lb Pound(s)
Log Koc Logarithmic Organic Carbon:Water Partition Coefficient
Log Kow Logarithmic Octanol: Water Partition Coefficient
m3 Cubic Meter(s)
MACT Maximum Achievable Control Technology
MCL Maximum Contaminant Level
MCLG Maximum Contaminant Level Goal
mg Milligram(s)
|ig Microgram(s)
mmHg Millimeter(s) of Mercury
MOA Mode of Action
MSDS Material Safety Data Sheet
n Number
NAAQS National Ambient Air Quality Standards
NAC National Advisory Committee
NAICS North American Industry Classification System
NCEA National Center for Environmental Assessment
NEI National Emissions Inventory
NESHAP National Emission Standards for Hazardous Air Pollutants
NHANES National Health and Nutrition Examination Survey
NICNAS National Industrial Chemicals Notification and Assessment Scheme
NIH National Institutes of Health
NIOSH National Institute of Occupational Safety and Health
NITE National Institute of Technology and Evaluation
NPL National Priorities List
NTP Nati onal Toxi col ogy Program
OAQPS Office of Air Quality Planning and Standards
OCSPP Office of Chemical Safety and Pollution Prevention
ODS Ozone Depleting Substance
OECD Organisation for Economic Co-operation and Development
OEHHA Office of Environmental Health Hazard Assessment
OEL Occupational Exposure Limit
ONU Occupational Non-User
OPPT Office of Pollution Prevention and Toxics
OSHA Occupational Safety and Health Administration
PBZ Personal Breathing Zone
PCE Perchloroethylene
PEL Permissible Exposure Limit
PESS Potentially Exposed Susceptible Subpopulation
POD Point of Departure
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POTW
Publicly Owned Treatment Works
ppb
Part(s) per Billion
PPE
Personal Protective Equipment
ppm
Part(s) per Million
PWS
Public Water System
RCRA
Resource Conservation and Recovery Act
SARA
Superfund Amendments and Reauthorization Act
SCHER
Scientific Committee on Health and Environmental Risks
SDS
Safety Data Sheet
SDWA
Safe Drinking Water Act
SIDS
Screening Information Data Set
SNAP
Significant New Alternatives Policy
STEL
Short-Term Exposure Limit
tl/2
Half-life
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
TTO
Total Toxic Organics
TWA
Time-Weighted Average
U.S.
United States
VOC
Volatile Organic Compound
WHO
World Health Organization
Yr
Year(s)
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EXECUTIVE SUMMARY
TSCA § 6(b)(4) requires the U.S. Environmental Protection Agency (EPA) to establish a risk evaluation
process. In performing risk evaluations for existing chemicals, EPA is directed to "determine whether a
chemical substance presents an unreasonable risk of injury to health or the environment, without
consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed
or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator under the
conditions of use." In December of 2016, EPA published a list of 10 chemical substances that are the
subject of the Agency's initial chemical risk evaluations ( 7), as required by TSCA §
6(b)(2)(A). Perchloroethylene 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
perchloroethylene. 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
perchloroethylene. 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 perchloroethylene and presents refined conceptual models and
analysis plans that describe how EPA expects to evaluate the risk for perchloroethylene.
Perchloroethylene, also known as ethene, 1,1,2,2-tetrachloro, tetrachloroethylene and PCE, is a high
production volume (HPV) solvent. Perchloroethylene is subject to a number of federal and state
regulations and reporting requirements. For example, perchloroethylene has been a Toxics Release
Inventory (TRI) reportable chemical under Section 313 of the Emergency Planning and Community
Right-to-Know Act (EPCRA) since 1995. It is designated a Hazardous Air Pollutant (HAP) under the
Clean Air Act (CAA), a hazardous waste under the Comprehensive Environmental Response,
Compensation and Liability Act (CERCLA) and a regulated drinking water contaminant under the Safe
Drinking Water Act (SDWA).
Information on the domestic manufacture, processing and use of perchloroethylene is available to EPA
through its Chemical Data Reporting (CDR) Rule, issued under TSCA. According to the 2016 CDR,
more than 324 million pounds of perchloroethylene were manufactured (including imported) in the
United States in 2015. According to the Use and Market Profile for Tetrachloroethylene (EPA-HQ-
QPPT-2016-0732). perchloroethylene is primarily used to produce fluorinated compounds, such as
hydrofluorocarbons (HFCs) and hydrochlorofluorocarbons (HCFCs) (65%) followed by dry cleaning
(15%) and vapor degreasing solvents (10%). Other uses can be quite varied, including:
• Adhesives
• Degreasing
• Brake cleaner
• Laboratories
• Lubricants
• Mold cleaners, releases and protectants
• Oil refining
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• Sealants
• Stainless steel polish
• Tire buffers and cleaners and
• Vandal mark removers.
This document presents the potential exposures that may result from the conditions of use of
perchloroethylene. Exposures may occur to workers and occupational non-users (workers who do not
directly handle the chemical but perform work in an area where the chemical is used), consumers and
bystanders (non-product users that are incidentally exposed to the product) and the general population
through inhalation, dermal and oral pathways. Workers and occupational non-users (ONU), who do not
directly handle the chemical but perform work in an area where the chemical is used, may be exposed to
perchloroethylene during a variety of conditions of use, such as manufacturing, processing and industrial
and commercial uses, including uses in degreasing and adhesives. EPA expects that the highest
exposures to perchloroethylene generally involve workers in industrial and commercial settings.
Perchloroethylene can be found in numerous products and can, therefore, result in exposures to
commercial and consumer users in indoor or outdoor environments. For perchloroethylene, EPA
considers workers, occupational non-users, consumers, bystanders, and certain other groups of
individuals who may experience greater exposures than the general population due to proximity to
conditions of use to be potentially exposed or susceptible subpopulations. Exposures to the general
population may occur from industrial and/or commercial uses; industrial releases to air, water or land;
and other conditions of use. EPA will evaluate whether groups of individuals within the general
population may be exposed via pathways that are distinct from the general population due to unique
characteristics (e.g., life stage, behaviors, activities, duration) that increase exposure and whether groups
of individuals have heightened susceptibility, and should therefore be considered potentially exposed or
susceptible subpopulations for purposes of the risk evaluation. EPA plans to further analyze inhalation
exposures to vapors and mists for workers and occupational non-users and dermal exposures for skin
contact with liquids in occluded situations for workers in the risk evaluation. For environmental release
pathways, EPA plans to further analyze surface water exposure to aquatic vertebrates, invertebrates and
aquatic plants and exposure to sediment-dwelling organisms.
Perchloroethylene has been the subject of several prior health hazard and risk assessments, including
EPA's Integrated Risk Information System (IRIS) Toxicological Review and a draft Agency for Toxic
Substances and Disease Registry's (ATSDR's) Toxicological Profile. A number of targets of toxicity
from exposures to perchloroethylene have been identified in animal and human studies for both oral and
inhalation exposures. EPA plans to evaluate all potential hazards for perchloroethylene, using the
primary literature identified in human health reviews and including any found in recent literature.
Hazard endpoints identified in previous assessments include: acute toxicity, neurotoxicity, kidney
toxicity, liver toxicity, developmental and reproductive toxicity and cancer. Support for an association
with immune and blood effects was less well characterized. Perchloroethylene is also considered to be
irritating.
The revised conceptual models presented in this problem formulation identify conditions of use;
exposure pathways (e.g., media); exposure routes (e.g., inhalation, dermal, oral); potentially exposed or
susceptible subpopulations; and hazards EPA expects to consider in the risk evaluation. The initial
conceptual models provided in the scope document were revised during problem formulation based on
evaluation of reasonably available information for physical and chemical properties, fate, exposures,
hazards and conditions of use, and based upon consideration of other statutory and regulatory
authorities. In each problem formulation document for the first 10 chemical substances, EPA also
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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
perchloroethylene 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, including the hazards,
exposures, conditions of use, and the potentially exposed or susceptible subpopulations that the
Administrator expects to consider in the risk evaluation. In the future, EPA expects scoping and problem
formulation to be completed prior to the issuance of scope documents and intends to issue scope
documents that include problem formulation.
As explained in the scope document, because there was insufficient time for EPA to provide an
opportunity for comment on a draft of the scope, as EPA intends to do for future scope documents, EPA
is publishing and taking public comment on a problem formulation document to refine the current scope,
as an additional interim step prior to publication of the draft risk evaluation for perchloroethylene.
Comments received on this problem formulation document will inform development of the draft risk
evaluation.
The Agency defines problem formulation as the analytical phase of the risk assessment in which "the
purpose for the assessment is articulated, the problem is defined, and a plan for analyzing and
characterizing risk is determined" (see Section 2.2 of the Framework for Human Health Risk
Assessment to Inform Decision Making). The outcome of problem formulation is a conceptual model(s)
and an analysis plan. The conceptual model describes the linkages between stressors and adverse human
health effects, including the stressor(s), exposure pathway(s), exposed life stage(s) and population(s),
and endpoint(s) that will be addressed in the risk evaluation (U.S. EPA, 2014e). The analysis plan
follows the development of the conceptual model(s) and is intended to describe the approach for
conducting the risk evaluation, including its design, methods and key inputs and intended outputs as
described in the EPA Human Health Risk Assessment Framework (U.S. EPA, 2014e). The problem
formulation documents refine the initial conceptual models and analysis plans that were provided in the
scope documents.
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First, EPA has removed from the risk evaluation any activities and exposure pathways that EPA has
concluded do not warrant inclusion in the risk evaluation. For example, for some activities which were
listed as "conditions of use" in the scope document, EPA has insufficient information following the
further investigations during problem formulation to find they are circumstances under which the
chemical is actually "intended, known, or reasonably foreseen to be manufactured, processed,
distributed in commerce, used, or disposed of."
Second, EPA also identified certain exposure pathways that are under the jurisdiction of regulatory
programs and associated analytical processes carried out under other EPA-administered environmental
statutes - namely, the Clean Air Act (CAA), the Safe Drinking Water Act (SDWA), the Clean Water
Act (CWA), and the Resource Conservation and Recovery Act (RCRA) - and which EPA does not
expect to include in the risk evaluation.
As a general matter, EPA believes that certain programs under other Federal environmental laws
adequately assess and effectively manage the risks for the covered exposure pathways. To use Agency
resources efficiently under the TSCA program, to avoid duplicating efforts taken pursuant to other
Agency programs, to maximize scientific and analytical efforts, and to meet the three-year statutory
deadline, EPA is planning to exercise its discretion under TSCA 6(b)(4)(D) to focus its analytical efforts
on exposures that are likely to present the greatest concern and consequently merit a risk evaluation
under TSCA, by excluding, on a case-by-case basis, certain exposure pathways that fall under the
jurisdiction of other EPA-administered statutes.1 EPA does not expect to include tany such excluded
pathways as further explained below in the risk evaluation. The provisions of various EPA-administered
environmental statutes and their implementing regulations represent the judgment of Congress and the
Administrator, respectively, as to the degree of health and environmental risk reduction that is sufficient
under the various environmental statutes.
Third, EPA identified any conditions of use, hazards, or exposure pathways which were included in the
scope document and that EPA expects to include in the risk evaluation but which EPA does not expect
to further analyze in the risk evaluation. EPA expects to be able to reach conclusions about particular
conditions of use, hazards or exposure pathways without further analysis and therefore expects to
conduct no further analysis on those conditions of use, hazards or exposure pathways in order to focus
the Agency's resources on more extensive or quantitative analyses. Each risk evaluation will be "fit-for-
purpose," meaning not all conditions of use will warrant the same level of evaluation and the Agency
may be able to reach some conclusions without comprehensive or quantitative risk evaluations 82 FR
33726, 33734, 33739 (July 20, 2017).
EPA received comments on the published scope document for perchloroethylene and has considered the
comments specific to perchloroethylene in this problem formulation document. EPA is soliciting public
comment on this problem formulation document and when the draft risk evaluation is issued the Agency
intends to respond to comments that are submitted. In its draft risk evaluation, EPA may revise the
conclusions and approaches contained in this problem formulations, including the conditions of use and
pathways covered and the conceptual models and analysis plans, based on comments received.
1 As explained in the final rule for chemical risk evaluation procedures, "EPA may, on a case-by case basis, exclude certain
activities that EPA has determined to be conditions of use in order to focus its analytical efforts on those exposures that are
likely to present the greatest concern, and consequently merit an unreasonable risk determination." [82 FR 33726, 33734,
33729 (July 20, 2017)]
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1.1 Regulatory History
EPA conducted a search of existing domestic and international laws, regulations and assessments
pertaining to perchloroethylene. EPA compiled this summary from data available from federal, state,
international and other government sources, as cited in Appendix A. EPA has evaluated and considered
the impact of these 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 conditions of use may additionally be made as detailed/specific conditions of use and
exposure scenarios are developed in conducting the analysis phase of the risk evaluation.
Federal Laws and Regulations
Perchloroethylene 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
Perchloroethylene 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
Perchloroethylene is subject to statutes or regulations in countries other than the United States. A
summary of these laws and regulations 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. This table includes one additional document identified since the
publication of the Scope document from the Office of Health and Environmental Assessment.
In addition to using this information, EPA intends to conduct a full review of the relevant
data/information collected in the initial comprehensive search [sqq Perchloroethylene (CASRN127-18-
4) Bibliography: Supplemental File for the TSCA Scope Document (EP A-HQ-OPPT-2016-0732)1. using
the literature search strategy [see Strategy for Conducting Literature Searches for Perchloroethylene:
Supplemental File for the TSCA Scope Document, (EPA-H T-2016-0732Y1. This will ensure that
EPA considers data/information that has been made available since these assessments were conducted.
Table 1-1. Assessment History of Perchloroethylene
Authoring Organization
Assessment
EPA Assessments
Integrated Risk Information System (IRIS)
lexicological Review of Tetrachloroethvlene
(Perchloroethylene U S.
EPA (2012e)
Office of Air Quality Planning and Standards
(OAQPS)
Perchloroethylene Dry Cleaners Refined Human
Health Risk Characterization U.S. EPA (2005b)
Page 16 of 167
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Authoring Organization
Assessment
National Center for Environmental Assessment
(NCEA)
Sources. Emission and Exposure for
iloroethvlene (TCE) and Related Chemicals
U.S. EPA (2001c)
Office of Air Toxics
TetracMoroethylene (Perchloroethvlene)
± U.S. EPA (2000b)
Office of Pesticides and Toxic Substances
(now, Office of Chemical Safety and Pollution
Prevention [OCSPP])
Occupational Exposure and Environmental
Release Assessment of Tetrachloroethvlene U.S.
EPA (1985b)
Office of Health and Environmental Assessment
Final Health. Effects Criteria Document for
Tetrachloroethvlene U.S. EPA (1985a)
Office of Water (OW)
Update of Human Health Ambient Water Oualitv
Criteria: Tetrachloroethvlene (Perchloroethvlene)
U.S. EPA (2015b)
Office of Water (OW)
Ambient Water Oualitv Criteria for
Tetrachloroethvlene U.S. EPA (1980a)
Other U.S.-Based Organizations
California Environmental Protection Agency,
Office of Environmental Health Hazard
Assessment (OEHHA), Air Toxics Hot Spots
Program
Perchloroethvlene Inhalation Cancer Unit Risk
Factor Cal/EPA (2016)
Agency for Toxic Substances and Disease Registry
(AT SDR)
Toxicologic^ "rotile f * l^nachloroethvlene
(PERC) (Draft) AT SDR (2014)
National Advisory Committee for Acute Exposure
Guideline Levels for Hazardous Substances
(NAC/AEGL Committee)
Tetrachloroethvlene NAC/AEGL (2009)
California Environmental Protection Agency,
OEHHA, Pesticide and Environmental Toxicology
Section
Public Health Goal for Tetrachloroethvlene in
Drinking Water Cal/EPA (2001)
National Toxicology Program (NTP)
Toxicology and Carcinogenesis Studies of
Tetrachloroethvlene (Perchloroethvlene); (CAS
i B6C3F1 Mice
NTP (1986)
International
International Agency for Research on Cancer
(IARC)
IARC Monographs on the Evaluation of
Carcinogenic Risks to Humans.
Tetrachloroethvlene IARC (2014b)
European Union (EU), Scientific Committee on
Health and Environmental Risks (SCHER)
SCHER. Scientific Opinion on the Risk
Assessment Report on Tetrachloroethvlene.
Human Health Part. CAS ]
SCHER (2008)
Page 17 of 167
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Authoring Organization
Assessment
World Health Organization (WHO)
Concise International Chemical Assessment
Document 6 achloroethvlene WHO (2006)
EU, European Chemicals Bureau (ECB)
EURisk Assessment Report; Tetrachloroethvlene.
Part 1 - environment (2005a)
National Industrial Chemicals Notification and
Assessment Scheme (NICNAS), Australia
Tetrachloroethvlen itv Existing Chemical
Assessment Report No. 15 NICNAS (2001)
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 may 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 perchloroethylene.
Data Collection: Data Search
EPA/OPPT conducted chemical-specific searches for information on: physical and chemical properties;
environmental fate and transport; conditions of use information; environmental and human exposures,
including potentially exposed or susceptible subpopulations; ecological 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). For human health hazard, EPA/OPPT relied on the search strategies
from recent assessments, such as EPA Integrated Risk Information System (IRIS) assessments, to
identify relevant information published after the end date of the previous search to capture more recent
literature. The Strategy for Conducting Literature Searches for Perchloroethylene: Supplemental File
for the TSCA Scope Document (EPA-HQ-OPPT-2Q16-0732) provides details about the data and
information sources and search terms that were used in the literature search.
Data Collection: Data Screening
Following the data search, references were screened and categorized using selection criteria outlined in
the Strategy for Conducting Literature Searches for Perchloroethylene: Supplemental File for the TSCA
Scope Document (U.S. EPA, 2017d). Titles and abstracts were screened against the criteria as a first step
with the goal of identifying a smaller subset of the relevant data to move into the subsequent data
extraction and data evaluation steps. Prior to full-text review, EPA/OPPT anticipates refinements to the
search and screening strategies, as informed by an evaluation of the performance of the initial
title/abstract screening and categorization process.
The categorization scheme (or tagging structure) used for data screening varies by scientific discipline
(i.e., physical and chemical properties; environmental fate and transport; chemical use/conditions of use
information; human and environmental exposures, including potentially exposed or susceptible
subpopulations identified by virtue of greater exposure; human health hazard, including potentially
Page 18 of 167
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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
relevant to the risk evaluation. The supplemental document: Strategy for Conducting Literature
Searches for Perchloroethylene: Supplemental File for the TSCA Scope Document discusses the
inclusion and exclusion criteria that EPA/OPPT used to categorize references as on-topic or off-topic
(U.S. EPA, 2017d).
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 supplemental document: Strategy for Conducting
Literature Searches for Perchloroethylene: Supplemental File for the TSCA Scope Document and will
be used to organize the different streams of data during the stages of data evaluation and data integration
steps of systematic review (U.S. EPA, 2017d).
Results of the initial search and categorization can be found in the supplemental document
Perchloroethylene (CASRN127-18-4) Bibliography: Supplemental File for the TSCA Scope Document
(EPA-HO-QPPT-2016-0732) (U.S. EPA, 2017b). 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 Perchloroethylene (CASRN: 127-18-4) Bibliography: Supplemental File for the TSCA Scope
Document (U.S. EPA, 2017b). The screening process at the full-text level is described in the Application
of Systematic Review in TSCA Risk Evaluations (U.S. EPA, 2018a). 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 Application of Systematic Review in TSCA Risk
Evaluations (U.S. EPA, 2018b).
Page 19 of 167
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2 PROBLEM FORMULATION
As required by TSCA, the scope of the risk evaluation identifies the conditions of use, hazards,
exposures and potentially exposed or susceptible subpopulations that the Administrator expects to
consider. To communicate and visually convey the relationships between these components, EPA
included in the scope document a life cycle diagram and conceptual models that describe the actual or
potential relationships between perchloroethylene and human and ecological receptors. During the
problem formulation, EPA revised the conceptual models based on further data gathering and analysis as
presented in this problem formulation document. An updated analysis plan is also included which
identifies, to the extent feasible, the approaches and methods that EPA may use to assess exposures,
effects (hazards) and risks under the conditions of use of perchloroethylene.
2.1 Physical and Chemical Properties
Physical-chemical properties influence the environmental behavior and the toxic properties of a
chemical, thereby informing the potential conditions of use, exposure pathways and routes and hazards
that EPA intends to consider. For scope development, EPA considered the measured or estimated
physical-chemical properties set forth in Table 2-1; EPA found no additional information during
problem formulation that would change these values.
Table 2-1. Physical and Chemical Properties of Perchloroethylene
Property
Value3
References
Molecular formula
C2CI4
Molecular weight
165.833
Physical form
Colorless liquid; ether-
like, mildly sweet odor
Lewis (2007); NIOSH (2005);
U.S. Coast Guard (1984)
Melting point
-22.3°C
Lide(2007)
Boiling point
121.3°C
Lide (2007)
Density
1.623 g/cm3 at 20°C
Lide(2007)
Vapor pressure
18.5 mmHg at 25°C
Riddick et al. (1985)
Vapor density
5.7 (relative to air)
Browning (1965)
Water solubility
206 mg/L at 25°C
Horvath (1982)
Octanol:water partition coefficient (Kow)
3.40
Hansch et al. (1995)
Henry's Law constant
0.0177 atmm3/mole
Gossett (1987)
Flash point
Not applicable
NFPA (2010)
Autoflammability
Not readily available
Viscosity
0.839 cP @at 25°C
Hickman (2000)
Refractive index
1.4775
Lide(2007)
Dielectric constant
0D
a Measured unless otherwise noted.
Page 20 of 167
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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. As further described in this document, EPA searched a number of
available data sources (e.g., Use and Market Profile for Tetrachloroethylene, EP A-HQ-OPPT-2016-
0732). Based on this search, EPA published a preliminary list of information and sources related to
chemical conditions of use [sqq Preliminary Information on Manufacturing, Processing, Distribution,
Use, and Disposal: Tetrachloroethylene (Perchloroethylene) and Use, EPA-HQ-QPPT-2016-07321
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 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 perchloroethylene 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 perchloroethylene and queried government and commercial trade databases. EPA also
received comments on the Scope of the Risk Evaluation for perchloroethylene (EPA-HQ-OPPT-2016-
0732) that were used to determine the conditions of use. In addition, EPA convened meetings with
companies, industry groups, chemical users, states, environmental groups, and other stakeholders to aid
in identifying conditions of use and verifying conditions of use identified by EPA. Those meetings
included a February 14, 2017 public meeting with such entities (EPA-HQ-QPPT-2016-0732).
EPA has removed from the risk evaluation any activities that EPA concluded do not constitute
conditions of use - for example because EPA has insufficient information to find certain activities are
circumstances under which the chemical is actually "intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used or disposed of." EPA has also identified any
conditions of use that EPA does not expect to include in the risk evaluation. As explained in the final
rule for Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act,
TSCA Section 6(b)(4)(D) requires EPA to identify "the hazards, exposures, conditions of use, and the
potentially exposed or susceptible subpopulations the Administrator expects to consider" in a risk
evaluation, suggesting that EPA is not required to consider all conditions of use, and EPA may exclude
certain activities that EPA has determined to be conditions of use on a case-by-case basis 82 FR 33736,
33729 (July 20, 2017). For example, EPA may exclude conditions of use that the Agency has sufficient
basis to conclude would present only de minimus exposures or otherwise insignificant risks (such as use
in a closed system that effectively precludes exposure or as an intermediate).
Page 21 of 167
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The activities that EPA no longer believes are conditions of use or were otherwise excluded during
problem formulation are described in Section 2.2.2.1. The conditions of use included in the scope of the
risk evaluation are summarized in Section 2.2.2.2.
2.2.2.1 Categories and Subcategories Determined Not to be Conditions of Use
During Problem Formulation
For perchloroethylene, EPA has conducted public outreach and literature searches to collect information
about perchloroethylene's conditions of use and has reviewed reasonably available information obtained
or possessed by EPA concerning activities associated with perchloroethylene. Based on the foregoing
research and outreach, EPA does not have reason to believe that any categories or subcategories
identified in the perchloroethylene scope should be excluded from the scope of the risk evaluation.
Therefore, no categories or subcategories of use for perchloroethylene will be excluded from the scope
of the risk evaluation.
Table 2-2. Categories and Subcategories Determined Not to be Conditions of Use During Problem
Formulation
l.il'e Cycle Stage
Category "
Subcategory h
References
No categories or subcategories have been excluded from the risk evaluation.
2.2.2.2 Categories and Subcategories of Conditions of Use Included in the Scope of
the Risk Evaluation
The uses of perchloroethylene include the production of fluorinated compounds, dry cleaning and vapor
degreasing, as well as a number of smaller uses. Nearly 65% of the production volume of
perchloroethylene is used as an intermediate in industrial gas manufacturing, more specifically to
produce fluorinated compounds, such as hydrofluorocarbons (HFCs) and hydrochlorofluorocarbons
(HCFCs) (NTP, 2014; ICIS, 2011). HFCs 134a and 125 are alternatives to chlorofluorocarbons (CFCs)
and HCFCs, which are ozone depleting substances (ODSs), and the subject of a phase-out
(https://www.epa.gov/ods-phaseout). HCFCs are transitional substances in the phase-out of ODSs (ICIS,
2011) (Public Comment, EPA-HO-QPPT-2016-0732-0033). Previously, perchloroethylene was widely
used to manufacture CFCs (esp. trichlorotrifluoroethane (CFC-113)) until production and importation of
CFCs for most uses were phased out in the United States by regulations implementing the Montreal
Protocol (40 CFR part 82). A relatively small amount of CFC-113 is still produced for exempted uses
(teleconference with Honeywell, 2017; summary is available in the docket: EPA-HQ-Q] ).
The second largest use of perchloroethylene (-15%) is as a solvent in dry cleaning facilities (NTP,
2014). Perchloroethylene is non-flammable and effectively dissolves fats, greases, waxes and oils,
without harming natural or human-made fibers. These properties enabled it to replace traditional
petroleum solvents(ATSDR, 2014; Dow Chemical Co, 2008; Tirsell, 2000). The demand for
perchloroethylene dry cleaning solvents has steadily declined as a result of the improved efficiency of
dry cleaning equipment, increased chemical recycling and the popularity of wash-and-wear fabrics that
eliminate the need for dry cleaning (ATSDR, 2014). Perchloroethylene is also used in dry cleaning
detergent and dry cleaning sizing.
Page 22 of 167
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Approximately 60% of dry cleaning machines now use perchloroethylene as a solvent (DLI and NCA,
2017). In 1991, EPA estimated that 83% of all dry cleaning facilities used perchloroethylene as solvent
(U.S. EPA, 1991). In 2008, the Halogenated Solvents Industry Association (HSIA) estimated that 70%
of dry cleaners used perchloroethylene as dry cleaning solvent (EPA.-H.Q-QP 27).
Similarly, in 2011, King County, WA conducted a profile of the dry cleaning industry and found that
69% of respondents (105 of the 152 respondents) used perchloroethylene in their primary machine
(Whittaker and Johanson, 2011). Hence, there appears to be a trend towards alternatives to
perchloroethylene in dry cleaning. According to the dry cleaning industry, a majority of new
perchloroethylene dry cleaning machines are sold in locations where local fire codes preclude the use of
Class III combustible alternative solvents or where the nature of the dry cleaning operation requires the
use of perchloroethylene (DLI and NCA, 2017).
The third most prevalent use of perchloroethylene (—10%) is as a vapor degreasing solvent (NTP, 2014).
Perchloroethylene can be used to dissolve many organic compounds, select inorganic compounds and
high-melting pitches and waxes making it ideal for cleaning contaminated metal parts and other
fabricated materials (ATSDR, 2014). It is a very good solvent for greases, fats, waxes, oils, bitumen, tar
and many natural and synthetic resins for use in chemical cleaning systems, degreasing light and heavy
metals, degreasing pelts and leather (tanning), extraction of animal and vegetable fats and oils and
textile dyeing (solvent for dye baths)(Stoye, 2000). Perchloroethylene is also used in cold cleaning,
which is similar to vapor degreasing, except that cold cleaning does not require the solvent to be heated
to its boiling point in order to clean a given component. Vapor degreasing and cold cleaning scenarios
may include a range of open-top or closed systems, conveyorized/enclosed/inline systems, spray wands,
dip containers and wipes.
Perchloroethylene has many other uses, which collectively constitute —10% of the production volume.
EPA's search of safety data sheets, government databases and other sources found over 375 products
containing perchloroethylene. These uses include (but are not limited to):
• Adhesives
• Aerosol degreasing
• Brake cleaner
• Laboratories
• Lubricants
• Mold cleaners, releases and protectants
• Oil refining
• Sealants
• Stainless steel polish
• Tire buffers and cleaners
• Vandal mark removers
Many of these uses include consumer products, such as adhesives (arts and crafts, as well as light
repairs), aerosol degreasing, brake cleaners, aerosol lubricants, sealants, sealants for gun ammunition,
stone polish, stainless steel polish and wipe cleaners. The uses of perchloroethylene in consumer
adhesives and brake cleaners are especially prevalent; EPA has found 16 consumer adhesive products
and 14 consumer brake cleaners containing perchloroethylene [see Preliminary Information on
Manufacturing, Processing, Distribution, Use, and Disposal: Tetrachloroethylene (Perchloroethylene)
and Use and Market Profile for Tetrachloroethylene, EP A-HQ-OPPT-2016-0732-00031.
Page 23 of 167
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Table 2-3 summarizes each life cycle stage and the corresponding categories and subcategories of
conditions of use for perchloroethylene that EPA expects to consider in the risk evaluation. Using the
2016 CDR (U.S. EPA, 2016b), EPA identified industrial processing or use activities, industrial function
categories and commercial and consumer use product categories. EPA identified the subcategories by
supplementing CDR data with other published literature and information obtained through stakeholder
consultations. For risk evaluations, EPA intends to consider each life cycle stage (and corresponding use
categories and subcategories) and assess certain relevant potential sources of release and human
exposure associated with that life cycle stage.
Beyond the uses identified in the Scope of the Risk Evaluation for Perchloroethylene, EPA has received
no additional information identifying additional current conditions of use for perchloroethylene from
public comment and stakeholder meetings.
Page 24 of 167
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Table 2-3. Categories and Subcategories of Conditions of Use Included in the
Scope of the Risk Evaluation
Life Cycle
Stage
Category 11
Subcategory h
References
Manufacture
Domestic
manufacture
Domestic manufacture
U.S. EPA
(2016b)
Import
Import
U.S. EPA (2016b)
Processing
Processing as
a reactant or
intermediate
Intermediate in industrial gas
manufacturing
U.S. EPA (2016b); Market
Profile. EPA-H0-OPPT-2016-
0732; Public Comment EPA-
HO-OPPT-2016-0732-001 \
Public Comment Public
memt EPA-HO-OPPT-
U ! -imu,
Public Comment, Public
Comment EPA-HO-OPPi
Intermediate in basic organic
chemical manufacturing
U.S. EPA (2016b); Market
Profile. O-OPPT-2016-
0732;
Intermediate in petroleum refineries
U.S. EPA (2016b); Market
Profile. O-OPPT-2016-
0732; Public Comment. EPA-
HO-OPPT-2016-0732-001S
Residual or byproduct
Public Comment. EPA-HO-
OPPT-2.01 0 ?,„> 00 [3
Incorporated
into
formulation,
Cleaning and degreasing products
U.S. EPA (2016b); Public
Comment. EPA-HO-OPPT-
2
mixture or
reaction
product
Adhesive and sealant products
U.S. EPA (2016b)
Paint and coating products
U.S. EPA (2016b)
Other chemical products and
preparations
U.S. EPA (2016b)
Incorporated
into articles
Plastic and rubber products
Use Document. EPA-HO-
OPPT-21 32-0003
Repackaging
Solvent for cleaning or degreasing
U.S. EPA (2016b)
Intermediate
U.S. EPA (2016b)
Recycling
Recycling
U.S. EPA (2016b)
Distribution in
commerce
Distribution
Distribution
Use Document. EPA-HO-
OPPT-21 3
-------
Life C'vclc
Slsigo
C'silogorv 11
SuhciiU'gorv h
Uol'oiTIKTS
1 nckislrial use
Sol\ enls (for
cleaning or
degreasing)
SoKenls and or Deureasers (cold.
aerosol spray or vapor degreaser;
not specified in comment)
Market Profile.
OPPT-21 Public
Comment. EPA-HO-OPPT-
32-0022; Public
Comment. EPA-HO-OPPT-
2 32-002.9
Batch vapor degreaser (e.g., open-
top, closed-loop)
U.S. EPA (1985b); Public
Comment. EPA-HO-OPPT-
2 , Public
Comment. EPA-HO-OPPT-
2 32-0027
In-line vapor degreaser (e.g.,
conveyorized, web cleaner)
U.S. EPA (1985b); Public
Comment. EPA-HO-OPPT-
20 i - • 0 32-0014
Solvents (for
cleaning or
degreasing)
Cold cleaner
Market Profile. EPA-HO-
OPPT-21 . Public
Comment. EPA-HO-OPPT-
2 .o-oor
Aerosol spray degreaser/cleaner
Use Document. EPA-HO-
OPPT-21 32-0003; Market
Profile. O-OPPT-2016-
0732; Public Comment, EPA-
HO-OPI -0009;
Public Comment, EPA-HQ-
OPP'r J2-00I;
Dry cleaning solvent
Market Profile. EPA-HO-
OPPT-21 U S. EPA
(2006a)
Spot cleaner
Market Profile. EPA-HO-
OPPT-2016-0732; Public
Comment, EPA-HO-OPPT-
2 32-0009
Lubricants
and greases
Lubricants and greases (e.g.,
penetrating lubricants, cutting tool
coolants, aerosol lubricants)
U.S. EPA (2016b); Market
Profile, ffi^Public Comment,
EP A-HO-OPPT-2016-0732-
0027; Public Comment, EPA-
HO-OPI 19;
Public Comment EPA-HO-
Public
Comment, EPA-HO-OPPT-
2 32-002.7; Public
Page 26 of 167
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Life C'vclc
Slsigo
C'silogorv 11
SuhciiU'gorv h
Uol'oiTIKTS
Comment.
2 32-0029
Adhesive and
sealant
chemicals
Solvent-based adhesives and
sealants
U.S. EPA (2016b); Use
Document. l-'PA-HO-OPPT-
2016-0732-0003; Market
Profile. O-GPPT-2016-
0732; Public Comment. EPA-
HO-OPI I o
Public Comment, EPA-HO-
OPP'I k 3. .Public
Comment. EPA-HO-OPPT-
32-0022; Public
Comment. EPA-HO-OPPT-
2 32-0027
Paints and
coatings
including
paint and
coating
removers
Solvent-based paints and coatings,
including for chemical milling
U.S. EPA (2016b); Use
Document. l;PA-HO-OPPT-
2016-0732-0003; Market
Profile. O-OPPT-2016-
0732; Public Comment. EPA-
HO-OPPT-2016-0732-0006;
Public Comment, EPA-HO-
OPP 32-0009; Public
Comment. EPA-HO-OPPT-
, Public
Comment. EPA-HO-OPPT-
2 32-0020; Public
Comment. EPA-HO-OPPT-
32-0027; Public
Comment, EP A -HO-OPPT-
2 32-0062
Processing
aids, not
otherwise
listed
Pesticide, fertilizer and other
agricultural chemical
manufacturing
U.S. EPA (2016b)
Processing
aids, specific
to petroleum
production
Catalyst regeneration in
petrochemical manufacturing
U.S. EPA (2016b); Use
Document. \ »lO-OPPT-
2016-0732-0003; Market
Profile. O-OPPT-2016-
0732; Dow Chemical Co
(2008); Public Comment,
HO-OPPT-20L* 07/,; 00IS;
Public Comment, EPA-HO-
OPP 32-0027
Page 27 of 167
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Life C'vclc
Slsigo
C'silogorv 11
Suhcsi(c«orv h
Uol'oiTIKTS
Oilier uses
Textile processing
I se Document.
OPPT-21 32-0003; Market
Profile. O-OPPT-2016-
0732
Wood furniture manufacturing
Use Document, EPA-HQ;
OPPT-2016-0732-0003
Laboratory chemicals
Use Document EPA-HO-
OPP' 3; Market
Profile. O-OPPT-2016-
0732; Public Comment, EPA-
HO-OPPi Jf'i • o ' J-001 -
Foundry applications
Use Document. EPA-HO-
OPPT-21 32-0003; Market
Profile. O-OPPT-2016-
0732
Commercial/con
sumer use
Cleaning and
furniture care
products
Cleaners and degreasers (other)
Market Profile, EPA-HO-
OPPT-2016-0732; Public
2016-0732-0009; Public
Comment. EPA-HO-OPPT-
, Public
Comment. EPA-HO-OPPT-
2 32-0022; EPA-HO-
3; Public
Comment. EPA-HO-OPPT-
2 32-0027; Public
Comment. EPA-HO-OPPT-
2 32-0029
Dry cleaning solvent
Market Profile. EPA-HO-
OPPT-2016-0732; U.S. EPA
(2006a); Public Comment,
EP A-HO-OPPT-2016-0732-
0007; Public Comment. EPA-
HO-OPI
Spot cleaner
Market Profile, EPA-HQ-
OPPT-21 U S. EPA
(2006a); Public Comment,
EP A-HO-OPPT-2016-0732-
0009
Automotive care products (e.g.,
engine degreaser and brake cleaner)
U.S. EPA (2016b), Use
Document. L;P-\-HO-OPPT-
2016-0732-0003; Market
Page 28 of 167
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Life C'vclc
Slsigo
C'silogorv 11
SuhciiU'gorv h
Uol'oiTIKTS
Profile.
0732; Public Comment EPA-
HO-OPI i • o oui .
Public Comment, EPA-HO-
OPPT-21 32-0027
Aerosol cleaner
Use Document EPA-HO-
OPPT-21 3; Market
Profile. O-OPPT-2016-
0732; Public Comment, EPA-
HO-OPI -0009
Non-aerosol cleaner
Use Document EPA-HO-
OPP' 3; Market
Profile. O-OPPT-2016-
0732; Public Comment, EPA-
HO-OPI 02-0009
Lubricants
and greases
Lubricants and greases (e.g.,
penetrating lubricants, cutting tool
coolants, aerosol lubricants)
U.S. EPA (2016b); Market
Profile. l-'PA-l 1D-GPPT-2016-
0732; Public Comment, EPA-
HO-OPI -0027;
Public Comment, EPA-HQ-
OPP' 32-0029
Adhesives
and sealant
chemicals
Adhesives for arts and crafts
U.S. EPA (2016b); Use
Document. EPA-HO-OPPT-
2016-0732-0003; Market
Profile. O-OPPT-2016-
0732; Public Comment, EPA-
HO-OPI -0009
Light repair adhesives
U.S. EPA (2016b); Use
Document. \ »lO-OPPT-
2016-0732-0003
Paints and
coatings
Solvent-based paints and coatings
U.S. EPA (2016b); Use
Document. L;P-\-HO-OPPT-
2016-0732-0003; Market
Profile. O-OPPT-2016-
0732; Public Comment, EPA-
HO-OPI -0009;
Public Comment, EPA-HQ-
OPP' 3; Public
2016-0732-002.7
Other uses
Carpet cleaning
Use Document. EPA-HO-
OPPT-21 32-0003; Market
Page 29 of 167
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Life C'vclc
Slsigo
C'silogorv 11
SuhciiU'gorv h
Uol'oiTIKTS
Profile.
0732; Public Comment EPA-
HO-OPPT-2016-0732-0009
Laboratory chemicals
Use Document. EPA-HO-
OPPT-21 32-0003; Market
Profile. O-OPPT-2016-
0732
Metal (e.g., stainless steel) and
stone polishes
Use Document. EPA-HO-
OPPT-21 32-0003; Market
Profile. O-OPPT-2016-
0732
Inks and ink removal products
Use Document. EPA-HO-
OPPT-21 32-0003; Market
Profile. O-OPPT-2016-
0732
Welding
Use Document. EPA-HO-
OPPT-21 32-0003; Market
Profile. O-OPPT-2016-
0732;
Photographic film
Use Document. EPA-HO-
OPPT-21 32-0003
Mold cleaning, release and
protectant products
Use Document, EPA-HO-
OPPT-21 3; Market
Profile. O-OPPT-2016-
0732; Public Comment, EPA-
HO-OPI
Disposal
Industrial pre-treatment
Use Document. EPA-HO-
Industrial wastewater treatment
OPPT-21 32-0003
Publicly owned treatment works
(POTW)
Underground injection
Disposal
Municipal landfill
Hazardous landfill
Other land disposal
Municipal waste incinerator
Hazardous waste incinerator
Off-site waste transfer
Off-site waste transfer
Page 30 of 167
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l.il'e ( vole
Slsigo
C'silogorv 11
SuhciiU'gorv h
UoI'oitiuts
a These categories of conditions of use appear in the initial life cycle diagram, reflect CDR codes and broadly represent
conditions of use for perchloroethylene in industrial and/or commercial settings.
b These subcategories reflect more specific uses of perchloroethylene.
Page 31 of 167
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2.2.2.3 Overview of Conditions of Use and Lifecycle Diagram
The life cycle diagram provided in Figure 2-1 depicts the conditions of use that are considered within
the scope of the risk evaluation during various life cycle stages including manufacturing, processing,
distribution, use (industrial, commercial, consumer, where distinguishable) and disposal. Additions or
changes to conditions of use based on additional information gathered or analyzed during problem
formulation were described in Sections 2.2.2.1 and 2.2.2.2. 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, 2016a).
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 (U.S. EPA, 2016b), when the volume was not claimed
confidential business information (CBI).
The 2016 CDR reporting data for perchloroethylene are provided in Table 2-4 from EPA's CDR
database (U.S. EPA, 2016b). This information has not changed from that provided in the scope
document.
Table 2-4. Production Volume of Perchloroethylene in CDR Reporting Period (2012 to 2015) a
Reporting Year
2012
2013
2014
2015
Total Aggregate
Production Volume (lbs)
387,623,401
391,403,540
355,305,850
324,240,744
aThe CDR data for the 2016 reoortine ocriod is available via ChemView ChttDs://iava.eDa.eov/chemview) (U.S. EPA.
2016b). The CDR data presented in the problem formulation is more specific than currently available in ChemView.
Descriptions of the industrial, commercial and consumer use categories identified from the ;
(U.S. EPA, 2016b) and included in the life cycle diagram (Figure 2-1) are summarized below. The
descriptions provide a brief overview of the use category; Appendix B contains more detailed
descriptions (e.g., process descriptions, 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 2 JR and can be found in EPA's Instructions
for Reporting 2016 TSC-A Chemical Data Reyortim .(U.S. EPA, 2016b).
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 (U.S. EPA,
-------
2016a)). This category includes a wide variety of uses, including, but not limited to, the use of
perchloroethylene as a commercial dry cleaning solvent, in spot cleaning formulations, in automotive
care products such as brake cleaners and engine degreasers, and other aerosol and non-aerosol type
cleaners.
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 textile (U.S. EPA, 2016a). This category includes the use of perchloroethylene in vapor
degreasing, cold cleaning, in industrial and commercial aerosol degreasing products and in industrial dry
cleaning applications, including spot cleaning.
The "Lubricants and Greases" category encompasses chemical substances contained in products used
to reduce friction, heat generation and wear between solid surfaces (U.S. EPA, 2016a). This category
covers a variety of lubricants and greases that contain perchloroethylene including, but not limited to,
penetrating lubricants, cutting tool coolants, aerosol lubricants, red greases, white lithium greases,
silicone-based lubricants and chain and cable lubricants.
The "Adhesives and Sealants" category encompasses chemical substances contained in adhesive and
sealant products used to fasten or bond other materials together (U.S. EPA, 2016a). EPA anticipates that
the primary subcategory will be the use of perchloroethylene in solvent-based adhesives and sealants.
This category covers industrial, commercial and consumer uses of adhesives and sealants.
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 (U.S. EPA,
2016a; OECD, 2009c). Coating may provide protection to surfaces from a variety of effects such as
corrosion and UV degradation; may be purely decorative; or provide other functions (OECD, 2009c).
EPA anticipates that the primary subcategory will be the use of perchloroethylene in solvent-based
coatings. This category covers industrial, commercial and consumer uses of paints and coatings.
The "Processing aids for agricultural product manufacturing" category encompasses a variety of
chemical substances that are used to improve the processing characteristics or operation of process
equipment or to alter or buffer the pH of the substance (U.S. EPA, 2016a). Processing aids do not
become a part of the final reaction product and are not intended to affect the function of the product
(U.S. EPA, 2016a). Based on the 2016 CDR, EPA anticipates the primary subcategory will be the use in
pesticide, fertilizer or other agricultural product manufacturing; however, the exact use in this
subcategory has yet to be identified be EPA. Examples of processing aids include buffers,
dehumidifiers, dehydrating agents, sequestering agents and chelators (U.S. EPA, 2016a).
The "Processing aid for petrochemical manufacturing" category is similar to the "Processing aid for
agricultural product manufacturing" category except the chemicals are used specifically during the
production of oil, gas and other similar products (U.S. EPA, 2016a). Based on the U.S. EPA (2016a) and
a Dow Chemical Company Product Safety Assessment (Dow Chemical Co, 2008), EPA anticipates the
primary subcategory will be the use of perchloroethylene for catalyst regeneration in petrochemical
manufacturing.
Figure 2-1 depicts the life cycle diagram for perchloroethylene from manufacture to the point of
disposal. Activities related to distribution (e.g., loading, unloading) will be considered throughout the
perchloroethylene life cycle, rather than using a single distribution scenario.
Page 33 of 167
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MFG/IMPORT
PROCESSING
INDUSTRIAL, COMMERCIAL, CONSUMER USES a
RELEASES and WASTE DISPOSAL
Manufacture
(Including Import)
(324.2 million lbs)
Processing as
Reactant/lntermediate
(Volume CBI)
e.g., intermediate for
refrigerant manufacture
Incorporated into
Formulation, Mixture,
or Reaction Product
(>285,800 lb)
Incorporated into
Article
(Not reported to 2016
CDR)
Repackaging
(Volume CBI)
I
Recycling
(Volume CBI)
4
Cleaning and Furniture Care Products
(>348,770 lb)
e.g., dry cleaning, spot cleaning, aerosol cleaner and
degreaser, aerosol spot remover, non-aerosol cleaner
Solvents for Cleaning and Degreasing
(>327,150 lb)
e.g., vapor degreaser, cold cleaner, aerosol degreaser
Lubricants and Greases
(316,716 lb)
e.g., penetrating lubricants
Adhesive and Sealant Chemicals
(Volume CBI)
e.g., solvent-based adhesives and sealants
Paints and Coatings
(Volume CBI)
e.g., solvent-based paints and coatings
Processing Aid for Agricultural Product
Manufacturing (Volume CBI)
e.g., pesticide, fertilizer, and other agricultural
product manufacturing
Processing Aid for Petrochemical
Manufacturing (Volume CBI)
e.g., catalyst regeneration
Other Uses
e.g., mold release product, metal polishes, inks
Disposal
See Figure 2-4 for Environmental
Releases and Wastes
Manufacture (Including Import)
] Processing
Uses. At the scope level of detail in the life
cycle diagram EPA is not distinguishing
between industrial/commercial/consumer
uses. The differences between these uses
will be further investigated and defined
during risk evaluation.
Figure 2-1. Perchloroethyiene 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, where distinguishable), distribution and disposal. The production volumes
shown are for reporting year 2015 from the 2016 CDR reporting period (U.S. EPA, 2016b). Activities related to distribution (e.g., loading,
unloading) will be considered throughout the perchloroethyiene life cycle, rather than using a single distribution scenario.
a See Table 2-3 for additional uses not mentioned specifically in this diagram.
Page 34 of 167
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2.3 Exposures
For TSCA exposure assessments, post-release pathways and routes will be described to characterize the
relationship or connection between the conditions of use of perchloroethylene 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 perchloroethylene.
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 scoping and
problem formulation for perchloroethylene.
Fate data including volatilization during wastewater treatment, volatilization from lakes and rivers,
biodegradation rates, and organic carbon:water partition coefficient (log Koc) were used when
considering changes to the conceptual models. Model results and basic principles were used to support
the fate data used in problem formulation while the literature review is currently underway through the
systematic review process.
The environmental fate and transport of perchloroethylene has been assessed by WHO (2006); (ECB,
2005a). This section was prepared, in part, based on these reviews, supplemented by information from
EPI Suite™ (U.S. EPA, 2012b) modules.
Based on its vapor pressure and Henry's Law constant, perchloroethylene will tend to partition from
water to air and, to a lesser extent, soil to air. The persistence of perchloroethylene is highly dependent
on specific environmental and microbial conditions (WHO, 2006; ECB, 2005a). In the vapor phase,
perchloroethylene can be slowly transformed by reaction with hydroxyl and other radicals with half-
lives of months or greater, and long-range transport may occur. In water, perchloroethylene is generally
stable. Aqueous photolysis has not been observed and is not expected to be a significant degradation
process. Hydrolysis, if it occurs, is expected to be slow with a half-life of greater than months to years.
Chemicals that enter wastewater treatment plants (WWTP) may be incorporated into sludge if they are
not rapidly degraded or transferred into the vapor phase. Sorption to organic and inorganic solids will
result in the chemical being settled out during coagulation and flocculation. EPI Suite™ (U.S. EPA,
2012b) modules were used to predict volatilization of perchloroethylene from wastewater treatment
plants, lakes, and rivers and to confirm the data showing slow biodegradation. The EPI Suite™ module
that estimates chemical removal in sewage treatment plants ("STP" module) was run using default
settings to evaluate the potential for perchloroethylene to volatilize to air or adsorb to sludge during
wastewater treatment. The STP module estimates that about 80% of perchloroethylene in wastewater
will be removed by volatilization. Based on measured log Koc = 1.6-2.7 perchloroethylene is not
expected to sorb to a large extent but may also be settled out by entrainment and incorporation into
floes. During sludge processing perchloroethylene will tend to be transferred to air during dewatering
and volume reduction processes. When biosolids (processed sludge) are land applied perchloroethylene
will be transferred to air during spraying and over time by volatilization from solids and liquid phases.
Page 35 of 167
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Perchloroethylene in surface waters can be expected to volatilize into the atmosphere. However,
perchloroethylene is denser than water and only slightly soluble in water. In soil and aquifers, it will
tend to remain in the aqueous phase and be transported to ground water. Anaerobic biodegradation is
expected to be a significant degradation mechanism in soil and ground water.
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 perchloroethylene in surface
water. The parameters required for volatilization (evaporation) rate of an organic chemical from the
water body to air are water depth, wind, and current velocity of the river or lake. The volatilization
module estimates that the half-life of perchloroethylene in a model river will be 0.05 days and the half-
life in a model lake will be 5 days.
In ground water, perchloroethylene may be present as a dense non-aqueous phase liquid (DNAPL),
which, because it is denser than water, means that it will form a separate phase, often at the base of an
aquifer. The half-life degradation rate in ground water is estimated to be between one to two years,
based on aqueous aerobic biodegradation (Howard, 1991) but may be considerably longer under certain
conditions.
Table 2-5. Environmental Fate Characteristics of Perchloroethylene
Property or Endpoint
Value a
References
Direct photodegradation
3 years (atmosphere)
ECB (2005a)
Indirect photodegradation
96 days (atmosphere)
ECB (2005a)
Hydrolysis half-life
Months-years
ECB (2005a)
Biodegradation
No degradation (aerobic in mixed and
pure culture, modified shake flask, river
die-away study, sewage inoculated).
<1 day to weeks (anaerobic, based on
multiple studies).
ECB (2005a)
Bioconcentration factor
(BCF)
40 and 49 (fish)
312 and 101 (marine algae)
ECB (2005a)
Bioaccumulation factor
(BAF)
46 (estimated)
U.S. EPA (2012b); ECB
(2005a)
Organic carbon:water
partition coefficient (log Koc)
1.62.7
2.9 (estimated)
U.S. EPA (2012b); ECB
(2005a)
a Measured unless otherwise noted.
The EPI Suite™ module that predicts biodegradation rates ("BIOWIN" module) was run using default
settings to estimate biodegradation rates of perchloroethylene in soil and sediment. Mixed results were
obtained: four of the models built into the BIOWIN module (BIOWIN 1, 2, 5 and 6) estimate that
perchloroethylene will not rapidly biodegrade in aerobic environments, while two (BIOWIN 3 and 4)
estimate that perchloroethylene will rapidly biodegrade in aerobic environments. These results support
the biodegradation data presented in the perchloroethylene Scope Document (U.S. EPA, 2017c), which
Page 36 of 167
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indicated that in soil and sediment, aerobic and anaerobic degradation can occur but is generally slow.
Several microbial species have been identified that are capable of degrading perchloroethylene under
certain conditions but overall biodegradation in these environments is expected to be slow with half-life
of months or greater. The model that estimates anaerobic biodegradation (BIOWIN 7) predicts that
perchloroethylene will degrade more rapidly under anaerobic conditions.
With BCFs and BAFs ranging from 40 to 100, ECB (2005a),WHO (2006) and ECB (2005a) indicate
that there is limited potential for perchloroethylene to bioaccumulate in plants and animals.
2.3.2 Releases to the Environment
Releases to the environment from conditions of use (e.g., industrial and commercial processes,
commercial or consumer uses resulting in down-the-drain releases) are one component of potential
exposure and may be derived from reported data that are obtained through direct measurement,
calculations based on empirical data and/or assumptions and models.
A source of information that EPA considered in evaluating exposure are data reported under the Toxics
Release Inventory (TRI) program. Under the Emergency Planning and Community Right-to-Know Act
(EPCRA) Section 313 rule, perchloroethylene 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., RCRA Subtitle C hazardous landfill and Class I underground Injection
wells) and incineration. EPA also examined how perchloroethylene is treated at industrial facilities.
Table 2-6 provides production-related waste managed data (also referred to as waste managed) for
perchloroethylene reported by industrial facilities to the TRI program for 2015. Table 2-7 provides more
detailed information on the quantities released to air or water or disposed of on land.
Table 2-6. Summary of Perchloroethylene TRI Production-Related Waste Managed in 2015 (lbs)
Number of
Kacilities
Uecvcliii"
Kncr«y
Recovery
Treatment
Releases "•h-'
Total
Production
Related \Yaste
27
46,406,761
2,341,981
15,132,768
1,177,484
65,058,994
Data source: 2015 TRI Data [updated March 2017 (U.S. EPA, 2017f));OBJ;.
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.
In 2015, 27 facilities reported a total of 65 million pounds of perchloroethylene waste managed. Of this
total, roughly 46 million pounds were recycled, 2.3 million pounds were recovered for energy,
15 million pounds were treated and 1.18 million pounds were released into the environment.
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 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
Page 37 of 167
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disposal. As a result, release quantities may differ slightly and may further reflect differences in TRI
calculation methods for reported release range estimates (U.S. EPA, 2017e).
Table 2-7. Summary of Perchloroethylene TRI Releases to the Environment in 2015 (lbs)
Nil m her
of
Incilhics
Air Releases
\\
-------
Table 2-8. Summary of 2015 TRI Releases for Perchloroethylene (CASRN 127-18-4)
Number of
0 ii of Total
Production Related
Waste Type
Conceptual Model Release
Category
TRI Cateuorv
Volume from
TRI (His)
Reporting
Sites from
TRI
Waste Managed
Industrial Pre-Treatment
POTW
857
15
<0.001%
(indirect discharge)
Wastewater
or Liquid
Industrial WWT (indirect
discharge)
Off-site WWT (non-POTW)
9,187
5
<0.001%
Wastes
Industrial WWT (direct
discharge)
Water
349
19
<0.001%
Underground Injection
Class I Underground Injection
271
6
<0.001%
Hazardous and Municipal Waste
Landfill
RCRA Subtitle C Landfill
78,120
20
0.12%
Other Landfills, Land Treatment,
and Disposal
413
19
<0.001%
Solid Wastes
and Liquid
Wastes
Off-site Incineration
1,098,035
65
1.7%
Energy Recovery
2,341,981
44
3.6%
Hazardous and Municipal Waste
Incinerators, Recycling and
Other Treatment and Management
Methods
269,529
19
0.41%
Other Treatment
Transfers to Waste Broker
138,052
16
0.21%
Recycling
46,406,761
51
71.3%
Unspecified Treatment Methods2
14,000,805
44
21.5%
Emissions to
Emissions to Air
Fugitive Air1
279,073
152
0.43%
Air
Stack Air1
435,558
119
0.70%
Total Production Related Waste Managed
65,067,293
219
Total One-Time Release Waste
31,082
6
<0.001%
Total Waste Managed
65,098,375
219
2 Because sites such as treatment, storage, and disposal facilities (TSDFs) are required to report to TRI, the total volumes for these categories may include volumes
reported as transferred to off-site treatment, such as off-site incineration.
Page 39 of 167
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Releases to Air
TRI data in Table 2-8 show air as a primary medium of environmental release. These releases include
both fugitive air emissions and point source (stack) air emissions. Fugitive air emissions (totaling
279,073 pounds from 2015 TRI data) are emissions that do not occur through a confined air stream,
which may include equipment leaks, releases from building ventilation systems, and evaporative losses
from surface impoundments and spills. Point source (stack) air emissions (totaling 435,558 pounds from
TRI reporting year 2015 data) are releases to air that occur through confined air streams, such as stacks,
ducts or pipes.
Releases to Water
In the 2015 TRI, 349 lbs of perchloroethylene were reported as directly released to surface water
discharge, 857 lbs were sent to POTWs, and 9,187 lbs were sent to off-site non-POTW wastewater
treatment.
Releases to Land
As shown in Table 2-8, TRI reports approximately 78,000 pounds transferred to RCRA Subtitle C
landfills. EPA will not further analyze releases to hazardous waste landfills because these types of
landfill mitigate exposure to the wastes. TRI also reports approximately 414 pounds transferred to other
land disposal methods. As discussed in Section 2.3.5.3, perchloroethylene will not appreciably bind to
sediment, soil or biosolids.
Incineration
During problem formulation, EPA reviewed air emissions from on-site incineration and energy
recovery. Air emissions resulting from these operations are already included in the TRI reports and will
be used in the analysis of air releases.
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 perchloroethylene:
Environment
Perchloroethylene has been found in air, soil, surface water, salt water, drinking water, aquatic
organisms and terrestrial organisms (WHO, 2006). Historic industrial, commercial and military use of
perchloroethylene, including unregulated or improper disposal of perchloroethylene wastes, has resulted
in location-specific soil and ground water contamination. Perchloroethylene is a common ground water
contaminant at hazardous waste sites in the U.S. (ATSDR, 2014) and a common drinking water
contaminant (U.S. EPA, 2016b). EPA will analyze manufacturing, processing, distribution, use, disposal
and recycling to identify and characterize current sources of release and contamination.
Urban and industrial areas are prone to higher perchloroethylene air concentrations than rural areas due
to the concentration of sources (ATSDR, 2014; U.S. EPA, 2012e; WHO, 2006). EPA air monitoring
data from 2013 reported detection of perchloroethylene in 77% of ambient air samples, with 58% of
detects above the method detection limit (U.S. EPA, 2015a)(Table 4.1). Indoor air concentrations of
perchloroethylene tend to be greater than concentrations in outdoor air (ATSDR, 2014; U.S. EPA,
2012e).
Page 40 of 167
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Perchloroethylene is a common contaminant in municipal drinking water supplies and ground water,
with some of the highest measured concentrations in ground water occurring near perchloroethylene
contaminated sites (for some examples, see (ATSDR, 2014; WHO, 2006) and references therein). EPA
and the USGS National Water Quality Assessment Program (Cycle 1, 1992-2001) reported
perchloroethylene contamination in U.S. surface water and ground water in 19.6% of samples (n=5,911)
and at 13.2% of sites (n=4,295), with detection in surface water occurring more frequently than in
ground water (U.S. EPA, 2009). EPA's Second Six-Year Review Contaminant Occurrence Data
reported occurrence of monitored chemicals in U.S. drinking water supplies from 1998 to 2005. The
Second Six-Year Review data showed perchloroethylene occurrence in 2.5% of roughly 50,000 public
water systems, with thirty-six states reporting drinking water systems with at least one detection above
the maximum contaminant level (MCL: 5 |ig/L) (U.S. EPA, 2009).
Air
Urban and industrial areas are prone to higher perchloroethylene air concentrations than rural areas due
to the concentration of sources (ATSDR, 2014; U.S. EPA, 2012e; WHO, 2006). Monitoring data
(measured) from EPA's Air Quality System (AQS) and the open literature, as well as modeled estimates
based on the National Air Toxics Assessment (NATA) and TRI emissions data suggest that
perchloroethylene (tetrachloroethylene) is present in ambient air. The 2011 NATA analysis indicates
perchloroethylene concentrations range from non-detect to 5.07 (J,g/m3, with amean 0.1 |ig/m3, EPA air
monitoring data from 2013 reported detection of perchloroethylene in 11% of ambient air samples, with
58%) of detects above the method detection limit (U.S. EPA, 2015a) (Table 4.1). The EPA Report on the
Environment (U.S. EPA, 2017a) evaluated perchloroethylene concentrations from ambient air
monitoring data, 2003-2013, and demonstrated that the annual average perchloroethylene air
concentration is decreasing over time, from 0.429 |ig/m3 to 0.115 |ig/m3
(https://cfpub.epa.gov/roe/index.cfm).
Indoor air concentrations of perchloroethylene tend to be greater than concentrations in outdoor air
(ATSDR, 2014; U.S. EPA, 2012e). In a multi-city study that evaluated the relationship between indoor
and outdoor air pollutant concentrations, perchloroethylene was measured in 44.3%> of 555 homes in
three US cities (Weisel et al., 2005). In this study, the median concentration was 0.56 |ig/m3 and the 99th
percentile was 20.9 [j,g/m3. The median indoor air level of perchloroethylene in about 400 Dutch homes
was 4 (J,g/m3, while maximum levels varied between 49 and 205 [j,g/m3. Levels can be much higher in
buildings housing dry cleaning facilities. For example, sampling (over 100 samples) of air in six
residential apartments in two buildings where dry cleaning was carried out on the ground floor revealed
tetrachloroethene concentrations ranging from 50 to 6100 (J,g/m3, with means ranging
from 358 to 2408 |ig/m3 (ECB, 2005a).
Surface Water
Discharge Monitoring data (measured) were reported in EPA's Discharge Monitoring Report (DMR)
Pollutant Loading Tool (https://cfpub.epa.gov/dmr/ez_search.cfm). The tool uses discharge monitoring
report (DMR) data from IC1S-NPDES to calculate pollutant discharge amounts. This tool includes the
top facility discharges for 2017. This information was used as a screening tool to evaluate some
preliminary drinking concentrations. Using this tool an average concentration from the top discharger
(total of 70 samples) would be 0.019 mg/L (19 ug/L) and the average maximum concentration for
discharge would be 0.05 mg/L (50 ug/L). Note that this would only report the discharge to stream based
on permits and would not report the actual stream concentrations. Reporting discharge would likely
overestimate the actual stream concentrations.
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A search was done through the European IPCheM database which is a single access point for locating
and retrieving chemical surface water monitoring data collections
(https://ec.europa.eu/jrc/en/event/conference/ipchem). Using this tool, an average concentration from the
top dischargers (total of 20 samples) in surface water was 0.0058 mg/L (5.8 ug/L) and the average of the
maximum concentration for 20 dischargers would be 0.0089 mg/L (8.9 ug/L) with >1000 samples
collected indicating that ICIS-NPDES discharges would result in an overestimate to actual stream
concentrations.
According to WHO (2006), perchloroethylene has been measured in surface (river) waters in Germany,
Finland, the Netherlands, Italy, France, Switzerland, the United Kingdom, and the USA. Concentrations
ranged from 0.01 to 168 j_ig/l, with levels typically below 5 (j.g/1.
Groundwater
Although groundwater can be higher than concentrations in surface water, this could reflect the fact that
groundwater measurements tend to be taken where a problem (e.g. a spill) is thought to exist.
Groundwater levels are usually below 10 jag/1, but concentrations as high as 1300 jj.g/1 have been
reported for a legacy contaminated site. Historic industrial, commercial, and military use of
perchloroethylene, including unregulated or improper disposal of perchloroethylene wastes are
considered legacy uses, but have resulted in location-specific soil and groundwater contamination (ECB,
2005a).
Sediment
Perchloroethylene is not likely to be in the sediment based on its physical and chemical properties.
Nevertheless, perchloroethylene has been measured in sediment samples at 1-50 (J,g/kg wet weight in
Germany and at <5 (.ig/kg wet weight in the USA (WHO, 2006). A search was done through the
European IPCheM database. Using this tool, an average sediment concentration (from only 12 samples
collected) was <15 |ig/kg.
Soil
According to ECB (2005a), volatilization of perchloroethylene from dry soil is likely to be rapid due to
its high vapor pressure and low adsorption to soil.
Biota
The EU Risk Assessment Report (ECB, 2005a) summarized data on measured levels of
perchloroethylene in biota, including algae, invertebrates, fish and terrestrial plants. Nearly all reported
concentrations are from locations in the EU and are below -25 |ig/kg.
Biomonitoring
Perchloroethylene has been measured in biomonitoring samples of U.S. populations. A subset of
National Health and Nutrition Examination Survey (NHANES) data (1999-2000) reported in Lin et al.
(2008) show the presence of perchloroethylene in 77% of human blood samples from non-smoking U.S.
adults. Updated biomonitoring data reported by the Centers for Disease Control (CDC), sampled
between 2001 and 2008, show a possible decline in the prevalence of perchloroethylene in U.S.
population human blood samples, however limits of detection differ between the two data sets,
complicating direct comparison. The CDC data show a decreasing concentration trend over the
timeframe of data collection (CDC, 2017).
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2.3.4 Environmental Exposures
The manufacturing, processing, use and disposal of perchloroethylene can result in releases to the
environment. In this section, EPA presents exposures to aquatic and terrestrial organisms.
Aquatic Environmental Exposures
EPA identified and reviewed national scale monitoring data to support this problem formulation. EPA
and the USGS National Water Quality Assessment Program (Cycle 1, 1992-2001) reported
perchloroethylene contamination in U.S. surface water and ground water in 19.6% of samples (n=5,911)
and at 13.2% of sites (n=4,295), with detection in surface water occurring more frequently than in
ground water (U.S. EPA, 2009). More recently measured, national-scale monitoring data was from
EPA's STOrage and RETreival (STORET) and National Water Information System (NWIS). Based on
STORET query for perchloroethylene for the past ten years, perchloroethylene is detected in surface
water in the United States. The data showed a detection rate (above quantification limit and/or above
reporting limit) of approximately 15% for surface water, with detections ranging from 0.02 |ig/L to 26.7
Hg/L-
Terrestrial Environmental Exposures
Terrestrial species populations living near industrial and commercial facilities using perchloroethylene
may be exposed via multiple routes such as ingestion of surface waters and inhalation of outdoor air. As
described in Section 2.3.3, perchloroethylene is present and measurable through monitoring in a variety
of environmental media including ambient and indoor air, surface water and ground water.
2.3.5 Human Exposures
In this section EPA presents occupational, consumer 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 (industrial or commercial) described in Section 2.2. In addition, exposures to
occupational non-users (ONU) who do not directly handle the chemical but perform work in an area
where the chemical is present are listed. Engineering controls and/or personal protective equipment may
impact occupational exposure levels.
Workers and occupational non-users may be exposed to perchloroethylene when performing activities
associated with the conditions of use described in Section 2.2, including, but not limited to:
• Unloading and transferring perchloroethylene to and from storage containers to process vessels;
• Handling, transporting and disposing of waste containing perchloroethylene;
• Using perchloroethylene in process equipment (e.g., vapor degreasing machine);
• Cleaning and maintaining equipment;
• Sampling chemicals, formulations or products containing perchloroethylene for quality control;
• Repackaging chemicals, formulations or products containing perchloroethylene;
• Applying formulations and products containing perchloroethylene onto substrates (e.g., spray
applying coatings or adhesives containing perchloroethylene);
• Use in dry cleaning processes; and
• Performing other work activities in or near areas where perchloroethylene is used.
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During problem formulation, EPA further analyzed the expected physical form, associated exposure
route, and exposure pathway for each condition of use.
Key Data
Key data that inform occupational exposure assessment include: the OSHA Chemical Exposure Health
Data (CEHD) and NIOSH Health Hazard Evaluation (HHE) Program data. OSHA data are workplace
monitoring data from OSHA inspections. The inspections can be random or targeted or can be the result
of a worker complaint. OSHA data can be obtained through the OSHA Occupational Safety and Health
Information System (OIS) at https://ois.osha.gov/portal/server.pt Appendix B includes a summary of
perchloroethylene personal monitoring air samples obtained from OSHA inspections conducted between
2011 and 2016. NIOSH HHEs are conducted at the request of employees, union officials or employers
and help inform potential hazards at the workplace. HHEs can be downloaded at
https://www.cdc.gov/niosh/hhe/. HHE will be considered during risk evaluation.
Inhalation
Based on these occupational exposure scenarios, inhalation exposure to vapor is expected. EPA
anticipates this is the most important perchloroethylene exposure pathway for workers and occupational
nonusers based on the high volatility of perchloroethylene. Based on the potential for spray application
of some products containing perchloroethylene exposures to mists are also expected for workers and
ONU and will be incorporated into the occupational inhalation exposure estimates.
The United States has several regulatory and non-regulatory exposure limits for perchloroethylene: An
OSHA Permissible Exposure Limit (PEL) of 100 ppm (685 mg/m3), the ceiling is 200 ppm and the peak
for a single time period up to 5 minutes for any 3 hours is 300 ppm, based on central nervous system
effects, eye and skin irritation and liver and kidney damage.(OSHA, 1997) and an American Conference
of Government Industrial Hygienists (ACGIH) Threshold Limit Value (TLV) of 25 ppm 8-hour TWA
(ACGIH, 2001). A NIOSH Recommended Exposure Limit (REL) has not been established, but
California has set its PEL at 25 ppm (170 mg/m3) as a time weighted average, 100 ppm (685 mg/m3) as
a short term exposure limit (STEL) and 300 ppm as a ceiling.
The influence of these exposure limits on occupational exposures will be considered in the occupational
exposure assessment. Also, the National Institute for Occupational Safety and Health (NIOSH) indicates
that perchloroethylene has an immediately dangerous to life and health (IDLH) value of 150 ppm based
on effects that might occur from a 20-30-minute exposure, and NIOSH provides a notation that
perchloroethylene is a potential occupational carcinogen (NIOSH, 1994a).
Dermal
Based on the conditions of use, EPA expects dermal exposures for workers who have skin contact with
liquids and vapors. Occupational non-users are not directly handling perchloroethylene; therefore, skin
contact with liquid perchloroethylene is not expected for occupational non-users but skin contact with
vapors is expected for occupational nonusers.
2.3.5.2 Consumer Exposures
Perchloroethylene can be found in consumer and/or commercial products that are readily available for
public purchase at common retailers CEPA-HQ-OPPT-z 12-0003. Sections 3 and 4 and Table 2-3)
and can therefore result in exposures to consumers and bystanders (non-product users that are
incidentally exposed to the product). The magnitude of exposure will depend upon the concentration of
perchloroethylene products, use patterns (including frequency, duration, amount of product used, room
of use) and application methods. Several consumer products need to be analyzed including solvents for
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cleaning and degreasing, lubricants and greases, adhesives and sealant chemicals, paints and coatings,
cleaning and furniture care products, and other uses such as mold release products, metal polishes and
inks. Application activities include using aerosol and non-aerosol spraying, wiping, and painting. Other
activities include mixing, pouring, and placing various types of liquids, slurries and pastes. Information
regarding use patterns and application methods will be needed to build exposure scenarios. Any
products which are spray applied are likely to result in some level of inhalation exposure to the
consumer user and bystander in the room of use. Products used in the liquid form are also likely to result
in some level of inhalation exposure to the consumer given the high vapor pressure of
perchloroethylene. Consumer exposures are expected to be acute in nature, however, there may be a
subset of consumers who use products on a frequent or regular basis resulting in sub-chronic or chronic
exposures.
Although perchloroethylene is a liquid at room temperature, it has a high vapor pressure and tends to
volatilize to air. It should be noted that the nature of the consumer solvent (whether the solvent has a
high vapor pressure) and the overall percentage of perchloroethylene in the mixture may either increase
or decrease the evaporation rates. Consumer products formulated with a high vapor pressure solvent and
have high weight fraction of perchloroethylene will vaporize at a faster rate. The nature of the solvent
and weight fraction will influence the exposure pathway.
Inhalation
EPA expects that inhalation exposure to vapor will be the primary route of exposure for consumer users
of perchloroethylene containing products. The magnitude of exposure will depend upon the
concentration of perchloroethylene in products, use patterns (including frequency, duration, amount of
product used, room of use) and application methods. Several product types and scenarios will be
analyzed including spray adhesives, spray degreasers (engine cleaning and electronics cleaning), and
aerosol spot removers. Information regarding use patterns and application methods will be needed to
build exposure scenarios for other products identified during scoping (e.g., liquid cleaners, adhesive
accelerants, building and construction materials, cutting oils). Any products which are spray applied are
likely to result in some level of inhalation exposure to the consumer user and also to a bystander in the
room of use. Products used in the liquid form are also likely to result in some level of inhalation
exposure to the consumer given the high vapor pressure of perchloroethylene. Consumer exposures are
expected to be acute in nature, however, there may be a subset of consumers who use products on a
frequent or regular basis resulting in sub-chronic or chronic exposures.
Exposures routes for consumers using perchloroethylene-containing products primarily include direct
inhalation of vapors, mists and aerosols (e.g., aerosols from spray applications), indirect inhalation
exposures after application and dermal exposure to products. Bystanders may be exposed through
inhalation of vapors and mists that deposit in the upper respiratory tract; EPA assumes mists will be
absorbed via inhalation.
Dermal
There is the potential for dermal exposures to perchloroethylene in consumer uses. Exposure to
perchloroethylene may also occur via dermal contact with dry-cleaned fabrics or other articles treated
with products containing perchloroethylene (U.S. EPA, 2012e). Perchloroethylene is absorbed dermally,
and potential exposures will depend on exposure characteristics such as skin surface area, product
volume and exposure duration. The potential for dermal absorption is limited based on high vapor
pressure, and perchloroethylene is expected to volatilize quickly from surfaces (see Section 2.5.2).
However, the nature of the product or article containing perchloroethylene, chemical loading, other
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components present in product mixtures and the weight fraction of perchloroethylene in the product will
affect dermal absorption.
Oral
Consumers may be exposed to perchloroethylene via transfer of chemical from hand to mouth.
However, this exposure pathway is expected to be limited by a combination of dermal absorption and
volatilization of perchloroethylene from skin. Due to the expected very low magnitude of accidental
hand to mouth exposure, EPA does not plan to further assess this pathway.
Exposures from Disposal
EPA does not expect exposure to consumers from disposal of consumer products. It is anticipated that
most products will be disposed of in original containers, particularly those products that are purchased as
aerosol cans.
2.3.5.3 General Population Exposures
Wastewater/liquid wastes, solid wastes or air emissions of perchloroethylene could result in potential
pathways for oral, dermal or inhalation exposure to the general population.
Inhalation
General population inhalation exposure to perchloroethylene in air may result from industrial
manufacturing and processing plant fugitive and stack emissions. Perchloroethylene volatilizes from
contaminated soil and shallow ground water, possibly resulting in elevated outdoor inhalation exposure.
Through a process known as vapor intrusion, volatilized perchloroethylene may also infiltrate residential
and commercial buildings through cracks in floors, crawl spaces, pipe fittings and toilet and sewer
junctions, leading to elevated indoor concentrations of perchloroethylene and greater inhalation
exposure (ATSDR, 2014; U.S. EPA, 2012f). In addition, inhalation exposures to perchloroethylene may
occur due to volatilization of perchloroethylene from contaminated water (municipal or well water)
during showering and bathing (U.S. EPA, 2012e).
Families of workers with occupational perchloroethylene exposure are exposed secondarily by
perchloroethylene volatilization from workers clothing, and from exhaled breath, as un-metabolized
perchloroethylene is exhaled on the breath as the primary excretion mechanism in humans (ATSDR,
2014; U.S. EPA, 2012e).
Indoor emissions, from the use of perchloroethylene containing products and articles (e.g., degreasers;
recently dry-cleaned clothing), may also be sources of perchloroethylene in indoor air (ATSDR, 2014;
U.S. EPA, 2012e).
Oral
The general population may ingest perchloroethylene via contaminated drinking water, ground water
and/or surface water (ATSDR, 2014; U.S. EPA, 2012e). Perchloroethylene enters water supplies
through industrial and commercial wastewater and liquid waste streams, sewage sludge land application,
wet deposition (rain) and leaching from contaminated soils (U.S. EPA, 2009). Oral ingestion pathways
may include exposure to contaminated drinking water or breast milk, or incidental ingestion of
contaminated water while swimming or bathing. Infants and young children may also be exposed to
perchloroethylene via mouthing of treated products and articles (e.g., spot treatment of carpets; dry
cleaned blanket).
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The EU Risk Assessment Report (ECB, 2005a) indicates that perchloroethylene may be present in fish,
although EPA does not anticipate fish ingestion to be a significant general population exposure pathway,
as perchloroethylene has a low bioaccumulation potential in aquatic organisms (BCF 40 50\ Kow <
3)(WHO, 2006).
Dermal
General population dermal exposure to perchloroethylene is possible from showering, bathing and
swimming in contaminated water (U.S. EPA, 2012e). Perchloroethylene is absorbed dermally, and
potential exposures will depend on exposure characteristics such as skin surface area, exposure media
concentration and exposure duration. The potential for dermal absorption is limited based on high vapor
pressure, and perchloroethylene is expected to volatilize quickly from surfaces (see Section 2.5.2).
However, the nature of the environmental media containing perchloroethylene and chemical loading will
affect dermal absorption.
2.3.5.4 Potentially Exposed or Susceptible Subpopulations
TSCA requires the determination of whether a chemical substance presents an unreasonable risk to "a
potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation" by EPA.
TSCA § 3(12) states that "the term 'potentially exposed or susceptible subpopulation' means a group of
individuals within the general population identified by the Administrator who, due to either greater
susceptibility or greater exposure, may be at greater risk than the general population of adverse health
effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women,
workers, or the elderly." General population is "the total of individuals inhabiting an area or making up a
whole group" and refers here to the U.S. general population (U.S. EPA, 2011).
As part of the Problem Formulation, EPA identified potentially exposed and susceptible subpopulations
for further analysis during the development and refinement of the life cycle, conceptual models,
exposure scenarios, and analysis plan. In this section, EPA addresses the potentially exposed or
susceptible subpopulations identified as relevant based on greater exposure. EPA will address the
subpopulations identified as relevant based on greater susceptibility in the hazard section.
EPA identifies the following as potentially exposed or susceptible subpopulations that EPA plans to
analyze in the risk evaluation due to their greater exposure:
• Workers and occupational non-users.
• Consumers and bystanders associated with consumer use. Perchloroethylene has been identified
in products available to consumers; however, only some individuals within the general
population may use these products. Therefore, those who do use these products are a potentially
exposed or susceptible subpopulation due to greater exposure.
• Other groups of individuals within the general population who may experience greater exposures
due to their proximity to conditions of use identified in Section 2.2 that result in releases to the
environment and subsequent exposures (e.g., individuals who live or work near manufacturing,
processing, distribution or use sites).
Perchloroethylene is lipophilic, and accumulates in fatty fluids and tissues in the human body.
Subpopulations that may have higher body fat composition, and may be more highly exposed include
pubescent and adult women, including women of child-bearing age. The EPA IRIS Assessment for
perchloroethylene (U.S. EPA, 2012e) also identified the developing fetus as potentially exposed, as well
as infants consuming breastmilk, particularly for mothers with occupational exposure to
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perchloroethylene or exposure due to proximity to industrial or commercial sources (U.S. EPA, 2012e).
Infants fed by formula may also experience increased perchloroethylene exposure if perchloroethylene is
present in drinking water supplies (U.S. EPA, 2012e).
In developing exposure scenarios, EPA will analyze available data to ascertain whether some human
receptor groups may be exposed via exposure pathways that may be distinct to a particular
subpopulation or lifestage and whether some human receptor groups may have higher exposure via
identified pathways of exposure due to unique characteristics (e.g., activities, duration or location of
exposure) when compared with the general population (U.S. EPA, 2006b).
The behavior of children may put them in closer contact with some sources of perchloroethylene, such
as carpet cleaners. Children may be exposed via inhalation as bystanders, during consumer use in the
home. Children tend to consume more water and food per body weight relative to adults, and have
greater skin surface area and skin permeability than adults, relative to weight, which can result in
proportionally higher ingestion and dermal exposures. Children's exposure to perchloroethylene via
ingestion of contaminated food is likely to be low. Perchloroethylene has low bioaccumulation potential
and, if present, would have low concentrations in fish or seafood. The half-life of perchloroethylene in
soil is short, and is unlikely to be found in food crops. Perchloroethylene has been measured in fatty
foods (butter, oils and meats) when stored in proximity to indoor perchloroethylene sources (U.S. EPA,
2012d). Drinking water could be a significant source of perchloroethylene ingestion exposure for
children, who drink roughly four times as much water as adults (U.S. EPA, 2011).
EPA will continue to analyze available data to ascertain whether some human receptor groups may be
exposed via pathways that may be distinct to a particular subpopulation or lifestage (e.g., children's
crawling, mouthing or hand-to-mouth behaviors).
In summary, in the risk evaluation for perchloroethylene, EPA expects to analyze the following
potentially exposed groups of human receptors: workers, occupational non-users, consumers, bystanders
associated with consumer use, and other groups of individuals within the general population who may
experience greater exposure. EPA may also identify additional potentially exposed or susceptible
subpopulations that will be considered based on greater exposure.
2.4 Hazards
For scoping, EPA conducted comprehensive searches for data on hazards of perchloroethylene, as
described in the supplemental document: Strategy for Conducting Literature Searches for
Perchloroethylene: Supplemental File for the TSCA Scope Document. Based on initial screening, EPA
expects to analyze the hazards of perchloroethylene identified in this problem formulation document.
However, when conducting the risk evaluation, the relevance of each hazard within the context of a
specific exposure scenario will be judged for appropriateness. For example, hazards that occur only as a
result of chronic exposures may not be applicable for acute exposure scenarios. This means that it is
unlikely that every hazard identified will be analyzed for every exposure scenario.
2.4.1 Environmental Hazards
EPA identified the following existing sources of environmental hazard data for perchloroethylene:
European Chemicals Bureau (ECB) EU Risk Assessment Report Tetrachloroethylene, Part 1 -
environment (E 05a) and World Health Organization (WHO) Concise International Chemical
Assessment Document 68; Tetrachloroethylene WHO (WHO. 2006). Only the on-topic references listed
in the Ecological Hazard Literature Search Results were considered as potentially relevant
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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
Perchloroethylene: Supplemental Document to the TSCA Scope Document, CASRN: 127-18-4. Data from
the screened literature are summarized below (Table 2-9) as ranges (min-max). EPA expects to review
these data/information sources during risk evaluation using the data quality review evaluation metrics
and the rating criteria described in the Application of Systematic Review in TSCA Risk Evaluations (U.S.
EPA. 2018a).
Toxicity to Aquatic Organisms
The acute 96-hour LC50 values for fish range from 4 mg/L for Flagfish (,Jordanella floridae) to 28.1
mg/L for Indian Silverside (Menidia berylina). With aquatic invertebrates, the LC/EC50 values ranged
from 2.85 - 30.8 mg/L. For algal toxicity 72/96-hr EC50 values were 3.64 - 500 mg/L based on biomass
and abundance (Table 2-9).
Chronic aquatic toxicity data for perchloroethylene are available. Chronic toxicity to fish values range
from 0.5- 1.4 mg/L. A 28-day Daphnia magna study reported NOEC value of 0.505 mg/L based on
reproduction using measured concentrations. Another 28-day Opossum Shrimp (Americanmysis bahia)
study reported NOEC value of 0.370 mg/L. For the most conservative chronic toxicity values were
reported as algal 72-h NOEC= 0.01 - 0.02 mg/L and LOEC= 0.02- 0.05 mg/L. Based on these NOEC
and LOEC, the chronic toxicity values are calculated as 0. 0.014 - 0.032 mg/L (Table 2-9).
Toxicity to Soil/Sediment and Terrestrial Organisms
An earthworm (Eisenia foetida) toxicity study of perchloroethylene has been tested using OECD
Guideline No. 207. The 14-day LC50 was 100-320 mg/kg, the 28-day NOEC (based upon cocoons) was
<18 mg/kg, and the 28-day NOEC (based upon appearance) was 18-32 mg/kg. Another
perchloroethylene study using the carabid beetle (Poecilus cupreus) was conducted. No mortality or
behavioral changes were observed in this study (Table 2-9).
For terrestrial plants, a 21-day study of lettuce (Lactuca sativa) showed EC50 of 12 mg/L based on
biomass. Another study looked at the effects on the early developmental stage of lettuce (Avena sativa),
germinated plants, the 16-day EC50 (growth) was 861 mg/kg based on the converted standard organic
matter content.
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Table 2-9: Ecological Hazard Characterization of Perchloroethylene
Duration
Test
organism
Kndpoinl
Hazard
value*
I nils
KITed
r.ndpoinl
References
Aquatic Organisms
Acute
Fish
LC50
4-28.1
mg/L
Mortality
Smith (1991); Home
(1983)
Aquatic
invertebrates
LC/ECso
2.85 - 30.8
mg/L
Immobilization
Hollister (1968); Call
(1983) as cited in WHO
(2006)
Algae
EC50
3.64 - 500
mg/L
Biomass/
Abundance
Brack (1994) as cited in
ECB (2005); U.S. EPA
(1980a) as cited in WHO
(2006)
Amphibians
EC50
2.5 -20.0
mg/L
Mortality
McDaniel (2004)
Acute COC
0.80 mg/L
Chronic
Fish
ChV
0.5-1.4
mg/L
Growth
Ahmad (1984); Smith
(1991) as cited in ECB
(2005)
Aquatic
invertebrates
ChV
0.37-1.11
(NOEC)
mg/L
Mortality/
Reproduction
Hollister (1968); Richter et
al. (1983) as cited in ECB
(2005); Call (1983) as cited
in WHO (2006)
Algae
NOEC
LOEC
ChV
0.01-0.02
0.02-0.05
0.014-0.032
mg/L
Abundance
Labra (2010);
Chronic
COC
0.001 mg/L
Terrestrial
Organisms
Acute
Terrestrial
invertebrates
LC50
100 - 320
m g/kg
Cocoons
appearance
(Vonk et al., 1986) as cited
in WHO (2006)
Terrestrial
plants
ECso
861
m g/kg
Growth
(Bauer and Dietze, 1992)
as cited in WHO (2006)
Chronic
Terrestrial
plants
ECso
12
mg/L
Biomass
Hulzebos, 1993
* Values in the tables are presented as reported by the study authors
Concentrations of Concern
The screening-level acute and chronic concentrations of concern (COCs) for perchloroethylene were
derived based on the lowest or most toxic ecological toxicity values (e.g., L/EC50). The information
below describes how the acute and chronic COC's were calculated for environmental toxicity of
perchloroethylene using assessment factors.
The application of assessment factors is based on established EPA/OPPT methods (U.S. EPA.!
2012c) and were used in this hazard assessment to calculate lower bound effect levels (referred to as the
concentration of concern; COC) that would likely encompass more sensitive species not specifically
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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, due to limited
data availability.
The concentrations of concern for each endpoint were derived based on the ecological hazard data for
perchloroethylene. The information below describes how the acute and chronic COCs were calculated
for aquatic toxicity.
The acute COC is derived by dividing acute aquatic invertebrates LC50 of 2.85 mg/L (the lowest acute
value in the dataset) by an assessment factor (AF) of 5:
Lowest value for aquatic invertebrates LC50 (2.85 mg/L) / AF of 5 = 0.57 mg/L or 570 |ig/L.
The acute COC of 570 |ig/L, derived from experimental aquatic invertebrate's endpoint, is used as a
conservative hazard level in this problem formulation for perchloroethylene.
The chronic COC was determined based on the lowest chronic toxicity value divided by an assessment
factor of 10.
• Lowest chronic value for 72-h algal ChV = 0.014 mg/L / 10 = 0.0014 mg/L or 1.4 |ig/L.
The chronic COC of 1.4 |ig/L, derived from experimental algae endpoint, is used as the lower bound
hazard level in this problem formulation for perchloroethylene.
2.4,2 Human Health Hazards
Perchloroethylene has an existing EPA IRIS Assessment and a draft ATSDR
Toxicological Profile (ATSDR. 2014); hence, many of the hazards of perchloroethylene have been
previously compiled. 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 perchloroethylene (Perchloroethylene (CASRN127-
18-4) Bibliography: Supplemental File for the TSCA Scope Document). EPA expects to consider
potential human health hazards associated with perchloroethylene. Based on reasonably available
information, the following sections describe the potential hazards associated with perchloroethylene.
2.4.2.1 Non-Cancer Hazards
The EPA IRIS Assessment on perchloroethylene ( ) evaluated the following non-cancer
hazards that may be associated with perchloroethylene exposures: the central nervous system
(neurotoxicity), kidney, liver and development and reproduction. In general, neurological effects were
found to be associated with lower perchloroethylene inhalation exposures. According to the EPA IRIS
Assessment ( '12e). support for an association with immune and blood effects were less well
characterized. In their draft Toxicological Profile for perchloroethylene, ATSDR (2014) identified
similar hazard concerns. The National Advisory Committee for Acute Exposure Guideline Levels for
Hazardous Substances (NAC/AEGL. 2009) also identified irritation as a hazard concern.
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Acute Toxicity
Data from acute exposure studies in animals and human incidents indicate that short term exposure to
perchloroethylene may cause irritation and neurotoxicity and can impair cognitive function in humans
(U.S. EPA.: ). An Acute Exposure Guidance Limit (AEGL) values, established by the National
Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances (N AC/AEGL,
2009). has been developed based on irritation to humans (AEGL-1), ataxia in rodents (AEGL-2), and
lethality in mice (AEGL-3) (NAC/AEGL. 2.009).
Neurotoxicity
Evidence in humans and animals show that chronic exposure to perchloroethylene can cause
neurotoxicity, resulting in decrements in color vision, visuospatial memory and possibly other aspects of
cognition and neuropsychological function (U.S. EPA. 2012e). Neurotoxic effects have been
characterized in human controlled exposure, occupational exposure and residential studies, as well as in
experimental animal studies, providing evidence of an association between perchloroethylene exposure
and neurological deficits (\ -<¦ < \
-------
Irritation
1 r ^ \ < JO I Jet and AT SDR (2014) indicate perchloroethylene is irritating. Irritation data for
perchloroethylene have also been reviewed outside the EPA IRIS Assessment. Controlled exposures in
humans and case reports have identified eye and nose irritation (NA.C/AEGL. 2009).
2.4.2.2 Genotoxicity and Cancer Hazards
Epidemiologic data provide evidence associating perchloroethylene with several cancer types, including
non-Hodgkin lymphoma, multiple myeloma and bladder cancer, with more limited evidence for
esophageal, kidney, lung, cervical and breast cancer (U.S. EPA. 2012e). Perchloroethylene is generally
considered to be non-genotoxic, however several metabolites exhibit mutagenic and/or genotoxic
properties and may contribute to potential genotoxic mode of action (MOA) (U.S. EPA. 2012e). In
2012, EPA released the outcome of the weight-of-evidence cancer assessment, which described the
weight-of-evidence judgment of the likelihood that perchloroethylene is a human carcinogen, and
quantitative estimates of risk from oral and inhalation exposure (1 1 \ JO 12c). Following >. v l'P \
(2005a) Guidelines for Carcinogen Risk Assessment, EPA concluded that perchloroethylene is "likely to
be carcinogenic in humans by all routes of exposure" ( 2012e).
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 analyze available data to ascertain whether some human
receptor groups may show greater susceptibility to the chemical's hazards due to intrinsic factors. EPA
plans to analyze the susceptibility factors identified in the EPA IRIS assessment for perchloroethylene
U.S. EPA. (2012e) and AT SDR (2 evaluations. These assessments both identified the following
subpopulations as possibly more susceptible to adverse effects associated with perchloroethylene
exposures: early and later lifestages and groups defined by health and nutrition status, gender,
race/ethnicity, genetics and multiple exposures and cumulative risk. However )12e) also
determined that the available data was insufficient to allow for a quantitative assessment of the impact of
susceptibility on risk.
The California Office of Environmental Health Hazard Assessment OEH.HA. (2016) derived an
inhalation cancer unit risk factor for perchloroethylene based on the same physiologically based
pharmacokinetic (PBPK) model (Chiu and Ginsberg. 2011) used in the EPA IRIS assessment (U.S.
EPA. 2012e). The model included both oxidative metabolism and glutathione conjugation metabolism;
the latter varies greatly within the human population, with some variation representing sensitive
subpopulations (Spearow et aL 2017; OEHHA. ). EPA will consider this information during the
risk evaluation phase.
2.5 Conceptual Models
EPA risk assessment guidance (U.S. EPA. 2014d). defines Problem Formulation as the part of the risk
assessment framework that identifies the major factors to be considered in the assessment. It draws from
the regulatory, decision-making and policy context of the assessment and informs the assessment's
technical approach.
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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 perchloroethylene, 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 TSCA 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 perchloroethylene 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. 82 FR 33726, 33734, 33739 (July 20, 2017).
As part of this problem formulation, EPA also identified exposure pathways under regulatory programs
of other environmental statutes, administered by EPA, which adequately assess and effectively manage
exposures and for which long-standing regulatory and analytical processes already exist, i.e., the Clean
Air Act (CAA), the Safe Drinking Water Act (SDWA), the Clean Water Act (CWA) and the Resource
Conservation and Recovery Act (RCRA). OPPT worked closely with the offices within EPA that
administer and implement the regulatory programs under these statutes. In some cases, EPA has
determined that chemicals present in various media pathways (i.e., air, water, land) fall under the
jurisdiction of existing regulatory programs and associated analytical processes carried out under other
EPA-administered statutes and have been assessed and effectively managed under those programs. EPA
believes that the TSCA risk evaluation should generally focus on those exposure pathways associated
with TSCA conditions of use that are not adequately assessed and effectively managed under the
regulatory regimes discussed above because these pathways are likely to represent the greatest areas of
risk concern. As a result, EPA does not expect to include in the risk evaluation certain exposure
pathways identified in the perchloroethylene scope document.
2.5,1 Conceptual Model for Industrial and Commercial Activities and Uses: Potential
Exposures and Hazards
The revised conceptual model (Figure 2-2) describes the pathways of exposure from industrial and
commercial activities and uses of perchloroethylene that EPA expects to include in the risk evaluation.
There are exposures to workers and/or occupational non-users via inhalation routes and/or exposures to
workers via dermal routes for all conditions of use identified in this problem formulation. In 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
Inhalation exposures for workers are regulated by OSHA's occupational safety and health standards for
perchloroethylene which include a PEL of 100 ppm TWA, exposure monitoring, control measures and
respiratory protection (29 CFR 1910.134). EPA expects that for workers and occupational non-users
exposure via inhalation will be the most significant route of exposure for most exposure scenarios. EPA
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expects to further analyze inhalation exposures to vapors and mists for workers and occupational non-
users in the risk evaluation.
Dermal
There is the potential for dermal exposures to perchloroethylene in many worker scenarios. Where
workers may be exposed to perchloroethylene, the OSHA standard requires that workers are protected
from contact (e.g. gloves) (29 CFR 1910.132). Dermal exposures would be concurrent with inhalation
exposures and the overall contribution of dermal exposure to the total exposure is expected to be small
however there may be exceptions for occluded scenarios. Occupational non-users are not directly
handling perchloroethylene; therefore, skin contact with liquid perchloroethylene is not expected for
occupational non-users and EPA does not expect to further analyze this pathway in the risk evaluation.
EPA expects to further analyze dermal exposures for skin contact with liquids.
The parameters determining the absorption of perchloroethylene vapor are based on the concentration of
the vapor, the duration of exposure and absorption. As described by ATSDR, a human study comparing
absorption of perchloroethylene vapor via the dermal and inhalation routes {i.e., exposure to vapor with
and without respiratory protection) found that absorption via the dermal route is only 1% of the
combined dermal and inhalation routes (ATSDR. 2014). Therefore, EPA will not further analyze worker
or occupational non-user exposure via vapor-to-dermal contact, because the contribution to overall
exposure will be orders of magnitude lower than direct inhalation of vapors.
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 perchloroethylene.
For each condition of use identified in Table 2-3, a determination was made as to whether or not each
unique combination of exposure pathway, route, and receptor will be further analyzed in the risk
evaluation. The results of that analysis along with the supporting rationale are presented in Appendix C
and Appendix E.
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INDUSTRIAL AND COMMERCIAL EXPOSURE PATHWAY EXPOSURE ROUTE RECEPTORS c HAZARDS
ACTIVITIES / USES
Manufacturing
Processing:
• As reactant/ intermediate
• Incorporated into
formulation, mixturer or
reaction product
• Incorporated into article
• Repackaging
Workers *
Dermal
Solvents for Cleaning and
Degreasing
Fugitive
Emissions y
Adhesive and Sealant
Chemicals
Paints and Coatings
Processing Aid for Agricultural
Products
Cleaning and Furniture Care
Products
Processing Aid for
Petrochemical Manufacturing
Other Uses *
Wastewater or Liquid Wastes
-~ (See Figure 2-4)
Inhalation d
Vapor/ Mist
Liquid Contact
Waste Handling,
Treatment and Disposal
KEY:
—Pathways that will be further analyzed
- - ~ Pathwaysthat will not be further analyzed
Hazards Potentially Associated
with Acute and/or Chronic
Exposures
See Section 2.4.2
Figure 2-2. Perchloroethylene 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 perchloroethylene.
a Some products are used in both commercial and consumer applications such adhesives and sealants. Additional uses of perchloroethylene are included in Table 2-3.
b Fugitive air emissions are those that are not stack emissions and include fugitive equipment leaks from valves, pump seals, flanges, compressors, sampling connections
and open-ended lines; evaporative losses from surface impoundment and spills; and releases from building ventilation systems.
0 Receptors include potentially exposed or susceptible subpopulations.
d Exposure may occur through mists that deposit in the upper respiratory tract however, based on physical chemical properties, mists of perchloroethylene will likely be
rapidly absorbed in the respiratory tract or evaporate and will be considered as an inhalation exposure.
e When data and information are available to support the analysis, EPA also considers the effect that engineering controls and/or personal protective equipment have on
occupational exposure levels.
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2.5.2 Conceptual Model for Consumer Activities and Uses: Potential Exposures and
Hazards
The revised conceptual model (Figure 2-3) illustrates the pathways of exposure from consumer uses of
perchloroethylene that EPA expects to include in the risk evaluation. It should be noted that some
consumers may purchase and use products primarily intended for commercial use.
Inhalation
EPA expects inhalation to be the primary route of exposure and plans to further analyze inhalation
exposures to perchloroethylene vapor and mist for consumers and bystanders.
Dermal
There is potential for dermal exposures to perchloroethylene from consumer uses. Dermal exposure may
occur via direct liquid contact during use. Direct contact with liquid perchloroethylene would be
concurrent with inhalation exposures and dermal exposures to consumers in occluded and non-occluded
scenarios are expected. Bystanders will not have direct dermal contact with liquid perchloroethylene.
EPA expects to further analyze direct dermal contact with liquid perchloroethylene for consumers.
Consumers and bystanders can have skin contact with perchloroethylene vapor concurrently with
inhalation exposures. Similar to workers (see Section 2.5.1) the parameters determining the absorption
of perchloroethylene vapor are based on the concentration of the vapor, the duration of exposure and
absorption. The concentration of the vapor and the duration of exposure are the same for concurrent
dermal and inhalation exposures. Therefore, the differences between dermal and inhalation exposures
depend on the absorption. As described by ATSDR, a human study comparing absorption of
perchloroethylene vapor via the dermal and inhalation routes {i.e., exposure to vapor with and without
respiratory protection) found that absorption via the dermal route is only 1% of the combined dermal
and inhalation routes (ATSDR. 2014). Therefore, EPA will not further analyze consumer or bystander
exposure via vapor-to-dermal contact, because the contribution to overall exposure will be orders of
magnitude lower than direct inhalation of vapors.
Oral
Consumers may be exposed to perchloroethylene via transfer of chemical from hand to mouth. This
exposure pathway will be limited by a combination of dermal absorption and volatilization; therefore,
this pathway will not be further evaluated.
Furthermore, based on available toxicological data, EPA does not expect that considering separate oral
routes of exposure for mists or for incidental ingestion would have significantly different toxicity, rather
mists will be included as part of consumer inhalation exposures and skin contact will be included as part
of consumer dermal exposures. Bystanders are not directly handling perchloroethylene; therefore,
inhalation exposure to mists and incidental ingestion via contact with perchloroethylene are not expected
for bystanders. EPA plans no further analysis of this pathway for consumers or bystanders.
Disposal
EPA does not expect to further analyze exposure to consumers from disposal of consumer products. It is
anticipated that most products will be disposed of in original containers, particularly those products that
are purchased as aerosol cans.
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CONSUMER ACTIVITIES / USES *
EXPOSURE PATHWAY
EXPOSURE ROUTE
RECEPTORS 0
HAZARDS
Cleaning and Furniture Care
Products
e.g. aerosol spat removers,
nan-aerosol cleaners, aerosol
degreasers, brake cleaners,
engine degreasers
Lubricants and G'eases
Adhesiwes ard Sealants
Paints and Coatings
Dry Cleaned Clothing and
Textiles
Other Uses 1
e.g. mold release products,
metal polishes, inks
Consumer Handling and Disposal
of Waste
¦V
KEY:
Gray Text: Use or route that will not be further
analyzed
—Pathways that will be further analyzed
Pathways that will not be further analyzed
Figure 2-3. Perchloroethylene 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
perchl oroethy 1 ene.
a Some products are used in both commercial and consumer applications. Additional uses of perchloroethylene are included in Table 2.3.
b Receptors include potentially exposed or susceptible subpopulations
0 .Consumers may be exposed to perchloroethylene via transfer of chemical from hand to mouth. This exposure pathway will be limited by a combination of dermal
absorption and volatilization; therefore, this pathway will not be further evaluated.
Consumers
Bystanders
Liquid Contact
~ Vapor/Wist
Inhalation -
Hazards Potentially
Associated with Acute
and/or Chronic
Exposures:
See Section 2,4.2
Dermal
Oral
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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 (i.e.,
general population) and ecological receptors (i.e., aquatic and terrestrial) from environmental releases
and waste streams associated with industrial and commercial activities for perchloroethylene that EPA
expects to include in the risk evaluation. The pathways that EPA expects to include and analyze further
in the risk evaluation is described in Section 2.5.3.1 and shown in the conceptual model Figure 2-4. The
pathways that EPA does not expect to include in the risk evaluation s are described in Section 2.5.3.2.
2.5.3.1 Pathways That EPA Expects to Include and Further Analyze in the Risk
Evaluation
EPA plans to analyze aquatic organisms exposed via contaminated surface water.
There are no national recommended water quality criteria for the protection of aquatic life for
perchloroethylene and as a result EPA does not believe that perchloroethylene exposure to aquatic
organisms in surface water has been adequately assessed or effectively managed under other EPA
statutory authorities (see Section 2.5.3.2). EPA identified and reviewed national scale monitoring data to
support this problem formulation. EPA and the USGS National Water Quality Assessment Program
(Cycle 1, 1992-2001) reported perchloroethylene contamination in U.S. surface water and ground water
in 19.6% of samples (n=5,911) and at 13.2% of sites (n=4,295), with detection in surface water
occurring more frequently than in ground water (U.S. EPA, 2009). More recently measured, national-
scale monitoring data was from EPA's STOrage and RETreival (STORET) and National Water
Information System (NWIS). Based on STORET query for perchloroethylene for the past ten years,
perchloroethylene is detected in surface water in the United States. The data showed a detection rate
(above quantification limit and/or above reporting limit) of approximately 15% for surface water, with
detections ranging from 0.02 |ig/L to 26.7 |ig/L. As summarized in Section 2.4.1 perchloroethylene
showed hazard at concentrations as low as 14 |ig/L for aquatic plants. The chronic COC value of 1 |ig/L
is not sufficiently below the range of monitored concentrations to eliminate risk concerns. Therefore,
EPA plans to evaluate risks to aquatic organisms from exposures to perchloroethylene in surface waters.
2.5.3.2 Pathways That EPA Does Not Expect to Include in the Risk Evaluation
Exposures to receptors 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, 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 will not be
included in the risk evaluation. 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.
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Perchloroethylene is a HAP. EPA has issued a number of technology-based standards for source
categories that emit perchloroethylene to ambient air and, as appropriate, has reviewed, or is in the
process of reviewing remaining risks. Because stationary source releases of perchloroethylene 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) for perchloroethylene
under the Safe Drinking Water Act. EPA has set an enforceable Maximum Contaminant Level (MCL) as
close as feasible to a health based, non-enforceable Maximum Contaminant Level Goal (MCLG).
Feasibility refers to both the ability to treat water to meet the MCL and the ability to monitor water
quality at the MCL, SDWA Section 1412(b)(4)(D), and public water systems are required to monitor for
the regulated chemical based on a standardized monitoring schedule to ensure compliance with the
(MCL).
Hence, because the drinking water exposure pathway for perchloroethylene 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 perchloroethylene under TSCA. EPA's Office of Water and Office of
Pollution Prevention and Toxics will continue to work together providing understanding and analysis of
the SDWA regulatory analytical processes and to exchange information related to toxicity and
occurrence data on chemicals undergoing risk evaluation under TSCA.
Ambient Water Pathways
EPA develops recommended water quality criteria under section 304(a) of the CWA for pollutants in
surface water that are protective of aquatic life or human health designated uses. EPA develops and
publishes water quality criteria based on priorities of states and others that reflect the latest scientific
knowledge. A subset of these chemicals are identified as "priority pollutants" (103 human health and 27
aquatic life). The CWA requires states adopt numeric criteria for priority pollutants for which EPA has
published recommended criteria under section 304(a), the discharge or presence of which in the affected
waters could reasonably be expected to interfere with designated uses adopted the state. When states
adopt criteria that EPA approves as part of state's regulatory water quality standards, exposure is
considered when state permit writers determine if permit limits are needed and at what level for a
specific discharger of a pollutant to ensure protection of the designated uses of the receiving water. Once
states adopt criteria as water quality standards, the CWA requires National Pollutant Discharge
Elimination System (NPDES) discharge permits include effluent limits as stringent as necessary to meet
standards. CWA section 301(b)(1)(C). This is the process used under the CWA to address risk to human
health and aquatic life from exposure to a pollutant in ambient waters.
EPA has identified perchloroethylene as a priority pollutant and EPA has developed recommended
water quality criteria for protection of human health for perchloroethylene which are available for
adoption into state water quality standards for the protection of human health and are available for use
by NPDES permitting authorities in deriving effluent limits to meet state narrative criteria. As such,
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EPA does not expect to include this pathway in the risk evaluation under TSCA. EPA's Office of Water
and Office of Pollution Prevention and Toxics will continue to work together providing understanding
and analysis of the CWA water quality criteria development process and to exchange information related
to toxicity of chemicals undergoing risk evaluation under TSCA. EPA may update its CWA section
304(a) water quality criteria for perchloroethylene in the future under the CWA.
EPA has not developed CWA section 304(a) recommended water quality criteria for the protection of
aquatic life for perchloroethylene, so there are no national recommended criteria for this use available
for adoption into state water quality standards and available for use in NPDES permits. As a result, this
pathway will undergo aquatic life risk evaluation under TSCA (see Section 2.4.1). EPA may publish
CWA section 304(a) aquatic life criteria for perchloroethylene in the future if it is identified as a priority
under the CWA.
Biosolids Pathways
CWA Section 405(d) requires EPA to 1) promulgate regulations that establish numeric criteria and
management practices that are adequate to protect public health and the environment from any
reasonably anticipated adverse effects of toxic pollutants during the use or disposal of sewage sludge,
and 2) review such regulations at least every two years to identify additional toxic pollutants that occur
in biosolids (i.e., "Biennial Reviews") and regulate those pollutants if sufficient scientific evidence
shows they may be present in sewage sludge in concentrations which may adversely affect public health
or the environment. EPA also periodically conducts surveys to determine what may be present in sewage
sludge. EPA has conducted four sewage sludge surveys and identified compounds that occur in biosolids
in seven Biennial Reviews. EPA has regulated 10 chemicals in biosolids under CWA 405(d).
EPA has identified perchloroethylene in biosolids biennial reviews. The purpose of such reviews is to
identify additional toxic pollutants in biosolids. EPA can potentially regulate those pollutants under
CWA 405(d), based on a subsequent assessment of risk. EPA's Office of Water is currently developing
modeling tools in order to conduct risk assessments for chemicals in biosolids. Because the biosolids
pathway for perchloroethylene is currently being addressed in the CWA regulatory analytical process,
this pathway will not be further analyzed in the risk evaluation for perchloroethylene under TSCA.
EPA's Office of Water and Office of Pollution Prevention and Toxics will continue to work together to
discuss significant data gaps and exchange information related to exposure and toxicity of this chemical
as OW conducts the risk assessment under the CWA.
Disposal Pathways
Perchloroethylene is included on the list of hazardous wastes pursuant to RCRA 3001 (40 CFR §§
261.33) as a listed waste on the F, K and U lists. The general RCRA standard in Section RCRA 3004(a)
for the technical criteria that govern the management (treatment, storage, and disposal) of hazardous
waste are those "necessary to protect human health and the environment," RCRA 3004(a). The
regulatory criteria for identifying "characteristic" hazardous wastes and for "listing" a waste as
hazardous also relate solely to the potential risks to human health or the environment. 40 C.F.R. §§
261.11, 261.21-261.24. RCRA statutory criteria for identifying hazardous wastes require EPA to "tak[e]
into account toxicity, persistence, and degradability in nature, potential for accumulation in tissue, and
other related factors such as flammability, corrosiveness, and other hazardous characteristics." Subtitle
C control cover not only hazardous wastes that are landfilled, but also hazardous wastes that are
incinerated (subject to joint control under RCRA Subtitle C and the Clean Air Act (CAA) hazardous
waste combustion MACT) or injected into UIC Class I hazardous waste wells (subject to joint control
under Subtitle C and the Safe Drinking Water Act (SDWA)).
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EPA does not expect to include emissions to ambient air from municipal and industrial waste
incineration and energy recovery units in the risk evaluation, as they are regulated under section 129 of
the Clean Air Act. CAA section 129 also requires EPA to review and, if necessary, add provisions to
ensure the standards adequately protect public health and the environment. Thus, combustion by-
products from incineration treatment of perchloroethylene wastes (the majority of the 1.1 million lbs
identified as treated in Tables 2-6 - 2-8) would be subject to these regulations, as would
perchloroethylene burned for energy recovery (2.3 million lbs).
EPA does not expect to include on-site releases to land that go to underground injection in its risk
evaluation. TRI reporting in 2016 indicated 272 pounds released to underground injection to a Class I
well and no releases to underground injection wells of Classes II-VI. Environmental disposal of
perchloroethylene injected into Class I well types managed and prevented from further environmental
release by RCRA and SDWA regulations. Therefore, disposal of perchloroethylene via underground
injection is not likely to result in environmental and general population exposures.
EPA does not expect to include on-site releases to land from RCRA Subtitle C hazardous waste landfills
or exposures of the general population (including susceptible populations) or terrestrial species from
such releases in the TSCA evaluation. Based on 2015 reporting to TRI, the majority of the land
disposals occur in Subtitle C landfills (78,120 lbs). Design standards for Subtitle C landfills require
double liner, double leachate collection and removal systems, leak detection system, run on, runoff, and
wind dispersal controls, and a construction quality assurance program. They are also subject to closure
and post-closure care requirements including installing and maintaining a final cover, continuing
operation of the leachate collection and removal system until leachate is no longer detected, maintaining
and monitoring the leak detection and groundwater monitoring system. Bulk liquids may not be
disposed in Subtitle C landfills. Subtitle C landfill operators are required to implement an analysis and
testing program to ensure adequate knowledge of waste being managed, and to train personnel on
routine and emergency operations at the facility. Hazardous waste being disposed in Subtitle C landfills
must also meet RCRA waste treatment standards before disposal. Given these controls, general
population exposure to perchloroethylene in groundwater from Subtitle C landfill leachate is not
expected to be a significant pathway.
EPA does not expect to include on-site releases to land from RCRA Subtitle D municipal solid waste
landfills or exposures of the general population (including susceptible populations) or terrestrial species
from such releases in the TSCA evaluation. While permitted and managed by the individual states,
municipal solid waste (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 may not be disposed in Subtitle C
landfills.
EPA does not expect to include on-site releases to land from industrial non-hazardous waste and
construction/demolition waste landfills in the perchloroethylene risk evaluation. Industrial non-
hazardous and construction/demolition waste landfills are primarily regulated under state regulatory
programs. States must also implement limited federal regulatory requirements for siting, groundwater
monitoring and corrective action and a prohibition on open dumping and disposal of bulk liquids. States
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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 USES
Direct
discharge
Water,
Sediment
Aquatic
Species
Indirect
discharge
POTW
Wastewater or
Liquid Wastes a
Industrial Pre-
Treatment or
Industrial WWT
KEY:
Pathways that will be further analyzed
Hazards Potentially Associated with
Acute and Chronic Exposures
See Section 2.4.1
Figure 2-4. Perchloroethylene 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 perchloroethylene that will be analyzed.
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 in the problem formulation elaborates on the initial analysis plan that was
published in th q Scope of the Risk Evaluation for Perchloroethylene ' I T \ J.
The analysis plan outlined here is based on the conditions of use for perchloroethylene, 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, provides additional information about criteria and methods that have
been and will be applied to the first 10 chemical risk evaluations.
While EPA has conducted a comprehensive search for reasonably available data, as described in the
Scope of the Risk Evaluation for Perchloroethylene ( ), 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 risk evaluation. EPA will continue to consider new information submitted by the
public.
During risk evaluation, EPA will rely on the comprehensive literature results [Perchloroethylene
(CASRN127-18-4) Bibliography: Supplemental File for the TSCA Scope Document (EP A-HQ-OPPT -
2016-0732)1 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 perchloroethylene to date, which includes partial, but not complete review of
identified literature. If additional data or approaches become available, EPA may refine its analysis plan
based on this information.
2.6.1 Exposure
Based on their physical-chemical properties, expected sources, and transport and transformation within
the outdoor and indoor environment chemical substances are more likely to be present in some media
and less likely to be present in others. Media-specific levels will vary based on the chemical substance
of interest. For most chemical substances level(s) can be characterized through a combination of
available monitoring data and modeling approaches.
2.6.1.1 Environmental Releases
EPA expects to consider and analyze releases to relevant environmental media as follows:
1) Review reasonably available published literature or information on processes and activities
associated with the conditions of use to evaluate the types of releases and wastes generated. EPA
has reviewed some key data sources containing information on processes and activities resulting
in releases, and the information found is shown in Appendix B-l. EPA will continue to review
potentially relevant data sources identified in Table Apx B-3.1 in Appendix B during risk
evaluation.
EPA plans to review the following key data sources in Table 2-10 for additional information on
activities resulting in environmental releases. The evaluation strategy for engineering and
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occupational data sources discussed in the Application of Systematic Review in TSCA Risk
Evaluations describes how data, information, and studies will be reviewed.
Table 2-10. Potential Sources of Environmental Release Data
U.S. EPA TRI Data (Reporting Year 2016 only)
U.S. EPA Generic Scenarios
OECD Emission Scenario Documents
EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Specific
Environmental Release Categories (SpERC) factsheets
Discharge Monitoring Report (DMR) surface water discharge data for perchloroethylene from
NPDES-permitted facilities
2) Review reasonably available chemical-specific release data, including measured or estimated
release data (e.g., data collected under the TRI program). EPA has reviewed key release data
sources including the Toxics Release Inventory (TRI), and the data from this source is
summarized in Section 2.3.2 above and also in Appendix B. EPA will continue to review
relevant data sources as identified in Table Apx B-3.2 in Appendix B during risk evaluation.
EPA will match identified data to applicable conditions of use and identify data gaps where no
data are found for particular conditions of use. EPA will attempt to address data gaps identified
as described in steps 3 and 4 below by considering potential surrogate data and models.
3) Review reasonably available measured or estimated release data for surrogate chemicals that
have similar uses and chemical and physical properties. Data for solvents that are used in the
same types of applications may be considered as surrogate data for perchloroethylene. As with
perchloroethylene, trichloroethylene is used in paints and coatings, in adhesives and sealants, and
as solvents for cleaning and degreasing. EPA will evaluate the use of data for solvents such as
trichloroethylene as surrogates to fill data gaps where uses of perchloroethylene and other
solvents align. If surrogate data are used, EPA normally converts air concentrations using the
ratio of the vapor pressures of the two chemicals. EPA will review literature sources identified
and if surrogate data are found, EPA will match these data to applicable conditions of use for
potentially filling data gaps.
4) Understand and consider regulatory limits that may inform estimation of environmental releases.
EPA has identified information from various EPA statutes (including, for example, regulatory
limits, reporting thresholds or disposal requirements) that may be relevant to release estimation.
Some of the information has informed revision of the conceptual models during problem
formulation. EPA will further consider relevant regulatory requirements in estimating releases
during risk evaluation.
5) Review and determine applicability of OECD Emission Scenario Documents (ESDs) and EPA
Generic Scenarios to estimation of environmental releases. Potentially relevant OECD Emission
Scenario Documents (ESDs) and EPA Generic Scenarios (GS) have been identified that
correspond to some conditions of use. For example, the ESD on Industrial Use of Adhesives for
Substrate Bonding, the ESD on the Coating Industry (Paints, Lacquers and Varnishes), and the
GS on the Use of Vapor Degreasers are some of the ESDs and GSs that EPA may use to assess
potential releases. EPA will need to critically review these generic scenarios and ESDs to
determine their applicability to the conditions of use assessed. EPA was not able to identify
ESDs or GSs corresponding to several conditions of use, including use of perchloroethylene as
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an intermediate, recycling of perchloroethylene, use of perchloroethylene as an industrial
processing aid, and use of perchloroethylene in commercial carpet cleaning. EPA will perform
additional targeted research to understand those conditions of use which may inform
identification of release scenarios. EPA may also need to perform targeted research for
applicable models and associated parameters that EPA may use to estimate releases for certain
conditions of use. If ESDs and GSs are not available, other methods may be considered.
Additionally, for conditions of use where no measured data on releases are available, EPA may
use a variety of methods including the application of default assumptions such as standard loss
fractions associated with drum cleaning (3%) or single process vessel cleanout (1%).
6) Map or group each condition(s) of use to a release assessment scenario. EPA has identified
release scenarios and mapped them to some conditions of use. For example, some scenario
groupings include Contractor Adhesive Removal and Industrial In-line Vapor Degreasing. EPA
grouped similar conditions of use (based on factors including process equipment and handling,
release sources and usage rates of perchloroethylene and formulations containing
perchloroethylene, or professional judgment) into scenario groupings but may further refine
these groupings as additional information becomes available during risk evaluation.
EPA was not able to identify release scenarios corresponding to several conditions of use due to
a lack of general knowledge of those conditions of use. EPA will perform additional targeted
research to understand those uses which may inform identification of release scenarios.
7) Complete the weight of the evidence of environmental release data.
EPA will rely on the weight of the scientific evidence when evaluating and integrating
environmental release data. The data integration strategy will be designed to be fit-for-purpose in
which EPA will use systematic review methods to assemble the relevant data, evaluate the data
for quality and relevance, including strengths and limitations, followed by synthesis and
integration of the evidence.
2.6.1.2 Environmental Fate
EPA expects to consider and analyze fate and transport in environmental media as follows:
1) Review reasonably available measured or estimated environmental fate endpoint data collected
through the literature search.
Key environmental fate characteristics were included in assessments conducted by the EPA
Integrated Risk Information System ( ), EPA Office of Water (U.S. EPA.
2015b). US Agency for Toxic Substances and Disease Registry (ATSDR. 2014) and European
Chemicals Bureau (ECB. 2005b). These information sources will be used as a starting point for
the environmental fate assessment. Other sources that will be consulted include those that are
identified through the systematic review process. Studies will be evaluated using the evaluation
strategies laid out in Application of Systematic Review in TSCA Risk Evaluations.
If measured values resulting from sufficiently high-quality studies are not available (to be
determined through the systematic review process), chemical properties will be estimated using
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EPI Suite, SPARC, and other chemical parameter estimation models. Estimated fate properties
will be reviewed for applicability and quality.
2) Using measured environmental fate data and/or environmental fate modeling, determine the
influence of environmental fate endpoints (e.g., persistence, bioaccumulation, partitioning,
transport) on exposure pathways and routes of exposure to environmental receptors.
Measured fate data including volatilization from water, sorption to organic matter in soil and
sediments, aqueous and atmospheric photolysis rates, and aerobic and anaerobic biodegradation
rates, along with physical-chemical properties and models such as the EPI Suite™ STP model
(which estimates removal in wastewater treatment due to adsorption to sludge and volatilization
to air) and volatility model (which estimates half-life from volatilization from a model river and
model lake), will be used to characterize the movement of perchloroethylene within and among
environmental media and the persistence of perchloroethylene in media.
3) Evaluate the weight of the evidence of environmental fate data.
EPA will rely on the weight of the scientific evidence when evaluating and integrating
environmental fate data. The data integration strategy will be designed to be fit-for-purpose in
which EPA will use systematic review methods to assemble the relevant data, evaluate the data
for quality and relevance, including strengths and limitations, followed by synthesis and
integration of the evidence.
2.6.1.3 Environmental Exposures
EPA expects to consider the following in developing its environmental exposure assessment of
perchl 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 perchloroethylene, exposure scenarios for environmental
receptors include exposures from surface water.
2) Review reasonably available environmental and biological monitoring data for environmental
exposure to surface water. EPA will rely on databases (see examples below) and literature
obtained during systematic review to include ranges and trends of chemical in surface water,
including any trends seen in concentrations and spatial trends.
• STORET andNWIS (USGS/EPS): https://www.epa.gov/waterdata/storage-and-retrieval-and-
water-quality-exchange#portal
• OPPT monitoring database
3) Review reasonably available information on releases to determine how modeled estimates of
concentrations near industrial point sources compare with available monitoring data. Available
exposure models that estimate surface water (e.g. E-FAST) will be evaluated and considered
alongside available surface water data to characterize environmental exposures. Modeling
approaches to estimate surface water concentrations generally consider the following inputs:
direct release into surface water and transport (partitioning within media) and characteristics of
the environment (river flow, volume of pond, meteorological data).
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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
perchloroethylene 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 integration.
2.6.1.4 Occupational Exposures
EPA expects to consider and analyze both worker and occupational non-user exposures as follows:
1) Review reasonably available exposure monitoring data for specific condition(s) of use. 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 of Occupational Safety and Health (NIOSH), and monitoring data found in published
literature. These workplace monitoring data include personal exposure monitoring data (direct
exposures) and area monitoring data (indirect exposures).
EPA has reviewed available monitoring data collected by OSHA and NIOSH and will match
these data to applicable conditions of use. EPA has also identified additional data sources that
may contain relevant monitoring data for the various conditions of use. EPA will review these
sources (identified in Table 2-11 and in Table Apx-B-3.3) and extract relevant data for
consideration and analysis during risk evaluation.
OSHA has established a permissible exposure limit (PEL) of 100 ppm 8-hour time-weighted
average (TWA). The American Conference of Government Industrial Hygienists (ACGIH) has
established a Threshold Limit Value (TLV) of 25 ppm 8-hour TWA. Also, NIOSH has
established an immediately dangerous to life or health (IDLH) value of 150 ppm. EPA will
consider the influence of these regulatory limits and recommended exposure guidelines on
occupational exposures in the occupational exposure assessment.
Table 2-11. Potential Sources of Occupational Exposure Data
2014 Draft ATSDR Toxicological Profile for Perchloroethylene
U.S. OSHA Chemical Exposure Health Data (CEHD) program data
U.S. NIOSH Health Hazard Evaluation (HHE) Program reports
1985 EPA Occupational Exposure and Release Assessment for Tetrachloroethylene
2) Review reasonably available exposure data for surrogate chemicals that have uses, volatility and
chemical and physical properties similar to perchloroethylene. 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., vapor degreasing, cold
cleaning, coating applications, adhesive applications), EPA believes trichloroethylene and other
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similar solvents that share the same conditions of use may serve as surrogate for
perchl oroethy 1 ene.
3) For conditions of use where data is limited or not available, review existing exposure models that
may be applicable in estimating exposure levels. EPA has identified potentially relevant OECD
ESDs and EPA GS 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 or GS's
corresponding to several conditions of use, including use of perchloroethylene as an
intermediate, recycling of perchloroethylene, use as an industrial processing aid, and commercial
carpet cleaning. EPA will perform additional targeted research to understand those conditions of
use, which may inform identification of exposure scenarios. EPA may also need to perform
targeted research to identify applicable models that EPA may use to estimate exposures for
certain conditions of use.
EPA was not able to identify release scenarios corresponding to several conditions of use. EPA
may conduct industry outreach efforts or perform supplemental, targeted literature searches to
better understand the process steps involved in that condition of use before occupational
exposure assessment can be made. EPA will perform additional targeted research to understand
those conditions of use, which may inform identification of exposure scenarios. EPA will
consider exposure models in the Chemical Screening Tool For Exposure and Environmental
Releases (ChemSTEER) Tool that are routinely used for assessing new chemicals. EPA may
also need to perform targeted research to identify other 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. 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 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 risk assessment (RA) and subsequent Section 6 rulemaking for TCE and the
2016 draft RA for 1-BP, EPA developed models to assess inhalation exposures to workers and
occupational non-users during the use of these chemicals in dry cleaning, spot cleaning, vapor
degreasing, cold cleaning, and aerosol degreasing. During risk evaluation, EPA will evaluate the
applicability of these models to perchloroethylene, and adapt and refine these models as
necessary for evaluating exposure to perchloroethylene in these scenarios.
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
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contacts. EPA anticipates that existing EPA/OPPT dermal exposure models would not be
suitable for quantifying dermal exposure to semi-volatile chemicals such as perchloroethylene.
5) Consider and incorporate applicable engineering controls and/or personal protective equipment
into exposure scenarios. EPA will review potentially relevant data sources on engineering
controls and personal protective equipment as identified in Table Apx B-3.4 in the Appendix
and to determine their applicability and incorporation into exposure scenarios during risk
evaluation. EPA will assess worker exposure pre- and post-implementation of engineering
controls, using available information on available control technologies and control effectiveness.
For example, EPA may assess worker exposure in industrial use scenarios before and after
implementation of local exhaust ventilation.
6) Map or group each condition of use to occupational exposure assessment scenario(s). EPA has
identified exposure scenarios and mapped them to some (or most) conditions of use. 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 (e.g., use of perchloroethylene
metal and stone polishes). EPA will perform targeted research to understand those uses which
may inform identification of occupational exposure scenarios. EPA grouped similar conditions of
use (based on factors including process equipment and handling, usage rates of
perchloroethylene and formulations containing perchloroethylene, exposure/release sources) into
scenario groupings but may further refine these groupings as additional information is identified
during risk evaluation.
7) Evaluate the weight of the evidence of occupational exposure data. EPA will rely on the weight
of the scientific evidence when evaluating and integrating occupational 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 document for more information on the general
process for data integration.
2.6.1.5 Consumer Exposures
EPA expects to consider and analyze both consumers using a consumer product and bystanders
associated with the consumer using the product as follows:
1) Refine and finalize exposure scenarios for consumers by mapping sources of exposure (i.e.,
consumer products), exposure pathways, exposure settings, exposure routes, and populations
exposed. Considerations for constructing exposure scenarios for consumers:
• Reasonably available data on consumer products or products available for consumer use
including the weight fraction of perchloroethylene in products;
• Information characterizing the use patterns of consumer products containing
perchloroethylene including the following: intended or likely consumer activity, method
of application (e.g., spray-applied, brush-applied, dip), formulation type, amount of
product used, frequency and duration of individual use events, and room or setting of use;
• The associated route of exposure for consumers; and
• Populations who may be exposed to products as users or bystanders in the home,
including potentially exposed and susceptible subpopulations such as children or women
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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.
Evaluate the potential and magnitude of exposure routes based on available data,
perchloroethylene, inhalation of vapor is expected to result in higher exposure to consumers and
bystanders in the home compared to dermal absorption through direct contact due to fate and
exposure properties. 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.
Review and use existing indoor exposure models that may be applicable in estimating inhalation
and dermal exposure. For example, the Consumer Exposure Model (CEM version 2.0) and the
Multi-Chamber Concentration and Exposure Model (MCCEM) to estimate and evaluate indoor
exposures to perchloroethylene in consumer and commercial products.
Review reasonably available empirical data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation. For example, existing models developed for a
chemical assessment may be applicable to another chemical assessment if model parameter data
are available.
Review reasonably available consumer product-specific sources to determine how those
exposure estimates compare with each other and with indoor air and product use monitoring data
for perchloroethylene.
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. For a small subset of uses (e.g.
craft glues and adhesives) children may be users of perchloroethylene containing products. For
other uses of perchloroethylene containing products children and/or infants would 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.
Evaluate the weight of evidence of consumer exposure estimates based on different approaches.
EPA will rely on the weight of the scientific evidence when evaluating and integrating consumer
exposure data. The data integration strategy will be designed to be fit-for-purpose in which EPA
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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. Map or group each
condition of use to consumer exposure assessment scenario(s). Refine and finalize exposure
scenarios for consumers by mapping sources of exposure (i.e., consumer products), exposure
pathways, exposure settings, exposure routes, and populations exposed. Considerations for
constructing exposure scenarios for consumers:
2.6.1.6 General Population
EPA does not expect to consider and analyze general population exposures in the risk evaluation for
perchloroethylene EPA has determined that the existing regulatory programs and associated analytical
processes have addressed or are in the process of addressing potential risks of perchloroethylene 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.
2.6.2 Hazards (Effects)
2.6.2.1 Environmental Hazards
EPA will conduct an environmental hazard assessment of perchloroethylene 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 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 perchloroethylene to aquatic species.
2) Derive aquatic concentrations of concern (COC) for acute and, where possible, chronic endpoints. The
aquatic environmental hazard studies may be used to derive acute and chronic concentrations of concern
(COC) for mortality, behavioral, developmental and reproductive or other endpoints determined to be
detrimental to environmental populations. Depending on the robustness of the evaluated data for a
particular organism (e.g. aquatic invertebrates), environmental hazard values (e.g.
ECx/LCx/NOEC/LOEC, etc.) may be derived and used to further understand the hazard characteristics of
perchloroethylene to aquatic species.
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3) Evaluate the weight of the evidence of environmental hazard data. EPA will rely on the weight of the
scientific evidence when evaluating and integrating environmental hazard data. The data integration
strategy will be designed to be fit-for-purpose. EPA will use systematic review methods to assemble the
relevant data, evaluate the data for quality and relevance, including strengths and limitations, followed by
synthesis and integration of the evidence. Refer to the supplemental document, Application of Systematic
Review in TSCA Risk Evaluations, for more information on the general process for data integration.
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 organisms from exposures to perchloroethylene in ground
water and surface water.
2.6.2.2 Human Health Hazards
EPA expects to consider and analyze human health hazards as follows:
1) Review reasonably available human health hazard data, including data from alternative test
methods as needed (e.g., computational toxicology and bioinformatics; high-throughput
screening methods; data on categories and read-across; in vitro studies; systems biology).
For the perchloroethylene risk evaluation, EPA will evaluate information in the IRIS assessment
and human health studies using OPPT's structured process described in the document,
Application of Systematic Review in TSCA Risk Evaluations. Human and animal data will be
identified and included as described in the inclusion and exclusion criteria in Appendix F. EPA
expects to prioritize the evaluation of mechanistic evidence. Specifically, EPA does not plan to
evaluate mechanistic studies unless needed to clarify questions about associations between
perchloroethylene and health effects and its relevance to humans. The Applications of Systematic
Review document describes the process of how studies will be evaluated using specific data
evaluation criteria and a predetermined approach. Study results will be extracted and presented in
evidence tables by hazard endpoint. EPA expects to evaluate relevant studies identified in the
Integrated Risk Information System (IRIS) ToxicologicalReview of Tetrachloroethylene (U.S.
EPA. 2012e). In addition, EPA intends to review studies published after the acute reference
values were published (e.g. AEGLs) from January 1, 2010 to March 2, 2017 that were captured
in the comprehensive literature search conducted by the Agency for perchloroethylene (see
Perchloroethylene (CASRN127-18-4) Bibliography: Supplemental File for the TSCA Scope
Document) using the approaches described in Application of Systematic Review in TSCA Risk
Evaluations. To more fully understand circumstances related to deaths by individuals using
perchloroethylene, EPA/OPPT will review case reports, case series and ecological studies related
to deaths and effects that may imminently lead to death (respiratory distress). EPA/OPPT will
not be evaluating case reports and series or ecological studies for endpoints that appear to be less
severe endpoints (e.g., nausea).
2) In evaluating reasonably available data, determine whether particular human receptor groups
may have greater susceptibility to the chemical's hazard(s) than the general population.
Reasonably available human health hazard data will be evaluated to ascertain whether some
human receptor groups may have greater susceptibility than the general population to
perchloroethylene hazard(s).
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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 data quality criteria described in Application of Systematic
Review in TSCA Risk Evaluations. Data quality evaluation will be performed on relevant studies
identified in the IRIS assessment (U.S. EPA. 2Q12e). and assessments of the effects of acute
exposures in the (NAC/AEGL). Data quality evaluation will also be performed on studies that
were identified in the comprehensive literature search and that met the inclusion criteria for full-
text screening (see Application of Systematic Review in TSCA Risk Evaluations. Hazards
identified by studies meeting data quality criteria will be grouped by routes of exposure relevant
to humans (oral, inhalation) and by cancer and noncancer endpoints.
Dose-response assessment will be performed in accordance with EPA guidance (U.S. EPA.
2012a. 2011. 1994). Dose-response analyses performed to support the IRIS oral and inhalation
reference dose determinations and for the cancer unit risk and slope factor ( 012e)
may be used if the data meet data quality criteria and if additional information on the identified
hazard endpoints or additional hazard endpoints would not alter the analysis.
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,
if the dose-response modeling requires updating. 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, NOAELs or LOAELs will be identified.
EPA will evaluate whether the available PBPK and empirical kinetic models are adequate for
route-to-route and interspecies extrapolation of the POD, or for extrapolation of the POD to
appropriate exposure durations for the risk evaluation.
5) 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 are sufficient data to conduct dose-response analysis with benchmark dose
modeling or NOAELs or LOAELs for both inhalation and oral routes of exposure.
A route-to-route extrapolation from the inhalation and oral toxicity studies is needed to assess
systemic risks from dermal exposures. Without an adequate PBPK model, 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.
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6) Evaluate the weight of the evidence of human health hazard data. EPA will rely on the weight of
the scientific evidence when evaluating and integrating human health hazard data. The 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 Systematic Review Approaches and Methods Applied to TSCA Risk Evaluations document
for more information on the general process for data evaluation.
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. 2000a). 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. 2000a). 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
(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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Report]. Washington, DC. http://www.epa.gov/sites/production/files/2015~05/documents/05~
iad discretes june2013.pdf
U.S. EPA (U.S. Environmental Protection Agency). (2014a). Degreasing with TCE in commercial facilities:
Protecting workers [EPA Report]. Washington, DC: U.S. Environmental Protection Agency, Office
of Pollution Prevention and Toxics.
U.S. EPA (U.S. Environmental Protection Agency). (2014b). Draft generic scenario on the use of
additives in plastics compounding. Washington D.C.: Office of Pollution Prevention and Toxics.
U.S. EPA (U.S. Environmental Protection Agency). (2014c). Draft generic scenario on the use of
additives in the thermoplastics converting industry. Washington, DC: U.S. Environmental
Protection Agency, Office of Pollution Prevention and Toxics.
U.S. EPA (U.S. Environmental Protection Agency). (2014d). Framework for human health risk
assessment to inform decision making. Final [EPA Report]. (EPA/100/R-14/001). Washington,
DC: U.S. Environmental Protection, Risk Assessment Forum.
https://www.epa.gov/risk/framework-human~health~risk-assessment~inform~decision~making
U.S. EPA (U.S. Environmental Protection Agency). (2014e). TSCA work plan chemical risk assessment.
Trichloroethylene: Degreasing, spot cleaning and arts & crafts uses. (740-R1-4002). Washington,
DC: Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention.
http://www2.epa.gov/sites/production/files/2015~
09/documents/tce opptworkplanchemra final 062414.pdf
U.S. EPA (U.S. Environmental Protection Agency). (2015a). 2013 National Monitoring Programs Annual
Report (UATMP, NATTS, CSATAM). (EPA-454/R-15-005a).
https://www3.epa.gov/ttn/amtic/files/ambient/airtox/2013nmpreport.pdf
U.S. EPA (U.S. Environmental Protection Agency). (2015b). Update of human health ambient water
quality criteria: Tetrachloroethylene (Perchloroethylene) 127-18-4. (EPA 820-R-15-063).
U.S. EPA (U.S. Environmental Protection Agency). (2016a). Instructions for reporting 2016 TSCA
chemical data reporting. Washington, DC: Office of Pollution Prevention and Toxics.
Page 90 of 167
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https://www.epa.gov/chemical-data-reportinE/instructions-reporting-2Q16-tsca-chemical-data-
reporting
U.S. EPA (U.S. Environmental Protection Agency). (2016b). Public database 2016 chemical data
reporting (May 2017 release). Washington, DC: US Environmental Protection Agency, Office of
Pollution Prevention and Toxics. Retrieved from https://www.epa.gov/chemical-data-reporting
U.S. EPA. (2016c). 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/2Q16~03/documents/l~
bp report and appendices final.pdf
U.S. EPA (U.S. Environmental Protection Agency). (2017a). EPA's report on the environment (ROE).
https://cfpub.epa.gov/roe/index.cfm
U.S. EPA (U.S. Environmental Protection Agency). (2017b). Perchloroethylene (CASRN: 127-18-4)
bibliography: Supplemental file for the TSCA Scope Document [EPA Report].
https://www.epa.gov/sites/production/files/2Q17~Q6/documents/perc comp bib.pdf
U.S. EPA (U.S. Environmental Protection Agency). (2017c). Scope of the risk evaluation for
perchloroethylene (ethene, 1,1,2,2-tetrachloro). CASRN: 127-18-4 [EPA Report]. (EPA-740-R1-
7007). https://www.epa.gov/sites/production/files/2017~06/documents/perc scope 06-22-
df
U.S. EPA (U.S. Environmental Protection Agency). (2017d). Strategy for conducting literature searches
for tetrachloroethylene (perc): Supplemental document to the TSCA Scope Document. CASRN:
127-18-4 [EPA Report], https://www.epa.gov/sites/production/files/
06/documents/perc lit search strategy 05 01 ^ pdf
U.S. EPA (U.S. Environmental Protection Agency). (2017e). Toxics Release Inventory (TRI). Retrieved
from https://www.epa.gov/toxics-release-inventory-tri-program/tri~data-and-tools
U.S. EPA. (2017f). Toxics release inventory: Tetrachloroethylene. Washington, DC. Retrieved from
http://iava.epa.gov/chemview
U.S. EPA (U.S. Environmental Protection Agency). (2018a). Application of systematic review in TSCA risk
evaluations: DRAFT Version 1.0. (740P18001). Washington, D.C.: U.S. Environmental Protection
Agency, Office of Chemical Safety and Pollution Prevention.
U.S. EPA (U.S. Environmental Protection Agency). (2018b). Application of systematic review in TSCA risk
evaluations: Version 1.0. (740P18001). Washington, D.C.: U.S. Environmental Protection
Agency, Office of Chemical Safety and Pollution Prevention.
U.S. EPA; ICF Consulting. (2004). The U.S. solvent cleaning industry and the transition to non ozone
depleting substances. http://www.hsia.org/applications/QDS%20report.pdf
van Wijngaarden, E; Hertz-Picciotto, I. (2004). A simple approach to performing quantitative cancer risk
assessment using published results from occupational epidemiology studies. Sci Total Environ
332: 81-87. http://dx.doi.Org/10.1016/i.scitotenv.2004.04.005
Verplanke, AJ; Leummens, MH; Herber, RF. (1999). Occupational exposure to tetrachloroethene and its
effects on the kidneys. J Occup Environ Med 41: 11-16.
von Grote, J; Hurlimann, C; Scheringer, M; Hungerbuhler, K. (2006). Assessing occupational exposure to
perchloroethylene in dry cleaning. J Occup Environ Hyg 3: 606-619.
http://dx.doi.org/10.1080/1545962060Q912173
Von Grote, J; Hurlimann, JC; Scheringer, M; Hungerbuhler, K. (2003). Reduction of Occupational
Exposure to Perchloroethylene and Trichloroethylene in Metal Degreasing over the Last 30
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years: Influence of Technology Innovation and Legislation. J Expo Anal Environ Epidemiol 13:
325-340. http://dx.doi.ore/10.103S/si.iea.7500288
Weisel, CP; Zhang, J; Turpin, BJ; Morandi, MT; Colome, S; Stock, TH; Spektor, DM; Korn, L; Winer, AM;
Kwon, J; Meng, QY; Zhang, L; Harrington, R; Liu, W; Reff, A; Lee, JH; Alimokhtari, S; Mohan, K;
Shendell, D; Jones, J; Farrar, L; Maberti, S; Fan, T. (2005). Relationships of indoor, outdoor, and
personal air (RIOPA): Part I. Collection methods and descriptive analyses (pp. 1-107; discussion
109-127). (ISSN 1041-5505
HEI Research Report 130). Boston, MA: Health Effects Institute.
White, GL; Schwartz, E. (1979). Health hazard evaluation report no. HEE 79-41-594, Stout Sportswear,
Queens Long Island City, New York. (HEE 79-41-594). Cincinnati, OH: National Institute for
Occupational Safety and Health.
Whittaker, SG; Johanson, CA. (2011). A profile of the dry cleaning industry in King County, Washington.
Final report. King County, Washington: Local Hazardous Waste Management Program.
http://www.hazwastehelp.org/publications/publications detail.aspx?DoclD=Oh73%2fQilg9Q%
M
Whittaker, SG; Johanson, CA. (2013). A health and environmental profile of the dry cleaning industry in
King County, Washington. J Environ Health 75: 14-22.
WHO (World Health Organization). (2006). Concise international chemical assessment document 68:
Tetrachloroethene. Geneva, Switzerland: World Health Organization, International Programme
on Chemical Safety, http://www.inchem.org/documents/cicads/cicads/cicad68.htm
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APPENDICES
Appendix A REGULATORY HISTORY
A.l Federal Laws and Regulations
Table Apx A-l. Federal Laws and Regulations
Mai ulcs/Uegiilal ions
Description of Aiilhorhy/Ucgulalion
Description of Regulation
EPA Regulations
Toxics Substances
Control Act (TSCA)
- Section 6(b)
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.
Perchloroethylene is on the initial list
of chemicals to be evaluated for
unreasonable risk under TSCA (81 FR
91927, December 19, 2016).
Toxics Substances
Control Act (TSCA)
- Section 8(a)
The TSCA Section 8(a) Chemical Data
Reporting (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.
Perchloroethylene manufacturing
(including importing), processing, and
use information is reported under the
Chemical Data Reporting (CDR) rule
(76 FR 50816, August 16, 2011).
Toxics Substances
Control Act (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.
Perchloroethylene was on the initial
TSCA Inventory and therefore was not
subject to EPA's new chemicals
review process (76 FR 50816, August
16, 2011).
Toxics Substances
Control Act (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.
Eleven risk reports received for
perchloroethylene (1978-2010) (US
EPA, ChemView. Accessed April 13,
2017).
Toxics Substances
Control Act (TSCA)
- Section 4
Provides EPA with authority to issue
rules and orders requiring
manufacturers (including importers)
and processors to test chemical
substances and mixtures.
Nine chemical data submissions from
test rules received for
perchloroethylene (1978-1980) (US
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
Perchloroethylene is a listed substance
subject to reporting requirements
under 40 CFR 372.65 effective as of
January 1, 1987.
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MnliiU's/Ucguliilions
Description of Aiilhorily/Ucgiihilion
Description of Ucgnhilion
TRI-listed chemical in quantities above
threshold levels.
Federal Insecticide,
Fungicide, and
Rodenticide Act
(FIFRA) - Sections 3
and 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.
EPA removed perchloroethylene and
other chemical substances from its list
of pesticide product inert ingredients
used in pesticide products (63 FR
34384, June 24, 1998).
Clean Air Act (CAA)
- Section 112(b)
Defines the original list of
189 hazardous air pollutants (HAP).
Under 112(c) of the CAA, EPA must
identify and list source categories that
emit HAP and then set emission
standards for those listed source
categories under CAA section 112(d).
CAA section 112(b)(3)(A) specifies
that any person may petition the
Administrator to modify the list of HAP
by adding or deleting a substance. Since
1990 EPA has removed two pollutants
from the original list leaving 187 at
present.
Lists perchloroethylene as a
Hazardous Air Pollutant (42 U.S.
Code § 7412), and is considered an
"urban air toxic" (CAA Section
112(k)).
Clean Air Act (CAA)
- Section 112(d)
Section 112(d) states that the EPA must
establish national emission standards
for HAP (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 the 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
There are a number of source-specific
CAA, Section 112, NESHAPs for
perchloroethylene, including:
Dry cleaners (73 FR 39871, July 11,
2008)
Organic liquids distribution (non-
gasoline) (69 FR 5038, February 3,
2004)
Off-site waste and recovery operations
(64 FR 38950, July 20, 1999)
Rubber Tire Manufacturing (67 FR
45588, July 9, 2002)
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MnliiU's/Ucguliilions
Description of Aiilhorily/Ucgiihilion
Description of Ucgnhilion
standards, known as generally available
control technology (GACT) standards,
are allowed at the Administrator's
discretion for area sources.
Wood furniture manufacturing (60 FR
62930, December 7, 1995)
Synthetic organic chemical
manufacturing (59 FR 19402, April
22,1994)
Chemical Manufacturing Area Source
Categories (74 FR 56008, October 29,
2009)
Publicly Owned Treatment Works (64
FR 57572, October 26, 1999)
Site Remediation includes
perchloroethylene (68 FR 58172,
October 8, 2003)
Clean Air Act (CAA)
- Section 112(d) and
112(f)
Risk and technology review (RTR) of
section 112(d) MACT standards.
Section 112(f)(2) requires EPA to
conduct risk assessments for each
source category subject to section
112(d) MACT standards, and to
determine if additional standards are
needed to reduce remaining risks.
Section 112(d)(6) requires EPA to
review and revise the MACT standards,
as necessary, taking into account
developments in practices, processes
and control technologies."
EPA has promulgated a number of
RTR NESHAP (e.g., the RTR
NESHAP for Perchloroethylene Dry
Cleaning (71 FR 42724; July 27,
2006) and the RTR NESHAP for
Halogenated Solvent Cleaning (72 FR
25138; May 3, 2007) and will do so,
as required, for the remaining source
categories with NESHAP
Clean Air Act (CAA)
- Section 183(e)
Section 183(e) requires EPA to list the
categories of consumer and commercial
products that account for at least
80 percent of all VOC emissions in
areas that violate the National Ambient
Air Quality Standards (NAAQS) for
ozone and to issue standards for these
categories that require "best available
controls." In lieu of regulations, EPA
may issue control techniques guidelines
if the guidelines are determined to be
substantially as effective as regulations.
Perchloroethylene is listed under the
National Volatile Organic Compound
Emission Standards for Aerosol
Coatings (40 CFR part 59, subpart E).
Perchloroethylene has a reactivity
factor of 0.04g 03/g VOC.
Clean Air Act (CAA)
- Section 612
Under Section 612 of the Clean Air Act
(CAA), EPA's Significant New
Alternatives Policy (SNAP) program
reviews substitutes for ozone depleting
substances within a comparative risk
framework. EPA publishes lists of
acceptable and unacceptable
alternatives. A determination that an
Under the SNAP program, EPA listed
perchloroethylene as an acceptable
substitute in cleaning solvent for metal
cleaning, electronics cleaning and
precision cleaning (59 FR 13044,
March 18, 1994). Perchloroethylene is
cited as an alternative to methyl
chloroform and CFC-113 for metals,
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MnliiU's/Ucguliilions
Description of Aiilhorily/Ucgiihilion
Description of Ucgnhilion
alternative is unacceptable or
acceptable only with conditions, is
made through rulemaking.
electronics and precision cleaning.
Perchloroethylene was also noted to
have no ozone depletion potential and
cited as a VOC-exempt solvent and
acceptable ozone-depleting substance
substitute (72 FR 30142, May 30,
2007).
Clean Water Act
(CWA) - Section
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.
Perchloroethylene is designated as a
toxic pollutant under section 307(a)(1)
of CWA and as such is subject to
effluent limitations. Also under
section 304, perchloroethylene is
included in the list of total toxic
organics (TTO) (40 CFR 413.02(i)).
Clean Water Act
(CWA) 304(a)
Section 304(a)(1) of the Clean Water
Act (CWA) requires EPA to develop
and publish, and from time to time
revise, recommended criteria for the
protection of water quality that
accurately reflect the latest scientific
knowledge. Water quality criteria
developed under section 304(a) are
based solely on data and scientific
judgments on the relationship between
pollutant concentrations and
environmental and human health
effects.
Clean Water Act
(CWA) - Section
307(a)
Establishes a list of toxic pollutants or
combination of pollutants under the
CWA. The statute specifies a list of
families of toxic pollutants also listed in
the Code of Federal Regulations at 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 (Sections 301(b), 304(b),
307(b), 306), or on a case-by-case best
professional judgement basis in NPDES
permits (Section 402(a)(1)(B)).
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MnliiU's/Ucguliilions
Description of Aiilhorily/Ucgiihilion
Description of Ucgnhilion
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 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 judgment 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
Perchloroethylene is subject to
National Primary Drinking Water
Regulations (NPDWR) under SDWA
with a MCLG of zero and an
enforceable maximum contaminant
level (MCL) of 0.005 mg/L (40 CFR
141.61). On January 11,2017, EPA
announced a review of the eight
existing NPDWRs (82 FR 3518).
Perchloroethylene is one of the eight
NPDWRs. EPA requested comment
on the eight NPDWRs identified as
candidates for revision.
Comprehensive
Environmental
Response,
Compensation and
Liability Act
(CERCLA) - Section
102(a) and 103
Authorizes EPA to promulgate
regulations designating as hazardous
substances those substances which,
when released into the environment,
may present substantial danger to the
public health or welfare or the
environment. EPA must also
promulgate regulations establishing the
quantity of any hazardous substance the
release of which must be reported under
Section 103.
Section 103 requires persons in charge
of vessels or facilities to report to the
National Response Center if they have
knowledge of a release of a hazardous
substance above the reportable quantity
threshold.
Perchloroethylene is a hazardous
substance under CERCLA. Releases
of perchloroethylene in excess of
100 pounds must be reported (40 CFR
302.4).
Resource
Conservation and
Recovery Act
(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
Perchloroethylene is included on the
list of hazardous wastes pursuant to
RCRA 3001. RCRA Hazardous Waste
Code: D039 at 0.7 mg/L; F001, F002;
U210.
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Mai ulcs/Uegiilal ions
Description of Aiilhorhy/Ucgulalion
Description of Regulation
degradability in nature, potential for
accumulation in tissue, and other
related factors such as flammability,
corrosiveness, and other hazardous
characteristics.
In 2013, EPA modified its hazardous
waste management regulations to
conditionally exclude solvent-
contaminated wipes that have been
cleaned and reused from the definition
of solid waste under RCRA (78 FR
46447, July 31, 2013).
Superfund
Amendments and
Reauthorization Act
(SARA) -
Requires the Agency to revise the
hazardous ranking system and update
the National Priorities List of hazardous
waste sites, increases state and citizen
involvement in the superfund program
and provides new enforcement
authorities and settlement tools.
Perchloroethylene is listed on SARA,
an amendment to CERCLA and the
CERCLA Priority List of Hazardous
Substances. This list includes
substances most commonly found at
facilities on the CERCLA National
Priorities List (NPL) that have been
deemed to pose the greatest threat to
public health.
Other Federal Regulations
Federal Hazardous
Substance Act
(FHSA)
Allows the Consumer Product Safety
Commission (CPSC) to (1) require
precautionary labeling on the
immediate container of hazardous
household products or (2) to ban certain
products that are so dangerous or the
nature of the hazard is such that
required labeling is not adequate to
protect consumers.
Under the Federal Hazardous
Substance Act, section 1500.83(a)(31),
visual novelty devices containing
perchloroethylene are regulated by
CPSC.
Federal Food, Drug,
and Cosmetic Act
(FFDCA)
Provides the U.S. FDA (Food and Drug
Administration) with authority to
oversee the safety of food, drugs and
cosmetics.
The FDA regulates perchloroethylene
in bottled water. The maximum
permissible level of perchloroethylene
in bottled water is 0.005 mg/L (21
CFR 165.110).
Occupational Safety
and Health Act (OSH
Act)
Requires employers to provide their
workers with a place of employment
free from recognized hazards to safety
and health, such as exposure to toxic
chemicals, excessive noise levels,
mechanical dangers, heat or cold stress
or unsanitary conditions. Under the Act,
the Occupational Safety and Health
Administration can issue occupational
safety and health standards including
such provisions as Permissible
Exposure Limits (PELs), exposure
In 1970, OSHA issued occupational
safety and health standards for
perchloroethylene that included a
Permissible Exposure Limit (PEL) of
100 ppm TWA, exposure monitoring,
control measures and respiratory
protection (29 CFR 1910.1000).
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Mat ulcs/Uegulat ions
Description of Authority/Regulation
Description of Regulation
monitoring, engineering and
administrative control measures and
respiratory protection.
Atomic Energy Act
Department of
Energy (DOE)
The Atomic Energy Act authorizes
DOE 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 ACGIH TLVs if they are
more protective than the OSHA PEL.
The 2005 TLV for perchloroethylene
is 25 ppm (8hr Time Weighted
Average) and 100 ppm Short Term
Exposure Limit(STEL).
A.2 State Laws and Regulations
Table Apx A-2. State Laws and Regulations
Slate Actions
Description of Action
State actions
State Permissible
Exposure Limits
California has a workplace PEL of 25 ppm (California, OEHHA, 1988)
State Right-to-
Know Acts
Massachusetts (454 CMR 21.00), New Jersey (42 N.J.R 1709(a)), Pennsylvania
(Chapter 323, Hazardous Substance List), Rhode Island (RI Gen. Laws Sec. 28-21-
let seq).
Volatile Organic
Compound
(VOC)
Regulations for
Consumer
Products
Many states regulate perchloroethylene 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, 20737), 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
There are several state level NESHAPs for dry cleaning and restrictions or phase
outs of perchloroethylene (e.g. California, Maine, Massachusetts). Numerous states
list perchloroethylene on a list of chemical substances of high concern to children
(e.g. Oregon, Vermont, Washington). Under the California Proposition 65 list
Page 99 of 167
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Slsitc Actions
Description of Action
(California OEHHA), perchloroethylene is known to the state of California to cause
cancer.
A.3 International Laws and Regulations
C'ou ill rv/Or^sini/sil ion
Requirements sind Restrictions
Canada
Perchloroethylene is on the Canadian List of Toxic Substances (CEPA 1999
Schedule 1). The use and sale of perchloroethylene in the dry cleaning industry
is regulated under Use in Dry Cleaning and Reporting Requirements
Regulations (Canada Gazette, Part II on March 12, 2003. Perchloroethylene 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
perchloroethylene into the environment from solvent degreasing facilities using
more than 1,000 kilograms of perchloroethylene per year. The regulation
includes a market intervention by establishing tradable allowances for the use
of perchloroethylene in solvent degreasing operations that exceed the
1,000 kilograms threshold per year.
European Union
Perchloroethylene was evaluated under the 2013 Community Rolling Action
Plan (CoRAP). The conclusion was no additional regulatory action was
required (European Chemicals Agency (ECHA) database. Accessed April, 18
2017).
Australia
In 2011, a preliminary assessment of perchloroethylene was conducted
(National Industrial Chemicals Notification and Assessment Scheme,
NICNAS, 2016, Tetrachloroethylene. Accessed April, 18 2017).
Japan
Perchloroethylene is regulated in Japan under the following legislation:
• Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc. (Chemical Substances Control Law; CSCL)
• Act on Confirmation, etc. of Release Amounts of Specific Chemical
Substances in the Environment and Promotion of Improvements to the
Management Thereof
• Industrial Safety and Health Act (ISHA)
• Air Pollution Control Law
• Water Pollution Control Law
• Soil Contamination Countermeasures Act
• 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, European
Union, Finland, France,
Occupational exposure limits for perchloroethylene (GESTIS International
limit values for chemical agents (Occupational exposure limits, OELs)
database. Accessed April 18, 2017).
Page 100 of 167
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C'ou ill rv/Orgsinizsil ion
Requirements sind Restrictions
Germany, Hungary,
Ireland, Israel, Japan,
Latvia, New Zealand,
People's Republic of
China, Poland,
Singapore, South
Korea, Spain, Sweden,
Switzerland, United
Kingdom
Basel Convention
Halogenated organic solvents (Y41) are listed as a category of waste under the
Basel Convention - Annex I. Although the United States is not currently a
party to the Basel Convention, this treaty still affects U.S. importers and
exporters.
OECD Control of
Transboundary
Movements of Wastes
Destined for Recovery
Operations
Halogenated organic solvents (A3150) are listed as a category of waste subject
to The Amber Control Procedure under Council Decision C (2001) 107/Final.
Page 101 of 167
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Appendix B PROCESS, RELEASE AND OCCUPATIONAL
EXPOSURE INFORMATION
This appendix provides information and data found in preliminary data gathering for perchloroethylene.
B.l Process Information
Process-related information potentially relevant to the risk evaluation may include process diagrams,
descriptions and equipment. Such information may inform potential release sources and worker
exposure activities. EPA will consider this information in combination with available monitoring data
and estimation methods and models, as appropriate, to quantify occupational exposure and releases for
the various conditions of use in the risk evaluation.
B.l.l Manufacture (Including Import)
B.l.1.1 Domestic Manufacture
Perchloroethylene was previously produced through chlorination of acetylene to tetrachloroethane, then
dehydrochlorination to trichloroethylene (TCE), followed by chlorination of TCE to pentachloroethane
and finally dehydrochlorination to perchloroethylene (Snedecor et at.. 2004). The last U.S. plant using
the acetylene process was shut down in 1978 (Snedecor et at... 2004). Currently, most perchloroethylene
is manufactured using one of three methods: chlorination of ethylene dichloride (EDC); chlorination of
hydrocarbons containing one to three carbons (CI to C3) or their partially chlorinated derivatives; or
oxychlorination of two-carbon (C2) chlorinated hydrocarbons (ATSDR. 2014; Snedecor et at.. 2004;
EPA. 1985b).
Chlorination of EDC - The chlorination of EDC involves a non-catalytic reaction of chlorine and EDC
or other C2 chlorinated hydrocarbons to form perchloroethylene and TCE as co-products and
hydrochloric acid (HC1) as a byproduct (ATSDR. 2014; Snedecor et at.. 2004; U.S. EPA. 1985b).
Following reaction, the product undergoes quenching, HC1 separation, neutralization, drying and
distillation (U.S. EPA. 1985b). This process is advantageous at facilities that have a feedstock source of
mixed C2 chlorinated hydrocarbons from other processes and an outlet for the HQ byproduct (Snedecor
et at.. 2004). FigureApx B-l illustrates a typical process diagram of the production of
perchloroethylene via EDC chlorination (U.S. EPA. 1985b).
Chlorination of C1-C3 hydrocarbons - The chlorination of C1-C3 hydrocarbons involves the reaction
of chlorine with a hydrocarbon such as methane, ethane, propane, propylene or their chlorinated
derivatives, at high temperatures (550-700°C), with or without a catalyst, to form perchloroethylene and
carbon tetrachloride (CCU) as co-products and HC1 as a byproduct (ATSDR. 2014; Snedecor et at..
2004; U.S. EPA. 1985b). This process is advantageous because mixed chlorinated hydrocarbon wastes
from other processes can be used as a feedstock (ATSDR, 2014; (Snedecor et at.. 2004)). Due to phase-
out of CFC-11 and CFC-12 and most CCU uses, most facilities using this method maximize the
production of perchloroethylene and minimize or eliminate the production of CCU (Snedecor et at..
2004). Figure Apx B-2 illustrates a typical process diagram of the production of perchloroethylene via
C1-C3 hydrocarbon chlorination (U.S. EPA. 1985b).
Oxychlorination of C2 chlorinated hydrocarbons - The oxychlorination of C2 chlorinated
hydrocarbons involves the reaction of either chlorine or HC1 and oxygen with EDC in the presence of a
catalyst to produce perchloroethylene and TCE as co-products (ATSDR. 2014; Snedecor et at... 2004).
Following reaction, the product undergoes HC1 separation, drying, distillation, neutralization with
ammonia and a final drying step (U.S. EPA. 1985b). The advantage of this process is that no byproduct
Page 102 of 167
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HC1 is produced and can be combined with other processes as a net HC1 consumer (ATSDR. 2014;
Snedecor et ai. 2004). Figure Apx B-3 illustrates a typical process diagram of the production of
perchloroethylene via oxychlorination of C2 hydrocarbons (U.S. EPA. 1985b).
In all three processes the product ratio of perchloroethylene to TCE/CCU products are controlled by
adjusting the reactant ratios (Snedecor et ai. 2004).
Page 103 of 167
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VfSTf
T RICHLQROETHY L E NE
out
PROCESS
' WATER
CHLORINE
J
(WAS1L)
DISTILLATION
COLUMN
TRICHltWOeTHTtENt/
PERCHUffiOETKYlENE
OJST!LIAlton
COLUMN
TR1CHIOROE1HYLENE
DISTILLATION
COLUWt
f E RCHtORQE Wl E NE
REACTDS
PEaCKLCHOElHYLENE
STORAGE
HEAVY
ENSS
FigureApx B-l. Process Flow Diagram for the Manufacture of Perchloroethvlene via Chlorination of EDC (EPA, 1985)
Page 104 of 167
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VENT
VENT
STABILIZER
REACTOR
CATALYST
STABILIZER
CRUDE
STORAGE
CHLOfllNOLYSIS
REACTOR
ccl4
STORAGE
PERCHLORQETHYLENE
STORAGE
HC I AND CI
REMOVAL
CO!UMN
CO,
DISTILLATION
(HEAVY i'ASTE)
PERCMLORGUHYLtilE
OISTILLAT10N
OTHER SOURCES
WASTE
JT
WATER
CAUSTIC
CARBON TETRACHLORIDE FROM
METHANOL HYOROCHLORI NAT ION
and hethylchloridc chldrina-
tion PROCESS
NE1
MCI
ABSORBER
CHLORINATED HYDROCARBON
CHLORINE
ABSORPTION
COLUMN
HU BY-PRODUCT
STORAGE
Figure Apx B-2. Process Flow Diagram for the Manufacture of Perchloroethylene via Chloriuation of Hydrocarbons (EPA, 1985)
Page 105 of 167
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WASTE
WASTE WASTE
CATAIW
<~>
CHLORlNE/HCl
ETHYLENE
D [ CHLOR]OE
k
PROCESS
WATER
HCt ABSORBER WSTE
HASTE
UISTILLATION
Ml LIMN
nEACfOR
STEW
STEUM
1R KHLOMUlTHYLtNE
STORAGt
ORIlNC
COL UHf I
J
PROCESS
WATER
OjtGEN
10 WASTE
TRCATHENT
TRICWLDRQCTHYtEftE NEUTRALIZES! DRtEH
DISTILLATION
STEAM
WASTE WASTE
WASTE
AHHOfl A
MSANIC
STORAGE
HEAVY
CtfOS
COLIMN
ORGANIC
RECYCLt
SrSTCM
PROCESS
WiTEB
HtAVt ENDS
C? CHLORINATED-
PEHEHLDSOETMYLENE
STQfLA&E
HEAVY PESCH10RQETHYLEKE
ENDS COtUtIK
COUWN WElfTRAtJ JTR
DRYER
FigureApx B-3. Process Flow Diagram for the Manufacture of Perchloroethvlene via Oxychlorination of C2 Chlorinated
Hydrocarbons (EPA, 1985)
Page 106 of 167
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B.l.1.2 Import
According to Snedecor et al. (2004). perchloroethylene may be shipped by barge, tank car, tank truck or
55-gallon steel drums. Perchloroethylene may be stored in steel tanks that are dry, free of rust and
equipped with a chemical vent dryer and controlled evaporation vent (Snedecor et al.. 2.004).
B.1.2 Processing and Distribution
Based on the reported industrial processing operations in the 2016 CDR, perchloroethylene may be
incorporated into a variety of formulations, products and articles, or used industrially as a chemical
intermediate (U.S. EPA. 2.016b). Some industrial or commercial products may also be repackaged into
appropriately-sized containers to meet specific customer demands ( »)•
B.l.2.1 Reactant or Intermediate
Processing as a reactant or intermediate is the use of perchloroethylene as a feedstock in the production
of another chemical product via a chemical reaction in which perchloroethylene is consumed to form the
product. In the past, perchloroethylene was used as feedstock (with chlorine) for the manufacture of one-
and two-carbon (CI and C2) CFCs (Smart and Fernandez. 2000). However, due to discovery that CFCs
contribute to stratospheric ozone depletion, the use of CFCs was phased-out by the year 2000 to comply
with the Montreal Protocol (Smart and Fernandez. 2000). Since the phase-out of CFCs,
perchloroethylene has been used to manufacture the CFC alternatives, HCFCs, specifically the HCFC-
123 alternative to CFC-11 (Smart and Fernandez. 2000). Perchloroethylene is also used as a feedstock in
the production of trichloroacetyl chloride (Smart and Fernandez. 2000).
HCFC-123 is produced by fluorination of perchloroethylene with liquid or gaseous hydrofluoric acid
(HF). The manufacture of HCFC is more complex than the manufacture of CFCs due to potential
byproduct formation or catalyst inactivation caused by the extra hydrogen atom in the HCFCs (Smart
and I'ciuandez. 2000). Therefore, the process involved in the manufacture of HCFCs requires additional
reaction and distillation steps as compared to the CFC manufacturing process (Smart and Fernandez.
2000).
Perchloroethylene is also used by Honeywell International Inc. in the manufacture of HFC-125 (R-125),
HCFC-124 (R-124), and CFC-113 (R-113) (Honeywell. 2017). In 2016, Honeywell used approximately
65 million pounds of perchloroethylene to manufacture R-125 and R-124 and approximately 20 million
pounds to manufacture R-1 13 (Honeywell. 2017). The majority of the R-l 13 is used as an intermediate
for manufacture of chlorotrifluoroethylene (CTFE) monomer; however, a small portion is used in
exempted applications vital to U.S. security (Honeywell. 2017). Perchloroethylene is received at the
Honeywell facilities in railcars and trucks and is transferred into storage vessels with a pump and vapor
balance (Honeywell. 2017). Some perchloroethylene is lost when disconnecting the hose; however, the
storage tank is pressurized so there are no point emissions or breathing losses (Honeywell. 2017). The
primary emission of perchloroethylene at Honeywell facilities are from fugitive emissions. The facilities
utilize a fugitive emissions monitoring program and leak detection program to reduce fugitive emissions
(Honeywell. 2017).
Honeywell representatives indicated that the R-125/R-124 processes achieve a once through
perchloroethylene conversion of 95% and the remaining 5% is recovered and recycled back into the
process (Honeywell. 2017). For the R-1 13 process, the once through conversion rate is 99% and the
remaining 1% is recovered and recycled back into the process (Honeywell 2017). The ultimate
conversion from both processes is 100%. Honeywell indicated they do not detect any perchloroethylene
in their products (Honeywell.: ).
Page 107 of 167
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Perchloroethylene is also used in catalyst regeneration at petroleum refineries (Dow Chemical Co.,
2008; Public Comment, EPA-HQ-OPPT-2016-0732-0018). Perchloroethylene is consumed in the
catalyst regeneration process; therefore, EPA considers this use as a reactant/intermediate. According to
public comments from the American Fuel and Petrochemical Manufacturers (AFPM) (Public Comment,
EPA-HQ-OPPT-2016-0732-0018), perchloroethylene is used in both the reforming and isomerization
processes at refineries. In the reforming process, perchloroethylene is added directly to a regenerator in a
Continuous Catalytic Regeneration reforming unit, and in the isomerization process, perchloroethylene
is added to the hydrocarbon feed (Public Comment, EPA-HQ-OPPT-2016-0732-0018). In both
processes, perchloroethylene provides chlorine ions to regenerate the catalysts and is consumed in the
process (Public Comment, EPA-HQ-OPPT-2016-0732-0018).
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 perchloroethylene that
may require incorporation into a formulation include adhesives, sealants, coatings, inks, lubricants and
plastic and rubber manufacturing. Perchloroethylene specific formulation processes were not identified;
however, several ESDs published by the OECD and Generic Scenarios published by EPA have been
identified that provide general process descriptions for these types of products.
The formulation of coatings and inks typically involves dispersion, milling, finishing and filling into
final packages (OB 09c; U.S. EPA. 2001b). Adhesive formulation involves mixing together
volatile and non-volatile chemical components in sealed, unsealed or heated processes (OECD. 2009a).
Sealed processes are most common for adhesive formulation because many adhesives are designed to set
or react when exposed to ambient conditions (OECD. 2009a). Lubricant formulation typically involves
the blending of two or more components, including liquid and solid additives, together in a blending
vessel (OECD. 2004a). In plastics and rubber manufacturing the formulation step usually involves the
compounding of the polymer resin with additives and other raw materials to form a masterbatch in either
open or closed blending processes ( 314b; OECD. 2009b). After compounding, the resin is
fed to an extruder where is it converted into pellets, sheets, films or pipes (U.S. EPA. 2014b).
B. 1.2.3 Incorporating into an Article
Incorporation into an article typically refers to a process in which a chemical becomes an integral
component of an article (as defined at 40 CFR 704.3) that is distributed for industrial, trade or consumer
use. The use of perchloroethylene in plastic and rubber manufacturing and the use in textile processing
(as a finishing agent) are the only uses that would incorporate perchloroethylene into an article.
Perchloroethylene may also be used in the plastics and rubber product manufacturing as a degreasing
solvent (NIOSH. 1994b). For descriptions of degreaser uses see Appendix B. 1.3.2.
Plastics and Rubber Product Manufacturing
In plastic manufacturing, the final plastic article is produced in a conversion process that forms the
compounded plastic into the finished products (\. . j j_.\. 1:0)4c; t »| ~^09b). The converting
process is different depending on whether the plastic is a thermoplastic or a thermosetting material
(OECD. 2009b). Thermoplastics converting involves the melting of the plastic material, forming it into a
new shape and then cooling it (U.S. EPA. 2014c; OECD. 2009b). The converting of thermoplastics may
involve extrusion, injection molding, blow molding, rotational molding or thermoforming (U.S. EPA.
2014c; OECD. 2009b).
Page 108 of 167
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Conversion of thermosetting materials involves using heat and pressure to promote curing, typically
through cross-linking ( 39b). The primary conversion process for thermosetting materials is
compression molding; however, fiber reinforced thermosetting plastics are converted using hand layup,
spray molding and filament winding (OECD. 2009b). After the forming process, finishing operations
such as filing, grinding, sanding, polishing, painting, bonding, coating and engraving are performed to
complete the process 0 ' ^ ^ \ 2014c).
Textile Processing
In textile processing, the purpose of the finishing stage is to impart special qualities to the textile (i.e.
article). Perchloroethylene may be used as a water and stain repellant or as a fabric protector during
textile finishing [cite market report]. Finishes may include mechanical treatments (e.g., calendaring and
napping) or chemical treatments (e.g. stiffening, softening, water and soil repellents, antimicrobials, and
fire retardants) (OECD. 2004b). The finishing process occurs after the textile is pre-treated and/or
dyed/printed (OECD. 2004b). Chemical finishes are applied from aqueous solution/dispersions using the
pad/dry/cure process (OECD. 2004b). In this process, the fabric is immersed in the aqueous finishing
solution and then squeezed between metal rolls to remove excess solution and evenly distribute the
finishing agent (OECD. 2004b). The fabric is then passed over a series of heated metal rolls for drying
and cured using an oven (OECD. 2004b).
B.l.2.4 Repackaging
Typical repackaging sites receive the chemical in bulk containers and transfer the chemical from the
bulk container into another smaller container in preparation for distribution in commerce.
B.l.2.5 Recycling
Waste perchloroethylene solvent is generated when it becomes contaminated with suspended and
dissolved solids, organics, water or other substance ( 80c). Waste solvents can be restored
to a condition that permits reuse via solvent reclamation/recycling (U.S. EPA. 1985a. 1980c). Waste
perchloroethylene is shopped to a solvent recovery site where it is piped or manually loaded into process
equipment (U.S. EPA. 1985a). The waste solvent then undergoes a 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 (l_ _> J\ \ \ "s5a, 1980c).
Figure Apx B-4 illustrates a typical perchloroethylene solvent recovery process flow diagram (
EPA. 1985a).
Page 109 of 167
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STORAGE TANK
VENT
4
WASTE SOLVENTS
STORAGE AND
INITIAL
1
HANDLING
TREATMENT
VENT i
WASTE TO
f DISPOSAL
PURIFICATION
DISTILLATION
VENT
j
L
STORAGE AND
HANDLING
RECLAIMED
SOLVENT
FigureApx B-4. Process Flow Diagram of Perchloroethylene Solvent Recovery (U.S. EPA, 1985b)
Page 110 of 167
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B.1.3 Uses
In this document, EPA has grouped uses based on CDR categories, and identified examples within these
categories as subcategories of use. Note that some subcategories of use may be grouped under multiple
CDR categories. The differences between these uses will be further investigated and defined later during
risk evaluation.
B.l.3.1 Cleaning and Furniture Care Products
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. Products
designed to clean wood floors or other substrates which contain perchloroethylene are used in industrial
or commercial settings and are primarily formulated as liquids.
Dry Cleaning Solvent and Spot Cleaner
Perchloroethylene can be used as a solvent in dry cleaning machines and is found in products used to
spot clean garments. 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 EPA's 1-Bromopropane (1-BP) Draft Risk Assessment
(U.S. EPA. 2016c). Note: The 1-BP risk assessment focuses on use at commercial dry cleaning
facilities; however, according to EPA's Economic Impact Analysis of the Final Perchloroethylene Dry
Cleaning Residual Risk Standard ( 06a). there are seven industrial dry cleaners that use
perchloroethylene. Industrial dry cleaners clean heavily stained articles such as work gloves, uniforms,
mechanics' overalls, mops and shop rags (U.S. EPA. 2006a). The general worker activities at industrial
dry cleaners are not expected to significantly differ from activities at commercial dry cleaners.
Non-Aerosol Degreasers and Cleaners
Perchloroethylene 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 ( ) 14a).The cleaning
solvent is usually applied in excess and allowed to air-dry ( 14a). Parts may be cleaned in
place or removed from the service item for more thorough cleaning (U.S. EPA. 2014a).
Aerosol Spray Degreasers and Cleaners
Aerosol degreasing is a process that uses an aerosolized solvent spray, typically applied from a
pressurized can, to remove residual contaminants from fabricated parts. Products containing
perchloroethylene 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 (l_ _S .LlA, .-L0i:J£)- 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.
B.l.3.2 Solvents for Cleaning and Degreasing
EPA has gathered information on different types of cleaning and degreasing systems from recent TCE
risk assessment (U.S. EPA. 2014e) and risk management activities (FR 81(242): 91592-91624.
December 16, 2016, and FR 82(12): 7432-7461. January 19, 2017) and 1-BP risk assessment (U.S. EPA.
2016c) activities. Provided below are descriptions of five cleaning and degreasing uses of
perchl oroethy 1 ene.
Page 111 of 167
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Vapor Degreasers
Vapor degreasing is a process used to remove dirt, grease and surface contaminants in a variety of metal
cleaning industries. Vapor degreasing may take place in batches or as part of an in-line (i.e., continuous)
system. Vapor degreasing equipment can generally be categorized into one of three degreaser types
described below:
Batch vapor degreasers: In batch machines, each load (parts or baskets of parts) is loaded into the
machine after the previous load is completed. Individual organizations, regulations and academic studies
have classified batch vapor degreasers differently. For the purposes of the scope document, EPA
categories the batch vapor degreasers into five types: open top vapor degreasers (OTVDs); OTVDs with
enclosures; closed-loop degreasing systems (airtight); airless degreasing systems (vacuum drying); and
airless vacuum-to-vacuum degreasing systems.
• 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 (NEWMOA 2001). Figure Apx B-5 illustrates a standard OTVD.
Condensing Coils
.Water Jacket
Vapor Zone
rater Separator
O
Boiling sump
Heat Source
FigureApx B-5. Open Top Vapor Degreaser
Page 112 of 167
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• 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 (U.S. EPA; ICF Consulting. 2004; U.S. EPA).
FigureApx B-6 illustrates an OTVD with an enclosure. The dotted lines in FigureApx B-6
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
2:
]
Wate
1/W,
Condensing Coils
Jacket
er Separator
Figure Apx B-6. 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
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). Figure Apx B-7 illustrates a standard
closed-loop vapor degreasing system.
Page 113 of 167
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Vent
Solvent Abatement Loop
Refrigeration
Distillation
Solvent Sump
Electric Heat
Solvent Tank(s)
Working Chamber
Workload
FigureApx B-7. 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 (Kanegsberg and Kanegsberg. 2011; NEWMOA 2001; U.S. EPA
2001a).
• 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.
Conveyorized vapor degreasers: In conveyorized systems, an automated parts handling system,
typically a conveyor, continuously loads parts into and through the vapor degreasing equipment and the
subsequent drying steps. Conveyorized degreasing systems are usually fully enclosed except for the
conveyor inlet and outlet portals. Conveyorized degreasers are likely used in shops where there are a
large number of parts being cleaned. There are seven major types of conveyorized degreasers: monorail
degreasers; cross-rod degreasers; vibra degreasers; ferris wheel degreasers; belt degreasers; strip
degreasers; and circuit board degreasers (U.S. EPA 1977).
Page 114 of 167
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• Monorail Degreasers - Monorail degreasing systems are typically used when parts are already
being transported throughout the manufacturing areas by a conveyor (J.S. EPA. 1976). 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. 1976). Figure_Apx B-8 illustrates atypical monorail degreaser (J.S. EPA.
1976).
Monora i1
Conveyop^ —
BoiTTTig-
Chamber
Water
Jacket
FigureApx B-8. Monorail Convevorized Vapor Degreasing System (EPA, 1977a)
• 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. 1976).
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-9 illustrates atypical cross-rod
degreaser (U.S. EPA. 1976).
Page 115 of 167
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Conveyor Path
Chain Support
Water
Jacket
Boiling Chamber
FigureApx B-9. Cross-Rod Conveyorized Vapor Degreasing System (EPA, 1977a)
• 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 1976). Figure_Apx B-
10 illustrates a typical vibra degreaser ( J.S. EPA. 1976).
Workload Discharger Chute
Ascending
Vibrating
Trough —
Condensers
Distillate
Trough
Workload
Entry Chute
Distillate Return
For Counter-
flow Wash
Steam Coils
Figure Apx B-10, Vibra Conveyorized Vapor Degreasing System (U.S. EPA, 1977)
Page 116 of 167
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• Ferris wheel degreasers - Ferris wheel degreasing systems are generally the smallest of all the
conveyorized degreasers (J.S. EPA. 1976). In these systems, parts are manually loaded into
perforated baskets or cylinders and then rotated vertically through the cleaning zone and back
out. Figure_Apx B-l 1 illustrates a typical fems wheel degreaser ( J.S. EPA. 1976).
tumble
FigureApx B-ll. Ferris Wheel Conveyorized Vapor Degreasing System (EPA, 1977a)
• 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. 1976). Parts are
loaded onto a mesh conveyor belt that transports them through the cleaning zone and out the
other side. Figure_Apx B-12 illustrates a typical belt or strip degreaser ( J.S. EPA. 1976).
Conveyor.
Path
Boiling
Chamber
Figure Apx B-12. Belt/Strip Conveyorized Vapor Degreasing System (U.S. EPA, 1977)
Page 117 of 167
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-12
illustrates a typical belt or strip degreaser (U.S. EPA. 1976).
• 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. 1976).
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. 2006b). The parts are
then recoiled or cut after exiting the cleaning machine (Kanegsberg and Kanegsberg. 2011; U.S. EPA.
2006b). Figure Apx B-13 illustrates a typical continuous web cleaning machine.
Figure Apx B-13. Continuous Web Vapor Degreasing System
Cold Cleaners
Perchloroethylene 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. In a
typical batch-loaded, maintenance cold cleaner, dirty parts are cleaned manually by spraying and then
soaking in the tank. After cleaning, the parts are either suspended over the tank to drain or are placed on
an external rack that routes the drained solvent back into the cleaner. Batch manufacturing cold cleaners
could vary widely, but have two basic equipment designs: the simple spray sink and the dip tank. The
dip tank design typically provides better cleaning through immersion, and often involves an immersion
tank equipped with agitation (U.S. EPA. 1981). Emissions from batch cold cleaning machines typically
result from (1) evaporation of the solvent from the solvent-to-air interface, (2) "carry out" of excess
solvent on cleaned parts and (3) evaporative losses of the solvent during filling and draining of the
machine (U.S. EPA. 2006b).
Page 118 of 167
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Non-Aerosol Degreasers and Cleaners
Perchloroethylene 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 ( j). The cleaning
solvent is usually applied in excess and allowed to air-dry ( 14a). Parts may be cleaned in
place or removed from the service item for more thorough cleaning (U.S. EPA. 2.014a).
Aerosol Spray Degreasers and Cleaners
Aerosol degreasing is a process that uses an aerosolized solvent spray, typically applied from a
pressurized can, to remove residual contaminants from fabricated parts. Products containing
perchloroethylene 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 016c). 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.
B.l.3.3 Lubricant and Greases
In the 2016 CDR (U.S. EPA. 2016b). two companies reported commercial use of perchloroethylene in
lubricants and greases. The Preliminary Information on Manufacturing, Processing, Distribution, Use,
and Disposal: Tetrachloroethylene (Perchloroethylene) [EPA-HQ-OPPT-2Q16-0732-0003 1 identified
perchloroethylene in penetrating lubricants, cutting oils, aerosol lubricants, red greases, white lithium
greases, silicone lubricants and greases and chain and cable lubricants. Most of the products identified
by EPA are applied by either aerosol or non-aerosol spray applications.
B.l.3.4 Adhesives and Sealants
Based on products identified in Preliminary Information on Manufacturing, Processing, Distribution,
Use, and Disposal: Tetrachloroethylene (Perchloroethylene) \ s S\Q-OPPT-2
-------
B.l.3.5 Paints and Coatings
Based on products identified in Preliminary Information on Manufacturing, Processing, Distribution,
Use, and Disposal: Tetrachloroethylene (Perchloroethylene) (TP \ i iO-OPP TOO lo-0"32-QQ03) 1 and
2016 CDR reporting (U.S. EPA. 2016b). perchloroethylene may be used in various paints and coatings
for industrial, commercial and consumer applications. 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. 2009c). After application, solvent-based coatings typically undergo a drying
stage in which the solvent evaporates from the coating (OECD. 2009c).
B.l.3.6 Processing Aid for Pesticide, Fertilizer and Other Agricultural
Manufacturing
In the 2016 CDR J J'. ). two sites owned by Olin Corporation reported use of
perchloroethylene as a "processing aid, not otherwise listed" for use in the "pesticide, fertilizer, and
other agricultural chemical manufacturing" industry.
B.l.3.7 Processing Aid, Specific to Petroleum Production
In the 2016 CDR ; h), two sites owned by Olin Corporation reported use of
perchloroethylene as a "processing aid, specific to petroleum production" for use in the "Petrochemical
Manufacturing" industry. A Dow Product Safety Assessment (Dow Chemical Co. 2.008) for
perchloroethylene describes a use at oil refineries for catalyst regeneration. However, a public comment
from AFPM (Public Comment, EPA-HQ-OPPT-2016-0732-0018) indicates that perchloroethylene is
consumed in the catalyst regeneration process and therefore would be considered an "intermediate" (see
Appendix B. 1.2.1 for description). It is unclear if this CDR reporting code is related to the use in catalyst
regeneration or another processing aid use.
B.l.3.8 Other Uses
Other Industrial Uses
Based on products identified in Preliminary Information on Manufacturing, Processing, Distribution,
Use, and Disposal: Tetrachloroethylene (Perchloroethylene) (^ V \ Q-0 PP I 32-0003) , a
variety of other industrial uses may exist for perchloroethylene, including textile processing, laboratory
applications, foundry applications and wood furniture manufacturing. It is unclear at this time the total
volume of perchloroethylene used in any of these applications. More information on these uses will be
gathered through expanded literature searches in subsequent phases of the risk evaluation process.
Other Commercial/Consumer Uses
Based on products identified in EPA's Preliminary Information on Manufacturing, Processing,
Distribution, Use, and Disposal: Tetrachloroethylene (Perchloroethylene) (EP A-HQ-OPPT-2016-0732-
0003) , a variety of other commercial and consumer uses may exist for perchloroethylene including
carpet cleaning; laboratory applications; metal and stone polishes; inks and ink removal products;
welding applications; photographic film applications; mold cleaning, release and protectant products.
Similar to the "Other" industrial uses, more information on these uses will be gathered through
expanded literature searches in subsequent phases of the risk evaluation process.
B.1.4 Disposal
Perchloroethylene is listed as a hazardous waste under RCRA and federal regulations prevent land
disposal of various chlorinated solvents that may contain perchloroethylene (ATSDR. 2014).
Page 120 of 167
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Perchloroethylene may be disposed of by absorption in vermiculite, dry sand, earth or other similar
material and then buried in a secured sanitary landfill or incineration (H.SDB. 2012). In incineration,
complete combustion is necessary to prevent phosgene formation and acid scrubbers must be used to
remove any haloacids produced ("ATSDR. 2014). Perchloroethylene may also be discharged to
waterways if proper permits are held (ATSDR. 2014).
B.2 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 personal monitoring OSHA CEHD data by NAICS code (OSH )
and Table Apx B-2 summarizes NIOSH HHE data.
Page 121 of 167
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TableApx B-l. Summary of Perchloroethylene Personal Monitoring Air Samples Obtained from OSHA Inspections Conducted
Between 2011 and 2016
X-lir T\\ A (onceiilriilioii (ppm)-'
STKI.. Peak. or Ceiling ( oiicenlralion (ppm)
Release/r.xposure
Scenario
NAICS
Y\l( S Description
Nil ill her
of Diilii
Points
Minim
mil
M ;i\i ill
mil
A\e
ra»e
Number
of Zero
Values1'
N u in her
ol' Diilii
Points
Minim
mil
Maxim
mil
A\e
ra»e
\ ii ill her
of Zero
Values1'
Unknown, company
inspected is an
excavation contractor,
possibly from contact
with soil contaminated
236220
Commercial and
Institutional Building
Construction
2
0
0
0
2
2
0
0
0
2
with perchloroethylene
Unknown, likely
impurity in refrigerant
238220
Plumbing, Heating, and
Air-Conditioning
Contractors
1
5.2
0
No Data Available
Textile pre-treatment or
313310
Textile and Fabric
1
0
1
1
0
1
textile finishing
Finishing Mills
Textile and Fabric
Textile pre-treatment or
textile finishing
313312
Finishing (except
Broadwoven Fabric)
Mills0
1
0
1
1
0
1
Other uses (ink and ink
removal products), wipe
cleaning, or aerosol
degreasing
323113
Commercial Screen
Printing
1
0
1
1
0
1
Plastics converting
(possibly as a
degreaser/cleaner, mold
release agent, or
paint/coating)
326199
All Other Plastics
Product Manufacturing
2
0.2
0.3
0.2
0
1
0.9
0
Vapor degreasing or
cold cleaning
331512
Steel Investment
Foundries
3
0.02
0.03
0.02
0
No Data Available
Vapor degreasing or
cold cleaning
332439
Other Metal Container
Manufacturing
2
0.03
0.03
0.03
0
No Data Available
Vapor degreasing or
cold cleaning
332991
Ball and Roller Bearing
Manufacturing
3
0
0
0
3
3
0
0
0
3
Vapor degreasing or
cold cleaning
332996
Fabricated Pipe and
Pipe Fitting
Manufacturing
3
0
0
0
3
3
0
0
0
3
Page 122 of 167
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Release/r.xposure
Scenario
NAICS
NAICS Description
X-hr TW A Concenlriilion (|)|)in)'
S rill.. Pi-ilk. or Ceiling Concenlriilion (ppm)
N u in her
of Diilii
Points
Minim
mil
M ;i\i ill
mil
A\e
ra»e
Number
of Zero
Values1'
Nu in her
of Diilii
Points
Minim
urn
Maxim
urn
A\e
raiic
N urn her
of Zero
Values1'
Vapor degreasing or
cold cleaning
334511
Search, Detection,
Navigation, Guidance,
Aeronautical, and
Nautical System and
Instrument
Manufacturing
1
0.3
0
1
0.3
0
Vapor degreasing or
cold cleaning
335999
All Other
Miscellaneous
Electrical Equipment
and Component
Manufacturing
1
2.1
0
1
19
0
Unknown, likely
impurity in refrigerant
445110
Supermarkets and Other
Grocery (except
Convenience) Stores
2
0
0
0
2
2
0
0
0
2
Industrial and
commercial dry
cleaning
448110
Men's Clothing Stores
1
7.8
0
1
8.6
0
Commercial auto
repair/servicing
485410
School and Employee
Bus Transportation
1
63
0
1
100
0
Commercial auto
repair/servicing
811198
All Other Automotive
Repair and Maintenance
1
110
0
1
120
0
Industrial and
commercial dry
cleaning
812310
Coin-Operated
Laundries and
Drycleaners
1
2.3
0
1
9.1
0
Industrial and
commercial dry
cleaning
812320
Drycleaning and
Laundry Services
(except Coin-Operated)
30
0.1
390
27.8
0
22
0.5
480
55.4
0
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
6
0
7.2
1.4
3
6
0
7.2
1.6
3
Vapor degreasing, cold
cleaning, aerosol
degreasing, wipe
cleaning or other uses
(laboratory chemical)
927110
Space Research and
Technology
1
0
1
1
0
1
a Assumes all TWA data are 8-hr TWA.
b For facilities where all samples are measured as zero, it is unclear if perchloroethylene is present at the facility. For facilities where the samples are zero and other samples are greater than
zero, the zero values likely represent non-detects.
c This is a 2007 NAICS code, the corresponding 2012 and 2017 NAICS code is 313310 for "Textile and Fabric Finishing Mills."
Note: The data set also includes samples for a facility classified using the 2012/2017 NAICS code as a separate line item. All data for both NAICS codes were zero values.
Page 123 of 167
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TableApx B-2. Summary of Monitoring Data from NIOSH Health Hazard Evaluations
Conducted since 1990
l);il;i
Source
Report
Number
l'l\|)OMirc/Kclciisc
Scciiiirio
l-'2,000 ppm.
NIOSH,
2008
HETA
07-0055-
3073
Commercial auto
repair/ servicing
School bus
maintenance
shop
0
No exposure data
provided.
SID - Non-detect
Page 124 of 167
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B.3 References related to Risk Evaluation - Environmental Release and Occupational Exposure
Table Apx B-3. Potentially Relevant Data Sources for Process Description Relatet
Information for Perchloroethylene3
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3)
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White and
Schwartz
il
Burr, G. A.,Todd, W. (1986). Health hazard evaluation report no. HETA 86-005-1679, Dutch Girl Cleaners, Springdale, Ohio
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Burr and
Todd (.1.986)
Moseley, C. L. (1980). Health hazard evaluation report no. HHE 79-42-685, Motion Picture Screen Cartoonists, Local 841, New York,
New York journal#, #volume#(#issue#), #Pages#
Moselev
Burotn, N. C. (1994). Health hazard evaluation report no. HETA 93-0351-2413, Goodwill Industires of America, Inc. Bethesda,
Maryland journal#, #volume#(#issue#), #Pages#
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other chlorinated agents journal#, 106(#issue#), #Pages#
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(20.1.4a)
Niosh, (1995). In-depth survey report: Control of perchloroethylene exposure in commercial dry cleaners at Appearance Plus Cleaners
journal#, #volume#(#issue#), #Pages#
NIOSH.
(.1.995)
Niosh, (2002). In-depth survey report: Control of perchloroethylene (perchloroethylene) in vapor degreasing operations, site #2
journal#, #volume#(#issue#), #Pages#
NIOSH.
(2002)
Niosh, (1993). Walk-through survey report: Perchloroethylene exposures in commercial dry cleaners at Widmer's Dry Cleaning
journal#, #volume#(#issue#), #Pages#
NIOSH.
Niosh, (1989). Health hazard evaluation report no. HETA-88-082-1971, Jostens Incorporated, Princeton, Illinois #journal#,
#volume#(#issue#), #Pages#
Seitz and
Driscoll
Niosh, (1990). Health hazard evaluation report no. HETA-90-172-2076, Bussmann/Cooper Industries, Elizabethtown, Kentucky
journal#, #volume#(#issue#), #Pages#
Sussell and
Lushniak
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Osha, (2017). Guidance and information for: Reducing worker exposure to perchloroethylene (perc) in dry cleaning #journal#,
#volume#(#issue#), #Pages#
OSHA
(20.1.7b)
Osha, (2004). Guidance and information for: Reducing worker exposure to perchloroethylene (perc) in dry cleaning #journal#,
#volume#(#issue#), #Pages#
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Atsdr, (2011). Case studies in environmental medicine: tetrachloroethylene toxicity journal#, #volume#(#issue#), #Pages#
ATSDR
i
Hsia, (2010). Freasibility advisory committee - Trichloroethylene #journal#, #volume#(#issue#), #Pages#
HSIA (2010)
TableApx B-6. Potentially Relevant Data Sources for Engineering Controls and Personal Protective Equipment Information for
Perchloroethylene6
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_
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Todd(1986)
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New York journal#, #volume#(#issue#), #Pages#
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41
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Niosh, (2002). In-depth survey report: Control of perchloroethylene (perchloroethylene) in vapor degreasing operations, site #2
journal#, #volume#(#issue#), #Pages#
NIOSH
(2002)
Niosh, (1993). Walk-through survey report: Perchloroethylene exposures in commercial dry cleaners at Widmer's Dry Cleaning
journal#, #volume#(#issue#), #Pages#
NIOSH
Niosh, (1989). Health hazard evaluation report no. HETA-88-082-1971, Jostens Incorporated, Princeton, Illinois #journal#,
#volume#(#issue#), #Pages#
Seitz and
Driscoll
?
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journal#, #volume#(#issue#), #Pages#
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[
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Page 142 of 167
-------
Appendix C SUPPORTING TABLE FOR INDUSTRIAL AND COMMERCIAL ACTIVITIES
AND USES CONCEPTUAL MODEL
Table Apx C-l. Industrial
and Commercial Activities and Uses Conceptual
Model Supporting Tab
e
l.il'c Cu'le
Sliiiic
CsiU'Sion
Siihciilciion
Kck'iisc /
|-l\|)OMMV
Sccnsirio
l''.\|)OMir
e
P;i I liw
l'l\|)OMIIV
Roulc
Km'plor/
I'opn hit ion
Proposed
for
lurllur
Risk
l'\ion
Killioiiiilc for I'lirlhcr l-'\:iln;ilion / no
I iii Iliei- l-l\iilii;ilion
Contact time with skin is expected to be
Manufacture
of
perchloroethyl
ene via
Liquid
Contact
Dermal
Workers
Yes
<10 min due to volatilization. Number of
exposed workers may be high per CDR (2
submissions reported 100-500 workers
each).
chlorination of
perchloroethylene is semi-volatile (VP =
ethylene
dichloride,
Vapor
Inhalation
Workers
Yes
18.5 mmHg) at room temperature,
inhalation pathway should be further
Manufacture
Domestic
Domestic
chlorination of
analyzed.
Manufacture
Manufacture
C1-C3
Liquid
( ouiacl
Dermal exposure is expected In he
hydrocarbons,
oxychlorinatio
Dermal
()\l
\n
primariK in workers direelK uiuil\ediu
workiuu u nh ilie chemical
nof C2
perchloroethylene is semi-volatile (VP =
chlorinated
hydrocarbons,
and as a
Vapor
Inhalation
ONU
Yes
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
byproduct
\lls|
Dermal
Inhalation
Workers.
()\l
\n
Misi izeueralion nni e\pecled diuiiiu
maiiiiracluriuu.
Contact time with skin is expected to be
Liquid
Contact
Dermal
Workers
Yes
<10 min due to volatilization. Exposure
will only occur in the event the imported
material is repackaged.
Manufacture
Import
Import
Repackaging
of import
containers
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
( ouiacl
Dermal e\posuie is e\peeled In he
Dermal
<>\l
\o
primariK in wnrkeiN dueells ui\ol\ediu
wnrkiiiu u illi llie chemical
Page 143 of 167
-------
l.il'c Cu'le
Sliiiic
CsiU'Sion
Suhciilciion
Kck'iisc /
|-l\|)OMMV
SiTiisirio
l''.\|)OMir
e
P;i 1 liw
l'l\|)OMIIV
Roulc
Km'plor/
I'opn hit ion
Proposed
for
l-'n rllior
Risk
l'\ion
Killioiiiilc for I'lirllior l-'\:iln;ilion / no
I iii Iliei- l-l\iilii;ilion
Vapor
Inhalation
ONU
Yes
Exposure expected only in the event the
imported material is repackaged into
different sized containers. Exposure
frequency mav be low
\lls|
Dermal
Inhalation
Workers.
()\l
\o
Misi ueuerciliou uoi e\peeled durum
import
Intermediate in
industrial gas
manufacturing;
all other basic
inorganic
chemical
manufacturing;
all other basic
organic
chemical
manufacturing;
and petroleum
refining
Liquid
Contact
Dermal
Workers
Yes
Coiiiael lime w ilh skin is expected lo be
<10 min due to volatilization. However,
the number of workers may be high per
CDR (1 submission reporting 10-25
workers, 2 submissions reporting 100-500
workers, and 5 submissions reporting
NKRA).
Processing
Processing as
a reactant
Manufacture
of HCFCs,
HFCs, CFCs,
trichloroacetyl
chloride, HC1,
muriatic acid,
and refinery
reformer and
isomerization
catalyst
regeneration
Vapor
Inhalation
Workers
Yes
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed. However, potential for
exposure may be low in scenarios where
perchloroethylene is consumed as a
chemical intermediate.
Liquid
( ouiael
Dermal
()\l
\o
Dermal exposure is e\peeled lo he
primarily lo workeis direelk ui\ol\ediu
workiim u ilh ilie chemical
Vapor
Inhalation
ONU
Yes
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed. However, potential for
exposure may be low in scenarios where
perchloroethylene is consumed as a
chemical intermediate.
\1lsl
Dermal
InhalalKiii
Workers.
<>\l
No
Misi ueiieraliou uoi e\peeled durum
proeessiim as au iiiieruiediale
Page 144 of 167
-------
l.il'c Cu'le
Sliiiic
CsiU'Sion
Siihciilciion
Kck'iisc /
|-l\|)OMMV
SiTiisirio
l'.\|)()siir
e
Piilhwin
l'l\|)OMIIV
Roulc
Km'plor/
I'opn hit ion
Proposed
for
l-'n rllior
Risk
l'\ion
Killioiiiilc for I'lirllior l-'\:iln;ilion / no
I iii Iliei- l-l\iilii;ilion
Contact time with skin is expected to be
<10 min due to volatilization. However,
the number of workers may be high per
Liquid
Contact
Dermal
Workers
Yes
CDR (1 submission reporting <10
workers, 1 submission reporting 10-25
workers, 1 submission reporting 25-50
workers, 2 submissions reporting 50-100
workers, 2 submissions reporting 100-500
workers, and 3 submissions reporting
Solvent for
NKRA).
Incorporated
into
formulation,
mixture or
reaction
product
cleaning or
degreasing;
adhesive and
sealant
Formulation of
aerosol and
non-aerosol
products
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected at
processing sites that formulate products
containing perchloroethylene.
perchloroethylene is semi-volatile (VP =
Processing
chemicals; paint
and coating
products; and
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
other chemical
Liquid
( nulacl
Dermal e\pnsui"e is e\peeled in he
products and
Dermal
<>\l
No
pi'iniariK in workeis direelK ui\ ol\ ed mi
preparations
wiirkiiiu u nh ilie chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected at
processing sites that formulate products
containing perchloroethylene.
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
\1ls|
Dermal
Inhalation
Workers.
()\l
No
Misi ueueialinu nni e\peeled durum
pi'iieessiuu fiiniiiilaliiiii operalions
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be
<10 min due to volatilization.
Processing
Incorporated
into articles
Plastics and
rubber products
manufacturing;
and textile
processing
Plastics
converting;
and textile
finishing
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected at
processing sites that incorporate
perchloroethylene into articles,
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Page 145 of 167
-------
l.il'c Cu'le
Sliiiic
CsiU'Sion
Siihciilciion
Kck'iisc /
|-l\|)OMMV
Sccnsirio
l'.\|)()siir
e
Piilhwin
l'l\|)OMIIV
Roulc
Km'plor/
I'opn hit ion
Proposed
for
l-'n rllior
Risk
l'\ion
Kill ioiiiilc fo r furl her l-'\:iln;il ion / no
I iii Iliei- l-l\iilii;ilion
Liquid
( ouiael
Dermal e\pnsure is c\pecled in he
Dermal
()\l
\o
priniariK lo workeis direell\ ui\ol\ediu
workum w nil ilie chemical
Inhalation exposure is expected at
Vapor
Inhalation
ONU
Yes
processing sites that incorporate
perchloroethylene into articles,
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
\1ls|
Dermal
Inhalation
Workers.
()\l
No
Misi ueiieraliou uoi e\peeled durum
proeessiim operal ions
Liquid
Contact
Conlael lime w illi skin is expected lo he
Dermal
Workers
Yes
<10 min due to volatilization. Exposure
frequency may be low.
Solvent for
Repackaging
Vapor
Iiihalaliou
Workers
Yes
Exposure freqiieues uia\ below
Processing
Repackaging
cleaning or
degreasing; and
intermediate
into large and
small
containers
Liquid
( ouiael
Dermal
<>\l
\o
Dermal exposure is expected lo he
priniariK lo workers direell\ ui\ol\cdiu
workum w illi ilic ehemieal
\ apor
Inhalation
()\l
Yes
Lxposure 1 requeues uia\ he low
\1ls|
Dermal
Inhalation
Workers.
()\l
No
Misi ucueraliou uoi e\peeled durum
repaekauiuu
Contact time with skin is expected to be
<10 min due to volatilization. EPA
Recycling of
process
Liquid
Contact
Dermal
Workers
Yes
expects significant volume of
perchloroethylene to be sent to off-site
recycling (-67% of reported
releases/transfers in TRI were reported as
transfers to off-site recycling).
Processing
Recycling
Recycling
solvents
containing
perchloroethyl
ene
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected at
recycling sites, perchloroethylene is semi-
volatile (VP =18.5 mmHg) at room
temperature, inhalation pathway should
be further analyzed. EPA expects
significant volume of perchloroethylene
to be sent to off-site recycling (-67% of
reported releases/transfers in TRI were
reported as transfers to off-site recycling).
Page 146 of 167
-------
l.il'c Cu'le
Sliiiic
CsiU'Sion
Suhciilciion
Kck'iisc /
|-l\|)OMMV
Sccnsirio
l''.\|)OMir
e
P;i 1 liw
l'l\|)OSIIIV
Knuli*
Km'plor/
Population
Proposed
for
l-'urlhor
Risk
l'\ion
Rationale fo r I'ii rl her l'\;i In ;i I ion / no
I nrlher K\alna(ion
Liquid
( ouiael
Dermal
()\l
\o
Dermal e\pnsure is e\peeled in he
priuiariK lo workeis direelh ui\ol\ediu
uorkum u nil ilie eliemieal
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected at
recycling sites, perchloroethylene is semi-
volatile (VP =18.5 mmHg) at room
temperature, inhalation pathway should
be further analyzed. EPA expects
significant volume of perchloroethylene
to be sent to off-site recycling (-67% of
reported releases/transfers in TRI were
reported as transfers to off-site recycling1)
\1lsl
Dermal
luhalalioii
Workers.
()\l
No
Misi ueueraliou uoi e\peeled durum
reeselum
Distribution
in commerce
Distribution
Distribution
Distribution of
bulk shipment
of
perchloroethyl
ene; and
distribution of
formulated
products
Liquid
(ouiael.
\ apor
Dermal
Inhalation
Workers.
()\l
\o
1 Aposure u ill oul\ occur in ilie e\ eul of
spills
Page 147 of 167
-------
l.il'c Cu'le
Sliiiic
CsiU'Sion
Siihciilciion
Kck'iisc /
|-l\|)OMMV
SiTiisirio
l''.\|)OMir
e
Piilhwin
l'l\|)OMIIV
Roulc
Km'plor/
I'opn hit ion
Proposed
for
l-'n rllior
Risk
l'\ion
Killioiiiilc for I'lirllior l-'\:iln;ilion / no
I iii Iliei- l-l\iilii;ilion
Industrial 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 dr\ mu
degreasing
system
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be
<10 min due to volatilization. However,
repeat contact or dermal immersion may
occur, especially while cleaning and
maintaining degreasing equipment.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected for vapor
degreasing activities, perchloroethylene is
semi-volatile (VP =18.5 mmHg) at room
temperature, inhalation pathway should
be further analyzed.
Liquid
( oniacl
Dermal
()\l
\n
Domini e\posure is e\pecled In he
pmunriK lo workers direclk uiuil\ediu
workum w uli ilic chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected for vapor
degreasing activities, perchloroethylene is
semi-volatile (VP =18.5 mmHg) at room
temperature, inhalation pathway should
be further analyzed.
\1lS|
Dermal
Inhalation
Workers.
<>\l
\n
\lisi ueiieraliou uni e\pecled durum
deurensiuu nperalinus
Industrial use
Solvents (for
cleaning or
degreasing)
Cold cleaner
Cold cleaning
- maintenance
(manual spray;
spray sink; dip
tank)
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be
<10 min due to volatilization. However,
repeat contact or dermal immersion may
occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected for cold
cleaning activities, perchloroethylene is
semi-volatile (VP =18.5 mmHg) at room
temperature, inhalation pathway should
be further analyzed.
Page 148 of 167
-------
l.il'c Cu'le
Sliiiic
CsiU'Sion
Siihciilciion
Kck'iisc /
|-l\|)OMMV
SiTiisirio
l'l\|)OSIII'
e
P;i 1 liw
l'l\|)OMIIV
Roulc
Km'plor/
I'opn hit ion
Proposed
for
lurllur
Risk
l'\ion
Killioiiiilc for I'lirllior l-'\:iln;ilion / no
I iii Iliei- l-l\iilii;ilion
Liquid
( ouiacl
Dermal
()\l
\n
Dermal e\posurc is e\pecled u» he
piiuiariK lo workeis direelK ui\ ol\ ed in
workiuu w nil ilie chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected for cold
cleaning activities, perchloroethylene is
semi-volatile (VP =18.5 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.
Industrial use
Processing
aids
Pesticide,
fertilizer and
other
agricultural
chemical
manufacturing;
and
petrochemical
manufacturing
Industrial
processing aid
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be
<10 min due to volatilization.
Additionally, EPA will need additional
information to fully understand the use of
perchloroethylene in this scenario to
determine potential for dermal exposure.
Vapor
Inhalation
Workers
Yes
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed. However, EPA will need
additional information to fully understand
the use of perchloroethylene in this
scenario to determine potential for
inhalation exposure.
Liquid
( ouiacl
Dermal
<>\l
\n
Dermal exposure is expected In he
primarily in workers direelK iuuil\ediu
workiuu u uh ilic chemical
Vapor
Inhalation
ONU
Yes
peivliloroellislene is senii-\olalile (VP
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed. However, EPA will need
additional information to fully understand
the use of perchloroethylene in this
scenario to determine potential for
inhalation exposure.
\lls|
Dermal
Inhalation
Workers.
()\l
\o
Misi ueiieralkiu uoi e\peeled durum use
of iiidiisinal pi'oeessiuu aid
Page 149 of 167
-------
l.il'c Cu'le
Sliiiic
CsiU'Sion
Siihciilciion
Kck'iisc /
|-l\|)OMMV
SiTiisirio
l''.\|)OMir
e
P;ilh\\;n
l'l\|)OMIIV
Roulc
Km'plor/
Population
Proposed
for
lurllur
Risk
l'\ion
Kiilioiiiik* for I'iirlIht l-'\:iln;ilion / no
l-'urllK-r l-l\iiliiiilion
Industrial use
Other uses
Textile
processing;
wood furniture
manufacturing;
laboratory
chemicals; and
foundry
applications
See Table XX
for specific
scenario
corresponding
to the
condition of
use.
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be
<10 min due to volatilization. However,
repeat contact may occur for some
miscellaneous conditions of use.
Vapor
Inhalation
Workers
Yes
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Liquid
( onincl
Dermal
<>\l
\o
Domini e\posure is e\pecled In he
primnriK lo uorkei's dueclK iuuil\ed in
\uirkinu w uli ilie chemical
Vapor
Inhalation
ONU
Yes
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
EPA will further analyze to determine if
mist generation is applicable to specific
conditions of use in this scenario.
Industrial /
commercial /
consumer use
Solvents (for
cleaning or
degreasing)
Aerosol spray
degreaser/
cleaner
Aerosol use in
degreasing/
cleaning
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be
<10 min due to volatilization. However,
repeat contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected for
aerosol degreasing activities,
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Liquid
( onincl
Dermal
()\l
\o
Dermal e\pnsuie is e\pecled In he
primariK lo woikeis direclK uiuil\ediu
\uirkuiu u uli ilie chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected for
aerosol degreasing activities,
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analylzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
Mist generation expected for aerosol
applications.
Page 150 of 167
-------
l.il'c Cu'le
Sliiiic
CsiU'Sion
Siihciilciion
Kck'iisc /
|-l\|)OMMV
SiTiisirio
l''.\|)OMir
e
P;i 1 liw
l'l\|)OSIIIV
Roulc
Rm-plor /
I'opn hit ion
Proposed
for
lurllur
Risk
l'\ion
Kiilioiiiik* lor furl her l-'\:iln;il ion / no
l-'urllK-r l-l\iiliiiilion
Industrial /
commercial /
consumer use
Solvents (for
cleaning or
degreasing);
and cleaning
and furniture
care products
Dry cleaning
solvent; and
spot cleaner
Industrial and
commercial
dry cleaning
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be
<10 min due to volatilization. However,
repeat contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected for dry
cleaning activities, perchloroethylene is
semi-volatile (VP =18.5 mmHg) at room
temperature, inhalation pathway should
be further analyzed.
Liquid
( oniael
Dermal
()\l
\o
Dermal exposure is e\peeled lo he
primarily lo workers direelk ui\ol\ediu
workum w uli ilie eliemieal
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected for dry
cleaning activities, perchloroethylene is
semi-volatile (VP =18.5 mmHg) at room
temperature, inhalation pathway should
be further analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
Mist generation expected for spot
cleaning.
Indoor
\apor
Dermal
( o-loealed
population
\o
1 \posure \ ia dermal and oral routes ma>
he uulikeK
Indoor
\apor
Oral
( o-loealed
populalioii
\o
1 Aposure \ ia dermal and oral routes ma>
he milikelv
Indoor
\apor
liihalaliou
( o-loealed
populalioii
\o
1 !l* \ e\peels persons h\ mu in residences
eo-loealed w illi dr\ cleaners in he
e\posed lo \apor l!\piisure will iieeur
primarils \ ia llie liihalaliou rouie
llo\\e\er. 11 le \ 1!S11 \l' lor llie use of
pereliloroellis leue in l)r\ Cleaners
required llie pliase-oul of
pereliloroellis leue in eo-loealed huildiims
In :o:o
Page 151 of 167
-------
l.il'c Cu'le
Sliiiic
CsiU'Sion
Siihciilciion
Kck'iisc /
|-l\|)OMMV
SiTiisirio
l''.\|)OMir
e
Piilhwin
l'l\|)OMIIV
Knuli*
Km'plor/
Population
Proposed
for
l-'n rllior
Risk
l'\ion
Kiilioiiiik* for I'iirlIht l-'\:iln;ilion / no
I iii Iliei- K\;ilu;i(ion
Liquid
Contact
Contact time with skin is expected to be
Dermal
Workers
Yes
<10 min due to volatilization. However,
repeat contact may occur.
Industrial /
commercial /
consumer use
Lubricants and
greases (e.g.,
penetrating
Aerosol
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected for
application of aerosol lubricants,
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Lubricants
and greases
lubricants,
cutting tool
coolants,
application of
lubricants to
substrates
Liquid
( onincl
Dermal
()\l
\o
Domini e\posure is e\pecled In he
prnunriK lo workers direelK iimil\ediu
workum w uli ilic chemical
aerosol
lubricants)
Inlialalion exposure is expected for
application of aerosol lubricants.
Vapor
Inhalation
ONU
Yes
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
Mist generation expected for aerosol
applications.
Liquid
Contact
Contact time with skin is expected to be
Dermal
Workers
Yes
<10 min due to volatilization. However,
repeat contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected for use of
metalworking fluids, perchloroethylene is
semi-volatile (VP =18.5 mmHg) at room
Industrial /
commercial /
consumer use
Metalworking
lubricants
(cutting fluids)
Use of
temperature, inhalation pathway should
be further auahved
Lubricants
and greases
metalworking
fluids (cutting
fluids)
Liquid
( onincl
Dermal
<>\l
\o
Dermal e\pnsuie is e\pecled In he
pmuni'iK ii< workers duvclK ui\ ol\ ed m
workiuu w uli ilic chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected for use of
metalworking fluids, perchloroethylene is
semi-volatile (VP =18.5 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 152 of 167
-------
l.il'c Cu'le
Sliiiic
CsiU'Sion
Siihciilciion
Kck'iisc /
|-l\|)OMMV
SiTiisirio
l''.\|)OMir
e
Piilhwin
l'l\|)OMIIV
Knuli*
Km'plor/
Population
Proposed
for
l-'n rllior
Risk
l'\ion
Kiilioiiiik* fo r furl her l-'\:iln;il ion / no
I iii Iliei- K\;ilu;ilion
Industrial /
commercial /
consumer use
Adhesives
and sealants
Solvent-based
adhesives and
sealants; and
light repair
adhesives
Spray adhesive
application;
and other
adhesive and
sealant
applications
(e.g. roll)
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be
<10 min due to volatilization. However,
repeat contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
adhesive applications, perchloroethylene
is semi-volatile (VP =18.5 mmHg) at
room temperature, inhalation pathway
should be further analyzed.
Liquid
( ouiacl
Dermal
<>\l
\n
Dermal c\pnsui'c is e\pecled In he
prnuariK lo woikeis dueclls uiuil\cdiu
\uirkuiu u uh ilie chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected from
adhesive applications, perchloroethylene
is semi-volatile (VP =18.5 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
analyze to determine if mist generation is
applicable for each adhesive/sealant
product.
Industrial /
commercial /
consumer use
Paints and
coatings
including
paint and
coating
removers
Solvent-based
paints and
coatings
Spray coating
application;
and other paint
and coating
applications
(e.g. roll)
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be
<10 min due to volatilization. However,
repeat contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
coating applications, perchloroethylene is
semi-volatile (VP =18.5 mmHg) at room
temperature, inhalation pathway should
be further analyzed.
Liquid
( ouiacl
Dermal
<>\l
\n
Dermal e\pnsuie is e\pecled In he
prnuariK lo woikeis direelK uiuil\ediu
\uirkuiu u uh ilie chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected from
coating applications, perchloroethylene is
semi-volatile (VP =18.5 mmHg) at room
temperature, inhalation pathway should
be further analyzed.
Page 153 of 167
-------
l.il'c Cu'le
Sliiiic
CsiU'Sion
Siihciilciion
Kck'iisc /
|-l\|)OMMV
SiTiisirio
l''.\|)OMir
e
P;i 1 liw
l'l\|)OMIIV
Roulc
Km'plor/
I'opn hit ion
Proposed
for
l-'n rllior
Risk
l'\ion
Killioiiiilc for I'lirllior l-'\:iln;ilion / no
I iii Iliei- l-l\iilii;ilion
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
Mist generation expected for spray and
roll applications. EPA will further
analyze to determine if mist generation is
applicable for each paint/coating product.
Commercial /
consumer use
Cleaning and
furniture care
products
Automotive
care products
(e.g., engine
degreaser and
brake cleaner)
Commercial
auto repair/
servicing
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be
<10 min due to volatilization. However,
repeat contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected for
aerosol degreasing activities,
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Liquid
( ouiacl
Dermal
()\l
\n
Dermal c\pnsui'c is e\pecled In he
prnuariK lo woikeis dueclls uiuil\ediu
\uirkuiu u uh ilie chemical
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected for
aerosol degreasing activities,
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
Mist generation expected for aerosol
applications.
Commercial /
consumer use
Cleaning and
furniture care
products
Non-aerosol
cleaner
Wipe cleaning
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be
<10 min due to volatilization. However,
repeat contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
wipe cleaning, perchloroethylene is semi-
volatile (VP =18.5 mmHg) at room
temperature, inhalation pathway should
be further analyzed.
Liquid
( ouiacl
Dermal
<>\l
\n
Dermal e\pnsuie is e\pecled In he
prnuariK lo workeiN dueells uiuil\ediu
workiiiu u nil ilie chemical
Page 154 of 167
-------
l.il'c Cu'le
Sliiiic
CsiU'Sion
Siihciilciion
Kck'iisc /
Kxposiiiv
Sccnsirio
l''.\|)OMir
e
P;i 1 liw
l'l\|)OMIIV
Roulc
Km'plor/
I'opn hit ion
Proposed
for
l-'n rllior
Risk
l'\ion
Kill ioiiiilc fo r furl her l-'\:iln;il ion / no
I iii Iliei- l-l\iilii;ilion
Vapor
Inhalation
ONU
Yes
Inhalation exposure is expected from
wipe cleaning, perchloroethylene is semi-
volatile (VP =18.5 mmHg) at room
temperature, inhalation pathway should
be further anallyzed.
\1ls|
Dermal
IiiIi;iI;iIioii
Workers.
()\l
No
Misi ueueraliou noi e\peeled durum w ipe
eleaiiiuu
Commercial /
consumer use
Cleaning and
furniture care
products
Carpet cleaner
Commercial
carpet spottinu
and stain
removers
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be
<10 min due to volatilization. However,
repeat contact may occur.
Vapor
Inhalation
Workers
Yes
Inhalation exposure is expected from
carpet cleaning, perchloroethylene is
semi-volatile (VP =18.5 mmHg) at room
temperature, inhalation pathway should
be further analyzed.
Liquid
( oniael
Dermal
<>\l
\o
Dermal e\posuie is e\peeled In he
primariK lo workersdueelK uiuil\ediu
workiiiu u uh ilie eliemieal
Vapor
Inhalation
ONU
Yes
InlialaUon exposure is expeeled from
carpet cleaning, perchloroethylene is
semi-volatile (VP =18.5 mmHg) at room
temperature, inhalation pathway should
be furtheranalyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
EPA will further analyze to determine if
mist generation is applicable.
Page 155 of 167
-------
l.il'c Cu'le
Sliiiic
CsiU'Sion
Siihciilciion
Kck'iisc /
|-l\|)OMMV
SiTiisirio
l''.\|)OMir
e
P;ilh\\;i\
l'l\|)OMIIV
Roulc
Km'plor/
I'opn hit ion
Proposed
for
l-'urlhor
Risk
l.\;ilu;ilion
Kiilioiiiik* for I'iirlher l-'\:iln;ilion / no
I iii Iliei- l-l\iilii;ilion
Commercial /
consumer use
Other uses
Laboratory
chemicals;
metal and stone
polishes; inks
and ink removal
products;
welding;
photographic
film; and mold
cleaning,
release and
protectant
products
See Table XX
for specific
scenario
corresponding
to the
condition of
use.
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be
<10 min due to volatilization. However,
repeat contact may occur may occur for
some miscellaneous conditions of use.
Vapor
Inhalation
Workers
Yes
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Liquid
( ouiacl
Dermal
<>\l
\n
Dermal exposure is expected In he
primariK in workers direclh iiiuihcdiu
workum w uh ilie chemical
Vapor
Inhalation
ONU
Yes
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
Yes
EPA will further analyze to determine if
mist generation is applicable to specific
conditions of use in this scenario.
Disposal
Waste
Handling,
Treatment
and Disposal
Disposal of
perchloroethyle
ne wastes
Worker
handling of
wastes
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be
<10 min due to volatilization. Frequency
of exposure and the potential for dermal
immersion needs to be further analyzed.
Vapor
Inhalation
Workers
Yes
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
Liquid
( ouiacl
Dermal
()\l
\n
Dermal exposure is expected In he
primariK in worker direelh uiuihediii
wnrkiiiu u illi llie chemical
Vapor
Inhalation
ONU
Yes
perchloroethylene is semi-volatile (VP =
18.5 mmHg) at room temperature,
inhalation pathway should be further
analyzed.
\lls|
Dermal
Inhalation
Workers.
()\l
\o
Misi ueuerciliuii nm e\peeled from wasie
handling
Page 156 of 167
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Appendix D SUPPORTING TABLE FOR CONSUMER ACTIVITIES
AND USES CONCEPTUAL MODEL
Table Apx D-l. Consumer Activities and Uses Conceptual Model Supporting Table
( ;Mejiories of
Conditions of I so
for Consumer
Ac(i\ ilies
r.\|xisuiv
PiidiNin
I'1\|)omiiv P;i 1 liw ;i>
Km'plor
K;ilion;ik' l«ir Inclusion
Cleaning and
Furniture Care
Products; Lubricants
and Greases;
Adhesives and
Sealants; Paints and
Coatings; Dry
Cleaned Clothing and
Textiles; Other Uses
Liquid
Contact
Dermal
Consumer
Perdllui'uelhylelle is lulllld ill
consumer products, dermal contact to
perchloroethylene containing liquids
will be further analyzed for consumer
exposure
Vapor/Mist
(Includes
Liquid
Contact)
Inhalation (includes
Oral)
Consumer,
Bystanders
Perchloroethylene is found in
consumer products and may volatilize,
depending on product formulation and
percent composition. Inhalation
exposure to perchloroethylene
containing liquids will be further
analyzed for consumers and
bystanders
ONU = Occupationa
Non-User
Page 157 of 167
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Appendix E SUPPORTING TABLE FOR ENVIRONMENTAL
RELEASES AND WASTES CONCEPTUAL MODEL
Table Apx E-1. Environmental Releases and Wastes Conceptual Model Supporting Table
l.ili( \ik-
Si sim-
Ki'li-:isi-
Ri'k'iisi-/
I".\|)IISIIIV
Sii-iiiiriii
l!\|)osuiv
Mi-di;i
l!\|)osuiv
kllllll-s
Ri-ivplor/
Piipuhiliiin
Propusi-d fur
I'lirlhi-r Risk
l!\iilu;iliiiii
Riiliiimik- fur
l'iirllii-r
l!\;iln:ilion/ no
I'liiilu-r
Manufacture and
Import; Processing
as Reactant/
Intermediate;
Incorporation into
Formulation;
Mixture or
Reaction Product;
Incorporation into
Article; Use of
Product of Article;
Repackaging;
Recycling
Wastewater or
Liquid Wastes
Industrial Pre-
Treatment and
Industrial WWT
and/or
Municipal
WWT
Water,
Sediment
Water
Aquatic
Species
Yes
Perchloroethylene
toxicity to aquatic and
sediment dwelling
aquatic species is
expected to be low-
moderate;
perchloroethylene has
low bioaccumulation
potential, and
conservative estimates
for surface water and
sediment
concentrations due to
current TSCA uses
were below identified
COCs
Page 158 of 167
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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.cfm?helptabs=tab4) and in the
Strategy for Conducting Literature Searches document published along with each of the TSCA Scope
documents.
Since full text screening commenced right after the publication of the TSCA Scope document, the criteria
were set to be broad to capture relevant information that would support the initial risk evaluation. Thus, the
inclusion and exclusion criteria for full text screening do not reflect the refinements to the conceptual model
and analysis plan resulting from problem formulation. As part of the iterative process, EPA is in the process
of refining the results of the full text screening to incorporate the changes in information/data needs to
support the revised risk evaluation.
These refinements will include changes to the inclusion and exclusion criteria discussed in this appendix to
better support the revised risk evaluation and will likely reduce the number of data/information sources that
will undergo evaluation.
F.l Inclusion Criteria for Data Sources Reporting Environmental Fate
Data
EPA/OPPT developed a generic PESO statement to guide the full text screening of environmental fate data
sources. PESO stands for Pathways and Processes, Exposure, Setting or Scenario, and Outcomes.
Subsequent versions of the PESO statement may be produced throughout the process of screening and
evaluating data for the chemicals undergoing TSCA risk evaluation. Studies that comply with the inclusion
criteria in the PESO statement are eligible for inclusion, considered for evaluation, and possibly included in
the environmental fate assessment. On the other hand, data sources are excluded if they do not meet the
criteria in the PESO statement.
Page 159 of 167
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EPA describes the expected exposure pathways to human receptors from consumer uses of
perchloroethylene 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. In the
absence of exposure pathways for further analysis, environmental fate data will not be further evaluated.
Therefore, PESO statements describing fate endpoints, associated processes, media and exposure pathways
that were considered in the development of the environmental fate assessment for perchloroethylene will
not be presented.
Page 160 of 167
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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(Table Apx F-3). RESO stands for Receptors, Exposure, Setting or
Scenario, and Outcomes. Subsequent versions of the RESO statement may be produced throughout the
process of screening and evaluating data for the chemicals undergoing TSCA risk evaluation. Studies
that comply with the inclusion criteria specified in the RESO statement will be eligible for inclusion,
considered for evaluation, and possibly included in the environmental release and occupational exposure
assessments, while those that do not meet these criteria will be excluded.
The RESO statement should be used along with the engineering and occupational exposure data needs
table (TableApx F-3) when screening the literature.
Since full text screening commenced right after the publication of the TSCA Scope document, the
criteria for engineering and occupational exposure data were set to be broad to capture relevant
information that would support the risk evaluation. Thus, the inclusion and exclusion criteria for full text
screening do not reflect the refinements to the conceptual model and analysis plan resulting from
problem formulation. As part of the iterative process, EPA is in the process of refining the results of the
full text screening to incorporate the changes in information/data needs to support the revised risk
evaluation.
Table Apx F-l. Inclusion Criteria for Data Sources Reporting Engineering and Occupational
Exposure Data
kl !S() 1 ilemeiil
l'.\ iricncc
Receptors
• Humans:
Workers, including occupational non-users
• Environment:
Aquatic ecological receptors (release estimates input to Exposure)
Please refer to the conceptual models for more information about the ecological and human
receptors included in the TSCA risk evaluation.
Exposure
• Worker exposure to and occupational environmental releases of the chemical substance of
interest
o Dermal and inhalation exposure routes (as indicated in the conceptual model)
o Surface water (as indicated in the conceptual model)
Please refer to the conceptual models for more information about the routes and media/pathways
included in the TSCA risk evaluation.
Setting or
Scenario
• Any occupational setting or scenario resulting in worker exposure and environmental releases
(includes all manufacturing, processing, use, disposal indicated in Table A-3.
Outcomes
• Quantitative estimates* of worker exposures and of environmental releases from
occupational settings
• General information and data related and relevant to the occupational estimates*
* Metrics (e.g., mg/kg/day or mg/m3 for worker exposures, kg/site/day for releases) are determined by
toxicologists for worker exposures and by exposure assessors for releases; also, the Engineering, Release, and
Occupational Exposure Data Needs (Table 2) provides a list of related and relevant general information.
Page 161 of 167
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TSCA=Toxic Substances Control Act
TableApx F-2. Engineering, Environmental Release and Occupational Data Necessary to Develop
the Environmental Release and Occupational Exposure Assessments
Ohjiiiitc
Ik'k'nniiK'd
(Inrinvi Scoping
Tjpc ol° l);K;i
General
Engineering
Assessment (may
apply for either
or both
Occupational
Exposures and /
or Environmental
Releases)
1. Description of die lile c\ cle of die chemicaloj of iiiiercbl, 1'roni manufacture to eiid-ol-lile (.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]a
5. Number of sites that manufacture, process, or use the chemical(s) of interest for each industrial/
commercial life cycle step and site locations. [Tags: Numbers of sites (manufacture, import, processing,
use), Site locations]"
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)]a
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
Page 162 of 167
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Objec(i\e
Delermineri
(Inrinvi Scopiii"
l \|H' of Dala
exposure reductions. [Tags: Engineering controls (manufacture, import, processing, use), Engineering
control effectiveness data]a
Environmental
Releases
19. Description of relvant sources of potential environmental releases, including cleaning of residues from
process equipment and transport containers, involved during the manufacture, processing, or use of the
chemical(s) of interest in each life cycle stage. [Tags: Release sources (manufacture, import, processing,
use)]a
20. Estimated mass (lb or kg) of the chemical(s) of interest released from industrial and commercial sites to
each relevant environmental media (air, water, land) and treatment and disposal methods (POTW,
incineration, landfill), including releases per site and aggregated over all sites (annual release rates, daily
release rates) [Tags: Release rates (manufacture, import, processing, use)]a
21. Release or emission factors. [Tags: Emission factors (manufacture, import, processing, use)]a
22. Number of release days per year. [Tags: Release frequencies (manufacture, import, processing, use)]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=Particle volume
PBZ=
POTW=Publicly owned treatment works
PPE=Personal projection 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 exposed or susceptible subpopulations) and ecological receptors.
Subsequent versions of the PECO statements may be produced throughout the process of screening and
evaluating data for the chemicals undergoing TSCA risk evaluation. Studies that comply with the
inclusion criteria in the PECO statement are eligible for inclusion, considered for evaluation, and
possibly included in the exposure assessment. On the other hand, data sources are excluded if they do
not meet the criteria in the PECO statement. The perchloroethylene-specific PECO is provided in
TableApx F-5.
Page 163 of 167
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Since full text screening commenced right after the publication of the TSCA Scope document, the
criteria for exposure data were set to be broad to capture relevant information that would support the risk
evaluation. Thus, the inclusion and exclusion criteria for full text screening do not reflect the
refinements to the conceptual model and analysis plan resulting from problem formulation. As part of
the iterative process, EPA is in the process of refining the results of the full text screening to incorporate
the changes in information/data needs to support the risk evaluation.
TableApx F-3. Inclusion Criteria for the Data Sources Reporting Perchloroethylene Exposure
Data on Consumers and Ecological Receptors
PI'.CO I k-im-iil
l.\ irience
Population
Human: Consumers: bystanders in the home: children; infants: pre enant women; lactatins
women.
Ecological: Aquatic species.
Exposure
Expected Primary Exposure Sources, Pathways, Routes:
• Sources: Industrial and commercial activities involving non-closed svslcms producing
releases to surface water: consumer uses in the home producing releases to air and dermal
contact
• Pathwavs: indoor air. direct contact and surface water.
• Routes of Exposure: Inhalation via indoor air (consumer and bvstandcr populations) and
incidental ingestion of aerosols and mists: dermal exposure via direct contact with
consumer products containing perchloroethylene
Comparator
(Scenario)
Human: Consider media-SDCcific background exposure scenarios and use/source specific
exposure scenarios as well as which receptors are and are not reasonably exposed across the
projected exposure scenarios.
Ecological: Consider media-specific backsround exposure scenarios and use/source specific
exposure scenarios as well as which receptors are and are not reasonably exposed across the
projected exposure scenarios.
Outcomes for
Exposure
Concentration or
Dose
Human: Acute, subchronic. and/or chronic external dose estimates (mg/kg/da\): acute,
subchronic. and/or chronic air and water concentration estimates (nig/m1 or mg/L). Both
external potential dose and internal dose based on biomonitoring and reverse dosimetry
mg/kg/day will be considered.
Ecological: A wide range of ecological receptors will be considered (range depending on
available ccoloxicily data).
Abbreviations:
Kg=Kilogram(s)
Mg=Milligram(s)
M3=Cubic meter
L=Liter(s)
Page 164 of 167
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F.4 Inclusion Criteria for Data Sources Reporting Ecological Hazards
TableApx F-4. Ecological Hazard PECO (Populations, Exposures, Comparators, Outcomes)
Statement for Perchloroethylene
PI CO
rJemenl
Kviik'iHT
Population
Tests of the single chemical {i.e., PERC) on live, whole, taxonomically
verifiable organisms, (including gametes, embryos, or plant or fungal
sections capable of forming whole, new organisms) and in vitro systems.
Exposure
Chemical:
Tests using single, verifiable chemical, administered through an
acceptable route. Must also be used in relevant environmental exposure
studies, as determined by usual toxicology standards.
Concentration:
Study must specify the amount of chemical the organisms were exposed
to, either as a concentration in the environment when administered via
environmental media (e.g. air, soil, water, or sediment), or as a dosage
when introduced directly into or on the organism via oral (e.g. diet or
gavage), topical or injection routes.
Duration:
Study must specify the duration from the time of initial exposure to the
time of measurement. May be imprecise, as in "less than 6 months,"
"one growing season," or "from 3 to 5 weeks."
Comparator
Study must have controls or reference locations.
Outcome
Measurable/observable biological effect(s) (e.g. mortality, behavioral,
population, biochemical, cellular, physiological, growth, reproduction,
etc.) of an acceptable organism to a chemical.
F.5 Inclusion Criteria for Data Sources Reporting Human Health
Hazards
EPA/OPPT developed a perchloroethylene-specific PECO statement (Table Apx F-7) 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.
Page 165 of 167
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TableApx F-5. Inclusion and Exclusion Criteria for Data Sources Reporting Human Health
Hazards Related to Perchloroethylene (PERC)a
PECO
Element
Evidence
Stream
Papers/Features Included
Papers/Features Excluded
Population b
Human
• Any population
• All lifestages
• All study designs, includes:
o Controlled exposure, cohort, case-control, cross-
sectional, case-crossover, ecological, case studies and
case series
Animal
• All non-human whole-organism mammalian species
• All lifestages
• Non-mammalian species
Exposure
Human
• Exposure based on administered dose or concentration of
perchloroethylene, biomonitoring data (e.g., urine, blood
or other specimens), environmental or occupational-
setting monitoring data (e.g., air, water levels), job title
or residence
• Any metabolites of interest as identified in
biomonitoring studies
• Exposure identified as or vresumed 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
perchloroethylene 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 perchloroethylene (or
related metabolite)
Animal
• A minimum of 2 quantitative dose or concentration
levels of perchloroethylene plus a negative control
group a
• Acute, subchronic, chronic exposure from oral, dermal,
inhalation routes
• Exposure to perchloroethylene only (no chemical
mixtures)
• 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 perchloroethylene in a
chemical mixture
Comparator
Human
• Any or no comparison
Animal
• Negative controls that are vehicle-only treatment
and/or no treatment
• Neaative controls other than vehicle-
only treatment or no treatment
Outcome
Human and
Animal
• Endpoints described in the perchloroethylene scope
documentc:
o Acute toxicity
o Neurotoxicity
o Liver toxicity
o Reproductive/developmental toxicity
o Irritation
o Cancer
• Other endpoints d
(¦I'liiTuI ( iinsiik-raiions
PapiTs/IValinvs liuliuk'd
Papi-rs/l-Valuivs l-Ailudi-d
• Written in English e
• Not written in English e
Page 166 of 167
-------
IM'.CO
l.k'ilK'iH
l.\ idi-ncc
Siiviim
Piipc'is/l c'iKuivs Included
Piipci's/l-oiiluivs i:\cliidod
• Reports a primary source or meta-analysis a
• Full-text available
• Reports both perchloroethylene exposure and a health
outcome
• Reports secondary source (e.g., review
papers)a
• No full-text available (e.g., only a
study description/abstract, out-of-print
text)
• Reports a perchloroethylene-related
exposure or a health outcome, but not
both (e.g. incidence, prevalence
report)
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