EPA Document# EPA-740-R1-7007
June 2017
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!¦! M lk. Environmental Protection Agency Pollution Prevention
EPA United States Office of Chemical Safety and
Scope of the Risk Evaluation for
Perchloroethylene
(Ethene, 1,1/2,2-Tetrachloro)
CASRN: 127-18-4
CI CI
W I Smr» I
June 2017
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 5
ABBREVIATIONS 6
EXECUTIVE SUMMARY 9
1 INTRODUCTION 12
1.1 Regulatory History 14
1.2 Assessment History 14
1.3 Data and Information Collection 16
2 SCOPE OF THE EVALUATION 18
2.1 Physical and Chemical Properties 18
2.2 Conditions of Use 19
2.2.1 Data and Information Sources 19
2.2.2 Identification of Conditions of Use 19
2.3 Exposures 32
2.3.1 Fate and Transport 32
2.3.2 Releases to the Environment 33
2.3.3 Presence in the Environment and Biota 35
2.3.4 Environmental Exposures 36
2.3.5 Human Exposures 36
2.3.5.1 Occupational Exposures 36
2.3.5.2 Consumer Exposures 37
2.3.5.3 General Population Exposures 37
2.3.5.4 Potentially Exposed or Susceptible Subpopulations 39
2.4 Hazards (Effects) 40
2.4.1 Environmental Hazards 40
2.4.2 Human Health Hazards 40
2.4.2.1 Non-Cancer Hazards 41
2.4.2.2 Genotoxicity and Cancer Hazards 42
2.4.2.3 Potentially Exposed or Susceptible Subpopulations 42
2.5 Initial Conceptual Models 42
2.5.1 Initial Conceptual Model for Industrial and Commercial Activities and Uses: Potential
Exposures and Hazards 43
2.5.2 Initial Conceptual Model for Consumer Activities and Uses: Potential Exposures and
Hazards 45
2.5.3 Initial Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards 47
2.6 Initial Analysis Plan 49
2.6.1 Exposure 49
2.6.1.1 Environmental Releases 49
2.6.1.2 Environmental Fate 49
2.6.1.3 Environmental Exposures 50
2.6.1.4 Occupational Exposures 50
2.6.1.5 Consumer Exposures 50
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2.6.1.6 General Population 51
2.6.2 Hazards (Effects) 51
2.6.2.1 Environmental Hazards 51
2.6.2.2 Human Health Hazards 52
2.6.3 Risk Characterization 52
REFERENCES 53
APPENDICES 58
Appendix A REGULATORY HISTORY 58
A.l Federal Laws and Regulations[[[ 58
A.2 State Laws and Regulations 68
A3 International Laws and Regulations[[[ 67
Appendix B PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION 69
B.l Process Information 69
B.l.l Manufacture (Including Import) 69
B.l.1.1 Domestic Manufacture 70
B.l.1.2 Import 70
B.l.2 Processing and Distribution 71
B.l.2.1 Reactant or Intermediate 71
B.l.2.2 Incorporating into a Formulation, Mixture or Reaction Product 71
B.l.2.3 Incorporating into an Article 71
B.l.2.4 Repackaging 72
B.l.2.5 Recycling 72
B.l.3 Uses 72
B.l.3.1 Cleaning and Furniture Care Products 72
B.l.3.2 Solvents for Cleaning and Degreasing 73
B.l.3.3 Lubricant and Greases 74
B.l.3.4 Adhesives and Sealants 74
B.l.3.5 Paints and Coatings 75
B.l.3.6 Processing Aid for Pesticide, Fertilizer and Other Agricultural Manufacturing 75
B.l.3.7 Processing Aid, Specific to Petroleum Production 75
B.l.3.8 Other Uses 76
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LIST OF TABLES
Table 1-1. Assessment History of Perchloroethylene 15
Table 2-1. Physical and Chemical Properties of Perchloroethylene 18
Table 2-2. Production Volume of Perchloroethylene in CDR Reporting Period (2012 to 2015) 20
Table 2-3. Categories and Subcategories of Use for Perchloroethylene 23
Table 2-4. Environmental Fate Characteristics of Perchloroethylene 32
Table 2-5. Summary of Perchloroethylene TRI Production-Related Waste Managed in 2015 (lbs) 34
Table 2-6. Summary of Perchloroethylene TRI Releases to the Environment in 2015 (lbs) 34
LIST OF FIGURES
Figure 2-1. Initial Perchloroethylene Life Cycle Diagram 21
Figure 2-2. Initial Perchloroethylene Conceptual Model for Industrial and Commercial Activities and
Uses: Potential Exposures and Hazards 44
Figure 2-3. Initial Perchloroethylene Conceptual Model for Consumer Activities and Uses: Potential
Exposures and Hazards 46
Figure 2-4. Initial Perchloroethylene Conceptual Model for Environmental Releases and Wastes:
Potential Exposures and Hazards 48
LIST OF APPENDIX TABLES
Table_Apx A-l. Federal Laws and Regulations 58
Table_Apx A-2. State Laws and Regulations 66
Table_Apx A-3. Regulatory Actions by Other Governments and Tribes 67
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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 or input from EPA's Office of
General Counsel, Office of Research and Development and assistance from EPA contractors CSRA LLC
(Contract No. CIO-SP3, HHSN316201200013W), ERG (Contract No. EP-W-12-006), ICF (Contract No.
EP-C-14-001) and SRC (Contract No. EP-W-12-003).
Docket
Supporting information can be found in public docket: EPA-HQ-OPPT-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
ATSDR 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
CCL4 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 Chlorofluorocarbon
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 Hydrochlorofluorocarbon
HCI Hydrochloric Acid
HFC Hydrofluorocarbon
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HSIA Halogenated Solvents Industry Association
HPV High Production Volume
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
Log Koc Logarithmic Organic Carbon:Water Partition Coefficient
Log Kow Logarithmic OctanokWater Partition Coefficient
m3 Cubic Meter(s)
MACT Maximum Achievable Control Technology
MCL Maximum Contaminant Level
MCLG Maximum Contaminant Level Goal
mg Milligram(s)
lag 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 National Toxicology 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
OPPT Office of Pollution Prevention and Toxics
OSHA Occupational Safety and Health Administration
OW Office of Water
PCE Perchloroethylene
PEL Permissible Exposure Limit
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POD Point of Departure
POTW Publicly Owned Treatment Works
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
SNAP Significant New Alternatives Policy
STEL Short-Term Exposure Limit
11/2 Half-life
TCCR Transparent, Clear, Consistent, and Reasonable
TCE Trichloroethylene
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
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EXECUTIVE SUMMARY
TSCA § 6(b)(4) requires 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 (81 FR 91927). 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. This document fulfills the TSCA § 6(b)(4)(D) requirement for
perchloroethylene.
This document presents the scope of the risk evaluation to be conducted for perchloroethylene. If a
hazard, exposure, condition of use or potentially exposed or susceptible subpopulation has not been
discussed, EPA, at this point in time, is not intending to include it in the scope of the risk evaluation. As
per the rulemaking, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances
Control Act (TSCA), with respect to conditions of use in conducting a risk evaluation under TSCA, EPA
will first identify "circumstances" that constitute "conditions of use" for each chemical. While EPA
interprets this as largely a factual determination—i.e., EPA is to determine whether a chemical
substance is actually involved in one or more of the activities listed in the definition—the
determination will inevitably involve the exercise of some discretion.
To the extent practicable, EPA has aligned this scope document with the approach set forth in the risk
evaluation process rule; however, the scope documents for the first 10 chemicals in the risk evaluation
process differ from the scope documents that EPA anticipates publishing in the future. Time
constraints have resulted in scope documents for the first 10 chemicals that are not as refined or
specific as future scope documents are anticipated to be.
Because there was insufficient time for EPA to provide an opportunity for comment on a draft of this
scope document, as it intends to do for future scope documents, EPA will publish and take public
comment on a problem formulation document which will refine the current scope, as an additional
interim step, prior to publication of the draft risk evaluation for perchloroethylene. This problem
formulation is expected to be released within approximately 6 months of publication of the scope.
Perchloroethylene, also known as ethene, 1,1,2,2-tetrachloro, tetrachloroethylene and PCE, is a high
production volume (HPV) solvent [see Preliminary Information on Manufacturing, Processing,
Distribution, Use, and Disposal: Tetrachloroethylene (Perchloroethylene), EPA-HQ-QPPT-2016-0732-
00031. 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).
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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
• Sealants
• Stainless steel polish
• Tire buffers and cleaners and
• Vandal mark removers.
The initial conceptual models presented in Section 2 identify conditions of use; exposure pathways
(e.g., media); exposure routes (e.g., inhalation, dermal, oral); potentially exposed populations,
including potentially exposed or susceptible subpopulations; and hazards EPA expects to evaluate
based on the inherent hazards of the chemical.
This document presents the occupational scenarios in which workers and occupational non-users may
be exposed to perchloroethylene during a variety of conditions of use, such as manufacturing,
processing and uses in dry cleaning, adhesives and degreasing. EPA expects that the highest exposures
to perchloroethylene generally involve workers in industrial and commercial settings.
Perchloroethylene can be found in numerous commercial and consumer products, resulting in
exposures to commercial workers and consumers. The consumer conceptual model indicates
exposures occurring from perchloroethylene-containing products in either indoor or outdoor
environments. For perchloroethylene, EPA believes that workers, consumers, and bystanders as well as
certain other groups of individuals may experience greater exposures than the general population. EPA
will evaluate whether other 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), or have greater susceptibility than the general population, and should
therefore be considered relevant potentially exposed or susceptible subpopulations for purposes of
this risk evaluation.
Exposures to the general population may occur from industrial releases. The Toxics Release Inventory
identifies releases of perchloroethylene to air, water and land, with the majority being releases to air.
The general population can be exposed to perchloroethylene through inhalation, oral and dermal
pathways due to its widespread presence in a variety of environmental media such as in air, drinking
water, ground water and/or surface water. EPA considers workers, occupational nonusers, consumers
and bystanders and certain groups of individuals who may experience greater exposures due to
proximity to conditions of use, as potentially exposed or susceptible subpopulations.
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Perchloroethylene has been the subject of numerous health hazard and risk assessments, based on
human and animal data. Any existing assessments will be a starting point as EPA will conduct a
systematic review of the literature, including new literature since the existing assessments, as available
in Perchloroethylene (CASRN127-18-4) Bibliography: Supplemental File for the TSCA Scope Document
(EPA-HQ-QPPT-2016-0732). EPA expects to consider hazards identified in the recent assessment by the
EPA Integrated Risk Information System (IRIS) Program: 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 initial analysis plan describes EPA's plan for conducting systematic review of readily available
information and identification of assessment approaches to be used in conducting the risk evaluation
for perchloroethylene. The initial analysis plan will be used to develop the problem formulation and
final analysis plan for the risk evaluation of perchloroethylene.
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1 INTRODUCTION
This document presents the scope of the risk evaluation to be conducted for perchloroethylene. If a
condition of use has not been discussed, EPA, at this point in time, is not intending to include that
condition of use in the scope of the risk evaluation. Moreover, during problem formulation EPA may
determine that not all conditions of use mentioned in this scope will be included in the risk evaluation.
Any condition of use that will not be evaluated will be clearly described in the problem formulation
document.
On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended
the Toxic Substances Control Act (TSCA), the nation's primary chemicals management law, was signed
into law. The new law includes statutory requirements and deadlines for actions related to conducting
risk evaluations of existing chemicals.
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 (81 FR 91927). 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. On February 14, 2017, EPA convened a public meeting to
receive input and information to assist the Agency in its efforts to establish the scope of the risk
evaluations under development for the ten chemical substances designated in December 2016 for risk
evaluations pursuant to TSCA. EPA provided the public an opportunity to identify information, via oral
comment or by submission to a public docket, specifically related to the conditions of use for the ten
chemical substances. EPA used this information in developing this scope document, which fulfills the
TSCA § 6(b)(4)(D) requirement for perchloroethylene.
As per the rulemaking, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances
Control Act (TSCA), in conducting a risk evaluation under TSCA EPA will first identify "circumstances"
that constitute "conditions of use" for each chemical. While EPA interprets this as largely a factual
determination—i.e., EPA is to determine whether a chemical substance is actually involved in one or
more of the activities listed in the definition—the determination will inevitably involve the exercise of
some discretion. Based on legislative history, statutory structure and other evidence of Congressional
intent, EPA has determined that certain activities may not generally be considered to be conditions of
use. In exercising its discretion, for example, EPA would not generally consider that a single
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unsubstantiated or anecdotal statement (or even a few isolated statements) on the internet that a
chemical can be used for a particular purpose would necessitate concluding that this represented part
of the chemical substance's "conditions of use." As a further example, although the definition could be
read literally to include all intentional misuses (e.g., inhalant abuse), as a "known" or "reasonably
foreseen" activity in some circumstances, EPA does not generally intend to include such activities in
either a chemical substance's prioritization or risk evaluation. In addition, EPA interprets the mandates
under section 6(a)-(b) to conduct risk evaluations and any corresponding risk management to focus on
uses for which manufacture, processing, or distribution in commerce is intended, known to be
occurring, or reasonably foreseen (i.e., is prospective or on-going), rather than reaching back to
evaluate the risks associated with legacy uses, associated disposal, and legacy disposal, and interprets
the definition of "conditions of use" in that context. For instance, the conditions of use for purposes of
section 6 might reasonably include the use of a chemical substance in insulation where the
manufacture, processing or distribution in commerce for that use is prospective or on-going, but would
not include the use of the chemical substance in previously installed insulation, if the manufacture,
processing or distribution for that use is not prospective or on-going. In other words, EPA interprets
the risk evaluation process of section 6 to focus on the continuing flow of chemical substances from
manufacture, processing and distribution in commerce into the use and disposal stages of their
lifecycle. That said, in a particular risk evaluation, EPA may consider background exposures from legacy
use, associated disposal, and legacy disposal as part of an assessment of aggregate exposure or as a
tool to evaluate the risk of exposures resulting from non-legacy uses.
Furthermore, in exercising its discretion under section 6(b)(4)(D) to identify the conditions of use that
EPA expects to consider in a risk evaluation, EPA believes it is important for the Agency to have the
discretion to make reasonable, technically sound scoping decisions in light of the overall objective of
determining whether chemical substances in commerce present an unreasonable risk. Consequently,
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 meriting an unreasonable risk consideration. For example, EPA intends to exercise discretion
in addressing circumstances where the chemical substance subject to scoping is unintentionally
present as an impurity in another chemical substance that is not the subject of the pertinent scoping,
in order to determine which risk evaluation the potential risks from the chemical substance should be
addressed in. As an additional example, EPA may, on a case-by-case basis, exclude uses that EPA has
sufficient basis to conclude would present only "de minimis" exposures. This could include uses that
occur in a closed system that effectively precludes exposure or use as an intermediate. During the
scoping phase, EPA may also exclude a condition of use that has been adequately assessed by another
regulatory agency, particularly where the other agency has effectively managed the risks.
The situations identified above are examples of the kinds of discretion that EPA will exercise in
determining what activities constitute conditions of use, and what conditions of use are to be included
in the scope of any given risk evaluation. See the preamble to Procedures for Chemical Risk Evaluation
Under the Amended Toxic Substances Control Act (TSCA) for further discussion of these issues.
To the extent practicable, EPA has aligned this scope document with the approach set forth in the risk
evaluation process rule; however, the scope documents for the first 10 chemicals in the risk evaluation
process differ from the scope documents that EPA anticipates publishing in the future. The first
10 chemical substances were not subject to the prioritization process that will be used in the future in
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accordance with amendments to TSCA. EPA expects to collect and screen much of the relevant
information about chemical substances that will be subject to the risk evaluation process during and
before prioritization. The volume of data and information about the first 10 chemicals that is available
to EPA is extremely large and EPA is still in the process of reviewing it, since the Agency had limited
ability to process the information gathered before issuing the scope documents for the first
10 chemicals. As a result of the statutory timeframes, EPA had limited time to process all of the
information gathered during scoping for the first 10 chemicals within the time provided in the statute
for publication of the scopes after initiation of the risk evaluation process. For these reasons, EPA's
initial screenings and designations with regard to applicability of data (e.g., on-topic vs. off-topic
information and data) may change as EPA progresses through the risk evaluation process. Likewise, the
Conceptual Models and Analysis Plans provided in the first 10 chemical scopes are designated as
"Initial" to indicate that EPA expects to further refine them during problem formulation.
The aforementioned time constraints have resulted in scope documents for the first 10 chemicals that
are not as refined or specific as future scope documents are anticipated to be. In addition, there was
insufficient time for EPA to provide an opportunity for comment on a draft of this scope document, as
it intends to do for future scope documents. For these reasons, EPA will publish and take public
comment on a problem formulation document which will refine the current scope, as an additional
interim step, prior to publication of the draft risk evaluations for the first 10 chemicals. This problem
formulation is expected to be released within approximately 6 months of publication of the scope.
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. During risk evaluation, EPA will
evaluate and consider the impact of these existing laws and regulations in the problem formulation
step to determine what, if any further analysis might be necessary as part 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—information useful to EPA
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in preparing this scope for risk evaluation. Table 1-1 shows the assessments that have been conducted.
In addition to using this information, EPA intends to conduct a full review of the data collected see
Perchloroethylene (CASRN 127-18-4) Bibliography: Supplemental File for the TSCA Scope Document
(EPA-HQ-QPPT-2016-0732). using the literature search strategy [see Strategy for Conducting Literature
Searches for Perchloroethylene: Supplemental File for the TSCA Scope Document, (EPA-HQ-QPPT-2016-
0732)1 to ensure that EPA is considering 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)
Toxicological Review of Tetrachloroethvlene
(Perchloroethylene) (CAS No. 127-18-4) (U.S. EPA.
2012b)
Office of Air Quality Planning and Standards
(OAQPS)
Perchloroethylene Dry Cleaners Refined Human
Health Risk Characterization (2005b)
National Center for Environmental Assessment
(NCEA)
Sources, Emission and Exposure for
Trichloroethvlene (TCE) and Related Chemicals
(2001)
Office of Air Toxics
Tetrachloroethvlene (Perchloroethvlene); 127-18-
4 (2000b)
Office of Pesticides and Toxic Substances
(now, Office of Chemical Safety and Pollution
Prevention [OCSPP])
Occupational Exposure and Environmental
Release Assessment of Tetrachloroethvlene
(1985b)
Office of Water
Final Health Effects Criteria Document for
Tetrachloroethvlene (U.S. EPA, 1985a)
Office of Water (OW)
Ambient Water Qualitv 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 (2016)
Agency for Toxic Substances and Disease Registry
(ATSDR)
Toxicological Profile for Tetrachloroethvlene
(PERC) (Draft) (2014)
National Advisory Committee for Acute Exposure
Guideline Levels for Hazardous Substances
(NAC/AEGL Committee)
Tetrachloroethvlene (2009)
California Environmental Protection Agency,
OEHHA, Pesticide and Environmental Toxicology
Section
Public Health Goal for Tetrachloroethvlene in
Drinking Water (2001)
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Authoring Organization
Assessment
National Toxicology Program (NTP)
Toxicology and Carcinogenesis Studies of
Tetrachloroethvlene (Perchloroethylene); (CAS
No. 127-18-4) in F344/N Rats and B6C3F1 Mice
(1986)
International
International Agency for Research on Cancer
(IARC)
IARC Monographs on the Evaluation of
Carcinogenic Risks to Humans,
Tetrachloroethvlene (2014)
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 No.: 127-18-4, 12 (2008)
World Health Organization (WHO)
Concise International Chemical Assessment
Document 68; Tetrachloroethvlene (2006)
EU
EU Risk Assessment Report; Tetrachloroethvlene,
Part 1 - environment (2005)
National Industrial Chemicals Notification and
Assessment Scheme (NICNAS), Australia
Tetrachloroethvlene; Prioritv Existing Chemical
Assessment Report No. 15 (2001)
1.3 Data and Information Collection
EPA/OPPT generally applies a process and workflow that includes: (1) data collection (2) data
evaluation and (3) data integration of the scientific data used in risk assessments developed under
TSCA. Scientific analysis is often iterative in nature as new knowledge is obtained. Hence, EPA/OPPT
expects that multiple refinements regarding data collection will occur during the process of risk
evaluation.
Data Collection: Data Search
EPA/OPPT conducted chemical-specific searches for data and information on: physical and chemical
properties; environmental fate and transport; conditions of use information; environmental exposures,
human exposures, including potentially exposed or susceptible subpopulations; ecological hazard,
human health hazard, including potentially exposed or susceptible subpopulations.
EPA/OPPT designed its initial data search to be broad enough to capture a comprehensive set of
sources containing data and/or information potentially relevant to the risk evaluation. Generally, the
search was not limited by date and was conducted on a wide range of data sources, including but not
limited to: peer-reviewed literature and gray literature (e.g., publicly-available industry reports, trade
association resources, government reports). When available, EPA/OPPT relied on the search strategies
from recent assessments, such as EPA Integrated Risk Information System (IRIS) assessments and the
National Toxicology Program's (NTP) Report on Carcinogens, to identify relevant references and
supplemented these searches to identify relevant information published after the end date of the
previous search to capture more recent literature. Strategy for Conducting Literature Searches for
Perchloroethylene: Supplemental File for the TSCA Scope Document (EPA-HQ-QPPT-2016-0732)
provides details about the data sources and search terms that were used in the initial search.
Page 16 of 77
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Data Collection: Data Screening
Following the data search, references were screened and categorized using selection criteria outlined
in the supplemental document: Strategy for Conducting Literature Searches for Perchloroethylene:
Supplemental File for the TSCA Scope Document Titles and abstracts were screened against the criteria
as a first step with the goal of identifying a smaller subset of the relevant data to move into the
subsequent data extraction and data evaluation steps. Prior to full-text review, EPA/OPPT anticipates
refinements to the search and screening strategies, as informed by an evaluation of the performance
of the initial title/abstract screening and categorization process.
The categorization scheme (or tagging structure) used for data screening varies by scientific discipline
(i.e., physical and chemical properties; environmental fate and transport; chemical use/conditions of
use information; human and environmental exposures, including potentially exposed or susceptible
subpopulations identified by virtue of greater exposure; human health hazard, including potentially
exposed or susceptible subpopulations identified by virtue of greater susceptibility; and ecological
hazard), 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.
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.
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~HOQPPT~2Q16~Q732). 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.
Page 17 of 77
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2 SCOPE OF THE EVALUATION
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 is
including an initial life cycle diagram and initial conceptual models that describe the actual or potential
relationships between perchloroethylene and human and ecological receptors. An initial 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. As
noted previously, EPA intends to refine this analysis plan during the problem formulation phase of risk
evaluation.
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.
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 atm-m3/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
0 D
a Measured unless otherwise noted.
-------
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
As the first step in preparing these 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, EPA-1 32). Based on this search, EPA published a preliminary list
of information and sources related to chemical conditions of use [see Preliminary Information on
Manufacturing, Processing, Distribution, Use, and Disposal: Tetrachloroethylene (Perchloroethylene)
and Use, EPA-H1 16-07321 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 scope document to the extent
appropriate, as indicated in Table 2-3. Thus, EPA believes the manufacture, processing, distribution,
use and disposal activities identified in these documents constitute the intended, known, and
reasonably foreseen activities associated with the subject chemicals, based on reasonably available
information. The documents do not, in most cases, specify whether activity under discussion
is intended, known, or reasonably foreseen, in part due to the time constraints in preparing these
documents.
2.2.2 Identification of Conditions of Use
As part of the scope, an initial life cycle diagram is provided (Figure 2-1) depicting 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 information is grouped according to Chemical Data Reporting (CDR) processing codes and use
categories (including functional use codes for industrial uses and product categories for commercial
and consumer uses), in combination with other data sources (e.g., published literature and
consultation with stakeholders) to provide an overview of conditions of use. EPA notes that some
subcategories may be grouped under multiple CDR categories.
For the purposes of this scope, CDR definitions were used. CDR 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
Page 19 of 77
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are provided in Table 2-2 from EPA's CDR database (U.S. EPA. 2016b). As demonstrated in Table 2-2,
production and importation of perchloroethylene has decreased since 2012.
Table 2-2. 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 reporting period is available via ChemView (https://iava.eoa.gov/chemview) (U.S. EPA.
2016b). Because of an ongoing CBI substantiation process reauired bv amended TSCA. the CDR data available in the scope
document is more specific than currently in ChemView.
Figure 2-1 depicts the initial life cycle diagram of perchloroethylene from manufacture to the point of
disposal. EPA identified the use categories by reviewing the industrial processing use activities, and
commercial and consumer use product categories reported in the 2016 CDR (U.S. EPA. 2016b). Then,
EPA identified the subcategories by supplementing CDR data with information from Preliminary
Information on Manufacturing, Processing, Distribution, Use, and Disposal: Tetrachloroethylene
(Perchloroethylene) and Use and Market Profile for Tetrachloroethylene, both available in the public
docket (EPA-HQ-QPPT-2016-0732). For risk evaluations, EPA will assess each use subcategory by
identifying all potential sources of release and human exposure associated with that subcategory.
Page 20 of 77
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INTERNAL DELIBERATIVE - DO NOT QUOTE OR CITE
MFC/IMPORT
PROCESSING
INDUSTRIAL, COMMERCIAL. CONSUMER USES ¦ RELEASES and WASTE DISPOSAL
Manufacture
[Including Imparl)
[324.2 million lbs)
Processing as
Reacts nt/tniermediate
(Volume CBI)
e.g.. intermediate for
refrigerant manufacture
Incorporated Into
Formulation, Mixture,
or Reaction Product
(>285,SOO lb)
Incorporated Into
Article
[Not reported to 2016
CDR)
Repackaging
[Volume CBI)
3
Ftecycllng
Cleaning and Furniture Care Products
[>348,770 lb)
eg. dry deaniog. spot cleaning, aerosol cleaner and
degreaser. aerosol -spot ramowr, ricm-ae/owl cleaner
Solvents for Cleaning and Degreaslng
(>327,150 lb)
eg.v«n>- eegreaser, colt! rt?aner, aerosol i&s'easer
Lubricant: and Greases
(316,716 lb)
e.g.. penetrating lufcrlcamts
Adhesive and Sealant Chemical*
(Volume CBI)
eg-, sD^rt-Tit-tjascd adhesive* and sealants
Paints and Coating
[Volume CBI)
E.g., Mk'rr 1 bssec pamts and coflftmgs
Processing Aid for Agricultural Product
Manufacturing [Volume CBI)
e.g., pesticide, feitlllae-f. and othe* agricultural
product manufacturing
Processing Aid for Petrochemical
Manufacturing [Vol ume CBI)
e.g.. catalyst reewiaratlod
Other Uses
e^, maid release product, metsi polishes, Irts
f missions to Air
Wastewater1,
Liquid Wastes'
Solid Wastes
Sw Figure 2-4 jc* EnvifomKntaf
Reieote s unrf Wastes
I I Manufacture (HAKftng irnoorti
^ Processing
"1 Uses, Atthescoj>e»?*elof
-------
Descriptions of the industrial, commercial and consumer use categories identified from the 2016 CDR
(U.S. EPA. 2016b) and included in the life cycle diagram 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, use and disposal category. The descriptions provided below are primarily
based on the corresponding industrial function category and/or commercial and consumer product
category descriptions from the 2016 CDR and can be found in EPA's Instructions for Reporting 2016
TSCA Chemical Data Reporting (U.S. EPA. 2016a).
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
Page 22 of 77
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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 use 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.
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, 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 relevant potential sources of release and human exposure associated
with that life cycle stage.
Table 2-3. Categories and Subcategories of Use for Perchloroethylene
Life Cycle Stage
Categorya
Subcategory b
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-HQ-
OPPT-2016-0732: Public
Comment, EPA-HQ-
OPPT-2016-0732-0013:
Public Comment, Public
Comment, EPA-HQ-
OPPT-2016-0732-
DRAFT-0018: Public
Comment, Public
Comment, EPA-HQ-
OPPT-2016-0732-0033
Intermediate in basic organic
chemical manufacturing
U.S. EPA (2016b):
Market Profile. EPA-HQ-
OPPT-2016-0732:
Intermediate in petroleum
refineries
U.S. EPA (2016b):
Market Profile. EPA-HQ-
OPPT-2016-0732: Public
Page 23 of 77
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Life Cycle Stage
Categorya
Subcategory b
References
Comment, EPA-HQ-
OPPT-2016-0732-0018
Residual or byproduct
Public Comment, EPA-
HQ-OPPT-2016-0732-
0013
Incorporated into
formulation, mixture
or reaction product
Cleaning and degreasing
products
U.S. EPA (2016b): Public
Comment, EPA-HQ-
OPPT-2016-0732-0017
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-
HQ-OPPT-2016-0732-
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-
HQ-OPPT-2016-0732-
0003
Industrial use
Solvents (for cleaning
or degreasing)
Solvents and/or Degreasers
(cold, aerosol spray or vapor
degreaser; not specified in
comment)
Market Profile. EPA-HQ-
OPPT-2016-0732: Public
Comment, EPA-HQ-
OPPT-2016-0732-0022:
Public Comment, EPA-
HQ-OPPT-2016-0732-
0029
Batch vapor degreaser (e.g.,
open-top, closed-loop)
U.S. EPA (1985b): Public
Comment, EPA-HQ-
OPPT-2016-0732-0015:
Public Comment, EPA-
HQ-OPPT-2016-0732-
0027
In-line vapor degreaser (e.g.,
conveyorized, web cleaner)
U.S. EPA (1985b): Public
Comment, EPA-HQ-
OPPT-2016-0732-0014
Page 24 of 77
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Life Cycle Stage
Categorya
Subcategory b
References
Solvents (for cleaning
or degreasing)
Cold cleaner
Market Profile. EPA-HQ-
OPPT-2016-0732: U.S.
EPA (1985b): Public
Comment, EPA-HQ-
OPPT-2016-0732-0017
Aerosol spray
degreaser/cleaner
Use Document, EPA-
HQ-OPPT-2016-0732-
0003; Market Profile,
EPA-HQ-OPPT-2016-
0732; Public Comment,
EPA-HQ-OPPT-2016-
0732-0009: Public
Comment, EPA-HQ-
OPPT-2016-0732-0017
Dry cleaning solvent
Market Profile. EPA-HQ-
OPPT-2016-0732: U.S.
EPA (2006a)
Spot cleaner
Market Profile. EPA-HQ-
OPPT-2016-0732: U.S.
EPA (2006a): Public
Comment, EPA-HQ-
OPPT-2016-0732-0009
Lubricants and
greases
Lubricants and greases (e.g.,
penetrating lubricants,
cutting tool coolants, aerosol
lubricants)
U.S. EPA (2016b):
Market Profile. EPA-HQ-
OPPT-2016-0732: Public
Comment, EPA-HQ-
OPPT-2016-0732-0027:
Public Comment, EPA-
HQ-OPPT-2016-0732-
0029
Adhesive and sealant
chemicals
Solvent-based adhesivesand
sealants
U.S. EPA (2016b): Use
Document, EPA-HQ-
OPPT-2016-0732-0003:
Market Profile. EPA-HQ-
OPPT-2016-0732: Public
Comment, EPA-HQ-
OPPT-2016-0732-0009:
Public Comment, EPA-
HQ-OPPT-2016-0732-
0015; Public Comment,
EPA-HQ-OPPT-2016-
0732-0022: Public
Page 25 of 77
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Life Cycle Stage
Categorya
Subcategory b
References
Comment, EPA-HQ-
OPPT-2016-0732-0027
Paints and coatings
including paint and
coating removers
Solvent-based paints and
coatings
U.S. EPA (2016b): Use
Document, EPA-HQ-
OPPT-2016-0732-0003:
Market Profile. EPA-HQ-
OPPT-2016-0732: Public
Comment, EPA-HQ-
OPPT-2016-0732-0006:
Public Comment, EPA-
HQ-OPPT-2016-0732-
0009; Public Comment,
EPA-HQ-OPPT-2016-
0732-0015: Public
Comment, EPA-HQ-
OPPT-2016-0732-0020:
Public Comment, EPA-
HQ-OPPT-2016-0732-
0027
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, EPA-HQ-
OPPT-2016-0732-0003:
Market Profile. EPA-HQ-
OPPT-2016-0732: Dow
Chemical Co (2008);
Public Comment, EPA-
HQ-OPPT-2016-0732-
0018; Public Comment,
EPA-HQ-OPPT-2016-
0732-0027
Other uses
Textile processing
Use Document, EPA-
HQ-OPPT-2016-0732-
0003; Market Profile,
EPA-HQ-OPPT-2016-
0732
Wood furniture
manufacturing
Use Document, EPA-
HQ-OPPT-2016-0732-
0003
Page 26 of 77
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Life Cycle Stage
Categorya
Subcategory b
References
Laboratory chemicals
Use Document, EPA-
HQ-OPPT-2016-0732-
0003; Market Profile,
EPA-HQ-OPPT-2016-
0732; Public Comment,
EPA-HQ-OPPT-2016-
0732-0015
Foundry applications
Use Document, EPA-
HQ-OPPT-2016-0732-
0003; Market Profile,
EPA-HQ-OPPT-2016-
0732
Commercial/consumer
use
Cleaning and
furniture care
products
Cleaners and degreasers
(other)
Market Profile. EPA-HQ-
OPPT-2016-0732: Public
Comment, EPA-HQ-
OPPT-2016-0732-0009:
Public Comment, EPA-
HQ-OPPT-2016-0732-
0017; Public Comment,
EPA-HQ-OPPT-2016-
0732-0022; EPA-HQ-
OPPT-2016-0732-0023;
Public Comment, EPA-
HQ-OPPT-2016-0732-
0027; Public Comment,
EPA-HQ-OPPT-2016-
0732-0029
Dry cleaning solvent
Market Profile. EPA-HQ-
OPPT-2016-0732: U.S.
EPA (2006a); Public
Comment, EPA-HQ-
OPPT-2016-0732-0007;
Public Comment, EPA-
HQ-OPPT-2016-0732-
0009
Spot cleaner
Market Profile. EPA-HQ-
OPPT-2016-0732; U.S.
EPA (2006a); Public
Comment, EPA-HQ-
OPPT-2016-0732-0009
Page 27 of 77
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Life Cycle Stage
Categorya
Subcategory b
References
Automotive care products
(e.g., engine degreaser and
brake cleaner)
U.S. EPA (2016b). Use
Document, EPA-HQ-
OPPT-2016-0732-0003:
Market Profile. EPA-HQ-
OPPT-2016-0732: Public
Comment, EPA-HQ-
OPPT-2016-0732-0017:
Public Comment, EPA-
HQ-OPPT-2016-0732-
0027
Aerosol cleaner
Use Document, EPA-
HQ-OPPT-2016-0732-
0003; Market Profile,
EPA-HQ-OPPT-2016-
0732; Public Comment,
EPA-HQ-OPPT-2016-
0732-0009
Non-aerosol cleaner
Use Document, EPA-
HQ-OPPT-2016-0732-
0003; Market Profile,
EPA-HQ-OPPT-2016-
0732; Public Comment,
EPA-HQ-OPPT-2016-
0732-0009
Lubricants and
greases
Lubricants and greases (e.g.,
penetrating lubricants,
cutting tool coolants, aerosol
lubricants)
U.S. EPA (2016b);
Market Profile. EPA-HQ-
OPPT-2016-0732; Public
Comment, EPA-HQ-
OPPT-2016-0732-0027;
Public Comment, EPA-
HQ-OPPT-2016-0732-
0029
Adhesives and
sealant chemicals
Adhesives for arts and crafts
U.S. EPA (2016b); Use
Document, EPA-HQ-
OPPT-2016-0732-0003;
Market Profile. EPA-HQ-
OPPT-2016-0732; Public
Comment, EPA-HQ-
OPPT-2016-0732-0009
Light repair adhesives
U.S. EPA (2016b); Use
Document, EPA-HQ-
OPPT-2016-0732-0003
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Life Cycle Stage
Categorya
Subcategory b
References
Paints and coatings
Solvent-based paints and
coatings
U.S. EPA (2016b): Use
Document, EPA-HQ-
OPPT-2016-0732-0003:
Market Profile. EPA-HQ-
OPPT-2016-0732: Public
Comment, EPA-HQ-
OPPT-2016-0732-0009:
Public Comment, EPA-
HQ-OPPT-2016-0732-
0020; Public Comment,
EPA-HQ-OPPT-2016-
0732-0027
Other uses
Carpet cleaning
Use Document, EPA-
HQ-OPPT-2016-0732-
0003; Market Profile,
EPA-HQ-OPPT-2016-
0732; Public Comment,
EPA-HQ-OPPT-2016-
0732-0009
Laboratory chemicals
Use Document, EPA-
HQ-OPPT-2016-0732-
0003; Market Profile,
EPA-HQ-OPPT-2016-
0732
Metal (e.g., stainless steel)
and stone polishes
Use Document, EPA-
HQ-OPPT-2016-0732-
0003; Market Profile,
EPA-HQ-OPPT-2016-
0732
Inks and ink removal
products
Use Document, EPA-
HQ-OPPT-2016-0732-
0003; Market Profile,
EPA-HQ-OPPT-2016-
0732
Welding
Use Document, EPA-
HQ-OPPT-2016-0732-
0003; Market Profile,
EPA-HQ-OPPT-2016-
0732;
Photographic film
Use Document, EPA-
HQ-OPPT-2016-0732-
0003
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Life Cycle Stage
Categorya
Subcategory b
References
Mold cleaning, release and
protectant products
Use Document, EPA-
HQ-OPPT-2016-0732-
0003; Market Profile,
EPA-HQ-OPPT-2016-
0732; Public Comment,
EPA-HQ-OPPT-2016-
0732-0017
Disposal
Emissions to air
Air
Use Document, EPA-
Wastewater
Industrial pre-treatment
HQ-OPPT-2016-0732-
0003
Industrial wastewater
treatment
Publicly owned treatment
works (POTW)
Underground injection
Solid wastes and
Municipal landfill
liquid wastes
Hazardous landfill
Other land disposal
Municipal waste incinerator
Hazardous waste incinerator
Off-site waste transfer
a These categories appear in the Life Cycle Diagram, reflect CDR codes and broadly represent conditions of use of
perchloroethylene in industrial and/or commercial settings.
b These subcategories reflect more specific uses of perchloroethylene.
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 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-HQ-QPPT-2016-0732-0033). Previously,
perchloroethylene was widely used to manufacture CFCs (esp. trichlorotrifluoroethane (CFC-113)) until
CFCs were essentially eliminated in the United States by the Montreal Protocol; 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-QPPT-2016-0732).
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
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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.
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-HQ-QPPT-2016-0732-0027). 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) (Stove, 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,
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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, EPA-HQ-OPPT-2016-0732-00031.
2.3 Exposures
For TSCA exposure assessments, EPA expects to evaluate exposures and releases to the environment
resulting from the conditions of use applicable to perchloroethylene. 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 2-4 provides environmental fate data that EPA has identified and considered in
developing the scope for perchloroethylene.
Table 2-4. Environmental Fate Characteristics of Perchloroethylene
Property or Endpoint
Valuea
References
Direct photodegradation
3 years (atmosphere)
ECB (2005)
Indirect photodegradation
96 days (atmosphere)
ECB (2005)
Hydrolysis half-life
Months-years
ECB (2005)
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 (2005)
Bioconcentration factor (BCF)
40 and 49 (fish)
312 and 101 (marine algae)
ECB (2005)
Bioaccumulation factor (BAF)
46 (estimated)
ECB (2005): (U.S. EPA.
2012a)
Organic carbon:water
partition coefficient (log Koc)
1.6-2.7
2.9 (estimated)
ECB (2005)
a Measured unless otherwise noted.
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The environmental fate and transport of perchloroethylene has been reviewed by ATSDR (2014). WHO
(2006) and ECB (2005). This section was prepared based on these reviews.
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 complicated, with
results highly dependent on specific environmental and microbial conditions (WHO. 2006; ECB. 2005).
In the vapor phase perchloroethylene can be slowly transformed by reaction with hydroxyl and other
radicles 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 processes. Hydrolysis, if it occurs, is expected to be slow with a half-life
(ti/2) of greater than months to years.
Aerobic biodegradation may occur but degradation is slow with rates and pathways that are
environment- and population-dependent. Anaerobic degradation has been observed to be faster than
aerobic degradation under some conditions with acclimated microbial populations.
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.
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.
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 biodegradation in the environment is expected to be slow with ti/2 of months or
greater.
With BCFs and BAFs ranging from 40 to 100, ATSDR (2014). WHO (2006) and ECB (2005) 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 key source of information that EPA expects to consider in evaluating exposure are data reported
under the 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.
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Table 2-5 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 2-6 provides
more detailed information on the quantities released to air or water or disposed of on land.
Table 2-5. Summary of Perchloroethylene TRI Production-Related Waste Managed in 2015 (lbs)
Number of
Energy
Total Production
Facilities
Recycling
Recovery
Treatment
Releasesa,b,c
Related Waste
27
46,406,761
2,341,981
15,130,958
1,167,367
65,047,068
Data source: 2015 TRI Data (updated March 2017) U.S. EPA (2017).
aTerminology 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.
c 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, 46 million pounds were recycled, 2.3 million pounds were recovered for energy, 15 million
pounds were treated and 1.1 million pounds were released into the environment. Of these releases,
the majority, or 63 percent, were released to air: 0.7 million pounds were released to air (stack and
fugitive air emissions), 349 pounds were released to water (surface water discharges), 78 thousand
pounds were released to land (of which disposal to Resource Conservation and Recovery Act (RCRA)
Subtitle C landfills is the primary disposal method) and 334 thousand pounds were released in other
forms such as to waste brokers.
Release quantities in Table 2-6 are more representative of actual releases during the year. Production-
related waste managed shown in Table 2-5 excludes any quantities reported as catastrophic or one-
time releases (TRI section 8 data), while release quantities shown in Table 2-6 include both production-
related and non-routine quantities (TRI section 5 and 6 data). Table 2-5 counts all release quantities
reported to TRI while Table 2-6 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
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. 2017).
Table 2-6. Summary of Perchloroethylene TRI Releases to the Environment in 2015 (lbs)
Number
of
Facilities
Air Releases
Water
Releases
Land Releases
Other
Releasesa
Total
Releasesbc
Stack
Air
Releases
Fugitive
Air
Releases
Class 1
Under-
ground
Injection
RCRA
Subtitle C
Landfills
All other
Land
Disposala
Subtotal
435,558
279,073
272
78,036
414
Totals
27
714,631
349
78,722
334,148
1,127,864
Data source: 2015 TRI Data (updated March 2017) U.S. EPA (2017).
3 Terminology used in these columns may not match the more detailed data element names used in the TRI public data and analysis access points.
b These release quantities do include releases due to one-time events not associated with production such as remedial actions or earthquakes.
c Counts release quantities once at final disposition, accounting for transfers to other TRI reporting facilities that ultimately dispose of the chemical
waste.
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While production-related waste managed shown in Table 2-5 excludes any quantities reported as
catastrophic or one-time releases (TRI Section 8 data), release quantities shown in Table 2-6 include
both production-related and non-routine quantities (TRI section 5 and 6 data). As a result, release
quantities may differ slightly and may further reflect differences in TRI calculation methods for
reported release range estimates (U.S. EPA. 2017).
Other sources of information provide evidence of releases of perchloroethylene, including EPA effluent
guidelines (EGs) promulgated under the Clean Water Act (CWA), National Emission Standards for
Hazardous Air Pollutants (NESHAPs) promulgated under the Clean Air Act (CAA) or other EPA standards
and regulations that set legal limits on the amount of perchloroethylene that can be emitted to a
particular media. EPA expects to consider these data in conducting the exposure assessment
component of the risk evaluation for perchloroethylene.
2.33 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(WHQ, 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. 2012b). EPA will evaluate 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. 2012b; 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. 2015, Table 4.1). Indoor air concentrations of
perchloroethylene tend to be greater than concentrations in outdoor air (ATSDR, 2014; U.S. EPA.
2012b).
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; Wf iO, 006 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 tig/L. U.S. EPA. 2009).
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Biota
The EU Risk Assessment Report (ECB, 2005) 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.
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).
2.3.4 Environmental Exposures
The manufacturing, processing, use and disposal of perchloroethylene can result in releases to the
environment. EPA expects to consider exposures to the environment and ecological receptors that
occur via the exposure pathways or media shown in Figure 2-4 in conducting the risk evaluation for
perchloroethylene.
2.3.5 Human Exposures
The manufacturing, processing, distribution, use and disposal of perchloroethylene can result in
releases to the environment. EPA expects to consider exposures to the environment and ecological
receptors that occur via the exposure pathways or media shown in Figure 2-4 in conducting the risk
evaluation for perchloroethylene.
2.3.5.1 Occupational Exposures
EPA expects to consider worker activities where there is a potential for exposure under the various
conditions of use described inSection 2.2. In addition, EPA expects to consider exposure to
occupational non-users, who do not directly handle the chemical but perform work in an area where
the chemical is present. When data and information are available to support the analysis, EPA also
expects to consider the effect(s) that engineering controls and/or personal protective equipment have
on 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, that may include:
• Unloading and transferring perchloroethylene to and from storage containers to process
vessels;
• Using perchloroethylene in process equipment (e.g., vapor degreasing machine);
• Applying formulations and products containing perchloroethylene onto substrates (e.g., spray
applying coatings or adhesives containing perchloroethylene);
• Performing other work activities in or near areas where perchloroethylene is used.
Based on these activities, EPA expects to consider inhalation exposure to vapor and mists, and dermal
exposure, including skin contact with liquids and vapors for workers and occupational non-users. EPA
also expects to consider potential worker exposure through mists that deposit in the upper respiratory
tract and are swallowed.
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The United States has several regulatory and non-regulatory exposure limits for perchloroethylene: An
OSHA Permissible Exposure Limit (PEL) of 100 ppm 8-hour time-weighted average (TWA) (OSHA, 1997)
and an American Conference of Government Industrial Hygienists (ACGIH) Threshold Limit Value (TLV)
of 25 ppm 8-hour TWA (AC DPI). 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, 1994).
Key data that inform occupational exposure assessment and which EPA expects to consider
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 Integrated Management Information System (IMIS) at
https://www.osha.gov/oshstats/index.html.
Table_Apx B-1 in Appendix B provides a summary of industry sectors with 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/.
During the problem formulation, EPA will review these data and evaluate their utility in the risk
evaluation.
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 (EPA~HQ~OPPT~2016~0732~00Q3. Sections 3 and 4 and Table 2-3)
and can therefore result in exposures to consumers.
Exposures routes for consumers using perchloroethylene-containing products may include inhalation
of vapors mists and aerosols (e.g., aerosols from spray applications), dermal exposure to products and
oral exposure to mists that deposit in the upper respiratory tract and are swallowed. Although unlikely
given the physical-chemical properties, EPA also expects to consider oral ingestion via oral route such
as from incidental ingestion of methylene chloride residue on hands and body.
EPA expects to consider inhalation, dermal and oral exposures to consumers and bystanders associated
with the consumer use in the home.
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. EPA will consider each
media, route and pathway to estimate general population exposures.
Inhalation
General population inhalation exposure to perchloroethylene in air may result from industrial
manufacturing and processing plant fugitive emissions. Perchloroethylene volatizes from contaminated
soil and shallow ground water, possibly resulting in elevated outdoor inhalation exposure. Through a
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process known as vapor intrusion, volatized 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. 2012c). 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. 2012b).
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. 2012b).
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. 2012b).
Based on these potential sources and pathways of exposure, EPA expects to consider inhalation
exposures of the general population to air containing perchloroethylene that may result from the
conditions of use of perchloroethylene.
Oral
The general population may ingest perchloroethylene via contaminated drinking water, ground water
and/or surface water (ATSDR. 2014; U.S. EPA. 2012b). 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. EPA also expects to consider ingestion
via the oral route such as from incidental ingestion of perchloroethylene residue on the hand/body.The
EU Risk Assessment Report (ECB. 2005) 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,. i'06).
Based on these potential sources and pathways of exposure, EPA expects to consider oral exposures to
the general population that may result from the conditions of use of perchloroethylene.
Dermal
Exposure to perchloroethylene may occur via use of products containing perchloroethylene, and
through dermal contact with dry-cleaned fabrics or other articles treated with products containing
perchloroethylene (U.S. EPA. 2012b). Dermal exposure to perchloroethylene from showering, bathing
and swimming is also possible (U.S. EPA. 2012b).
Based on these potential sources and pathways of exposure, EPA expects to consider dermal exposures
to the general population that may result from the conditions of use of perchloroethylene.
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2.3.5.4 Potentially Exposed or Susceptible Subpopulations
TSCA requires that the determination of whether a chemical substance presents an unreasonable risk
include consideration of unreasonable risk to "a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation" by EPA. TSCA § 3(12) states that "the term 'potentially
exposed or susceptible subpopulation' means a group of individuals within the general population
identified by the Administrator who, due to either greater susceptibility or 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 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.
Of the human receptors identified in the previous sections, EPA identifies the following as potentially
exposed or susceptible subpopulations due to their greater exposure, that EPA expects to consider in
the risk evaluation:
• Workers and occupational non-users, including women of childbearing age.
• Consumers and bystanders associated with consumer use. Perchloroethylene has been
identified as being used in products available to consumers; however, only some individuals
within the general population may use these products. Therefore, those who do use these
products, including hobbyists, 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, use or disposal sites).
In developing exposure scenarios, EPA will evaluate available data to ascertain whether some human
receptor groups may be exposed via exposure pathways that may be distinct to a particular
subpopulation or lifestage (e.g., children's crawling, mouthing or hand-to-mouth behaviors) and
whether some human receptor groups may have higher exposure via identified pathways of exposure
due to unique characteristics (e.g., activities, duration or location of exposure) when compared with
the general population (U.S. EPA. 2006b).
For example, the behavior of children may put them in closer contact with some sources of
perchloroethylene, such as carpet cleaners. The hand-to-mouth/mouthing behaviors of small children
may increase accidental ingestion of perchloroethylene from dry cleaned articles and contaminated
soils. Children may be exposed via inhalation as bystanders, during consumer use in the home.
Although the amount of perchloroethylene children may ingest through water and food is not well
described (U.S. EPA. 2012b), children tend to consume more water and food per body weight relative
to adults, and have greater skin surface area than adults, relative to weight, which can result in
proportionally higher ingestion and dermal exposures.
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
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perchloroethylene (U.S. EPA. 2012b) also identified the developing fetus as potentially exposed, as well
as infants consuming breastmilk, particularly for mothers with occupational exposure to
perchloroethylene or exposure due to proximity to industrial or commercial sources (U.S. EPA, 2012b).
Infants fed by formula may also experience increased perchloroethylene exposure if perchloroethylene
is present in drinking water supplies (U.S. EPA. 2012b).
In summary, in the risk evaluation for perchloroethylene, EPA expects to consider the following
potentially exposed groups of human receptors: workers, occupational non-user, consumers and
bystanders associated with consumer use. As described above, EPA may also identify additional
potentially exposed or susceptible subpopulations that will be considered based on greater exposure.
2.4 Hazards (Effects)
For scoping, EPA conducted comprehensive searches for data on hazards of 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 consider the hazards of perchloroethylene identified in this scope document. However,
when conducting the risk evaluation, the relevance of each hazard within the context of a specific
exposure scenario will be judged for appropriateness. For example, hazards that occur only as a result
of chronic exposures may not be applicable for acute exposure scenarios. This means that it is unlikely
that every hazard identified in the scope will be considered for every exposure scenario.
2.4.1 Environmental Hazards
For scoping purposes, EPA consulted the following sources of environmental hazard data for
perchloroethylene: 005) and WHO (2006). However, 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
(CASRN 127-18-4) Bibliography: Supplemental File for the TSCA Scope Document, EPA-HQ-QPPT-2016-
0732).
EPA expects to consider the hazards of perchloroethylene to aquatic organisms including fish, aquatic
invertebrates and algae potentially exposed under acute and chronic exposure conditions. The ECB
(2005) Risk Assessment for perchloroethylene suggests acute and chronic hazard for the environment
based on mortality, immobility, cell growth inhibition and reproduction. EPA also expects to consider
the hazards of perchloroethylene to terrestrial organisms including soil invertebrates, birds, insects and
mammals and amphibians exposed to relevant media under acute and/or chronic exposure conditions.
2.4.2 Human Health Hazards
Perchloroethylene has an existing EPA IRIS Assessment (U.S. EPA. 2012b) and a draft ATSDR
Toxicological Profile (ATSDR, 2014); hence, many of the hazards of perchloroethylene have been
previously compiled and systematically reviewed. EPA has relied heavily on these comprehensive
reviews in preparing this scope. 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 (CASRN 127-18-4)
Bibliography: Supplemental File for the TSCA Scope Document). EPA expects to consider all potential
hazards associated with perchloroethylene. Based on reasonably available information, the following
are the hazards that have been identified in previous government documents and that EPA currently
expects will likely be the focus of its analysis.
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2.4.2.1 Non-Cancer Hazards
The EPA IRIS Assessment on perchloroethylene (U.S. EPA, 2012b) 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 (U.S. EPA. 2012b), 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.
Acute Toxicity
Data from acute 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. 2012b). An Acute Exposure Guidance Limit (AEGL) values, established by the
National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances
(NAC/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. 2009).
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. 2012b). 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 (U.S. EPA. 2012b). The EPA IRIS assessment for perchloroethylene
(U.S. EPA. 2012b) further notes that the nervous system is an expected target with oral
perchloroethylene exposures because perchloroethylene and metabolites produced from inhalation
exposures will also reach the target tissue via oral exposure.
Kidney Toxicity
Animal and epidemiologic evidence supports an association between perchloroethylene exposure and
chronic kidney disease. Adverse effects on the kidney (e.g., kidney-to-body weight ratios, hyaline droplet
formation, glomerular "nephrosis," karyomegaly (enlarged nuclei), cast formation, and other lesions or
indicators of renal toxicity) have been observed in studies of rodents exposed to high concentrations of
perchloroethylene by inhalation, oral and intraperitoneal (i.p.) injection of perchloroethylene
metabolites, supporting the human incidence information (U.S. EPA. 2012b).
Liver Toxicity
Liver toxicity (i.e., necrosis, vacuolation, etc) has been reported in multiple animal species by inhalation
and oral exposures to perchloroethylene, with the mouse typically being more sensitive than the rat
(U.S. EPA. 2012b). The liver effects are characterized by increased liver weight, necrosis, inflammatory
cell infiltration, triglyceride increases proliferation, cytoplasmic vacuolation (fatty changes), pigment in
cells, oval cell hyperplasia and regenerative cellular foci. The EPA IRIS Assessment for
perchloroethylene (U.S. EPA. 2012b) found suggestive evidence that perchloroethylene is a liver
toxicant in humans.
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Reproductive/Developmental Toxicity
The EPA IRIS Assessment for perchloroethylene (U.S. EPA. 2012b) evaluated the developmental and
reproductive toxicity of perchloroethylene in humans and animals. Studies of tetrachloroethylene
exposure in humans have evaluated several reproductive outcomes including effects on menstrual
disorders, semen quality, fertility, time to pregnancy, and risk of adverse pregnancy outcomes including
spontaneous abortion, low birth weight or gestational age, birth anomalies, and stillbirth (U.S. EPA,
2012b). Data from animal studies identified various manifestations of developmental toxicity including,
increased mortality and decreased body weight in the offspring of rodents exposed via inhalation.
Irritation
Irritation data for perchloroethylene have been reviewed outside the EPA IRIS Assessment. Controlled
exposures in humans and case reports have identified eye and nose irritation (NAC/AEGL. 2009).
2.4.2.2 Genotoxicity and Cancer Hazards
Epidemiologic data indicate several cancer types, including non-Hodgkin lymphoma, multiple myeloma,
bladder, esophageal, kidney, lung, cervical and breast cancer (U.S. EPA. 2012b). 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.
2012b). 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 (U.S. EPA. 2012b).
Following U.S. EPA (2005a) Guidelines for Carcinogen Risk Assessment, EPA concluded that
perchloroethylene is "likely to be carcinogenic in humans by all routes of exposure" (U.S. EPA. 2012b).
2.4.2.3 Potentially Exposed or Susceptible Subpopulations
TSCA requires that the determination of whether a chemical substance presents an unreasonable risk
include consideration of unreasonable risk to "a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation" by EPA. TSCA § 3(12) states that "the term 'potentially
exposed or susceptible subpopulation' means a group of individuals within the general population
identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at
greater risk than the general population of adverse health effects from exposure to a chemical
substance or mixture, such as infants, children, pregnant women, workers, or the elderly." In
developing the hazard assessment, EPA will evaluate available data to ascertain whether some human
receptor groups may have greater susceptibility than the general population to the chemical's
hazard(s).
The EPA IRIS Assessment for perchloroethylene (U.S. EPA. 2012b) and ATSDR (21 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 EPA
(2012b) also determined that the available data was insufficient to allow for a quantitative assessment
of the impact of susceptibility on risk.
2.5 Initial Conceptual Models
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
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the conditions of use, exposures (pathways and routes), hazards and receptors. As part of the scope for
perchloroethylene, EPA developed three conceptual models, presented here.
2.5,1 Initial Conceptual Model for Industrial and Commercial Activities and Uses:
Potential Exposures and Hazards
Figure 2-2 presents the initial conceptual model for human receptors from industrial and commercial
activities and uses of perchloroethylene. EPA expects that workers and occupational non-users may be
exposed to perchloroethylene via inhalation and dermal routes. EPA also expects to consider workers'
potential exposure through mists that deposit in the upper respiratory tract and are swallowed.
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INDUSTRIAL AND COMMERCIAL
ACTIVITIES / USES
EXPOSURE PATH WAV
EXPOSURE ROUTE
RECEPTORS r
HAZARDS
Mar jfactf ng
Processing:
~ As reaetantf interrelate
~ incorporated into
fO«r*ulatiOn. WitlXe, Of
taction product
* incorporated into article
~ flepackagiog
ftecydlrg
Srivwits far Cleaning and
Oegreaslrg
UAricants and Greases
Adhesive and Sealant
Cftemi&aH
Paints and Coatings
Processing Aid fix Agricultural
Products
Processing Aid for
PetrocMn*al Manufacturing
OtHer mdustrfa* and
ConvnvE*cial Uses*
Cleaning and Furniture Care
Products
-# Liquid Contact
Fugrtjve
Emissions*
VapOf/ Mitt
Inhalationd
Workers1,
Occupational
Wofv users
Hazards Potential? Associated
with Acute and/or Chronic
Exposures
See Section 2.4,2
Outdoor Air
4See Figure 2-4 far
Emissions to Air)
Stack
Emissions b
> A* Pollution Control
Indoor vapor from Co-
located flesidences
and/or Businesses or
vapor intrusione
Waste Handling. Treatment and
Disposal
Population "«n
Co-located
Buildings
Dermal, kihalstnii
Workers \
Occupational
Nor-Users
i Liqud Contact Vapor
Dermal, mhjistion
wastewater, Liquid Wastes, Sofef W
-------
2.5.2 Initial Conceptual Model for Consumer Activities and Uses: Potential
Exposures and Hazards
Figure 2-3 presents the initial conceptual model for human receptors from consumer uses of
perchloroethylene. Similar to Figure 2-2, consumers and bystanders may be exposed via inhalation,
dermal and oral routes. It should be noted that some consumers may purchase and use products
primarily intended for commercial use. It also shows emissions of perchloroethylene to wastewater,
liquid and solid wastes containing perchloroethylene.
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CONSUMER ACTIVITIES / USES
EXPOSURE PATHWAY
EXPOSURE ROUTE
RECEPTORS c
HAZARDS
Ueanlngar.d F jrr I jrclare
Products
e.g. aerosol sport removers,
non-aerosol cleaners, Aerosol
degreasers, brake cleaners,
engine degreasers
Lubricants *n
-------
2,53 Initial Conceptual Model for Environmental Releases and Wastes: Potential
Exposures and Hazards
As shown in Figure 2-4, EPA anticipates that industrial, commercial and consumer activities could result
in emissions of perchloroethylene to outdoor air, as well as liquid and solid wastes containing
perchloroethylene. EPA anticipates that general populations living near industrial and commercial
facilities using perchloroethylene may be exposed via inhalation of outdoor air. General populations
may also be exposed via ingestion of contaminated drinking water, dermal and inhalation exposure
from showering/bathing with contaminated drinking water and inhalation exposure from the migration
of vapor in air, soil or ground water to air. In addition, aquatic and terrestrial life may be exposed to
perchloroethylene-contaminated water, sediment and soil.
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RELEASES AND WASTES FROM EXPOSURE PATHWAY EXPOSURE ROUTE RECEPTORS* EFFECTS
INDUSTRIAL / COMMERCIAL / CONSUMER USES
Aquatic
Spect«
General
Papulation
Soli
Hiwrvin Health Pattiray
EcotoflJoal Pathway
Air
Cmtssnncs to Air
WatfCWit W or
LitjUiC IWiSteS-1
Off-rslte Waste
Transfer
Recycllrft. Other
Treatment *
Oral
Dermal.,1 nh a I a 11 on5
Incinerators
{Municipal &
Hazardous Waste)
Industrial Pre-
TrestWit or
incHjsTfiji Vi%VT
Municipal,
Hazardous Lardfl
ar Other Land
Disposal
Hazards Potentufty Associated
with Acute and/or Chronic
Exposures
See Section 2.4.2
Hazards Potcrt -a v Associated with
Acute ar d Chronic Exposures
i-ee Section 2.4.1
Hatnrtfa Ppl«hli|% AisecidtH-d with
Aeuie Ch'
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2.6 Initial Analysis Plan
The initial analysis plan will be used to develop the eventual problem formulation and final analysis
plan for the risk evaluation. While EPA has conducted a search for readily available data and
information from public sources (see Perchloroethylene (127-18-4) Bibliography: Supplemental File for the
TSCA Scope Document) as described in Section 1.3, 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.
The analysis plan outlined here is based on the conditions of use of perchloroethylene, as described in
Section 2.2 of this scope. The analysis plan may be refined as EPA proceeds with the systematic review
of the information in the Perchloroethylene (CASRN 127-18-4) Bibliography: Supplemental File for the
TSCA Scope Document. EPA will be evaluating the weight of the scientific evidence for both hazard and
exposure. Consistent with this approach, EPA will also use a systematic review approach. As such, EPA
will use explicit, pre-specified criteria and approaches to identify, select, assess, and summarize the
findings of studies. This approach will help to ensure that the review is complete, unbiased,
reproducible, and transparent.
2.6.1 Exposure
2.6.1.1 Environmental Releases
EPA expects to consider and analyze releases to 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 (Perchloroethylene
(CASRN 127-18-4) Bibliography: Supplemental File for the TSCA Scope Document) (EPA 2017).
2) Review reasonably available chemical-specific release data, including measured or estimated
release data (e.g., data collected under the TRI and National Emissions Inventory [NEI]
programs).
3) Review reasonably available measured or estimated release data for surrogate chemicals that
have similar uses, volatility, chemical and physical properties.
4) Understand and consider regulatory limits that may inform estimation of environmental
releases.
5) Review and determine applicability of Organisation for Economic Co-operation and
Development (OECD) Emission Scenario Documents (ESDs)and EPA Generic Scenarios to
estimation of environmental releases.
6) Evaluate the weight of the evidence of environmental release data.
7) Map or group each condition(s) of use to a release assessment scenario.
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 (Perchloroethylene (CASRN 127-18-4) Bibliography:
Supplemental File for the TSCA Scope Document.
2) Using measured data and/or modeling, determine the influence of environmental fate
endpoints (e.g., persistence, bioaccumulation, partitioning, transport) on exposure pathways
and routes of exposure to human and environmental receptors.
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3) Evaluate the weight of the evidence of environmental fate data.
2.6.1.3 Environmental Exposures
EPA expects to consider the following in developing its environmental exposure assessment of
perchloroethylene:
1) Review reasonably available environmental and biological monitoring data for all media
relevant to environmental exposure.
2) 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 will be evaluated and considered alongside available monitoring data to
characterize environmental exposures. Modeling approaches to estimate surface water
concentrations, sediment concentrations and soil concentrations generally consider the
following inputs: release into the media of interest, fate and transport and characteristics of the
environment.
3) Review reasonably available biomonitoring data. Consider whether these monitoring data could
be used to compare with species or taxa-specific toxicological benchmarks.
4) Determine applicability of existing additional contextualizing information for any monitored
data or modeled estimates during risk evaluation. Review and characterize the spatial and
temporal variability, to extent data are available, and characterize exposed aquatic and
terrestrial populations.
5) Evaluate the weight of evidence of environmental occurrence data and modeled estimates.
6) Map or group each condition(s) of use to environmental assessment scenario(s).
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. Exposure
data to be reviewed may include workplace monitoring data collected by government agencies
such as OSHA and the National Institute of Occupational Safety and Health (NIOSH), and
monitoring data found in published literature (e.g., personal exposure monitoring data (direct
measurements) and area monitoring data (indirect measurements) (Perchloroethylene (CASRN
127-18-4) Bibliography: Supplemental File for the TSCA Scope Document).
2) Review reasonably available exposure data for surrogate chemicals that have uses, volatility
and chemical and physical properties similar to perchloroethylene.
3) For conditions of use where data limited or not available, review existing exposure models that
may be applicable in estimating exposure levels.
4) Review reasonably available data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation.
5) Evaluate the weight of the evidence of occupational exposure data.
6) Map or group each condition of use to occupational exposure assessment scenario(s).
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} Review reasonably available consumer product-specific exposure data related to consumer
uses/exposures.
2) Evaluate the weight of the evidence of consumer exposure data.
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3) For exposure pathways where data are not available, review existing exposure models that may
be applicable in estimating exposure levels.
4) Review reasonably available data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation. For example, existing models developed for a
chemical assessment may be applicable to another chemical assessment if model parameter
data are available.
5) Review reasonably available consumer product-specific sources to determine how those
exposure estimates compare with those reported in monitoring data.
6) Review reasonably available population- or subpopulation-specific exposure factors and activity
patterns to determine if potentially exposed or susceptible subpopulations need be further
refined.
7) Map or group each condition of use to consumer exposure assessment scenario(s).
2.6.1.6 General Population
EPA expects to consider and analyze general population exposures as follows:
1) Review reasonably available environmental and biological monitoring data for media to which
general population exposures are expected.
2) For exposure pathways where data are not available, review existing exposure models that may
be applicable in estimating exposure levels.
3) Consider and incorporate applicable media-specific regulations into exposure scenarios or
modeling.
4) Review reasonably available data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation. For example, existing models developed for a
chemical assessment may be applicable to another chemical assessment if model parameter
data are available.
5} Review reasonably available information on releases to determine how modeled estimates of
concentrations near industrial point sources compare with available monitoring data.
6) Review reasonably available population- or subpopulation-specific exposure factors and activity
patterns to determine if potentially exposed or susceptible subpopulations need be further
defined.
7) Evaluate the weight of the evidence of general population exposure data.
8) Map or group each condition of use to general population exposure assessment scenario(s).
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).
2) 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.
3) Derive concentrations of concern (COC) for all identified ecological endpoints.
4) Evaluate the weight of the evidence of environmental hazard data.
5) Consider the route(s) of exposure, available biomonitoring data and available approaches to
integrate exposure and hazard assessments.
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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 (e.g., computational toxicology and bioinformatics; high-throughput screening
methods; data on categories and read-across; in vitro studies; systems biology.
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.
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.
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.
5) Evaluate the weight of the evidence of human health hazard data.
6) Consider the route(s) of exposure (oral, inhalation, dermal), available route-to-route
extrapolation approaches, available biomonitoring data and available approaches to correlate
internal and external exposures to integrate exposure and hazard assessment.
2.63 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 forTSCA 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 Risk Evaluation
Framework Rule.
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OSHA (Occupational Safety & Health Administration). (2017). Chemical Exposure Health Data (CEHD)
provided by OSHA to EPA. U.S. Occupational Safety and Health Administration.
Riddick. JA; Bunger, WB; TK, S. (1985). Techniques of Chemistry. Fourth edition. Organic solvents. New
York, NY: John Wiley and Sons.
SCHER (Scientific Committee on Health and Environmental Risks). (2008). Scientific opinion on the risk
assessment report on tetrachloroethylene (CAS no. 127-18-4; EINECS no. 204-825-9). Human
health part. European Union.
https://ec.europa.eu/health/archive/ph risk/committees/04 scher/docs/schet 3.pdf
Smart. BE: Fernandez, RE. (2000). Kirk-Othmer encyclopedia of chemical technology Fluorinated
aliphatic compounds [Encyclopedia]. Hoboken, NJ: John Wiley and Sons, Inc.
http://dx.doi.org/10.1002/0471238961.061221151913Q113.a01
Snedeco ckman, JC; Mertens, JA. (2004). Kirk-Othmer Encyclopedia of Chemical Technology
Chloroethylenes. [online]: John Wiley & Sons, Inc.
Stove, D. (2000). Ulmann's Encyclopedia of Industry Chemistry Solvents, [online]: John Wiley & Sons.
Tirsell, D. (2000). Ulmann's Encyclopedia of Industry Chemistry Dry cleaning, [online]: John Wiley &
Sons.
U.S. Coast Guard. (1984). The chemical hazards response information system (CHRIS) hazardous
chemical data. Washington, DC: Department of Transportation.
U.S. EPA (U.S. Environmental Protection Agency). (1977). Control of volatile organic emissions from
solvent metal cleaning [EPA Report]. (EPA-450/2-77-022). Research Triangle Park, NC: U.S.
Environmental Protection Agency, Office of Air and Waste Management, Office of Air Quality
Planning and Standards.
U.S. EPA. (1980a). Ambient Water Quality Criteria for Tetrachloroethylene. Washington, D.C.: U.S.
Environmental Protection Agency.
U.S. EPA (U.S. Environmental Protection Agency). (1980b). Compilation of air pollutant emission
factors. Chapter 4.7: Wste solvent reclamation. Office of Air and Radiation, Office of Air Quality
and Planning Standards.
U.S. EPA. (1985a). Health Assessment Document fo Tetrachloroethylene (Perchloroethylene)
Washington, D.C.: U.S. Environmental Protection Agency.
U.S. EPA (U.S. Environmental Protection Agency). (1985b). Occupational exposure and environmental
release assessment of tetrachloroethylene. Office of Pesticides and Toxic Substances.
U.S. EPA (U.S. Environmental Protection Agency). (1991). Economic impact analysis of regulatory
controls in the dry cleaning industry. Final. (EPA-450/3-91-021). Office of Air Quality, Planning
and Standards.
U.S. EPA (U.S. Environmental Protection Agency). (2000a). Science policy council handbook: Risk
characterization (pp. 1-189). (EPA/100/B-00/002). Washington, D.C.: U.S. Environmental
Protection Agency, Science Policy Council, https://www.epa.gov/risk/risk-characterization-
handbook
U.S. EPA (U.S. Environmental Protection Agency). (2000b). Tetrachloroethylene (perchloroethylene)
127-18-4. Office of Air Toxics, https://www.epa.gov/sites/production/files/2016-
09/documents/tetrachloroethylene.pdf
U.S. EPA (U.S. Environmental Protection Agency). (2001). Sources, emission and exposure for
trichloroethylene (TCE) and related chemicals [EPA Report]. (EPA/600/R-00/099). Washington,
DC.
U.S. EPA (U.S. Environmental Protection Agency). (2005a). Guidelines for carcinogen risk assessment
[EPA Report] (pp. 1-166). (EPA/630/P-03/001F). Washington, DC: U.S. Environmental Protection
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Agency, Risk Assessment Forum, http://www2.epa.gov/osa/guidelines-carcinogen-risk-
assessment
U.S. EPA (U.S. Environmental Protection Agency). (2005b). Perchloroethylene dry cleaners refined
human health risk characterization, https://www.epa.gov/sites/production/files/2015-
06/documents/riskassessment dry cleaners.pdf
U.S. EPA (U.S. Environmental Protection Agency). (2006a). Economic impact analysis of the
perchloroethylene dry cleaning residual risk standard. (EPA 452/R-06-005).
U.S. EPA (U.S. Environmental Protection Agency). (2006b). A framework for assessing health risk of
environmental exposures to children (pp. 1-145). (EPA/600/R-05/093F). Washington, DC: U.S.
Environmental Protection Agency, Office of Research and Development, National Center for
Environmental Assessment. http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=158363
U.S. EPA (U.S. Environmental Protection Agency). (2006c). Risk assessment for the halogenated solvent
cleaning source category [EPA Report]. (EPA Contract No. 68-D-01-052). Research Triangle Park,
NC: U.S. Environmental Protection Agency, Office of Air Quality Planning and Standards.
http://www3.epa.gov/airtoxics/degrea/residrisk2008.pdf
U.S. EPA (U.S. Environmental Protection Agency). (2009). Contaminant occurrence support document
for category 1 contaminants for the second six-year review of national primary drinking water
regulations. (EPA-815-B-09-010).
U.S. EPA (U.S. Environmental Protection Agency). (2011). Exposure factors handbook: 2011 edition
(final) [EPA Report]. (EPA/600/R-090/052F). Washington, DC: U.S. Environmental Protection
Agency, Office of Research and Development, National Center for Environmental Assessment.
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=236252
U.S. EPA. (2012a). Estimation Programs Interface (EPI) Suite™ for Microsoft® Windows (Version 4.11).
Available online at http://www.epa.gov/opptintr/exposure/pubs/episuite.htm
U.S. EPA (U.S. Environmental Protection Agency). (2012b). Toxicological Review of Tetrachloroethylene
(Perchloroethylene) (CAS No. 127-18-4) In Support of Summary Information on the Integrated
Risk Information System (IRIS) (pp. 1077).
U.S. EPA (U.S. Environmental Protection Agency). (2012c). Vapor intrusion database: evaluation and
characterization of attenuation factors for chlorinated volatile organic compounds and
residential buildings. (EPA 530-R-10-002). Washington, D.C.: Office of Solid Waste and
Emergency Response.
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). TSCA work plan chemical risk assessment.
Trichloroethylene: Degreasing, spot cleaning and arts & crafts uses. (EPA Document #740-Rl-
4002). Washington, DC: Office of Chemical Safety and Pollution Prevention.
http://www2.epa.gov/sites/production/files/2015-
09/documents/tce opptworkplanchemra final 062414.pdf
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U.S. EPA (U.S. Environmental Protection Agency). (2015). 2013 National Monitoring Programs Annual
Report (UATMP, NATTS, CSATAM). (EPA-454/R-15-005a).
https://www3.epa.eov/ttn/amtic/files/ambient/airtox/2013nmpreport.pdf
U.S. EPA (U.S. Environmental Protection Agency). (2016a). Instructions for reporting 2016 TSCA
chemical data reporting, https://www.epa.gov/chemical-data-reporting/instructions-reporting-
2016-tsca-chemical-data-re porting
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 (U.S. Environmental Protection Agency). (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/2016-03/documents/l-
bp report and appendices final.pdf
U.S. EPA (U.S. Environmental Protection Agency). (2017). Toxics Release Inventory (TRI). Retrieved
from https://www.epa.gov/toxics-release-inventorv-tri-program/tri-data-and-tools
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%
3d
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
Statutes/Regulations
Description of
Authority/Regulation
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).
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Statutes/Regulations
Description of
Authority/Regulation
Description of Regulation
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 TRI-listed
chemical in quantities above
threshold levels.
Perchloroethylene is a listed
substance subject to
reporting requirements under
40 CFR 372.65 effective as of
January 1,1987.
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
Lists perchloroethylene as a
Hazardous Air Pollutant (42
U.S. Code § 7412), and is
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Statutes/Regulations
Description of
Authority/Regulation
Description of Regulation
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.
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
standards, known as generally
available control technology
(GACT) standards, are allowed
at the Administrator's
discretion for area sources.
There are a number of
source-specific CAA, Section
112, NESHAPsfor
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)
RubberTire Manufacturing
(67 FR 45588, July 9, 2002)
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)
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Statutes/Regulations
Description of
Authority/Regulation
Description of Regulation
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 alternative is
unacceptable or acceptable
only with conditions, is made
through rulemaking.
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, 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
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
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Statutes/Regulations
Description of
Authority/Regulation
Description of Regulation
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.
included in the list of total
toxic organics (TTO) (40 CFR
413.02(i)).
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)).
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
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
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Statutes/Regulations
Description of
Authority/Regulation
Description of Regulation
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
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).
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Statutes/Regulations
Description of
Authority/Regulation
Description of Regulation
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 degradability
in nature, potential for
accumulation in tissue, and
other related factors such as
flammability, corrosiveness,
and other hazardous
characteristics.
Perchloroethylene is included
on the list of hazardous
wastes pursuant to RCRA
3001.
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).
RCRA Hazardous Waste Code:
D039 at 0.7 mg/L; F001, F002;
U210.
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.
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Statutes/Regulations
Description of
Authority/Regulation
Description of Regulation
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 monitoring,
engineering and
administrative control
measures and respiratory
protection.
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).
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 TLVfor
perchloroethylene is 25 ppm
(8hrTime Weighted Average)
and 100 ppm Short Term
Exposure Limit(STEL).
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A.2 State Laws and Regulations
Table_Apx A-2. State Laws and Regulations
State 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 (Rl 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, 20-737),
Illinois (35 Adm Code 223), Indiana ( 326 IAC 8-15), Maine
(Chapter 152 of the Maine Department of Environmental
Protection Regulations), Maryland (COMAR 26.11.32.00 to
26.11.32.26), Michigan (R 336.1660 and R 336. 1661), New
Hampshire (Env-A 4100) New Jersey (Title 7, Chapter 27,
Subchapter 24), New York (6 CRR-NY III A 235), Rhode Island (Air
Pollution Control Regulation No. 31), and Virginia (9VAC5
CHAPTER 45) all have VOC regulations or limits for consumer
products. Some of these states also require emissions reporting.
Other
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 (California OEHHA), perchloroethylene is known to the state
of California to cause cancer.
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A.3 International Laws and Regulations
Table_Apx A-3. Regulatory Actions by Other Governments and Tribes
Country/Organization
Requirements and Restrictions
Canada
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, Germany, Hungary,
Ireland, Israel, Japan,
Occupational exposure limits for perchloroethylene (GESTIS International
limit values for chemical agents (Occupational exposure limits, OELs)
database. Accessed April 18, 2017).
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Country/Organization
Requirements and Restrictions
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 1. 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.
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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.I 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 for consideration. The following subsections provide process descriptions based on
cursory review of several sources identified from the preliminary literature search. EPA will continue to
review and further refine the descriptions for each life cycle stage throughout the risk evaluation
process.
B.l.l Manufacture (Including Import)
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 al,, 2004). The
last U.S. plant using the acetylene process was shut down in 1978 (Snedecor et al., 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 al.. 2004; U.S. 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 (HCI) as a byproduct (ATSDR. 2014; Snedecor et al.. 2004; U.S. EPA. 1985b). Following reaction, the
product undergoes quenching, HCI separation, neutralization, drying and distillation (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 HCI as a byproduct (ATSDR. 2014; Snedecor et al..
2004; U.S. EPA, 1985b). 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 al., 2004).
Oxychlorination of C2 chlorinated hydrocarbons-The oxychlorination of C2 chlorinated hydrocarbons
involves the reaction of either chlorine or HCI and oxygen with EDC in the presence of a catalyst to
produce perchloroethylene and TCE as co-products (ATSDR. 2014; Snedecor et a!.. 2004). Following
reaction, the product undergoes HCI separation, drying, distillation, neutralization with ammonia and a
final drying step (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 al., 2004).
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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.. 2004).
B.1.1.1 Domestic Manufacture
Perchloroethylene was previously produced through chlorination of acetylene to tetrachloroethane,
then dehydrochlorination to TCE, followed by chlorination of TCE to pentachlorethane and finally
dehydrochlorination to perchloroethylene (Snedecor et al.. 2004). The last U.S. plant using the
acetylene process was shut down in 1978 (Snedecor et al.. 2004). Currently, most perchloroethylene is
manufactured using one of three methods: chlorination of 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 al.. 2004; U.S. EPA. 1985b).
• Chlorination of EDC - The chlorination of EDC involves a noncatalytic reaction of chlorine and
EDC or other C2 chlorinated hydrocarbons to form perchloroethylene and TCE as co-products
and HCI as a byproduct (ATSDR. 2014; Snedecor et al.. 2004; U.S. EPA. 1985b). Following
reaction, the product undergoes quenching, HCI 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 HCI
byproduct (Snedecor et al.. 2004).
• 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 CCU as co-products and HCI as a byproduct (ATSDR. 2014; Snedecor et
al.. 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 al.. 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 al.. 2004).
• Oxychlorination of C2 chlorinated hydrocarbons - The oxychlorination of C2 chlorinated
hydrocarbons involves the reaction of either chlorine or HCI and oxygen with EDC in the
presence of a catalyst to produce perchloroethylene and TCE as co-products (ATSDR. 2014;
Snedecor et al.. 2004). Following reaction, the product undergoes HCI separation, drying,
distillation and neutralization with ammonia, and a final drying step (U.S. EPA. 1985b). The
advantage of this process is that no byproduct HCI is produced and can be combined with other
processes as a net HCI consumer (ATSDR. 2014; Snedecor et al.. 2004).
In all three processes the product ratio of perchloroethylene to TCE/CCU products are controlled by
adjusting the reactant ratios (Snedecor et al.. 2004).
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.. 2004).
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B.1.2 Processing and Distribution
B.1.2.1 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 (Sm; 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 Fernandez. 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).
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 (OECD. 2009c; U.S. EPA, 2001). Adhesive formulation involves mixing together volatile and
non-volatile chemical components in sealed, unsealed or heated processes (OECD, 2009a). Sealed
processes are most common for adhesive formulation because many adhesives are designed to set or
react when exposed to ambient conditions (OECD, 2009a). Lubricant formulation typically involves the
blending of two or more components, including liquid and solid additives, together in a blending vessel
(OECD, 2004). 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 (U.S. EPA. 2014b; 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 is the only use that
would incorporate perchloroethylene into an article. An ESD published by the OECD and one generic
scenario published by EPA were identified that include general process descriptions for the formation
of plastic articles.
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In plastic manufacturing, the final plastic article is produced in a conversion process that forms the
compounded plastic into the finished products (U.S. EPA, 2014c; OECD, 2009b). 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).
Conversion of thermosetting materials involves using heat and pressure to promote curing, typically
through cross-linking (OECD, 2009b). 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 (U.S. EPA. 2014c).
B.1.2.4 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.1.2.5 Recycling
Waste perchloroethylene solvent is generated when it becomes contaminated with suspended and
dissolved solids, organics, water or other substance (U.S. EPA, 1980b). Waste solvents can be restored
to a condition that permits reuse via solvent reclamation/recycling (U.S. EPA. 1985b, 1980b). Waste
perchloroethylene is shopped to a solvent recovery site where it is piped or manually loaded into
process equipment (U.S. EPA. 1985b). 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 (U.S. EPA. 1985b,
1980b).
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.1.3.1 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 methylene chloride 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
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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 (2006a), 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 (U.S. EPA. 2014a). The cleaning
solvent is usually applied in excess and allowed to air-dry (U.S. EPA. 2014a). 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 (2016c). 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. 2014d) 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 perchloroethylene.
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.
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
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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).
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. 2006c). In
continuous web degreasers, parts are uncoiled and loaded onto rollers that transport the parts
through the cleaning and drying zones at speeds greater than 11 feet per minute (U.S. EPA. 2006c). The
parts are then recoiled or cut after exiting the cleaning machine (Kanegsberg and Kanegsberg. 2011;
U.S. EPA. 2006c).
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; the use
process and worker activities associated with cold cleaning have been previously described in EPA's 1-
BP Draft Risk Assessment (U.S. EPA. 2016c).
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 (U.S. EPA. 2014a). The cleaning
solvent is usually applied in excess and allowed to air-dry (U.S. EPA. 2014a). 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 (U.S. EPA. 2016c). 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-QPPT-2016-0732-0003 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) rEPA~HQ~OPPT~2016~0732~0003 1 and 2016
CDR reporting, perchloroethylene may be used in adhesive and sealants for industrial, commercial and
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consumer applications (U.S. EPA. 2016b). The OECD ESD for Use of Adhesives (2013) provides general
process descriptions and worker activities for industrial adhesive uses.
Liquid adhesives are unloaded from containers into the coating reservoir, applied to a flat or three-
dimensional substrate and the substrates are then joined and allowed to cure (OECD, 2013). The
majority of adhesive applications include spray, roll, curtain, syringe or bead application (OECD, 2013).
For solvent-based adhesives, the volatile solvent (in this case perchloroethylene) evaporates during the
curing stage (OECD. 2013). Worker activities include unloading activities, container and equipment
cleaning activities and manual applications of adhesive (OECD, 2013). Based on EPA's knowledge of the
industry, overlap in process descriptions, worker activities and application methods are expected.
EPA's Preliminary Information on Manufacturing, Processing, Distribution, Use, and Disposal:
Tetrachloroethylene (Perchloroethylene) (EPA-HQ-QPPT-2016-0732-0003) states that the use of
perchloroethylene in consumer adhesives is especially prevalent with uses in arts and crafts and light
repairs. EPA has also identified several sealants and adhesives that contain perchloroethylene and are
marketed for commercial uses, such as construction applications. Based on EPA's knowledge of the
industry, the likely application methods for commercial and consumer uses include spray, brush,
syringe, eyedropper, roller and bead applications.
B.l.3.5 Paints and Coatings
Based on products identified in Preliminary Information on Manufacturing, Processing, Distribution,
Use, and Disposal: Tetrachloroethylene (Perchloroethylene) (EPA-HQ-QPPT-2016-0732-0003) ] 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 (U.S. EPA. 2016b), 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 (U.S. EPA. 2016b), 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. 2008)
for perchloroethylene describes a use at oil refineries for catalyst regeneration. EPA assumes this CDR
reporting code is related to the use in catalyst regeneration.
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B.1.3.8 Other Uses
Other Industrial Uses
Based on products identified in Preliminary Information on Manufacturing, Processing, Distribution,
Use, and Disposal: Tetrachloroethylene (Perchloroethylene) (EPA-HQ-QPPT-2016-0732-0003), 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) (EPA-HQ-QPPT-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).
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 (HSDB. 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.
Table_Apx B-1 summarizes OSHA CEHD data by NAICS code (OSHA. 2017).
Table_Apx B-1. Summary of Industry Sectors with Perchloroethylene Personal Monitoring Air
Samples Obtained from OSHA Inspections Conducted Between 2011 and 2016
NAICS
NAICS Description
236220
Commercial and Institutional Building Construction
238220
Plumbing, Heating, and Air-Conditioning Contractors
313310
Textile and Fabric Finishing Mills
313312
Textile and Fabric Finishing (except Broadwoven Fabric) Mills
323113
Commercial Screen Printing
326199
All Other Plastics Product Manufacturing
331512
Steel Investment Foundries
332439
Other Metal Container Manufacturing
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NAICS
NAICS Description
332991
Ball and Roller Bearing Manufacturing
332996
Fabricated Pipe and Pipe Fitting Manufacturing
334511
Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument
Manufacturing
335999
All Other Miscellaneous Electrical Equipment and Component Manufacturing
445110
Supermarkets and Other Grocery (except Convenience) Stores
448110
Men's Clothing Stores
485410
School and Employee Bus Transportation
811198
All Other Automotive Repair and Maintenance
812310
Coin-Operated Laundries and Drycleaners
812320
Drycleaning and Laundry Services (except Coin-Operated)
926150
Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors
927110
Space Research and Technology
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