EPA Document# EPA- 740-D-20-009
April 2020
FPA United Statcs Office of Chemical Safety and
!¦¦¦ Environmental Protection Agency Pollution Prevention
Draft Scope of the Risk Evaluation for
Tris(2-chloroethyl) Phosphate
CASRN 115-96-8
April 2020
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 5
ABBREVIATIONS AND ACRONYMS 6
EXECUTIVE SUMMARY 7
1 INTRODUCTION 10
2 SCOPE OF THE EVALUATION 10
2.1 Reasonably Available Information 10
2.1.1 Search of Gray Literature for All Disciplines 11
2.1.1 Search of Literature from Publicly Available Databases (Peer-Reviewed Literature) 11
2.1.2 Search of TSCA Submissions 16
2.2 Conditions of Use 17
2.2.1 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 17
2.2.2 Activities Excluded from the Scope of the Risk Evaluation 19
2.2.3 Production Volume 20
2.2.4 Overview of Conditions of Use and Lifecycle Diagram 20
2.3 Exposures 22
2.3.1 Physical and Chemical Properties 22
2.3.2 Environmental Fate and Transport 22
2.3.3 Releases to the Environment 22
2.3.4 Environmental Exposures 22
2.3.5 Occupational Exposures 23
2.3.6 Consumer Exposures 24
2.3.7 General Population Exposures 24
2.4 Hazards (Effects) 24
2.4.1 Environmental Hazards 24
2.4.2 Human Health Hazards 25
2.5 Potentially Exposed or Susceptible Subpopulations 25
2.6 Conceptual Models 25
2.6.1 Conceptual Model for Industrial and Commercial Activities and Uses 26
2.6.2 Conceptual Model for Consumer Activities and Uses 28
2.6.3 Conceptual Model for Environmental Releases and Wastes 30
2.7 Analysis Plan 32
2.7.1 Physical and Chemical Properties and Environmental Fate 32
2.7.2 Exposure 33
2.7.2.1 Environmental Releases 33
2.7.2.2 Environmental Exposures 35
2.7.2.3 Occupational Exposures 37
2.7.2.4 Consumer Exposures 38
2.7.2.5 General Population 40
2.7.3 Hazards (Effects) 42
2.7.3.1 Environmental Hazards 42
2.7.3.2 Human Health Hazards 43
2.7.4 Summary of Risk Approaches for Characterization 45
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2.8 Peer Review 46
REFERENCES 47
APPENDICES 52
Appendix A LIST OF GRAY LITERATURE SOURCES 52
Appendix B PHYSICAL AND CHEMICAL PROPERTIES 55
Appendix C ENVIRONMENTAL FATE AND TRANSPORT PROPERTIES 57
Appendix D REGULATORY HISTORY 59
D.l Federal Laws and Regulations .....59
D.2 State Laws and Regulations 60
D.3 International Laws and Regulations..... ..61
Appendix E PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION.. 62
Process Information. ......................... 62
E.l Manufacture (Including Import)... 62
E.l.l Import 62
E.2 Processing and Distribution 62
E.2.1 Incorporated into a Formulation, Mixture or Reaction Product 62
E.2.2 Incorporated into an Article 62
E.2.3 Recycling 62
E.2.4 Uses Included in Scope 62
E.2.4.1 Aircraft Interiors and Aerospace Products 62
E.2.4.2 Building / Construction Materials 63
E.2.4.3 Foam Seating and Bedding Products 63
E.2.4.4 Other: e.g., Laboratory Use 63
E.2.4.5 Paints and Coatings 63
E.2.4.6 Fabric, Textile, and Leather Products 63
E.2.4.7 Disposal 64
E.3 Preliminary Occupational Exposure Data... .....64
Appendix F SUPPORTING INFORMATION- CONCEPTUAL MODEL FOR INDUSTRIAL
AND COMMERCIAL ACTIVITIES AND USES 65
Appendix G SUPPORTING INFORMATION- CONCEPTUAL MODEL FOR CONSUMER
ACTIVITIES AND USE 71
Appendix H SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES 74
LIST OF TABLES
Table 2-1 Results of Title Screening of Submissions to EPA under Various Sections of TSCA 17
Table 2-2 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 18
Table 2-3 Categories and Sources of Environmental Release Data 33
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LIST OF FIGURES
Figure 2-1 Gray Literature Tags by Discipline for TCEP 11
Figure 2-2 Peer-reviewed Literature - Physical-Chemical Properties Search Results for TCEP 12
Figure 2-3 Peer-reviewed Literature - Fate and Transport Search Results for TCEP 13
Figure 2-4 Peer-reviewed Literature - Engineering Search Results for TCEP 14
Figure 2-5 Peer-reviewed Literature - Exposure Search Results for TCEP 15
Figure 2-6 Peer-reviewed Literature - Hazard Search Results for TCEP 16
Figure 2-7 TCEP Life Cycle Diagram 21
Figure 2-8 Conceptual Model for Industrial and Commercial Activities and Uses: Worker and
Occupational Non-User Exposures and Hazards 27
Figure 2-9 TCEP Conceptual Model for Consumer Activities and Uses: Consumer Exposures and
Hazards 29
Figure 2-10 TCEP Conceptual Model for Environmental Releases and Wastes: Environmental
Exposures and Hazards 31
LIST OF APPENDIX TABLES
TableApx A-l Gray Literature Sources that Yielded Results for TCEP 52
TableApx B-l Physical and Chemical Properties of TCEP 55
Table_Apx C-l Environmental Fate Characteristics of TCEP 57
Table_Apx D-l Federal Laws and Regulations 59
Table_Apx D-2 State Laws and Regulations 60
Table Apx D-3 Regulatory Actions by other Governments, Tribes, and International Agreements 61
Table Apx E-l Potentially Relevant Data Sources for Exposure Monitoring and Area Monitoring Data
from NIOSH Health Hazard Evaluations for TCEPa 64
Table Apx F-l Worker and Occupational Non-User Exposure Conceptual Model Supporting Table... 65
Table Apx G-l Consumer Exposure Conceptual Model Supporting Table 71
Table Apx H-l General Population and Environmental Exposure Conceptual Model Supporting Table
74
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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 intra-agency
reviewers that included multiple offices within EPA, inter-agency reviewers that included multiple
federal agencies, and assistance from EPA contractors GDIT (Contract No. HHSN316201200013W),
ERG (Contract No. EP-W-12-006), Versar (Contract No. EP-W-17-006), ICF (Contract
No.68HERC19D0003), Abt Associates (Contract No. EP-W-16-009) and SRC (Contract No.
68HERH19F0213). EPA also acknowledges the contributions of technical experts from EPA's Office of
Research and Development.
Docket
Supporting information can be found in public docket: [Docket ID: EPA.~H.Q~QP >4621
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 AND ACRONYMS
ADME Absorption, Distribution, Metabolism, and Excretion
BAF Bioaccumulation factor
BCF Bioconcentration factor
BMF Biomagnification factor
CBI Confidential Business Information
CDR Chemical Data Reporting
ChemSTEER Chemical Screening Tool for Exposure and Environmental Releases
CHRIP Chemical Risk Information Platform
COC Concentration of concern
CPCat Chemical and Product Categories
CSCL Chemical Substances Control Law
EC Engineering control
ECHA European Chemical Agency
ECx Concentration that causes a response that is x% of the maximum
ESD Emission Scenario Document
FYI For Your Information
GS Generic Scenario
HAP Hazardous Air Pollutant
LC50 Lethal concentration of 50% of the test organisms
LCx Lethal concentration that is x% of the maximum
LOAEL Lowest observed adverse effect level
LOEC Lowest observed effect concentration
mm Hg Millimeter(s) of Mercury
NIOSH National Institute for Occupational Safety and Health
NOAEL No observed adverse effect level
NOEC No observed effect concentration
ONU Occupational Non-User
OPPT Office of Pollution Prevention and Toxics
OSHA Occupational Safety and Health Administration
PBT Persistent, bioaccumulative, toxic
P-chem Physical-chemical
PECO Population, exposure, comparator, outcome
PEL Permissible Exposure Limit
PESS Potentially Exposed or Susceptible Subpopulation
PNOR Particulates Not Otherwise Regulated
POTW Publicly Owned Treatment Works
PPE Personal Protective Equipment
SDS Safety Data Sheet
TCEP Tris(2-chloroethyl) Phosphate
TIAB Title and abstract
TRI Toxics Release Inventory
WWTP Wastewater Treatment Plant
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EXECUTIVE SUMMARY
In December 2019, EPA designated tris(2-chloroethyl) phosphate (TCEP) (CASRN 115-96-8) as a high-
priority substance for risk evaluation following the prioritization process required by Section 6(b) of the
Toxic Substances Control Act (TSCA) and implementing regulations (40 CFR Part 702) (Docket ID:
EPA-HQ-OI < 1 -IvM n Pi A ¦-000 ). The first step of the risk evaluation process is the development of the
scope document, and this document fulfills the TSCA regulatory requirement to issue a draft scope
document as described in 40 CFR 702.41(c)(7). The draft scope for TCEP includes the following
information: the conditions of use, potentially exposed or susceptible subpopulations (PESS), hazards,
and exposures that EPA plans to consider in this risk evaluation, along with a description of the
reasonably available information, conceptual model, analysis plan and science approaches, and plan for
peer review for this chemical substance. EPA is providing a 45-day comment period on the draft scope.
Comments received on this draft scope document will help inform development of the final scope
document and the risk evaluation.
General Information. TCEP is a liquid and primarily used as a flame retardant with a total production
volume in the United States between 25 and 100 million pounds.
Reasonably Available Information. EPA leveraged the data and information sources already described
in the document supporting the High-Priority Substance designation for TCEP to inform the
development of this draft scope document. To further develop this draft scope document, EPA
conducted a comprehensive search to identify and screen multiple evidence streams (i.e., chemistry, fate,
release and engineering, exposure, hazard), and the search and screening results to date are provided in
Section 2.1. EPA is seeking public comment on this draft scope document and will consider additional
information identified following publication of this draft scope document, as appropriate, in developing
the final scope document. EPA is using the systematic review process described in the Application of
Systematic Review in TSCA Risk Evaluations document (U.S. EPA, 2018) to guide the process of
searching for and screening reasonably available information, including information already in EPA's
possession, for use and inclusion in the risk evaluation. EPA is applying these systematic review
methods to collect reasonably available information regarding hazards, exposures, PESS, and conditions
of use that will help inform the risk evaluation for TCEP.
Conditions of Use. EPA plans to evaluate manufacturing, including importing; processing; distribution
in commerce; industrial, commercial and consumer uses; and disposal of TCEP in the risk evaluation.
TCEP is imported into the United States and is primarily used as a flame retardant in paint and coating
manufacturing, polyester resin, thermoplastics, and articles, such as aircraft interiors. In addition, TCEP
is used as a laboratory chemical. TCEP is incorporated into fabric and textiles as well as paints and
coatings. In the past, TCEP was incorporated into foam seating and bedding products, including
polyurethane foam, and building and construction materials, such as roofing insulation and wood resin
composites. Some of these products may still be present in consumers' homes and commercially. EPA
identified these conditions of use from information reported to EPA through Chemical Data Reporting
(CDR), published literature, and consultation with stakeholders for both uses currently in production and
uses whose production may have ceased. In addition, EPA plans to analyze distribution in commerce
and disposal as part of the risk evaluation.
Conceptual Model. The conceptual models for TCEP are presented in Section 2.6. Conceptual models
are graphical depictions of the actual or predicted relationships of conditions of use, exposure pathways
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(e.g., media), exposure routes (e.g., inhalation, dermal, oral), hazards, and receptors throughout the life
cycle of the chemical substance. EPA plans to focus the risk evaluation for TCEP on the following
exposures, hazards, and receptors with the understanding that updates may be made in the final scope
document after consideration of public comments and completion of the systematic review data
collection phase.
• Exposures (Pathways and Routes), Receptors and PESS. EPA plans to analyze both human and
environmental exposures resulting from the conditions of use of TCEP that EPA plans to
consider in the risk evaluation. Exposures for TCEP are discussed in Section 2.3. EPA identified
environmental monitoring data reporting the presence of TCEP in surface water, groundwater,
biosolids and sediment. Additional information gathered through systematic review searches will
also inform expected exposures.
In Section 2.6.3, EPA presents the conceptual models describing the identified exposures
(pathways and routes), receptors and hazards associated with the conditions of use of TCEP
within the scope of the risk evaluation.
Preliminarily, EPA plans to evaluate the following human and environmental exposure
pathways, routes, receptors and PESS in the scope of the risk evaluation. However, EPA plans to
consider comments received on this draft scope and other reasonably available information when
finalizing this scope document, and to adjust the exposure pathways, exposure routes and
hazards included in the scope document as needed.
- Occupational exposures associated with manufacturing, import, processing and
industrial and commercial conditions of use: EPA plans to evaluate exposures to
workers and/or occupational non-users via the inhalation route and exposures to workers
via the dermal route associated with the manufacturing, processing, use, or disposal of
TCEP (Section 2.2.2).
- Consumer and bystander exposures associated with consumer conditions of use: EPA
plans to evaluate the inhalation and dermal exposure to TCEP when consumers are using
paints and coatings, fabric, textiles and leather products, foam setting and bedding
products, building/construction materials, wood and engineered wood products
containing TCEP, and children's mouthing or products/articles containing TCEP.
- General population exposures: EPA plans to evaluate exposure to TCEP via drinking
water, groundwater, ambient air, fish ingestion, human breast milk, and soil for the
general population.
- Environmental exposures: EPA plans to evaluate exposure to TCEP for aquatic and
terrestrial receptors via various pathways including surface water, sediment, and soil.
- Human receptors and PESS: EPA plans to evaluate children, women of reproductive age
(including, but not limited to pregnant women), workers, and consumers as receptors and
PESS in the risk evaluation.
• Hazards. Hazards for TCEP are discussed in Section 2.4. EPA completed preliminary reviews of
information from peer-reviewed assessments and databases to identify potential environmental
and human health hazards for TCEP as part of the prioritization process. Environmental hazard
effects were identified for aquatic and terrestrial organisms. Information collected through
systematic review methods and public comments may identify additional environmental hazards
that warrant inclusion in the environmental hazard assessment of the risk evaluation.
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EPA plans to use systematic review methods to evaluate the epidemiological and toxicological
literature for TCEP. Relevant mechanistic evidence will also be considered, if reasonably
available, to inform the interpretation of findings related to potential human health effects and
the dose-response assessment. EPA plans to evaluate all of the potential human health hazards
for TCEP identified in Section 2.4.2. The broad health effect categories include reproductive and
developmental, nervous system, genotoxicity, carcinogenicity effects.
Analysis Plan. The analysis plan for TCEP is presented in Section 2.7. The analysis plan outlines the
general science approaches that EPA plans to use for the various information streams (i.e., chemistry,
fate, release and engineering, exposure, hazard) supporting the risk evaluation. The analysis plan is
based on EPA's knowledge of TCEP to date which includes a partial, but ongoing, review of identified
information as described in Section 2.1. EPA will continue to consider new information submitted by
the public. Should additional data or approaches become reasonably available, EPA may update its
analysis plan in the final scope document.
EPA will seek public comments on the systematic review methods supporting the risk evaluation for
TCEP, including the methods for assessing the quality of data and information and the approach for
evidence synthesis and evidence integration supporting the exposure and hazard assessments. The
details will be provided in a supplemental document that EPA anticipates releasing for public comment
prior to the finalization of the scope document.
Peer Review. The draft risk evaluation for TCEP will be peer-reviewed. Peer review will be conducted
in accordance with relevant and applicable methods for chemical risk evaluations, including using
EPA's Peer Review Handbook and other methods consistent with Section 26 of TSCA (See 40 CFR
702.451
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1 INTRODUCTION
This document presents for comment the draft scope of the risk evaluation to be conducted for tris(2-
chloroethyl) phosphate (TCEP) under the Frank R. Lautenberg Chemical Safety for the 21st Century
Act. The Frank R. Lautenberg Chemical Safety for the 21st Century Act amended the Toxic Substances
Control Act (TSCA) on June 22, 2016. The new law includes statutory requirements and deadlines for
actions related to conducting risk evaluations of existing chemicals.
Under TSCA § 6(b), the Environmental Protection Agency (EPA) must designate chemical substances
as high-priority substances for risk evaluation or low-priority substances for which risk evaluations are
not warranted at the time, and upon designating a chemical substance as a high-priority substance,
initiate a risk evaluation on the substance. TSCA § 6(b)(4) directs EPA, in conducting risk evaluations
for existing chemicals 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."
TSCA § 6(b)(4)(D) and implementing regulations require that EPA publish the scope of the risk
evaluation to be conducted, including the hazards, exposures, conditions of use and potentially exposed
or susceptible subpopulations that the Administrator expects to consider, within 6 months after the
initiation of a risk evaluation. In addition, a draft scope is to be published pursuant to 40 CFR 702.41. In
December 2019, EPA published a list of 20 chemical substances that have been designated high-priority
substances for risk evaluations (& |), as required by TSCA § 6(b)(2)(B), which initiated the
risk evaluation process for those chemical substances. TCEP is one of the chemicals designated as a
high priority substance for risk evaluation.
2 SCOPE OF THE EVALUATION
2.1 Reasonably Available Information
EPA conducted a comprehensive search for reasonably available information1 to support the
development of this draft scope document for TCEP. EPA leveraged the data and information sources
already identified in the documents supporting the chemical substance's high-priority substance
designation. In addition, EPA searched for additional data and information on physical and chemical
properties, environmental fate, engineering, exposure, environmental and human health hazards that
could be obtained from the following general categories of sources:
1. Databases containing publicly available, peer-reviewed literature;
2. Gray literature, which is defined as the broad category of data/information sources not found in
standard, peer-reviewed literature databases.
3. Data and information submitted under TSCA Sections 4, 5, 8(e), and 8(d), as well as "for your
information" (FYI) submissions.
1 Reasonably available information means information that EPA possesses or can reasonably generate, obtain, and synthesize
for use in risk evaluations, considering the deadlines specified in TSCA section 6(b)(4)(G) for completing such evaluation.
Information that meets the terms of the preceding sentence is reasonably available information whether or not the
information is confidential business information, that is protected from public disclosure under TSCA section 14. (40 CFR
702.33).
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After completing the screening of all identified reasonably available information, the Agency will
evaluate the quality of relevant information, synthetize and integrate it to form overall conclusions about
the potential hazards and exposures to support the risk characterization for TCEP. This systematic
review process will be documented and made public as EPA undergoes the risk evaluation process. The
details are not part of this document but will be provided in a supplemental document that EPA
anticipates releasing prior to the finalization of the scope document.
The subsequent sections summarize the data collection activities completed up to date for the general
categories of sources and topic areas (or disciplines) using systematic review methods. EPA plans to
seek public comments on the systematic review methods supporting the risk evaluation for TCEP upon
publication of the supplemental documentation of those methods.
2.1.1 Search of Gray Literature for All Disciplines
EPA surveyed the gray literature2 and identified 101 search results relevant to EPA's risk assessment
needs for TCEP. Appendix A lists the gray literature sources that yielded 101 discrete data or
information sources relevant to TCEP. EPA further categorized the data and information into the various
topic areas (or disciplines) supporting the risk evaluation (e.g., physical chemistry, environmental fate,
ecological hazard, human health hazard, exposure, engineering) and the breakdown is shown in Figure
2-1. EPA is currently identifying additional reasonably available information (e.g., public comments),
and the reported numbers in Figure 2-1 may change.
Gray Literature Tags by Discipline
Physical.Chemical ¦
IlumanJIealth.Hazard -
>5 Fate-
.&
• Exposure ¦
Q
Environmental. Hazard ¦
Engineering ¦
0 25 50 75 100
Percent Tagged (%)
Figure 2-1 Gray Literature Tags by Discipline for TCEP
Note: The percentages across disciplines do not add up to 100%, as each source may provide data or information for various
topic areas (or disciplines).
2.1.1 Search of Literature from Publicly Available Databases (Peer-Reviewed
Literature)
EPA is currently conducting a systematic review of the reasonably available literature. This includes
performing a comprehensive search of the reasonably available peer review literature on physical-
chemical (p-chem) properties, environmental fate and transport, engineering (environmental release and
34/101
45/101
28/101
58/101
14/101
70/101
2 Gray literature is defined as the broad category of data/information sources not found in standard, peer-reviewed literature
databases (e.g., PubMed and Web of Science). Gray literature includes data/information sources such as white papers,
conference proceedings, technical reports, reference books, dissertations, information on various stakeholder websites, and
other databases.
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occupational exposure), exposure (environmental, general population and consumer) and environmental
and human health hazards of TCEP. Eligibility criteria were applied in the form of population, exposure,
comparator, outcome (PECO) or similar statements. Included references met the PECO or similar
criteria, whereas excluded references did not meet the criteria (i.e., not relevant), and supplemental
material was considered as potentially relevant. EPA plans to analyze the reasonably available
information identified for each discipline during the development of the risk evaluation. The literature
inventory trees depicting the number of references that were captured and those that were included,
excluded, or tagged as supplemental material during the screening process for each discipline area are
shown in Figure 2-2 through Figure 2-6. "TIAB" in these figures refers to title and abstract screening.
Note that the sum of the numbers for the various sub-categories may be larger than the broader category
because some studies may be included under multiple sub-categories. In other cases, the sum of the
various sub-categories may be smaller than the main category because some studies may not be depicted
in the sub-categories if their relevance to the risk evaluation was unclear.
Retrieved for Full-text
Review
Total for TIAB:
P-Chem
Exclusion
Figure 2-2 Peer-reviewed Literature - Physical-Chemical Properties Search Results for TCEP
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©
Bioconcentration, Biomagnification, etc.
©
Bio degradation
©
Hydrolysis
©
Photolysis
©
Sorption
Q
Volatilization
©
Wastewater Treatment
©
Other
Figure 2-3 Peer-reviewed Literature - Fate and Transport Search Results for TCEP
Click here for interactive HAWC (Health Assessment Workspace Collaborative) Diagram.
©
Included
321 ^215^
TSCA Fate TCEP (2020) Excluded
SO
Supplemental
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o
General Facility Estimate
©
included Environmental Release
164 y 130 J ©
Occupational Exposure
TSCA Engineering TCEP (2020) Excluded
©
Supplemental
Figure 2-4 Peer-reviewed Literature - Engineering Search Results for TCEP
Click here for interactive HAWC Diagram.
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terrestrial species (15)
surface water (61)
soil (10)
sediment (18)
indoor air (75)
ground water (13)
foreign language (1)
evidence unclear (PECO relevancy unclear) (1)
Relevant (253)
epidemiological/ biomonitoring study (44)
drinking water (15)
dietary (12)
consumer uses and/or products (19)
Exclude (213)
Unique HERO IDs (502)
biosolids/ sludge (10)
Include (289)
aquatic species (15)
ambient air (30)
surface water (2)
sediment (1)
Unclear (36)
no evidence (not PECO-relevant) (1)
evidence unclear (PECO relevancy unclear) (35)
aquatic species (1)
Figure 2-5 Peer-reviewed Literature - Exposure Search Results for TCEP
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©
Retrieved for Full-text Review
©
Human
©
Animal
©
©
Human Health Model
©
Ecotoxicological Model
TSCA Hazard TCEP (2020)
©
Supplemental Material
©
Mechanistic
©
ADME/TK/PBPK
©
Mixture
0
Case Study or Case Series
©
No Original Data
0
Conference Abstract
©
Susceptible Population
0
Non-English Record
©
Field Study
0
Agent to Induce Allergenic Response
0
PECO-Relevant Isomer Study
Figure 2-6 Peer-reviewed Literature - Hazard Search Results for TCEP
Click here for interactive HAWC Diagram.
2.1.2
Search of TSCA Submissions
Table 2-1 presents the results of screening the titles of data sources and reports submitted to EPA under
various sections of TSCA. EPA screened a total of 15 submissions using inclusion/exclusion criteria
specific to individual disciplines (see Table 2-1 for the list of disciplines). The details about the criteria
are not part of this document but will be provided in a supplemental document that EPA anticipates
releasing prior to the finalization of the scope document. EPA identified 13 submissions that met the
inclusion criteria in these statements and identified 2 submissions with supplemental data. EPA excluded
zero submissions. EPA plans to conduct additional deduplication at later stages of the systematic review
process (e.g., full text screening), when more information regarding the reports is available.
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Table 2-1 Results of Title Screening of Submissions to EPA under Various Sections of TSCA
Discipline
Included
Supplemental
Physicochemical Properties
1
0
Environmental Fate and Transport
2
0
Environmental and General
Population Exposure
4
0
Occupational Exposure/Release
Information
1
0
Environmental Hazard
4
0
Human Health Hazard
6
2
2.2 Conditions of Use
As described in the Promised Designation of Trisf2-chloroethyl) Phosphate (CASRN115-96-8) as a
High-Priority Substance for Risk Evaluation (U.S. EPA 2019a), EPA assembled information from the
CDR program to determine conditions of use3 or significant changes in conditions of use of the chemical
substance. EPA also consulted a variety of other sources to identify uses of TCEP, including: published
literature, company websites, and government and commercial trade databases and publications. To
identify formulated products containing TCEP, EPA searched for safety data sheets (SDS) using internet
searches, EPA Chemical and Product Categories (CPCat) data, and other resources in which SDSs could
be found. SDSs were cross-checked with company websites to make sure that each product SDS was
current. In addition, EPA incorporated communications with companies, industry groups, and public
comments to supplement the condition of use information.
EPA identified and described the categories and subcategories of conditions of use that EPA plans to
include in the scope of the risk evaluation (Section 2.2.1; Table 2-2). The conditions of use EPA plans to
include in the scope are those reflected in the life cycle diagrams and conceptual models.
After gathering reasonably available information related to the manufacture, processing, distribution in
commerce, use, and disposal of TCEP, EPA identified those categories or subcategories of use activities
for TCEP the Agency determined not to be conditions of use or will otherwise be excluded during
scoping. These categories and subcategories are described in Section 2.2.2.
2.2.1 Categories and Subcategories of Conditions of Use Included in the Scope of
the Risk Evaluation
Table lists the conditions of use that are included in the scope of the risk evaluation. Appendix E
provides additional descriptions of the uses.
3 Conditions of use means 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.
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Table 2-2 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
Life Cycle
Slsi«e
CsiU'Sorv
SiihciHe»orv
References
Manufacturing
Import
Import
U.S. EPA (2019b)
Processing
Processing -
incorporation into
formulation, mixture or
reaction product
Flame retardant in:
Paint and coating
manufacturing
U.S. EPA (2019b);
Duratec Surfacing Technology
(2018); BJB Enterprises (2018)
Processing -
incorporation into
formulation, mixture or
reaction product
Flame retardant in:
Polyester resin
EPA-HI r-2018-0476-
Processing -
incorporation into
formulation, mixture or
reaction product
Flame retardant in:
Thermoplastics
EP A-HO-OPPT-2018-0476-
Processing -
incorporation into
article
Flame retardant (e.g.,
aircraft interiors)
EP A-H0-OPPT-2018-0476-
0006
Recycling
Recycling
U.S. EPA (2019b)
Distribution in
commerce
Distribution in
commerce
Distribution in
commerce
Industrial Use
Other use
Aircraft interiors and
aerospace products
EP A-HO-OPPT-2018-0476-
0006
Commercial
Use
Other use
Aircraft interiors and
aerospace products
EPA-HI r-2018-0476-
0006
Commercial
Use
Paints and coatings
Paints and coatings
U.S. EPA (2019b)
Other use
e.g., Laboratory
chemicals
TCI America (2018)
Furnishing, Cleaning,
Treatment/Care
Products
Fabric, textile, and
leather products not
covered elsewhere
EPA-HI r-2018-0476-
Construction, Paint,
Electrical, and Metal
Products
Building/construction
materials not covered
elsewhere (e.g.,
roofing insulation)
EPA-HI r-2018-0476-
0015: Environment Canada
(2009) cites Plastics Technology
(2009)
Furnishing, Cleaning,
Treatment/Care
Products
Foam Seating and
Bedding Products
Stapleton (2011)
18
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Life Cycle
Slsi«e
Csitesorv
SiihciHe»orv
References
Construction, Paint,
Electrical, and Metal
Products
Building/construction
materials - wood and
engineered wood
products (e.g.,
composites)
Environment Canada (2009)
cites IARC (1990); IPCS (1998);
EC (2009); OECD (2006)
Consumer Use
Paints and coatings
Paints and coatings
U.S. EPA (2019b)
Furnishing, Cleaning,
Treatment/Care
Products
Fabric, textile, and
leather products not
covered elsewhere
EPA-HI r-2018-0476-
Construction, Paint,
Electrical, and Metal
Products
Building/construction
materials not covered
elsewhere (e.g.,
roofing insulation)
EPA-BB r-2018-0476-
0015; Environment Canada
(2009) cites Plastics Technology
(2009)
Furnishing, Cleaning,
Treatment/Care
Products
Foam Seating and
Bedding Products
Stapleton (2011)
Construction, Paint,
Electrical, and Metal
Products
Building/construction
materials - wood and
engineered wood
products (e.g., wood
resin composites)
Environment Canada (2009)
cites IARC (1990); IPCS (1998);
EC (2009); OECD (2006)
Disposal
Disposal
Disposal
• Life Cycle Stage Use Definitions (40 CFR § 711.3)
- "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.
• Although EPA has identified both industrial and commercial uses here for purposes of distinguishing scenarios in
this document, the Agency interprets the authority over "any manner or method of commercial use" under TSCA
section 6(a)(5) to reach both.
2.2.2 Activities Excluded from the Scope of the Risk Evaluation
As explained in the final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic
Substances Control Act, TSCA Section 6(b)(4)(D) requires EPA to identify the hazards, exposures,
conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to
consider in a risk evaluation, suggesting that EPA may exclude certain activities that it determines to be
conditions of use on a case-by-case basis (82 FR 33726, 33729; July 20, 2017). TSCA Section 3(4) also
grants EPA the authority to determine what constitutes a condition of use for a particular chemical
substance. EPA does not plan to include in this scope or in the risk evaluation activities that the Agency
has concluded do not constitute conditions of use. No conditions of use were excluded for TCEP.
19
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2.2.3 Production Volume
As reported to EPA during the 2016 CDR reporting period and described here as a range to protect
production volumes that were claimed as confidential business information (CBI), total production
volume of TCEP in 2015 was 25,000 to 100,000 pounds (U.S. EPA, 2017). EPA also uses pre-2015
CDR production volume information, as detailed in the Proposed Designation o f Trisf 2-chloroethvl)
Phosphate (CASKN115-96-8) as a Hish-Priority Substance for Risk Evaluation (U.S. EPA 2019a), and
will include future production volume information as it becomes available to support the exposure
assessment.
2.2.4 Overview of Conditions of Use and Lifecycle Diagram
The life cycle diagram provided in Figure 2-7 depicts the conditions of use that are considered within
the scope of the risk evaluation for the various life cycle stages as presented in Section 2.2.1. Section
2.2.3 summarizes the descriptions of the industrial, commercial and consumer use categories and
included in the life cycle diagram. The activities that EPA determined are out of scope are not included
in the life cycle diagram. Appendix E contains more detailed descriptions (e.g., process descriptions,
worker activities, process flow diagrams) for each manufacture, processing, distribution in commerce,
use and disposal category.
The information in the life cycle diagram is grouped according to the CDR processing codes and use
categories (including functional use codes for industrial uses and product categories for industrial,
commercial and consumer uses)4
4 The descriptions are primarily based on the corresponding industrial function category and/or commercial and consumer
product category descriptions and can be found in EPA's Instructions for Reporting 20.1.6 TSCA Chemical Data Reporting.
20
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MFGIMPORT
PROCESSING
INDUSTRIAL. COMMERCIAL, CONSUMER USES
RELEASES and WASTE DISPOSAL
Manufacture
(Including Import)
(25.000 - 100.000
n>yr)
Incoiporation into Formulation,
Mixture, or Reaction Product
(Flame retardant in paint and coating
manufacturing: polyester resin,
thermoplastics)
Incorporation into .Article
(Flame retardant)
i
Paints and Coatings1"
Other Use1
aircraft interiors and aerospace
products: laboratory- chemicals
Furnishing, Cleaning,
Treatment/Care Products1-2
fabric, textile, and leather products not
covered elsewhere: foam setting and
bedding products
Construction, Paint, Electrical, and
Metal Products1,2
building construction materials not
covered elsewhere; wood and
engineered wood products
Recycling
i
Disposal
See Conceptual Model for
Environmental Releases and Wastes
~
~
~
Manufacture (Including Import)
Processing
Uses:
1. Commercial
2. Consumer
Figure 2-7 TCEP Life Cycle Diagram
Volume is not depicted in the life cycle diagram for processing and industrial, commercial, and consumer uses as specific production volume is claimed confidential
business information (CBI). withheld pursuant to TSCA section § 14 or unknown. There may be additional activities and uses not shown in the diagram that are claimed
CBI.
21
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2.3 Exposures
For TSCA exposure assessments, EPA plans to analyze exposures and releases to the environment
resulting from the conditions of use within the scope of the risk evaluation for TCEP. Release pathways
and routes will be described to characterize the relationship or connection between the conditions of use
of the chemical and the exposure to human receptors, including potentially exposed or susceptible
subpopulations, and environmental receptors. EPA plans to take into account, where relevant, the
duration, intensity (concentration), frequency and number of exposures in characterizing exposures to
TCEP.
2.3.1 Physical and Chemical Properties
Consideration of physical and chemical properties is essential for a thorough understanding or prediction
of environmental fate (i.e., transport and transformation) and the eventual environmental concentrations.
They can also inform the hazard assessment. EPA plans to use the physical and chemical properties
described in the Promised Designation of Tris(2-chloroethyl) Phosphate (CASRN 115-96-8) as a High-
Priority Substance for Risk Evaluation (U.S. EPA, 2019) to support the development of the risk
evaluation for TCEP. The values for the physical and chemical properties (Appendix B) may be updated
as EPA collects additional information through systematic review methods.
2.3.2 Environmental Fate and Transport
Understanding of environmental fate and transport processes assists in the determination
of the specific exposure pathways and potential human and environmental receptors that need to be
assessed in the risk evaluation for TCEP. EPA plans to use the environmental fate characteristics
described in the Proposed Designation of Trisf'2-chloroethyl) Phosphate (CASRN 115-96-8) as a High-
Priority Substance for Risk Evaluation to support the development of the risk evaluation for TCEP. The
values for the environmental fate properties (Appendix C) may be updated as EPA collects additional
information through systematic review methods.
2.3.3 Releases to the Environment
Releases to the environment from conditions of use are a 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.
TCEP is not reported to the Toxics Release Inventory (TRI). There may be releases of TCEP from
industrial sites to wastewater treatment plants (WWTP), surface water, air and landfill. Articles that
contain TCEP may release TCEP to the environment during use or through recycling and disposal. EPA
plans to review these data in conducting the exposure assessment component of the risk evaluation for
TCEP.
2.3.4 Environmental Exposures
The manufacturing, processing, distribution, use and disposal of TCEP can result in releases to the
environment and exposure to aquatic and terrestrial receptors (biota) via surface water, sediment, soil
and ambient air. Environmental exposures to biota are informed by releases into the environment,
overall persistence, degradation, bioaccumulation and partitioning across different media.
Concentrations of chemical substances in biota provide evidence of exposure. EPA plans to review
available environmental exposure data in biota in the risk evaluation. Monitoring data were identified in
EPA's search for reasonably available information on environmental exposures in biota to inform
development of the environmental exposure assessment for TCEP. Relevant and reliable monitoring
22
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studies provide 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.
EPA plans to review available environmental monitoring data for TCEP. USGS's Monitoring Data -
National Water Quality Monitoring Council has identified TCEP in surface water, ground water and
sediment. In the screening study from the Norwegian Arctic (Evenset, 2009), TCEP were detected in the
fish samples (< 0.6 - 26 ng/g ww) and TCEP was detected in the seabird samples (< 0.5 - 4.7 ng/g ww).
TCEP in herring gull eggs from the Lake Huron area in the US have been measured (Chen et al., 2012).
In Sengupta et al., 2014, water samples were collected during two low-flow events at locations above
and below the discharge points of water reclamation plants in Southern California. TCEP was quantified
found in aggregate with other chemicals chlorinated chemicals.
2.3.5 Occupational Exposures
EPA plans to analyze worker activities where there is a potential for exposure under the various
conditions of use described in Section 2.2. In addition, EPA plans analyze exposure to occupational non-
users (ONUs), workers who do not directly handle the chemical but perform work in an area where the
chemical is present. EPA also plans to consider the effect(s) that engineering controls (ECs) and/or
personal protective equipment (PPE) have on occupational exposure levels as part of the draft risk
evaluation.
EPA plans to evaluate potential exposures from the processing of the chemical as it is incorporated into
formulations and products. TCEP is used as an additive flame retardant. In general, EPA plans to
evaluate the potential for exposure from additive flame retardants due to blooming and release from
article components during their manufacture and industrial/commercial use.
Worker activities associated with the conditions of use within the scope of the risk evaluation for TCEP
that will be analyzed, include, but are not limited to:
• Unloading and transferring TCEP to and from storage containers to process vessels during
manufacturing, processing and use;
• Handling, transporting and disposing of waste containing TCEP during manufacturing,
processing, use and recycling;
• Cleaning and maintaining equipment during manufacturing, processing, uses and recycling;
• Sampling chemicals, formulations or products containing TCEP for quality control during
manufacturing, processing, use and recycling;
• Performing other work activities in or near areas where TCEP is used.
• Repackaging chemicals, formulations or products containing TCEP during manufacturing,
processing, use and recycling.
TCEP can exist as a liquid and a wet solid and reported vapor pressure varies widely: 8.6x 10"6 mm Hg at
20 °C and ranging between 1.6x 10"5 mm Hg at 25 °C. EPA anticipates inhalation of mist, dust and/or
other respirable particles as an exposure pathway for workers and occupational non-users during the
manufacture, processing, and commercial/industrial use of various products containing TCEP (for
example, particulate generated during manufacture and handling of foam and incorporation of foam
other article components into finished products, and mist generated during application to textiles and
application of paints and coatings). Occupational exposure limits for TCEP have not been established by
the Occupational Safety and Health Administration (OSHA), the American Conference of Government
23
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Industrial Hygienists (ACGIH), or the National Institute for Occupational Safety and Health (NIOSH).
However, the OSHA Permissible Exposure Limit (PEL) for Particulates Not Otherwise Regulated
(PNOR) (15 mg/m3) may be applicable if particulate matter containing TCEP is generated during
industrial operations.
EPA generally does not evaluate occupational exposures through the oral route. Workers may
inadvertently transfer chemicals from their hands to their mouths, ingest inhaled particles that deposit in
the upper respiratory tract or consume contaminated food. The frequency and significance of this
exposure route are dependent on several factors including the p-chem properties of the substance during
expected worker activities, workers' awareness of the chemical hazards, the visibility of the chemicals
on the hands while working, workplace practices, and personal hygiene that is difficult to predict
(Cherrie et al., 2006). However, EPA will consider oral exposure on a case-by-case basis for certain
COUs and worker activities where there is information and data on incidental ingestion of inhaled dust.
EPA will consider ingestion of inhaled dust as an inhalation exposure for TCEP.
EPA anticipates dermal exposure to workers from contact with liquids during packaging and
repackaging operations at import sites when TCEP is handled as a liquid. EPA also anticipates dermal
exposure to solids during these operations if TCEP is formulated with solid chemicals and handled as a
solid.
2.3.6 Consumer Exposures
TCEP appears to be widely used in consumer products, specifically paints and coatings, electrical and
electronic products, building/construction materials, and batteries. The main exposure routes for these
uses where consumers interact with products and articles containing TCEP are dermal, inhalation, and
dust ingestion, including children's mouthing of articles (e.g., plastics, textiles, wood products)
containing TCEP.
2.3.7 General Population Exposures
Releases of TCEP from certain conditions of use, such as manufacturing, processing or disposal
activities, may result in general population exposures. EPA plans to evaluate the reasonably available
literature for the presence of TCEP in drinking water, ground water, ambient air, indoor air, fish, human
breast milk, and dust and soil, which may be mouthed or ingested.
2.4 Hazards (Effects)
2.4.1 Environmental Hazards
As described in the Proposed Designation of Tris(2-chloroethyl) Phosphate fCASRN 115-96-8) as a
High-Priority Substance for Risk Evaluation (U.S. EPA, 2019), EPA considered reasonably available
information from peer-reviewed assessments and databases to identify potential environmental hazards
for TCEP. EPA considers all the potential environmental hazards for TCEP identified during
prioritization (U.S. EPA 2019) to be relevant for the risk evaluation and thus they remain within the
scope of the evaluation. EPA is in the process of identifying additional reasonably available information
through systematic review methods and public comments, which may update the list of potential
environmental hazards associated with TCEP. If necessary, EPA plans to update the list of potential
hazards in the final scope document of TCEP. Based on information identified during prioritization,
environmental hazard effects were identified for aquatic and terrestrial organisms.
24
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2.4.2 Human Health Hazards
As described in the Promised Designation of Trisf2-chloroethyl) Phosphate (CASRN115-96-8) as a
High-Priority Substance for Risk Evaluation (U.S. EPA, 2019), EPA considered reasonably available
information from peer-reviewed assessments and databases to identify potential human health hazards
for TCEP. EPA plans to consider all the potential human health hazards for TCEP identified during
prioritization (U.S. EPA, 2019). The health effect categories screened for during prioritization included
acute toxicity, irritation/corrosion, dermal sensitization, respiratory sensitization, genetic toxicity,
repeated dose toxicity, reproductive toxicity, developmental toxicity, immunotoxicity, neurotoxicity,
carcinogenicity, epidemiological or biomonitoring studies and absorption, distribution, metabolism, and
excretion (ADME). The broad health effect categories include reproductive and developmental, nervous
system, hepatic, renal and other effects after single or repeated exposure to TCEP. Epidemiological or
biomonitoring studies were identified reporting health effects after exposure to TCEP. Studies were
identified reporting information on genotoxicity, carcinogenicity, and ADME. EPA is in the process of
identifying additional reasonably available information through systematic review methods and public
input, which may update the list of potential human health hazards under the scope of the risk
evaluation. If necessary, EPA plans to update the list of potential hazards in the final scope document of
the TCEP risk evaluation.
2.5 Potentially Exposed or Susceptible Subpopulations
TSCA § 6(b)(4) requires EPA to determine whether a chemical substance presents an unreasonable risk
to "a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation."
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 for adverse health
effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women,
workers, or the elderly." General population is "the total of individuals inhabiting an area or making up a
whole group" and refers here to the U.S. general population ( 011).
During the Prioritization process, EPA identified the following potentially exposed or susceptible
subpopulations based on CDR information and studies reporting developmental and reproductive
effects: children, women of reproductive age (including, but not limited to pregnant women), workers,
and consumers (U.S. EPA, 2019). EPA plans to evaluate these potentially exposed or susceptible
subpopulations in the risk evaluation.
In developing exposure scenarios, EPA plans to analyze reasonably available information to ascertain
whether some human receptor groups may be exposed via exposure pathways that may be distinct to a
particular subpopulation or life stage (e.g., children's crawling, mouthing or hand-to-mouth behaviors,
ingestion of breast milk) 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 ( 36a). Likewise, EPA plans to
evaluate reasonably available human health hazard information to ascertain whether some human
receptor groups may have greater susceptibility than the general population to the chemical's hazard(s).
2.6 Conceptual Models
In this section, EPA presents the conceptual models describing the identified exposures (pathways and
routes), receptors and hazards associated with the conditions of use of TCEP. Pathways and routes of
exposure associated with workers and occupational non-users are described in Section 2.6.1, and
25
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pathways and routes of exposure associated with consumers are described in Section 2.6.2. Pathways
and routes of exposure associated with environmental releases and wastes are discussed and depicted the
conceptual model shown in Section 2.6.3.
2.6,1 Conceptual Model for Industrial and Commercial Activities and Uses
Figure 2-8 illustrates the conceptual model for the pathways of exposure from industrial and commercial
activities and uses of TCEP that EPA plans to include in the risk evaluation. There is potential for
exposure to workers and/or occupational non-users via inhalation routes and exposures to workers via
dermal routes. Dermal exposure to TCEP in both liquid and solid form is expected, as TCEP can be
used/transported in liquid or wet solid form. Additionally, potential inhalation exposures to TCEP in
mist or dust form are expected for certain conditions of use. EPA plans to evaluate activities resulting in
exposures associated with distribution in commerce (e.g., loading, unloading) throughout the various
lifecycle stages and conditions of use (e.g., manufacturing, processing, industrial use, commercial use,
and disposal) rather than a single distribution scenario. For each condition of use identified in Table 2-2,
an initial determination was made as to whether or not each combination of exposure pathway, route,
and receptor will be assessed in the risk evaluation. The supporting rationale are presented in Appendix
F.
26
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INDUSTRIAL AND COMMERCIAL EXPOSURE PATHWAY EXPOSURE ROtTE RECEPTORS HAZARDS
ACTIVITIES / USES
?.::t.. . ;
- :
Formulation. Mixture. or
: ri".:.'. r
- Incorporation into
Article
Hazards px.v..:.:..;
associated Kith aeate
i"...
exposures
Indoor Mist-Dust
r r i..
furnishing, Cleaning,
Construction, Paint, Electrical,
and Metal Products
Waste Handing. Treatment
Wastewater; Liquid Wiisies mdSolid Wastes (see
Emwomtimial Release Conceptual Models)
Figure 2-8 Conceptual Model for Industrial and Commercial Activities and Uses: Worker and Occupational Non-User Exposures and
Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human receptors from industrial and commercial activities and uses TCEP.
27
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2.6.2 Conceptual Model for Consumer Activities and Uses
The conceptual model in Figure 2-9 presents the exposure pathways, exposure routes and hazards to
human receptors from consumer activities and uses of TCEP that EPA plans to include in the risk
evaluation. EPA expects inhalation and dermal to be the primary routes of exposure and plans to
evaluate inhalation exposures to TCEP vapors or dust containing TCEP for consumers and bystanders.
There is potential for dermal exposures to TCEP via direct contact with liquid or solid products or
articles containing TCEP during consumer uses, and inhalation exposures to TCEP via dust, vapor or
mist generated from use of consumer products. There is also potential for oral ingestion of dust
containing TCEP - for example, via children's hand-to-mouth behavior. The supporting rationale for
consumer pathways that are in scope for TCEP are included in 2.8Appendix G.
28
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CONSUMER ACTIVITIES &
USES
EXPOSURE
PATHWAY
EXPOSURE
ROUTE
RECEPTORS
HAZARDS
Paints and Coatings
Furnishing, Cleaning,
Treatment/Care
Products
I:'—
Electro^ srd Metai
= :::
Indoor Air/Dust
Vac r . r
Oral
P Derm;
r
inhalation
K
Consumers
B-itarcers
Hazards Potentially
Associated with
Acute and/or
Chronic Exposures
Consumer Handling st
and Waste
Wastewater, Liquid Wastes arte
Solid Wastes (See
Environmental Releases
Figure 2-9 TCEP Conceptual Model for Consumer Activities and Uses: Consumer Exposures and Hazards
29
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2.6.3 Conceptual Model for Environmental Releases and Wastes
Figure 2-10 presents the exposure pathways, exposure routes, and hazards to human and environmental
receptors for releases and waste streams associated with environmental releases of TCEP. EPA plans to
evaluate pathways and routes of exposures to receptors (e.g., general population, aquatic, terrestrial
species) that may occur from industrial and/or commercial uses, releases to air, water or land, including
biosolids and soil, and other conditions of use. EPA expects humans to be exposed to TCEP from air
emissions via inhalation as well as from water, liquid, and solid waste releases - orally via drinking
water, fish and soil ingestion, and dermally from contact with groundwater and soil. The supporting
rationale for general population and environmental pathways considered for TCEP are included in
Appendix H.
30
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RELEASES AND WASTES FROM INDUSTRIAL /
COMMERCIAL / CONSUMER USES
EXPOSURE PATHWAYS
EXPOSURE ROUTES
RECEPTORS
IsuuNmi Pre
01
Imliivliwl WWT
Water. Sediment
fiidirevi (iM-inj
Aquatic
Wastewater or
Liquid Wast.es
IV m
'niectfon
Dtml in
WuJei
Bifftvsiids.
iHwatid
\}!«ikip>il \vu-4c
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t'rcucraJ
f-'ofuji.ilion
I Jems si
frOUHtf
ft'akt
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Liquid Wasies
i Usi inio'i* atui
\funtviual Wu-J
iHuiiaatyr
bueitive Emissions
Tiaiislcr
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Emission-* k* Atr
HanovK IViiciiuaiiv
AsMKMlcJ wifh
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"Kpi'^iiCs
!. Drinking Water lo inhaiatkm woulc. bt it tlurv vvi
2. For regulation of hazardous and nmnkipii a Wi
have shared regulatory oversight.
>»ir
-------
2.7 Analysis Plan
The analysis plan is based on EPA's knowledge of TCEP to date which includes a partial, but not
complete review of reasonably available information as described in Section 2.1. EPA encourages
submission of additional data, such as full study reports or workplace monitoring from industry sources,
that may be relevant for EPA's evaluation of conditions of use, exposures, hazards and potentially
exposed or susceptible subpopulations during risk evaluation. Further, EPA may consider any relevant
CBI in a manner that protects the confidentiality of the information from public disclosure. EPA will
continue to consider new information submitted by the public. Should additional data or approaches
become reasonably available, EPA may update its analysis plan in the final scope document. As
discussed in the Application of Systematic Review in TSCA Risk Evaluations document [EPA
Document #740-Pl-8001], targeted supplemental searches during the analysis phase may be necessary
to identify additional reasonably available information (e.g., commercial mixtures) for the risk
evaluation of TCEP.
2.7.1 Physical and Chemical Properties and Environmental Fate
EPA plans to analyze the physical and chemical (p-chem) properties and environmental fate and
transport of TCEP as follows:
1) Review reasonably available measured or estimated environmental fate endpoint data
collected through the literature search.
EPA plans to review data and information collected through the systematic review methods and
public comments about the p-chem properties (Appendix B) and fate endpoints (Appendix C)
previously summarized in the Proposed Designation of Trisf2-chloroethyl) Phosphate (CASRN
115-96-8) as a High-Priority Substance for Risk Evaluation (U.S. EPA 2019a). All sources cited
in EPA's analysis will be reviewed according to the procedures described in the systematic
review documentation that EPA plans to publish prior to finalizing the scope document. Where
the systematic review process fails to identify experimentally measured chemical property values
of sufficiently high quality, these values will be estimated using chemical parameter estimation
models as appropriate. Model-estimated fate properties will be reviewed for applicability and
quality.
2) Using measured data and/or modeling, determine the influence of p-chem properties and
environmental fate endpoints (e.g., persistence, bioaccumulation, partitioning, transport)
on exposure pathways and routes of exposure to human and environmental receptors.
Measured data and, where necessary, model predictions of p-chem properties and environmental
fate endpoints will be used to characterize the persistence and movement of TCEP within and
across environmental media. The fate endpoints of interest include volatilization, sorption to
organic matter in soil and sediments, water solubility, aqueous and atmospheric photolysis rates,
aerobic and anaerobic biodegradation rates, and potential bioconcentration and bioaccumulation.
These endpoints will be used in exposure calculations.
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3) Conduct a weight-of-evidence evaluation of p-chem and environmental fate data, including
qualitative and quantitative sources of information.
During risk evaluation, EPA plans to evaluate and integrate the p-chem and environmental fate
evidence identified in the literature inventory using the methods described in the systematic
review documentation that EPA plans to publish prior to finalizing the scope document.
2.7.2 Exposure
EPA plans to analyze exposure levels to TCEP via indoor air, ambient air, surface water, sediment, soil,
aquatic biota and terrestrial biota. EPA has not yet determined the exposure levels in these media or how
they may be used in the risk evaluation. Exposure scenarios are combinations of sources (uses),
exposure pathways and exposed receptors. Draft release/exposure scenarios corresponding to various
conditions of use for TCEP are presented in Appendix G and Appendix H. EPA plans to analyze
scenario-specific exposures.
Based on their p-chem properties, expected sources and transport and transformation within the outdoor
and indoor environment, chemical substances are more likely to be present in some media and less likely
to be present in others. Exposure level(s) can be characterized through a combination of reasonably
available monitoring data and modeling approaches.
2.7.2.1 Environmental Releases
EPA plans to analyze releases to environmental media as follows:
1) Review reasonably available published literature and other reasonably available
information on processes and activities associated with the conditions of use to analyze the
types of releases and wastes generated.
EPA has reviewed some key data sources containing information on processes and activities
resulting in releases, and the information found is described in Appendix A. EPA plans to
continue to review data sources identified in Appendix A during risk evaluation using the
evaluation strategy in the systematic review documentation that EPA plans to publish prior to
finalizing the scope document. Potential sources of environmental release data are:
Table 2-3 Categories and Sources of Environmental Release Data
U.S. EPA Generic Scenarios
OECD Emission Scenario Documents
EU Risk Assessment Report
Discharge Monitoring Report (DMR) surface water discharge data for TCEP from
NPDES-permitted facilities.
EPA plans to consider using the manufacture and import volume identified in CDR to estimate
releases resulting from repackaging of imported TCEP and subsequent processing.
Furthermore, EPA plans to consider whether scrap articles and used finished products containing
TCEP are recycled. If EPA proceeds with the evaluation of any of the recycling processes, then
EPA may perform targeted data searches as needed.
33
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2) Review reasonably available chemical-specific release data, including measured or
estimated release data (e.g., data from risk assessments by other environmental agencies).
EPA plans to continue to review relevant data sources as identified in Appendix B during the risk
evaluation. EPA plans to match identified data to applicable conditions of use and identify data
gaps where no data are found for particular conditions of use.
Additionally, for conditions of use where no measured data on releases are available, EPA may
use a variety of methods including release estimation approaches and assumptions in the
Chemical Screening Tool for Occupational Exposures and Releases (Chem.STEER ) (EPA,
2016).
3) Review reasonably available measured or estimated release data for surrogate chemicals
that have similar uses and physical properties.
EPA has not yet identified surrogate chemicals and data that can be used to estimate releases
from uses of TCEP. EPA plans to review release data for surrogate chemicals that have uses and
chemical and physical properties similar to TCEP as it is identified. EPA may conduct targeted
searches for surrogate data.
4) Review reasonably available data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation.
This item will be performed after completion of #2 and #3 above. EPA plans to evaluate relevant
data to determine whether the data can be used to develop, adapt, or apply models for specific
conditions of use (and corresponding release scenarios).
5) Review and determine applicability of OECD Emission Scenario Documents (ESDs) and
EPA Generic Scenarios to estimation of environmental releases.
EPA has identified potentially relevant OECD Emission Scenario Documents (ESDs) and EPA
Generic Scenarios (GS) that correspond to some conditions of use; for example, the 2009 ESD
on Plastics Additives and the 2011 ESD on the Chemical Industry may be useful. EPA plans to
need to critically review these generic scenarios and ESDs to determine their applicability to the
conditions of use.
EPA Generic Scenarios are available at the following: https://www.epa.gov/tsca-screening-
tools/chemsteer-chemical-screening-tool-exposures-and-environmental-releases
Generic Scenarios that contain information that may be related to the potential uses of TCEP
include, but are not limited to:
• EPA's Additives in Plastics Processing (Compounding) - Draft Generic Scenario for
Estimating Occupational Exposures and Environmental Releases (May 2004);
• EPA's Spray Coatings in the Furniture Industry - Generic Scenario for Estimating
Occupational Exposures and Environmental Releases (April 2004);
• EPA's Leather Dyeing - Generic Scenario for Estimating Occupational Exposures and
Environmental Releases (September 2000);
• EPA's Fabric Finishing - Draft Generic Scenario for Estimating Occupational
Exposures and Environmental Releases (September 1994);
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• EPA's Application of Spray Polyur ethane Foam Insulation - Generic Scenario for
Estimating Occupational Exposures and Environmental Releases (March 2019);
• EPA's Industry Profile for the Flexible Polyurethane Foam Industry- Generic Scenario
for Estimating Occupational Exposures and Environmental Releases (February 2004);
and,
• EPA's Industry Profile for the Rigid Polyurethane Foam Industry - Draft Generic
Scenario for Estimating Occupational Exposures and Environmental Releases
(September 2004).
OECD Emission Scenario Documents are available at the following: https://www.epa.gov/tsca-
screening-tools/chemsteer-chemical-screening-tool-exposures-and-environmental-releases
ESDs that contain information that may be related to the potential uses of TCEP include, but are
not limited to;
• OECD's Complementing Document to the ESI) On Plastic Additives: Plastic Additives
During the Use of End Products (May 2019):
• OECD's C Complementing Document for ESP on Coating Industry: Application of Point
Solvents for Industrial Coating (December 2015):
• OECD's ESI) on the Chemical Industry (September 2011):
• OECD's ESI) on Radiation Curable Coating, Inks, and Adhesives (July 2011):
• OECD's ESI) on Plastic Additives (July 2009): and
• OECD's ESP on Coating Industry (Paints, Lacquers and Varnishes) (July 2009).
6) Map or group each condition of use to a release assessment scenario(s).
EPA has identified release scenarios and mapped (i.e., grouped) them to relevant conditions of
use as shown in Appendix H. EPA was not able to identify release scenarios corresponding to
some conditions of use (e.g., recycling, construction and demolition). EPA plans to perform
targeted research to understand those uses, which may inform identification of release scenarios.
EPA may further refine the mapping/grouping of release scenarios based on factors (e.g., process
equipment and handling, magnitude of production volume used, and exposure/release sources)
corresponding to conditions of use as additional information is identified during risk evaluation.
7) Evaluate the weight of the scientific evidence of environmental release data.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation that
EPA plans to publish prior to finalizing the scope document. The data integration strategy will be
designed to be fit-for-purpose in which EPA plans to use systematic review methods to assemble
the relevant data, evaluate the data for quality and relevance, including strengths and limitations,
followed by synthesis and integration of the evidence.
2.7.2.2 Environmental Exposures
EPA plans to analyze the following in developing its environmental exposure assessment of TCEP:
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1) Review reasonably available environmental and biological monitoring data for all media
relevant to environmental exposure.
For TCEP, environmental media which plans to evaluate are sediment, biosolids, soil, air, and
water. The environmental exposure pathways which have been identified in the literature include
aquatic and terrestrial.
2) Review reasonably available information on releases to determine how modeled estimates
of concentrations near industrial point sources compare with available monitoring data.
EPA plans to analyze reasonably available environmental exposure models that meet the TSCA
Section 26(h) and (i) Science Standards and that estimate surface water, sediment, and soil
concentrations alongside reasonably available surface water, sediment, and soil monitoring data
to characterize environmental exposures. Modeling approaches to estimate surface water
concentrations, sediment concentrations, and soil concentrations generally consider the following
inputs: direct release into surface water, sediment, or soil, indirect release into surface water,
sediment, or soil (i.e., air deposition), fate and transport (partitioning within media) and
characteristics of the environment (e.g., river flow, volume of lake, meteorological data).
3) Review reasonably available environmental monitoring data for vegetation, invertebrates,
fish, non-fish vertebrates (i.e., amphibians, reptiles, mammals). Plan to consider whether
these data could be used to compare with comparable species or taxa-specific toxicological
benchmarks.
EPA plans to analyze predatory bird species that consume fish with elevated levels of TCEP. If
species-specific environmental monitoring data matches toxicity studies, direct comparisons can
be made. EPA plans to consider refining data for other species by using body weight of the birds,
fish ingestion rate of birds, and typical fish species consumed.
4) Determine applicability of existing additional contextualizing information for any
monitored data or modeled estimates during risk evaluation.
There have been changes to use patterns of TCEP over the last few years. Monitoring data or
modeled estimates will be reviewed to determine how representative they are of applicable use
patterns.
EPA plans to evaluate any studies which relate levels of TCEP in the environment or biota with
specific sources or groups of sources.
5) Group each condition(s) of use to environmental assessment scenario(s).
EPA plans to refine and finalize exposure scenarios for environmental receptors by considering
combinations of sources, exposure pathways including routes and populations exposed. For
TCEP, the following are noteworthy considerations in constructing exposure scenarios for
environmental receptors:
Estimates of surface water concentrations, sediment concentrations and soil
concentrations near industrial point sources based on available monitoring data.
Modeling inputs such as releases into the media of interest, fate and transport and
characteristics of the environment.
Reasonably available biomonitoring data, which could be used to compare with
species or taxa-specific toxicological benchmarks.
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Applicability of existing additional contextual information for any monitored data or
modeled estimates during risk evaluation. Review and characterize the spatial and
temporal variability, to the extent that data are available, and characterize exposed
aquatic and terrestrial populations.
Weight of the scientific evidence of environmental occurrence data and modeled
estimates.
6) Evaluate the weight of the scientific evidence of environmental occurrence data and
modeled estimates.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using systematic review methods.
2.7.2.3 Occupational Exposures
EPA plans to analyze both worker and occupational non-user exposures as follows:
1) Review reasonably available exposure monitoring data for specific condition(s) of use.
EPA plans to review available TCEP exposure monitoring data for specific conditions of use.
Example exposure data include workplace monitoring data collected by government agencies
such as OSHA and NIOSH, and monitoring data in published literature. The data may include
both personal exposure monitoring measurements and area monitoring measurements.
2) Review reasonably available exposure data for surrogate chemicals that have uses,
volatility and chemical and physical properties similar to TCEP.
EPA plans to review literature sources identified and if surrogate data are found, these data will
be matched to applicable conditions of use for potentially filling data gaps.
3) For conditions of use where data are limited or not available, review existing exposure
models that may be applicable in estimating exposure levels.
For conditions of use where data are not available, EPA plans to review existing exposure
models that may be applicable in estimating exposure levels of TCEP.
EPA has identified potentially relevant OECD ESDs and EPA Generic Scenarios corresponding
to some conditions of use. EPA plans to critically review these generic scenarios and ESDs to
determine their applicability to the conditions of use assessed. EPA may conduct industry
outreach efforts or perform supplemental, targeted literature searches to better understand the
process steps involved in conditions of use. EPA plans to also consider the applicability of
exposure models in the Chemical Screening Tool for Occupational Exposure and Releases
(ChemSTEER) (U.S. EPA, 2016) tool that are routinely used for assessing new chemicals to
assess exposures during various conditions of use. EPA may also perform targeted research to
identify other models that EPA could use to estimate exposures for certain conditions of use.
4) Review reasonably available data that may be used in developing, adapting or applying
exposure models to a particular risk evaluation scenario.
This step will be performed after Steps #2 and #3 are completed. Based on information
developed from Steps #2 and #3, EPA plans to evaluate relevant data to determine whether the
data can be used to develop, adapt, or apply models for specific conditions of use (and
corresponding exposure scenarios). EPA may utilize existing, peer-reviewed exposure models
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developed by EPA or other government agencies, or reasonably available in the scientific
literature, or EPA may elect to develop additional models to assess specific condition(s) of use.
Inhalation exposure models may be simple box models or two-zone (near-field/far-field) models.
In two-zone models, the near-field exposure represents potential inhalation exposures to workers,
and the far-field exposure represents potential inhalation exposures to occupational non-users.
5) Consider and incorporate applicable engineering controls (ECs) and/or personal protective
equipment (PPE) into exposure scenarios.
EPA plans to review potentially relevant data sources on ECs and PPE as identified in Appendix
E to determine their applicability and incorporation into exposure scenarios during risk
evaluation. EPA plans to assess worker exposure pre- and post-implementation of ECs, using
reasonably available information on available control technologies and control effectiveness. For
example, EPA may assess worker exposure in industrial use scenarios before and after
implementation of local exhaust ventilation.
6) Map or group each condition of use to occupational exposure assessment scenario(s).
EPA has identified occupational exposure scenarios and mapped them to relevant conditions of
use. As presented in Appendix F, EPA has grouped the scenarios into representative
release/exposure scenarios, all of which will be evaluated. EPA was not able to identify
occupational scenarios corresponding to some conditions of use (e.g., recycling, construction and
demolition). EPA may further refine the mapping/grouping of occupational exposure scenarios
based on factors (e.g., process equipment and handling, magnitude of production volume used,
and exposure/release sources) corresponding to conditions of use as additional information is
identified during risk evaluation.
7) Evaluate the weight of the scientific evidence of occupational exposure data, which may
include qualitative and quantitative sources of information.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation that
EPA plans to publish prior to finalizing the scope document. EPA plans to rely on the weight of
the scientific evidence when evaluating and integrating occupational data. The data integration
strategy will be designed to be fit-for-purpose in which EPA plans to use systematic review
methods to assemble the relevant data, evaluate the data for quality and relevance, including
strengths and limitations, followed by synthesis and integration of the evidence.
2.7.2.4 Consumer Exposures
EPA plans to analyze both consumers using a consumer product and bystanders associated with the
consumer using the product as follows:
1) Group each condition of use to consumer exposure assessment scenario(s).
Refine and finalize exposure scenarios for consumers by considering combinations of sources
(ongoing consumer uses), exposure pathways including routes and exposed populations.
For TCEP, the following are noteworthy considerations in constructing consumer exposure
scenarios:
Conditions of use and type of consumer product
Duration, frequency and magnitude of exposure
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Weight fraction of chemical in products
Amount of chemical used
2) Evaluate the relative potential of indoor exposure pathways based on reasonably available
data.
Indoor exposure pathways expected to be relatively higher include particle inhalation, dust
ingestion, and dermal contact as a result of indoor use of TCEP consumer products. Indoor
exposure pathways expected to be relatively lower include inhalation of vapor and mist and
liquid and mist oral ingestion. The data sources associated with these respective pathways have
not yet been comprehensively evaluated, so quantitative comparisons across exposure pathways
or in relation to toxicity thresholds are not yet available.
3) Review existing indoor exposure models that may be applicable in estimating indoor air,
indoor dust concentrations, or indoor dust surface loadings.
Indoor exposure models that estimate emission and migration of SVOCs into the indoor
environment are available. These models generally consider mass transfer as informed by the
gas-phase mass transfer coefficient, the solid-phase diffusion coefficient, and the material-air
partition coefficient. In addition, direct transfer to surface dust or physical abrasion may
influence emissions over time. These properties vary based on p-chem properties and properties
of the material. The OPPT's Indoor Environmental Concentrations in Buildings with
Conditioned and Unconditioned Zones (IECCU) model and other similar models can be used to
estimate indoor air and dust exposures from indoor sources.
4) Review reasonably available empirical data that may be used in developing, adapting or
applying exposure models to a particular risk evaluation scenario. For example, existing
models developed for a chemical assessment may be applicable to another chemical
assessment if model parameter data are available.
To the extent other organizations have already modeled a TCEP consumer exposure scenario that
is relevant to the OPPT's assessment, EPA plans to evaluate those modeled estimates. In
addition, if other chemicals similar to TCEP have been modeled for similar uses, those modeled
estimates will also be evaluated. The underlying parameters and assumptions of the models will
also be evaluated.
5) Review reasonably available consumer product-specific sources to determine how those
exposure estimates compare with each other and with indoor monitoring data reporting
TCEP in specific media (e.g., dust or indoor air).
The availability of TCEP concentration for various ongoing uses will be evaluated. This data
provides the source term for any subsequent indoor modeling. Source attribution between overall
indoor air and dust levels and various indoor sources will be analyzed.
6) Review reasonably available population- or subpopulation-specific exposure factors and
activity patterns to determine if potentially exposed or susceptible subpopulations need to
be further refined.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation that
EPA plans to publish prior to finalizing the scope document.
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7) Evaluate the weight of the scientific evidence of consumer exposure estimates based on
different approaches.
EPA plans to rely on the weight of the scientific evidence when evaluating and integrating data
related to consumer exposure. The weight of the scientific evidence may include qualitative and
quantitative sources of information. The data integration strategy will be designed to be fit-for-
purpose in which EPA plans to use systematic review methods to assemble the relevant data,
evaluate the data for quality and relevance, including strengths and limitations, followed by
synthesis and integration of the evidence.
2.7.2.5 General Population
EPA plans to analyze general population exposures as follows:
1) Refine and finalize exposure scenarios for general population by considering sources and
uses, exposure pathways including routes, and exposed populations.
For TCEP, the following are noteworthy considerations in constructing exposure scenarios for
the general population: routes of exposure, releases to air, water or land resulting from industrial,
commercial, and other conditions of use, in addition to:
Review of reasonably available environmental and biological monitoring data for media
to which general population exposures are expected;
For exposure pathways where data are not available, review existing exposure models
that may be applicable in estimating exposure levels;
Consider and incorporate applicable media-specific regulations into exposure scenarios
or modeling;
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;
Review reasonably available information on releases to determine how modeled
estimates of concentrations near industrial point sources compare with available
monitoring data;
Review reasonably available population- or subpopulation-specific exposure factors and
activity patterns to determine if potentially exposed or susceptible subpopulations need
be further defined;
Evaluate the weight of the scientific evidence of general population exposure data; and
Mapping or grouping each condition of use to general population exposure assessment
scenario(s).
EPA plans to evaluate a variety of data types to determine which types are most appropriate
when quantifying exposure scenarios. Environmental monitoring data, biomonitoring data,
modeled estimates, experimental data, epidemiological data, and survey-based data can all be
used to quantify exposure scenarios. In an effort to associate exposure estimates with sources of
exposure and/or conditions of use, EPA plans to consider source apportionment across exposure
scenarios during risk evaluation. EPA anticipates that there will be a wide range in the relative
exposure potential of the exposure scenarios identified in Appendix G. Source apportionment
characterizes the relative contribution of any of the following: a use/source toward a total media
concentration, a media concentration toward a total exposure route, or an exposure route toward
a total external or internal dose. This consideration may be qualitative, semi-quantitative, or
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quantitative, and is dependent upon reasonably available data and approaches. For example, EPA
may consider the co-location of TSCA industrial facilities with reasonably available monitoring
data or modeled estimates. EPA may compare modeled estimates for discrete outdoor and indoor
sources/uses that apply to unique receptor groups. If available, EPA plans to compare multiple
scenario-specific and background exposure doses estimated from media-specific concentrations
and exposure factors with available biomonitoring data. The forward-calculated and back-
calculated exposures could be compared to characterize the relative contribution from defined
exposure scenarios.
After refining and finalizing exposure scenarios, EPA plans to quantify concentrations and/or
doses for these scenarios. The number of scenarios will depend on how combinations of uses,
exposure pathways, and receptors are characterized. The number of scenarios is also dependent
upon the reasonably available data and approaches to quantify scenarios. When quantifying
exposure scenarios, EPA plans to use a tiered approach. First-tier analysis is based on data that is
reasonably available without a significant number of additional inputs or assumptions, and may
be qualitative, semi-quantitative, or quantitative. The results of first tier analyses inform whether
scenarios require more refined analysis. Refined analyses will be iterative and will require
careful consideration of variability and uncertainty. Should data become available that
summarily alters the overall conclusion of a scenario through iterative tiering, EPA can refine its
analysis during risk evaluation.
2) Review reasonably available environmental and biological monitoring data for exposure
pathways and media to which general population exposures are expected.
General population exposure pathways expected to be relatively higher include: ingestion of
water and food including fish, root crops, and mother's milk. General population exposure
pathways expected to be relatively lower include: dermal contact to TCEP via liquids, and
inhalation of TCEP via vapors, mists and dusts. The data sources associated with these respective
pathways have not been comprehensively evaluated, so quantitative comparisons across
exposure pathways or in relation to toxicity thresholds are not yet available.
3) For exposure pathways where empirical data is not available, review existing exposure
models that may be applicable in estimating exposure levels.
For TCEP, media where exposure models will be considered for general population exposure
include models that estimate, surface water concentrations, sediment concentrations, soil
concentrations and uptake from aquatic and terrestrial environments into edible aquatic and
terrestrial organisms.
4) Review reasonably available exposure modeled estimates. For example, existing models
developed for a previous TCEP chemical assessment may be applicable to EPA's
assessment. In addition, another chemical's assessment may also be applicable if model
parameter data are available.
To the extent other organizations have already modeled TCEP general population exposure
scenario that is relevant to the OPPT's assessment, EPA plans to evaluate those modeled
estimates. In addition, if modeled estimates for other chemicals with similar physical chemical
properties and similar uses are available, those modeled estimates will also be evaluated. The
underlying parameters and assumptions of the models will also be evaluated.
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5) Review reasonably available information on releases to determine how modeled estimates
of concentrations near industrial point sources compare with reasonably available
monitoring data.
For TCEP, exposure scenarios that involve potentially exposed or susceptible subpopulations
will consider age-specific behaviors, activity patterns, and exposure factors unique to those
subpopulations. For example, children will have different intake rates for soil than adults.
6) Review reasonably available information about population- or subpopulation-specific
exposure factors and activity patterns to determine if potentially exposed or susceptible
subpopulations need to be further defined (e.g., early life and/or puberty as a potential
critical window of exposure).
For TCEP, exposure scenarios that involve potentially exposed or susceptible subpopulations
will consider age-specific behaviors, activity patterns, and exposure factors unique to those
subpopulations. For example, children will have different intake rates for dust, soil, and diet than
adults.
7) Evaluate the weight of the scientific evidence of general population exposure estimates
based on different approaches.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation that
EPA plans to publish prior to finalizing the scope document
2.7.3 Hazards (Effects)
2.7.3.1 Environmental Hazards
EPA plans to conduct an environmental hazard assessment of TCEP 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).
EPA plans to analyze the hazards of TCEP to aquatic and/or terrestrial organisms, including
plants, invertebrates (e.g., insects, arachnids, mollusks, crustaceans), and vertebrates (e.g.,
mammals, birds, amphibians, fish, reptiles) across exposure durations and conditions if potential
environmental hazards are identified through systematic review results and public comments.
Additional types of environmental hazard information will also be considered (e.g., analogue and
read-across data) when characterizing the potential hazards of TCEP to aquatic and/or terrestrial
organisms.
Environmental hazard data will be evaluated using the environmental toxicity data quality
criteria outlined in the systematic review documentation that EPA plans to publish prior to
finalizing the scope document. The study evaluation results will be documented in the risk
evaluation phase and data from suitable studies will be extracted and integrated in the risk
evaluation process.
Hazard endpoints (e.g., mortality, growth, immobility, reproduction) will be evaluated, while
considering data availability, relevance, and quality.
2) Derive hazard thresholds for aquatic and/or terrestrial organisms.
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Depending on the robustness of the evaluated data for a particular organism or taxa (e.g., aquatic
invertebrates), environmental hazard values (e.g., ECx. LCx, NOEC, LOEC) may be derived and
used to further understand the hazard characteristics of TCEP to aquatic and/or terrestrial
species. Identified environmental hazard thresholds may be used to derive concentrations of
concern (COC), based on endpoints that may affect populations of organisms or taxa analyzed.
3) Evaluate the weight of the scientific evidence of environmental hazard data.
During risk evaluation, EPA plans to evaluate and integrate the environmental hazard evidence
identified in the literature inventory using the methods described in the systematic review
documentation that EPA plans to publish prior to finalizing the scope document.
4) Consider the route(s) of exposure, based on available monitoring and modeling data and
other available approaches to integrate exposure and hazard assessments.
EPA plans to consider aquatic (e.g., water and sediment exposures) and terrestrial pathways in
the TCEP conceptual model. These organisms may be exposed to TCEP via a number of
environmental pathways (e.g., surface water, sediment, soil, diet).
5) Conduct an environmental risk characterization of TCEP.
EPA plans to conduct a risk characterization of TCEP to identify if there are risks to the aquatic
and/or terrestrial environments from the measured and/or predicted concentrations of TCEP in
environmental media (i.e., water, sediment, soil). Risk quotients (RQs) may be derived by the
application of hazard and exposure benchmarks to characterize environmental risk (
1998; Bamthouse et at... 1982).
6) Consider a Persistent, Bioaccumulative, and Toxic (PBT) Assessment of TCEP.
EPA plans to consider the persistence, bioaccumulation, and toxic (PBT) potential of TCEP after
reviewing relevant p-chem properties and exposure pathways. EPA plans to assess the
reasonably available studies collected from the systematic review process relating to
bioaccumulation and bioconcentration (e.g., BAF, BCF) of TCEP. In addition, EPA plans to
integrate traditional environmental hazard endpoint values (e.g., LCso, LOEC) and exposure
concentrations (e.g., surface water concentrations, tissue concentrations) for TCEP with the fate
parameters (e.g., BAF, BCF, BMF, TMF).
2.7.3.2 Human Health Hazards
EPA plans to analyze human health hazards as follows:
1) Review reasonably available human health hazard data, including data from alternative
test methods (e.g., computational toxicology and bioinformatics; high-throughput screening
methods; data on categories and read-across; in vitro studies; systems biology).
Human health studies will be evaluated using the evaluation strategies laid out in the
Applications of Systematic Review under TSCA document.
Mechanistic data may include analyses of alternative test data such as novel in vitro test methods
and high throughput screening. The association between acute and chronic exposure scenarios to
the agent and each health outcome will also be integrated. Study results will be extracted and
presented in evidence tables or another appropriate format by organ/system.
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2) In evaluating reasonably available data, determine whether particular human receptor
groups may have greater susceptibility to the chemical's hazard(s) than the general
population.
Reasonably available human health hazard data will be evaluated to ascertain whether some
human receptor groups may have greater susceptibility than the general population to TCEP
hazard(s). Susceptibility of particular human receptor groups to TCEP will be determined by
evaluating information on factors that influence susceptibility.
EPA has reviewed some sources containing hazard information associated with potentially
exposed or susceptible populations and lifestages such as pregnant women and infants.
Pregnancy (i.e., gestation) and childhood are potential susceptible lifestages for TCEP exposure.
Children, women of reproductive age, workers and consumers are subpopulations who may be
potentially exposed or susceptible subpopulations. EPA plans to review the current state of the
literature in order to potentially quantify these differences for risk evaluation purposes.
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 identified human health hazard endpoints.
EPA plans to identify and evaluate human health hazards from acute and chronic exposures by
analyzing the human and animal data that meet the systematic review data quality criteria
described in the systematic review documentation that EPA plans to publish prior to finalizing
the scope document. Hazards identified by studies meeting data quality criteria will be grouped
by routes of exposure relevant to humans (oral, dermal, inhalation) and by cancer and noncancer
endpoints.
Dose-response assessment will be performed in accordance with EPA guidance (U.S. EPA.
2012a. 2011. 1994). Dose-response analyses may be used if the data meet data quality criteria
and if additional information on the identified hazard endpoints are not available or would not
alter the analysis.
The cancer mode of action (MOA) determines how cancer risks can be quantitatively evaluated.
If cancer hazard is determined to be applicable to TCEP, EPA plans to evaluate information on
genotoxicity and the mode of action for all cancer endpoints to determine the appropriate
approach for quantitative cancer assessment in accordance with the U.S. EPA Guidelines for
Carcinogen Risk Assessment (U.S. EPA. 2005).
4) Derive points of departure (PODs) where appropriate; conduct benchmark dose modeling
depending on the available data. Adjust the PODs as appropriate to conform (e.g., adjust
for duration of exposure) to the specific exposure scenarios evaluated.
Hazard data will be evaluated to determine the type of dose-response modeling that is applicable.
Where modeling is feasible, a set of dose-response models that are consistent with a variety of
potentially underlying biological processes will be applied to empirically model the dose-
response relationships in the range of the observed data consistent with EPA's Benchmark Dose
Technical Guidance Document. Where dose-response modeling is not feasible, NOAELs or
LOAELs will be identified. Non-quantitative data will also be evaluated for contribution to
weight of the scientific evidence or for evaluation of qualitative endpoints that are not
appropriate for dose-response assessment.
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5) Evaluate the weight of the scientific evidence of human health hazard data.
During risk evaluation, EPA plans to evaluate and integrate the human health hazard evidence
identified in the literature inventory under acute and chronic exposure conditions using the
methods described in the systematic review documentation that EPA plans to publish prior to
finalizing the scope document.
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.
At this stage of review, EPA believes there will be sufficient reasonably available data to
conduct dose-response analysis and/or benchmark dose modeling for the oral route of exposure.
EPA plans to also evaluate any potential human health hazards following dermal and inhalation
exposure to TCEP, which could be important for worker, consumer, and general population risk
analysis. Reasonably available data will be assessed to determine whether or not a point of
departure can be identified for the dermal and inhalation routes. This may include using route-to-
route extrapolation methods where appropriate and depending on the nature of available data.
If sufficient toxicity studies are not identified in the literature search to assess risks from dermal
and inhalation exposures, then a route-to-route extrapolation from oral toxicity studies would be
needed to assess systemic risks from dermal or inhalation exposures. Without an adequate PBPK
model, the approaches described in EPA's guidance document Risk Assessment Guidance for
Superfund Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance for
Dermal Risk Assessment) ( 34) could be applied to extrapolate from oral to dermal
exposure. These approaches may be able to further inform the relative importance of dermal
exposures compared with other routes of exposure. Similar methodology may also be used for
assessing inhalation exposures
2.7.4 Summary of Risk Approaches for Characterization
Risk characterization is an integral component of the risk assessment process for both environmental and
human health risks. EPA plans to derive the risk characterization in accordance with EPA's Risk
Characterization Handbook (U.S. EPA. 2000). As defined in EPA's Risk Characterization Policy, "the
risk characterization integrates information from the preceding components of the risk evaluation and
synthesizes an overall conclusion about risk that is complete, informative and useful for decision
makers." Risk characterization is considered to be a conscious and deliberate process to bring all
important considerations about risk, not only the likelihood of the risk but also the strengths and
limitations of the assessment, and a description of how others have assessed the risk into an integrated
picture.
The level of information contained in each risk characterization varies according to the type of
assessment for which the characterization is written. Regardless of the level of complexity or
information, the risk characterization for TSCA risk evaluations will be prepared in a manner that is
transparent, clear, consistent, and reasonable ( KMX) and consistent with the requirements of
the Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR
6). For instance, in the risk characterization summary, EPA plans to further carry out the
requirements under TSCA Section 26; for example, by identifying and assessing uncertainty and
variability in each step of the risk evaluation, discussing considerations of data quality such as the
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reliability, relevance and whether the methods utilized were reasonable and consistent, explaining any
assumptions used, and discussing information generated from independent peer review.
EPA plans to also be guided by EPA's Information Quality Guidelines ( 302.) as it provides
guidance for presenting risk information. Consistent with those guidelines, EPA plans to identify in the
risk characterization the following: (1) Each population addressed by an estimate of applicable risk
effects; (2) The expected risk or central estimate of risk for the potentially exposed or susceptible
subpopulations affected; (3) Each appropriate upper-bound or lower-bound estimate of risk; (4) Each
significant uncertainty identified in the process of the assessment of risk effects and the studies that
would assist in resolving the uncertainty; and (5) Peer reviewed studies known to the Agency that
support, are directly relevant to, or fail to support any estimate of risk effects and the methodology used
to reconcile inconsistencies in the scientific information.
2.8 Peer Review
Peer review will be conducted in accordance with EPA's regulatory procedures for chemical risk
evaluations, including using EPA's Peer Review Handbook and other methods consistent with Section
26 of TSCA (See 40 CFR 702.45). As explained in the Risk Evaluation Rule, the purpose of peer review
is for the independent review of the science underlying the risk assessment. Peer review will therefore
address aspects of the underlying science as outlined in the charge to the peer review panel such as
hazard assessment, assessment of dose-response, exposure assessment, and risk characterization. The
draft risk evaluation for TCEP will be peer reviewed.
46
-------
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5185382
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48
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Knowledge database (J-CHECK). CASRN: 115-96-8. Available online at
https://www.nite. go.jp/chem/jcheck/detail. action? cno=115-96-8&mno=2-1941&request_locale=en
HERO ID: 5186038
Noack. (1993). Unveroffentl. Unters. im Auftrag der Hoechts AG. (Priif. Nr. AAE37081, ProjektNr
930818HH). Germany: Hoechts AG. HERO ID: 5237078
OECD (Organization for Economic Co-operation and Development). (2006). SIDS initial assessment
profile for SIAM 23: Tris(2-chloroethyl)phosphate (CAS no. 115-96-8). Paris, France: Organization for
Economic Co-operation and Development. https://hpvchemicals.oecd.org/UI/handler.axd?id=bl86df35-
d9cc- * • t._ s • >03aeU\'M l'». HERO ID: 5186096
OECD. (2018). OECD Monitoring Database [Database], HERO ID: 4571754
SPIN (Substances in preparations in Nordic Countries). (2019). Tris(2-chlorethyl)phosphat.
http://www.spin2000.net/spinm.vphp/7pit 68. HERO ID: 6301427
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(2011). Identification of Flame Retardants in Polyurethane Foam Collected from Baby Products.
Environ Sci Technol 45: 5323-5331. http://dx.doi.org/10.1021 /es2007462. HERO ID: 2648828
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6301434
Toscano, WA;Coleman, KP. (2012). Esters of carbonic and orthocarbonic acid, organic phosphorous,
monocarboxylic halogenated acids, haloalcohols, and organic silicon. In Patty's Toxicology (6th ed.).
Hoboken, NJ: John Wiley & Sons.
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inhalation dosimetry [EPA Report], (EPA/600/8-90/066F). Research Triangle Park, NC: U.S.
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Environmental Assessment, Environmental Criteria and Assessment Office.
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2. HERO ID: 6488
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Environmental Protection Agency, Risk Assessment Forum. Washington, DC.
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00/002). Washington, D.C.: U.S. Environmental Protection Agency, Science Policy Council.
https://www.epa.gov/risk/risk-characterization-handbook. HERO ID: 52149ra
U.S. EPA. (2002). Guidelines for ensuring and maximizing the quality, objectivity, utility, and integrity
of information disseminated by the Environmental Protection Agency. (EPA/260/R-02/008).
Washington, DC: U.S. Environmental Protection Agency, Office of Environmental Information.
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https://www.epa.eov/sites/production/files/2i 'documents/epa-info-qualitv-guidelines.pdf. HERO
ID: 635281
U.S. EPA. (2005). Guidelines for carcinogen risk assessment [EPA Report], (EPA/630/P-03/001F).
Washington, DC: U.S. Environmental Protection Agency, Risk Assessment Forum.
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HERO ID: 86237
U.S. EPA. (2006). 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=l58363. HERO ID: 194567
U.S. EPA (U.S. Environmental Protection Agency). (2009). Provisional peer-review toxicity values for
tris(2-chloroethyl)phosphate (TCEP) (CASRN 115-96-8). Cincinnati, OH: U.S. Environmental
Protection Agency, National Center for Environmental Assessment, Superfund Health Risk Technical
Support Center, https://hhpprtv.ornl.eov/issue papers/Tris2chloroethylphosphate.pdf. HERO ID:
5113339
U.S. EPA. (2011). Final rule. TSCA inventory update modifications: Chemical data reporting. Fed Reg
76: 50815-50879. HERO ID: 3808939
U.S. EPA (U.S. Environmental Protection Agency). (2012a). Estimation Programs Interface Suite™
for Microsoft® Windows, v 4.11 [Computer Program], Washington, DC. Retrieved from
https://www.epa.gov/tsca-screening-tools/epi-suitetm-estimation-program-interface. HERO ID:
2347246
U.S. EPA (U.S. Environmental Protection Agency). (2012b). PhysProp database. Estimation
Programs Interface Suite™ for Microsoft® Windows, v 4.11: Tris(2-chloroethyl) phosphate
(CASRN 115-96-8). Washington, DC: U.S. Environmental Protection Agency
https://www.epa.gov/tsca-screening-tools/epi-suitetm-estimation-program-interface. HERO ID:
5335539
U.S. EPA (U.S. Environmental Protection Agency). (2012c). Benchmark dose technical guidance.
(EPA/100/R-12/001). Washington, DC: U.S. Environmental Protection Agency, Risk Assessment
Forum, https://www.epa.gov/risk/ben.chmark-dose4echnical-euidan.ce. HERO ID: 1239433
U.S. EPA. (2014). Flame retardant alternatives for hexabromocyclododecane (HBCD) [EPA Report],
(EPA/740/R-14/001). Washington, D.C. http://www2.epa.gov/saferchoice/partnership-evaluate-flame-
retardant-alternatives-hbcd-publications. HERO ID: 2533762
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15/001). Washington, DC: U.S. Environmental Protection Agency, Science Policy Council.
https://www.epa.gov/osa/peer-review-handbook-4th-edition-2015. HERO ID: 3350604
U.S. EPA (U.S. Environmental Protection Agency). (2016). Chemical Screening Tool for Exposure and
Environmental Releases (ChemSTEER) v. 3.2. https://www.epa.gov/tsca-screening-tools/chemsteer-
chemical-screenine-tool-exposures-and-environmental-releases. HERO ID: 6306744
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U.S. EPA (U.S. Environmental Protection Agency). (2017). Chemical data reporting (2012 and 2016
Public CDR database) [Database], Washington, DC: U.S. Environmental Protection Agency, Office of
Pollution Prevention and Toxics. Retrieved from ChemView: June 2019.
https://chemview.epa.gov/chemview . HERO ID: 6275311
U.S. EPA (2018). Applications of Systematic Review in TSCA Risk Evaluations. EPA Document #470-
Pl-8001. Office of Chemical Safety and Pollution Prevention. May.
U.S. EPA (U.S. Environmental Protection Agency). (2019a). Proposed Designation of Tris(2-
chloroethyl) Phosphate (CASRN 115-96-8) as a High-Priority Substance for Risk Evaluation.
Washington, DC: Office of Pollution Prevention and Toxics.
https://www.epa.gov/sites/production/files/2019-08/documents/tris2-chloroethylphosphate_115-96-
8_high-priority_proposeddesignation_082319.pdf. HERO ID: 6306746
U.S. EPA (U.S. Environmental Protection Agency) (2019b). Chemical Data Reporting (2012 and 2016
CBI CDR database). Washington, DC. U.S. Environmental Protection Agency, Office of Pollution
Prevention and Toxics, (accessed April 25, 2019). HERO ID: 6301193
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Council - Groundwater [Database], Retrieved from https://www.waterqualitvdata.us/portal/#siteType=
Aggregate%20groundwater%20use&sample Media=Water&mimeType=csv&dataProfile=activityAll
USGS (U.S. Geological Survey). (1991d). USGS Monitoring Data: National Water Quality Monitoring
Council - Sediment [Database], Retrieved from https://www.waterqualitvdata.us/portal/#sampleMedia=
Sediment&mimeType=csv
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Soil&mimeType=csv
USGS (U.S. Geological Survey). (1991f). USGS Monitoring Data: National Water Quality Monitoring
Council - Surface Water [Database], Retrieved from
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use&sampleMedia=Water&mimeType=csv
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Council - Tissue [Database], Retrieved from
https://www.waterqualitvdata.us/portal/#sampleMedia=Tissue&mimeType=csv
Washington State Dept. ofEcology. (2019). Children's Safe Product Act Reported Data. Retrieved
from https://apps.ecology.wa.eov/cspareportine (accessed on October 1,2019)
51
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APPENDICES
Appendix A LIST OF GRAY LITERATURE SOURCES
Table Apx A-l Gray Literature Sources that Yielded
Results for TCEP
Source/
Agency
Source Name
Source Type
Source Category
AT SDR
ATSDR Tox Profile Updates and
Addendums
Other US
Agency
Resources
Assessment or Related
Document
Australian
Government
Department
of Health
NICNAS Assessments (human
health. Tier I, 11 or 111)
International
Resources
Assessment or Related
Document
CPSC
Technical Reports: Exposure/Risk
Assessment
Other US
Agency
Resources
Assessment or Related
Document
CPSC
Technical Reports: Toxicity Review
Other US
Agency
Resources
Assessment or Related
Document
ECHA
European Union Risk Assessment
Report
International
Resources
Assessment or Related
Document
ECHA
Annex XV Restriction Report
International
Resources
Assessment or Related
Document
ECHA
Annex XIV Restriction Report
International
Resources
Assessment or Related
Document
Env Canada
Screening Assessment for the
Challenge
International
Resources
Assessment or Related
Document
Env Canada
Chemicals at a Glance (fact sheets)
International
Resources
Assessment or Related
Document
Env Canada
Priority Substances List Assessment
Report; State of Science Report,
Environment Canada Assessment
International
Resources
Assessment or Related
Document
EPA
Office of Water: STORET and WQX
US EPA
Resources
Database
52
-------
Source/
Vacuo
Source Nstnic
Source Type
Source Category
EPA
Design for the Environment (DfE)
Alternatives Assessments
US EPA
Resources
Assessment or Related
Document
EPA
Included in 201 1 NATA
US EPA
Resources
Assessment or Related
Document
EPA
PPRTV Derivation Support
Document
US EPA
Resources
Assessment or Related
Document
EPA
Other EPA: Misc sources
US EPA
Resources
General Search
EPA
EPA: AP-42
US EPA
Resources
Regulatory Document or
List
EPA
Chemical Data Reporting (2012 and
2016 non-CBI CDR database)
US EPA
Resources
Database
EPA
Chemical Data Reporting (2012 and
2016 CBI CDR database)
US EPA
Resources
Database
EPA
EPA: Generic Scenario
US EPA
Resources
Assessment or Related
Document
EPA
EPA Discharge Monitoring Report
Data
US EPA
Resources
Database
EPA
Office of Water: CFRs
US EPA
Resources
Regulatory Document or
List
EPA
Office of Air: National Emissions
Inventory (NE1) - National Emissions
Inventory (NE1) Data (2014, 201 1,
2008)
US EPA
Resources
Database
EPA
Office of Air: CFRs and Dockets
US EPA
Resources
Regulatory Document or
List
I ARC
I ARC Monograph
International
Resources
Assessment or Related
Document
Japan
Japanese Ministry of the
Environment Assessments -
Environmental Risk Assessments
(Class I Designated Chemical
Substances Summary Table)
International
Resources
Regulatory Document or
List
53
-------
Source/
Vacuo
Source Nstnic
Source Type
Source Category
KOECT
Kirk-Othmer Encyclopedia of
Chemical Technology Journal Article
Other
Resource
Encyclopedia
NIOSH
CDC NIOSH - Health Hazard
Evaluations (HHEs)
Other US
Agency
Resources
Assessment or Related
Document
NIOSH
CDC NIOSH - Workplace Survey
Reports
Other US
Agency
Resources
Assessment or Related
Document
NLM
National Library of Medicine's
Hazardous Substance Databank
Other US
Agency
Resources
Database
NLM
National Library of Medicine's
HazMap
Other US
Agency
Resources
Database
NTP
Technical Reports
Other US
Agency
Resources
Assessment or Related
Document
OECD
OECD Substitution and Alternatives
Assessment
International
Resources
Assessment or Related
Document
OECD
OECD Emission Scenario
Documents
International
Resources
Assessment or Related
Document
OECD
OECD: General Site
International
Resources
General Search
OSHA
U.S. OSHA Chemical Exposure
Health Data (CEHD) program data
[ERG]
Other US
Agency
Resources
Database
RIVM
RIVM Reports: Risk Assessments
International
Resources
Assessment or Related
Document
TERA
Toxicology Excellence for Risk
Assessment
Other
Resources
Assessment or Related
Document
54
-------
Appendix B PHYSICAL AND CHEMICAL PROPERTIES
This appendix provides p-chem information and data found in preliminary data gathering for TCEP.
Table Apx B-l summarizes the p-chem property values preliminarily selected for use in the risk
evaluation from among the range of reported values collected as of March 2020. This table differs from
that presented in the Promised Designation of Tris(2-chloroethyl) Phosphate fCASRN"115-96-8} as a
High-Priority Substance for Risk Evaluation (U.S. EPA 2019a) and may be updated as EPA collects
additional information through systematic review methods. All p-chem property values that were
extracted and evaluated as of March 2020 are presented in the supplemental file Data Extraction and
Data Evaluation Tables for Physical Chemical Property Studies (EPA-HQ-OPPT-2018-0476).
Table Apx B-l Physical and Chemical Properties of TCEP
Properly or Kmlpoinl
Value51
Reference
Dala Quality
K;i( in«
Molecular formula
C6H12CI3O4P
NA
NA
Molecular weight
285.49 g/mol
NA
NA
Physical state
Liquid
NLM, 2015
High
Physical properties
Clear, transparent liquid
NLM, 2015
High
Melting point
-55°C
NLM, 2015
High
Boiling point
330°C
NLM, 2015
High
Density
1.39 g/cm3 at 25°C
Haynes. 2014
High
Vapor pressure
0.0613 mm Hg at 25°C
NLM, 2015
High
Vapor density
Not available
Water solubility
7820 rng/L at 20°C
NLM, 2015
High
Log Octanol/water partition
coefficient (Log Kow)
1.78
NLM, 2015
High
Henry's Law constant
2.55 • 10"s atnvnrVmole
at 25°C (Bond method)
U.S. EPA, 2012
Flash point
jjlulf jjimtf jjrnlf V-| '
RSC, 2019
Medium
55
-------
Propcrlv or Kmlpoinl
\ Slllll"1
UeferciKT
Dsilsi Qusililv
K;i( in«
Auto flammability
Not available
Viscosity
45 cP at 20°C
NLM, 2015
High
Refractive index
1.4721
Haynes. 2014
High
Dielectric constant
Not available
a Measured unless otherwise noted.
NA = Not applicable
56
-------
Appendix C ENVIRONMENTAL FATE AND TRANSPORT
PROPERTIES
Table Apx C-l Environmental Fate Characteristics of TCEP
Properly or
K nd point
Value"
References
Direct
Photodegradati on
Not expected to be susceptible to direct photolysis by
sunlight because the chemical structure of TCEP does not
contain chromophores that absorb at wavelengths >290 nm
HSDB (2015)
Indirect
Photodegradati on
ti/2 =5.8 hours (based on -OH rate constant of
2.2 x 10-11 cm3/molecule-sec at 25 °C and 12-hour day
with 1.5 x 106-OH/cm3; estimated)13
U.S. EPA. (2012a)
Hydrolysis
ti/2 = stable at pH 3
ti/2 = 3,980 days at pH 7 ti/2 = 101 days at pH 10
EnvCanada (2009)
citing Brown et al.
(1975)
Biodegradation
(Aerobic)
Water: 4%/28 days based on BOD 0%/28 days based on
TOC
l%/28 days based on HPLC
Test substance concentration 100 ppm (MITI test)
NTTE (2010); EC HA
(2019)
Water: 10%/27 days (OECD 302B)
15%/21 days (OECD 302B) in activated non- adapted
industrial sludge
EnvCanada (2009);
EC (2000)
4 and 13%/28 days (OECD 301B) at 20 and 10 mg/L test
substance concentration in activated domestic sludge,
adaption not specified
70-90%/48 days (OECD 301B) at 20 mg/L test substance
concentration in activated domestic sludge, adaption not
specified
Soil: DT50 = 167 days, DT90 »100 days based on test
substance concentration 5 mg/kg in standard soil laboratory
test
EnvCanada (2009)
Biodegradation
(Anaerobic)
Soil: 0%/58 days at 80 mg/L test substance concentration
related to DOC (ISO DIS 11734)
EC (2000) citing
Noack (1993)
Wastewater
Treatment
9.2% total removal (7.3% by biodegradation, 1.9 by sludge
and 0% by volatilization to air; estimated)13
U.S. EPA (2012a)
Bioconcentration
Factor
0.6-0.8 and <1.2-5.1 attest substance concentrations of
0.1 and 1.0 ppm (w/v), respectively (Cyprinus carpio)
NTTE (2010)
57
-------
Properly or
Kmlpoinl
\ ill III'"
UoferciuTs
1 ii oiiccn inn 1 ali on
Factor
(v3 (cslinialcclj1.
¦¦
Soil Organic
Carbon:Water
Partition
Coefficient (Log
Koc)
2.6 (Koc = 388; MCI method);
2 (Koc =103; KOW method) (estimated)13
U.S. EPA. (2012a)
Notes:
a Measured unless otherwise noted;
bEPI Suite™ physical property inputs: Log KOW = 1.78, BP = 330 °C, MP = -55 °C, VP = 1.6 x 10-5 mm Hg, WS = 7,820
mg/L, SMILES 0=P(0CCC1)(0CCC1)0CCC1
Abbreviations and acronyms: TOC = total organic carbon; HPLC = High-Performance Liquid Chromatography; DOC =
dissolved organic carbon;-OH = hydroxyl radical; OECD = Organization for Economic Cooperation and Development; TG =
test guideline; GC = gas chromatography; MITI = Ministry of International Trade and Industry; BOD = biochemical oxygen
demand
58
-------
Appendix D REGULATORY HISTORY
D.l Federal Laws and Regulations
"able Apx D-l Federal Laws and Regulations
Statutes/Regulations
Description of AulhorilY/kegulalion
Description of Regulation
EPA Regulations
Toxic Substances Control
Act (TSCA) - Section
6(b)
EPA is directed to identify high-priority
chemical substances for risk evaluation; and
conduct risk evaluations on at least 20 high
priority substances no later than three and
one-half years after the date of enactment of
the Frank R. Lautenberg Chemical Safety
for the 21st Century Act.
TCEP is one of the 20 chemicals
EPA designated as a High-
Priority Substance for risk
evaluation under TSCA (84 FR
.December 30, 2019).
Designation of TCEP as high-
priority substance constitutes the
initiation of the risk evaluation
on the chemical.
Toxic Substances Control
Act (TSCA) - Section
8(a)
The TSCA section 8(a) CDR Rule requires
manufacturers (including importers) to give
EPA basic exposure-related information on
the types, quantities and uses of chemical
substances produced domestically and
imported into the United States.
TCEP manufacturing (including
importing), processing and use
information is reported under
the CDR rule (76 FR 50816.
August 16, 2011).
Toxic Substances Control
Act (TSCA) - Section
8(b)
EPA must compile, keep current and publish
a list (the TSCA Inventory) of each
chemical substance manufactured (including
imported) or processed in the United States.
TCEP was on the initial TSCA
Inventory and therefore was not
subject to EPA's new chemicals
review process under TSCA
section 5 (60 FR 16309, March
29, 1995).
The chemical is on the active
inventory.
Toxic Substances Control
Act (TSCA) - Section 4
Provides EPA with authority to issue rules,
enforceable consent agreements and orders
requiring manufacturers (including
importers) and processors to test chemical
substances and mixtures.
Three chemical data
submissions from test rules
received for TCEP: all three
were monitoring reports (1978,
1980, and 1981) (U.S. EPA,
ChemView. Accessed April 3,
2019).
59
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D.2 State Laws and Regulations
Table Apx D-2 State Laws and Regulations
Sliilc Actions
Description of Action
State Prohibitions
Three states have adopted prohibitions for the use of TCEP in children's
products, including Maryland (MD Health Gen § 24-306), New York (TRIS-
firee Children and Babies Act (NY Envir Conser § 37-0701 etseq.)),
Minnesota (Four flame Retardants in Furniture Foam and Children's Products
(Minn. Stat. § 32SF.071)).
California adopted a prohibition, effective on January 1, 2020, on the selling
and distribution in commerce of new, not previously owned juvenile
products, mattresses, or upholstered furniture that contains, or a constituent
component of which contains, covered flame retardant chemicals at levels
above 1,000 parts per million (A.B. 2998, Legislative Council, Sess. 2017-
2018, C.A. 2018)
State Drinking
Water Standards
and Guidelines
Minnesota developed a health-based guidance value for TCEP in drinking
water (Minn R. Chap. 4720)
Chemicals of High
Concern to Children
Several states have adopted reporting laws for chemicals in children's
products containing TCEP, including Maine (38 MRSA Chapter 16-D),
Minnesota (Toxic Free Kids Act Minn. Stat. 116.9401 to 116.9407), Oregon
(Toxic-Free Kids Act, Senate Bill 478, 2015), Vermont (18 V.S.A § 1776)
and Washington State (Wash. Admin. Code 173-334-130).
Other
California listed TCEP on Proposition 65 in 1992 due to cancer (Cal Code
Regs. Title 27, § 27001).
California issued a Health Hazard Alert for TCEP (Hazard Evaluation System
and Information Service, 2016).
California lists TCEP as a designated priority chemical for biomonitoring
(California SB 1379).
TCEP is listed as a Candidate Chemical under California's Safer Consumer
Products Program (Health and Safety Code § 25252 and 25253). The
regulation for Children's Foam-Padded Sleeping Products containing TCEP
as a Priority Product went into effect on July 1, 2017: Manufacturers' of this
product must notify the Department by September 1, 2017 (California
Department of Toxic Substances Control. Accessed April 12, 2019.)
60
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D.3 International Laws and Regulations
TableApx D-3 Regulatory Actions by other Governments, Tribes, and International
Agreements
Con 11 try/
()r»;iiiiz;ition
Requirements itiul Restrictions
Canada
TCEP (Ethanol, 2-chloro-, phosphate (3:1)) is on the Canadian List
of Toxic Substances (CEPA 1999 Schedule 1).
TCEP was added to Schedule 2 of the Canada Consumer Product Safety
Act (CCPSA), based on concerns for carcinogenicity and impaired fertility.
(Government Canada Chemical Safety portal. Accessed April 10, 2019).
In January 2013, a Significant New Activity was adopted for TCEP
{Canada Gazette, April 3, 2014; Vol. 148, No. 9).
European Union
In June 2017, TCEP was added to Annex XIV of REACH (Authorisation
List) with a sunset date of August 21, 2015 (European Chemicals Agency
(ECHA, 2019) database. Accessed April 10, 2019).
In 2010, TCEP was listed on the Candidate list as a Substance of Very
High Concern (SVHC) under regulation (EC) No 1907/2006 - REACH
(Registration, Evaluation, Authorization and Restriction of Chemicals due
to its reproductive toxicity (category 57C).
Australia
Ethanol, 2-chloro-, phosphate (3:1) (TCEP) was assessed under Human
Health Tier II and III of the Inventory Multi-Tiered Assessment and
Prioritisation (IMAP). Uses reported include commercial: (NICNAS, 2016,
Ethanol, 2-chloro-, phosphate (3:1): Human health tier II assessment.
Accessed April 8, 2019) (NICNAS, 2017, Ethanol, 2-chloro-, phosphate
(3:1): Human health tier III assessment. Accessed April 8, 2019).
Japan
TCEP 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
• Air Pollution Control Law
(National Institute of Technology and Evaluation [NITE] Chemical Risk
Information Platform [CHRIP], April 8, 2019).
Basel Convention
Waste substances and articles containing or contaminated
with polychlorinated biphenyls (PCBs) and/or polychlorinated
terphenyls (PCTs) and/or polybrominated biphenyls (PBBs) are listed as a
category of waste under the Basel Convention. Although the United States
is not currently a party to the Basel Convention, this treaty still affects U.S.
importers and exporters.
61
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Appendix E PROCESS, RELEASE AND OCCUPATIONAL
EXPOSURE INFORMATION
This appendix provides information and data found in preliminary data gathering for TCEP.
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.
E.l Manufacture (Including Import)
E.l.l Import
EPA expects that imported chemicals are often stored in warehouses prior to distribution for
further processing and use. In some cases, the chemicals may be repackaged into differently
sized containers, depending on customer demand, and QC samples may be taken for analyses
(EPA, 2018a).
E.2 Processing and Distribution
E.2.1 Incorporated 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. TCEP may undergo
several processing steps and the processing is dependent on its downstream incorporation into
articles, which is discussed in the next subsection (EPA, 2018b).
Incorporated into an Article
E.2.2 Incorporated 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) for distribution in commerce. Exact
process operations involved in the incorporation of TCEP-containing formulations or reaction
products are dependent on the article (EPA, 2018b). For example, TCEP may be incorporated
into aircraft interiors as a flame retardant (EPA-HQ-OPPT-2018-0476-0006Y EPA plans to
further investigate the use of TCEP being incorporated into articles during risk evaluation.
E.2.3 Recycling
EPA did not identify TCEP-specific information for recycling at this time; however, this
chemical has been identified in articles that are commonly recycled such as insulation, plastics
and foam. The processes for recycling these materials may include grinding, washing, and
rinsing the recycled material and incorporating it into new formulations and articles as described
more generally in Kirk Othmer (Borchardt, 2006). EPA has not identified specific worker
activities related to the recycling TCEP-containing products. Based on EPA's knowledge,
worker activities are anticipated to be exposed to TCEP from reclamation activities such as
sorting, materials grinding steps and loading recovered materials into transport containers.
E.2.4 Uses Included in Scope
E.2.4.1 Aircraft Interiors and Aerospace Products
The Aerospace Industries Association (AIA, 2019) informed EPA that TCEP is used as a constituent
62
-------
within products or formulations for the manufacture, operation and maintenance of aerospace products:
it is used as an additive plasticizer and viscosity regulator with flame-retarding properties for
polyurethane, polyesters, polyvinyl chloride and other polymers. TCEP is also used in the production of
unsaturated polyester resins and in acrylic resins, adhesives and coatings. Specific aerospace industrial
uses include resins and elastomeric coatings, polyurethane casting for aircraft interiors and as a flame
retardant (AIA, 2019). Aceto Corporation, an importer of TCEP, has indicated to EPA that TCEP is used
as a flame retardant for aircraft furniture (EPA-HQ-QPPT-2018-0476-0015).
E.2.4.2 Building / Construction Materials
Aceto Corporation, an importer of TCEP, informed EPA that the building industry (roof insulation) is
one potential field of application of the chemical (as used as a flame-retardant plasticizer in unsaturated
polyester resins) (EPA-HQ-OPPT-2018-1 ). The European Commission (2012) stated that
TCEP is used in the building industry, where roofing insulation accounted for more than 80% uses in the
EU. Substances in Preparations in Nordic Countries (SPIN, 2019) reported TCEP for use in construction
materials (up to 2003) and insulating materials (up to 2010). The World Health Organization's IARC
Monographs on the Evaluation of Carcinogenic Risks to Humans identifies the use of TCEP as a flame
retardant in rigid foams used for building insulation (WHO, 1999). NLM's PubChem states that TCEP is
used in cast acrylic sheet and wood-resin composites such as particle board, citing a 2001 posting of
Environment Canada's screening assessment report states that polymer products containing TCEP are
used in the building industry, specifically roofing insulation (Environment Canada, 2009). TCEP has
been identified in currently available foam products used in structural panels and insulation.
E.2.4.3 Foam Seating and Bedding Products
Aceto Corporation, an importer of TCEP, informed EPA that TCEP is sold into the furniture industry,
and that the furniture industry uses TCEP as a flame-retardant plasticizer in unsaturated polyester resins
(EPA-HO-OPPT-2018-0476-0015). NLM's Hazardous Substance Databank (HSDB) identifies the use
of TCEP with melamine in flexible urethane cushions and institutional mattresses (Kirk-Othmer
Encyclopedia of Chemical Technology, as cited in HSDB, 2015). According to Substances in
Preparations in Nordic Countries (SPIN, 2019) TCEP was reported for use in manufacture of furniture,
until 2007.
E.2.4.4 Other: e.g., Laboratory Use
TCEP is used as a laboratory chemical, such as in a chemical standard mixture.
E.2.4.5 Paints and Coatings
For the 2012 CDR, Aceto Corporation reported the use of TCEP as a flame retardant for processing
(incorporation into formulation, mixture, or reaction product) in the paint and coating manufacturing
sector (U.S. EPA 2014). Aceto Corporation is the only current domestic manufacturer and they did not
provide use information in the 2016 CDR. However, Aceto did inform EPA that coatings is one
potential field of application of the chemical (EP A-HQ-OPPT-201 ).
E.2.4.6 Fabric, Textile, and Leather Products
Aceto Corporation, an importer of TCEP, informed EPA that TCEP is sold into the textile industry, and
that the textile industry uses TCEP as a flame-retardant plasticizer in unsaturated polyester resins (
HO-QPPT-2018-0476-0015). Rudolf-Venture Chemical Inc., an importer of TCEP as of 2015, is a
supplier of chemicals specifically for the textile industry. The European Chemicals Agency (ECHA)
registration dossier reports the use of TCEP in coatings at industrial and professional sites (ECHA,
2019). Environment Canada's screening assessment reports that TCEP is used in polymer products that
are used in the textile industry, including back-coatings for carpets and upholstery (Environment
63
-------
Canada, 2009). The European Commission also lists the textile industry (e.g., back-coatings for carpets
and upholstery) as a use in the EU (EC, 2012).
E.2.4.7 Disposal
Disposal of a chemical should take into consideration the chemical's potential impact on air quality,
migration to groundwater, effect on biological species, and disposal regulations (if any) (ATSDR, 2017).
Currently, TCEP is not regulated under federal regulations as a hazardous waste. However, TCEP may
be disposed of as a hazardous waste if it is present in or co-mingled with solvent mixtures that are
RCRA regulated substances (EPA, 2018a).
Demolished building materials are classified as Construction and Demolition (C&D) waste, which may
be disposed in municipal solid waste landfills (MSWLFs) or C&D landfills (EPA, 2018b; U.S. EPA,
2014) (HERO: 2533762).
E.3 Preliminary Occupational Exposure Data
EPA plans to consider reasonably available data and information related to worker exposure and
environmental releases as they are identified during systematic review. Based on a preliminary data
gathering, there are no OSHA Chemical Exposure and Health Data (CEHD) specific to TCEP.
TableApx E-l Potentially Relevant Data Sources for Exposure Monitoring and Area Monitoring
Data from NIOSH Health Hazard Evaluations for TCEPa
Year of Publication
Report Number
l-'acilil.Y Description
2019
HHE-2016-0257-3333
Electronics recycling company
2018
HHE-2015-0050-3308
Electronics recycling company
2017
HHE-2014-0131-3268
Gymnastics studios
1977
HHE-77-3 9-400
Production of automobile
upholstery
a Table includes HHEs identified to date
64
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Appendix F SUPPORTING INFORMATION- CONCEPTUAL MODEL FOR INDUSTRIAL
AND COMMERCIAL ACTIVITIES AND USES
Table Apx F-l Worker and Occupational Non-User Exposure Conceptual Model Supporting Table
l.ili ( \ik-
Shim-
C;ik-»iir\
Sul>i;ik-»iir\
Ri-Ii-:im- /
r.\|xiMiiv
I'.\|)IISIIIV
l';illl\\;i\
I!\|)iisiiiv
Rmik-
Ri'i'i'plin* /
Piipukiliiiii
I'hilis In
l!\ ;illl;iU-
R.iliiill.ik-
Liquid
Contact
Dermal
Workers
Yes
According to CDR, one submitter indicated
that they import TCEP in liquid form.
Exposure will occur if the imported
material is repackaged
Manufacture
Import
Import
Repackaging
Solid
Contact
Dermal
Workers
Yes
According to CDR, one submitter indicated
that they imported TCEP in wet solid form.
Exposure will occur if the imported
material is repackaged
Mist, Dust
Inhalation
Workers,
ONI J
No
Mist generation is not expected during the
import (i.e., repackaging) process. Because
TCLP is imported as a liquid or wet solid,
dust generation is not expected during the
import (i.e., repackaging) process
Liquid.
Solid
Contact
I )ermal
ONI I
No
Dermal exposure by ()NIJ is not expected
for this condition of use as they are not
expected to directly handle the chemical.
Processing
Flame retardant in
Paint and coating
manufacturing;
polyester resin;
thermoplastics
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during unloading operations as TCEP
is in liquid form.
Incorporation
into Formulation,
Mixture, or
Reaction product
Unloading
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during unloading operations as TCEP
can be used/transported in wet solid form
(according to one importer reporting to
CDR).
Mist, Dust
Inhalation
Workers,
ONI J
No
Mist generation is not expected during
processing (incorporation into formulation,
mixture, or reaction product). TCLP is in
liquid lorni (or wet solid form according to
one importer reporting to CDR), so dust
generation is not expected during unloading
operations.
65
-------
l.il'i- ( \ik-
C;ik-»iir\
Sul>i;ik-»iir\
r.\|xiMiiv
Sun ;i liii
I'.\|)IISIIIV
l>;illl\\;i\
I!\|)iisiiiv
Kiuik-
Ri'i'i'plin* /
I'lipilhlliiill
I'hilis In
l!\ iiliiiili-
K.iliiill.ik-
I ,iquid.
Solid
Contact
1 )ermal
ONIJ
No
Dermal exposure by ONU is not expected
lor this condition of use as lliev are not
expected to directly handle the chemical.
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during unloading operations, as
TCEP is in liquid form.
Incorporation
into article
Flame retardant
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during unloading operations, as
TCEP can be used/transported in wet solid
form (according to one importer reporting
to CDR)
Unloading
Mist, Dust
Inhalation
Workers,
ONIJ
No
Mist generation is not expected during
processing (incorporation into articles).
TCLP is in liquid form (or wet solid form
according to one importer reporting to
CDR). so dust generation is not expected
during unloading operations.
Liquid.
Solid
Contact
I )ermal
ONIJ
No
1 )ermal exposure by ONU is not expected
for this condition of use as they are not
expected to directly handle the chemical.
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during recycling, as TCEP can be
incorporated in different liquid products
Recycling
Recycling
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during recycling, as TCEP can be
incorporated in different solid products.
Reclamation
Activities
Mist
Inhalation
Workers,
ONIJ
No
Mist generation is not expected during
recvclina
Dust
Inhalation
Workers,
ONU
Yes
Dust exposure is expected during recycling,
as particulates from solid products
containing TCEP can be generated
Liquid/Solid
Contact
Dermal
ONIJ
No
Dermal exposure by ONU is not expected
for this condition of use as they are not
expected to directly handle the chemical.
66
-------
l.ili-( \ik-
Shim-
C;ik-»iir\
Sul>i;ik-»iir\
Ki-k-:isi- /
r.\|xiMiiv
Sun ;i liii
I'.\|)IISIIIV
l';illl\\;i\
I!\|)iisiiiv
Kiuik-
Ki-ii-plur /
I'lipilhlliiill
I'hilis In
l!\ ;il u ilk-
K.iliiill.ik-
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during this use (Paints and Coatings),
as paints and coatings containing TCEP are
in liquid form.
Solid
Contact
I )ermal
W orkers
No
Paints and coatings containing TCLP are
not expected to be handled or used in solid
form.
Paints and
Coatings
Unloading;
Spray
Coating
Mist
Inhalation
Workers,
ONU
Yes
The potential for exposure to TCEP
suspended in mist exists during spray
coating applications (Paints and Coalings)
Applications
Dust
Inhalation
Workers,
ONU
No
TCLP and paints containing TCLP are in
liquid form so dust generation is not
expected during this use (paints and
coatings)
Industrial,
Commercial,
Liquid/Solid
Contact
I )ermal
ONU
No
Dermal exposure by ONU is not expected
for this condition of use as they are not
expected to directly handle the chemical.
Consumer Use
Liquid
Contact
I )ermal
W orkers
No
TCLPPP and TCLPPP-coiUaining article
components are not expected to be handled
or used in the liquid form.
Aircraft interiors
and aerospace
products
Use/Installati
on of
materials in
aircraft
interiors and
aerospace
products
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during the handling and manufacture
of aircraft interiors and aerospace products
containing article components with TCEP.
Other Use
Mist, Dust
Inhalation
Workers,
ONU
No
Mist and dusl generation is not expected
during this use (aircraft interiors and
aerospace products).
Liquid/Solid
Contact
1 )ermal
ONU
No
1 )ermal exposure by ONU is not expected
for this condition of use as they are not
expected to directly handle the chemical.
Laboratory
chemicals
Use of
laboratory
chemicals
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during this use (laboratory
chemicals), as TCEP is in liquid form.
67
-------
l.il'i- ( \ik-
C;ik-»iir\
Sul>i;ik-»iir\
Ri'k'usi- /
r.\|xiMiiv
Sun ;i liii
I'.\|)IISIIIV
l';illl\\;i\
I!\|)iisiiiv
Kiuik-
Ri'i'i'plin* /
I'lipilhlliiill
I'hilis In
l!\ ;il u ilk-
K.iliiill.ik-
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during this use (laboratory
chemicals), as TCEP can be
used/transported in wet solid form
(according to one importer reporting to
CDR)
Mist, Dust
Inhalation
Workers.
ONU
No
Mist generation is not expected during this
use (laboratory chemicals). TCPP is in
liquid lorni (or wet solid form according to
one importer reporting to CDR). so dust
generation is not expected during this use
(laboratory chemicals).
Liquid/Solid
Contact
1 )ermal
ONI J
No
Dermal exposure by ONU is not expected
for this condition of use as they are not
expected to directly handle the chemical.
I.iquid
Contact
1 )ermal
W orkers
No
TCKPPP and TCKPPP-conlaining article
components are not expected to be handled
or used in the liquid form.
Furnishing,
Fabric, textile, and
leather products not
covered elsewhere
Use of other
textile
products
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during this use (fabric, textile, and
leather products not covered elsewhere)
during the handling of textiles and
manufacture of products.
Cleaning,
Treatment Care
Products
Mist
Inhalation
Workers.
ONU
No
Mist generation is not expected during this
use (fabric, textile, and leather products not
covered elsewhere).
Dust
Inhalation
Workers,
ONU
Yes
Dust generation may occur as textiles are
cut and incorporated into finished products.
Liquid/Solid
Contact
I )ermal
ONU
No
Dermal exposure by ONU is not expected
for this condition of use as they are not
expected to directly handle the chemical.
I.iquid
Contact
1 )ermal
W orkers
No
TCKPPP and TCKPPP-containing article
components are not expected to be handled
or used in the liquid form.
Foam seating and
bedding products
Unloading
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during this use (foam seating and
bedding products) during the handling of
foam and manufacture of products.
68
-------
l.il'i- ( \ik-
C;ik-»iir\
Sul>i;ik-»iir\
Ri'k'usi- /
r.\|xiMiiv
Sun ;i liii
I'.\|)IISIIIV
l';illl\\;i\
I!\|)iisiiiv
Kiuik-
Ki'ivpliir /
I'lipilhlliiill
I'hilis In
ll\ iiliiiili-
K.iliiill.ik-
Mist
Inhalation
Workers.
ONI J
No
Mist generation is not expected during this
use.
Dust
Inhalation
Workers,
ONI J
No
Dust generation is expected during this use
(l-'oam Seating and Bedding Products), as
TCI-IP-containing articles may need to be
cut during finishing operations.
Liquid/Solid
Contact
I )ermal
ONIJ
No
Dermal exposure by ()NI J is not expected
for this condition of use as they are not
expected to directly handle the chemical.
Liquid
Contact
I )ermal
W orkers
No
TCFP and 'fCI-IP-containing article
components are not expected to be handled
or used in the liquid form.
Instillation/R
euse/Demolit
ion ol
materials in
residential,
public and
commercial
buildings,
and other
structures
Solid
Contact
Dermal
Workers
Yes
The potential for exposure to workers from
articles and article components containing
TCEP exists during this use
(building/construction materials not
covered elsewhere).
Building/construe ti
on materials not
covered elsewhere
Mist
Inhalation
Workers.
ONIJ
No
Mist generation is not expected during this
use (building/construction materials not
covered elsewhere).
Construction,
Paint, Electrical,
and Metal
Products
Dust
Inhalation
Worker,
ONU
Yes
Dust generation is expected during this use
(building/construction materials not
covered elsewhere).
Liquid/Solid
Contact
1 Dermal
ONIJ
No
1 Dermal exposure by ONI J is not expected
for this condition of use as they are not
expected to directly handle the chemical.
Wood and
Use of wood
and
Liquid
Contact
1 )ermal
W orkers
No
TCI-IP and TCI IP-containing article
components are not expected to be handled
or used in the liquid form
engineered wood
products
engineering
wood
products
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during this use (wood and
engineering wood products) during the
handling and manufacture of wood and
engineered wood products.
69
-------
l.il'i- ( \ik-
Shim-
C;ik-»iir\
Sul>i;ik-»iir\
Ri-Ii-:im- /
l'.\|)IISUIV
Sun ;i liii
I'.\|)IISIIIV
l';illl\\;i\
I!\|)iisiiiv
Rimk-
Ri'i'i'plin* /
I'lipilhlliiill
I'hilis In
l!\ iiliiiili-
R.iliiill.ik-
Mist. Dust
Inhalation
Workers,
ONI J
No
Mist generation is not expected during this
use (wood and engineering wood products).
Dust generation is not expected during this
use (wood and engineering wood products).
Liquid/Solid
Contact
I )ennal
ONI J
No
I )ermal exposure by ONU is not expected
lor this condition of use as lliev are not
expected to directly handle the chemical.
Liquid
Contact
Dermal
Worker
Yes
Dermal exposure is expected for this
condition of use
Waste Handling.
Disposal of TCEP
containing wastes
Worker
Dust
Inhalation
Worker
Yes
TCEP may be present in solid material.
EPA plans to evaluate the inhalation
pathway.
Disposal
Treatment and
Disposal
handling of
wastes
Liquid
Contact
I )ermal
ONI J
No
Dermal exposure by ONU is not expected
for this condition of use as they are not
expected to directly handle the chemical.
Dust
Inhalation
ONU
Yes
TCEP may be present in solid material.
EPA plans to evaluate the inhalation
pathway
70
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Appendix G SUPPORTING INFORMATION- CONCEPTUAL MODEL FOR CONSUMER
ACTIVITIES AND USE
Table Apx G-l Consumer Exposure Conceptual Model Supporting Table
Life (>ck
S(;i»e
( .lU'iion
Suhciik'iion
Kck'sisi* I'mm
SOIIIVC
Kxposuiv
P;i(h\\;n
Koulc
Km'plnr
I'hius (o
i:\iiiuiiio
Kiilioiiiilc
Direct contact
via application of
paints and
coatings
containing TCEP
Liquid Contact
Dermal
Consumers
Yes
The potential for exposures exists during
this use (Paints and Coatings), as paints
and coatings containing TCEP are in
liquid form.
Consumer Use
Paints and
Coatings
Paints and
Coatings
Vapor
Inhalation
Consumers/
Bystanders
Yes
Due to the volatility of TCEP (VP = 0.06
mmHg) at room temperature, inhalation
exposure to TCEP in the vapor phase is
possible.
Mist
Inhalation
Consumers/
Bystanders
Yes
The potential for exposure to TCEP
suspended in mist exists during spray
coating applications (Paints and
Coatings)
Direct contact
through use of
electrical and
electronic
products made
containing TCEP
Air/Particulate
Inhalation
Consumers/
Bystanders
Yes
Inhalation of air and/or particles from
electrical and electronic products
containing TCEP may occur for this
condition of use. EPA plans to
analyze inhalation exposure.
Construction,
Paint,
Electrical, and
Metal Products
Wood and
engineered wood
products
Dust
Ingestion
Consumers/
Bystanders
Yes
Ingestion of dust from electrical and
electronic products containing TCEP
may occur for this condition of use.
EPA plans to analyze dust exposure
via ingestion.
Consumer Use
Article/Product
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use. EPA plans to
analyze dermal exposure.
Building/
construction
materials not
covered
elsewhere
Direct contact
through use of
building/
construction
Air/Particulate
Inhalation
Consumers/
Bystanders
Yes
Inhalation of air and/or particles from
building/construction materials
containing TCEP may occur for this
condition of use. EPA plans to
analyze inhalation exposure.
materials made
containing TCEP
Dust
Ingestion
Consumers/
Bystanders
Yes
Ingestion of dust from
building/construction materials
containing TCEP may occur for this
71
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l.ile ( >cle
S(;i»o
("sik'Sion
Siibciik'jion
Kck'sisi* from
SOIIIVO
l'l\|)OMIIV
P;i(h\\;n
Koulc
Km'plor
Pliius In
I'1\;iIii;iU'
Kiilioiiiilo
condition of use. EPA plans to
analyze dust exposure via ingestion.
Article/Product
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use. EPA plans to
analyze dermal exposure.
Air/Particulate
Inhalation
Consumers/
Bystanders
Yes
Inhalation via air and/or particulate
exposure may occur during
product/article use. EPA plans to
analyze inhalation exposure.
Consumer Use
Furnishing,
Cleaning,
Treatment/
Care Products
Fabric, textile,
and leather
products not
Direct contact
through use of
products/articles
containing TCEP
Dust
Ingestion
Consumers/
Bystanders
Yes
Ingestion of TCEP sorbed onto dust
may occur for this condition of use.
EPA plans to analyze dust exposure
via ingestion.
covered
elsewhere
Article/Product
Contact
Dermal
Consumers
Yes
Dermal exposure may occur via use
of articles containing TCEP. EPA
plans to analyze dermal exposure.
Article/Product
Mouthing
Ingestion
Bystanders
Yes
Ingestion via object to mouth or
subsequent hand to mouth from
product dermal contact. EPA plans to
analyze mouthing via ingestion.
Air/Particulate
Inhalation
Consumers/
Bystanders
Yes
Inhalation via air and/or particulate
exposure may occur during
product/article use. EPA plans to
analyze inhalation exposure.
Consumer Use
Furnishing,
Cleaning,
Treatment/
Care Products
Foam setting and
bedding products
Direct contact
through use of
products/articles
containing TCEP
Dust
Ingestion
Consumers/
Bystanders
Yes
Ingestion of TCEP sorbed onto dust
may occur for this condition of use.
EPA plans to analyze dust exposure
via ingestion.
Article/Product
Contact
Dermal
Consumers
Yes
Dermal exposure may occur via use
of articles containing TCEP. EPA
plans to analyze dermal exposure.
Article/Product
Mouthing
Ingestion
Bystanders
Yes
Ingestion via object to mouth or
subsequent hand to mouth from
product dermal contact. EPA plans to
analyze mouthing via ingestion.
72
-------
l.ile ( >cle
S(;i»o
("sik'Sion
Siibciik'jion
Kck'sisi* from
SOIIIVC
l'l\|)OMIIV
P;i(h\\;n
Rouk'
Km'plor
Pliius In
I'1\;iIii;iU'
Kiilioiiiilo
Article/Product
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use. EPA plans to
analyze dermal exposure.
Direct contact
through use of
products/articles
Dust
Ingestion
Consumers
Yes
Ingestion of TCEP sorbed onto dust
may occur for this condition of use.
EPA plans to analyze dust exposure
via ingestion.
Consumer
Handling of
Disposal and
Waste
Wastewater,
Liquid wastes
and solid
wastes
Wastewater,
Liquid wastes
containing TCEP
Air/Particulate
Inhalation
Consumers
and
Bystanders
Yes
Inhalation of air and/or particles from
articles/products containing TCEP
may occur for this condition of use.
EPA plans to analyze inhalation
exposure.
and solid wastes
Long-term
emission/mass-
transfer through
use of products
containing TCEP
Dust
Ingestion
Consumers
Yes
Ingestion of TCEP sorbed onto dust
may occur for this condition of use.
EPA plans to analyze dust exposure
via ingestion.
Air/Particulate
Inhalation
Consumers
and
Bystanders
Yes
Inhalation of air and/or particles from
articles/products containing TCEP
may occur for this condition of use,
EPA plans to analyze inhalation
exposure
73
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Appendix H SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES
Table A
px H-l General Population and Environmental Exposure Conceptual Model Supporting r
"able
life
( > cle
Sl;i»c
Csili'Sittn
Ki'k'iisi*
l'l\|)OMIIV
Pillliw ;¦> /
Modiii
KxpuMiiv
Koii les
Kcccplor /
Population
I'lilllS lo
I.\;iIii;iK'
Kiilioiiiik-
All
Emissions to Air
Emissions to Air
Near facility
ambient air
concentrations
Inhalation
General
Population
Yes
TCEP deposition to nearby
bodies of water and soil are
expected exposure pathways, not
covered under other EPA
regulations, and, therefore in
scope.
Indirect
deposition to
nearby bodies
of water and
soil catchments
Oral
Dermal
General
Population
Yes
TBD
Aquatic and
Terrestrial
Receptors
Yes
Wastewater or
Liquid Wastes
Industrial pre-
treatment and
wastewater
treatment, or POTW
Direct release
into surface
water and
indirect
partitioning to
sediment
TBD
Aquatic and
Terrestrial
Receptors
Yes
EPA plans to analyze the release
of TCEP into surface water and
indirect partitioning to sediment
exposure pathways to aquatic and
terrestrial receptors.
Oral
Dermal
General
Population
Yes
EPA plans to analyze the release
of TCEP into surface water and
indirect partitioning to sediment
and bioaccumulation exposure
pathways to the general
population.
Drinking Water
via Surface or
Ground Water
Oral
Dermal and
Inhalation
(e.g.
showering)
General
Population
Yes
EPA plans to analyze the release
of TCEP into surface water and
indirect partitioning to drinking
water.
Biosolids:
application to
soil and/or
migration to
groundwater
and/or surface
water
Oral (e.g.
ingestion of
soil)
Inhalation
General
Population
Yes
EPA plans to analyze the
pathway from biosolids to the
general population and terrestrial
species.
TBD
Terrestrial
receptors
Yes
74
-------
1 -i IV
( > cle
Csili'Sittn
Ki'k'iisi*
I'lxposiiiv
Pillliw ;¦> /
Mcdiii
KxpuMiiv
Koii Ion
Kcccplor /
I'opiiliilion
I'lilllS lo
I.MllllillC
Kiilioiiiik-
Disposal
Solid and Liquid
Wastes
Municipal landfill
and other land
disposal
Leachate to
soil, ground
water and/or
mitigation to
surface water
Oral
Dermal
General
Population
Yes
EPA plans to analyze the
pathway from municipal landfills
and other land disposal to the
general population, aquatic and
terrestrial receptors.
TBD
Aquatic and
Terrestrial
Receptors
75
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