EPA Document# EPA- 740-R-20-009
August 2020
FPA United Statcs Office of Chemical Safety and
!¦¦¦ Environmental Protection Agency Pollution Prevention
Final Scope of the Risk Evaluation for
Tris(2-chloroethyl) Phosphate
(TCEP)
CASRN 115-96-8
August 2020
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 6
ABBREVIATIONS AND ACRONYMS 7
EXECUTIVE SUMMARY 2
1 INTRODUCTION 5
2 SCOPE OF THE EVALUATION 5
2.1 Reasonably Available Information 5
2.1.1 Search of Gray Literature for All Disciplines 6
2.1.2 Search of Literature from Publicly Available Databases (Peer-Reviewed Literature) 7
2.1.3 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 18
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 24
2.3.3 Releases to the Environment 24
2.3.4 Environmental Exposures 25
2.3.5 Occupational Exposures 25
2.3.6 Consumer Exposures 26
2.3.7 General Population Exposures 26
2.4 Hazards (Effects) 27
2.4.1 Environmental Hazards 27
2.4.2 Human Health Hazards 27
2.5 Potentially Exposed or Susceptible Subpopulations 27
2.6 Conceptual Models 28
2.6.1 Conceptual Model for Industrial and Commercial Activities and Uses 28
2.6.2 Conceptual Model for Consumer Activities and Uses 30
2.6.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards 32
2.7 Analysis Plan 34
2.7.1 Physical and Chemical Properties and Environmental Fate 34
2.7.2 Exposure 35
2.7.2.1 Environmental Releases 35
2.7.2.2 Environmental Exposures 38
2.7.2.3 Occupational Exposures 39
2.7.2.4 Consumer Exposures 40
2.7.2.5 General Population 42
2.7.3 Hazards (Effects) 44
2.7.3.1 Environmental Hazards 44
2.7.3.2 Human Health Hazards 45
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2.7.4 Summary of Risk Approaches for Characterization 48
2.8 Peer Review 49
REFERENCES 50
APPENDICES 55
Appendix A ABBREVIATED METHODS FOR SEARCHING AND SCREENING 55
A. '1 Literature Search of Publicly Available Databases. 55
A. 1.1 Search Term Genesis and Chemical Verification 55
A. 1.2 Publicly Available Database Searches 56
A. 1.2.1 Query Strings for the Publicly Available Database Searches on TCEP 57
A. 1.2.2 Data Prioritization for Environmental Hazard, Human Health Hazard, Fate and Physical
Chemistry 62
A. 1.2.3 Data Prioritization for Occupational Exposures and Environmental Releases and
General Population, Consumer and Environmental Exposures 63
A.2 Peer-Reviewed Screening Process ....63
A.2.1 Inclusion/Exclusion Criteria 64
A.2.1.1 PECO for Environmental and Human Health Hazards 64
A.2.1.2 PECO for Consumer, Environmental, and General Population Exposures 66
A.2.1.3 RESO for Occupational Exposure and Environmental Releases 67
A.2.1.4 PESO for Fate and Transport 70
A.2.1.5 Generation of Hazard Heat Maps 73
A.3 Gray Literature Search and Screening Strategies .73
A.3.1 Screening of Gray Literature 73
A.3.2 Initial Screening of Sources using Decision Logic Tree 74
A.3.3 TSCA Submission Searching and Title Screening 75
A.3.4 Gray Literature Search Results for TCEP 76
Appendix B PHYSICAL AND CHEMICAL PROPERTIES 79
Appendix C ENVIRONMENTAL FATE AND TRANSPORT PROPERTIES 81
Appendix I) REGULATORY HISTORY 83
D.l Federal Laws and Regulations ................83
D.2 State Laws and Regulations 84
D.3 International Laws and Regulations... ..85
Appendix E PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION.. 86
E.l Process Information.. .........86
E. 1.1 Manufacture (Including Import) 86
E.l. 1.1 Import 86
E.l.2 Processing and Distribution 86
E. 1.2.1 Incorporated into a Formulation, Mixture or Reaction Product 86
E. 1.2.2 Incorporated into an Article 86
E.l.2.3 Recycling 86
E. 1.3 Uses Included in Scope 86
E. 1.3.1 Aircraft Interiors and Aerospace Products 86
E.l.3.2 Building / Construction Materials 87
E.l.3.3 Foam Seating and Bedding Products 87
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E.l.3.4 Other: Uses (e.g., Laboratory Use) 87
E.l.3.5 Paints and Coatings 87
E.l.3.6 Fabric, Textile, and Leather Products 87
E.1.4 Disposal 88
E.2 Preliminary Occupational Exposure Data. 88
Appendix F SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR INDUSTRIAL
AND COMMERCIAL ACTIVITIES AND USES 89
Appendix G SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR CONSUMER
ACTIVITIES AND USE 96
Appendix H SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES 99
LIST OF TABLES
Table 2-1. Results of Title Screening of Submissions to EPA under Various Sections of TSCAa 17
Table 2-2. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 18
Table 2-3. Physical and Chemical Properties of TCEP 22
Table 2-4. Categories and Sources of Environmental Release Data 35
LIST OF FIGURES
Figure 2-1. Gray Literature Tags by Discipline for TCEP 7
Figure 2-2. Peer-reviewed Literature Inventory Tree - Physical and Chemical Properties Search Results
for TCEP 8
Figure 2-3. Peer-reviewed Literature Inventory Tree - Fate and Transport Search Results for TCEP 9
Figure 2-4. Peer-reviewed Literature Inventory Heat Map - Fate Search Results for TCEP 10
Figure 2-5. Peer-reviewed Literature Inventory Tree - Engineering Search Results for TCEP 11
Figure 2-6. Peer-reviewed Literature Inventory Heat Map - Engineering Search Results for TCEP 12
Figure 2-7. Peer-reviewed Literature Inventory Tree - Exposure Search Results for TCEP 13
Figure 2-8. Peer-reviewed and Gray Literature Inventory Heat Map - Exposure - Search Results for
TCEP 14
Figure 2-9. Peer-reviewed Literature Inventory Tree- Human Health and Environmental Hazard Search
Results for TCEP 15
Figure 2-10. Peer-reviewed Literature Inventory Heat Map - Human Health and Environmental Hazards
Search Results for TCEP 16
Figure 2-11. TCEP Life Cycle Diagram 21
Figure 2-12. Box and Whisker Plots of Reported Physical and Chemical Property Values 24
Figure 2-13. Conceptual Model for Industrial and Commercial Activities and Uses: Worker and
Occupational Non-User Exposures and Hazards 29
Figure 2-14. TCEP Conceptual Model for Consumer Activities and Uses: Consumer Exposures and
Hazards 31
Figure 2-15. TCEP Conceptual Model for Environmental Releases and Wastes: Environmental and
General Population Exposures and Hazards 33
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LIST OF APPENDIX TABLES
Table_Apx A-l. Sources of Verification for Chemical Names and Structures 55
TableApx A-2. Summary of Data Sources, Search Dates and Number of Peer-Reviewed Literature
Search Results for TCEP 57
Table Apx A-3. Hazards Title and Abstract and Full-Text PECO Criteria for TCEP 64
TableApx A-4. Major categories of Potentially Relevant Supplemental Material for TCEP 66
Table Apx A-5. Generic Inclusion Criteria for the Data Sources Reporting Exposure Data on General
Population, Consumers and Environmental Receptors 66
Table Apx A-6. Pathways Identified as Supplemental for TCEPa 67
Table Apx A-7. Inclusion Criteria for Data Sources Reporting Engineering and Occupational Exposure
Data 68
Table Apx A-8. Engineering, Environmental Release and Occupational Data Necessary to Develop the
Environmental Release and Occupational Exposure Assessments 69
Table Apx A-9. Inclusion Criteria for Data or Information Sources Reporting Environmental Fate and
Transport Data 71
Table Apx A-10. Fate Endpoints and Associated Processes, Media and Exposure Pathways Considered
in the Development of the Environmental Fate Assessment 72
Table_Apx A-l 1. Decision Logic Tree Overview 74
Table Apx A-12. Gray Literature Sources that Yielded Results for TCEP 76
Table_Apx B-l. Summary Statistics for Reviewed Physical Properties 79
Table Apx C-l. Environmental Fate Characteristics of TCEP 81
Table_Apx D-l. Federal Laws and Regulations 83
Table_Apx D-2. State Laws and Regulations 84
Table Apx D-3 Regulatory Actions by other Governments, Tribes, and International Agreements 85
Table Apx E-l. Potentially Relevant Data Sources for Exposure Monitoring and Area Monitoring Data
from NIOSH Health Hazard Evaluations for TCEPa 88
Table Apx F-l Worker and Occupational Non-User Exposure Conceptual Model Supporting Table... 89
Table Apx G-l Consumer Exposure Conceptual Model Supporting Table 96
Table Apx H-l General Population and Environmental Exposure Conceptual Model Supporting Table
99
LIST OF APPENDIX FIGURES
FigureApx A-l. Decision Logic Tree Used to Screen Gray Literature Results 74
FigureApx B-l. Tornado Diagram for Viscosity Data Identified in Systematic Review 80
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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: J Q-QPPT-2018-0476.
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
CSF
Cancer Slope Factor
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
IUR
Inhalation Unit Risk
LCso
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
lw
Lipid Weight
mm Fig
Millimeter(s) of Mercury
MOE
Margins Of Exposure
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
OSF
Oral Slope Factor
OSFLA
Occupational Safety and Health Administration
PBT
Persistent, bioaccumulative, toxic
PECO
Population, exposure, comparator, outcome
PEL
Permissible Exposure Limit
PESO
Pathways and processes, exposure, setting or scenario, and outcomes
PESS
Potentially Exposed or Susceptible Subpopulation
PNOR
Particulates Not Otherwise Regulated
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POD
Point of Departure
POTW
Publicly Owned Treatment Works
PPE
Personal Protective Equipment
RCRA
Resource Conservation and Recovery Act
RESO
Receptors, exposure, setting or scenario, and outcomes
SDS
Safety Data Sheet
TCEP
Tris(2-chloroethyl) Phosphate
TIAB
Title and abstract
TRI
Toxics Release Inventory
WW
Wet Weight
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-Q] ). The first step of the risk evaluation process is the development of the draft
scope document. EPA published the Draft Scope of the Risk Evaluation for Tris(2-chloroethyl)
Phosphate CASRN 115-96-8 ( 2020c) and provided a 45-day comment period on the draft
scope per 40 CFR 702.41(c)(7). EPA has considered comments received (Docket ID: EPA-HQ-OPPT-
2.018-0476) during the public comment period to inform the development of this final scope document,
and public comments received will continue to inform the development of the risk evaluation for TCEP.
This document fulfills the TSCA requirement to issue a final scope document per TSCA Section
6(b)(4)(D) and as described in 40 CFR 702.41(c)(8). The 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 the 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.
General Information. TCEP is a liquid and primarily used as a flame retardant with a total production
volume in the United States of 39,682 pounds.
Reasonably Available Information. EPA leveraged the data and information sources already described
in the Proposed Designation of Tris(2-chloroethyl) Phosphate (CASRN 115-96-8) as a High-Priority
Substance for Risk Evaluation (U.S. EPA. 2019c) to inform the development of this scope document.
Furthermore, 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 are
provided in Section 2.1. EPA used the systematic review process described in Appendix A to search for
and screen reasonably available information, including information already in EPA's possession, for
inclusion in the risk evaluation. This information includes the hazards, exposures, PESS, and conditions
of use that may help inform the risk evaluation for TCEP. EPA has focused on the data collection phase
(consisting of data search, data screening, and data extraction) during the preparation of the scope
document, whereas the data evaluation and integration stages will occur during the development of the
risk evaluation and thus are not part of the scoping activities described in this document. EPA will
consider additional information identified following publication of this scope document, as appropriate,
in developing the risk evaluation, including the Chemical Data Reporting (CDR) information that the
Agency will receive by the end of November 2020.
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, polymers including polyester resin, and articles, such as aircraft interiors. In addition,
TCEP is used as a laboratory chemical. TCEP is incorporated into fabric and textiles, foam seating and
bedding products, and paints and coatings. In the past, TCEP was incorporated into building and
construction materials, such as roofing insulation and wood resin composites. Some of these products
may still be present in consumers' homes and commercial infrastructure. EPA identified these
conditions of use from information reported to EPA through CDR, published literature, and consultation
with stakeholders for both uses currently in production and uses for which production may have ceased.
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EPA did not revise any conditions of use in the final scope document for TCEP based on public
comments received (Docket ID: EPA-HQ-OPPT-2018-0476) on the draft scope. Section 2.2 provides
details about the conditions of use within the scope 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
(e.g., media), exposure routes (e.g., inhalation, dermal, oral), hazards, and receptors throughout the life
cycle of the chemical substance. EPA considered reasonably available information as well as public
comments received on the draft scope document for TCEP in finalizing the exposure pathways,
exposure routes, and hazards EPA plans to evaluate in the risk evaluation. As a result, EPA plans to
focus the risk evaluation for TCEP on the following exposures, hazards, and receptors.
• Exposures (Pathways and Routes), Receptors and PESS. EPA plans to evaluate releases to the
environment as well as 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. Additional information gathered through systematic review searches will also
inform expected exposures.
EPA's plan for evaluating environmental exposure pathways in the scope of the risk evaluation
considers whether other EPA administered statutes and regulatory programs cover TCEP in
media pathways falling under the jurisdiction of those authorities. TCEP does not have pathways
covered under the jurisdiction of other EPA-administered laws. In Section 2.6, 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.
EPA considered reasonably available information and comments received on the draft scope for
TCEP in determining the human and environmental exposure pathways, routes, receptors and
PESS for inclusion in the final scope. EPA plans to evaluate the following human and
environmental exposure pathways, routes, receptors and PESS in the scope of the risk
evaluation:
- Occupational exposure: EPA plans to evaluate exposures to workers and occupational
non-users (ONUs) via the inhalation route and exposures to workers via the dermal route
associated with the manufacturing, processing, use, or disposal of TCEP.
- Consumer and bystander exposure: EPA plans to evaluate oral and dermal exposure to
TCEP for consumers, and inhalation exposure for consumers and bystanders from use of
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 of products/articles containing TCEP.
- General population exposure: EPA plans to evaluate general population exposure to
TCEP via the oral route from drinking water, surface water, groundwater, fish ingestion,
human breast milk and soil, via the inhalation route from ambient air and via dermal
route from contact with drinking water, surface water, groundwater and soil.
- PESS: EPA plans to evaluate children, women of reproductive age (e.g., pregnant
women, breast-feeding women), workers, and consumers as receptors and PESS in the
risk evaluation.
- Environmental exposure: EPA plans to evaluate exposure to TCEP for aquatic and
terrestrial receptors.
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• Hazards. Hazards for TCEP are discussed in Section 2.4. EPA completed preliminary reviews of
information (e.g., federal and international government chemical assessments) to identify
potential environmental and human health hazards for TCEP as part of the prioritization (
EPA. 2019c) and scoping process ( 320c). EPA also considered reasonably available
information collected through systematic review methods as outlined in Appendix A and public
comments received on the draft scope for TCEP in determining the broad categories of
environmental and human health hazard effects to be evaluated in the risk evaluation. EPA will
use systematic review methods to evaluate the epidemiological and toxicological literature for
TCEP.
EPA plans to evaluate all potential environmental and human health hazard effects identified for
TCEP in Sections 2.4.1 and 2.4.2, respectively. Identified through the data screening phase of
systematic review, the potential environmental hazard effects and related information that EPA
plans to consider for the risk evaluation include: ADME, PBPK, cancer, cardiovascular,
developmental, endocrine, gastrointestinal, hematological and immune, hepatic, mortality,
musculoskeletal, neurological, nutritional and metabolic, ocular and sensory, renal and
reproductive for TCEP. Similarly, the potential human health hazard effects and related
information identified through prioritization and the data screening phase of systematic review
for TCEP that EPA plans to consider for the risk evaluation include: ADME, PBPK, cancer,
cardiovascular, developmental, endocrine, gastrointestinal, hematological and immune, hepatic,
mortality, musculoskeletal, neurological, nutritional and metabolic, ocular and sensory, renal,
reproductive, respiratory and skin and connective tissue.
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 review of identified information as
described in Section 2.1. Should additional data or approaches become reasonably available, EPA may
consider them for the risk evaluation.
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 ( 015b) and other methods consistent with Section 26 of
TSCA (see 40 CFR 702.45).
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1 INTRODUCTION
This document presents the scope of the risk evaluation to be conducted for 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 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 nonrisk 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 PESS 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 (Docket ID:
EPA-HO-Q] ) (84 FR 71924, December 30, 2019), 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. On April 9, 2020, EPA published the Draft
Scope of the Risk Evaluation for Tris(2-chloroethyl) Phosphate CASRN115-96-8 (85 FR 19941, April 9,
2020) ( 020c) for a 45-day public comment period. After reviewing and considering the
public comments received (Docket ID: EPA-HQ-OPPT-2018-0476) on the draft scope document, EPA
is now publishing this final scope document pursuant to 40 CFR 702.41(c)(8).
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 scope document for TCEP. EPA leveraged the data and information sources already
collected 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;
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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3. Data and information submitted under TSCA Sections 4, 5, 8(e), and 8(d), as well as "for your
information" (FYI) submissions.
Following the comprehensive search, EPA performed a title and abstract screening to identify
information potentially relevant for the risk evaluation process. This step also classified the references
into useful categories or tags to facilitate the sorting of information through the systematic review
process.
Search terms were used to search each of the literature streams and gather TCEP studies. These terms
and the methods used to develop them are listed in Appendix A. The studies resulting from the search
process were loaded into the EPA Health and Environmental Research Online (HERO) database and
then prioritized to screen first the literature likely relevant for each of the disciplines: fate, physical and
chemical properties, engineering, exposure and hazard. The tools and methods used to manage the
screening process are also outlined in Appendix A. The studies resulting from the search underwent a
title/abstract screening process, which tagged them by topic or category. Following this, a determination
was made to move studies forward into full-text screening. The criteria used in the screening process for
each discipline are found in the population, exposure, comparator, outcome (PECO) statements listed in
Appendix A. The screening process results are presented in the form of literature inventory trees and
heat maps in Section 2.1.3. The screening process was conducted based on EPA's planning, execution
and assessment activities outlined in Appendix A.
EPA has focused on the data collection phase (consisting of data search, data screening, and data
extraction) during the preparation of the scope document, whereas the data evaluation and integration
stages will occur during the development of the risk evaluation and thus are not part of the scoping
activities described in this document.
The subsequent sections summarize the data collection activities completed to date for the general
categories of sources and topic areas (or disciplines) using systematic review methods.
2.1.1 Search of Gray Literature for All Disciplines
EPA surveyed the gray literature2 and identified 95 search results relevant to EPA's risk evaluation
needs for TCEP. Appendix A.3.4 lists the gray literature sources that yielded 95 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 and chemical properties,
environmental fate, environmental hazard, human health hazard, exposure, engineering), and the
breakdown is shown in Figure 2-1. EPA will consider additional reasonably available information from
gray literature if it becomes available during the risk evaluation phase.
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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Gray Literature Tags by Discipline
Q
&
3
ir>
Environmental.Hazard ¦
Human.Health. Hazard ¦
Phvsical.Chemical ¦
Engineering ¦
Exposure -
33/95
45/95
27/95
55/95
66/95
0
25
50
Percent Tagged (%)
75
100
Figure 2-1. Gray Literature Tags by Discipline for TCEP
The percentages across disciplines do not add up to 100%, as each source may provide data or
information for various topic areas (or disciplines).
2.1.2 Search of Literature from Publicly Available Databases (Peer-Reviewed
Literature)
EPA has begun the systematic review process and has conducted searching and screening of the
reasonably available literature using the process outlined in Appendix A. This includes performing a
comprehensive search of the reasonably available peer review literature physical and chemical
properties, environmental fate and transport, engineering (environmental release and occupational
exposure), exposure (environmental, general population and consumer) and environmental and human
health hazards of TCEP. Eligibility criteria were applied in the form of PECO 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.
EPA created literature inventory trees to graphically illustrate the flow of data and information sources
following full-text screening (see Figure 2-2, Figure 2-3,
Figure 2-5,
Figure 2-7, and Figure 2-9). EPA used the Health Assessment Workplace Collaborative (HAWC) tool to
develop web-based literature inventory trees illustrating, through interactive links, studies that were
included or excluded. These literature inventory trees enhance the transparency of the decisions resulting
from the screening process described in Appendix A. For each of the corresponding disciplines, the
literature was tagged to be included for evaluation during the risk evaluation. The literature inventory
tree for physical and chemical properties are provided as a static diagram (Figure 2-2). For all other
disciplines, static screen captures are provided in addition to links within each figure's caption to the
interactive trees. The links show individual studies that were tagged as included, excluded, or
supplemental. Supplemental studies did not meet all inclusion criteria but may be considered during the
risk evaluation as supporting information (see Appendix A). The citations for these studies can be
accessed through the hyperlink provided in the associated caption below each figure. In some figures,
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-
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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.
In addition, EPA tabulated the number and characteristics of the data and information sources included
in the full-text screening process in the form of a literature inventory heat map for the fate, engineering,
exposure and hazard information (see
Figure 2-4,
Figure 2-6, Figure 2-8, Figure 2-10). For each of these four disciplines, a static image of the literature
inventory heat map is provided, and a link to the interactive version presented in HAWC is included in
the caption below each diagram.
Retrieved for Full-text
Review
Total for TIAB:
P-Chem
Exclusion
Figure 2-2. Peer-reviewed Literature Inventory Tree - Physical and Chemical Properties Search
Results for TCEP
Data in this static figure represent references obtained from the publicly available databases search (see
Appendix A. 1.2) that were included during full-text screening as of June 2, 2020. TIAB refers to "title
and abstract" screening.
8
-------
©
Bioconcentration
o
Biodegradation
©
Hydrolysis
TSCA Fate TCEP (2020)
Retrieved for Full-text
Review
©
©
Supplemental
Included for Data Extraction
and Evaluation
©
Excluded at Full-text
©
Supplemental Material -
Full-text
0
Photolysis
©
Sorption
©
Volatilization
@
Wastewater Treatment
o
Other
Figure 2-3. Peer-reviewed Literature Inventory Tree - Fate and Transport Search Results for
TCEP
Click here for interactive literature inventory tree. Data in this figure represents references obtained
from the publicly available databases search (see Appendix A. 1.2) that were included during full-text
screening as of June 2, 2020. Additional data may be added to the interactive version as they become
available.
9
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Media
Endpoint
Air
Soil,
Sediment
Wastewater,
Biosolids
Water
Other
Grand Total
Bioconcentration
1
7
1
8
14
Biodegradation
1
4
1
6
7
Hydrolysis
3
3
Photolysis
5
5
Sorption
9
[•¦ — ij
3
7
11
Volatilization
2
2
1
3
Wastewater T reatment
1
10
8
10
Other
3
4
5
7
Grand Total
4
16
12
30
43
Figure 2-4. Peer-reviewed Literature Inventory Heat Map - Fate Search Results for TCEP
Click here to view the interactive version for additional study details. The column totals, row totals, and
grand totals indicate the total numbers of unique references, as some references may be included in
multiple cells. The various shades of color visually represent the number of relevant references
identified by media or endpoint. The darker the color, the more references are available for a given
media or endpoint. Data in this figure represents all references obtained from the publicly available
databases search (see Appendix A. 1.2) that were included during full-text screening as of June 2, 2020.
Additional data may be added to the interactive version as they become available.
10
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General Engineering
Assessment
©<
Retrieved for Full-text
Review
223
TSCA Engineering TCEP
(2020)
Q
Excluded
©
Supplemental
I 34 )
Included during Full-text
Review
18
Environmental Release
Q
Excluded during Full-text
Review
©
Occupational Exposure
Figure 2-5. Peer-reviewed Literature Inventory Tree - Engineering Search Results for TCEP
Click here to view the interactive literature inventory tree. Data in this figure represents references
obtained from the publicly available databases search (see Appendix A. 1.2) that were included during
full-text screening as of August 5, 2020. Additional data may be added to the interactive version as they
become available.
11
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Data Type z Evidence Tags
Description of release source
14
Wo evidence tag
1
Environmental
Releases
Release frequency
3
Release or emission factors
8
Release quantity
6
Waste treatment methods and pollution control
7
Total
18
Chemical concentration
11
Life cycle description
7
General
Engineering
Assessment
No evidence tag
2
Number of sites
5
Process description
17
Production, import, or use volume
11
Throughput
3
Total
26
Area sampling data
9
Dermal exposure data
10
Engineering control
4
Exposure duration
5
Exposure frequency
3
Exposure route
15
Occupational
No evidence tag
2
Exposures
Number of workers
6
Particle size characterization
Personal protective equipment
10
Personal sampling data
7
Physical form
10
Worker activity description
12
Total
24
Grand Total
34
Figure 2-6. Peer-reviewed Literature Inventory Heat Map - Engineering Search Results for TCEP
Click here to view the interactive version for additional study details. Data in this figure represent
references obtained from the publicly available databases search (see Appendix A. 1.2) that were
included during full-text screening as of August 5, 2020. Additional data may be added to the interactive
version as they become available.
12
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151
Data Sources Obtained
From Peer-Reviewed
Literature Search
>
kind
©
Included^Full-text
&
Excluded - Full-text
©
Supplemental - Full-text
Excluded - TIAB
<2>
Supplemental - TIAB
©
Data Sources Obtained
From Grey Literature Search
©
Monrtojjoa Study
0
Modeling Study
©
Completed Assessment
©
Experimental Study
-—®
Epidemiological Study
©
Database
©
Survey
0
Monitoring Study
O
Modeling Study
©
Completed Assessment
©
Experimental Study
Epidemiological Study
©
Database
©
Survey
Figure 2-7. Peer-reviewed Literature Inventory Tree - Exposure Search Results for TCEP
Click here to view the interactive literature inventory tree. Data in this static figure represents references
obtained from the publicly available databases search (see Appendix A. 1.2) that were included during
full-text screening as of July 31, 2020. Additional data may be added to the interactive version as they
become available.
13
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Data Type
Media (group)
Monitoring
Study
Modeling Study
Completed
Assessment
Experimental
Study
Epidemiological
Study
Database
Survey
Grand Total
Ambient Air
14
4
9
5
20
Biosolids/Sludge
Drinking Water
3
3
1
6
Groundwater
2
3
1
5
Land Disposal/Landfill
1
1
Sediment
5
2
1
8
Soil
5
2
4
8
Surface Water
7
1
4
1
1
1
11
Wastewater
1
3
1
4
Aquatic Species
3
1
3
6
Terrestrial Species
3
3
Consumer
23
9
10
18
1
2
35
Dietary
12
3
6
1
1
2
15
Dust
73
I 24
29
2
5
7
78
Exposure Factors
7
3
6
2
1
1
10
Exposure Pathway
12
5
9
3
2
1
19
Human Biomonitoring
38
5
10
4
1
4
41
Indoor Air
49
12
16
9
3
3
57
Isomers
1
1
1
1
Use Information
3
1
6
2
8
No Evidence Type
3
1
1
3
Grand Total
144
38
43
22
9
3
12
161
Figure 2-8. Peer-reviewed and Gray Literature Inventory Heat Map - Exposure Search Results
for TCEP
Click here to view the interactive version for additional study details. The column totals, row totals, and
grand totals indicate total numbers of unique references, as some references may be included in multiple
cells. The various shades of color visually represent the number of relevant references identified by
exposure media or data type. The darker the color, the more references are available for a given
exposure media or data type. Data in this figure represent all references obtained from the publicly
available databases search (see Appendix A. 1.2), and gray literature references search (see Appendix
A.3) that were included during full-text screening as of July 31, 2020. Additional data may be added to
the interactive version as they become available.
14
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27
Included during Full-text
Review
©
25
Animal
®
Plant
©
Human Health Model
Environmental Model
Retrieved for Full-text
Review
Excluded during Full-text
Review
H
Supplemental Material -
Full-text
549
©
Mechanistic
©
0
chanis
©
Mechanistic
ADME/TK/PBPK
©
No Original Data
0
Non-English Record
©
Field Study
78
Supplemental Material
ADME/TK/PBPK
©
Mixture
©
No Original Data
©
Susceptible Population
©
Field Study
Figure 2-9. Peer-reviewed Literature Inventory Tree - Human Health and Environmental Hazard
Search Results for TCEP
Click here to view the interactive literature inventory tree. Data in this figure represent references
obtained from the publicly available databases search (see Appendix A. 1.2) that were included during
full-text screening as of May 18, 2020. Additional data may be added to the interactive version as they
become available.
15
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Evidence Type
Animal -
Animal -
Health Outcomes
Human
Human Health
Environmental
Plant
Grand Total
Model
Model
ADME
S
S
10
Cancer
6
5
1
7
Cardiovascular
1
1
3
3
Developmental
1
1
5
6
Endocrine
8
6
3
10
Gastrointestinal
1
1
1
2
Hematological and Immune
4
3
2
4
Hepatic
4
3
1
4
Mortality
3
3
3
5
Musculoskeletal
1
1
6
6
Neurological
9
8
9
17
Nutritional and Metabolic
3
2
3
S
Ocular and Sensory
1
1
4
5
PBPK
_L
1
2
Renal
5
1
7
Reproductive
3
3
4
6
Respiratory
1
1
1
Skin and Connective Tissue
1
1
1
No Tag
Grand Total
15
12
14
27
Figure 2-10. Peer-reviewed Literature Inventory Heat Map - Human Health and Environmental
Hazards Search Results for TCEP
Click here to view the interactive version for additional study details. The numbers indicate the number
of studies with TIAB keywords related to a particular health outcome, not the number of studies that
observed an association with TCEP. Evidence types were manually extracted, and Health Systems were
determined via machine learning. Therefore, the studies examining multiple Health Outcomes and
Evidence types, connections between health outcome, and evidence type may not be accurately
represented. If a study evaluated multiple health outcomes or included multiple populations or study
designs, it is shown here multiple times. Data in this figure represent references obtained from the
publicly available databases search (see Appendix A. 1.2) that were included during full-text screening
as of May 18, 2020. Additional data may be added to the interactive version as they become available.
2.1.3 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 PECO or similar statements
that identify inclusion/exclusion criteria specific to individual disciplines (see Table 2-1 for the list of
disciplines). The details about the criteria are presented in Appendix A.2.1. EPA identified 13
16
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submissions that met the inclusion criteria in these statements and identified 2 submissions with
supplemental data.3 EPA excluded zero submissions.
Table 2-1. Results of Title Screening of Submissions to EPA under Various Sections of TSCAa
Discipline
Included
Supplemental1'
Physical and Chemical 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
a Individual submissions may be relevant to multiple disciplines.
b Included submissions may contain supplemental data for other disciplines, which will be identified at full-text review.
2.2 Conditions of Use
As described in the Proposed Designation of Tris(2-chloroethyl) Phosphate (CASRN115-96-8) as a
High-Priority Substance for Risk Evaluation ( ;), EPA assembled information from the
CDR program to determine conditions of use4 or significant changes in conditions of use of the chemical
substance. Once the 2020 CDR reporting period ends in November 2020, EPA will utilize the most
recent CDR information. 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) ( 2019b) 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 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 activities for TCEP the Agency determined
not to be conditions of use or will otherwise be excluded during scoping. These excluded activities are
described in Section 2.2.2.
3 EPA may further consider some supplemental references, depending on the reasons for tagging, as supplemental or
excluded.
4 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
(TSCA § 3(4)).
-------
2.2.1 Categories and Subcategories of Conditions of Use Included in the Scope of
the Risk Evaluation
Table 2-2 lists the conditions of use that EPA plans to include in the scope of the risk evaluation.
Table 2-2. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
Lilc Cycle
St:i«e
Categoryh
Subcategory''
References
Manufacturing
Import
Import
U.S. EPA. (2019a)
Processing
Processing -
Flame retardant in:
U.S. EPA (2019a);
incorporation into
Paint and coating
Duratec Surfacing Technology
formulation, mixture or
manufacturing
(2018)
reaction product
Processing -
Flame retardant in:
EPA-HI T-2018-0476-
incorporation into
formulation, mixture or
Polymers (e.g.
polyester resin)
OiM * ; r \ < H'l'T iOiS-
nterD rises
reaction product
(2018)
Processing -
Flame retardant (e.g.,
EP A-HO-OPPT-2018-0476-
incorporation into
article
aircraft interiors)
0006
Recycling
Recycling
2019a)
Distribution in
Distribution in
Distribution in
commerce
commerce
commerce
Industrial Use
Other use
Aircraft interiors and
aerospace products
EP A-HO-OPPT-2018-0476-
0006
Commercial
Other use
Aircraft interiors and
EPA-HI T-2018-0476-
Use
aerospace products
0006
Commercial
Use
Paints and coatings
Paints and coatings
U S, K P \ |2019a)
Other use
e.g., Laboratory
chemicals
TCI America (2018)
Furnishing, Cleaning,
Treatment/Care
Fabric, textile, and
leather products not
EP A-HO-OPPT-2018-0476-
Products
covered elsewhere
Construction, Paint,
Building/construction
EPA-HI r-2018-0476-
Electrical, and Metal
materials not covered
0015; Environment Canada
Products
elsewhere (e.g.,
roofing insulation)
(2009), cites Plastics
Technology (2003)
Furnishing, Cleaning,
Treatment/Care
Foam Seating and
Bedding Products
Staoleton et al. (2011)
Products
18
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Life Cycle
Sl:i«o
Ciitoyorvh
Siibcjilcjiorv'
References
Construction, Paint,
Electrical, and Metal
Products
Building/construction
materials - wood and
engineered wood
products (e.g.,
composites)
Environment Canada (2009),
cites Ufa »l VIMECD
(2006); IPC 8)
Consumer Use
Paints and coatings
Paints and coatings
U.S. EPA. (2019a)
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 (2003)
Furnishing, Cleaning,
Treatment/Care
Products
Foam Seating and
Bedding Products
Staoleton et al. (2011)
Construction, Paint,
Electrical, and Metal
Products
Building/construction
materials - wood and
engineered wood
products (e.g., wood
resin composites)
Environment Canada (2009),
cites I V i in ¦>* . ! 98),
OECD (2006)
Disposal
Disposal
Disposal
a 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.
b These categories of conditions of use appear in the Life Cycle Diagram, reflect CDR codes, and broadly represent
conditions of use of TCEP in industrial and/or commercial settings and for consumer uses.
0 These subcategories reflect more specific conditions of use of TCEP.
In the final scope, EPA made the following changes to the conditions of use:
EPA combined "processing - incorporation into formulation, mixture or reaction product - flame retardant in: polyester
resin" and "processing - incorporation into formulation, mixture or reaction product - flame retardant in: thermoplastics"
under "processing - incorporation into formulation, mixture or reaction product - flame retardant in: polymers (e.g.,
polyester resin)" to cover all types of polymers using TCEP.
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 (82 FR 33726, July 20, 2017), TSCA Section 6(b)(4)(D) requires EPA to
19
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identify the hazards, exposures, conditions of use, and the PESS 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
discretion to determine the circumstances that are appropriately considered to be conditions of use for a
particular chemical substance5. As a result, EPA does not plan to include in this scope or in the risk
evaluation activities described below that the Agency does not consider to be conditions of use or for
which EPA is exercising discretionary authority provided by TSCA Section 6(b)(4)(D).
No activities were excluded for TCEP.
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 39,682 pounds (U.S. EPA. 2020aY EPA also uses pre-2015 CDR
production volume information, as detailed in the Proposed Designation of Tris(2-chloroethyl)
Phosphate (CASRN115-96-8) as a High-Priority Substance for Risk Evaluation (EPA-HQ-OPPT-2018-
0476-0007) (U.S. EPA. 2019c). and will include more recent production volume information from the
2020 CDR reporting period in the risk evaluation to support the exposure assessment.
2.2.4 Overview of Conditions of Use and Lifecycle Diagram
Figure 2-11. TCEP Life Cycle Diagram provides the lifecycle diagram for TCEP. The life cycle diagram
is a graphical representation of the various life stages of the categories included within the scope of the
risk evaluation. 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). Appendix E contains additional descriptions (e.g., process
descriptions, worker activities, process flow diagrams) for each manufacture, processing, distribution in
commerce, use and disposal category.
5 Chemical substance means any organic or inorganic substance of a particular molecular identity, including any combination
of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any element or
uncombined radical. Chemical substance does not include (1) any mixture; (2) any pesticide (as defined in the Federal
Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a
pesticide; (3) tobacco or any tobacco product; (4) any source material, special nuclear material, or byproduct material (as
such terms are defined in the Atomic Energy Act of 1954 and regulations issued under such Act); (5) any article the sale of
which is subject to the tax imposed by Section 4181 of the Internal Revenue Code of 1954 (determined without regard to any
exemptions from such tax provided by Section 4182 or 4221 or any other provision of such Code), and; (6) any food, food
additive, drug, cosmetic, or device (as such terms are defined in Section 201 of the Federal Food, Drug, and Cosmetic Act)
when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device (TSCA
§ 3(2)).
20
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MFG/IMPORT
PROCESSING
INDUSTRIAL, COMMERCIAL, CONSUMER USES
RELEASES and WASTE DISPOSAL
Import
I lion |mr:ilinn inlu I hi niti l:i I
MiMiin-.'ir Ui.KliiMi I'iimIiu'I
it-Lmii; reuudani in paint and coaiiusr
manufacturing; polymers)
lllO'l|!(i|';l(i'>!l illi'i Ulitlv
(Flame retardanO
I ';l i 111 ;|||{I ( (i.i I in ! ¦'
Oiln-r I *i-:
aircraft interiors and aerospace
products. laboratory chemicals
I'tiimMiiim.( U.iniiiu.
I U JIIIU III ( aiv !'r(nl»n-l«.- -
fabric, textile, and leather products nof
covered elsewhere; foam settnur .1:1.!
beddins products
< nn-iriU'iiiiM. I'.iim. i kiiiiial. .mil
M1l.1l i'nnlin l>.: ¦'
building construction materials not
covered elsewhere, wood and
engineered wood products
Ktc>ciin^
S
Disposal
See Conceptual Model for
Environmental Releases and Wastes
Manufacture (Including
Import)
~
| | Processing
Uses:
1. Industrial/Commercial
2, Consumer
Figure 2-11. TCEP Life Cycle Diagram
21
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2.3 Exposures
For TSCA exposure assessments, EPA plans to analyze human and environmental exposures and
releases to the environment resulting from the conditions of use within the scope of the risk evaluation
for TCEP. In this section, the physical and chemical properties, environmental fate and transport
properties and releases to the environment are described in addition to potential human and
environmental exposures from TSCA conditions of use and from other possible or known sources.
Release pathways and routes will be described in Section 2.6. 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
consider, 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.
It can also inform the hazard assessment. Table 2-3 summarizes the physical and chemical property
values preliminarily selected for use in the risk evaluation from among the range of reported values
collected as of June 2020. This table differs from that presented in the Proposed Designation of Tris(2-
chloroethyl) Phosphate (CASRN115-96-8) as a High-Priority Substance for Risk Evaluation (U.S. EPA.
2.019c) and may be updated as EPA continues to evaluate and integrate additional information through
systematic review methods. Figure 2-12 summarizes the distribution of reported values for eight
physical and chemical properties routinely used in existing chemical risk evaluations. Appendix B
presents summary statistics for reported physical and chemical property values. All physical and
chemical property values that were extracted and evaluated as of June 2020 are presented in the
supplemental file Data Extraction and Data Evaluation Tables for Physical and Chemical Property
Studies (EP A-HO-OPPT-2018-0476).
Table 2-3. Physical and <
Chemical Properties of TCEP
Properly or Kndpoinl
Value"
Reference
Data Quality
Ualing
Molecular formula
C6H12CI3O4P
NA
NA
Molecular weight
285.49 g/mol
NA
NA
Physical state
Liquid
NLM (2.015)
High
Physical properties
Clear, transparent liquid
NLM (2015)
High
Melting point
-55°C
NLM (2015)
High
Boiling point
330°C
NLM (2.015)
High
Density
1.39 g/cm3 at 25°C
Havn.es (
High
Vapor pressure
0.0613 mm Hg at 25°C
NLM (2015)
High
Vapor density
Not available
22
-------
Properly or Kmlpoinl
Value"
Ueforonco
Dsiln Quality
Killing
Water solubility
7820 mg/L at 20°C
NLM (2015)
High
Octanol/water partition
coefficient (log Kow)
1.78
NLM (2015)
High
Henry's Law constant
2.55><10"8 atm m3/mole at
25°C (Bond method)
U.S. EPA. (2012b)
Flash point
222°C
K >19)
Medium
Auto flammability
Not available
Viscosity
45 cP at 20°C
U.S. EPA. (2012b)
High
Refractive index
1.4721
HayH.es (
High
Dielectric constant
Not available
a Measured unless otherwise noted.
NA = Not applicable
Figure 2-12 displays a summary of the data collected as of June 2020 for eight physical and chemical
values routinely used in TSCA existing chemical risk evaluations. The box and whisker plots for each
endpoint illustrate the mean (average, indicated by the blue diamond) and the 10th, 25th, 50th (median),
75th, and 90th percentiles. All individual data points are indicated by black squares, and value
preliminarily selected for use in the risk evaluation is overlaid (indicated by the orange circle) to provide
context for where it lies within the distribution of the dataset. The number of unique primary data
sources is indicated below each box and whisker plot. If multiple sources presented equivalent values
and cited the same primary source, only one of those was included in the statistical calculations. As a
result, the number of sources listed in Figure 2-12 may differ from the total number of data sources
presented in Figure 2-12. Where no data could be identified through systematic review, text appears to
clearly demonstrate the gap for the endpoint.
23
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222.050-
300-
o
f 250-
200-
Boiiim# Peinl
<"-*>
-35-
-40-
i -45'
-50-
-55-
MeMrtg Point
(n * 5)
222.025-
no data
identified
for Henry's
Law constant
o
S 222.000-
221.975-
221.950-
Flash Ptw*
(n = 1J
0.09-
i 0.06-
0.03-
40-
30-
E
1
> 20-
10'
Vapw PressutB
-------
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
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 (Ballanger et at.. 2015) TCEP were
detected in the fish samples (< 0.6 - 59 ng/g lw) 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 at.. 2012).
In (Sengupta et at.. 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 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 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.
Examples of worker activities associated with the conditions of use within the scope of the risk
evaluation for TCEP that EPA may analyze include, but are not limited to:
• Unloading and transferring TCEP to and from storage containers to process vessels during
manufacturing, processing and use;
• Handling 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.
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• 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 of 0.0613 mm Hg at 25°C (see
Section 2.3.1). EPA anticipates inhalation of vapor, 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 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) (29
) 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 and ONUs
may inadvertently ingest inhaled particles that deposit in the upper respiratory tract. In addition, workers
may transfer chemicals from their hands to their mouths. The frequency and significance of this
exposure route are dependent on several factors including the physical and chemical 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 training and practices, and personal hygiene
that is difficult to predict ("Cherrie et at.. 2006). EPA will consider the relevance of this exposure route
on a case-by-case basis, taking into consideration the aforementioned factors and any reasonably
available information, and may assess oral exposure for workers for certain COUs and worker activities
where warranted. For certain conditions of use of TCEP, EPA plans to consider inhalation exposure to
dust/particulates for workers and ONUs. As inhalation exposure to dust/particulates may occur, EPA
plans to consider potential exposure for particulates that deposit in the upper respiratory tract from
inhalation exposure and may be ingested via the oral route.
EPA plans to evaluate 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 plans to evaluate
dermal exposure to solids during these operations if TCEP is formulated with solid chemicals and
handled as a solid. Dermal exposure by ONUs is not expected for the condition of uses as they are not
expected to directly handle the chemical.
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. Based on these potential sources and pathways of exposure, EPA plans to analyze
oral, dermal and inhalation routes of exposure to consumers and the inhalation route for bystanders that
may result from the conditions of use of 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
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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
EPA considered reasonably available information (e.g., federal and international government chemical
assessments) on TCEP as well as public comments received on the Proposed Designation of Tris(2-
chloroethyl) Phosphate (CASRN115-96-8) as a High-Priority Substance for Risk Evaluation (
2019c) and draft scope for TCEP (U.S. EPA. 2020c) to identify potential environmental hazards. During
prioritization, EPA identified environmental hazard effects for aquatic and terrestrial organisms.
Since prioritization, EPA applied automated techniques during the data screening phase of systematic
review to identify the following potential environmental hazards and related information that may be
considered for the risk evaluation (as explained in Appendix A): ADME, PBPK, cancer, cardiovascular,
developmental, endocrine, gastrointestinal, hematological and immune, hepatic, mortality,
musculoskeletal, neurological, nutritional and metabolic ocular and sensory, renal, and reproductive
(Figure 2-10). A summary of references identified during the screening step of systematic review is
included in the interactive literature inventory trees (Figure 2-9). As EPA continues to evaluate
reasonably available and relevant hazard information identified through systematic review, EPA may
update the list of potential hazard effects to be analyzed in the risk evaluation.
2.4.2 Human Health Hazards
EPA considered reasonably available information (e.g., federal and international government chemical
assessments) on TCEP as well as public comments on the Proposed Designation of Tris(2-chloroethyl)
Phosphate (CASRN 115-96-8) as a High-Priority Substance for Risk Evaluation (U.S. EPA. 2019c) and
draft scope for TCEP ( 2.020c) to identify potential human health hazards. During
prioritization, EPA identified the following potential human health hazards and related information:
acute, repeated dose, genetic, reproductive, developmental, toxicokinetic, cancer and neurological
effects.
Since prioritization, EPA applied automated techniques during the data screening phase of systematic
review to identify the following additional potential human health hazards and related information that
may be considered for the risk evaluation (as explained in Appendix A): ADME, PBPK, cardiovascular,
endocrine, gastrointestinal, hematological and immune, hepatic, mortality, musculoskeletal, nutritional
and metabolic, ocular and sensory, renal, respiratory and skin and connective tissue (Figure 2-10). A
summary of references identified during the screening step of systematic review is included in the
interactive literature inventory trees (Figure 2-9). As EPA continues to evaluate reasonably available and
relevant hazard information identified through systematic review, EPA may update the list of potential
hazard effects to be analyzed in the 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 of adverse health
effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women,
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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 ( 011a).
EPA identified the following potentially exposed or susceptible subpopulations (PESS) based on CDR
information and studies reporting developmental and reproductive effects: children, women of
reproductive age (e.g., pregnant women), lactating females, workers, including ONUs and users, and
consumers, including users and bystanders ( 2019c). EPA plans to evaluate these potentially
exposed or susceptible subpopulations in the risk evaluation. Following further evaluation of the
reasonably available information, EPA may evaluate PESS in the general population as they relate to
fence line communities.
In developing exposure scenarios, EPA plans to analyze reasonably available data 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) and
whether some human receptor groups may have higher exposure via identified pathways of exposure
due to unique characteristics (e.g., activities, duration or location of exposure) when compared with the
general population (U.S. EPA. 2006b). 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). Based on these analyses, EPA
may update the list of PESS in the risk evaluation.
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
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 2-13 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 ONUs via inhalation/oral 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, a determination was made as to whether or not EPA
plans to evaluate each combination of exposure pathway, route, and receptor in the risk evaluation. The
supporting rationale are presented in Appendix F.
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INDUSTRIAL AND COMMERCIAL EXPOSURE PATHWAY EXPOSURE ROUTE RECEPTORS HAZARDS
ACTIVITIES / USES
r*C liquid/Solid Contact
Manufacturing (incl. Import)
Dermal
Workers
Processing:
- Incorporation into
Formulation, Mixture, or
Reaction Product
- Incorporation into
Article
Hazards potentially
associated with acute
and/or chronic
exposures
Occupational Non-
V T Ifan.
Indoor
Mist/Vapor/Dust
Recycling
Paints and Coatings
Fugitive Emissions
Other Use
Furnishing, Cleaning,
Treatment/Care Products
Construction, Paint, Electrical,
and Metal Products
Waste Handling, Treatment
and Disposal
Wastewater, Liquid Wastes and Solid Wastes (see
Environmental Release Conceptual Models)
Figure 2-13. 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.
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2.6.2 Conceptual Model for Consumer Activities and Uses
The conceptual model in Figure 2-14 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 in vapor or dust 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 Appendix G.
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CONSUMER ACTIVITIES
& USES
EXPOSURE
PATHWAY
EXPOSURE
ROUTE
RECEPTORS
HAZARDS
Paints and Cottiass
Furnishing, Cleaning,
Treatment'Care
Prod'jcts
Construction, Paint
Electrical and Metal
Froduets
E
Indoor Air'Dust
Inhalation
Bystanders
Consumer Handling of
Disposal and Waste
rl2U2I
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2.6.3 Conceptual Model for Environmental Releases and Wastes: Potential
Exposures and Hazards
Figure 2-15 presents the exposure pathways, exposure routes, and hazards to general population 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 and 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.
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RELEASES AND WASTES FROM INDUSTRIAL /
COMMERCIAL / CONSUMER USES
EXPOSURE PATHWAYS
EXPOSURE ROUTES RECEPTORS
HAZARDS
Wastewater or
Liquid Wastes
Industrial Pre
Treatment or
Industrial WW7
\\ ater. Sediment
Indirect discharge
t
POT\\
Drinking
Biosohds
Water
Hazardous
Municipal Waste
Landfill
Solid Wastes
Hazardous and
Liquid U astes
Inhalation
Recycling. Other
Treatment
Hazards Potentials-
Associated with
Acute and or Chronic
Exposures
Figure 2-15. TCEP Conceptual Model for Environmental Releases and Wastes: Environmental and General Population Exposures
and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human and environmental receptors from releases and
wastes from industrial, commercial, and consumer uses of TCEP.
a) Industrial wastewater or liquid wastes may be treated on-site and then released to surface water (direct discharge), or pre-treated and released to
Publicly Owned Treatment Works (POTW) (indirect discharge). For consumer uses, such wastes may be released directly to POTW. Drinking water
will undergo further treatment in drinking water treatment plant. Ground water may also be a source of drinking water. Inhalation from drinking water
may occur via showering.
b) Receptors include PESS (see Section 2.5).
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2.7 Analysis Plan
The analysis plan is based on EPA's knowledge of TCEP resulting from the full-text screening of
reasonably available information as described in Section 2.1. EPA encourages submission of additional
existing data, such as full study reports or workplace monitoring from industry sources, that may be
relevant to EPA's evaluation of conditions of use, exposures, hazards and PESS during risk evaluation.
As discussed in the Application of Systematic Review in TSCA Risk Evaluations document (U.S. EPA.
2018a). targeted supplemental searches during the analysis phase may be necessary to identify additional
information (e.g., commercial mixtures) for the risk evaluation of TCEP. For any additional data needs
identified during the risk evaluation, EPA may use the Agency's TSCA authorities under Sections 4, 8
or 11, as appropriate.
2.7.1 Physical and Chemical Properties and Environmental Fate
EPA plans to analyze the physical and chemical properties and environmental fate and transport of
TCEP as follows:
1) Review reasonably available measured or estimated physical and chemical properties and
environmental fate endpoint data collected using systematic review procedures and, where
reasonably available, environmental assessments conducted by other regulatory agencies.
EPA plans to review data and information collected through the systematic review methods and
public comments about the physical and chemical properties (Appendix B) and fate endpoints
(Appendix C), some of which appeared in the Proposed Designation of Tris(2-chloroethyl)
Phosphate (CASRN115-96-8) as a High-Priority Substance for Risk Evaluation (U.S. EPA.
2019c). All sources cited in EPA's analysis will be evaluated according to the procedures and
metrics described in the Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA.
2018a). Where the systematic review process does not identify experimentally measured
chemical property values of sufficiently high quality, testing will be requested under the TSCA
Section 4 authority, or 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 physical and chemical
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 physical and chemical 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 the scientific evidence evaluation of physical and chemical and
environmental fate data, including qualitative and quantitative sources of information.
During risk evaluation, EPA plans to evaluate and integrate the environmental fate evidence
identified in the literature inventory using the methods described in the Application of Systematic
Review in TSCA Risk Evaluations ( 318a).
2.7.2 Exposure
EPA plans to analyze exposure levels for indoor air, ambient air, surface water, sediment, soil, ground
water, aquatic biota, and terrestrial biota associated to exposure to TCEP. Based on its physical and
chemical properties, expected sources, and transport and transformation within the outdoor and indoor
environment, TCEP is more likely to be present in some of these media and less likely to be present in
others. EPA has not yet determined the exposure levels in these media. Exposure level(s) can be
characterized through a combination of reasonably available monitoring data and estimated exposure
levels from modeling approaches. Exposure scenarios are combinations of sources (uses), exposure
pathways, and exposed receptors. Draft exposure scenarios corresponding to various conditions of use
for TCEP are presented in Appendix F, Appendix G and Appendix H. EPA plans to analyze scenario-
specific exposures.
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 sources containing information on processes and activities resulting in
releases, and the information found is described in Appendix E. EPA plans to review additional
sources identified. Potential sources of environmental release data are summarized in Table 2-4:
Table 2-4. 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 supplemental targeted searches of peer-reviewed or gray literature as needed.
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 during risk evaluation. EPA will continue
to consider additional reasonably available information and will evaluate it during development
of 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. EPA plans to attempt
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to address data gaps identified as described in # 3 and #4 below by considering potential
surrogate data and models.
Additionally, for conditions of use where no measured data on releases are reasonably available,
EPA may use a variety of methods including release estimation approaches and assumptions in
the Chemical Screening Tool for Occupational Exposures and Releases (U.S. EPA. 2015a).
3) Review reasonably available measured or estimated release data for surrogate chemicals
that have similar uses and physical properties.
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.
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). EPA has identified information from
various EPA statutes and sources (including, for example, regulatory limits, reporting thresholds
or disposal requirements) that may be relevant to consider for release estimation and
environmental exposures. EPA plans to consider relevant regulatory requirements in estimating
releases during risk evaluation.
5) Review and determine applicability of OECD Emission Scenario Documents (ESDs) and
EPA Generic Scenarios to estimation of environmental releases.
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 July 2009
ESD on Plastics Additives (OECD. 2009) and the September 2011 ESD on Chemical Industry
(OECD. 2011) 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 (U.S. EPA. ^ ):
https://www.epa.gov/tsca-screening-tools/chernsteer-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);
• EPA's Application of Sway Polyur ethane Foam Insulation Generic Scenario for
Estimating Occupational Exposures and Environmental Releases (March 2019;
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• EPA's Industry Profile for me thane 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 toj.
• OECD's Complementing Document to the E Plastic Additives: Plastic Additives
During the Use of End Products (May 2019):
• OECD's C implementing Document for ESP on Coating Industry: Application of Paint
Solvents for Industrial Coating (December 2.015):
• OECD's ESI) on the Chemical Industry (September 2011):
• OECD's ESP on Radiation Curable Coating, Inks, and Adhesives (July 2011):
• OECD's ESP on Plastic Additives (July 2009): and
• OECD's ESP on Coating Industry (Pain juers and Varnishes) (July 2009).
If ESDs and GSs are not available, other methods may be considered. EPA may also perform
supplemental targeted searches of peer-reviewed or gray literature for applicable models and
associated parameters that EPA may use to estimate releases for certain conditions of use.
Additionally, for conditions of use where no measured data on releases are available, EPA may
use a variety of methods including the application of default assumptions such as standard loss
fractions associated with drum cleaning (3%) or single process vessel cleanout (1%).
6) Map or group each condition of use to a release assessment scenario(s).
EPA has completed an initial mapping of release scenarios to relevant conditions of use as
shown in Appendix F. EPA plans to 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 using reasonably available
information identified. EPA may perform supplemental targeted searches of peer-reviewed or
gray literature to better understand certain conditions of use to further develop release scenarios.
7) Evaluate the weight of the scientific evidence of environmental release data.
During risk evaluation, EPA plans to evaluate and integrate the environmental release evidence
identified in the literature inventory using the methods described in the Application of Systematic
Review in TSCA Risk Evaluation (U.S. EPA. 2018a). EPA plans to integrate the data using
systematic review methods to assemble the relevant data, evaluate the data for quality and
relevance, including strengths and limitations, followed by synthesis and integration of the
evidence.
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2.7.2.2 Environmental Exposures
EPA plans to analyze the following in developing its environmental exposure assessment of TCEP:
1) Review reasonably available environmental and biological monitoring data for all media
relevant to environmental exposure.
For TCEP, environmental media which EPA plans to analyze 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 reasonably available
monitoring data.
EPA plans to analyze and consider reasonably available environmental exposure models that
meet the scientific standards under TSCA Section 26(h) 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 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 (le., 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. Review and
characterize monitoring data or modeled estimates 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 reasonably available monitoring
data.
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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.
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 reasonably 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 described in the Application of
Systematic Review in TSCA Risk Evaluation (U.S. EPA. 2018a).
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 reasonably available exposure data including workplace monitoring data
collected by government agencies such as OSHA and NIOSH, and monitoring data found in
published literature. These workplace monitoring data include personal exposure monitoring data
(direct exposures) and area monitoring data (indirect exposures).
2) Review reasonably available exposure data for surrogate chemicals that have uses,
volatility and physical and chemical 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 reasonably 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 searches of peer-reviewed or gray literature to
better understand the process steps involved in conditions of use. EPA plans to also consider the
applicability of exposure models in ChemSTEER ( 2015a) tool that are routinely used
for assessing new chemicals to assess exposures during various conditions of use. EPA may also
perform supplemental targeted searches of peer-reviewed or gray literature 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.
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This will be performed after #2 and #3 are completed and based on information developed from
#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 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 ECs and/or PPE into exposure scenarios.
EPA plans to review potentially relevant data sources on ECs and PPE to determine their
applicability and incorporation into exposure scenarios during risk evaluation. OSHA
recommends employers utilize the hierarchy of controls to address hazardous exposures in the
workplace. The hierarchy of controls strategy outlines, in descending order of priority, the use of
elimination, substitution, engineering controls, administrative controls, and lastly personal
protective equipment (PPE). 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 (see Appendix F). As presented in the fourth column in Table Apx F-l, EPA has completed
an initial mapping of exposure scenarios to conditions of use. EPA plans to refine mapping or
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 is reviewed during risk evaluation. EPA may perform
supplemental targeted searches of peer-reviewed or gray literature to better understand certain
conditions of use to further develop exposure scenarios.
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 Application of Systematic Review in
TSCA Risk Evaluation ( ,). 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 integrate the data using 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.
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For TCEP, the following are noteworthy considerations in constructing consumer exposure
scenarios:
Conditions of use
Duration, frequency and magnitude of exposure
Weight fraction of chemical in products
Amount of chemical used
2) Evaluate the relative potential of indoor exposure pathways based on reasonably available
data.
Based on physical and chemical properties of TCEP and the consumer uses identified, inhalation
of particles is expected to be an important indoor exposure pathway for consumers. Other
pathways include dust ingestion and dermal contact as a result of indoor use of TCEP consumer
products. Inhalation of vapor and mist and oral ingestion of liquid and mist are also possible.
EPA plans to review all reasonably available information in developing the consumer exposure
scenarios and evaluating the exposure pathways in indoor environments.
3) Review existing indoor exposure models that may be applicable in estimating indoor air
exposures.
Indoor exposure models that estimate emissions from use of consumer products are available.
These models generally consider p-chem properties (e.g., vapor pressure, molecular weight),
product specific properties (e.g., weight fraction of the chemical in the product), use patterns
(e.g., duration and frequency of use), user environment (e.g., room of use, ventilation rates), and
receptor characteristics (e.g., exposure factors, activity patterns). The OPPT's Consumer
Exposure Model (CEM) and other similar models can be used to estimate indoor air exposures
from consumer products.
Models that estimate emission and migration of semi-volatile organic compounds (SVOCs) into
the indoor environment models generally consider indoor fate and transport properties such as
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 physical
and chemical 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 reasonably 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.
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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 conditions of use will be evaluated. This data
provides the source term for any subsequent indoor modeling. EPA plans to analyze source
attribution between overall indoor air and dust levels and various indoor sources.
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.
For TCEP, EPA plans to evaluate exposure scenarios that involve PESS and plans to consider
age-specific behaviors, activity patterns and exposure factors unique to those subpopulations. For
some exposure scenarios related to consumer uses, EPA plans to consider whether exposures for
adults may different from those of children due to different activities (e.g., children may mouth
certain products) or exposure factors (e.g., inhalation rates).
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. EPA plans to integrate the data using 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 the general population by considering sources,
conditions of use, exposure pathways and routes.
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 reasonably available, review existing exposure
modelling approaches 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 reasonably available and relevant.
Review reasonably available information on releases to determine how modeled
estimates of concentrations near industrial point sources compare with available
monitoring data.
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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.
Map or group 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 inform exposure scenarios. EPA anticipates that there will be a range in the potential
exposures associated with the exposure scenarios identified in Section 2.6.
After refining and finalizing exposure scenarios, EPA plans to quantify concentrations and/or
doses. The number of scenarios will depend on the conditions of use, exposure pathways and
receptors. 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 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 include careful consideration of variability and uncertainty.
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 considered for TCEP: ingestion of water
and food including fish and breast milk as well as dermal contact to TCEP via water and
inhalation of TCEP via ambient air.
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 reasonably 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 and
chemical properties and similar uses are reasonably available, those modeled estimates will also
be evaluated. The underlying parameters and assumptions of the models will also be evaluated.
5) Review reasonably available information on releases to determine how modeled estimates
of concentrations near industrial point sources compare with reasonably available
monitoring data.
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The expected releases from industrial facilities are changing over time. Any modeled
concentrations based on recent release estimates will be carefully compared with reasonably
available monitoring data to determine representativeness.
6) Review reasonably available information about population- or subpopulation-specific
exposure factors and activity patterns to determine if PESS 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 PESS 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 Application of Systematic Review in
TSCA Risk Evaluation ( .).
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.gcomputational 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 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 terrestrial
organisms.
EPA plans to evaluate environmental hazard data using the evaluation strategies laid out in the
Application of Systematic Review in TSCA Risk Evaluations ( '018a). The study
evaluation results will be documented in the risk evaluation phase and data from acceptable
studies will be extracted and integrated in the risk evaluation process.
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.
2) Derive hazard thresholds for aquatic and terrestrial organisms.
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 terrestrial species.
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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 Application of Systematic
Review in TSCA Risk Evaluation ( 18a).
4) Consider the route(s) of exposure, based on reasonably 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) 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 physical and chemical 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).
6) Conduct an environmental risk estimation and characterization of TCEP.
EPA plans to conduct a risk estimation and characterization of TCEP to identify if there are risks
to the aquatic and terrestrial environments from the measured and/or predicted concentrations of
TCEP in environmental media (e.g., water, sediment, soil). Risk quotients (RQs) may be derived
by the application of hazard and exposure benchmarks to characterize environmental risk (U.S.
EPA. 1998; Bamtfaouse et at.. 1982). Analysis of risk for characterization includes a confidence
statement in risk estimation which qualitative judgment describing the certainty of the risk
estimate considering the strength the evidence scores for hazard and exposure and the
limitations, and relevance.
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).
EPA plans to evaluate human health studies using the evaluation strategies laid out in the
Application of Systematic Review in TSCA Risk Evaluations (l__5 J_0j8a) and updates to
the epidemiological data quality criteria released with the first ten risk evaluations. The study
evaluation results will be documented in the risk evaluation phase and data from acceptable
studies will be extracted and integrated in the risk evaluation process.
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
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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.
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 susceptible
populations and lifestages such as pregnant women and infants. Pregnancy (i.e., gestation) and
childhood are potential susceptible lifestages for TCEP exposure. EPA may quantify these
differences in the risk evaluation following further evaluation of the reasonably available data
and information.
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.
Human health hazards from acute and chronic exposures will be identified by evaluating the
human and animal data that meet the systematic review data quality criteria described in the
Application of Systematic Review in TSCA Risk Evaluations ( :018a). Hazards
identified by studies meeting data quality criteria will be grouped by routes of exposure relevant
to humans (e.g., oral, dermal, inhalation) and by the cancer and noncancer endpoints identified in
Section 2.4.2.
Dose-response assessment will be performed in accordance with EPA guidance (U.S. EPA.
2012a. 201 la. 1994) developing points of departure (POD) for either margins of exposure
(MOEs), cancer slope factors (CSFs), oral slope factors (OSFs), and/or inhalation unit risks
(IURs). Dose-response analyses may be used if the data meet data quality criteria and if
additional information on the identified hazard endpoints are not reasonably available or would
not alter the analysis
The cancer mode of action (MOA) analyses determine the relevancy of animal data to human
risk and how data can be quantitatively evaluated. If cancer hazard is determined to be applicable
to TCEP, EPA plans to evaluate information on genotoxicity and the MOA 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. 2005a). In
accordance with EPA's Supplemental Guidance for Assessing Susceptibility from Early-Life
Exposures to Carcinogens (U.S. EPA. 2005b). EPA plans to determine whether age-dependent
adjustment factors (ADAFs) are appropriate for TCEP for specific conditions of use based upon
potential exposures to children.
4) Derive points of departure (PODs) where appropriate; conduct benchmark dose modeling
depending on the reasonably available data. Adjust the PODs as appropriate to conform
(e.g., adjust for duration of exposure) to the specific exposure scenarios evaluated.
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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 (U.S. EPA. 2012a). 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.
EPA plans to evaluate whether the reasonably available PBPK and empirical kinetic models are
adequate for route-to-route and interspecies extrapolation of the POD or for extrapolation of the
POD to standard exposure durations (e.g., lifetime continuous exposure). If application of the
PBPK model is not possible, oral PODs may be adjusted by BW3/4 scaling in accordance with
U.S. EPA (2 ), and inhalation PODs may be adjusted by exposure duration and chemical
properties in accordance with U.S. EPA (1994).
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 Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA.
2018a).
6) Consider the route(s) of exposure (e.goral, inhalation, dermal), reasonably available
route-to-route extrapolation approaches; biomonitoring data; and 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 a 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.
If sufficient reasonably available toxicity studies are not identified through the systematic review
process to assess risks from inhalation or dermal exposure, then a route-to-route extrapolation
may be needed. The preferred approach is to use a PBPK model (U.S. EPA. 2006a). Without an
adequate PBPK model, considerations regarding the adequacy of data for route-to-route
extrapolation are described in Methods for Derivation of Inhalation Reference Concentrations
and Application of Inhalation Dosimetry ( ). EPA may use these considerations
when determining whether to extrapolate from the oral to the inhalation route of exposure.
Similar approaches for oral-to-dermal route extrapolation are described in EPA guidance
document Risk Assessment Guidance for Superfund Volume I: Human Health Evaluation
Manual (Part Supplemental Guidance for Dermal Risk Assessment) ( 004b).
If there are acceptable inhalation data after completion of systematic review, EPA may also
consider extrapolating from the inhalation to the dermal route if first-pass metabolism through
the liver via the oral route is expected because in that case, use of data from the oral route is not
recommended (U.S. EPA. 1994). EPA may also consider inhalation-to-dermal route
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extrapolation if an inhalation toxicity study with a sensitive hazard endpoint is used to evaluate
risks. Based on these considerations, EPA extrapolated from the inhalation to the dermal route
for several of the first ten risk evaluations under amended TSCA, including methylene chloride
(U.S. EPA. 2020d) and carbon tetrachloride ( 20b).
7) Conduct a human health risk estimation and characterization of TCEP.
Analysis of risk for characterization includes a confidence statement in risk estimation. This
confidence statement is based on qualitative judgment describing the certainty of the risk
estimate considering the strength of the evidence scores for hazard and exposure along with their
limitations and relevance. The lowest confidence evaluation for either hazard or exposure will
drive the overall confidence estimate.
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" ( JOG). 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 ( XX)) and consistent with the requirements of
the Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR
33726, September 18, 2017). As discussed in 40 CFR 702.43, risk characterization has a number of
considerations. This is the step where EPA integrates the hazard and exposure assessments into risk
estimates for the identified populations (including any PESS) and ecological characteristics and weighs
the scientific evidence for the identified hazards and exposures. The risk characterization does not
consider costs or other nonrisk factors, and takes into account, "where relevant, the likely duration,
intensity, frequency, and number of exposures under the condition(s) of use . . . The risk
characterization also summarizes the following considerations: (1) uncertainty and variability in each
step of the risk evaluation; (2) data quality, and any applicable assumptions used; (3) alternative
interpretations of data and analyses, where appropriate; and (4) any considerations for environmental
risk evaluations, if necessary (e.g., related to nature and magnitude of effects).
EPA plans to also be guided by EPA's Information Quality Guidelines ( .002) 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.
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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 (U.S. EPA. 2015b) 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.
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reference concentrations and application of inhalation dosimetry [EPA Report], (EPA/600/8-
90/066F). Research Triangle Park, NC: U.S. Environmental Protection Agency, Office of
Research and Development, Office of Health and Environmental Assessment, Environmental
Criteria and Assessment Office.
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[EPA Report], (EPA/630/R-95/002F). Washington, DC: U.S. Environmental Protection Agency,
Risk Assessment Forum, https://www.epa.gov/risk/giiidelines-ecological-risk-assessment
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characterization handbook. (EPA/100/B-00/002). Washington, DC: U.S. Environmental
Protection Agency, Science Policy Council, https://www.epa.gov/risk/risk-characterization-
handbook
(U.S. Environmental Protection Agency). (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, https://www.epa. gov/sites/production/files/^
03/documents/epa-info-qualitv-guidelines.pdf
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polyurethane foam industry - generic scenario for estimating occupational exposures and
environmental releases: Draft. Washington, DC: U.S. Environmental Protection Agency.
https://www.epa.gov/tsca-screening-tools/ch.em.steer-chemical-screening-tool-exposiires-and-
environmental-releases#genericscenarios
I Fill* (U.S. Environmental Protection Agency). (2004b). Risk Assessment Guidance for Superfund
(RAGS), Volume I: Human health evaluation manual, (Part E: Supplemental guidance for
dermal risk assessment). (EPA/540/R/99/005). Washington, DC: U.S. Environmental Protection
Agency, Risk Assessment Forum, http://www.epa.gov/oswer/riskassessment/ragse/index.htm
EPA. (U.S. Environmental Protection Agency). (2005a). Guidelines for carcinogen risk assessment
[EPA Report], (EPA/630/P-03/001B). Washington, DC: U.S. Environmental Protection Agency,
Risk Assessment Forum, https://www.epa.gov/sites/production/files/2013-
09/documents/cancer guidelines final 3-25-05.pdf
EPA. (U.S. Environmental Protection Agency). (2005b). Supplemental guidance for assessing
susceptibility from early-life exposure to carcinogens [EPA Report], (EPA/630/R-03/003F).
Washington, DC: U.S. Environmental Protection Agency, Risk Assessment Forum.
https://www3.epa.gov/airtoxics/childrens supplement final.pdf
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physiologically based pharmacokinetic (PBPK) models and supporting data in risk assessment
(Final Report) [EPA Report] (pp. 1-123). (EPA/600/R-05/043F). Washington, DC: U.S.
Environmental Protection Agency, Office of Research and Development, National Center for
Environmental Assessment, http://cfpiib.epa.gov/ncea/cfm/recordisplav.cfm7dei' >68
L !LJ (U.S. Environmental Protection Agency). (2006b). A framework for assessing health risk of
environmental exposures to children (pp. 1-145). (EPA/600/R-05/093F). Washington, DC: U.S.
Environmental Protection Agency, Office of Research and Development, National Center for
Environmental Assessment, http://cfpub.epa. gov/ncea/cfm/recordisplay.cfm?deid=l 58363
L ^ EPA (U.S. Environmental Protection Agency). (201 la). Exposure factors handbook: 2011 edition
[EPA Report], (EPA/600/R-090/052F). Washington, DC.
http://cfpub.epa. gov/ncea/cfrn/recordisplav.cfm?deid=236252
(U.S. Environmental Protection Agency). (201 lb). Recommended use of body weight 3/4 as
the default method in derivation of the oral reference dose (pp. 1-50). (EPA/100/R-11/0001).
Washington, DC: U.S. Environmental Protection Agency, Risk Assessment Forum, Office of the
Science Advisor. https://www.epa.gov/sites/production/files/2Q13~09/documents/recomrnended~
use~of~bw34.pdf
L (U.S. Environmental Protection Agency). (2012a). Benchmark dose technical guidance.
(EPA/100/R-12/001). Washington, DC: U.S. Environmental Protection Agency, Risk
Assessment Forum, https://www.epa.gov/risk/benchm.ark~dose~technical~guidance
(U.S. Environmental Protection Agency). (2012b). Estimation Programs Interface Suite™ for
Microsoft® Windows, v 4.11. Washington, DC. Retrieved from https://www.epa.gov/tsca-
screening-tools/epi-suitetm -estimation-program-interface
(U.S. Environmental Protection Agency). (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
(U.S. Environmental Protection Agency). (2015a). ChemSTEER user guide - Chemical
screening tool for exposures and environmental releases. Washington, D.C.
https://www.epa.gOv/sites/prodiiction/files/2015-05/dociiments/iiser guide.pdf
II ^ EPA (U.S. Environmental Protection Agency). (2015b). Science Policy Council peer review
handbook [EPA Report] (4th ed.). (EPA/100/B-15/001). Washington, DC: U.S. Environmental
Protection Agency, Science Policy Council, https://www.epa.gov/osa/peer-review-handbook-
4th-edition-J h <
L )'T..* (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-screening-tool-exposures-and-environmental-releases
L SJ L!* (U.S. Environmental Protection Agency). (2018a). Application of systematic review in TSCA
risk evaluations. (740-P1-8001). Washington, DC: U.S. Environmental Protection Agency,
Office of Chemical Safety and Pollution Prevention.
https://www.epa.gov/sites/production/files/2018-
06/documents/final application of sr in tsi df
L J"!!.!* (U.S. Environmental Protection Agency). (2018b). Problem formulation of the risk evaluation
for 1-bromopropane. (EPA-740-R1-7019). Washington, DC: U.S. Environmental Protection
Agency, Office of Chemical Safety and Pollution Prevention.
https://www.epa.gov/sites/prodiiction/files/2018-06/documents/lbp problem formulation 05-
53
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EPA. (U.S. Environmental Protection Agency). (2018c). Problem formulation of the risk evaluation
for cyclic aliphatic bromides cluster (HBCD). (EPA-740-R1-7012). Washington, DC: U.S.
Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention.
https://www.epa.gov/sites/production/files/2018-06/documents/hbcd problem formulation 05-
n i* |..h
(U.S. Environmental Protection Agency). (2019a). Chemical Data Reporting (2012 and 2016
CBI CDR database). Washington, DC: U.S. Environmental Protection Agency, Office of
Pollution Prevention and Toxics.
K ^ a * \ (U.S. Environmental Protection Agency). (2019b). CPCat (Chemical and Product Categories).
https://actor.epa.gov/cpcat/faces/home.xhtml
L J I!.!- (U.S. Environmental Protection Agency). (2019c). 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/prodiiction/files/2019-08/dociiments/tris2-chloroethylphosphate 115-
96-8 high-priority proposeddesignation 082319.pdf
(U S Environmental Protection Agency). (2020a). Chemical Data Reporting (2012 and 2016
Public CDR database) [Database], Washington, DC: U.S. Environmental Protection Agency,
Office of Pollution Prevention and Toxics. ChemView: July 2020.
https://chemview.epa.gov/chemview
(U.S. Environmental Protection Agency). (2020b). Draft risk evaluation for carbon
tetrachloride (methane, tetrachloro-); CASRN: 56-23-5 (pp. 1-301). (EPA-740-R1-8014). Office
of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency.
https://nepis.epa. gov/Exe/ZvPDF.cgi/P100YHLJW.PDF?Dockev=P 100YHLJW.PDF
(U.S. Environmental Protection Agency). (2020c). Draft Scope of the Risk Evaluation for
Tris(2-chloroethyl) Phosphate CASRN 115-96-8 [EPA Report], (EPA-740-D-20-009).
Washington, DC. https://www.epa.gov/sites/production/files/2020-04/dociiments/casm-l 15-96-
8 tris2-chloroethyl phosphatetcep draft scope.pdf
(U.S. Environmental Protection Agency). (2020d). Risk evaluation for methylene chloride
(dichloromethane, dcm); CASRN: 75-09-2 (pp. 1-753). (EPA-740-R1-8010). Office of Chemical
Safety and Pollution Prevention, U.S. Environmental Protection Agency.
https://www.epa.gov/sites/production/files/2020-
06/documents/l mecl risk evaluation final.pdf
54
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APPENDICES
Appendix A ABBREVIATED METHODS FOR SEARCHING AND
SCREENING
A.l Literature Search of Publicly Available Databases
A.l.l Search Term Genesis and Chemical Verification
To develop the chemical terms for the subsequent literature search for TCEP, several online sources
were queried.
• California Department of Pesticide Regulation:
https://www.cdpr.ca.gov/docs/chemical/monster2.htm
• USEPA Chemistry Dashboard: https://comptox.epa.gov/dashboard
• University of Hertfordshire PPDB: Pesticide Properties DataBase:
https://sitem.herts.ac.uk/aeru/ppdb/en/search.htm
• USEPA Reregi strati on Eligibility Decision (RED) documents:
https://archive.epa.gov/pesticides/reregistration/web/html/status.html
• Office of Pesticide Programs Pesticide Chemical Search:
https://ofmpub.epa.gov/apex/pesticides/f?p=CHEMICALSEARCH:l
• Food and Agriculture Organization of the United Nations: http://www.fao.org/home/en/
• PAN Pesticides Database: http://www.pesticideinfo.org/Search Chemicals.isp
Prior to inclusion in the search term string, all forms of chemical names were subjected to verification
from several potential sources (e.g., US EPA Chemistry Dashboard, STN International-CAS; see
complete list of sources for chemical verification in Table Apx A-l). From these sources, all chemical
names, synonyms, CAS number(s), trade names, etc. were documented and used to generate terms for
database searches.
Table Apx A-l. Sources of Verification for Chemical Names and Structures
CHEMICAL SOURCE
CONTENTS
DOCUMENT
LOCATION
Chemistry Dashboard
dittos ://coniDtox,CDa. uo\/dashboard)
CAS Numbers, Synonyms, Structures, Properties,
Environmental Fate and Transport.
Online
Dictionary of Chemical Names and
Synonyms
Wide assortment of chemical compounds by chemical
name and synonym, has CAS index and some structure
data
ECOTOX
Farm Chemicals Handbook-1992
Pesticide information, CAS numbers and synonyms, some
structure data
***Sometimes CAS number presented for a compound is
for the main constituent only
ECOTOX
OPPT SMILES Verification Source
Structure Data
Electronic
verification
RTECS (Registry of Toxic Effects of
chemical substance, 1983-84 ed., 2
vols)
Chemical names, synonyms and CAS numbers
ECOTOX
Sigma - Aldrich website58784
htte>://www. sisma-aldrich.com
Organic and inorganic Compounds by chemical name, has
CAS index and some structure and Physical Property data
Online
55
-------
CHEMICAL SOURCE
CONTENTS
DOCUMENT
LOCATION
STN International (CAS) 1994
***Most complete source of chemical name, synonym and
structure information, no physical properties
Online
The Pesticide Manual 10th edition,
1994
Pesticide Compounds by chemical name, synonym,
product code, has CAS index and some structure and
Physical Property data
ECOTOX
TSCA (Toxic Substances Control
Act Chemical Substance Inventory,
1985 ed., 5 vols)
Chemical names, synonyms and CAS numbers
ECOTOX
World Wide Web (misc. web
sources) A copy of the verification
page is saved to the Attachments tab
of the chemical entry. This includes
company MSDS sheets or Chemical
Labels.
Chemical names, synonyms and CAS numbers
Online
California Department of Pesticide
Regulation
(htte>://www.cdr>r.ca.eov/dt>rdatabase
.htm)
Multiple databases containing chemicals, pesticides,
companies, products, etc.
Online
PAN Pesticide Database
(htte>://www.r>esticideinfo.ore/Search
Chemicals.iso)
Pesticides searchable by name or CAS #. Includes CAS #,
Name, synonyms, targets, toxicity data, related chemicals
and regulatory information.
Online
US EPA Office of Pesticide
Programs Pesticide Fate Database -
No web access available. An
electronic copy of the data file is
located at the Contractor site:
PFATE 37 Tables.mdb.
Multiple databases containing chemicals, pesticides,
companies, products, etc.
Online
A.1.2 Publicly Available Database Searches
The databases listed below were searched for literature containing the chemical search terms. Database
searching occurred during April and May of 2019 by an information specialist and the results were
stored in the Health and Environmental Research Online (HERO) database and assigned a HERO
reference identification number.6 The present literature search focused only on the chemical name
(including synonyms and trade names) with no additional limits. Full details of the search strategy for
each database are presented in Appendix A. 1.2.1.
After initial deduplication in HERO7, these studies were imported into SWIFT Review software
(Howard et at.. 2016) to identify those references most likely to be applicable to each discipline area (i.e.
consumer, environmental, and general population exposure, occupational exposure and environmental
releases, environmental hazards, human health hazards, and fate and physical chemistry).
6EPA's HERO database provides access to the scientific literature behind EPA science assessments. The database includes
more than 600,000 scientific references and data from the peer-reviewed literature used by EPA to develop its regulations.
7 Deduplication in HERO involves first determining whether a matching unique ID exists (e.g., PMID, WOSid, or DOI). If
one matches one that already exists in HERO, HERO will tag the existing reference instead of adding the reference again.
Second, HERO checks if the same journal, volume, issue and page number are already in HERO. Third, HERO matches on
the title, year, and first author. Title comparisons ignore punctuation and case.
-------
A. 1.2.1 Query Strings for the Publicly Available Database Searches on TCEP
Table Apx A-2 presents a list of the data sources, the search dates and number of peer-reviewed
references resulting from the searches for TCEP. The sources are found as online databases and the
resulting references were gathered and uploaded into the EPA Health and Environmental Research
Online (HERO) database for literature screening.
Table_Apx A-2. Summary of Data Sources, Search Dates and Number of Peer-Reviewed Literature
Search Results for TCEP
Source
Date of Search
Number ol' References
Current Contents
06/11/2019
313
Web of Science
09/13/2019
361
ProQuest CSA
06/11/2019
599
Dissertation Abstracts
06/11/2019
0
Science Direct
06/11/2019
960
Agricola
06/11/2019
244
TOXNET
06/11/2019
632
PubMed
07/03/2019
274
UNIFY
06/11/2019
32
Totals:
3415
GENERAL:
General search terms were compiled and used in the search strategies for each of the databases/sources
listed below. Based upon the online search manuals for the respective databases/sources, it was
necessary to construct searches as noted for each of the sources. The search terms are listed below in full
for each source and noted if the general search terms or other search terms were used.
"2-Chloroethanol phosphate" OR "Amgard TCEP" OR "Antiblaze 100" OR "BRN 1710938" OR
"Celluflex" OR "Celluflex CEF" OR "Disflamoll TCA" OR "Ethanol, 2-chloro-, l,l',r'-phosphate" OR
"ETHANOL, 2-CHLORO-, PHOSPHATE" OR "Ethanol, 2-chloro-, phosphate (3:1)" OR "Fyrol CEF"
OR "Fyrol CF" OR "Genomoll P" OR "NCI-C60128" OR "Niax 3CF" OR "Niax Flame Retardant 3CF"
OR "NSC 3213" OR "Phosphoric acid tris(2-chloroethyl) ester" OR "Phosphoric acid, tris(2-
chloroethyl)ester" OR "Roflam E" OR "Tri(2-chloroethyl) phosphate" OR "Tri(2-
chloroethyl)phosphate" OR "Tri(beta-chloroethyl) phosphate" OR "Tri(chloroethyl) phosphate" OR
"Tri-beta-chloroethyl phosphate" OR "Tris (2-chloroethyl) phosphate" OR "TRIS-(2-
CHLORAETHYL)-PHOSPHAT" OR "Tris(2-chlorethyl)phosphat" OR "Tris(2-chloroethyl)
orthophosphate" OR "Tris(2-chloroethyl) phosphate" OR "Tris(2-chloroethyl) phosphate (TCEP)" OR
"Tris(2-chloroethyl)phosphate" OR "Tris(beta-chloroethyl) phosphate" OR "Tris(beta-chloroethyl)
phosphate" OR "Tris(beta-chloroethylphosphate)" OR "Tris(chloroethyl) phosphate" OR
"Tris(chloroethyl)phosphate" OR "Tris-2-chloroethyl phosphate" OR "UNII-32IVO568B0"
CURRENT CONTENTS CONNECT:
Current Contents Connect may be accessed through EPA Desktop Library
(https://intranet.epa.gov/desktop/databases.htm).
Date Searched: 06/11/2019
Date Range of Search: 1998 to Present
N = 313
57
-------
TS=("2-Chloroethanol phosphate" OR "Amgard TCEP" OR "Antiblaze 100" OR "BRN 1710938" OR
"Celluflex" OR "Celluflex CEF" OR "Disflamoll TCA" OR "Ethanol, 2-chloro-, l,l,,l"-phosphate" OR
"ETHANOL, 2-CHLORO-, PHOSPHATE" OR "Ethanol, 2-chloro-, phosphate (3:1)" OR "Fyrol CEF"
OR "Fyrol CF" OR "Genomoll P" OR "NCI-C60128" OR "Niax 3CF" OR "Niax Flame Retardant 3CF"
OR "NSC 3213" OR "Phosphoric acid tris(2-chloroethyl) ester" OR "Phosphoric acid, tris(2-
chloroethyl)ester" OR "Roflam E" OR "Tri(2-chloroethyl) phosphate" OR "Tri(2-
chloroethyl)phosphate" OR "Tri(beta-chloroethyl) phosphate" OR "Tri(chloroethyl) phosphate" OR
"Tri-beta-chloroethyl phosphate" OR "Tris (2-chloroethyl) phosphate" OR "TRIS-(2-
CHLORAETHYL)-PHOSPHAT" OR "Tris(2-chlorethyl)phosphat" OR "Tris(2-chloroethyl)
orthophosphate" OR "Tris(2-chloroethyl) phosphate" OR "Tris(2-chloroethyl) phosphate (TCEP)" OR
"Tris(2-chloroethyl)phosphate" OR "Tris(beta-chloroethyl) phosphate" OR "Tris(beta-chloroethyl)
phosphate" OR "Tris(beta-chloroethylphosphate)" OR "Tris(chloroethyl) phosphate" OR
"Tris(chloroethyl)phosphate" OR "Tris-2-chloroethyl phosphate" OR "UNII-32IVO568B0")
N = 313
WOS Core Collection:
Web of Science Core Collection may be accessed through EPA Desktop Library
(https://intranet.epa.eov/desktop/databases.htm) by clicking on the Web of Science Link or copying and
pasting (https://apps.webofknowledge. com).
Date Searched: 09/13/2019
Date Range of Search: 1970 to Present
N = 361
TS=("2-Chloroethanol phosphate" OR "Amgard TCEP" OR "Antiblaze 100" OR "BRN 1710938" OR
"Celluflex" OR "Celluflex CEF" OR "Disflamoll TCA" OR "Ethanol, 2-chloro-, l,l,,l"-phosphate" OR
"ETHANOL, 2-CHLORO-, PHOSPHATE" OR "Ethanol, 2-chloro-, phosphate (3:1)" OR "Fyrol CEF"
OR "Fyrol CF" OR "Genomoll P" OR "NCI-C60128" OR "Niax 3CF" OR "Niax Flame Retardant 3CF"
OR "NSC 3213" OR "Phosphoric acid tris(2-chloroethyl) ester" OR "Phosphoric acid, tris(2-
chloroethyl)ester" OR "Roflam E" OR "Tri(2-chloroethyl) phosphate" OR "Tri(2-
chloroethyl)phosphate" OR "Tri(beta-chloroethyl) phosphate" OR "Tri(chloroethyl) phosphate" OR
"Tri-beta-chloroethyl phosphate" OR "Tris (2-chloroethyl) phosphate" OR "TRIS-(2-
CHLORAETHYL)-PHOSPHAT" OR "Tris(2-chlorethyl)phosphat" OR "Tris(2-chloroethyl)
orthophosphate" OR "Tris(2-chloroethyl) phosphate" OR "Tris(2-chloroethyl) phosphate (TCEP)" OR
"Tris(2-chloroethyl)phosphate" OR "Tris(beta-chloroethyl) phosphate" OR "Tris(beta-chloroethyl)
phosphate" OR "Tris(beta-chloroethylphosphate)" OR "Tris(chloroethyl) phosphate" OR
"Tris(chloroethyl)phosphate" OR "Tris-2-chloroethyl phosphate" OR "UNII-32IVO568B0")
N = 361
PROOUEST Agricultural and Environmental Science Database:
ProQuest Agricultural and Environmental Science Database may be accessed through EPA Desktop
Library (https://intranet.epa.gov/desktop/databases.htm).
Date Searched: 06/11/2019
Date Range of Search: 1900 to Present
N = 599
58
-------
ALL("2-Chloroethanol phosphate" OR "Amgard TCEP" OR "Antiblaze 100" OR "BRN 1710938" OR
"Celluflex" OR "Celluflex CEF" OR "Disflamoll TCA" OR "Ethanol, 2-chloro-, l,r,l"-phosphate" OR
"ETHANOL, 2-CHLORO-, PHOSPHATE" OR "Ethanol, 2-chloro-, phosphate (3:1)" OR "Fyrol CEF"
OR "Fyrol CF" OR "Genomoll P" OR "NCI-C60128" OR "Niax 3CF" OR "Niax Flame Retardant 3CF"
OR "NSC 3213" OR "Phosphoric acid tris(2-chloroethyl) ester" OR "Phosphoric acid, tris(2-
chloroethyl)ester" OR "Roflam E" OR "Tri(2-chloroethyl) phosphate" OR "Tri(2-
chloroethyl)phosphate" OR "Tri(beta-chloroethyl) phosphate" OR "Tri(chloroethyl) phosphate" OR
"Tri-beta-chloroethyl phosphate" OR "Tris (2-chloroethyl) phosphate" OR "TRIS-(2-
CHLORAETHYL)-PHOSPHAT" OR "Tris(2-chlorethyl)phosphat" OR "Tris(2-chloroethyl)
orthophosphate" OR "Tris(2-chloroethyl) phosphate" OR "Tris(2-chloroethyl) phosphate (TCEP)" OR
"Tris(2-chloroethyl)phosphate" OR "Tris(beta-chloroethyl) phosphate" OR "Tris(beta-chloroethyl)
phosphate" OR "Tris(beta-chloroethylphosphate)" OR "Tris(chloroethyl) phosphate" OR
"Tris(chloroethyl)phosphate" OR "Tris-2-chloroethyl phosphate" OR "UNII-32IVO568B0") AND
STYPE(" Scholarly Journals" OR Reports OR Thesis OR "Government Documents") AND LA(ENG)
N = 599
PROOUEST Dissertations and Theses:
ProQuest Dissertations and Theses may be accessed through the Kathryn A. Martin Library at the
University of Minnesota at Duluth (https://libguides.d.umn.edu/az.php).
Date Searched: 06/11/2019
Date Range of Search: 1900 to Present
N = 0
ALL("2-Chloroethanol phosphate" OR "Amgard TCEP" OR "Antiblaze 100" OR "BRN 1710938" OR
"Celluflex" OR "Celluflex CEF" OR "Disflamoll TCA" OR "Ethanol, 2-chloro-, l,l',r'-phosphate" OR
"ETHANOL, 2-CHLORO-, PHOSPHATE" OR "Ethanol, 2-chloro-, phosphate (3:1)" OR "Fyrol CEF"
OR "Fyrol CF" OR "Genomoll P" OR "NCI-C60128" OR "Niax 3CF" OR "Niax Flame Retardant 3CF"
OR "NSC 3213" OR "Phosphoric acid tris(2-chloroethyl) ester" OR "Phosphoric acid, tris(2-
chloroethyl)ester" OR "Roflam E" OR "Tri(2-chloroethyl) phosphate" OR "Tri(2-
chloroethyl)phosphate" OR "Tri(beta-chloroethyl) phosphate" OR "Tri(chloroethyl) phosphate" OR
"Tri-beta-chloroethyl phosphate" OR "Tris (2-chloroethyl) phosphate" OR "TRIS-(2-
CHLORAETHYL)-PHOSPHAT" OR "Tris(2-chlorethyl)phosphat" OR "Tris(2-chloroethyl)
orthophosphate" OR "Tris(2-chloroethyl) phosphate" OR "Tris(2-chloroethyl) phosphate (TCEP)" OR
"Tris(2-chloroethyl)phosphate" OR "Tris(beta-chloroethyl) phosphate" OR "Tris(beta-chloroethyl)
phosphate" OR "Tris(beta-chloroethylphosphate)" OR "Tris(chloroethyl) phosphate" OR
"Tris(chloroethyl)phosphate" OR "Tris-2-chloroethyl phosphate" OR "UNII-32IVO568B0") AND
LA(ENG)
N = 0
SCIENCE DIRECT:
Science Direct may be accessed through the EPA Desktop Library
(https://intranet.epa.gov/desktop/databases.htm).
Date Searched: 06/11/2019
Date Range of Search: 1823 to Present
N = 805
59
-------
Science Direct 01:
"2-Chloroethanol phosphate" OR "Amgard TCEP" OR "Antiblaze 100" OR "BRN 1710938" OR
"Celluflex" OR "Celluflex CEF" OR "Disflamoll TCA" OR "Ethanol, 2-chloro-, l,l',l"-phosphate" OR
"ETHANOL, 2-CHLORO-, PHOSPHATE"
N = 0
Science Direct 02:
"Ethanol, 2-chloro-, phosphate (3:1)" OR "Fyrol CEF" OR "Fyrol CF" OR "Genomoll P" OR "NCI-
C60128" OR "Niax 3CF" OR "Niax Flame Retardant 3CF" OR "NSC 3213" OR "Phosphoric acid
tris(2-chloroethyl) ester"
N = 1
Search string returned 0 results, searching on the highlighted returned N = 1
Science Direct 03:
"Phosphoric acid, tris(2-chloroethyl)ester" OR "Roflam E" OR "Tri(2-chloroethyl) phosphate" OR
"Tri(2-chloroethyl)phosphate" OR "Tri(beta-chloroethyl) phosphate" OR "Tri(chloroethyl) phosphate"
OR "Tri-beta-chloroethyl phosphate" OR "Tris (2-chloroethyl) phosphate" OR "TRIS-(2-
CHLORAETHYL)-PHO SPHAT"
N = 200
Search string returned 0 results, searching on the highlighted returned N = 200
Science Direct 04:
"Tris(2-chlorethyl)phosphat" OR "Tris(2-chloroethyl) orthophosphate" OR "Tris(2-chloroethyl)
phosphate" OR "Tris(2-chloroethyl) phosphate (TCEP)" OR "Tris(2-chloroethyl)phosphate" OR
"Tris(beta-chloroethyl) phosphate" OR "Tris(beta-chloroethyl) phosphate" OR "Tris(beta-
chloroethylphosphate)" OR "Tris(chloroethyl) phosphate"
N = 355
Search string returned 0 results, searching on the highlighted returned N = 355
Science Direct 05:
"Tris(chloroethyl)phosphate" OR "Tris-2-chloroethyl phosphate" OR "UNII-32IVO568B0"
N = 404
AGRICOLA:
Agricola may be accessed through the EPA Desktop Library
(https://intranet.epa.gov/desktop/databases.htm) or within the EndNote environment.
Date Searched: 06/11/2019
Date Range of Search: 15th century to the Present
N = 244
Agricola 01:
2-Chloroethanol phosphate
Amgard TCEP
Antiblaze 100
BRN 1710938
Celluflex
Celluflex CEF
60
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Disflamoll TCA
Ethanol, 2-chloro-, 1,1', 1 "-phosphate
ETHANOL, 2-CHLORO-, PHOSPHATE
Ethanol, 2-chloro-, phosphate (3:1)
N = 1
Agricola 02:
Fyrol CEF
Fyrol CF
Genomoll P
NCI-C60128
Niax 3CF
Niax Flame Retardant 3CF
NSC 3213
Phosphoric acid tris(2-chloroethyl) ester
Phosphoric acid, tris(2-chloroethyl)ester
Roflam E
N = 0
Agricola 03:
Tri(2-chloroethyl) phosphate
Tri(2-chloroethyl)phosphate
Tri(beta-chloroethyl) phosphate
Tri(chloroethyl) phosphate
Tri-beta-chloroethyl phosphate
Tris (2-chloroethyl) phosphate
TRIS-(2-CHLORAETHYL)-PHOSPHAT
Tris(2-chlorethyl)phosphat
Tris(2-chloroethyl) orthophosphate
Tris(2-chloroethyl) phosphate
N= 129
Agricola 04:
Tris(2-chloroethyl) phosphate (TCEP)
T ri s(2-chloroethyl)phosphate
Tris(beta-chloroethyl) phosphate
Tris(beta-chloroethyl) phosphate
Tris(beta-chloroethylphosphate)
Tris(chloroethyl) phosphate
T ri s(chloroethyl)phosphate
Tris-2-chloroethyl phosphate
UNII-3 2IVO568B0
N= 114
TOXNET/f T oxline):
TOXNET(Toxline) may be accessed through the EPA Desktop Library
(https://intranet.epa.gov/desktop/databases.htm).
Date Searched: 06/11/2019
61
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Date Range of Search: 1900 to Present
N = 632
TOXNET 01:
115-86-6 OR 21343-84-0
N = 632
PubMed:
Pub Med may be accessed through the EPA Desktop Library (https://www.ncbi.nlm.nih.eov/pubm.ed/)
Date Searched: 07/03/2019
Date Range of Search: 1900 to present
N = 274
"2-Chloroethanol phosphate" OR "Amgard TCEP" OR "Antiblaze 100" OR "BRN 1710938" OR
"Celluflex" OR "Celluflex CEF" OR "Disflamoll TCA" OR "Ethanol, 2-chloro-, l,r,l"-phosphate" OR
"ETHANOL, 2-CHLORO-, PHOSPHATE" OR "Ethanol, 2-chloro-, phosphate (3:1)" OR "Fyrol CEF"
OR "Fyrol CF" OR "Genomoll P" OR "NCI-C60128" OR "Niax 3CF" OR "Niax Flame Retardant 3CF"
OR "NSC 3213" OR "Phosphoric acid tris(2-chloroethyl) ester" OR "Phosphoric acid, tris(2-
chloroethyl)ester" OR "Roflam E" OR "Tri(2-chloroethyl) phosphate" OR "Tri(2-
chloroethyl)phosphate" OR "Tri(beta-chloroethyl) phosphate" OR "Tri(chloroethyl) phosphate" OR
"Tri-beta-chloroethyl phosphate" OR "Tris (2-chloroethyl) phosphate" OR "TRIS-(2-
CHLORAETHYL)-PHOSPHAT" OR "Tris(2-chlorethyl)phosphat" OR "Tris(2-chloroethyl)
orthophosphate" OR "Tris(2-chloroethyl) phosphate" OR "Tris(2-chloroethyl) phosphate (TCEP)" OR
"Tris(2-chloroethyl)phosphate" OR "Tris(beta-chloroethyl) phosphate" OR "Tris(beta-chloroethyl)
phosphate" OR "Tris(beta-chloroethylphosphate)" OR "Tris(chloroethyl) phosphate" OR
"Tris(chloroethyl)phosphate" OR "Tris-2-chloroethyl phosphate" OR "UNII-32IVO568B0"
N = 274
ECOTOX UNIFY:
This is an internal EPA database that is not accessible to the public. Results from the ECOTOX Unify
search strategy.
Date Searched: 06/11/2019
Date Range of Search: all years
N = 32
A.l.2.2 Data Prioritization for Environmental Hazard, Human Health Hazard, Fate
and Physical Chemistry
In brief, SWIFT Review has pre-set literature search strategies ("filters") developed by information
specialists that can be applied to identify studies that are more likely to be useful for identifying human
health and ecotoxicity content from those that likely do not (e.g., analytical methods). The filters
function like a typical search strategy where studies are tagged as belonging to a certain filter if the
terms in the filter literature search strategy appear in title, abstract, keyword or medical subject headings
(MeSH) fields content. The applied SWIFT Review filters focused on lines of evidence: human, animal
models for human health, ecological taxa (which includes ecotoxicological animal models, plants, and
other taxa), and in vitro studies. The details of the search strategies that underlie the filters are available
online. Studies not retrieved using these filters were not considered further. Studies that included one or
62
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more of the search terms in the title, abstract, keyword, or MeSH fields were exported as a RIS file for
screening in Swift-ActiveScreener or DistillerSR8.
A.l.2.3 Data Prioritization for Occupational Exposures and Environmental Releases
and General Population, Consumer and Environmental Exposures
To prioritize references related to occupational exposure, environmental release, general population
exposure, consumer exposure, and environmental exposure, EPA used positive and negative seed studies
to build a classification model in SWIFT Review. The positive seeds were identified using relevant
literature pool for the first ten TSCA risk evaluations, while the negative seeds were identified from a
subset of literature for the current high-priority substances. The model was then applied to the
unclassified literature to generate a classification score for each reference. Scores above a certain
threshold value were then prioritized for further review in SWIFT-ActiveScreener.
A.2 Peer-Reviewed Screening Process
The studies identified from publicly available database searches and SWIFT-Review
filtering/prioritization were housed in HERO system and imported into SWIFT-ActiveScreener or
DistillerSR for title/abstract and full-text screening. Both title/abstract and full-text screening were
conducted by two independent reviewers. Screening is initiated with a pilot phase of screening (between
10 and 50) studies to identify areas where clarification in screening criteria might be needed or
chemical-specific supplemental material tags might be identified. Records that met PECO (or equivalent
criteria (Appendix A.2.1) during title and abstract screening were considered for full-text screening. At
both the title/abstract and full-text review levels, screening conflicts were resolved by topic-specific
experts and/or discussion among the primary screeners. For citations with no abstract, the articles are
initially screened based on all or some of the following: title relevance (titles that suggest a record is not
relevant can be excluded rather than marked as unclear), and page numbers (articles two pages in length
or less were assumed to be conference reports, editorials, or letters). During title/abstract or full-text
level screening in DistillerSR, studies that did not meet the PECO criteria, but which could provide
supporting information were categorized (or "tagged") as supplemental information.
It is important to emphasize that being tagged as supplemental material does not mean the study would
necessarily be excluded from consideration in an assessment. The initial screening level distinctions
between a study meeting the PECO criteria and a supplemental study are often made for practical
reasons and the tagging structures (as seen in the literature inventory trees and heat maps in Section 2.1.
of this document) are designed to ensure the supplemental studies are categorized for easy retrieval if
needed while conducting the assessment. The impact on the assessment conclusions of individual studies
tagged as supporting material is often difficult to assess during the screening phase of the assessment.
These studies may emerge as being critically important to the assessment and need to be evaluated and
summarized at the individual study level (e.g., cancer MOA mechanistic or non-English-language
studies), or be helpful to provide context (e.g., summarize current levels of exposure, provide hazard
evidence from routes or durations of exposure not pertinent to the PECO), or not be cited at all in the
assessment (e.g., individual studies that contribute to a well-established scientific conclusion). Studies
maybe be tagged as supplemental material during either title and abstract or full-text screening. When
tagged as supplemental material during title and abstract screening, it may not be completely clear
whether the chemical of interest is reported in the study (i.e., abstracts may not describe all chemicals
investigated). In these cases, studies are still tagged with the expectation that if full-text retrieval is
pursued, then additional screening would be needed to clarify if the study is pertinent.
8DistitterSR is a web-based systematic review software used to screen studies available at
https://www.evidencepartiiers.com/products/distiHersr-SYStematic-review-software.
63
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A.2.1 Inclusion/Exclusion Criteria
A PECO statement is typically used to focus the research question(s), search terms, and
inclusion/exclusion criteria in a systematic review. PECO criteria were developed a priori to screening
and modified to fit the various discipline areas supporting the TSCA risk evaluations. Variations include
the RESO (receptor, exposure, scenario/setting, and outcome) used for the occupational exposure and
environmental releases discipline, and PESO (pathways/ processes, exposures, setting/scenario, and
outcomes) used by the fate and transport discipline. All PECOs and PECO-equivalent criteria can be
found in the following sections.
A.2.1.1 PECO for Environmental and Human Health Hazards
The PECO used in this evidence map to identify literature pertinent to TCEP effects on human health
and environmental hazard is presented in TableApx A-3. In addition to the PECO criteria, studies
containing potentially relevant supplemental material were tracked and categorized during the literature
screening process as outlined in Table Apx A-4.
Table_Apx A-3. Hazards Title and Abstract and Full-Text PECO Criteria for TCEP
pi:co
Klcmcnl
Kvidence
P
Human: Any population and life stage (e.g., occupational or general population, including children
and other sensitive populations).
Animal: Aquatic and terrestrial species (live, whole organism) from any life stage (e.g.,
preconception, inutero, lactation, peripubertal, and adult stages). Animal models will be
inventoried according to the categorization below:
Human health models: rat. mouse, rabbit, doe. hamster, euinea Die. cat. non-human Drimatc.
pig, hen (neurotoxicity only)
Ecotoxicoloeical models: invertebrates (e.s.. insects, soidcrs. crustaceans, mollusks. and
worms) and vertebrates (e.g., mammals and all amphibians, birds, fish, and reptiles). All
hen studies (including neurotoxicity studies) will be included for ecotoxicological models.
Plants: All aquatic and terrestrial species (live), including algal, moss, lichen and fungi species.
Screener note:
To identify human health and environmental hazards, other organisms not listed above in their
respective categories can also be used. Non-mammalian model systems are increasingly used to
identify potential human health hazards (e.g., Xenopus, zebrafish), and traditional human health
models (e.g., rodents) can be used to identify potential environmental hazard. Neurotoxicity
studies performed in hens (e.g., OECD 418 and 419) are considered relevant to both human and
eco hazard.
PECO considerations should be directed toward effects on target species only and not on the
indirect effects expressed in taxa as a result of chemical treatment (e.g., substance is lethal to a
targeted pest species leading to positive effects on plant growth due to diminished presence of
the targeted pest species).
Tests of the single toxicants in in vitro and ex vitro systems or on gametes, embryos, or plant or
fungal sections capable of forming whole, new organisms will be tagged as potentially
supplemental (mechanistic studies). Bacteria and yeast studies specific for assessing
genotoxicity or mutagenicity (e.g., Ames assay) will also be tagged as potentially supplemental
(mechanistic studies) but are otherwise excluded. Studies on viruses are excluded.
E
Relevant forms and isomers:
Tris(2-chloroethyl) phosphate (CASRN 115-96-8)
For synonyms see the EPA Chemistry Dashboard.
64
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i»i:( o
Klcincnl
Kvidencc
No isomers were included for TCEP.
Human: Any exposure to Tris(2-chloroethyl) phosphate (TCEP 115-96-8) singularly or in mixture,
including exposure as measured by internal concentrations of these chemicals or metabolites of
these chemicals in a biological matrix (i.e. urine, blood, semen, etc.).
Animal: Any exposure to Tris(2-chloroethyl) phosphate (TCEP 115-96-8) including via water
(including environmental aquatic exposures), soil or sediment, diet, gavage, injection, dermal,
and inhalation.
Plants: Exposure to Tris(2-chloroethyl) phosphate (TCEP 115-96-8) via water, soil, or sediment.
Screener note:
Field studies with media concentrations (surface water, interstitial water, soil, sediment) and/or
body/tissue concentrations of animals or plants are to be identified as Supplemental if any
biological effects are reported.
Animal and plant studies involving exposures to mixtures will be included only if they also include
exposure to Tris(2-chloroethyl) phosphate) (TCEP 115-96-8) alone. Otherwise, animal and
plant mixture studies will be tagged as Supplemental. Human mixture studies are included.
Controlled outdoor experimental studies (e.g., controlled crop/greenhouse studies, mesocosm
studies, artificial stream studies) are considered to be laboratory studies (not field studies)
because there is a known and prescribed exposure dose(s) and an evaluation of hazardous
effect(s). Whereas field studies (e.g., biomonitoring) where there is no prescribed exposure
dose(s) will be excluded if there is no evaluated hazardous effect, and tagged as supplemental
field, if there is an evaluated hazardous effect.
C
Human: A comparison or referent population exposed to lower levels (or no exposure/exposure
below detection limits) of Tris(2-chloroethyl) phosphate (TCEP 115-96-8), or exposure to
Tris(2-chloroethyl) phosphate (TCEP 115-96-8) for shorter periods of time.
Animal and Plants: A concurrent control group exposed to vehicle-only treatment and/or untreated
control (control could be a baseline measurement).
Screener note:
If no control group is explicitly stated or implied (e.g. by mention of statistical results that could
only be obtained if a control group was present), the study will be marked as Unclear during
Title/Abstract Screening.
All case series and case studies describing findings in a sample size of less than 20 people in any
setting (e.g., occupation, general population) will be tracked as Supplemental. Case-control,
case-crossover, case-referent, case-only, case-specular, case-cohort, case-parent, nested case-
control study designs are all Included.
O
Human: All health outcomes (cancer and noncancer) at the organ level or higher.
Animal and Plants: All apical biological effects (effects measured at the organ level or higher)
and bioaccumulation from laboratory studies with concurrently measured media and/or tissue
concentrations. Apical endpoints include but are not limited to reproduction, survival, and growth.
Screener note:
Measurable biological effects relevant for humans, animals and plants may include but are
not limited to: mortality, behavioral, population, cellular, physiological, growth, reproduction,
systemic, point of contact effects.
Effects measured at the cellular level of biological organization and below are to be tagged as
supplemental, mechanistic.
65
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Table Apx A-4. Major categories of Potentially Relevant Supplemental Material for TCEP
Category
Kvidence
Mechanistic studies
All studies that report results at the cellular level and lower in both mammalian and non-
mammalian model systems, including in vitro, in vivo, ex vivo, and in silico studies.
These studies include assays for genotoxicity or mutagenicity using bacteria or yeast.
ADME, PBPK, and
toxicokinetic
Studies designed to capture information regarding absorption, distribution, metabolism,
and excretion (ADME), toxicokinetic studies, or physiologically based pharmacokinetic
(PBPK) models.
Case reports or case series
Case reports (n < 3 cases) and case series (non-occupational) will be tracked as
potentially relevant supplemental information.
Susceptible populations
(no health outcome)
Studies that identify potentially susceptible subgroups; for example, studies that focus on
a specific demographic, life stage, or genotype. This tag applies primarily during full-text
screening.
Screener note: if biological susceptibility issues are clearly present or strongly implied
in the title/abstract, this supplemental tag may be applied at the title abstract level. If
uncertain at title/abstract, do not apply this tag to the reference during title/abstract
screening.
Mixture studies
Experimental mixture studies that are not considered PECO-relevant because they do not
contain an exposure or treatment group assessing only the chemical of interest. Human
health animal model and eco animal model/plant will be tagged separately for mixture
studies.
Non-English records
Non-English records will be tracked as potentially relevant supplemental information.
Records with no original
data
Records that do not contain original data, such as other agency assessments, informative
scientific literature reviews, editorials or commentaries.
Conference abstracts
Records that do not contain sufficient documentation to support study evaluation and
data extraction.
Field Studies
Field studies with media concentrations (e.g., surface water, interstitial water, soil,
sediment) and/or body /tissue concentrations of animals or plants if biological effects
reported.
A.2.1.2 PECO for Consumer, Environmental, and General Population Exposures.
Table Apx A-5. Generic Inclusion Criteria for the Data Sources Reporting Exposure Data on
General Population, Consumers and Environmental Receptors
PI'.CO l lemenl
l.\ idcncc
Population
Human: General do mil at ion: consumers: bvstanders in the home: near-facilitv Dooulations
(includes industrial and commercial facilities manufacturing, processing, or using the chemical
substance); children; susceptible populations (life stages, preexisting conditions, genetic
factors), pregnant women; lactating women, women of childbearing age. Many human
population groups may be exposed. No chemical-specific exclusions are suggested at this time.
Environmental: aauatic soecies. terrestrial soecies. terrestrial olants. aauatic olants (field
studies only)
66
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Pl.( () I kllH'lll
l.\ idence
Exposure
Expected Primary Exposure Sources, Pathways, Routes:
Pathways: indoor air/vapor/mist: indoor dust: particles: outdoor/ambient air; surface water;
biosolids; sediment; breastmilk; food items containing TCEP including fish; consumer product
uses in the home (including consumer product containing chemical);
Routes of Exposure: Inhalatioa Oral. Dermal
Comparator
(Scenario)
Human: Consider mcdia-SDCcific background exposure scenarios and use/source specific
exposure scenarios as well as which receptors are and are not reasonably exposed across the
projected exposure scenarios.
Environmental Consider media-specific background exposure scenarios and use/source
specific exposure scenarios as well as which receptors are and are not reasonably exposed
across the projected exposure scenarios.
Outcomes for
Exposure
Concentration or
Dose
Human: Acute, subchronic. and/or indoor air and water concentration estimates (me/m3 or
mg/L). Both external potential dose and internal dose based on biomonitoring and reverse
dosimetry mg/kg/day will be considered. Characteristics of consumer products or articles
(weight fraction, emission rates, etc) containing TCEP.
Environmental: A wide ranee of ecoloeical receptors will be considered (ranee dependine on
available ecotoxicity data) using surface water concentrations, sediment concentrations.
Table Apx A-6. Pathways Identified as Sup
plemental for TCEPa
Chemical
Drinking
\\ silcr
Amhicnl Air
Air
Dispossil
land
Dispossil
I ndcr^roiind
Dispossil
(ironnd \\ siler
T ris(2-chloroethyl)
phosphate (TCEP)
--
--
--
--
--
--
a "Supplemental pathways" refer to pathways addressed by other EPA administered statutes.
Studies tagged under these pathways provide media information that is not prioritized in the screening process
A.2.1.3 RESO for Occupational Exposure and Environmental Releases
EPA developed a generic RESO statement to guide the screening of engineering and occupational
exposure data or information sources for the TSCA risk evaluations. Data or information sources that
comply with the inclusion criteria specified in the RESO statement are eligible for inclusion, considered
for evaluation, and possibly included in the environmental release and occupational exposure
assessments. On the other hand, data or information sources that fail to meet the criteria in the RESO
statement are excluded from further consideration.
Assessors seek information on various chemical-specific engineering and occupational exposure data
needs as part of the process of developing the exposure assessment for each risk evaluation. EPA uses
the RESO statement (TableApx A-7) along with the information in TableApx A-8 when screening the
engineering and occupational exposure data and information.
67
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TableApx A-7. Inclusion Criteria for Data Sources Reporting Engineering and Occupational
Exposure Data
KI-'.SO l.k-im-nl
l'.\ iricncc
Receptors
• Humans:
Workers, including occupational non-users
• Environment:
All environmental receptors (relevant release estimates input to Exposure)
Please refer to the conceptual models for more information about the environmental and human
receptors included in the TSCA risk evaluation.
Exposure
• Worker exposure to and relevant environmental releases of the chemical substance from
occupational scenarios:
Dermal and inhalation exposure routes (as indicated in the conceptual model)
Oral route (as indicated in the conceptual model)
Please refer to the conceptual models for more information about the routes and media/pathways
included in the TSCA risk evaluation.
Setting or
Scenario
• Any occupational setting or scenario resulting in worker exposure and relevant environmental
releases (includes all manufacturing, processing, use, disposal.
Outcomes
• Quantitative estimates* of worker exposures and of relevant environmental releases from
occupational settings
• General information and data related and relevant to the occupational estimates*
* Metrics (e.g., mg/kg/day or mg/m3 for worker exposures, kg/site/day for releases) are determined by toxicologists for
worker exposures and by exposure assessors for releases; also, the Engineering, Release and Occupational Exposure Data
Needs (Table Apx A-8) provides a list of related and relevant general information.
TSCA=Toxic Substances Control Act
68
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TableApx A-8. Engineering, Environmental Release and Occupational Data Necessary to
Develop the Environmental Release and Occupational Exposure Assessments
Ohji'iiitc
Dokrininod
during Scoping
T\|>e or Diilii ¦'
General
Engineering
Assessment (may
apply to
Occupational
Exposures and /
or Environmental
Releases)
Description of the life cycle of the chemical(s) of interest, from manufacture to end-of-life (e.g., each
manufacturing, processing, or use step), and material flow between the industrial and commercial life
cycle stages.
The total annual U.S. volume (lb/yr or kg/yr) of the chemical(s) of interest manufactured, imported,
processed, and used; and the share of total annual manufacturing and import volume that is processed
or used in each life cycle step.
Description of processes, equipment, and unit operations during each industrial/ commercial life cycle
step.
Material flows, use rates, and frequencies (lb/site-day or kg/site-day and days/yr; lb/site-batch and
batches/yr) of the chemical(s) of interest during each industrial/ commercial life cycle step. Note: if
available, include weight fractions of the chemicals (s) of interest and material flows of all associated
primary chemicals (especially water).
Number of sites that manufacture, process, or use the chemical(s) of interest for each industrial/
commercial life cycle step and site locations.
Concentration of the chemical of interest
Occupational
Exposures
Description of worker activities with exposure potential during the manufacture, processing, or use of
the chemical(s) of interest in each industrial/commercial life cycle stage.
Potential routes of exposure (e.g., inhalation, dermal).
Physical form of the chemical(s) of interest for each exposure route (e.g., liquid, vapor, mist) and
activity.
Breathing zone (personal sample) measurements of occupational exposures to the chemical(s) of
interest, measured as time-weighted averages (TWAs), short-term exposures, or peak exposures in
each occupational life cycle stage (or in a workplace scenario similar to an occupational life cycle
stage).
Area or stationary measurements of airborne concentrations of the chemical(s) of interest in each
occupational setting and life cycle stage (or in a workplace scenario similar to the life cycle stage of
interest).
For solids, bulk and dust particle size characterization data.
Dermal exposure data.
Exposure duration (hr/day).
Exposure frequency (days/yr).
Number of workers who potentially handle or have exposure to the chemical(s) of interest in each
occupational life cycle stage.
PPE types employed by the industries within scope.
ECs employed to reduce occupational exposures in each occupational life cycle stage (or in a
workplace scenario similar to the life cycle stage of interest), and associated data or estimates of
exposure reductions.
Environmental
Releases (to
relevant
environmental
media)
Description of sources of potential environmental releases, including cleaning of residues from process
equipment and transport containers, involved during the manufacture, processing, or use of the
chemical(s) of interest in each life cycle stage.
Estimated mass (lb or kg) of the chemical(s) of interest released from industrial and commercial sites to
each environmental medium (water) and treatment and disposal methods (POTW), including releases
per site and aggregated over all sites (annual release rates, daily release rates)
Release or emission factors.
Number of release days per year.
Waste treatment methods and pollution control devices employed by the industries within scope and
associated data on release/emission reductions.
69
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Ohji'iiitc
Dokrininod
Tjpc or Dalii ¦'
(lurinii Scoping
llicbc arc llie lay;
included 111 llie full-ioxl bcieeiung form, t he bcieener makeb a bekvlioiifioni ilios>o specific lagb, w Inch
describe more specific types of data or information.
In addition to the data types listed above, EPA may identify additional data needs for mathematical modeling. These data
needs will be determined on a case-by-case basis.
Abbreviations:
hr=Hour
kg=Kilogram(s)
lb=Pound(s)
yr=Year
PV=Particle volume
POTW=Publicly owned treatment works
PPE=Personal protection equipment
PSD=Particle size distribution
TWA=Time-weighted average
A.2.1.4 PESO for Fate and Transport
EPA developed a generic PESO statement to guide the screening of environmental fate data or
information sources for the TSCA risk evaluations. Data or information sources that comply with the
inclusion criteria in the PESO statement are eligible for inclusion, considered for evaluation, and
possibly included in the environmental fate assessment. On the other hand, data or information sources
that fail to meet the criteria in the PESO statement are excluded from further consideration.
Assessors seek information on various chemical-specific fate endpoints and associated fate processes,
environmental media and exposure pathways as part of the process of developing the environmental fate
assessment for each risk evaluation. EPA uses the PESO statement (TableApx A-9) along with the
information in Table Apx A-10 when screening the fate data or information sources to ensure complete
coverage of the processes, pathways and data or information relevant to the environmental fate and
transport of the chemical substance undergoing risk evaluation.
70
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TableApx A-9. Inclusion Criteria for Data or Information Sources Reporting Environmental
Fate and Transport Data
PI so
r.k-iiK'iii
l.\ idcnce
Pathways and
Processes
Environmental fate, transport, partitioning and degradation behavior across
environmental media to inform exposure pathways of the chemical substance of
interest
Exposure pathways included in the conceptual models: air, surface water, groundwater,
wastewater, soil, sediment and biosolids.
Processes associated with the target exposure pathways
Bioconcentration and bioaccumulation
Destruction and removal by incineration
Please refer to the conceptual models for more information about the exposure pathways
included in each TSCA risk evaluation.
Exposure
Environmental exposure of environmental receptors (i.e., aquatic and terrestrial
organisms) to the chemical substance of interest, mixtures including the chemical
substance, and/or its degradation products and metabolites
Environmental exposure of human receptors, including any potentially exposed or
susceptible subpopulations, to the chemical substance of interest, mixtures including
the chemical substance, and/or its degradation products and metabolites
Please refer to the conceptual models for more information about the environmental and
human receptors included in each TSCA risk evaluation.
Setting or
Scenario
Any setting or scenario resulting in releases of the chemical substance of interest into the
natural or built environment (e.g., buildings including homes or workplaces, or wastewater
treatment facilities) that would expose environmental (i.e., aquatic and terrestrial
organisms) or human receptors (i.e., general population, and potentially exposed or
susceptible subpopulation)
Outcomes
Fate properties which allow assessments of exposure pathways:
Abiotic and biotic degradation rates, mechanisms, pathways, and products
Bioaccumulation magnitude and metabolism rates
Partitioning within and between environmental media (see Pathways and Processes)
71
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TableApx A-10. Fate Endpoints and Associated Processes, Media and Exposure Pathways
Considered in the Development of the Environmental Fate Assessment
l-'iilo Diilii I.iitlpoint
Associiilod I'mccsslcs)
Associiilcd Mo(li;i/r.\|)osuro Piilhwiivs
Sii rliicc
\\ SIUT.
\\
ScdiiiK'iH
Soil,
liiosolids
(ii'diiiidwiilci'
Aii-
Abiotic reduction rates or
half-lives
Abiotic reduction, Abiotic
dehalogenation
X
Aerobic biodegradation rates
or half-lives
Aerobic biodegradation
X
X
Anaerobic biodegradation
rates or half-lives
Anaerobic biodegradation
X
X
X
Aqueous photolysis (direct
and indirect) rates or half-
lives
Aqueous photolysis (direct
and indirect)
X
Atmospheric photolysis
(direct and indirect) rates or
half-lives
Atmospheric photolysis
(direct and indirect)
X
Bioconcentration factor
(BCF), Bioaccumulation
factor (BAF)
Bioconcentration,
Bioaccumulation
X
X
X
Biomagnification and related
information
Trophic magnification
X
Desorption information
Sorption, Mobility
X
X
X
Destruction and removal by
incineration
Incineration
X
Hydrolysis rates or half-lives
Hydrolysis
X
X
X
Koc and other sorption
information
Sorption, Mobility
X
X
X
Wastewater treatment
removal information
Wastewater treatment
X
X
Abiotic transformation
products
Hydrolysis, Photolysis,
Incineration
X
X
Aerobic biotransformation
products
Aerobic biodegradation
X
X
Anaerobic biotransformation
products
Anaerobic biodegradation
X
X
X
Atmospheric deposition
information
Atmospheric deposition
X
Coagulation information
Coagulation, Mobility
X
X
Incineration removal
information
Incineration
X
72
-------
A.2.1.5 Generation of Hazard Heat Maps
As stated in Appendix A. 1.2.1, SWIFT Review has pre-set literature search strategies ("filters")
developed by information specialists that can be applied to identify studies that are more likely to be
useful for identifying human health and ecotoxicity content. The filters function like a typical search
strategy where studies are tagged as belonging to a certain filter if the terms in the filter literature search
strategy appear in title, abstract, keyword or MeSH fields content.
After the completion of full-text screening for hazard data, all references tagged as included (or "PECO-
relevant) were uploaded to the SWIFT Review tool for further filtering. The SWIFT Review filters
applied at this phase focused on types of health outcomes included: "ADME", "PBPK", "cancer",
"cardiovascular", "developmental", "endocrine", "gastrointestinal", "hematological and immune",
"hepatic", "mortality", "musculoskeletal", "neurological", "nutritional and metabolic", "ocular and
sensory", "renal", "reproductive", "respiratory", and "skin and connective tissue". The details of these
health outcome search strategies that underlie the filters are available online. Studies that included one
or more of the search terms in the title, abstract, keyword, or MeSH fields were exported and used to
populate the Hazard Heat Map (Figure 2-10). Studies that were not retrieved using these filters were
tagged as "No Tag". The evidence type listed in the heat map (e.g., human, animal-human health model,
animal- environmental model, and plant) was manually assigned to each reference by screeners during
the full-text screening.
The health outcome tags were originally designed for vertebrate systems, and as such, did not conform
well to plant evidence. Therefore, any plant studies tagged for: "cancer", "cardiovascular",
"gastrointestinal", "hematological and immune", "hepatic", "musculoskeletal", "neurological", "ocular
and sensory" and "renal and respiratory" were manually reviewed and re-tagged to more appropriate
health outcomes.
A3 Gray Literature Search and Screening Strategies
EPA conducted a gray literature search for available information to support the TSCA risk evaluations
for the next twenty TSCA risk evaluations. 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. Given the nature of how gray literature is searched and collected, results
may not come with a bibliographic citation or abstract and were therefore processed using a decision
tree logic described in Appendix A.3.1 for potential relevance prior to entering full text screening where
a discipline-specific PECO is applied.
Search terms were variable dependent on source and based on knowledge of a given source to provide
discipline-specific information. A summary of sources is provided in Appendix A.3.4. The criteria for
determining the potential relevance of documents identified from gray literature sources is described in
the following sections for each discipline.
A.3.1 Screening of Gray Literature
To reduce the overall burden of processing gray literature results, EPA developed a screening process to
determine the potential relevance of gray literature. This step was introduced prior to collecting the
resulting documents. Figure Apx A-l. describes the decision logic used to screen gray literature results.
73
-------
I\>icntully Relevant
L. Information (quantitative
qualifitive) related K> Ihe TSCA
risk evaluation? (*)
Gray Literature Sources
Yew to Ate^ats Processes
Complete/Avai abe
2.2.1 Hs ir.e source been
provided from a US state
source"
A. Fottov.'
Procedure for LS
Gov. source vaHxSati
2.1.1 Is tta secoTadaij
source (assessment, robust
summary, etc.)"
collection
com nsai canon
2.22 Has ibe source been
provided fro ma
International Gov. source
Follow
validation
2.1.2 Is this study tn a peer
reviewedpubtshed
journal?
Is the source Publically Available
Accessible ?
.1.1 Is the source TSCA
CBI. proprietaiy. TSCA
or NGO stakeholder
submission
CF.
procedure
incorporating
proprietary- TSCA
Duplicate
Exclude from Gray Lterature
Check if caught in Peer Review
Search
Does the source contain duplicative
information with other sour
dedupLtcate
FigureApx A-l. Decision Logic Tree Used to Screen Gray Literature Results
A.3.2 Initial Screening of Sources using Decision Logic Tree
The purpose of the inclusion/exclusion decision logic tree in Figure_Apx A-l. is to provide a broad,
general screening technique to determine whether each gray literature source should be included and
further screened or excluded with no additional screening necessary. The diamonds in the decision tree
require analysis by the screener, whereas the rectangular boxes are used to classify the type of source.
All the questions used in the decision process are provided in Table_Apx A-l 1.
Table Apx A-ll. Decision Logic Tree Overview
Step
Metric
Questions to Consider
1
Potential Relevance
Does the result have information (qualitative or quantitative) related to TSCA
risk evaluations?
* Apply Discipline relevancy metric
2.1.1
Complete / Available
Is it a secondary data source (assessment, robust summary, TSCA submission
databases, etc.)?
2.1.2
Is the document from a peer reviewed/published journal?
74
-------
2.2
Is there an established procedure for data collection, communication, peer
review, and/or reporting?
2.2.1
Has the data been provided by a US governmental/state source?
2.2.2
Has the data been provided by an international governmental source?
2.3
Are these data publicly available/accessible?
2.3.1
Is the source TSCA CBI, proprietary, TSCA or NGO stakeholder submission?
3
Duplicate
Does the result contain any duplicative information found in other sources?
Results of the gray literature search and decision tree process are included in Appendix A.3.4.
A.3.3 TSCA Submission Searching and Title Screening
EPA screens information submitted under TSCA Sections 4, 5, 8(e), and 8(d), as well as for your
information (FYI) submissions. In the gray literature process defined in Appendix A.3.2, EPA considers
the databases that contain TSCA submissions to be secondary sources (Step 1.1) because the metadata in
the databases are secondary. These databases then advance to Step 2.3.1 and then to Process C. The
Process C steps are described here.
EPA first screens the titles using two screeners per title. EPA conducts this step primarily to reduce the
number of full studies to be obtained because some studies are available only on microfiche or in long-
term storage. Screening is done using the inclusion and exclusion criteria within the relevant PECOs,
PESOs or RESOs for each topic area (Appendix A.2.1). EPA excludes interim reports (e.g., interim
sacrifices for toxicity studies) and only final reports are further considered. If the title is not clear
regarding the document's contents, EPA obtains the full text and advances to the next steps.
After full texts are obtained, EPA reviewed some sources (prior to full-text screening) based on whether
they have several factors; primary data, an established procedure for peer review, data collection,
communication and/or reporting and are publicly available. Sources that have these factors will move on
to full text screening. Other sources will go straight to full text screening using PECO-type criteria
without going through this extra step.
EPA may decide to initiate a backwards search on sources that are deemed to have secondary data. In
situations where parameters such as procedures for peer review and data collection are unclear, EPA
may reach out to the authors to retrieve information to gauge whether the source should be included or
excluded. Studies that are not publicly available (such as proprietary or CBI sources) may undergo
additional screening steps.
During the full-text screening step, two individuals screen each source according to the PECOs, PESOs
and RESOs (Appendix A.2.1).
Results of the TSCA submission search and decision tree process are included in Appendix A.3.4.
75
-------
A.3.4 Gray Literature Search Results for TCEP
Table Apx A-12 provides a list of gray literature sources that yielded results for TCEP.
Table Apx A-12. Gray Literature Sources that Yielded Results for TCEP
Source ,. „ ,. ... Source ,. ,,. . .
, Source Vime Source 1 vne Source \\ensile
A«encv • ( sileaorv
ATSDR
ATSDR Tox Profile Updates
and Addendums
Other US
Agency
Resources
Assessment
or Related
Document
httos://www.atsdr.cdc.gov/tox
Australian
Government,
Department
of Health
NICNAS Assessments
(human health. Tier I. 11 or
III)
International
Resources
Assessment
or Related
Document
littj3s://www. industrial dieniic
al s. gov. au/chem ical-
information/search-
assessments
CPSC
Technical Reports:
Exposure/Risk Assessment
Other US
Agency
Resources
Assessment
or Related
Document
fattj3s://www. CDSc.gov/Resear
ch—Statistics/Che m ical s
CPSC
Technical Reports: Toxicity
Review
Other US
Agency
Resources
Assessment
or Related
Document
httDs://www. cosc.gov/Resear
ch ™ Statistics/Che m ical s
ECHA
Annex XIV Restriction
Report
International
Resources
Assessment
or Related
Document
llfMsj//etfe
/guidance-on-inclusion-of-
substances-in-annex-xiv
ECHA
Annex XV Restriction Report
International
Resources
Assessment
or Related
Document
httos ://echa.eu roDa.eu/cii rrent
-activities-on-restrictions
ECHA
European Union Risk
Assessment Report
International
Resources
Assessment
or Related
Document
httos://echa.euroDa.eu/inform
ation-on-
chemicals/information-from-
existing-substances-
regulation
Env Canada
Chemicals at a Glance (fact
sheets)
International
Resources
Assessment
or Related
Document
httos://www.canada.ca/en/hea
lth-canada/services/chemical-
substances/fact-
sheets/chem icals-glance.htm 1
Env Canada
Screening Assessment for the
Challenge
International
Resources
Assessment 1 httos://www.canada.ca/en/hea
or Related Ith-canada/services/chemical-
Document | substances/cliallen.ee/list.litml
EPA
OPPT: TSCATS database
maintained at SRC (TSCA
submissions)
US EPA
Resources
Database j
EPA
OPPT: Chemview (TSCA
submissions - chemical test
rule data and substantial risk
reports)
US EPA ! „ , I httos://chem view. epa. gov/che
„ Database
Resources I mview
76
-------
Source Nsinio Source Type Source Website
( silegorv
EPA
OPPT: CIS (CBI LAN)
(TSCA submissions)
US EPA
Resources
Database
EPA
Office of Water: STORET
and WQX
US EPA
Resources
Database
https ://www.waterciual itvdata
.us/do rtal/
EPA
PPRTV Derivation Support
Document
US EPA
Resources
Assessment
or Related
Document
https://fahpprtv.oml.eov/aiiick
view/pprtv papers, php
EPA
Design for the Environment
(DfE) Alternatives
Assessments
US EPA
Resources
Assessment
or Related
Document
https://www.epa.20v/safercho
ice/design-environment-
altematives-assessments
EPA
TSC A Data Needs
Assessments or Problem
Formulation
US EPA
Resources
Assessment
or Related
Document
https://hhpprtv.ornl.eov/auick
view/pprtv.php
EPA
Other EPA: Misc sources
US EPA
Resources
General
Search
https://www.epa.eov/
EPA
EPA: AP-42
US EPA
Resources
Regulatory
Document or
List
httos ://www .eoa. sov/air-
emissions-factors-and-
aiiantification/aD-42-
comoilation-air-emissions-
factors
EPA
Office of Air: National
Emissions Inventory (NEI) -
National Emissions Inventory
(NEI) Data (2014. 2011,
2008)
US EPA
Resources
Database
httos ://www .eoa. eov/air-
emissions-inventories/2014-
national-eniissions-inventorv'-
nei-data
EPA
Office of Water: CFRs
US EPA
Resources
Regulatory
Document or
List
httDs://www.eDa.sov/ee
EPA
Office of Air: CFRs and
Dockets
US EPA
Resources
Regulatory
Document or
List
httos://www.eDa.sov/stationar
v-soiirces-air-Dollution
EPA
EPA: Generic Scenario
US EPA
Resources
Assessment
or Related
Document
httos ://www .eoa. eov/tsca-
screenine-tools/chemsteer-
chemical-screenins-tool-
exDosures-and-
environmental-
re!eases#eenericscenarios
I ARC
I ARC Monograph
y . . Assessment
International „ , ^ ,
„ or Related
Resources „
j Document
httD://monoera.Dhs.iarc.fr/EN
G/Monographs/PDFs/iridex.p
hp
1 IL0
International Chemical Safety
Cards (ICSCs)
International Database
Resources
h tto s: //www. i 1 o. o re/safe wo rk/
info/publications/WCMS 11
3134/lans—en/index.htm
77
-------
Source Nsinio Source Type Source Website
( silegorv
Japan
Japanese Ministry of the
Environment Assessments -
Environmental Risk
Assessments (Class I
Designated Chemical
Substances Summary Table)
International
Resources
Regulatory
Document or
List
httos ://www .env .so. i o/en/clie
m i/Drtr/substances/
KOECT
Kirk-Othmer Encyclopedia of
Chemical Technology Journal
Article
Other
Resource
Encyclopedia
m/doi/book/10.1002/0471238
96.1.
NIOSH
CDC NIOSH - Health Hazard
Evaluations (HHEs)
Other US
Agency
Resources
Assessment
or Related
Document
httos://www2a.cdc.eov/hhe/s
NIOSH
CDC NIOSH - Workplace
Survey Reports
Other US
Agency
Resources
Assessment
or Related
Document
httos ://www .cdc. eov/n. iosh/su
rvevreoorts/allre Dorts.html
NTP
Technical Reports
Other US
Agency
Resources
Assessment
or Related
Document
h tto s: //n to. n ieli s. n ih. go"v/du b 1 i
cations/reports/indexlitm 1 ?tv
oe=T ecli n ical +Reoo rt
OECD
OECD Substitution and
Alternatives Assessment
International
Resources
Assessment
or Related
Document
htto ://www .oecdsaatool box.o
mL
OECD
OECD Emission Scenario
Documents
International
Resources
Assessment
or Related
Document
htto://www.oecd.org/docume
nt/46/0.2340.en 2649 20! 18
5 24.1.2462 1 1 1 LOO.litml
OECD
OECD: General Site
International
Resources
General
Search
h tto s: //www. oecd. o re/
RIVM
RIVM Reports: Risk
Assessments
International
Resources
Assessment
or Related
Document
httos://www. rivm. n 1/en
TERA
Toxicology Excellence for
Risk Assessment
Other
Resources
Assessment
or Related
Document
https://www.tera.org/
78
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Appendix B PHYSICAL AND CHEMICAL PROPERTIES
Table Apx B-l summarizes statistics for the physical and chemical property values identified through
systematic review as of June 2020. The "N" column indicates the number of unique primary sources of
data for that endpoint. That is, if multiple sources presented equivalent values and cited the same
primary source, only one of those was included in these statistics and included in the statistical
calculations. All physical and chemical property values that were extracted and evaluated as of June
2020 are presented in the supplemental file Data Extraction and Data Evaluation Tables for Physical
and Chemical Property Studies (EPA.~H.0~0 ).
Table Apx B-l. Summary Statistics for Reviewed Physical Properties
Properly or Kndpoinl
\
1 nil
Mean
Standard
Deviation
Min
Max
Molecular formula
-
-
NA
NA
NA
NA
Molecular weight
-
g/mol
NA
NA
NA
NA
Physical state
1
-
NA
NA
NA
NA
Physical properties
2
-
NA
NA
NA
NA
Melting point
5
°C
-49
8.3
-55
-35
Boiling point
4
°C
296
69.0
192
330
Density
4
g/cm3
1.407
0.020
1.39
1.4289
Vapor pressure
1
mm Hg
0.0613
-
0.0613
0.0613
Vapor density
0
-
-
-
-
-
Water solubility
2
mg/L
7410
579.8
7000
7820
Octanol/water partition coefficient
(log Kow)
4
-
1.29
0.53
0.54
1.78
Henry's Law constant
0
atmm3/m
ol
-
-
-
-
Flash point
1
°C
222
-
222
222
Auto flammability
0
°C
-
-
-
-
Viscosity
3
CP
17.62
23.71
3.57
45
Refractive index
5
-
1.4731
0.0031
1.4707
1.4786
Dielectric constant
0
-
-
-
-
-
NA = Not applicable
The preliminarily selected value for the log Kow lies outside the 95% confidence interval, defined as ±2
standard deviations from the mean under the assumption that the data are normally distributed (see
Figure 2-12). All of the log Kow values were reported in secondary sources, and EPA will attempt to
obtain and review the primary data sources before identifying the final selected log Kow value.
79
-------
Information about all reported log Kow values are summarized in FigureApx B-l and presented in the
supplemental file Data Extraction and Data Evaluation Tables for Physical and Chemical Property
Studies (EPA-HO-QPPT-2018-0476).
NLM,2015
U.S. EPA. 2019
Elsevier, 2019
(Measured)
(Measured)
(Measured)
0.00 0.50 1.00 1.50 2.00 2.50
Reference
Value
Quality Type
NLM, 2015
U.S. EPA, 2019
Elsevier, 2019
1.78
1.44
0.54- 1.4
High Measured
High Measured
High Measured
Bolded value represent proposed value for use in risk
evaluation
Graph Legend
High Data Quality ~ Proposed Value
~
~
Medium Data Quality
Low Data Quality
Value reported as
greater than (>)
, Value reported as
lesser than (<)
Figure Apx B-l. Tornado Diagram for Viscosity Data Identified in Systematic Review
80
-------
Appendix C
ENVIRONMENTAL FATE AND TRANSPORT
PROPERTIES
Table Apx C-l provides the environmental fate characteristics that EPA identified and considered in
developing the scope for tris(2-chloroethyl) phosphate. This information was presented in the Proposed
Designation of Tris(2-chloroethyl) Phosphate (CASRN115-96-8) as a High-Priority Substance for Risk
Evaluation (U.S. EPA. 2019c) and may be updated as EPA collects additional information through
systematic review methods.
Table_Apx C-1. Environmental Fate Characteristics of TCEP
Properly or
Kmlpoinl
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
>012b)
Hydrolysis
ti/2 = stable at pH 3
ti/2 = 3,980 days at pH 7 ti/2 = 101 days at pH 10
Environment Canada
(2009), citing Brown
etal. (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)
NITE (2.010). ECHA
Water: 10%/27 days (OECD 302B)
15%/21 days (OECD 302B) in activated non- adapted
industrial sludge
Environment Canada
), \ y ^<00)
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
Environment Canada
(2009)
Biodegradation
(Anaerobic)
Soil: 0%/58 days at 80 mg/L test substance concentration
related to DOC (ISO DIS 11734)
EC (2000). citing
Noac
81
-------
Wastewater
Treatment
9.2% total removal (7.3% by biodegradation, 1.9 by sludge
and 0% by volatilization to air; estimated)13
JO12b)
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)
NITE (2010). ECHA
Bioaccumulation
Factor
6.3 (estimated)13
>012b)
Soil Organic
Carbon:Water
Partition
Coefficient (Log
Koc)
2.6 (Koc = 388; MCI method);
2 (Koc =103; KOW method) (estimated)13
JO12b)
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 OP(OCCC1)(OCCC1)OCCC1
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
82
-------
Appendix D REGULATORY HISTORY
D.l Federal Laws and Regulations
Table Apx D-l. Federal Laws and Regulations
Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
EPA Statutes/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 71924.
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 (85 FR 20122. Aoril
2. 2020).
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).
83
-------
D.2 State Laws and Regulations
Table Apx D-2. State Laws and Regulations
Stsile 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-free Children
and Babies Act ( /ir Conser § 37-0701 et see.)). Minnesota ("Four flame
Retardants in Furniture Foam and Children's Products (Minn. Stat. § 325F.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. 2 18, C.A. 2018).
State Drinking
Water Standards
and Guidelines
Minnesota developed a health-based guidance value for TCEP in drinking water
(Minn R Qiao. 4720).
Chemicals of High
Concern to Children
Several states have adopted reporting laws for chemicals in children's products
containing TCEP, including Maine (38 MRS A Chapter 16-D). Minnesota (Toxic
Free Kids Act Minn. Stat I lo 'H01 1 (o 9407). Oregon (Toxic-Free Kids Act,
Senate Bill 478, 2015). Vermont (1 ^ \ 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 \ > .'7001).
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 Proaram ("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).
84
-------
D.3 International Laws and Regulations
TableApx D-3 Regulatory Actions by other Governments, Tribes, and International
Agreements
Con 11 try/
()r»;iniz:ition
Requirements mill Restrictions
Canada
TCEP (Ethanol, 2-chloro-, phosphate (3:1)) is on the Canadian List of Toxic
Substances (TIE 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.; ol. 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
57Q).
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-chlorophosphate (3:1):
'Human health tier 11 assessment. Accessed April 8. 2019) (NICNAS. .2017. Ethanol, 2-
chloro-, phosphate (3:1): Human health tier 111 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 rCHRIPl. 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.
http://www.base!.int/Portals/4/Basel%20Convention/docs/text/BaselConventionText-
e.pdf.
85
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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.
E.l Process Information
Process-related information potentially relevant to the risk evaluation may include process diagrams,
descriptions and equipment. Such information may inform potential release sources and worker
exposure activities.
E.l.l Manufacture (Including Import)
E.l.1.1 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 ( 18b).
E.1.2 Processing and Distribution
E.l.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 (U.S. EPA. 2018c).
E. 1.2.2 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 ( ,018c). For example, TCEP may be incorporated into aircraft
interiors as a flame retardant (!
-------
unsaturated polyester resins and in acrylic resins, and coatings. Specific aerospace industrial uses
include resins and elastomeric coatings, polyurethane casting for aircraft interiors and as a flame
retardant (AIA. ) Aceto US, LLC, a former importer of TCEP, has indicated to EPA that TCEP is
used as a flame retardant for aircraft furniture (EPA-HQ-OPPT-2018- ).
E.l.3.2 Building/ Construction Materials
Aceto US, LLC, a former 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) (<_ IQ-OPPT-2^ sj 00! The European Commission (20j 2)
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 (IARC. 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.l.3.3 Foam Seating and Bedding Products
Aceto US, LLC, a former 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-HQ-OP ). Polyester fibers are processed into yarns and fabrics
in the same manner as other fibers, thus bedding products may contain polyester in the yarns and threads
used in bed sheets and blankets ( j94). 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 (H.S1 15). Flexible urethane cushions have
many applications in furniture and automotive products. Specific uses include furniture foam padding,
automotive seat cushions and padding, flooring (carpet underlay), pillows and mattress foam padding
( 2004a). According to Substances in Preparations in Nordic Countries (SPIN. 2019) TCEP
was reported for use in manufacture of furniture, until 2007.
K. 1.3.4 Other: Uses (e.g., Laboratory Use)
TCEP is used as a laboratory chemical, such as in a chemical standard mixture. A commenter (EPA-HQ-
QPPT-2018-0476-0032) provided descriptions of their use of TCEP in analytical standard, research,
equipment calibration and sample preparation applications, including reference sample for analysis of
terrestrial and extraterrestrial material samples, which the commenter also indicated was a critical use,
further informing EPA's understanding of this condition of use.
E.l.3.5 Paints and Coatings
For the 2012 CDR, Aceto US, LLC 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 US, LLC was a former importer and manufacturer and they did not
provide use information in the 2016 CDR. However, Aceto US, LLC did inform EPA that coatings is
one potential field of application of the chemical (EP A-HQ-OPPT-2018-t ).
E.l.3.6 Fabric, Textile, and Leather Products
Aceto US, LLC, a former importer of TCEP, informed EPA that TCEP is sold into the textile industry,
87
-------
and that the textile industry uses TCEP as a flame-retardant plasticizer in unsaturated polyester resins
CEPA-HQ-OPPT-2018-0476-0015). Fabric and textile products using polyester resins include polyester
yarns and fabrics, in the same manner as other fibers ( 94). Polyester yarns and fabrics can be
found in clothing, bed sheets, blankets, and upholstered furniture while industrial polyester fibers, yarns,
and ropes are used in car tire reinforcements, fabrics for conveyor and safety belts, and coated fabric and
plastic reinforcements with high-energy absorption. 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 CECHA. 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 CEnvironment Canada. 2009). The European Commission also lists the textile industry (e.g.,
back-coatings for carpets and upholstery) as a use in the Ell (EC.! ).
E.1.4 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, i ).
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
Resource Conservation and Recovery Act (RCRA) regulated substances
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 (U.S. EPA. 2018c. 2014).
E.2 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 summarizes NIOSH Health Hazard Evaluations identified during EPA's preliminary
data gathering. HHEs can be found at https://www.cdc.eov/niosh/hhe/.
Table Apx E-l. Potentially Relevant Data Sources for Exposure Monitoring and Area Monitoring
Data from NIOSH Health Hazard Evaluations for TCEPa
Year of Publication
Ueporl Number
l-'acilily 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
88
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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.il'i- (\ik-
Shim-
C;ik-»iir\
Sul>i;ik-»iir\
Ri'k'usi- /
r.\|xiMiiv
Sii-ii;iriii
I'.\|)IISIIIV
l>;illl\\;i\
I!\|)iisiiiv
kiiuk-
Ri'i'i'plin* /
Piipuhiliiiii
I'hilis In
l!\ ;illl;iU-
K.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
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
Manufacture
Import
Import
Repackaging
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
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility of TCEP
(0.06 mmHg at 25°C), EPA plans to
evaluate inhalation exposure to vapor.
Liquid.
Solid
Contact
I )ermal
ONU
No
I)ermal exposure by ONU is not expected
lor this condition of use as they are not
expected to directly handle the chemical.
Processing
Incorporation
into Formulation,
Mixture, or
Reaction product
Flame retardant in
Paint and coating
manufacturing;
polymers
Unloading
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during unloading operations as TCEP
is in liquid form.
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).
89
-------
l.il'i- ( \ik-
C;ik-»iir\
Sul>i;ik-»iir\
l'.\|)IISUIV
Sun ;i liii
I'.\|)IISIIIV
I'iilllWiiv
I!\|)iisiiiv
Kiuik-
Ki'ivpliir /
I'lipilhlliiill
I'hilis In
l!\ ;il u ilk-
K.iliiill.ik-
Mist. Dust
Inhalalion
Workers,
ONI J
No
Mist generation is not expected during
processing (incorporation into formulation,
mixture, or reaction product). 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.
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility ofTCEP
(0.06 mmHg at 25°C), EPA plans to
evaluate inhalation exposure to vapor.
Liquid,
Solid
Contact
I )ermal
ONU
No
Dermal exposure by C)NIJ 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 unloading operations, as
TCEP is in liquid form.
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)
Incorporation
into article
Flame retardant
Unloading
Mist, Dust
Inhalation
Workers.
ONU
No
Mist generation is not expected during
processing (incorporation into articles).
I'CLP is in liquid form (or wet solid form
according to one importer reporting to
CDR), so dust generation is not expected
during unloading operations.
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility of TCEP
(0.06 mmHg at 25°C), EPA plans to
evaluate inhalation exposure to vapor.
I .iquid.
Solid
Contact
I )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.
90
-------
l.ili- (\ik-
Shim-
C;ik-»iir\
Sul>i;ik-»iir\
Ki-k-:isi- /
l'.\|)IISUIV
Sun ;i liii
I'.\|)IISIIIV
I'iilllWiiv
I!\|)iisiiiv
Kiuik-
Ri'i'i'plin* /
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 recycling, as TCEP can be
incorporated in different liquid products
Solid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during recycling, as TCEP can be
incorporated in different solid products.
Recycling
Recycling
Mist
Inhalation
Workers.
ONU
No
Mist generation is not expected during
recvclina
Reclamation
Activities
Dust
Inhalation
Workers.
ONU
Yes
Dust exposure is expected during recycling,
as particulates from solid products
containing TCEP can be generated
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility of TCEP
(0.06 mmHg at 25°C). EPA plans to
evaluate inhalation exposure to vapor.
Liquid/Solid
Contact
I )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.
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 TCEP are
not expected to be handled or used in solid
form.
Industrial,
Commercial,
Consumer Use
Paints and
Coatings
Unloading;
Spray
Coating
Applications
Mist
Inhalation
Workers,
ONU
Yes
The potential for exposure to TCEP
suspended in mist exists during spray
coating applications (Paints and Coatings)
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility of TCEP
(0.06 mmHg at 25°C), EPA plans to
evaluate inhalation exposure to vapor.
Dust
Inhalation
Workers,
ONU
No
TCEP and paints containing TCEP are in
liquid lorm so dust generation is not
expected during this use (paints and
coatings)
91
-------
l.il'i- ( \ik-
C;ik-»iir\
Sul>i;ik-»iir\
Ri'k'usi- /
l'.\|)IISUIV
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
Dermal
ONIJ
No
1 )ermal exposure by ONI 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
TCEP and TCEP-containing 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
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 TCT.P.
Mist, Dust
Inhalation
Workers,
ONIJ
No
Mist and dust generation is not expected
during this use (aircraft interiors and
aerospace products).
aerospace
products
Vapor
Inhalation
Workers.
ONIJ
Yes
Due to high volatility of TCEP
(0.06 mmllg at 25°C). EPA plans to
evaluate inhalation exposure to vapor.
Other Use
I.iquid/Solid
Contact
1 )ermal
ONIJ
No
Dermal exposure by ONIJ 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 this use (laboratory
chemicals), as TCEP is in liquid form.
Laboratory
chemicals
Use of
laboratory
chemicals
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,
ONIJ
No
Mist generation is not expected during this
use (laboratory chemicals). TCEP is in
liquid form (or wet solid form according to
one importer reporting to CDR), so dust
generation is not expected during this use
(1 abora torv chem ic a 1 s).
92
-------
( \ ik-
C;ik-»iir\
Sul>i;ik-»iir\
Ri'k'usi- /
r.\|xiMiiv
Sun ;i liii
I'.\|)IISIIIV
I!\|)iisiiiv
Ki'ivpliir /
I'hilis In
K.iliiill.ik-
Kiuik-
I'lipilhlliiill
l!\ iiliiiili-
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility of TCEP
(0.06 mmHg at 25°C), EPA plans to
evaluate inhalation exposure to vapor.
Liquid/Solid
Contact
] )ermal
ONI J
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
I )ermal
W orkers
No
TCLP and TCLP-containing article
components are not expected to be handled
or used in the liquid form.
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.
Fabric, textile, and
leather products not
covered elsewhere
Use of other
textile
products
Mist
Inhalation
Workers.
ONU
No
Mist generation is not expected during this
use ( fabric, textile, and leather products not
covered elsewhere).
Furnishing,
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility of TCEP
(0.06 mmHg at 25°C), EPA plans to
evaluate inhalation exposure to vapor.
Cleaning,
Treatment Care
Products
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.
Liquid
Contact
I )ermal
W orkers
No
TCLP and TCI IP-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.
Mist
Inhalation
Workers,
ONU
No
Mist generation is not expected during this
use (Ibam seating and bedding products).
93
-------
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
IC\ ;il u ilk-
K.iliiill.ik-
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility of TCEP
(0.06 mmHg at 25°C), EPA plans to
evaluate inhalation exposure to vapor.
Dust
Inhalation
Workers,
ONU
No
Dust generation is expected during this use
(Foam Seating and Bedding Products), as
TCFP-containing articles may need to be
cut during finishing operations.
Liquid/Solid
Contact
1 )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
Dermal
W orkers
No
TCFP and TCI CP-containing article
components are not expected to be handled
or used in the liquid form.
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/constructi
on materials not
covered elsewhere
Instillation/R
euse/Demolil
ion of
materials in
residential.
Mist
Inhalation
Workers.
ONU
No
Mist generation is not expected during this
use (building/construction materials not
covered elsewhere).
Construction,
Paint, Electrical,
and Metal
Products
public and
commercial
buildings,
and other
structures
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility of TCEP
(0.06 mmHg at 25°C), EPA plans to
evaluate inhalation exposure to vapor.
Dust
Inhalation
Worker,
ONU
Yes
Dust generation is expected during this use
(building/construction materials not
covered elsewhere).
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.
Wood and
engineered wood
products
I.iquid
Contact
Dermal
W orkers
No
TCI CP and TCI CP-containing article
components are not expected to be handled
or used in the liquid form
94
-------
l.il'i- ( \ik-
Shim-
C;ik-»iir\
Sul>i;ik-»iir\
Ri'k'usi- /
l'.\|)IISUIV
Sun ;i liii
I'.\|)IISIIIV
l';illl\\;i\
I!\|)iisiiiv
Kiuik-
Ki'ivpliir /
I'lipilhlliiill
I'hilis In
l!\ iiliiiili-
K.iliiill.ik-
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.
Use of wood
and
engineering
Mist. Dust
Inhalation
Workers.
ONU
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).
wood
products
Vapor
Inhalation
Workers,
ONU
Yes
Due to high volatility of TCEP
(0.06 mmHg at 25°C), EPA plans to
evaluate inhalation exposure to vapor.
Liquid/Solid
Contact
I )ermal
ONU
\()
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
Worker
Yes
Dermal exposure is expected for this
condition of use
Dust
Inhalation
Worker
Yes
TCEP may be present in solid material.
EPA plans to evaluate the inhalation
pathway.
Disposal
Waste Handling.
Treatment and
Disposal
Disposal of TCEP
containing wastes
Worker
handling of
wastes
Vapor
Inhalation
Worker,
ONU
Yes
Due to high volatility of TCEP
(0.06 mmHg at 25°C), EPA plans to
evaluate inhalation exposure to vapor.
Liquid
Contact
1 )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.
Dust
Inhalation
ONU
Yes
TCEP may be present in solid material.
EPA plans to evaluate the inhalation
pathway
95
-------
Appendix G SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR CONSUMER
ACTIVITIES AND USE
Table Apx G-l Consumer Exposure Conceptual Model Supporting Table
l.il'e ( \clc
St;i»e
CsilcKon
Siibciik'iion
Koloiisc from
sou ive
l'l\|)OSIIIV
Koulc
Km*|)lor
I'liius In
K\
-------
l.ile ( >cle
Slii«o
CsilcKon
Siibciik'iion
Koloiisc from
sou ive
l'l\|)OSIIIV
Koulc
Km*|)lor
I'liius In
K\
-------
l.ile ( >cle
Slii«o
( .Motion
Subc.ik'iion
Koloiisc from
sou ive
l'l\|)OMIIV
Roulo
Km*|)lor
I'liius In
K\
-------
Appendix H
SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES
Table Apx H-l General Population and Environmental Exposure Conceptual
Model Supporting Table
Life
( \cle
Sliiiio
Release
r.\|)ONIMY
l\ilh\\;i\ / Modiii
I'1\|)osiiiv
Koii li-s
Reeeplor/
Population
Phins Ki
R;ilion;ile
Near facility
ambient air
concentrations
Inhalation
General
Population
Yes
Emissions
to Air
Emissions to Air
Indirect
deposition to
nearby bodies of
water and soil
catchments
Oral
Dermal
General
Population
Yes
TBD
Aquatic
and
Terrestrial
Receptors
TCEP deposition to nearby bodies of water and soil
are expected exposure pathways, not covered under
other EPA regulations, and, therefore in scope.
Yes
All
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.
Wastewater
or Liquid
Wastes
Industrial pre-
treatment and
wastewater
treatment, or
POTW
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
TBD
Aquatic
and
Terrestrial
Receptors
EPA plans to analyze the pathway from biosolids to
the general population, aquatic and terrestrial
species.
Yes
99
-------
l.ifc
( \cle
S(;i»e
( iileiion
Uok'iiso
I'1\|)osiiiv
P;iIliw ;i> / Modiii
l'l\|)OMIIV
Koii li-s
Km'plor/
Population
Pliins Id
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
100
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