EPA Document# EPA-740-R1-7012
May 2018
United States Office of Chemical Safety and
LhI Environmental Protection Agency Pollution Prevention
Problem Formulation for
Cyclic Aliphatic Bromides Cluster
(HBCD)
CASUN
NA.MK
25637-99-4
Hexabromocyclododecane
3194-55-6
1,2,5,6,9,10-Hexabromocyclododecane
3194-57-8
1,2,5,6-Tetrabromocyclooctane
May 2018
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 6
ABBREVIATIONS 7
EXECUTIVE SUMMARY 9
1 INTRODUCTION 12
1.1 Regul atory Hi story 14
1.2 Assessment History 14
1.3 Data and Information Collection 16
1.4 Data Screening During Problem Formulation 17
2 PROBLEM FORMULATION 18
2.1 Physical and Chemical Properties 18
2.2 Conditions of Use 19
2.2.1 Data and Information Sources 19
2.2.2 Identification of Conditions of Use 19
2.2.2.1 Categories and Subcategories Determined not to be Conditions of Use or Otherwise
Excluded During Problem Formulation 20
2.2.2.2 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 26
2.2.2.3 Overview of Conditions of Use and Lifecycle Diagram 30
2.3 Exposures 33
2.3.1 Fate and Transport 33
2.3.2 Releases to the Environment 34
2.3.3 Presence in the Environment and Biota 35
2.3.4 Environmental Exposures 35
2.3.5 Human Exposures 36
2.3.5.1 Occupational Exposures 36
2.3.5.2 Consumer Exposures 36
2.3.5.3 General Population Exposures 38
2.3.5.4 Potentially Exposed or Susceptible Subpopulations 39
2.4 Hazards (Effects) 40
2.4.1 Environmental Hazards 40
2.4.2 Human Health Hazards 42
2.4.2.1 Non-Cancer Hazards 42
2.4.2.2 Genotoxicity and Cancer Hazards 43
2.4.2.3 Potentially Exposed or Susceptible Subpopulations 44
2.5 C onceptual Model s 44
2.5.1 Conceptual Model for Industrial and Commercial Activities and Uses: Potential Exposures
and Hazards 45
2.5.2 Conceptual Model for Consumer Activities and Uses: Potential Exposures and Hazards.... 47
2.5.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards 50
2.5.3.1 Pathways that EPA Plans to Include and Further Analyze in Risk Evaluation 50
2.5.3.2 Pathways that EPA Plans to Include in the Risk Evaluation but Not Further Analyze.. 51
2.5.3.3 Pathways that EPA Does Not Expect to Include in the Risk Evaluation 52
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2.6 Analysis Plan 56
2.6.1 Exposure 56
2.6.1.1 Environmental Releases 57
2.6.1.2 Environmental Fate 60
2.6.1.3 Environmental Exposures 61
2.6.1.4 Occupational Exposures 62
2.6.1.5 Consumer Exposures 64
2.6.1.6 General Population 66
2.6.2 Hazards (Effects) 68
2.6.2.1 Environmental Hazards 68
2.6.2.2 Human Health Hazards 70
2.6.3 Risk Characterization 73
REFERENCES 74
APPENDICES 84
Appendix A REGULATORY HISTORY 84
A.l Federal Laws and Regulations .84
A.2 State Laws and Regulations .......85
A.3 International Laws and Regulations...... ....86
Appendix B PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION.. 88
B.l Process Information.. 88
B. 1.1 Manufacture (Including Import) 88
B.l. 1.1 Import 88
B. 1.2 Processing and Distribution 88
B. 1.2.1 Incorporated into a Formulation, Mixture or Reaction Product 88
B. 1.2.2 Incorporated into an Article 88
B. 1.2.3 Recycling 89
B.1.3 Uses 89
B. 1.3.1 Building/Construction Materials 89
B.1.4 Disposal 89
B.2 Sources Containing Potentially Relevant Data or Information.......................................... ....90
Appendix C SUPPORTING INFORMATION FOR OCCUPATIONAL EXPOSURE
CONCEPTUAL MODEL 95
Appendix D SUPPORTING INFORMATION FOR CONSUMER, GENERAL POPULATION
AND ENVIRONMENTAL EXPOSURE CONCEPTUAL MODEL 99
Appendix E INCLUSION AND EXCLUSION CRITERIA FOR FULL TEXT SCREENING 106
E.l inclusion Criteria for Data Sources Reporting Em ironmental Fate Data.... ........................106
E.2 Inclusion Criteria for Data Sources Reporting Engineering and Occupational Exposure Datal 10
E.3 Inclusion Criteria for Data Sources Reporting Exposure Data on General Population,
Consumers and Ecological Receptors ...............112
E.4 Inclusion Criteria for Data Sources Reporting Human Health Hazards ..113
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LIST OF TABLES
Table 1-1. Assessment History ofHBCD 15
Table 2-1. Physical and Chemical Properties ofHBCD 18
Table 2-2. Categories and Subcategories Determined not to be Conditions of Use or Otherwise Excluded
During Problem Formulation 24
Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 29
Table 2-4. Production Volume ofHBCD in CDR Reporting Period (2012 to 2015)a 30
Table 2-5. Environmental Fate Characteristics ofHBCD 33
Table 2-6. Summary of Aquatic and Sediment Environmental Hazard Information for HBCD 41
Table 2-7. Summary of Industrial Activities EPA Will Analyze 57
LIST OF FIGURES
Figure 2-1. HBCD Life Cycle Diagram 32
Figure 2-2. HBCD Conceptual Model for Industrial and Commercial Activities and Uses: Worker and
Occupational Non-User Exposures and Hazards 46
Figure 2-3. HBCD Conceptual Model for Consumer Activities and Uses: Consumer Exposures and
Hazards 49
Figure 2-4a. HBCD Conceptual Model for Environmental Releases and Wastes: General Population
Exposures and Hazards 54
Figure 2-4b. HBCD Conceptual Model for Environmental Releases and Wastes: Ecological Exposures
and Hazards 55
LIST OF APPENDIX TABLES
Table_Apx A-l. Federal Laws and Regulations 84
Table_Apx A-2. State Laws and Regulations 85
Table_Apx A-3. Regulatory Actions by other Governments and Tribes 86
TableApx B-l. Potentially Relevant Data Sources for Information Related to Process Description.... 91
TableApx B-2. Potentially Relevant Data Sources for Measured or Estimated Release Data 92
Table Apx B-3. Potentially Relevant Data Sources for Personal Exposure Monitoring and Area
Monitoring Data 93
Table Apx B-4. Potentially Relevant Data Sources for Engineering Controls and Personal Protective
Equipment 94
Table Apx C-l. Worker and Occupational Non-User Exposure Conceptual Model Supporting Table. 95
Table Apx D-l. Consumer Exposure Conceptual Model Supporting Table 99
Table Apx D-2. General Population and Environmental Exposure Conceptual Model Supporting Table
101
Table Apx E-l. Inclusion Criteria for Data Sources Reporting Environmental Fate Data 107
Table Apx E-2. Fate Endpoints and Associated Processes, Media and Exposure Pathways Considered
in the Development of the Environmental Fate Assessment 108
Table Apx E-3. Inclusion Criteria for Data Sources Reporting Engineering and Occupational Exposure
Data 110
Table Apx E-4. Engineering, Environmental Release and Occupational Data Necessary to Develop the
Environmental Release and Occupational Exposure Assessments Ill
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TableApx E-5. Inclusion Criteria for the Data Sources Reporting HBCD Exposure Data on General
Population, Consumers and Ecological Receptors 113
Table Apx E-6. Inclusion and Exclusion Criteria for Data Sources Reporting Human Health Hazards
Related to Cyclic Aliphatic Bromide Cluster (HBCD Cluster) Exposure a 114
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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. CIO-SP3,
HHSN316201200013W), ERG (Contract No. EP-W-12-006), Versar (Contract No. EP-W-17-006), ICF
(Contract No. EPC14001), and SRC (Contract No. EP-W-12-003).
Docket
Supporting information can be found in public docket: EPA-HQ-QPPT-2016-0735.
Disclaimer
Reference herein to any specific commercial products, process or service by trade name, trademark,
manufacturer or otherwise does not constitute or imply its endorsement, recommendation or favoring by
the United States Government.
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ABBREVIATIONS
°C Degrees Celsius
atm Atmosphere(s)
BAF Bioaccumulation Factor
BCF Bioconcentration Factor
C&D Construction and Demolition
CAA Clean Air Act
CASRN Chemical Abstracts Service Registry Number
CBI Confidential Business Information
CCL Candidate Contaminant List
CDR Chemical Data Reporting
cm3 Cubic Centimeter(s)
COC Concentration of Concern
CPSC Consumer Product Safety Commission
EC European Commission
ECHA European Chemicals Agency
EPA Environmental Protection Agency
EPCRA Emergency Planning and Community Right-to-Know Act
EPS Expanded Polystyrene
EPS-IA Expanded Polystyrene Industry Alliance
ESD Emission Scenario Document
g Gram(s)
HAP Hazardous Air Pollutant
HBCD Hexabromocyclododecane
HIPS High Impact Polystyrene
HPV High Production Volume
IRIS Integrated Risk Information System
kg Kilogram(s)
Koa Octanol: Air Partition Coefficient
L Liter(s)
lb Pound
LCD Liquid-Crystal Display
LOAEL Lowest Observed Adverse Effect Level
LOEC Lowest Observed Effect Concentration
Log Koc Logarithmic Organic Carbon:Water Partition Coefficient
Log Kow Logarithmic Octanol:Water Partition Coefficient
m3 Cubic Meter(s)
MATC Maximum Acceptable Toxicant Concentration
|ig Microgram(s)
mmHg Millimeter(s) of Mercury
MSW Municipal Solid Waste
MSWLF Municipal Solid Waste Landfills
NICNAS National Industrial Chemicals Notification and Assessment Scheme
NIOSH National Institute of Occupational Safety and Health
NOEC No Observed Effect Concentration
OCSPP Office of Chemical Safety and Pollution Prevention
OECD Organisation for Economic Co-operation and Development
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OPPT
Office of Pollution Prevention and Toxics
OSHA
Occupational Safety and Health Administration
PBPK
Physiologically Based Pharmacokinetic
PEC
Predicted Environmental Concentration
PESS
Potentially Exposed or Susceptible Subpopulation
POD
Point of Departure
POP
Persistent Organic Pollutant
POTW
Publicly Owned Treatment Works
ppm
Part(s) per Million
PQL
Practical Quantitation Limit
SDS
Safety Data Sheet
SIPS
Structural Insulated Panels
SNUR
Significant New Use Rule
TRI
Toxics Release Inventory
TSCA
Toxic Substances Control Act
TURA
Toxics Use Reduction Act
U.S.
United States
UNEP
United Nations Environment Programme
WEEE
Waste Electrical and Electronic Equipment
WSDE
Washington State Department of Ecology
WWTP
Wastewater Treatment Plant
XPS
Extruded Polystyrene
XPSA
Extruded Polystyrene Association
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EXECUTIVE SUMMARY
TSCA § 6(b)(4) requires the United States Environmental Protection Agency (U.S. EPA) to establish a
risk evaluation process. In performing risk evaluations for existing chemicals, EPA is directed to
"determine whether a chemical substance presents an unreasonable risk of injury to health or the
environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the
Administrator under the conditions of use." In December of 2016, EPA published a list of 10 chemical
substances that are the subject of the Agency's initial chemical risk evaluations ( ), as
required by TSCA § 6(b)(2)(A). The cyclic aliphatic bromide cluster (HBCD) was one of these
chemicals.
TSCA § 6(b)(4)(D) requires that EPA publish the scope of the risk evaluation to be conducted, including
the hazards, exposures, conditions of use and potentially exposed or susceptible subpopulations that the
Administrator expects to consider. In June 2017, EPA published the Scope of the Risk Evaluation for
HBCD. As explained in the Scope Document, because there was insufficient time for EPA to provide an
opportunity for comment on a draft of the scope, as EPA intends to do for further scope documents, EPA
is publishing and taking public comment on a problem formulation document to refine the current scope,
as an additional interim step prior to publication of the draft risk evaluation for HBCD. Comments
received on this problem formulation document will inform development of the draft risk evaluation.
This problem formulation document refines the conditions of use, exposures and hazards presented in
the scope of the risk evaluation for HBCD and presents refined conceptual models and analysis plans
that describe how EPA expects to analyze the risk associated with the conditions of use of HBCD.
The cyclic aliphatic bromide cluster chemicals, including HBCD (Chemical Abstracts Service Registry
Number [CASRN] 25637-99-4), 1,2,5,6,9,10-hexabromocyclododecane (1,2,5,6,9,10-HBCD; CASRN
3194-55-6 are flame retardants. Uses for 1,2,5,6-tetrabromocyclooctane have not been identified. For the
purposes of this problem formulation document, the use of "HBCD" refers to either CASRN 25637-99-4
or 3194-55-6, or both.
The primary use of HBCD is as a flame retardant in expanded polystyrene (EPS) foam and extruded
polystyrene (XPS) foam in the building and construction industry for thermal insulation boards and
foam insulation panels. HBCD also has limited use in replacement parts for automobiles. Past uses of
HBCD have included use in HIPS (high impact polystyrene) and textiles. Information gathered from
research, industry and consumer product organizations, however, has led EPA to conclude that those
past uses are not ongoing; there is no longer manufacture, processing or distribution of HBCD for HIPS
or textiles; and therefore, those uses are not included in the scope of the risk evaluation of HBCD.
With the listing of HBCD as a persistent organic pollutant under the Stockholm Convention in 2013,
industry began to phase out manufacture and use of HBCD. In recent years, domestic manufacture of
HBCD has ceased. Some HBCD was imported in 2017 and EPA believes that a small amount of import
of HBCD may be ongoing. Use of stockpiles and exportation from the United States was completed at
the end of 2017, and is further discussed in Section 2.2.2 of the Problem Formulation. EPA concludes
that the import and processing of HBCD for use in EPS and XPS in buildings may be ongoing.
The conditions of use of EPS and XPS building insulation are within the scope of the evaluation and are
anticipated to continue to contribute to exposures in indoor environments. In indoor environments, there
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may also be exposures resulting from legacy uses of HBCD in articles (textiles, electronics and electrical
products) containing HBCD. These exposures are expected to decline over time as use of these articles
is phased out. The time scales for this are dependent on the age of the products, their useful service lives
and time lines for replacement.
While environmental exposures are expected to decline as importing and processing of the chemical are
phased out, based on past production volumes (millions of pounds per year) and the only recent
cessation of domestic manufacturing, reductions in environmental concentrations will occur gradually
over a period of time for this persistent and bioaccumulative compound.
This document presents the potential exposures that may result from the conditions of use of HBCD.
Exposures to workers, consumers and/or the general population may occur from industrial, commercial,
and consumer uses of HBCD and releases to air, water or land. Workers and occupational non-users may
be exposed to HBCD during conditions of use such as import, processing, distribution, repackaging and
recycling. Consumers and bystanders may also be exposed to HBCD via inhalation of particulates,
dermal contact with HBCD in articles and oral exposure via ingestion of settled dust. Exposures to the
general population may occur from industrial releases related to the import, processing, distribution and
use of HBCD. For HBCD, EPA considers workers, occupational non-users, consumers, and bystanders
and certain other groups of individuals who may experience greater exposures than the general
population due to proximity to conditions of use to be potentially exposed or susceptible subpopulations.
EPA will evaluate whether groups of individuals within the general population may be exposed via
pathways that are distinct from the general population due to unique characteristics (e.g., life stage,
behaviors, activities, duration) that increase exposure, and whether groups of individuals have
heightened susceptibility, and should therefore be considered potentially exposed or susceptible
subpopulations for purposes of the risk evaluation.
For aquatic ecological receptors, sediment-dwelling benthic species are expected to be exposed to
HBCD. Exposures to pelagic species are also expected from HBCD present in surface water. Trophic
magnification may result in greater exposure following bioaccumulation. It is expected that aquatic and
terrestrial species will be exposed to HBCD through the dietary exposure pathway. EPA will consider
which aquatic and terrestrial species are related via the food chain.
HBCD has been the subject of several prior health hazard, ecological hazard and risk assessments.
Human health hazards of HBCD have been reviewed previously and include toxicity following acute
(e.g., potential neurological effects, clinical signs of toxicity, and death at high-doses), and chronic (liver
toxicity, thyroid toxicity, reproductive/developmental toxicity, neurotoxicity, immunotoxicity)
exposures, and sensitization/irritation, all of which EPA expects to evaluate in the scope of the TSCA
risk evaluation. HBCD hazards to fish, aquatic plants, sediment invertebrates and terrestrial organisms
have also previously been assessed. If additional hazard concerns are identified during the systematic
review of the literature, these will also be considered. These hazards will be evaluated based on the
specific exposure scenarios identified.
The revised conceptual models presented in this problem formulation identify conditions of use;
exposure pathways (e.g., media); exposure routes (e.g., inhalation, dermal, oral); potentially exposed or
susceptible subpopulations; and hazards EPA expects to consider in the risk evaluation. The initial
conceptual models provided in the HBCD Scope Document ( 017d) were revised during
problem formulation based on evaluation of reasonably available information for physical-chemical
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properties, fate, exposures, hazards and conditions of use and based upon consideration of other
statutory and regulatory authorities. In each problem formulation document for the first 10 chemical
substances, EPA also refined the activities, hazards, and exposure pathways that will be included in and
excluded from the risk evaluation.
EPA's overall objectives in the risk evaluation process are to conduct timely, relevant, high-quality, and
scientifically credible risk evaluations within the statutory deadlines, and to evaluate the conditions of
use that raise the greatest potential for risk. 8 6, 33728 (July 20, 2017).
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1 INTRODUCTION
This document presents for comment the problem formulation of the risk evaluation to be conducted for
HBCD under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The Frank R.
Lautenberg Chemical Safety for the 21st Century Act amended the Toxic Substances Control Act
(TSCA), the Nation's primary chemicals management law, on June 22, 2016. The new law includes
statutory requirements and deadlines for actions related to conducting risk evaluations of existing
chemicals.
In December of 2016, EPA published a list of 10 chemical substances that are the subject of the
Agency's initial chemical risk evaluations (81 FR 91927), as required by TSCA § 6(b)(2)(A). These 10
chemical substances were drawn from the 2014 update of EPA's TSCA Work Plan for Chemical
Assessments, a list of chemicals that EPA identified in 2012 and updated in 2014 (currently totaling 90
chemicals) for further assessment under TSCA. EPA's designation of the first 10 chemical substances
constituted the initiation of the risk evaluation process for each of these chemical substances, pursuant to
the requirements of TSCA § 6(b)(4).
TSCA § 6(b)(4)(D) requires that EPA publish the scope of the risk evaluation to be conducted, including
the hazards, exposures, conditions of use and potentially exposed or susceptible subpopulations that the
Administrator expects to consider, within 6 months after the initiation of a risk evaluation. The scope
documents for all first 10 chemical substances were issued on June 22, 2017. The first 10 problem
formulation documents are a refinement of what was presented in the first 10 scope documents. TSCA §
6(b)(4)(D) does not distinguish between scoping and problem formulation, and requires EPA to issue
scope documents that include information about the chemical substance, such as the hazards, exposures,
conditions of use, and the potentially exposed or susceptible subpopulations that the Administrator
expects to consider in the risk evaluation. In the future, EPA expects scoping and problem formulation
to be completed prior to the issuance of scope documents and intends to issue scope documents that
include problem formulation.
As explained in the scope document, because there was insufficient time for EPA to provide an
opportunity for comment on a draft of the scope, as EPA intends to do for future scope documents, EPA
is publishing and taking public comment on a problem formulation document to refine the current scope,
as an additional interim step prior to publication of the draft risk evaluation for HBCD. Comments
received on this problem formulation document will inform development of the draft risk evaluation.
The Agency defines problem formulation as the analytical phase of the risk assessment in which "the
purpose for the assessment is articulated, the problem is defined and a plan for analyzing and
characterizing risk is determined" [see Section 2.2 of the Framework for Human Health Risk
Assessment to Inform Decision Making (U.S. EPA. 2014c)"I. The outcome of problem formulation is a
conceptual model(s) and an analysis plan. The conceptual model describes the linkages between
stressors and adverse human health effects, including the stressor(s), exposure pathway(s), exposed life
stage(s) and population(s), and endpoint(s) that will be addressed in the risk evaluation (U.S. EPA.
2014c). The analysis plan follows the development of the conceptual model(s) and is intended to
describe the approach for conducting the risk evaluation, including its design, methods and key inputs
and intended outputs as described in the EPA Human Health Risk Assessment Framework (
2.014c). The problem formulation documents refine the initial conceptual models and analysis plans that
were provided in the scope documents.
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First, EPA has removed from the risk evaluation any activities and exposure pathways that EPA has
concluded do not warrant inclusion in the risk evaluation. For example, for some activities which were
listed as "conditions of use" in the scope document, EPA has insufficient information following the
further investigations during problem formulation to find they are circumstances under which the
chemical is "intended, known, or reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of." Other activities, for example, may have been determined to be legacy
use, associated disposal, or legacy disposal during problem formulation. EPA does not expect to
consider or evaluate any such activities or associated hazards or exposures in the applicable risk
evaluation - that is to say, EPA does not expect to determine whether these activities, hazards or
exposures present unreasonable risk.
Second, EPA also identified certain exposure pathways that are under the purview of regulatory
programs and associated analytical processes carried out under other EPA-administered environmental
statutes - namely, the Safe Drinking Water Act (SDWA), the Clean Water Act (CWA), and the
Resource Conservation and Recovery Act (RCRA) - and which EPA does not expect to include in the
risk evaluation.
As a general matter, EPA believes that certain programs under other Federal environmental laws
adequately assess and effectively manage the risks for the covered exposure pathways. To use Agency
resources efficiently under the TSCA program, to avoid duplicating efforts taken pursuant to other
Agency programs, to maximize scientific and analytical efforts, and to meet the three-year statutory
deadline, EPA is planning to exercise its discretion under TSCA 6(b)(4)(D) to focus its analytical efforts
on exposures that are likely to present the greatest concern and consequently merit a risk evaluation
under TSCA, by excluding, on a case-by-case basis, certain exposure pathways that fall under the
jurisdiction of other EPA-administered statutes.1 EPA does not expect to include any such excluded
pathways as further explained below in the risk evaluation. The provisions of various EPA-administered
environmental statutes and their implementing regulations represent the judgment of Congress and the
Administrator, respectively, as to the degree of health and environmental risk reduction that is sufficient
under the various environmental statutes.
Third, EPA identified any conditions of use, hazards, or exposure pathways which were included in the
scope document and that EPA expects to include in the risk evaluation but which EPA does not expect
to further analyze in the risk evaluation. EPA expects to be able to reach conclusions about particular
conditions of use, hazards or exposure pathways without further analysis and therefore plans to conduct
no further analysis on those conditions of use, hazards or exposure pathways in order to focus the
Agency's resources on more extensive or quantitative analyses. Each risk evaluation will be "fit-for-
purpose," meaning not all conditions of use will warrant the same level of evaluation and the Agency
may be able to reach some conclusions without comprehensive or quantitative risk evaluations. 82 FR
33726, 33734, 33739 (July 20, 2017).
EPA received comments on the published scope document for HBCD and has considered the comments
specific to HBCD in this problem formulation document. EPA is soliciting public comment on this
problem formulation document and when the draft risk evaluation is issued, the Agency intends to
1 As explained in the final rule for chemical risk evaluation procedures, "EPA may, on a case-by case basis, exclude certain
activities that EPA has determined to be conditions of use in order to focus its analytical efforts on those exposures that are
likely to present the greatest concern, and consequently merit an unreasonable risk determination". [82 FR 33726, 33729
(July 20, 2017)].
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respond to comments that are submitted. In its draft risk evaluation, EPA may revise the conclusions and
approaches contained in this problem formulation, including the conditions of use and pathways covered
and the conceptual models and analysis plans, based on comments received.
1.1 Regulatory History
EPA conducted a search of existing domestic and international laws, regulations and assessments
pertaining to HBCD. EPA compiled this summary from data available from federal, state, international
and other government sources, as cited in Appendix A. EPA evaluated and considered the impact of
these existing laws and regulations (e.g. regulations on landfill disposal, design and operations) in the
problem formulation step to determine what, if any further analysis might be necessary as part of the risk
evaluation. Consideration of the nexus between these existing regulations and TSCA uses may
additionally be made as detailed/specific conditions of use and exposure scenarios are developed in
conducting the analysis phase of the risk evaluation.
Federal Laws and Regulations
HBCD is subject to federal statutes or regulations, other than TSCA, that are implemented by other
offices within EPA and/or other federal agencies/departments. A summary of federal laws, regulations
and implementing authorities is provided in Appendix A.l.
State Laws and Regulations
HBCD is subject to state statutes or regulations implemented by state agencies or departments. A
summary of state laws, regulations and implementing authorities is provided in Appendix A.2.
Laws and Regulations in Other Countries and International Treaties or Agreements
HBCD is subject to statutes or regulations in countries other than the United States and/or international
treaties and/or agreements. A summary of these laws, regulations, treaties and/or agreements is provided
in Appendix A. 3.
1.2 Assessment History
EPA has identified assessments conducted by other EPA Programs and other organizations (see Table
1-1). Depending on the source, these assessments may include information on conditions of use,
hazards, exposures and potentially exposed or susceptible subpopulations. Table 1-1 shows the
assessments that have been conducted.
In addition to using this information, EPA intends to conduct a full review of the relevant
data/information collected in the initial comprehensive search (see HBCD (CASRN25637-99-4, 3194-
55-6, 3194-57-8) Bibliography: Supplemental File for the TSCA Scope Document, EP A-HQ-OPPT -
2016-0735) following the literature search and screening strategies documented in the Strategy for
Conducting Literature Searches for HBCD: Supplemental File for the TSCA Scope Document, EPA-
HQ-OPPT-2016-0735). This will ensure that EPA considers information that has been made available
since these evaluations were conducted.
A Problem Formulation and Initial Assessment (PFIA) for the Cyclic Aliphatic Bromides Cluster was
published in 2015 (U.S. EPA. 2015c); however, a draft risk assessment was not completed. As part of
the scope, EPA developed an initial life cycle diagram and initial conceptual models for HBCD that re-
considered reasonably available information.
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Table 1-1. Assessment History of HBCD
Authoring Organi/alion
Assessment
EPA assessments
EPA, Office of Chemical Safety and Pollution
Prevention (OCSPP), Office of Pollution Prevention and
Toxics (OPPT)
Initial Risk Based Prioritization of High
Production Volume Chemicals.
Chemical/Category:
1! ibromocyclododecane (Hlh P i (I r
08)
EPA, OCSPP, OPPT
Hexabromocvclododecane on
Plan ( )
EPA, OCSPP, OPPT
Flame Retard ant Alternatives for
li- ibromocyclododecane ill- I > 0 r
)
EPA, OCSPP, OPPT
Toxic Chemical Work Plan Problem
Formulation and Initial Assessment for
Mt>J" »> ;lic Aliphatic Bromides Cluster
£ )
Other U.S.-based organizations
Consumer Product Safety Commission (CPSC)
CPSC osure and Risk Assessment of
Flame Retardant Chemicals in Residential
Upholstered Furniture (CPSC. 2001)
National Research Council
National Academy of Sciences .Report:
Toxicological Risks of Selected Flame
Retardant Chemicals CNRC. 2000)
International
Organisation for Economic Co-operation and
Development (OECD), Screening Information Data Set
(SIDS)
itial Assessment Profile
( 07b)
European Commission (EC), European Chemicals
Bureau
European Union Risk Assessment Report,
ibromocyclododecane CASRN 25637-
99-4. EINECS No: 247-148-4 fEINECS.
2008)
United Nations Environment Programme (UNEP);
Stockholm Convention on Persistent Organic Pollutants
(POPs)
ibromocyclododecane Draft Risk Profile
OJNEP. 2.010)
Hexabromocvclododecane Risk Management
Evaluation ( ( )
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Authoring Orgnni/silion
Assessment
Environment Canada and Health Canada
reening Assessment of
ibromocvclododecane (Environment
Canada. )
Australian Government Department of Health, National
Industrial Chemicals Notification and Assessment
Scheme (NICNAS)
itv Eixi sting Chemical Assessment
Report. Hexabromocvcl ododecane
( )
1.3 Data and Information Collection
EPA/OPPT generally applies a systematic review process and workflow that includes: (1) data
collection; (2) data evaluation; and (3) data integration of the scientific data used in risk assessments
developed under TSCA. Scientific analysis is often iterative in nature as new knowledge is obtained.
Hence, EPA/OPPT expects that multiple refinements regarding data collection will occur during the
process of risk evaluation. Additional information that may be considered and was not part of the
comprehensive bibliographies will be documented in the Draft Risk Evaluation for HBCD.
Data Collection: Data Search
EPA/OPPT conducted chemical-specific searches for information on: physical and chemical properties;
environmental fate and transport; conditions of use information; environmental and human exposures,
including potentially exposed or susceptible subpopulations; and ecological hazard and human health
hazard, including potentially exposed or susceptible subpopulations.
EPA/OPPT designed its initial data search to be broad enough to capture a comprehensive set of sources
containing data and/or information potentially relevant to the risk evaluation. Generally, the search was
not limited by date and was conducted on a wide range of data sources, including but not limited to:
peer-reviewed literature and gray literature (e.g., publicly-available industry reports, trade association
resources, government reports). When available, EPA/OPPT relied on the search strategies from recent
assessments, such as EPA Integrated Risk Information System (IRIS) assessments and the National
Toxicology Program's (NTP) Report on Carcinogens, to identify relevant references and supplemented
these searches to identify relevant information published after the end date of the previous search to
capture more recent literature. Strategy for Conducting Literature Searches for HBCD: Supplemental
File for the TSCA Scope Document (EP A-HQ-OPPT-2016-073 5) provides details about the data sources
and search terms that were used in the literature search.
Data Collection: Data Screening
Following the data search, references were screened and categorized using selection criteria outlined in
Strategy for Conducting Literature Searches for HBCD: Supplemental File for the TSCA Scope
Document (EPA-HQ-OPP' 35. (U.S. EPA. 2017fY). Titles and abstracts were screened against
the criteria as a first step with the goal of identifying a smaller subset of the relevant data to move into
the subsequent data extraction and data evaluation steps. Prior to full-text review, EPA/OPPT anticipates
refinements to the search and screening strategies, as informed by an evaluation of the performance of
the initial title/abstract screening and categorization process.
The categorization scheme (or tagging structure) used for data screening varies by scientific discipline
(i.e., physical and chemical properties; environmental fate and transport; chemical use/conditions of use
Page 16 of 115
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information; environmental exposures, human exposures, including potentially exposed or susceptible
subpopulations identified by virtue of greater exposure; human health hazard, including potentially
exposed or susceptible subpopulations identified by virtue of greater susceptibility; and ecological
hazard). However, within each data set, there are two broad categories or data tags: (1) on-topic
references or (2) off-topic references. On-topic references are those that may contain data and/or
information relevant to the risk evaluation. Off-topic references are those that do not appear to contain
data or information relevant to the risk evaluation. The supplemental document, Strategy for Conducting
Literature Searches for HBCD: Supplemental File for the TSCA Scope Document (EP A-HQ-OPPT -
2016-0735. (U.S. EPA. 2017fT) discusses the inclusion and exclusion criteria that EPA/OPPT used to
categorize references as on-topic or off-topic.
Additional data screening using sub-categories (or sub-tags) was also performed to facilitate further
sorting of data/information - for example, identifying references by source type (e.g., published peer-
reviewed journal article, government report); data type (e.g., primary data, review article); human health
hazard (e.g., liver toxicity, cancer, reproductive toxicity); or chemical-specific and use-specific data or
information. These sub-categories are described in Strategy for Conducting Literature Searches for
HBCD: Supplemental File for the TSCA Scope Document (EPA-H.Q-OPPT-2^' 'J j' S _ > j _\.
201TfT) and will be used to organize the different streams of data during the stages of data evaluation
and data integration steps of systematic review.
Results of the initial search and categorization results can be found in the HBCD (CASRN 25637-99-4,
3194-55-6, 3194-57-8) Bibliography: Supplemental File for the TSCA Scope Document (EP A-HQ-
OPPT -2016-073 5). This document provides a comprehensive list (bibliography) of the sources of data
identified by the initial search and the initial categorization for on-topic references and off-topic
references. Because systematic review is an iterative process, EPA/OPPT expects that some references
may move from the on-topic to the off-topic categories, and vice versa. Moreover, targeted supplemental
searches may also be conducted to address specific needs for the analysis phase (e.g., to locate specific
data needed for modeling); hence, additional on-topic references not initially identified in the initial
search may be identified as the systematic review process proceeds.
1.4 Data Screening During Problem Formulation
EPA/OPPT is in the process of completing the full text screening of the on-topic references identified in
the HBCD (CASRN 25637-99-4, 3194-55-6, 3194-57-8) Bibliography: Supplemental File for the TSCA
Scope Document. The screening process at the full-text level is described in the Application of
Systematic Review in TSCA Risk Evaluations ( 018). Appendix E provides the inclusion and
exclusion criteria applied at the full text screening. The eligibility criteria are guided by the analytical
considerations in the revised conceptual models and analysis plan, as discussed in the problem
formulation document. Thus, it is expected that the number of data/information sources entering
evaluation is reduced to those that are relevant to address the technical approach and issues described in
the analysis plan of this document.
Following the screening process, the quality of the included data/information sources will be assessed
using the evaluation strategies that are described in the Application of Systematic Review in TSCA Risk
Evaluations (U.S. EPA. 2018).
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2 PROBLEM FORMULATION
As required by TSCA, the scope of the risk evaluation identifies the conditions of use, hazards,
exposures and potentially exposed or susceptible subpopulations that the Administrator expects to
consider. To communicate and visually convey the relationships between these components, EPA
included in the scope document a life cycle diagram and conceptual models that describe the actual or
potential relationships between HBCD and human and ecological receptors. During the problem
formulation, EPA revised the conceptual models based on further data gathering and analysis, as
presented in this problem formulation document. An updated analysis plan is also included which
identifies, to the extent feasible, the approaches and methods that EPA may use to assess exposures,
effects (hazards) and risks under the conditions of use for HBCD.
2.1 Physical and Chemical Properties
Physical-chemical properties influence the environmental behavior and the toxic properties of a
chemical, thereby informing the potential conditions of use, exposure pathways and routes and hazards
that EPA intends to consider. For scope development, EPA considered the measured or estimated
physical-chemical properties set forth in Table 2-1 and EPA found no additional information during
problem formulation that would change these values.
HBCD is a white odorless non-volatile solid that is used as a flame retardant. Technical HBCD is often
characterized as a mixture of mainly three diastereomers, which differ only in the spatial disposition of
the atoms. Commercial-grade HBCD may contain some impurities, such as tetrabromocyclododecene or
other isomeric HBCDs (IXNEP, 2010). which are not separately included in this scope. The density of
HBCD is greater than that of water (2.24 g/cm3 at 20°C). It has low water solubility (66 |ig/L at 20°C)
and a log octanol:water partition coefficient (log Kow) of 5.62.
Table 2-1. Physical and Chemica
Properties of HBCD
Property
Value a
References
Molecular formula
Ci2Hi8Br6
Molecular weight
641.7 g/mole
Physical form
White solid; odorless
EINECS (2008)
Melting point
Ranges from approximately:
172-184°C to 201-205°C
EINECS (2008)
Boiling point
>190°C (decomposes)
EINECS (2008)
Density
2.24 g/cm3
EINECS (2008)
Vapor pressure
4.7E-07 mmHg at 21°C
EINECS (2008)
Vapor density
Not readily available
EINECS (2008)
Water solubility
66 |ig/L at 20°C
EINECS (2008)
Octanol:water partition
coefficient (log Kow)
5.625 at 25°C
EINECS (2008)
Henry's Law constant
7.4E-06 atm-m3/mole (estimated)
U.S. EPA. (2012b)
Flash point
Not readily available
EINECS (2008)
Page 18 of 115
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Property
Value a
References
Autoflammability
Decomposes at >190°C
EINECS (2008)
Viscosity
Not readily available
EINECS (2008)
Refractive index
Not readily available
EINECS (2008)
Dielectric constant
Not readily available
EINECS (2008)
a Measured unless otherwise noted.
2.2 Conditions of Use
TSCA § 3(4) defines the conditions of use as "the circumstances, as determined by the Administrator,
under which a chemical substance is intended, known, or reasonably foreseen to be manufactured,
processed, distributed in commerce, used, or disposed of."
2.2.1 Data and Information Sources
In the scope documents, EPA identified, based on reasonably available information, the conditions of
use for the subject chemicals. EPA searched a number of available data sources (e.g., Use and Market
Profile for HBCD, \ \ \ J f.Q-OPPT-2016-073 5). Based on this search, EPA published a preliminary list
of information and sources related to chemical conditions of use (see Preliminary Information on
Manufacturing, Processing, Distribution, Use, and Disposal: HBCD, EP A-HQ-OPPT-z 15-0003)
prior to a February 2017 public meeting on scoping efforts for risk evaluation convened to solicit
comment and input from the public. EPA also convened meetings with companies, industry groups,
chemical users and other stakeholders to aid in identifying conditions of use and verifying conditions of
use identified by EPA. The information and input received from the public, stakeholder meetings and
the additional contacts was incorporated into this problem formulation to the extent appropriate. Thus,
EPA believes the manufacture, processing, distribution, use and disposal activities constitute the
intended, known, and reasonably foreseen activities associated with the subject chemical, based on
reasonably available information.
2.2.2 Identification of Conditions of Use
To determine the conditions of use of HBCD and inversely, activities that do not qualify as conditions of
use, EPA conducted extensive research and outreach. This included EPA's review of published literature
and online databases including the most recent data available from: U.S. Consumer Product Safety
Commission (CPSC), CPSC staff exposure and risk assessment of flame retardant chemicals in
residential upholstered furniture, 2001; National Institute of Health's (NIH) Household Product
Database; EPA's Chemical/Product Categorical Data (CPcat) database; the most recent data available
from EPA's Chemical Data Reporting program (CDR); Safety Data Sheets (SDSs); European Chemical
Agency (ECHA) reports; United Nations Environment Program (UNEP) reports. EPA also conducted
online research by reviewing company websites of potential manufacturers, importers, distributors,
retailers, or other users of HBCD and queried government and commercial trade databases. EPA also
received comments (EP A-HQ-OPPT-2016-073 5) on the Scope of the Risk Evaluation for HBCD (U.S.
)that were used to determine the current conditions of use. In addition, EPA convened
meetings and personal communications with companies, industry groups, chemical users, states,
environmental groups, federal agencies, and other stakeholders to aid in identifying conditions of use
and verifying conditions of use identified by EPA. Those meetings included a February 14, 2017 public
meeting with such entities (EPA-HQ-OP ) in addition to meeting with: Adhesives and
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Sealants Council, American Chemistry Council, Alliance of Automobile Manufacturers, Association of
Global Automakers, Motor and Equipment Manufacturers Association, Business and Institutional
Furniture Manufacturer's Association, Consumer Specialty Products Association, Duke University
Faculty, Design Chain, Eagle Performance Products, Ecology Center, EPS Industry Alliance, Green
Policy Institute, Motor & Equipment Manufacturers Association, National Council of Textile
Organizations, Plastics Industry Association, XPS Association, and others.
EPA has removed from the risk evaluation any activities that EPA concluded do not constitute
conditions of use - for example, because EPA has insufficient information to find certain activities are
circumstances under which the chemical is actually "intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed of." EPA has also identified any
conditions of use that EPA does not expect to include in the risk evaluation. As explained in the final
rule for Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act,
TSCA section 6(b)(4)(D) requires EPA to identify "the hazards, exposures, conditions of use, and the
potentially exposed or susceptible subpopulations the Administrator expects to consider" in a risk
evaluation, suggesting that EPA may exclude certain activities that EPA has determined to be conditions
of use on a case-by-case basis. (82 FR 33736, 33729; July 20, 2017). For example, EPA may exclude
conditions of use that the Agency has sufficient basis to conclude would present only de minimis
exposures or otherwise insignificant risks (such as use in a closed system that effectively precludes
exposure or use as an intermediate).
The activities that EPA no longer believes are conditions of use or were otherwise excluded during
problem formulation are described in Section 2.2.2.1. The conditions of use included in the scope of the
risk evaluation are summarized in Section 2.2.2.2.
2.2.2.1 Categories and Subcategories Determined not to be Conditions of Use
or Otherwise Excluded During Problem Formulation
Domestic Manufacture of HBCD
Domestic manufacture of HBCD has ceased. Domestic manufacture of HBCD is not intended, known,
or reasonably foreseen and is therefore not considered a condition of use under which EPA will evaluate
HBCD.
U.S. manufacturers have indicated complete replacement of HBCD in their product lines (
2j ) and that use of stockpiles and exportation was completed in 2017. Communication with
Chemtura (Lanxess Solutions, US) indicates that the company has not manufactured HBCD since 2015,
and that there are currently no U.S. manufacturers of the chemical (LANXESS. 2017b). The company
does not intend to manufacture, import, or export HBCD in the future and has no existing stockpiles
(I sSS. 2017a). Albemarle Corporation, another historic manufacturer of HBCD, indicated that
they stopped manufacturing HBCD flame retardants around 2016 and do not intend to resume the
manufacture of HBCD-based flame retardants. In 2017, Albemarle exported its entire inventory of
approximately 57 metric tons (MT) of HBCD to Mexico and Turkey for use in construction (EPS/XPS)
applications (Albemarle. 2017b). Albemarle does not intend to import HBCD in the future (Albemarle.
2.017a).
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Domestic Manufacture of EPS Resin and XPS Masterbatch
In the past, the process for making insulation with HBCD included an intermediate step of resin
manufacture. A small group of EPS and XPS resin manufacturers purchased HBCD (domestically
manufactured or imported) and combined it with polystyrene and other ingredients to produce resin.
Separate facilities used the resin to make foam insulation products for construction. Domestic
manufacturers of EPS and XPS resin have phased out the use of HBCD due to international bans and the
availability of alternative flame retardants. The EPS Industry Alliance (EPS-IA) which represents all
major North American manufacturers (including Canada and Mexico) of EPS resin, reports that its
members have phased out of the use of HBCD in the production of EPS resins (Public comment, EPA-
HQ-OPPT-2 '35-0026). Similar to the EPS resin industry, major producers of XPS masterbatch
have fully transitioned out of using HBCD (XPS A.: ).
Use in High Impact Polystyrene (HIPS)
Use of HBCD in High Impact Polystyrene (HIPs) appears to have ceased and EPA does not believe this
use is intended, known, or reasonably foreseen. Therefore, use of HBCD in HIPS is not considered a
condition of use under which EPA will evaluate HBCD.
HBCD was used as a flame retardant in HIPS in electronic components. The most recent information
showing use, in both the United States and Europe, of HBCD as a flame retardant in HIPS for electrical
and electronic appliances, such as audio-visual equipment, refrigerator lining and some wire and cable
applications was based on a 2009 data source (ECHA. 2009b; Morose. 2006a). Use in television sets at
that time was the predominant application of HIPS (Weil ai ;hik. 2009). EPA's recent research and
outreach did not yield data showing current use of HBCD in HIPS for electrical and electronic
appliances (Design Chain Associates. 2017).
The Australian Department of Health and Aging reported in 2012 that minimal amounts of HBCD were
imported into Australia already incorporated into various articles, such as inkjet printers, projectors,
scanners, ventilation units for offices, compact fluorescent lights and liquid-crystal display (LCD) digital
audiovisual systems (NICNAS. 2012a). Similar current uses of HBCD in electronic articles or import of
those articles into the U.S. have not been found.
The use of HBCD in electronic equipment is legacy and therefore disposal of HBCD containing HIPS is
also considered legacy (associated disposal). Electronic products (which may or may not contain
HBCD) can be recycled and HIPS materials constitute more than half the plastic materials recovered
from household electronics (Borchardt. 2006). However, no information was identified that confirms use
of HBCD in recycled HIPS for the purposes of flame retardancy. EPA, therefore, does not believe that
this use is intended, known, or reasonably foreseen and is not a condition of use for HBCD. Nor is there
information that the recycling (i.e., processing) of HIPS containing HBCD is done to retrieve the HBCD
or to otherwise use the flame retardant properties of HBCD. Therefore, EPA believes the manufacturing,
processing, or distribution in commerce for use of HBCD as a flame retardant in HIPS is not intended,
known, or reasonably foreseen and is not a condition of use of HBCD.
Use in Textiles
In the United States, HBCD was historically used as a flame retardant in the back coating of textiles.
Use in this application was quite small; in 2005, manufacturers reported only 1% of HBCD was used in
textiles in the United States and only for commercial, not consumer use (I, S J \. 201 >/).
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Use in Consumer Textiles: EPA found that a small amount of HBCD was being used in consumer
textiles, i.e., floor mats, headliners and possibly other interior fabrics in motor vehicles made or
imported to the United States in 2011 (U.S. EPA. 2012e). Based on this information and the CDR
reporting in 2005, EPA finalized a SNUR in 2015 ( 2015b) which requires persons who intend
to manufacture (including import) or process HBCD for use in consumer textiles (other than for use in
motor vehicles) to notify EPA at least 90 days before commencing that activity. EPA has received no
notifications since the rule became effective in late 2012, and therefore does not expect HBCD to be
used in such consumer textiles. Articles containing HBCD that were manufactured prior to the effective
date of the SNUR might continue to be in service.
Information from industry indicates that HBCD is no longer used in textiles in motor vehicles (Alliance
of Automobile Manufacturers. 2.018) and EPA does not believe the use is intended, known, or
reasonably foreseen. Therefore, use in textiles in motor vehicles is not a condition of use under which
EPA will evaluate HBCD.
From June 2012 to March 2017, the use of HBCD in children's clothing and blankets was self-reported
44 times by manufacturers and retailers to Washington State under state law (Public comment,
HQ-OPPT-2 '35-0022). The forty-four reports are associated with consumer textiles which are
expected to have been covered by the SNUR (U.S. EPA. 2015b); and therefore may reflect textiles
produced prior to 2015. The textile products were reported with practical quantitation levels (PQL) of
less than 100 parts per million (ppm). EPA further assessed the data and concluded that none of the
products appear to contain intentionally-added HBCD.
Information gathered from research, industry and consumer product organizations has led EPA to
believe that HBCD is no longer used in consumer textiles. Current use in consumer textiles has not been
confirmed and EPA does not believe it is known, intended, or reasonably foreseen. Therefore, use in
consumer textiles is not a condition of use under which EPA will evaluate HBCD.
Use in Commercial Textiles: EPA received information in 2011 from a group of textile formulators that
the end uses of HBCD-containing textiles are for military, institutional and aviation applications, such as
durable carpet tiles for hospitals or prisons (U.S. EPA. 2012e; Friddle. 2011). By 2017, HBCD use in
these textile applications appeared to be phasing out (Friddle. 2017). The U.S. Department of Defense
found no direct use of HBCD (Underwood. 2017). According to the National Council of Textile
Organizations, HBCD has not been used in textiles for more than a decade (Poole. 2017). Current use in
commercial textiles could not been confirmed, but EPA concludes that based on the information above,
HBCD use in these textiles is not intended, known, or reasonably foreseen. Therefore, use in
commercial textiles is not a condition of use under which EPA will evaluate HBCD.
Use in Adhesives
Use of HBCD in adhesives was one of several minor uses included in the HBCD Scope Document,
however further research could not confirm current use in adhesives. During Problem Formulation, EPA
found that the Henkel company manufactured a pressure sensitive adhesive containing HBCD for use in
flexible air duct core under the product name Aquence AV 7584 Black, according to the company's
website and product Safety Data Sheet (Henkel Corp. 2017). However, as of January 2018 (Pierson.
2018). EPA has learned that the company will no longer use HBCD in their product line and does not
have a current supply of HBCD to draw from. EPA could find no evidence of ongoing manufacture,
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processing or distribution of adhesives using HBCD. Therefore, adhesives are not included as a
condition of use for which EPA will evaluate HBCD.
Use in Automotive Sector
Use of HBCD in the automotive sector was not reported in the 2012/2016 CDR or 2006 IUR datasets.
EPA received a public comment from the Global Automakers Association stating that "our members
have not identified any ongoing uses [of HBCD] in the manufacture of new vehicles. However, [HBCD]
has been and currently is being used in the manufacture of replacement parts only - replacement parts
designed prior to the date of the publication of the EPA HBCD Scoping Document" (Public comment,
EP A-HO-OPPT-2016-073 5-0027).
The Motor and Equipment Manufacturers Association reports that HBCD "is not used during the
manufacturing process of any automotive components. Information from our members submitted in
2015 also indicated it had nearly phased out completely the use of HBCD. Our data indicates HBCD is
phased out" (Public comment, EPA-HQ-QPPT-20f - 0: > 001 4).
In a public comment on the Use Document, however, the Alliance of Automotive Manufacturers wrote:
"Our members have indicated to us that this chemical is not used during the auto manufacturing process.
HBCD has been aggressively phased out by the auto industry over the past several years. However, the
chemical may still be used by some automakers as a flame retardant in coatings of certain components
(e.g., dashboards and headliners) and in solder paste in interior components (e.g., circuits). This
chemical may also be present in adhesives and foams." (Public comment, EPA-HQ-OPPT735-
0015). Specifics on these uses by non-member companies could not be verified.
Based on the information provided above, EPA concludes that use of HBCD in the manufacture of new
automobiles is not occurring (U.S. EPA. , 2.012d. 2006b). Therefore, the use of HBCD in
manufacture of new automobiles is not intended, known, or reasonably foreseen and therefore is not a
condition of use under which EPA will evaluate HBCD. Automotive replacement parts, however, are
considered a condition of use and will be included within the scope of the risk evaluation based on the
information provided above.
Other Uses
In order to determine whether other uses exist and to what extent, EPA reviewed state databases, product
testing results and information from foreign countries, in addition to the literature search and contacts
with industry groups.
Detections of HBCD in children's products reported by industry to Washington State Department of
Ecology (WSDE) include three products listed as "toy/games variety pack" and one entry for a baby
car/booster seat. The HBCD was found in surface coatings and polymers. One toy product and the car
seat were reported to have practical quantitation limits (PQLs) of "equal to or greater than 100 but less
than 5000 ppm" As this data is self-reported to the WSDE state database, more specific information
regarding the contaminant test methodologies, tested components, or prevalence of HBCD in the
products information could not be verified. The WSDE tested for flame retardants in a set of 169 general
and consumer products purchased between August 2012 and August 2013 from local stores in the south
Puget Sound area and online retailers. HBCD was detected in two of the products: in the polystyrene of
a child's bean bag chair at a concentration of 0.06%, and in the plastic of a protective work glove at
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4.4% fWSDE. 2014). WSDE noted in a 2015 report to the Washington state legislature that these test
results showed HBCD at percent levels but concluded: "TBBPA and HBCD were not detected in
children's products and furniture at levels consistent with use as a flame retardant in products tested by
Ecology" (https://fortress.wa.gov/ecy/piiblications/dociiments/1404047.pdf). EPA followed up with the
supplier of the Carbon X brand of work glove that WSDE had tested in 2012-2013. The company
provided documentation that HBCD is not used in four varieties of the Carbon X work glove (Mechanix
Wear. 2018). EPA concludes that other uses are not intended, known, or reasonably foreseen and are not
considered conditions of use under which EPA will evaluate HBCD.
EPA has concluded that legacy uses of HBCD include adhesives, textiles (including upholstery fabric,
floor mats and headliners in automobiles, and commercial uses) and electronics and electrical products.
EPA has concluded that the following are not conditions of use: coatings, solder, children's products
including toys and car seats; furniture (such as bean bag chairs).
Beyond the uses identified in the Scope of the Risk Evaluation for HBCD, EPA has received no
additional information identifying additional current conditions of use for HBCD from public comment
and stakeholder meetings.
Table 2-2. Categories and Subcategories Determined not to be Conditions of Use or Otherwise
Excluded During Pro
)lem Formulation
Life Cycle
Ciilo'iorv'
SiihcsHefiorv1'
References
Manufacture
Domestic manufacture
Domestic manufacture
U.S. EPA (2016b)
Processing
Processing as a
reactant/ intermediate
Intermediate for all other
basic inorganic chemical
manufacturing
U.S. EPA (2016b)
Processing -
incorporated into
formulation, mixture or
reaction product
Flame retardants used in
plastic material and resin
manufacturing (e.g.,
manufacture of EPS resin
beads)
Use Document. EPA-HO-
OPPT-2016-073 5-0003:
EINECS (2008); Market
Profile. EPA-HO-OPPT-
0735.
Processing -
incorporated into
formulation, mixture or
reaction product
Flame retardants used in
paints and coatings
manufacturing (e.g.,
micronisation and
formulation of polymer-
based dispersions for
textile coatings).
Use Document. EPA-HO-
OPPT-2016-073 5-0003:
Market Profile, EPA-HQ-
OPPT-2016-0735; EINECS
(2008)
Processing -
incorporated into
formulation, mixture or
reaction product
Flame retardants used in
adhesive manufacturing
(e.g., manufacture of
solder paste and other
adhesives)
Public Comment. EPA-HO-
OPPT-2016-0735 -0008;
Public Comment. EPA-HQ-
OPPT-2016-0735 -0015
Incorporated into article
Flame retardants used in
plastics product
manufacturing
Use Document. EPA-HO-
OPPT-2016-073 5-0003;
Market Profile, EPA-HQ-
Page 24 of 115
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Life Cycle Sl:i»c
Ciilo'iorv'
SiihcsHefiorv1'
UcfomuTs
(manufacture of HIP S;
manufacture of electronics
articles)d
OPPT-2016-0735: U.S. EPA
£2014b)
Incorporated into article
Flame retardants used in
textiles, apparel and
leather manufacturing
(e.g., coatings used at
textile and fabric finishing
mills, fabric coating mills
and carpet and rug mills)d
Use Document. EPA-HQ-
OPPT-2016-0735 -0003; U. S.
EPA (2014b)
Incorporated into article
Flame retardants used in
transportation equipment
manufacturing (e.g.,
manufacture of interior
components in
automobiles, including
fabrics, coatings, solder
paste, adhesives and
foams)d
Use Document, EPA-HO-
OPPT-2016-073 5-0003:
Market Profile, EPA-HQ-
OPPT-2016-073 5: Public
Comment. EPA-HO-OPPT-
2016-0735-0015
Processing
Recycling
Recycling of Products and
Articles Containing
HBCD for applications
that do not have
intentional flame
retardancy
Commercial/consumer
Use
Electrical and
electronic products
Plastic articles (soft) (e.g.,
wire and cable)
Use Document. EPA-HO-
OPPT-2016-073 5-0003;
Market Profile. EPA-HQ-
OPPT-2016-073?
(2016b)
Plastic articles (hard) (e.g.,
distribution boxes, audio-
visual equipment;
refrigerator lining;
computers; Inkjet
printers/ scanners)
Use Document. EPA-HO-
OPPT-2016-073 5-0003;
Market Profile. EPA-HQ-
OPPT-2016-0735; U.S. EPA
£2016b)
Adhesives
Adhesives (e.g., ductwork)
fflenkel Core. 2017).
(Pierson,_ 2018).
Floor coverings
Fabrics, textiles and
apparel (e.g., carpets and
rugs)
Use Document, EPA-HO-
OPPT-2016-073 5-0003
Furniture and
furnishings
Fabrics, textiles and
apparel: Furniture and
furnishings, including
furniture coverings (e.g.,
institutional furniture)
Use Document, EPA-HQ-
OPPT-2016-073 5-0003:
Page 25 of 115
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I.il'c Cvcli' Sl:i»i'
C':ili'«iorv''
SuhcsHi'sorv1'
Ui'fi'ri'iHTs
Fabric, textile and
leather products d
Fabrics, textiles and
apparel (e.g., interior
fabrics for automobiles)
Use Document,
16-0735-0003:
Market Profile, E
OPPT-2016-073 f
Fabric, textile and
leather products d
Textile finishing and
impregnating/ surface
treatment products (e.g.,
other textile products)
Use Document,
-0735-0003:
Public Comment, EPA-HQ-
Public Comment, EPA-E
OPPT-2016-0735 -0008;
Commercial/consumer
Use
Other uses6
Other (e.g., toys and
games, car seats, toys and
toy vehicles)
Use Document,
OPPT-2016-073 5-0003;
Market Profile, EPA-HO-
OPPT-2016-073 5; Public
Comment, EPA-HQ-OI
1.6-0735-0022; Public
Comment,
2016-0735-0008; Public
Comment,
20.1.6-0735-00.1
JT-20.1.6-073 5-00.1
Note: This table presents categories and subcategories of activities that are based on the 2016 CDR
industrial function category and industrial sector descriptions and the OECD product and article
category descriptions for the HBCD uses identified. Clarification on the subcategories of use from the
listed data sources are provided in parentheses.
a These categories of activities appear in the Life Cycle Diagram, reflect CDR codes and broadly
represent activities in industrial and/or consumer settings.
b These subcategories reflect more specific uses of HBCD.
c 2015 SNUR; (U.S. EPA, 2015a). EPA requires 90-day notification before manufacture or processing of
HBCD in consumer textiles, except those used in motor vehicles.
d Historically have been used.
e Other uses in EPA's Market Report 2017 (U.S. EPA.: ) were identified from foreign studies and
product testing results, reporting by manufacturers to the state of Washington, and other sources. For
the uses in other countries, it is uncertain whether similar U.S. products contain HBCD. In some of the
articles, HBCD is present but may not have been intentionally used.
2.2.2.2 Categories and Subcategories of Conditions of Use Included in the
Scope of the Risk Evaluation
Table 2-3 summarizes each life cycle stage and the corresponding categories and subcategories of
conditions of use for HBCD that EPA expects to consider in the risk evaluation. Using the 2016 CDR,
EPA identified industrial processing or use activities, industrial function categories and commercial use
product categories. EPA identified the subcategories by supplementing CDR data with other published
literature and information obtained through stakeholder consultations. For risk evaluations, EPA intends
to consider each life cycle stage (and corresponding use categories and subcategories) and assess
relevant potential sources of release and human exposure associated with that life cycle stage.
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Automotive Replacement Parts
EPA received a public comment from the Global Automakers Association stating that HBCD is no
longer used in new automobile manufacturing and is only present in replacement parts manufactured
prior to date of the EPA HBCD Scoping Document (Public comment, EP A-HQ-OPPT
0027). Major automobile manufacturers have phased out use of HBCD in U.S. production but continue
to use it in a few replacement parts, according to information provided to EPA by the Alliance of
Automotive Manufacturers since publication of the HBCD Scope Document. Manufacturers identified
three replacement parts containing HBCD, these are absorbers (front roof rail energy) and two types of
insulator panels (Alliance of Automobile Manufacturers. 2018). EPA assumes that HBCD in these
replacement parts is incorporated into EPS and XPS based on CDR reporting that showed the vast
majority of use of HBCD was for EPS and XPS. For the risk evaluation, EPA will try to obtain more
specific information on the three replacement parts, including whether they are domestically
manufactured or imported, what materials incorporate the HBCD, and volumes used.
Expanded Polystyrene (EPS) and Extruded Polystyrene (XPS) Foam
"Building/Construction Materials" include products containing HBCD as a flame retardant primarily in
XPS and EPS foam insulation products that are used for the construction of residential, public,
commercial or other structures (UNEP. 2010; Weil and Levchik. 2009).
Use in EPS and XPS foam had accounted for 95% of all HBCD applications in the past decade (U.S.
i ^ \ _'* '14a; UNEP. 2010). Based on information from market reports (!_ <_ j_2\), HBCD is
used primarily in construction materials, which may include structural insulated panels (SIPS). The
building and construction industry uses EPS and XPS foam thermal insulation boards and laminates for
sheathing products. EPS foam prevents freezing, provides a stable fill material and creates high-strength
composites in construction applications. XPS foam board is used mainly for roofing applications and
architectural molding. HBCD is used in both types of foams because it is highly effective at levels less
than 1% and, therefore, maintains the insulation properties of EPS and XPS foam (Morose. 2006a). EPS
foam boards contain approximately 0.5% HBCD by weight in the final product and XPS foam boards
contain 0.5-1% HBCD by weight (Public comment, EPA-HQ-OPPT-2016-0735-001"/) (XPV \ _'* '17b;
^ \ -014a: Morose. 2006b).
According to the EPS-IA, an estimated 80-85% of EPS rigid foam insulation manufactured in the United
States is molded from EPS resins supplied by EPS-IA member companies, none of which use HBCD
(EPS Industry Alliance. 2017).
The XPS Association (XPSA) stated that its members, which are the major producers of XPS resin,
supply the resin for more than 95% of the XPS foam insulation products manufactured for the North
American market and that the remaining small percentage is probably made using imported resin
(XPS A.! ). An intermediate step in manufacture of XPS foam insulation, compounding of
masterbatch, in which HBCD, resins, and other chemicals are processed is described in Appendix B.
Some companies reuse EPS and XPS insulation. See discussion below in Recycling of EPS and XPS
foam.
EPA is including the use of HBCD in XPS and EPS insulation using imported HBCD in the risk
evaluation. There is a potential for import of HBCD for use in the manufacture of EPS and XPS foam
insulation. Taking into account the high percentage of HBCD production volume dedicated to these two
Page 27 of 115
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uses in previous years and the fact that smaller EPS and XPS manufacturers may be currently using
imported HBCD resin, EPA is including the processing and use of HBCD in XPS and EPS insulation
and import of HBCD resin in the risk evaluation.
Recycling of EPS and XPS foam
To date, little is known by EPA about the recycling of EPS and XPS products containing HBCD.
Schlummer et al. (Schlummer et at.. 2.017) notes that EPS and XPS foam in construction insulation
materials are rarely recycled for numerous reasons, including that insulation waste is typically not
separated from mixed waste stream and most insulation containing HBCD is still in place. Schlummer et
al- (Schlummer et al... 2017) describe technologies available only on a small scale to separate HBCD
from insulation panels and recycle polystyrene.
Reuse and recycling is available in the United States for consumers through removal of insulation during
re-roofing projects. Two companies were identified that directly reuse (e.g., reuse without reforming)
and recycle (e.g., melting and inserting into the manufacturing process) XPS and EPS foam insulation.
Green Insulation Group: http://www.greeninsulatioiigroup.com/products/
Nationwide Foam Recycling: http://natioiiwidefoam.com/what-you-can-recycle.cfiii
Nationwide Foam Recycling, which is owned by Conigliaro Industries, Inc., indicate that their plant
recycles all EPS insulation and reuses all XPS insulation Q s. H' \ i V). Once processed, their
recycled EPS roofing insulation is taken to polystyrene product manufacturers, notably picture frame
manufacturers, mostly in China but also in domestic markets. The company also delivers recycled
roofing material to other local EPS recycling plants that may use different processes. Nationwide Foam
Recycling processes 90,000 pounds/year of EPS standard packaging and 10,000 pounds/year of EPS
roofing material and estimated that 10-20% of EPS roofing material is recycled nationally. The company
also reuses XPS roofing material due the special equipment needed to recycle XPS and indicated that
XPS is rarely recycled in the United States. It was estimated that the majority (>50%) of XPS roofing
material is sent to landfills or waste energy plants. Processing estimates for XPS material were not
provided by the company.
Disposal of Existing HBCD Products
Despite industry indicating that production of HBCD products is declining, there is a large of amount of
HBCD products still in use, particularly in construction materials. Eventually, buildings constructed
with HBCD-containing products will be either demolished or remodeled and the HBCD containing
products will need to be removed and either reused, disposed of or recycled.
Summary of Conditions of Use Included in the Risk Evaluation
Based on the information described in this section, EPA plans to analyze HBCD importation;
incorporation into formulation, mixture or reaction product (e.g. compounding of masterbatch XPS);
incorporation into articles (e.g. manufacture of EPS and XPS and the manufacture of structural insulated
panels from EPS and XPS); disposal; recycling; and the industrial, commercial and consumer use of
EPS and XPS in construction materials (e.g. insulation boards).
Page 28 of 115
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Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
l.il'e Cycle Stage
Category11
Subcategory1'
References
Manufacture
Import
Import
1016b}
Processing
Processing -
incorporated into
formulation, mixture
or reaction product
Flame retardants used in
custom compounding of
resin (e.g., compounding
in XPS masterbatch)
EINECS (2008)
Incorporated into
article
Flame retardants used in
plastics product
manufacturing
(manufacture of XPS and
EPS foam; manufacture of
structural insulated panels
(SIPS) and automobile
replacement parts from
XPS and EPS foam)
Use Document. EPA-HO-
OPPT-2016-073 5-0003:
Market Profile, Q_-
OPPT-2016-0735: U.S. EPA
(2014a)
( ance of Automobile
Manufacturers. 2018).
Recycling
Recycling of XPS and
EPS foam, resin, panels
containing HBCD
Use Document. EPA-HO-
OPPT-21 35-0003
Distribution
Distribution
Distribution
Commercial/consumer
Use
Building/construction
materials
Plastic articles (hard):
construction and building
materials covering large
surface areas (e.g.,
EPS/XPS foam insulation
in residential, public and
commercial buildings, and
other structures)
Use Document, EPA-HO-
OPF 3;
U.S. EPA. (2016b): U.S.
EPA (2014a)
Other
Automobile replacement
parts
( ance of Automobile
Manufacturers. 2018)
Disposal
Disposal
Other land disposal (e.g.
Construction and Demolition
Waste)
EINECS (2008)
Note: This table presents categories and subcategories of conditions of use that are based on the 2016
CDR industrial function category and industrial sector descriptions and the OECD product and article
category descriptions for the HBCD uses identified. Clarification on the subcategories of use from the
listed data sources are provided in parentheses.
a These categories of conditions of use appear in the Life Cycle Diagram, reflect CDR codes and
broadly represent conditions of use of HBCD in industrial and/or consumer settings.
b These subcategories reflect more specific uses of HBCD.
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2.2.2.3 Overview of Conditions of Use and Lifecycle Diagram
The life cycle diagram provided in Figure 2-1 depicts the conditions of use that are considered within
the scope of the risk evaluation during various life cycle stages including manufacturing, processing, use
(industrial, commercial, and consumer), distribution and disposal. Additions or changes to the conditions
of use based on additional information gathered or analyzed during problem formulation are described in
Sections 2.2.2.1 and 2.2.2.2. The activities that EPA determined are out of scope during problem
formulation are not included in the life cycle diagram. The information is grouped according to
Chemical Data Reporting (CDR) processing codes and use categories (including functional use codes
for industrial uses and product categories for industrial, commercial and consumer uses), in combination
with other data sources (e.g., published literature and consultation with stakeholders) to provide an
overview of conditions of use. EPA notes that some subcategories of use may be grouped under multiple
CDR categories.
Use categories include the following: "industrial use" means use at a site at which one or more
chemicals or mixtures are manufactured (including imported) or processed. "Commercial use" means
the use of a chemical or a mixture containing a chemical (including as part of an article) in a commercial
enterprise providing saleable goods or services. "Consumer use" means the use of a chemical or a
mixture containing a chemical (including as part of an article, such as furniture or clothing) when sold to
or made available to consumers for their use ( ))
To understand conditions of use relative to one another and associated potential exposures under those
conditions of use, the life cycle diagram includes the production volume associated with each stage of
the life cycle, as reported in the 2016 CDR reporting ( 016b). However, the life cycle
diagram for HBCD does not include specific production volumes because the information was claimed
as confidential business information (CBI).
The 2016 CDR reporting data for HBCD are provided in Table 2-4 from EPA's CDR database (U.S.
16b). This information has not changed from that provided in the HBCD Scope Document.
Reporting Year
2012
2013
2014
2015
Total Aggregate
Production Volume (lbs)
CASRN 25637-99-4
1-10 million
1-10 million
1-10 million
1-10 million
CASRN 3194-55-6
10-50 million
10-50 million
1-10 million
1-10 million
1 The CDR data for the 2016 rcDortinu period is available via ChemView (littDs://iava.eDa.gov/clienwiew) (IIS. EPA. 2016b").
Because of an ongoing CBI substantiation process required by amended TSCA, the CDR data available in the HBCD Scope
Document is more specific than currently in ChemView.
HBCD Production Volume (Manufacture and Import)
Data reported for the CDR period for 2016 for HBCD indicate that between 1 and 10 million lbs of each
CASRN were manufactured in or imported into the United States in 2015; the national production
volume is CBI ( ). For both CASRNs, site-specific production volumes for the 2015
reporting year were withheld as TSCA CBI. Six firms comprised of nine sites are identified by the 2016
CDR as manufacturers or importers of HBCD: Chemtura Corporation, Albemarle Corporation, Dow
Chemical Company, Campine NV, BASF Corporation, and Styropek USA, Inc (U.S. EPA. ).
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Current Status of Domestic Manufacture of HBCD
Industry has indicated complete replacement of HBCD in their product lines ( ) and that
use of stockpiles and exportation was completed in 2017, as discussed in Section 2.2.2.1.
Current Status of Importation of HBCD
The companies that previously reported HBCD import volumes to CDR have stated to EPA that they
permanently stopped the activity in 2016 or 2017. The Dow Chemical Company imported 19 metric tons
(MT) of HBCD in 2016 and roughly 48 MT in 2017. Dow possessed roughly 41 MT of HBCD in
stockpiles as of September 2017, which the company then used to produce XPS foam. By November
2017, Dow had stopped using HBCD at all of its plants and had no intention of importing HBCD in the
future. (Dow Chemical Company. 2017).
Similarly, Campine NV indicated in a correspondence with EPA that they had ceased importation of
HBCD in 2016 (Campine. ). BASF has indicated in a correspondence with EPA (BASF. 2017) that
the company ceased importing HBCD in 2016 and currently has no stockpiles. ICL-IP2 previously
manufactured an HBCD-containing flame retardant marketed as FR-1206. However, this product has
been discontinued, and ICL-IP has reportedly ceased production of products containing HBCD
(Additives for Polymers. 2015). Styropek also indicated in its correspondences with EPA that the
company phased out HBCD as a flame retardant in 2016.
Although there are a number of possible source countries for importation of HBCD to the United States,
under the Stockholm Convention on Persistent Organic Pollutants (POPs), 171 of the 188 Parties
(countries) have agreed to ban the production, use, import, and export of HBCD, consistent with the
obligations of that Convention (SCCH. 2018a. b) . The Convention does include a process by which a
party can apply for a time limited exemption to continue production and/or use of a listed chemical,
however, that exemption is limited to the specific use(s) identified in the Convention. In accordance
with Article 4, specific exemptions expire five years after the date of entry into force of the Convention
with respect to that particular chemical, unless an additional five-year extension in granted by the
Conference of the Parties (SCCH. 2018b). For HBCD, the specific uses for which a Party can register a
production or use exemption is limited to use "in EPS and XPS in buildings." According to the Register
of Specific Exemptions for the Convention, there are currently three Parties registered for production for
those uses and six Parties registered for use. The United States is not a Party to the Convention (SCCH.
2018c).
Descriptions of the industrial, commercial and consumer use categories identified from the 2016 CDR
(U.S. EPA. 2016b) and included in the life cycle diagram are summarized in Section 2.2.2.2. The
descriptions provide a brief overview of the use category; Appendix B contains more detailed
descriptions (e.g., process descriptions, worker activities, process flow diagrams, equipment
illustrations) for each manufacture, processing, use and disposal category. The descriptions provided
below are primarily based on the corresponding industrial function category and/or commercial and
consumer product category descriptions from the 2016 CDR and can be found in EPA's Instructions for
Reporting 2010 I'SC A. Chemical Data Reporting > * v * \ s ,016a).
Figure 2-1 depicts the life cycle diagram of HBCD from manufacture to the point of disposal. Activities
related to distribution (e.g., loading, unloading) will be considered throughout the HBCD life cycle,
rather than using a single distribution scenario.
2 ICL-IP did not report to the 2016 CDR.
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MFG/lMPORT
PROCESSING
INDUSTRIAL, COMMERCIAL, CONSUMER USES
RELEASES and WASTE DISPOSAL
Demolition
j j Manufacture (Includes Import) j j Processing
Uses: Industrial, Commercial or Consumer.
- Import of HBCD
Recycling
Automobile Replacement Parts
Incorporated into Formulation,
Mixture, or Reaction Product
(2016 CDR Volume CBI)
compounding of XPS masterbatch
Building/Construction Materials
insulation material for residential, public and
commercial buildings or other structures
Incorporated into Article
(2016 CDR Volume CBI]
manufacture of XPS and EPS,
manufacture of SIPs and automobile
replacement partsfrom XPS and EPS
KEY:
Black Text: In scope; will be further analyzed.
~ Pathways that will be further analyzed.
Disposal
Reuse
Figure 2-1. HBCD Life Cycle Diagram
The life cycle diagram depicts the conditions of use that are within the scope of the risk evaluation during various life cycle stages including
manufacturing, processing, use (industrial, commercial, consumer), distribution and disposal. Activities related to distribution (e.g., loading,
unloading) will be considered throughout the HBCD life cycle, rather than using a single distribution scenario.
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2.3 Exposures
For TSCA exposure assessments, EPA expects to analyze exposures and releases to the environment
resulting from the conditions of use applicable to HBCD. Post-release pathways and routes will be
described to characterize the relationship or connection between the conditions of use of the chemical
and the exposure to human receptors, including potentially exposed or susceptible subpopulations and
ecological receptors. EPA will take into account, where relevant, the duration, intensity (concentration),
frequency and number of exposures in characterizing exposures to HBCD.
2.3.1 Fate and Transport
Environmental fate includes both transport and transformation processes. Environmental transport is the
movement of the chemical within and between environmental media. Transformation occurs through the
degradation or reaction of the chemical with other species in the environment. Hence, knowledge of the
environmental fate of the chemical informs the determination of the specific exposure pathways and
potential human and environmental receptors EPA expects to analyze in the risk evaluation. Table 2-5
provides environmental fate data that EPA identified and considered in developing the scope for HBCD.
This information has not changed from that provided in the HBCD Scope Document.
During problem formulation, EPA/OPPT considered volatilization during wastewater treatment,
volatilization from lakes and rivers, biodegradation rates, organic carbon: water partition coefficient (log
Koc) and bioaccumulation potential when making changes to the conceptual models as described in
Section 2.5. Systematic literature review is currently underway, so model results and basic principles
were used to support the fate data used in problem formulation.
The environmental fate information on HBCD presented in Table 2-5 is based on information published
in a number of publications (U.S. EPA. 2.015c. 2014a: NICNA.S. 2012b: EC/HC. 2011: EINECS. 2008:
EPA. 2008: OECD. 2007a).
Table 2-5. Environmental Fate Characteristics of HBCD
Properly or Kndpoinl
Value"
References
Direct photodegradation
Does not undergo direct photolysis (estimated)
>015
Indirect photodegradation
2.1 days (air)
>015c)
Hydrolysis half-life
Does not undergo hydrolysis
>015c)
Biodegradation half life
0% in 28 days (aerobic in wastewater, OECD 301D)
ti/2 = 63 days (aerobic soil, OECD 307)
ti/2 = 7 days (anaerobic soil, OECD 308)
ti/2 = 11-32 days (aerobic sediment, OECD 308)
ti/2 = 1.1-1.5 days (anaerobic sediment, OECD 308)
ti/2 = 0.66 days (anaerobic in sludge)
>015c)
Bioconcentration factor
(BCF)
8,974-18,100 (fish)
>015c)
Bioaccumulation factor
(BAF)
3,556,000 (estimated)
>012b)
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Properly or Knripoinl
Value"
References
Organic carbon:water
partition coefficient (log
Koc)
4.9
A. (2015-: ¦
aMeasured unless otherwise noted. Based on literature review described in (U.S. EPA. 2015c). Problem formulation
document httos://www.era.eov/sites/t>roduction/files/2015-09/documents/hbcd problem formulation.odf
HBCD is persistent in environmental media. HBCD is expected to be stable to hydrolysis and direct
photolysis. Measured aerobic biodegradation half-lives are on the order of months. Anaerobic
biodegradation may be more rapid but in anaerobic conditions, degradation is also slow with half-lives
on the order of days. HBCD is expected to sorb to particulates and sediments and has limited mobility in
soil. Low water solubility (66 ju.g/1), organic carbon:water partitioning (log Koc = 4.9) and limited
potential for aerobic and anaerobic biodegradation (tv2 of up to months) suggest that HBCD in
wastewater treatment plants (WWTPs) will associate with biosolids which may subsequently be land
applied.
HBCD has a low vapor pressure and Henry's law constant so is expected to have limited volatilization
from soils and water surfaces. However, in air, HBCD is expected to occur primarily associated with
particulates and exposure from dust and atmospheric particulates is likely. HBCD may undergo long-
range transport and particulate bound HBCD will be removed from the atmosphere by wet or dry
deposition, resulting in widespread occurrence in soil and water.
HBCD is highly bioaccumulative with BCF values of 8,974-18,100 indicating that consumption of
animal products from aquatic and terrestrial species (fish, meat, and dairy) may result in exposure from
bioaccumulation and trophic magnification. HBCD's estimated upper trophic level bioaccumulation
factor (BAF) is 3,556,000 indicating very high bioaccumulation potential. The model prediction was
obtained using the default settings of the EPI Suite (U.S. EPA. 2012c) BCFBAF module.
2.3.2 Releases to the Environment
Releases to the environment from conditions of use (e.g., industrial and commercial processes,
commercial or consumer uses resulting in down-the-drain releases) are one component of potential
exposure and may be derived from reported data that are obtained through direct measurement,
calculations based on empirical data and/or assumptions and models.
A source of information that EPA expects to consider in the risk evaluation in evaluating exposure are
data reported under the Toxics Release Inventory (TRI) program, however, TRI data are not yet
available for HBCD. Under the Emergency Planning and Community Right-to-Know Act (EPCRA)
Section 313 rule, HBCD is a TRI-reportable substance effective November 30, 2016. HBCD is
reportable beginning with the 2017 calendar year and has been assigned a 100-pound reporting
threshold. The first reporting forms from facilities are due by July 1, 2018.
There may be releases of HBCD from industrial sites to wastewater treatment plants (WWTP), surface
water, air and landfill ( 2.015c). Sawing of EPS or XPS foam during commercial and
consumer use results in release of HBCD to the environment and emissions of HBCD from EPS and
XPS foam and wear of these products result in release of HBCD during their service life (U.S. EPA.
2.015c). Disposal of EPS and XPS foam may result in releases to the environment as a result of
demolition of buildings or material that is left on or in the soil ( 15c).
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Articles that contain HBCD may release HBCD to the environment during use or through recycling and
disposal. Examples of HBCD releases that are more recently being explored in the literature include
release of HBCD from building materials through demolition (Duam et at.. 2016) and sorption of
suspended particles to clothing and transport down the drain during washing of textiles (Salmi et at..
2016V
EPA expects to review these data in conducting the exposure assessment component of the risk
evaluation for HBCD.
2.3.3 Presence in the Environment and Biota
Monitoring studies or a collection of relevant and reliable monitoring studies provide(s) information that
can be used in an exposure assessment. Monitoring studies that measure environmental concentrations
or concentrations of chemical substances in biota provide evidence of exposure.
Monitoring and biomonitoring data were identified in EPA's data search for HBCD.
Environment
HBCD has been widely detected in both the environment and biota. When considering monitoring
studies reported in risk assessments completed to date and monitoring studies reported to open literature,
there are hundreds of studies that have reported HBCD in various media ([HBCD (CASRN25637-99-4,
3194-55-6, 3194-57-8) Bibliography: Supplemental File for the TSCA Scope Document, EPA-HQ-
QPPT-2016-073 51: (NICNAS. 2.012b: EC/HC. 2011: EINECS. 2008V
HBCD has been detected in a wide variety of environmental media. Based on review of previously
completed assessments and EPA's problem formulation ( c), HBCD is expected to be
present at relatively higher levels in sediment, soil and indoor dust. HBCD is also expected to be present
in ambient air, indoor air and surface water at relatively lower levels. Physical-chemical properties
influence the fate and transport of HBCD between media. For example, EPA expects to consider
partitioning of HBCD to sediment within the water column and to suspended particles and dust in indoor
environments (Law et at.. 2014). HBCD has also been detected in remote areas as a result of long range
transport and in very close proximity to industrial sources and many sampling locations in between
(Law et at..: ).
EPA plans to evaluate and review available environmental monitoring data in the risk evaluation.
Biota
HBCD has the potential to both persist (1V2 of months or longer in some media) and bioaccumulate
(BCF = 9000 - 18,000) in the environment (UNEP. 2010). Once HBCD is present in the environment, it
is available for uptake by a variety of species, including humans. HBCD has been detected in human
milk, adipose tissue, blood and hair. HBCD has been detected in invertebrates, fish, birds, mammals and
plants. HBCD is also present in edible fish, plants, milk and other food sources, and there are existing
studies that quantify potential dietary exposures (NICNAS. 2012b: EC/HC. 2011: EINECS. 2008).
EPA plans to review available biomonitoring data in the risk evaluation.
2.3.4 Environmental Exposures
The manufacturing, processing, distribution, use and disposal of HBCD can result in releases to the
environment.
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Environmental exposures are informed by releases into the environment, overall persistence,
degradation, and bioaccumulation within the environment, and partitioning across different media. EPA
will evaluate exposures to aquatic and terrestrial organisms in aquatic and terrestrial environments. EPA
will evaluate food-chain relationships where appropriate.
2.3.5 Human Exposures
EPA plans to analyze occupational, consumer and general population exposures. Subpopulations,
including potentially exposed and susceptible subpopulations, within these exposed groups will also be
considered.
2.3.5.1 Occupational Exposures
EPA plans to analyze worker activities where there is a potential for exposure under the various
conditions of use described in Section 2.2.2. In addition, EPA may analyze exposure to occupational
non-users (i.e. workers, who do not directly handle the chemical but perform work in an area where the
chemical is present) depending on available information. When data and information are available to
support the analysis, EPA also expects to consider the effect(s) that engineering controls and/or personal
protective equipment have on occupational exposure levels.
EPA anticipates inhalation of dust and other respirable particles (for example, particulate generated by
hot wire cutting of EPS or XPS foam) as the most important HBCD exposure pathway for workers and
occupational non-users (U.S. EPA. 2.015c: NICNAS. 2.012b: ECHA. 2.009c: EINECS. 200%) however,
dermal exposure, may also occur when performing certain work activities.
Workers and occupational non-users may be exposed to HBCD when performing activities associated
with the conditions of use described in Section 2.2.2, including, but not limited to:
Repackaging or unloading containers of HBCD powder or pellets.
Handling, transporting and disposing waste containing HBCD.
Cutting EPS or XPS foam (e.g., at constructions sites).
Based on these activities, EPA expects to analyze inhalation exposure to particulates and dermal
exposure, including skin contact with particulates for workers and may also do so in the case of
occupational non-users depending on available information. EPA also expects to consider potential
worker exposure via the oral route such as from incidental ingestion of HBCD particulates that deposit
in the upper respiratory tract from inhalation exposure.
Occupational exposure limits for HBCD have not been established by the Occupational Safety and
Health Administration (OSHA), the American Conference of Government Industrial Hygienists
(ACGIH), or the National Institute of Occupational Safety and Health (NIOSH).
https://www.ncbi.nlm.nih.gov/books/NBK225635/
2.3.5.2 Consumer Exposures
Exposure routes for consumers using HBCD-containing products and bystanders (non-product users that
are incidentally exposed to the product or article, ( 017a)) may include inhalation of
suspended particulates, dermal exposure due to contact with articles, and ingestion of settled dust and
mouthing of articles.
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Consumer exposure to articles containing HBCD is somewhat different from consumer exposure to a
product where the chemical is consumed during its use and then discarded (for example, a can of spray
paint). HBCD is incorporated into articles that may be present during the entire useful life of the article
in microenvironments where consumers may be continually exposed until the article is disposed.
HBCD-containing articles (e.g., insulation, electronics products, plastic based products and textiles)
have relatively long service lives in comparison to other consumer products that are quickly used and
discarded. Indoor environments with elevated levels of HBCD in indoor air and dust may contain some
combination of articles containing HBCD.
The primary on-going consumer use of HBCD is within EPS and XPS insulation. In the 2015 Problem
Formulation and Initial Assessment of HBCD (U.S. EPA. 2.015c). EPA did not anticipate evaluating
EPS and XPS insulation as a stand-alone scenario and instead planned to analyze indoor exposures from
all sources of reported indoor air and dust concentrations. EPA will further analyze the source
contribution of EPS and XPS insulation to levels of HBCD in indoor air and dust. EPA will also assess
on-going uses of HBCD within automobile replacement parts. EPA plans to analyze uses of recycled
articles back into EPS and XPS insulation. EPA does not expect to consider recycled articles, where
those articles do not have intended flame retardant applications.
Inhalation and Oral
Consumer exposure to HBCD may include inhalation and ingestion exposure related to emissions of
HBCD from articles. Indoor air and indoor dust concentrations may vary based on the source strength of
emissions associated with the presence of articles. Emission from articles will vary based on the surface
area of the article present in the building, the weight fraction of HBCD within the article and building
characteristics such as air exchange and inter-zonal air flow. Based on the relatively high octanol: air
partition coefficient (Koa) and relatively low vapor pressure, HBCD emitted to indoor air is likely to
partition to suspended particles and settle to indoor dust rather than be emitted in its vapor phase. EPA
expects to further analyze ingestion of dust and inhalation of dust associated with conditions of use of
HBCD.
Dermal
Consumer exposure to HBCD may include dermal exposure related to direct skin contact with articles
containing HBCD. However, there are several factors to be considered and this is likely a relatively
minor pathway compared to dermal contact with dust. The contact duration, solubility and diffusivity of
HBCD within different articles, and contact surface area of skin all influence potential exposures
(EINECS. 2008). EPA expects to consider dermal exposure associated with use of HBCD in EPS and
XPS during installation and removal, contact with dust, and with recycled use applications.
There may be some consumers who may have greater exposure potential to HBCD such as:
Children or adults who spend time in microenvironments with elevated dust or indoor air
concentrations due to presence of multiple article which contain elevated levels of HBCD.
Children or adults who have elevated dermal contact with EPS/XPS insulation containing
HBCD.
EPA expects to analyze inhalation, dermal and oral exposures to consumers and bystanders associated
with the conditions of use by consumers.
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2.3.5.3 General Population Exposures
Wastewater/liquid wastes, solid wastes or air emissions of HBCD could result in potential pathways for
oral, dermal or inhalation exposure to the general population.
Inhalation
There is the potential for inhalation exposure to HBCD by breathing ambient air and indoor air. Ambient
air concentrations may vary by proximity to an industrial source, while indoor air concentrations are
discussed in the consumer exposure section. Based on the relatively high Koa and relatively low vapor
pressure, HBCD is expected to be present primarily in suspended particles in the air rather than in the
vapor phase.
Based on these potential sources and pathways of exposure, EPA expects to analyze inhalation
exposures of the general population to air/particulates containing HBCD that may result from the
conditions of use of HBCD.
Oral
The general population may ingest HBCD via several exposure pathways.
There is potential for oral exposure to HBCD by ingestion of dust and soil; drinking water and breast
milk; and edible aquatic and terrestrial biota (e.g., from fishing, hunting, gathering and farming). There
is a wide range of dust and soil monitoring data available. Dust concentrations vary widely across
different microenvironments and within microenvironments and are generally reported in the ng/g or
jug/g range (U.S. EPA. 2015c). Existing exposure assessments outside of the United States have
quantified dietary exposure from a variety of food sources and compared these values to other pathways
(Environment Canada. n, I 1 m v S. 2008).
EPA does not expect to further analyze exposures from drinking water sources. Exposures from drinking
water containing HBCD are possible, but are likely to be relatively lower than other oral exposure
pathways (Environment Canada. 2.011; EINECS. 2008). Drinking water monitoring data is generally
unavailable. There are existing data on HBCD concentrations in surface water which are relatively low,
below 1 ng/L. The physical-chemical and fate properties of HBCD, such as high sorption, low water
solubility, and high Koc indicate that concentrations of HBCD in drinking water would be expected to
be low prior to treatment. When sediment monitoring data is used with assumptions about Koc, organic
content and density of water and sediment, surface water concentrations can be estimated and are
generally below the highest levels reported in surface water (ECHA. 2016). These same physical-
chemical properties indicate that drinking water treatment processes would further reduce HBCD
concentrations in drinking water. Overall, the contribution to exposure to HBCD via drinking water is
expected to be low compared to other exposures.
Based on these potential sources and pathways of exposure, EPA expects to analyze oral exposures to
the general population that may result from the conditions of use of HBCD.
Dermal
There is potential for dermal exposure to HBCD through contact with dust and soil containing HBCD.
Dermal exposure is likely to vary based on the contact time with the material, the concentration of
HBCD and properties of HBCD that influence dermal absorption (EINECS. 2008).
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Based on these potential sources and pathways of exposure, EPA expects to analyze dermal exposures to
the general population that may result from the conditions of use of HBCD.
2.3.5.4 Potentially Exposed or Susceptible Subpopulations
TSCA 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,
workers, or the elderly." General population is "the total of individuals inhabiting an area or making up a
whole group" and refers here to the U.S. general population ( 011).
As part of the Problem Formulation, EPA identified potentially exposed and susceptible subpopulations
for further analysis during the development and refinement of the life cycle, conceptual models,
exposure scenarios, and analysis plan. In this section, EPA addresses the potentially exposed or
susceptible subpopulations identified as relevant based on greater exposure. EPA will address the
subpopulations identified as relevant based on greater susceptibility in the hazard section.
Of the human receptors identified in the previous sections, EPA identifies the following as potentially
exposed or susceptible subpopulations due to their greater exposure that EPA expects to consider in the
risk evaluation:
Workers and occupational non-users.
Consumers and bystanders associated with consumer use. HBCD has been identified as being
used in products available to consumers; however, only some individuals within the general
population may use these products. Therefore, those who do use these products are a potentially
exposed or susceptible subpopulation due to greater exposure.
Other groups of individuals within the general population who may experience greater exposures
due to their proximity to conditions of use identified in Section 2.2 that result in releases to the
environment and subsequent exposures (e.g., individuals who live or work near manufacturing,
processing, distribution, use or disposal sites).
There are some reasonably likely exposure scenarios where greater exposure from multiple sources may
occur. There may be some individuals who have greater potential for exposure to HBCD such as:
Children who spend time in microenvironments with elevated dust concentrations.
Breast-fed infants where concentrations of breast milk containing HBCD are elevated.
Children or adults who ingest soil or sediment in environments where HBCD concentrations are
elevated.
Children or adults who consume edible aquatic biota or terrestrial biota containing elevated
levels of HBCD.
In developing exposure scenarios, EPA will analyze available data to ascertain whether some human
receptor groups may be exposed via exposure pathways that may be distinct to a particular
subpopulation or lifestage (e.g., children's crawling, mouthing or hand-to-mouth behaviors) and whether
some human receptor groups may have higher exposure via identified pathways of exposure due to
unique characteristics (e.g., activities, duration or location of exposure) when compared with the general
population (U.S. EPA. 2.006a).
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In summary, in the risk evaluation for HBCD, EPA plans to analyze the following potentially exposed
groups of human receptors: workers, occupational non-users, consumers, bystanders associated with
consumer use. As described above, EPA may also identify additional potentially exposed or susceptible
subpopulations that will be considered based on greater exposure.
2.4 Hazards (Effects)
For scoping, EPA conducted comprehensive searches for data on hazards of HBCD, as described in
Strategy for Conducting Literature Searches for HBCD: Supplemental File for the TSCA Scope
Document (EPA-HQ-QPPT-2016-0735) (U.S. EPA. 2017f). Based on initial screening, EPA plans to
analyze the hazards of HBCD identified in this problem formulation document. However, when
conducting the risk evaluation, the relevance of each hazard within the context of a specific exposure
scenario will be judged for appropriateness. For example, hazards that occur only as a result of chronic
exposures may not be applicable for acute exposure scenarios. This means that it is unlikely that every
identified hazard will be analyzed for every exposure scenario.
2.4.1 Environmental Hazards
For scoping purposes, EPA consulted the sources of environmental hazard data for HBCD found in
Table 2-6. However, EPA also expects to consider other studies (e.g., more recently published,
alternative test data) that have been published since these reviews, as identified in the literature search
conducted by the Agency for HBCD [HBCD (CASRN25637-99-4, 3194-55-6, 3194-57-8)
Bibliography: Supplemental File for the TSCA Scope Document, EPA-HO-OPPT-2Q16-07351. Only the
on-topic references listed in the Ecological Hazard Literature Search Results were considered as
potentially relevant data/information sources for the risk evaluation. Inclusion criteria were used to
screen the results of the ECOTOX literature search (as explained in the Strategy for Conducting
Literature Searches for HBCD: Supplemental File for the TSCA Scope Document (EPA-HQ-OPPT-
2016-0735) (U.S. EPA. 201 If). Data from the screened literature are summarized below (Table 2-6)as
ranges (min-max). EPA plans to review these data/information sources during risk evaluation using the
data quality review evaluation metrics and the rating criteria described in the Application of Systematic
Review in TSCA Risk Evaluations ( )18).
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Table 2-6. Summary of Aquatic and Sediment Environmental Hazard Information for HBCD
Test Organism
Duration
llndpoinl
lla/ard
Value
F.ITccl Tjpe
I nils
Reference
Aquatic Organisms
Fish
Acute
LC50
0.0025 - >100
mortality
mg/L
("WILDLIFE
INTERNATIO
19971 (Calmbacher.
1978)
Chronic
NOEC
0.0037 - <500
growth and
reproduction
mg/L
(Zhang et aL 2008;
Drottar and Krueger.
2000)
LOEC
0.1
DNA damage
mg/L
(Zhang et aL 2008)
MATC
>0.032
Larvae
malformations
mg/L
(Hong et aL 2014)
Invertebrates
Acute
EC50
>0.0032 - 146
immobility
mg/L
(Wildlife I nil LTD. 1997;
BASF. 1990)
Chronic
NOEC
0.0031
growth and
reproduction
mg/L
(Drottar and Krueger.
1998)
LOEC
0.0056-0.1
Growth; gill
degeneration
mg/L
(Smolarz and Berger.
2009; Drottar and
MATC
0.0042
growth
mg/L
(Drottar and Krueger.
1998)
Plants
Chronic
EC50
0.009 - >500
Growth;
mg/L
(Walsh et aL. 1987);
MATC
0.01
mg/L
(BASF CORP. 1990)
Amphipod
NOEC
100 - 1,000
No effect
mentioned in
Thomas paper
mg/kg dwt
(Thomas et al.. 2003a. b)
for both ends of range
LOEC
500
Survival
mg/kg dwt
(Thomas et aL. 2003a. b)
Oligochaetes
NOEC
3.1
population
mg/kg dwt
(Oetken et aL, 2001)
LOEC
28.7
population
mg/kg dwt
(Oetken et aL, 2001)
MATC
15.4 (normalized)
population
mg/kg dwt
(Oetken et aL, 2001)
Terrestrial Organisms
Avian
Chronic
LOEC
125
reduction in
hatchability
Hg/L
(MOEJ. 2009)
15
reduced chick
mg/L
2.1
survival
mg/kg/day
5
mg/L
LOEC
164.3
reduced
corticosterone
ng/g wet
weight of egg
(Kobiliris. 2010)
response in male
nestling kestrels,
reduced flying
activities in
juvenile males,
delayed response
time to predator
avoidance in
juvenile females
Earthworm
Chronic
EC10
21
reproduction
mg/kg/dwt.
(Aufderheide et aL, 2003)
NOEC
128
Plants
Chronic
NOEC
>5,000
Not reported
mg/kg/dwt
(Porch et aL, 2002)
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EPA expects to analyze the hazards of HBCD to aquatic organisms including fish, aquatic invertebrates,
aquatic plants and sediment invertebrates exposed to relevant media under acute and chronic exposure
conditions. Based on the assessments mentioned above, there was acute toxicity to aquatic invertebrates
from HBCD, based on mortality and immobilization. Chronic toxicity to aquatic invertebrates (growth
and reproduction) was observed when exposed to HBCD. Chronic toxicity was observed in sediment
dwelling organisms based on reduced survivability when exposed to HBCD.
EPA expects to analyze the hazards of HBCD to terrestrial organisms including soil invertebrates and
avian species exposed to relevant media under acute and chronic exposure conditions. Based on
previous assessments, chronic toxicity to terrestrial invertebrates (reproduction) was observed when
exposed to HBCD. Also, toxicity to avian species was observed, based on reduced hatchability and
survival, when exposed to HBCD.
2.4,2 Human Health Hazards
The human health hazard of HBCD has been examined in several publications (U.S. EPA. 2016c. 2014a.
d; NICNAS. 2012b: Environment Canada. 2011; EINECS. 200V ^ i ^ 2008; OECD. 2007b). EPA
expects to consider potential human health hazards associated with HBCD. Based on reasonably
available information, the following sections describe the hazards EPA expects to further analyze.
HBCD does not have an existing EPA IRIS Assessment; however, as part of a coordinated agency
effort, in the TRI Technical Review of HBCD (U.S. EPA. 2016c). the TSCA Work Plan Problem
Formulation and Initial Assessment, (U.S. EPA. 2015c). and Preliminary Materials for the IRIS
Toxicological Review of HBCD (I r { V \ i.V I -1» I), non-cancer health hazards of HBCD were compiled
and reviewed, including: acute toxicity, liver toxicity, thyroid toxicity, reproductive/developmental
toxicity, neurotoxicity, immunotoxicity, sensitization and irritation. EPA relied heavily on this
comprehensive review in preparing this Problem Formulation. EPA also expects to evaluate other
studies (e.g., more recently published, alternative test data) that have been published since these reviews
during the analysis phase of the risk evaluation, as identified in the literature search conducted by the
Agency for HBCD [HBCD (CASRN25637-99-4, 3194-55-6, 3194-57-8) Bibliography: Supplemental
File for the TSCA Scope Document, EPA-HO-OPPT-2Q16-073 51. EPA expects to use these previous
analyses as a starting point for identifying key and supporting studies to inform the human health hazard
assessment, including dose-response analysis. The relevant studies will be evaluated using the data
quality criteria in the Application of Systematic Review in TSCA Risk Evaluations document (l__S
2018).
2.4.2.1 Non-Cancer Hazards
Acute Toxicity
Animal studies have observed potential neurological effects and clinical signs of toxicity including death
following high-dose acute administration of HBCD ( ).
Liver Toxicity
Increased liver weight has been observed in multiple laboratory animal studies, in both sexes, across
species and following both adult and developmental exposures. In mice, HBCD exposure induced
evidence of inflammatory changes in the liver and hepatic fatty changes (steatosis) in animals with a
high-fat diet ( ).
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Thyroid Toxicity
Human epidemiological studies have reported potential effects of HBCD on thyroid hormones. Animal
toxicity studies provide stronger evidence of thyroid perturbation associated with HBCD exposure,
including altered levels of thyroid hormones, histological changes and increased thyroid weight, with
effects observed across multiple lifestages, sexes, species and exposure durations ( 014d).
Reproductive/Developmental Toxicity
For female reproductive effects, there is some rodent evidence that HBCD may alter fertility and
pregnancy outcomes as well as reduce the number of mature and developing follicles in the ovary;
however, effects on reproductive organ weight are inconsistent. The potential for HBCD to affect the
female reproductive system has not been investigated in humans. For male reproductive effects, there is
some epidemiological support of an association between HBCD exposure and altered serum testosterone
and sex hormone binding globulin (SHGB) levels; however, animal studies did not report any effects on
male reproductive organ weights, reproductive development, hormone concentrations or spermatogenic
measures. There is mixed epidemiological data on developmental toxicity of HBCD, while animal
toxicity studies suggest that early life exposure to HBCD at high doses can affect various developmental
outcomes, including reduced offspring viability, decrements in pup weight and alterations in eye
opening (U.S. EPA. 2014dY
Neurotoxicity
There is an absence of a strong association between HBCD exposure and developmental neurotoxicity in
various neuropsychological domains observed in the limited epidemiological studies that are available;
however, there is evidence of potential developmental neurotoxicity in rodents. Perinatal HBCD
exposure was shown to alter neurodevelopmental milestones while eliciting changes in locomotor
activity and executive function that persisted into adulthood. HBCD exposure also appears to affect
other neurological endpoints related to changes in auditory sensitivity, dopamine system function and
brain weight in multiple studies. Effects on neurodevelopmental endpoints were observed in both sexes
and across a wide range of doses and exposure durations. However, there is currently not any substantial
evidence to support concern for neurotoxicity when exposure is limited to adulthood ( ).
Immunotoxicity
The effects of HBCD on both functional and structural immune endpoints have been evaluated in animal
models. Overall, immunological effects from HBCD exposure are variable and inconsistent across
studies for endpoints such as immune organ weights, hematology or histopathology (U.S. EPA. 2014d).
and its relevance to the risk evaluation will require further evaluation.
Sensitization/Irritation
There is limited information available suggesting potential mild irritation and sensitizing potential of
HBCD (U.S. EPA. 2015cY
2.4.2.2 Genotoxicity and Cancer Hazards
Available data suggest that HBCD is not genotoxic. Existing assessments have also concluded, based on
genotoxicity information and a limited lifetime study, that HBCD is not carcinogenic (NICNAS. 2012b;
EINECS. 2008; TemaNord. 2008; OECD. 2007b). Although the current data does not appear to provide
sufficient evidence that HBCD is carcinogenic, EPA will further evaluate genotoxicity and other cancer
hazards in the risk evaluation as part of a systematic review.
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2.4.2.3 Potentially Exposed or Susceptible Subpopulations
TSCA requires that the determination of whether a chemical substance presents an unreasonable risk
include consideration of unreasonable risk to "a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation" by EPA. TSCA § 3(12) states that "the term 'potentially
exposed or susceptible subpopulation' means a group of individuals within the general population
identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at
greater risk than the general population of adverse health effects from exposure to a chemical substance
or mixture, such as infants, children, pregnant women, workers, or the elderly." In developing the hazard
assessment, EPA will evaluate available data to ascertain whether some human receptor groups may
have greater susceptibility than the general population to the chemical's hazard(s).
2.5 Conceptual Models
EPA risk assessment guidance ( , ), defines Problem Formulation as the part of the
risk assessment framework that systematically identifies the factors to be considered in the assessment.
It draws from the regulatory, decision-making and policy context of the assessment and informs the
assessment's technical approach.
A conceptual model describes the actual or predicted relationships between the chemical substance and
receptors, either human or environmental. These conceptual models are integrated depictions of the
conditions of use, exposures (pathways and routes), hazards and receptors. The initial conceptual models
describing the scope of the assessment for HBCD, have been refined during problem formulation. The
changes to the conceptual models in this problem formulation are described along with the rationales.
In this section EPA outlines those pathways that will be included and further analyzed in the risk
evaluation; will be included but will not be further analyzed in the risk evaluation; and will not be
included in the TSCA risk evaluation and the underlying rationale for these decisions.
EPA determined as part of problem formulation that it is not necessary to conduct further analysis on
certain exposure pathways that were identified in the HBCD Scope Document and that remain in the risk
evaluation. Each risk evaluation will be "fit-for-purpose," meaning not all conditions of use will warrant
the same level of evaluation and the Agency may be able to reach some conclusions without extensive
or quantitative risk evaluations. 82 FR 33726, 33734, 33739 (July 20, 2017).
As part of this problem formulation, EPA also identified exposure pathways under regulatory programs
of other environmental statutes, administered by EPA, which adequately assess and effectively manage
exposures and for which long-standing regulatory and analytical processes already exist, i.e., the Safe
Drinking Water Act (SDWA), the Clean Water Act (CWA) and the Resource Conservation and
Recovery Act (RCRA). OPPT worked closely with the offices within EPA that administer and
implement the regulatory programs under these statutes. In some cases, EPA has determined that the
chemicals present in various media pathways (i.e., air, water, land) fall under the jurisdiction of existing
regulatory programs and associated analytical processes carried out under other EPA-administered
statutes and have been assessed and effectively managed under those programs. EPA believes that the
TSCA risk evaluation should generally focus on those exposure pathways associated with TSCA
conditions of use that are not adequately assessed and effectively managed under the regulatory regimes
discussed above because these pathways are likely to represent the greatest areas of risk concern. As a
result, EPA does not expect to include in the risk evaluation certain exposure pathways identified in the
HBCD Scope Document.
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2.5.1 Conceptual Model for Industrial and Commercial Activities and Uses: Potential
Exposures and Hazards
The revised conceptual model (Figure 2-2) illustrates the pathways of exposure from industrial and
commercial activities and uses of HBCD that EPA plans to evaluate. There are exposures to workers and
occupational non-users via the inhalation and oral routes and to workers via the dermal route during
processing and use for the conditions of use identified in this problem formulation.
The industrial and commercial activities/uses that EPA expects to consider are those that are conditions
of use. As discussed in Section 2.2.2.2, these activities include importation of HBCD; compounding of
XPS master batch; manufacture of XPS; manufacture of EPS; manufacture of SIPs; manufacture of
automobile replacement parts; and use of XPS, EPS, and SIPs in construction.
EPA expects to further analyze pathways and routes of exposure that may occur during repackaging,
processing steps (i.e., plastics compounding; plastics converting and SIP assembly; recycle of EPS), use
(i.e., installation/reuse/demolition of EPS/XPS foam) and disposal (i.e., handling of wastes) including:
Inhalation of dust containing HBCD by workers and occupational non-users. EPA expects this
to be an important exposure route for workers and occupational non-users (U.S. EPA. 2015c).
Dermal exposure to HBCD solids by workers that may occur as a result of handling particulate
solids (QE 15: EINECS. 20081
Ingestion of HBCD by workers and occupational non-users from ingestion of dust that deposits
in the upper respiratory tract and is swallowed.
EPA does not plan to further analyze exposure to liquid. Based on information from the 2016 CDR, all
importers reported solid physical forms of HBCD and therefore, worker and non-occupational user
exposure to liquid HBCD is not expected.
For each condition of use identified in Table 2-3 a determination was made as to whether or not each
unique combination of exposure pathway, route, and receptor will be further analyzed in the risk
evaluation. The results of that analysis along with the supporting rationale are presented in Appendix C.
Waste Handling, Treatment and Disposal
Figure 2-2 shows that waste handling, treatment and disposal is expected to lead to the same pathways
as other industrial and commercial activities and uses. The path leading from the "Waste Handling,
Treatment and Disposal" box to the "Hazards Potentially Associated with Acute and/or Chronic
Exposures" box was re-routed to accurately reflect the expected exposure pathways, routes, and
receptors associated with these conditions of use of HBCD.
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INDUSTRIAL AND COMMERCIAL
ACTIVITIES /USES
EXPOSURE PATHWAY
EXPOSURE ROUTE
RECEPTORS3
HAZARDS
Import of HBCD
Incorporated into Formulation,
Mixture, or Reaction Product:
compounding of XPS
masterbatch
Incorporated into Article:
manufacture of XPS/EPS,
manufacture of SIPs and
automobile replacement parts
from XPS/EPS
Recycling
Dust
Emissions 0
Liquid Contact
Solid Contact
Indoor Air
I
Outdoor Air
(see Emissions to Air,
Figures 2-4a and 2-4b)
Occupational
Non-Users
Dermal
Workers b
Workers
Inhalation
N Occupational
Non-Users
Hazards Potentially Associated with
Acute and/or Chronic Exposures
Building/Construction Materials
Dust emissions from
product installation,
reuse, and demolition.
.
.
Waste
Treatment
andling,
nd Disposal
Liquid Contact
Solid Contact, Dust
¦-K
Occupational
Non-Users
Dermal, Oral,
Inhalation
Workers
Occupational
\ Non-Users
Wastewater, Solid Wastes, Air Emissions
(see Figures 2-4a and 2-4b)
KEY:
Black Text: Included in risk evaluation and will be further analyzed.
Gray Text: Included in risk evaluation, but will not be further analyzed
~ Pathways that will be further analyzed.
^ Pathways that will not be further analyzed.
Figure 2-2. HBCD 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 of HBCD.
a Receptors include potentially exposed or susceptible subpopulations (see Section 2.3.5.4).
b When data and information are available to support the analysis, EPA also considers the effect that engineering controls and/or personal
protective equipment have on occupational exposure levels.
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2.5.2 Conceptual Model for Consumer Activities and Uses: Potential Exposures and
Hazards
Figure 2-3 presents the conceptual model for human receptors from consumer uses of HBCD. This
conceptual model has been modified to indicate the exposure pathways that will and will not be further
analyzed. More detailed information can be found in Appendix D.
EPA expects to consider certain conditions of use related to consumer uses. As described in Section
2.2.2.2, these uses include building and construction materials.
HBCD is present in consumer articles, many of which are found in indoor environments such as the
home. The service-life of articles will vary based on the type of article (e.g., textile, electronics,
structural insulation panel) but are expected to range from months to years. Service-life is defined as the
length of time an article or consumer good is used before it is disposed of or recycled. Over this period
of time, there is potential for long-term continuous low-level releases which may contribute to levels of
HBCD found within indoor dust and air. These articles may be recycled and reintroduced into the indoor
environment at the end of their service-life. HBCD within indoor air is expected to be present primarily
as a particulate, rather than a vapor. Depending on recycling/reuse patterns and processes for different
types of articles, HBCD may continue to be present within articles for another service life of the
recycled or reused product.
Figure 2-3 illustrates exposure pathways for consumers from consumer uses of HBCD. EPA expects to
analyze pathways and routes of exposure that may occur during use or disposal of building and
construction materials or recycled products including:
Ingestion of suspended or settled dust containing HBCD by consumers and bystanders.
Ingestion of suspended dust may occur by inhalation of dust that deposits in the upper
respiratory tract and is swallowed. Ingestion of settled dust may occur via hand to mouth
behavior.
Inhalation of suspended dust containing HBCD by consumers and bystanders. EPA expects this
to be an important route of exposure.
Dermal exposure to HBCD solids by consumers that may occur as a result of handling of
articles or dermal contact with dust.
The primary route of exposure for consumers to HBCD is via ingestion of suspended or settled dust.
This will be evaluated for both EPS/XPS insulation and for replacement automobile parts. Oral exposure
related to mouthing of articles is not expected for the primary ongoing use of HBCD in EPS/XPS
insulation. Ingestion of dust via hand to mouth behavior may also occur. Younger children (e.g., infants
and toddlers) may be susceptible receptors due to higher dust ingestion rates and higher frequency and
duration of hand and object to mouth contact, when compared to older children and adults.
Inhalation of suspended dust may also occur from abraded particles or resuspended settled dust and this
will be further analyzed.
Dermal exposure to consumers from HBCD containing articles may occur during contact with dust and
handling of articles. The potential for HBCD to absorb dermally under different conditions, will be
further analyzed during risk evaluation.
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The primary routes of exposure resulting from consumer handing of disposal of waste is inhalation and
oral ingestion of suspended particulate including dust. Under some conditions such as renovation of a
home, it is possible that abraded dust from articles, such as structural insulation panels, could result in
elevated levels of dust compared to those typically found in monitoring studies. Renovation and
abrasion of dust will be further analyzed during risk evaluation as part of an EPS/XPS exposure scenario
rather than as a stand-alone consumer handling and disposal of waste scenario.
EPA does not plan to further analyze liquid contact to HBCD for consumers or bystanders as HBCD is
incorporated into articles in the solid form.
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CONSUMER ACTIVITIES / USES EXPOSURE PATHWAY EXPOSURE ROUTE RECEPTORS3 HAZARDS
Wastewater, Solid Wastes
(See Figures 2-4a and 2-4b)
r Consumers /
General Population;
v Bystanders .
Dermal
Oral
Solid, Liquid Contact
Consumer Handling and
Disposal of Waste
Solid Wastes and
Recycling
Reused-recycled EPS
and XPS
Automobile
Replacement Parts
Hazards Potentially Associated with
Acute and/or Chronic Exposures
Building/Construction
Materials-Primary
(building panels)
Indoor Air, Settled and
Suspended Dust
(in buildings and
automobiles)
KEY:
Black Text: Included in risk evaluation and will be further analyzed.
Gray Text: Included in risk evaluation, but will not be further analyzed
> Pathways that will be further analyzed.
~ Pathways that will not be further analyzed.
Figure 2-3. HBCD Conceptual Model for Consumer Activities and Uses: Consumer Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human receptors from consumer activities and uses
HBCD.
a Receptors include potentially exposed or susceptible subpopulations (see Section 2.3.5.4).
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2.5.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures
and Hazards
The revised conceptual models (Figure 2-4a and Figure 2-4b) illustrate the expected exposure pathways
to human and ecological receptors from environmental releases and waste streams associated with
industrial and commercial activities for HBCD that EPA expects to include in the risk evaluation. The
pathways that EPA plans to include and analyze further in the risk evaluation are described in Section
2.5.3.1 and are shown in the conceptual models. The pathways that EPA plan to include in the risk
evaluation but not further analyze are described in Section 2.5.3.2 and the pathways that EPA does not
expect to include in risk evaluation are described in Section 2.5.3.3.
2.5.3.1 Pathways that EPA Plans to Include and Further Analyze in Risk
Evaluation
Pathways that EPA expects to further analyze include:
Emissions to air: The general population including populations and ecological receptors living
near industrial and commercial facilities processing, using or disposing of HBCD may be
exposed via inhalation of suspended HBCD particulate in the ambient air from fugitive or stack
emissions; and ingestion of HBCD from uptake from the environment into food sources (via
indirect deposition into water bodies or soil).
Releases to surface water (and sediment): The general population including populations living
near industrial and commercial facilities processing, using or disposing of HBCD may be
exposed by incidental ingestion of surface water and suspended particulates and by ingestion of
HBCD from uptake (via direct or indirect deposition into water bodies or soil) from the
environment into food sources. Aquatic and terrestrial ecological receptors may also be directly
exposed due to proximity to surface water and sediment.
Biosolid application to soil from wastewater: Ecological receptors and the general population
including populations living near industrial and commercial facilities processing, using or
disposing of HBCD may be exposed by incidental soil ingestion or uptake from the environment
into food sources, particularly for backyard fruit and vegetable gardens near facilities.
HBCD has a relatively low water solubility (66 ug/L) and high log Koc (4.9) and tends to sorb to solids
in surface water, groundwater and wastewater. It is resistant to aerobic biodegradation (ty2= months) and
hydrolysis; therefore, it is not degraded during wastewater treatment and will tend to associate with
sludge. If land applied, treated biosolids will transfer HBCD to soil where it will be taken up by biota
and bioaccumulate in the terrestrial and human food chain. From soil, it may be transported to surface
water by runoff and particulate erosion and be taken up by and bioaccumulate in aquatic species.
Emissions to air are also expected to occur and a long vapor (tv2 > days) and particulate phase half-life
indicates that long range transport can occur. Deposition to soil and water from air may also lead to
HBCD concentrations in soil and water far from the source location.
As HBCD is bioaccumulative (estimated BAF of 3,556,000, see Table 2-5), oral exposure via ingestion
of food items such as fish, meat, eggs, dairy products and plants are expected. The primary route of
exposure for the general population is expected to be via ingestion of terrestrial biota and aquatic biota.
There may be additional oral exposure to young children from ingestion of breast milk and from indoor
dust exposure.
As shown in Figure 2-4a, EPA anticipates that the general population living near industrial and
commercial facilities processing, using or disposing of HBCD may be exposed via several pathways. As
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HBCD is persistent and bioaccumulative, releases to the environment from industrial or commercial
activities are expected to result in exposures to human receptors via inhalation, ingestion of water, breast
milk and edible aquatic and terrestrial biota (e.g., from fishing, hunting, gathering, farming).
Releases of HBCD to the environment from industrial or commercial activities may also result in
exposure to aquatic and terrestrial life via contaminated water, sediment or soil as shown in Figure 2-4b.
Trophic magnification may result in greater exposure following bioaccumulation. Based on the potential
for bioaccumulation, it is expected that terrestrial species will also be exposed to HBCD via the food
chain.
Air Pathways
Particulate-associated HBCD may result in transport and subsequent inhalation exposure. This is not
expected to be a primary route of exposure although those living near a facility which release HBCD
may experience higher levels of exposure than the general population. Atmospheric transport and off-
site deposition may also contribute to low levels of contamination away from the release location which
may contribute to environmental bioaccumulation from water and soil.
Water Pathways
Currently, no states or tribes include criteria for HBCD in water quality standards and values are not
available for use in NPDES permits. Thus, EPA cannot conclude that risk to human health and aquatic
life from exposure to HBCD in ambient waters has been effectively managed. As a result, this pathway
will undergo risk evaluation under TSCA. EPA may publish CWA section 304(a) human health or
aquatic life criteria for HBCD in the future if it is identified as a priority under the CWA.
Biosolids Pathways
This pathway will undergo risk evaluation under TSCA.
Disposal Pathways
HBCD or HBCD containing articles may be disposed of in construction and demolition waste landfills
by commercial and consumer users. Land disposal of HBCD in EPS/XPS building materials (e.g.
insulation) is expected to be the primary disposal pathway for these materials and is likely to occur at
construction and demolition landfills.
2.5.3.2 Pathways that EPA Plans to Include in the Risk Evaluation but Not
Further Analyze
Drinking Water Pathways
Exposures from drinking water containing HBCD are possible, but are likely to be relatively lower than
other oral exposure pathways (Environment Canada. 2011; EINECS. 2008). Drinking water monitoring
data is generally unavailable. There are existing data on HBCD concentrations in surface water which
are relatively low, below 1 |ig/L. The physical-chemical and fate properties of HBCD, such as high
sorption, low water solubility, and high Koc indicate that concentrations of HBCD in drinking water
would be expected to be low prior to treatment. When sediment monitoring data is used with
assumptions about Koc, organic content and density of water and sediment, surface water concentrations
can be estimated and are generally below the highest levels reported in surface water (ECHA. 2.016).
These same chemical and fate properties would indicate that drinking water treatment processes would
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further reduce HBCD concentrations in finished drinking water. Overall, the contribution to exposure to
HBCD via drinking water is expected to be low compared to other exposures.
Direct or indirect discharge of wastewater to surface water may occur and runoff from land application
fields may transport HBCD into surface water. Leaching to groundwater is expected to be limited by
low water solubility and high sorption potential. HBCD has a relatively low water solubility and will
tend to sorb to solids in surface and groundwater. It is expected to be removed by water treatment and
exposure to the general population via drinking water is expected to be low. HBCD will tend to sorb to
subsurface soils. Reductive de-bromination may result in subsurface degradation with ti/2 of months or
longer. HBCD may migrate to groundwater but exposure via this pathway may be limited.
2.5.3.3 Pathways that EPA Does Not Expect to Include in the Risk Evaluation
Exposures to receptors (i.e. general population, terrestrial species) may occur from industrial and/or
commercial uses, industrial releases to air, water or land, and other conditions of use. As described in
Section 2.5, EPA does not expect to include in the risk evaluation pathways under programs of other
environmental statutes, administered by EPA, which adequately assess and effectively manage
exposures and for which long-standing regulatory and analytical processes already exist. These
pathways are described below.
Disposal Pathways
Because HBCD is not classified as a RCRA hazardous waste, wastes are not expected to be sent to
Subtitle C incinerators, due to the higher cost of such incineration as compared with MSW or other
incinerators; therefore emissions from hazardous waste incinerators will not be included in the risk
evaluation. 40 CFR 264.345 specifies performance standards for hazardous waste incinerators. An
incinerator burning hazardous waste must achieve a destruction and removal efficiency (DRE) of
99.99% for each principal organic hazardous constituent. Furthermore, RCRA provisions for site-
specific risk assessments and the Hazardous Waste Combustor maximum achievable control technology
(MACT) rule provisions for a Residual Risk and Technology Review together cover risks for RCRA
hazardous wastes.
EPA does not expect to include on-site releases to land that go to underground injection in its risk
evaluation. Environmental disposal of HBCD injected into Class I well types are presumed to be
managed and prevented from further environmental release by RCRA and SDWA regulations.
Therefore, disposal of HBCD via underground injection is not likely to result in environmental and
general population exposures.
EPA does not expect to include on-site releases to land that go to RCRA Subtitle C hazardous waste
landfills. Design standards for Subtitle C landfills require double liner, double leachate collection and
removal systems, leak detection system, run on, runoff, and wind dispersal controls, and a construction
quality assurance program. They are also subject to closure and post-closure care requirements including
installing and maintaining a final cover, continuing operation of the leachate collection and removal
system until leachate is no longer detected, maintaining and monitoring the leak detection and
groundwater monitoring system. Subtitle C landfill operators are required to implement an analysis and
testing program to ensure adequate knowledge of waste being managed, and to train personnel on
routine and emergency operations at the facility. Hazardous waste being disposed in Subtitle C landfills
must also meet RCRA waste treatment standards before disposal. Given these controls, general
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population exposure to HBCD in groundwater from Subtitle C landfill leachate is not expected to be a
significant pathway.
EPA does not expect to include on-site releases to land from RCRA Subtitle D municipal solid waste
landfills (MWSLFs), other than for construction and demolition wastes as described in Section 2.3.5.1.
While permitted and managed by the individual states, municipal solid waste landfills (MSWLFs) are
required by federal regulations to implement many of the same requirements as Subtitle C landfills.
MSWLFs must have a liner system with leachate collection and conduct groundwater monitoring and
corrective action when releases are detected. MSWLFs are also subject to closure and post-closure care
requirements, as well as providing financial assurance for funding of any needed corrective actions.
MSWLFs have also been designed to allow for the small amounts of hazardous waste generated by
households and very small quantity waste generators (less than 100 kg per month).
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RELEASESAND WASTES FROM EXPOSURE PATHWAY EXPOSURE ROUTE RECEPTORS'1 HAZARDS
INDUSTRIAL/ COMMERCIAL / CONSUMER USES
Drinking
Water
Direct
discharge
Water8
Industrial Pre-Treatment or
Industrial WWT
Sediment
Aquatic Biota
Indirect
Wastewater
or Liquid Waste
POTW
liosolids
Breast Milk
si
U
Oral
Terrestrial
Biota
Soil
Hazards Potentially Associated with
Acute and/or Chronic Exposures
General
Population
Dermal
Disposal
(e.g.. Construction and
Demolition Waste)
Inhalation
Solid Wastes
Air
KEY:
Black Text: Included in risk evaluation and will be further analyzed.
Gray Text: Included in risk evaluation, but will not be further analyzed
~ Pathways that will be further analyzed.
~ Pathways that will not be further analyzed.
Emissions to Air
Figure 2-4a. HBCD Conceptual Model for Environmental Releases and Wastes: General Population Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human receptors from releases and wastes from
industrial and commercial uses of HBCD.
a Industrial wastewater or liquid wastes may be treated on-site and then released to surface water (direct discharge), or pre-treated and released to POTW
(indirect discharge). For consumer uses, such wastes may be released directly to POTW (i.e., down the drain). Drinking water will undergo further
treatment in drinking water treatment plant. Ground water may also be a source of drinking water.
b Receptors include potentially exposed or susceptible subpopulations (see Section 2.3.5.4).
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RELEASES AND WASTES FROM EXPOSURE PATHWAY RECEPTORS HAZARDS
INDUSTRIAL / COMMERCIAL / CONSUMER USES
Direct
discharge
Water 8
Sediment
rW
Indirect
discharge
Biosolids
Terrestrial
Species
Soil
Air
Emissions to Air
POTW
Wastewater
or Liquid Waste
Industrial Pre-Treatment
or Industrial WWT
Disposal
(e.gv Construction and
Demolition Waste)
Hazards Potentially Associated
with Acute and/or Chronic
Exposures
KEY:
BlackText: Included in risk evaluation and will be further analyzed.
~ Pathways that will be further analyzed.
Figure 2-4b. HBCD Conceptual Model for Environmental Releases and Wastes: Ecological Exposures and Hazards
The conceptual model presents the exposure pathways and hazards for environmental receptors from industrial and commercial uses of
HBCD.
a Industrial wastewater or liquid wastes may be treated on-site and then released to surface water (direct discharge), or pre-treated and released to POTW
(indirect discharge). For consumer uses, such wastes may be released directly to POTW (i.e., down the drain).
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2.6 Analysis Plan
The analysis plan presented here is a refinement of the initial analysis plan that was published in the
Scope of the Risk Evaluation for HB( ( j_7e).
The analysis plan is based on the conditions of use of HBCD, as described in Section 2.2 of this problem
formulation. EPA is implementing systematic review approach and/or methods to identify, select, assess,
integrate and summarize the findings of studies supporting the TSCA risk evaluation. The analytical
approaches and considerations in the analysis plan are used to frame the scope of the systematic review
activities for this assessment. The supplemental documents, Application of Systematic Review in TSCA
Risk Evaluations (U.S. EPA. 2018). provides additional information about the criteria, approaches
and/or methods that have been and will be applied to the first 10 chemical risk evaluations.
While EPA has conducted a comprehensive search for reasonably available data as described in the
Scope of the Risk Evaluation for HB( He), EPA encourages submission of additional
existing data, such as full study reports or workplace monitoring from industry sources, that may be
relevant for further evaluating conditions of use, exposures, hazards and potentially exposed or
susceptible subpopulations during risk evaluation. EPA will continue to consider new information
submitted by the public.
During the risk evaluation, EPA will rely on the search results HBCD (CASRN25637-99-4, 3194-55-6,
3194-57-8) Bibliography: Supplemental File for the TSCA Scope Document, EP A-HQ-OPPT-2016-
0735) or perform supplemental searches to address specific questions. Further, EPA may consider any
relevant CBI information in the risk evaluation in a manner that protects the confidentiality of the
information from public disclosure. The analysis plan is based on EPA's knowledge of HBCD to date
which includes a partial, but not complete review of identified information. Should additional data or
approaches become available, EPA may refine its analysis plan based on this information.
2.6.1 Exposure
Based on their physical-chemical properties, expected sources, and transport and transformation within
the outdoor and indoor environment chemical substances are more likely to be present in some media
and less likely to be present in others. Media-specific levels will vary based on the chemical substance
of interest. For some high-priority chemical substances, non-zero background level(s) can be
characterized through a combination of available monitoring data and modeling approaches.
Background levels can be used to:
Better characterize the overall magnitude and distribution of exposures when considered
alongside scenario-specific exposures.
Serve as a comparison or point of reference for scenario-specific exposure estimates.
o Scenario-specific exposures that are lower than background exposure levels may
not need to be further analyzed,
o Scenario-specific exposures that are approximately the same or higher than
background exposure levels warrant further consideration.
For HBCD, EPA plans to analyze background levels for indoor dust, indoor air, ambient air, surface
water, sediment, soil, dietary food sources, aquatic biota, and terrestrial biota. EPA has not yet
determined the background levels in these media or how they may be used in the risk evaluation.
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Exposure scenarios are unique combinations of sources (uses), exposure pathways, and exposed
receptors. Draft release/exposure scenarios corresponding to various conditions of use for HBCD are
presented in Appendix D. EPA plans to analyze background exposures and scenario-specific exposures.
2.6.1.1 Environmental Releases
EPA expects to analyze releases to environmental media as follows:
1) Review reasonably available published literature and other reasonably available
information on processes and activities associated with the conditions of use to analyze the
types of releases and wastes generated.
EPA has reviewed some key data sources containing information on processes and activities
resulting in releases, and the information found is described in Appendix B. EPA will continue to
review data sources identified in Appendix B during risk evaluation using the evaluation strategy
for environmental releases and occupational exposure data sources discussed in the Application
of Systematic Review in TSCA Risk Evaluations and Strategy for Assessing Data Quality in
TSCA Risk Evaluations (U.S. EPA. 2018).
The specific industrial activities that EPA expects to analyze are summarized in Table 2-7 below:
Table 2-7. Summary of Industrial Activities EPA Will Analyze
l.ile Cycle
Stage
Category
Subcategory
Specific Scenarios that KIW will
Assess
Manufacture
Import
Repackaging
Import of HBCD as powder or
pellets and/or as part of XPS
masterbatch, and/or as part of EPS
resin beads to a single site and
subsequent repackaging of the
imported material and its transfer to
other sites for the following
purposes:
1. The production of XPS master
batch at a generic compounding
site using the imported HBCD;
2. The production of XPS at a
generic site for the manufacture
of XPS using the imported HBCD
or the imported XPS masterbatch.
3. The production of EPS at a
generic site for the manufacture
of EPS using the imported EPS
resin beads.
Processing
Incorporation
into formulation,
mixture, or
reaction product
Compounding of
XPS master batch
The compounding of XPS master
batch at a generic site by the
processing of imported HBCD
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l.ile Cycle
Stage
Category
Subcategory
Specific Scenarios that KI'A will
Assess
Incorporation
into an article
Manufacture of
XPS
The manufacture of XPS at a generic
site from the XPS master batch
produced at a generic compounding
site or the imported HBCD or the
imported XPS masterbatch.
Manufacture of
EPS
The manufacture of EPS at a generic
site from imported EPS resin beads.
Manufacture of
SIPs and
automobile
replacement parts
from XPS or EPS
The manufacture of SIPs at a generic
site.
The manufacture of replacement
automobile parts at a generic site.
EPA will consider using an import volume of up to 100,000 lbs (i.e. the highest CDR reporting
threshold) to estimate releases resulting from repackaging of imported product and subsequent
processing (i.e., production of XPS master batch, XPS and EPS). EPA will conduct additional
data collection to estimate the quantity of the imported HBCD that is used for the manufacture of
XPS and EPS, SIPs, and replacement automobile parts.
Furthermore, EPA will further consider whether EPS and XPS, are recycled to produce products
that contain HBCD as a flame retardant. If EPA proceeds with the evaluation of any of the
recycling processes, then EPA may perform targeted data searches 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).
There are currently no reported Toxics Release Inventory (TRI) data for HBCD. EPA will
review the TRI data for the first reporting year of 2017 when they become available in
approximately July 2018. EPA will continue to review relevant data sources as identified in
Appendix B during the risk evaluation. EPA will match identified data to applicable conditions
of use and identify data gaps where no data are found for particular conditions of use. EPA will
assess releases from the specific industrial activities identified above and will compare the
results of this assessment with any release data that will reported in the TRI.
Additionally, for conditions of use where no measured data on releases are available, EPA may
use a variety of methods including release estimation approaches and assumptions in the
Chemical Screening Tool for Occupational Exposures and Releases ChemSTEEl (
2013).
3) Review reasonably available measured or estimated release data for surrogate chemicals
that have similar uses and physical properties.
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EPA has not identified surrogate chemicals and data that can be used to estimate releases from
uses of HBCD. EPA may conduct targeted searches for surrogate data. For example, EPA may
search for data on release of chemicals as a result of building demolition and will then evaluate
the utility of any such data as surrogate data for release of HBCD due to building demolition.
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 will evaluate relevant
data to determine whether the data can be used to develop, adapt or apply models for specific
conditions of use (and corresponding release scenarios).
5) Review and determine applicability of OECD Emission Scenario Documents (ESDs) and
EPA Generic Scenarios to estimation of environmental releases.
EPA has identified potentially relevant OECD Emission Scenario Documents (ESDs) and EPA
Generic Scenarios (GS) that correspond to some conditions of use; for example, the 2009 ESD
on Plastics Additives and the 2011 ESD on Chemical Industry may be useful. EPA will need to
critically review these generic scenarios and ESDs to determine their applicability to the
conditions of use assessed.
EPA Generic Scenarios are available at the following: https://www.epa.gov/tsca-screening-
tools/using-predictive-methods-assess-exposure-and-fate-under-tsca#fate.
OECD Emission Scenario Documents are available at the following:
http://www.oecd.org/chemicalsafetv/risk-assessment/emissionscenariodociiments.htm
EPA was not able to identify release scenarios corresponding to several conditions of use (e.g.
recycling, construction and demolition) of products containing HBCD. EPA may conduct
industry outreach efforts, or perform supplemental, targeted literature searches to better
understand the process steps involved in that condition of use before a release assessment can be
made.
6) Map or group each condition of use to a release assessment scenario(s).
EPA has identified release scenarios and mapped (i.e. grouped) them to relevant conditions of
use as shown in B.2. EPA was not able to identify release scenarios corresponding to some
conditions of use (e.g. recycling, construction and demolition). EPA will perform targeted
research to understand those uses, which may inform identification of release scenarios. EPA
may further refine the mapping/grouping of release scenarios based on factors (e.g., process
equipment and handling, magnitude of production volume used, and exposure/release sources)
corresponding to conditions of use as additional information is identified during risk evaluation.
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7) Evaluate the weight of evidence of environmental release data.
EPA will rely on the weight of the scientific evidence when evaluating and integrating
environmental release data. The data integration strategy will be designed to be fit-for-purpose in
which EPA will use systematic review methods to assemble the relevant data, evaluate the data
for quality and relevance, including strengths and limitations, followed by synthesis and
integration of the evidence.
2.6.1.2 Environmental Fate
EPA expects analyze fate and transport in environmental media as follows:
1) Review reasonably available measured or estimated environmental fate endpoint data
collected through the literature search.
A general overview of persistence and bioaccumulation was presented in the TSCA Work Plan
Chemical Problem Formulation and Initial Assessment for HBCD ( )15c). Key
environmental fate characteristics were included in the Scope of the Risk Evaluation for HBCD
G X ' V; I f) and in previous assessments of HBCD, including those conducted by the US
EPA (U.S. EPA, 2014b. 2008), Australian National Industrial Chemicals Notification and
Assessment Scheme flSflCNAS. 2012b). Environment Canada (Environment Canada. 2011).
European Inventory of Existing Commercial Chemical Substances (EINECS. 2008). and the
Organization for Economic Cooperation and Development Screening Information Datasets
(J )7b). These information sources will be used as a starting point for the environmental
fate assessment. Other sources that will be consulted include those that are identified through the
systematic review process. Studies will be evaluated using the evaluation strategies laid out in
the Application of Systematic Review in TSCA Risk Evaluations ( 1018).
If measured values resulting from sufficiently high-quality studies are not available (to be
determined through the systematic review process), chemical properties will be estimated using
EPI Suite, SPARC, and other chemical parameter estimation models. Estimated fate properties
will be reviewed for applicability and quality.
2) Using measured data and/or modeling, determine the influence of environmental fate
endpoints (e.g., persistence, bioaccumulation, partitioning, transport) on exposure
pathways and routes of exposure to human and environmental receptors.
Measured fate data including volatility from water, sorption to organic matter in soil and
sediments, aqueous and atmospheric photolysis rates, and aerobic and anaerobic biodegradation
rates, along with physical-chemical properties and models such as the EPI Suite STP model
(which estimates removal in wastewater treatment due to adsorption to sludge and volatilization
to air), will be used to characterize the movement of HBCD within and among environmental
media and the persistence of HBCD in media.
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3) Evaluate the weight of the evidence of environmental fate data, which include qualitative
and quantitative sources of information.
EPA will rely on the weight of the scientific evidence when evaluating and integrating
environmental fate data. The data integration strategy will be designed to be fit-for-purpose in
which EPA will use systematic review methods to assemble the relevant data, evaluate the data
for quality and relevance, including strengths and limitations, followed by synthesis and
integration of the evidence.
2.6.1.3 Environmental Exposures
EPA expects to analyze the following in developing its environmental exposure assessment of HBCD:
1) Review available environmental and biological monitoring data for all media relevant to
environmental exposure.
For HBCD, environmental media which will be analyzed are sediment, soil, and surface water.
In addition, air deposition of HBCD, effluent, landfill leachate, and biosolids may contribute to
HBCD levels in sediment, soil, and surface water. Biological media which will be analyzed are
targeted species of predatory birds, fish, and invertebrates. Full-text screening is underway, but
not yet complete and over 100 monitoring studies have been identified across all media types.
2) Review reasonably available information on releases to determine how modeled estimates
of concentrations near industrial point sources compare with available monitoring data.
Available environmental exposure models that meet the TSCA Science Standards and that
estimate surface water, sediment, and soil concentrations will be analyzed and considered
alongside available surface water, sediment, and soil monitoring data to characterize
environmental exposures. Modeling approaches to estimate surface water concentrations,
sediment concentrations and soil concentrations generally consider the following inputs: direct
release into surface water, sediment, or soil, indirect release into surface water, sediment, or soil
(i.e., air deposition), fate and transport (partitioning within media) and characteristics of the
environment (e.g., river flow, volume of lake, meteorological data).
3) Review reasonably available biomonitoring data for predatory bird species. Consider
whether these data could be used to compare with comparable species or taxa-specific
toxicological benchmarks.
Predatory bird species that consume fish with elevated levels of HBCD will be analyzed. If
species-specific biomonitoring data matches toxicity studies, direct comparisons can be made.
EPA will also consider refining data for other species by using body weight of the birds, fish
ingestion rate of birds, and typical fish species consumed.
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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 HBCD over the last few years. Monitoring data or
modeled estimates will be reviewed to determine how representative they are of ongoing use
patterns.
Any studies which relate levels of HBCD in the environment or biota with specific sources or
groups of sources will be evaluated.
HBCD has been widely studied with several monitoring studies reporting detected levels in biota
and the indoor and outdoor environment. However, many of these monitoring studies do not
attempt to describe potential sources or groups of sources that could have resulted in the
presence of HBCD in a given media. EPA will evaluate all monitoring studies, and note any
monitoring studies that include some description of source attribution.
5) Group each condition(s) of use to environmental assessment scenario(s).
Refine and finalize exposure scenarios for environmental receptors by considering unique
combinations of sources (use descriptors), exposure pathways including routes, and populations
exposed. For HBCD, the following are noteworthy considerations in constructing exposure
scenarios for environmental receptors:
temporal trends in uses and resulting sources of HBCD to the environment over time
overall persistence in the environment and bioaccumulation into a wide variety of aquatic
and terrestrial species
characterization of background levels in the environment that are not generally attributable
to any one use or source
possible interactions within food-chains and relative contribution of dietary vs. non-
dietary sources for predatory animals
6) Evaluate the weight of evidence of environmental occurrence data and modeled estimates.
Both environmental occurrence data and modeled estimates will be evaluated by EPA. EPA will
rely on the weight of the scientific evidence when evaluating and integrating environmental
occurrence data. The data integration strategy will be designed to be fit-for-purpose in which
EPA will use systematic review methods to assemble the relevant data, evaluate the data for
quality and relevance, including strengths and limitations, followed by synthesis and integration
of the evidence.
2.6.1.4 Occupational Exposures
EPA expects to analyze both worker and occupational non-user exposures as follows:
1) Review reasonably available exposure monitoring data for specific condition(s) of use.
No occupational exposure limits have been established or recommended by OSHA or NIOSH.
EPA expects to review monitoring data found in published literature including both personal
exposure monitoring data (direct exposure) and area monitoring data (indirect exposures). EPA
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has identified data sources that contain measured monitoring data and or/estimated data for the
various conditions of use (including import and processing of HBCD), for example, HBCD risk
assessments published by the European Chemicals Agency, Environment Canada, and
Australia's Department of Health. EPA will review these sources and other data sources (as
identified in Appendix B) to extract relevant data for consideration and analysis during risk
evaluation.
2) Review reasonably available exposure data for surrogate chemicals that have uses,
volatility and chemical and physical properties similar to HBCD.
EPA has not identified surrogate chemicals and data that can be used for estimating occupational
exposures to HBCD at this time. Based on cursory review of some data sources, EPA does not
anticipate a need to identify surrogate data. However, if surrogate data are needed to augment
HBCD-specific data, EPA will review literature sources identified and if surrogate data are
found, these data will be matched to applicable conditions of use for potentially filling data gaps.
3) For conditions of use where data are limited or not available, review existing exposure
models that may be applicable in estimating exposure levels.
EPA has identified potentially relevant OECD ESDs and EPA GS's corresponding to some
conditions of use, for example, the 2009 ESD on Plastics Additives and the 2011 ESD on
Chemical Industry. EPA will need to critically review these generic scenarios and ESDs to
determine their applicability to the conditions of use assessed. EPA was not able to identify
release scenarios corresponding to several conditions of use (e.g. recycling, construction and
demolition) of products containing HBCD. EPA may conduct industry outreach efforts or
perform supplemental, targeted literature searches to better understand the process steps involved
in those conditions of use. EPA will consider the applicability of exposure models in the
Chemical Screening Tool for Occupational Exposure and Releases rChemSTEER (U.S. EPA.
2013)1 tool that are routinely used for assessing new chemicals to assess inhalation exposures
during various conditions of use. EPA may also need to perform targeted research to identify
other models that EPA could use to estimate exposures for certain conditions of use.
4) Review reasonably available data that may be used in developing, adapting or applying
exposure models to a particular risk evaluation scenario.
This step will be performed after Steps #2 and #3 are completed. Based on information
developed from Steps #2 and #3, EPA will evaluate relevant data to determine whether the data
can be used to develop, adapt, or apply models for specific conditions of use (and corresponding
exposure scenarios).
5) Consider and incorporate applicable engineering controls and/or personal protective
equipment into exposure scenarios.
EPA will review potentially relevant data sources on engineering controls and personal
protective equipment as identified in Appendix B to determine their applicability and
incorporation into exposure scenarios during risk evaluation.
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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 B.2). As presented in the fourth column in Table Apx C-l. Worker and Occupational
Non-User Exposure Conceptual Model Supporting Table, EPA has grouped the scenarios into 8
representative release/exposure scenarios of which 7 will be further analyzed. EPA was not able
to identify occupational scenarios corresponding to some conditions of use (e.g. recycling,
construction and demolition). EPA may further refine the mapping/grouping of occupational
exposure scenarios based on factors (e.g., process equipment and handling, magnitude of
production volume used, and exposure/release sources) corresponding to conditions of use as
additional information is identified during risk evaluation.
7) Evaluate the weight of the evidence of occupational exposure data, which may include
qualitative and quantitative sources of information.
EPA will rely on the weight of the scientific evidence when evaluating and integrating
occupational data. The data integration strategy will be designed to be fit-for-purpose in which
EPA will use systematic review methods to assemble the relevant data, evaluate the data for
quality and relevance, including strengths and limitations, followed by synthesis and integration
of the evidence.
2.6.1.5 Consumer Exposures
EPA expects 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 unique combinations of
sources (ongoing consumer uses), exposure pathways including routes, and exposed populations.
For HBCD, the following are noteworthy considerations in constructing consumer exposure
scenarios:
reasonably available information on sources including the concentration of HBCD in
newly made or recycled consumer products and articles including temporal trends
associated with such information;
information characterizing the release potential of HBCD from products and articles into
the indoor environment through diffusion from materials to air, physical abrasion, direct
transfer to dust, or leaching into sweat, and skin oil;
populations who may be more greatly exposed to products, including potentially exposed
and susceptible subpopulations such as infants, children, pregnant women; and,
the associated exposure setting and route for exposed populations.
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2) Evaluate the relative potential of indoor exposure pathways based on available data.
Indoor exposure pathways expected to be relatively higher include dust ingestion and mouthing
of products. Indoor exposure pathways expected to be relatively lower include inhalation of
indoor air, dermal contact with dust and articles. The data sources associated with these
respective pathways have not been comprehensively evaluated, so quantitative comparisons
across exposure pathways or in relation to toxicity thresholds are not yet available.
3) Review existing indoor exposure models that may be applicable in estimating indoor air,
indoor dust concentrations, or indoor dust surface loadings.
Indoor exposure models that estimate emission and migration of SVOCs into the indoor
environment are available. These models generally consider mass transfer as informed by the
gas-phase mass transfer coefficient, the solid-phase diffusion coefficient, and the material-air
partition coefficient. In addition, direct transfer to surface dust or physical abrasion may
influence emissions over time. These properties vary based on physical-chemical properties and
properties of the material. OPPT's Indoor Environmental Concentrations in Buildings with
Conditioned and Unconditioned Zones (IECCU) model and other similar models can be used to
estimate indoor air and dust exposures from indoor sources.
4) Review reasonably available empirical data that may be used in developing, adapting or
applying exposure models to a particular risk evaluation scenario. For example, existing
models developed for a chemical assessment may be applicable to another chemical
assessment if model parameter data are available.
To the extent other organizations have already modeled an HBCD consumer exposure scenario
that is relevant to OPPT's assessment, EPA will evaluate those modeled estimates. In addition, if
other chemicals similar to HBCD have been modeled for similar uses, those modeled estimates
will also be evaluated. The underlying parameters and assumptions of the models will also be
evaluated.
5) Review reasonably available consumer product-specific sources to determine how those
exposure estimates compare with each other and with indoor monitoring data reporting
HBCD in specific media (e.g., dust or indoor air).
The availability of HBCD concentration for various ongoing uses will be evaluated. This data
provides the source term for any subsequent indoor modeling. Source attribution between overall
indoor air and dust levels and various indoor sources will be analyzed.
6) Review reasonably available population- or subpopulation-specific exposure factors and
activity patterns to determine if potentially exposed or susceptible subpopulations need to
be further refined.
For HBCD, exposure scenarios that involve potentially exposed and susceptible subpopulations
will consider age-specific behaviors, activity patterns, and exposure factors unique to those
subpopulations. For example, children spend different amounts of time in microenvironments
throughout the day.
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7) Evaluate the weight of the evidence of consumer exposure estimates based on different
approaches.
EPA will rely on the weight of the scientific evidence when evaluating and integrating data
related to consumer exposure. The weight of the evidence may include qualitative and
quantitative sources of information. The data integration strategy will be designed to be fit-for-
purpose in which EPA will use systematic review methods to assemble the relevant data,
evaluate the data for quality and relevance, including strengths and limitations, followed by
synthesis and integration of the evidence.
2.6.1.6 General Population
EPA expects to analyze general population exposures as follows:
1) Refine and finalize exposure scenarios for general population by considering unique
combinations of sources and uses, exposure pathways including routes, and exposed
populations.
For HBCD, the following are noteworthy considerations in constructing exposure scenarios for
the general population:
temporal trends in uses and resulting sources/releases of HBCD to the environment over
time;
overall persistence in the environment and bioaccumulation into a wide variety of aquatic
and terrestrial species relevant to human consumption;
characterization of background levels in the environment that are not generally
attributable to any one condition of use or source; and,
consideration of spatial differences between populations located near industrial point
sources and those exposed at lower background levels.
releases to the environment. For HBCD, TRI releases are expected to be reported for
2017. These releases are not yet linked to a specific lifecycle stage and use. Approaches
for estimating exposures from the conditions of use as they relate to the reported TRI
emissions will be further explored.
EPA plans to evaluate a variety of data types to determine which types are most appropriate
when quantifying exposure scenarios. Environmental monitoring data, biomonitoring data,
modeled estimates, experimental data, epidemiological data, and survey-based data can all be
used to quantify exposure scenarios. In an effort to associate exposure estimates with sources of
exposure and/or conditions of use, EPA will consider source apportionment across exposure
scenarios during risk evaluation. EPA anticipates that there will be a wide range in the relative
exposure potential of the exposure scenarios identified in Appendix C. Source apportionment
characterizes the relative contribution of any of the following: a use/source toward a total media
concentration, a media concentration toward a total exposure route, or an exposure route toward
a total external or internal dose. This consideration may be qualitative, semi-quantitative, or
quantitative, and is dependent upon available data and approaches. For example, EPA may
consider the co-location of TSCA industrial facilities with available monitoring data or modeled
estimates. EPA may compare modeled estimates for discrete outdoor and indoor sources/uses
that apply to unique receptor groups. If available, EPA will compare multiple scenario-specific
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and background exposure doses estimated from media-specific concentrations and exposure
factors with available biomonitoring data. The forward-calculated and back-calculated exposures
could be compared to characterize the relative contribution from defined exposure scenarios.
After refining and finalizing exposure scenarios, EPA will quantify concentrations and/or doses
for these scenarios. The number of scenarios will depend on how unique combinations of uses,
exposure pathways, and receptors are characterized. The number of scenarios is also dependent
upon the available data and approaches to quantify scenarios. When quantifying exposure
scenarios, EPA plans to use a tiered approach. First-tier analysis is based on data that is readily
available without a significant number of additional inputs or assumptions, and may be
qualitative, semi-quantitative, or quantitative. First-tier analyses were conducted during problem
formulation and are expected to continue during risk evaluation. The results of first tier analyses
inform whether scenarios require more refined analysis. Refined analyses will be iterative, and
require careful consideration of variability and uncertainty. Should data become available that
summarily alters the overall conclusion of a scenario through iterative tiering, EPA can refine its
analysis during risk evaluation.
2) Review available environmental and biological monitoring data for exposure pathways and
media to which general population exposures are expected.
General population exposure pathways expected to be relatively higher include: dietary ingestion
for lipid rich food sources, soil ingestion, sediment ingestion, and inhalation of suspended
particles. General population exposure pathways expected to be relatively lower include:
drinking water, dietary ingestion for non-lipid rich food sources, incidental ingestion of surface
water and suspended particulates during recreation, and dermal contact with particles. In
addition, dust ingestion is an important pathway that will be considered for consumer exposure
as well for general population exposure. The data sources associated with these respective
pathways have not been comprehensively evaluated, so quantitative comparisons across
exposure pathways or in relation to toxicity thresholds are not yet available.
3) For exposure pathways where empirical data is not available, review existing exposure
models that may be applicable in estimating exposure levels.
For HBCD, media where exposure models will be considered for general population exposure
include models that estimate ambient air concentrations, surface water concentrations, sediment
concentrations, soil concentrations, and uptake from aquatic and terrestrial environments into
edible aquatic and terrestrial organisms.
4) Consider and incorporate applicable media-specific regulations into exposure scenarios or
modeling approaches.
5) Review available exposure modeled estimates. For example, existing models developed for
a previous HBCD chemical assessment may be applicable to EPA's assessment. In addition,
another chemical's assessment may also be applicable if model parameter data are
available.
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To the extent other organizations have already modeled an HBCD general population exposure
scenario that is relevant to OPPT's assessment, EPA will evaluate those modeled estimates. In
addition, if modeled estimates for other chemicals with similar physical chemical properties and
similar uses are available, those modeled estimates will also be evaluated. The underlying
parameters and assumptions of the models will also be evaluated.
6) Review available information on releases to determine how modeled estimates of
concentrations near industrial point sources compare with available monitoring data.
The expected releases from industrial facilities are changing over time. Any modeled
concentrations based on recent release estimates will be carefully compared with available
monitoring data to determine representativeness.
7) Review available information about population- or subpopulation-specific exposure factors
and activity patterns to determine if potentially exposed or susceptible subpopulations need
to be further defined (e.g., early life and/or puberty as a potential critical window of
exposure).
For HBCD, exposure scenarios that involve potentially exposed and susceptible subpopulations
will consider age-specific behaviors, activity patterns, and exposure factors unique to those
subpopulations. For example, children will have different intake rates for dust, soil, and diet than
adults.
8) Evaluate the weight of the evidence of general population exposure estimates based on
different approaches.
EPA will rely on the weight of the scientific evidence when evaluating and integrating data
related to general population exposures. The weight of the evidence may include qualitative and
quantitative sources of information. The data integration strategy will be designed to be fit-for-
purpose in which EPA will use systematic review methods to assemble the relevant data,
evaluate the data for quality and relevance, including strengths and limitations, followed by
synthesis and integration of the evidence.
2.6.2 Hazards (Effects)
2.6.2.1 Environmental Hazards
EPA will conduct an environmental hazard assessment of HBCD as follows:
1) Review reasonably available environmental hazard data, including data from alternative
test methods (e.g., computational toxicology and bioinformatics; high-throughput screening
methods; data on categories and read-across; in vitro studies).
Environmental hazard data will be evaluated using the ecological toxicity data quality criteria
outlined in the Application of Systematic Review in TSCA Risk Evaluations document. The
study evaluation results will be documented in the risk evaluation phase and data from
suitable studies will be extracted and integrated in the risk evaluation process.
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Conduct hazard identification (the qualitative process of identifying acute and chronic
endpoints) and concentration-response assessment (the quantitative relationship between
hazard and exposure) for all identified environmental hazard endpoints. Suitable
environmental hazard data will be reviewed for acute and chronic endpoints for mortality and
other effects (e.g. growth, immobility, reproduction, etc.). EPA will evaluate the character of
the concentration-response relationship {i.e. positive, negative or no response) as part of the
review.
2) Derive aquatic and terrestrial concentrations of concern (COC) for acute and, where
possible, chronic endpoints.
The aquatic environmental hazard studies may be used to derive acute and chronic
concentrations of concern (COC) for mortality, behavioral, developmental and reproductive or
other endpoints determined to be detrimental to environmental populations. Depending on the
robustness of the evaluated data for a particular organism (e.g. aquatic invertebrates),
environmental hazard values (e.g. ECx/LCx/NOEC/LOEC, etc.) may be derived and used to
further understand the hazard characteristics of HBCD to aquatic species.
3) Evaluate the weight of the evidence of environmental hazard data.
EPA will rely on the weight of the scientific evidence when evaluating and integrating
environmental hazard data. The data integration strategy will be designed to be fit-for-purpose.
EPA will use systematic review methods to assemble the relevant data, evaluate the data for
quality and relevance, including strengths and limitations, followed by synthesis and integration
of the evidence.
4) Consider the route(s) of exposure, available biomonitoring data and available approaches
to integrate exposure and hazard assessments.
Based on the physical-chemical and fate properties (low water solubility and high
absorption), EPA plans to consider the aquatic, sediment and terrestrial pathways in the
HBCD conceptual model. These organisms are likely to be exposed to HBCD in liquid waste
from industrial wastewater treatment facility, municipal and hazardous waste landfills and
incineration of municipal hazardous waste pathways. These pathways can result in
groundwater and eventually surface water exposure to terrestrial, aquatic and sediment
organisms.
EPA plans to consider benthic and pelagic species in the HBCD conceptual model. HBCD
exposure from POTWs can affect these organisms and trophic magnification could result
from over exposure following bioaccumulation of HBCD.
EPA plans to consider soil organisms in the HBCD conceptual model. Land application of
biosolids containing HBCD could transfer to soil thus exposing terrestrial organisms.
5) Conduct an ecological risk characterization of HBCD.
EPA plans to conduct a risk characterization of HBCD to determine whether there are risks to the
aquatic and/or terrestrial environments from the measured levels of HBCD found in wastewater,
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surface water, sediment or soil. The data for environmental monitoring and toxicity will be used
in this risk assessment to determine if:
The acute exposure to levels of HBCD measured in wastewater in the US pose risks for
adverse effects in aquatic invertebrates, fish, or plants.
The chronic exposure to levels of HBCD measured in surface water in the US pose risks for
adverse effects in aquatic invertebrates, fish, or plants or terrestrial species.
The chronic exposure to levels of HBCD measured in sediment in the US pose risks for
adverse effects in sediment-dwelling invertebrates.
Environmental risk will be characterized by calculating risk quotients (RQs) (
1998; Bamthouse et a J). The COCs derived from aquatic and terrestrial organisms
hazard data will be used to calculate RQs. The environmental concentration for each
compartment (i.e., wastewater, surface water, sediment, soil) will be based on measured and
modeled concentrations of HBCD.
6) Conduct a Persistent, Bioaccumulative, and Toxic (PBT) Assessment of HBCD.
EPA will assess the persistence, bioaccumulation, and toxic (PBT) potential of HBCD in
accordance with U.S. EPA Final Water Quality Guidance for Great Lakes System (l_ .
1995). EPA will assess the available studies collected from the systematic review process
relating to bioaccumulation and bioconcentration (BAF/BCF) of HBCD. In addition, EPA will
integrate traditional environmental hazard endpoint values (e.g., LCso, LOEC) and exposure
concentrations (e.g., surface water concentrations, tissue concentrations) for HBCD with the fate
parameters (BAF/BCF/BMF/TMF).
2.6.2.2 Human Health Hazards
EPA expects to analyze human health hazards as follows:
1) Review reasonably available human health hazard data, including data from alternative
test methods (e.g., computational toxicology and bioinformatics; high-throughput screening
methods; data on categories and read-across; in vitro studies; systems biology).
Human health studies will be evaluated using the evaluation strategies laid out in the Application
of Systematic Review in TSCA Risk Evaluations ( >18). For the HBCD risk
evaluation, EPA will evaluate information in the Preliminary Materials for the IRIS
Toxicological Review of HBCD (\ p.Oj Jd), Strategy for Conducting Literature Searches
for Cyclic Aliphatic Bromine Cluster (HBCD): Supplemental Document to the TSCA Scope
Document,( , 2002). and studies published after 2015 that were captured in the
comprehensive literature search conducted by the agency for HBCD (Cyclic Aliphatic Bromides
Cluster (HBCD) (CASRN: 25637-99-4; 3194-55-6; 3194-57-8) Bibliography: Supplemental File
for the TSCA Scope Document (U.S. EPA. 2017b) using OPPT's structured process described in
the document, Application of Systematic Review in TSCA Risk Evaluations.
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 HBCD
hazard(s). Susceptibility of particular human receptor groups to HBCD 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 HBCD exposure. The document Cyclic
Aliphatic Bromides Cluster (HBCD) (CASRN: 25637-99-4; 3194-55-6; 3194-57-8)
Bibliography: Supplemental File for the TSCA Scope Document ( 2017b) contains a
list of studies that will be evaluated to ascertain whether some human receptor groups may have
greater susceptibility than the general population to HBCD's hazard(s). Also, EPA/OPPT will
further examine the availability of any new chemical-specific information on susceptible
populations or the distribution of susceptibility in the general population since the TSCA. Work
Plan Problem. Formulation and Initial Assessment (U.S. EPA. 2.015c) and their impact in
decreasing or increasing the default uncertainty factors for variability. EPA will review the
current state of the literature since the TSCA. Work Plan Problem Formulation and Initial
Assessment (U.S. EPA. 2015c) in order to potentially quantify these differences for risk
evaluation purposes.
3) Conduct hazard identification (the qualitative process of identifying non-cancer and cancer
endpoints) and dose-response assessment (the quantitative relationship between hazard
and exposure) for identified human health hazard endpoints.
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 document ( 018). Data
quality evaluation will be performed on key studies identified from the TSCA. Work Plan
Problem Formulation and Initial Assessment (U.S. EPA. 2015c). Preliminary Materials for the
IRIS Toxicological Review of HBCD (U.S. EPA. 2014d). Strategy for Conducting Literature
Searches for Cyclic Aliphatic Bromine Cluster (HBCD): Supplemental Document to the TSCA
Scope Document,{ *017f. 2002). and studies published after 2015 that were captured
in the comprehensive literature search conducted by the agency for HBCD (Cyclic Aliphatic
Bromides Cluster (HBCD) (CASRN: 25637-99-4; 3194-55-6; 3194-57-8) Bibliography:
Supplemental File for the TSCA Scope Document; (U.S. EPA. 2017b). Hazards identified by
studies meeting data quality criteria will be grouped by routes of exposure relevant to humans
(oral, dermal, inhalation) and by cancer and noncancer endpoints.
Dose-response assessment will be performed in accordance with EPA guidance (U.S. EPA.
2012a. 2011. 1994). Dose-response analyses may be used if the data meet data quality criteria
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and if additional information on the identified hazard endpoints are not available or would not
alter the analysis.
The cancer mode of action (MOA) determines how cancer risks can be quantitatively evaluated.
If cancer hazard is determined to be applicable to HBCD, EPA will evaluate information on
genotoxicity and the mode of action for all cancer endpoints to determine the appropriate
approach for quantitative cancer assessment in accordance with the U.S. EPA Guidelines for
Carcinogen Risk Assessment ( D5).
4) Derive points of departure (PODs) where appropriate; conduct benchmark dose modeling
depending on the available data. Adjust the PODs as appropriate to conform (e.g., adjust
for duration of exposure) to the specific exposure scenarios evaluated.
Hazard data will be evaluated to determine the type of dose-response modeling that is applicable.
Where modeling is feasible, a set of dose-response models that are consistent with a variety of
potentially underlying biological processes will be applied to empirically model the dose-
response relationships in the range of the observed data consistent with the EPA Benchmark
Dose Technical Guidance Document. Where dose-response modeling is not feasible, NOAELs
or LOAELs will be identified. Non-quantitative data will also be evaluated for contribution to
weight of evidence or for evaluation of qualitative endpoints that are not appropriate for dose-
response assessment.
EPA will evaluate whether the available 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.
(2011). 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 evidence of human health hazard data.
EPA will rely on the weight of the scientific evidence when evaluating and integrating human
health hazard data. The data integration strategy will be designed to be fit-for-purpose in which
EPA will use systematic review methods to assemble the relevant data, evaluate the data for
quality and relevance, including strengths and limitations, followed by synthesis and integration
of the evidence.
6) Consider the route(s) of exposure (oral, inhalation, dermal), available route-to-route
extrapolation approaches, available biomonitoring data and available approaches to
correlate internal and external exposures to integrate exposure and hazard assessment.
At this stage of review, EPA believes there will be sufficient data to conduct dose-response
analysis and/or benchmark dose modeling for the oral route of exposure. EPA will also evaluate
any potential human health hazards following dermal and inhalation exposure to HBCD, which
could be important for worker, consumer, and general population risk analysis. Available data
will be assessed to determine whether or not a point of departure can be identified for the dermal
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and inhalation routes. This may include using route-to-route extrapolation methods where
appropriate, and depending on the nature of available data.
If sufficient toxicity studies are not identified in the literature search to assess risks from dermal
and inhalation exposures, then a route-to-route extrapolation from oral toxicity studies would be
needed to assess systemic risks from dermal or inhalation exposures. Without an adequate PBPK
model, the approaches described in the EPA guidance document Risk Assessment Guidance for
Superfund Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance for
Dermal Risk Assessment) ( 34) could be applied to extrapolate from oral to dermal
exposure. These approaches may be able to further inform the relative importance of dermal
exposures compared with other routes of exposure. Similar methodology may also be used for
assessing inhalation exposures.
2.6.3 Risk Characterization
Risk characterization is an integral component of the risk assessment process for both ecological and
human health risks. EPA will derive the risk characterization in accordance with EPA's Risk
Characterization Handbook (U.S. EPA. 2000). As defined EPA's Risk Characterization Policy, "the risk
characterization integrates information from the preceding components of the risk evaluation and
synthesizes an overall conclusion about risk that is complete, informative and useful for decision
makers." Risk characterization is considered to be a conscious and deliberate process to bring all
important considerations about risk, not only the likelihood of the risk but also the strengths and
limitations of the assessment, and a description of how others have assessed the risk into an integrated
picture.
Risk characterization at EPA assumes different levels of complexity depending on the nature of the risk
assessment being characterized. The level of information contained in each risk characterization varies
according to the type of assessment for which the characterization is written. Regardless of the level of
complexity or information, the risk characterization for TSCA risk evaluations will be prepared in a
manner that is transparent, clear, consistent, and reasonable (TCCR) (U.S. EPA. 2000). EPA will also
present information in this section consistent with approaches described in the Procedures for Chemical
Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726). For instance, in the
risk characterization summary, EPA will further carry out the obligations under TSCA section 26; for
example, by identifying and assessing uncertainty and variability in each step of the risk evaluation,
discussing considerations of data quality such as the reliability, relevance and whether the methods
utilized were reasonable and consistent, explaining any assumptions used, and discussing information
generated from independent peer review. EPA will also be guided by EPA's Information Quality
Guidelines (U.S. 2002) as it provides guidance for presenting risk information. Consistent with those
guidelines, in the risk characterization, EPA will also identify: (1) Each population addressed by an
estimate of applicable risk effects; (2) the expected risk or central estimate of risk for the potentially
exposed or susceptible subpopulations affected; (3) each appropriate upper-bound or lower bound
estimate of risk; (4) each significant uncertainty identified in the process of the assessment of risk effects
and the studies that would assist in resolving the uncertainty; and (5) peer reviewed studies known to the
Agency that support, are directly relevant to, or fail to support any estimate of risk effects and the
methodology used to reconcile inconsistencies in the scientific information.
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reporting (May 2017 release). Washington, DC: US Environmental Protection Agency, Office of
Pollution Prevention and Toxics. Retrieved from https://www.epa.eov/chemical-data-reportine
L (U.S. Environmental Protection Agency). (2016c). Technical review of
hexabromocyclododecane (HBCD) CAS registry numbers 3194-55-6 and 25637-99-4.
Washington, DC: U. S. Environmental Protection Agency.
https://www.regulations.gov/document?D=EPA-HQ-TRI-2015-0607-0028
L SJ L!* (U.S. Environmental Protection Agency). (2017a). Consumer Exposure Model (CEM) version
2.0: User guide. U.S. Environmental Protection Agency, Office of Pollution Prevention and
Toxics, https://www.epa.eov/sites/production/files/zOI ' 06/documents/ctH^ J ^ i^er euide.pdf
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L J"!!.!* (U.S. Environmental Protection Agency). (2017b). Cyclic aliphatic bromides cluster (HBCD)
(CASRN: 25637-99- 4; 3194-55-6; 3194-57-8) bibliography: Supplemental file for the TSCA
Scope Document [EPA Report], https://www.epa.gov/sites/production/files/2017-
06/documents/hbcd comp bib.pdf
II ^ EPA (U.S. Environmental Protection Agency). (2017c). Preliminary chemical data reporting
(CDR) information on manufacturing, processing, distribution, use, and disposal: Cyclic
aliphatic bromide cluster (HBCD). OCSPP. Support document. (EPA-HQ-OPPT-2016-0735).
(U.S. Environmental Protection Agency). (2017d). Preliminary information on manufacturing,
processing, distribution, use, and disposal: Cyclic aliphatic bromide cluster (HBCD) [Comment],
(EPA-HQ-OPPT-2016-0735-0003). https://www .regulations, gov/docum e SPA-HQ-OPPT-
2 3003
(U.S. Environmental Protection Agency). (2017e). Scope of the risk evaluation for cyclic
aliphatic bromides cluster [EPA Report], (EPA-740-R1-7002).
https://www.epa.gOv/sites/production/files/2 /docum ents/hb cd scope 06-22-17 O.pdf
(U.S. Environmental Protection Agency). (2017f). Strategy for conducting literature searches
for cyclic aliphatic bromine cluster (HBCD): Supplemental document to the TSCA Scope
Document. CASRN: 25637-99-4; 3194-55-6; 3194-57-8 [EPA Report],
https://www.epa.gov/sites/production/files/2Q17-
06/docum ents/hb cd lit search strategy f
(2017g). Use and market profile for hexabromocyclododecane (HBCD). Draft.
L J5 EPA (U.S. Environmental Protection Agency). (2018). Application of systematic review in TSCA
risk evaluations: DRAFT Version 1.0. (740P18001). Washington, D.C.: U.S. Environmental
Protection Agency, Office of Chemical Safety and Pollution Prevention.
Underwood. PM. (2017). RE: FW: Need Help...HBCD (Unclassified). Available online
UNEP (United Nations Environment Programme). (2010). Hexabromocyclododecane Draft Risk Profile
(pp. 1-39). Europe.
http://chm.pops.int/Convention/POPsReviewCommittee/hrPOPRCMeetings/POPRC5/POPRC5F
ollowupcommunications/HBCDInvitationforcommentsondraftRP/tabid/742/language/en-
US/Default.aspx.
UNEP (United Nations Environment Programme). (201 1). Report of the Persistent Organic Pollutants
Review Committee on the Work of Its Seventh Meeting. Addendum. Risk management
evaluation on hexabromocyclododecane. In Stockholm Convention on Persistent Organic
Pollutants. (UNEP/POPS/POPRC.7/19/Add. 1). Geneva, Switzerland,
file -JIIC:/Users/2616 l/Saved%20Games/Downloads/UNEP-POPS-POPRC. 7-19-
Add.l.English.pdf
Velsicol Chero Corp (Velsicol Chemical Corporation). (1978). Industrial hygiene survey, Velsicol
Chemical Corporation, El Dorado, Ark Plant, Fire Master 680 Unit and semi-works summary
with attachments and cover letter dated 071978 [TSCA Submission], (EPA/OTS Doc #88-
7800228). Chicago, IL.
https://ntrl.ntis.gov/NTRL/dashboard/searchResults.xhtml?searchQuery=OTS0200544
Walsh. GE; Yoder. MI; Mclaughlin. LL; Lores. EM. (1987). Responses of marine unicellular algae to
brominated organic compounds in six growth media. Ecotoxicol Environ Saf 14: 215-222.
Weil. E; Levchik. S. (2009). Flame Retardants for Plastics and Textiles: Practical Applications.
Cincinnati, OH: Hanser Publications, http://www.hanserelibrary.com/isbn/9783446416529
WILI '1 H J ^ TER'\ \ I10NAL LTD. (1997). FINAL REPORT, HEXABROMOCYCLODODECANE
(HBCD): A 96-HOUR FLOW-THROUGH ACUTE TOXICITY TEST WITH THE RAINBOW
Page 82 of 115
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TROUT (ONCORHYNCHUS MYKISS), WITH COVER LETTER DATED 6/27/1997.
(TSCATS/445565). WILDLIFE INTERNATIONAL LTD.
Wildlife Intl LTD (Wildlife International Limited). (1997). HEXABROMOCYCLODODECANE
(HBCD): A 48-HOUR FLOW-THROUGH ACUTE TOXICITY TEST WITH THE
CLADOCERAN (DAPHNIA MAGNA) WITH COVER LETTER DATED 06/20/1997.
(TSCATS/452984).
WSDE. (2014). Flame Retardants in General Consumer and Children's Products (pp. 41). (14-04-021).
Olympia, WA: Washington State Department of Ecology, Hazardous Waste and Toxics
Reduction Program. https://fortress.wa.gov/ecy/publications/SummaryPages/1404021 .html
W SDE (Washington State Department of Ecology). (2017). Children's safe product act reported data:
Products containing HBCD. Lacey, WA. https://fortress.wa.gov/ecy/cspareporting/
XPSA. (Extruded Polystyrene Foam Association). (2017a). Communication between John Ferraro,
XPSA, and Sue Slotnick, EPA, regarding Hexabromocyclododecane (HBCD) [Personal
Communication].
XPSA. (Extruded Polystyrene Foam Association). (2017b). Preliminary information on manufacturing,
processing, distribution, use, and disposal: Cyclic aliphatic bromide cluster (HBCD). OCSPP.
Public comment. (EPA-HQ-OPPT-2016-0735-0017).
Yi. S; Liu. JG: Jin. J; Zhu. J. (2016). Assessment of the occupational and environmental risks of
hexabromocyclododecane (HBCD) in China. Chemosphere 150: 431-437.
http://dx.doi.on . ch em o spb. er e.2016.01.047
Zhang. H; Kuo. YY; Gerecke. AC; Wang. I. (2012). Co-release of hexabromocyclododecane (HBCD)
and Nano- and microparticles from thermal cutting of polystyrene foams. Environ Sci Technol
46: 10990-10996. http://dx.doi.org/10.1021/es302559v
Zhang. X; Yang I 'bang. \ \u \ I tao. T; Song. S; Wang. J. (2008). Induction of hepatic enzymes
and oxidative stress in Chinese rare minnow (Gobiocypris rarus) exposed to waterborne
hexabromocyclododecane (HBCDD). Aquat Toxicol 86: 4-11.
http://dx.doi.org/lO tQlo/|.aquatox.2QQ Q QQ2
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APPENDICES
Appendix A REGULATORY HISTORY
The chemical substance, HBCD, is subject to federal and state laws and regulations in the United States.
The federal laws and regulations applicable to HBCD are listed along with the regulating agencies
below in TableApx A-l. States also regulate HBCD through state laws and regulations, which are also
listed within this section in Table Apx A-2.
A.l Federal Laws and Regulations
Table Apx A-l. Federal Laws and Regulations
Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
Toxic Substances
Control Act (TSCA) -
Section 5(a)
Once EPA determines that a use of a chemical
substance is a significant new use under TSCA
section 5(a), persons are required to submit a
significant new use notice (SNUN) to EPA at
least 90 days before they manufacture (including
import) or process the chemical substance for
that use.
In September 2015, EPA
promulgated a SNUR to
designate manufacture or
processing of HBCD for
use as a flame retardant in
consumer textiles (apart
from use in motor
vehicles) as a significant
new use. Manufacturers
(which includes importers)
and processors are required
to notify EPA 90 days
before commencing the
activity (80 FR 57293,
September 23, 2015).
TSCA - Section 6(b)
EPA is directed to identify and begin risk
evaluations on 10 chemical substances drawn
from the 2014 update of the TSCA Work Plan
for Chemical Assessments.
Cyclic Aliphatic Bromide
Cluster (HBCD) is on the
initial list of chemicals to
be evaluated for
unreasonable risk under
TSCA (81 FR 91927,
December 19, 2016).
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.
HBCD manufacturing
(including importing),
processing, and use
information is reported
under the CDR rule (76 FR
50816, August 16, 2011)
TSCA - Section 8(b)
EPA must compile, keep current and publish a
list (the TSCA Inventory) of each chemical
HBCD (CASRN 25637-
99-4 and CASRN 3194-55-
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Mat ulcs/Uegulal ions
Description of Authority/Regulation
Description of Regulation
substance manufactured, processed or imported
into the United States.
6) was on the initial TSCA
Inventory and therefore
was not subject to EPA's
new chemicals review
process (60 FR 16309,
March 29, 1995).
Emergency Planning
and Community Right-
to-Know Act (EPCRA)
- Section 313
Requires annual reporting from facilities in
specific industry sectors that employ 10 or more
full-time equivalent employees and that
manufacture, process or otherwise use a TRI-
listed chemical in quantities above threshold
levels.
EPA listed HBCD on the
TRI under 81 FR 85440
effective November 28,
2016. The first TRI
reporting deadline for
HBCD is July 1,2018.
A.2 State Laws and Regulations
Table Apx A-2. State Laws and Regulations
Stale Actions
Description of Action
Classification of HBCD
as Chemical of Concern
to Children; law
requiring reporting by
manufacturers
Maine classifies HBCD as a chemical of high concern (Maine 38 M.R.S.A.
§ 1693-A(1))
Maine requires manufacturers or distributers to report the use of deca BDE
and/or hexabromocylododecane, when intentionally added to certain
children's products which are sold in the State of Maine. The first reporting
deadline was August 31, 2017. (Rule Chapter 889)
http: //www. maine. gov/dep/safechem/
Minnesota classifies HBCD as a chemical of high concern (Toxic Free Kids
Act Minn. Stat. 2010 116.9401-116.9407)
Oregon's Toxic-Free Kids Act requires manufacturers of children's products
sold in Oregon to report products containing HBCD or other high priority
chemicals of concern for children's health if found at or above specific
levels in those products. Ultimately, manufacturers are to remove these
chemicals from certain products or seek a waiver. Products that fall under
this law are those that are marketed to or intended for children. The first
deadline for providing notice was January 2018.
Washington requires manufacturers of children's products sold in
Washington to report if their product contains certain chemicals of high
concern to children, including HBCD. The law also bans from manufacture
or sale, in the state, children's products or residential upholstered furniture
containing >1,000 ppm of five flame retardants, including HBCD (Wash.
Admin. Code § 173-334-130)
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State Actions
Description of Action
Other
In California, HBCD is listed as an initial informational candidate under
California's Safer Consumer Products regulations, on the state's Proposition
65 list (Cal. Code Regs, tit. 22, § 69502.3, subd. (a))
California lists HBCD as a designated priority chemical for biomonitoring.
However, California has not yet started biomonitoring HBCD. (California
SB 1379)
The Oregon Department of Environmental Quality lists HBCD as a priority
persistent pollutant and publishes use, exposure pathways and release data
for HBCD (Oregon SB 737)
In Massachusetts, HBCD will be reportable under the Toxics Use Reduction
Act beginning in reporting year 2018. (300 CMR 41.00)
A.3 International Laws and Regulations
Table Apx A-3. Regulatory Actions by other Governments and Tribes
Country/Organi/ation
Requirements and Restrictions
Canada
In October 2016, the Regulations Amending the Prohibition of Certain
Toxic Substances Regulations, 2012 (the Amendments) were published in
the Canada Gazette, Part II: Vol. 150, No. 20 - October 5, 2016 and will
come into force in December 2016. The Amendments include controls on
HBCD that prohibit HBCD and certain products containing the substance.
Time-limited exemptions for certain uses are included to allow industry to
Dhase-out their use of HBCD. (Government of Canada)
European Union
HBCD is listed as a substance of very high concern (SVHC) and it is also
listed under Annex XIV (Authorisation list) of European Union's
Registration, Evaluation, Authorisation and Restriction of Chemicals
(REACH). After August 21, 2015, only persons with approved
authorization applications mav continue to use the chemical (European
Chemicals Agency)
The Waste Electrical and Electronic Equipment (WEEE) directive in the
European Union requires the separation of plastics containing brominated
flame retardants prior to recycling (European Commission WEEE).
Japan
HBCD is subject to mandatory reporting requirements in Japan under the
Chemical Substances Control Law (CSCL); specifically, Japan requires
type III monitoring for all substances that may interfere with the survival
and/or growth of flora and fauna (Ministry of Economy. Trade and Industry
Japan).
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C'ou ill r\/Or«sinizsil ion
Requirements sind Restrictions
Stockholm Convention
on POPs
In May 2013, HBCD was added to the United Nation's Stockholm
Convention list of POPs with specific exemptions for production and use in
EPS or XPS in buildings. As required by the convention, Parties that use
these exemptions must register with the secretariat and the exemptions,
unless extended in accordance with the obligations of the Convention,
expire five years from after the date of entry into force of the Convention
with respect to the particular chemical (SCCH. 2018b).
Page 87 of 115
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Appendix R PROCESS, RELEASE AND OCCUPATIONAL
EXPOSURE INFORMATION
This appendix provides information and data found in preliminary data gathering for HBCD.
B.l Process Information
Process-related information potentially relevant to the risk evaluation may include process diagrams,
descriptions and equipment. Such information may inform potential release sources and worker
exposure activities.
B.l.l Manufacture (Including Import)
B.l.1.1 Import
EPA has not identified specific activities related to the import of HBCD at this time. EPA anticipates
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 quality control (QC) samples may be taken for analyses.
B.1.2 Processing and Distribution
B.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. HBCD may undergo several
processing steps and the processing is dependent on its downstream incorporation into articles, which is
discussed in the next subsection. EPA identified the following processing activities for HBCD.
Compounding into XPS Masterbatch
HBCD is compounded into an XPS masterbatch prior to being sold to XPS plastic converters, who then
convert the XPS into a final article. Compounding likely occurs in a partially open process using
extruders. In extruders, blends of polymer, additives and/or masterbatch are mixed either in the hopper
or in tumblers and then fed into an extruder comprising one or two screws. These both shear the material
and transport it through a heating regime. Volatile emissions may be produced and these are vented at
various points in the extruder barrel (j 34). The compounded masterbatch may be converted
into a final extrudate; however, EPA expects that the masterbatch is sent to industrial customers for
further processing into a final article. HBCD concentration in the masterbatch is expected to be 50-70%
(EINECS. 2008V
B. 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 HBCD-containing formulations or reaction products are
dependent on the article. EPA identified the following processing activities that incorporate HBCD and
HBCD formulations or reaction products into articles.
Page 88 of 115
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EPS resin beads are converted into EPS products by expansion and then molding into rigid closed-cell
foam. Once expanded, the beads are fused in a steam heated mold to form a specific shape or can be
formed in a billet or block that can be hot-wire cut to its desired shape and size by users (Priddv. 2006).
HBCD powder or granules are incorporated into XPS products by extrusion. The HBCD powder or
granules are unloaded into a hopper and fed into an extruder along with polystyrene resin, a blowing
agent and other ingredients. A viscous plastic fluid is formed in the extruder and is discharged under
pressure through a die onto a moving belt at ambient conditions. The blowing agent vaporizes, causing
the polymer to expand into a desired shape or form, most likely continuous sheets (boards) of closed cell
insulation. Alternatively, a vacuum is used in addition to the blowing agent to cause polymer expansion.
XPS masterbatch is similarly converted into XPS products (NICNAS. 2012b; EINECS. 2008; Suh.
2000).
B. 1.2.3 Recycling
As stated in Section 2.2.2, construction insulation materials are rarely recycled for numerous reasons,
including that insulation waste is typically not separated from mixed waste stream. However, reuse and
recycle does occur in the United States. At the end-of-life, polystyrene insulation boards (i.e., EPS and
XPS foam insulation containing HBCD) may still have beneficial value for insulation. The insulation
can be removed in whole and reused in the same capacity. Polystyrene insulation may also be
demolished, melted and reformed into new insulation materials boards or other applications. Typically,
polystyrene insulation containing HBCD can only be recycled into building insulation or other building
applications (U.S. EPA. 2014a).
Electronic products (which may or may not contain HBCD) can also be recycled. HIPS materials
constitute more than half the plastic materials recovered from household electronics (B orchard! 2006).
No information was identified that further described the processes used in recovering the plastics from
electronics and how those plastics are reprocessed into other products.
B.1.3 Uses
B. 1.3.1 Building/Construction Materials
A major use of HBCD is in XPS and EPS foam for continuous insulation applications such as in walls
and roofs on the exterior of buildings, ceilings and subfloor systems. The materials may be incorporated
into building products such as structural insulated panels or insulating concrete forms or used in other
below grade or geotechnical applications for foundations or highways or for dimensional stability or
strength applications (e.g., insulated cold storage applications) (U.S. EPA. 2017g. 2014a; NICNAS.
2012b).
B.1.4 Disposal
Releases from industrial sites to surface water (via direct discharge or indirect discharge through
POTWs), air and landfill are expected during manufacture, processing, use, product usage and disposal
of HBCD or products containing HBCD (U.S. EPA. 2014a; NICNAS. 2012b; Environment Canada.
2.011; EINECS. 2008).
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 ( 2014a). XPS
foam may also be disposed of via waste energy plants.
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B.2 Sources Containing Potentially Relevant Data or Information
Some sources of information and data related to releases and worker exposure were found during the
systematic review literature search. Sources of data or information identified in the Analysis Plan
Sections 2.6.1.1 and Section 2.6.1.4 are shown in the four tables below. The data sources identified are
based on preliminary results to date of the full-text screening step of the systematic review process.
Further screening and quality evaluation are on-going. These sources will be reviewed to determine the
utility of the data and information in the Risk Evaluation.
Page 90 of 115
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Table Apx B-l. Potentially Relevant Data Sources for Information Related to Process Description
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Gorga, M., et al. (2013). "Determination of PBDEs, HBB, PBEB, DBDPE, HBCD, TBBPA and related
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Velsicol Chem Corp (1978). Industrial hygiene survey, Velsicol Chemical Corporation, El Dorado, Ark
Plant, Fire Master 680 Unit and semi-works summary with attachments and cover letter dated 071978.
Chicago, IL.
Velsicol Chem Corp (1978)
OECD (2015). Emission scenario document on use of adhesives. Paris, France.
Pubchem (2017). PubChem: 1,2,5,6,9,10-Hexabromocyclododecane. Bethesda, MD, National Institute
of Health, U.S. National Library of Medicine.
Pubchem (1
ToxNet Hazardous Substances Data Bank (2017). HSDB: 1,2,5,6,9,10-Hexabromocyclododecane.
Bethesda, MD, National Institute of Health, U.S. National Library of Medicine.
ToxNet Hazardous Substances
Data Bank (2017)
ECHA (2017). Guidance on safe use: hexabromocyclododecane. Helsinki, Finland.
I v l-l \ u>01 /c)
ECHA (2017). Chemical safety report: Hexabromocyclododecane and all major diastereoisomers
identified, Part 2. Helsinki, Finland.
ECHA (2017b)
NIOSH (2014). International chemical safety cards (ICDC): Hexabromocyclododecane (mixture of
isomers). Atlanta, GA.
NIOSH (2014)
Page 94 of 115
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Appendix C SUPPORTING INFORMATION FOR OCCUPATIONAL EXPOSURE
CONCEPTUAL MODEL
TableApx C-l. Worker and Occupational Non-User Exposure Conceptual Model Supporting Table
Life ( \ik-
Ri-k'iisi- /
l!\|)iisu iv
Sivn;iriii
I!\|)iisiiiv
l';illi\\;i\
I!\|)iisiiiv
kiiuk-
Ri'i'i'plin* /
Piipuhiliiiii
PmpiiM-d
1'nr I 'lirllu i'
Aiisil\sis
K.ilimi.ik-
Manufacture
Import
Import
Repackaging
of import
containers
Liquid
1 )ermal
Workers
No
According to CDR, all importers reported
solid physical lornis of I IliCI) and
therefore, exposure to liquid IIBCI) during
repackaging is not likely.
Solid
Dermal
Workers
Yes
Exposure will only occur in the event the
imported material is repackaged. In that
case, EPA expects potential exposure as a
result of dust generation during repackaging
of solid particulates.
Fugitive
Dust
Inhalation
Workers,
ONU
Yes
Exposure will only occur in the event the
imported material is repackaged.
Fugitive
Dust
Oral
Workers,
ONU
Yes
Oral exposure of workers to HBCD may
occur through ingestion of dust that
deposits in the upper respiratory tract and is
swallowed during repackaging.
Liquid,
Solid
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly involved in
working with the chemical.
Processing
Incorporated into
formulation,
mixture or
reaction product
Flame retardants
used in custom
compounding of
purchased resin
(e.g., compounding
inXPS
masterbatch)
Plastics
compounding
Solid
Dermal
Workers
Yes
EPA expects potential exposure during the
unloading of HBCD.
Fugitive
Dust
Inhalation
Workers,
ONU
Yes
EPA anticipates inhalation of dust as a
result of generation of dust during the
unloading of HBCD as the most important
HBCD exposure pathway.
Page 95 of 115
-------
l.ili-( \ik-
Shim-
Sul>i;ik-»iir\
Ri'k'iisi- /
l!\|)iisuiv
Siviiiiriii
I!\|)iisiiiv
l';illi\\;i\
I!\|)iisiiiv
Ki hi it-
Ri-ii-plur /
Piipukiliiiii
PropuM-d
1'nr I-'iii'IIut
Aii;il\sis
R.ilimi.ik-
Fugitive
Dust
Oral
Workers,
ONU
Yes
Oral exposure of workers to HBCD may
occur through ingestion of dust that
deposits in the upper respiratory tract and is
swallowed.
Solid
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly involved in
working with the chemical.
Flame retardants
used in plastics
product
manufacturing
(manufacture of
XPS and EPS
foam; manufacture
of structural
insulated panels
(SIPS) and
automobile
replacement parts
from XPS and EPS
foam)
Processing
Incorporated into
articles
Plastics
converting;
SIP assembly
Solid
Dermal
Workers
Yes
As an additive flame retardant, HBCD is
not chemically bonded to the base material
(resin) and therefore there may be a
potential for release and subsequent
exposure during handling.
Fugitive
Dust
Inhalation
Workers,
ONU
Yes
Fugitive
Dust
Oral
Workers,
ONU
Yes
Oral exposure of workers to HBCD may
occur through ingestion of dust that
deposits in the upper respiratory tract and is
swallowed.
Solid
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly involved in
working with the chemical.
Processing
Recycling
Recycling
Recycle of
EPS.
Solid
Dermal
Workers
Yes
As an additive flame retardant, HBCD is
not chemically bonded to the base material
(resin) and therefore there may be a
potential for release and subsequent
exposure during recycling activities.
Fugitive
Inhalation
Workers,
ONU
Yes
Page 96 of 115
-------
l.ili-( \ik-
Shim-
Sul>i;ik-»iir\
Ri'k'iisi- /
l!\|)iisuiv
Siviiiiriii
I!\|)iisiiiv
l';illi\\;i\
I!\|)iisuiv
Ki hi it-
Ri-ii-plur /
Piipukiliiiii
PropuM-d
1'nr I-'iii'IIut
Aii;il\sis
R.ilimi.ik-
Fugitive
Oral
Workers,
ONU
Yes
Oral exposure of workers to HBCD may
occur through ingestion of dust that deposits
in the upper respiratory tract and is
swallowed.
Solid
Dermal
ONU
No
Dermal exposure is expected to be primarily
to workers directly involved in working
with the chemical.
Distribution in
Commerce
Distribution
Distribution
Distribution of
bulk raw
material;
Distribution of
formulated
products
--
--
--
No
Potential for exposure expected only in the
event the packaged raw material or
formulated products are damaged, resulting
in the potential release of HBCD.
Plastic articles
(hard):
construction and
building
materials covering
large
surface areas
Installation/Re
use/Demolitio
n of EPS/XPS
foam
Solid
Dermal
Workers
Yes
Potential for exposure highly expected
because the building/construction materials
can be roughly handled during construction
use, which could result in the release of
HBCD in dust emissions from this activity.
Building/construe
tion materials
insulation in
residential,
public and
commercial
buildings, and
other
structures
Fugitive
and
Installation/
Reuse/Dem
olition Dust
Inhalation
Workers,
ONU
Yes
EPA anticipates inhalation of dust and other
respirable particles as the most important
HBCD exposure pathway.
Commercial
Use
Fugitive
and
Installation/
Reuse/Dem
olition Dust
Oral
Workers,
ONU
Yes
Oral exposure of workers to HBCD may
occur through ingestion of dust that deposits
in the upper respiratory tract and is
swallowed.
Solid
Dermal
ONU
No
Dermal exposure is expected to be primarily
to workers directly involved in working
with the chemical.
Automobile
replacement parts
Automobile
replacement parts
Use of
automobile
replacement
parts
Fugitive
dust
Dermal,
inhalation
and oral
Workers
No
Emissions of HBCD from automobile
replacement parts are not expected to be
significant and the EPS or XPS that
comprises these replacement parts is
expected to be covered with other material
thereby limiting emissions.
Page 97 of 115
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Life ( \ik-
Kck'iisc /
l!\|)iisuiv
Siviiiiriii
I!\|)iisiiiv
I!\|)iisiiiv
kiiuk-
Ki'ivpliir /
Piipuhiliiiii
PropuM-d
liir I'lirllu i'
Aii;il\sis
K;ilii>n;ik-
I )isposal
Waste I Iandling.
Treatment and
I )isposal
Disposal of IIIJCI)
w astes
Worker
handling of
wastes
Liquid
1 )ermal
Workers
No
l.iquid contact is not assessed due to
subcategories of uses that have ceased as
discussed in Section 2.2.
Solid
Dermal
Workers
Yes
Highest potential for exposure for
workers/occupational non-users would be to
wastes from handling HBCD in powder
form (e.g., disposal of raw material
packaging, baghouse dust).
Fugitive
Dust
Inhalation
Workers,
ONU
Yes
EPA anticipates inhalation of dust as the
most important HBCD exposure pathway.
Fugitive
and Settled
Dust
Oral
Workers,
ONU
Yes
Oral exposure of workers to HBCD may
occur through ingestion of dust that deposits
in the upper respiratory tract and is
swallowed.
Solid
1 )ennal
ONU
No
1 )ennal exposure is expected to be primarily
to workers directly involved in working
with the chemical.
Page 98 of 115
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Appendix D SUPPORTING INFORMATION FOR CONSUMER, GENERAL POPULATION
AND ENVIRONMENTAL EXPOSURE CONCEPTUAL MODEL
Table Apx D-l. Consumer Exposure Conceptual Model Supporting Table
Life ( u'lo
SlilJiO
Release from
sou ree
r.\|)(tsui"e
Palh\\a>
Koulo
Rm-plor
Proposed
lor
l-'urlluT
Analvsis
Kiilioiiiile
('iiiiMimcr
I so
l.uildiim
a>iM niclio n
malenals
1 !I'S M'S loam
insulation mi
lesideuiial hiukhims
co\eriim la rue
surface areas- hard
plasiic ariicle
1 .oim-kTiii
emission niass-
irausfer.
\hraskni. Direcl
Transfer lo 1 )usi
Moulhiiiu
Oral
( ousuniei's
(children)
\o
( ousuniei's are nol likels lo he mi direel
couiacl and nioiiih 1 PS insulalioii.
Consumer
Use;
Consumer
Reuse and
Recyling
Building/
construction
materials
EPS/XPS foam
insulation in
residential buildings
covering large
surface areas- hard
plastic article
Long-term
emission/mass-
transfer,
Abrasion, Direct
Transfer to Dust
Suspended
particles in
Air
Inhalation
Consumers:
Adults and
Children
with EPS
insulation
in their
residence
Yes
Based on HBCD's relatively low vapor
pressure and relatively high octanol-air
partition coefficient, it is likely to
preferentially partition to smaller
suspended particles in the air. Note, EPS
and XPS will be compared and may be
considered together or separately.
Long-term
emission/mass-
transfer,
Abrasion, Direct
Transfer to Dust
Settled
Dust
Oral
Dermal
Consumers:
Adults and
Children
with EPS
insulation
in their
residence
Yes
Based on HBCD's relatively low vapor
pressure and relatively high octanol-air
partition coefficient, it is likely to
preferentially partition to settled dust
from the air, and directly to surface dust
on the material.
Direct contact
during
installation,
renovation, and
removal
Abrasion
through
drilling/saw
ing
Direct
contact
Dermal,
Inhalation,
Oral
Consumers:
Adults who
install or
remove
EPS
insulation
Yes
Drilling is a common mechanism to
attach panels to surfaces. The material
may be similarly abraded during
renovation and removal. It is expected
that adults would perform these
activities. EPS insulation is typically in
unfinished spaces where children would
not spend long amounts of time.
Page 99 of 115
-------
l.il'e ( \ele
S(;i»e
( ;i(eiion
Suhe.ilegnn
Kelense from
sou ree
l-'.xposiire
P;i(h\\;n
Uoiile
Receptor
Proposed
for
I'll rl her
\n;il\sis
Kiilioiiiile
Consumer
Use
Automotive
products
Automobile
Replacement Parts
Long-term
emission/mass-
transfer,
Abrasion, Direct
Transfer to Dust
Suspended
particles in
Air
Inhalation
Consumers:
Adults and
Children
with
replace-
ment parts
within their
automobile
Yes
Based on HBCD's relatively low vapor
pressure and relatively high octanol-air
partition coefficient, it is likely to
preferentially partition to smaller
suspended particles in the air. Note, EPS
and XPS will be compared and may be
considered together or separately.
Long-term
emission/mass-
transfer,
Abrasion, Direct
Transfer to Dust
Settled
Dust
Oral
Dermal
Consumers:
Adults and
Children
with
replace-
ment parts
in their
automobile
Yes
Based on HBCD's relatively low vapor
pressure and relatively high octanol-air
partition coefficient, it is likely to
preferentially partition to settled dust
from the air, and directly to surface dust
on the material.
Background
All
All
Suspended
particles
Indoor Air
Inhalation
Bystander/
Resident
Yes
EPA plans to analyze background levels
of HBCD in indoor air.
Background
All
All
Settled Dust
Indoor Dust
Ingestion
Bystander/
Resident
Yes
EPA plans to analyze background levels
of HBCD in indoor dust and associated
ingestion.
Background
All
All
Settled Dust
Indoor Dust
Dermal
Bystander/
Resident
Yes
EPA plans to analyze background levels
of HBCD in indoor dust and associated
dermal exposure.
Page 100 of 115
-------
Table Apx D-2. General Population and
Environmental
Exposure Conceptual Model Supporting Table
l.ilV
( \ck
Sl;i»e
Kck'sisc
I'1\|)osiiiv I\i(Iin;i\ /
Media
r.\|)(isuiv
Kuii les
Rcccplor /
Population
Proposed
for
l-'urllKT
A iiiiK sis
Kiilioiiido
All
Emissions
to Air
Near facility ambient
air concentrations
Inhalation;
Ingestion of
suspended
particles
General
Population:
Adults and
Children
living near
facilities
Yes
EPA believes that release of HBCD to air is probable
based on a preliminary review of the literature. TRI
data will be available starting in mid-2018. EPA is
currently conducting a systematic review of the
scientific literature. Based on the results of this
review, EPA will either confirm the rationale or
reach a different conclusion.
Indirect deposition to
nearby bodies of
water and soil
catchments
Surface water
and sediment
(lakes)-
Ingestion
Soil
(catchments)-
Ingestion
Uptake from
environment into
food sources-
Ingestion
General
Population:
Adults and
Children
living near
facilities
Yes
Based on HBCD's physical chemical properties, it is
likely to be released as a particulate and be deposited
to nearby water bodies and soil catchments.
Surface water
and sediment
(lakes)
Soil
(catchments)
Aquatic and
Terrestrial
Receptors
Yes
All
Industrial
pre-
treatment
and
wastewater
treatment-
Direct release into
surface water and
indirect partitioning
to sediment
Surface water
and Sediment
(rivers)
Aquatic and
Terrestrial
Receptors
Yes
EPA believes that release of HBCD in wastewater is
probable based on a preliminary review of the
literature. Its subsequent release through the
exposure pathway may result in potential for
exposure. TRI data will be available starting in mid-
2018. EPA is currently conducting a systematic
review of the scientific literature. Based on the
results of this review, EPA will either confirm the
rationale or reach a different conclusion.
Page 101 of 115
-------
l.ilV
Cu-le
S(;i»c
Rek'.ise
I'1\|)omiiv l';itliw;i> /
Media
l'l\|)UMIIV
Ron les
Receptor/
Population
Proposed
for
l-'iirlher
An;il\sis
Kiilioiiiilo
Direct release into
surface water and
partitioning to
sediment and
bioaccumulation into
edible aquatic species
Surface water
and Sediment
(rivers)
Uptake from
environment into
food sources-
Ingestion
General
Population:
Adults and
Children
living near
facilities
Yes
HBCD has been reported in surface water and
sediment concentrations near industrial facilities.
Biosolids application
to soil
Soil ingestion
Uptake from
environment into
food sources-
Ingestion
General
Population:
Adults and
Children
living near
facilities
Yes
HBCD has been detected in biosolids and soil
samples.
Biosolids application
to soil
Soil
Terrestrial
receptors
Yes
HBCD has been detected in soil samples.
Disposal
Solid and
Liquid
Wastes sent
to
Municipal
Incinerator
Indirect deposition to
nearby bodies of
water and soil
catchments
Surface water
and sediment
(lakes)-
Ingestion
Soil
(catchments)-
Ingestion
Uptake from
environment into
food sources-
Ingestion
General
Population:
Adults and
Children
living near
facilities
Yes
Municipal incinerators may release HBCD due to
incomplete removal during burning.
Solid and
Liquid
Wastes sent
to
Municipal
Incinerator
Indirect deposition to
nearby bodies of
water and soil
catchments
Surface water
and sediment
(lakes)
Soil
(catchments)
Aquatic and
Terrestrial
Receptors
Yes
Municipal incinerators may release HBCD due to
incomplete removal during burning.
Page 102 of 115
-------
l.ilV
Cu-le
S(;i»c
Rek'.ise
I'1\|)omiiv l';itliw;i> /
Media
l'l\|)UMIIV
Ron les
Receptor/
Population
Proposed
for
l-'iirlher
An;il\sis
Kiilioiiiilo
Municipal
landfill and
other land
disposal
Leachate to POTW
and surface water
Ingestion
General
Population:
Adults and
Children
living near
facilities
Yes
HBCD has been detected in leachate and HBCD
containing materials are sent to landfill as part of
disposal.
Municipal
landfill and
other land
disposal
Leachate to POTW
and surface water and
partitioning to
sediment
Surface water
and sediment
(rivers)
Aquatic
Receptors
Yes
HBCD has been detected in leachate and HBCD
containing materials are sent to landfill as part of
disposal.
Recycling
Recycling
of
EPS/XPS
materials
and
emissions
to air
Near Facility
Ambient Air
Concentrations
Inhalation
Ingestion of
suspended
particles
General
Population:
Adults and
Children
living near
facilities
Yes
EPS/XPS is the primary use HBCD and there is
continuing exposure potential near these recycling
facilities.
Indirect deposition to
nearby bodies of
water and soil
catchments
Surface water
and sediment
(lakes)-
Ingestion
Soil
(catchments)-
Ingestion
Uptake from
environment into
food sources-
Ingestion
General
Population:
Adults and
Children
living near
facilities
Yes
EPS/XPS is the primary use of HBCD and there is
continuing exposure potential near these recycling
facilities.
Indirect deposition to
nearby bodies of
water and soil
catchments
Surface water
and sediment
(lakes)
Soil
(catchments)
Aquatic and
Terrestrial
Receptors
Yes
EPS/XPS is the primary use HBCD and there is
continuing exposure potential near these recycling
facilities.
Page 103 of 115
-------
l.ilV
Cu-le
S(;i»c
Rek'.ise
I'1\|)omiiv l';itliw;i> /
Modiii
l'l\poslllV
Ron les
Rm-plor /
Population
Proposed
for
l-'iirlluT
An;il\sis
Kiilioiiiilo
All
Background
Surface water
Ingestion
General
Population:
Adults and
Children;
Aquatic and
Terrestrial
Receptors
Yes
HBCD has been detected in surface water sampling
at locations away from facilities. EPA plans to
analyze background levels of HBCD in these media
Sediment
Ingestion
Aquatic
Receptors
Yes
HBCD has been detected in sediment sampling
locations not near facilities. EPA plans to analyze
background levels of HBCD in these media
Soil
Ingestion
General
Population:
Adults and
Children;
Terrestrial
Receptors
Yes
HBCD has been detected in soil sampling locations
not near facilities. EPA plans to analyze background
levels of HBCD in these media
Aquatic Biota
n/a
Aquatic
Receptors
Yes
HBCD has been detected in aquatic biota. EPA plans
to analyze background levels of HBCD in these
organisms.
Terrestrial Biota
n/a
Terrestrial
receptors
Yes
HBCD has been detected in aquatic biota. EPA plans
to analyze background levels of HBCD in these
organisms.
Indoor Air
Inhalation
Ingestion of
suspended
particles
General
Population
Yes
HBCD has been detected in a wide range of indoor
air and dust samples. It is likely that the predominant
source of exposure is from indoor sources. However,
other sources could also contribute. Background
indoor dust concentrations will also be analyzed
Indoor Dust
Ingestion,
Dermal
General
Population
Yes
All
Background
Dietary Food Sources
Ingestion
General
Population
Yes
HBCD has been detected in a variety of dietary food
sources. These background levels will be analyzed.
All
Background
Human
Biomonitoring -
breast milk
n/a
General
Population
Yes
HBCD has been detected in breast milk and this is a
source of exposure for nursing infants and helps
inform adult exposure intakes.
Page 104 of 115
-------
l.ilV
Cu-le
S(;i»c
Rek'.ise
I'1\|)omiiv l';itliw;i> /
Modiii
l'l\pOMIIV
Routes
Km'plor/
Population
Proposed
I'or
lurllur
An;il\sis
Kiilioiiiilo
All
Background
Human
Biomonitoring-
seram-blood
n/a
General
Population
Yes
HBCD has been detected in human matrices. These
measured levels may be considered with
toxicokinetics data to compare estimates of dose.
Page 105 of 115
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Appendix E INCLUSION AND EXCLUSION CRITERIA FOR FULL
TEXT SCREENING
Appendix E contains the eligibility criteria for various data streams informing the TSCA risk evaluation:
environmental fate; engineering and occupational exposure; exposure to the general population and
consumers; and human health hazard. The criteria are applied to the on-topic references that were
identified following title and abstract screening of the comprehensive search results published on June 22,
2017.
Systematic reviews typically describe the study eligibility criteria in the form of PECO statements. PECO
stands for Population, Exposure, Comparator and Outcome and the approach is used to formulate explicit
and detailed criteria about those characteristics in the publication that should be present in order to be
eligible for inclusion in the review. EPA/OPPT adopted the PECO approach or variant to guide the
inclusion/exclusion decisions during full text screening.
Inclusion and exclusion criteria were also used during the title and abstract screening, and documentation
about the criteria can be found in the Strategy for Conducting Literature Searches document published in
June 2017 along with each of the TSCA scope documents. The list of on-topic references resulting from
the title and abstract screening is undergoing full text screening using the criteria in the PECO statements.
The overall objective of the screening process is to select the most relevant evidence for the TSCA risk
evaluation. As a general rule, EPA is excluding non-English data/information sources and will translate on
a case by case basis.
The inclusion and exclusion criteria for ecotoxicological data have been documented in the ECOTOX
SOPs. The criteria can be found at https://cfpub.epa.gov/ecotox/help.cfm?helptabs=tab4) and in the
Strategy for Conducting Literature Searches document published along with each of the TSCA scope
documents.
E.l Inclusion Criteria for Data Sources Reporting Environmental Fate
Data
EPA/OPPT developed a generic PESO statement to guide the full text screening of environmental fate data
sources. PESO stands for Pathways and Processes, Exposure, Setting or Scenario, and Outcomes.
Subsequent versions of the PESO statement may be produced throughout the process of screening and
evaluating data for the chemicals undergoing TSCA risk evaluation. Studies that comply with the inclusion
criteria in the PESO statement are eligible for inclusion, considered for evaluation, and possibly included in
the environmental fate assessment. On the other hand, data sources are excluded if they do not meet the
criteria in the PESO statement.
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 (TableApx E-2). Those that will be the focus of the environmental fate assessment for HBCD
have been indicated in Table Apx E-2. The PESO statement and information in Table Apx E-l will be
used when screening the fate data sources to ensure complete coverage of the processes, pathways and data
relevant to the fate of the chemical substance of interest.
Page 106 of 115
-------
TsihlcApx K-l. Inclusion (rilc'iin lor l):il:i Sources Reporting Knvironnienlsil l-'sile l):il:i
PI SO
l.lenienl
Kvidence
Pathways and
Processes
Environmental fate, transport, partitioning and degradation behavior across environmental
media to inform exposure pathways of the chemical substance of interest
Media of interest may include:
- Air
Surface water
Ground water
- Soil
Sediment
Biosolids
Other media including anthropogenic materials and media in the indoor
environment (e.g., dust)
Please refer to the conceptual models for more information about the exposure pathways
included in each TSCA risk evaluation.
Exposure
Environmental exposure of ecological receptors (i.e., aquatic and terrestrial organisms) to
the chemical substance of interest and/or its degradation products and metabolites
Environmental exposure of human receptors, including any potentially exposed or
susceptible subpopulations, to the substance of interest and/or its degradation products
and metabolites
Please refer to the conceptual models for more information about the ecological 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 ecological (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:
o Abiotic and biotic degradation rates, mechanisms, pathways, and products
o Bioaccumulation magnitude and metabolism rates
o Partitioning within and between environmental media (see Pathways and
Processes)
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Table Apx 1.-2. I'silc Kndpoints and Associated Processes. Media and K
Knvironiiienlsd l-'ate Assessment
vposnre Pathways Considered in (lie Development of (lie
Associated Mcdia/Kxposnri
I'illllWSIVS
Indoor
l":itc Data Kndpoint
Associated l'rocess(es)
SuiTsice wilier.
Sediment
Soil,
liiosolids
(iroiindwatcr
Air
cm i roil in en t.
anthropogenic
niiiteriids,
other mcdi;i
Required Environmental Fate Data
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
X
Bioconcentration factor (BCF), Bioaccumulation
factor (BAF)
Bioconcentration, Bioaccumulation
X
Hydrolysis rates or half-lives
Hydrolysis
X
Kaw, Henry's Law constant, and other
volatilization information
Volatilization
X
X
X
X
Koc and other sorption information
Sorption, Mobility
X
X
X
Optional Environmental Fate Data
Abiotic transformation products
Hydrolysis, Photolysis
X
X
Aerobic biotransformation products
Aerobic biodegradation
X
X
Anaerobic biotransformation products
Anaerobic biodegradation
X
X
X
Atmospheric deposition information
Atmospheric deposition
X
X
Biomagnification and related information
Trophic magnification
X
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Tsihle Apx K-2. I'silc Kndpoinls ;intl Associated Processes. Medisi iind Kxposnre Psithwsivs Considered in (lie Development of the
Knvironnienlsd I nle Assessnienl
Coagulation information
Coagulation, Mobility
X
Desorption information
Sorption, Mobility
X
X
X
Incineration removal information
Incineration
X
Suspension/resuspension information
Suspension/resuspension, Mobility
X
X
Wastewater treatment removal information
Wastewater treatment
X
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E.2 Inclusion Criteria for Data Sources Reporting Engineering and
Occupational Exposure Data
EPA/OPPT developed a generic RESO statement to guide the full text screening of engineering and
occupational exposure literature (TableApx E-3). RESO stands for Receptors, Exposure, Setting or
Scenario, and Outcomes. Subsequent versions of the RESO statement may be produced throughout the
process of screening and evaluating data for the chemicals undergoing TSCA risk evaluation. Studies
that comply with the inclusion criteria specified in the RESO statement will be eligible for inclusion,
considered for evaluation, and possibly included in the environmental release and occupational exposure
assessments, while those that do not meet these criteria will be excluded.
The RESO statement should be used along with the engineering and occupational exposure data needs
table (Table Apx E-4) when screening the literature.
TsibloApx K-
Occupsilionsil
3. Inclusion (liU'iin lor l):il:i Sources Reporting Knginccring sind
Kxposurc l);il:i
KI-'.SO l.k-im-nl
M\ iricncc
Humans:
Workers, including occupational non-users
Receptors
Environment:
Aquatic and possibly terrestrial ecological receptors (release estimates input to Exposure)
Please refer to Appendix C and Appendix D for more information about the ecological and
human receptors included in each TSCA risk evaluation.
Exposure
Worker exposure to and relevant environmental releases of the chemical substance of interest
o Any exposure route (list included: dermal, inhalation, oral) as indicated in the
conceptual model
o Any relevant media/pathway as indicated in the conceptual model
Please refer to the conceptual models for more information about the routes and media/pathways
included in each TSCA risk evaluation.
Setting or
Scenario
Any occupational setting or scenario resulting in worker exposure and environmental releases
(includes all manufacturing, processing, use, disposal indicated in Table Apx E-4 below.
Outcomes
Quantitative estimates* of worker exposures and of relevant environmental releases from
occupational settings
General information and data related and relevant to the occupational estimates*
* Metrics (e.g., mg/kg/day or mg/m3 for worker exposures, kg/site/day for releases) are determined by
toxicologists for worker exposures and by exposure assessors for releases; also, the Engineering Data Needs
(Table Apx E-4) provides a list of related and relevant general information.
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TsihlcApx K-4. Knginccring. Kiivironiiicnlsil Kolosiso :iihI Oeeupnlionnl Necessary lo
Develop
-------
TsihlcApx K-4. Knginccring. Kiivironiiicnlsil Kolosiso :iihI Oeeupnlionnl Necessary lo
Develop
-------
TsihloApx K-5. Inclusion ( ritorin lor (lie l):il:i Sources Reporting II IJ('I) Kxposurc Dsitsi 011
(.cncnil Population. C onsumers nntl Kcologic;il Ueceplors
PI CO l.k'UK'iH
l.\ idence
Population
Human: Manv different human DODulation aroiiDS mav be exposed to HBCD - including Potentially
Exposed or Susceptible Subpopulations (e.g., children, susceptible populations (lifestages, preexisting
conditions, genetic factors, pregnant women, women of child bearing age, infants), general population
exposures through all relevant media, populations with subsistence diets (fish, plants, mammals, game
animals, etc.), near facility populations, consumers and bystanders. EPA will also consider typical and
potentially highly exposed groups within these general categories. Examples may include take-home
exposures and renovation scenarios. No chemical-specific exclusions are suggested at this time. Human
biomonitoring data to be considered.
Ecological: Aauatic biota (edible and non-edible fish, daphnia. marine mammals), sediment dwelling
worms, birds, earthworms. Consider ways to target the species list-for example, edible wildlife and
species that have eco data. Many different aquatic and terrestrial species may be exposed to HBCD. No
chemical specific exclusions are suggested at this time. Wildlife biomonitoring data to be considered.
Exposure
Expected Primary Exposure Sources. Pathways, Routes:
Sources: Manufacturing. Processing. Use. and Disoosal of building insulation (extruded
polysty rene XPS and expanded polystyrene EPS). Indoor sources/materials that cover a large
surface area, arc abraded during use. or have high potential for direct contact.
Pathways: dust. soil, food (fish, brcastmilk. meat, eggs. dairy), biosolids. sediment, indoor air.
outdoor air. media specific background and source attribution to be considered.
Routes of Exposure: oral (dictarv ingestion of food, dust ingestion, soil ingestion, indoor air
ingestion of particles, mouthing of products/materials. Inhalation (indoor air and outdoor air).
Dermal (contact with dust).
Expected Lesser Exposure Sources. Pathways, Routes
Sources: Manufacturing. Processing. Use. and Disposal of products containing rccvclcd HBCD and
associated releases to water, or solid wastes. Indoor sources/materials that arc less prevalent and/or
contain relatively low concentrations of HBCD.
Pathway: surface water, outdoor air deposition, food (fruits and vegetables), media specific
background and source attribution to be considered.
Routes of Exposure: Dermal (contact with soil, contact with products/materials)
Comparator
(Scenario)
Human: 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.
Ecological: 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: Both external potential dose and internal dose based on biomonitoring and reverse dosimetry
mg/kg/day will be considered (to compare with a wide range of health effects following acute through
chronic exposures).
Ecological: Surface water concentrations, sediment concentrations, and soil concentrations will be
used (to compare with metrics used for ecological toxicity values). Targeted use of wildlife
biomonitoring data such as in certain bird species will also be explored.
E.4 Inclusion Criteria for Data Sources Reporting Human Health
Hazards
EPA/OPPT developed an HBCD-specific PECO statement (Table Apx E-6) to guide the full text
screening of the human health hazard literature. Subsequent versions of the PECOs may be produced
throughout the process of screening and evaluating data for the chemicals undergoing TSCA risk
evaluation. Studies that comply with the criteria specified in the PECO statement will be eligible for
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inclusion, considered for evaluation, and possibly included in the human health hazard assessment,
while those that do not meet these criteria will be excluded according to the exclusion criteria.
In general, the PECO statements were based on (1) information accompanying the TSCA scope
document, and (2) preliminary review of the health effects literature from sources cited in the TSCA
scope documents. When applicable, these sources (e.g., IRIS assessments, EPA/OPPT's Work Plan
Problem Formulations or risk assessments) will serve as starting points to identify PECO-relevant
studies.
'I'iihie Apx K-6. Inclusion ;iihI Inclusion Critcrin lor l);il;i Sources Reporting lluimin llcnllh
llii/nrds Uelnled lo Cyclic Aliphsilic liromiric Cluster (IlliCI) Cluster) Kxposurc 11
IM'.CO
r.k-iiK'iii
l.\ idonco
Siiviim
Piipcrs/I-Viiluivs Included
Piipers/I-Viiluivs l.xcludcd ¦'
Population b
Human
Any population
All lifestages
All study designs:
o Controlled exposure, cohort, case-control, cross-
sectional, case-crossover
Animal
All standard whole-organism mammalian species,
including rat, mouse, hamster, rabbit, guinea pig,
monkey, dog
All lifestages
Wildlife species
Non-mammalian species
Agricultural species/livestock
Mechanistic
Human or animal cells (including nonmammalian
model systems), tissues, or biochemical reactions
(e.g., ligand-binding assays); bioinformatics pathways
of disease analysis; or high-throughput screening data.
Exposure
Human and
Animal
Exposure to an administered dose or concentration of
HBCD
Exposure is measured as a concentration in an
environmental medium (e.g., air, dust, soil, diet) or
biological fluid or tissue (e.g., blood, milk, urine,
adipose tissue), or administered as a controlled dose
Exposure is in vivo
Exposure identified as or presumed to be from oral,
dermal, and inhalation routes
Not a chemical specific (study
population is not exposed to HBCD)
Exposure is to a mixture only, i.e.,
simultaneous exposure to other
chemicals in addition to HBCD (applies
to animal studies only)
Exposure via injection (e.g.,
intravenous [i.v.])
Mechanistic
Exposure based on concentrations of HBCD (individual
a-, P-, or y-isomers or the commercial/technical
mixtures)
Comparator
Human
A comparison population [not exposed, exposed to
lower levels, exposed below detection] for all endpoints
No comparison population for
endpoints
Animal and
Mechanistic
Negative controls that are vehicle-only treatment
and/or no treatment
No minimum number of dose or concentration groups
Negative controls other than vehicle-
only treatment or no treatment
Outcome
Human and
Animal
Health Endpointsb:
Irritation
Sensitization
Liver effects
Endocrine/thyroid effects
Developmental effects
Immune effects
No health outcome evaluated (e.g., a
study of HBCD exposure levels)
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Neurological effects
Reproductive effects
Acute toxicity
Other endpoints d
Mechanistic
Mechanistic data that supports the characterization of
the identified endpoints of interest
General Considerations
Papers/Features Included
Papers/Features Excluded
Written in Englishe
Reports primary source or meta-analysis.a
Full-text available
Not written in English
Reports a secondary source (e.g.,
review papers)a
No full-text available (e.g., only a
study description/abstract, out-of-
print text)
" Some of the studies that are excluded based on the PECO statement may be considered later during the systematic review process. For HBCD, EPA will
evaluate studies related to susceptibility and may evaluate toxicokinetic and physiologically based pharmacokinetic models after other data (e.g., human
and animal data identifying adverse health outcomes) are reviewed.
b EPA will review studies identified in the Preliminary Materials for the IRIS Toxicological Review of HBCD (U.S. EPA. 2014d). Mechanistic data will
be considered to support hazard characterization for these endpoints.
'Measurement of HBCD includes individual a-, (3-, or y-isomer; commercial or technical mixtures of HBCD isomers; CASRN 3194-55-6 (1,2,5,6,9,10-
hexabromocyclododecane technical mixtures); CASRN 25637-99-4 (hexabromocyclododecane, all isomers)
EPA may screen for hazards other than those listed in the scope document if they were identified in the updated literature search that accompanied the
scope document.
e EPA may translate studies as needed.
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