EPA Document # 740-D-20-008
April 2020
mzmz* ~ United States Office of Chemical Safety and
LhI i^lk Environmental Protection Agency Pollution Prevention
Draft Scope of the Risk Evaluation for
4,4'-(l-Methylethylidene)bis[2, 6-dibromophenol]
CASRN 79-94-7
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April 2020
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 5
ABBREVIATIONS AND ACRONYMS 6
EXECUTIVE SUMMARY 8
1 INTRODUCTION 11
2 SCOPE OF THE EVALUATION 11
2.1 Reasonably Available Information 11
2.1.1 S earch of Gray Literature 12
2.1.2 Search of Literature from Publicly Available Databases (Peer-Reviewed Literature) 13
2.1.3 Search of TSCA Submissions 18
2.2 Conditions of Use 19
2.2.1 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 20
2.2.2 Activities Excluded from the Scope of the Risk Evaluation 22
2.2.3 Production Volume 22
2.2.4 Overview of Conditions of Use and Lifecycle Diagram 22
2.3 Exposures 24
2.3.1 Physical and Chemical Properties 24
2.3.2 Environmental Fate and Transport 24
2.3.3 Releases to the Environment 24
2.3.4 Environmental Exposures 26
2.3.5 Occupational Exposures 26
2.3.6 Consumer Exposures 27
2.3.7 General Population Exposure 28
2.4 Hazards (Effects) 28
2.4.1 Environmental Hazards 28
2.4.2 Human Health Hazards 28
2.5 Potentially Exposed or Susceptible Subpopulations 29
2.6 Conceptual Models 29
2.6.1 Conceptual Model for Industrial and Commercial Activities and Uses 29
2.6.2 Conceptual Model for Consumer Activities and Uses 32
2.6.3 Conceptual Model for Environmental Releases and Waste: Potential Exposures and Hazards
34
2.7 Analysis Plan 36
2.7.1 Physical and Chemical Properties and Environmental Fate 36
2.7.2 Exposure 37
2.7.2.1 Environmental Releases 37
2.7.2.2 Environmental Exposures 39
2.7.2.3 Occupational Exposures 40
2.7.2.4 Consumer Exposures 42
2.7.2.5 General Population 43
2.7.3 Hazards (Effects) 46
2.7.3.1 Environmental Hazards 46
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2.7.3.2 Human Health Hazards 47
2.7.4 Summary of Risk Approaches for Characterization 49
2.8 Peer Review 50
REFERENCES 51
APPENDICES 58
Appendix l^IST OF (JILW LI I LRAT 1.RE SOI Rt LS 58
Appendix B PHYSICAL
Appendix C ENVIRONMENTAL FATE AND TRANSPORT PROPERTIES 63
Appendix D REGULATOR IIISTORY 65
D.l Federal Laws and Regulations 65
D.2 State Laws and Regulations. 66
D.3 International Laws and Regulations[[[ 67
Appendix E PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION 69
ill Process Information.................... 69
E. 1.1 Manufacture (Including Import) 69
E. 1.1.1 Domestic Manufacturing 69
E.l.1.2 Import 69
E. 1.2 Processing and Distribution 69
E. 1.2.1 Processing as a Reactant 69
E. 1.2.2 Incorporated into a Formulation, Mixture or Reaction Product 69
E. 1.2.3 Incorporated into an Article 69
E. 1.2.4 Recycling 69
E.1.3 Uses Included in Scope 70
E. 1.3.1 Adhesive Manufacturing 70
E. 1.3.2 Intermediate (e.g., transportation equipment manufacturing) 70
E.1.3.3 Intermediate (e.g., all other chemical product and preparation manufacturing) 70
E.1.3.4 Building/Construction Materials 70
E. 1.3.5 El ectri cal and El ectroni c Products 70
E.1.3.6 Plastic Products and Resins 71
E.1.3.7 Fabric, Textiles and Leather Products not Covered Elsewhere 71
E.1.3.8 Batteries 72
E.1.3.9 Laboratory Chemical 72
E.1.3.10 Disposal 72
E.2 Preliminary Occupational Exposure Data 72
Appendix K SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR INDUSTRIAL AND
COMMERCIAL ACTIVITIES AND USES 73
Appendix C SUPPORTING INFORMATION - CONCECPTUAL MODEL FOR CONSUMER
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LIST OF TABLES
Table 2-1 Results of Title Screening of Submissions to EPA Under Various Sections of TSCA 19
Table 2-2 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 20
Table 2-3 Summary of TBBPA TRI Production-Related Waste Managed in 2018 25
Table 2-4 Summary of Releases of TBBPA to the Environment During 2018 25
Table 2-5 Categories and Sources of Environmental Release Data 37
LIST OF FIGURES
Figure 2-1 Gray Literature Search Results for TBBPA 12
Figure 2-2 Peer-reviewed Literature - Physical-Chemical Properties Search Results for TBBPA 14
Figure 2-3 Peer-reviewed Literature - Fate and Transport Search Results for TBBPA 15
Figure 2-4 Peer-reviewed Literature - Engineering Search Results for TBBPA 16
Figure 2-5 Peer-reviewed Literature - Exposure Search Results for TBBPA 17
Figure 2-6 Peer-reviewed Literature - Hazard Search Results for TBBPA 18
Figure 2-7 TBBPA Life Cycle Diagram 23
Figure 2-8 TBBPA Conceptual Model for Industrial and Commercial Activities and Uses: Worker and
ONU Exposures and Hazards 31
Figure 2-9 TBBPA Conceptual Model for Consumer Activities and Uses: Consumer Exposures and
Hazards 33
Figure 2-10 TBBPA Conceptual Model for Environmental Releases and Wastes: Environmental and
General Population Exposures and Hazards 35
LIST OF APPENDIX TABLES
TableApx A-l Gray Literature Sources That Yielded Results for TBBPA 58
TableApx B-l Physical and Chemical Properties of TBBPA 61
Table Apx C-l Environmental Fate Characteristics of TBBPA 63
Table_Apx D-l Federal Laws and Regulations 65
Table_Apx D-2 State Laws and Regulations 66
Table Apx D-3 Regulatory Actions by other Governments, Tribes, and International Agreements 67
Table Apx E-l Potentially Relevant Data Sources for Exposure Monitoring and Area Monitoring Data
from NIOSH Health Hazard Evaluations for TBBPAa 72
Table Apx F-l Worker and ONU Exposure Conceptual Model Supporting Table 73
Table Apx G-l Consumer Exposure Conceptual Model Supporting Table 81
Table Apx H-l Environmental Releases and Wastes Conceptual Model Supporting Table 83
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ACKNOWLEDGEMENTS
This report was developed by the United States Environmental Protection Agency (U.S. EPA), Office of
Chemical Safety and Pollution Prevention (OCSPP), Office of Pollution Prevention and Toxics (OPPT).
Acknowledgements
The OPPT Assessment Team gratefully acknowledges participation or input from intra-agency reviewers
that included multiple offices within EPA, inter-agency reviewers that included multiple federal agencies,
and assistance from EPA contractors GDIT (Contract No. HHSN316201200013W), ERG (Contract No.
EP-W-12-006), Versar (Contract No. EP-W-17-006), ICF (Contract No.68HERC19D0003), Abt
Associates (Contract No. EP-W-16-009) and SRC (Contract No. 68HERH19F0213). EPA also
acknowledges the contributions of technical experts from EPA's Office of Research and Development.
Docket
Supporting information can be found in public docket: ] Q-QPPT-2018-0462
Disclaimer
Reference herein to any specific commercial products, process or service by trade name, trademark,
manufacturer or otherwise does not constitute or imply its endorsement, recommendation or favoring by
the United States Government.
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ABBREVIATIONS AND ACRONYMS
ACA
The American Coatings Association
ACGIH
American Conference of Government Industrial Hygienists
AIA
The Aerospace Industry Association
BAF
Bioaccumulation factor
BCF
Bioconcentration factor
BMF
Biomagnification factor
BW 3/4
Body weight scaling to the 3/4 power
C&D
Construction and demolition
CAA
Clean Air Act
CBI
Confidential business information
CDR
Chemical Data Reporting
ChemSTEER Chemical Screening Tool for Exposure and Environmental Releases
CHRIP
Chemical Risk Information Platform
COC
Concentration of concern
CoRAP
Community Rolling Action Plan
CPCat
Chemical and Product Categories
CSCL
Chemical Substances Control Law
ECHA
European Chemicals Agency
EC
Engineering controls
ECx
Concentration that causes a response that is x% of the maximum
EPCRA
Emergency Planning and Community Right-to-Know Act
ESD
Emission Scenario Document
FYI
For Your Information
GS
Generic Scenario
HAP
Hazardous air pollutant
HAWC
Health Assessment Workspace Collaborative
HHE
Health hazard evaluation
IECCU
Indoor Environmental Concentrations in Buildings with Conditioned and Unconditioned
Zones
Koc
Organic carbon: water partition coefficient
LCso
Lethal concentration of 50% of test organisms
LCx
Lethal concentration that is x% of the maximum
LOAEL
Lowest observed adverse effect level
LOEC
Lowest observed effect concentration
MCI
Molecular conductivity index
MITI
Ministry of International Trade and Industry
mm Hg
Millimeter(s) of mercury
MOA
Mode of action
MSWLF
Municipal Solid Waste Landfill(s)
NAMs
New approach methods
NIEHS
National Institute of Environmental Health Sciences
NIOSH
National Institute for Occupational Safety and Health
NITE
National Institute of Technology and Evaluation
NOAEL
No observed adverse effect level
NOEC
No observed effect concentration
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NTP
National Toxicology Program
OH
Hydroxide
OECD
Organisation for Economic Cooperation and Development
ONU
Occupational non-user
OPPT
Office of Pollution Prevention and Toxics
OSHA
Occupational Safety and Health Administration
P-chem
Phy si cal -chemi cal
PBB
Polybrominated biphenyls
PBPK
Physiologically based pharmacokinetic
PBB
Polybrominated biphenyl
PBT
Persistent, bioaccumulative, toxic
PCB
Polychlorinated biphenyls
PCN
Polychlorinated naphthalene
PCT
Polychlorinated terphenyl
PECO
Population, exposure, comparator, outcome
PEL
Permissible Exposure Limit
PESS
Potentially Exposed or Susceptible Subpopulation
PNOR
Particulates Not Otherwise Regulated
POD
Point of departure
PPE
Personal protective equipment
POTW
Publicly Owned Treatment Works
RCRA
Resource Conservation and Recovery Act
RoHS
Restriction of Hazardous Substances
RQ
Risk quotient
SDS
Safety data sheet
SMILES
Simplified molecular-input line-entry system
SVOC
Semi-volatile organic compound
TBBPA
Tetrabromobisphenol A or 4,4'-( 1 -Methylethylidene)bis[2, 6-dibromophenol]
TIAB
Title and abstract
TMF
Trophic magnification factor
TRI
Toxics Release Inventory
TSCA
Toxic Substances Control Act
VP
Vapor pressure
WEEE
Waste electrical and electronic equipment
WWT
Wastewater treatment
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EXECUTIVE SUMMARY
In December 2019, EPA designated 4,4'-(l-methylethylidene)bis[2, 6-dibromophenol], also known as
tetrabromobisphenol A (TBBPA) (CASRN 79-94-7), as a high-priority substance for risk evaluation
following the prioritization process required by Section 6(b) of the Toxic Substances Control Act (TSCA)
and implementing regulations (10 O R Part702) (Docket ID: i H 1 '0-QPPT-2018-0462V The first step
of the risk evaluation process is the development of the scope document and this document fulfills the
TSCA regulatory requirement to issue a draft scope document as described in 40 CFR 702.41(c)(7). The
draft scope for TBBPA includes the following information: the conditions of use, potentially exposed or
susceptible subpopulations (PESS), hazards, and exposures that EPA plans to consider in this risk
evaluation, along with a description of the reasonably available information, conceptual model, analysis
plan and science approaches, and plan for peer review for this chemical substance. EPA is providing a 45-
day comment period on the draft scope. Comments received on this draft scope document will help
inform development of the final scope document and the risk evaluation.
General Information. TBBPA is a crystalline solid with a total production volume in the United States
between 50 million and 100 million pounds.
Reasonably Available Information. EPA leveraged the data and information sources already described in
the document supporting the High-Priority Substance designation for TBBPA to inform the development
of this draft scope document. To further develop this draft scope document, EPA conducted a
comprehensive search to identify and screen multiple evidence streams (i.e., chemistry, fate, release and
engineering, exposure, hazard), and the search and screening results to date are provided in Section 2.1.
EPA is seeking public comment on this draft scope document and will consider additional information
identified following publication of this draft scope document, as appropriate, in developing the final scope
document. EPA is using the systematic review process described in the Application of Systematic Review
in TSCA Risk Evaluations document (U.S. EPA, 2018a) to guide the process of searching for and
screening reasonably available information, including information already in EPA's possession, for use
and inclusion in the risk evaluation. EPA is applying these systematic review methods to collect
reasonably available information regarding hazards, exposures, PESS, and conditions of use that will help
inform the risk evaluation for TBBPA.
Conditions of Use. EPA plans to evaluate manufacturing (including import), processing, distribution in
commerce, industrial, commercial and consumer uses, and disposal of TBBPA in the risk evaluation.
TBBPA is manufactured within the U.S. as well as imported into the U.S. The chemical is processed as a
reactant, incorporated into a formulation, mixture or reaction products and incorporated into articles. The
identified processing activities also include the recycling of TBBPA and TBBPA containing products.
TBBPA is primarily used as a flame retardant in electrical and electronic products, adhesives,
transportation equipment, building/construction materials and textiles. It is also used as an intermediate to
create other flame retardants and as a laboratory chemical. The predominate uses for TBBPA are as a
reactive flame retardant in electrical and electronic products (e.g., printed circuit boards) and as an
additive flame retardant in electrical and electronic products (e.g., plastic enclosures). The epoxy resin
containing TBBPA can also be used in adhesives, transportation equipment and building/construction
materials. The information on the use in textiles is limited in detail and the public is invited to submit
information on this use. EPA identified these conditions of use from information reported to EPA through
Chemical Data Reporting (CDR) and Toxics Release Inventory (TRI) reporting, published literature and
consultation with stakeholders. Section 2.2 details about the conditions of use within the scope of the risk
evaluation.
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Conceptual Models. The conceptual models for TBBPA are presented in Section 2.6. Conceptual models
are graphical depictions of the actual or predicted relationships of conditions of use, exposure pathways
(e.g., media), exposure routes (e.g., inhalation, dermal, oral), hazards, and receptors throughout the life
cycle of the chemical substance. EPA plans to focus the risk evaluation for TBBPA on the following
exposures, hazards, and receptors with the understanding that updates may be made in the final scope
document after consideration of public comments and completion of the systematic review data collection
phase.
• Exposures (Pathways and Routes), Receptors and PESS. EPA plans to analyze both human and
environmental exposures resulting from the conditions of use of TBBPA that EPA plans to
consider in the risk evaluation. Exposures for TBBPA are discussed in Section 2.3. EPA identified
environmental monitoring data reporting the presence of TBBPA in surface water, groundwater,
biosolids and sediment. Additional information gathered through systematic review searches will
also inform expected exposures.
In Section 2.6.3, EPA presents the conceptual models describing the identified exposures
(pathways and routes), receptors and hazards associated with the conditions of use of TBBPA
within the scope of the risk evaluation.
Preliminarily, EPA plans to include the following human and environmental exposure pathways,
routes, receptors and PESS in the scope of the risk evaluation. However, EPA plans to consider
comments received on this draft scope and other reasonably available information when finalizing
this scope document, and to adjust the exposure pathways, exposure routes and hazards included
in the scope document as needed.
- Occupational exposures associated with manufacturing (including import), processing,
industrial and commercial use, and disposal: EPA plans to evaluate exposures to workers
and/or occupational non-users (ONUs) via the inhalation route and exposures to workers
via the dermal route associated with the manufacturing, processing, use or disposal of
TBBPA (Section 2.2.1).
- Consumer and bystander exposures associated with consumer conditions of use: EPA
plans to evaluate inhalation and dermal exposure to TBBPA when consumers are handling
electrical and electronic products, batteries, building/construction materials, and fabric,
textiles and leather products containing TBBPA, and children's mouthing or
products/articles containing TBBPA.
- General population exposures: EPA plans to evaluate exposure via the oral route to
TBBPA via drinking water, groundwater, fish ingestion, human breast milk and soil for the
general population and via the inhalation route for ambient air.
- Environmental exposures: EPA plans to evaluate exposure to TBBPA for aquatic and
terrestrial receptors via various pathways including surface water, sediment and soil.
- Receptors and PESS: EPA plans to include children, women of reproductive age
(including, but not limited to, pregnant women), workers and consumers as receptors and
PESS in the risk evaluation.
Hazards. Hazards for TBBPA are discussed in Section 2.4. EPA completed preliminary reviews of
information from peer-reviewed assessments and databases to identify potential environmental and
human health hazards for TBBPA as part of the prioritization process. Environmental hazard
effects were identified for aquatic and terrestrial organisms. Information collected through
systematic review methods and public comments may identify additional environmental hazards
that warrant inclusion in the environmental hazard assessment of the risk evaluation.
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EPA will use systematic review methods to evaluate the epidemiological and toxicological
literature for TBBPA. Relevant mechanistic evidence will also be considered, if reasonably
available, to inform the interpretation of findings related to potential human health effects and the
dose-repose assessment. EPA plans to evaluate all potential human health hazards for TBBPA
identified in Section 2.4.2. The broad health effect categories include immunological,
neurological, carcinogenic, developmental and reproductive effects. Effects were seen in
epidemiological and biomonitoring human studies.
Analysis Plan. The analysis plan for TBBPA is presented in Section 2.7. The analysis plan outlines the
general science approaches that EPA plans to use for the various evidence streams (i.e., chemistry, fate,
release and engineering, exposure, hazard) supporting the risk evaluation. The analysis plan is based on
EPA's knowledge of TBBPA to date, which includes a partial, but ongoing, review of identified
information as described in Section 2.1. EPA will continue to consider new information submitted by the
public. Should additional data or approaches become reasonably available, EPA may update its analysis
plan in the final scope document.
EPA will seek public comments on the systematic review methods supporting the risk evaluation for
TBBPA, including the methods for assessing the quality of data and information and the approach for
evidence synthesis and evidence integration supporting the exposure and hazard assessments. The details
will be provided in a supplemental document that EPA anticipates releasing for public comment prior to
the finalization of the scope document.
Peer Review. The draft risk evaluation for TBBPA will be peer reviewed. Peer review will be conducted
in accordance with relevant and applicable methods for chemical risk evaluations, including using EPA's
Peer Review Handbook (U.S. EPA, 2015b) and other methods consistent with Section 26 of TSCA (See
40 CFR 702.45V
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1 INTRODUCTION
This document presents for comment the draft scope of the risk evaluation to be conducted for TBBPA
under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The Frank R. Lautenberg
Chemical Safety for the 21st Century Act amended the Toxic Substances Control Act (TSCA) on June 22,
2016. The new law includes statutory requirements and deadlines for actions related to conducting risk
evaluations of existing chemicals.
Under TSCA § 6(b), the Environmental Protection Agency (EPA) must designate chemical substances as
high-priority substances for risk evaluation or low-priority substances for which risk evaluations are not
warranted at the time, and upon designating a chemical substance as a high-priority substance, initiate a
risk evaluation on the substance. TSCA § 6(b)(4) directs EPA, in conducting risk evaluations for existing
chemicals, to "determine whether a chemical substance presents an unreasonable risk of injury to health
or the environment, without consideration of costs or other non- risk factors, including an unreasonable
risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by
the Administrator, under the conditions of use."
TSCA § 6(b)(4)(D) and implementing regulations require that EPA publish the scope of the risk
evaluation to be conducted, including the hazards, exposures, conditions of use and potentially exposed or
susceptible subpopulations that the Administrator expects to consider, within 6 months after the initiation
of a risk evaluation. In addition, a draft scope is to be published pursuant to 40 CFR 702.41. In December
2019, EPA published a list of 20 chemical substances that have been designated high priority substances
for risk evaluations (84 FR 71924). as required by TSCA § 6(b)(2)(B), which initiated the risk evaluation
process for those chemical substances. TBBPA is one of the chemicals designated as a high-priority
substance for risk evaluation.
2 SCOPE OF THE EVALUATION
2.1 Reasonably Available Information
EPA conducted a comprehensive search for reasonably available information1 to support the development
of this draft scope document for TBBPA. EPA leveraged the data and information sources already
identified in the documents supporting the chemical substance's high-priority substance designation for
TBBPA to inform the development of this draft scope document. To further develop this draft scope
document, EPA searched for additional data and information on physical and chemical properties,
environmental fate, engineering, exposure and environmental and human health hazards that could be
obtained from the following general categories of sources:
1. Databases containing publicly available, peer-reviewed literature;
2. Gray literature, which is defined as the broad category of data/information sources not found in
standard, peer-reviewed literature databases.
3. Data and information submitted under TSCA sections 4, 5, 8(e), and 8(d), as well as "for your
information" (FYI) submissions.
1 Reasonably available information means information that EPA possesses or can reasonably generate, obtain, and synthesize
for use in risk evaluations, considering the deadlines specified in TSCA section 6(b)(4)(G) for completing such evaluation.
Information that meets the terms of the preceding sentence is reasonably available information whether or not the information
is confidential business information, that is protected from public disclosure under TSCA section 14 (40 CFR 702.33).
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Following the comprehensive search, EPA performed a title and abstract screening to identify information
potentially relevant for the risk evaluation process. This step also classified the references into useful
categories or tags to facilitate the sorting of information through the systematic review process. The
search and screening process was conducted based on EPA's general expectations for the planning,
execution and assessment activities outlined in the Application of Systematic Review in TSCA Risk
Evaluations document (U.S. EPA, 2018a). EPA will publish supplemental documentation on the
systematic review methods supporting the TBBPA risk evaluation to explain the literature and screening
process presented in this document in the form of literature inventory trees. Please note that EPA focuses
on the data collection phase (consisting of data search, data screening, and data extraction) during the
preparation of the TSCA scope document, whereas the data evaluation and integration stages will occur
during the development of the draft risk evaluation and thus are not part of the scoping activities
described in this document.
The subsequent sections summarize the data collection activities completed to date for the general
categories of sources and topic areas (or disciplines) using systematic review methods. EPA plans to seek
public comments on the systematic review methods supporting the risk evaluation for TBBPA upon
publication of the supplemental documentation of those methods.
2.1.1 Search of Gray Literature
EPA surveyed the gray literature2 and identified 99 search results relevant to EPA's risk assessment needs
for TBBPA. 0 lists the gray literature sources that yielded 99 discrete data or information sources relevant
to TBBPA. EPA further categorized the data and information into the various topic areas (or disciplines)
supporting the risk evaluation (e.g., physical chemistry, environmental fate, ecological hazard, human
health hazard, exposure, engineering) and the breakdown is shown in Figure 2-1. EPA is currently
identifying additional reasonably available information (e.g., public comments), and the reported numbers
in Figure 2-1 may change.
Gray Literature Tags by Discipline
21/99
Physical.Chemical
I IumanJ Iealth. I Iazard
20/99
55/99
Exposure
Environmental. Hazard
64/99
Engineering
0 25 50 75 100
Percent Tagged (%)
Figure 2-1 Gray Literature Search Results for TBBPA
The percentages across disciplines do not add up to 100%, as each source may provide data or information for various topic
areas (or disciplines).
2 Gray literature is defined as the broad category of data/information sources not found in standard, peer-reviewed literature
databases (e.g., PubMed and Web of Science). Gray literature includes data/information sources such as white papers,
conference proceedings, technical reports, reference books, dissertations, information on various stakeholder websites, and
other databases.
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2.1.2 Search of Literature from Publicly Available Databases (Peer-Reviewed Literature)
EPA is currently conducting a systematic review of the reasonably available literature. This includes
performing a comprehensive search of the reasonably available peer review literature on physical-
chemical (p-chem) properties, environmental fate and transport, engineering (environmental release and
occupational exposure), exposure (environmental, general population and consumer) and
environmental and human health hazards of TBBPA. Eligibility criteria were applied in the form of
population, exposure, comparator, outcome (PECO) or similar statements. Included references met
the PECO or similar criteria, whereas excluded references did not meet the criteria (i.e., not
relevant), and supplemental material was considered as potentially relevant. EPA plans to analyze
the reasonably available information identified for each discipline during the development of the
risk evaluation. The literature inventory trees depicting the number of references that were
captured and those that were included, excluded, or tagged as supplemental material during the
screening process for each discipline area are shown in
Figure 2-2 through Figure 2-6. "TIAB" in these figures refers to title and abstract screening. Note
that in some figures the sum of the numbers for the various sub-categories may be larger than the
broader category because some studies may be included under multiple sub-categories. In other
cases, the sum of the various sub-categories may be smaller than the main category because some
studies may not be depicted in the sub-categories if their relevance to the risk evaluation was
unclear.
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Boiling Point
Melting Point
Water Solublity
log KOW
Henry's Law Constant
Vapor Pressure
Vapor Density
Density
Viscosity
Retrieved for Full-text
Review
Included for Data
Extraction and Data
Evaluation
Dielectric Constant
Refractive Index
Total for TIAB:
P-Chem
Supplemental Information
Exclusion
Exclusion
Figure 2-2 Peer-reviewed Literature - Physical-Chemical Properties Search Results for TBBPA
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©
Bioconcentration, Biomagnification, etc.
Biodegradation
®
Hydrolysis
©
Photolysis
©
Sorption
©
Volatilization
©
Wastewater Treatment
©
Other
Included
TSCA Fate TBBPA (2020)
Excluded
©
Supplemental
Figure 2-3 Peer-reviewed Literature - Fate and Transport Search Results for TBBPA
Click here for interactive Health Assessment Workspace Collaborative (HAWC) Diagram.
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General Facility Estimate
Environmental Releases
Occupational Exposure
429
345
Total for TIAB:
Engineering
Excluded
Figure 2-4 Peer-reviewed Literature - Engineering Search Results for TBBPA
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surface water (2)
soil (1)
ground water (2)
foreign language (2)
Supplemental (4)
epidemiological/ biomonitoring study (1)
consumer uses and/or products (1)
ambient air (1)
terrestrial species (27)
surface water (48)
soil (32)
Unique HERO IDs (814)
Exclude (375)
sediment (70)
no evidence (not PECO-relevant) (4)
indoor air (67)
ground water (10)
foreign language (1)
Include (435)
Relevant (350)
evidence unclear (PECO relevancy unclear) (1)
epidemiological/ biomonitoring study (66)
drinking water (3)
dietary (51)
consumer uses and/or products (49)
biosolids/ sludge (28)
aquatic species (58)
ambient air (31)
Unclear (85)
evidence unclear (PECO relevancy unclear) (85)
Figure 2-5 Peer-reviewed Literature - Exposure Search Results for TBBPA
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185
Retrieved for Full-text Review
0
Human
{125 )
Animal
©
Riant
Human Health Model
Q
Ecotoxicological Model
1328
TSCA Hazard TBBPA (2020)
Q
Exclusion
Mechanistic
rs*
ADMEfTKIPBPK
0
Mixture
Case Study or Case Series
298
Supplemental Material
No Original Data
0
Conference Abstract
<§>
Susceptible Population
<£)
Non-English Record
0
Field Study
V ®
Agent to Induce Allergenic Response
0
PECO-Relevant Isomer Study
Figure 2-6 Peer-reviewed Literature - Hazard Search Results for TBBPA
Click here for interactive HAWC Diagram.
2.1.3 Search of TSCA Submissions
Table 2-1 presents the results of screening the titles of data sources and reports submitted to EPA under
various sections of TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century
Act. EPA screened a total of 96 submissions using inclusion/exclusion criteria specific to individual
disciplines (see Table 2-1 for the list of disciplines). The details about the criteria are not part of this
document but will be provided in a supplemental document that EPA anticipates releasing prior to the
finalization of the scope document. EPA identified 70 submissions that met the inclusion criteria in these
statements and identified 10 submissions with supplemental data. EPA excluded 16 submissions because
the reports were identified as one of the following:
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• Preliminary, interim or draft report of a final available submitted report
• Status report
• Data not relevant to any discipline
• Letter with no data
• Material safety data sheet
EPA plans to conduct additional deduplication at later stages of the systematic review process (e.g., full
text screening), when more information regarding the reports is available.
Table 2-1 Results of Title Screening of Submissions to EPA Under Various Sections of TSCA
Discipline
Included"
Supplemental11
Physicochemical Properties
5
0
Environmental Fate and Transport
13
0
Environmental and General Population
Exposure
1
0
Occupational Exposure/Release
Information
1
0
Environmental Hazard
28
1
Human Health Hazard
35
9
aA given submission may have information on multiple disciplines; therefore, the sum of submissions in each column may be
greater than the total number of included or supplemental submissions.
2.2 Conditions of Use
As described in the Proposed Designation of 4,4'-(l-Methylethylidene)bisf2,6-dibromophenoll (CASRN
79-94-7) as a High-Priority Substance for Risk Evaluation (U.S. EPA 2019a), EPA assembled
information from the CDR and TRI programs to determine conditions of use3 or significant changes in
conditions of use of the chemical substance. EPA also consulted a variety of other sources to identify uses
of TBBPA including: published literature, company websites, government and commercial trade
databases and publications. To identify formulated products containing TBBPA, EPA searched for safety
data sheets (SDS) using internet searches, EPA Chemical and Product Categories (CPCat) data (U.S.
EPA, 2019b) and other resources in which SDSs could be found. SDSs were cross-checked with company
websites to make sure that each product's SDS was current. In addition, EPA incorporated
communications with companies, industry groups, environmental organizations and public comments to
supplement the conditions of use information.
EPA identified and described the categories and subcategories of conditions of use that will be included in
the scope of the risk evaluation (Section 2.2.1; Table 2-2). The conditions of use included in the scope are
those reflected in the life cycle diagrams and conceptual models.
After gathering reasonably available information related to the manufacture, processing, distribution in
commerce, use, and disposal of TBBPA, EPA identified those categories or subcategories of use activities
3 Conditions of use means the circumstances, as determined by the Administrator, under which a chemical substance is
intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.
19
-------
for TBBPA the Agency determined not to be conditions of use or will otherwise be excluded during
scoping. These categories and subcategories are described in Section 2.2.2.
2.2.1 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
Table 2-2 lists the conditions of use that are included in the scope of the risk evaluation.
Table 2-2 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
l.il'c C ycle
C':ile«iorv
Siihciilc«iorv
References
Manufacturing
Domestic manufacture
Domestic manufacture
U.S. EPA, 2019c
Import
Import
U.S. EPA, 2019c
Processing
Processing as a
reactant
Flame retardant (e.g.,
plastic material and resin
manufacturing)
U.S. EPA, 2019c
Intermediate (e.g., all other
chemical product and
preparation manufacturing)
U.S. EPA, 2019c
Processing -
incorporating into
formulation, mixture
or reaction product
Flame retardant (e.g.,
electrical equipment,
appliance and component
manufacturing)
U.S. EPA, 2019c; EPA-F
OPPT-2018-0462-0006:
HO-OPPI-2018-0462-0(
10-
EPA-
)17
Flame retardant (e.g.,
plastic material and resin
manufacturing)
U.S. EPA, 2019c; EPA-F
OPPT-2018-0462-0006:
HO-OPPT-2018-0462-0(
1.0-
EPA-
LLZ
Flame retardant (e.g.,
plastics product
manufacturing)
U.S. EPA, 2019c; EPA-F
OPPT-2018-0462-0006:
HO-OPPT-2018-0462-0(
10-
EPA-
)16
Flame retardant (e.g.,
computer and electronic
product manufacturing)
U.S. EPA, 2019c: EPA-F
OPPT-2018-0462-0006:
HO-OPPT-2018-0462-0(
iQ=
EPA-
)16
Intermediate (e.g.,
transportation equipment
manufacturing)
U.S. EPA, 2019c; EPA-F
OPPT-2018-0462-0004:
HO-OPPT-2018-0462-0(
10-
EPA-
U6
Adhesive Manufacturing
EPA-HO-OPPT-2018-0462-
0003; NIEHS (2002): CPSC
(2015): EPA-HO-OPPT-2018-
0462-0004: EPA-HO-OPPT-
2018-0462-0016
Processing -
incorporating into
articles
Flame retardant (e.g.,
Electrical equipment,
appliance and component
manufacturing)
U.S. EPA, 2019c
Flame retardant (e.g.,
Plastics product
manufacturing)
U.S. EPA, 2019c
20
-------
Life Cycle Sl:i»e
C:ile«><>rY
Siihc:ile«ior\
Uelerences
Recycling
Recycling
U.S. EPA, 2019c; U.S. EPA,
2019d: EPA-HO-OPPT-2018-
0462-
Distribution in
com mora.1 1''
Distribution in
commerce
Distribution in commerce
Industrial and
Commercial0
Construction, Paint,
Electrical and Metal
Products
Electrical and electronic
products (e.g., reactive
flame retardant)
U.S. EPA, 2019c; EPA-F
OPPT-2018-0462-0006:
HO-OPPT-2018-0462-0(
1.0-
EPA-
U6
Electrical and electronic
products (e.g., additive
flame retardant in plastic
enclosures)
U.S. EPA, 2019c; EPA-F
OPPT-2018-0462-0006:
HO-OPPT-2018-0462-0(
iQ=
E.PA-
)16
Building/construction
materials not covered
elsewhere
U.S. EPA, 2019c; NIEHS,
2002
Batteries (e.g., adhesive in
lead-acid battery casings)
Yuasa, 2015
Furnishing, Cleaning
and Treatment/Care
Products
Fabric, textile and leather
products not covered
elsewhere
EPA-HO-OPPT-2018-0462-
00.1.6: NIEHS (2002): IPCS,
1995; Gain, 1997; Gustafsson,
1988
Other
E.g. Laboratory chemical
Sigma-Aldrich, 2019
Consumer
Construction, Paint,
Electrical and Metal
Products
Electrical and electronic
products (e.g., reactive
flame retardant)
U.S. EPA, 2019c: EPA-F
OPPT-2018-0462-0006:
HQ-OPPT-20.1.8-0462-0(
EPA-HO-OPPT-20.1.8-04
00.1.6
KJt;
EPA-
>17;
62-
Electrical and electronic
products (e.g., additive
flame retardant in plastic
enclosures)
U.S. EPA, 2019c; EPA-F
OPPT-20.1.8-0462-0006:
HO-OPPT-20.1.8-0462-0(
I.O-
EPA-
)16
Batteries (e.g., adhesive in
lead-acid battery casings)
Yuasa, 2015
Furnishing, Cleaning
and Treatment/Care
Products
Fabric, textile and leather
products not covered
elsewhere
EPA-Fi.O-OPPI-20.1.8-0462-
00.1.6; NIEHS, 2002; IPCS,
1995; Gain, 1997; Gustafsson,
1988
Disposal a
Disposal
Disposal
a CDR includes information on the manufacturing, processing and use of chemical substances. CDR may not
provide information on other life-cycle phases such as distribution or chemical end-of-life after use in products (i.e.,
disposal). The table rows are highlighted in gray to indicate that no CDR information is provided for this life-cycle
stage.
b EPA is particularly interested in information from the public on distribution in commerce.
0 For the purposes of distinguishing scenarios in this document, the Agency interprets the authority over "any manner or
method of commercial use" under TSCA section 6(a)(5) to reach both commercial and industrial uses.
dUse definitions also applicable to the life cycle diagram:
- "Industrial use" means use at a site at which one or more chemicals or mixtures are manufactured (including
imported) or processed.
21
-------
I.il'c C Ycli' Sl:i»i'
CiiU'fiorv
S»hc:Hi'»ory
Ul'll'ITIlCl'S
- "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.
2.2.2 Activities Excluded from the Scope of the Risk Evaluation
As explained in the final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic
Substances Control Act, TSCA section 6(b)(4)(D) requires EPA to identify the hazards, exposures,
conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to
consider in a risk evaluation, suggesting that EPA may exclude certain activities that it determines to be
conditions of use on a case-by-case basis (82 FR 33726, 33729; July 20, 2017). TSCA section 3(4) also
grants EPA the authority to determine what constitutes a condition of use for a particular chemical
substance. EPA does not plan to include in this scope or in the risk evaluation activities that the Agency
has concluded do not constitute conditions of use. No conditions of use were excluded for TBBPA.
2.2.3 Production Volume
Total production volume of TBBPA in 2015 was between 50 million and 100 million pounds, as reported
to EPA in the 2016 CDR reporting period (U.S. EPA, 2017). EPA also plans to use CDR production
volume information prior to 2015, as detailed in the ProposedDesisnation of 4,4'-(l-
Metkyleihytidem)bisf2,6-dibromovhenol] (CASRN 79-94-7) as a High-Priority Substance for Risk
Evaluation (U.S. EPA, 2019a) and will include future production volume information as it becomes
available to support the exposure assessment.
2.2.4 Overview of Conditions of Use and Lifecycle Diagram
The life cycle diagram provided in Figure 2-7 depicts the conditions of use that are considered within the
scope of the risk evaluation for the various life cycle stages as presented in Section 2.2.1. Section 2.2.1
provides a brief overview of the industrial, commercial and consumer use categories included in the life
cycle diagram. Appendix E contains more detailed descriptions (e.g., process descriptions, worker
activities, process flow diagrams) for each manufacture, processing, distribution in commerce, use and
disposal category.
The information in the life cycle diagram is grouped according to the CDR processing codes and use
categories (including functional use codes for industrial uses and product categories for industrial,
commercial and consumer uses). The production volume of TBBPA in 2015 is included in the lifecycle
diagram, as reported to EPA during the 2016 CDR reporting period, as a range between 50 million and
100 million pounds (Figure 2-7) (U.S. EPA, 2017).
22
-------
MFG/LMPORT
PROCESSING
INDUSTRIAL, COMMERCIAL, CONSUMER USES
RELEASES and WASTE DISPOSAL
Manufacture
(Including Import)
(50,000,000 -
100:0005000 Ib/yr)
Processing as Reactant
(Flame retardant in: Plastic material and
resin manufacturing; Intermediate in: All
other chemical product and preparation
manufacturing)
Incorporating into Formulation.
Mixture, or Reaction Product
(Flame Retardant in: electrical equipment,
appliance, and component manufacturing:
plastic material and resin manufacturing:
plastics pro duct manufacturing; computer
and electronic product manufacturing;
Intermediate in: Transportation equipment
manufacturing; Adhesive Manufacturing)
Incorporating into Articles
(Flame Retardant in: Electrical equipment,
appliance, and component manufacturing;
plastic s pro duct manufacturing)
Construction, Paint, Electrical, and
Metal Products1*"
Electrical and electronic products (e.g. reactive
flame retardant and additive flame retardant in
plastic enclosures), building construction materials
not covered elsewhere, and batteries (e.g. adhesive
in lead-acid battery casings)
Other1
Laboratory chemical
Furnishing. Cleaning, Treatment/Care
Products1*2
Fabric, textile, and leather pro ducts not covered
elsewhere
4
Recycling
Disposal
See Conceptual Model for
Environmental Releases and Wastes
Manufacture (Including Import)
~
~
Processing
Uses:
1. Commercial
2. Consumer
Figure 2-7 TBBPA Life Cycle Diagram
Volume is not depicted in the life cycle diagram for processing and some commercial and consumer uses as specific production volume from the 2016 CDR
is claimed confidential business information (CBI), withheld pursuant to TSCA Section § 14 or unknown.
23
-------
2.3 Exposures
For TSCA exposure assessments, EPA plans to analyze exposures and releases to the environment
resulting from the conditions of use within the scope of the risk evaluation for TBBPA. Release pathways
and routes will be described to characterize the relationship or connection between the conditions of use
of the chemical and the exposure to human receptors, including potentially exposed or susceptible
subpopulations, and environmental receptors. EPA plans to consider, where relevant, the duration,
intensity (concentration), frequency, and number of exposures in characterizing exposures to TBBPA.
2.3.1 Physical and Chemical Properties
Consideration of physical and chemical properties is essential for a thorough understanding or prediction
of environmental fate (i.e., transport and transformation) and the eventual environmental concentrations.
They can also inform the hazard assessment. EPA plans to use the physical and chemical properties
described in the Proposed Designation o f 4,41-Methylethylidene) bis[2,6-dibromophenol/ (CASRN 79-
94-7) as a High-Priority Substance for Risk 'Evaluation (U.S. EPA, 2019a) to support the development of
the risk evaluation for TBBPA. The values for the physical and chemical properties (Appendix B) may be
updated as EPA collects additional information through systematic review methods.
2.3.2 Environmental Fate and Transport
Understanding of environmental fate and transport processes assists in the determination
of the specific exposure pathways and potential human and environmental receptors that need to be
assessed in the risk evaluation for TBBPA. EPA plans to use the environmental fate characteristics
described in the Proposed Designation of 4,4'-(.1-Methylethylidene) bis [2,6-dibromovhenol 1 (CASRN 79-
94-7) as a High-Priority Substance _ for Risk Evaluation (U.S. EPA 2019a) to support the development of
the risk evaluation for TBBPA. The values for the environmental fate properties (Appendix C) may be
updated as EPA collects additional information through systematic review methods.
2.3.3 Releases to the Environment
Releases to the environment from conditions of use are a component of potential exposure and may be
derived from reported data that are obtained through direct measurement, calculations based on empirical
data or assumptions and models.
A source of information that EPA plans to consider in evaluating exposure are data reported to the TRI
program. EPA's TRI database contains information on chemical waste management activities that are
reported to EPA by industrial and federal facilities, including quantities released into the environment
(i.e., to air, water and disposed of to land), treated, burned for energy, recycled, or transferred off-site to
other facilities for these purposes.
Under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), TBBPA is
a TRI-reportable substance effective January 1, 1987 (40 CFR 372.65). For TRI reporting 4, facilities in
covered sectors in the United States are required to disclose release and other waste management activity
quantities of TBBPA under the CASRN 79-94-7 if they manufacture (including import) or process more
than 25,000 pounds or otherwise use more than 10,000 pounds of the chemical in a given year by July 1
of the following year.
4 For TRI reporting criteria see U.S. EPA (2018b): https://www.ee
repotting
a.gov/toxics-release-inventorv-tri-pr
24
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Table 2-3 provides production-related waste management data for TBBPA reported by facilities to the
TRI program for reporting year 2018. As shown in the table, 48 facilities reported a total of 138,456
pounds of TBBPA waste managed. Of the total waste managed, 8,170 pounds were treated, 8,274 pounds
were recycled, and 15,252 pounds were combusted for energy recovery. Most TBBPA production-related
waste was released to the environment, accounting for 106,760 pounds.
Table 2-3 Summary of TBBPA TRI Production-Related Waste Managed in 2018
Year
Number of
l-'acilities
Recycled
(lbs)
Recovered
for
Knergy
(lbs)'
Treated
(lbs)
Released111"
(lbs)
Total
Production
Related Waste
(lbs)
2018
48
S.274
15.252
8,170
106,760
138,456
Data source: 2018 TRI Data (U.S. EPA, 2019d)
3 Terminology used in these columns may not match the more detailed data element names used in the TRI public data and analysis access points.
b Does not include releases due to one-time event not associated with production such as remedial actions or earthquakes.
c Counts all releases including release quantities transferred and release quantities disposed of by a receiving facility reporting to TRI.
Table 2-4 provides a summary to the environment for the reporting year 2018. Facilities released TBBPA
to air (in the form of stack and fugitive emissions), water and land (via underground injection to Class I
wells, Resource Conservation and Recovery Act (RCRA) Subtitle C landfills and other land disposal
methods). The 99,595 pounds of TBBPA released to land comprised the majority of all TBBPA releases
from facilities, accounting for 93% of the total releases. Land disposal methods such as Class I
underground injection and RCRA Subtitle C landfills accounted for a relatively small proportion of land
releases, whereas "all other land disposal" accounted for 85% of land disposal. Of the 5,887 pounds of
TBBPA released to air, on-site stack air releases account for 90% of the total (5,275 pounds). During
2018, 133 pounds of TBBPA were discharged to surface waters on site.
Of the total 106,059 pounds of TBBPA disposed of or otherwise released by TRI facilities during 2018,
65,309 pounds were disposed of or otherwise released on site. Disposal in non-RCRA Subtitle C landfills
accounted for 72% (46,742 pounds) of all waste disposed of on site, with on-site disposal in RCRA
Subtitle C landfills accounting for the next largest amount at 19% (12,497 pounds). Off-site disposal or
other releases of TBBPA comprised 40,750 pounds, with 98% of this waste sent to non-RCRA Subtitle C
landfills.
Table 2-4 Summary of Releases of TBBPA to the Environment During 2018
Ail- Rclcsiscs
I.siihI Dispossil
Nil in her
ol
l-'sicililics
Si sick Air
Rclcsiscs
(Ihs)
l"iiiiili\c
Air
Rclcsiscs
(Ihs)
\\ siler
Kelcsises
(Ihs)
(hiss 1
I ndcr-
limund
Injection
(Ihs)
R( RA
Subtitle (
I.siikHiIIs
(Ihs)
All oilier
I.siihI
Dispossil''
(Ihs)
Oilier
Rclcsiscs •'
(Ihs)
lolsil
Rclcsiscs 1,1
(Ihs)
Totals
2018
48
5,275
612
133
50
12,497
87,048
444
106,059
5,887
99,595
Data source: 2018 TRI Data (U.S. EPA, 2019d)
a Terminology used in these columns may not match the more detailed data element names used in the TRI public data and analysis access points.
b These release quantities do include releases due to one-time events not associated with production such as remedial actions or earthquakes.
c Counts release quantities once at final disposition, accounting for transfers to other TRI reporting facilities that ultimately dispose of the chemical waste.
25
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The total production-related waste managed quantity shown in Table 2-3 does not include any quantities
reported as catastrophic or one-time release (TRI Form R Section 8 data). It does include quantities
transferred off site to receiving facilities for release or disposal and these same quantities are included in
the aggregate as on-site releases by the receiving facilities. This is referred to as "double counting,"
because the quantities are counted twice. That is, when a facility transfers a quantity of a chemical off site
for disposal to another facility, the facility reports the quantity as transferred off site for disposal and the
receiving facility reports the same quantity of the chemical as disposed of on site. In processing the data,
the TRI program recognizes that this is the same quantity of the chemical and includes it only once in the
total releases value, such as in Table 2-3. The production-related waste value in the TRI database,
however, considers all instances where the waste is managed (first as a quantity sent off site for disposal
and next as a quantity disposed of on-site), and reflects both the off-site transfer and the on-site disposal.
As a result, the total release quantities shown in the two tables differ slightly. EPA plans to review these
data in conducting the exposure assessment component of the risk evaluation for TBBPA. EPA will use
reasonably available information to address potential gaps in TRI reporting.
2.3.4 Environmental Exposures
The manufacturing, processing, distribution, use and disposal of TBBPA can result in releases to the
environment and exposure to aquatic and terrestrial receptors (biota) via surface water, sediment, soil and
ambient air. Environmental exposures to biota are informed by releases into the environment, overall
persistence, degradation, bioaccumulation and partitioning across different media. Concentrations of
chemical substances in biota provide evidence of exposure. EPA plans to review available environmental
exposure data in biota in the risk evaluation. Monitoring data were identified in EPA's search for
reasonably available information and can be used in the exposure assessment. Relevant and reliable
monitoring studies provide information that can be used in an exposure assessment. Monitoring studies
that measure environmental concentrations or concentrations of chemical substances in biota provide
evidence of exposure.
EPA plans to review available environmental monitoring data found in the literature for TBBPA found in
surface water, sediment and soil near and far from point sources. EPA plans to review available
monitoring data found in the literature on the presence of TBBPA in various wildlife species such as
marine mammals, aquatic invertebrates, fish, and avian species.
2.3.5 Occupational Exposures
EPA plans to analyze worker activities where there is a potential for exposure under the various
conditions of use described in Section 2.2.1. In addition, EPA plans analyze exposure to occupational
non-users (ONUs), workers who do not directly handle the chemical but perform work in an area where
the chemical is present. EPA also plans to consider the effect(s) that engineering controls (EC) and/or
personal protective equipment (PPE) have on occupational exposure levels as part of the draft risk
evaluation.
EPA plans to evaluate potential exposures from the processing of the chemical as it is incorporated into
formulations and products. TBBPA can be used as both a reactive and additive flame retardant. EPA plans
to evaluate the potential for occupational exposure when TBBPA is used as an additive flame retardant. In
general, EPA plans to evaluate the potential for exposure from additive flame retardants due to blooming
and release from article components during their manufacture, industrial/commercial use, recycling and
disposal.
EPA plans to evaluate the potential for exposure to unreacted TBBPA during the manufacture and
industrial/commercial use of article components when it is used as a reactive flame retardant.
26
-------
EPA also expects to consider potential worker and ONU exposure via the oral route such as from
incidental ingestion of TBBPA particulates that deposit in the upper respiratory tract from inhalation
exposure.
Worker activities associated with the conditions of use within the scope of the risk evaluation for TBBPA
that will be analyzed, include, but are not limited to:
• Unloading and transferring TBBPA to and from storage containers to process vessels during
manufacturing, processing and use;
• Handling, transporting and disposing of waste containing TBBPA during manufacturing,
processing (including recycling), and use and recycling;
• Cleaning and maintaining equipment; during manufacturing, processing, use and recycling;
• Sampling chemicals, formulations or products containing TBBPA for quality control during
manufacturing, processing, and use and recycling;
• Performing other work activities in or near areas where TBBPA is used.
TBBPA is a solid with a vapor pressure of 4.68x 10"8 mm Hg at 25 °C/77 °F (See 2.8Appendix B). EPA
anticipates inhalation of dust and other respirable particles as an exposure pathway for workers and ONUs
during the manufacture and processing of various articles containing TBBPA (e.g., particulate generated
during handling of plastic resins, finishing operations associated with the manufacture and finishing of
plastics and plastic articles and incorporation of plastics and other article components into finished
products). Occupational exposure limits for TBBPA have not been established by the Occupational Safety
and Health Administration (OSHA), the American Conference of Government Industrial Hygienists
(ACGIH) or the National Institute for Occupational Safety and Health (NIOSH). However, the OSHA
Permissible Exposure Limit (PEL) for Particulates Not Otherwise Regulated (PNOR) (15 mg/m3) (29
) may be applicable if particulate matter is generated during industrial operations.
EPA generally does not evaluate occupational exposures through the oral route. Workers may
inadvertently transfer chemicals from their hands to their mouths, ingest inhaled particles that deposit in
the upper respiratory tract or consume contaminated food. The frequency and significance of this
exposure route are dependent on several factors including the p-chem properties of the substance during
expected worker activities, workers' awareness of the chemical hazards, the visibility of the chemicals on
the hands while working, workplace practices, and personal hygiene that is difficult to predict (Cherrie et
al., 2006). However, EPA will consider oral exposure on a case-by-case basis for certain COUs and
worker activities where there is information and data on incidental ingestion of inhaled dust. EPA will
consider ingestion of inhaled dust as an inhalation exposure for TBBPA.
Based on the conditions of use, EPA plans to evaluate worker dermal exposure from contact with solid
during the manufacture of TBBPA, packaging operations and formulation of plastic resins. Dermal
exposures for workers are possible during the conditions of uses within the scope of the risk evaluation
for TBBPA. Dermal exposure by ONU is not expected for the condition of uses as they are not expected
to directly handle the chemical.
2.3.6 Consumer Exposures
Based on CDR reporting information, TBBPA appears to be widely used in consumer products used in
indoor environments, specifically fabric, textile, and leather products, electrical and electronic products,
building/construction materials and batteries (U.S. EPA, 2019c). TBBPA has been detected in children's
products (such as electronics) as well as in small plastic toys and jewelry (U.S. EPA 2015a). Several of
27
-------
these products have the potential to be mouthed by children. In addition, consumer handling TBBPA
containing materials during disposal can lead to consumer and bystander exposures. The main exposure
routes where consumers interact with products and articles containing TBBPA are dermal, inhalation and
dust ingestion, including children's mouthing of articles (e.g., plastics, textiles, wood products) containing
TBBPA.
2.3.7 General Population Exposure
Releases of TBBPA from certain conditions of use, such as manufacturing, processing or disposal
activities, may result in general population exposures. EPA plans to evaluate the reasonably available
literature for the presence of TBBPA in drinking water, ground water, ambient air, indoor air, fish, human
breast milk, and dust and soil, which may be mouthed or ingested.
2.4 Hazards (Effects)
2.4.1 Environmental Hazards
As described in the Proposed Designation of 4,4'-(l-Methvlethylidene)bisf2,6-dibromophenoll (CASRN
79-94-7) as a High-Priority Substance for Risk Evaluation (U.S. EPA 2019a), EPA considered reasonably
available information from peer-reviewed assessments and databases to identify potential environmental
hazards for TBBPA. EPA considers all the potential environmental hazards for TBBPA identified during
prioritization (U.S. EPA 2019) to be relevant for the risk evaluation and thus they remain within the scope
of the evaluation. EPA is in the process of identifying additional reasonably available information through
systematic review methods and public comments, which may update the list of potential environmental
hazards associated with TBBPA. If necessary, EPA plans to update the list of potential hazards in the final
scope document of TBBPA. Based on information identified during prioritization, environmental hazard
effects were identified for aquatic and terrestrial organisms.
2.4.2 Human Health Hazards
As described in the Proposed Designation of 4,4'-(l-Methylethylidene)bisf2,6-dibromophenol] (CASRN
79-94-7) as a High-Priority Substance for Risk Evaluation (U.S. EPA 2019a), EPA considered reasonably
available information from peer-reviewed assessments and databases to identify potential human health
hazards for TBBPA. EPA considers all potential human health hazards for TBBPA identified during
prioritization (U.S. EPA 2019a) to be relevant for the risk evaluation and thus they remain within the
scope of the evaluation. The health effect categories screened for during prioritization included acute
toxicity, irritation/corrosion, dermal sensitization, respiratory sensitization, genetic toxicity, repeated dose
toxicity, reproductive toxicity, developmental toxicity, immunotoxicity, neurotoxicity, carcinogenicity,
epidemiological or biomonitoring studies and ADME (absorption, distribution, metabolism, and
excretion). The broad health effect categories include immunological, neurological, carcinogenic and
developmental effects. Genetic toxicity studies were conducted as were respiratory and dermal
sensitization tests; however, no effects were observed. Effects were seen in epidemiological and
biomonitoring human studies.
Although the high priority designation dossier for TBBPA did not identify reproductive effects, The
National Toxicology Program (NTP, 2014) did actually identify atypical endometrium hyperplasia in the
uterus as well as uterine tumors. Thus, EPA plans to consider reproductive effects in addition to the other
effects identified in U.S. EPA (2019a).
In addition, EPA will also consider new approach methods (NAMs) such as high-throughput assays when
evaluating hazards and risks during risk evaluation.
28
-------
EPA is in the process of identifying additional reasonably available information through systematic
review methods and public input, which may update the list of potential human health hazards under the
scope of the risk evaluation. If necessary, EPA plans to update the list of potential hazards in the final
scope document of the TBBPA risk evaluation.
2.5 Potentially Exposed or Susceptible Subpopulations
TSCA § 6(b)(4) requires EPA to determine whether a chemical substance presents an unreasonable risk to
"a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation." TSCA
§3(12) states that "the term 'potentially exposed or susceptible subpopulation' means a group of
individuals within the general population identified by the Administrator who, due to either greater
susceptibility or greater exposure, may be at greater risk than the general population for adverse health
effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women,
workers or the elderly." General population is "the total of individuals inhabiting an area or making up a
whole group" and refers here to the U.S. general population (U.S. EPA, 201 la).
During the prioritization process, EPA identified the following potentially exposed or susceptible
subpopulations based on CDR information and studies reporting developmental and reproductive effects:
women of reproductive age (e.g., pregnant women per TSCA statute), workers and consumers (U.S. EPA
2019a). EPA has also added children as a potentially exposed as well as a susceptible subpopulation based
on distinct exposure pathways (e.g., children's crawling, mouthing or hand-to-mouth behaviors) and a
toxicity study that identified kidney lesions in newborns exposed to TBBPA (Fukuda et al., 2004) briefly
discussed in the TSCA Work Plan Chemical Problem Formulation and Initial Assessment document for
TBBPA (U.S. EPA, 2015a). EPA plans to evaluate these potentially exposed or susceptible
subpopulations in the risk evaluation.
In developing exposure scenarios, EPA plans to analyze reasonably available data to ascertain whether
some human receptor groups may be exposed via exposure pathways that may be distinct to a particular
subpopulation or life stage (e.g., children's crawling, mouthing or hand-to-mouth behaviors, ingestion of
breast milk) (U.S. EPA, 2006) 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, elevated fish ingestion due to subsistence fishing) when compared with the general population.
Likewise, EPA plans to evaluate reasonably available human health hazard information to ascertain
whether some human receptor groups may have greater susceptibility than the general population to the
chemical's hazard(s).
2.6 Conceptual Models
In this section, EPA presents the conceptual models describing the identified exposures (pathways and
routes), receptors and hazards associated with the conditions of use of TBBPA. Pathways and routes of
exposure associated with workers and ONUs are described in Section 2.6.1 and pathways and routes of
exposure associated with consumers are described in Section 2.6.2. Pathways and routes of exposure
associated with environmental releases and wastes are shown in Section 2.6.3.
2.6.1 Conceptual Model for Industrial and Commercial Activities and Uses
Figure 2-8 illustrates the conceptual model for the pathways of exposure from industrial and commercial
activities and uses of TBBPA that EPA plans to include in the risk evaluation. There is potential for
exposure to workers and/or ONUs via inhalation routes and exposures to workers via dermal routes.
Dermal exposure to TBBPA in both liquid and solid form is expected, as TBBPA can be used/transported
as a solid powder or suspended in solution. Inhalation exposure to dust is expected to be a significant
exposure pathway. Additionally, potential inhalation exposure to TBBPA in mist form is expected for
29
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certain conditions of use. EPA plans to evaluate activities resulting in exposures associated with
distribution in commerce (e.g., loading, unloading) throughout the various lifecycle stages and conditions
of use (e.g., manufacturing, processing, industrial use, commercial use and disposal) rather than a single
distribution scenario. For each condition of use identified in Table 2-2, an initial determination was made
as to whether or not each combination of exposure pathway, route and receptor will be assessed in the risk
evaluation. The supporting rationale is presented in Appendix F.
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INDUSTRIAL AND COMMERCIAL
ACTIVITIES .'USES
EXPOSURE PATHWAY
EXPOSURE ROUTE
RECEPTORS
HAZARDS
Manufacturing (anel. Import)
Processing:
- Processing as a Reaetant
• Incorporation into
Formulation, Mixture, or
Reaction Product
- Incorporation into
Article
Recvcline
Construction, Paint, Electrical,
and Metal Products
Other
Furnishing, Cleaning,
Treatment Care Products
Waste Handling, Treatment
and Disposal
TtL
Liquid Solid Contact
c
Indoor Mist Dust
Fugitive Emissions
D
Wastewater. Liquid Wastes and Solid Wastes (see
Environmental Release Conceptual Mode's)
Jernia.
iVorkers
Occupational Non
\ Users
Initiation
Hazards potentially
associated trith acute
and or chronic
exposures
Figure 2-8 TBBPA Conceptual Model for Industrial and Commercial Activities and Uses: Worker and ONU 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 TBBPA.
31
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2,6.2 Conceptual Model for Consumer Activities and Uses
The conceptual model in Figure 2-9 presents the exposure pathways, exposure routes and hazards to
human receptors from consumer activities and uses of TBBPA that EPA plans to include in the risk
evaluation. Inhalation is expected to be a route of exposure for consumers and EPA plans to evaluate
inhalation exposures to TBBPA vapors, mists and dusts for consumers and bystanders. Consumer oral
exposures may also result from direct contact with mists and powders or dust containing TBBPA during
use. Dermal exposures may result from liquids and mists containing TBBPA. Bystanders are not expected
to have significant direct dermal or oral contact to TBBPA products. The supporting rationale for
consumer pathways considered for TBBPA are included in Appendix G.
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CONSUMER ACTIVITIES
&
EXPOSURE
PATHWAY
EXPOSURE
ROUTE
RECEPTORS
HAZARDS
Famishing. Cleaning,
7.-rlV.. l.t
Products
Construction. Paint
Ft:
Consumer Hasdlmg of
Disposal aid Waste
Liquid Contact
Indoor Air'Dust
Inkakiion
Wastewater. Liquid Wastes and
Solid Wastes (See Emiroiaxuental
Releases Conceptual Models)
Hazards Potentially
Associated with Aeits
and'or Chronic
Exposures
Figure 2-9 TBBPA Conceptual Model for Consumer Activities and Uses: Consumer Exposures and Hazards
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2.6.3 Conceptual Model for Environmental Releases and Waste: Potential Exposures and
Hazards
Figure 2-10 presents the exposure pathways, exposure routes and hazards to human and environmental
receptors, respectively, for releases and waste streams associated with environmental releases of and
waste from TBBPA. EPA plans to evaluate pathways and routes of exposures to receptors (e.g., general
population, aquatic, terrestrial species) that may occur from industrial and/or commercial uses, releases to
air, water or land, including biosolids and soil and other conditions of use. EPA expects humans to be
exposed to TBBPA from air emissions via inhalation as well as from water, liquid, and solid waste
releases; orally via drinking water, fish and soil ingestion; and dermally from contact with groundwater
and soil. The supporting rationale for general population and environmental pathways considered for
TBBPA are included in Appendix H.
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2.7 Analysis Plan
The analysis plan is based on EPA's knowledge of TBBPA to date which includes a partial, but not
complete review of reasonably available information as described in Section 2.1. EPA encourages
submission of additional existing data, such as full study reports or workplace monitoring from industry
sources that may be relevant EPA's evaluation of conditions of use, exposures, hazards and potentially
exposed or susceptible subpopulations during risk evaluation. Further, EPA may consider any relevant
CBI in the risk evaluation in a manner that protects the confidentiality of the information from public
disclosure. EPA plans to continue to consider new information submitted by the public. Should additional
data or approaches become reasonably available, EPA may update its analysis plan in the final scope
document. As discussed in Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA,
2018a), targeted supplemental searches during the analysis phase may be necessary to identify additional
reasonably available information (e.g., commercial mixtures) for the risk evaluation of TBBPA.
2.7.1 Physical and Chemical Properties and Environmental Fate
EPA plans to analyze the physical and chemical properties and environmental fate and transport of
TBBPA as follows:
1) Review reasonably available measured or estimated physical chemical and environmental
fate endpoint data collected using systematic review procedures and, where available,
environmental assessments conducted by other regulatory agencies.
EPA plans to review data and information collected through the systematic review methods and
public comments about the p-chem properties (Appendix B) and fate endpoints (Appendix C)
previously summarized in the Proposed Designation of 4,4'-(l-Methylethvlidene)bis[2,6-
dibromonhenoll (CASRN 79-94-7) as a Hieh-Priority Substance for Risk Evaluation (U.S. EPA,
2019a). All sources cited in EPA's analysis will be reviewed according to the procedures
described in the systematic review documentation that EPA plans to publish prior to finalizing the
scope document. Where the systematic review process fails to identify experimentally measured
chemical property values of sufficiently high quality, these values will be estimated using
chemical parameter estimation models as appropriate. Model-estimated fate properties will be
reviewed for applicability and quality.
2) Using measured data and/or modeling, determine the influence of physical chemical
properties and environmental fate endpoints (e.g., persistence, bioaccumulation,
partitioning, transport) on exposure pathways and routes of exposure to human and
environmental receptors.
Measured data and, where necessary, model predictions of physical chemical properties and
environmental fate endpoints will be used to characterize the persistence and movement of
TBBPA within and across environmental media. The physical chemical and fate endpoints of
interest include sorption to organic matter in soil and sediments, water solubility, aqueous and
atmospheric photolysis rates, aerobic and anaerobic biodegradation rates and potential
bioconcentration and bioaccumulation. Additional endpoints include removal in wastewater
treatment and degradation and partitioning in land-applied biosolids. These endpoints will be used
in exposure calculations.
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3) Conduct a weight-of-evidence evaluation of p-chem and environmental fate data, including
qualitative and quantitative sources of information.
During risk evaluation, EPA plans to evaluate and integrate the p-chem and environmental fate
evidence identified in the literature inventory using the methods described in the systematic
review documentation that EPA plans to publish prior to finalizing the scope document.
2.7.2 Exposure
EPA plans to analyze exposure levels to TBBPA via indoor air, ambient air, surface water, ground water,
drinking water, sediment, soil, aquatic biota and terrestrial biota. EPA has not yet determined the
exposure levels in these media or how they may be used in the risk evaluation. Exposure scenarios are
combinations of sources (uses), exposure pathways and exposed receptors. Draft release/exposure
scenarios corresponding to various conditions of use for TBBPA are presented in Appendix G and
Appendix H. EPA plans to analyze scenario-specific exposures.
Based on their p-chem properties, expected sources and transport and transformation within the outdoor
and indoor environment, chemical substances are more likely to be present in some media and less likely
to be present in others. Exposure level(s) can be characterized through a combination of reasonably
available monitoring data and modeling approaches.
2.7.2.1 Environmental Releases
EPA plans to analyze releases to environmental media as follows:
1) Review reasonably available published literature and other reasonably available information
on processes and activities associated with the conditions of use to analyze the types of
releases and wastes generated.
EPA has reviewed some key data sources containing information on processes and activities
resulting in releases, and the information found is described in Appendix A. EPA plans to continue
to review data sources identified in Appendix A during risk evaluation using the evaluation
strategy in the systematic review documentation that EPA plans to publish prior to finalizing the
scope document. Potential sources of environmental release data are:
Table 2-5 Categories and Sources of Environmental Release Data
U.S. EPA TRI Data
U.S. EPA Generic Scenarios (GSs)
OECD Emission Scenario Documents (ESDs)
Canada Screening Assessment Report
EU Risk Assessment Report
2) Review reasonably available chemical-specific release data, including measured or estimated
release data (e.g., data from risk assessments by other environmental agencies).
EPA has reviewed key release data sources including TRI, and the data from this source is
summarized in Section 2.3.3. EPA plans to continue to review relevant data sources during risk
evaluation. EPA plans to match identified data to applicable conditions of use and identify data
gaps where no data are found for particular conditions of use. EPA plans to attempt to address data
gaps identified as described in steps 3 and 4 below by considering potential surrogate data and
models.
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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 (ChemSTEER, EPA, 2016)
3) Review reasonably available measured or estimated release data for surrogate chemicals
that have similar uses and physical properties.
EPA has not yet identified surrogate chemicals and data that can be used to estimate releases from
uses of TBBPA. EPA plans to review release data for surrogate chemicals that have uses and
chemical and physical properties similar to TBBPA as it is identified. EPA may conduct targeted
searches for surrogate data.
4) Review reasonably available data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation.
This item will be performed after completion of steps 2 and 3 above. EPA plans to evaluate
relevant data to determine whether the data can be used to develop, adapt or apply models for
specific conditions of use (and corresponding release scenarios).
5) Review and determine applicability of OECD Emission Scenario Documents (ESDs) and
EPA Generic Scenarios (GSs) to estimation of environmental releases.
EPA has identified potentially relevant OECD ESDs and EPA GSs that correspond to some
conditions of use; for example, the 2009 ESD on Plastics Additives and the 2011 ESD on the
chemical industry may be useful. EPA plans to critically review these generic scenarios and ESDs
to determine their applicability to the conditions of use.
EPA GSs are available at the following: https://www.epa.gov/tsca-screening-tools/chemsteer-
chemical-screening-tool-exposures-and-environmental-releases
GSs that contain information that may be related to the potential uses of TBBPA include, but are
not limited to:
• EPA's Additives in Plastics Processing (Compounding) - Draft Generic Scenario for
Estimating Occupational Exposures and Environmental Releases (May 2004);
• EPA's Spray Coatings in the Furniture Industry - Generic Scenario for Estimating
Occupational Exposures and Environmental Releases (April 2004);
• EPA's Manufacture and Use of Printing Ink - Generic Scenario for Estimating Occupational
Exposures and Environmental Releases (September 2001);
• EPA's Leather Dyeing - Generic Scenario for Estimating Occupational Exposures and
Environmental Releases (September 2000);
• EPA's Fabric Finishing - Draft Generic Scenario for Estimating Occupational Exposures and
Environmental Releases (September 1994) (U.S. EPA, 1994a); and,
• EPA's Material Fabrication Process for Manufacture of Printed Circuit Boards - Generic
Scenario for Estimating Occupational Exposures and Environmental Releases (1994).
OECD ESDs are available at the following: https://www.epa.gov/tsca-screening-tools/chemsteer-
chemical-screening-tool-exposures-and-environmental-releases
ESDs that contain information that may be related to the potential uses of TBBPA include, but are
not limited to:
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• OECD's Complementtm Document to the E Plastic Additives: Plastic Additives During
. * i \ . " • ! v. \ t\h\ ),
• OECD's ESP on the Use of Textile Dyes (February l ),
• OECD's Complemt ument for ESP) on Coating Industry: Application of Paint
Solvents for Industrial Coating (December 2015);
• OECD's ESP on the Chemical Industry (September 2011);
• OECD's ESP on Radiation Curable Coating, Inks, and Adhesives (July 2011);
• OECD's ESP on Plastic Additives (July 2.009); and
• OECD's ESP on Coating Industry (Paints, Lacquers and Varnishes) (July 2009).
6) Map or group each condition of use to a release assessment scenario(s).
EPA has identified release scenarios and mapped (i.e., grouped) them to relevant conditions of use
as shown in Appendix F. EPA was not able to identify release scenarios corresponding to some
conditions of use (e.g., recycling, building/construction materials not covered elsewhere). EPA
plans to perform targeted research to understand those uses, which may inform identification of
release scenarios. EPA may further refine the mapping/grouping of release scenarios based on
factors (e.g., process equipment and handling, magnitude of production volume used, and
exposure/release sources) corresponding to conditions of use as additional information is
identified during risk evaluation.
7) Evaluate the weight of the scientific evidence of environmental release data.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in the
literature inventory using the methods described in the systematic review documentation that EPA
plans to publish prior to finalizing the scope document. The data integration strategy will be
designed to be fit-for-purpose in which EPA plans to use systematic review methods to assemble the
relevant data, evaluate the data for quality and relevance, including strengths and limitations, followed
by synthesis and integration of the evidence.
2.7.2.2 Environmental Exposures
EPA plans to analyze the following in developing its environmental exposure assessment of TBBPA:
1) Review available environmental and biological monitoring data for all media relevant to
environmental exposure.
For TBBPA, environmental media which will be analyzed are sediment, biosolids, soil, air and
water. The environmental exposure pathways which have been identified in the literature include
aquatic and terrestrial.
2) Review reasonably available information on releases to determine how modeled estimates of
concentrations near industrial point sources compare with available monitoring data.
EPA plans to analyze reasonably available environmental exposure models that meet the TSCA
section 26(h) and (i) Science Standards and that estimate water, sediment and soil concentrations
alongside reasonably available 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
water, sediment or soil, indirect release into water, sediment or soil (i.e., air deposition), fate and
39
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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 vegetation, invertebrates, fish, non-fish
vertebrates (i.e., amphibians, reptiles, mammals). Plan to consider whether these data could
be used to compare with comparable species or taxa-specific toxicological benchmarks.
EPA plans to analyze predatory bird species that consume fish with elevated levels of TBBPA will
be analyzed. If species-specific biomonitoring data matches toxicity studies, direct comparisons
can be made. EPA plans to consider refining data for other species by using body weight of the
birds, fish ingestion rate of birds and typical fish species consumed.
4) Determine applicability of existing additional contextualizing information for any monitored
data or modeled estimates during risk evaluation.
There have been changes to use patterns of TBBPA over the last few years. Monitoring data or
modeled estimates will be reviewed to determine how representative they are of applicable use
patterns.
EPA plans to evaluate any studies that relate levels of TBBPA in the environment or biota with
specific sources or groups of sources.
5) Group each condition(s) of use to environmental assessment scenario(s).
Refine and finalize exposure scenarios for environmental receptors by considering combinations
of sources (use descriptors), exposure pathways including routes and populations exposed. For
TBBPA, the following are noteworthy considerations in constructing exposure scenarios for
environmental receptors:
• Estimates of surface water concentrations, sediment concentrations and soil concentrations
near industrial point sources based on available monitoring data.
• Modeling inputs such as releases into the media of interest, fate and transport and
characteristics of the environment.
• Reasonably available biomonitoring data, which could be used to compare with species or
taxa-specific toxicological benchmarks.
• Applicability of existing additional contextual information for any monitored data or modeled
estimates during risk evaluation. Review and characterize the spatial and temporal variability,
to the extent that data are available, and characterize exposed aquatic and terrestrial
populations.
• Weight of the scientific evidence of environmental occurrence data and modeled estimates.
6) Evaluate the weight of the scientific evidence of environmental occurrence data and modeled
estimates.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in the
literature inventory using systematic review methods.
2.7.2.3 Occupational Exposures
EPA plans to analyze both worker and ONU exposures as follows:
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1) Review reasonably available exposure monitoring data for specific condition(s) of use.
EPA plans to review exposure data including workplace monitoring data collected by government
agencies such as OSHA and NIOSH and monitoring data found in published literature. These
workplace monitoring data include personal exposure monitoring data (direct exposures) and area
monitoring data (indirect exposures).
2) Review reasonably available exposure data for surrogate chemicals that have uses and
chemical and physical properties similar to TBBPA.
EPA plans to review exposure data for surrogate chemicals that have uses and chemical and
physical properties similar to TBBPA.
3) For conditions of use where data are limited or not available, review existing exposure
models that may be applicable in estimating exposure levels.
For conditions of use where data are not available, EPA plans to review existing exposure models
that may be applicable in estimating exposure levels of TBBPA.
EPA has identified potentially relevant OECD ESDs and EPA GSs corresponding to some
conditions of use. EPA plans to critically review these GSs and ESDs to determine their
applicability to the conditions of use assessed. EPA may conduct industry outreach efforts or
perform supplemental, targeted literature searches to better understand the process steps involved
in conditions of use. EPA plans to also consider the applicability of exposure models in
ChemSTEER (U.S. EPA, 2016)) tool that are routinely used for assessing new chemicals to assess
exposures during various conditions of use. EPA may also perform targeted research to identify
other models that EPA could use to estimate exposures for certain conditions of use.
4) Review reasonably available data that may be used in developing, adapting or applying
exposure models to a particular risk evaluation scenario.
This step will be performed after steps 2 and 3 are completed. Based on information developed
from steps 2 and 3, EPA plans to evaluate relevant data to determine whether the data can be used
to develop, adapt or apply models for specific conditions of use (and corresponding exposure
scenarios). EPA may utilize existing, peer-reviewed exposure models developed by EPA/OPPT,
other government agencies, or available in the scientific literature, or EPA may elect to develop
additional models to assess specific condition(s) of use. Inhalation exposure models may be
simple box models or two-zone (near-field/far-field) models. In two-zone models, the near-field
exposure represents potential inhalation exposures to workers, and the far-field exposure
represents potential inhalation exposures to ONUs.
5) Consider and incorporate applicable engineering controls (ECs) and/or personal protective
equipment (PPE) into exposure scenarios.
EPA plans to review potentially relevant data sources on ECs and PPE as identified in Appendix E
to determine their applicability and incorporation into exposure scenarios during risk evaluation.
EPA plans to assess worker exposure pre- and post-implementation of EC, using reasonably
available information on available control technologies and control effectiveness. For example,
EPA may assess worker exposure in industrial use scenarios before and after implementation of
local exhaust ventilation.
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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. As presented in Appendix F, EPA has grouped the scenarios into representative
release/exposure scenarios, all of which will be 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 scientific evidence of occupational exposure data, which may
include qualitative and quantitative sources of information.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in the
literature inventory using the methods described in the systematic review documentation that EPA
plans to publish prior to finalizing the scope document. EPA plans to rely on the weight of the
scientific evidence when evaluating and integrating occupational data. The data integration
strategy will be designed to be fit-for-purpose in which EPA plans to use systematic review
methods to assemble the relevant data, evaluate the data for quality and relevance, including
strengths and limitations, followed by synthesis and integration of the evidence.
2.7.2.4 Consumer Exposures
EPA plans to analyze both consumers using a consumer product and bystanders associated with the
consumer using the product as follows:
1) Group each condition of use to consumer exposure assessment scenario(s).
Refine and finalize exposure scenarios for consumers by considering combinations of sources
(ongoing consumer uses), exposure pathways including routes and exposed populations.
For TBBPA, the following are noteworthy considerations in constructing consumer exposure
scenarios:
• Conditions of use and type of consumer product
• Duration, frequency and magnitude of exposure
• Weight fraction of chemical in products
• Amount of chemical used
2) Evaluate the relative potential of indoor exposure pathways based on reasonably available
data.
Indoor exposure pathways expected to be relatively higher include particle inhalation, dust
ingestion, and dermal contact as a result of indoor use of TBBPA consumer products. Indoor
exposure pathways expected to be relatively lower include inhalation of vapor and mist and liquid
and mist oral ingestion. The data sources associated with these respective pathways have not yet
been comprehensively evaluated, so quantitative comparisons across exposure pathways or in
relation to toxicity thresholds are not yet available.
3) Review existing indoor exposure models that may be applicable in estimating indoor air,
indoor dust concentrations, or indoor dust surface loadings.
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Indoor exposure models that estimate emission and migration of semi-volatile organic compounds
(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. These properties vary based on p-chem
properties and properties of the material. The OPPT's Indoor Environmental Concentrations in
Buildings with Conditioned and Unconditioned Zones (IECCU) model and other similar models
can be used to estimate indoor air and dust exposures from indoor sources.
4) Review reasonably available empirical data that may be used in developing, adapting or
applying exposure models to a particular risk evaluation scenario. For example, existing
models developed for a chemical assessment may be applicable to another chemical
assessment if model parameter data are available.
To the extent other organizations have already modeled a TBBPA consumer exposure scenario
that is relevant to the OPPT's assessment, EPA plans to evaluate those modeled estimates. In
addition, if other chemicals similar to TBBPA 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
TBBPA in specific media (e.g., indoor air).
The availability of TBBPA 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 levels and various indoor sources will be analyzed.
6) Review reasonably available population- or subpopulation-specific exposure factors and
activity patterns to determine if potentially exposed or susceptible subpopulations need to be
further refined.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in the
literature inventory using the methods described in the systematic review documentation that EPA
plans to publish prior to finalizing the scope document.
7) Evaluate the weight of the scientific evidence of consumer exposure estimates based on
different approaches.
EPA plans to rely on the weight of the scientific evidence when evaluating and integrating data
related to consumer exposure. The weight of the scientific evidence may include qualitative and
quantitative sources of information. The data integration strategy will be designed to be fit-for-
purpose in which EPA plans to use systematic review methods to assemble the relevant data,
evaluate the data for quality and relevance, including strengths and limitations, followed by
synthesis and integration of the evidence.
2.7.2.5 General Population
EPA plans to analyze general population exposures as follows:
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1) Refine and finalize exposure scenarios for general population by considering sources and
uses, exposure pathways including routes and exposed populations.
For TBBPA, the following are noteworthy considerations in constructing exposure scenarios for
the general population: routes of exposure, releases to air, water or land resulting from industrial,
commercial, and other conditions of use, in addition to:
• Review of reasonably available environmental and biological monitoring data for media to
which general population exposures are expected;
• For exposure pathways where data are not available, review existing exposure models that
may be applicable in estimating exposure levels;
• Consider and incorporate applicable media-specific regulations into exposure scenarios or
modeling;
• Review reasonably available data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation. For example, existing models developed
for a chemical assessment may be applicable to another chemical assessment if model
parameter data are available;
• Review reasonably available information on releases to determine how modeled estimates
of concentrations near industrial point sources compare with available monitoring data;
• Review reasonably available population- or subpopulation-specific exposure factors and
activity patterns to determine if potentially exposed or susceptible subpopulations need be
further defined;
• Evaluate the weight of the evidence of general population exposure data; and
• Mapping or grouping each condition of use to general population exposure assessment
scenario(s).
EPA plans to evaluate a variety of data types to determine which types are most appropriate when
quantifying exposure scenarios. Environmental monitoring data, biomonitoring data, modeled
estimates, experimental data, epidemiological data and survey-based data can all be used to
quantify exposure scenarios. In an effort to associate exposure estimates with sources of exposure
and/or conditions of use, EPA plans to consider source apportionment across exposure scenarios
during risk evaluation. EPA anticipates that there will be a wide range in the relative exposure
potential of the exposure scenarios identified in Appendix H. 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 reasonably available data and approaches. For example, EPA may consider the
co-location of TSCA industrial facilities with reasonably available monitoring data or modeled
estimates. EPA may compare modeled estimates for discrete outdoor and indoor sources/uses that
apply to unique receptor groups. If available, EPA plans to compare multiple scenario-specific and
background exposure doses estimated from media-specific concentrations and exposure factors
with available biomonitoring data. The forward-calculated and back-calculated exposures could be
compared to characterize the relative contribution from defined exposure scenarios.
After refining and finalizing exposure scenarios, EPA plans to quantify concentrations and/or
doses for these scenarios. The number of scenarios will depend on how combinations of uses,
exposure pathways and receptors are characterized. The number of scenarios is also dependent
upon the reasonably available data and approaches to quantify scenarios. When quantifying
exposure scenarios, EPA plans to use a tiered approach. First-tier analysis is based on data that is
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reasonably available without a significant number of additional inputs or assumptions, and may be
qualitative, semi-quantitative or quantitative. The results of first tier analyses inform whether
scenarios require more refined analysis. Refined analyses will be iterative and require careful
consideration of variability and uncertainty. Should data become available that summarily alters
the overall conclusion of a scenario through iterative tiering, EPA can refine its analysis during
risk evaluation.
2) Review reasonably available environmental and biological monitoring data for exposure
pathways and media to which general population exposures are expected.
General population exposure pathways expected to be relatively higher include: ingestion of water
and food including fish, root crops, and mother's milk. General population exposure pathways
expected to be relatively lower include: dermal contact to TBBPA via liquids, and inhalation of
TBBPA via vapors, mists and dusts. The data sources associated with these respective pathways
have not been comprehensively evaluated, so quantitative comparisons across exposure pathways
or in relation to toxicity thresholds are not yet available.
3) For exposure pathways where empirical data is not available, review exposure models that
may be applicable in estimating exposure levels.
For TBBPA, EPA plans to consider exposure models for general population exposure, including
models that estimate surface water concentrations, sediment concentrations, soil concentrations
and uptake from aquatic and terrestrial environments into edible aquatic and terrestrial organisms.
4) Review reasonably available exposure modeled estimates. For example, existing models
developed for a previous TBBPA chemical assessment may be applicable to EPA's
assessment. In addition, another chemical's assessment may also be applicable if model
parameter data are available.
To the extent other organizations have already modeled TBBPA general population exposure
scenario that is relevant to this assessment, EPA plans to evaluate those modeled estimates. In
addition, if modeled estimates for other chemicals with similar physical chemical properties and
similar uses are available, those modeled estimates will also be evaluated. The underlying
parameters and assumptions of the models will also be evaluated.
5) Review reasonably available information on releases to determine how modeled estimates of
concentrations near industrial point sources compare with reasonably 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.
6) Review reasonably available information about population- or subpopulation-specific
exposure factors and activity patterns to determine if potentially exposed or susceptible
subpopulations need to be further defined (e.g., early life and/or puberty as a potential
critical window of exposure).
For TBBPA, EPA plans to evaluate exposure scenarios that involve potentially exposed or
susceptible subpopulations and plans to consider age-specific behaviors, activity patterns and
exposure factors unique to those subpopulations. For example, children will have different intake
rates for soil than adults.
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7) Evaluate the weight of the scientific evidence of general population exposure estimates based
on different approaches.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in the
literature inventory using the methods described in the systematic review documentation that EPA
plans to publish prior to finalizing the scope document.
2.7.3 Hazards (Effects)
2.7.3.1 Environmental Hazards
EPA plans to conduct an environmental hazard assessment of TBBPA as follows:
1) Review reasonably available environmental hazard data, including data from alternative test
methods (e.g., computational toxicology and bioinformatics; high-throughput screening
methods; data on categories and read-across; in vitro studies).
EPA plans to analyze the hazards of TBBPA to aquatic and/or terrestrial organisms, including
plants, invertebrates (e.g., insects, arachnids, mollusks, crustaceans) and vertebrates (e.g.,
mammals, birds, amphibians, fish, reptiles) across exposure durations and conditions if potential
environmental hazards are identified through systematic review results and public comments.
Additional types of environmental hazard information will also be considered (e.g., analogue and
read-across data) when characterizing the potential hazards of TBBPA to aquatic and/or terrestrial
organisms.
Environmental hazard data will be evaluated using the environmental toxicity data quality criteria
outlined in the systematic review documentation that EPA plans to publish prior to finalizing the
scope document. The study evaluation results will be documented in the risk evaluation phase and
data from suitable studies will be extracted and integrated in the risk evaluation process.
Hazard endpoints (e.g., mortality, growth, immobility, reproduction) will be evaluated while
considering data availability, relevance and quality.
2) Derive hazard thresholds for aquatic and/or terrestrial organisms.
Depending on the robustness of the evaluated data for a particular organism or taxa (e.g., aquatic
invertebrates), environmental hazard values (e.g., ECx. LCx, NOEC, LOEC) may be derived and
used to further understand the hazard characteristics of TBBPA to aquatic and/or terrestrial
species. Identified environmental hazard thresholds may be used to derive concentrations of
concern (COC) based on endpoints that may affect populations of organisms or taxa analyzed.
3) Evaluate the weight of the scientific evidence of environmental hazard data.
During risk evaluation, EPA plans to evaluate and integrate the environmental hazard evidence
identified in the literature inventory using the methods described in the systematic review
documentation that EPA plans to publish prior to finalizing the scope document.
4) Consider the route(s) of exposure, based on reasonably available monitoring and modeling
data and other available approaches to integrate exposure and hazard assessments.
EPA plans to consider aquatic (e.g., water and sediment exposures) and terrestrial pathways in the
TBBPA conceptual model. These organisms may be exposed to TBBPA via a number of
environmental pathways (e.g., surface water, sediment, soil, diet).
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5) Conduct an environmental risk characterization of TBBPA.
EPA plans to conduct a risk characterization of TBBPA to identify if there are risks to the aquatic
and/or terrestrial environments from the measured and/or predicted concentrations of TBBPA in
environmental media (i.e., water, sediment, soil). Risk quotients (RQs) may be derived by the
application of hazard and exposure benchmarks to characterize environmental risk (U.S. EPA,
1998; Barnthouse et al., 1982).
6) Consider a Persistent, Bioaccumulative and Toxic (PBT) Assessment of TBBPA.
EPA plans to consider the PBT potential of TBBPA after reviewing relevant p-chem properties
and exposure pathways. EPA plans to assess the reasonably available studies collected from the
systematic review process relating to bioaccumulation and bioconcentration (e.g., BAF, BCF) of
TBBPA. In addition, EPA plans to integrate traditional environmental hazard endpoint values
(e.g., LC50, LOEC) and exposure concentrations (e.g., surface water concentrations, tissue
concentrations) for TBBPA with the fate parameters (e.g., BAF, BCF, BMF, TMF).
2.7.3.2 Human Health Hazards
EPA plans to analyze human health hazards as follows:
1) Review reasonably available human health hazard data, including data from alternative test
methods (e.g., computational toxicology and bioinformatics; high-throughput screening
methods; data on categories and read-across; in vitro studies; systems biology).
EPA plans to use systematic review methods to evaluate the epidemiological and toxicological
literature for TBBPA. EPA plans to publish the systematic review documentation prior to
finalizing the scope document.
EPA plans to also consider relevant mechanistic evidence, if reasonably available, to inform the
interpretation of findings related to potential human health effects and the dose-repose assessment.
Mechanistic data may include analyses of alternative test data such as novel in vitro test methods
and high throughput screening. The association between acute and chronic exposure scenarios to
the agent and each health outcome will also be integrated. Study results will be extracted and
presented in evidence tables or another appropriate format by organ/system.
2) 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.
EPA plans to evaluate reasonably available human health hazard data to ascertain whether some
human receptor groups may have greater susceptibility than the general population to TBBPA
hazard(s). Susceptibility of particular human receptor groups to TBBPA 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 TBBPA exposure. EPA plans to review the
current state of the literature in order to potentially quantify these differences for risk evaluation
purposes.
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3) Conduct hazard identification (the qualitative process of identifying non-cancer and cancer
endpoints) and dose-response assessment (the quantitative relationship between hazard and
exposure) for identified human health hazard endpoints.
EPA plans to identify and evaluate human health hazards from acute and chronic exposures by
analyzing the human and animal data that meet the systematic review data quality criteria
described in the systematic review documentation that EPA plans to publish prior to finalizing the
scope document. Hazards identified by studies meeting data quality criteria will be grouped by
routes of exposure relevant to humans (oral, dermal, inhalation) and by cancer and noncancer
endpoints.
Dose-response assessment will be performed in accordance with EPA guidance (U.S. EPA, 2012a,
201 lb, 1994b). Dose-response analyses may be used if the data meet data quality criteria and if
additional information on the identified hazard endpoints are not available or would not alter the
analysis.
The cancer mode of action (MOA) determines how cancer risks can be quantitatively evaluated. If
cancer hazard is determined to be applicable to TBBPA, EPA plans to evaluate information on
genotoxicity and the mode of action for all cancer endpoints to determine the appropriate approach
for quantitative cancer assessment in accordance with the U.S. EPA Guidelines for Carcinogen
Risk Assessment (U.S. EPA, 2005).
4) Derive points of departure (PODs) where appropriate; conduct benchmark dose modeling
depending on the available data. Adjust the PODs as appropriate to conform (e.g., adjust for
duration of exposure) to the specific exposure scenarios evaluated.
EPA plans to evaluate hazard data to determine the type of dose-response modeling that is
applicable. Where modeling is feasible, a set of dose-response models that are consistent with a
variety of potentially underlying biological processes will be applied to empirically model the
dose-response relationships in the range of the observed data consistent with EPA's Benchmark
Dose Technical Guidance Document. Where dose-response modeling is not feasible, NOAELs or
LOAELs will be identified. Non-quantitative data will also be evaluated for contribution to weight
of the scientific evidence or for evaluation of qualitative endpoints that are not appropriate for
dose-response assessment.
EPA plans to 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
(201 lb), and inhalation PODs may be adjusted by exposure duration and chemical properties in
accordance with U.S. EPA (1994b).
5) Evaluate the weight of the scientific evidence of human health hazard data.
During risk evaluation, EPA plans to evaluate and integrate the human health hazard evidence
identified in the literature inventory under acute and chronic exposure conditions using the
methods described in the systematic review documentation that EPA plans to publish prior to
finalizing the scope document.
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6) Consider the route(s) of exposure (oral, inhalation, dermal), available route-to-route
extrapolation approaches, available biomonitoring data and available approaches to
correlate internal and external exposures to integrate exposure and hazard assessment.
At this stage of review, EPA believes there will be sufficient reasonably available data to conduct
a dose-response analysis and/or benchmark dose modeling for the oral route of exposure. EPA
plans to also evaluate any potential human health hazards following dermal and inhalation
exposure to TBBPA, which could be important for worker, consumer and general population risk
analysis. Reasonably available data will be assessed to determine whether or not a point of
departure can be identified for the dermal and inhalation routes. This may include using route-to-
route extrapolation methods where appropriate and depending on the nature of available data.
If sufficient toxicity studies are not identified in the literature search to assess risks from dermal
and inhalation exposures, then a route-to-route extrapolation from oral toxicity studies would be
needed to assess systemic risks from dermal or inhalation exposures. Without an adequate PBPK
model, the approaches described in EPA guidance document Risk Assessment Guidance for
Superfund Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance for
Dermal Risk Assessment) (U.S. EPA, 2004) could be applied to extrapolate from oral to dermal
exposure. These approaches may be able to further inform the relative importance of dermal
exposures compared with other routes of exposure. Similar methodology may also be used for
assessing inhalation exposures.
2.7.4 Summary of Risk Approaches for Characterization
Risk characterization is an integral component of the risk assessment process for both environmental and
human health risks. EPA plans to derive the risk characterization in accordance with EPA's Risk
Characterization Handbook (U.S. EPA, 2000). As defined in EPA's Risk Characterization Policy, "the
risk characterization integrates information from the preceding components of the risk evaluation and
synthesizes an overall conclusion about risk that is complete, informative and useful for decision makers."
Risk characterization is considered to be a conscious and deliberate process to bring all important
considerations about risk, not only the likelihood of the risk but also the strengths and limitations of the
assessment and a description of how others have assessed the risk into an integrated picture.
The level of information contained in each risk characterization varies according to the type of assessment
for which the characterization is written. Regardless of the level of complexity or information, the risk
characterization for TSCA risk evaluations will be prepared in a manner that is transparent, clear,
consistent and reasonable (U.S. EPA, 2000) and consistent with the requirements of the Procedures for
Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726). For
instance, in the risk characterization summary, EPA plans to 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, EPA plans to identify in the risk
characterization the following: (1) Each population addressed by an estimate of applicable risk effects; (2)
The expected risk or central estimate of risk for the potentially exposed or susceptible subpopulations
affected; (3) Each appropriate upper-bound or lower-bound estimate of risk; (4) Each significant
uncertainty identified in the process of the assessment of risk effects and the studies that would assist in
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resolving the uncertainty; and (5) Peer reviewed studies known to the Agency that support, are directly
relevant to, or fail to support any estimate of risk effects and the methodology used to reconcile
inconsistencies in the scientific information.
2.8 Peer Review
Peer review will be conducted in accordance with EPA's regulatory procedures for chemical risk
evaluations, including using EPA's Peer Review Handbook (U.S. EPA, 2015b) and other methods
consistent with section 26 of TSCA (See 40 CFR 702.45). As explained in the preamble to the Risk
Evaluation Rule, the purpose of peer review is for the independent review of the science underlying the
risk assessment (see 82 Fed. Reg. 33726, 33744 (July 12, 2017). Peer review will therefore address
aspects of the underlying science as outlined in the charge to the peer review panel such as hazard
assessment, assessment of dose-response, exposure assessment and risk characterization.
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U.S. EPA. (U.S. Environmental Protection Agency). (1999). Risk Assessment Guidance for Superfund
(RAGS): Volume I - human health evaluation manual, supplement to part A: Community involvement in
Superfund risk assessments [EPA Report], (EPA/540-R-98-042). Washington, DC.
http://www.epa.gov/oswer/riskassessment/ragsa/pdf/ci_ra.pdf. HERO ID: 664509
U.S. EPA. (U.S. Environmental Protection Agency). (2000). Science policy council handbook: Risk
characterization [EPA Report], (EPA/100/B-00/002). Washington, D.C.: U.S. Environmental Protection
Agency, Science Policy Council. HERO ID: 52149
U.S. EPA. (U.S. Environmental Protection Agency). (2002). Guidelines for ensuring and maximizing the
quality, objectivity, utility, and integrity of information disseminated by the Environmental Protection
Agency. (EPA/260/R-02/008). Washington, DC: U.S. Environmental Protection Agency, Office of
Environmental Information. HERO ID: 635281
U.S. EPA. (U.S. Environmental Protection Agency). (2004). Emission Scenario Document on Additives
in Plastics Processing (Compounding) (pp. 141). U.S. Environmental Protection Agency.
http://www.oecd. org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2004)8/revl&doc
language=en. HERO ID: 3809273
U.S. EPA. (U.S. Environmental Protection Agency). (2005). Guidelines for carcinogen risk assessment
[EPA Report], (EPA/630/P-03/001F). Washington, DC: U.S. Environmental Protection Agency, Risk
Assessment Forum. HERO ID: 86237
U.S. EPA. (U.S. Environmental Protection Agency). (2006). A framework for assessing health risk of
environmental exposures to children (pp. 1-145). (EPA/600/R-05/093F). Washington, DC: U.S.
Environmental Protection Agency, Office of Research and Development, National Center for
Environmental Assessment. http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=l58363. HERO ID:
194567
U.S EPA. (U.S. Environmental Protection Agency). (201 la). Exposure Factors Handbook: 2011 edition
[EPA Report], (EPA/600/R-090/052F). Washington, DC.
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=236252. HERO ID: 786546
U.S. EPA. (U.S. Environmental Protection Agency). (201 lb). Recommended Use of Body Weight 3/4 as
the Default Method in Derivation of the Oral Reference Dose. (EPA/100/R-l 1/0001). Washington, DC:
55
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U.S. Environmental Protection Agency, Risk Assessment Forum. February.
https://www.epa.gov/sites/production/files/2013-09/documents/recommended-use-of-bw34.pdf HERO
ID:752972
U.S. EPA. (U.S. Environmental Protection Agency). (2012a). Benchmark dose technical guidance.
(EPA/100/R-12/001). Washington, DC: U.S. Environmental Protection Agency, Risk Assessment Forum.
https://www.epa.gov/risk/benchmark-dose-technical-guidance. HERO ID: 1239433
U.S EPA. (U.S. Environmental Protection Agency). (2012b). Estimation Programs Interface Suite™ for
Microsoft® Windows, v 4.11. Washington, DC. https://www.epa.gov/tsca-screening-tools/epi-suitetm-
estimation-program-interface. HERO ID: 2347246
U.S. EPA. (U.S. Environmental Protection Agency). (2014). Flame retardant alternatives for
hexabromocyclododecane (HBCD) [EPA Report], (EPA/740/R-14/001). Washington, D.C.
http://www2.epa.gov/saferchoice/partnership-evaluate-flame-retardant-alternatives-hbcd-publications.
HERO ID: 2533762
U.S EPA. (U.S. Environmental Protection Agency). (2015a). TSCA work plan chemical, problem
formulation and initial assessment, tetrabromobisphenol A and related chemicals cluster flame retardants.
(EPA Document# 740-R1-4004). Washington, DC: U.S. Environmental Protection Agency, Office of
Chemical Safety and Pollution Prevention, https://www.epa.gov/sites/production/files/2015-
09/documents/tbbpa_problem_formulati on_august_2015.pdf. HERO ID: 5113343
U.S. EPA. (U.S. Environmental Protection Agency). (2015b). Science policy council peer review
handbook [EPA Report] (4th ed.). (EPA/100/B-15/001). Washington, DC: U.S. Environmental Protection
Agency, Science Policy Council, https://www.epa.gov/osa/peer-review-handbook-4th-edition-2015.
HERO ID: 3350604
U.S. EPA. (U.S. Environmental Protection Agency). (2016). Chemical Screening Tool for Occupational
Exposures and Releases (ChemSTEER). HERO ID: 6305895
U.S. EPA. (U.S. Environmental Protection Agency). (2017). Chemical data reporting (2012 and 2016
Public CDR database) [Database], Washington, DC: U.S. Environmental Protection Agency, Office of
Pollution Prevention and Toxics. Retrieved from ChemView: June 2019. HERO ID: 6275311
U.S. EPA. (U.S. Environmental Protection Agency). Application of systematic review in TSCA risk
evaluations. (740-P1-8001). Washington, DC: U.S. Environmental Protection Agency, Office of
Chemical Safety and Pollution Prevention, https://www.epa.gov/sites/production/files/2018-
06/documents/final_application_of_sr_in_tsca_05-3l-18.pdf. HERO ID: 4532281
U.S. EPA. (U.S. Environmental Protection Agency). (2018b). Basics of TRI reporting.
https://www.epa.gov/toxics-release-inventory-tri-program/basics-tri-reporting. HERO ID: 6181671
U.S. EPA. (U.S. Environmental Protection Agency). (2018c). Problem formulation of the risk evaluation
for 1-bromopropane. (EPA-740-R1-7019). Washington, DC: Office of Chemical Safety and Pollution
Prevention, United States Environmental Protection Agency.
https://www.epa.gov/sites/production/files/2018-06/documents/lbp_problem_formulation_05-31-18.pdf.
HERO ID: 5085557
56
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U.S. EPA. (U.S. Environmental Protection Agency). (2018d). Problem formulation of the risk evaluation
for cyclic aliphatic bromides cluster (HBCD). (EPA-740-R1-7012). Washington, DC: Office of Chemical
Safety and Pollution Prevention, United States Environmental Protection Agency.
https://www.epa.gov/sites/production/files/2018-06/documents/hbcd_problem_formulation_05-31-18.pdf.
HERO ID: 5085560
U.S. EPA. (U.S. Environmental Protection Agency). (2019a). Proposed designation of 4,4'-(l-
methylethylidene)bis [2,6-dibromophenol] (CASRN 79-94-7) as a high-priority substance for risk
evaluation. Washington, DC: U.S. Environmental Protection Agency, Office of Chemical Safety and
Pollution Prevention, https://www.epa.gov/sites/production/files/2019-08/documents/44-l-
methylethylidenebis_26-dibromophenol_79-94-7_high-priority_proposeddesignation_082319_0.pdf.
HERO ID: 6305896
U.S. EPA. (U.S. Environmental Protection Agency). (2019b). CPCat: Chemical and Product Categories.
https://actor.epa.gov/cpcat/ faces/home.xhtml. HERO ID: 6276340
U.S. EPA (U.S. Environmental Protection Agency) (2019c). Chemical Data Reporting (2012 and 2016
CBI CDR database). Washington, DC. U.S. Environmental Protection Agency, Office of Pollution
Prevention and Toxics, (accessed April 25, 2019). HERO ID: 6301193
U.S. EPA (U.S. Environmental Protection Agency). (2019d). TRI Explorer (2018 dataset released
November 2019). Washington, DC: U.S. Environmental Protection Agency.
https://enviro.epa.gov/triexplorer/. (accessed January 17, 2020). HERO ID: 6323208
Voordeckers, J;Fennell, D;Jones, K;Haggblom, M. (2002). Anaerobic biotransformation
of tetrabromobisphenol A, tetrachlorobisphenol A, and bisphenol A in estuarine sediments. Environ Sci
Technol 36: 696-701. https://www.ncbi.nlm.nih.gov/pubmed/11878385. HERO ID: 5230666
Yuasa. (2016). Safety data sheet: Valve regulated lead acid battery. Revised 2016.01.04. Yuasa. HERO
ID:6301194
57
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APPENDICES
Appendix A LIST OF GRAY LITERATURE SOURCES
Table Apx A-l Gray Literature Sources That Yielded Results for TBBPA
Source/
Agency
Source Nitme
Source
Type
Source ('silegory
ATSDR
ATSDR Toxicological Profiles (original
publication)
Other US
Agency
Resources
Assessment or Related
Document
Australian
Government
Department
of Health
NICNAS Assessments (eco)
International
Resources
Assessment or Related
Document
CAL EPA
Technical Support Documents for
regulations: Proposition 65, Cancer, Notice
Other US
Agency
Resources
Assessment or Related
Document
CPSC
Technical Reports: Exposure/Risk
Assessment
Other US
Agency
Resources
Assessment or Related
Document
ECHA
European Union Risk Assessment Report
International
Resources
Assessment or Related
Document
ECHA
ECHA Documents
International
Resources
Assessment or Related
Document
Env Canada
Chemicals at a Glance (fact sheets)
International
Resources
Assessment or Related
Document
Env Canada
Guidelines, Risk Management,
Regulations
International
Resources
Assessment or Related
Document
EPA
Office of Water: STORET and WQX
US EPA
Resources
Database
EPA
Design for the Environment (DfE)
Alternatives Assessments
US EPA
Resources
Assessment or Related
Document
EPA
TSCA Assessments
US EPA
Resources
Assessment or Related
Document
EPA
Other EPA: Misc sources
US EPA
Resources
General Search
EPA
EPA: AP-42
US EPA
Resources
Regulatory Document or List
58
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EPA
TRI: Envirofacts Toxics Release Inventory
2017 Updated Dataset
US EPA
Resources
Database
EPA
Chemical Data Reporting (2012 and 2016
non-CBI CDR database)
US EPA
Resources
Database
EPA
Chemical Data Reporting (2012 and 2016
CBI CDR database)
US EPA
Resources
Database
EPA
EPA: Generic Scenario
US EPA
Resources
Assessment or Related
Document
EPA
EPA Discharge Monitoring Report Data
US EPA
Resources
Database
EPA
Office of Water: CFRs
US EPA
Resources
Regulatory Document or List
EPA
Office of Air: National Emissions
Inventory (NEI) - National Emissions
Inventory (NEI) Data (2014, 2011, 2008)
US EPA
Resources
Database
EPA
Office of Air: CFRs and Dockets
US EPA
Resources
Regulatory Document or List
I ARC
IARC Monograph
International
Resources
Assessment or Related
Document
KOECT
Kirk-Othmer Encyclopedia of Chemical
Technology Journal Article
Other
Resource
Encyclopedia
NIOSH
CDC NIOSH - Pocket Guides
Other US
Agency
Resources
Database
NIOSH
CDC NIOSH - Health Hazard Evaluations
(HHEs)
Other US
Agency
Resources
Assessment or Related
Document
NIOSH
CDC NIOSH - Publications and Products
Other US
Agency
Resources
Assessment or Related
Document
NLM
National Library of Medicine's Hazardous
Substance Databank
Other US
Agency
Resources
Database
NLM
NIEHS Tox Review
Other US
Agency
Resources
Assessment or Related
Document
NLM
National Library of Medicine's PubChem
Other US
Agency
Resources
Database
59
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NTP
Technical Reports
Other US
Agency
Resources
Assessment or Related
Document
OECD
OECD Substitution and Alternatives
Assessment
International
Resources
Assessment or Related
Document
OECD
OECD Emission Scenario Documents
International
Resources
Assessment or Related
Document
OECD
OECD: General Site
International
Resources
General Search
OSHA
U.S. OSHA Chemical Exposure Health
Data (CEHD) program data | ERG|
Other US
Agency
Resources
Database
RIVM
RIVM Reports: Dietary Intake
International
Resources
Assessment or Related
Document
TERA
Toxicology Excellence for Risk
Assessment
Other
Resources
Assessment or Related
Document
60
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Appendix B PHYSICAL AND CHEMICAL PROPERTIES
This appendix provides p-chem information and data found in preliminary data gathering for TBBPA.
Table Apx B-l summarizes the p-chem property values preliminarily selected for use in the risk
evaluation from among the range of reported values collected as of March 2020. This table differs from
that presented in the Proposed Designation of4A'-(l-MeihvlethvUdem}bis[2,6-dibromoi)henol] (CASRN
79-94-7) as a Hieh-Priority Substance for Risk Evaluation (U.S. EPA, 2019a) and may be updated as
EPA collects additional information through systematic review methods. All p-chem property values that
were extracted and evaluated as of March 2020 are presented in the supplemental file Data Extraction and
Data Evaluation Tables for Physical Chemical Property Studies (EPA-HQ-OPPT-2018-0462).
Table Apx B-l Physical and Chemical Properties of TBBPA
Properly or Kmlpoinl
Value51
Reference
Data Quality
Ualing
Molecular formula
Ci5Hi2Br402
NA
NA
Molecular weight
543.88 g/mol
NA
NA
Physical state
Solid crystals
O'Neil, 2013
High
Physical properties
Odorless
NLM, 2018
High
White
Elsevier, 2019
High
Melting point
181°C
U.S. EPA, 2019
High
Boiling point
316°C
NLM, 2018
High
Density
2.158 g/cm3 at 19.85°C
Elsevier, 2019
High
Vapor pressure
4.68x 10"9 mm Hg at
25°C
NLM, 2018
High
Vapor density
Not available
Water solubility
4.15 rng/L at 298 K
(pH 7.56)
Kuramochi, 2008
High
Log Octanol/water partition
coefficient (Log Kow)
4.75 at 298 K
(pH 7.53
Kuramochi, 2008
High
Henry's Law constant
1.45><10"10 atm-m Vmol at
298 K
Kuramochi, 2008
Medium
Flash point
Not available
61
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Auto flammability
Not available
Viscosity
Not available
Refractive index
Not available
Dielectric constant
Not available
a Measured unless otherwise noted.
NA = Not applicable
62
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Appendix C
ENVIRONMENTAL FATE AND TRANSPORT
PROPERTIES
Table Apx C-l provides the environmental fate characteristics that EPA identified and considered in
developing the scope for TBBPA. This information has not changed from that provided in the Proposed
Designation of 4,4'-(l-Methylethylidene)bisi womovhenol1 fCASRN 79-94-7} as a High-Priority
Substance for Risk Evaluation (U.S. EPA 2019a).
Table_Apx C-1 Environmental Fate Characteristics of TBBPA
Properly or Kmlpoinl
\ aluca
Reference
Direct Photodegradation
ti/2 =17 minutes-5.8 hours based on ultraviolet
absorption maximum at 310 nm, a quantum yield
of
0.042 and decomposition rates ranging from 3.3 x
10"5 (at pH 5.5) to 6.8 x 10"4 (at pH 9) per second
HSDB (2018) citing
Eriksson (2004)
2,6-dibromo-p-benzosemiquinone anions and
TBBPA were identified as the main
photodecomposition byproducts
HSDB (2018) citing
Han (2016)
Indirect Photodegradation
ti/2 = 3.615 days (based on -OH rate constant of 2.96
x 10"12 cmVmol sec at 25 °C and 12-hour day with
1.5 x 106 OH/cm3; estimated)13
U.S. EPA (2012b)
Hydrolysis
Not expected to undergo hydrolysis in the
environment due to the lack of functional groups
that hydrolyze under environmental conditions
HSDB (2018) citing
Lyman (1990)
Biodegradation (Aerobic)
Water: 0%/14 days (MITI)
HSDB (2018); NITE
(2018)
Water: ti/2 = 48-84 days (natural river water)
HSDB (2018) citing
U.S. EPA (1989)
Soil: ti/2 >6 months (18-22% mineralization/6
months); 18-64%/64 days primary degradation
OECD (2005)
Sandy soil: ti/2 = 14.7 days; full degradation after
143 days; primary byproducts are the mono and
dimethyl ethers
HSDB (2018) citing Li
(2015)
Biodegradation (Anaerobic)
Soil and sediment: Anaerobic biodegradation of
2,2',6,6'-TBBPA has been shown to occur in soil
and sediment studies with primary degradation
being complete in 64 days in some; the primary
byproduct from anaerobic biodegradation is
bisphenol A
HSDB (2018) citing
Voordeckers (2002)
Wastewater Treatment
Wastewater influent containing 2,2',6,6'-TBBPA
concentration range of 10-145 ng/L had removal
HSDB (2018) citing
Islam (2015)
63
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of 76-83% with conventional activated sludge and
bioreactor systems
Bioconcentration Factor
30-341 and 52-485 for Carp (Cyprinus carpio),
which were exposed over an 8-week period to
concentrations of 80 and 8 |ig/L, respectively
NITE (2018)
307 measured in fathead minnow (Pimephales
promelas)
HSDB (2018) citing
Hardy (2004)
Bioaccumulation Factor
720 (estimated)13
U.S. EPA (2012b)
Soil Organic Carbon:Water
Partition Coefficient (Log
Koc)
5.4 (Koc = 2.7 x 105 MCI method; estimated)13
U.S. EPA (2012b)
Soil column and batch adsorption studies using
loam soil and sand found 2,2',6,6'-TBBPA is
sorbed extensively by both soil and sand
ECHA (2018)
Notes: aMeasured unless otherwise noted;
bEPI SuiteTM physical property inputs: SMILES 0c(c(cc(cl)C(c(cc(c(0)c2Br)Br)c2)(C)C)Br)clBr)
64
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Appendix D REGULATORY HISTORY
The chemical substance, TBBPA, is subject to federal and state laws and regulations in the United States
(TableApx D-l and TableApx D-2 respectively). Regulatory actions by other governments, tribes and
international agreements applicable to TBBPA are listed in Table Apx D-3.
TBBPA is regulated in the United States within EPA, in multiple states and internationally. Primarily
TBBPA is regulated by TSCA, but it also included in the Emergency Planning and Community Right-To-
Know Act (EPCRA); therefore, listed on the Toxics Release Inventory. Several states list TBBPA as a
chemical of concern or a chemical of high concern for children. California regulates TBBPA through
multiple processes such as Proposition 65, California's Safer Consumer Products Program, a Health
Hazard Alert and TBBPA is designated for biomonitoring. Internationally, TBBPA is either listed as a
domestically used chemical, assessed or regulated in Canada, the European Union, Australia, Japan, the
Basel Convention and OECD's Control of Transboundary Movements of Wastes Destined for Recovery
Operations.
D.l Federal Laws and Regulations
Table Apx D-l Federal Laws and Regulations
Mat ulcs/Uegulal ions
Description of Aiilhoril\/Ucgulation
Description of Regulation
EPA Regulations
Toxic Substances Control
Act (TSCA) - Section
6(b)
EPA is directed to identify high-priority chemical
substances for risk evaluation; and conduct risk
evaluations on at least 20 high priority substances no
later than three and one-half years after the date of
enactment of the Frank R. Lautenberg Chemical Safety
for the 21st Century Act.
TBBPA is one of the 20
chemicals EPA designated as
a High-Priority Substance for
risk evaluation under TSCA
(84 FR 7.1.924. December 30,
2019). Designation of
TBBPA as high-priority
substance constitutes the
initiation of the risk
evaluation on the chemical.
Toxic Substances Control
Act (TSCA) - Section
8(a)
The TSCA section 8(a) CDR Rule requires
manufacturers (including importers) to give EPA basic
exposure-related information on the types, quantities
and uses of chemical substances produced domestically
and imported into the United States.
TBBPA manufacturing
(including importing),
processing and use
information is reported under
the CDR rule (76 FR 508.1.6.
August 16, 2011).
Toxic Substances Control
Act (TSCA) - Section
8(b)
EPA must compile, keep current and publish a list (the
TSCA Inventory) of each chemical substance
manufactured (including imported) or processed in the
United States.
TBBPA was on the initial
TSCA Inventory and
therefore was not subject to
EPA's new chemicals review
process under TSCA section
5 (60 FR .1.6309. March 29.
1995).
Toxic Substances Control
Act (TSCA) - Section
8(e)
Manufacturers (including importers), processors, and
distributors must immediately notify EPA if they
obtain information that supports the conclusion that a
11 risk reports received for
TBBPA (1992-2005) (U.S.
65
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chemical substance or mixture presents a substantial
risk of injury to health or the environment.
EPA. ChemView. Accessed
June 25, 2019).
Toxic Substances Control
Act (TSCA) - Section 4
Provides EPA with authority to issue rules,
enforceable consent agreements and orders requiring
manufacturers (including importers) and processors to
test chemical substances and mixtures.
14 chemical data submissions
from test rules received for
TBBPA: eight ecotoxicity
reports and six environmental
fate reports (1986-1994) (U.S.
EPA. ChemView. Accessed
April 2, 2019).
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. A facility that meets reporting
requirements must submit a reporting form for each
chemical for which it triggered reporting, providing
data across a variety of categories, including activities
and uses of the chemical, releases and other waste
management (e.g., quantities recycled, treated,
combusted) and pollution prevention activities (under
section 6607 of the Pollution Prevention Act). These
data include on- and off-site data as well as
multimedia data (i.e., air, land and water).
TBBPA is a listed substance
subject to reporting
requirements (40 CFR
372.65. effective January 1.
2000).
D.2 State Laws and Regulations
Table Apx D-2 State Laws and Regulations
Slate Actions
Description of Action
Stale Prohibitions
California adopted a prohibition on the selling and distribution in commerce of new, not
previously owned juvenile products, mattresses, or upholstered furniture that contains, or
a constituent component of which contains, covered flame retardant chemicals at levels
above 1,000 parts per million (A.B. 2998, Legislative Council, Sess. 2017-2018, C.A.
2018).
State Right-to-Know
Acts
New Jersey lists TBBPA as a chemical of concern: persistent, bioaccumulative, toxic
(PBT) substance on the Environmental Hazardous Substance List, (N.J.A.C. 7:lG-2).
Chemicals of High
Concern to Children
Several states have adopted reporting laws for chemicals in children's products containing
TBBPA, including Maine (38 MRSA Chapter 16-D), Minnesota (Toxic Free Kids Act
Minn. Stat. 116.9401 to 116.9407), Oregon (Toxic-Free Kids Act, Senate Bill 478, 2015),
Vermont (18 V.S.A § 1776) and Washington State (Wash. Admin. Code 173-334-130).
Other
California listed TBBPA on Proposition 65 in 2017 due to cancer. (Cal Code Regs. Title
27, §27001).
TBBPA is listed as a Candidate Chemical under California's Safer Consumer Products
Program (Health and Safety Code § 25252 and 25253).
66
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California issued a Health Hazard Alert for TBBPA (Hazard Evaluation System and
Information Service, 2016). https://oehha.ca.gov/chemicals/tetrabromobisphenol
California lists TBBPA as a designated priority chemical for biomonitoring (California
SB 1379). http://www.biomonitoring.ca.gov/chemicals/chemicals-biomonitored-
california
The Oregon Department of Environmental Quality lists TBBPA as a priority persistent
pollutant (Oregon SB 737). 2009. page 39 https://
digital ¦osl.state.or.us/islandora/obiect/osl%3A20601/datastream/OBJ/view
D.3 International Laws and Regulations
Table Apx D-3 Regulatory Actions by other Governments, Tribes, and International Agreements
Country/Tribe/
Organization
Requirements and Restrictions
Canada
TBBPA is on the Domestic Substances List (Government of Canada. Managing
substances in the environment. Substances search. Database accessed April 16. 2019).
European Union
TBBPA is registered for use in the EU. (European Chemicals Aeencv (ECHA
database. Accessed April 16, 2017).
The Waste Electrical and Electronic Equipment (WEEE) directive 2012/19/EU
requires the separation of plastics containing brominated flame retardants prior to
recycling (European Commission WEEE).
TBBPA was evaluated under the 2015 Community rolling action plan (CoRAP) under
regulation (European Commission [EC]) No 1907/2006 - REACH (Registration,
Evaluation, Authorisation and Restriction of Chemicals). Additional information was
requested and is due January 2021. (ECHA database. Accessed April 16. 2019V
TBBPA is being evaluated and considered by the European Commission for addition
to the Restriction of Hazardous Substances Directive, which currently restricts the use
of ten hazardous substances at more than 0.1% by weight at the 'homogeneous
material' level in electrical and electronic eauipment. (European Commission RoHSV
Australia
In 2001. TBBPA was assessed. (Polvbrominated Flame Retardants. Priority Existing
Chemical Assessment Report No. 20 (2001V).
Japan
TBBPA is regulated in Japan under the following legislation:
• Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc. (Chemical Substances Control Law; CSCL)
• Water Pollution Control Law
(National Institute of Technology and Evaluation [NITE] Chemical Risk
Information Platform |0 IKIP|. Accessed April 9. 2019V
Basel Convention
Waste substances and articles containing or contaminated
with polychlorinated biphenyls (PCBs) and/or polychlorinated
67
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terphenyls (PCTs) and/or polybrominated biphenyls (PBBs) and wastes, substances
and articles containing, consisting of or
contaminated with polychlorinated biphenyl (PCB), polychlorinated terphenyl (PCT),
polychlorinated naphthalene
(PCN) or polybrominated biphenyl (PBB), or any other polybrominated analogues of
these compounds, at a concentration level of 50 mg/kg or more are listed as a
cateaorv of waste under the Basel Convention. Althouah the United States is not
currently a party to the Basel Convention, this treaty still affects U.S. importers and
exporters.
OECD Control of
Transboundary Movements
of Wastes Destined for
Recovery Operations
Wastes, substances and articles containing, consisting of or contaminated with
polychlorinated biphenyl (PCB), polychlorinated terphenyl (PCT), polychlorinated
naphthalene (PCN) or polybrominated biphenyl (PBB), or any other polybrominated
analogues of these compounds, at a concentration level of 50 mg/kg or more are
listed as a cateaorv of waste subject to The Amber Control Procedure under Council
Decision C(2001) 107/Final.
68
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Appendix E PROCESS, RELEASE AND OCCUPATIONAL
EXPOSURE INFORMATION
This appendix provides information and data found in preliminary data gathering for TBBPA.
E.l Process Information
Process-related information potentially relevant to the risk evaluation may include process diagrams,
descriptions and equipment. Such information may inform potential release sources and worker exposure
activities.
E.l.l Manufacture (Including Import)
E.l.1.1 Domestic Manufacturing
TBBPA is produced by the bromination of bisphenol-A in the presence of a solvent. This reaction may be
conducted in the presence of a hydrocarbon solvent only or with water, 50% hydrobromic acid or aqueous
alkyl mono ethers. When methanol is used as the solvent, methyl bromide is formed as a by-product. The
production process is largely conducted in closed systems. (EFSA, 2018)
E.l.1.2 Import
EPA expects that imported chemicals are often stored in warehouses prior to distribution for further
processing and use. In some cases, the chemicals may be repackaged into differently sized containers,
depending on customer demand, and quality control samples may be taken for analyses (U. S. EPA,
2018c).
E.1.2 Processing and Distribution
E.l.2.1 Processing as a Reactant
Processing as a reactant or intermediate is the use of TBBPA as a feedstock in the production of another
chemical product via a chemical reaction in which TBBPA is consumed to form the product (U.S. EPA,
2018c).
E.l.2.2 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. TBBPA may undergo several
processing steps and the processing is dependent on its downstream incorporation into articles.
E. 1.2.3 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 TBBPA-containing formulations or reaction products are
dependent on the article (EPA, 2018d). For example, TBBPA may be incorporated into electrical
equipment, appliance and component and plastics products as a flame retardant (U.S. EPA, 2019c). EPA
plans to further investigate the use of TBBPA being incorporated into articles during risk evaluation.
E. 1.2.4 Recycling
EPA did not identify TBBPA-specific information for recycling at this time; however, this chemical has
been identified in articles that are commonly recycled such as plastics and electronic materials which
indicates that recycling may occur for waste plastics and for electronics wastes. The processes for
69
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recycling these materials may include grinding, washing, and rinsing the recycled material and
incorporating it into new formulations and articles. Electronics waste recycling may include recovery of
plastics through similar recycling processes, which are described more generally in Kirk Othmer (Kirk-
Othmer, 2006). EPA has not identified specific worker activities related to the recycling TBBPA-
containing products. Based on EPA's knowledge, worker activities are anticipated to be exposed to
TBBPA from reclamation activities such as sorting, materials grinding steps and loading recovered
materials into transport containers.
E.1.3 Uses Included in Scope
E.l.3.1 Adhesive Manufacturing
The American Coatings Association (ACA) informed EPA that TBBPA is used as a flame retardant in
adhesives and sealants and that specialty products may have amounts above 10% (EPA-1 PT-2018-
0462-0003). The Aerospace Industry Association (A1A) informed EPA that TBBPA is used as an adhesive
(films and epoxy) used by the aerospace industry (EPA-HO-OPPT-2Q18-0462-0004). The National Institute
of Environmental Health Sciences (NIEHS) identified the use of TBBPA in adhesives and coatings
(NIEHS, 2002). Four facilities in the "Adhesive Manufacturing" sector reported to TRI in 2017 for
TBBPA.
K. 1.3.2 Intermediate (e.g., transportation equipment manufacturing)
One company, Huntsman Corporation - The Woodlands Corporate Site, reported to CDR (U.S. EPA,
2019c) that TBBPA is used as an intermediate in transportation equipment manufacturing, for industrial
manufacturing. The Government of Canada's Screening Assessment Report (Canada, 2013) states that
TBBPA is used to make motor housings, and that ABS resins containing are used in automotive parts. An
ABS product was identified as containing TBBPA and used in automobile interior housing. Furthermore,
the Aerospace Industry Association (AIA) informed EPA that TBBPA is used as an adhesive (films and
epoxy) and in prepreg used by the aerospace industry (EPA-H.Q-QPPT-2018-0462-0004). Specifically, AIA
noted that TBBPA is used for its flame retardance and temperature stability properties on structural film
adhesives, resins for honeycomb core, and in epoxy pre-impregnated fiberglass or graphite tapes or woven
fabrics. According to AIA, TBBPA-containing materials are qualified for use in company proprietary
specifications and are certified/approved by civil aviation airworthiness authorities and DOD customers
used by the aerospace industry. Six facilities in the "Other Aircraft Parts and Auxiliary Equipment
Manufacturing" sector and three facilities in the "Aircraft Manufacturing" sector reported to TRI in 2017
for TBBPA.
E.l.3.3 Intermediate (e.g., all other chemical product and preparation manufacturing)
The Chemtura company, at two sites, reported to CDR (U.S. EPA, 2019c) that TBBPA is used as an
intermediate in chemical product and preparation manufacturing. Two facilities in the "Other Basic
Inorganic Chemical Manufacturing" sector reported to TRI in 2017 for TBBPA.
E.l.3.4 Building/Construction Materials
One company, Lintech International Inc., reported to CDR (U.S. EPA, 2019c) that it is used as a
processing aid in plastic material and resins manufacturing, to make building/construction materials. The
Government of Canada's Screening Assessment Report for TBBPA (Canada, 2013) states that it is used
flame-retardant resins containing TBBPA are found in glass-reinforced construction panels.
E.l.3.5 Electrical and Electronic Products
Three companies reported to CDR (U.S. EPA, 2019c) that TBBPA is used as a flame retardant in
electrical equipment, appliance and component manufacturing and in computer and electronic product
70
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manufacturing. Electrical and electronics are divided into two groups those that use TBBPA as an additive
flame retardant in plastic enclosures and those that use TBBPA as a reactive flame retardant such as in
printed circuit boards. Additive flame retardants are not chemically bonded to the base material while
reactive flame retardants are chemically bonded. The American Chemistry Council in its public comments
noted that the main application of TBBPA is in printed circuit boards or laminates (EPA-HQ-QPPT-2018-
0462-0003). The National Institute of Environmental Health Sciences identifies the use of TBBPA in
electronic enclosures made of polycarbonate-acrylonitrile-butadiene-styrene and in integrated circuit
chips (NIEHS, 2002). The Government of Canada's Screening Assessment Report (2013) states that
TBBPA is used to make rigid epoxy-laminated printed circuit boards and terminal boards. Canada (2013)
further reports that flame-retarded resins made with TBBPA are used in communications and electronics
equipment, appliances and lighting fixtures, while acrylonitrile-butadiene-styrene (ABS) resins containing
TBBPA are used in refrigerators and other appliances, business machines and telephones. One facility in
the "Semiconductor and Related Device Manufacturing" sector, one facility in the "Current-Carrying
Wiring Device Manufacturing" sector and one facility in the "Other Electronic Component
Manufacturing" sector reported to TRI in 2017 for TBBPA.
E.l.3.6 Plastic Products and Resins
One company, Sabic Innovatice Plastics, reported to CDR (U.S. EPA, 2019c) that TBBPA is used as a
flame retardant in plastics product manufacturing. According to Canada (2013), TBBPA is incorporated
into polymers as a reactive or additive flame retardant for use in flame-retarded epoxy and polycarbonate
resins and, to a lesser extent, in acrylonitrile-butadiene-styrene (ABS) resins and phenolic resins.
Applications of flame-retarded polycarbonate resins include communications and electronics equipment,
appliances, transportation devices, sports and recreation equipment, lighting fixtures and signs. ABS
resins containing TBBPA are used in automotive parts, pipes and fittings, refrigerators and other
appliances, business machines and telephones. The ECHA registration dossier for TBBPA (ECHA, 2019)
identifies the use of TBBPA as a reactive intermediate in the manufacture of polymer resins, and in the
manufacture of polymer resins/articles containing additive flame retardant, in European countries. Ten
facilities in the "Plastics Material and Resin Manufacturing" sector and five facilities in the "All Other
Plastics Product Manufacturing" reported to TRI in 2017 for TBBPA. One facility in the "Other Industrial
Machinery Manufacturing" sector also reported to TRI in 2017 for TBBPA; this company, LMR Plastics,
is a thermoplastic injection molding company. The plastic products and resins condition of use overlaps
with the electrical and electronic products conditions of use. Further research and stakeholder outreach
will be conducted to increase understanding and reduce overlap. EPA does not believe that TBBPA is
used in plastics other than those which are electronics unless electronic plastic is recycled and reformed
into a plastic product with no electronic component.
E.l.3.7 Fabric, Textiles and Leather Products not Covered Elsewhere
The National Institute of Environmental Health Sciences identifies the use of TBBPA as a flame retardant
in textiles, and further states that TBBPA is applied to carpeting and office furniture (NIEHS, 2002). Two
facilities in the "Fabric Coating Mills" sector reported to TRI in 2017 for TBBPA. There also provides
evidence that TBBPA was once used in textiles (NIEHS, 2002; IPCS, 1995; Gain, 1997; Gustafsson,
1988). However, specific uses of TBBPA in textiles are unknown. Based on Washington State data it is
believed that presence of TBBPA in textiles for children's clothing is only at contaminant levels. EPA
plans to further investigate if there is any evidence of TBBPA in textiles as an ongoing use during this
risk evaluation and encourages the public to submit information pertaining to this use.
71
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E.l.3.8 Batteries
Based on SDS information provided by the State of California, TBBPA may be used as an adhesive in
lead acid battery casings. EPA did not identify TBBPA-specific process information for adhesive and
sealant use within batteries; however, the OECD ESD for Use of Adhesives provides general process
descriptions and worker activities for industrial adhesive uses. Liquid adhesives are unloaded from
containers into the coating reservoir, applied to a flat or three-dimensional substrate and the substrates are
then joined and allowed to cure (OECD, 2013). The majority of adhesive applications include spray, roll,
curtain, syringe or bead application (OECD, 2013). For solvent-based adhesives, the volatile solvent
evaporates during the curing stage (OECD, 2013). Based on EPA's knowledge of the industry, overlap in
process descriptions, worker activities and application methods are expected for sealant products.
E.l.3.9 Laboratory Chemical
A safety data sheet for TBBPA (<=100% percent purity) indicates recommended use as a laboratory
chemical (Sigma-Aldrich, 2020). However, specific laboratory use activities are unknown. EPA plans to
further investigate the laboratory use of TBBPA during the risk evaluation.
E.l.3.10 Disposal
Disposal of a chemical should take into consideration the chemical's potential impact on air quality,
migration to groundwater, effect on biological species, and disposal regulations (ATSDR, 2017).
Currently, TBBPA is not regulated under federal regulations as a hazardous waste (HAP List/RCRA
Hazardous Waste Lists). However, TBBPA may be disposed of as a hazardous waste if it is present in or
co-mingled with solvent mixtures that are RCRA regulated substances (U.S. EPA, 2018c).
Demolished building materials are classified as Construction and Demolition (C&D) waste, which may be
disposed in municipal solid waste landfills (MSWLFs) or C&D landfills (EPA, 2018d; EPA, 2014).
E.2 Preliminary Occupational Exposure Data
EPA plans to consider reasonably available data and information related to worker exposure and
environmental releases as they are identified during systematic review. Based on a preliminary data
gathering, there are no OSHA Chemical Exposure and Health Data (CEHD) specific to TBBPA.
However, EPA identified three NIOSH health hazard evaluations, which may have relevant monitoring
data.
Table Apx E-l Potentially Relevant Data Sources for Exposure Monitoring and Area Monitoring
Data from NIOSH Health Hazard Evaluations for TBBPAa
Year of Publication
Report Number
Facility Description
2018
HHE-2015-0050-3308
Electronics recycling company
2017
HETA-2014-0131-3308
Gymnastics studios
2016
HHE-2013-0075-3 264
Production of automotive parts
a Table includes HHEs identified to date
72
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Appendix F SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR INDUSTRIAL
AND COMMERCIAL ACTIVITIES AND USES
l.ili- (\ik-
Shim-
Ciik-»iir\
Slll)i;iu-»iir\
Ri-k'iisi- /
F.\|>IISIIIV
Siiiiiiriii
l'A|)IIMIIV
P;ilh\\;i\
l!\|)iisuiv
RiuiU-
lii-ii-plnl" /
Piipilhlliiill
Plans In
l!\ ;illl;ik-
K;iliiill;ik-
Liquid
Contact
Dermal
Workers
Yes
Due to the presence of solvent in the manufacturing
process, exposure to TBBPA suspended in liquid will
occur during equipment cleaning and
transfer/loading/packaging operations.
Manufacture of
TBBPA via
Solid Contact
Dermal
Workers
Yes
According to CDR, all domestically manufactured
TBBPA is in the form of a dry powder. Dermal
exposure will occur when the material is packaged.
Manufacture
Domestic
Manufacture
Domestic
Manufacture
bromination of
bisphenol-A in
the presence of
solvent
Vapor, Mist
Inhalation
Workers,
ONI J
No
Due to the volatility of TBBPA (VP =4.68* 10 -8 Torn
at room temperature, inhalation exposure to TBBPA in
the vapor phase is not expected. Mist generation is not
expected durinsi the maniifacturin" process.
Dust
Inhalation
Workers,
ONU
Yes
According to CDR, all domestically manufactured
TBBPA is in the form of a dry powder. Inhalation
exposure to TBBPA via fugitive dust will occur when
the material is packaged.
Liquid, Solid
Contact
Dermal
ONU
No
Dermal exposure by ONU is not expected for this
condition of use as they are not expected to directly
handle the chemical.
73
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l.ili- ( \ik-
Ciik-»iir\
Slll)i;iu-»iir\
Ri-k'iisi- /
F.\|>IISIIIV
Sii-n;iriii
l'A|>HMIIV
P;illl\\;i\
l!\|)iisuiv
KouU-
Ri'ivpliir /
Population
Plans In
l".\ ;i III ilk-
K;iliiill;ili-
Liquid
Contact
Dermal
Workers
Yes
According to CDR, one submitter indicated that they
import TBBPA in liquid form (30-60% concentration).
EPA interprets this as solid TBBPA suspended in
solution. Exposure will occur if the imported material is
repackaged
Solid Contact
Dermal
Workers
Yes
According to CDR, multiple submitters indicated that
they imported TBBPA in solid form. Exposure will
occur if the imported material is repackaged.
Manufacture
Import
Import
Repackaging
of import
containers
Vapor, Mist
Inhalation
Workers.
o\r
No
Due to the volatility of TBBPA (VP =4.68* I0A -8 I'orr)
at room temperature, inhalation exposure to TBBPA in
the vapor phase is not expected. Mist generation is not
expected during the import (i.e. repackaging) process.
Dust
Dermal
Workers
Yes
According to CDR, multiple submitters indicated that
they imported TBBPA in the form of dry powder.
Exposure will occur if the imported material is
repackaged.
Liquid. Solid
Contact
I )ermal
ONI J
No
I )ermal exposure by ONI J is not expected for this
condition of use as they are not expected to directly
handle the chemical.
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during
manufacturing of other chemicals, as TBBPA can be
used/transported suspended in solution (according to
CDR data).
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during
manufacturing of other chemicals, as TBBPA is in solid
form, including dust.
Processing
As a reactant
Flame retardant
in plastic
material and
resin
Unloading
Vapor. Mist
Inhalation
Workers,
ONI J
No
Due to the volatility of TBBPA (VP =4.68*10A -8 loir)
at room temperature, inhalation exposure to TBBPA in
the vapor phase is not expected. Mist generation is not
expected during the manufacturing of other chemicals.
manufacturing
Dust
Inhalation
Workers
ONI J
Yes
TBBPA is often used/transported as a solid powder, thus
exposure to dust is likely during the manufacturing of
other chemicals (e.g.. unloading TBBPA powder).
Liquid. Solid
Contact
1 )ermal
ONLJ
No
Dermal exposure by ONIJ is not expected for this
condition of use as they are not expected to directly
handle the chemical.
74
-------
l.ili- ( \ik-
Sln»i-
Ciik-»iir\
Slll)i;iu-»iir\
Ri-k'iisi- /
F.\|>IISIIIV
Sii-n;iriii
l'A|>HMIIV
P;ilh\\;i\
l!\|)iisuiv
KouU-
Ri'ivpliir /
Population
Plans In
l".\ ;i III ilk-
Kaliiiliali-
Processing
As a reactant
Intermediate in
all other
chemical
product and
preparation
manufacturing
Unloading
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during
manufacturing of other chemicals, as TBBPA can be
used/transported while suspended in solution (according
to CDR data).
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during
manufacturing of other chemicals, as TBBPA is in solid
form, including dust.
Vapor, Mist
Inhalation
Workers.
ONI J
No
Due to the volatility of TBBPA (VP =4.68* l()A -8 I'orr)
at room temperature, inhalation exposure to TBBPA in
the vapor phase is not expected. Mist generation is not
expected during the manufacturing of other chemicals.
Dust
Inhalation
Workers,
ONU
Yes
TBBPA is often used/transported as a solid powder, thus
exposure to dust is likely during the manufacturing of
other chemicals (e.g., unloading TBBPA powder).
Liquid, Solid
Contact
Dermal
ONI J
No
Dermal exposure by ()NU is not expected for this
condition of use as they are not expected to directly
handle the chemical.
Processing
Incorporated
into
Formulation,
Mixture, or
Reaction
Product
Flame retardant
in electrical
equipment,
appliance, and
component
manufacturing;
plastic material
and resin
manufacturing;
plastics product
manufacturing;
computer and
electronic
product
manufacturing
Unloading
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during
unloading operations for incorporation into formulation,
mixture, or reaction product, as TBBPA can be
used/transported while suspended in solution (according
to CDR data).
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during
unloading operations for incorporation into formulation,
mixture, or reaction product,, as TBBPA is in solid
form.
Vapor. Mist
Inhalation
Workers,
ONU
No
Due to the volatility of TBBPA (VP =4.68* l()A -8 Loir)
at room temperature, inhalation exposure to TBBPA in
the vapor phase is not expected. Mist generation is not
expected during processing (incorporation into
formulation, mixture, or reaction product).
Dust
Dermal
Workers
Yes
TBBPA is often used/transported as a solid powder, thus
exposure to dust is likely during unloading operations
for incorporation into formulation, mixture, or reaction
product.
Liquid. Solid
Contact
1 )ermal
ONU
No
Dermal exposure by ONU is not expected for this
condition of use as they are not expected to directly
handle the chemical.
75
-------
l.ili- (\ik-
Ciik-»iir\
Slll)i;iu-»iir\
Ri-k'iisi- /
F.\|>IISIIIV
Sii-n;iriii
l'A|)IIMIIV
l!\|)iisuiv
Ri'ivpliir /
I'hms In
K;iliiill;ili-
P;i 1 hw ;i\
KouU-
Population
l".\ ;illi;ik-
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during
unloading operations, as TBBPA can be
used/transported while suspended in solution (according
to CDR data).
Intermediate in
transportation
equipment
manufacturing;
adhesive
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during
unloading operations, as TBBPA is in solid form.
Unloading
Vapor. Mist
Inhalation
Workers,
ONU
No
Due to the volatility of TBBPA (VP =4.68* l()A -8 Ion)
at room temperature, inhalation exposure to TBBPA in
the vapor phase is not expected. Mist generation is not
expected during unloading operations.
manufacturing
Dust
Inhalation
Workers,
ONU
Yes
TBBPA is often used/transported as a solid powder, thus
exposure to dust is likely during unloading operations.
Processing
Liquid. Solid
Contact
Dermal
ONU
No
Dermal exposure by ()NU is not expected for this
condition of use as they are not expected to directly
handle the chemical.
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during
unloading operations, as TBBPA can be
used/transported while suspended in solution (according
to CDR data)
Flame retardant
in Electrical
equipment,
appliance, and
component
manufacturing;
plastics product
manufacturing
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during
loading operations, as TBBPA is in solid form
Incorporated
into article
Unloading
Vapor, Mist
Inhalation
Workers.
ONU
No
Due to the volatility of TBBPA (VP =4.68* l()A -8 I'orr)
at room temperature, inhalation exposure to TBBPA in
the vapor phase is not expected. Mist generation is not
expected during loading operations.
Dust
Inhalation
Workers,
ONU
Yes
TBBPA is often used/transported as a solid powder, thus
exposure to dust is likely during loading operations.
Liquid, Solid
Contact
1 )ermal
ONU
No
1 )ermal exposure by ONU is not expected for this
condition of use as they are not expected to directly
handle the chemical.
76
-------
Life ( \ ik-
Ciik-»iir\
Slll)i;iu-»iir\
Ri-k'iisi- /
F.\|>IISIIIV
Sii-n;iriii
l'A|)IIMIIV
l';illl\\;i\
l!\|)iisuiv
Kouli-
Ki'ivpliir /
I'opuhilion
Philis In
l".\ :ilu:iU-
K;iliiill;ili-
Liquid
Contact
I )ermal
Workers
No
The potential for exposures to workers does not exist
during processing (recycling), as recycled materials
containing TBBPA are primarily solid.
Solid Contact
I )ermal
Workers
Yes
Potential for exposure during recycling of articles
containing residual (unreacted) TBBPA .
Processing
Recycling
Recycling
Recycling
Vapor. Mist
Inhalation
Workers,
ONU
No
Due to the volatility of TBBPA (VP =4.68* l()A -8 I on)
at room temperature, inhalation exposure to TBBPA in
the vapor phase is not expected. Mist generation is not
expected during recycling operations).
Dust
Inhalation
Workers.
ONU
Yes
Potential for exposure during recycling of articles
containing residual (unreacted) TBBPA
Liquid. Solid
Contact
1 )ermal
ONU
No
1 )ermal exposure by ONU is not expected for this
condition of use as they are not expected to directly
handle the chemical.
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during this
use (Electrical and Electronic Products), as TBBPA can
be used/transported while suspended in solution
(according to CDR data)
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during this
use (Electrical and Electronic Products), as TBBPA is in
solid form
Industrial
and
Commercial
Use
Construction,
Paint,
Electrical,
and Metal
Products
Electrical and
Electronic
Products (e.g.,
reactive flame
retardant)
Production of
electrical and
electronic
products
Vapor. Mist
Inhalation
Workers,
ONU
No
Due to the volatility of TBBPA (VP =4.68* l()A -8 Ton)
at room temperature, inhalation exposure to TBBPA in
the vapor phase is not expected. Mist generation is not
expected during this use (Electrical and Electronic
Products).
Dust
Inhalation
Workers,
ONU
Yes
TBBPA is often used/transported as a solid powder, thus
exposure to dust is likely during this use (Electrical and
Electronic Products).
Liquid, Solid
Contact
1 )ermal
ONU
No
Dermal exposure by ONU is not expected for this
condition of use as they are not expected to directly
handle the chemical.
77
-------
l.ili- ( \ik-
Ciik-»iir\
Slll)i;iu-»iir\
Ri-k'iisi- /
F.\|>IISIIIV
Sii-n;iriii
l'A|>HMIIV
P;illl\\;i\
l!\|)iisuiv
KouU-
Ri'ivpliir /
Popiikiliun
Plans In
l".\ ;i III ilk-
K;iliiill;ili-
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during this
use (Electrical and Electronic Products), as TBBPA can
be used/transported while suspended in solution
(according to CDR data)
Electrical and
Electronic
Products (e.g.,
additive flame
retardant in
plastic
enclosures)
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during this
use (Electrical and Electronic Products), as TBBPA is in
solid form
Production of
electrical and
electronic
products
Vapor, Mist
Inhalation
Workers,
ONU
No
Due to the volatility of TBBPA (VP =4.68* l()A -8 loir)
at room temperature, inhalation exposure to TBBPA in
the vapor phase is not expected. Mist generation is not
expected during this use (Electrical and Electronic
Products).
Dust
Inhalation
Workers.
ONU
Yes
TBBPA is often used/transported as a solid powder, thus
exposure to dust is likely during this use (Electrical and
Electronic Products).
Industrial
and
Construction,
Paint,
Electrical,
and Metal
Products
Liquid. Solid
Contact
1 )ermal
ONU
No
Dermal exposure by ()NU is not expected for this
condition of use as they are not expected to directly
handle the chemical.
Commercial
Use
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during this
use (Building/Construction Materials), as TBBPA can
be used/transported while suspended in solution
(according to CDR data)
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during this
use (Building/Construction Materials), as TBBPA is in
solid form
Building/
construction
materials not
covered
elsewhere
Use of
construction
panels and
other materials
Vapor. Mist
Inhalation
Workers,
ONU
Yes
Due to the volatility of TBBPA (VP =4.68* 1()A -8 'Ion)
at room temperature, inhalation exposure to TBBPA in
the vapor phase is not expected. Mist generation is not
expected during this use (Building/Construction
Materials).
Dust
Inhalation
Workers,
ONU
Yes
TBBPA is often used/transported as a solid powder and
in articles that could be cut and sawed during
construction processes, thus exposure to dust is likely
during this use (Building/Construction Materials).
Liquid. Solid
Contact
Dermal
ONU
No
Dermal exposure by ()NI J is not expected for this
condition of use as they are not expected to directly
handle the chemical.
78
-------
l.ili- ( \ik-
Sln»i-
Ciik-»iir\
Slll)i;iu-»iir\
Ri-k'iisi- /
F.\|>IISIIIV
Sii-n;iriii
l'A|>HMIIV
P;i 1 hw ;i\
l!\|)iisuiv
KouU-
Ri'ivpliir /
Popiikiliun
Pkilis In
l".\ ;i III ilk-
K;iliiill;ili-
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during this
use (Batteries, adhesives in lead acid battery casings), as
TBBPA can be used/transported while suspended in
solution (according to CDR data)
Construction,
Paint,
Electrical,
and Metal
Products
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during this
use (Batteries, adhesives in lead acid battery casings), as
TBBPA is in solid form
Batteries (e.g.,
adhesive in lead
acid battery
casings)
Battery
production
Vapor. Mist
Inhalation
Workers,
ONI J
No
Due to the volatility of TBBPA (VP =4.68*10A -8 I'oit)
at room temperature, inhalation exposure to TBBPA in
the vapor phase is not expected. Mist generation is not
expected during this use (Batteries, adhesives in lead
acid batten casinas).
Dust
Inhalation
Workers,
ONU
Yes
TBBPA is often used/transported as a solid powder, thus
exposure to dust is likely during this use (Batteries,
adhesives in lead acid batten casings).
Industrial
and
Liquid. Solid
Contact
Dermal
ONIJ
No
Dermal exposure by ONU is not expected for this
condition of use as they are not expected to directly
handle the chemical.
Commercial
Use
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during this
use (Laboratory Chemical), as TBBPA can be
used/transported while suspended in solution (according
to CDR data)
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during this
use (Laboratory Chemical), as TBBPA is in solid form
Other
Laboratory
chemical
Use of
laboratory
chemicals
Vapor, Mist
Inhalation
Workers.
ONU
No
Due to the volatility of TBBPA (VP =4.68* l()A -8 I'orr)
at room temperature, inhalation exposure to TBBPA in
the vapor phase is not expected. Mist generation is not
expected during this use (Laboratory Chemical).
Dust
Inhalation
Workers.
ONU
Yes
TBBPA is often used/transported as a solid powder, thus
exposure to dust is likely during this use (Laboratory
Chemical).
Liquid
Contact
1 )ermal
Workers
Yes
I'he potential for exposures to workers exists during this
use (Laboratory Chemical), as TBBPA can be
used/transported while suspended in solution (according
to CDR data)
79
-------
l.ili- ( \ik-
Ciik-»iir\
Slll)i;iu-»iir\
Ri-k'iisi- /
F.\|>IISIIIV
Sii-n;iriii
l'A|>HMIIV
P;ilh\\;i\
l!\|)iisuiv
KouU-
Ri'ivpliir /
Population
Plans In
l".\ ;i III ilk-
K;iliiill;ili-
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during this
use (Fabric, textile and leather products not covered
elsewhere), as TBBPA can be used/transported while
suspended in solution (according to CDR data)
Fabric, textile,
and leather
products not
covered
elsewhere
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers exists during this
use (Fabric, textile and leather products not covered
elsewhere), as TBBPA is in solid form
Industrial
and
Commercial
Use
Furnishing,
Cleaning,
Treatment/
Care Products
Textile
finishing
Vapor. Mist
Inhalation
Workers,
ONU
No
Due to the volatility of TBBPA (VP =4.68*10A -8 I'oit)
at room temperature, inhalation exposure to TBBPA in
the vapor phase is not expected. Mist generation is not
expected during this use (fabric, textile and leather
products not covered elsewhere)).
Dust
Inhalation
Workers,
ONU
Yes
TBBPA is often used/transported as a solid powder, thus
exposure to dust is likely during this use (Fabric, textile
and leather products not covered elsewhere).
Liquid. Solid
Contact
Dermal
ONU
No
Dermal exposure by ONU is not expected for this
condition of use as they are not expected to directly
handle the chemical.
Solid Contact
Dermal
Worker
Yes
Dermal exposure is expected for this condition of
use
Disposal
Waste
Handling,
Disposal of
TBBPA
Worker
handling of
wastes
Dust
Inhalation
Worker
Yes
TBBPA is solid at room temperature, EPA plans
to evaluate the inhalation pathway.
Treatment
and Disposal
containing
wastes
Liquid
Contact
Dermal
<>\l
\n
Dermal exposure h\ < )M is iiol cxpcclcd fur lliis
condition of use as ihc> are nui cxpcclcd In
dircclK handle llie chemical
Dust
Inhalation
ONU
Yes
TBBPA is solid at room temperature, EPA plans
to evaluate the inhalation pathway.
80
-------
Appendix G SUPPORTING INFORMATION - CONCECPTUAL MODEL FOR CONSUMER
ACTIVITIES AND USES
Table Apx G-l Consumer Exposure Conceptual Model Supporting Table
l.ilV Cji'lc
Sl;i»c
("sik'Sion
Siibciik'jion
Kck'sisi* from
SOIIIVO
l'l\|)OMIIV
Koule
Km'plor
PlilllS lo
i:\iiiuiiic
Kiilioiiiilc
Direct contact
through use of
Air/Particulate/
Vapor/Mist
Inhalation
Consumers
Yes
Inhalation of air and/or particles from
electrical and electronic products containing
TBBPA may occur for this condition of use.
EPA plans to analyze inhalation exposure.
Electrical and
electronic
products
electrical and
electronic
products made
containing
Dust
Ingestion
Consumers
Yes
Ingestion of dust from electrical and electronic
products containing TBBPA may occur for
this condition of use. EPA plans to analyze
dust exposure via ingestion.
TBBPA
Article/Product
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this condition
of use. EPA plans to analyze dermal exposure.
Consumer Use
Construction,
Paint,
Building/
Direct contact
through use of
Air/Particulate/
Vapor/Mist
Inhalation
Consumers
Yes
Inhalation of air and/or particles from
building/construction materials containing
TBBPA may occur for this condition of use.
EPA plans to analyze inhalation exposure.
Electrical, and
Metal Products
construction
materials not
covered
elsewhere
building/
construction
materials made
containing
Dust
Ingestion
Consumers
Yes
Ingestion of dust from building/construction
materials containing TBBPA may occur for
this condition of use. EPA plans to analyze
dust exposure via ingestion.
TBBPA
Article/Product
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this condition
of use. EPA plans to analyze dermal exposure.
Batteries
Direct contact
through use of
batteries made
containing
TBBPA
Air/Particulate/
Vapor/Mist
Inhalation
Consumers
Yes
Inhalation of air and/or particles from batteries
containing TBBPA may occur for this
condition of use. EPA plans to analyze
inhalation exposure.
Dust
Ingestion
Consumers
Yes
Ingestion of dust from batteries containing
TBBPA may occur for this condition of use.
EPA plans to analyze dust exposure via
ingestion.
81
-------
l.ilV Cji'lc
Sl.iiio
("sik'Sion
Siibciik'jion
Kck'sisi* from
SOIIIVO
l'l\|)OMIIV
P;i(h\\;n
Koule
Km'plor
PlilllS lo
i:\iiiuiiio
Kiilioiiiilc
Article/Product
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this condition
of use. EPA plans to analyze dermal exposure.
Air/Particulate/
Vapor/Mist
Inhalation
Consumers
Yes
Inhalation via air and/or particulate exposure
may occur during product/article use. EPA
plans to analyze inhalation exposure.
Consumer Use
Furnishing,
Cleaning,
Fabric, textile,
and leather
products not
covered
elsewhere
Direct contact
through use of
products/articles
containing
TBBPA
Dust
Ingestion
Consumers
Yes
Ingestion of TBBPA sorbed onto dust may
occur for this condition of use. EPA plans to
analyze dust exposure via ingestion.
Treatment/
Care Products
Article/Product
Contact
Dermal
Consumers
Yes
Dermal exposure may occur via use of articles
containing TBBPA. EPA plans to analyze
dermal exposure.
Article/Product
Mouthing
Ingestion
Consumers
Yes
Ingestion via object to mouth or subsequent
hand to mouth from product dermal contact.
EPA plans to analyze mouthing via ingestion.
Direct contact
Article/Product
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this condition
of use, dermal exposure will be analyzed.
TBBPA is semi-volatile at room temperature.
EPA plans to analyze dermal exposure.
through use of
products/articles
containing
Dust
Ingestion
Consumers
Yes
Ingestion of TBBPA sorbed onto dust may
occur for this condition of use. EPA plans to
analyze dust exposure via ingestion.
Consumer
Handling of
Disposal and
Waste
Wastewater,
liquid wastes
and solid
wastes
Wastewater,
liquid wastes and
TBBPA
Air/Particulate/
Vapor/Mist
Inhalation
Consumers
and
Bystanders
Yes
Inhalation of air and/or particles from
articles/products containing TBBPA may
occur for this condition of use. EPA plans to
analyze inhalation exposure.
solid wastes
Long-term
emission/mass-
transfer through
use of products
Dust
Ingestion
Consumers
and
Bystanders
Yes
Ingestion of TBBPA sorbed onto dust may
occur for this condition of use. EPA plans to
analyze dust exposure via ingestion.
containing
TBBPA
Air/Particulate/
Vapor/Mist
Inhalation
Consumers
and
Bystanders
Yes
Inhalation of air and/or particles from
articles/products containing TBBPA may
occur for this condition of use. EPA plans to
analyze inhalation exposure.
82
-------
Appendix H SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES
Table A
r>x H-1 Environmental Releases and Wastes Conceptual Model Supporting Table
life
( > cle
Si;i«»c
C.ili'uon
Release
r.\|)(isuiv P;illiw
/ Media
r.\|)(isuiv Routes
Reeeplor /
Population
Pliins lo
I.MllllillC
Ralionale
Near facility
ambient air
concentrations
Inhalation
General
Population
Yes
Emissions to Air
Emissions to Air
Indirect deposition
to nearby bodies of
water and soil
catchments
Oral
Dermal
General
Population
Yes
TBD
Aquatic and
Terrestrial
Receptors
Yes
TBBPA deposition to nearby bodies of
water and soil are expected exposure
pathways, not covered under other
EPA regulations, and, therefore in
scope.
TBD
All
Direct release into
surface water and
indirect partitioning
to sediment
Aquatic and
Terrestrial
Receptors
Yes
EPA plans to analyze the release of
TBBPA into surface water and indirect
partitioning to sediment exposure
pathways to aquatic and terrestrial
receptors.
Wastewater or
Liquid Wastes
Industrial pre-
treatment and
wastewater
treatment, or
POTW
Oral
Dermal
General
Population
Yes
EPA plans to analyze the release of
TBBPA into surface water and indirect
partitioning to sediment and
bioaccumulation exposure pathways to
the general population.
Drinking Water via
Surface or Ground
Water
Oral
Dermal and
Inhalation (e.g.
showering)
General
Population
Yes
EPA plans to analyze the release of
TBBPA into surface water and indirect
partitioning to drinking water.
Biosolids:
application to soil
and/or migration to
groundwater and/or
surface water
Oral (e.g.
ingestion of soil)
Inhalation
General
Population
Yes
TBD
Terrestrial
receptors
Yes
EPA plans to analyze the pathway
from biosolids to the general
population and terrestrial species.
Underground
injection
Migration lo
groundwater.
potential
Oral
Dermal
Inhalation
General
Population
No
TBBPA is released lo Class I
Underground Injection Wells which
are covered bv SDWA and RCRA.
83
-------
Life
Cjtflc
Csili'Sion
Uck'iiso
l'.\|)(isiiiv P;illiw :¦>
/ Mcrii.i
llxposiiiv Routes
Km'plor /
Population
Pliins lo
l'\;i In ;ito
Kiilioiiiilo
surface di'inkiiiu
waler
ri :i)
\t|iialic and
1 ci'icsiiial
Species
1 !l' \ does ik
------- |