LpA United States
Mwk Environmental Protection Agency
Office of Chemical Safety and
Pollution Prevention
Proposed Designation of
4,4'-(l-Methylethylidene)bis
[2,6-dibromophenol]
(CASRN 79-94-7)
as a High-Priority Substance
for Risk Evaluation
August 22, 2019
-------
Table of Contents
List of Tables iii
Acronyms and Abbreviations iv
1. Introduction 1
2. Production volume or significant changes in production volume 3
Approach 3
Results and Discussion 3
3. Conditions of use or significant changes in conditions of use 4
Approach 4
CDR and TRI Tables 4
CDR and TRI Summary and Additional Information on Conditions of Use 14
4. Potentially exposed or susceptible subpopulations 15
Approach 15
Results and Discussion 15
5. Persistence and bioaccumulation 17
Approach 17
Physical and Chemical Properties and Environmental Fate Tables 17
Results and Discussion 20
6. Storage near significant sources of drinking water 20
Approach 20
Results and Discussion 20
7. Hazard potential 21
Approach 21
Potential Human Health and Environmental Hazard Tables 21
8. Exposure potential 25
Approach 25
Results and Discussion 25
9. Other risk-based criteria that EPA determines to be relevant to the designation of the
chemical substance's priority 28
10. Proposed designation and Rationale 28
11. References 29
ii
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List of Tables
Table 1. 1986-2015 National Aggregate Production Volume Data (Production Volume in
Pounds) 3
Table 2. 4,4'-(l-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) (CASRN 79-94-7)
Categories and Subcategories of Conditions of Use (2016 CDR reporting cycle) 5
Table 3. 4,4'-(l-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) (CASRN 79-94-7)
Categories and Subcategories of Conditions of Use (2012 CDR Reporting Cycle) 6
Table 4. Activities and Uses Reported to TRI for 4,4'-(l-Methylethylidene)bis[2, 6-
dibromophenol] (TBBPA), Reporting Year 2011 7
Table 5. Activities and Uses Reported to TRI for 4,4'-(l-Methylethylidene)bis[2, 6-
dibromophenol] (TBBPA), Reporting Year 2015 9
Table 6. Activities and Uses Reported to TRI for 4,4'-(l-Methylethylidene)bis[2, 6-
dibromophenol] (TBBPA), Reporting Year 2017 12
Table 7. Uses in Children's Products Information 16
Table 8. Physical and Chemical Properties of 4,4'-(l-Methylethylidene)bis[2, 6-dibromophenol]
(TBBPA) 17
Table 9. Environmental Fate Characteristics of 4,4'-(l-Methylethylidene)bis[2, 6-
dibromophenol] (TBBPA) 18
Table 10. Potential Human Health Hazards Identified for 4,4'-(l-Methylethylidene)bis[2, 6-
dibromophenol] (TBBPA) 21
Table 11. Potential Environmental Hazards Identified for 4,4'-(l-Methylethylidene)bis[2, 6-
dibromophenol] (TBBPA) 23
Table 12. The TRI Data on 4,4'-(l-Methylethylidene)bis[2,6-dibromophenol] (TBBPA) from
Reporting Years 2011, 2015, and 2017 and Used in this Document to Assess Exposure
Potential 26
Table 13. Exposure Information for the Consumers 27
in
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Acronyms and Abbreviations
Term Description
CAA Clean Air Act
CASRN Chemical Abstracts Service Registry Number
CBI Confidential Business Information
CDR Chemical Data Reporting
CERCLA Comprehensive Environmental Response, Compensation, and Liability Act
CFR Code of Federal Regulations
CPDat Chemical and Products Database
CWA Clean Water Act
ECHA European Chemicals Agency
EPA Environmental Protection Agency
EPCRA Emergency Planning and Community Right-to-Know Act
IARC International Agency for Research on Cancer
IUR Inventory Update Reporting
K0c Organic carbon-water partitioning coefficient
Kow Octanol-water partitioning coefficient
M Million
MITI Ministry of International Trade and Industry
NA Not Available
NAICS North American Industry Classification System
NIH National Institutes of Health
NKRA Not known or reasonably ascertainable
NR Not reported
OECD Organisation for Economic Co-operation and Development
•OH Hydroxyl radical
POTW Publicly owned treatment works
RY Reporting Year
SMILES Simplified Molecular-Input Line-Entry System
iv
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Term Description
TBBPA 4,4'-(l-Methylethylidene)bis[2,6-dibromophenol]
TBD To be determined
TRI Toxics Release Inventory
TSCA Toxic Substances Control Act
v
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1. Introduction
In section 6(b)(1)(B) of the Toxic Substances Control Act (TSCA), as amended, and in the U.S.
Environmental Protection Agency's (EPA) implementing regulations (40 CFR 702.3)1, a high-
priority substance for risk evaluation is defined as a chemical substance that EPA determines,
without consideration of costs or other non-risk factors, may present an unreasonable risk of
injury to health or the environment because of a potential hazard and a potential route of
exposure under the conditions of use, including an unreasonable risk to potentially exposed or
susceptible subpopulations identified as relevant by EPA.
Before designating prioritization status, under EPA's regulations at 40 CFR 702.9 and pursuant
to TSCA section 6(b)(1)(A), EPA will generally use reasonably available information to screen
the candidate chemical substance under its conditions of use against the following criteria and
considerations:
• the hazard and exposure potential of the chemical substance;
• persistence and bioaccumulation;
• potentially exposed or susceptible subpopulations;
• storage near significant sources of drinking water;
• conditions of use or significant changes in the conditions of use of the chemical substance;
• the chemical substance's production volume or significant changes in production volume;
and
• other risk-based criteria that EPA determines to be relevant to the designation of the chemical
substance's priority.
This document presents the review of the candidate chemical substance against the criteria and
considerations set forth in 40 CFR 702.9 for a may present risk finding. The information sources
used are relevant to the criteria and considerations and consistent with the scientific standards of
TSCA section 26(h), including, as appropriate, sources for hazard and exposure data listed in
Appendices A and B of the TSCA Work Plan Chemicals: Methods Document (February 2012)
(40 CFR 702.9(b)). Final designation of the chemical substance as a high-priority chemical
substance would immediately initiate the risk evaluation process as described in the EPA's final
rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control
Act (40 CFR 702).
4,4'-(l-Methylethylidene)bis[2,6-dibromophenol] (TBBPA) is one of the 40 chemical substances
initiated for prioritization as referenced in the March 21, 2019 notice (84 FR 10491)2. EPA has
determined that TBBPA is a suitable candidate for the proposed designation as a high-priority
chemical substance. The proposed designation is based on the results of the review against the
aforementioned criteria and considerations as well as review of the reasonably available
information on TBBPA, including relevant information received from the public and other
information as appropriate.
1 For all 40 CFR 702 citations, please refer to:
https://www.govinfo.gov/content/pkg/CFR-2018-fitle40-vol33/xml/CFR-2018-tifle40-vol33-part702.xml and
https://www.regulations.gov/document?D=EPA-HO-OPPT-2Q .1.6-0654-0.1.08
2 https://www.federalregister.gov/docnments/2019/03/21/2019-05404/initiation-of-prioritization-nnder-the-toxic-
substances-control-act-tsca
1
-------
EPA will take comment on this proposed designation for 90 days before finalizing its designation
of TBBPA. The docket number for providing comments on TBBPA is EPA-HQ-OPPT-2018-
0462-0002 and is available at www.regulations.gov.
The information, analysis, and basis used for the review of the chemical is organized as follows:
• Section 1 (Introduction): This section explains the requirements of the amended TSCA
and implementing regulations - including the criteria and considerations — pertinent to
the prioritization and designation of high-priority chemical substances.
• Section 2 (.Production volume or significant changes in production volume): This section
presents information and analysis on national aggregate production volume of the
chemical substance.
• Section 3 (Conditions of use or significant changes in conditions of use): This section
presents information and analysis regarding the chemical substance's conditions of use
under TSCA.
• Section 4 (Potentially exposed or susceptible subpopulations): This section presents
information and analysis regarding potentially exposed or susceptible subpopulations,
including children, women of reproductive age, and workers, with respect to the chemical
substance.
• Section 5 (.Persistence and bioaccumulation)\ This section presents information and
analysis regarding the physical and chemical properties of the chemical substance and the
chemical's fate characteristics.
• Section 6 (Storage near significant sources of drinking water): This section presents
information and analysis considered regarding the risk from the storage of the chemical
substance near significant sources of drinking water.
• Section 7 (Hazardpotential): This section presents the hazard information relevant to the
chemical substance.
• Section 8 (Exposurepotential): This section presents information and analysis regarding
the exposures to the chemical substance.
• Section 0 (Other risk-based criteria): This section presents the extent to which EPA
identified other risk-based criteria that are relevant to the designation of the chemical
substance's priority.
• Section 10 (Proposed designation): Based on the results of the review performed and the
information and analysis presented, this section describes the basis used by EPA to
support the proposed designation.
2
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2. Production volume or significant changes in production volume
Approach
EPA considered current volume or significant changes in volume of the chemical substance
using information reported by manufacturers (including importers). EPA assembled reported
information for years 1986 through 2015 on the production volume for TBBPA reported under
the Inventory Update Reporting (IUR) rule and Chemical Data Reporting (CDR) rule.3
Results and Discussion
The national aggregate production volume, which is presented as a range to protect individual
site production volumes that are confidential business information (CBI), is presented in Table 1.
Table 1.1986-2015 National Aggregate Production Volume Data (Production Volume in
Pounds) i
Chemical ID
1986
1990
1994
1998
2002
2006
2011
2012
2013
2014
2015
4,4'-(l-
Methylethyliden
e)bis[2,6-
dibromophenol]
(TBBPA)
(79-94-7)
>10Mto
50M
>50M to
100M
>100Mto
500M
>100Mto
500M
>100Mto
500M
>100Mto
500M
119,837,559
>50M to
100M
>50M to
100M
>50M to
100M
>50M to
100M
Notes: M = million
Reference: U.S. EPA (2013); U.S. EPA (2017)
Production volume of TBBPA in 2015, as reported to EPA during the 2016 CDR reporting
period, was between 50 and 100 million pounds per year. National aggregate production volume
for TBBPA was at its highest from reporting years (RY) 1994 to 2006, during which 100 million
to 500 million pounds of the chemical was manufactured or imported. In 2011, 119,837,559
pounds of TBBPA was manufactured or imported. In RY 1990 and again from 2012 to 2015, the
aggregate production volume was between 50 million and 100 million pounds. In RY 1986, 10
million to 50 million pounds of TBBPA was manufactured or imported (Table 1).
3 Over time, the requirements for reporting frequency, production volume thresholds, and chemical substances under
the Chemical Data Reporting (CDR) have changed. CDR was formerly known as the Inventory Update Rule (IUR).
The first IUR collection occurred in 1986 and continued every four years through 2006. As part of two rulemakings
in 2003 and 2005, EPA made a variety of changes to the IUR, including to change the reporting frequency to every
five years to address burdens associated with new reporting requirements. Additional changes to reporting
requirements were made in 2011, including to suspend and replace the 2011 submission period with a 2012
submission period, return to reporting every four years, and require the reporting of all years beginning with 2011
production volumes. The reporting of production volumes for all years was added because of the mounting evidence
that many chemical substances, even larger production volume chemical substances, often experience wide
fluctuations in production volume from year to year. In addition, also as part of the 2011 IUR Modifications final
rule (76 FR 50816, Aug 16, 2011), EPA changed the name of the regulation from IUR to CDR to better reflect the
distinction between this data collection (which includes exposure-related data) and the TSCA Inventory itself (which
only involves chemical identification information).
3
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3. Conditions of use or significant changes in conditions of use
Approach
EPA assembled information to determine conditions of use or significant changes in conditions
of use of the chemical substance. TSCA section 3(4) defines the term "conditions of use" to
mean 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.
A key source of reasonably available information that EPA considered for determining the
conditions of use for TBBPA was submitted by manufacturers (including importers) under the
2012 and 2016 CDR reporting cycles. CDR requires manufacturers (including importers) to
report information on the chemical substances they produce domestically or import into the
United States greater than 25,000 pounds per site, except if certain TSCA actions apply (in
which case the reporting requirement is greater than 2,500 lbs per site). CDR includes
information on the manufacturing, processing, and use of chemical substances. Based on the
known manufacturing, processing and uses of this chemical substance, EPA assumes distribution
in commerce. 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). While EPA may be aware of
additional uses, CDR submitters are not required to provide information on chemical uses that
are not regulated under TSCA.
For chemical substances under review that are included on the Toxics Release Inventory (TRI)
chemical list, information disclosed by reporting facilities in Part II Section 3 ("Activities and
Uses of the Toxic Chemical at the Facility") of their TRI Form R reports was used to supplement
the CDR information on conditions of use (Tables 4, 5, and 6). There is not a one-to-one
correlation between conditions of use reported under CDR and information reported in Part II
Section 3 of the TRI Form R because facilities are not required to disclose in their Form R
submissions the specific uses of TRI chemical substances they manufactured on-site or imported.
In addition to the information disclosed in Part II Section 3 of the TRI Form R, the information
pertaining to waste management activities (i.e., disposal/releases, energy recovery, recycling, and
treatment) disclosed in other sections of the Form R was also used to supplement the CDR
information on conditions of use as shown in Tables 4, 5, and 6. EPA assumed end-of-life
pathways that include releases to air, wastewater, and solid and liquid waste based on the
conditions of use.
CDR and TRI Tables
Based on the publicly available4 manufacturing information, industrial processing and use
information, and consumer and commercial use information reported under CDR, EPA
developed a list of conditions of use for the 2016 and 2012 reporting cycles (Table 2 and 3,
respectively).
4 Some specific chemical uses may be claimed by CDR submitters as confidential business information (CBI) under
section 14 of TSCA. In these cases, EPA has indicated that the information is CBI.
4
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Table 2. 4,4'-(l-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) (CASRN 79-94-7)
Categories and Subcategories of Conditions of Use (2016 CDR reporting cycle)5
Life-Cycle
Stage
Category
Subcategory of Use
Reference
Manufacture
Domestic
manufacture
Domestic manufacture
U.S. EPA (2019a)
Import
Import
U.S. EPA (2019a)
Processing
Processing -
incorporating 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
U.S. EPA (2019a)
Intermediates in transportation equipment
manufacturing
\ (20.1.9a)
Processing aids not otherwise listed in plastic
material and resin manufacturing
U.S. EPA (20.1.9a)
Other in miscellaneous manufacturing
U.S. EPA (20.1.9a)
Processing -
incorporating into
articles
Flame retardant in:
Electrical equipment, appliance, and
component manufacturing
Plastics product manufacturing
U.S. EPA (20.1.9a)
Processing as a
reactant
Flame retardant in:
Plastic material and resin manufacturing
U.S. EPA (20.1.9a)
Intermediate in all other chemical product and
preparation manufacturing
U.S. EPA (20.1.9a)
Rcc\ cluiij
( m
Distribution in
Distribution
commerce
Commercial Us
Electrical and
Electrical and electronic products
¦. EPA (20.1.9a ;
es
electronic
products
Industrial
manufacturing
Industrial manufacturing
U.S. EPA (20.1.9a)
Building/
construction
materials not
covered
elsewhere
Building/construction materials not covered
elsewhere
U.S. EPA (20.1.9a)
5 Certain other uses that are excluded from TSCA are not captured in this table.
6 At this time, "CBI" indicates that a data element has been claimed confidential business information (CBI) by the
information submitter; it does not reflect the result of an EPA substantiation review.
5
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Life-Cycle
Stage
Category
Subcategory of Use
Reference
Consumer Uses
Electrical and
electronic
products
Electrical and electronic products
U.S. EPA (2019a)
Disposal
Disposal
a CDR includes information on the manufacturing, processing, and use of chemicals. 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 row is highlighted in gray to indicate that no information is provided for this life-cycle stage.
b EPA is particularly interested in information from the public on distribution in commerce.
Table 3. 4,4'-(l-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) (CASRN 79-94-7)
Categories and Subcategories of Conditions of Use (2012 CDR Reporting
Cycle)7
Life-Cycle Stage
Category
Subcategory of Use
Reference
Manufacture
Domestic
manufacture
Domestic manufacture
U.S. EPA (2019a)
Import
Import
U.S. EPA (2019a)
Processing
Distribution in
commerce
Processing -
incorporating
into formulation,
mixture or
reaction product
Flame retardant in:
Plastics material and resin manufacturing
Computer and electronic
product
manufacturing
U.S. EPA (2019a)
Processing as a
reactant
Flame retardant in:
All other basic
organic chemical
manufacturing
U.S. EPA (2019a)
Rcc\ clniij
Dislnliulion
Commercial Uses
Electrical
and electronic
products
Electrical and electronic products
EPA (20 19e
Plastic
and rubber product
s not covered
elsewhere
Plastic and rubber products not covered
elsewhere
U.S. EPA (2019a)
Consumer Uses
Electrical
and electronic
products
Electrical and electronic products
U.S. EPA (2019a)
Disposal
Disposal
11 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
7 Certain other uses which are excluded from TSCA are not captured in this table.
6
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Life-Cycle Stage Category
Subcategory of Use
Reference
(i.e., disposal). The table row is highlighted in gray to indicate that no information is provided for this life-cycle
stage.
b EPA is particularly interested in information from the public on distribution in commerce.
EPA used TRI data to identify additional conditions of use and to supplement CDR information
about conditions of use. In addition, TRI information from 2017 is useful for demonstrating that
a condition of use reported to CDR in 2015 is still ongoing.
Table 4. Activities and Uses Reported to TRI for 4,4'-(l-Methylethylidene)bis[2, 6-
dibromophenoll (TBBPA), Reporting Year 2011
Activity
Type
Activity
Industry Group
NAICS
Code
Manufacture
Produce
Basic chemical manufacturing
3251
Import
Other chemical product and preparation manufacturing
3259
Semiconductor and other electronic component
manufacturing
3344
Produce or import for
on-site use/processing
Semiconductor and other electronic component
manufacturing
3344
Produce or import for
sale/distribution
Basic chemical manufacturing
3251
Other chemical product and preparation manufacturing
3259
Process
Process as a reactant
Basic chemical manufacturing
3251
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Other chemical product and preparation manufacturing
3259
Semiconductor and other electronic component
manufacturing
3344
Aerospace product and parts manufacturing
3364
Process as an article
component
Paint, coating, and adhesive manufacturing
3255
Plastics product manufacturing
3261
Semiconductor and other electronic component
manufacturing
3344
Aerospace product and parts manufacturing
3364
Process as a
formulation
component
Textile and fabric finishing and fabric coating mills
3133
Converted paper product manufacturing
3222
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Paint, coating, and adhesive manufacturing
3255
7
-------
Activity
Type
Activity
Industry Group
NAICS
Code
Other chemical product and preparation manufacturing
3259
Plastics product manufacturing
3261
Computer and peripheral equipment manufacturing
3341
Semiconductor and other electronic component
manufacturing
3344
Motor vehicle parts manufacturing
3363
Aerospace product and parts manufacturing
3364
Process -
repackaging
Textile and fabric finishing and fabric coating mills
3133
Otherwise
Use
Otherwise use - as a
manufacturing aid
Semiconductor and other electronic component
manufacturing
3344
Otherwise use -
ancillary or other use
Other chemical product and preparation manufacturing
3259
Waste treatment and disposal
5622
Waste
Management
Disposal/releases
Textile and fabric finishing and fabric coating mills
3133
Converted paper product manufacturing
3222
Basic chemical manufacturing
3251
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Paint, coating, and adhesive manufacturing
3255
Other chemical product and preparation manufacturing
3259
Plastics product manufacturing
3261
Semiconductor and other electronic component
manufacturing
3344
Motor vehicle parts manufacturing
3363
Aerospace product and parts manufacturing
3364
Waste treatment and disposal
5622
Energy recovery
Converted paper product manufacturing
3222
Basic chemical manufacturing
3251
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Semiconductor and other electronic component
manufacturing
3344
8
-------
Activity
Type
Activity
Industry Group
NAICS
Code
Aerospace product and parts manufacturing
3364
Waste treatment and disposal
5622
Recycling
Other chemical product and preparation manufacturing
3259
Plastics product manufacturing
3261
Aerospace product and parts manufacturing
3364
Treatment
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Paint, coating, and adhesive manufacturing
3255
Other chemical product and preparation manufacturing
3259
Computer and peripheral equipment manufacturing
3341
Semiconductor and other electronic component
manufacturing
3344
Aerospace product and parts manufacturing
3364
Waste treatment and disposal
5622
Reference: U.S. EPA. 2019c
Table 5. Activities and Uses Reported to TRI for 4,4'-(l-Methylethylidene)bis[2, 6-
dibromophenol] (TBBPA), Reporting Year 2015
Activity
Type
Activity
Industry Group
NAICS
Code
Manufacture
Produce
Basic chemical manufacturing
3251
Import
Semiconductor and other electronic component
manufacturing
3344
Produce or import for
on-site use/processing
Semiconductor and other electronic component
manufacturing
3344
Produce or import for
sale/distribution
Basic chemical manufacturing
3251
Produce or import as
a byproduct
Basic chemical manufacturing
3251
Process
Process as a reactant
Textile and fabric finishing and fabric coating mills
3133
Basic chemical manufacturing
3251
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Other electrical equipment and component
manufacturing
3359
9
-------
Activity
Type
Activity
Industry Group
NAICS
Code
Aerospace product and parts manufacturing
3364
Process as an article
component
Paint, coating, and adhesive manufacturing
3255
Plastics product manufacturing
3261
Industrial machinery manufacturing
3332
Semiconductor and other electronic component
manufacturing
3344
Aerospace product and parts manufacturing
3364
Process as an
impurity
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Process as a
formulation
component
Textile and fabric finishing and fabric coating mills
3133
Converted paper product manufacturing
3222
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Paint, coating, and adhesive manufacturing
3255
Other chemical product and preparation manufacturing
3259
Plastics product manufacturing
3261
Semiconductor and other electronic component
manufacturing
3344
Motor vehicle parts manufacturing
3363
Aerospace product and parts manufacturing
3364
Other miscellaneous manufacturing
3399
Process -
repackaging
Semiconductor and other electronic component
manufacturing
3344
Otherwise
Use
Otherwise use - as a
chemical processing
aid
Converted paper product manufacturing
3222
Semiconductor and other electronic component
manufacturing
3344
Otherwise use - as a
manufacturing aid
Aerospace product and parts manufacturing
3364
Otherwise use -
ancillary or other use
Other chemical product and preparation manufacturing
3259
Waste treatment and disposal
5622
Waste
Management
Disposal/releases
Textile and fabric finishing and fabric coating mills
3133
Converted paper product manufacturing
3222
10
-------
Activity
Type
Activity
Industry Group
NAICS
Code
Basic chemical manufacturing
3251
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Paint, coating, and adhesive manufacturing
3255
Other chemical product and preparation manufacturing
3259
Plastics product manufacturing
3261
Semiconductor and other electronic component
manufacturing
3344
Other electrical equipment and component
manufacturing
3359
Motor vehicle parts manufacturing
3363
Aerospace product and parts manufacturing
3364
Other miscellaneous manufacturing
3399
Waste treatment and disposal
5622
Energy recovery
Textile and fabric finishing and fabric coating mills
3133
Converted paper product manufacturing
3222
Basic chemical manufacturing
3251
Semiconductor and other electronic component
manufacturing
3344
Aerospace product and parts manufacturing
3364
Recycling
Converted paper product manufacturing
3222
Other chemical product and preparation manufacturing
3259
Plastics product manufacturing
3261
Industrial machinery manufacturing
3332
Treatment
Textile and fabric finishing and fabric coating mills
3133
Converted paper product manufacturing
3222
Basic chemical manufacturing
3251
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Paint, coating, and adhesive manufacturing
3255
Other chemical product and preparation manufacturing
3259
11
-------
Activity
Type
Activity
Industry Group
NAICS
Code
Semiconductor and other electronic component
manufacturing
3344
Aerospace product and parts manufacturing
3364
Waste treatment and disposal
5622
Reference: U.S. EPA. 2019c
Table 6. Activities and Uses Reported to TRI for 4,4'-(l-Methylethylidene)bis[2, 6-
dibromophenol] (TBBPA), Reporting Year 2017
Activity
Type
Activity
Industry Group
NAICS
Code
Manufacture
Produce
Basic chemical manufacturing
3251
Waste treatment and disposal
5622
Import
Basic chemical manufacturing
3251
Semiconductor and other electronic component
manufacturing
3344
Waste treatment and disposal
5622
Produce or import for
on-site use/processing
Basic chemical manufacturing
3251
Semiconductor and other electronic component
manufacturing
3344
Produce or import for
sale/distribution
Basic chemical manufacturing
3251
Produce or import as
a byproduct
Waste treatment and disposal
5622
Produce or import as
an impurity
Waste treatment and disposal
5622
Process
Process as a reactant
Textile and fabric finishing and fabric coating mills
3133
Basic chemical manufacturing
3251
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Other electrical equipment and component
manufacturing
3359
Aerospace product and parts manufacturing
3364
Process as an article
component
Paint, coating, and adhesive manufacturing
3255
Plastics product manufacturing
3261
Industrial machinery manufacturing
3332
12
-------
Activity
Type
Activity
Industry Group
NAICS
Code
Semiconductor and other electronic component
manufacturing
3344
Aerospace product and parts manufacturing
3364
Process as an
impurity
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Process as a
formulation
component
Textile and fabric finishing and fabric coating mills
3133
Converted paper product manufacturing
3222
Basic chemical manufacturing
3251
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Paint, coating, and adhesive manufacturing
3255
Other chemical product and preparation manufacturing
3259
Plastics product manufacturing
3261
Semiconductor and other electronic component
manufacturing
3344
Aerospace product and parts manufacturing
3364
Process -
repackaging
Basic chemical manufacturing
3251
Other chemical product and preparation manufacturing
3259
Semiconductor and other electronic component
manufacturing
3344
Otherwise
Use
Otherwise use - as a
chemical processing
aid
Semiconductor and other electronic component
manufacturing
3344
Otherwise use - as a
manufacturing aid
Aerospace product and parts manufacturing
3364
Otherwise use -
ancillary or other use
Waste treatment and disposal
5622
Waste
Management
Disposal/releases
Textile and fabric finishing and fabric coating mills
3133
Converted paper product manufacturing
3222
Basic chemical manufacturing
3251
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Paint, coating, and adhesive manufacturing
3255
Other chemical product and preparation manufacturing
3259
13
-------
Activity
Type
Activity
Industry Group
NAICS
Code
Plastics product manufacturing
3261
Semiconductor and other electronic component
manufacturing
3344
Other electrical equipment and component
manufacturing
3359
Aerospace product and parts manufacturing
3364
Waste treatment and disposal
5622
Energy recovery
Converted paper product manufacturing
3222
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Plastics product manufacturing
3261
Aerospace product and parts manufacturing
3364
Waste treatment and disposal
5622
Recycling
Other chemical product and preparation manufacturing
3259
Plastics product manufacturing
3261
Industrial machinery manufacturing
3332
Treatment
Resin, synthetic rubber, and artificial and synthetic
fibers and filaments manufacturing
3252
Paint, coating, and adhesive manufacturing
3255
Other chemical product and preparation manufacturing
3259
Semiconductor and other electronic component
manufacturing
3344
Aerospace product and parts manufacturing
3364
Waste treatment and disposal
5622
Reference: U.S. EPA. 2019c
CDR and TRI Summary and Additional Information on Conditions of Use
The number of sites reporting use of TBBPA in consumer and commercial electrical and
electronic products increased from two to three between 2012 and 2016 from the CDR data. Two
sites reported unspecified consumer or commercial use in both 2012 and 2016. One site reported
use in plastic or rubber products in 2012 but not 2016. The 2016 CDR reported one site that used
TBBPA for building/construction materials and one site that used the chemical in industrial
manufacturing, two uses that are not present in the 2012 CDR. The use of TBBPA in industrial
computer and electronic product manufacturing as well as plastic and resin manufacturing, is
consistent between 2012 and 2016. The 2016 CDR reports additional industrial uses not reported
14
-------
in 2012: all other chemical product and preparation manufacturing; electrical equipment,
appliance, and component manufacturing; transportation equipment manufacturing; and
miscellaneous manufacturing. Consumer uses were also identified in additional databases, which
are included in the Exposure Potential section (Section 8).
TRI data reported in Part II Section 3 of the TRI Form R ("Activities and Uses of the Toxic
Chemical at the Facility") were compiled for RY 2011, RY 2015, and RY 2017. RY 2011, RY
2015, and RY 2017 reflect the chemical activities at reporting facilities in calendar years 2011,
2015, and 2017, respectively. Each facility filing a TRI Form R discloses activities that apply to
the TRI chemical at the facility. The TRI data presented above are from the TRI dataset updated
in April 2019. Tables 4, 5 and 6 present the activities and uses reported to TRI by industry group
for 2011, 2015, and 2017. Waste management activity type includes all industry groups that
reported to TRI using each waste management activity for TBBPA.
Public comments received for the proposed designation support the use of TBBPA as a flame
retardant. The American Coatings Association states that TBBPA is a flame retardant in
adhesives and sealants. Specialty products may have amounts above 10 percent (EPA-HQ-
OPPT-2018-0462-0003). The Aerospace Industries Association provides further detail by stating
that TBBPA is used as a flame retardant specifically in structural film adhesives, resins for
honeycomb core, epoxy pre-impregnated fiberglass or graphite tapes or woven fabrics (EPA-
HQ-OPPT-2018-0462-0004). Lastly the American Chemistry Council's North American Flame
Retardant Alliance separates the uses of TBBPA as a reactive or additive flame retardant. For
instance, TBBPA is identified as a reactive flame retardant in printed circuit boards or laminates.
Conversely TBBPA is identified as an additive flame retardant in acrylonitrile-butadiene-styrene
plastics, formed into light, rigid, molded products such as electrical housings or piping (EPA-
HQ-OPPT-2018-0462-0006).
Should the Agency decide to make a final decision to designate this chemical substance as a
high-priority substance, further characterization of relevant TSCA conditions of use will be
undertaken as part of the process of developing the scope of the risk evaluation.
4. Potentially exposed or susceptible subpopulations
Approach
In this review, EPA considered reasonably available information to identify potentially exposed
or susceptible subpopulations, such as children, women of reproductive age, workers, consumers
or the elderly. EPA analyzed processing and use information included on the CDR Form U.
These data provide an indication about whether children or other susceptible subpopulation may
be potentially exposed. EPA also used human health hazard information to identify potentially
exposed or susceptible subpopulations.
Results and Discussion
At this stage, EPA identified children, women of reproductive age, consumers and workers as
subpopulations who may be potentially exposed or susceptible subpopulations for TBBPA.
15
-------
Children
EPA used data reported to the 2012 and 2016 CDR to identify uses in products and articles
intended for children over time for TBBPA. Table 7 summarizes the non-CBI CDR information
regarding commercial and consumer use and notes whether the chemical substance was
identified as used in products intended for children. The 2016 CDR identified use of TBBPA in
children's electrical and electronic products (Table 7). Previous EPA assessments also indicated
TBBPA has been detected in children's products such as small plastic toys and jewelry (U.S.
EPA. 2015aY
Table 7. Uses in Children's Products Information8
Chemical
Year
Product Category
Consumer or
Commercial
Used in
Products
Intended for
Children
4,4'-(l-
Methylethylidene)bis
[2,6-dibromophenol]
(TBBPA)
(79-94-7)
2012
Electrical and electronic
products
Consumer and
commercial
No
Plastic and Rubber Products not
covered elsewhere
Commercial
No
2016
Electrical and electronic
products
Consumer and
commercial
Yes
Industrial manufacturing
Commercial
No
Building/construction materials
not covered elsewhere
Commercial
No
References: U.S. EPA (20.1.9a)
Women of reproductive age (e.g., pregnant women per TSCA statute)
EPA identified studies that observed developmental effects following exposure to TBBPA
(Section 7, Table 10). Although no reproductive hazards were identified in the identified studies,
EPA considers women of reproductive age as potentially exposed. During the scoping and risk
evaluation process, reproductive hazards will be considered again following a systematic search
of the relevant scientific literature.
Consideration of women of reproductive age as a potentially exposed or susceptible
subpopulation was also based on exposure because women of reproductive age are potential
workers in the manufacturing, processing, distribution in commerce, use, or disposal of the
chemical substance.
Workers
Please refer to the Exposure Potential section (Section 8) for a summary of potential
occupational exposures, which EPA indicates that workers are potentially exposed or susceptible
subpopulations based on greater exposure.
8 Certain other uses that are excluded from TSCA are not captured in this table.
16
-------
Consumers
Please refer to the Exposure Potential section (Section 8) for a summary of potential consumer
exposures, which EPA indicates that consumers are potentially exposed or susceptible
subpopulations based on greater exposure.
5. Persistence and bioaccumulation
Approach
EPA reviewed reasonably available information, such as physical and chemical properties and
environmental fate characteristics, to understand TBBPA's persistence and bioaccumulation.
Physical and Chemical Properties and Environmental Fate Tables
Table 8 and 9 summarize the physical and chemical properties and the environmental fate
characteristics of TBBPA, respectively.
Table 8. Physical and Chemical Properties of 4,4'-(l-Methylethylidene)bis[2, 6-
dibromophenol] (r
rBBPA)
Property or
Endpoint
Value3
Reference
Molecular Formula
Ci5Hi2Br402
HSDB (2018)
Molecular Weight
543.88 g/mole
CRC (2014)
Physical State
Solid
HS
DB (2018)
Physical Form
White crystalline
HS
DB (2018)
Purity
Purity 98.5%; impurities include 0.1% water, <60 mg
hydrolysable bromine/kg, and a <100 mg ionic
bromide/kg.
HS
(19
DB (2018) citina WHO
95)
<0.01 pg/kg 2,3,7,8-TeBDD; <0.02 pg/kg 1,2,3,7,8-
PeBDD; <0.05 pg/kg 1,2,3,4,7,8-HxBDD; <0.05
pg/kg 1,2,3,6,7,8-HxBDD; <0.05 pg/kg 1,2,3,7,8,9-
HxBDD; <0.01 pg/kg 2,3,7,8-TeBDF; <0.02 pg/kg
1,2,3,7,8-PeBDF; <0.02 pg/kg 2,3,4,7,8-PeBDF
ECB (2006)
Melting Point
179 °C
PhvsDroD (2012); HSDB
(2018)
181 °C
HS
DB (2018)
Boiling Point
316 °C (decomposes at 200-300 °C)
HS
DB (2018)
Density
2.2 kg/L at 4 °C
HS
O'T
DB (2018) citina
STeil (2013)
Vapor Pressure
4.68 x 10"8 mm Hg at 25 °Cb
HSDB (2018) BRE (2009)
<8.9 x 10"8 mm Hg at 20 °C
HSDB (2018);
ECHA (2018)
Vapor Density
TBD
TBD
Water Solubility
0.148 mg/L (pH 5); 1.26 mg/L (pH 7)b; 2.34 mg/L (pH
9) at 25 °C
OECD (2005); ECHA
(2018)
17
-------
Property or
Endpoint
Value3
Reference
0.171 mg/L (non-ionic form, pH 3.05); 4.15 mg/L (pH
7.56); 30.5 mg/L (pH 7.99); 228 mg/ L (pH 8.48);
1,510 mg/L (pH 8.91) at 25 °C
HSDB (2018) citina
Kuramochi (2007)
Log Kow
6.53 (pH 3.05), 4.75 (pH 7.53), 3.00 (pH 8.12), 1.25
(pH 9.18) at 25 °C
OECD (2005); HSDB
(20.1.8) citing Kuramochi
(2007)
Henry's Law
Constant
2.0 x 10"7 atm-m3/mol at 25 °C (estimated)0
U.S. EPA (20.1.2)
Flash Point
Not relevant/the substance does not have a flash point;
the substance is used as a flame retardant
ECB (2006)
pKa
pKal = 7.50; pKa2 = 8.5
ECB (2006):
HSDB (20.1.8)
pKa= 9.40 at 20 °C
HSDB (20.1.8);
ECHA (20.1.8)
Auto Flammability
The material does not undergo autoignition, but
ECB (2006)
decomposes at elevated temperatures
Viscosity
TBD
TBD
Refractive Index
TBD
TBD
Dielectric Constant
TBD
TBD
Surface Tension
TBD
TBD
Notes:
aMeasured unless otherwise noted;
bSelected value; °EPI Suite™ SMILES input: 0c(c(cc(cl)C(c(cc(c(0)c2Br)Br)c2)(C)C)Br)clBr).
TBD= to be determined, if reasonably available. EPA is particularly interested in information from the public
on these properties or endpoints.
Table 9. Environm
dibromophenol] (r
lental Fate Characteristics of 4,4'-(l-Methylethylidene)bis[2, 6-
fBBPA)
Property or
Endpoint
Value3
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 (20.1.8) citina
Eriksson (2004)
2,6-dibromo-p-benzosemiquinone anions and TBBPA
were identified as the main photodecomposition
byproducts
HSDB (20.1.8) citina Han
(2016)
18
-------
Property or
Endpoint
Value8
Reference
Indirect
Photodegradation
ti/2 = 3.615 days (based on -OH rate constant of 2.96 x
10"12cm3/mol sec at 25 °C and 12-hour day with 1.5 x
106 OH/cm3; estimated)13
U.S. EPA (2012)
Hydrolysis
Not expected to undergo hydrolysis in the
environment due to the lack of functional groups that
hydrolyze under environmental conditions
HSDB (2018) citina
Lyman (1990)
Biodegradation
(Aerobic)
Water: 0%/14 days (MITI)
HSDB (2018); NITE
(2018)
Water: tin = 48-84 days (natural river water)
HSDB (2018) citina 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) citina 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) citina
Voordeckers (2002)
Wastewater
Treatment
Wastewater influent containing 2,2',6,6'-TBBPA
concentration range of 10-145 ng/L had removal of
76-83% with conventional activated sludge and
bioreactor systems
HSDB (2018) citina Islam
(2015)
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
is ) 18)
307 measured in fathead minnow (Pimephales
promelas)
HSDB (2018) citina Hardv
(2004)
Bioaccumulation
Factor
720 (estimated)13
U.S. EPA (2012)
Soil Organic
Carbon:Water
Partition
Coefficient (Log
Koc)
5.4 (Koc = 2.7 x 105 MCI method; estimated)13
U.S. EPA (2012)
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: "Measured unless otherwise noted; bEPI Suite™physical property inputs: SMILES
0c(c(cc(cl)C(c(cc(c(0)c2Br)Br)c2)(C)C)Br)clBr)
19
-------
Results and Discussion
TBBPA is a crystalline solid with moderate water solubility expected under environmental
conditions (measured water solubility of 1.26 and 2.34 mg/L at pH 7 and 9 respectively), but
lower water solubility in more acidic environments (0.148 mg/L at pH 5). The estimated Henry's
Law constant (2.00 x 10"7 atm-m3/mol) and measured vapor pressure (4.68 x 10"8 mm Hg)
indicate that this chemical will have negligible volatility and may be persistent in both surface
water and soil. TBBPA undergoes direct photodegradation in water with half-lives between 17
minutes and 5.8 hours depending on the pH (where higher pH corresponds to faster degradation).
If released to air, TBBPA is estimated to react with photochemically-produced hydroxyl radicals
(OH) at a rate corresponding to a half-life of 3.6 days.
TBBPA may undergo some biodegradation under certain conditions. In aerobic natural river
water, TBBPA had a half-life of 48-84 days and in aerobic soil, TBBPA displayed 18-64
percent primary degradation in 64 days and 18-22 percent mineralization in 6 months (half-life
>6 months). However, in a Japanese MITI test, TBBPA showed 0 percent degradation over 14
days. Under anaerobic conditions in soil and sediment, TBBPA underwent complete primary
degradation over 64 days with the main product being bisphenol A. These combined data suggest
that TBBPA has slow to negligible biodegradability and is likely to persist in the environment. In
Cyprinus carpio and Pimephales promelas, TBBPA has a bioconcentration factor between 30-
485 and 307, respectively, suggesting that TBBPA has low potential for bioaccumulation.
6. Storage near significant sources of drinking water
Approach
To support the proposed designation, EPA screened each chemical substance under its conditions
of use with respect to the seven criteria in TSCA section 6(b)(1)(A) and 40 CFR 702.9. The
statute specifically requires the Agency to consider the chemical substance's storage near
significant sources of drinking water, which EPA interprets as direction to focus on the chemical
substance's potential human health hazard and exposure.
EPA reviewed reasonably available information, specifically looking to identify certain types of
existing regulations or protections for the proposed chemical substances. EPA considered the
chemical substance's potential human health hazards, including to potentially exposed or
susceptible subpopulations, by identifying existing National Primary Drinking Water
Regulations under the Safe Drinking Water Act (40 CFR Part 141) and regulations under the
Clean Water Act (CWA; 40 CFR 401.15). In addition, EPA considered the consolidated list of
chemical substances subject to reporting requirements under the Emergency Planning and
Community Right-to-Know Act (EPCRA; Section 302 Extremely Hazardous Substances and
Section 313 Toxic Chemicals), the Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA; Hazardous Substances), and the Clean Air Act (CAA) Section 112(r)
(Regulated Chemicals for Accidental Release Prevention). Regulation by one of these authorities
is an indication that the substance is a potential health or environmental hazard which, if released
near a significant source of drinking water, could present an unreasonable risk of injury to human
health or the environment.
Results and Discussion
TBBPA is subject to reporting requirements under EPCRA 015b). TBBPA is not
subject to any of the other regulations described in the previous paragraph.
20
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7. Hazard potential
Approach
EPA considered reasonably available information from peer-reviewed assessments and databases
to identify potential human health and environmental hazards for TBBPA (Tables 10 and 11,
respectively
EPA/OPPT used the infrastructure of ECOTOXicology knowledgebase (ECOTOX) to identify
single chemical toxicity data for aquatic and terrestrial life (U.S. EPA, 2018). It uses a
comprehensive chemical-specific literature search of the open literature that is conducted
according to the Standard Operating Procedures (SOPs)9. The environmental hazard
information was populated in ECOTOX and is available for the public. In comparison to the
approach used to survey human health hazard data, EPA also used a read-across approach to
identify additional environmental hazard data for isomers of TBBPA, if available, to fill in
potential data gaps should there not be when there were no reported observed effects for specific
taxa exposed to the TBBPA (Table 11).
Potential Human Health and Environmental Hazard Tables
EPA identified potential human health and environmental hazards based on a review of the
reasonably available information for TBBPA (Tables 10 and 11, respectively).
Table 10. Potential Human Health Hazards Identified for 4,4'-(l-Methylethylidene)bis[2, 6-
dibioniophenol| (TBBPA)
Human Health
Hazards
Tested for
Specific
Effect
Effect
Observed
Data Source
Acute Toxicity
X
U.S. EPA (2015a . )15c). NIP (2014).
Environment Canada (2013). ECB (2006). NICNAS
(2001). IPCS (1995)
Repeated Dose
Toxicity
X
X
)15a). U.S. EPA (2015c). NIP (2014).
Environment Canada (2013). ECB (2006). EFSA (2005).
NICNAS (2001). IPC 5)
Genetic Toxicity
X
318). U.S. EPA (2015a). U.S. EPA (2015c). NIP
(2014). Environment Canada (2013). ECB (2006).
NICNAS (200! >. iPCS (1995)
Reproductive
Toxicity
X
U.S. EPA (2015a). U.S. EPA (2015c). NIP (2014).
Environment Canada (2013). ECB (2006). EFSA (2005)
Developmental
Toxicity
X
X
U.S. EPA (2015s . ) 15c). NIP (2014).
Environment Canada (2013). ECB (2006). NICNAS
(2001). IPCS (1995)
9 The ECOTOX Standard Operating Procedures (SOPs) can be found at:
21
-------
Human Health
Hazards
Tested for
Specific
Effect
Effect
Observed
Data Source
Toxicokinetic
X
X
318). U.S. EPA (2015a). U.S. EPA (2015c). NIP
(2014). Environment Canada (2013). ECB (2006).
NICNAS (200 * \ ^ m
Irritation/Corrosion
X
X
Environment Canada (2013). ECB (2006). NICNAS
Dermal
Sensitization
X
U.S. EPA (2015a . )15c). NIP (2014).
Environment Canada (2013). ECB (2006). NICNAS
Respiratory
Sensitization
X
U.S. EPA (2015a). Environment Canada (2013). ECB
(2006)
Carcinogenicity
X
X
I \!\C (2018). U.S. EPA (2015a). U.S. EPA (2015c). NIP
G
Immunotoxicity
X
X
) 15c). NIP (2014). Environment Canada
(2013)
Neurotoxicity
X
X
318). U.S. EPA (2015a). U.S. EPA (2015c). NIP
(2014). Environment Canada (2013). ECB (2006). EFSA
(2005)
Epidemiological
Studies or
Biomonitoring
Studies
X
X
IARC (2018). U.S. EPA (2015a). U.S. EPA (2015c). NIP
(2014). Environment Canada (2013). ECB (2006). IPCS
Ll
Note: The "X" in the "Effect Observed" column indicates when a hazard effect was reported by one or more of the
referenced studies. Blank rows indicate when information was not identified during EPA's review of reasonably
available information to support the proposed designation.
22
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Table 11. Potential Environmental Hazards Identified for 4,4'-(l-Methylethylidene)bis[2, 6-dibroniophenol| (TBBPA)
Media
Study
Duration
Taxa Groups
High Priority Chemical
Candidate
4,4'-(l-
Methylethylidene)bis [2,
6-dibromophenol]
TBBPA
Isomers of
4,4'-(l-
Methylethylidene)bis [2,
6-dibromophenol]
TBBPA (CAS # 79947)
NONE
Data Sources
(CAS # 79947)
Number of
Observed
Number of
Observed
Studies
Effects
Studies
Effects
Aquatic
Acute
Vegetation
4
X
-
Debenest et al. (2011); Walsh et al. (1987)
exposure
Invertebrate
5
X
Anselmo etal. (2011); Brooke (1991);
Fabbri et al. (2014); Goodman et al.
(1988); Wildlife International Ltd. (2003)
Fish
10
X
Brooke (1991); Chan and Chan (2012);
Chow et al. (2013); Godfrey et al. (2017a);
Hu et al. (2009); Kalasekar et al. (2015);
McCormick et al. (2010); Ronisz et al.
(2004); Thienpont et al. (2011); Wildlife
International Ltd. (2003)
Non-Fish
Vertebrates
2
X
-
Fini et al. (2007); Fini et al. (2012)
(i.e., amphibians,
reptiles, mammals)
Chronic
Vegetation
-
-
exposure
Invertebrate
1
X
-
Anselmo et al. (2011)
Fish
7
X
Feng et al. (2013); Godfrey et al. (2017b);
Kuiper et al. (2007); Lower (2008);
McCormick et al. (2010); Riu et al.
(2014); Ronisz etal. (2004)
Non-Fish
Vertebrates
2
X
-
Fini et al. (2012); Zhang et al. (2014)
(i.e., amphibians,
reptiles, mammals)
Terrestrial
Vegetation
-
-
23
-------
Media
Study
Duration
Taxa Groups
High Priority Chemical
Candidate
4,4'-(l-
Methylethylidene)bis [2,
6-dibromophenol]
TBBPA
Isomers of
4,4'-(l-
Methylethylidene)bis [2,
6-dibromophenol]
TBBPA (CAS # 79947)
NONE
Data Sources
(CAS # 79947)
Number of
Observed
Number of
Observed
Studies
Effects
Studies
Effects
Acute
Invertebrate
1
X
-
Boyd et al. (2016)
exposure
Vertebrates
1
X
-
Maetal. (2015)
Chronic
Vegetation
-
-
exposure
Invertebrate
1
X
-
Shi et al. (2015)
Vertebrates
-
-
The dash indicates that no studies relevant for environmental hazard were identified during the initial review and thus the "Observed Effects" column is left blank. The
"X" in the "Observed Effects" column indicates when a hazard effect was reported by one or more of the referenced studies. The "N/A" in the "Observed
Effects" column indicates when a hazard effect was not reported by one of the referenced studies' abstract (full reference review has not been conducted).
24
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8. Exposure potential
Approach
EPA considered reasonably available information to identify potential environmental, worker/
occupational, consumer, and general population exposures to TBBPA.
Release potential for environmental and human health exposure
In addition to other required information, a submission of a TRI Form R report must include the
quantities of a TRI chemical the facility released on-site to air, water, or land, and the quantities
it transferred off-site to another facility for further waste management. On-site release quantities
are reported in Part II Section 5 of the TRI Form R, and off-site transfers are reported in Part II
Section 6. Waste management activities include: transfers of a TRI chemical in wastewater to a
publicly owned treatment works (POTWs) facility or to a non-POTW wastewater treatment
facility for the purpose of treatment for destruction or removal; combustion for energy recovery;
treatment (treatment includes treatment via incineration for destruction and waste stabilization);
recycling; and release, including disposal. During treatment, combustion for energy recovery, or
recycling activities, it is possible that some of the quantities of the TRI chemical will be released
to the environment.
Worker/Occupational and consumer exposure
EPA's approach for assessing exposure potential was to review the physical and chemical
properties, conditions of use reported in CDR, and information from the National Institutes of
Health Consumer Product Database and the Chemical and Products Database (CPDat) for
TBBPA to inform occupational and consumer exposure potential. The results of this review are
detailed in the following tables.
General population exposure
EPA did not identify environmental concentration, human and ecological biomonitoring data to
inform TBBPA's exposure potential.
Results and Discussion
Release potential for environmental and human health exposure
Aggregated quantities of TBBPA released on-site to air, water, and land, and aggregated
quantities of TBBPA transferred off-site to POTW and other wastewater treatment facilities
(non-POTW) are presented in Table 12. RY 2011, 2015, and 2017. The table does not include
any of the reported quantities pertaining to other waste management activities (e.g., recycling,
combustion for destruction) that occurred on-site or off-site during RY 2011, 2015, and 2017.
The "Number of Facilities" is the count of unique facilities that filed a TRI Form R report for
TBBPA for RY 2011, 2015, and 2017. The TRI data presented were obtained from the TRI
dataset following its update in April 2019.
25
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Table 12. The TRI Data on 4,4'-(l-Methylethylidene)bis[2,6-dibromophenol] (TBBPA)
from Reporting Years 2011, 2015, and 2017 and Used in this Document to Assess Exposure
Potential
Year
Number of
Facilities
That
Reported
Total
Quantities
Released
On-Site to
Air (lbs.)
Total
Quantities
Released On-
Site to Water
(lbs.)
Total
Quantities
Released
(Disposed
of) On-Site
to Land
(lbs.)
Total
Quantities
Transferred
to POTWs
(lbs.)
Total Quantities
Transferred to
Other (Non-
POTWs)
Wastewater
Treatment
Facilities (lbs.)
2011
50
2,111
8
23,694
10
0
2015
55
2,895
11
72,027
10
0
2017
53
2,624
26
8,661
10
4
Note: POTW: publicly owned treatment works
Reference: U.S. EPA 20.1.9c
For RY 2017, 53 facilities submitted TRI reports for TBBPA. The total quantities of TBBPA
these facilities released on-site to air (as fugitive and stack emissions), surface water, and land
are: 2,624 pounds; 26 pounds; and 8,661 pounds, respectfully. These facilities reported 10
pounds of the chemical transferred to POTW and 4 pounds transferred off-site to other non-
POTW wastewater treatment facilities for the purpose of wastewater treatment. These transfer
categories represent two types of off-site transfers for wastewater treatment that may lead to
releases from the receiving facilities. They do not include quantities sent off-site for other types
of waste management activities that include, or may lead to, releases of the chemical.
Quantities transferred off-site represent the amount of a toxic chemical a facility sent off-site
prior to any waste management (e.g., treatment) at a receiving facility. Some of the quantities of
TBBPA received by POTW and non-POTW wastewater treatment facilities may have been
released to surface waters or to air during treatment processes at the facilities.
When chemical substances are used as reactants and as intermediates, the industrial releases may
be a relatively low percentage of the production volume. Lower percentage releases occur when
a high percentage of the chemical reacts without excess loss during its use as a reactant or an
intermediate. The actual percentages, quantities, and media of releases of the reported chemical
associated with this processing or use are not known.
When chemical substances are incorporated into formulations, mixtures, or reaction products, the
industrial releases may be a relatively low percentage of the production volume. Lower
percentage releases occur when a high percentage of the volume is incorporated without
significant process losses during its incorporation into a formulation, mixture, or product. The
actual percentages, quantities, and media of releases of the reported chemical associated with this
processing or use are not known.
Worker/Occupational exposure
Worker exposures to this chemical may be affected by many factors, including but not limited to
volume produced, processed, distributed, used and disposed of; physical form and concentration;
26
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processes of manufacture, processing, and use; chemical properties such as vapor pressure,
solubility, and water partition coefficient; local temperature and humidity; and exposure controls
such as engineering controls, administrative controls, and the existence of a personal protective
equipment (PPE) program.
TBBPA does not have an Occupational Safety and Health Administration (OSHA) Permissible
Exposure Limit (PEL) 10, a National Institute for Occupational Safety and Health (NIOSH)
Recommended Exposure Limit (REL)11, or the Threshold Limit Value (TLV) set by American
Conference of Governmental Industrial Hygienists (ACGIH).
TBBPA has a vapor pressure of 4.68x 10"8 mm Hg at 25 °C/77 °F and is solid. Experience has
shown that inhalation exposure to vapors generated from solids with vapor pressures below
0.001 mm Hg at ambient room temperature conditions may be negligible. However, some
handling activities of TBBPA may generate dust when handled as a dry powder. Workers may be
exposed to aerosolized particles.
Consumer exposure
Based on CDR reporting information, TBBPA appears to be widely used in consumer products,
specifically electrical and electronic products. TBBPA is intended for and has also been detected
in children's products (such as electronics) as well as in small plastic toys and jewelry (U.S. EPA.
2015a). The NIH Consumer Product Database and the Chemical and Products Database (CPI)at)
have no reported use of TBBPA in consumer products (Table 13) ( 2.019b).
Table 13. Exposure Information for the Consumers
Chemical Identity
Consumer Product Database
Consumer Uses (List).
4,4'-( 1 -Methylethylidene)bis
[2, 6-dibromophenol] (79-94-7)
Adhesive, automotive, electronics, plastic, sports equipment
Reference: CPDat
General population exposure
Although EPA did not identify environmental concentration, human and ecological
biomonitoring data to inform TBBPA's exposure potential, release from certain conditions of
use, such as manufacturing and disposal, may result in general population exposure to TBBPA
via drinking water ingestion, dermal contact, and inhalation from air release.
10 OSHA, 2009. Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs).
https://www.osha.gov/dse/annotated-pels/tablez-l.html
11 NIOSH, 2005. NIOSH Pocket Guide to Chemical Hazards. https://www.cdc.gov/niosIi/npg/npgdcas.html
27
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9. Other risk-based criteria that EPA determines to be relevant to the designation of
the chemical substance's priority
EPA did not find other risk-based criteria relevant to the designation of the chemical substance's
priority.
10. Proposed designation and Rationale
Proposed Designation: High-priority substance
Rationale: EPA identified and analyzed reasonably available information for exposure and
hazard and is proposing to find that TBBPA may present an unreasonable risk of injury to health
and/or the environment, including potentially exposed or susceptible subpopulations, (e.g.,
workers, consumers, women of reproductive age, children). This is based on the potential hazard
and potential exposure of TBBPA under the conditions of use described in this document to
support the prioritization designation. Specifically, EPA expects that the manufacturing,
processing, distribution, use and disposal of TBBPA may result in presence of the chemical in
surface water, inhalation of the chemical from air releases, exposure to workers, exposure to
consumers and exposure to the general population, including exposure to children. In addition,
EPA identified potential environmental (e.g., aquatic toxicity, terrestrial toxicity), and human
health hazards (e.g., repeated dose toxicity, developmental toxicity, toxicokinetics,
irritation/corrosion, carcinogenicity, immunotoxicity, neurotoxicity, observations in
epidemiological studies or biomonitoring studies).
28
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