^^EZDy% United States
LhI	Environmental Protection Agency
Office of Chemical Safety and
Pollution Prevention
Proposed Designation of
Ethylene Dibromide
(CASRN 106-93-4)
as a High-Priority Substance
for Risk Evaluation
August 22,2019

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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	5
CDR and TRI Summary and Additional Information on Conditions of Use	10
4.	Potentially exposed or susceptible subpopulations	11
Approach	11
Results and Discussion	11
5.	Persistence and bioaccumulation	12
Approach	12
Physical and Chemical Properties and Environmental Fate Tables	12
Results and Discussion	15
6.	Storage near significant sources of drinking water	15
Approach	15
Results and Discussion	16
7.	Hazard potential	16
Approach	16
Potential Human Health and Environmental Hazard Tables	16
8.	Exposure potential	21
Approach	21
Results and Discussion	21
9.	Other risk-based criteria that EPA determines to be relevant to the designation of the
chemical substance's priority	25
10.	Proposed designation and Rationale	25
11.	References	26
ii

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List of Tables
Table 1. 1986-2015 National Aggregate Production Volume Data (Production Volume in
Pounds)	3
Table 2. Ethylene Dibromide (106-93-4) Categories and Subcategories of Conditions of Use
(2016 CDR Reporting Cycle)	5
Table 3. Ethylene Dibromide (106-93-4) Categories and Subcategories of Conditions of Use
(2012 CDR Reporting Cycle)	6
Table 4. Activities and Uses Reported to TRI for Ethylene Dibromide, Reporting Year 2011	6
Table 5. Activities and Uses Reported to TRI for Ethylene Dibromide, Reporting Year 2015	8
Table 6. Activities and Uses Reported to TRI for Ethylene Dibromide, Reporting Year 2017	9
Table 7. Physical and Chemical Properties of Ethylene Dibromide	12
Table 8. Environmental Fate Characteristics of Ethylene Dibromide	13
Table 9. Potential Human Health Hazards Identified for Ethylene Dibromide	17
Table 10. Potential Environmental Hazards Identified for Ethylene Dibromide	18
Table 11. The TRI Data on Ethylene Dibromide from Reporting Years 2011, 2015, and 2017
Used in this Document to Assess Exposure Potential	22
Table 12. Exposure Information for Consumers	23
Table 13. Exposure Information for the Environment and General Population	24
in

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Acronyms and Abbreviations
Term
Description
ACGIH
American Conference of Governmental Industrial Hygienists
ATSDR
Agency for Toxic Substances and Disease Registry
Biomon.
Biomonitoring
BOD
Biochemical oxygen demand
BP
Boiling point
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
Concen.
Concentration
CWA
Clean Water Act
CPDat
Chemical and Products Database
ECOTOX
Ecotoxicology Database
EPA
U.S. Environmental Protection Agency
EPCRA
Emergency Planning and Community Right-to-Know Act
FDA
U.S. Food and Drug Administration
FR
Federal Register
GC
Gas chromatography
HPLC
High performance liquid chromatography
IRIS
Integrated Risk Information System
IUR
Inventory Update Rule
K
Thousand
Koc
Organic carbon-water partition coefficient
Kow
Octanol-water partition coefficient
M
Million
iv

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Term
Description
MITI
Ministry of International Trade and Industry
MP
Melting point
NAICS
North American Industry Classification System
NIH
National Institute of Health
NIOSH
National Institute for Occupational Safety and Health
NR
Not reported
OECD
Organisation for Economic Co-operation and Development
OH
Hydroxyl radical
OPPT
Office of Pollution Prevention and Toxics
OSHA
Occupational Safety and Health Administration
PEL
Permissible Exposure Limit
POTW
Publicly owned treatment works
PPE
Personal protective equipment
PPM
Parts per million
RCRA
Resource Conservation and Recovery Act
REL
Recommended Exposure Limit
RY
Reporting Year
SOP
Standard Operating Procedure
SMILES
Simplified Molecular-Input Line-Entry System
Tl/2
Half-life
TG
Test guidance
TLV
Threshold Limit Value
TRI
Toxics Release Inventory
TSCA
Toxic Substances Control Act
TWA
Time weighted average
USGS
United States Geological Survey
VP
Vapor pressure
WS
Water solubility
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)). EPA uses scientific information that is consistent with the best available
science. 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).
Ethylene dibromide 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 ethylene dibromide 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 ethylene
dibromide, 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/confent/pkg/CFR-2018-title40-vol33/xml/CFR-2018-title40-vol33-part702.xml and
fattps://www.regutations.gov/doeiiment?D=EPA~HO~OPPT~20.1.6-0654-0.1.08
2	https://www.federalregister.gov/docnments/2019/03/21/2019-05404/init.iation-of-prioritization-niider-the-toxic-
subsfances-control-act-tsca
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EPA will take comment on this proposed designation for 90 days before finalizing its designation
of ethylene dibromide. The docket number for providing comments on ethylene dibromide is
EPA-HQ-OPPT-2018-0488 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 9 (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.
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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 ethylene dibromide
reported under the Inventory Update Reporting (IUR) rule and Chemical Data Reporting (CDR)
rule.3 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.
Results and Discussion
Production volume of ethylene dibromide in 2015, as reported to EPA during the 2016 CDR
reporting period, was withheld. In reporting years (RY) 1986-1994, aggregate production
volume of ethylene dibromide declined, from >100-500 million pounds in 1986, to >50-100
million pounds in 1990, and to >10-50 million pounds in 1994. Aggregate production volume
stayed between 1 and 10 million pounds for RY 1998-2006. In the RY 2011-2015, aggregate
production volume for ethylene dibromide was withheld (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
Ethylene
Dibromide
(106-93-4)
>100
Mto
500M
>50M
to
100M
>10M
to
50M
>1M
to
10M
>1M
to
10M
lMto
<10M
Withheld4
Withheld
Withheld
Withheld
Withheld
Notes: M = million,
Reference: U.S. EPA (2013) and U.S. EPA (2017)
3	Over time, the requirements for reporting frequency, production volume thresholds, and chemical substances under
the Chemical Data Reporting (CDR) rule 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).
4	This information is withheld, because EPA is releasing the 2016 CDR data in stages. EPA released the initial 2016
CDR data in May 2017. The initial data included national production volume (released in ranges), other
manufacturing information, and processing and use information, except for information claimed by the submitter to
be confidential business information (CBI) or information that EPA is withholding to protect claims of CBI. EPA
anticipates releasing additional data after completion of an effort to obtain CBI substantiation required by the Frank
R. Lautenberg Chemical Safety for the 21st Century Act, which amended the Toxic Substances Control Act.
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In the past, the largest use of ethylene dibromide in the United States was as a lead scavenger in
fuels; the next largest use was as a fumigant and pesticide. In 1977, U.S. production of ethylene
dibromide was approximately 300 million pounds with approximately 93 percent used as a lead
scavenger and 6.5 percent used as a fumigant. The remainder was used in other uses. In 1974,
EPA mandated that lead content of fuels be reduced and by 1996, lead and lead scavengers,
including ethylene dibromide, were largely removed from conventional fuels, only remaining in
aviation gasoline and certain racing fuels (	)08a). In addition, in 1983, EPA issued an
immediate suspension of the use of ethylene dibromide as a soil fumigant for agricultural crops.
In 1993, the last registered (garment) fumigant product containing ethylene dibromide cancelled
production (U.S. EPA. 2006a).
Production volume trends illustrate the effect of the regulation of ethylene dibromide. According
to CDR data, since 1986, the production volume of ethylene dibromide has trended downward to
remain at 1M to less than 10M through 2006. After that time, CDR data are withheld from the
public. However, based on the uses there is no information that would suggest that production
volume after 2006 and into the future would increase over the 2006 levels.
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 ethylene dibromide 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
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treatment) disclosed in other sections of the Form R was also used to supplement the CDR
information on conditions of use as shown in Table 4, 5, and 6. For purposes of this proposed
prioritization designation, 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 available5 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 (Tables 2 and 3,
respectively).
Table 2. Ethylene Dibromide (106-93-4) Categories and Subcategories of Conditions of Use
(2016 CDR Reporting Cycle)6			
Life-Cycle Stage
Category
Subcategory of Use
Reference
Manufacturing
Domestic
manufacturing/import
CBI7
U.S. EPA (2019a)

Processing
Incorporation into
formulation, mixture, or
reaction product
Fuels and fuel additives
in:
-	Petroleum
refineries
-	All other Petroleum
and coal products
manufacturing
U.S. EPA (2019a)

Distribution in commerce
Distribution in commerce
Distribution in
commerce

Commercial Uses
Fuels and related products
Fuels and related
products
U.S. EPA (2019a)

Consumer Uses
Fuels and related products
Fuels and related
products
U.S. EPA (2019a)

Disposal
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 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.
5	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.
6	Certain other uses that are excluded from TSCA are not captured in this table.
7	At this time, "CBI" indicates that a data element has been claimed CBI by the information submitter; it does not
reflect the result of an EPA substantiation review.
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Table 3. Ethylene Dibromide (106-93-4) Categories and Subcategories of Conditions of Use
(2012 CDR Reporting Cycle)8			
Life-Cycle Stage
Category
Subcategory of Use
Reference
Manufacturing
Domestic
CBI9
U.S. EPA
manufacturing/import

(20.1.9a)

Import
Import
U.S. EPA

(20.1.9a)
Processing
CBI
CBI
U.S. EPA


(201M
Distribution in commerce
Distribution in commerce
Distribution in
commerce

Commercial/Consumer Uses
CBI
CBI
U.S. EPA
(20.1.9a)
Disposal
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 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 Ethylene Dibromide, Reporting Year 2011
Activity Type
Activity
Industry Group
NAICS
Code
Manufacture
Produce
Petroleum and coal products manufacturing
3241


Basic chemical manufacturing
3251

Import
Basic chemical manufacturing
3251


Scientific research and development services
5417

Produce or import for
on-site use/processing
Scientific research and development services
5417

Produce or import for
sale/distribution
Basic chemical manufacturing
3251

Produce or import as a
byproduct
Petroleum and coal products manufacturing
3241

Basic chemical manufacturing
3251
8	Certain other uses that are excluded from TSCA are not captured in this table.
9	At this time, "CBI" indicates that a data element has been claimed CBI by the information submitter; it does not
reflect the result of an EPA substantiation review.
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Activity Type
Activity
Industry Group
NAICS
Code

Produce or import as an
impurity
Scientific research and development services
5417
Process
Process as a reactant
Basic chemical manufacturing
3251
Process as an impurity
Petroleum and coal products manufacturing
3241
Process as a formulation
component
Petroleum and coal products manufacturing
3241
Basic chemical manufacturing
3251
Process - repackaging
Petroleum and coal products manufacturing
3241
Basic chemical manufacturing
3251
Otherwise Use
Otherwise use -
ancillary or other use
Other nonmetallic mineral product
manufacturing
3279
Scientific research and development services
5417
Waste treatment and disposal
5622
Waste
Management
Disposal/releases
Petroleum and coal products manufacturing
3241
Basic chemical manufacturing
3251
Other nonmetallic mineral product
manufacturing
3279
Waste treatment and disposal
5622
Energy recovery
Petroleum and coal products manufacturing
3241
Other nonmetallic mineral product
manufacturing
3279
Waste treatment and disposal
5622
Recycling
Petroleum and coal products manufacturing
3241
Other nonmetallic mineral product
manufacturing
3279
Treatment
Petroleum and coal products manufacturing
3241
Basic chemical manufacturing
3251
Other nonmetallic mineral product
manufacturing
3279
Waste treatment and disposal
5622
Reference: U.S. EPA. 20.1.9b
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Table 5. Activities and Uses Reported to TRI for Ethylene Dibromide, Reporting Year 2015
Activity
Type
Activity
Industry Group
NAICS
Code
Manufacture
Produce
Petroleum and coal products manufacturing
3241


Basic chemical manufacturing
3251

Import
Basic chemical manufacturing
3251

Produce or import for
sale/distribution
Basic chemical manufacturing
3251

Produce or import as a
byproduct
Petroleum and coal products manufacturing
3241

Basic chemical manufacturing
3251
Process
Process as an article
component
Waste treatment and disposal
5622

Process as a
formulation
component
Petroleum and coal products manufacturing
3241

Basic chemical manufacturing
3251

Process - repackaging
Petroleum and coal products manufacturing
3241


Basic chemical manufacturing
3251
Otherwise
Use
Otherwise use -
ancillary or other use
Other nonmetallic mineral product manufacturing
3279
Scientific research and development services
5417


Waste treatment and disposal
5622
Waste
Management
Disposal/Releases
Petroleum and coal products manufacturing
3241

Basic chemical manufacturing
3251


Other nonmetallic mineral product manufacturing
3279


Waste treatment and disposal
5622

Energy recovery
Petroleum and coal products manufacturing
3241


Other nonmetallic mineral product manufacturing
3279

Recycling
Petroleum and coal products manufacturing
3241


Other nonmetallic mineral product manufacturing
3279

Treatment
Petroleum and coal products manufacturing
3241


Basic chemical manufacturing
3251


Other nonmetallic mineral product manufacturing
3279


Waste treatment and disposal
5622
Reference: U.S. EPA. 20.1.9b
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Table 6. Activities and Uses Reported to TRI for Ethylene Dibromide, Reporting Year 2017
Activity Type
Activity
Industry Group
NAICS
Code
Manufacture
Produce
Petroleum and coal products manufacturing
3241


Basic chemical manufacturing
3251

Import
Basic chemical manufacturing
3251

Produce or import for
sale/distribution
Basic chemical manufacturing
3251

Produce or import as a
byproduct
Petroleum and coal products manufacturing
3241

Basic chemical manufacturing
3251
Process
Process as a formulation
component
Petroleum and coal products manufacturing
3241

Basic chemical manufacturing
3251

Process - repackaging
Petroleum and coal products manufacturing
3241


Basic chemical manufacturing
3251
Otherwise Use
Otherwise use -
ancillary or other use
Other nonmetallic mineral product
manufacturing
3279


Scientific research and development services
5417


Waste treatment and disposal
5622
Waste
Management
Disposal/Releases
Petroleum and coal products manufacturing
3241

Basic chemical manufacturing
3251


Other nonmetallic mineral product
manufacturing
3279


Waste treatment and disposal
5622

Energy recovery
Petroleum and coal products manufacturing
3241


Other nonmetallic mineral product
manufacturing
3279

Recycling
Waste treatment and disposal
5622

Treatment
Petroleum and coal products manufacturing
3241


Basic chemical manufacturing
3251


Other nonmetallic mineral product
manufacturing
3279


Waste treatment and disposal
5622
Reference: U.S. EPA. 20.1.9b
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CDR and TRI Summary and Additional Information on Conditions of Use
In the reports to 2016 CDR, manufacturing (domestic manufacturing or import) was claimed as
CBI. Two sites reported consumer and/or commercial use of ethylene dibromide in fuels and
related products.
Reports to the 2016 CDR included processing information of ethylene dibromide was for in all
other petroleum and coal products manufacturing (one site) and petroleum refineries (one site).
Both uses were reported under the functional category fuels and fuel additives. Commercial
and/or consumer use was fuels and related products. Consumer uses were also identified in
additional databases, which are included in the Exposure Potential section (Section 8).
In the 2012 CDR, reports of manufacturing (domestic manufacture or import) and processing
information was claimed as CBI. Two sites reported commercial and/or consumer use of
ethylene dibromide, and the product category was claimed as CBI for one site and not reported
for the other site. Due to the lack of information, it is difficult to determine whether there was a
significant change in producers or conditions of use.
Data from the ECHA registration dossier for ethylene dibromide provide similar information
regarding conditions of use. The dossier lists the use of ethylene dibromide as an anti-knock
additive in refineries in production of aviation fuel in European countries. Ethylene dibromide is
used in aviation gasoline (Avgas) as a lead scavenger (ECHA. 2019).
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, respectively. Waste management activity type include all industry
groups that reported to TRI using each waste management activity for ethylene dibromide.
Information from public comments confirm that the use of ethylene dibromide is almost
exclusively as part of a fuel additive (EPA-HQ-OPPT-2018-0488-0006). According to another
public comment, the aerospace industrial uses include use as an additive in aviation gasoline. In
addition, the aerospace industry uses ethylene dibromide as an additive in vinyl lacquers (EPA-
HQ-OPPT-2018-0488-0008).
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.
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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 may be potentially exposed or other
susceptible subpopulations may be 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 ethylene
dibromide.
Children
EPA used data reported to the 2012 and 2016 CDR to identify uses in products and articles
intended for children over time for ethylene dibromide. The 2012 and 2016 CDR did not report
any use in children's products. In the existing assessments reviewed, there was no discussion on
the susceptibility of children to ethylene dibromide. EPA also identified potential developmental
hazards that would impact any stage of children's development.
Women of reproductive age (e.g., pregnant women per TSCA statute)
EPA identified studies that observed developmental and reproductive toxicity following
exposure to ethylene dibromide (Section 7, Table 9). Thus, women of reproductive age were
identified as a potentially exposed or susceptible subpopulation.
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.
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.
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5. Persistence and bioaccumulation
Approach
EPA reviewed reasonably available information, such as physical and chemical properties and
environmental fate and characteristics, to understand ethylene dibromide's persistence and
bioaccumulation.
Physical and Chemical Properties and Environmental Fate Tables
Tables 7 and 8 summarize the physical and chemical properties, and the environmental fate
characteristics of ethylene dibromide, respectively.
Table 7. Physical and Chemical Properties of Et
lylene Dibromide
Property or
Endpoint
Value3
Reference
Molecular
Formula
C2H4Br2
CRC Handbook (Haneys, 2014)
Molecular
Weight
187.861 g/mole
CRC Handbook (Haneys, 2014)
Physical State
Liquid
HSDB (2018)
Physical Form
Colorless liquid or solid below 10 C
HSDB (2018)
Purity
>99% and 99% reported in studies
HSDB (2018)
Melting Point
10Cb
ATSDR (2018) citina NIOSH (1978)

9.9 C
PlivsoroD (2012): OECD (2012)

9.8 C
HSDB (2018) citina CRC Handbook (Hanevs.
2014)
Boiling Point
131.6 Cb
PlivsoroD (2012); OECD (2012)

131-132C
ATSDR (2018) citina Windholz (1983)

131.3 C
HSDB (2018) citina CRC Handbook (Hanevs.
2014)
Density
2.17 g/cm3
ATSDR (2018) citina Windholz (1983)
Vapor
11 mm Hg at 25 C
ATSDR (2018) citina Windholz (1983)
Pressure
11.2 mm Hg at 25 Cb
PlivsoroD (2012); HSDB (2018)

8.5 mm Hg at 20 C
HSDB (2018) citina Ioffe and Frim (2011)
Vapor Density
6.48 (relative vapor density to air = 1)
HSDB (2018) citina Lewis (2012)
Water
Solubility
3,910 mg/L at 25 Cb
PlivsoroD (2012); OECD (2012); HSDB (2018)
citing Horvath et al. (1999)

4,310 mg/L at 30 C
HSDB (2018) citina Yalkowskv et al. (2010)

4,000 mg/L at 20 C
ATSDR (2018)

4,290 mg/L at 25 C
ATSDR (2018)
12

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Property or
Endpoint
Value3
Reference
Log Kow
1.96
11SDB (2018) citina Hansch et al. (*1995);
PhvsDroD (2012)
Henry's Law
Constant
6.5 x 10"4 atm-m3/molb
11SDB (2018) citina Rathbun (2000); PhvsDroD
(2012)
8.2 x 10"4 atm-m3/mol
DR (2018)
Flash Point
Not flammable
DR (2018) citina Weiss (1986)
Auto
Flammability
Not flammable
DR (2018) citina Weiss (1986)
Viscosity
1.73 at 20 C
HSDB (20.1.8) citing CRC Handbook (Haneys,
2014)
Refractive
Index
1.54 at 20 C
HSDB (20.1.8) citina CRC Handbook (Hanevs.
2014)
Dielectric
Constant
4.77 at 20.5 C
HSDB (20.1.8) citina Ioffe and Frim (2011)
Surface
Tension
38.75 dynes/cm = 0.03875
Newtons/m at 20 C
HSDB (20.1.8) citina NO A A (20.1.8)
Notes: aMeasured unless otherwise noted. b Selected value
Table 8. Environmental Fate Characteristics of Ethylene Dibromide
Property or
Endpoint
Value3
Reference
Direct
Photodegradation
No photolysis was observed when
exposed to ultraviolet light between
300 and 400 nm
HSDB (20.1.8) citina Ollis (1985)
Direct photolysis of ethylene
dibromide in the troposphere is not
expected to occur
DR (20.1.8) citina Jaber et al. (1984)
Indirect
Photodegradation
ti/2 = 64 days (based on -OH reaction
rate constant of 2.34 x 10"13
cm3/mol- second at 25 C)
HSDB (20.1.8) citina Atkinson (1989)
Hydrolysis
ti/2 = 2.5-13.2 years
DR (20.1.8) citina Voael and Reinhard
(1986)
ti/2 = 6.4 years (at 25 C in pure
water; rate constant = 2.1 x 10~7
minute"1)
HSDB (20.1.8)
ti/2 = 141 hours at 67 C and 380 days
at 25 C for test solutions at pH 4
ECHA (20.1.9) citina Sarvari (2010)
13

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Property or
Endpoint
Value3
Reference

T1/2 =114 hours at 67 C and 2.3
years at 25 C for test solutions at pH
9 (OECD 111)

Biodegradation
(Aerobic)
Water: tin = 35-350 days; shallow
aquifer material and groundwater
HSDB (2018) citing Pianatello (1987)
Water: 213 5 %/3 days in a die-away
test using Japanese river and seawater
HSDB (2018) citina Kondo et al. (1988)
Water: 0% after 2 weeks based on
BOD (MITI test); degradation
effected by volatilization
HSDB (2018) citina Pianatello and Cohen
(1990)
4.2% after 28 days
ECHA (2019) citina Sipos (2010)
Biodegradation
(Anaerobic)
63% degradation after 25 weeks
ECHA (2019) citina Bouwer (1983)
ti/2 = 2 weeks (17 C, methanogenic
aquifer) Bromoethanol detected as a
metabolite
HSDB (20.1.8) citing Verschueren (1996)
ti/2 = 0.8 days by reductive
dehalogenation (22 C, anoxic
sediment with 6% organic carbon)
HSDB (20.1.8) citina Rathbun (2000)
Wastewater
Treatment
ti/2 = 1-16 days by evaporation from
flowing and standing surface waters
[)R (20.1.8) citina EPA (.1.987)
24% total removal (0.08% by
biodegradation,
1.8% by sludge, and 22% by
volatilization to air; estimated)13
EPI Suite (20.1.2)
Bioconcentration
Factor
<3.5-14.9 (carp)
HSDB (20.1.8) citina Kawasaki. 1980
<1-20
OECD (20.1.2)
Bioaccumulation
Factor
8.3 (estimated)13
EPI Suite (20.1.2)

Soil Organic
Carbon:Water
Partition
Coefficient (Log
Koc)
1.82
DR (20.1.8) citina Roaers and McFarlane
(1981)
1.1-2.2
HSDB (20.1.8) citina Rathbun (2000); Falta
(2004)
1.69 (in peat soil)
HSDB (20.1.8) citina Chiou and Kile (1998)
Notes:
aMeasured unless otherwise noted
bEPI Suitephysical property inputs: Log K0w = 1.96, BP = 131.60 C, MP = 9.9 C, VP = 11.2 mm Hg, WS =
3910 mg/L, Henry LC = 6.5 x 1 () ' atm-m3/mol
OH = hydroxyl radical; OECD: Organisation for Economic Co-operation and Development; MITI = Ministry of
International Trade and Industry; BOD = biochemical oxygen demand; K0c = organic carbon-water partitioning
coefficient; K0w = octanol-water partitioning coefficient
14

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Results and Discussion
Ethylene dibromide is a volatile, highly water-soluble liquid (3,910 mg/L). Measured Henry's
Law constant (6.5 x 10"4 atm-m3/mol) and vapor pressure (11.2 mm Hg) data indicate that this
chemical is not likely to be persistent in surface water or soil as it will volatilize upon release. In
the air, ethylene dibromide is expected to exist in the vapor phase where it may react with
photochemically-produced hydroxyl radicals at a rate corresponding to a half-life of 64 days. It is
not expected to be susceptible to direct photodegradation. Hydrolysis is expected to be negligible
under environmental conditions based on half-lives ranging from 2.5 to 13.2 years.
In aerobic aquatic environments ethylene dibromide is not readily biodegradable; however, it
may biodegrade slowly under certain conditions. In water, this chemical showed no
biodegradation over a 2-week incubation period using the OECD 301C test method in which
degradation was affected by volatilization of the test substance. In Japanese river and seawater,
this chemical reached 21-35 percent biodegradation after 3 days using the die-away test method.
Additionally, half-lives ranging from 35 to 350 days were reported for shallow aquifer material
and groundwater.
In anaerobic environments, biodegradation of ethylene dibromide is expected to be moderate.
This chemical reached 63% degradation over a 25-week incubation period in an anaerobic
biodegradation test and has a reported half-life of 2 weeks in methanogenic aquifer material. In
addition, a half-life of 0.8 days in anoxic sediment was reported for reductive debromination of
ethylene dibromide. Therefore, ethylene dibromide has the potential to persist in subsurface
environments, groundwater, or enclosed pipes when volatilization is not an option. Furthermore,
this chemical is expected to have low potential for bioaccumulation based on a measured
bioconcentration factor in carp (<3.5-14.9) and a bioaccumulation factor estimate of 8.3.
6. Storage near significant sources of drinking water
Approach
To support the proposed designation, EPA analyzed 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 (SDWA; 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
15

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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
Ethylene dibromide is subject to National Primary Drinking Water Regulation (NPDWR) under
SDWA with a Maximum Contaminant Level Goal (MCLG) of zero and an enforceable
Maximum Contaminant Level (MCL) of 0.00005 mg/L. The chemical has been designated as a
hazardous substance under the Federal Water Pollution Control Act. Ethylene dibromide is
subject to TRI reporting requirements under EPCRA. Ethylene dibromide is considered a
CERCLA hazardous substance and releases of quantities in excess of 1 pound are subject to
reporting to the National Response Center under CERCLA.
Ethylene dibromide is also subject to Resource Conservation and Recovery Act (RCRA) and has
the hazardous waste code U067. RCRA directs EPA to develop and promulgate criteria for
identifying the characteristics of hazardous waste, and for listing hazardous waste, taking into
account toxicity, persistence, and degradability in nature, potential for accumulation in tissue and
other related factors such as flammability, corrosiveness, and other hazardous characteristics.
7. Hazard potential
Approach
EPA considered reasonably available information from peer-reviewed assessments and databases
to identify potential human health and environmental hazards for ethylene dibromide (Tables 9
and 10, respectively).
Because there are very few publicly available assessments for ethylene dibromide with cited
environmental hazard data, EPA uses the infrastructure of ECOTOXicology knowledgebase
(ECOTOX) to identify single chemical toxicity data for aquatic and terrestrial life (U.S. EPA.
2018b). It uses a comprehensive chemical-specific literature search of the open literature that is
conducted according to the Standard Operating Procedures (SOPs)10. The environmental hazard
information was populated in ECOTOX and is available to 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 ethylene dibromide, if available, to
fill in potential data gaps when there were no reported observed effects for specific taxa exposed
to the ethylene dibromide (Table 10).
Potential Human Health and Environmental Hazard Tables
EPA identified potential human health and environmental hazards based on a review of the
reasonable available information for ethylene dibromide (Tables 9 and 10, respectively).
10 The ECOTOX Standard Operating Procedures (SOPs) can be found at:
https://cfpub.epa.gov/ecotox/help.cfm?helptabs=tab4
16

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Table 9. Potent
ial Human Health Hazards Identified for Ethylene Dibromide
Human Health
Hazards
Tested for
Specific Effect
Effect
Observed
Data Source
Acute Toxicity
X
X
3R (2018). NICNAS (2013). Environment Canada
(2013). U.S. EPA (2009). U.S. EPA (2008b). U.S. EPA
(2004a). OEHHA (20' .
Repeated Dose
Toxicity
X
X
3R (2018). NICNAS (2013). NTP (2016). U.S. EPA
(2009). U.S. EPA (2008b). U.S. EPA (2004a). U.S. EPA
(2004b). OEHHA (20 .
NTP (1982)
Genetic
Toxicity
X
X
\ f r'OR (2018). NICNAS (2013). OEC lt h>KM.
Environment Canada (201 . 009). U.S. EPA
(2008b). U.S. EPA (2004a). OEHHA (2003). IARC
2)
Reproductive
Toxicity
X
X
3R (2018). NICNAS (2013). Environment Canada
(2013). U.S. EPA (2009). U.S. EPA (2008b). U.S. EPA
(2004a). U.S. EPA (2004b). OEHHA (2003). OEHHA
.NTP (1982)
Developmental
Toxicity
X
X
)R (2018). NICNAS (2013). U.S. EPA (2009). U.S.
EPA (2008b). U.S. EPA (2004a). U.S. EPA (2004b).
OEHHA (2003). OEHHA (1999). IARC (1999)
Toxicokinetics
X
X
)R (2018). NICNAS (2013). U.S. EPA (2008b). U.S.
EPA (2004a). OEHHA (2003). OEHHA (1999). IARC
(1999)
Irritation/
Corrosion
X
X
3R (2018). NICNAS (2013). U.S. EPA (2009). U.S.
EPA (2008b). U.S. EPA (2004a). OEHHA (2003)
Dermal
Sensitization



Respiratory
Sensitization



Carcinogenicity
X
X
AT SDR (2018). NICNAS (2013). NTP (2016).
Environment Canada (2013). U.S. EPA (2009). U.S. EPA
(2008b). RIVM (2007). U.S. EPA (2004a). U.S. EPA
(2004b). OEHHA (200 n. LVUe t ;\Vi 1^2).
OEHHAi
Immunotoxicity



Neurotoxicity
X
X
3R (2018). NICNAS (2013). U.S. EPA (2008b). U.S.
EPA (2004a). U.S. EPA (2004b). OEHHA (2003)
Epidemiological
Studies or
Biomonitoring
Studies
X
X
CDC (2019). ATSDR (2018). NICNAS (2013). NTP
(2016). Environment Canada (2013). U.S. EPA (2009).
U.S. EPA (2008b). U.S. EPA (2004a). U.S. EPA (2004b).
OEHHA (2003). ( . 0. OEHHA
il
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.
17

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Table 10. Poten
ial Environmental Hazards Identified for Ethylene Dibromide



High-Priority
Chemical Candidate
Isomers of
Ethylene Dibromide
(CASRN 106-93-4)
1,1-Dibromoethane
(CASRN 557-91-5)

Media
Study
Duration
Taxa Groups
Ethylene Dibromide
(CASRN 106-93-4)
Data Sources





Dibromoethane
(CASRN 25620-62-6)




Number
of Studies
Observed
Effects
Number
of Studies
Observed
Effects

Aquatic
Acute
Vegetation
-
X
-



exposure
Invertebrate
7
X
-

Adams and Kennedy (1992); Adams et al. (1988); Herring et al.
(1988); Kszos et al. (2003); Rogers et al. (2005)


Fish
2
X
-

Holcombe et al. (1995); Kszos et al. (2003)


Non-fish vertebrate
(i.e., amphibians,
reptiles, mammals)






Chronic
Vegetation
-

-



exposure
Invertebrate
1
X
-

Adams and Kennedy (1992)


Fish
2
X
-

Hawkins et al. (1998); Holcombe et al. (1995)


Non-fish vertebrate
(i.e., amphibians,
reptiles, mammals)





Terrestrial
Acute
exposure
Vegetation
14
X


Broadley (1979); Crebelli et al. (1985); Johnson and Leonard (1995);
Queneherve et al. (1991); Reddy and Nettles (1955); Saidi et al.
(1992); Sholberg et al. (1986)


Invertebrate
21
X


Adu and Muthu (1985); Bhatia and Bansode (1971); Broadley
(1979); Evans and Thomason (1971); Graf et al. (1984); Foureman et
al. (1994); Kincaid and Volk (1952); Leesch (1984); Mehta et al.
(1984); Minton et al. (1985); Muthu et al. (1970); Queneherve et al.
18

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High-Priority
Chemical Candidate
Isomers of
Ethylene Dibromide
(CASRN 106-93-4)
1,1-Dibromoethane
(CASRN 557-91-5)

Media
Study
Duration
Taxa Groups
Ethylene Dibromide
(CASRN 106-93-4)
Data Sources





Dibromoethane
(CASRN 25620-62-6)




Number
of Studies
Observed
Effects
Number
of Studies
Observed
Effects








(1991); Rajendran and Muthu (1987); Rodriguez-Kabana and King
(1985); Rodriguez-Kabana et al. (1981); Saidi et al. (1992); Sholberg
et al. (1986); Swaine et al. (1978)


Vertebrate
4
X
-

Nachtomi et al. (1968); Sasaki et al. (1998); Schlinke (1970)

Chronic
exposure
Vegetation
65
X


Aycock (1955); Broadley (1979); Ijani and Mmbaga (1988); Kincaid
and Volk (1952); Kinloch (1983a); Kinloch (1983b); Kulkarni et al.
(1975); Lawn et al. (1988); Madamba et al. (1967); McDonald and
De Waele (1987); Meagher and Jenkins (1970); Middleton et al.
(1949); Minton and Parker (1979); Minton and Parker (1987);
Minton et al. (1985); Niblack and Hussey (1986); Oduor-Owino and
Waudo (1994); Onsager (1969); Potter et al. (1956); Reddy and
Nettles (1955); Rodriguez-Kabana and King (1985); Rodriguez-
Kabana et al. (1987); Schmitt and Nelson (1987); Sholberg et al.
(1986); Stanton and Fisher (1985); Stirling and Nikulin (1993);
Stirling and Wachtel (1985); Stirling et al. (1989); Stirling (1989);
Weaver et al. (1987); Youmans (1985)


Invertebrate
84
X


Adu and Muthu (1985); Aycock (1955); Bang and Telford (1966);
Barker (1976); Bond et al. (1973); Bowiy (1985); Broadley (1979);
Christie and Perry (1951); Gough and Brown (1988); Ijani and
Mmbaga (1988); Johnson and Leonard (1995); Kincaid and Volk
(1952); Kinloch (1983a); Kinloch (1983b); Kulkarni et al. (1975);
Lawn et al. (1988); Lindgren et al. (1954); Madamba et al. (1967);
McDonald and De Waele (1987); McKenry and Thomason (1974);
Meagher and Jenkins (1970); Middleton et al. (1949); Minton and
Parker (1979); Minton and Parker (1987); Minton et al. (1982);
19

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High-Priority
Chemical Candidate
Isomers of
Ethylene Dibromide
(CASRN 106-93-4)
1,1-Dibromoethane
(CASRN 557-91-5)

Media
Study
Duration
Taxa Groups
Ethylene Dibromide
(CASRN 106-93-4)
Data Sources





Dibromoethane
(CASRN 25620-62-6)




Number
of Studies
Observed
Effects
Number
of Studies
Observed
Effects


Chronic
exposure





Minton et al. (1985); Niblack and Hussey (1986); Oduor-Owino and
Waudo (1994); Onsager (1969); Philis (1978); Potter et al. (1956);
Punj and Verma (1970); Punj (1970); Rajendran and Muthu (1981);
Rajendran and Muthu (1987); Rajendran and Muthu (1989);
Rajendran and Shivaramaiah (1985); Rajendran (1982); Rodriguez-
Kabana et al. (1979); Rodriguez-Kabana et al. (1981); Rodriguez-
Kabana et al. (1987); Saidi et al. (1992); Schmitt and Nelson (1987);
Sharma and Tara (1986); Shivanandappa and Rajendran (1987);
Stanton and Fisher (1985); Stirling and Nikulin (1993); Stirling and
Wachtel (1985); Stirling et al. (1989); Stirling et al. (1995); Stirling
(1989); Tappan (1966); Weaver et al. (1987);Youmans (1985)


Vertebrate
2
X
-

Bernard et al. (1989); Hardin et al. (1981)
Note: 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).
20

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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 ethylene dibromide.
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 (POTW) 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
ethylene dibromide to inform occupational and consumer exposure potential. The results of this
review are detailed in the following tables.
General population exposure
EPA identified environmental concentration and human biomonitoring data to inform ethylene
dibromide's exposure potential to the general population (Table 13).
Results and Discussion
Release potential for environmental and human health exposure
Aggregated quantities of ethylene dibromide released on-site to air, water, and land, and
aggregated quantities of ethylene dibromide transferred off-site to POTW and other wastewater
treatment facilities (non-POTW) are presented in Table 11 for 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 ethylene dibromide for RY 2011, 2015, and 2017. The TRI data presented
were obtained from the TRI dataset following its update in April 2019.
21

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Table 11. The TRI Data on Ethylene Dibromide from Reporting Years 2011, 2015, and
2017
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
POTW (lbs.)
Total Quantities
Transferred to
Other (Non-
POTW)
Wastewater
Treatment
Facilities (lbs.)
2011
12
2,279
1
6
0
32
2015
13
836
0
90,000
0
0
2017
11
788
70
0
0
0
Note: POTW = publicly owned treatment works
Reference: U.S. EPA. 20.1.9b
For RY 2017, 11 facilities submitted TRI reports for ethylene dibromide. The total quantities of
ethylene dibromide these facilities released on-site to air (as fugitive and stack emissions),
surface water and land are: 788 pounds; 70 pounds; and 0 pounds, respectively. These facilities
reported zero pounds of the chemical transferred to POTW and zero 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
ethylene dibromide received by the non-POTW wastewater treatment facilities may have been
released to surface waters or to air during treatment processes at the facilities.
Ethylene dibromide has a vapor pressure of approximately 11 mm Hg at 25 C. This chemical's
vapor pressure indicates potential for air releases from volatilization during manufacturing,
processing, and use.
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 production 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; processes of manufacture, processing, and use; chemical properties such as vapor
pressure, solubility, and water partition coefficient; local temperature and humidity; and
22

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exposure controls such as engineering controls, administrative controls, and the existence of a
personal protective equipment (PPE) program.
Ethylene dibromide has an Occupational Safety and Health Administration (OSHA) Permissible
Exposure Limit (PEL). The PEL is 20 parts per million (ppm) over an 8-hour work day, time
weighted average (TWA), with 30 ppm Ceiling limit (OSHA..! ). The acceptable maximum
peak above the acceptable ceiling concentration for an 8-hr shift is 50 ppm for 5-minute duration.
This chemical also has a National Institute for Occupational Safety and Health (NIOSH)
Recommended Exposure Limit (REL) of 0.045 ppm TWA, with 0.13 ppm Ceiling limit for 15-
minute (NIOSH. 20051
Ethylene dibromide has a vapor pressure of approximately 11 mm Hg at 25 C. Ethylene
dibromide's vapor pressure indicates the potential for inhalation exposure to vapors generated by
the liquid at ambient room temperature conditions. The extent of inhalation exposure could vary
from facility to facility depending on many factors including but not limited to engineering
controls, type of facility and process design.
Consumer exposure
Based on CDR reporting information, ethylene dibromide is used in fuels and fuel additives for
both consumer and commercial use (	:016). For the 2012 CDR, two sites reported use
of ethylene dibromide and the reporting information for these two sites were claimed as CBI.
The Chemical and Products Database (CPDat) reported only one specific product a lubricant that
could be used by consumers and two undefined consumer products that had detected levels of
ethylene dibromide (Table 12). In the most recent assessments reviewed, no uses of ethylene
dibromide in consumer products have been identified (Environment Canada 2013).
Table 12. Exposure Information for Consumers
Chemical Identity
Consumer Product Database
Consumer Uses (List)
Ethylene Dibromide (106-93-4)
Lubricant
Reference: CPDat
General population exposure
Releases of ethylene dibromide from certain conditions of use, such as manufacturing and
processing activities, may result in general population exposures via inhalation of air near
processing facilities or ingestion of contaminated drinking water (ATSDR 2018. NTP 2016.
OEH 33). Ethylene dibromide was reported in air, water, soil/sediment environmental
concentrations, as well as in human blood/serum samples; it was not reported in ecological
biomonitoring matrices (Table 13).
Existing assessments also indicated ethylene dibromide was detected in ambient air, surface
water, groundwater, drinking water, soil, diet (U.S. EPA. 2004a.	'99. NICNAS 2013.
NTP 11 , FDA 2006, Environment Canada >, \ ? ** 1 HI 2018). Based on fate properties, such
as vapor pressure, Henry's Law constant, water solubility, and soil organic carbon-water
partition coefficient, EPA anticipates possible presence of ethylene dibromide in air, water, and
23

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soil, depending on the media of release (ATSDR 2018. Environment Canada I v' l , \ K NAS
201-, ^ ^ i \ 2<	i-P \ 2004a. OEHHA 20031
Table 13. Exposure Information for the Environment and General Population
Database Name
Env.
Concen.3
Data
Present?
Human
Biomon.b
Data
Present?
Ecological
Biomon.
Data
Present?
Reference
California Air Resources Board
no
no
no
CARB (2005)
Comparative Toxicogenomics Database
no
no
no
MDI (2002)
EPA Ambient Monitoring Technology
Information Center - Air Toxics Data
yes
no
no
4(1990)
EPA Discharge Monitoring Report Data
yes
no
no
U.S. EPA (2007)
EPA Unregulated Contaminant Monitoring
Rule
yes
no
no
\(1996)
FDA Total Diet Study
no
no
no
FDA (1991)
Great Lakes Environmental Database
yes
no
no
! SNA
Information Platform for Chemical
Monitoring Data
yes
no
no
EC (20.1.8)
International Council for the Exploration of
the Sea
no
no
no
ICES (20.1.8)
OECD Monitoring Database
no
no
no
OECD (2018)
Targeted National Sewage Sludge Survey
no
no
no
(2006b)
The National Health and Nutrition
Examination Survey
no
yes
no
CDC (20.1.3)
USGS Monitoring Data -National Water
Quality Monitoring Council
no
no
no
USG a)
USGS Monitoring Data -National Water
Quality Monitoring Council, Air
no
no
no
I SUS UonH<)
USGS Monitoring Data -National Water
Quality Monitoring Council, Ground Water
yes
no
no
IS (1991c)
USGS Monitoring Data -National Water
Quality Monitoring Council, Sediment
yes
no
no
I SJS Unnl'U
USGS Monitoring Data -National Water
Quality Monitoring Council, Soil
yes
no
no
i.sus unniri
USGS Monitoring Data -National Water
Quality Monitoring Council, Surface Water
yes
no
no
l SJStJnnit*
USGS Monitoring Data -National Water
Quality Monitoring Council, Tissue
no
no
no
OntHg)
aConcen.= concentration
bBiomon.= biomonitoring
24

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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 identify 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 ethylene dibromide 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 ethylene dibromide 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 ethylene dibromide may
result in presence of the chemical in surface water and groundwater, ingestion of the chemical in
drinking water, inhalation of the chemical from air releases, and exposure to workers and
consumers. In addition, EPA identified potential environmental (e.g., aquatic toxicity, terrestrial
toxicity) and human health hazards (e.g., acute toxicity, repeated dose toxicity, genetic toxicity,
reproductive toxicity, developmental toxicity, irritation/corrosion, carcinogenicity, neurotoxicity,
and observations in epidemiologic and/or biomonitoring studies).
25

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