&EPA
EPA Document # EPA- 740-R1-7019
May 2018
United States Office of Chemical Safety and
Environmental Protection Agency Pollution Prevention
Problem Formulation of the Risk Evaluation for
1-Bromopropane
CASRN: 106-94-5
CH
May 2018
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 6
ABBREVIATIONS 7
EXECUTIVE SUMMARY 10
1 INTRODUCTION 12
1.1 Regul atory Hi story 13
1.2 Assessment History 14
1.3 Data and Information Collection 15
1.4 Data Screening During Problem Formulation 16
2 PROBLEM FORMULATION 17
2.1 Physical and Chemical Properties 17
2.2 Conditions of Use 18
2.2.1 Data and Information Sources 18
2.2.2 Identification of Conditions of Use 18
2.2.2.1 Categories and Subcategories Determined Not to be Conditions of Use
During Problem Formulation 19
2.2.2.2 Categories and Subcategories of Conditions of Use Included in the Scope of
the Risk Evaluation 20
2.2.2.3 Overview of Conditions of Use and Life Cycle Diagram 26
2.3 Exposures 30
2.3.1 Fate and Transport 30
2.3.2 Releases to the Environment 31
2.3.2.1 Disposal of Wastes containing 1-BP 32
2.3.3 Presence in the Environment and Biota 34
2.3.4 Environmental Exposures 35
2.3.5 Human Exposures 35
2.3.5.1 Occupational Exposures 35
2.3.5.2 Consumer Exposures 37
2.3.5.3 General Population Exposures 39
2.3.5.4 Potentially Exposed or Susceptible Subpopulations 40
2.4 Hazards (Effects) 40
2.4.1 Environmental Hazards 41
2.4.2 Human Health Hazards 43
2.4.2.1 Non-Cancer Hazards 43
2.4.2.2 Mutagenicity/Genotoxicity and Cancer Hazards 44
2.4.2.3 Potentially Exposed or Susceptible Subpopulations 45
2.5 Conceptual Models 45
2.5.1 Conceptual Model for Industrial and Commercial Activities and Uses: Potential
Exposures and Hazards 46
2.5.2 Conceptual Model for Consumer Activities and Uses: Potential Exposures and
Hazards 49
2.5.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures
and Hazards 52
2.5.3.1 Pathways That EPA Expects to Include and Further Analyze in the Risk
Evaluation 52
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2.5.3.2 Pathways That EPA Expects to Include in the Risk Evaluation But Not
Further Analyze 53
2.5.3.3 Pathways That EPA Does Not Expect to Include in the Risk Evaluation... 54
2.6 Analysis Plan 57
2.6.1 Exposure 57
2.6.1.1 Environmental Releases 57
2.6.1.2 Environmental Fate 60
2.6.1.3 Environmental Exposures 60
2.6.1.4 General Population 60
2.6.1.5 Occupational Exposures 64
2.6.1.6 Consumer Exposures 66
2.6.2 Hazards (Effects) 68
2.6.2.1 Environmental Hazards 68
2.6.2.2 Human Health Hazards 68
2.6.3 Risk Characterization 70
REFERENCES 72
APPENDICES 77
APPENDIX A REGULATORY HISTORY 77
A. 1 Federal Laws and Regulations 77
A.2 State Laws and Regulations 80
A.3 International Laws and Regulations 81
APPENDIX B PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION 82
B.l Process Information 82
B. 1.1 Manufacture (Including Import) 82
B. 1.1.1 Domestic Manufacture 82
B.l. 1.2 Import 82
B. 1.1.3 Processing and Distribution 82
B. 1.1.4 Processing as a Reactant 82
B. 1.1.5 Incorporated into Formulation, Mixture or Reaction Product 82
B. 1.1.6 Incorporated into Article 83
B.l. 1.7 Repackaging 83
B.l. 1.8 Recycling 83
B.1.2 Uses 83
B. 1.2.1 Solvents for Cleaning and Degreasing 83
B.1.2.2 Adhesives and Sealants 91
B. 1.2.3 Cleaning and Furniture Care Products 91
B. 1.2.4 Other Uses 91
B.1.3 Disposal 92
B.2 Occupational Exposure Data 92
B.3 References related to Risk Evaluation - Environmental Release and Occupational Exposure..93
APPENDIX C ESTIMATES OF SURFACE WATER CONCENTRATION 97
APPENDIX D SUPPORTING TABLE FOR INDUSTRIAL AND COMMERCIAL ACTIVITIES
AND USES CONCEPTUAL MODEL 98
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APPENDIX E SUPPORTING TABLE FOR CONSUMER ACTIVITIES AND USES,
GENERAL POPULATIONS, ECOLOGICAL RECEPTORS, AND ENVIRONMENTAL
RELEASES AND WASTES CONCEPTUAL MODEL 106
APPENDIX F INCLUSION AND EXCLUSION CRITERIA FOR FULL TEXT SCREENING
115
F. 1 Inclusion Criteria for Data Sources Reporting Environmental Fate Data 115
F.2 Inclusion Criteria for Data Sources Reporting Exposure Data on Consumers, General
Population, and Ecological Receptors 118
F.3 Inclusion Criteria for Data Sources Reporting Engineering and Occupational Exposure Datal 19
F.4 Inclusion Criteria for Data Sources Reporting Human Health Hazards 122
LIST OF TABLES
Table 1-1. Assessment History of 1-BP 14
Table 2-1. Physical and Chemical Properties of 1-BP 17
Table 2-2. Categories and Subcategories Determined Not to be Conditions of Use During Problem
Formulation 20
Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 21
Table 2-4. Production Volume of 1-BP in CDR Reporting Period (2012 to 2015) a 27
Table 2-5. Environmental Fate Characteristics of 1-BP 31
Table 2-6. Summary of 2016 TRI Releases for 1-BP (CASRN 106-94-5) 33
Table 2-7. Ecological Hazard Characterization of 1-Bromopropane 42
Table 2-8. Potential Sources of Environmental Release Data 58
Table 2-9. Potential Sources of Occupational Exposure Data 64
LIST OF FIGURES
Figure 2-1. 1-BP Life Cycle Diagram 29
Figure 2-2. 1-BP Conceptual Model for Industrial and Commercial Activities and Uses: Potential
Exposures and Hazards 48
Figure 2-3. 1-BP Conceptual Model for Consumer Activities and Uses: Potential Exposures and
Hazards 51
Figure 2-4. 1-BP Conceptual Model for Environmental Releases and Wastes: Potential Exposures
and Hazards 56
LIST OF APPENDIX TABLES
Table_Apx A-l. Federal Laws and Regulations 77
Table_Apx A-2. State Laws and Regulations 80
Table_Apx A-3. Regulatory Actions by other Governments and Tribes 81
Table Apx B-l. Summary of Release/Exposure Scenarios and Industry Sectors with 1-BP Personal
Monitoring Air Samples Obtained from OSHA Inspections Conducted Between 2013 and
2016 92
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TableApx B-2. Summary of Release/Exposure Scenarios and Industry Sectors with 1-BP Area
Monitoring Air Samples Obtained from OSHA Inspections Conducted Between 2013 and
2016 93
Table Apx B-3. Potentially Relevant Data Sources for Process Description Related Information for
1-BP a 93
Table Apx B-4. Potentially Relevant Data Sources for Estimated or Measured Release Data for 1-
BP a 94
Table Apx B-5. Potentially Relevant Data Sources for Personal Exposure Monitoring and Area
Monitoring Data for 1-BP a 94
Table Apx B-6. Potentially Relevant Data Sources for Engineering Controls and Personal Protective
Equipment Information for 1-BP a 95
Table Apx C-l. Estimated Surface Concentrations from Water Releases Reported to TRI 97
Table Apx D-l. Industrial and Commercial Activities and Uses Conceptual Model Supporting Table. 98
Table_Apx E-l. Consumer Scenario Table 106
Table Apx E-2. General Population, Ecological Receptors, and Environmental Releases and Wastes
Scenario Table 110
Table Apx F-l. Inclusion Criteria for Data Sources Reporting Environmental Fate Data 116
Table Apx F-2. Fate Endpoints and Associated Processes, Media and Exposure Pathways
Considered in the Development of the Environmental Fate Assessment 117
Table Apx F-3. Inclusion Criteria for the Data Sources Reporting 1-BP Exposure Data on
Consumers and General Population 118
Table Apx F-4. Inclusion Criteria for Data Sources Reporting Engineering and Occupational
Exposure Data 119
Table Apx F-5. Engineering, Environmental Release and Occupational Data Necessary to Develop
the Environmental Release and Occupational Exposure Assessments 120
Table Apx F-6. Inclusion and Exclusion Criteria for the Data Sources Reporting Human Health
Hazards Related to 1-BP Exposure51 122
LIST OF APPENDIX FIGURES
Figure_Apx B-l. Open Top Vapor Degreaser 84
Figure_Apx B-2. Open Top Vapor Degreaser with Enclosure 85
Figure_Apx B-3. Closed-Loop/Vacuum Vapor Degreaser 85
Figure_Apx B-4. Monorail Degreaser 87
Figure_Apx B-5. Cross-Rod Degreaser 87
Figure_Apx B-6. Vibra Degreaser 88
Figure_Apx B-7. Ferris Wheel Conveyorized Vapor Degreasing System 89
Figure_Apx B-8. Belt/Strip Conveyorized Vapor Degreasing System 89
Figure_Apx B-9. Continuous Web Vapor Degreasing System 90
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ACKNOWLEDGEMENTS
This report was developed by the United States Environmental Protection Agency (U.S. EPA), Office of
Chemical Safety and Pollution Prevention (OCSPP), Office of Pollution Prevention and Toxics (OPPT).
Acknowledgments
The OPPT Assessment Team gratefully acknowledges participation and/or input from Intra-agency
reviewers that included multiple offices within EPA, Inter-agency reviewers that included multiple
Federal agencies, and assistance from EPA contractors GDIT (Contract No. CIO-SP3,
HHSN316201200013W), ERG (Contract No. EP-W-12-006), Versar (Contract No. EP-W-17-006), ICF
(Contract No. EPC14001) and SRC (Contract No. EP-W-12-003).
Docket
Supporting information can be found in public docket (Docket: EPA-HQ-OP ).
Disclaimer
Reference herein to any specific commercial products, process or service by trade name, trademark,
manufacturer or otherwise does not constitute or imply its endorsement, recommendation or favoring by
the United States Government.
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ABBREVIATIONS
°C Degrees Celsius
ACGIH American Conference of Government Industrial Hygienists
ACR Acute-to-Chronic Ratio
atm Atmosphere(s)
ATCM Airborne Toxic Control Measure
ATSDR Agency for Toxic Substances and Disease Registry
AF Assessment Factor
BAF Bioaccumulation Factor
BCF Bioconcentration Factor
BMD Benchmark Dose Modeling
1-BP 1-Bromopropane
CAA Clean Air Act
CARB California Air Resources Board
CASRN Chemical Abstracts Service Registry Number
CBI Confidential Business Information
CCL Contaminant Candidate List
CDR Chemical Data Reporting
CEHD Chemical Exposure Health Data
CEM Consumer Exposure Model
CFC Chlorofluorocarbon
CFR Code of Federal Regulations
ChV Chronic Value (MATC)
COC Concentration of Concern
COU Conditions of Use
CSCL Chemical Substances Control Law
CWA Clean Water Act
DIY Do It Yourself
DOE Department of Energy
DNA Deoxyribonucleic Acid
DRE Destruction Removal Efficiencies
ECso Effective Concentration with 50% immobilized test organisms
ECHA European Chemicals Agency
EPA Environmental Protection Agency
EPCRA Emergency Planning and Community Right-to-Know Act
ESD Emissions Scenario Document
g/L Gram(s) per Liter
GS Generic Scenario
HAP Hazardous Air Pollutant
HCFC Hydrochlorofluorocarbon
HHE Health Hazard Evaluation
Hr Hour
IMAP Inventory Multi-Tiered Assessment and Prioritisation (Australia)
IRIS Integrated Risk Information System
ISHA Industrial Safety and Health Act
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ISOR
Initial Statement of Reasons
IUR
Inhalation Unit Risk
kg
Kilogram(s)
kPa
Kilopascal(s)
L
Liter(s)
LOAEL
Lowest Observed Adverse Effect Level
lb
Pound(s)
LCso
Lethal Concentration of 50% test organisms
LOEC
Lowest Observed Effect Concentration
Log Koc
Logarithmic Soil Organic Carbon:Water Partitioning Coefficient
Log Kow
Logarithmic Octanol:Water Partition Coefficient
3
m
Cubic Meter(s)
mg/L
Milligram(s) per Liter
mmHg
Millimeter(s) of Mercury
mPas
Millipascal(s)-Second
MACT
Maximum Achievable Control Technology
MATC
Maximum Acceptable Toxicant Concentration
MSWLFs
Municipal Solid Waste Landfills
NAAQS
National Ambient Air Quality Standards
NAICS
North American Industry Classification System
NEI
National Emissions Inventory
NESHAP
National Emission Standards for Hazardous Air Pollutants
NF/FF
Near Field/Far Field
NICNAS
National Industrial Chemicals Notification and Assessment Scheme (Australia)
NIOSH
National Institute for Occupational Safety and Health
NOAEL
No Observed Adverse Effect Level
NOEC
No Observed Effect Concentration
NTP
National Toxicology Program
OAQPS
Office of Air Quality Planning and Standards
OCSPP
Office of Chemical Safety and Pollution Prevention
OECD
Organisation for Economic Co-operation and Development
ONU
Occupational Non-User
OPPT
Office of Pollution Prevention and Toxics
OSHA
Occupational Safety and Health Administration
OTVD
Open Top Vapor Degreaser
PECO
Populations, Exposures, Comparisons, Outcomes
PESS
Potentially Exposed or Susceptible Subpopulations
PBPK
Physiologically Based Pharmacokinetic
PBZ
Personal Breathing Zone
PEL
Permissible Exposure Limit
PERC
Perchl oroethyl ene
POD
Point of Departure
POTW
Publicly Owned Treatment Works
PPE
Personal Protective Equipment
ppm
Part(s) per Million
PSD
Particle Size Distribution
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PV
Production Volume
QC
Quality Control
RCRA
Resource Conservation and Recovery Act
REACH
Registration, Evaluation, Authorisation and Restriction of Chemicals (European Union)
REL
Recommended Exposure Limit
SDS
Safety Data Sheet
SDWA
Safe Drinking Water Act
SNAP
Significant New Alternatives Policy
STP
Sewage Treatment Plant
SVHC
Substance of Very High Concern (European Union)
tV2
Half-Life
TCE
T ri chl oroethyl ene
TLV
Threshold Limit Value
TRI
Toxics Release Inventory
TSCA
Toxic Substances Control Act
TWA
Time-Weighted Average
VP
Vapor Pressure
VOC
Volatile Organic Compound
U.S.
United States
WTP
Wastewater Treatment Plant
WWT
Wastewater Treatment
Yr
Year
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EXECUTIVE SUMMARY
TSCA § 6(b)(4) requires the U.S. Environmental Protection Agency (U.S. EPA) to establish a risk
evaluation process. In performing risk evaluations for existing chemicals, EPA is directed to "determine
whether a chemical substance presents an unreasonable risk of injury to health or the environment,
without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially
exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator
under the conditions of use." In December of 2016, EPA published a list of 10 chemical substances that
are the subject of the Agency's initial chemical risk evaluations ( 7), as required by TSCA §
6(b)(2)(A). 1-Bromopropane (1-BP) was one of these chemicals.
TSCA § 6(b)(4)(D) requires that EPA publish the scope of the risk evaluation to be conducted, including
the hazards, exposures, conditions of use and potentially exposed or susceptible subpopulations that the
Administrator expects to consider. In June, 2017, EPA published the Scope of the Risk Evaluation for 1-
BP (S cope Document; EPA-HQ-OPPT- 49). As explained in the Scope Document, because
there was insufficient time for EPA to provide an opportunity for comment on a draft of the scope, as
EPA intends to do for future scope documents, EPA is publishing and taking public comment on a
problem formulation document to refine the current scope, as an additional interim step prior to
publication of the draft risk evaluation for 1-BP. Comments received on this problem formulation
document will inform development of the draft risk evaluation.
This problem formulation document refines the conditions of use, exposures and hazards presented in
the scope of the risk evaluation for 1-BP and presents refined conceptual models and analysis plans that
describe how EPA expects to evaluate risk for 1-BP.
1-BP is primarily used as a solvent cleaner in vapor and immersion degreasing operations to clean
optics, electronics and metals, but it has also been reported to be used as an alternative to ozone-
depleting substances and chlorinated solvents, as a solvent vehicle in industries using spray adhesives
such as foam cushion manufacturing and in the dry cleaning industry. Information from the 2016
Chemical Data Reporting (CDR) for 1-BP indicates the reported production volume is 25.9 million
lbs/year (manufacture and import).
This document presents the potential exposures that may result from the conditions of use of 1-BP.
Exposures to workers, consumers, and/or the general population may occur from industrial, commercial,
consumer uses of 1-BP and industrial releases to air, water or land. Workers and occupational non-users
(i.e., workers who do not directly handle the chemical but perform work in an area where the chemical is
used) may be exposed to 1-BP during a variety of conditions of use such as manufacturing, processing,
distribution, repackaging, spray adhesives, dry cleaning (including spot cleaning) and degreasing (vapor,
cold cleaning, and aerosol). Consumers and bystanders may be exposed to 1-BP from various consumer
uses such as aerosol and spray adhesives, aerosol spot removers and aerosol cleaning and degreasing
products. For 1-BP, EPA considers workers, occupational non-users, consumers, bystanders, and certain
other groups of individuals who may experience greater exposures than the general population due to
proximity to conditions of use to be potentially exposed or susceptible subpopulations. Exposures to the
general population may occur from industrial and/or commercial uses; industrial releases to air, water, or
land; and other conditions of use. EPA will evaluate whether groups of individuals within the general
population may be exposed via pathways that are distinct from the general population due to unique
characteristics (e.g., life stage, behaviors, activities, or duration) that increase exposure and whether
groups of individuals have heightened susceptibility, and should therefore be considered potentially
exposed or susceptible subpopulations for purposes of the risk evaluation. EPA plans to further analyze
inhalation exposures to vapors and mists for workers and occupational non-users (workers who do not
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directly handle the chemical but perform work in an area where the chemical is present) and dermal
exposures for skin contact with liquids in occluded situations for workers in the risk evaluation. EPA
plans to further analyze inhalation exposures to vapors and mists for consumers and bystanders and
dermal exposures for skin contact with liquids in the risk evaluation. For environmental release
pathways, EPA does not plan to further analyze surface water exposure to aquatic invertebrates and
aquatic plants in the risk evaluation.
1-BP has been the subject of numerous health hazard reviews including the Agency for Toxic
Substances and Disease Registry's (ATSDR's) Toxicological Profile, and the National Institute for
Occupational Safety and Health's (NIOSH's) Criteria Document, in addition to the 2016 Draft Risk
Assessment (\_ _S \ P ~0j >_>b). Any existing assessments will be a starting point as EPA conducts a
systematic review of the literature, including new literature since the existing assessments, as available
in 1-Bromopropane (CASRN106-94-5) Bibliography: Supplemental File for the TSCA Scope
DocumentEPA-HQ-OPPT-2 ). If additional hazard concerns are identified during the
systematic review of the literature, these will also be considered. These hazards will be evaluated based
on the specific exposure scenarios identified.
The revised conceptual models presented in this problem formulation identify conditions of use;
exposure pathways (e.g., media); exposure routes (e.g., inhalation, dermal, oral); potentially exposed or
susceptible subpopulations; and hazards EPA expects to consider in the risk evaluation. The initial
conceptual models provided in the scope document were revised during problem formulation based on
evaluation of reasonably available information for physical and chemical properties, fate, exposures,
hazards, and conditions of use and based upon consideration of other statutory and regulatory
authorities. In each problem formulation document for the first 10 chemical substances, EPA also
refined the activities, hazards, and exposure pathways that will be included in and excluded from the risk
evaluation.
EPA's overall objectives in the risk evaluation process are to conduct timely, relevant, high-quality, and
scientifically credible risk evaluations within the statutory deadlines, and to evaluate the conditions of
use that raise greatest potential for risk. 82 FR 33726. 33728 (July 20, 2017).
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1 INTRODUCTION
This document presents for comment the problem formulation of the risk evaluation to be conducted for
1-Bromopropane (1-BP) under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The
Frank R. Lautenberg Chemical Safety for the 21st Century Act amended the Toxic Substances Control
Act (TSCA), the Nation's primary chemicals management law, on June 22, 2016. The new law includes
statutory requirements and deadlines for actions related to conducting risk evaluations of existing
chemicals.
In December of 2016, EPA published a list of 10 chemical substances that are the subject of the
Agency's initial chemical risk evaluations (81 FR 91927), as required by TSCA § 6(b)(2)(A). These
10 chemical substances were drawn from the 2014 update of EPA's TSCA Work Plan for Chemical
Assessments, a list of chemicals that EPA identified in 2012 and updated in 2014 (currently totaling
90 chemicals) for further assessment under TSCA. EPA's designation of the first 10 chemical
substances constituted the initiation of the risk evaluation process for each of these chemical substances,
pursuant to the requirements of TSCA § 6(b)(4).
TSCA § 6(b)(4)(D) requires that EPA publish the scope of the risk evaluation to be conducted, including
the hazards, exposures, conditions of use (COU) and potentially exposed or susceptible subpopulations
(PESS) that the Administrator expects to consider, within 6 months after the initiation of a risk
evaluation. The scope documents for all first 10 chemical substances were issued on June 22, 2017. The
first 10 problem formulation documents are a refinement of what was presented in the first 10 scope
documents. TSCA § 6(b)(4)(D) does not distinguish between scoping and problem formulation, and
requires EPA to issue scope documents that include information about the chemical substance, including
the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations that
the Administrator expects to consider in the risk evaluation. In the future, EPA expects scoping and
problem formulation to be completed prior to the issuance of scope documents and intends to issue
scope documents that include problem formulation.
As explained in the scope document, because there was insufficient time for EPA to provide an
opportunity for comment on a draft of the scope, as EPA intends to do for future scope documents, EPA
is publishing and taking public comment on a problem formulation document to refine the current scope,
as an additional interim step prior to publication of the draft risk evaluation for 1-BP. Comments
received on this problem formulation document will inform development of the draft risk evaluation.
The Agency defines problem formulation as the analytical phase of the risk assessment in which "the
purpose for the assessment is articulated, the problem is defined and a plan for analyzing and
characterizing risk is determined" [see Section 2.2 of the Framework for Human Health Risk
Assessment to Inform Decision Making; ( ;)]. The outcome of problem formulation is a
conceptual model(s) and an analysis plan. The conceptual model describes the linkages between
stressors and adverse human health effects, including the stressor(s), exposure pathway(s), exposed life
stage(s) and population(s), and endpoint(s) that will be addressed in the risk evaluation (U.S. EPA.
2014b). The analysis plan follows the development of the conceptual model(s) and is intended to
describe the approach for conducting the risk evaluation, including its design, methods and key inputs
and intended outputs as described in ( ). The problem formulation documents refine the
initial conceptual models and analysis plans that were provided in the scope documents.
First, EPA has removed from the risk evaluation any activities and exposure pathways that EPA has
concluded do not warrant inclusion in the risk evaluation. For example, for some activities that were
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listed as "conditions of use" in the scope document, EPA has insufficient information following the
further investigations during problem formulation to find they are circumstances under which the
chemical is actually "intended, known, or reasonably foreseen to be manufactured, processed,
distributed in commerce, used, or disposed of."
Second, EPA also identified certain exposure pathways that are under the jurisdiction of regulatory
programs and associated analytical processes carried out under other EPA-administered environmental
statutes - namely, the Safe Drinking Water Act (SDWA), the Clean Water Act (CWA), and the
Resource Conservation and Recovery Act (RCRA) - and which EPA does not expect to include in the
risk evaluation.
As a general matter, EPA believes that certain programs under other Federal environmental laws
adequately assess and effectively manage the risks for the covered exposure pathways. To use Agency
resources efficiently under the TSCA program, to avoid duplicating efforts taken pursuant to other
Agency programs, to maximize scientific and analytical efforts, and to meet the three-year statutory
deadline, EPA is planning to exercise its discretion under TSCA 6(b)(4)(D) to focus its analytical efforts
on exposures that are likely to present the greatest concern and consequently merit a risk evaluation
under TSCA, by excluding, on a case-by-case basis, certain exposure pathways that fall under the
jurisdiction of other EPA-administered statutes.1 EPA does not expect to include any such excluded
pathways as further explained below in the risk evaluation. The provisions of various EPA-administered
environmental statutes and their implementing regulations represent the judgment of Congress and the
Administrator, respectively, as to the degree of health and environmental risk reduction that is sufficient
under the various environmental statutes.
Third, EPA identified any conditions of use, hazards, or exposure pathways which were included in the
scope document and that EPA expects to include in the risk evaluation but which EPA does not plan to
further analyze in the risk evaluation. EPA expects to be able to reach conclusions about particular
conditions of use, hazards or exposure pathways without further analysis and therefore plans to conduct
no further analysis on those conditions of use, hazards or exposure pathways in order to focus the
Agency's resources on more extensive or quantitative analyses. Each risk evaluation will be "fit-for-
purpose," meaning not all conditions of use will warrant the same level of evaluation and the Agency
may be able to reach some conclusions without comprehensive or quantitative risk evaluations. 82 FR
33726, 33734, 33739 (July 20, 2017).
EPA received comments on the published scope document for 1-BP and has considered the comments
specific to 1-BP in this problem formulation document. EPA is soliciting public comment on this
problem formulation document and when the draft risk evaluation is issued the Agency intends to
respond to comments that are submitted. In its draft risk evaluation, EPA may revise the conclusions and
approaches contained in this problem formulation, including the conditions of use and pathways covered
and the conceptual models and analysis plans, based on comments received.
1.1 Regulatory History
EPA conducted a search of existing domestic and international laws, regulations and assessments
pertaining to 1-BP. EPA compiled this summary from data available from federal, state, international
1 As explained in the final rule for chemical risk evaluation procedures, "EPA may, on a case-by case basis, exclude certain
activities that EPA has determined to be conditions of use in order to focus its analytical efforts on those exposures that are
likely to present the greatest concern, and consequently merit an unreasonable risk determination [82 FR 33726 (July 20
2017)].
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and other government sources, as cited in Appendix A. EPA evaluated and considered the impact of
existing laws and regulations (e.g., regulations on landfill disposal, design, and operations) in the
problem formulation step to determine what, if any further analysis might be necessary as part of the risk
evaluation. Consideration of the nexus between these existing regulations and TSCA conditions of use
may additionally be made as detailed/specific conditions of use and exposure scenarios are developed in
conducting the analysis phase of the risk evaluation.
Federal Laws and Regulations
1-BP is subject to federal statutes or regulations, other than TSCA, that are implemented by other offices
within EPA and/or other federal agencies/departments. A summary of federal laws, regulations and
implementing authorities is provided in Appendix A.l.
State Laws and Regulations
1-BP is subject to state statutes or regulations implemented by state agencies or departments. A
summary of state laws, regulations and implementing authorities is provided in Appendix A.2.
Laws and Regulations in Other Countries and International Treaties or Agreements
1-BP is subject to statutes or regulations in countries other than the United States and/or international
treaties and/or agreements. A summary of these laws, regulations, treaties and/or agreements is provided
in Appendix A. 3.
1.2 Assessment History
EPA has identified assessments conducted by other EPA Programs and other organizations (see Table
1-1). Depending on the source, these assessments may include information on conditions of use,
hazards, exposures and potentially exposed or susceptible subpopulations. Table 1-1 shows the
assessments that have been conducted. EPA found no additional assessments beyond those listed in the
Scope Document (Scope Docume Q-OPPT-2016-0741 -0049).
In addition to using this information, EPA intends to conduct a full review of the relevant data and
information collected in the initial comprehensive search (see 1-Bromopropane (CASRN106-94-5)
Bibliography: Supplemental File for the TSCA Scope Document, EP A-HQ-OPPT-2( >048)
using the literature search and screening strategies documented in the Strategy for Conducting
Literature Searches for 1-Bromopropane: Supplemental File for the TSCA Scope Document. (EP A-HQ-
OPPT -2016-0741 -0048). This will ensure that EPA considers data and information that has been made
available since these assessments were conducted.
Table 1-1. Assessment History of 1-BP
Authoring Organization
Assessment
EPA Assessments
Office of Chemical Safety and Pollution Prevention
(OCSPP)/Office of Pollution Prevention and Toxics
(OPPT)
TSCA work plan chemical risk assessment: Peer review
draft 1-bromoDroDane: (n-ProDvl bromide) sorav
adhesives. drv cleaning, and desreasine uses CASRN:
106-94-5 (2016b) T2016 Draft Risk Assessment (U.S.
EPA. 2016bVI
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Table 1-1. Assessment History of 1-BP
Authoring Organization
Assessment
Office of Air Quulil) Planning and Standards
(OAQPS)
Droll notice lo grant llie pcliLion lo add 1 -UP Lo llic 11si
of HAPs
(httDs://www. regulations. sov/document?D=EP A-HQ-
OAR-2014-0471-0062)
Other U.S.-Based Organizations
National Institute for Occupational Safety and Health
(NIOSH)
Criteria for a Recommended Standard: Occupational
(2016)
Agency for Toxic Substances and Disease Registry
(ATSDR)
Toxicolosical Profile for 1-BromoDroDane
(2017)
1.3 Data and Information Collection
EPA/OPPT generally applies a systematic review process and workflow that includes: (1) data
collection; (2) data evaluation; and (3) data integration of the scientific data used in risk evaluations
developed under TSCA. Scientific analysis is often iterative in nature as new knowledge is obtained.
Hence, EPA/OPPT expects that multiple refinements regarding data collection may occur during the
process of risk evaluation. Additional information that may be considered and was not part of the initial
comprehensive bibliographies will be documented in the Draft Risk Evaluation for 1-BP.
Data Collection: Data Search
EPA/OPPT conducted chemical-specific searches for data and information on: physical and chemical
properties; environmental fate and transport; conditions of use information; environmental exposures,
human exposures, including potentially exposed or susceptible subpopulations; ecological hazard,
human health hazard, including potentially exposed or susceptible subpopulations.
EPA/OPPT designed its initial data search to be broad enough to capture a comprehensive set of sources
containing information potentially relevant to the risk evaluation. For most disciplines, the search was
not limited by date and was conducted on a wide range of data sources, including but not limited to:
peer-reviewed literature and gray literature (e.g., publicly-available industry reports, trade association
resources, government reports). For human health hazard, EPA/OPPT relied on the search strategies
from recent assessments, such as the National Toxicology Program's (NTP) Report on Carcinogens
(NTP. 2013), to identify relevant information published after the end date of the previous search to
capture more recent literature. The Strategy for Conducting Literature Searches for 1-Bromopropane:
Supplemental File for the TSCA Scope Document, (EP A-HQ-OPPT-2016-0741 -0048) provides details
about the data sources and search terms that were used in the literature search.
Data Collection: Data Screening
Following the data search, references were screened and categorized using selection criteria outlined in
the Strategy for Conducting Literature Searches for 1-Bromopropane: Supplemental File for the TSCA
Scope Document, (EPA-HQ-OPPT-2016-0741 -0048). Titles and abstracts were screened against the
Page 15 of 123
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criteria as a first step with the goal of identifying a smaller subset of the relevant data to move into the
subsequent data extraction and data evaluation steps. Prior to full-text review, EPA/OPPT anticipates
refinements to the search and screening strategies, as informed by an evaluation of the performance of
the initial title/abstract screening and categorization process.
The categorization scheme (or tagging structure) used for data screening varies by scientific discipline
(i.e., physical and chemical properties; environmental fate and transport; chemical use/conditions of use
information; human and environmental exposures, including potentially exposed or susceptible
subpopulations identified by virtue of greater exposure; human health hazard, including potentially
exposed or susceptible subpopulations identified by virtue of greater susceptibility; and ecological
hazard. However, within each data set, there are two broad categories or data tags: (1) on-topic
references or (2) off-topic references. On-topic references are those that may contain data and/or
information relevant to the risk evaluation. Off-topic references are those that do not appear to contain
data or information relevant to the risk evaluation. The supplemental document, Strategy for Conducting
Literature Searches for 1-Bromopropane: Supplemental File for the TSCA Scope Document, (EPA-H.Q-
OPPT-2016-0741 -0048) discusses the inclusion and exclusion criteria that EPA/OPPT used to
categorize references as on-topic or off-topic.
Additional data screening using sub-categories (or sub-tags) was also performed to facilitate further
sorting of data/information - for example, identifying references by source type (e.g., published peer-
reviewed journal article, government report); data type (e.g., primary data, review article); human health
hazard (e.g., liver toxicity, cancer, reproductive toxicity); or chemical-specific and use-specific data or
information. These sub-categories are described in the supplemental document, Strategy for Conducting
Literature Searches for 1-Bromopropane: Supplemental File for the TSCA Scope Document, (EPA-H.Q-
OPPT-2016-0741 -0048) and will be used to organize the different streams of data during the stages of
data evaluation and data integration steps of systematic review.
Results of the initial search and categorization can be found in the 1-Bromopropane (CASRN106-94-5)
Bibliography: Supplemental File for the TSCA Scope Document. EPA-HQ-0 '047).
This document provides a comprehensive list (bibliography) of the sources of data identified by the
initial search and the initial categorization for on-topic and off-topic references. Because systematic
review is an iterative process, EPA/OPPT expects that some references may move from the on-topic to
the off-topic categories, and vice versa. Moreover, targeted supplemental searches may also be
conducted to address specific needs for the analysis phase (e.g., to locate specific data needed for
modeling); hence, additional on-topic references not initially identified in the initial search may be
identified as the systematic review process proceeds.
1.4 Data Screening During Problem Formulation
EPA/OPPT is in the process of completing the full text screening of the on-topic references identified in
the 1-Bromopropane (CASRN 106-94-5) Bibliography: Supplemental File for the TSCA Scope
Document. EPA-HQ-QPPT-2016-0741 -0047). The screening process at the full-text level is described in
the Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2018). Appendix F provides
the inclusion and exclusion criteria applied at the full text screening. The eligibility criteria are guided
by the analytical considerations in the revised conceptual models and analysis plans, as discussed in the
problem formulation document. Thus, it is expected that the number of data/information sources
entering evaluation is reduced to those that are relevant to address the technical approach and issues
described in the analysis plan of this document.
Page 16 of 123
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Following the screening process, the quality of the included data/information sources will be assessed
using the evaluation strategies that are described in the Application of Systematic Review in TSCA Risk
Evaluations (U.S. EPA. 2018).
2 PROBLEM FORMULATION
As required by TSCA, the scope of the risk evaluation identifies the conditions of use, hazards,
exposures and potentially exposed or susceptible subpopulations that the Administrator expects to
consider. To communicate and visually convey the relationships between these components, EPA
included in the scope document (Scope Docume Q-OPPT-2016-0741 -0049) a life cycle
diagram and conceptual models that describe the actual or potential relationships between 1-BP and
human and ecological receptors. During the problem formulation, EPA revised the conceptual models
based on further data gathering and analysis as presented in this Problem Formulation document. An
updated analysis plan is also included which identifies, to the extent feasible, the approaches and
methods that EPA may use to assess exposures, effects (hazards) and risks under the conditions of use of
1-BP.
2.1 Physical and Chemical Properties
Physical-chemical properties influence the environmental behavior and the toxic properties of a
chemical, thereby informing the potential conditions of use, exposure pathways and routes and hazards
that EPA intends to consider. For scope development, EPA considered the measured or estimated
physical-chemical properties set forth in Table 2-1 and EPA found no additional information during
problem formulation that would change these values.
Table 2-1. Physical and Chemical Properties of 1-BP
Property
Value a
References
Molecular formula
C3H7Br
O'Neit C
Molecular weight
122.99
O'Neil (2013)
Physical form
Colorless liquid; sweet
hydrocarbon odor
O'Neil C
Melting point
-110°C
ONdlJ2013)
Boiling point
71°C at 760 mmHg
O'Neil Q
Density
1.353 g/cm3 at 20°C
O'Neil C
Vapor pressure
146.26 mmHg (19.5 kPa) at 20°C
Boublik 4)
Vapor density
4.25 (relative to air)
Patty et al. (1963)
Water solubility
2.450 g/L at 20°C
Yalkowskv et al. (2
Page 17 of 123
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Table 2-1. Physical and Chemical Properties of 1-BP
Octanol/water partition
coefficient (Log Kow)
2.10
Hansch (1995)
Henry's Law constant
7.3xl0"3 atm-m3/mole
(estimated)
>012b)
Flash point
22°C
O'Neil (2013)
Autoflammability
490°C
H \VA)I0}
Viscosity
5.241 mPas at 20°C
Havnes and Lide (20101
Refractive index
1.4341
O'Neil C
Dielectric constant
8.09 at 20°C
Havnes and Lide (201 Oi
a Measured unless otherwise noted.
2.2 Conditions of Use
TSCA § 3(4) defines the conditions of use as "the circumstances, as determined by the Administrator,
under which a chemical substance is intended, known, or reasonably foreseen to be manufactured,
processed, distributed in commerce, used, or disposed of."
2.2.1 Data and Information Sources
In the scope documents, EPA identified, based on reasonably available information, the conditions of
use for the subject chemicals. EPA searched a number of available data sources (e.g., Use and Market
Profile for 1-Bromopropane; EPA-HQ-OPPT-2016-0741-0050). Based on this search, EPA published a
preliminary list of information and sources related to chemical conditions of use (see Preliminary
Information on Manufacturing, Processing, Distribution, Use, and Disposal: 1-Bromopropane, EPA-
H.Q-OPPT-2 0) prior to a February 2017 public meeting on scoping efforts for risk
evaluation convened to solicit comment and input from the public. EPA also convened meetings with
companies, industry groups, chemical users and other stakeholders to aid in identifying conditions of use
and verifying conditions of use identified by EPA. The information and input received from the public
and stakeholder meetings was incorporated into the problem formulation document to the extent
appropriate. Thus, EPA believes the manufacture, processing, distribution, use and disposal activities
identified in these documents constitute the intended, known, or reasonably foreseeable activities
associated with the subject chemicals, based on reasonably available information.
2.2.2 Identification of Conditions of Use
To determine the current conditions of use of 1-BP and inversely, activities that do not qualify as
conditions of use, EPA conducted extensive research and outreach. This included EPA's review of
published literature and online databases including the most recent data available from EPA's Chemical
Data Reporting program (CDR) and Safety Data Sheets (SDSs). EPA also conducted online research by
reviewing company websites of potential manufacturers, importers, distributors, retailers, or other users
of 1-BP and queried government and commercial trade databases. EPA also received comments on the
Scope of the Risk Evaluation for 1-BP (Scope Document; EPA-H.Q-QPPT-2016-0741-0049) that were
Page 18 of 123
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used to determine the conditions of use. Some of the comments received were more relevant to the risk
evaluation process. In addition, EPA convened meetings with companies, industry groups, chemical
users, states, environmental groups, and other stakeholders to aid in identifying conditions of use and
verifying conditions of use identified by EPA. Those meetings included a February 14, 2017 public
meeting with such entities and an October 25, 2017 site visit to CRC Industries 0 ^ \ 4Q-QPPT-2016-
0741).
EPA has removed from the risk evaluation any activities that EPA has concluded do not constitute
conditions of use - for example, because EPA has insufficient information to find certain activities are
circumstances under which the chemical is actually "intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used, or disposed of." EPA has also identified any
conditions of use that EPA does not expect to include in the risk evaluation. As explained in the final
rule for Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act,
TSCA section 6(b)(4)(D) requires EPA to identify "the hazards, exposures, conditions of use, and the
potentially exposed or susceptible subpopulations the Administrator expects to consider in a risk
evaluation," suggesting that EPA may exclude certain activities that EPA has determined to be
conditions of use on a case-by-case basis (82 FR 33736, 33729; July 20, 2017). For example, EPA may
exclude conditions of use that the Agency has sufficient basis to conclude would present only de
minimis exposures or otherwise insignificant risks (such as use in a closed system that effectively
precludes exposure or use as an intermediate).
The activities that EPA no longer believes are conditions of use or that were otherwise excluded during
problem formulation are described in Section 2.2.2.1. The conditions of use included in the scope of the
risk evaluation are summarized in Section 2.2.2.2.
2.2.2.1 Categories and Subcategories Determined Not to be Conditions of Use During Problem
Formulation
EPA has conducted public outreach and literature searches to collect information about 1-BP's
conditions of use and has reviewed reasonably available information obtained or possessed by EPA
concerning activities associated with 1-BP. As a result of that analysis during problem formulation, EPA
determined there is insufficient information to support a finding that certain activities which were listed
as conditions of use in the Scope Document (Scope Document; EPA-HQ-QPPT-2016-0741 -0049) for 1-
BP actually constitute "circumstances.. .under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of."
Consequently, EPA intends to exclude these activities not considered conditions of use from the scope
of the evaluation. These activities are shown in Table 2-2, and consist of agricultural non-pesticidal
industrial/commercial/consumer use and the consumer use of: adhesives (except as an adhesive
accelerant for arts and crafts), engine degreasing, and brake cleaning.
Based on information available to EPA, EPA determined that 1-BP is not used in agricultural products
(non-pesticidal), only in the processing of such products.
A review of the use of 1-BP as a solvent in adhesives, engine degreasers, and in brake cleaners showed
that these uses of 1-BP are not consumer uses, except as an adhesive accelerant in arts and crafts. In all
other uses of 1-BP as an adhesive, 1-BP-containing adhesives are sold through wholesale channels for
commercial and industrial uses, and usually in amounts larger than consumers could use. 1-BP has never
been advertised (or used) as a consumer brake cleaner or engine degreaser. Instead, 1-BP has been
advertised and used as a specialized general duty industrial or commercial degreaser. 1-BP is sometimes
used by industrial and commercial users to degrease engines when these users want a nonflammable
Page 19 of 123
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degreaser, or are concerned about disposal of chlorinated solvents in the waste. In practice, this is only a
consideration for industrial and commercial users, and not for consumers. Some industrial and
commercial users use 1-BP as a general degreaser because chlorinated solvents are listed hazardous
wastes under RCRA, whereas 1-BP is not, and therefore waste containing 1-BP may not be hazardous
depending on the characteristics of the overall waste stream.
Also, consumers will avoid the use of 1-BP as an engine degreaser or brake cleaner because 1-BP is
expensive. In general, heavy duty degreasers containing 1-BP are twice the cost of other heavy duty
degreasers and five times the cost of other available consumer brake cleaners.
Table 2-2. Categories and Subcategories Determined Not to be Conditions of Use During
Problem Formulation
l.il'e Cycle Stage
Calegorv
Subcategory
References
Industrial/Commercial/
Consumer Use
Agricultural products
(non pesticidal)
Miscellaneous agricultural
products
U.S. EPA (2016a)
Consumer Use
Adhesives and
Sealants
Adhesive chemicals - spray
adhesive for foam cushion
manufacturing and other uses
U.S. EPA (2016b); Public
Comment. EPA-HO-
OPPT-20
Other Uses
Automotive care products -
engine degreaser, brake cleaner
Use Document. EPA-HO-
OPPT-2016-l 03
2.2.2.2 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
EPA has conducted public outreach and literature searches to collect information about 1-BP's
conditions of use and has reviewed reasonably available information obtained or possessed by EPA
concerning activities associated with 1-BP. Based on this research and outreach, other than the category
and subcategory described above in Section 2.2.2.1. EPA does not have reason to believe that any
conditions of use identified in the 1-BP scope should be excluded from risk evaluation. Therefore, all of
the remaining conditions of use for 1-BP will be included in the risk evaluation.
EPA currently believes that few dry cleaners use 1 -BP as a dry cleaning solvent. In the 2016 Draft Risk
Assessment (U.S. EPA. 2.016b). EPA estimated that about 267 (1.1% of all) dry cleaning establishments
used 1-BP. Recent (March 2017) public comments (EPA-HQ-OPPT-1 ) on the 1-BP
Preliminary Information on Manufacturing, Processing, Distribution, Use, and Disposal of 1-BP (EPA-
HQ-OPPT-2016-0741 -0003) suggest than only 23 machines used 1-BP in 2016, only about 30,000
pounds of 1-BP would be used in dry cleaning machines in 2017, and that almost no dry cleaning
machines would use 1-BP by 2020. However, the use of 1-BP in the dry cleaning industry remains a
reasonably foreseen condition of use. EPA is currently evaluating tetrachloroethylene (perc) under
TSCA, and if EPA were to restrict the use of perc in dry cleaning, many dry cleaners might use 1-BP in
their machines absent regulatory restrictions from doing so. For many dry cleaners, it is less expensive
to convert perc machines to use 1-BP than it is to purchase new machines that use alternative solvents.
This is especially true because many dry cleaners are small, capital-constrained, family-owned and
operated businesses. Most use of 1-BP in dry cleaning has been from converted machines; very few
machines designed to use 1-BP as a solvent have been sold. In addition, based on monitoring data and
Page 20 of 123
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the low ACGIH TLV-TWA, EPA expects that the use of 1-BP in dry cleaning results in unreasonable
risks to workers, as presented in the 201 >_< »>iaft Risk Assessment (U.S. EPA. *„0j v;h).
Table 2-3 summarizes each life cycle stage and the corresponding categories and subcategories of
conditions of use for 1-BP that EPA expects to consider in the risk evaluation. Using the 2.016 CDR.
EPA identified industrial processing or use activities, industrial function categories and commercial and
consumer use product categories. EPA identified the subcategories by supplementing CDR data with
other published literature and information obtained through stakeholder consultations. For risk
evaluations, EPA intends to consider each life cycle stage (and corresponding use categories and
subcategories) and assess relevant potential sources of release and human exposure associated with that
life cycle stage. In addition, activities related to distribution (e.g., loading and unloading) will be
considered throughout the life cycle rather than using a single distribution scenario.
Beyond the uses identified in the Scope Document (Scope Document; EPA-HQ-OPPT-!
0049). EPA has received no additional information identifying confirming additional current conditions
of use for 1-BP from public comment and stakeholder meetings.
Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
l.il'e Cycle Stage
Cat ego rv 11
Subcategory h
References
Manufacture
Domestic manufacture
Domestic manufacture
U.S. EPA (2016a)
Import
Import
U.S. EPA (2016a)
Processing
Processing as a reactant
Intermediate in all other basic
inorganic chemical
manufacturing, all other basic
organic chemical manufacturing,
and pesticide, fertilizer and other
agricultural chemical
manufacturing
U.S. EPA (2016a)
Page 21 of 123
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Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
l.il'e Cycle Stage
Category 11
Subcategory h
References
Processing
Processing -
incorporating into
formulation, mixture or
reaction product
Solvents for cleaning or
degreasing in manufacturing of:
- all other chemical product and
preparation
- computer and electronic
product
- electrical equipment,
appliance and component
- soap, cleaning compound and
toilet preparation
- services
U.S. EPA (2016a)
Processing -
incorporating into articles
Solvents (which become part of
product formulation or mixture)
in construction
U.S. EPA (2016a): Public
Comment. EPA-HO -
OPPT-20
Repackaging
Solvent for cleaning or degreasing
in all other basic organic chemical
manufacturing
U.S. EPA (2016a)
Recycling
Recycling
U.S. EPA (2016a): Use
Document. EPA-HO-
OPPT-2016-f 03
Distribution in
commerce
Distribution
Distribution
U.S. EPA (2016a): Use
Document, EPA-HO-
OPPT-20 03
Page 22 of 123
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Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
l.il'e Cycle Stage
Category 11
Subcategory h
References
Industrial/
commercial/ use
Solvent (for cleaning or
degreasing)
Batch vapor degreaser (e.g., open-
top, closed-loop)
U.S. EPA (2016b): Public
Comment. EPA-HO -
OPPT-20 :
Public Comment. EPA-
0015; Public Comment.
EP A-HO-OPPT -2016-
In-line vapor degreaser (e.g.,
conveyorized, web cleaner)
Kaneesberg and
Kanegsberg ( . Public
Comment. EPA-HO-
OPPT-20 ;
Public Comment. EPA-
HO-OPPT-20.1.6-
00.1.6
Cold cleaner
U.S. EPA (20.1.6b): Public
Comment. EPA-HO-
OPPT-2016-1
Aerosol spray degreaser/cleaner
U.S. EPA (20.1.6b); Public
Comment, EPA-HO -
OPPT-2C ;
Public Comment, EPA-
HO-OPPI-2016-i 4 ~l"
00.1.8; Public Comment.
EP A-HO-OPPT -20.1.6-
10
Adhesives and sealants
Adhesive chemicals - spray
adhesive for foam cushion
manufacturing and other uses
U.S. EPA (20.1.6b); Public
Comment. EPA-HO-
OPPT-201.6-f
Page 23 of 123
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Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
l.il'e Cycle Stage
Category 11
Subcategory h
References
Industrial/
commercial/use
(continued)
Cleaning and furniture
care products
Dry cleaning solvent
U.S. EPA (2016b): Public
Comment. EPA-HO -
OPPT-20 '05:
Public Comment. EPA-
HO-OPPT-20.1.6-
0016
Spot cleaner, stain remover
U.S. EPA (2016b): Public
Comment. EPA-HQ-
OPPT-20 :
Public Comment. EPA-
HO-OPPT-2016-
0022
Liquid cleaner (e.g., coin and
scissor cleaner)
Use Document. EPA-HO-
OPPT-2016-l 03
Liquid spray/aerosol cleaner
Use Document. EPA-HO-
OPPT-2016-f 03
Other uses
Arts, crafts and hobby materials -
adhesive accelerant
U.S. EPA (2016b)
Automotive care products -
engine degreaser, brake cleaner
Use Document. EPA-HO-
OPPT-2016-< 03
Anti-adhesive agents - mold
cleaning and release product
U.S. EPA (2016b): Public
Comment. EPA-HO-
OPPT-20 :
Public Comment. EPA-
HO-OPPT-20.1.6-
00.1.5: Public Comment,
EP A-HO-OPPT -2016-
. Public
Comment. EPA-H.O-
OPPT-2016-(^il -00 H
Building/construction materials
not covered elsewhere - insulation
Use Document, EPA-HQ-
OPPT-20.1.6-( 03:
Public Comment. EPA-
0027
Page 24 of 123
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Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
l.il'e Cycle Stage
Category 11
Subcategory h
References
Industrial/
commercial/use
(continued)
Other uses
Electronic and electronic products
and metal products
U.S. EPA (2016a): Public
Comment. EPA-HO -
OPPT-20 :
Public Comment. EPA-
HO-OPPT-20.1.6-
0024
Functional fluids (closed systems)
- refrigerant
Use Document. EPA-HO-
OPPT-2016-f 03
Functional fluids (open system) -
cutting oils
Use Document. EPA-HO-
OPPT-2016-f 03;
Public Comment. EPA-
HO-OPPT-2016-
00.1.4
Other - asphalt extraction
Use Document. EPA-HO-
OPPT-2016-l 03;
Public Comment. EPA-
H.O-OPPT-20.1.6-
00.1.6
Temperature Indicator -
Laboratory chemicals
Use Document. EPA-HO-
OPPT-2016-l 03
Temperature Indicator -
Coatings
Use Document. EPA-HO-
OPPT-20.1.6-( 03:
Public Comment. EPA-
00.1.4; Public Comment,
EP A-HO-OPPT -2016-
Consumer uses
Solvent (for cleaning or
degreasing)
Aerosol spray degreaser/cleaner
U.S. EPA (20.1.6b);
Cleaning and furniture
care products
Spot cleaner, stain remover
U.S. EPA (20.1.6b); Public
Comment. EPA-HO-
OPPT-2016-f 22
Liquid cleaner (e.g., coin and
scissor cleaner)
Use Document, EPA-HQ-
OPPT-20.1.6-( 03
Liquid spray/aerosol cleaner
Use Document. EPA-HO-
OPPT-2016-f 03
Other uses
Arts, crafts and hobby materials -
adhesive accelerant
U.S. EPA (20.1.6b)
Page 25 of 123
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Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
l.il'e Cycle Stage
Cat ego rv 11
Subcategory h
References
Automotive care products -
refrigerant flush
U.S. EPA (2016b)
Anti-adhesive agents - mold
cleaning and release product
U.S. EPA (2016b)
Building/construction materials
not covered elsewhere - insulation
Use Document. EPA-HO-
OPPT-2016-! 03:
Public Comment, EPA-
HQ-OPPI-2016-
0027
Disposal
(Manufacturing,
Processing, Use)
Disposal
Municipal waste incinerator
Off-site transfer
2016 TRI Data (updated
October 2017) U.S. EPA
£
Municipal waste incinerator
Off-site waste transfer
aThese categories of conditions of use appear in the Life Cycle Diagram, reflect CDR codes, and broadly represent
conditions of use of 1-BP in industrial and/or commercial settings.
bThese subcategories reflect more specific uses of 1-BP.
Although EPA indicated in the 1-BP Scope Document (Scope Document; EPA-HQ-OP1
0; • that EPA did not expect to evaluate the uses assessed in the : Risk Assessment (U.S.
EPA, 2016b) in the 1-BP risk evaluation, EPA has decided to evaluate these conditions of use in the risk
evaluation as described in this problem formulation. EPA is including these conditions of use so that
they are part of EPA's determination of whether 1-BP presents an unreasonable risk "under the
conditions of use," TSCA 6(b)(4)(A). EPA has concluded that the Agency's assessment of the potential
risks from this widely used chemical will be more robust if the potential risks from these conditions of
use are evaluated by applying standards and guidance under amended TSCA. In particular, this includes
ensuring the evaluation is consistent with the scientific standards in Section 26 of TSCA, the Procedures
for Chemical Risk Evaluation under the Amended Toxic Substances Control Act (40 CFR Part 702) and
EPA's supplemental document, Application of Systematic Review in TSCA Risk Evaluations (
2.018). EPA also expects to consider other available hazard and exposure data to ensure that all
reasonably available information is taken into consideration.
2.2.2.3 Overview of Conditions of Use and Life Cycle Diagram
The life cycle diagram provided in Figure 2-1 depicts the conditions of use that are considered within
the scope of the risk evaluation during various life cycle stages including manufacturing, processing,
distribution, use (industrial, commercial, and consumer; when distinguishable), and disposal. Additions
or changes to the conditions of use based on additional information gathered or analyzed during problem
Page 26 of 123
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formulation were described in Sections 2.2.2.1 and 2.2.2.2. The activities that EPA determined are out of
scope during problem formulation are not included in the life cycle diagram. The information is grouped
according to Chemical Data Reporting (CDR) processing codes and use categories (including functional
use codes for industrial uses and product categories for industrial, commercial and consumer uses), in
combination with other data sources (e.g., published literature and consultation with stakeholders), to
provide an overview of conditions of use. EPA notes that some subcategories of use may be grouped
under multiple CDR categories.
Use categories include the following: "industrial use" means use at a site at which one or more
chemicals or mixtures are manufactured (including imported) or processed. "Commercial use" means
the use of a chemical or a mixture containing a chemical (including as part of an article) in a commercial
enterprise providing saleable goods or services. "Consumer use" means the use of a chemical or a
mixture containing a chemical (including as part of an article, such as furniture or clothing) when sold to
or made available to consumers for their use (U.S. EPA. 2016a).
Based on market information from other sources, EPA expects degreasing and spray adhesive to be the
primary uses of 1-BP; however, the exact use volumes associated with these categories are claimed CBI
in the 2016 CDR (U.S. EPA. 2016a). EPA will evaluate activities resulting in exposures associated with
distribution in commerce (e.g. loading, unloading) throughout the various lifecycle stages and conditions
of use (e.g. manufacturing, processing, industrial use, consumer use, disposal) rather as a single
distribution scenario. EPA expects that some commercial products containing 1-BP are also available for
purchase by consumers, such that many products are used in both commercial and consumer
applications/scenarios.
To understand conditions of use relative to one another and associated potential exposures under those
conditions of use, the life cycle diagram includes the production volume associated with each stage of
the life cycle, as reported in the 2016 CDR reporting (U.S. EPA. 2016a). when the volume was not
claimed confidential business information (CBI). The 2016 CDR reporting data for 1-BP are provided in
Table 2-4 for 1-BP from EPA's CDR database ( 2016a). This information has not changed
from that provided in the Scope Document (EPA-HO-OPPT-2016-0741-0Q49).
Table 2-4. Production Volume of 1-BP in CDR Reporting Period (2012 to 2015) a
Reporting Year
2012
2013
2014
2015
Total Aggregate Production
Volume (lbs)
18,800,000
24,000,000
18,500,000
25,900,000
a The CDR data for the 2016 reporting period is available via ChemView (https://iava.epa.gov/chemview") (U.S. EPA.
2016a"). Because of an ongoing CBI substantiation process required by amended TSCA, the CDR data available in the
Scope Document (EP A-HQ-OPPT-2 >49") is more specific than currently in ChemView.
According to data collected in EPA's 201 ».¦ Chemical Data ReportiiK >|R) Rule, 25.9 million pounds
of 1-BP were produced or imported in the United States in 2015 ( 2016a). Data reported
indicate that there are two manufacturers and six importers of 1-BP in the United States. Additional
companies manufacturing or importing 1-BP are claimed as CBI.
Total production volume (manufacture plus import) of 1-BP has increased from 2012 to 2015, as can be
seen in Table 2-4 (U.S. EPA, 2.016a). 1-BP's use has increased because it has been an alternative to
ozone-depleting substances and chlorinated solvents. Import volumes for 1-BP reported to the 2016
Page 27 of 123
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CDR are between 10 million and 25 million pounds per year ( 2016a). In past years, import
data from 1-BP were claimed as CBI, but import data from other sources indicate that import volumes of
brominated derivatives of acyclic hydrocarbons (which includes 1-BP as well as other chemicals) were
10.9 million pounds in 2007, which dropped to 10.3 million pounds in 201 1 (NTP, 2013).
Descriptions of the industrial, commercial and consumer use categories identified from the 2016 CDR
and included in the life cycle diagram are summarized below ( 2016a). The descriptions
provide a brief overview of the use category; Appendix B contains more detailed descriptions (e.g.,
process descriptions, worker activities, process flow diagrams, equipment illustrations) for each
manufacture, processing, distribution, use and disposal category. The descriptions provided below are
primarily based on the corresponding industrial function category and/or commercial and consumer
product category descriptions from the R and can be found in EPA's Instructions for Reporting
2016 TSi U bemical Data Reporting 0 / !_r \ .'016a).
The "Solvents for Cleaning and Degreasing" category encompasses chemical substances used to
dissolve oils, greases and similar materials from a variety of substrates, including metal surfaces,
glassware and textile. This category includes the use of 1-BP in vapor degreasing, cold cleaning and in
industrial and commercial aerosol degreasing products.
The "Adhesives and Sealants" category encompasses chemical substances contained in adhesive and
sealant products used to fasten other materials together. EPA anticipates that a subcategory within the
Adhesives and Sealants category is the use of 1-BP as a solvent in spray adhesive for foam cushion
manufacturing. This category also covers uses of 1-BP in other adhesive products.
The "Cleaning and Furniture Care Products" category encompasses chemical substances contained in
products that are used to remove dirt, grease, stains and foreign matter from furniture and furnishings, or
to cleanse, sanitize, bleach, scour, polish, protect or improve the appearance of surfaces. This category
includes a wide variety of 1-BP uses, including, but not limited to, the use of 1-BP as dry cleaning
solvent, in spot cleaning formulations and in aerosol and non-aerosol type cleaners.
Figure 2-1 depicts the life cycle diagram of 1-BP from manufacture to the point of disposal. Activities
related to distribution (e.g., loading, unloading) will be considered throughout the 1-BP life cycle, rather
than using a single distribution scenario.
Page 28 of 123
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Mf<3/IMPGftT
PROCESSING
Manufacture
(Includes: Import)
(25.8 million lb*}
Proc*wing a* Rcactant
(Volum-eCBI)
Incorporated into
Formulation, Mixture,
or Reaction Product
(>131 million Ibsf
Incorporated into
Article
(Volume CBI}
Repackaging
(>SSrlD0 lbs|
INDUSTRIAL, COMMERCIAL, CONSUMER USES-
—+
RELEASES and WASTE DISPOSAL
Solvent* for Cleaning and
Degreasing
(Volume CBI)
e.g.. vapor degrease*, eo»d cleans,,
aerosol dkegrearser
Adhesive* and Sealants.
(Volume CBI|>
r- g.. spray acheiv^, aerosol spray
adhesive
Recycling
Cleaning and Furniture Care
Products
[714,000 lbs)
e.g.. <*#v ctoanlnfi. scot Cteanlng,
aerosol cleaner and degrea&e*, aerosol
spot ^eofxiver, nc*n--jerosol cleaner
Other Uw»
e.g., lubricant, insulation, aaintsbe
main! release product, refrigerant flush
Disposal
See Figure Zd forEwirwvnerrto)
Re teases otns Wostes
~| Man of acfcurIng (includes impart]
] Processing
f I Uses. At the level af detail In the life cycie
dkagrarn EPA is nat dlstzngLss.liing between
IredtEEtrlal/cDvnmercial/bansumer uses. The
differences between these uses will be
further investigated and defined curing risk
evaluation.
Figure 2-1. 1-BP Life Cycle Diagram
The life cycle diagram depicts the conditions of use that are within the scope of the risk evaluation during various life cycle stages including
manufacturing, processing, use (industrial, commercial, consumer), distribution and disposal. The production volumes shown are for reporting year 2015
from the 2016 CDR reporting period ( J.S. EPA. 2016a). EPA will evaluate activities resulting in exposures associated with distribution in commerce (e.g
loading, unloading) throughout the various lifecycle stages and conditions of use (e.g. manufacturing, processing, industrial use, consumer use, disposal)
rather as a single distribution scenario.
a See Table 2-3 for additional uses not mentioned specifically in this diagram.
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2.3 Exposures
For TSCA exposure assessments, EPA expects to evaluate exposures and releases to the environment
resulting from the conditions of use applicable to 1-BP. Post-release pathways and routes will be
described to characterize the relationship or connection between the conditions of use for 1-BP and the
exposure to human receptors, including potentially exposed or susceptible subpopulations and ecological
receptors. EPA will take into account, where relevant, the duration, intensity (concentration), frequency
and number of exposures in characterizing exposures to 1-BP.
2.3.1 Fate and Transport
Environmental fate includes both transport and transformation processes. Environmental transport is the
movement of the chemical within and between environmental media. Transformation occurs through the
degradation or reaction of the chemical with other species in the environment. Hence, knowledge of the
environmental fate of the chemical informs the determination of the specific exposure pathways and
potential human and environmental receptors EPA expects to consider in the risk evaluation. Table 2-5
provides environmental fate data that EPA identified and considered in developing the scope for 1-BP.
This information has not changed from that provided in the Scope Document CEPA-HQ-OPPT-
!9).
Fate data including volatilization during wastewater treatment, volatilization from lakes and rivers,
biodegradation rates, and organic carbon:water partition coefficient (log Koc) were used when
considering changes to the conceptual models. Model results and basic principles were used to support
the fate data used in problem formulation while the literature review is currently underway through the
systematic review process.
EPI Suite™ (U.S. EPA, 2.012b) modules were used to predict volatilization of 1-BP from wastewater
treatment plants, lakes, and rivers and to confirm the data showing moderate to rapid biodegradation.
The EPI Suite™ module that estimates chemical removal in sewage treatment plants ("STP" module)
was run using default settings to evaluate the potential for 1-BP to volatilize to air or adsorb to sludge
during wastewater treatment. The STP module estimates that 73% of 1-BP in wastewater will be
removed by volatilization while 1% of 1-BP will be removed by adsorption.
The EPI Suite™ module that estimates volatilization from lakes and rivers ("Volatilization" module)
was run using default settings to evaluate the volatilization half-life of 1-BP in surface water. The
parameters required for volatilization (evaporation) rate of an organic chemical from the water body are
water depth, wind and current velocity of the river or lake. The volatilization module estimates that the
half-life of 1-BP in a model river will be 1.2 hours and the half-life in a model lake will be 4.4 days.
The EPI Suite™ module that predicts biodegradation rates ("BIOWIN" module) was run using default
settings to estimate biodegradation rates of 1-BP under aerobic conditions. Three of the models built into
the BIOWIN module (BIOWIN 2, 5 and 6) estimate that 1-BP will not rapidly biodegrade in aerobic
environments, while a fourth (BIOWIN 1) estimates that 1-BP will rapidly biodegrade in aerobic
environments. These results support the biodegradation data presented in the 1-BP Scope Document
CEP A-HQ-OPPT-2( )Q49\ which demonstrate a range of biodegradation rates under aerobic
conditions. The model that estimates anaerobic biodegradation (BIOWIN 7) predicts that 1-BP will
rapidly biodegrade under anaerobic conditions. Further, previous assessments of 1-BP found that
biodegradation occurred over a range of rates from slow to rapid rToxicologi file for 1-
Bromopropane: CATSDR. 2017Y1.
Page 30 of 123
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The log Koc reported in the 1-BP scope document was predicted using EPI Suite™. That value (1.6) is
supported by the basic principles of environmental chemistry which states that the Koc is typically
within one order of magnitude (one log unit) of the octanol: water partition coefficient (Kow). Indeed, the
log Kow reported for 1-BP in the Scope Document (EPA-HQ-OPPT-7 -9) was 2.1, which is
within the expected range. Further, the Koc could be approximately one order of magnitude larger than
predicted by EPI Suite™ before sorption would be expected to significantly impact the mobility of 1-BP
in groundwater. No measured Koc values were found.
Table 2-5. Environmental Fate Characteristics of 1-BP
Properly or Kmlpoinl
Value 11
References
Dnvcl pholodcgmdalion
\ol c\pcclcd In undergo dnvcl pholohsis
Indirect photodegradation
9-12 days (estimated for atmospheric
degradation)
U.S. EPA (2016b)
Hydrolysis half-life
26 days
U.S. EPA (2016b)
Biodegradation
70% in 28 days (OECD 301C)
19.2% in 28 days (OECD 301D)
U.S. EPA (2016b)
Bioconcentration factor (BCF)
11 (estimated)
U.S. EPA (2012b)
Bioaccumulation factor (BAF)
12 (estimated)
U.S. EPA (2016b)
Organic carbon:water partition
coefficient (Log Koc)
1.6 (estimated)
U.S. EPA (2016b)
a Measured unless otherwise noted
1-BP is a water soluble, volatile liquid and mobile in soil. Adsorption to soils is not expected; therefore,
1-BP can migrate through soil to ground water. 1-BP is degraded by sunlight and reactants when
released to the atmosphere with a half-life of 9-12 days. Based on this estimated half-life in air, long-
range transport via the atmosphere is possible. Volatilization and microbial degradation influence the
fate of 1-BP when released to water, sediment or soil. Biotic and abiotic degradation rates ranging from
days to months have been reported.
Biotic and abiotic degradation studies have not shown this substance to be persistent (overall
environmental half-life of <2 months). No measured bioconcentration studies for 1-BP are available. An
estimated BCF of 11 and an estimated BAF of 12 suggest that bioconcentration and bioaccumulation
potential in aquatic organisms is low (BCF and BAF <1,000).
2.3.2 Releases to the Environment
Releases to the environment from conditions of use (e.g., industrial and commercial processes,
commercial or consumer uses resulting in down-the-drain releases) are one component of potential
exposure and may be derived from reported data that are obtained through direct measurement,
calculations based on empirical data and/or assumptions and models.
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1-BP is expected to be released to air during manufacturing, processing, distribution and use due to its
high volatility (vapor pressure of 146.26 mmHg at 20°C). 1-BP is also expected to be released to other
environmental media through waste disposal (e.g., disposal of spent solvent, rags, wipe materials, and
transport containers).
A source of information that EPA expects to consider in evaluating exposure are data reported under the
Toxics Release Inventory (TRI) program. Under the Emergency Planning and Community Right-to-
Know Act (EPCRA) Section 313 rule, 1-BP is a TRI-reportable chemical beginning with the 2016
calendar year with the first reporting forms from facilities were submitted on July 1, 2017 and on each
following year. During problem formulation, EPA analyzed the TRI data reported for 2016 and
examined the reported treatment and disposal methods employed to determine the level of confidence
that a release would result from certain types of disposal to land (e.g., Resource Conservation and
Recovery Act or RCRA Subtitle C hazardous waste landfills, Subtitle D municipal landfills, and Class I
underground injection wells) and incineration.
2.3.2.1 Disposal of Wastes containing 1-BP
Industrial wastewater containing 1-BP may be subject to state or local regulations or permit limits. Solid
wastes containing 1-BP may be regulated as a hazardous waste under the RCRA waste code D001
(ignitable liquids, 40 CFR 261.21). These wastes would be either incinerated in a hazardous waste
incinerator or disposed to a hazardous waste landfill. Consumer wastes containing 1-BP may be
disposed with general municipal wastes, which may be incinerated or landfilled. Depending on the
incinerator destruction efficiency, the incineration of 1-BP may result in subsequent releases to air.
Landfilling wastes containing 1-BP may result in subsequent fugitive emissions to air or migration to
groundwater. 1-BP migration to groundwater from RCRA Subtitle C landfills or RCRA Subtitle D
municipal landfills regulated by the state / local jurisdictions to groundwater will likely be mitigated by
landfill design (double liner, leachate capture for RCRA Subtitle C landfills and single liner for RCRA
Subtitle D municipal landfills) and requirements to adsorb liquids onto solid adsorbent and containerize
prior to disposal.
2016 TRI Data
A key source of information that EPA expects to consider in the risk evaluation in evaluating releases to
the environment are data reported under the TRI program. EPA published a final rule on November 23,
2015 (80 FR 72906) to add 1-BP to the TRI chemical list, as 1-BP meets the Emergency Planning and
Community Right-to-Know Act (EPCRA) Section 313(d)(2)(B) statutory listing criteria. Under this rule,
1-BP is reportable beginning with the 2016 calendar year with the first reporting forms from facilities
submitted on July 1, 2017.
Table 2-6 summarizes TRI release data for 1-BP. For the 2016 reporting year, 55 out of an estimated
140 facilities filed TRI reporting forms containing release and waste management data for 1-BP. The
estimated number of facilities expected to report was derived from the Economic Analysis Report of 1-
BP (https://www.regulations.gov/document?D=I ^ \_k iQ~TRI-A> I > 00j j 00j j).2 The difference in
estimated versus actual reporting facilities could be due to several factors such as, 1) facilities could be
moving away from using 1-BP; 2) some facilities may not yet be aware of the reporting requirements
since this is the first year of reporting; 3) facilities could be below the threshold for reporting. Facilities
2 Note: This estimated values of 140 facilities was derived from the Economic Analysis Report of 1-BP
(https://www.re aula lions. gov/document?D=EPA-HQ-TRI-20.1.5-00.1.1-00.1.1. Potential reporting for facilities was compiled
using available US facility data and other resources such as NAICS codes, Japanese PRTR data on 1 -BP, and from proxy
chemical models.
Page 32 of 123
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are required to report if they manufacture (including import) or process more than 25,000 pounds of
1-BP, or if they otherwise use more than 10,000 pounds of 1-BP.
Table 2-6. Summary of 2016 TRI Releases for 1-BP (CASRN 106-94-5)
Wsiste Type
('oncepliiiil Model
Kclciisc ( nlciiory
TRI Ciilo'iorv
Volume from
TRI (Ihs)
Number of
Report in»
Siles from
TRI
% of Tolsil
lYodiiclion-
Rchilcil Wiisle
Mil iisi*>e«.l
Wastewater
or Liquid
Wastes
Industrial Pre-
Treatment (indirect
discharge)
POTW
0
0
0%
Industrial WWT
(indirect discharge)
Off-site WWT (non-
POTW)
0
0
0%
Industrial WWT
(direct discharge)
Water
5
1
<0.001%
Underground Injection
Class I Underground
Injection
10
1
<0.001%
Solid
Wastes and
Liquid
Wastes
Hazardous and
Municipal Waste
Landfills
RCRA Subtitle C
Landfills
57,617
1
3.7%
Other Landfills
90,273
3
5.8%
Waste Treatment and
Management Methods
Off-site Incineration
61,301
10
3.9%
Energy Recovery
325,752
15
20.9%
Other Treatment and
Management Methods
20,892
5
1.3%
Transfer to Storage-
Only Facility
3,307
1
<0.001%
Transfer to Waste
Broker
750
1
<0.001%
Recycling
322,097
11
20.6%
On-site Waste
Treatment Methods3
53,550
2
3.4%
Emissions to
Air
Emissions to Air
Fugitive Air
394,469
43
25.3%
Stack Air
232,191
26
14.9%
Total Production Related Waste Managed
1,562,213
55
Total One-Time Release Waste
0
0
0%
Total Waste Managed
1,562,213
55
a Because sites such as treatment, storage, and disposal facilities (TSDFs) are required to report to TRI if they meet reporting
thresholds, the total volumes for these categories may include volumes that were reported as transferred off-site for waste
treatment purposes by other facilities, such as for off-site incineration.
Page 33 of 123
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Releases to Air
Table 2-6 shows air as a primary medium of environmental release. These releases include both fugitive
air emissions and point source (stack) air emissions. Fugitive air emissions (totaling 394,469 pounds
from 2016 TRI data) are emissions that do not occur through a confined air stream, which may include
equipment leaks, releases from building ventilation systems, and evaporative losses from surface
impoundments and spills. Point source (stack) air emissions (totaling 232,191 pounds from TRI 2016
data) are releases to air that occur through confined air streams, such as stacks, ducts or pipes.
Releases to Water
In the 2016 TRI, only 1 facility out of 55 reported releases to water. This facility reported 5 lbs of direct
surface water discharge; assuming the release occurred over a single day, the surface water
concentration in reported receiving waters is well below the COC based on EPA's preliminary
calculations. No facility reported any amounts of 1-BP sent to Publicly Owned Treatment Works
(POTWs).
Releases to Land
Table 2-6 shows TRI reports approximately 58,000 pounds of disposal to a single RCRA Subtitle C
landfill. EPA will not further analyze releases to hazardous waste landfills because these types of landfill
mitigate exposure to the wastes. TRI also reports approximately 90,000 pounds of 1-BP transferred to
other off-site landfills. Further review of TRI data indicated that all reported transfers "other off-site
landfills" were to facilities permitted to manage RCRA regulated waste.
Releases of Solid and Liquid Wastes to Incineration/Energy Recovery
On-site
On-site waste treatment (including incineration) and energy recovery total 275,917 lbs, which is
approximately 18% of the total production waste managed. Air emissions resulting from these
operations are already included in the TRI reports and will be used in the analysis of air releases.
Off-site
In Table 2-6, off-site transfers for incineration and energy recovery total 164,686 lbs, almost 10% of the
total production waste managed.
Recycling
Table 2-6 shows 1-BP recycling amounts totaling 322,097 lbs in 2016, approximately 21 percent of the
total production waste managed. This estimate includes all quantities of 1-BP recycled on-site and off-
site, as reported in Section 8 of the Form R. EPA expects recycling to involve recovery of waste solvents
containing 1-BP for re-use (e.g., using distillation, evaporation). Currently, EPA is not aware of the
presence of 1-BP in recycled articles.
2.3.3 Presence in the Environment and Biota
Monitoring studies or a collection of relevant and reliable monitoring studies provide(s) information that
can be used in an exposure assessment. Monitoring studies that measure environmental concentrations
or concentrations of chemical substances in biota provide evidence of exposure.
Environmental monitoring data were not identified in the 2 aft Risk Assessment (U.S. EPA.
2016b); however, any environmental monitoring data that may result from the updated literature search
will be considered. Biomonitoring data were identified in the 2 'aft Risk Assessment (U.S. EPA.
Page 34 of 123
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2.016b). Several human and laboratory animal studies have investigated the utility of both urine and
serum bromide ion levels, as well as urinary metabolites, as biomarkers of human exposure to 1-BP.
2.3.4 Environmental Exposures
The manufacturing, processing, use and disposal of 1-BP can result in releases to the environment. In
this section, EPA presents exposures to aquatic and terrestrial organisms. The predominance of these
exposures will be via the air pathway as releases to water are very low as described in Section 2.3.2.
Aquatic Environmental Exposures
EPA used the reported releases from EPA's Toxics Release Inventory (TRI) to predict surface water
concentrations near reported facilities for this Problem Formulation. To examine whether near-facility
surface water concentrations could approach 1-BP's aquatic concentrations of concern, EPA employed a
first-tier approach, using readily-available modeling tools and data, as well as conservative assumptions.
EPA's Exposure and Fate Assessment Screening Tool (E-FAST 2.014) was used to estimate site-specific
surface water concentrations based on estimated loadings of 1-BP into receiving water bodies as
reported to TRI. E-FAST 2014 incorporates stream dilution using stream flow information contained
within the model. E-FAST also incorporates wastewater treatment removal efficiencies. Wastewater
treatment removal was assumed to be 0% for this exercise, as reported loadings/releases are assumed to
account for any treatment. As days of release and operation are not reported, EPA assumed a range of
possible release days (i.e., 1, 20, and 100 days/year). Refer to the E-FAST 2014 Documentation Manual
for equations used in the model to estimate surface water concentrations (U.S. EPA. 2007).
Estimated surface water concentrations from all E-FAST 2014 runs ranged from 0.08 to 77.9 |ig/L, with
all values below the aquatic chronic concentration of concern by a factor of 3 - 3,038. For further details
of this estimation approach, see Appendix C.
Terrestrial Environmental Exposures
EPA does not plan to further analyze terrestrial exposures, due to low expected toxicity (see Section
2.4.1) and low expected exposure based on the physical/chemical properties (e.g., high vapor pressure;
see Section 2.1).
2.3.5 Human Exposures
In this section, EPA presents occupational, consumer, and general population exposures.
Subpopulations, including potentially exposed and susceptible subpopulations within these exposure
categories, are also presented.
2.3.5.1 Occupational Exposures
Exposure pathways and exposure routes are listed below for worker activities under the various
conditions of use (industrial or commercial) described in Section 2.3. In addition, exposures to
occupational non-users (ONU), who do not directly handle the chemical but perform work in an area
where the chemical is present are listed. Engineering controls and/or personal protective equipment may
affect the occupational exposure levels.
In the 20 I > > ("tuft Risk Assessment (' > I « \ 2016b), EPA evaluated inhalation exposures to 1-BP for
occupational use in spray adhesives, dry cleaning (including spot cleaning) and degreasing (vapor, cold
cleaning and aerosol), which will be considered in the 1-BP risk evaluation. As described in Section 2.2,
all the conditions of use identified which results in occupational exposures will be considered during the
risk evaluation.
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Worker Activities
Workers and occupational non-users may be exposed to 1-BP when performing activities associated
with the conditions of use described in Section 2.2. Work activities with potential for exposure may
include, but are not limited to:
• Unloading and transferring 1-BP to and from storage containers and to process vessels;
• Handling, transporting and disposing waste containing 1-BP;
• Handling and transporting 1-BP during distribution in commerce;
• Using 1-BP in process equipment (e.g., vapor degreasing machine);
• Cleaning and maintaining equipment;
• Sampling chemicals, formulations or products containing 1-BP for quality control (QC);
• Applying formulations and products containing 1-BP onto substrates (e.g., spray applying
adhesive containing 1-BP onto furniture pieces);
• Performing other work activities in or near areas where 1-BP is used.
Inhalation
Based on these occupational exposure scenarios, EPA expects inhalation of vapor to be the primary
route of exposure for workers and occupational non-users. Where mist generation is expected (e.g. spray
application), EPA will also analyze inhalation exposure to mist for workers and ONU.
The Occupational Safety and Health Administration (OSHA) has not set permissible exposure limits
(PELs) and the NIOSH has not recommended worker exposure limits (RELs) for 1-BP; however,
NIOSH recently proposed a REL of 0.3 ppm (Criteria for a Recommended Standard: Occupational
Exposure to 1-Bromopropane (2016); 81 FR 7122, February 10, 2016). A revised document was
released for comment in January of 2017. The American Conference of Governmental Industrial
Hygienists (ACGIH) has recommended a Threshold Limit Value (TLV) of 0.1 ppm 8-hour time-
weighted average (TWA) 1-BP for workers (ACGIH. 2015).
Oral
Worker exposure via the oral route is not expected. Exposure may occur through mists that deposit in
the upper respiratory tract however, based on physical chemical properties, mists of 1-BP will likely be
rapidly absorbed in the respiratory tract or evaporate and will be considered as an inhalation exposure.
Dermal
For conditions of use where workers may come into contact with liquids containing 1-BP, EPA
estimates the skin contact time to be less than 2 minutes due to rapid volatilization. The estimated
evaporation time is based on vapor generation rate of 1-BP at ambient conditions as calculated using the
EPA/OPPT Penetration Model. 1-BP is an organic chemical with vapor pressure of 111 mmHg at 20°C.
At the typical skin surface temperature of 32°C, the vapor pressure is estimated to be 186 mmHg (Frasch
et at.. 2014). The Penetration Model estimates the release of a chemical from an open, exposed liquid
surface in an indoor environment. Evaporation time can then be calculated from the vapor generation
rate, and the exposure load from EPA/OPPT 2-Hand Dermal Contact with Liquid Model or the
EPA/OPPT 2-Hand Dermal Immersion in Liquid Model (2.1 to 10.3 mg/cm2), and skin surface area of
two hands (1,070 cm2) from EPA/OPPT models (U.S. EPA. 2013a). Therefore, dermal exposure to 1-BP
based on a single finite exposure event is likely negligible.
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EPA also expects the dermal absorbed fraction to be low (0.16 percent - see discussion under Dermal
section of Section 2.3.5.2). However, there is potential for increased dermal penetration for uses where
occluded exposure, repeated contact, or dermal immersion may occur. For occupational non-users,
dermal exposure to liquid is generally not expected as they do not directly handle 1-BP.
Key Data
Key data that inform occupational exposure assessment include: the OSHA Chemical Exposure Health
Data (CEHD) and NIOSH Health Hazard Evaluation (HHE) program data. OSHA data are workplace
monitoring data from OSHA inspections. OSHA sampling data can be obtained through the CEHD at
https://www.osha.gov/opengov/healthsamples.html. TableApx B-l and TableApx B-2 summarize the
exposure scenarios and industry sectors where 1-BP personal and area monitoring data are available
from OSHA inspections conducted between 2013 and 2016.
2.3.5.2 Consumer Exposures
1-BP can be found in consumer products and/or commercial products that are readily available for
public purchase at common retailers (Sections 3 and 4 of Preliminary Information on Manufacturing,
Processing, Distribution, Use, and Disposal: 1-Bromopropane, EPA-HQ-OP >03) and
can therefore result in exposures to consumers and bystanders [non-product users that are incidentally
exposed to the product or article, (U.S. EPA, 2017b)1.
The previous 201 • \ Haft Risk Assessment (1 . S H'A. 2016b) characterized inhalation exposures to 1-
BP from the following uses:
1. Aerosol spray adhesives
2. Aerosol spot removers
3. Aerosol cleaners and degreasers (including engine degreasing, brake cleaning and electronics
cleaning)
During Problem Formulation, further review of consumer products and consumer uses was performed,
and is discussed in Section 2.2.2. It was concluded that there is no consumer use of 1-BP for engine
degreasers, brake cleaning, or aerosol spray adhesives (except as an adhesive accelerant in arts and
crafts applications). Although 1-BP is sometimes used by industrial and commercial users to degrease
engines when these users want a nonflammable degreaser, it is not expected to be used by consumers for
the purposes of engine degreasing or brake cleaning.
Based on information summarized in Section 2.2.2, additional consumer uses that will be further
analyzed include:
• Solvents (for cleaning or degreasing)
o Aerosol spray degreaser/cleaner
• Cleaning and Furniture Care Products
o Spot cleaner, stain remover
o Liquid cleaner (e.g., coin and scissor cleaner)
o Liquid spray/aerosol cleaner
• Other uses
o Arts, crafts and hobby materials - adhesive accelerant
o Automotive care products - refrigerant flush
Page 37 of 123
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o Anti-adhesive agents - mold cleaning and release product
o Building and construction materials not covered elsewhere - insulation
Use patterns and habits and practices may vary depending on the use and user. There may be higher end
users (e.g., DIY) who purchase consumer products, and use these products more frequently. Examples
may be small shops or businesses (e.g., art shops that routinely use a spray adhesive, small garages that
frequently use degreasers) where the frequency of use is higher or where users or hobbyists may use
products more than once per day on a regular basis. This may lead to chronic exposure whereas typical
consumer exposures are expected to be acute in nature based on the identified consumer products/uses.
Use of articles, such as insulation, may lead to exposures that occur over longer periods of time. Use
patterns for the consumer products identified will be considered using available information on
magnitude, frequency and duration of exposures.
Inhalation
Based on the physical-chemical properties of 1-BP and the conditions of use, inhalation is expected to
be the primary route of exposure for consumer users of 1-BP containing products. The magnitude of
exposure will depend upon the concentration of 1-BP in products, use patterns (including frequency,
duration, amount of product used, room of use) and application methods. Several product types and
scenarios were evaluated in the 201 • Otaft Risk Assessment 0 J* \ 2016b), including spray
adhesives, spray degreasers (engine cleaning and electronics cleaning), and aerosol spot removers.
Information regarding use patterns and application methods will be used to build exposure scenarios.
Any products which are spray applied will result in some level of inhalation exposure to the consumer
user and also to a bystander in the room of use. Products used in the liquid form are also likely to result
in some level of inhalation exposure to the consumer given the high vapor pressure of 1-BP. Consumer
exposures are expected to be acute in nature, however, there may be a subset of consumers who use
products on a frequent or regular basis resulting in sub-chronic or chronic exposures. Based on the
potential for spray application of some products containing 1-BP, exposures to mists are also expected.
The exposures to consumers and bystanders through mists may deposit in the upper respiratory tract and
EPA assumes these are absorbed via inhalation.
Acute inhalation exposures to consumers (such as residential users) and bystanders (those who may not
be actively engaged in the use of the product, but may be in the room of use) in residential settings were
also assessed for the consumer uses identified in the 2.016 Draft Risk Assessment ( 016b).
Oral
EPA does not plan to further analyze exposure to consumers via ingestion of 1-BP. Ingestion is not
expected to be a primary route of exposure. Based on the vapor pressure, 1-BP will exist as a vapor/mist
during use. A fraction of 1-BP may be available for absorption in the respiratory tract however ingestion
of 1-BP is anticipated to be low since 1-BP is expected to be absorbed in the lung quickly and not have
appreciable ability to travel up the mucosal elevator and be swallowed.
Dermal
There is the potential for dermal exposure from consumer uses of 1-BP. Dermal exposure may occur via
vapor/mist deposition onto skin or via direct liquid contact during use, particularly in occluded
scenarios. As described in the NIOSH Skin Notation Profile for 1-BP (NIOSH. 2017). in vitro dermal
penetration of 0.16% of the applied dose (13.5 mg/cm2) was measured following transient exposure in a
non-occluded environment to simulate splash scenarios; therefore, losses due to evaporation were
approximately 500-fold greater than the dermal absorption flux. However, measurements of skin
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penetration were one to two orders or magnitude higher in occluded environments where evaporation
losses were not considered (transient 10 minute exposures, or 'infinite' 3 hour exposures). Based on this
information, dermal exposure in non-occluded scenarios will be a less significant route of exposure
when compared to occluded scenarios, however there may be exceptions such as situations of transient
or infinite exposures (e.g., vapor trapped against skin by gloves or continued contact with a wet rag) or
where there is greater potential for dermal penetration due to longer durations of exposure.
Whereas users may be exposed dermally during use of consumer products depending on the specific use,
it is not expected that bystanders would be dermally exposed to 1-BP.
Exposures from Disposal
EPA does not expect exposure to consumers from disposal of consumer products. It is anticipated that
most products will be disposed of in original containers, particularly those products that are purchased as
aerosol cans. Liquid products may be recaptured in an alternate container following use (refrigerant
flush or coin cleaning).
2.3.5.3 General Population Exposures
Wastewater/liquid wastes, solid wastes or air emissions of 1-BP could result in potential pathways for
oral, dermal or inhalation exposure to the general population.
Inhalation
Emissions to air from industrial manufacturing, processing and use are expected. TRI data in Table 2-6
show air as a primary medium of environmental release. These releases include both fugitive air
emissions and point source (stack) air emissions. Based on the relatively long hydroxy radical oxidation
half-life (t V2 14 days) emissions to ambient air could results in exposures to near facility human
receptors and the general population. Inhalation is expected to be the primary route of exposure for the
general population and near facility populations.
Inhalation of 1-BP may also occur in indoor settings as a result of co-location with dry cleaning facilities
that use 1-BP.
Oral
Recent TRI reporting indicated 0 pounds released to POTWs and 5 pounds released directly to water in
2016. EPA pretreatment regulations for industrial users discharging wastewater to POTWs are expected
to limit the discharge of 1-BP to POTWs and ultimately to surface water (see Section 2.3.4). Waste
disposal practices and 1-BP's rapid volatilization from water are expected to mitigate drinking water
exposure potential and there is no data of 1-BP found in US drinking water.
Although incidental hand-to-mouth ingestion of soil may occur, adsorption to soils is not expected since
1-BP is volatile and mobile in soil (see Section 2.3.1); therefore, ingestion of soil and contaminated
drinking water are not expected.
Dermal
Based on the physical and chemical properties of 1-BP (relatively high volatility), low expected dermal
absorption, and expected media concentrations (see Section 2.3.4), dermal exposure to 1-BP via surface
water or soil is not expected to be a significant route of exposure.
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2.3.5.4 Potentially Exposed or Susceptible Subpopulations
TSCA requires the determination of whether a chemical substance presents an unreasonable risk to "a
potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation" by EPA.
TSCA § 3(12) states that "the term 'potentially exposed or susceptible subpopulation' means a group of
individuals within the general population identified by the Administrator who, due to either greater
susceptibility or greater exposure, may be at greater risk than the general population of adverse health
effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women,
workers, or the elderly." General population is "the total of individuals inhabiting an area or making up a
whole group" and refers here to the U.S. general population ( 011).
As part of the Problem Formulation, EPA identified potentially exposed and susceptible subpopulations
for further analysis during the development and refinement of the life cycle, conceptual models,
exposure scenarios, and analysis plan. In this section, EPA addresses the potentially exposed or
susceptible subpopulations identified as relevant based on greater exposure. EPA will address the
subpopulations identified as relevant based on greater susceptibility in the hazard section.
EPA identifies the following as potentially exposed or susceptible subpopulations that EPA expects to
consider in the risk evaluation due to their greater exposure:
• Workers and occupational non-users.
• Consumers and bystanders associated with consumer use. 1-BP has been identified in products
available to consumers; however, only some individuals within the general population may use
these products. Therefore, those who do use these products are a potentially exposed or
susceptible subpopulation due to greater exposure.
• Other groups of individuals within the general population who may experience greater exposures
due to their proximity to conditions of use identified in Section 2.2 that result in releases to the
environment and subsequent exposures (e.g., individuals who live or work near manufacturing,
processing, use or disposal sites).
In developing exposure scenarios, EPA will analyze available data to ascertain whether some human
receptor groups may be exposed via exposure pathways that may be distinct to a particular
subpopulation or lifestage and whether some human receptor groups may have higher exposure via
identified pathways of exposure due to unique characteristics (e.g., activities, duration or location of
exposure) when compared with the general population (U.S. EPA. 2006a).
In summary, in the risk evaluation for 1-BP, EPA plans to analyze the following potentially exposed
groups of human receptors: workers, occupational non-users, consumers, bystanders associated with
consumer use, and other groups of individuals within the general population who may experience
greater exposure. EPA may also identify additional potentially exposed or susceptible subpopulations
that will be considered based on greater exposure.
2.4 Hazards (Effects)
For scoping, EPA conducted comprehensive searches for data on hazards of 1-BP, as described in
Strategy for Conducting Literature Searches for 1-Bromopropane: Supplemental File for the TSCA
Scope Document, (EPA-HQ-OPPT-2016-0741 -0048). Based on initial screening, EPA plans to analyze
the hazards of 1-BP identified in the scope document (EPA-HQ-OPPT-2016-0741 -0049). However,
when conducting the risk evaluation, the relevance of each hazard within the context of a specific
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exposure scenario will be judged for appropriateness. For example, hazards that occur as a result of
chronic exposures may not be applicable for acute exposure scenarios. This means that it is unlikely that
every identified hazard will be analyzed for every exposure scenario.
2.4.1 Environmental Hazards
Environmental hazard data identified for 1-BP are studies described in the robust summaries in the
ECHA Database (ECHA, 2015) and the Ecological Hazard Literature Search Results in the 1-
Bromopropane (CASRN 106-94-5) Bibliography: Supplemental File for the TSCA Scope Document,
0 .1 Only the on-topic references listed in the Ecological Hazard Literature Search
Results were considered as potentially relevant data/information sources for the risk evaluation.
Inclusion criteria were used to screen the results of the ECOTOX literature search (as explained in the
Strategy for Conducting Literature Searches for 1-Bromopropane: Supplemental File for the TSCA
Scope Document, (EPA-HQ-OPPT-2016-0741 -0048). Data from the screened literature are summarized
below (Table 2-7). EPA expects to review these data/information sources during risk evaluation using
the data quality review evaluation metrics and the rating criteria described in the Application of
Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2.018).
Toxicity to Sediment and Terrestrial Organisms
During data screening, there were no available sediment, soil, nor avian toxicity studies found in the
scientific literature for 1-BP. The toxicity of 1-BP is expected to be low based on the lack of on-topic
environmental hazard data for 1-BP to sediment and terrestrial organisms in the published literature and
the physical/chemical/fate properties (relatively high volatility (Henry's Law constant of 7.3X10"3 atm-
m3/mole), high water solubility (2.4 g/L), and low log Koc (1.6) suggesting that 1-BP will only be
present at low concentrations in these environmental compartments.
Toxicity to Aquatic Organisms
During problem formulation, EPA identified aquatic (aqueous-only) data reported in the literature to
assess the aquatic hazard of 1-BP. The 96-hour LCso value for 1-BP with fish ranged from 24.3 to 67.3
mg/L. The acute aquatic invertebrate EC so for 1-BP was 99.3 mg/L. The EC so for the algae toxicity test
was 52.4 mg/L (biomass) and 72.3 mg/L (growth rate). The NOEC for the algae toxicity test was 12.4
mg/L.
Toxicity to Microorganisms
The ECso and NOEC for micro-organisms toxicity study for a 5-minute time period was 270 mg/L and
100 mg/L, respectively.
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Table 2-7. Ecological Hazard Characterization of 1-Bromopropane
Duration
ksl organism
1 indpoinl
1 ki/aal
MlllIC*
I nils
FlVecl FiKlpoini
( ilalion
Acute
Fish
LC50
24.3 -67.3
mg/L
Mortality
ECHA (2015):Geieer et
al. (1988)
Aquatic
invertebrates
EC50
99.3
mg/L
Immobilization
ECHA (2015)
Algae
EC50
52.4/72.3
mg/L
Biomass /
growth rate
ECHA (2015)
Microorganism
EC50
270
mg/L
Respiration
ECHA (2015)
Acute COC
4.86
mg/L
Chronic
Fish
ChV
2.43
mg/L
Acute to chronic
ratio of 10
ECHA (20.1.5)
Aquatic
invertebrates
ChV
9.93
mg/L
Acute to chronic
ratio of 10
ECHA (20.1.5)
Algae
NOEC
12.4
mg/L
Growth rate
'WAmm
Microorganism
NOEC
100
mg/L
Respiration
ECHA (20.1.5)
Chronic COC
0.24
mg/L
Values in the tables are presented as reported by t
le study authors
Concentrations of Concern
The screening-level acute and chronic concentrations of concern (COCs) for 1-BP were derived based
on the lowest or most toxic ecological toxicity values (e.g., L/EC50). The information below describes
how the acute and chronic COC's were calculated for environmental toxicity of 1-BP using assessment
factors. The application of assessment factors is based on established EPA/OPPT methods (U.S. EPA.
2.013b. 2012c) and were used in this Problem Formulation to calculate lower bound effect levels
(referred to as the concentration of concern; COC) that would likely encompass more sensitive species
not specifically represented by the available experimental data. Also, assessment factors are included in
the COC calculation to account for differences in inter- and intra-species variability, as well as
laboratory-to-field variability. It should be noted that these assessment factors are dependent upon the
availability of datasets that can be used to characterize relative sensitivities across multiple species
within a given taxa or species group, but are often standardized in risk evaluations conducted under
TSCA, due to limited data availability.
The acute COC is derived by dividing the fish 96-hr LC50 of 24.3 mg/L (the lowest acute value in the
dataset) by an assessment factor (AF) of 5:
• Lowest value for the 96-hr fish LC50 (24.3 mg/L) / AF of 5 = 4.86 mg/L or 4,860 |ig/L.
The acute COC of 4,860 |ig/L, derived from experimental fish endpoint, is used as a conservative hazard
level in this problem formulation for 1-BP.
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Since there are no long-term chronic studies for 1-BP, the fish 96-hr LC50 of 24.3 mg/L (the lowest acute
value in the dataset) is divided by an acute-to-chronic ratio (ACR) of 10 to obtain a chronic value (ChV)
for fish. The fish ChV is then divided by an assessment factor of 10 to obtain a chronic COC:
• Lowest value for the fish 96-hr LC50 (24.3 mg/L) / 10 (ACR) / AF of 10 = 0.243 mg/L or 243
Hg/L-
The chronic COC of 243 |ig/L, derived from experimental fish endpoint, is used as the lower bound
hazard level in this problem formulation for 1-BP.
The derived acute COC (4,860 ppb) and chronic COC (243 ppb) are based on environmental toxicity
endpoint values (e.g., LC50) from ECHA. Full study reports associated with these COCs were not
available and will not be available in the future. In addition, the data represent the lowest bound of all 1-
BP data available, so it represents the most conservative hazard value.
2.4.2 Human Health Hazards
1-BP does not have an existing EPA IRIS Assessment; however, EPA has previously reviewed
data/information on health effects endpoints, identified hazards and conducted dose-response analysis in
the 2/ 1 * Haft Risk Assessment 0 v " * 2016b); these hazard identification and dose-response
analyses on 1-BP have been recently peer reviewed (EPA-HQ-QPPT-2015-0805-0028). EPA expects to
use these previous analyses as a starting point for identifying key and supporting studies to inform the
human health hazard assessment, including dose-response analyses. The relevant studies will be
evaluated using the data quality criteria in the Application of Systematic Review in TSCA Risk
Evaluations (U.S. EPA. 2018). In addition, EPA intends to review studies published after the 2016 Draft
Risk Assessment (1 2016b) [see (1-Bromopropane (CASRN106-94-5) Bibliography:
Supplemental File for the TSCA Scope Document EP A-HQ-OPPT~2€ 0471, using the
approaches and/or methods described in the Application of Systematic Review in TSCA Risk Evaluations
( 2018) to ensure that EPA is considering information that has been made available since the
2 aft Risk Assessment (U.S. EPA. 2016b) was conducted. Based on reasonably available
information, the following sections describe the hazards EPA expects to further analyze.
2.4.2.1 Non-Cancer Hazards
For the 2 ~aft Risk Assessment (U.S. EPA, 2016b) on 1-BP, EPA evaluated studies for the
following non-cancer hazards: acute toxicity (acute lethality at high concentrations only), blood toxicity,
immunotoxicity, cardiovascular toxicity, liver toxicity, kidney toxicity, reproductive toxicity,
developmental toxicity, and neurotoxicity. A comprehensive summary of all endpoints considered can
be found in the, Risk Assessment. Five health hazards were used for quantitative risk
characterization and will be evaluated using our systematic review approach. These hazards include:
Liver Toxicity
Reported effects include liver histopathology (e.g., hepatocellular vacuolation, swelling, degeneration
and necrosis), increased liver weight and clinical chemistry changes indicative of hepatotoxicity r2016
Draft Risk Assessment ( )16b)l.
Kidney Toxicity
Laboratory animal studies have provided evidence of kidney toxicity following 1-BP exposure.
Reported kidney effects include increased organ weight, histopathology (pelvic mineralization, tubular
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casts) and associated clinical chemistry changes (e.g., increased blood urea nitrogen) |"2016 Draft Risk
Assessment ( >)]. Other kidney endpoints include increased incidence of pelvic
mineralization in male and female rats from a subchronic duration inhalation study.
Reproductive/Developmental Toxicity
A two-generation reproduction study in rats reported a variety of adverse effects on male and female
reproductive parameters (U.S. EPA. 2016b; ' ^search. 2001). including significant increases in the
number of implantation sites, decreases in mating indices, increased estrous cycle length, increased
numbers of females with evidence of mating without delivery, decreased absolute prostate and
epidydimal weights, decreased sperm motility and decreased mating and fertility indices. These findings
are supported by similar reports of reproductive toxicity from other laboratory studies with rats and
mice, including spermatogenic effects (decreased sperm count, altered sperm morphology and decreased
sperm motility), organ weight changes in males (decreased epididymis, prostate and seminal vesicle
weights), estrous cycle alterations and decreased numbers of antral follicles in females.
Developmental effects of 1-BP exposure have been evaluated on the basis of standard prenatal
developmental toxicity studies, and a two-generation reproductive toxicity study in rats exposed via
inhalation. Evidence for 1-BP-induced developmental toxicity includes dose-related adverse effects on
live litter size, postnatal survival, pup body weight, brain weight and skeletal development.
Neurotoxicity
Data from studies in humans and animals demonstrate that the nervous system is a sensitive target of 1-
BP exposure. Both the central and peripheral nervous systems are affected. Most inhalation studies using
concentrations >1,000 ppm reported ataxia progressing to severely altered gait, hindlimb weakness to
loss of hindlimb control, convulsions and death |"2016 Draft Risk Assessment (U.S. EPA. 2016bVI. Other
effects include neuropathological changes such as peripheral nerve degeneration, myelin sheath
abnormalities and spinal cord axonal swelling. Brain pathology has also been reported in several studies,
including white and gray matter vacuolization, degeneration of Purkinje cells in the cerebellum and
decreased noradrenergic but not serotonergic axonal density in frontal cortex and amygdala. Decreased
brain weight has been reported in adult and developmental studies. In a two-generation study, decreased
brain weight in F1-generation males was reported.
Human studies (case-control studies, industrial surveys and case reports) corroborate that the nervous
system is a sensitive target of 1-BP exposure in humans. Clinical signs of neurotoxicity (including
headache, dizziness, weakness, numbness in lower extremities, ataxia, paresthesias and changes in
mood) and motor and sensory impairments were noted in the case reports of workers occupationally
exposed to 1-BP for 2 weeks to 3 years, and in industrial surveys ranging from 2 weeks to 9 years l"2016
Draft Risk Assessment (U.S. EPA. 2016bVI.
2.4.2.2 Mutagenicity/Genotoxicity and Cancer Hazards
There is some evidence for mutagenicity and deoxyribonucleic acid (DNA) binding associated with
exposure to 1-BP in vitro, but the results are not conclusive as to whether and to what extent such effects
may occur in mammals in vivo. In vitro mammalian cell assays showed increased mutation frequency,
and DNA damage was significantly increased in human leukocytes; however, tests conducted in vivo
were mostly negative, including assays for dominant lethal mutations and micronuclei induction. An
evaluation of leukocytes in workers exposed to 1-BP showed no definitive evidence of DNA damage.
Positive results have been observed in several genotoxicity tests using known or postulated metabolites
of 1-BP.
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The National Toxicology Program's (NTP) Report on Carcinogens (NTP. 2013) concludes 1 -BP is
"reasonably anticipated to be a human carcinogen. In the "„0j c> jjs aft Risk Assessment (\ ^ < J \
2016b) on 1-BP, EPA evaluated cancer hazards from studies in laboratory animals and humans
following chronic [>10% of a lifetime (U.S. EPA, 2.011)1 inhalation exposures. Repeated exposures
(e.g., >5 consecutive days) are anticipated during chronic exposure. 1-BP has been shown to be a multi-
target carcinogen in rats and mice. The exact mechanism/mode of action of 1-BP carcinogenesis is not
clearly understood, however, the weight-of-evidence analysis for the cancer endpoint is inconclusive but
does not rule out a probable mutagenic mode of action for 1-BP carcinogenesis. In the 2 aft Risk
Assessment (U.S. EPA. 2016b). EPA derived an inhalation unit risk (IUR) based on lung tumors in
female mice. This health hazard was used for quantitative risk characterization and will be evaluated
using our systematic review approach.
2.4.2.3 Potentially Exposed or Susceptible Subpopulations
TSCA requires that the determination of whether a chemical substance presents an unreasonable risk
include consideration of unreasonable risk to "a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation" by EPA. TSCA § 3(12) states that "the term 'potentially
exposed or susceptible subpopulation' means a group of individuals within the general population
identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at
greater risk than the general population of adverse health effects from exposure to a chemical substance
or mixture, such as infants, children, pregnant women, workers, or the elderly." In developing the hazard
assessment, EPA will evaluate available data to ascertain whether some human receptor groups may
have greater susceptibility than the general population to the chemical's hazard(s).
2.5 Conceptual Models
EPA risk assessment guidance ( b, 1998). defines Problem Formulation as the part of the
risk assessment framework that identifies the major factors to be considered in the assessment. It draws
from the regulatory, decision-making and policy context of the assessment and informs the assessment's
technical approach.
A conceptual model describes the actual or predicted relationships between the chemical substance and
receptors, either human or environmental. These conceptual models are integrated depictions of the
conditions of use, exposures (pathways and routes), hazards and receptors. The initial conceptual models
describing the scope of the assessment for 1-BP (Scope Document, EPA-HQ-OPPT- 49).
which was published in June 2017, have been refined during problem formulation. The changes to the
conceptual models in this Problem Formulation are described along with the rationales.
In this section, EPA outlines those pathways that will and will not be further analyzed in the TSCA risk
evaluation and the underlying rationale for these decisions.
EPA determined as part of problem formulation that it is not necessary to conduct further analysis on
certain exposure pathways that were identified in the 1-BP scope document and that remain in the risk
evaluation. Each risk evaluation will be "fit-for-purpose," meaning not all conditions of use will warrant
the same level of evaluation and the Agency may be able to reach some conclusions without extensive
or quantitative risk evaluations. 82 FR 33726, 33734, 33739 (July 20, 2017).
As part of this problem formulation, EPA also identified exposure pathways under regulatory programs
of other environmental statutes, administered by EPA, which adequately assess and effectively manage
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exposures and for which long-standing regulatory and analytical processes already exist, i.e., the Safe
Drinking Water Act (SDWA), the Clean Water Act (CWA) and the Resource Conservation and
Recovery Act (RCRA). EPA worked closely with the offices within EPA that administer and implement
the regulatory programs under these statutes. In some cases, EPA has determined that chemicals present
in various media pathways (i.e., water, land) fall under the jurisdiction of existing regulatory programs
and associated analytical processes carried out under other EPA-administered statutes and have been
assessed and effectively managed under those programs. EPA believes that the TSCA risk evaluation
should generally focus on those exposure pathways associated with TSCA conditions of use that are not
adequately assessed and effectively managed under the regulatory regimes discussed above because
these pathways are likely to represent the greatest areas of risk concern. As a result, EPA does not
expect to include in the risk evaluation certain exposure pathways identified in the 1-BP scope
document.
2.5.1 Conceptual Model for Industrial and Commercial Activities and Uses: Potential
Exposures and Hazards
The revised conceptual model (Figure 2-2) illustrates the expected exposure pathways to workers and
occupational non-users from industrial and commercial activities and uses of 1-BP that EPA expects to
include in the risk evaluation. For most activities and uses, EPA anticipates that workers and
occupational non-users may be exposed to 1-BP via inhalation and dermal routes, with inhalation of
vapor/mist being the most likely exposure route. In addition to the pathways illustrated in the figure,
EPA will evaluate activities resulting in exposures associated with distribution in commerce (e.g.
loading, unloading) throughout the various lifecycle stages and conditions of use (e.g. manufacturing,
processing, industrial use, commercial use, disposal) rather than a single distribution scenario.
As discussed in Section 2.2.2.1, EPA will not assess the commercial use of 1-BP in non-pesticidal
agricultural products during risk evaluation. Based on information available to EPA, EPA determined
that 1-BP is not used in agricultural products (non-pesticidal), only in the processing of such products.
Inhalation
EPA expects to analyze inhalation exposure to workers during manufacturing, processing, use and
disposal of 1-BP for all uses identified in the scope (except use in non-pesticidal agricultural products).
The analysis will include worker exposure to vapor from open sources, and exposure to mist during
activities and uses where mist generation is expected (e.g. spray application of 1-BP).
Where inhalation exposure is expected, EPA will also analyze inhalation exposure to vapor and mists for
occupational non-users.
Dermal
For most industrial and commercial activities, EPA does not plan to further analyze dermal contact with
liquid because 1-BP readily evaporates from the skin. Based on the vapor generation rate of 1-BP at
ambient conditions as calculated using the EPA/OPPT Penetration Model, the contact time with skin is
expected to be less than 2 minutes. Further, the fraction absorbed was measured to be small (0.16%) by
bpcriteriadocument 03 ected.pdfi. This exposure pathway and route will not be further
analyzed for manufacturing, processing, and several uses, e.g. insulation materials, asphalt extraction,
temperature indicator.
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Certain conditions of use, such as maintenance of industrial degreasing tanks or commercial dry
cleaning machines, can present a potential for occluded exposure (e.g. where 1-BP is trapped within a
worker's gloves) or repeated dermal contacts. EPA plans to further analyze exposures to a subset of
workers where occluded/repeated contact or immersion exposure are likely.
Occupational non-users are not directly handling 1-BP; therefore, skin contact with liquid 1-BP is not
expected for occupational non-users and EPA does not expect to further analyze this pathway in the risk
evaluation.
Businesses Co-located with Dry Cleaners
For businesses co-located with dry cleaners, inhalation is expected to be the primary route of exposure.
EPA does not plan to further analyze dermal and oral exposure to indoor vapor for co-located
businesses. The potential for incidental ingestion of vapor is expected to be low, since 1-BP is absorbed
quickly in the lung and does not have appreciable ability to travel up the mucosal elevator to be
swallowed.
Waste Handling, Treatment and Disposal
Figure 2-2 shows that waste handling, treatment and disposal is expected to lead to the same pathways
as other industrial and commercial activities and uses. The path leading from the "Waste Handling,
Treatment and Disposal" box to the "Hazards Potentially Associated with Acute and/or Chronic
Exposures See Section 2.4.2" box was re-routed to accurately reflect the expected exposure pathways,
routes, and receptors associated with these conditions of use of 1-BP.
For each condition of use identified in Table 2-3, a determination was made as to whether or not each
unique combination of exposure pathway, route, and receptor will be further analyzed in the risk
evaluation. The results of that analysis along with the supporting rationale are presented in Appendix D.
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INDUSTRIAL AND COMMERCIAL EXPOSURE PATHWAY EXPOSURE ROUTE RECEPTORS' HAZARDS
ACTIVITIES / USES
Manufacturing
PvoMWl^e:
~ A* ftneuait
+ IneMpwsttd lute
or prcxdMset
+ lr«:i>ipp?*l*r$ irla
trtad*
+ R«p*ek*gil*f
ftaVdiltf
Solvtflt* for Cl#*nirtt
«i*d 0*er**»ir«f
Adhcs.ves
and Sealants
Or# Pr&cWti
Other Uses*
"C
W**t« Hardline
Treatment *niJ CKlp^wl
Liquid
Vapor/ Mist
Ojcdf-por Air
$5ee r1*
I nha Jt or
Dermd, Oril
W€i#?*d -with
Acute nrd/ar Chren<
KEY:
i: •*> Te» i: Uses or Heoeuftxs that wsi not it>e
fiirt he* ar^tyzed
—* Pathways tfiat wffl be fiirt he* arafyzed
- "* Pathways that waix»tfoe father analyzed
Figure 2-2.1-BP Conceptual Model for Industrial and Commercial Activities and Uses: Potential Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human receptors from industrial and commercial activities and uses
of 1-BP.
aSome products are used in both commercial and consumer applications. Additional uses of 1-BP are included in Table 2-3.
b Exposure may occur through mists that deposit in the upper respiratory tract, however based on physical chemical properties, mists of 1-BP will likely be rapidly absorbed in the respiratory
tract or evaporate and will be considered as an inhalation exposure.
cReceptors include potentially exposed or susceptible subpopulations.
d When data and information are available to support the analysis, EPA also considers the effect that engineering controls and/or personal protective equipment have on occupational
exposure levels.
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2.5.2 Conceptual Model for Consumer Activities and Uses: Potential Exposures and Hazards
The revised conceptual model (Figure 2-3) illustrates the expected exposure pathways to human
receptors from consumer uses of 1-BP that EPA expects to include in the risk evaluation. EPA expects
that the primary route of exposure for consumers will be via inhalation. There may also be dermal
exposure from skin contact with liquids in occluded scenarios, such as the use of a rag that has been
soaked in a product containing 1-BP. For bystanders, the primary route of exposure is expected to be
inhalation. Oral exposure from mists that deposit in the upper respiratory tract and are swallowed or
from incidental ingestion of 1-BP residue on hand/body is not expected to be a significant route of
exposure given the physical-chemical properties of 1-BP. It should be noted that some consumers may
purchase and use products primarily intended for commercial use.
EPA has reviewed the uses described in the IV1 • > 'raft Risk Assessmt >» f v V ^ >__<'.¦) including
aerosol spray degreaser/cleaners, use in adhesives and spot cleaners and has concluded that there is no
consumer use of 1-BP for engine degreasers, brake cleaning, or aerosol spray adhesives (except as an
adhesive accelerant in arts and crafts applications). EPA intends to continue to evaluate the uses
identified in the 2016 Draft Risk Assessment (U.S. EPA. 2016b) as aerosol spray degreaser/cleaner and
spot cleaners. EPA will further evaluate additional uses identified in problem formulation including:
stain remover, adhesive accelerant, automotive care products, anti-adhesive agents, liquid cleaners, and
building and construction materials.
Inhalation
Based on the physical-chemical properties of 1-BP and the conditions of use, inhalation exposures to 1-
BP in the vapor phase from use of consumer products is expected and will be further analyzed for
consumers and bystanders. This is expected to be the primary route of exposure.
Oral
EPA does not expect to further analyze exposure to consumers via ingestion of 1-BP. Ingestion is not
expected to be a primary route of exposure. Based on the vapor pressure, 1-BP is likely to exist as a
vapor during use. A fraction of 1-BP may be available for absorption in the respiratory tract however
ingestion of 1-BP is anticipated to be low since 1-BP is expected to be absorbed in the lung quickly and
not have appreciable ability to travel up the mucosal elevator and be swallowed.
Dermal
Based on the physical-chemical properties and high evaporative losses compared to dermal absorption
as described in Section 2.3.5.2, non-occluded dermal exposures are not expected to be the primary route
of exposure for consumers, although dermal exposures will contribute to the overall exposure. Some
products may be purchased and used as a liquid. For these uses, consumers may have dermal contact
from occluded exposures such as holding a rag soaked in liquid 1-BP where limited evaporation rates
and penetration may be expected to be higher in these scenarios. EPA does not expect to further analyze
dermal exposure to 1-BP vapor, however EPA does expect to further analyze direct dermal contact with
liquid 1-BP for consumers during the risk evaluation phase.
Whereas users may be exposed dermally during use of consumer products, particularly in occluded
scenarios, bystanders would generally not be expected to be dermally exposed to 1-BP in occluded or
non-occluded scenarios, therefore dermal exposure to bystanders will not be further analyzed.
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Disposal
EPA does not expect to further analyze exposure to consumers from disposal of consumer products. It is
anticipated that most products will be disposed of in original containers, particularly those products that
are purchased as aerosol cans. Liquid products may be recaptured in an alternate container following use
(e.g., refrigerant flush or coin cleaning).
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CONSUMER ACTIVITIES /USES
EXPOSURE PATHWAY
EXPOSURE ROUTE
RECEPTORS
HAZARDS
Cleaning and Furniture Care
Products
e,gv engine degreasing.
Spot cleaner, stain remover, liquid
cleaner, liquid spray/aerosol
cleaner
Solvents (for cleaning or
degr easing)
e.gv aerosol spray
degreaser/cleaner
Other Uses
e,gv adhesive accelerant,
refrigerant flush, mold cleaning and
release product
Other Uses
e.g. cold cleaner, asphalt extraction,
laboratory c hem ica Is, temperature
indicator coatings.
^ Liquid Contact
a ~ Vapor/Mist
Consumers
>-
Hazards Potentially Associated with
Acute and/or Chronic Exposures
Inhalation
Bystanders
—
Other Uses
e.g., insulation
Consumer Handling and
Disposal of Waste
Vapor, Liquid Contact
Dermal , Oral ,
Consumers,
Inhalation
Bystanders
Wastewater, Liquid Wastes and Solid Wastes
(See Figure 2-4)
Gray Text: Use, Route, or Receptor that will not
be further analyzed
» Pathwaysthat will be further analyzed
— Pathwaysthat will not be further analyzed
Figure 2-3.1-BP Conceptual Model for Consumer Activities and Uses: Potential Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human receptors from consumer activities and uses of 1-BP.
aSome products are used in both commercial and consumer applications. Additional uses of 1-BP are included in Table 2-3.
b Dermal exposure may occur through skin contact with liquids; ingestion is anticipated to be low since 1-BP is expected to be absorbed in the lung quickly and not have
appreciable ability to travel up the mucosal elevator and be swallowed.
°Receptors include potentially exposed or susceptible subpopulations.
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2.5.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards
The revised conceptual model (Figure 2-4) illustrates the expected exposure pathways to ecological
receptors from environmental releases and waste streams associated with industrial and commercial
activities for 1-BP that EPA expects to include in the risk evaluation. The pathways that EPA expects to
include and analyze further in the risk evaluation is described in Section 2.5.3.1 and shown in the
conceptual model. The pathways that EPA expects to include but not further analyze in risk evaluation
are described in Section 2.5.3.2 and the pathways that EPA does not expect to include in risk evaluation
are described in Section 2.5.3.3.
2.5.3.1 Pathways That EPA Expects to Include and Further Analyze in the Risk Evaluation
Air Pathways
EPA expects to further analyze air emissions resulting in the general population. Emissions to air from
industrial manufacturing, processing and use are expected. Based on the relatively long hydroxy radical
oxidation half-life (ty2 = 14 days) emissions to ambient air could travel far enough from the release point
to reach both near facility human receptors and the general population. Inhalation is expected to be the
primary route of exposure for the general population and near facility populations.
During problem formulation, EPA reviewed TRI data for on-site releases to air from fugitive and point
sources; these data will be used in EPA's release analysis during risk evaluation. The data also includes
any air release resulting from on-site waste treatment and energy recovery.
For off-site transfer of wastes, EPA will further analyze the Destruction Removal Efficiencies (DRE's)
occurring from incineration/energy recovery processes at off-site facilities, as well as the resulting air
emissions. It is possible that some of these air emissions are already accounted for in the TRI data (in the
on-site releases) if the off-site facility is also a TRI reporter (e.g. a TSDF facility).
These pathways include:
• The general populations living near industrial and commercial facilities using 1-BP that are
exposed via inhalation of outdoor air.
• The populations co-located with dry cleaners are expected to be exposed to 1-BP via the
inhalation route (recommended for assessment in peer review).
• Releases from Manufacturing, Processing, Use, Recycling to Air: land disposal, non-hazardous
waste incineration and emissions to air can be expected. In the atmosphere, 1-BP is expected to
occur primarily in the vapor phase and may undergo long-range transport. The 2016 TRI data
reported onsite recycling and transfers to offsite for recycling.
• Releases to Air from Disposal and Recycling: TRI reports a total of 115,222 pounds of off-site
releases after transfer (90,273 pounds of transfers to other landfills for disposal (3 facilities),
20,892 pounds of unknown transfers for disposal (6 facilities), 3307 pounds of transfer for
disposal to a storage only facility, and 750 pounds of transfer for disposal to a waste broker.
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2.5.3.2 Pathways That EPA Expects to Include in the Risk Evaluation But Not Further
Analyze
Air Pathways
EPA will not further analyze inhalation exposures for ecological terrestrial species in this risk evaluation
due to the physical/chemical properties associated with 1-BP (high vapor pressure; see Section 2.1) and
the low expected toxicity (see Section 2.4.1), and since their inhalation exposures are expected to be
short and/or of sporadic frequency due to their mobile behavior.
Water Pathways
As described in Section 2.3.5.3, there is no data of 1-BP found in US drinking water. Recent TRI
reporting indicated 0 pounds released to POTWs and 5 pounds released directly to water in 2016. In
addition, 1-BP is slightly soluble in water and its rapid volatilization from water are expected to mitigate
exposure potential from drinking water supplied from public water systems. Therefore, EPA does not
plan to further analyze drinking water pathways in the risk evaluation for 1-BP under TSCA.
EPA does not expect to further analyze releases to wastewater or surface water. As discussed in Section
2.1, 1-BP is volatile and has a relatively high Henry's law constant. 1-BP is somewhat biodegradable
and is not expected to sorb to solids in wastewater. EPA's STP WTP model predicts 73% removal of 1-
BP by volatilization in activated sludge treatment and 1% partitioning to biosolids. 1-BP discharged in
wastewater treatment plant effluent to the aquatic environment would be subject to volatilization and
biodegradation thereby reducing aquatic exposure. Although 1-BP is not a priority pollutant, EPA
pretreatment regulations for industrial users discharging wastewater to POTWs for treatment prohibit the
discharge of flammable substances and substances that could generate toxic vapors to POTWs. These
restrictions are expected to limit the discharge of 1-BP to POTWs and ultimately to surface water.
Recent TRI reporting indicated 0 pounds released to POTWs and 5 pounds released directly to water in
2016 further indicating that general population and environmental exposure via direct releases to surface
waters or releases of 1-BP by POTWs is not a pathway for further exposure analysis.
In addition, EPA does not expect to further analyze hazard to aquatic organisms exposed to 1-BP in
surface water. Based on 1-BP surface water concentrations estimated using TRI 2016 releases to water,
EFAST modeling and the acute fish toxicity EC so value 24.3 mg/L, the concentration of concern is not
expected to be exceeded. For three different conservative scenarios (1, 20, and 100 days per year), the
screening-level surface water concentrations were well below levels of concern for aquatic species. In
addition, 1-BP is expected to be volatile from surface water based on the estimated Henry's Law
Constant, mitigating exposure to aquatic life. Thus, EPA does not expect to further analyze ecological
aquatic species in the risk evaluation. This conclusion is supported by the ecological risk classification
derived for 1-BP by Environment and Climate Change Canada which identified a low ecological hazard
and exposure for 1-BP (https://www.ec.gc.ca/ese-ees/A96E2E98-2A04-40C8-9EDC-
08 A6DFF23 5F7/CMP3 %20ERC EN.pdf). (ECi l .AM *)
Biosolids, Sediment and Soil Pathways
EPA does not expect to further analyze releases to biosolids, sediment or soils. Based on the log Koc of
1.6, 1-BP is not expected to adsorb strongly to sediment or soil. If present in biosolids, 1-BP would be
expected to associate with the aqueous component and volatilize to air as the biosolids are applied to soil
and allowed to dry. Due to its water solubility and low sorption, some 1-BP associated with land applied
sludge could migrate with water towards groundwater, however, volatilization and biodegradation may
attenuate migration. Therefore, based on the characteristics of environmental fate and industrial release
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information, exposure to the general population and aquatic biota via surface water, drinking water, and
sediment is expected to be low. In addition, EPA does not plan to further analyze hazard to aquatic
organisms exposed to 1-BP in sediment or soil environments. Based on the log Koc of 1.6 and high water
solubility (2.45 g/L), 1-BP is not expected to significantly partition to sediments or soils. Given low
releases to water and low concentrations in the water column, low concentrations in sediments would
also be expected. 1-BP released to soil is not expected to be a viable pathway of exposure for terrestrial
species as 1-BP released to surface soil is expected to volatilize rapidly due to high vapor pressure (146
mmHg at 25 °C). Thus, EPA does not expect to further analyze sediment and soil ecological species in
the risk evaluation.
2.5.3.3 Pathways That EPA Does Not Expect to Include in the Risk Evaluation
Exposures to receptors (i.e., general population, terrestrial species) may occur from industrial and/or
commercial uses; industrial releases to air, water or land; and other conditions of use. As described in
Section 2.5, EPA does not expect to include in the risk evaluation pathways under programs of other
environmental statutes, administered by EPA, which adequately assess and effectively manage
exposures and for which long-standing regulatory and analytical processes already exist. These
pathways are described below.
Disposal Pathways
1-BP is regulated as a hazardous waste, waste code D001 (ignitable liquids, 40CFR 261.21). The general
RCRA standard in section 3004(a) for the technical (regulatory) criteria that govern the management
(treatment, storage, and disposal) of hazardous waste (i.e., Subtitle C) are those "necessary to protect
human health and the environment," RCRA 3004(a). The regulatory criteria for identifying
"characteristic" hazardous wastes and for "listing" a waste as hazardous also relate solely to the
potential risks to human health or the environment. 40 C.F.R. §§ 261.11, 261.21-261.24. RCRA
statutory criteria for identifying hazardous wastes require EPA to "tak[e] 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." Subtitle C controls cover not
only hazardous wastes that are landfilled, but also hazardous wastes that are incinerated (subject to joint
control under RCRA Subtitle C and the Clean Air Act (CAA) hazardous waste combustion MACT) or
injected into UIC Class I hazardous waste wells (subject to joint control under Subtitle C and the Safe
Drinking Water Act (SDWA)).
Emissions from hazardous waste incinerators will not be included in the risk evaluation. 40 CFR
264.345 specifies performance standards for hazardous waste incinerators. An incinerator burning
hazardous waste must achieve a destruction and removal efficiency (DRE) of 99.99% for each principal
organic hazardous constituent. Furthermore, RCRA provisions for site-specific risk assessments and the
Hazardous Waste Combustor maximum achievable control technology (MACT) rule provisions for a
Residual Risk and Technology Review together cover risks for RCRA hazardous wastes and CAA
HAPs. Air emissions from municipal and industrial waste incineration and energy recovery units are
regulated under the Clean Air Act. Incineration treatment of 1-BP would be subject to these regulations,
as would 1-BP burned for energy recovery.
EPA does not expect to include on-site releases to land that go to underground injection in its risk
evaluation. TRI reporting in 2016 only indicated 10 pounds released to underground injection to a Class
I well and no releases to underground injection wells of Classes II-VI. Environmental disposal of 1-BP
injected into Class I well types is managed and prevented from further environmental release by RCRA
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and SDWA regulations. Therefore, disposal of 1-BP via underground injection is not likely to result in
environmental and general population exposures.
EPA does not expect to include on-site releases to land that go to RCRA Subtitle C hazardous waste
landfills in its risk evaluation. Based on 2016 reporting to TRI, there were 57,617 pounds of 1-BP
disposal to an on-site RCRA Subtitle C landfill. Design standards for Subtitle C landfills require double
liner, double leachate collection and removal systems, leak detection system, run on, runoff, and wind
dispersal controls, and a construction quality assurance program. They are also subject to closure and
post-closure care requirements including installing and maintaining a final cover, continuing operation
of the leachate collection and removal system until leachate is no longer detected, maintaining and
monitoring the leak detection and groundwater monitoring system. Bulk liquids may not be disposed in
Subtitle C landfills. Subtitle C landfill operators are required to implement an analysis and testing
program to ensure adequate knowledge of waste being managed, and to train personnel on routine and
emergency operations at the facility. Hazardous waste being disposed in Subtitle C landfills must also
meet RCRA waste treatment standards before disposal. Given these controls, general population
exposure to 1-BP in groundwater from Subtitle C landfill leachate is not expected to be a significant
pathway.
EPA does not expect to include on-site releases to land from RCRA Subtitle D municipal solid waste
landfills (MSWLFs) or exposures of the general population (including susceptible populations) or
terrestrial species from such releases in the TSCA evaluation. While permitted and managed by the
individual states, municipal solid waste landfills (MSWLFs) are required by federal regulations to
implement many of the same requirements as Subtitle C landfills. MSWLFs must have a liner system
with leachate collection and conduct groundwater monitoring and corrective action when releases are
detected. MSWLFs are also subject to closure and post-closure care requirements, as well as providing
financial assurance for funding of any needed corrective actions. MSWLFs have also been designed to
allow for the small amounts of hazardous waste generated by households and very small quantity waste
generators (less than 100 kg per month). Bulk liquids, such as free solvent, may not be disposed of at
MSWLFs.
EPA does not expect to include on-site releases to land from industrial non-hazardous and
construction/demolition waste landfills. Industrial non-hazardous and construction/demolition waste
landfills are primarily regulated under state regulatory programs. States must also implement limited
federal regulatory requirements for siting, groundwater monitoring, and corrective action, and a
prohibition on open dumping and disposal of bulk liquids. States may also establish additional
requirement such as for liners, post-closure and financial assurance, but are not required to do so.
Therefore, EPA does not expect to include this pathway in the risk evaluation.
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RELEASES AND WASTES FROM
INDUSTRIAL / COMMERCIAL / CONSUMER USES
EXPOSURE PATHWAY
EXPOSURE ROUTE
RECEPTORS1
HAZARDS
r~ ~
Wastewater or
Uiiuid Wastes"
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- - *
ir'tduatrial Prt-
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IfldwRflilWWT
I
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4i
-------
2.6 Analysis Plan
The analysis plan presented in the Problem Formulation elaborates on the initial analysis plan that was
published in the Scope of the Risk Evaluation for 1-BP (Scope Document, EPA-HQ-QP
0049).
The analysis plan is based on the conditions of use of 1-BP, as described in Section 2.2 of this Problem
Formulation. EPA is implementing systematic review approaches and/or methods to identify, select,
assess, integrate and summarize the findings of studies supporting the TSCA risk evaluation. The
analytical approaches and considerations in the analysis plan are used to frame the scope of the
systematic review activities for this assessment. The supplemental document, Application of Systematic
Review in TSCA Risk Evaluations (U.S. EPA. 2018). provides additional information about criteria and
methods that have been and will be applied to the first 10 chemical risk evaluations.
While EPA has conducted a comprehensive search for reasonably available data as described in the
Scope of the Risk Evaluation for 1-BP (Scope Document, EPA~H.Q~Q?? 1' _:01 - y. i l_ 00 P), EPA
encourages submission of additional existing data, such as full study reports or workplace monitoring
from industry sources, that may be relevant for refining conditions of use, exposures, hazards and
potentially exposed or susceptible subpopulations during the risk evaluation. EPA will continue to
consider new information submitted by the public.
During the risk evaluation, EPA will rely on the search results \l-Bromopropane (CASRN106-94-5)
Bibliography: Supplemental File for the TSCA Scope Document EPA-HQ-QPPT-2016-0741 0047)1, or
perform supplemental searches to address specific questions. Further, EPA may consider any relevant
confidential business information (CBI) in the risk evaluation in a manner that protects the
confidentiality of the information from public disclosure. The analysis plan is based on EPA's
knowledge of 1-BP to date, which includes partial, but not complete review of identified literature. If
additional data or approaches become available, EPA may refine its analysis plan based on this
information.
2.6.1 Exposure
Based on their physical-chemical properties, expected sources, and transport and transformation within
the outdoor and indoor environment chemical substances are more likely to be present in some media
and less likely to be present in others. Media-specific levels will vary based on the chemical substance
of interest. For most high-priority chemical substances level(s) can be characterized through a
combination of available monitoring data and modeling approaches.
2.6.1.1 Environmental Releases
EPA expects to analyze releases to environmental media as follows:
1) Review reasonably available published literature or information on processes and
activities associated with the conditions of use to evaluate the types of releases and
wastes generated.
EPA has reviewed some key data sources containing information on processes and activities
resulting in releases, and the information found is shown in Appendix B.l. EPA will continue to
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review potentially relevant data sources identified in Table Apx B-3 in Appendix B during risk
evaluation.
EPA plans to review the following key data sources in Table 2-8 for information on processes
and activities resulting in environmental releases. The evaluation strategy for engineering and
occupational data sources discussed in the Application of Systematic Review in TSCA Risk
Evaluations (U.S. EPA, 2018) describes how studies will be reviewed. EPA has also previously
compiled process information for several conditions of use in the _ : Risk Assessment
( 2016b).
Table 2-8. Potential Sources of Environmental Release Data
2017 ATSDR Toxicological Profile for 1 -BP: Toxicologic; le for 1-
C )
U.S. EPA TRI Data (Reporting Year 2016 only)
EPA AP-42 Air Emission Factors
CARB ISOR for Proposed ATCM
2) Review reasonably available chemical-specific release data, including measured or
estimated release data (e.g., data collected under the TRI and National Emissions
Inventory [NEI] programs).
EPA plans to review release data to inform releases associated with the applicable conditions of
use for 1-BP. For example, EPA's Toxics Release Inventory (TRI) data will be used to inform
the various subcategories, such as air releases, associated with the disposal life cycle stage.
According to TRI data for Reporting Year 2016, the majority of on-site releases of 1-BP were to
air (fugitive and stack), followed by land disposal. Only five pounds of 1-BP were discharged to
water. Of the off-site transfers, the majority went to incineration and land disposal. No off-site
transfer to wastewater treatment were reported.
Additionally, for conditions of use where no measured data on releases are available, EPA may
use a variety of methods including the application of default assumptions such as standard loss
fractions associated with drum cleaning (3%) or single process vessel cleanout (1%), or the use
of EPA Generic Scenarios and/or OECD Emission Scenario Documents to predict releases and
their corresponding media.
EPA Generic Scenarios are available at the following: https://www.epa.gov/tsca-screening-
tools/using-predictive-methods-assess-exposure-and-fate-under-tsca#fate.
OECD Emission Scenario Documents are available at the following:
)ecd.org/c
EPA will also review data sources containing estimated data and identify data gaps. The 2016
Draft Risk Assessment (U.S. EPA. 2016b) contains estimates of 1-BP emission rates for several
conditions of use, including dry cleaning, spot cleaning, vapor degreasing, cold cleaning, and
aerosol degreasing. EPA will use existing emission factors and emission rate data to estimate
environmental releases of 1-BP to air from these uses.
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3) Understand and consider regulatory limits that may inform estimation of
environmental releases.
Information from various EPA statutes (including, for example, regulatory limits, reporting
thresholds, or disposal requirements) may be used to assess releases. EPA may determine that a
condition of use is unlikely to result in release to a particular media based on existing chemical-
specific regulations even though an Emission Scenario or EPA Generic Scenario document
indicates a likely release to that same media.
While 1-BP is not a hazardous air pollutant (HAP) regulated under the Clean Air Act, some
related rules may provide relevant information on sectors using 1-BP. For example, the
NESHAP for Halogenated Solvent Cleaning (40 CFR Part 63, Subpart T) may provide useful
information on industry sectors that use solvents (including 1-BP) for degreasing applications.
EPA will further consider the applicability of EPA regulations to 1-BP during the development
of the risk evaluation.
4) Review and determine applicability of Organization for Economic Co-operation and
Development (OECD) Emission Scenario Documents (ESDs) and EPA Generic
Scenarios (GSs) to estimation of environmental releases.
EPA will analyze the conditions of use to determine which ESDs and GSs can be applied. For
example, EPA may use the ESD on Industrial Use of Industrial Cleaners, the ESD on Industrial
Use of Adhesives for Substrate Bonding, and the GS on Application of Agricultural Pesticides to
assess potential releases to all relevant media for some conditions of use, such as the uses of 1-
BP in cleaning and degreasing, adhesive, and agricultural products.
For other conditions of use, such as manufacture and import of 1-BP, use of 1-BP in insulation
material, use of cutting oils, and use of 1-BP in asphalt extraction, EPA may not be able to apply
generic release scenarios. In those cases, EPA may conduct industry outreach efforts, consult
process technology literature sources such as the Kirk-Othmer Encyclopedia of Chemical
Technology, or perform supplemental literature searches to better understand the process steps
involved in that condition of use before a release assessment can be made.
5) Map or group each condition(s) of use to a release assessment scenario.
EPA has identified release/occupational exposure scenarios and mapped them to relevant
conditions of use in Appendix D. As presented in the fourth column of the table in this appendix,
EPA has grouped the uses into 16 representative release/exposure scenarios that will be further
evaluated. EPA may further refine the mapping/grouping of these scenarios based on factors
(e.g., process equipment and handling, magnitude of production volume used, and
exposure/release sources) corresponding to conditions of use as additional information is
identified during risk evaluation.
6) Evaluate the weight of the evidence of environmental release data.
EPA will rely on the weight of the scientific evidence when evaluating and integrating
environmental release data. The data integration strategy will be designed to be fit-for-purpose in
which EPA will use systematic review methods to assemble the relevant data, evaluate the data
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for quality and relevance, including strengths and limitations, followed by synthesis and
integration of the evidence.
2.6.1.2 Environmental Fate
EPA expects to analyze fate and transport in environmental media as follows:
1) Review reasonably available measured or estimated environmental fate endpoint data
collected through the literature search.
A general overview of persistence and bioaccumulation was presented in the 2016 Draft Risk
Assessment (U.S. EPA, 2016b). Key environmental fate characteristics were included in the
Scope Document CEPA-HQ-OPPT-2016-0741 -0049) and in previous assessments of 1-BP,
including that conducted by the US Agency for Toxic Substances and Disease Registry (A [ SDK.
2017). These information sources will be used as a starting point for the environmental fate
assessment. Other sources that will be consulted include those that are identified through the
systematic review process. Studies will be evaluated using the evaluation strategies laid out in
the Application of Systematic Review in TSCA Risk Evaluations ( £018) document.
If measured values resulting from sufficiently high-quality studies are not available (to be
determined through the systematic review process), chemical properties will be estimated using
EPI Suite, SPARC, and other chemical parameter estimation models. Estimated fate properties
will be reviewed for applicability and quality.
2) Using measured environmental fate data and/or environmental fate modeling, determine
the influence of environmental fate endpoints (e.g., persistence, bioaccumulation,
partitioning, transport) on exposure pathways and routes of exposure to human receptors.
Measured fate data including volatility and atmospheric photolysis rates along with physical-
chemical properties and models, such as the EPI Suite™ Atmospheric Oxidation Program (which
estimates rates of atmospheric oxidation), will be used to characterize the persistence of 1-BP in
air and its impact on exposure.
3) Evaluate the weight of the evidence of environmental fate data.
EPA will rely on the weight of the scientific evidence when evaluating and integrating
environmental fate data. The data integration strategy will be designed to be fit-for-purpose in
which EPA will use systematic review methods to assemble the relevant data, evaluate the data
for quality and relevance, including strengths and limitations, followed by synthesis and
integration of the evidence.
2.6.1.3 Environmental Exposures
EPA does not plan to further analyze environmental exposures to 1-BP, based on the rationale described
in Section 2.3.4.
2.6.1.4 General Population
EPA expects to analyze general population exposures as follows:
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1) Review reasonably available environmental and biological monitoring data for media to
which general population exposures are expected. For exposure pathways where data
are not available, review existing exposure models that may be applicable in estimating
exposure levels.
For 1-BP, the media of interest are expected to be ambient air and indoor air. EPA will review
existing exposure models for applicability in estimating general population exposure levels
associated with ongoing industrial and/or commercial releases. EPA will review reasonably
available data that may be used in developing, adapting or applying exposure models. These data
may include data on 1-BP or analogous chemical substances. Exposure pathways which may be
modeled include air releases from point sources using air dispersion models.
Available exposure models will be evaluated and considered alongside available monitoring data
to characterize environmental exposures for ambient air. Modeling approaches to estimate
ambient air will generally consider the following inputs: release into air, fate and transport
(partitioning within media) and characteristics of the environment (e.g., meteorological
information). Some preliminary analysis may be performed to understand the impact of known
releases to the overall characterization of concentrations in the environment.
Available release data (e.g. TRI data) will be used in informing releases to the environment. As
data are available, EPA will estimate the air concentrations near point sources using release
estimates or reported data using air dispersion models (e.g., AERMOD, AERSCREEN)
incorporating what is known of incineration efficiencies (where applicable), fate and transport
properties, and physical chemical properties.
2) Consider and incorporate applicable media-specific regulations into exposure scenarios or
modeling.
1-BP is not listed on the TNSSS (Targeted National Sewage Sludge Survey), DMR (Discharge
Monitoring Report), or as one of the 189 Hazardous Air Pollutants (HAPs) under Section 112(b)
of the Clean Air Act. There are no specific EPA regulations regarding drinking water health
advisories, ambient water quality criteria, or effluent level guidelines.
1-BP is a listed substance subject to reporting requirements under the Emergency Planning and
Community Right-To-Know Act (EPCRA) - Section 313, and the TRI reporting information
will be utilized for analyzing exposures to the general population via releases from
manufacturing, processing and use of 1-BP. EPA may model air concentrations near facilities
using air dispersion modeling applications (e.g., AERMOD or AERSCREEN).
3) Review reasonably available data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation. For example, existing models developed
for a chemical assessment may be applicable to another chemical assessment if model
parameter data are available.
EPA will review reasonably available data that may be used in developing, adapting or applying
exposure models. These data may include modeled exposure estimates conducted by other
organizations for 1-BP or analogous chemical substances. Fate and transport information will be
used to inform calculations of human exposures via air. The concentrations in air will be used as
inputs into exposure models to estimate general population exposures. Sources of data may
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include TRI reporting for 1-BP. TRI data show air as a primary medium of environmental
release. These releases include both fugitive air emissions and point source air emissions.
4) Review reasonably available information on releases to determine how modeled estimates
of concentrations near industrial point sources compare with available monitoring data.
General population exposure pathways expected to be relatively higher include inhalation of
ambient air or inhalation in co-located buildings. EPA will review results of use specific and
background exposure scenarios and select output metric relevant for exposure assessment. The
metrics most likely to be relevant for 1-BP are Lifetime Average Daily Concentration (mg/m3)
and Average Daily Concentration (mg/m3) for inhalation routes of exposure, and Lifetime
Average Daily Dose (mg/kg/day) and Average Daily Dose (mg/kg/day) for dermal routes of
exposure. Results within and across scenarios will be compared. For example, modeled estimates
near industrial point sources can be compared with those based on available monitoring data.
5) Review reasonably available population- or subpopulation-specific exposure factors and
activity patterns to determine if potentially exposed or susceptible subpopulations need be
further defined.
Considerations will include:
• Age-specific differences (exposure factors and activity patterns) for populations defined
in the exposure scenario table in Appendix E;
• Exposure factors and activities patterns will be sourced from EPA's 2011 Exposure
Factors Handbook ( 11);
• Subpopulations who may have greater exposure due to magnitude, frequency or duration
of exposure as they apply a person's activity patterns or exposure factors;
• Subpopulations who may have greater exposure or susceptibility due to spatial
characteristics (e.g., those who live near point sources, those who are co-located with
emission sources).
6) Analyze the weight of the evidence of general population exposure data.
EPA will rely on the weight of the scientific evidence when analyzing and integrating data
related to general population exposures. The weight of the evidence may include qualitative and
quantitative sources of information. The data integration strategy will be designed to be fit-for-
purpose in which EPA will use systematic review methods to assemble the relevant data, analyze
the data for quality and relevance, including strengths and limitations, followed by synthesis and
integration of the evidence.
7) Map or group each condition of use to general population exposure assessment scenarios.
EPA has identified general population exposure scenarios that include sources of exposure (i.e.,
releases to the environment), exposure pathways, exposure routes, and populations exposed and
mapped them to relevant releases and waste streams, as shown in Appendix E. EPA may refine
the mapping/grouping of general population exposures scenarios as the relationship between
sources of exposure and conditions of use are further characterized.
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EPA will further refine and finalize exposure scenarios for the general population with the
following considerations:
• Temporal trends in uses and resulting sources/releases of 1-BP to the environment over
time;
• Characterization of background levels in the environment that may or may not be
generally attributable to any one use or source but from a combination of uses or sources
which present exposure pathways for the general population;
• Further mapping of releases to lifecycle stages and uses/sources to environmental media;
• Consideration of spatial differences between populations located near industrial point
sources and those exposed at lower background levels;
• Refined definitions of potentially exposed or susceptible subpopulations.
EPA plans to analyze a variety of data types to determine which types are most appropriate when
quantifying exposure scenarios. Environmental monitoring data, biomonitoring data, modeled
estimates, experimental data, epidemiological data, and survey-based data can all be used to
quantify exposure scenarios. In an effort to associate exposure estimates with sources of
exposure and/or conditions of use, EPA will consider source apportionment across exposure
scenarios during risk evaluation. EPA anticipates that there will be a wide range in the relative
exposure potential of the exposure scenarios identified in Appendix E. Source apportionment
characterizes the relative contribution of any of the following: a use/source toward a total media
concentration, a media concentration toward a total exposure route, or an exposure route toward
a total external or internal dose. This consideration may be qualitative, semi-quantitative, or
quantitative, and is dependent upon available data and approaches. For example, EPA may
consider the co-location of TSCA industrial facilities with available monitoring data or modeled
estimates. EPA may compare modeled estimates for discrete outdoor and indoor sources/uses
that apply to unique receptor groups. If available, EPA will compare multiple scenario-specific
and background exposure doses estimated from media-specific concentrations and exposure
factors with available biomonitoring data. The forward-calculated and back-calculated exposures
could be compared to characterize the relative contribution from defined exposure scenarios.
After refining and finalizing exposure scenarios, EPA will quantify concentrations and/or doses
for these scenarios. The number of scenarios will depend on how unique combinations of uses,
exposure pathways, and receptors are characterized. The number of scenarios is also dependent
upon the available data and approaches to quantify scenarios. When quantifying exposure
scenarios, EPA plans to use a tiered approach. First-tier analysis is based on data that is readily
available without a significant number of additional inputs or assumptions, and may be
qualitative, semi-quantitative, or quantitative. First-tier analyses were conducted during problem
formulation and are expected to continue during risk evaluation. The results of first tier analyses
inform whether scenarios require more refined analysis. Refined analyses will be iterative, and
require careful consideration of variability and uncertainty. Should data become available that
summarily alters the overall conclusion of a scenario through iterative tiering, EPA can refine its
analysis during risk evaluation.
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2.6.1.5 Occupational Exposures
EPA expects to consider and analyze both worker and occupational non-user exposures as follows:
1) Review reasonably available exposure monitoring data for specific condition(s) of use.
Exposure data to be reviewed may include workplace monitoring data collected by government
agencies such as OSHA and NIOSH, and monitoring data found in published literature (e.g.,
personal exposure monitoring data (direct measurements) and area monitoring data (indirect
measurements)). Data, information, and studies will be evaluated using the evaluation strategies
laid out in the Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2018). For
some OSHA data, NAICS codes included with the data will be matched with potentially
applicable conditions of use, and data gaps will be identified where no data are found for
particular conditions of use. EPA will attempt to address data gaps identified as described in
steps 2 and 3 below. Where possible, job descriptions may be useful in distinguishing exposures
to different subpopulations within a particular condition of use. EPA has also identified
additional data sources that may contain relevant monitoring data for the various conditions of
use. EPA will review these sources, identified in Table 2-9 and in Table Apx B-3 in Appendix
B, and will extract relevant data for consideration and analysis during risk evaluation.
EPA will evaluate and consider applicable regulatory and non-regulatory exposure limits.
Available data sources that may contain relevant monitoring data for the various conditions of
use are listed in Table 2-9.
OSHA has not established any occupational exposure limits for 1-BP. However, the American
Conference of Governmental Industrial Hygienists (ACGIH) has adopted a recommended
Threshold Limit Value (TLV) of 0.1 ppm based on a time-weighted average (TWA) over an 8-
hour workday. EPA will consider the influence of the recommended exposure limits on
occupational exposures in the occupational exposure assessment.
Table 2-9. Potential Sources of Occupational Exposure Data
2017 ATSDR Toxicological Profile for 1-BP: Toxicological Profile for 1-Bromopropane
(2017)
U.S. OSHA Chemical Exposure Health Data (CEHD) program data
U.S. NIOSH Health Hazard Evaluation (HHE) Program reports
2016 Draft Risk Assessment (U.S. EPA. 2016b)
CARB ISOR for Proposed ATCM
Draft NIOSH Criteria Document for a Recommended Standard for Occupational Exposure to
1-Bromopropane
2) Review reasonably available exposure data for surrogate chemicals that have uses and
chemical and physical properties similar to 1-BP.
If surrogate data are identified, these data will be matched with applicable conditions of use for
potentially filling data gaps. For several uses including use of adhesives, and cleaning products,
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EPA believes that trichloroethylene and other similar solvents may share the same or similar
conditions of use and may be considered as surrogates for 1-BP.
3) For conditions of use where data are limited or not available, review existing exposure
models that may be applicable in estimating exposure levels.
EPA has identified potentially relevant OECD emissions scenario documents (ESDs) and EPA
generic scenarios (GSs) corresponding to some conditions of use. For example, the ESD on
Industrial Use of Adhesives for Substrate Bonding, the ESD on Metalworking Fluids, and the GS
on Use of Vapor Degreasers are some of the ESDs and GSs that EPA may use to estimate
occupational exposures. EPA will need to critically review these generic scenarios and ESDs to
determine their applicability to the conditions of use assessed. EPA was not able to identify
ESDs or GSs corresponding to several conditions of use, including recycling of 1-BP and solvent
mixtures containing 1-BP, processing and formulation of 1-BP into industrial, commercial and
consumer products, use of 1-BP in insulation materials, and use of 1-BP in asphalt extraction.
EPA will perform additional targeted research, such as consulting Kirk-Othmer, in order to better
understand those conditions of use, which may inform identification of exposure scenarios. EPA
may also need to perform targeted research to identify applicable models that EPA may use to
estimate exposures for certain conditions of use.
Furthermore, a mass-balance based model that has been used in addressing data gaps in some
conditions of use is the Near-Field/Far-Field (NF/FF) model. This or other models, may be
explored where models specific to conditions of use are not found. If any models are identified
as applicable, EPA will search for appropriate model parameter data. If parameter data can be
located or assumed, exposure estimates generated from these models may be used for potentially
filling data gaps. EPA may perform additional targeted research to better understand conditions
of use, which may inform identification of exposure scenarios. EPA may also need to perform
targeted research to identify applicable models that EPA may use to estimate exposures for
certain conditions of use.
4) Review reasonably available data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation.
If necessary, EPA will analyze relevant data to determine whether the data can be used to
develop, adapt, or apply models for specific conditions of use and corresponding exposure
scenarios.
In the -w i * aft Risk Assessment 0 s \ V \ 2016b). EPA previously developed models to
assess inhalation exposures to workers and occupational non-users during the use of 1-BP in dry
cleaning, spot cleaning, open-top batch vapor degreasing, cold cleaning, and aerosol degreasing.
The peer reviewers provided comments on EPA's modeling approach, including
recommendations on specific model input parameters. During risk evaluation, EPA will further
refine the exposure models for these uses based on peer reviewer feedback.
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5) Consider and incorporate applicable engineering controls and/or personal protective
equipment into exposure scenarios.
EPA will review potential data sources on engineering controls and personal protective
equipment as identified in Table Apx B-6 in Appendix B and determine their applicability and
incorporation into exposure scenarios during risk evaluation.
6) Map or group each condition of use to occupational exposure assessment scenario(s).
EPA has identified release/occupational exposure scenarios and mapped them to relevant
conditions of use in Appendix D. As presented in the fourth column of the table in this appendix,
EPA has grouped the uses into 16 representative release/exposure scenarios each with 5-6 unique
combinations of exposure pathway, route, and receptor that will be further analyzed. EPA may
further refine the mapping/grouping of occupational exposure scenarios based on factors (e.g.,
process equipment and handling, magnitude of production volume used, and exposure/release
sources) corresponding to conditions of use as additional information is identified during risk
evaluation.
7) Analyze the weight of evidence of occupational exposure data.
EPA will rely on the weight of the scientific evidence when evaluating and integrating
occupational exposure data. The data integration strategy will be designed to be fit-for-purpose
in which EPA will use systematic review methods to assemble the relevant data, analyze the data
for quality and relevance, including strengths and limitations, followed by synthesis and
integration of the evidence.
2.6.1.6 Consumer Exposures
EPA expects to analyze both consumers using a consumer product and bystanders associated with the
consumer using the product as follows:
1) Refine and finalize exposure scenarios for consumers by considering sources of
exposure (consumer products), exposure pathways, exposure settings, exposure routes,
and populations exposed.
Considerations for constructing exposure scenarios for consumers:
• Reasonably available data on consumer products or products available for consumer use
including the content of 1-BP in products;
• Information characterizing the use patterns of consumer products containing 1-BP
including how the product is used, the amount of product used, frequency and duration of
use, and room of use;
• The associated exposure setting and route of exposure for consumers;
• Populations who may be exposed to products, including potentially exposed and
susceptible subpopulations such as children or women of child bearing age;
• Subsets of consumers who may use commercially available products which have
different concentrations of 1-BP or subsets of consumers who may use products more
frequently.
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2) Analyze the relative potential of exposure routes based on available data.
Indoor exposure routes expected to be relatively higher and include inhalation of vapor. The data
sources associated with these respective pathways have not been comprehensively analyzed,
therefore quantitative comparisons across exposure pathways or in relation to toxicity thresholds
are not yet available.
3) Review existing consumer exposure models that may be applicable in estimating indoor
air concentrations (near field and far field) for the user and bystander; and in
estimating dermal exposure to the consumer in transient exposures and in longer term
(e.g., occluded) exposure scenarios. Determine the applicability of the identified models
for use in a quantitative exposure assessment.
Consumer exposure based indoor exposure models that estimate emission from spray products or
liquid products into the indoor environment are available. These models generally consider
overall mass transfer informed by the vapor pressure of the chemical, content of the chemical in
the product and use patterns and practices. OPPT's CEM or E-FAST model and other similar
models can be used to estimate indoor air concentration from use of consumer products
containing 1-BP.
4) Review reasonably available empirical data that may be used in developing, adapting or
applying exposure models to the exposure assessment of 1-BP. For example, existing
models developed for a chemical assessment may be applicable to another chemical
assessment if model parameter data are available.
To the extent other organizations have already modeled a 1-BP consumer exposure scenario that
is relevant to OPPT's assessment, EPA will analyze those modeled estimates. In addition, if
modeled estimates for other chemicals with similar physical chemical properties and similar uses
area available, those modeled estimates will also be evaluated. The underlying parameters and
assumptions of the models will also be analyzed.
5) Review reasonably available consumer product-specific sources to determine how those
exposure estimates compare with each other and with any relevant existing monitoring
data.
The availability of 1-BP concentrations in products will be analyzed. This data provides the
source term for any subsequent consumer modeling. Source attribution and comparison of indoor
air monitoring will be analyzed.
6) Review reasonably available population- or subpopulation-specific exposure factors
and activity patterns to determine if potentially exposed or susceptible subpopulations
need to be further refined.
Considerations will include:
• Age-specific differences (exposure factors and activity patterns) for populations defined
in the exposure scenario table in Appendix E;
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• Exposure factors and activities patterns will be sourced from EPA's 2011 Exposure
Factors Handbook (U.S. EPA. 2011)
• The characteristics of the user of the consumer product and the bystander in the room,
including for example, women of child bearing age and children;
• Subpopulations who may have greater exposure due to magnitude, frequency or duration
of exposure as they apply to specific consumer products.
7) Analyze the weight of the evidence of consumer exposure estimates based on different
approaches.
EPA will rely on the weight of the scientific evidence when evaluating and integrating data
related to consumer exposure. The weight of the evidence may include qualitative and
quantitative sources of information. The data integration strategy will be designed to be fit-for-
purpose in which EPA will use systematic review methods to assemble the relevant data, analyze
the data for quality and relevance, including strengths and limitations, followed by synthesis and
integration of the evidence.
2.6.2 Hazards (Effects)
2.6.2.1 Environmental Hazards
Environmental hazards will not be further analyzed because exposure analysis conducted using physical
and chemical properties, fate information and TRI environmental releases for 1-BP show that ecological
receptors are not significantly exposed to TSCA-related environmental releases of this chemical.
2.6.2.2 Human Health Hazards
EPA expects to analyze human health hazards as follows:
1) Review reasonably available human health hazard data, including data from
alternative test methods (e.g., computational toxicology and bioinformatics; high-
throughput screening methods; data on categories and read-across; in vitro studies;
systems biology).
Human health studies will be evaluated using the evaluation strategies laid out in the Application
of Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2018) document. Human and animal
data will be identified and included as described in the inclusions and exclusion criteria in
Appendix F. EPA plans to prioritize the evaluation of mechanistic evidence. Specifically, EPA
does not plan to evaluate mechanistic studies unless needed to clarify questions about
associations between 1-BP and health effects and its relevance to humans. The Application of
Systematic Review in TSCA Risk Evaluations ( 018). document describes the process
of how studies will be evaluated using specific data evaluation criteria and a predetermined
approach. Study results will be extracted and presented in evidence tables by hazard endpoint.
EPA plans to evaluate relevant studies identified in the„ I: Risk Assessment (U.S. EPA.
2016b) of 1-BP as well as those that were captured in the comprehensive literature search
conducted by the Agency for 1-Bromopropane (CASRN106-94-5) Bibliography: Supplemental
File for the TSCA Scope Document; rEP A-HO-QPPT-201.6-0741. -0047; (U.S. EPA. 2017aYl.
EPA intends to review studies published after the_20j u I naft Risk Assessment (I . IP \
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2016b) to ensure that EPA is considering information that has been made available since that
assessment was conducted.
2) In analyzing reasonably available data, determine whether particular human receptor
groups may have greater susceptibility to the chemical's hazard(s) than the general
population.
Reasonably available human health hazard data will be analyzed to ascertain whether some
human receptor groups may have greater susceptibility than the general population to 1-BP
hazard(s). Susceptibility of particular human receptor groups to 1-BP will be determined by
evaluating information on factors that influence susceptibility.
3) Conduct hazard identification (the qualitative process of identifying non-cancer and
cancer endpoints) and dose-response assessment (the quantitative relationship between
hazard and exposure) for all identified human health hazard endpoints.
Human health hazards from acute and chronic exposures will be identified by analyzing the
human and animal data that meet the systematic review data quality criteria described in the
Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA. 2018) document. Data
quality evaluation will be performed on key studies identified from the _2 aft Risk
Assessment (U.S. EPA. 2.016b) of 1-BP, and studies published after 2016 that were identified in
the comprehensive literature search (see 1-Bromopropane (CASRN106-94-5) Bibliography:
Supplemental File for the TSCA Scope Document (EPA-HQ-Q >047)). Hazards
identified by studies meeting data quality criteria will be grouped by routes of exposure relevant
to humans (oral, dermal, inhalation) and by cancer and noncancer endpoints.
Dose-response assessment will be performed in accordance with EPA guidance (U.S. EPA.
2012a. 2011. 1994). Dose-response analyses performed for the 2016 Draft Risk Assessment
(U.S. EPA. 2.016b) of 1-BP may be used if the data meet data quality criteria and if additional
information on the identified hazard endpoints or additional hazard endpoints would not alter the
analysis.
4) Derive points of departure (PODs) where appropriate; conduct benchmark dose
modeling (BMD) depending on the available data. Adjust the PODs as appropriate to
conform (e.g., adjust for duration of exposure) to the specific exposure scenarios
evaluated.
Hazard data will be evaluated to determine the type of dose-response modeling that is applicable.
Where modeling is feasible, a set of dose-response models that are consistent with a variety of
potentially underlying biological processes will be applied to empirically model the dose-
response relationships in the range of the observed data consistent with the EPA Benchmark
Dose Technical Guidance Document (U.S. EPA. 2012a). Where dose-response modeling is not
feasible, NOAELs or LOAELs will be identified.
EPA will evaluate whether the available PBPK and empirical kinetic models are adequate for
route-to-route and interspecies extrapolation of the POD, or for extrapolation of the POD to
appropriate exposure durations for the risk evaluation.
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5) Consider the route(s) of exposure (oral, inhalation, dermal), available route-to-route
extrapolation approaches, available biomonitoring data and available approaches to
correlate internal and external exposures to integrate exposure and hazard assessment.
EPA believes there are sufficient health effects data to conduct dose-response analysis and/or
benchmark dose modeling or NOAELs or LOAELs for inhalation route of exposure.
If sufficient dermal toxicity studies are not identified in the literature search to assess risks from
dermal exposures, then a route-to-route extrapolation from the inhalation and oral toxicity
studies would be needed to assess systemic risks from dermal exposures. Without an adequate
PBPK model, the approaches described in the EPA guidance document Risk Assessment
Guidance for Superfund Volume I: Human Health Evaluation Manual (Part E, Supplemental
Guidance for Dermal Risk Assessment) (U.S. EPA. 2004b) could be applied. These approaches
may be able to further inform the relative importance of dermal exposures compared with other
routes of exposure.
6) Evaluate the weight of the evidence of human health hazard data.
EPA will rely on the weight of the scientific evidence when analyzing and integrating human
health hazard data. The data integration strategy will be designed to be fit-for-purpose in which
EPA will use systematic review methods to assemble the relevant data, evaluate the data for
quality and relevance, including strengths and limitations, followed by synthesis and integration
of the evidence.
2.6.3 Risk Characterization
Risk characterization is an integral component of the risk assessment process for both ecological and
human health risks. EPA will derive the risk characterization in accordance with EPA's Risk
Characterization Handbook ( 2000). As defined in EPA's Risk Characterization Policy, "the
risk characterization integrates information from the preceding components of the risk evaluation and
synthesizes an overall conclusion about risk that is complete, informative and useful for decision
makers." Risk characterization is considered to be a conscious and deliberate process to bring all
important considerations about risk, not only the likelihood of the risk but also the strengths and
limitations of the assessment, and a description of how others have assessed the risk into an integrated
picture.
Risk characterization at EPA assumes different levels of complexity depending on the nature of the risk
assessment being characterized. The level of information contained in each risk characterization varies
according to the type of assessment for which the characterization is written. Regardless of the level of
complexity or information, the risk characterization for TSCA risk evaluations will be prepared in a
manner that is transparent, clear, consistent, and reasonable (TCCR) (U.S. EPA, 2000). EPA will also
present information in this section consistent with approaches described in the Procedures for Chemical
Risk Evaluation Under the Amended Toxic Substances Control Act (8! 5). For instance, in the
risk characterization summary, EPA will further carry out the obligations under TSCA section 26; for
example, by identifying and assessing uncertainty and variability in each step of the risk evaluation,
discussing considerations of data quality such as the reliability, relevance and whether the methods
utilized were reasonable and consistent, explaining any assumptions used, and discussing information
generated from independent peer review. EPA will also be guided by EPA's Information Quality
Guidelines (U.S. EPA. 2002) as it provides guidance for presenting risk information. Consistent with
those guidelines, in the risk characterization, EPA will also identify: (1) Each population addressed by
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an estimate of applicable risk effects; (2) the expected risk or central estimate of risk for the potentially
exposed or susceptible subpopulations affected; (3) each appropriate upper-bound or lower bound
estimate of risk; (4) each significant uncertainty identified in the process of the assessment of risk effects
and the studies that would assist in resolving the uncertainty; and (5) peer reviewed studies known to the
Agency that support, are directly relevant to, or fail to support any estimate of risk effects and the
methodology used to reconcile inconsistencies in the scientific information.
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Ichihara, G; Li, W; Shibata, E; Ding, X; Wang, H; Liang, Y; Peng, S; Itohara, S; Kamijima, M; Fan, Q;
Zhang, Y; Zhong, E; Wu, X; Valentine, WM; Takeuchi, Y. (2004). Neurologic abnormalities in
workers of a 1-bromopropane factory. Environ Health Perspect. 112: 1319-1325.
http://dx.doi.on 89/ehp.6995.
Japanese Ministry of Environment. (2017). 1-Bromopropane. (106-94-5). Tokyo, Japan.
https://www.env.eo.ip/en/chemi/chemicals/profile erac/profilel2/pfl -10 ndf.
Kanegsberg, B; Kanegsberg, E. (2011). Handbook of critical cleaning, applications, processes, and
controls. In Handbook for critical cleaning, cleaning agents and systems. Boca Raton: CRC
Press, http://dx.doi. )l/b!0858.
Kawai, T; Takeuchi, A; Miyama, Y; Sakamto, K; Zhang, ZW; Higashikawa, K; Ikeda, M. (2001).
Biological monitoring of occupational exposure to 1-bromopropane by means of urinalysis for 1-
bromopropane and bromide ion. Biomarkers. 6: 303-312.
http://dx.doi.ore/10 1080/135475001 10034817.
NEWMOA. (2001). Pollution prevention technology profile - Closed loop vapor degreasing. Boston,
MA. http://www.newmoa.ore/prevention/p2tech/ProfileYaporDeereasine.pdf.
NFPA. (2010). Fire Protection Guide to Hazardous Materials. Quincy, MA.
NIOSH. (1997). Control of health and safety hazards in commercial drycleaners: chemical exposures,
fire hazards, and ergonomic risk factors. In Education and Information Division. (DHHS
(NIOSH) Publication Number 97-150). Atlanta, GA. http://www.cdc.eov/niosh/docs/97-150/.
NIOSH. (2007a). Workers' exposures to n-propyl bromide at a hydraulic power control component
manufacturer. Cincinnati, OH: NIOSH Division of Surveillance, Hazard Evaluation and Field
Studies.
NIOSH. (2007b). Workers' exposures to n-propyl bromide at a printed electronics circuit assembly
manufacturer. Cincinnati, OH: NIOSH Division of Surveillance, Hazard Evaluation and Field
Studies, http://www.cdc.eov/niosh/nioshtic-2/20031860.html.
NIOSH. (2014). International chemical safety cards (ICDC): 1-bromopropane. Atlanta, GA.
https://www.cdc.eov/niosh/ipcsnene/nene0041.html.
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NIOSH. (2017). NIOSH Skin Notation Profiles: 1-Bromopropane. By Hudson NL, Dotson GS. (DHHS
(NIOSH) Publication No. 2017-187). Cincinnati, OH: U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety
and Health.
NTP. (2013). Report on carcinogens. Monograph for 1-bromopropane (Final) (pp. 1-168). (NIH
Publication No. 13-5982). Research Triangle Park, NC.
http://ntp.niehs.nih.gov/ntp/roc/thirteenth/monographs final/lbromopropane508.pdf.
O'Neil, MJ. (2013). The Merck index: An encyclopedia of chemicals, drugs, and biologicals. In MJ
O'Neil (Ed.), (15th ed.). Cambridge, UK: Royal Society of Chemistry.
OSHA. (2010). Input received through web forum for identifying hazardous chemicals for which OSHA
should develop exposure reduction strategies. Washington, DC: U.S. Department of Labor,
Occupational Safety and Health Administration. https://www.osha.gov/dsg/PEL-forum-
comments2010.html.
OSHA. (2013). OSHA/NIOSH hazard alert: 1-bromopropane. (OSHA HA-3676-2013). Washington,
DC: U.S. Department of Labor.
https://www.osha.gov/dts/hazardalerts/lbrom.opropane hazard alert.html.
OSHA. (2017). Chemical Exposure Health Data (CEHD) provided by OSHA to EPA. U.S. Occupational
Safety and Health Administration.
OSHA; NIOSH. (2013). Hazard alert: 1-Bromopropane. Washington, DC: Occupational Safety and
Health Administration & National Institute for Occupational Safety and Health.
http://www.cdc.gov/niosh/nioshtic-2/20C html.
Patty, FA; Fassett, DW; Irish, DD. (1963). Industrial hygiene and toxicology: Vol. II: Toxicology. In FA
Patty; DW Fassett; DD Irish (Eds.), (2nd revised ed.). New York, NY: Interscience Publishers.
Raymond, LW; Ford, MD. (2007). Severe illness in furniture makers using a new glue: 1-bromopropane
toxicity confounded by arsenic. J Occup Environ Med. 49: 1009-1019.
http://dx.doi.on, j_0 10<->_7,K»M.0b013c.U M f>h616.
Toraason, M; Lynch, DW; Debord, DG; Singh, N; Nemhauser, J. (2003). Assessment of DNA strand
breaks in leukocytes of workers occupationally exposed to 1-bromopropane [Abstract], Toxicol
Sci. 72: 250.
TURI. (2012). Assessment of Alternatives to the Perchloroethylene for Dry Cleaning Industry. In
UMASS Lowell. Toxics Use Reduction Institute.
http://www.turi.ore blications/TURI Methods Policy Reports/Assessment of Alterna
tives to Perchloroethylene for the Dry Cleaning Industry. JO I 2.
U.S. EPA. (1977). Control of volatile organic emissions from solvent metal cleaning [EPA Report],
(EPA-450/2-77-022). Research Triangle Park, NC: U.S. Environmental Protection Agency,
Office of Air and Waste Management, Office of Air Quality Planning and Standards.
U.S. EPA. (1980). Compilation of air pollutant emission factors. Chapter 4.7: Waste solvent
reclamation. Office of Air and Radiation, Office of Air Quality and Planning Standards.
U.S. EPA. (1981). AP-42. Compilation of air pollutant emission factors. Chapter 4. 6: Solvent
degreasing. Washington, DC. http://www3.epa.gov/ttn/chief/ap42/ch04/final/c4s06.pdf.
U.S. EPA. (1994). Methods for derivation of inhalation reference concentrations and application of
inhalation dosimetry [EPA Report] (pp. 1-409). (EPA/600/8-90/066F). Research Triangle Park,
NC: U.S. Environmental Protection Agency, Office of Research and Development, Office of
Health and Environmental Assessment, Environmental Criteria and Assessment Office.
https://cfpub. epa.gov/ncea/risk/recordisplay. cfm?deid=71993S 829&CFTOKEN=2
5006317.
U.S. EPA. (1995). Guidance document for the halogenated solvent cleaner NESHAP. (EPA-453/R-94-
081). Research Triangle Park, NC: Office of Air Quality Planning and Standards, Information
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Transfer and Program Integration Division, Control Technology Center, Federal Small Business
Assistance Program.
U.S. EPA. (1998). Guidelines for ecological risk assessment [EPA Report], (EPA/630/R-95/002F).
Washington, DC: U.S. Environmental Protection Agency, Risk Assessment Forum.
http://www.epa.gov/raf/publications/guidelines-ecological-risk-assessment.htm.
U.S. EPA. (2000). Science policy council handbook: Risk characterization (pp. 1-189). (EPA/100/B-
00/002). Washington, D.C.: U.S. Environmental Protection Agency, Science Policy Council.
https://www.epa.eov/risk/risk-characterization-h.andbook.
U.S. EPA. (2001). Guide to industrial assessments for pollution prevention and energy efficiency [EPA
Report], (EPA/625/R-99/003). Cincinnati, OH: Office of Research and Development, National
Risk Management Research Laboratory, Center for Environmental Research Information.
U.S. EPA. (2002). Guidelines for ensuring and maximizing the quality, objectivity, utility, and integrity,
of information disseminated by the Environmental Protection Agency. (EPA/260/R-02/008).
Washington, DC: U.S. Environmental Protection Agency, Office of Environmental Information.
http://www.epa.eov/qiialitv/informationeiiidelines/dociiments/EPA InfoOualityGuidelines.pdf.
U.S. EPA. (2004a). Guidance document for the halogenated solvent cleaning NESHAP. (EPA-453/R-
94-081). RTP, NC: Office of Air Quality Planning and Standards.
U.S. EPA. (2004b). Risk Assessment Guidance for Superfund (RAGS), Volume I: Human health
evaluation manual, (part E: Supplemental guidance for dermal risk assessment): Final.
(EPA/540/R/99/005). Washington, DC.
http://www.epa.eov/oswer/riskassessment/raese/in.dex.htm.
U.S. EPA. (2006a). A framework for assessing health risk of environmental exposures to children (pp.
1-145). (EPA/600/R-05/093F). Washington, DC: U.S. Environmental Protection Agency, Office
of Research and Development, National Center for Environmental Assessment.
http://cfpub.epa.eov/ncea/cfm/recordisplav.cfm.7dei 563.
U.S. EPA. (2006b). Risk assessment for the halogenated solvent cleaning source category [EPA Report],
(EPA Contract No. 68-D-01-052). Research Triangle Park, NC: U.S. Environmental Protection
Agency, Office of Air Quality Planning and Standards.
http://www3.epa.eov/airtoxics/deerea/residrisk2008.pdf.
U.S. EPA. (2007). Exposure and fate assessment screening tool (E-FAST): Version 2.0, documentation
manual [EPA Report],
U.S. EPA. (2011). Exposure factors handbook: 2011 edition (final) [EPA Report], (EPA/600/R-
090/052F). Washington, DC: U.S. Environmental Protection Agency, Office of Research and
Development, National Center for Environmental Assessment.
http://cfpub.epa. eov/ncea/cfin/recordisplav.cfm?deid=236252.
U.S. EPA. (2012a). Benchmark dose technical guidance. (EPA/100/R-12/001). Washington, DC: U.S.
Environmental Protection Agency, Risk Assessment Forum.
https://www.epa.eov/risk/benchmark-dose-technical-euidance.
U.S. EPA. (2012b). Estimation Programs Interface (EPI) Suite™ for Microsoft® Windows (Version
4.11). Washington D.C.: Environmental Protection Agency. Retrieved from
http ://www. epa. eov/opptintr/exposure/pub s/epi suite.htm
U.S. EPA. (2012c). Sustainable futures P2 framework manual [EPA Report], (EPA-748-B12-001).
Washington DC. http://www.epa.eov/sustainable-futures/sustainable-futures-p2-framework-
manual.
U.S. EPA. (2013a). ChemSTEER User Guide - Chemical Screening Tool for Exposures and
Environmental Releases. Environmental Protection Agency.
https://www.epa.eov/sites/prodiiction/files/2015-05/dociiments/user guide.pdf.
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U.S. EPA. (2013b). Interpretive assistance document for assessment of discrete organic chemicals.
Sustainable futures summary assessment [EPA Report], Washington, DC.
http://www.epa.gov/sites/production/files/2015-05/dociiments/0S4ad discretes iune2013.pdf.
U.S. EPA. (2014a). Degreasing with TCE in commercial facilities: Protecting workers [EPA Report],
Washington, DC: U.S. Environmental Protection Agency, Office of Pollution Prevention and
Toxics.
U.S. EPA. (2014b). Framework for human health risk assessment to inform decision making. Final
[EPA Report], (EPA/100/R-14/001). Washington, DC: U.S. Environmental Protection, Risk
Assessment Forum, https://www.epa.gov/risk/fram.ework-hiim.an.-health-risk-assessment-inform-
decision-making.
U.S. EPA. (2016a). Public database 2016 chemical data reporting (May 2017 release). Washington, DC:
US Environmental Protection Agency, Office of Pollution Prevention and Toxics. Retrieved
from https://www.epa.gov/ch.em.ical-data-reporting
U.S. EPA. (2016b). TSCA work plan chemical risk assessment: Peer review draft 1-bromopropane: (n-
Propyl bromide) spray adhesives, dry cleaning, and degreasing uses CASRN: 106-94-5 [EPA
Report], (EPA 740-R1-5001). Washington, DC.
https://www.epa.gOv/sites/prodiiction./files/2 /documents/1-
bp report and appendices final.pdf.
U.S. EPA. (2017a). 1-Bromopropane (CASRN: 106-94-5) bibliography: Supplemental file for the TSCA
Scope Document [EPA Report], fa.ftps://www.epa.gov/sites/production/files/z
06/documen np bib,pdf.
U.S. EPA. (2017b). Consumer Exposure Model (CEM) version 2.0: User guide. U.S. Environmental
Protection Agency, Office of Pollution Prevention and Toxics.
https://www.epa.gOv/sites/production/files/2 /documents/cem 2.0 user guide.pdf.
U.S. EPA. (2017c). Toxics Release Inventory (TRI). Retrieved from https://www.epa.gov/toxics-
release-inventory-tri-program/tri-data-and-tools
U.S. EPA. (2018). Application of systematic review in TSCA risk evaluations: DRAFT Version 1.0.
(740P18001). Washington, D.C.: U.S. Environmental Protection Agency, Office of Chemical
Safety and Pollution Prevention.
U.S. EPA; ICF Consulting. (2004). The U.S. solvent cleaning industry and the transition to non ozone
depleting substances. http://www.hsia.org/applications/ODS%20report.pdf.
WIL Research. (2001). An inhalation two-generation reproductive toxicity study of 1-bromopropane in
rats. (Study No. WIL-380001). Ashland, OH.
Yalkowsky, SH; He, Y; Jain, P. (2010). Handbook of aqueous solubility data (2nd ed.). Boca Raton, FL:
CRC Press. http://dx.doi.org/10.1201/EB 802458.
Young, ML. (2012). Pre-spotting step toward better cleaning [Website], Chicago, IL: American
Dry cleaner, American Trade Magazines LLC. fa tip s: //am eri can dry ct eaner. com/arti cles/pre-
spotting-step-toward-better-cleaning.
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APPENDICES
APPENDIX A REGULATORY HISTORY
A.l Federal Laws and Regulations
TableApx A-l. Federal Laws and Regulations
Sliitiitcs/kcgiihitions
Description of Aiilhoritv/ko^uliKion
Description of E^e^uliilion
US EPA Regulations
Toxic Substances Control
Act (TSCA) - Section 6(b)
EPA is directed to identify and begin risk
evaluations on 10 chemical substances drawn
from the 2014 update of the TSCA Work
Plan for Chemical Assessments.
1-BP is on the initial list of chemicals to
be evaluated for unreasonable risk
under TSCA (81 FR 91927, December
19, 2016)
Toxic Substances Control
Act (TSCA) - Section 8(a)
The TSCA section 8(a) Chemical Data
Reporting (CDR) Rule requires
manufacturers (including importers) to give
EPA basic exposure-related information on
the types, quantities and uses of chemical
substances produced domestically and
imported into the US.
1-BP manufacturing, importing,
processing, and use information is
reported under the Chemical Data
Reporting (CDR) rule (76 FR 50816,
August 16, 2011).
Toxic Substances Control
Act (TSCA) - Section 8(b)
EPA must compile, keep current, and publish
a list (the TSCA Inventory) of each chemical
substance manufactured, processed, or
imported in the United States.
1-BP was on the initial TSCA Inventory
and therefore was not subject to EPA's
new chemicals review process (60 FR
16309, March 29, 1995).
Toxic Substances Control
Act (TSCA) - Section 8(e)
Manufacturers (including importers),
processors, and distributors must
immediately notify EPA if they obtain
information that supports the conclusion that
a chemical substance or mixture presents a
substantial risk of injury to health or the
environment.
Eleven notifications of substantial risk
(Section 8(e)) received before 2001 (US
EPA, ChemView. Accessed April 13,
2017).
Toxic Substances Control
Act (TSCA) - Section 4
Provides EPA with authority to issue rules
and orders requiring manufacturers
(including importers) and processors to test
chemical substances and mixtures.
One submission from a test rule
(Section 4) received in 1981 (US EPA,
ChemView. Accessed April 13, 2017).
Emergency Planning and
Community Right-To-
Know Act (EPCRA) -
Section 313
Requires annual reporting from facilities in
specific industry sectors that employ 10 or
more full time equivalent employees and that
manufacture, process, or otherwise use a
Toxics Release Inventory (TRI)-listed
chemical in quantities above threshold levels.
1-BP is a listed substance subject to
reporting requirements under 40 CFR
372.65 effective as of January 1, 2016,
with reporting due July 1, 2017 (80 FR
72906, November 23, 2015).
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TableApx A-l. Federal Laws and Regulations
Stiilutes/Requhilions
Description ol' Autliorit\/E{c<>iil;itioii
Description of Requisition
Clean Air Act (CAA) -
Section 112(b)
This section lists 189 Hazardous Air
Pollutants (HAPs) that must be addressed by
EPA and includes authority for EPA to add
or delete pollutants. EPA may, by rule, add
pollutants that present, or may present, a
threat of adverse human health effects or
adverse environmental effects.
EPA received petitions from the
Halogenated Solvent Industry Alliance
and the New York State Department of
Environmental Conservation to list 1-
BP as a hazardous air pollutant (HAP)
under section 112(b)(1) of the Clean Air
Act (80 FR 6676, February 6, 2015). On
January 9, 2017, EPA published a draft
notice on the rational for granting the
petitions to add 1-BP to the list of
hazardous air pollutants. Comments are
due June 8, 2017 (82 FR 2354, January
9, 2017). Since 1-BP is not a HAP,
currently, there are no National
Emissions Standards for Hazardous Air
Pollutants (NESHAPs) that apply to the
life cycle.
Clean Air Act (CAA) -
Section 183(e)
Section 183(e) requires EPA to list the
categories of consumer and commercial
products that account for at least 80 percent
of all VOC emissions in areas that violate the
National Ambient Air Quality Standards
(NAAQS) for ozone and to issue standards
for these categories that require "best
available controls." In lieu of regulations,
EPA may issue control techniques guidelines
if the guidelines are determined to be
substantially as effective as regulations.
1-BP is listed under the National
Volatile Organic Compound Emission
Standards for Aerosol Coatings (40
CFR part 59, subpart E). 1-BP has a
reactivity factor of 0.35 g 03/g VOC.
Clean Air Act (CAA) -
Section 612
Under Section 612 of the Clean Air Act
(CAA), EPA's Significant New Alternatives
Policy (SNAP) program reviews substitutes
for ozone depleting substances within a
comparative risk framework. EPA publishes
lists of acceptable and unacceptable
alternatives. A determination that an
alternative is unacceptable, or acceptable
only with conditions, is made through
rulemaking.
Under EPA's SNAP program, EPA
evaluated 1-BP as an acceptable
substitute for ozone-depleting
substances. In 2007, EPA listed 1-BP as
an acceptable substitute for
chlorofluorocarbon (CFC)-113 and
methyl chloroform in the solvent and
cleaning sector for metals cleaning,
electronics cleaning, and precision
cleaning. EPA recommended the use of
personal protective equipment,
including chemical goggles, flexible
laminate protective gloves and
chemical-resistant clothing (72 FR
30142, May 30, 2007). In 2007, the
Agency also proposed to list 1-BP as an
unacceptable substitute for CFC-113,
hydrochlorofluorocarbon (HCFC)- 114b
and methyl chloroform when used in
adhesives or in aerosol solvents; and in
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TableApx A-l. Federal Laws and Regulations
Stiilutes/Requhilions
Description ol' Autliorit\/E{c<>iil;itioii
Description of Requisition
the coatings end use (subject to use
conditions) (72 FR 30168, May 30,
2007). The proposed rule has not been
finalized by the Agency. The rule
identifies 1-BP as acceptable and
unacceptable substitute for ozone-
depleting substances in several sectors.
Other Federal Regulations
Occupational Safety and
Health Act (OSHA)
Requires employers to provide their workers
with a place of employment free from
recognized hazards to safety and health, such
as exposure to toxic chemicals, excessive
noise levels, mechanical dangers, heat or
cold stress, or unsanitary conditions.
Under the Act, OSHA can issue occupational
safety and health standards including such
provisions as Permissible Exposure Limits
(PELs), exposure monitoring, engineering
and administrative control measures, and
respiratory protection.
OSHA has not issued a PEL for 1-BP.
OSHA and the National Institute for
Occupational Safety and Health
(NIOSH) issued a Hazard Alert
regarding 1-BP (OSHA-NIOSH, 2013)
providing information regarding health
effects, how workers are exposed, how
to control the exposures and how
OSHA and NIOSH can help.
Department of Energy
(DOE)
The Atomic Energy Act authorizes DOE to
regulate the health and safety of its contractor
employees.
10 CFR 851.23, Worker Safety and
Health Program, requires the use of the
2005 ACGIH TLVs if they are more
protective than the OSHA PEL. The
2005 TLV for 1-BP is 10 ppm (8hr
Time Weighted Average).
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A.2 State Laws and Regulations
TableApx A-2. State Laws and Regulations
Slate Actions
Description of Action
State Air Regulations
Allowable Ambient Levels
Rhode Island (Air Pollution Regulation No. 22)
New Hampshire (Env-A 1400: Regulated Toxic Air
Pollutants)
Chemicals of High Concern
Massachusetts designated 1-BP as a higher hazard
substance requiring reporting starting in 2016 (301 CMR
41.00).
Minnesota listed 1-BP as chemical of high concern to
children (Minnesota Statutes 116.9401 to 116.9407).
State Permissible Exposure Limits
California PEL: 5 ppm as an 8-hr-time-weighted average
(TWA) (California Code of Regulations, title 8, section
5155).
State Right-to-Know Acts
New Jersey (42 N.J.R. 1709(a)), Pennsylvania (Chapter
323. Hazardous Substance List).
Other
In California, 1-BP was added to proposition 65 list in
December 2004 due to developmental, female and male,
toxicity; and in 2016 due to cancer. (Cal. Code Regs, title
27, section 27001).
1-BP is listed as a Candidate Chemical under California's
Safer Consumer Products Program (Health and Safety Code
sections 25252 and 25253).
California also selected 1-BP as the first chemical for early
warning and prevention activities under SB 193 Early
Warning Authority and issued a Health Hazard Alert for 1-
BP (Hazard Evaluation System and Information Service,
2016).
Page 80 of 123
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A.3 International Laws and Regulations
TableApx A-3. Regulatory Actions by other Governments and Tribes
CoiiiKrv
/()r»:iniz;ilion
Requirements :mcl Restrictions
Luropcan Lmoii
In U1 J!, 1-BP was listed on the Candidate list as a Substance of Yen High Concern
(SVHC) under regulation (EC) No 1907/2006 - REACH (Registration, Evaluation,
Authorization and Restriction of Chemicals due to its reproductive toxicity (category
IB).
In June 2017, 1-BP was added to Annex XIV of REACH (Authorisation List) with a
sunset date of July 4, 2020 (European Chemicals Agency (ECHA) database. Accessed
December 6, 2017).
Australia
1-BP was assessed under Environment Tier II of the Inventory Multi-tiered
Assessment and Prioritisation (IMAP) (National Industrial Chemicals Notification
and Assessment Scheme (NICNAS), 2017, Human Health Tier II Assessment for
Propane, 1-bromo-. Accessed April, 18 2017).
Japan
1-BP is regulated in Japan under the following legislation:
Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture,
etc. (Chemical Substances Control Law; CSCL)
Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the
Environment and Promotion of Improvements to the Management Thereof
Industrial Safety and Health Act (ISHA)
Air Pollution Control Law
(National Institute of Technology and Evaluation (NITE) Chemical Risk Information
Platform (CHIRP). Accessed April 13, 2017).
Belgium, Canada,
Finland, Japan, Poland,
South Korea and Spain
Occupational exposure limits for 1-BP. (GESTIS International limit values for
chemical agents (Occupational exposure limits, OELs) database. Accessed April 18,
2017).
Basel Convention
Halogenated organic solvents (Y41) are listed as a category of waste under the Basel
Convention - Annex I. Although the United States is not currently a party to the Basel
Convention, this treaty still affects U.S. importers and exporters.
OECD Control of
Transboundary
Movements of Wastes
Destined for Recovery
Operations
Halogenated organic solvents (A3150) are listed as a category of waste subject to The
Amber Control Procedure under Council Decision C (2001) 107/Final.
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APPENDIX B PROCESS, RELEASE AND OCCUPATIONAL
EXPOSURE INFORMATION
This appendix provides information and data found in preliminary data gathering for 1-BP.
B.l Process Information
Process-related information for the risk evaluation may include process diagrams, descriptions and
equipment. Such information may inform potential release sources and worker exposure activities. EPA
will consider this information in combination with available monitoring data and estimation methods
and models, as appropriate, to quantity occupational exposure and releases for the various conditions of
use in the risk evaluation. Most of the process-related information provided below, especially
descriptions pertaining to 1-BP use in degreasing (vapor, cold and aerosol), spray adhesive, dry cleaning
and spot cleaning, has been previously compiled, described and peer reviewed in EPA's 2.016 Draft Risk
Assessment (\ v N \ -016b).
B.l.l Manufacture (Including Import)
B.l.1.1 Domestic Manufacture
1-BP is produced by reacting n-propyl alcohol with hydrogen bromide and then removing the excess
water that forms in the process (N 13.). The reaction product may then be distilled, neutralized
with sodium hydrogen carbonate, packaged and stored (Ichihara et at.. 2004).
B.l.1.2 Import
EPA expects that imported chemicals are often stored in warehouses prior to distribution for further
processing and use. In some cases, the chemicals may be repackaged into differently sized containers,
depending on customer demand, and QC samples may be taken for analyses.
B.l.1.3 Processing and Distribution
Based on the reported industrial processing operations in the 2) >R, 1-BP may be incorporated into
a variety of formulations, products and articles, or used industrially as a chemical intermediate (U.S.
EPA. 2016a). Some industrial or commercial products may also be repackaged into appropriately-sized
containers to meet specific customer demands ( 2016a).
B.l.1.4 Processing as a Reactant
Processing as a reactant or intermediate is the use of 1-BP as a feedstock in the production of another
chemical via a chemical reaction in which 1-BP is consumed to form the product. EPA has not identified
specific information for the processing of 1-BP as a reactant.
B.l.1.5 Incorporated into Formulation, Mixture or Reaction Product
Incorporation into a formulation, mixture or reaction product refers to the process of mixing or blending
of several raw materials to obtain a product or mixture (e.g., adhesives and sealants). EPA has not
identified 1-BP specific formulation processes.
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B.l.1.6 Incorporated into Article
Incorporation into an article typically refers to a process in which a chemical becomes an integral
component of an article that is distributed for industrial, trade, or consumer use. Exact process
operations involved in the incorporation of 1-BP are dependent on the article. EPA will further
investigate the potential use of 1-BP in this type of process during the risk evaluation.
B.l.1.7 Repackaging
Typically, repackaging sites receive the chemical in bulk containers and transfer the chemical from the
bulk container into another smaller container in preparation for distribution in commerce. Based on
EPA's knowledge of the chemical industry, worker activities at repackaging sites may involve manually
unloading 1-BP from bulk containers into the smaller containers for distribution or
connecting/disconnecting transfer lines used to transfer 1-BP product between containers and analyzing
QC samples. EPA will further investigate the potential use of 1-BP in this type of process during the risk
evaluation.
B.l.1.8 Recycling
A general description of waste solvent recovery processes was identified. Waste solvents are generated
when it becomes contaminated with suspended and dissolved solids, organics, water, or other substance
(U.S. EPA. 1980). Waste solvents can be restored to a condition that permits reuse via solvent
reclamation/recycling (U.S. EPA. 1980). The recovery process involves an initial vapor recovery (e.g.,
condensation, adsorption and absorption) or mechanical separation (e.g., decanting, filtering, draining,
setline and centrifuging) step followed by distillation, purification and final packaging (U.S. EPA,
1980).
B.1.2 Uses
In the Scope Document (EPA-HO-OPPT-20 M9), EPA has grouped uses based on CDR
categories and identified examples within these categories as subcategories of use. Note that some
subcategories of use may be grouped under multiple CDR categories. The differences between these
uses will be further investigated during risk evaluation.
B.l.2.1 Solvents for Cleaning and Degreasing
Solvents for Cleaning and Degreasing category encompasses chemical substances used to dissolve oils,
greases and similar materials from a variety of substrates including metal surfaces, glassware and
textiles. This category includes the use of 1-BP in vapor degreasing, cold cleaning and in industrial and
commercial aerosol degreasing products.
Vapor Degreasing
Vapor degreasing is a process used to remove dirt, grease and surface contaminants in a variety of metal
cleaning industries. 1-BP is often used to replace chlorinated solvents in vapor degreasing applications.
Vapor degreasing may take place in batches or as part of an in-line (i.e., continuous) system. In batch
machines, each load (parts or baskets of parts) is loaded into the machine after the previous load is
completed. With in-line systems, parts are continuously loaded into and through the vapor degreasing
equipment as well as the subsequent drying steps. Vapor degreasing equipment can generally be
categorized into one of the three categories: (1) batch vapor degreasers, (2) conveyorized vapor
degreasers and (3) web vapor degreasers.
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Each category of vapor degreaser is described below.
Batch Vapor Degreasers
• Open top vapor degreasers (OTVI)): In OTVDs, a vapor cleaning zone is created by heating the
liquid solvent in the OTVD causing it to volatilize. Workers manually load or unload fabricated
parts directly into or out of the vapor cleaning zone. The tank usually has chillers along the side
of the tank to prevent losses of the solvent to the air. However, these chillers are not able to
eliminate emissions, and throughout the degreasing process, significant air emissions of the
solvent can occur. These air emissions can cause issues with both worker health and safety as
well as environmental issues. Additionally, the cost of replacing solvent lost to emissions can be
expensive (NEWMOA. 2001). FigureApx B-l illustrates a standard OTVD. The use of 1-BP in
OTVD has been previously described in EPA's 2016 Draft Risk Assessment (U.S. EPA 2016b).
o
-a
Vapor Zone
]
Condensing Coils
Water Jacket
~ /Water Separator
Boiling sump
IZ£
Heat Source
Figure Apx B-l. Open Top Vapor Degreaser
• OTVD with enclosure: OTVDs with enclosures operate the same as standard OTVDs except that
the OTVD is enclosed on all sides during degreasing. The enclosure is opened and closed to add
or remove parts to/from the machine, and solvent is exposed to the air when the cover is open.
Enclosed OTVDs may be vented directly to the atmosphere or first vented to an external carbon
filter and then to the atmosphere (U.S. EPA 2004a). Figure Apx B-2 illustrates an OTVD with
an enclosure. The dotted lines in Figure Apx B-2 represent the optional carbon filter that may or
may not be used with an enclosed OTVD.
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Carbon Filter
Loading/
unloading
lock
Conden
vapor Zone
Boiling su
Heat Sou
sing Colls
Jacket
er Separator
FigureApx B-2. Open Top Vapor Degreaser with Enclosure
• Closed-loop degreasing system (airtight): In closed-loop degreasers, parts are placed into a
basket, which is then placed into an airtight work chamber. The door is closed and solvent vapors
are sprayed onto the parts. Solvent can also be introduced to the parts as a liquid spray or liquid
immersion. When cleaning is complete, vapors are exhausted from the chamber and circulated
over a cooling coil where the vapors are condensed and recovered. The parts are dried by forced
hot air. Air is circulated through the chamber and residual solvent vapors are captured by carbon
adsorption. The door is opened when the residual solvent vapor concentration has reached a
specified level (Kanegsberg and Kanegsberg. 2011). Figure_Apx B-3 illustrates a standard
closed-loop vapor degreasing system.
| Vent
Solvent Abatement Loop
Refrigeration
Distillation
Solvent Sump
Electric Heat
Solvent Tank(s)
Working Chamber
Workload
Figure Apx B-3. Closed-Loop/Vacuum Vapor Degreaser
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• Airless degreasing system (vacuum drying): Airless degreasing systems are also sealed, closed-
loop systems, but remove air at some point of the degreasing process. Removing air typically
takes the form of drawing vacuum, but could also include purging air with nitrogen at some point
of the process (in contrast to drawing vacuum, a nitrogen purge operates at a slightly positive
pressure). In airless degreasing systems with vacuum drying only, the cleaning stage works
similarly as with the airtight closed-loop degreaser. However, a vacuum is generated during the
drying stage, typically below 5 torr (5 mmHg). The vacuum dries the parts and a vapor recovery
system captures the vapors (Kanegsberg and Kanegsberg, 2011; NEWv R >A J\X< I, I v K \
200 n.
• Airless vacuum-to-vacuum degreasing system: Airless vacuum-to-vacuum degreasers are true
"airless" systems because the entire cycle is operated under vacuum. Typically, parts are placed
into the chamber, the chamber sealed, and then vacuum drawn within the chamber. The typical
solvent cleaning process is a hot solvent vapor spray. The introduction of vapors in the vacuum
chamber raises the pressure in the chamber. The parts are dried by again drawing vacuum in the
chamber. Solvent vapors are recovered through compression and cooling. An air purge then
purges residual vapors over an optional carbon adsorber and through a vent. Air is then
introduced in the chamber to return the chamber to atmospheric pressure before the chamber is
opened (Durkee. 2014; NEWMOA. 2001).
The general design of vacuum vapor degreasers and airless vacuum degreasers is similar as illustrated in
FigureApx B-3 for closed-loop systems except that the work chamber is under vacuum during various
stages of the cleaning process.
Conveyorized Vapor Degreasers
Conveyorized vapor degreasing systems are solvent cleaning machines that use an automated parts
handling system, typically a conveyor, to automatically provide a continuous supply of parts to be
cleaned. Conveyorized degreasing systems are usually fully enclosed except for the conveyor inlet and
outlet portals. Conveyorized degreasers are likely used in similar shop types as batch vapor degreasers
except for repair shops, where the number of parts being cleaned is likely not large enough to warrant
the use of a conveyorized system.
There are seven major types of conveyorized degreasers ( ):
• Monorail degreasers: Monorail degreasing systems are typically used when parts are already
being transported throughout the manufacturing areas by a conveyor ( ). They use
a straight-line conveyor to transport parts into and out of the cleaning zone. The parts may enter
one side and exit and the other or may make a 180° turn and exit through a tunnel parallel to the
entrance ( ). Figure Apx B-4 illustrates a typical monorail degreaser (
1977V
Page 86 of 123
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Spray
Pump
Boi
Chamber
Water
Jacket
FigureApx B-4. Monorail Degreaser
• Cross-rod degreasers: Cross-rod degreasing systems utilize two parallel chains connected by a
rod that support the parts throughout the cleaning process. The parts are usually loaded into
perforated baskets or cylinders and then transported through the machine by the chain support
system. The baskets and cylinders are typically manually loaded and unloaded ( J.S. EPA, 1977).
Cylinders are used for small parts or parts that need enhanced solvent drainage because of
crevices and cavities. The cylinders allow the parts to be tumbled during cleaning and drying and
thus increase cleaning and drying efficiency. Figure_ Apx B-5 illustrates a typical cross-rod
degreaser (U.S. EPA 1977).
Conveyor Path
Chain Support
Work Basket
Water
Jacket
Boiling Chamber
Figure Apx B-5. Cross-Rod Degreaser
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• Vibra degreasers: In vibra degreasing systems, parts are fed by conveyor through a chute that
leads to a pan flooded with solvent in the cleaning zone. The pan and the connected spiral
elevator are continuously vibrated throughout the process, causing the parts to move from the
pan and up a spiral elevator to the exit chute. As the parts travel up the elevator, the solvent
condenses and the parts are dried before exiting the machine (J.S. EPA. 1977).
Workload Discharger Chute
Ascending
Vibrating
Trough —
Condensers
Distillate
Trough
Workload
Entry Chute
Distillate Return
For Counter-
flow Wash
Steam Coils
FigureApx B-6. Vibra Degreaser
• Ferris wheel degreasers: Ferris wheel degreasing systems are generally the smallest of all the
conveyorized degreasers (J.S. EPA. 1977). In these systems, parts are manually loaded into
perforated baskets or cylinders and then rotated vertically through the cleaning zone and back
out. Figure Apx B-7 illustrates atypical ferris wheel degreaser (J.S. EPA. 1977).
Page 88 of 123
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Sear to tumble
baskets
Boiling
Chamber
FigureApx B-7. Ferris Wheel Conveyorized Vapor Degreasing System
• Belt degrecisers: Belt degreasing systems (similar to strip degreasers; see next bullet) are used
when simple and rapid loading and unloading of parts is desired (J.S. EPA. 1977). Parts are
loaded onto a mesh conveyor belt that transports them through the cleaning zone and out the
other side. Figure_Apx B-8 illustrates a typical belt or strip degreaser ( J.S. EPA, 1977).
Conveyor,
Path
Boiling
Chamber
Figure Apx B-8. Belt/Strip Conveyorized Vapor Degreasing System
Page 89 of 123
Work _
Basket
-------
• Strip degreasers: Strip degreasing systems operate similar to belt degreasers except that the belt
itself is being cleaned rather than parts being loaded onto the belt for cleaning.
• Circuit board cleaners: Circuit board degreasers use any of the conveyorized designs. However,
in circuit board degreasing, parts are cleaned in three different steps due to the manufacturing
processes involved in circuit board production (U.S. EPA, 1977).
Continuous Web Vapor Degreasers
Continuous web cleaning machines differ from typical conveyorized degreasers in that they are
specifically designed for cleaning parts that are coiled or on spools such as films, wires and metal strips
(Kanegsberg and Kanegsberg. 2011; U.S. EPA. 2006b). In continuous web degreasers, parts are
uncoiled and loaded onto rollers that transport the parts through the cleaning and drying zones at speeds
>11 feet/minute ( J.S. EPA. 2006b). The parts are then recoiled or cut after exiting the cleaning machine
(Kanegsberg and Kanegsberg. 2011; U.S. EPA. 2006b). FigureApx B-9 illustrates a typical continuous
web cleaning machine.
Figure Apx B-9. Continuous Web Vapor Degreasing System
Cold Cleaning
1-BP can also be used as a solvent in cold cleaners, which are non-boiling solvent degreasing units. Cold
cleaning operations include spraying, brushing, flushing and immersion. In atypical batch-loaded,
maintenance cold cleaner, dirty parts are cleaned manually by spraying and then soaking in the tank.
After cleaning, the parts are either suspended over the tank to drain or are placed on an external rack that
routes the drained solvent back into the cleaner. Batch manufacturing cold cleaners could vary widely,
but have two basic equipment designs: the simple spray sink and the dip tank. The dip tank design
typically provides better cleaning through immersion, and often involves an immersion tank equipped
with agitation (J.S. EPA. 1981). Emissions from batch cold cleaning machines typically result from (1)
evaporation of the solvent from the solvent-to-air interface, (2) "carry out" of excess solvent on cleaned
Page 90 of 123
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parts and (3) evaporative losses of the solvent during filling and draining of the machine ( L,
2006b).
Aerosol Degreasing
Aerosol degreasing is a process that uses an aerosolized solvent spray, typically applied from a
pressurized can, to remove residual contaminants from fabricated parts. The aerosol droplets bead up on
the fabricated part and then drip off, carrying away any contaminants and leaving behind a clean surface.
One example of commercial setting that uses aerosol degreasing operation is repair shops, where service
items are cleaned to remove any contaminants that would otherwise compromise the service item's
operation. Internal components may be cleaned in place or removed from the service item, cleaned, and
then re-installed once dry (U.S. EPA. 2.014a). Aerosol degreasing may occur at either industrial facilities
or at commercial repair shops to remove contaminants on items being serviced.
B.l.2.2 Adhesives and Sealants
1-BP is a component of spray adhesive. In foam cushion manufacturing, workers use a spray gun to
spray-apply adhesive containing 1-BP onto flexible foam surfaces. Adhesive spraying typically occurs
either on an open top workbench with side panels that may have some local ventilation, or in an open
workspace with general room ventilation. After the adhesive is applied, workers hand-press the flexible
foam pieces together to assemble the cushions.
B.l.2.3 Cleaning and Furniture Care Products
1-BP can be used as a solvent in dry cleaning machines and 1-BP formulations such as DrySolv® are
often marketed as "drop-in" replacements for PERC, which indicates that they can be used in third-
generation or higher PERC equipment (TURI. 2012). Dry cleaners who opt to use 1-BP can either
convert existing PERC machines or purchase a new dry cleaning machine specifically designed for 1-
BP. To convert existing PERC machines to use 1-BP, machine settings and components must be
changed to prevent machine overheating and solvent leaks (Btamdo et at... 2010). 1-BP is known to
damage rubber gaskets and seals. It can also degrade cast aluminum, which is sometimes used on
equipment doors and other dry cleaning machine components. In addition, 1-BP is not compatible with
polyurethane and silicone (TTJ ). Worker who handle 1-BP at dry cleaning facilities may be
exposed when 1) adding makeup solvent, typically by manually dumping it through the front hatch, 2)
opening the machine door during the wash cycle, and 3) removing loads from the machines (Btamdo et at..
2010).
In addition, 1-BP is found in products used to spot clean garments. Spot cleaning products can be
applied to the garment either before or after the garment is dry cleaned. Spot cleaning occurs on a
spotting board and spotting agent can be applied from squeeze bottles, hand-held spray bottles or even
from spray guns connected to pressurized tanks. Once applied, the dry cleaner may come into further
contact with the 1-BP if using a brush, spatula, pressurized air or steam or their fingers to scrape or flush
away the stain (Young, 2.012.; NIOSH, 1997).
B.l.2.4 Other Uses
Based on products identified in EPA's preliminary data gathering and information received in public
comments, a variety of other uses may exist for 1-BP including in lubricants, insulation, mold release
products, refrigerants, adhesive accelerants, asphalt extraction, and temperature indicators for laboratory
applications [sqq Preliminary Information on Manufacturing, Processing, Distribution, Use, and
Disposal: 1-Bromopropane, EPA-HQ-QPPT-20 003 (U.S. EPA. 1977)1. EPA has not
Page 91 of 123
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identified any process-specific information to further refine the use of 1-BP in these applications at this
time and more information on these uses will be gathered through expanded literature searches during
risk evaluation.
B.1.3 Disposal
Disposal of a chemical should take into consideration the chemical's potential impact on air quality,
migration to groundwater, effect on biological species, and disposal regulations (if any) (ATSDR.! ).
Due to the high volatility of 1-BP, releases to the atmosphere are expected to be the primary release
route of 1-BP (ATSDR, 2017). Currently, 1-BP is not regulated under federal regulations as a hazardous
waste ( ). However, 1-BP may be disposed of as a hazardous waste if it is present in or
co-mingled with solvent mixtures that are RCRA regulated substances. EPA has not identified further
process information specific to disposal of 1-BP at this time, but will review TRI data submitted for
1-BP, as it becomes available, for information on how wastes containing 1-BP are disposed.
B.2 Occupational Exposure Data
EPA presents below examples of occupational exposure-related information from the preliminary data
gathering. EPA will consider this information and data in combination with other data and methods for
use in the risk evaluation.
TableApx B-l summarizes the release/exposure scenarios and industry sectors with available 1-BP
personal monitoring data from OSHA inspections conducted between 2013 and 2016 (OSHA. , ).
Table Apx B-l. Summary of Release/Exposure Scenarios and Industry Sectors with 1-BP
Personal Monitoring Air Samples Obtained from OSHA Inspections Conducted Between 2013
and 2016
Release/ Kxposure Scenario
NAICS
NAICS Description
Solvents (for cleaning or degreasing)
336412
Aircraft Engine and Engine Parts Manufacturing
Commercial spot cleaning
448190
Other Clothing Stores
Solvents (for cleaning or degreasing)
333517
Machine Tool Manufacturing
Solvents (for cleaning or degreasing)
334418
Printed Circuit Assembly
Solvents (for cleaning or degreasing)
331210
Iron and Steel Pipe and Tube Manufacturing from
Purchased Steel
Solvents (for cleaning or degreasing)
336413
Other Aircraft Parts and Auxiliary Equipment
Manufacturing
Solvents (for cleaning or degreasing)
332813
Electroplating, Plating, Polishing, Anodizing, and
Coloring
Other
926150
Regulation, Licensing, and Inspection of Miscellaneous
Commercial Sectors
Unknown, likely commercial spot
cleaning
323113
Commercial Screen Printing
Page 92 of 123
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TableApx B-l. Summary of Release/Exposure Scenarios and Industry Sectors with 1-BP
Personal Monitoring Air Samples Obtained from OSHA Inspections Conducted Between 2013
and 2016
Release/ Kxposure Scenario
NAICS
NAICS Description
Solvents (for cleaning or degreasing)
332913
Plumbing Fixture Fitting and Trim Manufacturing
Solvents (for cleaning or degreasing)
332721
Precision Turned Product Manufacturing
Solvents (for cleaning or degreasing)
333911
Pump and Pumping Equipment Manufacturing
Table Apx B-2 summarizes the release/exposure scenarios and industry sectors with available area
monitoring data.
Table Apx B-2. Summary of Release/Exposure Scenarios and Industry Sectors with 1-BP Area
Monitoring Air Samples Obtained from OSHA Inspections Conducted Between 2013 and 2016
Kclciisc/ Kxposure Sccnsirio
NAICS
NAICS Description
Solvents (for cleaning or degreasing)
332721
Precision Turned Product Manufacturing
Solvents (for cleaning or degreasing)
333911
Pump and Pumping Equipment Manufacturing
B.3 References related to Risk Evaluation - Environmental Release and
Occupational Exposure
As part of the Systematic Review process, EPA has conducted a full-text screening of literature sources
and identified sources that may be relevant for risk evaluation. This section presents a list of data
sources that may contain process description, environmental release estimate, occupational exposure
data, engineering control and personal protective equipment information for 1-BP. EPA will further
review these data sources and determine their utility for risk evaluation.
Table Apx B-3. Potentially Relevant Data Sources for Process Description Related Information
for 1-BP a
liihlio^mpln
ml
NIOSH (1997). Control of health and safety hazards in commercial
drycleaners: chemical exposures, fire hazards, and ergonomic risk factors.
Education and Information Division. Atlanta. GA.
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3044963
U.S. EPA (2016). TSCA work plan chemical risk assessment: Peer review
draft 1-bromopropane: (n-Propyl bromide) spray adhesives, dry cleaning,
and degreasing uses CASRN: 106-94-5. Washington, DC.
U.S. EPA (2016b)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3355305
Page 93 of 123
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TableApx B-3. Potentially Relevant Data Sources for Process Description Related Information
for 1-BP a
Bil)lio«r;i|)h\
ml
NIOSH (200") Workers' exposures lo n-prop\ 1 bromide ;il ;i pruned
electronics circuit assembly manufacturer. Cincinnati, OH, NIOSH
Division of Surveillance, Hazard Evaluation and Field Studies.
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3355604
NIOSH (2007). Workers' exposures to n-propyl bromide at a hydraulic
power control component manufacturer. Cincinnati, OH, NIOSH Division
of Surveillance, Hazard Evaluation and Field Studies.
NIOSH (2007a)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3355621
U.S. EPA (1995). Guidance document for the halogenated solvent cleaner
NESHAP. Research Triangle Park, NC, Office of Air Quality Planning and
Standards, Information Transfer and Program Integration Division, Control
Technology Center, Federal Small Business Assistance Program.
U.S. EPA (1995)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/do wnload/reference_id/3 827323
NIOSH (2003). NIOSH Health Hazard Evaluation Report: HETA No. 99-
0260-2906. Marx Industries. Inc.. Sawmills. North Carolina. Hazard
Evaluation and Technical Assistance Branch. Cincinnati. OH. National
Institute for Occupational Health and Safety.
Harney et al. (2003)
https://hero.epa.gov/heronet/index.cfm/refer
ence/do wnload/reference_id/3 970467
U.S. EPA; ICF Consulting (2004). The U.S. solvent cleaning industry and
the transition to non ozone depleting substances.
U.S. EPA; ICF Consulting (2004)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3982140
HSIA (2008). Chlorinated solvents - The key to surface cleaning
performance.
HSIA (2008)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3982144
11 The data sources identified are based on preliminary results to date of the full-text screening step of the Systematic Review
process. Further screening and quality control are on-going.
Table Apx B-4. Potentially Relevant Data Sources for Estimated or Measured Release Data for
1-BP a
liihlio^mpln
ml
Japanese Ministry of Environment (2017). 1-Bromopropane. Tokyo, Japan.
Japanese Ministry of Environment (2017)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3980936
CAMP, Inc., (2000). Final report: Beyond pollution prevention: Removal
of organochlorines from industrial feedstocks and processes in the Great
Lakes Basin, The Great Lakes Protection Fund, The Joyce Foundation.
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3981054
HSIA (2008). Chlorinated solvents - The key to surface cleaning
performance.
(HSIA. 2008)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3982144
a The data sources identified are based on preliminary results to date of the full-text screening step of the Systematic Review
process. Further screening and quality control are on-going.
Table Apx B-5. Potentially Relevant Data Sources for Personal Exposure Monitoring and Area
Monitoring Data for 1-BP a
liihlio^mpln
ml
Hanley, K. W., et al. (2006). "Urinary bromide and breathing zone
concentrations of 1-bromopropane from workers exposed to flexible foam
sprav adhesives." Annals of Occupational Hveiene 50(6): 599-607.
Hanley et al. (2006a)
https ://hero. epa.gov/heronet/index. cfm/refere
nce/download/reference id/607476
NIOSH (2003). NIOSH Health Hazard Evaluation Report: HETA No. 99-
0260-2906. Marx Industries. Inc.. Sawmills. North Carolina. Hazard
Evaluation and Technical Assistance Branch. Cincinnati. OH. National
Institute for Occupational Health and Safety.
Harnev et al. (2003)
https ://hero. epa.gov/heronet/index. cfm/refere
nce/download/reference_id/1379492
Page 94 of 123
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TableApx B-5. Potentially Relevant Data Sources for Personal Exposure Monitoring and Area
Monitoring Data for 1-BP a
Bibliognipln
ml
Toraason,M.. el ;il (2(>Ui) " \sscsmiiciii nf l)\ \ sliand breaks in
leukocytes of workers occupationally exposed to 1-bromopropane."
Toxicoloeical Sciences 72rS-l"»: 250.
https ://hero. epa.gov/heronet/index. cfm/refere
nce/download/reference id/1733747
OSHA (2013). OSHA/NIOSH hazard alert: 1-bromopropane. Washington,
DC, U.S. Department of Labor.
https ://hero. epa.gov/heronet/index. cfm/refere
nce/download/reference id/2347177
NIOSH (1997). Control of health and safety hazards in commercial
drycleaners: chemical exposures, fire hazards, and ergonomic risk factors.
Education and Information Division. Atlanta. GA.
NIOSH (.1.997)
https ://hero .epa. gov/heronet/index. cfm/refere
nce/download/reference id/3044963
NIOSH (2007). Workers' exposures to n-propyl bromide at a printed
electronics circuit assembly manufacturer. Cincinnati, OH, NIOSH
Division of Surveillance, Hazard Evaluation and Field Studies.
https ://hero. epa.gov/heronet/index. cfm/refere
nce/download/reference id/3355604
NIOSH (2007). Workers' exposures to n-propyl bromide at a hydraulic
power control component manufacturer. Cincinnati, OH, NIOSH Division
of Surveillance, Hazard Evaluation and Field Studies.
https ://hero. epa.gov/heronet/index. cfm/refere
nce/download/reference id/3355621
CDC (2016). Criteria for a recommended standard: Occupational exposure
to 1-bromopropane. Cincinnati, OH, National Institute for Occupational
Safety and Health.
CDC (20.1.6)
https ://hero. epa.gov/heronet/index. cfm/refere
nce/download/reference id/3827326
NIOSH (2003). NIOSH Health Hazard Evaluation Report: HETA No. 99-
0260-2906. Marx Industries. Inc.. Sawmills. North Carolina. Hazard
Evaluation and Technical Assistance Branch. Cincinnati. OH. National
Institute for Occupational Health and Safety.
Harney et al. (2003)
https ://hero. epa.gov/heronet/index. cfm/refere
nce/download/reference_id/3970467
Hanley, K. W., et al. (2006). "Urinary bromide and breathing zone
concentrations of 1-bromopropane from workers exposed to flexible foam
sprav adhesives. Part3." Annals of Occupational Hveiene 6: 599-607.
Hanley et al. (2006b)
https ://hero. epa.gov/heronet/index. cfm/refere
nce/download/reference id/3974876
OSHA (2010). Input received through web forum for identifying hazardous
chemicals for which OSHA should develop exposure reduction strategies.
Washington, DC, U.S. Department of Labor, Occupational Safety and
Health Administration.
OSHA (20.1.0)
https ://hero. epa.gov/heronet/index. cfm/refere
nce/download/reference_id/3978176
ATSDR (2017). Toxicological profile forl-bromopropane. Atlanta, GA,
Division of Toxicology and Human Health Sciences, Environmental
Toxicology Branch.
ATSDR (20.1.7)
https ://hero. epa.gov/heronet/index. cfm/refere
nce/download/reference id/3982334
OSHA; NIOSH (2013). Hazard alert: 1-Bromopropane. Washington, DC,
Occupational Safety and Health Administration & National Institute for
Occupational Safety and Health.
https ://hero. epa.gov/heronet/index. cfm/refere
nce/download/reference id/3994171
a The data sources identified are based on preliminary results to date of the full-text screening step of the Systematic Review
process. Further screening and quality control are on-going.
Table Apx B-6. Potentially Relevant Data Sources for Engineering Controls and Personal
Protective Equipment Information for 1-BP a
liiblio»rnphv
ml
Raymond, L. W. and M. D. Ford (2007). "Severe illness in furniture makers
usins a new slue: 1-bromoDroDanc toxicity confounded bv arsenic." Journal
of Occupational and Environmental Medicine 49(9): 1009-1019.
Raymond and Ford (2007)
https ://hero .epa. gov/heronet/index. cfm/refer
ence/download/reference id/1025819
NIOSH (2003). NIOSH Health Hazard Evaluation Report: HETA No. 99-
0260-2906. Marx Industries. Inc.. Sawmills. North Carolina. Hazard
Evaluation and Technical Assisstance Branch. Cincinnati. OH. National
Institute for Occupational Health and Safety.
Harnev et al. (2003)
https ://hero .epa. gov/heronet/index. cfm/refer
ence/download/referenceid/1379492
Page 95 of 123
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TableApx B-6. Potentially Relevant Data Sources for Engineering Controls and Personal
Protective Equipment Information for 1-BP a
Bibliography
ml
Hanley, K. W . el al () "\-;ioM\ l-S-(ii-pinp\ h-l-c> sicmc in mi mic
from workers exposed to 1-bromopropane in foam cushion spray
adhesives." Annals of Occupational Hveiene 53(7): 759-769.
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ence/download/reference id/1689272
Kawai, T., et al. (2001). "Biological monitoring of occupational exposure
to 1-bromopropane by means of urinalysis for 1-bromopropane and
bromide ion." Biomarkers 6(5): 303-312.
Kawai et al. (2001)
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ence/download/reference id/1733 873
Eisenberg, J. and J. Ramsey (2010). Evaluation of 1-Bromopropane Use in
Four New Jersey Commercial Drv Cleanine Facilities. New Jersey
Dcnarlmerit of Health and Senior Services. July 2010. National Board of
Labour Protection (Finland).
Eisenberg and Ramsev ('2010)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/do wnload/referenceid/1737891
OSHA (2013). OSHA/NIOSH hazard alert: 1-bromopropane. Washington,
DC, U.S. Department of Labor.
OSHA (20.1.3)
https ://hero .epa. gov/heronet/index. cfm/refer
ence/download/reference id/2347177
NIOSH (1997). Control of health and safety hazards in commercial
drycleaners: chemical exposures, fire hazards, and ergonomic risk factors.
Education and Information Division. Atlanta. GA.
NIOSH (.1.997)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3044963
NIOSH (2007). Workers' exposures to n-propyl bromide at a printed
electronics circuit assembly manufacturer. Cincinnati, OH, NIOSH
Division of Surveillance, Hazard Evaluation and Field Studies.
NIOSH (2007b)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3355604
NIOSH (2007). Workers' exposures to n-propyl bromide at a hydraulic
power control component manufacturer. Cincinnati, OH, NIOSH Division
of Surveillance, Hazard Evaluation and Field Studies.
NIOSH (2007a)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3355621
U.S. EPA (1995). Guidance document for the halogenated solvent cleaner
NESHAP. Research Triangle Park, NC, Office of Air Quality Planning and
Standards, Information Transfer and Program Integration Division, Control
Technology Center, Federal Small Business Assistance Program.
U.S. EPA (.1.995)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/do wnload/reference_id/3 827323
CDC (2016). Criteria for a recommended standard: Occupational exposure
to 1-bromopropane. Cincinnati, OH, National Institute for Occupational
Safety and Health.
CDC (20.1.6)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3827326
CDPH (2017). 1-Bromopropane. Richmond, CA, California Department of
Public Health, California Department of Industrial Relations: 6.
CDPH (20.1.7)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3969295
NIOSH (2003). NIOSH Health Hazard Evaluation Report: HETA No. 99-
0260-2906. Marx Industries. Inc.. Sawmills. North Carolina. Hazard
Evaluation and Technical Assisstance Branch. Cincinnati. OH. National
Institute for Occupational Health and Safety.
Harnev et al. (2003)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/do wnload/reference_id/3 970467
NIOSH (2014). International chemical safety cards (ICDC): 1-
bromopropane. Atlanta, GA.
NIOSH (20.1.4)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3978148
HSIA (2008). Chlorinated solvents - The key to surface cleaning
performance.
HSIA (2008)
https://hero.epa.gov/heronet/index.cfm/refer
ence/download/reference id/3982144
OSHA; NIOSH (2013). Hazard alert: 1-Bromopropane. Washington, DC,
Occupational Safety and Health Administration & National Institute for
Occupational Safety and Health.
OSHA; NIOSH (20.1.3)
https ://hero .epa. gov/heronet/index.cfm/refer
ence/download/reference id/3994171
a The data sources identified are based on preliminary results to date of the full-text screening step of the Systematic Review
process. Further screening and quality control are on-going.
Page 96 of 123
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APPENDIX C ESTIMATES OF SURFACE WATER
CONCENTRATION
SCENARIO 1. REPORTED RELEASES TO TRI
For 1-BP, there is one facility reporting water releases from the 2016 TRI reporting period, the Flint
Hills Resources facility. This facility, located in Corpus Christi, TX, has reported 1 lb of 1-BP released
to the Nueces River with 100% from stormwater on an annual basis. They also reported 4 lbs of 1-BP
released to an unnamed water body with 83% from stormwater on an annual basis. These are direct
releases to water and thus are presumed to be untreated at a POTW. A quick calculation of site specific
surface water concentration was performed using E-FAST assuming that the total release occurs over 1
day, 20 days or 100 days. Two receiving waters were used:
a. Nueces River - the NPDES permit for Corpus Christ City POTW TX0047082 was used as a
surrogate for this direct release. 0% removal was assumed since this is listed as a direct release.
b. Unnamed Waterbody - the NPDES permit for the reporting facility was available in EFAST with
the receiving water body listed as the Corpus Christi Bay. Acute dilution factors were used to
estimate the surface water concentration, again with 0% removal.
The resulting estimated surface water concentrations, based on the reported releases and locations, are
well below the acute and chronic concentrations of concern even if the annual release amount occurs
over 1 day. The maximum estimated surface water concentration is 78 |ig/L for this scenario. The acute
concentration of concern is 4860 ppb and the chronic concentration of concern is 243 ppb.
TableApx C-l. Estimated Surface Concentrations from Water Releases Reported to TRI
SCENARIO 1: REPORTED RELEASES TO TRI
Acute COC = 4860 ppb
Chronic COC = 2430 ppb
From TRI reporting: 1 reporting facility: Flint Hills Resources Corpus Christi LLC - West Plant
1 lb to Nueces River (100% from stormwater);
4 lbs to 'unnamed water body" (83% from stormwater)
Wastewater Treatment Removal= 0%; direct release
(Note: NPDES for Corpus Christi City POTW used as surrogate for Nueces River. Flint Hills Resources facility
modeled directly)
Nueces River (Corpus Christi City -
TX0047082)
Flint Hills Resources - Corpus Christi Bay,
(TX0006289)
7Q10 SWC jig/L
SWC* jig/L
Annual Release
Amount lb (kg)
1 day/yr
20 days/yr
100 days/yr
1 day/yr
20 days/yr
100 days/yr
1 (0.45)
7.86
0.39
0.08
19.4
0.97
0.19
4 (1.81)
31.60
1.58
0.31
77.90
3.90
0.77
* Acute dilution factor for bay
Page 97 of 123
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APPENDIX D SUPPORTING TABLE FOR INDUSTRIAL AND COMMERCIAL ACTIVITIES
AND USES CONCEPTUAL MODEL
(Note that rows shaded in gray are not proposed for further analysis)
TableApx D-l. Industrial and Commercial Activities and Uses Conceptual Model Supporting Table
l.ili( \ik-
Slum-
r.\|>iisuiv
Sivn.irio
I!\|)iisuiv
l';illi\\;i\
I!\|)iisiiiv
KhmU-
Ri'i'i'plnr/
Piipukiliiiii
Proposi-d lor
I'll li Ik-r
All:il\sis
K;ilion;ik- fur 1'inllur Aii:il\sis / No I'lii'llur .\n;il\sis
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be <2 min due to
rapid volatilization and the fraction absorbed was
measured to be low (0.16%) by NIOSH. The number of
sites mfg 1-BP is limited per CDR (3 sites).
Domestic
Manufacture
Domestic
Manufacture
Manufacture of
1-BP via
reaction of n-
propyl alcohol
and hydrogen
Vapor
Inhalation
Workers
Yes
Due to high volatility (VP = 146 torr at 20°C),
inhalation pathway should be further analyzed.
Manufacture
I .iquid
Contact
] )ermal
ONLJ
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical
bromide
Vapor
Inhalation
ONU
Yes
Due to high volatility (VP = 146 torr at 20°C),
inhalation pathway will be further analyzed.
Mist
Dermal/
Inhalation
Workers,
ONU
No
Mist generation is not expected during mfg and will not
be further analyzed.
Liquid
Contact
Dermal
Workers
Yes
Contact time with skin is expected to be <2 min due to
rapid volatilization and the fraction absorbed was
measured to be low (0.16%) by NIOSH. The number of
import sites is limited (<9 sites) per CDR. Exposure will
only occur in the event the imported material is
repackaged.
Manufacture
Import
Import
Repackaging
of import
containers
Vapor
Inhalation
Workers
Yes
Exposure expected only in the event the imported
material is repackaged into different sized containers.
Exposure frequency may be low.
I .iquid
Contact
1 )ermal
ONLJ
No
Dermal exposure is expected to be primarily to workers
directly involved in working with the chemical.
Vapor
Inhalation
ONU
Yes
Exposure expected only in the event the imported
material is repackaged into different sized containers.
Exposure frequency may be low.
Page 98 of 123
-------
TableApx D-l. Industrial and Commercial Activities and Uses Conceptual Model Supporting Table
Life ( \ ik-
Sla»i-
I!\|)iisiiiv
Siviiuriii
I".\|)IISIIIV
l';illl\\;i\
l!\|)osuiv
KhmU-
Ri'i'i'plur/
I'lipilhlliiili
PropuM-d fur
I'll rl Ik-r
An
-------
TableApx D-l. Industrial and Commercial Activities and Uses Conceptual Model Supporting Table
l.ili( \ik-
Shim-
I!\|)iisiiiv
Sivii.irin
I".\|)IISIIIV
l';illl\\;i\
l!\|)osuiv
KhmU-
Ri'i'i'plur/
Piipukiliiiii
PropuM-d lor
I'll il Ik-|-
An
-------
TableApx D-l. Industrial and Commercial Activities and Uses Conceptual Model Supporting Table
Life ( \ ik-
Sla»i-
I!\|)iisiiiv
Sivnurin
I".\|)IISIIIV
l';illl\\;i\
l!\|)osuiv
KhmU-
Ri'i'i'plur/
I'lipilhlliiili
PropuM-d fur
I'll rl Ik-r
An
-------
TableApx D-l. Industrial and Commercial Activities and Uses Conceptual Model Supporting Table
Life ( \ ik-
(;iU-»nr\
I!\|)iisiiiv
Sivii.irin
I".\|)IISIIIV
l';illl\\;i\
l!\|)osuiv
KhmU-
Ri'i'i'plur/
I'lipilhlliiili
PropuM-d fur
I'll rl Ik-r
An
-------
TableApx D-l. Industrial and Commercial Activities and Uses Conceptual Model Supporting Table
Life ( \ ik-
(;iU-»iir\
I!\|)iisiiiv
Sivn.irin
I".\|)IISIIIV
l';illl\\;i\
l!\|)osuiv
KhmU-
Ri-i'i-plur/
I'lipilhlliiili
PropuM-d for
I'll il Ik-|-
An
-------
TableApx D-l. Industrial and Commercial Activities and Uses Conceptual Model Supporting Table
Life ( \ ik-
I!\|)iisiiiv
Sivnurin
I".\|)IISIIIV
l';illl\\;i\
l!\|)osuiv
KhmU-
Ri'i'i'plur/
I'lipilhlliiili
I'mpusi-d for
I'll il Ik-|-
An
-------
TableApx D-l. Industrial and Commercial Activities and Uses Conceptual Model Supporting Table
l.ili( \ik-
Shim-
I!\|)iisiiiv
Siviiuriii
I".\|)IISIIIV
Pathway
l!\|)osuiv
KhmU-
Ri'i'i'plur/
Population
Proposi-d lor
I'll il Ik-|-
An
-------
APPENDIX E SUPPORTING TABLE FOR CONSUMER ACTIVITIES AND USES, GENERAL
POPULATIONS, ECOLOGICAL RECEPTORS, AND ENVIRONMENTAL
RELEASES AND WASTES CONCEPTUAL MODEL
(Note that rows shaded in gray are not proposed for further analysis)
TableApx E-l. Consumer Scenario Table
l.ilo(\elo
S(;i»e
Siihciilo^on
Rolen so from
SOU TOO
I'.xposiiro
Palhwav
Route
Reeeptor
lu rl lior
An;il\sis
Killioiiiilo l«ir I'll r( her An;il\sis /
No lurlher \nal\sis
Co-
Location
with dry
cleaners
Cleaning and
Furniture Care
Products
Vapor
Vapor
Inhalation
Co-located
populations
Yes
Based on the VP (146 mm Hg) of
1-BP and the conditions of use,
inhalation exposures to 1-BP in
the vapor phase is expected.
\ apor
\ apor
Oral
Dermal
( o-localed
populations
\o
luuesiKHi of 1-1)1' is auiicipaled lo
he low since I-I5I' ise\pecled in
he absorbed in I lie hum quickls
and uoi ha\ e appreciable abiliiv
lo ira\el up ilic mucosal ele\alor
and be swallowed
Consumer
Use
Solvent (for
cleaning or
degreasing)
Aerosol spray
degreaser/cleaner
Spray
Vapor/Mist
Inhalation
Consumers
Bystanders
Yes
Based on the VP (146 mm Hg) of
1-BP and the conditions of use,
inhalation exposures to 1-BP in
the vapor phase from use of
consumer products is expected.
Spray
Direct dermal
contact; incl
occluded
dermal contact
Dermal
Consumers
Yes
Based on conditions of use,
consumers may have direct
dermal contact to 1-BP. Occluded
exposures may be higher.
Spra>
Direct dermal
contact. mcl
occluded
dermal contact
Dermal
l!> slanders
\o
I!>slanders are uoi expected lo
ha\e direct dermal contact lo 1-
151'
Spra>
Vapor \lisi
()ral
('oiisiiniers
P>\slanders
\o
limesiiouof I-I5I' is anticipated lo
be low since I-I5I' ise\pecled lo
be absorbed in I lie hum quickls
and uoi ha\ e appreciable abiliiv
Page 106 of 123
-------
TableApx E-l. Consumer Scenario Table
l.ilV < \cle
S(a»e
Csilcfion
Suhcaleiion
Release from
sou icc
r.\|)ONIMV
Palhwav
Rome
Reeeplor
I'll rl her
An;il\sis
Riilioiiiile lor l-'urlher Analysis /
No l-'n rl her An;il\sis
Ui ira\el up the niuensal elc\alnr
and be t.wallowed.
Consumer
Use
Cleaning and
Furniture Care
Products
Spot Cleaner, Stain
Remover
Spray
Vapor/Mist
Inhalation
Consumers
Bystanders
Yes
Based on the VP (146 mm Hg) of
1-BP and the conditions of use,
inhalation exposures to 1-BP in
the vapor phase from use of
consumer products is expected.
Spray
Direct dermal
contact; incl
occluded
dermal contact
Dermal
Consumers
Yes
Based on conditions of use,
consumers may have direct
dermal contact to 1-BP. Occluded
exposures may be higher.
Spray
Direct dermal
contact: incl
occluded
dermal contact
Dermal
Bystanders
No
Bystanders arc not expected to
have direct dermal contact to 1 -
BP
Spray
Vapor/Mist
Oral
Consumers
Bystanders
No
Ingestion of 1-BP is anticipated to
be low since 1-BP is expected to
be absorbed in the lung quickly
and not have appreciable ability
to travel up the mucosal elevator
and be swallowed.
Consumer
Use
Cleaning and
Furniture Care
Products
Liquid Cleaner (e.g.
coin and scissor
cleaner)
Volatilization
vapor
Inhalation
Consumers
Bystanders
Yes
Based on the VP (146 mm Hg) of
1-BP and the conditions of use,
inhalation exposures to 1-BP in
the vapor phase from use of
consumer products is expected.
Liquid
Direct dermal
contact; incl
occluded
dermal contact
Dermal
Consumers
Yes
Based on conditions of use,
consumers may have direct
dermal contact to 1-BP. Occluded
exposures may be higher.
Liquid
Duvet dermal
annuel
Dermal
l!> slanders
\n
I!> slanders are uoi expected lo
lia\e tlireel dermal enuiael In 1-
151'
Liquid or
\ apnr IIIISl
limesiinu
Oral
( ousuniei's
l!> slanders
\n
limesimii of l-ISI' is aniieipaled In
he Inw si nee 1-131' ise\peeled In
he ahsnrhed in ilie hum quiekh
and uni lia\ e appreciable ahiliiv
Page 107 of 123
-------
TableApx E-l. Consumer Scenario Table
l.ilV < \ck-
S(;i»o
Csilcfion
Siihciilciinn
Uck'iiso from
sou icc
I'1\|)osiiiv
PiKhwin
Roule
Km'plor
I'll rl her
An;il\sis
Killifiiiiilc lor l-'urther An;il\sis /
No l-'urllH-r An;il\sis
Ui ira\el np ihe mucosal ele\alor
and be t.wallowed.
Consumer
Use
Cleaning and
Furniture Care
Products
Liquid Spray/aerosol
Cleaner
Spray
Vapor/mist
Inhalation
Consumers
Bystanders
Yes
Based on the VP (146 mm Hg) of
1-BP and the conditions of use,
inhalation exposures to 1-BP in
the vapor phase is expected.
Spray
Dermal
contact; incl
occluded
dermal contact
Dermal
Consumers
Yes
Based on conditions of use,
consumers may have direct
dermal contact to 1-BP. Occluded
exposures may be higher.
Spra>
Direct Dermal
Contact.
Dermal
I3> slanders
\o
I!>slanders are noi e\peeled to
ha\e direct dermal annuel in 1-
131'
Spra>
Vapor misi
()ral
(oiisnniers
l>> slanders
\o
limesiion of 1-131' is anticipated lo
he low since 1-131' is expected In
he absorbed in I lie Imm quickls
and noi lia\ e appreciable abiliiv
lo Ii;inel np ihc mucosal ele\alor
and be swallowed
Consumer
Use
Other Uses
Arts, crafts and hobby
materials - adhesive
accelerant
Spray
Vapor/mist
Inhalation
Consumers
Bystanders
Yes
Based on the VP (146 mm Hg) of
1-BP and the conditions of use,
inhalation exposures to 1-BP in
the vapor phase is expected.
Spray
Dermal
contact; incl
occluded
dermal contact
Dermal
Consumers
Yes
Based on conditions of use,
consumers may have direct
dermal contact to 1-BP. Occluded
exposures may be higher.
Spra>
Direct Dermal
Contact
Dermal
I3> slanders
\o
I!>slanders are noi expected to
ha\e direct dermal contact to 1-
151'
Spra>
Vapor misi
Oral
(oiisnniers
P>\slanders
\o
limesiionof 1-131' is anticipated to
be low since 1-131' ise\pecled to
be absorbed in the Imm quickls
and noi ha\ e appreciable abiln\
lo ira\el np ihc mucosal ele\alor
and be swallowed
Page 108 of 123
-------
TableApx E-l. Consumer Scenario Table
l.ilV < \ck-
S(;i»o
Csilcfion
Siihciilciinn
Uck'iiso from
source
r.xposuiT
Roule
Km'plor
I'iii'IIkt
An;il\sis
K;ilifiiiiilc l«ir I'lirlhcr \n;il>sis /
No lull ho i- An;il\sis
Consumer
Use
Other Uses
Anti-adhesive agents
- mold cleaning and
release product
Spray
Vapor/mist
Inhalation
Consumers
Bystanders
Yes
Based on the VP (146 mm Hg) of
1-BP and the conditions of use,
inhalation exposures to 1-BP in
the vapor phase is expected.
Spray
Dermal
contact; incl
occluded
dermal contact
Dermal
Consumers
Yes
Based on conditions of use,
consumers may have direct
dermal contact to 1-BP. Occluded
exposures may be higher.
Spra>
Direct Dermal
Contact
Dermal
l!> slanders
\o
I!>slanders are not expected in
ha\e direct dermal annuel In 1-
151'
Spra>
\ apor misi
Oral
('oiisnniers
l>\slanders
\o
limesiion ill' I-I5I' is anticipated lo
he low since l-lil' ise\peeled In
he absorbed in ilie Imm qnickls
and noi li;i\ e appreciable ahilils
to um el np ilic mucosal ele\alor
and he swallowed
Consumer
Use
Other Uses
Automotive Care
Products, refrigerant
flush
Spray
Vapor/mist
Inhalation
Consumers
Bystanders
Yes
Emissions to air from spray
applied consumer uses is
expected.
Spray
Dermal
contact; incl
occluded
dermal contact
Dermal
Consumers
Yes
Dermal contact from emissions to
air from spray applied consumer
uses is expected.
Spra>
Direct Dermal
Contact
Dermal
l!> slanders
\o
Direct dermal annuel h\
h\slanders from is noi e\peeled
Spra>
Vapor misi
()ral
('oiisnniers
l>\slanders
\o
limesiion of I-I5I' is anticipated to
he low since 1-131' ise\peeled to
he absorbed in ilie Imm qnickls
and noi lia\ e appreciable ahihn
to ira\el np the mucosal ele\alor
and he swallowed.
Consumer
Use
Other Uses
Building/Construction
materials not covered
elsewhere - insulation
Offgassing
Vapor
Inhalation
Consumers
Bystanders
Yes
Based on the VP (146 mm Hg) of
1-BP and the conditions of use,
inhalation exposures to 1-BP in
the vapor phase is expected.
Page 109 of 123
-------
TableApx E-l. Consumer Scenario Table
l.il"c(\clc
S(;i»e
Csilcfion
Siihciilciinn
Uck'iiso from
source
r.\|)(isuiT
Palhwav
Roule
Km'plor
lu rl lier
\ual\sis
Killifiiiiilc l«ir l-'urther An;il\sis /
No lull ho i- \iial\sis
()l'l'uassiim
Yapnr
Dermal
()ral
('nilslllUei's
1 >\ slanders
\n
15\slanders are uni e\peeled in
lia\e direct dermal enulael In 1-
151' limeslinil ill" 1 -151' is
anticipated In he km
\ll
\ll
Ml
ii ;i
Solid Liquid
Cnulael linui
1 laudliim ;ind
1 )ispnsal nl'
Wasie
1 nli;il;il Kill.
Dermal.
IllUeslinil
( 'nilslllUei's
\n
1 -HP IS e\peeled In he disposed
nl" in elnsed cnulaiuers
TableApx E-2. General Population, Ecological Receptors, and Environmental Releases and Wastes Scenario Table
l.ilc
Cjclc
Si;i»o
Release
I'lxposuiv Palhwav
/ Modiii
r.xpdsuiv
Koulcs
Rcccplor / Population
l- u rl her
\nal\sis
Kill if niiile lor l- u rl her Analysis / No
I n rl her Aiiiil\sis
All
Stack Emissions
to Air
Near Facility
Ambient Air
Concentrations
Inhalation
General Population:
Adults and Children
living near facilities
Yes
Releases of 1-BP to air are expected based on
TRI data. Based on the relatively long
hydroxy radical oxidation half-life (t , = 14
days) emissions to ambient air could travel
far enough from the release point to reach
both near facility human receptors and the
general population.
All
Fugitive
Emissions to Air
Near Facility
Ambient Air
Concentrations
Inhalation
General Population:
Adults and Children
living near facilities
Yes
\ll
Si;iek 1 anissinus
in Mr
Indirect dcpnsiimu
In ueai'ln hndies nl"
water and sml
catchments
Surface water
;ind sedimenl
(lakes i-
limesiinn
Sml
(cakhniciiisi-
limesiinii
(icueral Pnpulalinu
\dlllls ;ind ( hildieii
1 in inu ne;ii' facilities
\n
liased mi I lie Kne nl" 4<>. I-lip is nnl e\pccled
In adsmh strnuuK in sediment nr sml l-HPis
\ nlalile and lias a ielali\ el> lnuli 1 lem> "s law
eniisianl ll is snniew lial hindemadahle and is
nnl e\pccled In sm'h In snlids mi water
Ml
Sl;ick 1 illllssKilis
in Mr
Indirect depnsiiinii
In ueai'ln hndies nl"
water and snil
catchments
Surface w;ilei"
;ind sedinienl
(lakes)
Sml
(e;iklmieiilsi
\t|iialic ;md Terrestrial
keeepims
\n
Page 110 of 123
-------
TableApx E-2. General Population, Ecological Receptors, and Environmental Releases and Wastes Scenario Table
l.ilV
( \clc
S(;i»c
Kck'iisc
I'lxposmv P;illiw ;i>
/ Mi'rihi
r.\pONIMY
Routes
Receplor / Population
lurllur
An;il\sis
Kill if tiiiilc lor I'in'Mut An;il\sis / No
I'llrlIter An;il\sis
\ll
I'umliN e
1 mnssinns in \ir
lllllll'ecl llcpusllllill
lii nemln hndies of
umermid snil
c;ilchnieiils
Siirkicc u;iicr
;niil sediment
(hikes 1-
limcsiinii
Siii 1
(cnlchniciilsi-
IllUCslliill
1 pt;ikc I'lHIII
cn\ ii\iiiiiicni
iniii Innd
siUII'CCs-
limcslinil
(leneriil I'npiikilinii
\ilnlis mill (Inklren
li\ inu neiir liieililies
\ll
\ll
I 'llUIIIN e
1 !|I1ISS|II|1S III \ll'
Indirect ilcpusiiinii
lii nemln hndies ii|'
umermid mhI
c;ilchniciils
Siirkicc u;iter
;niil sediment
( hikes)
Shi 1
(c;ilchniciilsi
\i|ii;iiie mill Terresiruil
keeepims
\ll
Ml
llldllslrml piv-
lic;ilmciil ;iinl
\x;isie\x;iler
liv;il iiiciil-
Direct rclcnsc iiiln
snrkicc umermid
p;ii l11 liiiii iiu lii
soil line ill
Siirkicc u;iicr
;niil Sediment
(I I \ Cl'sl
\i|iuilie mul Terresiml
keeepims
\ll
kcccni "I K 1 rcpm'tnm indicmcd <> piimuls
released in l'( )T\Vs mid 5 pounds released
dircclK lii u;iler in > 1 (• l!;ised mi I-I5I'
sinf;iee umer eiiiieeiiirmiiiiis esiininied nsiim
Tkl 2n|(i releases lii u;iicr. kk \S'k niiideliim
mid llicnciilc fish tii\icil> k(' \;ilne 24 '
nm 1.. ilie eiiiieeiiir;iiiiiii iil eiiiieeni is iki|
e\pecled In he exceeded l!;ised nil (lie Kne
nf 4<>. l-lik is nii| e\peeled in ndsnrh sininulv
In sedinienl
liiuesiinn nl'siirkiee u;iicr is nnl e\peeled In
he n simiil'iemii rnnie nf e\pnsure
Ml
liidiisirml pre-
ireiiinieiil ;iinl
\\;isie\\;iler
liv;il niciil-
Direct release inin
snrkicc umermid
pmlilininim lii
sediment
Siirkicc wilier
mill Seilinieni
(ri\ ersi-
limcsiinii
(leneriil l\ipiil;ilinii
\ilnlis mul (Inklren
1 in iiiu neiir kiciliiics
\ll
Ml
llidnsiml pre-
lic;ilmciil ;iinl
\x;isie\x;iler
liv;il niciil-
1illlSlllllls
;ipplk;iliiiii lii soil
Soil iimcsiinii
(leneriil l\ipiil;ilinii
\ilnlis mul ( hiklren
11\ iiiu no;ir liieililies
\ll
l!;ised nil I lie Kne nf 4<>. 1 -1 ilJ is nnl expected
In ndsni'h sirnimK In sedinienl nr sml II
presenl in hinsnhds. I-Uk uniild he e\peeled
In ;issnei;ile with I lie ;K|iienns ciinipniiciil mid
\ nl;ilili/e In ;nr ;is ilie hinsnhds ;ire npplied In
sml mul nllnucd In dr\
Ml
Indiisirml pre-
lic;ilmciil mill
1 jlllSlllllK
;ipplk;iliiiii lii siiil
Siii 1
1 erresi ri;i 1 recepinrs
\ll
l>;ised nil I he Kne nf 4<>. 1 -1 ilJ is nnl e\peeled
In ndsni'h sirnimK In sedinienl nr sml
Page 111 of 123
-------
TableApx E-2. General Population, Ecological Receptors, and Environmental Releases and Wastes Scenario Table
l.ilV
( \clc
S(;i»c
Kck'iisc
I'lxposuiv Palhwav
/ Media
l'l\|)OMIIV
Roulcs
Receplor / Population
l-'iirllicr
Analysis
Kill if tiiiilc lor I'll rl her \nal\sis / No
I'llrlher Analysis
wastewater
lival niciil-
\ll
Wastewaler
injected
IllldcrUI'nlllld
\n>
\n>
\ii>
\n
Tkl rcpnriiim nnl\ indicaled In pounds
released In imdcrurniiiid iiijcclinii in a Class 1
well mi 2(ilii. The iiiideruriMind iiiicclimi nf
ceriain classes of chemicals wasiesii c .
ha/ardniis) ma> he limned in practices that
miiiuale urniindwalcr impacls
\ll
Industrial pre-
livalmciil and
wastewater
lival niciil-
Direct release mm
sin lace walerand
nidirecl pariiiimiiim
in sedimeiil
Sim lace waler
and Sedimeiil
i i'i \ ers)
\i|iialic and 1 ei resirial
kecepini's
\n
kcccni "I K 1 rcpnriiim indicated <> pounds
released In I'OTWs and 5 pnmids released
dircclK in waler mi 2iilii liased mi I-I5I'
sin lace waler ci>iiceniralk>iis esiinialed iismu
I kl 2iilii releases in waler. I!l' \ST nindcliim
and llieacnie fish ln\icil> l!C \alne 24 '
nm 1.. llie cniiceiiiralinn nf cniicern is nnl
e\pecled In he exceeded liased nil I he knc
nf 4ii. l-lik is nnl expected In adsnrh strnimk
In sedimeiil
liiuesiinn nf surface waler is nnl e\pecled In
he a simiilicaiii rnnie nf e\pnsure
Ml
IndMsiiial pre-
livalmciil and
wastewater
lival niciil-
Direct release inin
sin lace walerand
pariitimiiim in
sed ime in
Sim lace waler
and Sedimeiil
i ri\ ersi-
limcsiimi
(icneral knpiilalinn
\d ill Is and Children
11\ miu near 1'acililics
\n
Ml
liidusiiial pre-
livalmciu and
wastewater
lival iiiciil-
1 iinsnllds
apphcalinn Ui soil
Shi 1
1 erresirial rcccpinrs
\n
liased nil I he Knc nf 4<>. I-I5I' is nnl e\pecled
In adsnrh sirnimk In sedimeiil nr sml lllii I)
litis not been detected in soil samples.
1 )lspnsal
1 la/ardnns Wasie
1 .aiidlill
Ml
\ll
Ml
\n
Due in desiun and nperalniu practices I'nr
Snhlille C landfills, ueneral pnpiilalinn
e\pnsnre In I-I5I' in urnimdwaler I'rnni
Snhlille ( ha/ardnns wasie landfill Icachalc
is not expected to be a significant pathway and
will not be further analyzed.
Disposal
Solid and Liquid
Wastes sent to On
or Off-site
Incineration/
Energy Recovery
Near Facility
Ambient Air
Concentrations
Inhalation
General Population:
Adults and Children
living near facilities
Yes
Air emissions resulting from these operations
are included in the TRI reports. Municipal
incinerators may release 1-BP due to
incomplete removal during burning.
Page 112 of 123
-------
TableApx E-2. General Population, Ecological Receptors, and Environmental Releases and Wastes Scenario Table
l.ilV
( \clc
S(;i»c
Kck'iisc
I'lxposuiv P;illiw ;i>
/ Mi'rihi
r.\i)(isuiv
Routes
Receplor / Population
1'iirlhor
An;il\sis
Kill if tiiiilc lor I'll rl her An;il> sis / No
I'llrlher An;il\sis
Disposal
Solid ;iud I.K|iikI
\V;isics SO 111 in
()u-Siie or ()IT-
SIIC IHCIIICI'IIUOU
Lucius kcco\ cr\
\c;ir L;icihi\
Mnhicui \ir
( 'oiicciiir;ilious
1 crrcsirul kecepiors
\o
Low ll;i/;ird' \o ;i\;ukihlc scdinicul. soil. nor
;i\ i;in lo\icil> siudics found in llic scientific
hlcr;ilurc lor I-I5I' 1 lie lo\icil> of I-I5I' is
e\pecled lo he low h;ised on I lie hick of on-
lopic cu\ iroiinicul;il li;i/;ird d;il;i for l-l.k lo
scdinicul ;md Icrrcstrul oru;uiisnis mi llic
published hiercilure ;ind I lie
pli>sie;il eliemie;il f;ile properiies (rckili\cl>
limli \okilihls (1 lenrs s l.;iw eons|;iiii of
v\|t> ;ilni-iii mole). Iiiuli w;ilersoliihilils
(2 4 u l.i. ;ind low lou K ( 1 <>) simucsium
lli;il l-l'.k will onl\ he presenl ;il kiw
eoiieeiiinilions mi ihese cu\ iixiii11leiil;i 1
eonip;irinieiils
1 )lspos;il
Municipal kuidfill
;iud oilier hind
disposal
Soil
Soil
1 crrcsiri;il kecepiors
\o
Low ll;i/;ird \o ;i\;iil;ihle sediiiienl. soil, nor
;i\ Kin lo\icil\ studies found mi I lie scientific
lileriiiure for 1-131'. The lo\icil\ of I-I5I' is
expected lo he low h;ised on ihe hick of ou-
lopic eu\ irounieul;il h;i/;ird d;il;i for 1-131' lo
seelinieiii ;iud lerresiri;il oruiuiisins mi ihe
published hier;iiure ;iud I he
ph\sic;il cheniic;il f;ile properiies irehili\el>
liiuli \ohililils 11 leurs s l.;iw cous|;iul of
" v\lu ;iiiii-iii molei. Iiiuli w;iier soluhiliis
(2.4 u l.i. ;iud low Ion K ( 1 (>i simucsium
lh;il l-lil' will oul\ he preseul ;il low
coiiceuiniiious iu ilicsc eu\ iroiiiueui;il
conip;iriniculs
1 )ispos;il
\ 11111 ici p;i 1 kuidfill
;ind oilier kind
disposal
Soil lo ;iir
(icucr;il I'opukilioir
\dulls ;ind (Inklivn
1 in iiiu ne;ir kicililics
\o
kclc;iscs from miluicip;i 1 hiudlill lo soil ;irc
noi e\pecled Suites ensure lhe feder;il
criieri;i for oper;iiiuu kCk \ Suhiiile 1)
in11111cip;11 solid w;isie;iud iudusiri;il w;isie
hiudlilis reuuhilKius ;ire mcl.
kccscliim
kccscliim of 1-
151' '
\ll
\ll
Ml
\o
kccscliuuof 1-131' is uoi e\pecled
Page 113 of 123
-------
TableApx E-2. General Population, Ecological Receptors, and Environmental Releases and Wastes Scenario Table
l.ilV
( \clc
S(a»c
Release
I'lxposuiv Palhwav
/ Media
I'1\|)osiiiv
Routes
Reeeplor / Population
l-'urlher
Analysis
Rationale lor I'll rt her Analysis / No
I'llrlher Analysis
\ll
1 >ackuroiuid
Surface waler
liiuesiiou
(icucral Population
\dulis and Children
\qualie and Terrestrial
keeepiors
\o
Tkl reporium uidicalcs liule lo uo releases io
waler
\ll
1 >ackurouud
Sedimenl
limesiiou
\qualie keeepiors
\o
Tkl reporiiim uidicalcs liule lo uo releases io
waler 1 Jascd on ilie koc of 4t>. l-l',Pisuoi
e\pcclcd lo adsorb strouuK lo sediuieui.
Ml
1 >ackuroiuid
Soil
liiuesiiou
(icucral Population.
\dulis and Children
lerresinal keeepiors
\o
ISased oil I lie Koc of 4t>. 1 -1 ilJ is uol c\pecled
lo adsorb siroimk lo sediuieui or soil 111 :c I)
litis not been delected in soil samples.
Ml
1 >ackurouud
\qiialie l>ioia
ii a
\t|iialie keeepiors
\o
Ml
15ackuroiuid
Terresinal liioia
ii a
lerresinal receptors
\o
All
Background
Ambient Air
Inhalation
General Population
Yes
Based on the VP (146 mm Hg) of 1-BP and
the conditions of use, inhalation exposures to
1-BP in the vapor phase is expected.
All
Background
Indoor Air
Inhalation
General Population
Yes
Based on the VP (146 mm Hg) of 1-BP and
the conditions of use, inhalation exposures to
1-BP in the vapor phase is expected.
Ml
1 >ackurouud
Indoor 1 )iis|
Inuesiioii.
Dermal
(icucral Population
\o
There are uo dala iiidicaliim l-I.P is preseui
in dusi
Ml
1 >ackurouud
Dielars food
Sources
liiuesiiou
(icucral Population
\o
There are no dala iiidiealiuu l-I.P is preseui
in food
Ml
1 >ackurouud
1 iionioiiiioriuu -
hreasi milk
ii a
(icucral Population
\o
Page 114 of 123
-------
APPENDIX F INCLUSION AND EXCLUSION CRITERIA FOR FULL
TEXT SCREENING
Appendix F contains the eligibility criteria for various data streams informing the TSCA risk evaluation:
environmental fate; engineering and occupational exposure; exposure to consumers; and human health
hazard. The criteria are applied to the on-topic references that were identified following title and abstract
screening of the comprehensive search results published on June 22, 2017.
Systematic reviews typically describe the study eligibility criteria in the form of PECO statements or a
modified framework. PECO stands for Population, Exposure, Comparator and Outcome and the
approach is used to formulate explicit and detailed criteria about those characteristics in the publication
that should be present in order to be eligible for inclusion in the review. EPA/OPPT adopted the PECO
approach to guide the inclusion/exclusion decisions during full text screening.
Inclusion and exclusion criteria were also used during the title and abstract screening, and
documentation about the criteria can be found in the Strategy for Conducting Literature Searches
document published in June 2017 along with each of the TSCA Scope documents. The list of on-topic
references resulting from the title and abstract screening is undergoing full text screening using the
criteria in the PECO statements. The overall objective of the screening process is to select the most
relevant evidence for the TSCA risk evaluation. As a general rule, EPA is excluding non-English
data/information sources and will translate on a case by case basis.
The inclusion and exclusion criteria for ecotoxicological data have been documented in the ECOTOX
SOPs. The criteria can be found at https://cfpub.epa.eov/ecotox/help.cftri?helptabs=tab4) and in the
Strategy for Conducting Literature Searches document published along with each of the TSCA Scope
documents.
F.l Inclusion Criteria for Data Sources Reporting Environmental Fate Data
EPA/OPPT developed a generic PESO statement to guide the full text screening of environmental fate
data sources. PESO stands for Pathways and Processes, Exposure, Setting or Scenario, and Outcomes.
Subsequent versions of the PESO statement may be produced throughout the process of screening and
evaluating data for the chemicals undergoing TSCA risk evaluation. Studies that comply with the
inclusion criteria in the PESO statement are eligible for inclusion, considered for evaluation, and
possibly included in the environmental fate assessment. On the other hand, data sources are excluded if
they do not meet the criteria in the PESO statement.
Assessors seek information on various chemical-specific fate endpoints and associated fate processes,
environmental media and exposure pathways as part of the process of developing the environmental fate
assessment (TableApx F-2). The PESO statement and information in TableApx F-l will be used when
screening the fate data sources to ensure complete coverage of the processes, pathways and data relevant
to the fate of the chemical substance of interest.
Page 115 of 123
-------
TsihloApx l -l. Inclusion Crilcrisi lor Dsiln Sources Reporting Kiivironnicnlsil I'silc l>;i 1 ;i
Pl.SO
I'JcillClll
r.vidcnce
Pathways
and
Processes
• Environmental fate, transport, partitioning and degradation behavior across
environmental media to inform exposure pathways of the chemical
substance of interest
• Media of interest may include:
- Air
Please refer to the conceptual models for more information about the
exposure pathways included in the TSCA risk evaluation.
Exposure
• Environmental exposure of ecological receptors (i.e., aquatic and
terrestrial organisms) to the chemical substance of interest and/or its
degradation products and metabolites
• Environmental exposure of human receptors, including any potentially
exposed or susceptible subpopulations, to the substance of interest and/or
its degradation products and metabolites
Please refer to the conceptual models for more information about the ecological
and human receptors included in the TSCA risk evaluation.
Setting or
Scenario
Any setting or scenario resulting in releases of the chemical substance of
interest into the natural or built environment (e.g., buildings including homes
or workplaces, or wastewater treatment facilities) that would expose
ecological (i.e., aquatic and terrestrial organisms) or human receptors (i.e.,
general population, and potentially exposed or susceptible subpopulation)
Outcomes
• Fate properties which allow assessments of exposure pathways:
o Abiotic and biotic degradation rates, mechanisms, pathways, and
products
o Bioaccumulation magnitude and metabolism rates
o Partitioning within and between environmental media (see Pathways
and Processes)
Page 116 of 123
-------
Table Apx l'"-2. Kale Kndpoinls and Associated Processes. Media and Kxposure Pathways
Considered in the Development of 1 lie Knvironnienlsil l-'sile Assessment
Fate Data Endpoint
Associated Process(es)
Associated Media/Exposure Pathways
Surface
water,
Sediment
Soil,
Biosolids
Ground-
water
Air
[Indoor
environment,
anthropogenic
materials,
other media]
Required Environmental
Fate Data
Abiotic reduction rates
or half-lives
Abiotic reduction,
Abiotic dehalogenation
X
Aerobic biodegradation
rates or half-lives
Aerobic biodegradation
X
X
Anaerobic
biodegradation rates or
half-lives
Anaerobic
biodegradation
X
X
X
Aqueous photolysis
(direct and indirect)
rates or half-lives
Aqueous photolysis
(direct and indirect)
X
Atmospheric photolysis
(direct and indirect)
rates or half-lives
Atmospheric photolysis
(direct and indirect)
X
Bioconcentration factor
(BCF),
Bioaccumulation factor
(BAF)
Bioconcentration,
Bioaccumulation
X
Hydrolysis rates or half-
lives
Hydrolysis
X
Kaw, Henry's Law
constant, and other
volatilization
information
Volatilization
X
X
X
Koc and other sorption
information
Sorption, Mobility
X
X
X
[Other required data)
Optional Environmental
Fate Data
Abiotic transformation
products
Hydrolysis, Photolysis
X
X
Aerobic
biotransformation
products
Aerobic biodegradation
X
X
Page 117 of 123
-------
Table Apx l'"-2. Kate Kndpoints mid Associated Processes. Media and Kxposnre Pathways
Considered in the Development ol'llic Knvironniental hate Assessment
Anaerobic
biotransformation
products
Anaerobic
biodegradation
X
X
X
Atmospheric deposition
information
Atmospheric deposition
X
Biomagnification and
related information
Trophic magnification
X
Coagulation information
Coagulation, Mobility
X
Desorption information
Sorption, Mobility
X
X
X
Incineration removal
information
Incineration
X
Suspension/resuspension
information
Suspension/resuspension,
Mobility
X
Wastewater treatment
removal information
Wastewater treatment
X
[Other optional data]
F.2 Inclusion Criteria for Data Sources Reporting Exposure Data on
Consumers, General Population, and Ecological Receptors
EPA/OPPT developed PECO statements to guide the full text screening of exposure data/information for
human (i.e., consumers, potentially exposed or susceptible subpopulations). Subsequent versions of the
PECO statements may be produced throughout the process of screening and evaluating data for the
chemicals undergoing TSCA risk evaluation. Studies that comply with the inclusion criteria in the
PECO statement are eligible for inclusion, considered for evaluation, and possibly included in the
exposure assessment. On the other hand, data sources are excluded if they do not meet the criteria in the
PECO statement. The 1 -BP-specific PECO is provided in Table_Apx F-3.
Table Apx 1-3. Inclusion Criteria lor the Data Sources Reporting 1-151' Kxposnrc Data on
Consumers and (icncral Population
Pl.( () r.lcmeni
l.\ irience
Population
Human: General DODulation. consumers (i.e.. rcccotors who use a oroduct directly) and
bystanders (i.e., receptors who are non-product users that are incidentally exposed to the
product or article) in residential settings, near-facility populations (includes industrial and
commercial facilities manufacturing, processing or using 1-BP); populations in co-located
residences or businesses; including potentially exposed or susceptible subpopulations such as
infants, children, pregnant women, lactating women, women of child bearing age, and high-
end consumers.
Ecological: None.
Exposure
Expected Primary Exposure Sources, Pathways, Routes: See I<'igure 2-3 and I<'igure 2-4
Page 118 of 123
-------
TsihleApx 1-3. Inclusion Crherhi lor (lie l):il:i Sources Reporting l-IJP Kxposure l);it;i on
Consumers nml (ieneml Population
PI'.CO l lcimm
l.\ iricncc
Source: Manufacturing. processing. commercial and consumer use of products containing 1-
BP as an ingredient, and associated emissions to air or dermal contact.
Pathwav: indoor air (including transfer from outdoor air), outdoor air. dermal contact with 1 -
BP in consumer products
Routes of Exposure: I nhalation of outdoor air or indoor air (consumer and bvstander
populations) and dermal exposure via contact with consumer products containing 1-BP.
Comparator
(Scenario)
Human: Consider media-specific background exposure scenarios and use/source specific
exposure scenarios as well as which receptors are and are not reasonably exposed across the
projected exposure scenarios.
Ecological: None.
Outcomes for
Exposure
Concentration or
Dose
Human: Acute, subchronic. and/or chronic external dose estimates (mg/kg/dav): acute,
subchronic. and/or chronic air concentration estimates (fig/nvl mg/m1). Both external potential
dose and internal dose based on biomoniloring and reverse dosimetry mg/kg/dav will be
considered.
Ecological: None.
F.3 Inclusion Criteria for Data Sources Reporting Engineering and
Occupational Exposure Data
EPA/OPPT developed a generic RESO statement to guide the full text screening of engineering and
occupational exposure literature (TableApx F-4). RESO stands for Receptors, Exposure, Setting or
Scenario, and Outcomes. Subsequent versions of the RESO statement may be produced throughout the
process of screening and evaluating data for the chemicals undergoing TSCA risk evaluation. Studies
that comply with the inclusion criteria specified in the RESO statement will be eligible for inclusion,
considered for evaluation, and possibly included in the environmental release and occupational exposure
assessments, while those that do not meet these criteria will be excluded.
The RESO statement should be used along with the engineering and occupational exposure data needs
table (Table Apx F-5) when screening the literature.
TsihleApx 1-
Occupsilionsil
RI.SO I!lemonl
4. Inclusion Crilerisi lor l):it:i Sources Reporting Knginccring ;iihI
Kxposurc l):il;i
l.\ iril'IKT
Receptors
• Humans:
Workers, including occupational non-users
Please refer to the conceptual models for more information about the human receptors included
in the TSCA risk evaluation.
Page 119 of 123
-------
Tsihle Apx 1-4. Inclusion Crilerisi lor l):il:i Sources Reporting Knginccring ;iihI
Occupsilionsil Kxposurc l>;il;i
Exposure
• Worker exposure lo and rele\ anl en\ iroiinienial releases of llie elienueal subsianee of iiileresi
o Any exposure route (list included: dermal, inhalation, oral) as indicated in the
conceptual model
o Any relevant media/pathway [list included: water, land, air, incineration, and
other(s)] as indicated in the conceptual model
Please refer to the conceptual models for more information about the routes and media/pathways
included in the TSCA risk evaluation.
Setting or
Scenario
• Any occupational setting or scenario resulting in worker exposure and relevant environmental
releases (includes all manufacturing, processing, use, disposal indicated in Table Apx F-5
below except (state none excluded or list excluded uses)
Outcomes
• Quantitative estimates* of worker exposures and of relevant environmental releases from
occupational settings
• General information and data related and relevant to the occupational estimates*
* Metrics (e.g., mg/kg/day or mg/m3 for worker exposures, kg/site/day for releases) are determined by toxicologists for
worker exposures and by exposure assessors for releases; also, the Engineering Data Needs (TableApx F-5) provides
a list of related and relevant general information.
TsihlcApx K-5. Knginccring. Kiivironnicnlsil Uclcsisc siml Occupsilionsil Dsilsi Nccesssirv (o Develop (lie
Knvironnienlsil Uclcsisc siml Occupsilionsil Kxposurc Assessments
()l>.jecli\e
Ik'kTiiiiiK'd
(Inrinvi Scoping
T\|H' of I);||;|
General
Engineering
Assessment (may
apply for either
or both
Occupational
Exposures and /
or Environmental
Releases)
1. Description of the life cycle of the chemical(s) of interest, from manufacture to end-of-life (e.g., each
manufacturing, processing, or use step), and material flow between the industrial and commercial life cycle
stages. {Tags: Life cycle description, Life cycle diagram}3
2. The total annual U.S. volume (lb/yr or kg/yr) of the chemical(s) of interest manufactured, imported,
processed, and used; and the share of total annual manufacturing and import volume that is processed or
used in each life cycle step. {Tags: Production volume, Import volume, Use volume, Percent PV}a
3. Description of processes, equipment, unit operations, and material flows and frequencies (lb/site-day or
kg/site-day and days/yr; lb/site-batch and batches/yr) of the chemical(s) of interest during each industrial/
commercial life cycle step. Note: if available, include weight fractions of the chemicals (s) of interest and
material flows of all associated primary chemicals (especially water). {Tags: Process description, Process
material flow rate, Annual operating days, Annual batches, Weight fractions (for each of above,
manufacture, import, processing, use)}a
4. Basic chemical properties relevant for assessing exposures and releases, e.g., molecular weight, normal
boiling point, melting point, physical forms, and room temperature vapor pressure. {Tags: Molecular
weight, Boiling point, Melting point, Physical form, Vapor pressure, Water solubility}a
5. Number of sites that manufacture, process, or use the chemical(s) of interest for each industrial/
commercial life cycle step and site locations. {Tags: Numbers of sites (manufacture, import, processing,
use), Site locations}a
Occupational
Exposures
6. Description of worker activities with exposure potential during the manufacture, processing, or use of the
chemical(s) of interest in each industrial/commercial life cycle stage. {Tags: Worker activities
(manufacture, import, processing, use)}3
Page 120 of 123
-------
TsihleApx I--5. K11 «ineeriii«. Kiivironiiicnlsil Uelesise mid Omipsilionsil Necessary lo Develop (lie
Knvironinenlsil Uelesise sind Oceupnlionnl Kxposure Assessments
()l>.jecli\e
IKkrinincd
(lui'inii Scoping
T\|H' of l);il;i
7. Potential routes of exposure (e.g., inhalation, dermal). {Tags: Routes of exposure (manufacture, import,
processing, use)}3
8. Physical form of the chemical(s) of interest for each exposure route (e.g., liquid, vapor, mist) and activity.
{Tags: Physical form during worker activities (manufacture, import, processing, use)}a
9. Breathing zone (personal sample) measurements of occupational exposures to the chemical(s) of interest,
measured as time-weighted averages (TWAs), short-term exposures, or peak exposures in each
occupational life cycle stage (or in a workplace scenario similar to an occupational life cycle stage). {Tags:
PBZ measurements (manufacture, import, processing, use)}a
10. Area or stationary measurements of airborne concentrations of the chemical(s) of interest in each
occupational setting and life cycle stage (or in a workplace scenario similar to the life cycle stage of
interest). {Tags: Area measurements (manufacture, import, processing, use)}a
11. For solids, bulk and dust particle size characterization data. {Tags: PSD measurements (manufacture,
import, processing, use)}"
12. Dermal exposure data. {Tags: Dermal measurements (manufacture, import, processing, use)}
13. Data needs associated with mathematical modeling (will be determined on a case-by-case basis). {Tags:
Worker exposure modeling data needs (manufacture, import, processing, use)}11
14. Exposure duration (hr/day). {Tags: Worker exposure durations (manufacture, import, processing, use)}a
15. Exposure frequency (days/yr). {Tags: Worker exposure frequencies (manufacture, import, processing,
use)}a
16. Number of workers who potentially handle or have exposure to the chemical(s) of interest in each
occupational life cycle stage. {Tags: Numbers of workers exposed (manufacture, import, processing, use)}
a
17. Personal protective equipment (PPE) types employed by the industries within scope. {Tags: Worker PPE
(manufacture, import, processing, use)}a
18. Engineering controls employed to reduce occupational exposures in each occupational life cycle stage (or
in a workplace scenario similar to the life cycle stage of interest), and associated data or estimates of
exposure reductions. {Tags: Engineering controls (manufacture, import, processing, use), Engineering
control effectiveness data}a
Environmental
Releases (to
relevant
environmental
media)
19. Description of relevant sources of potential environmental releases, including cleaning of residues from
process equipment and transport containers, involved during the manufacture, processing, or use of the
chemical(s) of interest in each life cycle stage. {Tags: Release sources (manufacture, import, processing,
use)}a
20. Estimated mass (lb or kg) of the chemical(s) of interest released from industrial and commercial sites to
each environmental medium (water) and treatment and disposal methods (POTW), including releases per
site and aggregated over all sites (annual release rates, daily release rates) {Tags: Release rates
(manufacture, import, processing, use)}a
21. Release or emission factors. {Tags: Emission factors (manufacture, import, processing, use)}3
22. Number of release days per year. {Tags: Release frequencies (manufacture, import, processing, use)}"
23. Data needs associated with mathematical modeling (will be determined on a case-by-case basis). {Tags:
Release modeling data needs (manufacture, import, processing, use)}"
24. Waste treatment methods and pollution control devices employed by the industries within scope and
associated data on release/emission reductions. {Tags: Treatment/ emission controls (manufacture, import,
processing, use), Treatment/ emission controls removal/ effectiveness data}a
Notes:
aThese are the tags included in the full text screening form. The screener makes a selection from these specific tags, which describe
more specific types of data or information.
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F.4 Inclusion Criteria for Data Sources Reporting Human Health Hazards
EPA/OPPT developed a 1-BP-specific PECO statement (Table Apx F-6) to guide the full text screening
of the human health hazard literature. Subsequent versions of the PECOs may be produced throughout
the process of screening and evaluating data for the chemicals undergoing TSCA risk evaluation.
Studies that comply with the criteria specified in the PECO statement will be eligible for inclusion,
considered for evaluation, and possibly included in the human health hazard assessment, while those that
do not meet these criteria will be excluded according to the exclusion criteria.
In general, the PECO statements were based on (1) information accompanying the TSCA Scope
document, and (2) preliminary review of the health effects literature from sources cited in the TSCA
Scope documents. When applicable, these sources (e.g., IRIS assessments, EPA/OPPT's Work Plan
Problem Formulations or risk assessments) will serve as starting points to identify PECO-relevant
studies.
TsihlcApx 1-6. Inclusion nntl Inclusion (rilcriii lor (lie l);il;i Sources Reporting Muninn llcnllh
llii/nrds UclnU'ri lo l-IJP Kxposurc"
PI'.CO
Ik'ilK'iK
l.\ idcnco
Siiviim
Piipors/l-'oiiliiivs Included
I'iipoi's/IViiliiivs l.xcludcd
Population b
Human
• Any population
• All lifestages
• Study designs:
o Controlled exposure, cohort, case-control, cross-sectional,
case-crossover
o Case studies and case series that are related to deaths from
acute exposure
• Case studies and case series for all
endpoints other than death from acute
exposure
Animal
• All non-human whole-organism mammalian species
• All lifestages
• Non-mammalian species
Exposure
Human
• Exposure based on administered dose or concentration of 1-BP,
biomonitoring data (e.g., urine, blood or other specimens),
environmental or occupational-setting monitoring data (e.g., air,
water levels), job title or residence
• Primary metabolites of interest as identified in biomonitoring
studies
• Exposure identified as or presumed to be from oral, dermal,
inhalation routes
• Any number of exposure groups
• Quantitative, semi-quantitative or qualitative estimates of
exposure
• Exposures to multiple chemicals/mixtures only if 1-BP or related
metabolites were independently measured and analyzed
• Route of exposure not by inhalation, oral
or dermal type (e.g., intraperitoneal,
injection)
• Multiple chemical/mixture exposures
with no independent measurement of or
exposure to 1-BP (or related metabolite)
Animal
• A minimum of 2 quantitative dose or concentration levels of 1-
BP plus a negative control groupa
• Acute, subchronic, chronic exposure from oral, dermal,
inhalation routes
• Exposure to 1-BP only (no chemical mixtures)
• Quantitative and/or qualitative relative/rank-order estimates of
exposure
• Only 1 quantitative dose or concentration
level in addition to the control
• Route of exposure not by inhalation, oral
or dermal type (e.g., intraperitoneal,
injection)
• No duration of exposure stated
• Exposure to 1-BP in a chemical mixture
Comparator
Human
• A comparison population [not exposed, exposed to lower
levels, exposed below detection] for endpoints other than
• No comparison population for
endpoints other than death from acute
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TsihlcApx 1-6. Inclusion nntl Inclusion (rilcriii lor (lie l);il;i Sources Reporting Muninn llcnllh
llii/nrds UclnU'ri lo l-IJP Kxposurc"
death from acute exposure
exposure
Animal
• Negative controls that are vehicle-only treatment and/or no
treatment
• Negative controls other than vehicle-
only treatment or no treatment
Outcome
Human
• Endpoints described in the 1-BP scope document0:
o Kidney toxicity
o Liver toxicity
o Neurotoxicity
o Reproductive toxicity
o Developmental toxicity
o Cancer
• Other endpoints d
Animal
General Consideration*
Pa pe rs/Featu res Included
Papers/Features Excluded
• Written in English e
• Reports primary source or meta-analysis.a
• Full-text available
• Reports both 1-BP exposure and a health outcome
• Not written in English
• Reports a secondary source (e.g., review
papers)a
• No full-text available (e.g., only a study
description/abstract, out-of-print text)
• Reports a 1-BP-related exposure or a
health outcome, but not both (e.g.
incidence, prevalence report)
"Some of the studies that are excluded based on the PECO statement may be considered later during the systematic review process. For 1-BP, EPA will
evaluate studies related to susceptibility and may evaluate, toxicokinetics and physiologically based pharmacokinetic models after other data (e.g., human
and animal data identifying adverse health outcomes) are reviewed. EPA may need to evaluate mechanistic data depending on the review of health effects
data. Finally, EPA may also review other data as needed (e.g., animal studies using one concentration, review papers).
b Mechanistic data are excluded during the full text screening phase of the systematic review process but may be considered later (see footnote a).
c EPA will review key and supporting studies that were considered in the 2016 Draft Risk Assessment (U.S. EPA. 2016b) for 1-BP for non-cancer and
cancer endpoints as well as studies published after the draft, assessment.
11 EPA may screen for hazards other than those listed in the scope document if they were identified in the updated literature search that accompanied the
scope document.
e EPA may translate studies as needed.
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