EPA Document# EPA-740-D-20-015
April 2020
FPA United Statcs	Office of Chemical Safety and
!¦¦¦	Environmental Protection Agency	Pollution Prevention
Draft Scope of the Risk Evaluation for
Butyl Benzyl Phthalate
(1,2-Benzenedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester)
CASRN 85-68-7

April 2020

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TABLE OF CONTENTS
ACKNOWLEDGEMENTS	5
ABBREVIATIONS AND ACRONYMS	6
EXECUTIVE SUMMARY	9
1	INTRODUCTION	12
2	SCOPE 01 THE EVALUATION	12
2.1	Reasonably Available Information	12
2.1.1	Search of Gray Literature	13
2.1.2	Search of Literature from Publicly Available Databases (Peer-Reviewed Literature)	14
2.1.3	Search of TSCA Submissions	18
2.2	Conditions of Use	19
2.2.1	Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation	20
2.2.2	Activities Excluded from the Scope of the Risk Evaluation	23
2.2.3	Production Volume	23
2.2.4	Overview of Conditions of Use and Lifecycle Diagram	24
2.3	Exposures	26
2.3.1	Physical and Chemical Properties	26
2.3.2	Environmental Fate and Transport	26
2.3.3	Releases to the Environment	26
2.3.4	Environmental Exposures	26
2.3.5	Occupational Exposures	27
2.3.6	Consumer Exposures	28
2.3.7	General Population Exposures	28
2.4	Hazards (Effects)	29
2.4.1	Environmental Hazards	29
2.4.2	Human Health Hazards	29
2.5	Potentially Exposed or Susceptible Subpopulations	29
2.6	Conceptual Models	30
2.6.1	Conceptual Model for Industrial and Commercial Activities and Uses	30
2.6.2	Conceptual Model for Consumer Activities and Uses	32
2.6.3	Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards (Regulatory Overlay)	34
2.6.3.1	Ambient Water Pathway	36
2.6.3.2	Disposal and Soil Pathways	36
2.6.4	Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards	37
2.7	Analysis Plan	40
2.7.1	Physical and Chemical Properties and Environmental Fate	40
2.7.2	Exposure	40
2.7.2.1	Environmental Releases	41
2.7.2.2	Environmental Exposures	42
2.7.2.3	Occupational Exposures	43
2.7.2.4	Consumer Exposures	45
2.7.2.5	General Population	46
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2.7.3	Hazards (Effects)	48
2.7.3.1	Environmental Hazards	48
2.7.3.2	Human Health Hazards	49
2.7.4	Summary of Risk Approaches for Characterization	51
2.8 Peer Review	52
REFERENCES	53
APPENDICES	59
Appendix A LIST OF GRAY LITERATURE SOURCES	59
Appendix B PHYSICAL AND CHEMICAL PROPERTIES	63
Appendix C ENVIRONMENTAL FATE AND TRANSPORT PROPERTIES	65
Appendix D REGULATORY HISTORY	67
D.l Federal Laws and Regulations											67
D.2 State Laws and Regulations										..........................70
D.3	International Laws and Regulations.....											.....71
Appendix E PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION	73
E.l	Process Information.									73
E. 1.1 Manufacturing (Including Import)	73
E. 1.1.1 Domestic Manufacturing	73
E.l. 1.2 Import	73
E. 1.2 Processing and Distribution	73
E. 1.2.1 Reactant or Intermediate	73
E. 1.2.2 Incorporated into a Formulation, Mixture or Reaction Product	74
E. 1.2.3 Incorporated into an Article	74
E. 1.2.4 Repackaging	74
E.l.2.5 Recycling	74
E.l.3 Uses	74
E.l.3.1 Adhesives, Sealants, Paints, and Coatings	74
E. 1.3.2 Automotive Products	75
E.l.3.3 Building/Construction Materials Not Covered Elsewhere	75
E.l.3.4 Ink, Toner, and Colorant Products	75
E.l.3.5 Plastic and Rubber Products	75
E.l.3.6 Other Uses	75
E.l.4 Disposal	75
E.2 Preliminary Occupational Exposure Data															..,.,76
Appendix F SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR INDUSTRIAL AND
COMMERCIAL ACTIVITIES AND USES	77
Appendix G SUPPORTING INFORMATION — CONCEPTUAL MODEL FOR CONSUMER
ACTIVITIES AND USES	85
Appendix H SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES	91
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LIST OF TABLES
Table 2-1 Results of Title Screening of Submissions to EPA under Various Sections of TSCA	19
Table 2-2 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation	20
Table 2-3 Potential Categories and Sources of Environmental Release Data	41
LIST OF FIGURES
Figure 2-1 Gray Literature Search Results for Butyl Benzyl Phthalate	13
Figure 2-2 Peer-reviewed Literature - Physical-Chemical Properties Search Results for Butyl Benzyl
Phthalate	14
Figure 2-3 Peer-reviewed Literature - Fate and Transport Search Results for Butyl Benzyl Phthalate... 15
Figure 2-4 Peer-reviewed Literature - Engineering Search Results for Butyl Benzyl Phthalate	16
Figure 2-5 Peer-reviewed Literature - Exposure Search Results for Butyl Benzyl Phthalate	17
Figure 2-6 Peer-reviewed Literature - Hazard Search Results for Butyl Benzyl Phthalate	18
Figure 2-7 Butyl Benzyl Phthalate Life Cycle Diagram	25
Figure 2-8 Butyl Benzyl Phthalate Conceptual Model for Industrial and Commercial Activities and
Uses: Worker and Occupational Non-User Exposures and Hazards	31
Figure 2-9 Butyl Benzyl Phthalate Conceptual Model for Consumer Activities and Uses: Consumer
Exposures and Hazards	33
Figure 2-10 Butyl Benzyl Phthalate Conceptual Model for Environmental Releases and Wastes:
Environmental and General Population Exposures and Hazards (Regulatory Overlay) ..35
Figure 2-11 Butyl Benzyl Phthalate Conceptual Model for Environmental Releases and Wastes:
Environmental and General Population Exposures and Hazards	39
LIST OF APPENDIX TABLES
TableApx A-l Gray Literature Sources that Yielded Results for Butyl Benzyl Phthalate	59
TableApx B-l Physical and Chemical Properties of Butyl Benzyl Phthalate	63
TableApx C-l Environmental Fate Characteristics of Butyl Benzyl Phthalate	65
Table_Apx D-l Federal Laws and Regulations	67
Table_Apx D-2 State Laws and Regulations	70
Table Apx D-3 Regulatory Actions by other Governments, Tribes, and International Agreements	71
Table Apx F-l Worker and Occupational Non-User Exposure Conceptual Model Supporting Table... 77
Table Apx G-l Consumer Exposure Conceptual Model Supporting Table	85
Table Apx H-l Environmental Exposure Conceptual Model Supporting Table	91
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ACKNOWLEDGEMENTS
This report was developed by the U. S. Environmental Protection Agency (U.S. EPA), Office of
Chemical Safety and Pollution Prevention (OCSPP), Office of Pollution Prevention and Toxics (OPPT).
Acknowledgements
The OPPT Assessment Team gratefully acknowledges participation or input from intra-agency
reviewers that included multiple offices within EPA, inter-agency reviewers that included multiple
federal agencies, and assistance from EPA contractors GDIT (Contract No. HHSN316201200013W),
ERG (Contract No. EP-W-12-006), Versar (Contract No. EP-W-17-006), ICF (Contract
No.68HERC19D0003), Abt Associates (Contract No. EP-W-16-009) and SRC (Contract No.
68HERH19F0213). EPA also acknowledges the contributions of technical experts from EPA's Office of
Research and Development.
Docket
Supporting information can be found in public docket: [Docket ID: EPA-HQ-OP	15011.
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 U.S. Government.
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ABBREVIATIONS AND ACRONYMS
ACGIH
American Conference of Governmental Industrial Hygienists
ADME
Absorption, Distribution, Metabolism, and Excretion
AEGL
Acute Exposure Guideline Level
AICS
Australian Inventory for Chemical Substances
AT SDR
Agency for Toxic Substances and Disease Registry
BAF
Bioaccumulation Factor
BCF
Bioconcentration Factor
BMF
Biomagnification Factor
BOD
Biochemical oxygen demand
BP
Boiling point
BW
Body weight
CAA
Clean Air Act
CASRN
Chemical Abstracts Service Registry Number
CBI
Confidential Business Information
CDR
Chemical Data Reporting
CEHD
Chemical Exposure Health Data
CERCLA
Comprehensive Environmental Response, Compensation and Liability Act
CFR
Code of Federal Regulations
CHRIP
Chemical Risk Information Platform
COC
Concentration of Concern
CPCat
Chemical and Product Categories
CPSC
Consumer Product Safety Commission
CSCL
Chemical Substances Control Law
CWA
Clean Water Act
DMR
Discharge Monitoring Report
EC
Engineering Controls
ECx
Effective Concentration
ECB
European Chemicals Bureau
ECHA
European Chemicals Agency
EPA
Environmental Protection Agency
EPCRA
Emergency Planning and Community Right-to-Know Act
ERG
Eastern Research Group
ESD
Emission Scenario Document
EU
European Union
FDA
Food and Drug Administration
FYI
For Your Information
FR
Federal Register
GDIT
General Dynamics Information Technology
GESTIS
International Occupational Exposure Limit Database
GS
Generic Scenario
Hg
Mercury
HHE
Health Hazard Evaluation
HMTA
Hazardous Materials Transportation Act
IARC
International Agency for Research on Cancer
ICF
ICF is a global consulting services company
IECCU
Indoor Environmental Concentrations in Buildings with Conditioned and Unconditioned
Zones
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IMAP
Inventory Multi-Tiered Assessment and Prioritisation (Australia)
Koc
Organic Carbon: Water Partition Coefficient
Kow
Octanol: Water Partition Coefficient
KOECT
Kirk-Othmer Encyclopedia of Chemical Technology
LCx
Lethal Concentration
LOAEL
Lowest Observed Adverse Effect Level
LOEC
Lowest Observed Effect Concentration
MACT
Maximum Achievable Control Technology
MDI
MDI Biological Laboratory
MITI
Ministry of International Trade and Industry
MOA
Mode of Action
MP
Melting point
NASA
National Air and Space Administration
NEI
National Emissions Laboratory
NICNAS
National Industrial Chemicals Notification and Assessment Scheme (Australia)
NIOSH
National Institute for Occupational Safety and Health
NITE
National Institute of Technology and Evaluation
NLM
National Library of Medicine
NOAEL
No Observed Adverse Effect Level
NOEC
No Observed Effect Concentration
NPDES
National Pollutant Discharge Elimination System
NPL
National Priorities List
NPRI
National Pollutant Release Inventory
NTP
National Toxicology Program
OCSPP
Office of Chemical Safety and Pollution Prevention
OECD
Organisation for Economic Co-operation and Development
OEHHA
Office of Environmental Health Hazard Assessment (California)
OEL
Occupational Exposure Limit
ONU
Occupational Non-User
OPPT
Office of Pollution Prevention and Toxics
OSHA
Occupational Safety and Health Administration
OW
Office of Water
PBPK
Physiologically Based Pharmacokinetic
PBT
Persistent, Bioaccumulative, Toxic
PPE
Personal Protective Equipment
P-Chem
Physical-Chemical
PECO
Population, Exposure, Comparator and Outcome
PESS
Potentially Exposed or Susceptible Populations
POD
Point of Departure
POTW
Publicly Owned Treatment Works
RCRA
Resource Conservation and Recovery Act
REACH
Registration, Evaluation, Authorisation and Restriction of Chemicals (European Union)
RIVM
Dutch National Institute for Public Health and the Environment
RQ
Risk Quotient
SARA
Superfund Amendments and Reauthorization Act
SDS
Safety Data Sheet
SDWA
Safe Drinking Water Act
SRC
SRC Inc., formerly Syracuse Research Corporation

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STORET
STORage and RETrieval (water quality data warehouse)
SVOC
Semivolatile Organic Compound
TBD
To be determined
TERA
Toxicology in Risk Assessment
TIAB
Title and Abstract
TMF
Trophic Magnification Factors
TRI
Toxics Release Inventory
TSCA
Toxic Substances Control Act
TURA
Toxics Use Reduction Act (Massachusetts)
UNEP
United Nations Environment Programme
USGS
United States Geological Survey
VP
Vapor Pressure
WS
Water solubility
WQX
Water Quality Exchange
WWT
Wastewater Treatment

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EXECUTIVE SUMMARY
In December 2019, EPA designated butyl benzyl phthalate (CASRN 85-68-7) as a high-priority
substance for risk evaluation following the prioritization process as required by Section 6(b) of the
Toxic Substances Control Act (TSCA) and implementing regulations (40 CFR 702) (Docket ID: EPA-
HQ-OPPT-2018-0501). The first step of the risk evaluation process is the development of the scope
document and this document fulfills the TSCA regulatory requirement to issue a draft scope document
as described in 40 CFR 70: (7). The draft scope for butyl benzyl phthalate includes the following
information: the conditions of use, potentially exposed or susceptible subpopulations (PESS), hazards,
and exposures that EPA plans to consider in this risk evaluation, along with a description of the
reasonably available information, conceptual model, analysis plan and science approaches, and plan for
peer review for this chemical substance. EPA is providing a 45-day comment period on the draft scope.
Comments received on this draft scope document will help inform development of the final scope
document and the risk evaluation.
General Information. Butyl benzyl phthalate is a clear, oily liquid with a total production volume in the
United States between 10 and 50 million pounds.
Reasonably Available Information. EPA leveraged the data and information sources already described
in the document supporting the High-Priority Substance designation for butyl benzyl phthalate to inform
the development of this draft scope document. To further develop this draft scope document, EPA
conducted a comprehensive search to identify and screen multiple evidence streams (i.e., chemistry, fate,
release and engineering, exposure, hazard) and the search and screening results are provided in Section
2.1. EPA is seeking public comment on this draft scope document and will consider additional
information identified following publication of this draft scope document, as appropriate, in developing
the final scope document. EPA is using the systematic review process described in the Application of
Systematic Review in TSCA Risk Evaluations document (U.S. EPA, 2018a) to guide the process of
searching for and screening reasonably available information, including information already in EPA's
possession, for inclusion in the risk evaluation. EPA is applying these systematic review methods to
collect reasonably available information regarding the hazards, exposures, PESS, and conditions of use
that may help inform the risk evaluation for butyl benzyl phthalate.
Conditions of Use. EPA plans to evaluate industrial, commercial and consumer, distribution, and
disposal uses of butyl benzyl phthalate in the risk evaluation. Butyl benzyl phthalate is manufactured
within the U.S. as well as imported into the United States. Production volumes were reported to the
Chemical Data Reporting (CDR) in 2016. The chemical is processed as a reactant, incorporated into a
formulation, mixture, or reaction product, and incorporated into articles. The identified processing
activities also include the repackaging and recycling of butyl benzyl phthalate. Several industrial and
commercial uses were identified that included adhesives and sealants, floor coverings, paints and
coatings, and use in plastic and rubber products. Multiple consumer uses were also reported to CDR.
Conceptual Model. The conceptual models for butyl benzyl phthalate are presented in Section 2.6.
Conceptual models are graphical depictions of the actual or predicted relationships of conditions of use,
exposure pathways (e.g., media), exposure routes (e.g., inhalation, dermal, oral), hazards, and receptors
throughout the life cycle of the chemical substance—from manufacturing, processing, distribution in
commerce, storage, or use, to release or disposal. EPA plans to focus the risk evaluation for butyl benzyl
phthalate on the following exposures, hazards, and receptors, however, EPA also plans to consider
comments received on this draft scope and other reasonably available information when finalizing this
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scope document, and to adjust the exposure pathways, exposure routes and hazards included in the scope
document as needed.
•	Exposures (Pathways and Routes), Receptors and PESS. EPA plans to analyze both human and
environmental exposures resulting from the conditions of use of butyl benzyl phthalate that EPA
plans to consider in the risk evaluation. Exposures for butyl benzyl phthalate are discussed in
Section 2.3. EPA identified environmental monitoring data reporting the presence of butyl
benzyl phthalate in air, water, sediment, and soil (U.S. EPA, 2019a). Additional information
gathered through the results of systematic review searches will also inform expected exposures.
EPA's plan as to evaluating environmental exposure pathways in the draft scope document
considers whether and how other EPA-administered statutes and regulatory programs address the
presence of butyl benzyl phthalate in media pathways falling under the jurisdiction of those
authorities. Section 2.6.3 discusses those pathways that may be addressed pursuant to other
Federal laws. In Section 2.6.4, EPA presents the conceptual model describing the identified
exposures (pathways and routes), receptors and hazards associated with the conditions of use of
butyl benzyl phthalate within the scope of the risk evaluation.
Preliminarily, EPA plans to evaluate the following exposure pathways, receptors and PESS in
the risk evaluation. However, EPA plans to consider comments received on this draft scope and
other reasonably available information when finalizing this scope document, and to adjust the
exposure pathways, exposure routes and hazards included in the scope document as needed.
-	Occupational exposures associated with industrial and commercial conditions of use :
EPA plans to evaluate exposures to workers and/or occupational non-users (ONUs) via
the inhalation route and exposures to workers via the dermal route associated with the
manufacturing, processing, use or disposal of butyl benzyl phthalate.
-	Consumer and bystander exposures associated with consumer conditions of use: EPA
plans to evaluate the oral, inhalation and dermal exposure to butyl benzyl phthalate when
consumers and bystanders are using and/or handling adhesives and sealants products,
automotive care products, arts, crafts, and hobby materials, cleaning and furnishing care
products, fabric, textile, and leather products, floor coverings, paints and coatings, plastic
and rubber products, toys, playground and sporting equipment, and ink, toner, and
colorant products.
-	General population exposures: EPA plans to evaluate exposure to butyl benzyl phthalate
via oral route from drinking water or groundwater, and soil for the general population and
via the inhalation route for ambient air.
-	Receptors and PESS: EPA plans to evaluate children, women of reproductive age, (e.g..,
pregnant women), workers and consumers as receptors and PESS in the risk evaluation.
-	Environmental exposures: EPA plans to evaluate exposure to butyl benzyl phthalate for
aquatic and terrestrial receptors.
•	Hazards. Hazards for butyl benzyl phthalate are discussed in Section 2.4. EPA completed
preliminary reviews of information from peer-reviewed assessments and databases to identify
potential environmental and human health hazards for butyl benzyl phthalate as part of the
prioritization process. Environmental hazard effects were identified for aquatic and terrestrial
organisms. Information collected through systematic review methods and public comments may
identify additional environmental hazards that warrant inclusion in the environmental hazard
assessment of the risk evaluation.
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EPA will use systematic review methods to evaluate the epidemiological and toxicological
literature for butyl benzyl phthalate. Relevant mechanistic evidence will also be considered, if
reasonably available, to inform the interpretation of findings related to potential human health
effects and the dose-repose assessment. EPA plans to evaluate all the potential human health
hazards for butyl benzyl phthalate identified in Section 2.4.2. The broad health effect categories
include reproductive and developmental, immunological, nervous system, genotoxicity,
carcinogenicity, absorption, distribution, metabolism, and excretion (ADME), and irritation
effects.
Analysis Plan. The analysis plan for butyl benzyl phthalate is presented in Section 2.7. The analysis
plan outlines the general scientific approaches that EPA plans to use for the various information streams
(i.e., chemistry, fate, release and engineering, exposure, hazard) supporting the risk evaluation. The
analysis plan is based on EPA's knowledge of butyl benzyl phthalate to date which includes a partial,
but ongoing, review of identified information as described in Section 2.1. EPA plans to continue to
consider new information submitted by the public. Should additional data or approaches become
reasonably available, EPA may update its analysis plan in the final scope document.
EPA plans to seek public comments on the systematic review methods supporting the risk evaluation for
butyl benzyl phthalate, including the methods for assessing the quality of data and information and the
approach for evidence synthesis and evidence integration supporting the exposure and hazard
assessments. The details will be provided in a supplemental document that EPA anticipates releasing for
public comment prior to the finalization of the scope document.
Peer Review. The draft risk evaluation for butyl benzyl phthalate will be peer reviewed. Peer review will
be conducted in accordance with EPA's regulatory procedures for chemical risk evaluations, including
using EPA's Peer Review Handbook and other methods consistent with Section 26 of TSCA (See 40
CFR 702.451
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1 INTRODUCTION
This document presents for comment the draft scope of the risk evaluation to be conducted for butyl
benzyl phthalate under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The Frank R.
Lautenberg Chemical Safety for the 21st Century Act amended the Toxic Substances Control Act
(TSCA) on June 22, 2016. The new law includes statutory requirements and deadlines for actions related
to conducting risk evaluations of existing chemicals.
TSCA § 6(b) and 40 CFR Part 702. Subpart A require the Environmental Protection Agency (EPA) to
designate chemical substances as high-priority substances for risk evaluation or low-priority substances
for which risk evaluations are not warranted at the time, and upon designating a chemical substance as a
high-priority substance, initiate a risk evaluation on the substance. TSCA § 6(b)(4) directs EPA, in
conducting risk evaluations for existing chemicals, to "determine whether a chemical substance presents
an unreasonable risk of injury to health or the environment, without consideration of costs or other non-
risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation by the Administrator, under the conditions of use."
TSCA § 6(b)(4)(D) and implementing regulations require that EPA publish the scope of the risk
evaluation to be conducted, including the hazards, exposures, conditions of use and potentially exposed
or susceptible subpopulations, that the Administrator expects to consider within 6 months after the
initiation of a risk evaluation. In addition, a draft scope is to be published pursuant to 40 CFR 702.41. In
December 2019, EPA published a list of 20 chemical substances that have been designated high priority
substances for risk evaluations (84 FR 71924). as required by TSCA § 6(b)(2)(B), which initiated the
risk evaluation process for those chemical substances. Butyl benzyl phthalate is one of the chemicals
designated as a high-priority substance for risk evaluation.
2 SCOPE OF THE EVALUATION
2.1 Reasonably Available Information
EPA conducted a comprehensive search for reasonably available information1 to support the
development of this draft scope document for butyl benzyl phthalate. EPA leveraged the data and
information sources already identified in the documents supporting the chemical substance's high-
priority substance designation. In addition, EPA searched for additional data and information on
physical and chemical properties, environmental fate, engineering, exposure, environmental and human
health hazards that could be obtained from the following general categories of sources:
1.	Databases containing publicly available, peer-reviewed literature;
2.	Gray literature, which is defined as the broad category of data/information sources not found in
standard, peer-reviewed literature databases.
3.	Data and information submitted under TSCA Sections 4, 5, 8(e), and 8(d), as well as "for your
information" (FYI) submissions.
Following the comprehensive search, EPA performed a title and abstract screening to identify
information potentially relevant for the risk evaluation process. This step also classified the references
1 Reasonably available information means information that EPA possesses or can reasonably generate, obtain, and synthesize
for use in risk evaluations, considering the deadlines specified in TSCA Section 6(b)(4)(G) for completing such evaluation.
Information that meets the terms of the preceding sentence is reasonably available information whether or not the information
is confidential business information, that is protected from public disclosure under TSCA Section 14 (40 CFR § 702.33).

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into useful categories or tags to facilitate the sorting of information through the systematic review
process. The search and screening processes were conducted based on EPA's general expectations for
the planning, execution and assessment activities outlined in the Application of Systematic Review in
TSCA Risk Evaluations document (U.S. EPA, 2018a). EPA will publish supplemental documentation on
the systematic review methods supporting the butyl benzyl phthalate risk evaluation to explain the
literature and screening process presented in this document in the form of literature inventory trees.
Please note that EPA focuses on the data collection phase (consisting of data search, data screening, and
data extraction) during the preparation of the TSCA scope document, whereas the data evaluation and
integration stages will occur during the development of the draft risk evaluation and thus are not part of
the scoping activities described in this document.
The subsequent sections summarize the data collection activities completed to date for the general
categories of sources and topic areas (or disciplines) using systematic review methods. EPA plans to
seek public comments on the systematic review methods supporting the risk evaluation for butyl benzyl
phthalate upon publication of the supplemental documentation of those methods.
2.1.1 Search of Gray Literature
EPA surveyed the gray literature2 and identified 89 search results relevant to EPA's risk assessment
needs for butyl benzyl phthalate. Appendix A lists the gray literature sources that yielded 89 discrete
data or information sources relevant to butyl benzyl phthalate. EPA further categorized the data and
information into the various topic areas (or disciplines) supporting the risk evaluation (e.g., physical
chemistry, environmental fate, environmental hazard, human health hazard, exposure, engineering) and
the breakdown is shown in Figure 2-1. EPA is currently identifying additional reasonable available
information (e.g., public comments), and the reported numbers in Figure 2-1 may change.
Gray Literature Tags by Discipline
27/89
Physical.Chemical
Hum an .Health. Hazard
54/89
Exposure
15/89
Environmental. Hazard
62/89
Engineering
0	25	50	75	100
Percent Tagged (%)
Figure 2-1 Gray Literature Search Results for Butyl Benzyl Phthalate
The percentages across disciplines do not add up to 100%, as each source may provide data or information for various topic
areas (or disciplines).
2 Gray literature is defined as the broad category of data/information sources not found in standard, peer-reviewed literature
databases (e.g., PubMed and Web of Science). Gray literature includes data/information sources such as white papers,
conference proceedings, technical reports, reference books, dissertations, information on various stakeholder websites, and
other databases.
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2.1.2 Search of Literature from Publicly Available Databases (Peer-Reviewed
Literature)
EPA is currently conducting a systematic review of the reasonably available literature. This includes
performing a comprehensive search of the reasonably available peer review literature on physical-
chemical (p-chem) properties, environmental fate and transport, engineering (environmental release and
occupational exposure), exposure (environmental, general population and consumer) and environmental
and human health hazards of butyl benzyl phthalate. Eligibility criteria were applied in the form of
PECO (population, exposure, comparator, outcome) statements. Included references met the PECO
criteria, whereas excluded references did not meet the criteria (i.e., not relevant), and supplemental
material was considered as potentially relevant. EPA plans to analyze the reasonably available
information identified for each discipline during the development of the risk evaluation. The literature
inventory trees depicting the number of references that were captured and those that were included,
excluded, or tagged as supplemental material during the screening process for each discipline area are
shown in Figure 2-2 through Figure 2-6. "TIAB" in these figures refers to title and abstract screening.
Note that in some figures the sum of the numbers for the various sub-categories may be larger than the
broader category because some studies may be included under multiple sub-categories. In other cases,
the sum of the various sub-categories may be smaller than the main category because some studies may
not be depicted in the sub-categories if their relevance to the risk evaluation was unclear.
Retrieved for Full-text
Review
Total for TIAB:
P-Chem
Boiling Point
Melting Point
Water Solubfity
togKOW
Henry's Law Constant
7
Vapor Pressure
included for Data
Extraction and Data
Evaluation
Vapor Density
-<
Density
Viscosity
Dieiectrio Constant
S
Refractive Index
Supplemental Information
Figure 2-2 Peer-reviewed Literature - Physical-Chemical Properties Search Results for Butyl
Benzyl Phthalate
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©
Bioconcertratior,
Biomagnification, etc.
TSCA Fate BBP (2020)
E
Included
^393^
Excluded
86
Supplemental
©
Biodegradation
Q
Hydrolysis
©
Photolysis
Sorption
©
Volatilization
©
Wastewater Treatment
19
Other
Figure 2-3 Peer-reviewed Literature - Fate and Transport Search Results for Butyl Benzyl
Phthalate
Click here for interactive Health Assessment Workplace Collaborative (HAWC) diagram.
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©
General Facility Estimate
60
Included
©
Environmental Release
336
TSCA Engineering BBP
(2020)
Excluded
50
Occupational Exposure
©
Supplemental
Figure 2-4 Peer-reviewed Literature - Engineering Search Results for Butyl Benzyl Phthalate
Click here for interactive HAWC diagram.
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339
Include
520
TSCA Exposure BBP (2020)
2S
O
indoor air
fs*")
ambient air
f y ©
soil
©
sediment
©
biosolids/sludge
98
surface water
©
drinking water
(5)
aquatic species
V	©
terrestrial species
96
epidemiological/human
biomonitoring study
consumer uses and/or
products
29
dietary
©
ground water
Supplemental
foreign language
KJ
Exclude
Figure 2-5 Peer-reviewed Literature - Exposure Search Results for Butyl Benzyl Phtlialate
Click here for interactive I-IAWC diagram.
17

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30
Retrieved for Full-text
Review
{27)
Human
®
Animal
®
Plant
3982
3951
TSCA Hazard BBP (2020)
Exclusion
O
Supplemental Material
Mechanistic
©
ADME/TK/PBPK
/
Mixture
' ^	®
Case Study or Case Series
No Original Data
®
Conference Abstract
©
Susceptible Population
®
Non-English Record
V	©
Field Study
V	©
Agent to Induce Allergenic
Response
©
PECO-Relevant Isomer
Study
Figure 2-6 Peer-reviewed Literature - Hazard Search Results for Butyl Benzyl Phthalate
Click here for interactive HAWC diagram.
2.1.3 Search of TSCA Submissions
Table 2-lpresents the results of screening the titles of data sources and reports submitted to EPA under
various sections of the TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the
21st Century Act. EPA screened a total of 185 submissions using inclusion/ exclusion criteria specific to
individual disciplines (see Table 2-1 for the list of disciplines). The details about the criteria are not part
of this document but will be provided in a supplemental document that EPA anticipates releasing prior
18

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to the finalization of the scope document. EPA identified 160 submissions that met the inclusion criteria
in these statements and identified 15 submissions with supplemental data. EPA excluded 10 submissions
because the reports were identified as one of the following:
•	Abstract or full prepublication copy of a manuscript that was later published and that would be
identified via other peer or gray literature searches
•	Record of telephone communication
•	Study of toxicity to bacteria
•	Notice of withdrawal of test rule by EPA
•	Letter with no data
•	Submission on a different chemical
•	Comparison of studies containing no primary data
•	Letter with correction to previous letter
EPA plans to conduct additional deduplication at later stages of the systematic review process (e.g., full
text screening), when more information regarding the reports is available.
Table 2-1 Results of Title Screening of Submissions to EPA under Various Sections of TSCA
Discipline
Included
Supplemental
P-Chem Properties
11
0
Environmental Fate and Transport
30
0
Environmental and General Population Exposure
29
1
Occupational Exposure/Release Information
10
0
Environmental Hazard
62
2
Human Health Hazard
35
12
2.2 Conditions of Use
As described in the Proposed Designation of Butyl Benzyl Phthalate (CASRN 85-68-7) as a High-
Priority Substance for Risk Evaluation (U.S. EPA, 2019a), EPA assembled information from the CDR
and TRI programs to determine conditions of use3 or significant changes in conditions of use of the
chemical substance. EPA also consulted a variety of other sources to identify uses of butyl benzyl
phthalate, including published literature, company websites, and government and commercial trade
databases and publications. To identify formulated products containing butyl benzyl phthalate, EPA
searched for safety data sheets (SDS) using internet searches, EPA Chemical and Product Categories
(CPCat) data, and other resources in which SDSs could be found. In addition, EPA incorporated
communications with companies, industry groups, environmental organizations, and public comments to
supplement the use information.
EPA identified and described the categories and subcategories of conditions of use that will be included
in the scope of the risk evaluation (Section 2.2.1;
Table 2-2). The conditions of use included in the scope are those reflected in the life cycle diagrams and
conceptual models.
3 Conditions of use means the circumstances, as determined by the Administrator, under which a chemical substance is
intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of (15
U.S.C. § 2602(4)).
19

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After gathering the conditions of use, EPA identified those categories or subcategories of use activities
for butyl benzyl phthalate the Agency determined not to be conditions of use or will otherwise be
excluded during scoping. These categories and subcategories are described in Section 2.2.2.
2.2.1 Categories and Subcategories of Conditions of Use Included in the Scope of the
Risk Evaluation
Table 2-2 lists the conditions of use that are included in the scope of the risk evaluation.
Table 2-2 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
Life-Cycle Stage
Category
Subcategory
Reference
Manufacture
Domestic
manufacturing
Domestic manufacturing
U.S. EPA (2019b)
Import
Import
U.S. EPA (2019b)
Processing
Incorporating into
formulation, mixture
or reaction product
Fillers in:
- Custom compounding of
purchased resin
U.S. EPA (2019b)
Plasticizers in:
-	Adhesive manufacturing
-	All Other Basic Inorganic Chemical
Manufacturing
-	Dental product manufacturing
-	Paints and coatings manufacturing
-	Personal care products
-	Printing ink manufacturing
U.S. EPA (2019b);
GoodGuide (2011);
SPIN (2019); Ash
et al. (2009)
Processing aid in:
- Petroleum production
Orem et al. (2007)
Laboratory chemical manufacturing
EP A-HO-OPPT -
2018-051
Biocide carrier manufacturing

2
Incorporating into
articles
Plasticizers in:
-	Asphalt paving, roofing, and coating
materials manufacturing
-	Fabric, textile, and leather products
not covered elsewhere
manufacturing
-	Floor coverings manufacturing
-	Food contact surfaces
manufacturing
-	Plastics product manufacturing
-	Rubber product manufacturing
-	Textiles, apparel, and leather
manufacturing
-	Transportation equipment
manufacturing
U.S. EPA (2019b);
FDA (2018); EPA-
HO-OPPT-2019-
0131-0022: Ash et
al. (2009)
20

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I.ifc-Cvclc Slsigc
(si logon
Suhcsi logon
Reference

Repackaging
Repackaging
EP A-HO-OPPT -
2018-051
Recycling
Recycling

Distribution in
commerce
Distribution in
commerce


Industrial use
Adhesives and
sealants
Adhesives and sealants
U.S. EPA (2019b)
Automotive, Fuel,
Agriculture,
Outdoor Use
Products
Automotive care products
ACC (2019); NLM
(2015)
Castings
Castings
BJB Enterprises
Inc. (2018)
Construction, Paint,
Electrical, and Metal
Products
Building/construction materials not
covered elsewhere
DeLima Associates
(2011)
Floor coverings
Floor coverings
U.S. EPA (2019b)
Furnishing,
Cleaning,
Treatment/Care
Products
Fabric, textile, and leather products
not covered elsewhere
U.S. EPA (2019b)
Paints and coatings
Paints and coatings
U.S. EPA (2019b)
Plastic and rubber
products not covered
elsewhere
Plastic and rubber products not
covered elsewhere in:
- Transportation equipment
manufacturing
EP A-HO-OPPT -
2 2

Processing aid,
specific to
petroleum
production
Hydraulic fracturing
Orem et al. (2007)
Other uses
Chemical intermediate
NLM (2015); SPIN
(2019); Ash et al.
(2009)
Laboratory Chemicals
Sigma-Aldrich
(2019)
Plastic and rubber products not
covered elsewhere
- Component of compound (resin)
used to cast models
NASA (2020)
Commercial uses
Adhesives and
sealants
Adhesives and sealants
U.S. EPA (2019b)
Automotive, Fuel,
Agriculture,
Outdoor Use
Products
Automotive care products
ACC (2019); NLM
(2015)
21

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I.ifc-Cvclc Slsigc
(si logon
Suhcsi logon
Reference

Castings
Castings
BJB Enterprises
Inc. (2018)
Construction, Paint,
Electrical, and Metal
Products
Building/construction materials not
covered elsewhere
DeLima Associates
(2011)
Floor coverings
Floor coverings
U.S. EPA (2019b)
Furnishing,
Cleaning,
Treatment/Care
Products
Fabric, textile, and leather products
not covered elsewhere
U.S. EPA (2019b)
Paints and coatings
Paints and coatings
U.S. EPA (2019b)
Plastic and rubber
products not covered
elsewhere
Plastic and rubber products not
covered elsewhere in:
- Transportation equipment
manufacturing
EP A-HO-OPPT -
2 2

Processing aid,
specific to
petroleum
production
Hydraulic fracturing
Orem et al. (2007)
Other uses
Chemical intermediate
NLM (2015); SPIN
(2019); Ash et al
(2009)
Laboratory Chemicals
Sigma-Aldrich
(2019)
Plastic and rubber products not
covered elsewhere
- Component of compound (resin)
used to cast models
NASA (2020)
Consumer uses
Adhesives and
sealants
Adhesives and sealants
U.S. EPA (2019b)
Automotive, Fuel,
Agriculture,
Outdoor Use
Products
Automotive care products
ACC (2019); NLM
(2015)
Construction, Paint,
Electrical, and Metal
Products
Building/construction materials not
covered elsewhere
DeLima Associates
(2011)
Floor coverings
Floor coverings
U.S. EPA (2019b)
Furnishing,
Cleaning,
Treatment/Care
Products
Fabric, textile, and leather products
not covered elsewhere
U.S. EPA (2019b)
Packaging, Paper,
Plastic, Hobby
Products
-	Arts, crafts, and hobby materials
-	Toys, playground, and sporting
equipment
-	Ink, toner, and colorant products
U.S. EPA (2019b)
22

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Lilc-Cyclc Singe
Category
Subcategory
Reference

Paints and coatings
Paints and coatings
U.S. EPA (2019b)
Plastic and rubber
products not covered
elsewhere
Plastic and rubber products not
covered elsewhere in:
- Transportation equipment
manufacturing
NLM (2015)
Disposal
Disposal
Disposal

Notes:
• Life Cycle Stage Use Definitions
-	"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.
2.2.2	Activities Excluded from the Scope of the Risk Evaluation
As explained in the final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic
Substances Control Act, TSCA Section 6(b)(4)(D) requires EPA to identify the hazards, exposures,
conditions of use, and the PESS the Administrator expects to consider in a risk evaluation, suggesting
that EPA may exclude certain activities that it determines to be conditions of use on a case-by-case
basis (82 FR 33726, 33729; July 20, 2017). As a result, EPA will not include in this scope or in the risk
evaluation the activities described below that the Agency has concluded do not constitute conditions of
use.
EPA has determined that the following uses of butyl benzyl phthalate are non-TSCA uses:
•	EPA determined that butyl benzyl phthalate is used in dental sealants and nail polish which
meets the definition of cosmetics under Section 201 of the Federal Food, Drug and Cosmetics
Act, 21 U.S.C. § 321, and are therefore excluded from the definition of "chemical substance" in
TSCA § 3(2)(B)(vi). Activities and releases associated with such cosmetics are therefore not
"conditions of use" (defined as circumstances associated with "a chemical substance," TSCA §
3(4)) and will not be evaluated during risk evaluation. However, manufacturing, processing, and
industrial uses of these products are covered by TSCA and will be considered a condition of use.
•	EPA recognizes that the Food and Drug Administration lists butyl benzyl phthalate as an
optional substance to be used in food packaging materials. Food packaging materials meet the
definition for a "food additive" described in Section 201 of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. § 321. Therefore, the consumer uses are excluded from the
definition of "chemical substance" in TSCA § 3(2)(B)(vi) and are not included in Table 2-2.
However, manufacturing, processing, and industrial uses of these products are covered by TSCA
and will be considered a condition of use.
2.2.3	Production Volume
Production volume of butyl benzyl phthalate in 2015, as reported to EPA during the 2016 CDR
reporting period, was between 10 million and 50 million pounds (U.S. EPA, 2017). EPA also uses pre-
2015 CDR production volume information, as detailed in the Proposed Designation of Butyl Benzyl
Phthalate (CASRN 85-68-7) as a Hieh-Priority Substance for Risk Evaluation (U.S. EPA, 2019a) and
23

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will include future production volume information as it becomes available to support the exposure
assessment.
2.2.4 Overview of Conditions of Use and Lifecycle Diagram
The life cycle diagram provided in Figure 2-7 depicts the conditions of use that are considered within
the scope of the risk evaluation for the various life cycle stages as presented in Section 2.2.1. Section
2.2.1 provides a brief overview of the industrial, commercial and consumer use categories included in
the life cycle diagram. The activities that EPA determined are out of scope are not included in the life
cycle diagram. Appendix E contains more detailed descriptions (e.g., process descriptions, worker
activities, process flow diagrams) for each manufacture, processing, distribution in commerce, use and
disposal category.
The information in the life cycle diagram is grouped according to the CDR processing codes and use
categories (including functional use codes for industrial uses and product categories for industrial,
commercial and consumer uses).
24

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MFG/IMPORT
Manufacture
(Including Import)
PROCESSING
		
Processing as a Reactant
(Chemical intermediate)
Incorporation into Formulation, Mixture, or Reaction
Product
(Fillers in: Custom compounding of purchased resin
Plasticizer in: Adhesives and sealant manufacturing: All
other basic inorganic chemical manufacturing: Dental
product manufacturing: Paints and coatings manufacturing;
Personal care products; Printing ink manufacturing
Processing aid in: Petroleum production
Laboratory chemical manufacturing
Biocide carrier manufacturing)
Incorporation into Article
(Plasticizers in: Asphalt paving, roofing, and coating
materials manufacturing; Fabric, textile, apparel, and
leather manufacturing; Floor coverings manufacturing;
Food contact materials manufacturing; Plastics and rubber
product manufacturing; Transportation and equipment
manufacturing)
Repackaging
Recycling

INDUSTRIAL, COMMERCIAL, CONSUMER USES R ELEASES AND WASTE DISPOSAL
't
-K>
Adhesives and sealants 1,2
Arts, crafts, and hobby materials 2
Automotive care products 1,2
Building and construction materials not covered elsewhere 1,2
Fabric, textile, and leather products 1,2
Floor coverings 1,2
Inks, toner, and colorant products 1,2
Paints and coatings 1,2
Plastic and rubber products not covered elsewhere 1.2
Miscellaneous uses 1,2
eg. Castings: Hydraulic fracturing: Laboratory chemicals; Toys,
playground, and sporting equipment;...
Disposal
See Conceptual Model for
Environmental Releases and
Wastes
Manufacture
(including import)
Processing
Uses
1.	Industrial and/or Commercial
2.	Consumer
Figure 2-7 Butyl Benzyl Phthalate Life Cycle Diagram
Volume is not depicted in the life cycle diagram for processing and industrial, commercial, and consumer uses as specific production volume is claimed confidential
business information (CBI) or withheld pursuant to TSCA Section § 14.
25

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2.3 Exposures
For TSCA exposure assessments, EPA plans to analyze exposures and releases to the environment
resulting from the conditions of use within the scope of the risk evaluation for butyl benzyl phthalate.
Release pathways and routes will be described to characterize the relationship or connection between the
conditions of use of the chemical and the exposure to human receptors, including PESS, and
environmental receptors. EPA will consider, where relevant, the duration, intensity (concentration),
frequency and number of exposures in characterizing exposures to butyl benzyl phthalate.
2.3.1	Physical and Chemical Properties
Consideration of p-chem properties is essential for a thorough understanding or prediction of
environmental fate (i.e., transport and transformation) and the eventual environmental concentrations.
They can also inform the hazard assessment. EPA plans to use the physical and chemical properties
described in Appendix B of the Proposed Designation of Butyl Benzyl Phthalate (CASRN 85-68-7) as a
High-Priority Substance for Risk Evaluation (U.S. EPA, 2019a) to support the development of the risk
evaluation for butyl benzyl phthalate. The values for the physical and chemical properties (Appendix B)
may be updated as EPA collects additional information through systematic review methods.
2.3.2	Environmental Fate and Transport
Understanding of environmental fate and transport processes assists in the determination
of the specific exposure pathways and potential human and environmental receptors that need to be
assessed in the risk evaluation for butyl benzyl phthalate. EPA plans to use the environmental fate
characteristics described in Appendix C of the Proposed Designation of Butyl Benzyl Phthalate (CASRN
85-68-7) as a High-Priority Substance for Risk Evaluation (U.S. EPA, 2019a) to support the
development of the risk evaluation for butyl benzyl phthalate. The values for the environmental fate
properties (Appendix C) may be updated as EPA collects additional information through systematic
review methods.
2.3.3	Releases to the Environment
Releases to the environment from conditions of use (e.g., manufacturing, industrial, and commercial
processes, commercial or consumer uses resulting in down-the-drain releases) are a component of
potential exposure and may be derived from reported data that are obtained through direct measurement,
calculations based on empirical data or assumptions and models.
Butyl benzyl phthalate was covered under the Toxics Release Inventory (TRI) program until 1993, at
which time it was removed from the TRI list of chemicals. Since 1993, butyl benzyl phthalate has not
been a TRI-listed chemical; therefore, release data from TRI are not available for butyl benzyl phthalate
for 1993 to present. There may be releases of butyl benzyl phthalate from industrial sites to wastewater
treatment plants (WWTP), surface water, air and landfill. Articles that contain butyl benzyl phthalate
may release butyl benzyl phthalate to the environment during use or through recycling and disposal.
2.3.4	Environmental Exposures
The manufacturing, processing, distribution, use and disposal of butyl benzyl phthalate can result in
releases to the environment and exposure to aquatic and terrestrial receptors (biota). Environmental
exposures to biota are informed by releases into the environment, overall persistence, degradation, and
bioaccumulation, and partitioning across different media. Concentrations of chemical substances in biota
provide evidence of exposure. EPA plans to review available environmental exposure data in biota to
inform development of the environmental exposure assessment for butyl benzyl phthalate.
26

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Monitoring data were identified in the EPA's data search for butyl benzyl phthalate and can be used in
the exposure assessment. Relevant and reliable monitoring studies provide information that can be used
in an exposure assessment. Monitoring studies that measure environmental concentrations or
concentrations of chemical substances in biota provide evidence of exposure. Monitoring data shows
that butyl benzyl phthalate has been identified in various environmental compartments including air,
water, sediment, and soil samples (U.S. EPA, 2019a). A review of the available literature has also
identified that there is environmental aquatic, non-mammalian biomonitoring data available (U.S. EPA,
2019a). EPA plans to review available environmental monitoring data in the risk evaluation.
2.3.5 Occupational Exposures
EPA plans to analyze worker activities where there is a potential for exposure under the various
conditions of use described in Section 2.2.1. In addition, EPA plans to analyze exposure to ONUs (i.e.,
workers, who do not directly handle the chemical but perform work in an area where the chemical is
present). EPA also plans to consider the effect(s) that engineering controls (ECs) and/or personal
protective equipment (PPE) have on occupational exposure levels as part of the draft risk evaluation.
Worker activities associated with conditions of use within the scope of the risk evaluation will be
analyzed, including, but not limited to:
•	Unloading and transferring butyl benzyl phthalate to and from storage containers to process
vessels;
•	Handling, transporting and disposing of waste containing butyl benzyl phthalate;
•	Cleaning and maintaining equipment;
•	Sampling chemicals, formulations or products containing butyl benzyl phthalate for quality
control;
•	Repackaging chemicals, formulations or products containing butyl benzyl phthalate;
Butyl benzyl phthalate is liquid at room temperature and has a vapor pressure of 8.25x 10"6 mm Hg at
25°c/77°f (NLM. 2015) and inhalation exposure to vapor is expected to be low when working with the
material at room temperature. However, EPA plans to analyze inhalation exposure in occupational
scenarios where butyl benzyl phthalate is applied via spray or roll application methods or is handled as a
dry powder or at elevated temperatures. Occupational exposure limits for butyl benzyl phthalate have
not been established by the Occupational Safety and Health Administration (OSHA), the National
Institute for Occupational Safety (NIOSH), or the American Conference of Governmental Industrial
Hygienists (ACGIH).
Based on the conditions of use, EPA also plans to analyze worker exposure to liquids and/or solids via
the dermal route. EPA does not expect to analyze dermal exposure for ONUs that do not directly handle
butyl benzyl phthalate.
EPA generally does not evaluate occupational exposures through the oral route. Workers may
inadvertently transfer chemicals from their hands to their mouths or ingest inhaled particles that deposit
in the upper respiratory tract. The frequency and significance of this exposure route are dependent on
several factors including the p-chem properties of the substance during expected worker activities,
workers' awareness of the chemical hazards, the visibility of the chemicals on the hands while working,
workplace practices, and personal hygiene that is difficult to predict (Cherrie et al., 2006). However,
EPA will consider oral exposure on a case-by-case basis for certain COUs and worker activities where
there is information and data on incidental ingestion of inhaled dust. EPA will consider ingestion of
inhaled dust as an inhalation exposure for butyl benzyl phthalate.
27

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2.3.6	Consumer Exposures
Based on CDR reporting and conversations with industry, butyl benzyl phthalate appears to be widely
used in consumer products and articles specifically adhesives and sealants, automotive care products,
arts, crafts, and hobby materials, cleaning and furnishing care products, fabric, textile, and leather
products, floor coverings, paints and coatings, plastic and rubber products, toys, playground and sporting
equipment, and ink, toner, and colorant products (See Section 2.6.2 and Figure 2-9). These uses can
result in exposures to consumers and bystanders. In addition, consumer handling of the disposal on butyl
benzyl phthalate containing materials can lead to consumer and bystander exposures.
Based on reasonably available known consumer conditions of use, inhalation of butyl benzyl phthalate is
possible through either inhalation of vapor/mist during product usage or indoor air/dust. Oral exposure
of butyl benzyl phthalate is possible through either ingestion through product use via transfer from hand
to mouth or via through mouthing of articles containing butyl benzyl phthalate. Dermal exposure may
occur via contact with vapor or mist deposition onto the skin, via direct liquid contact during use, or
direct dermal contact of articles containing butyl benzyl phthalate. Based on these potential sources and
pathways of exposure, EPA plans to analyze oral, dermal and inhalation exposures to consumers and
inhalation exposures to bystanders that may result from the conditions of use of butyl benzyl phthalate.
2.3.7	General Population Exposures
Releases of butyl benzyl phthalate from certain conditions of use, such as manufacturing, processing, or
disposal activities, may result in general population exposures. The general population is primarily
exposed via ingestion (NTP 2003,1ARC 1999, CPSC 2010). Monitoring data shows that butyl benzyl
phthalate has been identified in various environmental compartments including air, water, sediment, and
soil samples (U.S. EPA, 2019a). EPA plans to review the reasonably available information for the
presence of butyl benzyl phthalate in environmental media relevant to general population exposure.
EPA also plans to review any reasonably available human biomonitoring data in the risk evaluation for
butyl benzyl phthalate.
28

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2.4 Hazards (Effects)
2.4.1	Environmental Hazards
As described in the Promised Designation of Butyl Benzyl Phthalaie (CASRN 85-68-7) as a High-
Priority Substance for Risk Evaluation (U.S. EPA, 2019a), EPA considered reasonably available
information from peer-reviewed assessments and databases to identify potential environmental hazards
for butyl benzyl phthalate. EPA considers all the potential environmental hazards for butyl benzyl
phthalate identified during prioritization (U.S. EPA, 2019a) to be relevant for the risk evaluation and
thus they remain within the scope of the evaluation. EPA is in the process of identifying additional
reasonably available information through systematic review methods and public comments, which may
update the list of potential environmental hazards associated with butyl benzyl phthalate. If necessary,
EPA plans to update the list of potential hazards in the final scope document of butyl benzyl phthalate.
Based on information identified during prioritization, environmental hazard effects were identified for
aquatic and terrestrial organisms.
2.4.2	Human Health Hazards
As described in the Proposed Designation of Butyl Benzyl Phthalate (CASRN 85-68-7) as a High-
Priority Substance for Risk Evaluation (U.S. EPA, 2019a), EPA considered reasonably available
information from peer-reviewed assessments and databases to identify potential human health hazards
for butyl benzyl phthalate. The health effect categories screened during prioritization included acute
toxicity, repeat dose toxicity, irritation/corrosion, dermal sensitization, respiratory sensitization, genetic
toxicity, reproductive toxicity, developmental toxicity, immunotoxicity, neurotoxicity, carcinogenicity,
epidemiology or biomonitoring findings and absorption, distribution, metabolism, and excretion
(ADME).
The broad health effect categories included for further evaluation from designation are developmental
and reproductive effects. EPA is in the process of identifying additional reasonably available
information through systematic review methods and public input, which may update the list of potential
human health hazards under the scope of the risk evaluation. If necessary, EPA plans to update the list of
potential hazards in the final scope document of the butyl benzyl phthalate risk evaluation.
2.5 Potentially Exposed or Susceptible Subpopulations
TSCA §6(b)(4) requires EPA to determine whether a chemical substance presents an unreasonable risk
to "a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation."
TSCA §3(12) states that "the term 'potentially exposed or susceptible subpopulation' means a group of
individuals within the general population identified by the Administrator who, due to either greater
susceptibility or greater exposure, may be at greater risk than the general population for adverse health
effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women,
workers, or the elderly." General population is "the total of individuals inhabiting an area or making up a
whole group" and refers here to the U.S. general population (	011a).
During the Prioritization process, EPA identified the following PESS based on CDR information and
studies reporting developmental and reproductive effects: children, women of reproductive age
(including, but not limited to, pregnant women), workers and consumers (U.S. EPA, 2019a). EPA plans
to evaluate these PESS in the risk evaluation.
In developing exposure scenarios, EPA plans to analyze reasonably available information to ascertain
whether some human receptor groups may be exposed via exposure pathways that may be distinct to a
29

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particular subpopulation or life stage (e.g., children's crawling, mouthing or hand-to-mouth behaviors)
and whether some human receptor groups may have higher exposure via identified pathways of
exposure due to unique characteristics (e.g., activities that would lead to elevated fish ingestion or
otherwise lead to increased duration or level of exposure) when compared with the general population
(U.S. EPA. 2006a). Likewise, EPA plans to evaluate available human health hazard information to
ascertain whether some human receptor groups may have greater susceptibility than the general
population to the chemical's hazard(s).
2.6 Conceptual Models
In this section, EPA presents the conceptual models describing the identified exposures (pathways and
routes), receptors and hazards associated with the conditions of use of butyl benzyl phthalate. Pathways
and routes of exposure associated with workers and ONUs are described in Section 2.6.1, and pathways
and routes of exposure associated with consumers are described in Section 2.6.2. Pathways and routes of
exposure associated with environmental releases and wastes, including those pathways that may be
addressed pursuant to other Federal laws are discussed and depicted the conceptual model shown in
Section 2.6.3. Pathways and routes of exposure associated with environmental releases and wastes,
excluding those pathways that may be addressed pursuant to other Federal laws, are presented in the
conceptual model shown in Section 2.6.4.
2.6.1 Conceptual Model for Industrial and Commercial Activities and Uses
Figure 2-8 illustrates the conceptual model for the pathways of exposure from industrial and commercial
activities and uses of butyl benzyl phthalate that EPA plans to include in the risk evaluation. There is
potential for exposures to workers and/or ONUs via inhalation routes and exposures to workers via
dermal routes. EPA plans to evaluate activities resulting in exposures associated with distribution in
commerce (e.g., loading, unloading) throughout the various lifecycle stages and conditions of use (e.g.,
manufacturing, processing, industrial use, commercial use, and disposal) rather than a single distribution
scenario. For each condition of use identified in
Table 2-2, an initial determination was made as to whether or not EPA plans to analyze each
combination of exposure pathway, route, and receptor in the risk evaluation. The results of that analysis
along with the supporting rationale are presented in Appendix F.
30

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INDUSTRIAL AND COMMERC IAL
ACTIVITIES t USES
EXPOSURE PATHWAY
EXPOSURE ROUTE
RECEPTORS
HAZARDS
.Manufacturing
Processing
, -au.' "
huviuwh formulation, mixture, or
etvl.cu, Mtnlnca
locorporatiod ur > article
-Repack fin1
Adhesive* and sealants
Automotive care products
Building and construction materials not
covered elsewhere
Fabric, textile, and leather products
not covered elsewhere
Floor coverings
Inks, toner, and colorant products
Paints and coatings
Plastic and rubber products not
covered elsew here
Miscellaneous uses
Recycling
Waste Handling,
Treatment, and
Disposal
T
Liquid'Solid Contact
Dermal
worker
c
Inhalation-Oral
iikiooi
Yhv4 Mist P\m
fugitive emissions
F(Mtl V i
ah '! > ri u ( S i r ( i
(Release Conceptual Models}
Ha.oid- ouV[iti„lh
assaulted niM u ak-
uvi oi cmon.c
e\po^,ue
Figure 2-8 Butyl Benzyl Phthalate Conceptual Model for Industrial and Commercial Activities and Uses: Worker and Occupational
Non-User Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes, and hazards to human receptors from industrial and commercial activities and uses of butyl
benzyl phthalate.
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2,6.2 Conceptual Model for Consumer Activities and Uses
The conceptual model in Figure 2-9 presents the exposure pathways, exposure routes and hazards to
human receptors from consumer activities and uses of butyl benzyl phthalate. EPA expects that
consumers may be exposed through use of products or articles containing butyl benzyl phthalate through
oral, dermal, and inhalation routes. During use of articles, EPA expects that consumers may also be
exposed via direct dermal contact or mouthing. Bystanders are expected to be exposed through product
use via inhalation. It should be noted that some consumers may purchase and use products primarily
intended for commercial use. EPA plans to analyze pathways and routes of exposure that may occur
during the varied identified consumer activities and uses. The supporting rationale are presented in
Appendix G. The conceptual model in Figure 2-9 presents the exposure pathways, exposure routes and
hazards to human receptors from consumer activities and uses of butyl benzyl phthalate. EPA expects
that consumers may be exposed through product use or articles containing butyl benzyl phthalate
through oral, dermal, and inhalation routes. Bystanders are expected to be exposed through product use
via inhalation.
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C ONSUMER ACTIVITIES &	EXPOSURE	EXPOSURE
USES	PATHWAY	ROUTE
Oral
3 1
Dermal
Plastic and Rubber Product? not
Covered Elsewhere
Oral
Adbesives and Sealants
Automotive Care Produces
Arts. Crafts and Hobby Materials
d
Ink. loser., and ColorantProducts
Figure 2-9 Butyl Benzyl Phthalate Conceptual Model for Consumer Activities and Uses: Consumer Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes, and hazards to human receptors from consumer activities and uses of butyl benzyl phthalate.
33

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2.6.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures
and Hazards (Regulatory Overlay)
In this section, EPA presents the conceptual models describing the identified exposures (pathways and
routes), receptors and hazards associated with the conditions of use of butyl benzyl phthalate within the
scope of the risk evaluation. It also discusses those pathways that may be addressed pursuant to other
Federal laws.
In complying with TSCA, EPA plans to efficiently use Agency resources, avoid duplicating efforts
taken pursuant to other Agency programs, maximize scientific and analytical efforts, and meet the
statutory deadline for completing risk evaluations. OPPT is working closely with the offices within EPA
that administer and implement the Clean Air Act (CAA), the Safe Drinking Water Act (SDWA), the
Clean Water Act (CWA) and the Resource Conservation and Recovery Act (RCRA), to identify how
those statutes and any associated regulatory programs address the presence of butyl benzyl phthalate in
exposure pathways falling under the jurisdiction of these EPA statutes.
The conceptual model in Figure 2-10 presents the potential exposure pathways, exposure routes and
hazards to human and environmental receptors from releases and waste streams associated with
industrial, commercial, and consumer uses of butyl benzyl phthalate. This figure includes overlays,
labeled and shaded to depict the regulatory programs (e.g., CAA, SDWA, CWA, RCRA) and associated
pathways that EPA considered in developing this conceptual model for the draft scope document. The
pathways are further described in Section 2.6.3.1 through Section 2.6.3.2.
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RELEASES AND WASTES FROM
INDUSTRIAL / COMMERCIAL /
CONSUMER USES
EXPOSURE PATHWAYS
EXPOSURE
ROUTES
RECEPTORS
HAZARDS
CWA-AWOC
Industnal Pre-
T real men ( or
Industrial VVWT
Water, Sedtmenl
Aquatic
Indirect discharge
~
Fish Ingcstio
~
Species
w astewater or
Liquid Wastes
POTW
RCRA-HazList
Underground
Injection
Dunking
water
Biosohds
Hazardous and
Municipal Waste
Landfill
Land
Disposal
Genera]
Population
Dermal
( rl 11111H.I
Solid Wastes
water
Hazardous and
Municipal Waste
Incineraiors
Liquid Wastes
Inhalation
Fugitive Emissions
Cm-site Waste
Transfer
I errestnal
Species
Recycling, Other
Treatment
Hazards Potentially
Associated with
Acute and/or Chronic
Exposures
Emissions to Air
Figure 2-10 Butyl Benzyl Phthalate Conceptual Model for Environmental Releases and Wastes: Environmental and General
Population Exposures and Hazards (Regulatory Overlay)
The conceptual model presents the exposure pathways, exposure routes and hazards to human and environmental receptors from releases and wastes from industrial and
commercial, and consumer uses of butyl benzyl phthalate Including the enviromnental statutes covering those pathways. Notes:
a)	Industrial wastewater or liquid wastes may be treated on-site and then released to surface water (direct discharge), or pre-treated and released to Publicly Owned
Treatment Works (POTW) (indirect discharge). For consumer uses, such wastes may be released directly to POTW. Drinking water will undergo further treatment in
drinking water treatment plant. Ground water may also be a source of drinking water. Inhalation from drinking water may occur via showering.
b)	Receptors include potentially exposed or susceptible subpopulations (see Section 2.5).
c)	For regulation of hazardous and municipal waste incinerators and municipal waste landfills CAA and RCRA may have shared regulatory authority.
35

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2.6.3.1	Ambient Water Pathway
EPA develops recommended water quality criteria under Section 304(a) of the CWA for pollutants in
surface water that are protective of aquatic life or human health designated uses. EPA has developed
recommended water quality criteria for protection of human health for butyl benzyl phthalate which are
available for possible adoption into state water quality standards and are available for possible use by
NPDES permitting authorities in deriving effluent limits to meet state narrative criteria. As such, EPA
does not plan to include this pathway in the risk evaluation under TSCA. EPA's OW and OPPT will
continue to work together providing understanding and analysis of the CWA water quality criteria
development process and to exchange information related to toxicity of chemicals undergoing risk
evaluation under TSCA.
EPA has developed CWA Section 304(a) recommended human health criteria for 122 chemicals and
aquatic life criteria for 47 chemicals. A subset of these chemicals is identified as "priority pollutants"
(103 human health and 27 aquatic life), including butyl benzyl phthalate. The CWA requires that states
adopt numeric criteria for priority pollutants for which EPA has published recommended criteria under
Section 304(a), the discharge or presence of which in the affected waters could reasonably be expected
to interfere with designated uses adopted by the state.
For pollutants with recommended human health criteria, EPA regulations require that state criteria
contain sufficient parameters and constituents to protect designated uses. Once states adopt criteria as
water quality standards, the CWA requires that National Pollutant Discharge Elimination System
(NPDES) discharge permits include effluent limits as stringent as necessary to meet standards CWA
Section 301(b)(1)(C). This permit issuance process accounts for risk in accordance with the applicable
ambient water exposure pathway (human health or aquatic life as applicable) for the designated water
use.
EPA has not developed CWA Section 304(a) recommended water quality criteria for the protection of
aquatic life for butyl benzyl phthalate, so there are no national recommended criteria for this use
available for adoption into state water quality standards and available for use in NPDES permits. EPA
may issue CWA Section 304(a) aquatic life criteria for butyl benzyl phthalate in the future if it is
identified as a priority under the CWA.
2.6.3.2	Disposal and Soil Pathways
Butyl benzyl phthalate is included on the list of hazardous wastes pursuant to RCRA 3001 (40 CFR §§
261.33) as a hazardous constituent. The general standard in Section RCRA 3004(a) for the technical
criteria that govern the management (treatment, storage, and disposal) of hazardous waste 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 CFR §§ 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 Maximum
Achievable Control Technology (MACT)) or injected into Underground Injection Control (UIC) Class I
hazardous waste wells (subject to joint control under Subtitle C and the Safe Drinking Water Act
(SDWA)).
36

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EPA has not identified TRI releases since 1993. If butyl benzyl phthalate is present in commercial and
consumer products it may be disposed of in landfills, such as Municipal Solid Waste landfills. Design
standards for Subtitle C landfills require double liner, double leachate collection and removal systems,
leak detection system, run on, runoff, and wind dispersal controls, and a construction quality assurance
program. They are also subject to closure and post-closure care requirements including installing and
maintaining a final cover, continuing operation of the leachate collection and removal system until
leachate is no longer detected, maintaining and monitoring the leak detection and groundwater
monitoring system. 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 in groundwater from Subtitle C landfill leachate is not
expected to be a significant pathway.
Butyl benzyl phthalate is present in commercial and consumer products that may be disposed of in
Municipal Solid Waste (MSW) landfills. However, TRI releases have not been identified since 1993.
While permitted and managed by the individual states, municipal solid waste (MSW) landfills are
required by federal regulations to implement some of the same requirements as Subtitle C landfills.
MSW landfills generally must have a liner system with leachate collection and conduct groundwater
monitoring and corrective action when releases are detected. MSW landfills are also subject to closure
and post-closure care requirements and must have financial assurance for funding of any needed
corrective actions. MSW landfills have also been designed to allow for the small amounts of hazardous
waste generated by households and very small quantity waste generators (less than 220 lb per month).
Bulk liquids, such as free solvent, may not be disposed of at MSW landfills.
On-site releases to land from industrial non-hazardous and construction/demolition waste landfills may
occur for butyl benzyl phthalate. Industrial non-hazardous and construction/demolition waste landfills
are primarily regulated under authorized 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
requirements such as for liners, post-closure and financial assurance, but are not required to do so.
2.6.4 Conceptual Model for Environmental Releases and Wastes: Potential Exposures
and Hazards
As described in Section 2.6.3, some pathways in the conceptual models are covered under the
jurisdiction of other environmental statutes administered by EPA. The conceptual model depicted in
Figure 2-11 presents the exposure pathways, exposure routes and hazards to human and environmental
receptors from releases and wastes from industrial, commercial, and consumer uses of butyl benzyl
phthalate that EPA plans to consider in the risk evaluation. The exposure pathways, exposure routes and
hazards presented in this conceptual model are subject to change in the final scope, in light of comments
received on this draft scope and other reasonably available information. EPA continues to consider
whether and how other EPA-administered statutes and any associated regulatory programs address the
presence of butyl benzyl phthalate in exposure pathways falling under the jurisdiction of these EPA
statutes.
The diagram shown in Figure 2-11 includes releases from industrial, commercial and/or consumer uses
to water/sediment; biosolids and soil, via direct and indirect discharges to water and emissions to air that
may lead to exposure to aquatic and terrestrial receptors, and to the general population via drinking
37

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water and emissions to ambient air. The supporting basis for environmental pathways considered for
butyl benzyl phthalate are included in Appendix H.
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RELEASES AND WASTES FROM
INDUSTRIAL/COMMERCIAL /
CONSUMER USES
EXPOSURE PATHWAYS
EXPOSURE
ROUTES
RECEPTORS
HAZARDS
Wastew ater or
Liquid Wastes
Industrial Pre-
Treatment or
Industrial WWT
Indirect discharge
t		
RCRA
SI)\\ A
Water. Sedim<
Emissions to Air
Aquatic
Species
Drinking
Water
Biosoluls
Disposal
General
Population
Dl'I U:Ll!
(hound
Water
Inhalation
lerrestna
Species
Hazards Potentially
Associated with
Acute and/or Chronic
Exposures
Fugitive F.missions
Figure 2-11 Butyl Benzyl Phthalate Conceptual Model for Environmental Releases and Wastes: Environmental and General
Population Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human and environmental receptors from releases and wastes from industrial,
commercial and consumer uses of butyl benzyl phthalate that EPA plans to consider in the risk evaluation. Notes:
a)	Industrial wastewater or liquid wastes may be treated on-site and then released to surface water (direct discharge), or pre-treated and released to POTW (indirect
discharge). For consumer uses, such wastes may be released directly to POTW. Drinking water will undergo further treatment in drinking water treatment plant.
Ground water may also be a source of drinking water. Inhalation from drinking water may occur via showering.
b)	Receptors include potentially exposed or susceptible subpopulations (see Section 2.5).
39

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2.7 Analysis Plan
The analysis plan is based on EPA's knowledge of butyl benzyl phthalate to date which includes a
partial, but not complete, review of reasonably available information as described in Section 2.1. EPA
encourages submission of additional data, such as full study reports or workplace monitoring from
industry sources, that may be relevant for EPA's evaluation of conditions of use, exposures, hazards and
PESS during risk evaluation. Further, EPA may consider any relevant CBI in a manner that protects the
confidentiality of the information from public disclosure. EPA plans to continue to consider new
information submitted by the public. Should additional data or approaches become available, EPA may
update its analysis plan in the final scope document.
2.7.1	Physical and Chemical Properties and Environmental Fate
EPA plans to analyze the physical and chemical (p-chem) properties and environmental fate and
transport of butyl benzyl phthalate as follows:
1)	Review reasonably available measured or estimated p-chem and environmental fate
endpoint data collected using systematic review procedures and, where available,
environmental assessments conducted by other regulatory agencies.
EPA plans to review data and information collected through the systematic review methods and
public comments about the p-chem properties (Appendix B) and fate endpoints (Appendix C),
some of which appeared in the Proposed Designation of Butyl Benzyl Phthalate (CASRN 85-68-
7) as a High-Priority Substance for Risk Evaluation (U.S. EPA, 2019a). All sources cited in
EPA's analysis will be evaluated according to the procedures described in the systematic review
documentation that EPA plans to publish prior to finalizing the scope document. Where the
systematic review process fails to identify experimentally measured chemical property values of
sufficiently high quality, these values will be estimated using chemical parameter estimation
models as appropriate. Model-estimated fate properties will be reviewed for applicability and
quality.
2)	Using measured data and/or modeling, determine the influence of p-chem properties and
environmental fate endpoints (e.g., persistence, bioaccumulation, partitioning, transport)
on exposure pathways and routes of exposure to human and environmental receptors.
EPA plans to use measured data and, where necessary, model predictions of p-chem properties
and environmental fate endpoints will be used to characterize the persistence and movement of
butyl benzyl phthalate within and across environmental media. The fate endpoints of interest
include volatilization, sorption to organic matter in soil and sediments, water solubility, aqueous
and atmospheric photolysis rates, aerobic and anaerobic biodegradation rates, and potential
bioconcentration and bioaccumulation. These endpoints will be used in exposure calculations.
3)	Conduct a weight-of-evidence evaluation of p-chem and environmental fate data, including
qualitative and quantitative sources of information.
During risk evaluation, EPA plans to evaluate and integrate the p-chem and environmental fate
evidence identified in the literature inventory using the methods described in the systematic
review documentation that EPA plans to publish prior to finalizing the scope document.
2.7.2	Exposure
EPA plans to analyze exposure levels for indoor air, ambient air, surface water, groundwater, sediment,
soil, aquatic biota, and terrestrial biota associated to exposure to butyl benzyl phthalate. EPA has not yet
determined the exposure levels in these media or how they may be used in the risk evaluation. Exposure
40

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scenarios are combinations of sources (uses), exposure pathways, and exposed receptors. EPA plans to
analyze scenario-specific exposures.
Based on their p-chem properties, expected sources, and transport and transformation within the outdoor
and indoor environment, chemical substances are more likely to be present in some media and less likely
to be present in others. Exposure level(s) can be characterized through a combination of available
monitoring data and modeling approaches.
2.7.2.1 Environmental Releases
EPA plans to analyze releases to environmental media as follows:
1) Review reasonably available published literature and other reasonably available
information on processes and activities associated with the conditions of use to analyze the
types of releases and wastes generated.
EPA has reviewed some key data sources containing information on processes and activities
resulting in releases, and the information found is described in Appendix E. EPA plans to
continue to review data sources identified during risk evaluation using the evaluation strategy in
the systematic review documentation that EPA plans to publish prior to finalizing the scope
document. Potential sources of environmental release data are summarized in Table 2-3 below:
Table 2-3 Potential Categories and Sources of Environmental Release Data	
U.S. EPA Generic Scenarios	
OECD Emission Scenario Documents	
EU Risk Assessment Reports	
Discharge Monitoring Report (DMR) surface water discharge data from NPDES-permitted
facilities
2)	Review reasonably available chemical-specific release data, including measured or
estimated release data (e.g., data from risk assessments by other environmental agencies).
EPA plans to match identified data to applicable conditions of use and identify data gaps where
no data are found for particular conditions of use. EPA plans to attempt to address data gaps
identified as described in steps 3 and 4 below by considering potential surrogate data and
models.
Additionally, for conditions of use where no measured data on releases are available, EPA may
use a variety of methods including release estimation approaches and assumptions in the
Chemical Screening Tool for Occupational Exposures and Releases (ChemSTEER) (U.S. EPA.
2013V
3)	Review reasonably available measured or estimated release data for surrogate chemicals
that have similar uses and physical properties.
If surrogate data are identified, these data will be matched with applicable conditions of use for
potentially filling data gaps. Measured or estimated release data for other phthalate esters may be
considered as surrogates for butyl benzyl phthalate.
4)	Review reasonably available data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation.
This item will be performed after completion of #2 and #3 above. EPA plans to evaluate relevant
data to determine whether the data can be used to develop, adapt or apply models for specific
41

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conditions of use (and corresponding release scenarios). EPA has identified information from
various EPA statutes (including, for example, regulatory limits, reporting thresholds or disposal
requirements) that may be relevant to release estimation. EPA plans to further consider relevant
regulatory requirements in estimating releases during risk evaluation.
5)	Review and determine applicability of OECD Emission Scenario Documents (ESDs) and
EPA Generic Scenarios to estimation of environmental releases.
EPA has identified potentially relevant OECD Emission Scenario Documents (ESDs) and EPA
Generic Scenarios (GS) that correspond to some conditions of use; for example, the 2009 ESP
on Adhesive Formulation, the 2011 ESP on Coating Application via Spray-Painting in the
Automotive Refinishing Industry, the 2011 ESP on Chemical Industry, the	»D on
Radiation Curable Coating. Inks and Adhesives. the 2015 ESP on the Use of Adhesives. and the
2 D on Plastic Additives may be useful to assess potential releases. EPA intends to
critically review these generic scenarios and ESPs to determine their applicability to the
conditions of use assessed.
EPA Generic Scenarios are available at the following: https://www.epa.gov/tsca-screening-
tools/using-predictive-methods-assess-exposure-and~fate~under~tsca#fate.
OECP Emission Scenario Pocuments are available at the following:
http://www.oecd.org/chemicalsafetv/risk-assessment/emissionscenariodocuments.htm
EPA may also need to perform targeted research for applicable models and associated
parameters that EPA may use to estimate releases for certain conditions of use. If ESPs and GSs
are not available, other methods may be considered. 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%).
6)	Map or group each condition of use to a release assessment scenario(s).
EPA has identified release scenarios and mapped (i.e., grouped) them to relevant conditions of
use as shown in Appendix F. EPA may further refine the mapping of release scenarios based on
factors (e.g., process equipment and handling, magnitude of production volume used, and release
sources and usage rates of butyl benzyl phthalate and polymer products and formulations
containing butyl benzyl phthalate, or professional judgment) corresponding to conditions of use
as additional information is identified during risk evaluation.
7)	Evaluate the weight of the scientific evidence of environmental release data.
Puring risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation that
EPA plans to publish prior to finalizing the scope document. The data integration strategy will be
designed to be fit-for-purpose in which EPA plans to use systematic review methods to assemble the
relevant data, evaluate the data for quality and relevance, including strengths and limitations,
followed by synthesis and integration of the evidence.
2.7.2.2 Environmental Exposures
EPA plans to analyze the following in developing its environmental exposure assessment of butyl benzyl
phthalate:
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1) Review available environmental and biological monitoring data for all media relevant to
environmental exposure.
For butyl benzyl phthalate, environmental media which will be analyzed are sediment, soil, air,
groundwater, and surface water.
2)	Review reasonably available information on releases to determine how modeled estimates
of concentrations near industrial point sources compare with available monitoring data.
Reasonably available environmental exposure models that meet the TSCA Section 26(h) and (i)
Science Standards and that estimate water, sediment, and soil concentrations will be analyzed
and considered alongside reasonably available water, sediment, and soil monitoring data to
characterize environmental exposures. Modeling approaches to estimate surface water
concentrations, sediment concentrations and soil concentrations generally consider the following
inputs: direct release into air, groundwater, surface water, sediment, or soil, indirect release into
air, groundwater, surface water, sediment, or soil (i.e., air deposition), fate and transport
(partitioning within media) and characteristics of the environment (e.g., river flow, volume of
lake, meteorological data).
3)	Determine applicability of existing additional contextualizing information for any
monitored data or modeled estimates during risk evaluation.
Any studies which relate levels of butyl benzyl phthalate in the environment or biota with
specific sources or groups of sources will be evaluated.
4) Group each condition(s) of use to environmental assessment scenario(s).
EPA plans to refine and finalize exposure scenarios for environmental receptors by considering
combinations of sources (use descriptors), exposure pathways including routes, and populations
exposed. For butyl benzyl phthalate, the following are noteworthy considerations in constructing
exposure scenarios for environmental receptors:
Estimates of surface water concentrations, sediment concentrations and soil
concentrations near industrial point sources based on available monitoring data.
Modeling inputs for release into the media of interest, fate and transport and
characteristics of the environment.
Reasonably available biomonitoring data. Monitoring data could be used to compare
with species or taxa-specific toxicological benchmarks.
Applicability of existing additional contextualizing information for any monitored
data or modeled estimates during risk evaluation. Review and characterize the spatial
and temporal variability, to the extent that data are available, and characterize
exposed aquatic and terrestrial populations.
Weight of the scientific evidence of environmental occurrence data and modeled
estimates.
5) Evaluate the weight of the scientific evidence of environmental occurrence data and
modeled estimates.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation that
EPA plans to publish prior to finalizing the scope document.
2.7.2.3 Occupational Exposures
EPA plans to analyze both worker and ONU exposures as follows:
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1)	Review reasonably available exposure monitoring data for specific condition(s) of use.
EPA plans to review available butyl benzyl phthalate exposure monitoring data for specific
conditions of use. Example exposure data include workplace monitoring data collected by
government agencies such as OSHA and NIOSH, and monitoring data in published literature.
The data may include both personal exposure monitoring measurements and area monitoring
measurements.
2)	Review reasonably available exposure data for surrogate chemicals that have uses,
volatility and chemical and physical properties similar to butyl benzyl phthalate.
EPA plans to review literature sources identified and if surrogate data are found, these data will
be matched to applicable conditions of use for potentially filling data gaps. EPA believes other
phthalate esters utilized in similar ways to butyl benzyl phthalate may serve as surrogates for
butyl benzyl phthalate.
3)	For conditions of use where data are limited or not available, review existing exposure
models that may be applicable in estimating exposure levels.
EPA has identified potentially relevant OECD ESDs and EPA GS corresponding to some
conditions of use. For example, the 2015 ESP on the Use of Adhesives and the 2009 ESP on
Plastic Additives are some of the ESDs and GS's 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 plans to perform additional targeted
research to understand those conditions of use where ESDs or GS's were not identified, which
may inform the 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 a particular risk evaluation scenario.
This step will be performed after Steps #2 and #3 are completed. Based on information
developed from Steps #2 and #3, EPA plans to evaluate relevant data to determine whether the
data can be used to develop, adapt, or apply models for specific conditions of use (and
corresponding exposure scenarios). EPA may utilize existing, peer-reviewed exposure models
developed by EPA/OPPT, other government agencies, or available in the scientific literature, or
EPA may elect to develop additional models to assess specific condition(s) of use. Inhalation
exposure models may be simple box models or two-zone (near-field/far-field) models. In two-
zone models, the near-field exposure represents potential inhalation exposures to workers, and
the far-field exposure represents potential inhalation exposures to ONUs.
5)	Consider and incorporate applicable ECs and/or PPE into exposure scenarios.
EPA plans to review potentially relevant data sources on ECs and PPE to determine their
applicability and incorporation into exposure scenarios during risk evaluation. EPA plans to
assess worker exposure pre- and post-implementation of ECs, using reasonably available
information on available control technologies and control effectiveness. For example, EPA may
assess worker exposure in industrial use scenarios before and after implementation of local
exhaust ventilation.
6)	Map or group each condition of use to occupational exposure assessment scenario(s).
EPA has identified occupational exposure scenarios and mapped them to relevant conditions of
use (see Appendix F). As presented in the fourth column in Table Apx F-l, EPA has grouped
the scenarios into representative release/exposure scenarios. EPA was not able to identify
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occupational scenarios corresponding to some conditions of use. EPA plans to perform targeted
research to understand those uses which may inform identification of occupational exposure
scenarios. EPA may further refine the mapping of occupational exposure scenarios based on
factors (e.g., process equipment and handling, magnitude of production volume used, and
exposure/release sources) corresponding to conditions of use as additional information is
identified during risk evaluation.
7) Evaluate the weight of the scientific evidence of occupational exposure data, which may
include qualitative and quantitative sources of information.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation that
EPA plans to publish prior to finalizing the scope document. EPA plans to rely on the weight of
the scientific evidence when evaluating and integrating occupational data. The data integration
strategy will be designed to be fit-for-purpose in which EPA plans to use systematic review
methods to assemble the relevant data, evaluate the data for quality and relevance, including
strengths and limitations, followed by synthesis and integration of the evidence.
2.7.2.4 Consumer Exposures
EPA plans to analyze both consumers using a consumer product and bystanders associated with the
consumer using the product as follows:
1)	Group each condition of use to consumer exposure assessment scenario(s).
Refine and finalize exposure scenarios for consumers by considering combinations of sources
(ongoing consumer uses), exposure pathways including routes, and exposed populations.
For butyl benzyl phthalate, the following are noteworthy considerations in constructing
consumer exposure scenarios:
Conditions of use
Duration of exposure
Weight fraction of chemical in products
Amount of chemical used
2)	Evaluate the relative potential of indoor exposure pathways based on available data.
Indoor exposure pathways expected to be relatively higher include inhalation of vapors from
indoor air during butyl benzyl phthalate use and disposal. Indoor exposure pathways expected to
be relatively lower include dermal contact to liquid. The data sources associated with these
respective pathways have not yet been comprehensively evaluated, so quantitative comparisons
across exposure pathways or in relation to toxicity thresholds are not yet available.
3)	Review existing indoor exposure models that may be applicable in estimating indoor air.
Indoor exposure models that estimate emission and migration of SVOCs into the indoor
environment are available. These models generally consider mass transfer as informed by the
gas-phase mass transfer coefficient, the solid-phase diffusion coefficient, and the material-air
partition coefficient. These properties vary based on p-chem properties and properties of the
material. The OPPT's Indoor Environmental Concentrations in Buildings with Conditioned and
Unconditioned Zones (IECCU) model and other similar models can be used to estimate indoor
air and dust exposures from indoor sources.
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4)	Review reasonably available empirical data that may be used in developing, adapting or
applying exposure models to a particular risk evaluation scenario. For example, existing
models developed for a chemical assessment may be applicable to another chemical
assessment if model parameter data are available.
To the extent other organizations have already modeled a butyl benzyl phthalate consumer
exposure scenario that is relevant to the OPPT's assessment, EPA plans to evaluate those
modeled estimates. In addition, if other chemicals similar to butyl benzyl phthalate have been
modeled for similar uses, those modeled estimates will also be evaluated. The underlying
parameters and assumptions of the models will also be evaluated.
5)	Review reasonably available consumer product-specific sources to determine how those
exposure estimates compare with each other and with indoor monitoring data reporting
butyl benzyl phthalate in specific media (e.g., indoor air).
The availability of butyl benzyl phthalate concentration for various ongoing uses will be
evaluated. This data provides the source term for any subsequent indoor modeling. Source
attribution between overall indoor air levels and various indoor sources will be analyzed.
6)	Review reasonably available population- or subpopulation-specific exposure factors and
activity patterns to determine if PESS need to be further refined.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation that
EPA plans to publish prior to finalizing the scope document.
7)	Evaluate the weight of the scientific evidence of consumer exposure estimates based on
different approaches.
EPA plans to rely on the weight of the scientific evidence when evaluating and integrating data
related to consumer exposure. The weight of the scientific evidence may include qualitative and
quantitative sources of information. The data integration strategy will be designed to be fit-for-
purpose in which EPA plans to use systematic review methods to assemble the relevant data,
evaluate the data for quality and relevance, including strengths and limitations, followed by
synthesis and integration of the evidence.
2.7.2.5 General Population
EPA plans to analyze general population exposures as follows:
1) Refine and finalize exposure scenarios for general population by considering combinations
of sources and uses, exposure pathways including routes, and exposed populations.
For butyl benzyl phthalate, the following are noteworthy considerations in constructing exposure
scenarios for the general population:
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.
Consider and incorporate applicable media-specific regulations into exposure scenarios
or modeling.
Review reasonably available data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation. For example, existing models
developed for a chemical assessment may be applicable to another chemical assessment if
model parameter data are available.
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Review reasonably available information on releases to determine how modeled
estimates of concentrations near industrial point sources compare with available
monitoring data.
Review reasonably available population- or subpopulation-specific exposure factors and
activity patterns to determine if PES S need be further defined.
Evaluate the weight of the scientific evidence of general population exposure data.
Map or group each condition of use to general population exposure assessment
scenario(s).
Environmental Exposure pathways regulated by non-TSCA EPA laws and regulations
will be excluded from analysis
EPA intends to evaluate a variety of data types to determine which types are most appropriate
when quantifying exposure scenarios. Environmental monitoring data, biomonitoring data,
modeled estimates, experimental data, epidemiological data, and survey-based data can all be
used to quantify exposure scenarios. In an effort to associate exposure estimates with sources of
exposure and/or conditions of use, EPA plans to consider source apportionment across exposure
scenarios during risk evaluation. EPA anticipates that there will be a wide range in the relative
exposure potential of the exposure scenarios identified in Appendix G. 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.
After refining and finalizing exposure scenarios, EPA plans to quantify concentrations and/or
doses for these scenarios. The number of scenarios will depend on how combinations of uses,
exposure pathways, and receptors are characterized. The number of scenarios is also dependent
upon the available data and approaches to quantify scenarios. When quantifying exposure
scenarios, EPA plans to use a tiered approach. First-tier analysis is based on data that is readily
available without a significant number of additional inputs or assumptions, and may be
qualitative, semi-quantitative, or quantitative. First-tier analyses were conducted during problem
formulation and are expected to continue during risk evaluation. The results of first tier analyses
inform whether scenarios require more refined analysis. Refined analyses will be iterative and
require careful consideration of variability and uncertainty. Should data become available that
summarily alters the overall conclusion of a scenario through iterative tiering, EPA can refine its
analysis during risk evaluation.
2)	For exposure pathways where empirical data is not available, review existing exposure
models that may be applicable in estimating exposure levels.
For butyl benzyl phthalate, media where exposure models will be considered for general
population exposure include models that estimate, surface water concentrations, sediment
concentrations, soil concentrations, and uptake from aquatic and terrestrial environments into
edible aquatic and terrestrial organisms.
3)	Review available exposure modeled estimates. For example, existing models developed for
a previous butyl benzyl phthalate chemical assessment may be applicable to EPA's
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assessment. In addition, another chemical's assessment may also be applicable if model
parameter data are available.
To the extent other organizations have already modeled butyl benzyl phthalate general
population exposure scenario that is relevant to this assessment, EPA plans to evaluate those
modeled estimates. In addition, if modeled estimates for other chemicals with similar p-chem
properties and similar uses are available, those modeled estimates will also be evaluated. The
underlying parameters and assumptions of the models will also be evaluated.
4)	Review reasonably available information on releases to determine how modeled estimates
of concentrations near industrial point sources compare with available monitoring data.
The expected releases from industrial facilities may change over time. Any modeled
concentrations based on recent release estimates will be carefully compared with available
monitoring data to determine representativeness.
5)	Review reasonably available information about population- or subpopulation-specific
exposure factors and activity patterns to determine if PESS need to be further defined (e.g.,
early life and/or puberty as a potential critical window of exposure).
For butyl benzyl phthalate, exposure scenarios that involve PESS will consider age-specific
behaviors, activity patterns, and exposure factors unique to those subpopulations. For example,
children will have different intake rates for soil than adults.
6)	Evaluate the weight of the scientific evidence of general population exposure estimates
based on different approaches.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation that
EPA plans to publish prior to finalizing the scope document.
2.7.3 Hazards (Effects)
2.7.3.1 Environmental Hazards
EPA plans to conduct an environmental hazard assessment of butyl benzyl phthalate as follows:
1) Review reasonably available environmental hazard data, including data from alternative
test methods (e.g., computational toxicology and bioinformatics; high-throughput screening
methods; data on categories and read-across; in vitro studies).
EPA plans to analyze the hazards of butyl benzyl phthalate to aquatic and/or terrestrial
organisms, including plants, invertebrates (e.g., insects, arachnids, mollusks, crustaceans), and
vertebrates (e.g., mammals, birds, amphibians, fish, reptiles) across exposure durations and
conditions if potential environmental hazards are identified through systematic review results
and public comments. Additional types of environmental hazard information will also be
considered (e.g., analogue and read-across data) when characterizing the potential hazards of
butyl benzyl phthalate to aquatic and/or terrestrial organisms.
Environmental hazard data will be evaluated using the environmental toxicity data quality
criteria outlined in the systematic review documentation that EPA plans to publish prior to
finalizing the scope document. The study evaluation results will be documented in the risk
evaluation phase and data from suitable studies will be extracted and integrated in the risk
evaluation process.
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Hazard endpoints (e.g., mortality, growth, immobility, reproduction) will be evaluated, while
considering data availability, relevance, and quality.
2)	Derive hazard thresholds for aquatic and/or terrestrial organisms.
Depending on the robustness of the evaluated data for a particular organism or taxa (e.g., aquatic
invertebrates), environmental hazard values (e.g., ECx. LCx, NOEC, LOEC) may be derived and
used to further understand the hazard characteristics of butyl benzyl phthalate to aquatic and/or
terrestrial species. Identified environmental hazard thresholds may be used to derive
concentrations of concern (COC), based on endpoints that may affect populations of organisms
or taxa analyzed.
3)	Evaluate the weight of the scientific evidence of environmental hazard data.
During risk evaluation, EPA plans to evaluate and integrate the environmental hazard evidence
identified in the literature inventory using the methods described in the systematic review
documentation that EPA plans to publish prior to finalizing the scope document.
4)	Consider the route(s) of exposure, based on available monitoring and modeling data and
other available approaches to integrate exposure and hazard assessments.
EPA plans to consider aquatic (e.g., water and sediment exposures) and terrestrial pathways in
the butyl benzyl phthalate conceptual model. These organisms may be exposed to butyl benzyl
phthalate via a number of environmental pathways (e.g., surface water, sediment, soil, diet).
5)	Conduct an environmental risk characterization of butyl benzyl phthalate.
EPA plans to conduct a risk characterization of butyl benzyl phthalate to identify if there are
risks to the aquatic and/or terrestrial environments from the measured and/or predicted
concentrations of butyl benzyl phthalate in environmental media (i.e., water, sediment, soil).
Risk quotients (RQs) may be derived by the application of hazard and exposure benchmarks to
characterize environmental risk (	8; Bamthouse et al.. 1982.).
6)	Consider a Persistent, Bioaccumulative, and Toxic (PBT) Assessment of butyl benzyl
phthalate.
EPA plans to consider the persistence, bioaccumulation, and toxic (PBT) potential of butyl
benzyl phthalate after reviewing relevant p-chem properties and exposure pathways. EPA plans
to assess the available studies collected from the systematic review process relating to
bioaccumulation and bioconcentration (e.g., BAF, BCF) of butyl benzyl phthalate. In addition,
EPA plans to integrate traditional environmental hazard endpoint values (e.g., LCso, LOEC) and
exposure concentrations (e.g., surface water concentrations, tissue concentrations) for butyl
benzyl phthalate with the fate parameters (e.g., BAF, BCF, BMF, TMF).
2.7.3.2 Human Health Hazards
EPA plans to analyze human health hazards as follows:
1) Review reasonably available human health hazard data, including data from alternative
test methods (e.g., computational toxicology and bioinformatics; high-throughput screening
methods; data on categories and read-across; in vitro studies; systems biology).
EPA plans to use systematic review methods to evaluate the epidemiological and toxicological
literature for butyl benzyl phthalate. EPA plans to publish the systematic review documentation
prior to finalizing the scope document.
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Relevant mechanistic evidence will also be considered, if reasonably available, to inform the
interpretation of findings related to potential human health effects and the dose-repose
assessment. Mechanistic data may include analyses of alternative test data such as novel in vitro
test methods and high throughput screening. The association between acute and chronic exposure
scenarios to the agent and each health outcome will also be integrated. Study results will be
extracted and presented in evidence tables or another appropriate format by organ/system.
2)	Conduct hazard identification (the qualitative process of identifying non-cancer and cancer
endpoints) and dose-response assessment (the quantitative relationship between hazard
and exposure) for identified human health hazard endpoints.
Human health hazards from acute and chronic exposures will be identified by evaluating the
human and animal data that meet the systematic review data quality criteria described in the
systematic review documentation that EPA plans to publish prior to finalizing the scope
document. Hazards identified by studies meeting data quality criteria will be grouped by routes
of exposure relevant to humans (e.g., oral, dermal, inhalation) and by cancer and noncancer
endpoints.
Dose-response assessment will be performed in accordance with EPA guidance (U.S. EPA.
2.012a. 20 lib, r s s 0. Dose-response analyses may be used if the data meet data quality criteria
and if additional information on the identified hazard endpoints are not available or would not
alter the analysis.
The cancer mode of action (MOA) determines how cancer risks can be quantitatively evaluated.
If cancer hazard is determined to be applicable to butyl benzyl phthalate, EPA plans to evaluate
information on genotoxicity and the mode of action for all cancer endpoints to determine the
appropriate approach for quantitative cancer assessment in accordance with the U.S. EPA
Guidelines for Carcinogen Risk Assessment (	s05).
3)	In evaluating reasonably available data, determine whether particular human receptor
groups may have greater susceptibility to the chemical's hazard(s) than the general
population.
Reasonably available human health hazard data will be evaluated to ascertain whether some
human receptor groups may have greater susceptibility than the general population to butyl
benzyl phthalate hazard(s). Susceptibility of particular human receptor groups to butyl benzyl
phthalate will be determined by evaluating information on factors that influence susceptibility.
EPA has reviewed some sources containing hazard information associated with PESS and
lifestages such as pregnant women and infants. Pregnancy (i.e., gestation) and childhood are
potential susceptible lifestages for butyl benzyl phthalate exposure. EPA plans to review the
current state of the literature in order to potentially quantify these differences for risk evaluation
purposes.
4)	Derive points of departure (PODs) where appropriate; conduct benchmark dose modeling
depending on the reasonably 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-
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response relationships in the range of the observed data consistent with EP A's Benchmark Dose
Technical Guidance Document (U.S. EPA. 2012a). Where dose-response modeling is not
feasible, NOAELs or LOAELs will be identified. Non-quantitative data will also be evaluated
for contribution to weight of the scientific evidence or for evaluation of qualitative endpoints that
are not appropriate for dose-response assessment.
EPA plans to evaluate whether the available PBPK and empirical kinetic models are adequate for
route-to-route and interspecies extrapolation of the POD, or for extrapolation of the POD to
standard exposure durations (e.g., lifetime continuous exposure). If application of the PBPK
model is not possible, oral PODs may be adjusted by BW3 4 scaling in accordance with U.S. EPA.
£ , and inhalation PODs may be adjusted by exposure duration and chemical properties in
accordance with	).
5)	Evaluate the weight of the scientific evidence of human health hazard data.
During risk evaluation, EPA plans to evaluate and integrate the human health hazard evidence
identified in the literature inventory under acute and chronic exposure conditions using the
methods described in the systematic review documentation that EPA plans to publish prior to
finalizing the scope document.
6)	Consider the route(s) of exposure (oral, inhalation, dermal), reasonably available route-to-
route extrapolation approaches, reasonably available biomonitoring data and reasonably
available approaches to correlate internal and external exposures to integrate exposure and
hazard assessment.
At this stage of review, EPA believes there will be sufficient data to conduct a dose-response
analysis and/or benchmark dose modeling for the oral route of exposure. EPA plans to also
evaluate any potential human health hazards following dermal and inhalation exposure to butyl
benzyl phthalate, which could be important for worker, consumer, and general population risk
analyses. Reasonably available data will be assessed to determine whether or not a POD can be
identified for the dermal and inhalation routes. This may include using route-to-route
extrapolation methods, where appropriate and depending on the nature of available data.
If sufficient toxicity studies are not identified in the literature search to assess risks from dermal
and inhalation exposures, then a route-to-route extrapolation from oral toxicity studies would be
needed to assess systemic risks from dermal or inhalation exposures. Without an adequate PBPK
model, the approaches described in EPA guidance document Risk Assessment Guidance for
Superfund Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance for
Dermal Risk Assessment) (U.S. EPA, 2004) could be applied to extrapolate from oral to dermal
exposure. These approaches may be able to further inform the relative importance of dermal
exposures compared with other routes of exposure. Similar methodology may also be used for
assessing inhalation exposures.
2.7.4 Summary of Risk Approaches for Characterization
Risk characterization is an integral component of the risk assessment process for both environmental and
human health risks. EPA plans to derive the risk characterization in accordance with EPA's Risk
Characterization Handbook (U.S. EPA. 2000). As defined in EPA's Risk Characterization Policy, "the
risk characterization integrates information from the preceding components of the risk evaluation and
synthesizes an overall conclusion about risk that is complete, informative and useful for decision
makers." Risk characterization is considered to be a conscious and deliberate process to bring all
important considerations about risk, not only the likelihood of the risk but also the strengths and
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limitations of the assessment, and a description of how others have assessed the risk into an integrated
picture.
The level of information contained in each risk characterization varies according to the type of
assessment for which the characterization is written. Regardless of the level of complexity or
information, the risk characterization for TSCA risk evaluations will be prepared in a manner that is
transparent, clear, consistent, and reasonable (U.S. EPA. 2000) and consistent with the requirements of
the Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR
6). For instance, in the risk characterization summary, EPA plans to further carry out the
requirements 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 plans to be guided by EPA's Information Quality Guidelines (II.S. EPA. 2002) as it provides
guidance for presenting risk information. Consistent with those guidelines, EPA plans to identify in the
risk characterization the following: (1) Each population addressed by an estimate of applicable risk
effects; (2) The expected risk or central estimate of risk for the PESS 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.
2.8 Peer Review
Peer review will be conducted in accordance with EPA's regulatory procedures for chemical risk
evaluations, including using EPA's Peer Review Handbook and other methods consistent with Section
26 of TSCA (See 40 CFR 702.45). As explained in the preamble to Risk Evaluation Rule, the purpose of
peer review is for the independent review of the science underlying the risk assessment (See 82 Fed.
Reg. 33726, 33744 (July 12, 2017)). Peer review will therefore address aspects of the underlying science
as outlined in the charge to the peer review panel such as hazard assessment, assessment of dose-
response, exposure assessment, and risk characterization. The draft risk evaluation for butyl benzyl
phthalate will be peer reviewed.
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om%2F catal og%2F search%3 Fterm%3 D 8 5 -68-
7%26interface%3DCAS%2520No.%26N%3D0%2B%26mode%3Dpartialmax%261ang%3Den%26regi
on%3DUS%26focus%3Dproduct. HERO ID: 6311346
SPIN (Substances in Preparations in Nordic Countries). (2019). BENZYLBUTYLPHTHALAT.
http://www.spin2000.net/spinmyphp/. HERO ID: 6302501
Tomer, A.; Kane, J. (2015). The Great Port Mismatch. U.S. Goods trade and International
Transportation. The Global Cities Initiative, https://www.brookings.edu/wp-
content/uploads/2015/06/brgkssrvygcifreightnetworks.pdf
U.S. EPA (U.S. Environmental Protection Agency). (1994). Methods for derivation of inhalation
reference concentrations and application of inhalation dosimetry [EPA Report], (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=71993&CFID=51174829&CFTOKEN=25
006317. HERO ID: 6488
U.S. EPA (U.S. Environmental Protection Agency). (1998). Guidelines for ecological risk assessment
[EPA Report], (EPA/630/R-95/002F). Washington, DC: U.S. Environmental Protection Agency, Risk
Assessment Forum, https://www.epa.gov/risk/guidelines-ecological-risk-assessment. HERO ID: 42805
U.S. EPA (U.S. Environmental Protection Agency). (2000). Science policy council handbook: Risk
characterization handbook [EPA Report], (EPA/100/B-00/002). Washington, D.C.: U.S. Environmental
Protection Agency, Science Policy Council, https://www.epa.gov/risk/risk-characterization-handbook.
HERO ID: 52149
U.S. EPA (U.S. Environmental Protection Agency). (2002). Guidelines for ensuring and maximizing the
quality, objectivity, utility, and integrity of information disseminated by the Environmental Protection
Agency. (EPA/260/R-02/008). Washington, DC: U.S. Environmental Protection Agency, Office of
Environmental Information, https://www.epa.gov/sites/production/files/2017-03/documents/epa-info-
quality-guidelines.pdf. HERO ID: 635281
U.S. EPA (U.S. Environmental Protection Agency). 2004. Risk Assessment Guidance for Superfund
Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance for Dermal Risk
Assessment). (EPA/540/R/99/005). Washington, DC: U.S. Environmental Protection Agency, Risk
Assessment Forum, http://www.epa.gov/oswer/riskassessment/ragse/index.htm HERO ID: 664634.
U.S. EPA (U.S. Environmental Protection Agency). (2005). Guidelines for carcinogen risk assessment
[EPA Report], (EPA/630/P-03/001F). Washington, DC: U.S. Environmental Protection Agency, Risk
56

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Assessment Forum, https://www.epa.gov/sites/production/files/2013-
09/documents/cancer_guidelines_final_3-25-05.pdf. HERO ID: 86237
U.S. EPA (U.S. Environmental Protection Agency). (2006). A framework for assessing health risk of
environmental exposures to children (pp. 1-145). (EPA/600/R-05/093F). Washington, DC: U.S.
Environmental Protection Agency, Office of Research and Development, National Center for
Environmental Assessment. http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=l58363. HERO ID:
194567
U.S. EPA (U.S. Environmental Protection Agency) (2010). Draft Generic Scenario on Manufacture and
Use of Printing Inks. Available to download at: https://www.epa.gov/tsca-screening-tools/chemsteer-
chemical-screening-tool-exposures-and-environmental-releases
U.S EPA. (U.S. Environmental Protection Agency). (201 la). Exposure Factors Handbook: 2011 edition
[EPA Report], (EPA/600/R-090/052F). Washington, DC.
http://cfpub.epa.gov/ncea/cfm/recordisplav.cfm?deid=236252. HERO ID: 786546
U.S. EPA. (U.S. Environmental Protection Agency). (201 lb). Recommended Use of Body Weight 3/4 as
the Default Method in Derivation of the Oral Reference Dose. (EPA/100/R-11/0001). Washington, DC:
U.S. Environmental Protection Agency, Risk Assessment Forum. February.
https://www.epa.gov/sites/production/files/2013-09/documents/recommended-use-of-bw34.pdfHERO
ID: 752972
U.S. EPA (U.S. Environmental Protection Agency). (2012a). Benchmark dose technical guidance.
(EPA/100/R-12/001). Washington, DC: U.S. Environmental Protection Agency, Risk Assessment
Forum, https://www.epa.gov/risk/benchmark-dose-technical-guidance. HERO ID: 1239433
U.S. EPA (U.S. Environmental Protection Agency). (2012b). Estimation Programs Interface Suite for
Microsoft Windows, v 4.11 [Computer Program], Washington, DC. https://www.epa.gov/tsca-
screening-tools/epi-suitetm-estimation-program-interface. HERO ID: 2347246
U.S. EPA (U.S. Environmental Protection Agency). (2013). ChemSTEER user guide - Chemical
screening tool for exposures and environmental releases. Washington, D.C.
https://www.epa.gov/sites/production/files/2015-05/documents/user_guide.pdf. HERO ID: 3809033
U.S. EPA (U.S. Environmental Protection Agency). (2017). Chemical Data Reporting (2012 and 2016
Public CDR database). U.S. Environmental Protection Agency, Office of Pollution Prevention and
Toxics, https://www.epa.gov/chemical-data-reporting. HERO ID: 6275311
U.S. EPA (U.S. Environmental Protection Agency). (2018). Application of systematic review in TSCA
risk evaluations. (740-P1-8001). Washington, DC: U.S. Environmental Protection Agency, Office of
Chemical Safety and Pollution Prevention, https://www.epa.gov/sites/production/files/2018-
06/documents/final_application_of_sr_in_tsca_05-3l-18.pdf. HERO ID: 4532281
U.S. EPA (U.S. Environmental Protection Agency). (2019a). Proposed designation of butyl benzyl
phthalate (CASRN 85-68-7) as a high priority substance for risk evaluation. HERO ID: 6311347
57

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U.S. EPA (U.S. Environmental Protection Agency) (2019b). Chemical Data Reporting (2012 and 2016
CBI CDR database). Washington, DC. U.S. Environmental Protection Agency, Office of Pollution
Prevention and Toxics, (accessed April 25, 2019). HERO ID: 6301193
U.S. EPA (U.S. Environmental Protection Agency). (2020). Using Predictive Methods to Assess
Exposure and Fate under TSCA. https://www.epa.gov/tsca-screening-tools/using-predictive-methods-
assess-exposure-and-fate-under-tsca#fate.
Ziogou, K; Kirk P, WW; Lester, JN. (1989). Behavior of phthalic acid esters during batch anaerobic
digestion of sludge. Water Research 23: 743-748.
Zurmuehl, T; Durner, W; Herrmann, R. (1991). Transport of phthalate esters in undisturbed and
unsaturated soil columns. Journal of Contaminant Hydrology 8: 111-134.
58

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APPENDICES
Appendix A LIST OF GRAY LITERATURE SOURCES
Table Apx A-l provides a list of gray literature sources that yielded results for butyl benzyl phthalate.
Table Apx A-l Gray Literature Sources that Yielded Results for Butyl Benzyl Phthalate
Source/Agency
Source Name
Source Type
Source Category
Australian
Government
Department of
Health
NICNAS Assessments (eco)
International
Resources
Assessment or
Related Document
Australian
Government
Department of
Health
NICNAS Assessments (human
health. Tier I, 11 or 111)
International
Resources
Assessment or
Related Document
CAL EPA
Technical Support Documents for
regulations: Proposition 65, Cancer
Other U. S.
Agency
Resources
Assessment or
Related Document
CAL EPA
Technical Support Documents for
regulations: Proposition 65,
Reproductive Toxicity
Other U.S.
Agency
Resources
Assessment or
Related Document
CPSC
Chronic Hazard Advisory Panel
Reports
Other U.S.
Agency
Resources
Assessment or
Related Document
CPSC
Technical Reports: Exposure/Risk
Assessment
Other U.S.
Agency
Resources
Assessment or
Related Document
CPSC
Technical Reports: Toxicity Review
Other U.S.
Agency
Resources
Assessment or
Related Document
ECHA
European Union Risk Assessment
Report
International
Resources
Assessment or
Related Document
ECHA
ECHA Documents
International
Resources
Assessment or
Related Document
ECHA
Annex XVII Restriction Reports
International
Resources
Assessment or
Related Document
ECHA
Annex XVII To REACH -
Conditions of Use
International
Resources
Assessment or
Related Document
59

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Source/Agency
Source Name
Source Type
Source Category
Env Canada
Priority Substances List Assessment
Report; State of Science Report,
Environment Canada Assessment
International
Resources
Assessment or
Related Document
Env Canada
Canada Substance Grouping Pages
International
Resources
Assessment or
Related Document
Env Canada
Guidelines, Risk Management,
Regulations
International
Resources
Assessment or
Related Document
EPA
Office of Water: STORET and WQX
U.S. EPA
Resources
Database
EPA
EPA Office of Water: Ambient
Water Quality Criteria documents
U.S. EPA
Resources
Assessment or
Related Document
EPA
TSCA. Hazard Characterizations
U.S. EPA
Resources
Assessment or
Related Document
EPA
Included in 201 1 NATA
U.S. EPA
Resources
Assessment or
Related Document
EPA
Office of Air: National Emissions
Inventory (NEI) - National Emissions
Inventory (NEI) Data (2014, 201 1,
2008)
U.S. EPA
Resources
Database
EPA
Other EPA: Misc sources
U.S. EPA
Resources
General Search
EPA
EPA: AP-42
U.S. EPA
Resources
Regulatory
Document or List
EPA
TR1: Envirofacts Toxics Release
Inventory 2017 Updated Dataset
U.S. EPA
Resources
Database
EPA
Chemical Data Reporting (2012 and
2016 non-CBI CDR database)
U.S. EPA
Resources
Database
EPA
Chemical Data Reporting (2012 and
2016 CBI CDR database)
U.S. EPA
Resources
Database
EPA
EPA: Generic Scenario
U.S. EPA
Resources
Assessment or
Related Document
EPA
EPA Discharge Monitoring Report
Data
U.S. EPA
Resources
Database
EPA
Office of Water: CFRs
U.S. EPA
Resources
Regulatory
Document or List
60

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Source/Agency
Source Name
Source Type
Source Category
EPA
Office of Air: CFRs and Dockets
U.S. EPA
Resources
Regulatory
Document or List
I ARC
I ARC Monograph
International
Resources
Assessment or
Related Document
Japan
Japanese Ministry of the
Environment Assessments -
Environmental Risk Assessments
(Class I Designated Chemical
Substances Summary Table)
International
Resources
Regulatory
Document or List
KOECT
Kirk-Othmer Encyclopedia of
Chemical Technology Journal Article
Other Resource
Encyclopedia
NIOSH
CDC NIOSH - Health Hazard
Evaluations (HHEs)
Other U. S.
Agency
Resources
Assessment or
Related Document
NIOSH
CDC NIOSH - Workplace Survey
Reports
Other U.S.
Agency
Resources
Assessment or
Related Document
NIOSH
CDC NIOSH - Publications and
Products
Other U.S.
Agency
Resources
Assessment or
Related Document
NLM
National Library of Medicine's
Pub C hem
Other U.S.
Agency
Resources
Database
NTP
OHAT Monographs
Other U.S.
Agency
Resources
Assessment or
Related Document
NTP
Technical Reports
Other U.S.
Agency
Resources
Assessment or
Related Document
OECD
OECD Substitution and Alternatives
Assessment
International
Resources
Assessment or
Related Document
OECD
OECD Emission Scenario
Documents
International
Resources
Assessment or
Related Document
OECD
OECD: General Site
International
Resources
General Search
61

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Source/Agency
Source Name
Source Type
Source Category
OSHA
OSHA Chemical Exposure Health
Data
Other U.S.
Agency
Resources
Database
OSHA
U.S. OSHA Chemical Exposure
Health Data (CEHD) program data
[ERG]
Other U.S.
Agency
Resources
Database
RIVM
RIVM Reports: Risk Assessments
International
Resources
Assessment or
Related Document
TERA
Toxicology Excellence for Risk
Assessment
Other Resources
Assessment or
Related Document
UNEP
Risk Profile / Stockholm Convention
International
Resources
Assessment or
Related Document
62

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Appendix B PHYSICAL AND CHEMICAL PROPERTIES
This appendix provides p-chem information and data found in preliminary data gathering for butyl
benzyl phthalate. Table Apx B-l summarizes the p-chem property values preliminarily selected for use
in the risk evaluation from among the range of reported values collected as of March 2020. This table
differs from that presented in the Proposed Designation of Butyl Benzyl Phthalate (CASRN 85-68- 7) as
a Hish-Priority Substance for Risk Evaluation (U.S. EPA, 2019a) and may be updated as EPA collects
additional information through systematic review methods. All p-chem property values that were
extracted and evaluated as of March 2020 are presented in the supplemental file Data Extraction and
Data Evaluation Tables for Physical Chemical Property Studies (EPA-H.) 1-2018-0501).
Table Apx B-l Physical and Chemical Properties of Butyl Benzyl Phthalate
Properly or Knripoinl
Value51
Reference
Dala Quality
Kill in«
Molecular formula
C19H20O4
NA
NA
Molecular weight
312.37 g/mol
NA
NA
Physical state
Liquid
NLM. 2015
High
Physical properties
Clear oil, liquid; slight odor
NLM. 2015
High
Melting point
-35°C
NLM, 2015
High
Boiling point
370°C
NLM, 2015
High
Density
1.119 g/crn3 at 25°C
Haynes. 2014
High
Vapor pressure
8.25xl0"6 111m Hg at 25°C
NLM. 2.015
High
Vapor density
10.8 (air = 1)
NLM. 2015
High
Water solubility
2.69 rng/L at 25°C
NLM. 2015
High
Log Octanol/water
partition coefficient (Log
Kow)
4.73
NLM. 2015
High
Henry's Law constant
7.61 xlO"7 atm m Vmol
Elsevier, 2019
High
Flash point
110-113°C
RSC. 2019
Medium
Auto flammability
NA


63

-------
Propcrlv or Knripoinl
\ iilut*11
Reference
Dnlsi Qusililv
Killing
Viscosity
55 cP at 20°C
vier, 2019
High
Refractive index
1.5356
Elsevier, 2019
High
Dielectric constant
NA


a Measured unless otherwise noted.
NA = Not applicable
64

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Appendix C ENVIRONMENTAL FATE AND TRANSPORT
PROPERTIES
Table Apx C-l provides the environmental fate characteristics that EPA identified and considered in
developing the scope for butyl benzyl phthalate.
Table Apx C-l Environmental Fate Characteristics of Butyl Benzyl Phthalate
Properly or
Kmlpoinl
Value11
Reference
Direct
Photodegradati on
0%/10 days; 43%/28 days
ECB (2007) citing Monsanto,
(1979)
<5%/28 days
ECB (2007) citing Monsanto,
(1980)
ti/2 >100 Days
ECB (2007) citing Gledhill et al.
(1980)
Indirect
Photodegradati on
ti/2 =11.6 hours at 25 °C based on
•OH rate constant of 1.1 x io-11 cmVmolecule
second and 1.5 x 106-OH/cm3; estimated)13
U.S. EPA (2012b)
Hydrolysis
ti/2 >100 days
citing Gledhill et
al. (1980)
Biodegradation
(Aerobic)
74-79%/10-50 days at 25 °C (activated
sludge)
NLM. 2015 citing Desai C I 992)
ti/2 = 5 days (lake water/sediment microcosm)
NLM. 2015 citing Carson et al.
(1990)
81%/2 weeks based on BOD (MITI test)
NLM. 2015 citingNITE C2015)
Biodegradation
(Anaerobic)
ti/2 = 107 hours (sewage sludge)
NLM. 2015 citing Ziogou et al.
(1989)
98.3%/120 days at 35 °C
NLM. 2015 citing Parker et al.
(1994)
Wastewater
Treatment
80% of sewage treatment plants had a 90%
removal of 1,2- benzenedicarboxylic acid, 1-
butyl 2- (phenylmethyl) ester in secondary
sewage treatment plant, whereas 10% had less
than 40% removal
ECB (2007) citing U.S. EPA
(1982)
100%) total removal (90%
biodegradation, 10% sludge, 0% air; estimated)13
U.S. EPA (2012b)
Bioconcentration
Factor
663 and 772 (Lepomis macrochirus)
NLM. 2015 citing Carr et al.
(1992)
0.13 to 45 (Ipomoea aquatica)
NLM. 2015 citing Cai et al.
(2006)
65

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Properly or
Kmlpoinl
Value"
Ucl'crenec
Soil Organic
Carbon:Water
Partition
Coefficient (Log
Koc)
3 3 ai pi 14 s
citing /urnuichl cl
al. (1991)
3.21
NLM. 2015 citing Sabliic et al.
(1995)
Notes: aMeasured unless otherwise noted. bEPI SuiteTMphysical property inputs: Log Kow = 4.73, BP = 370 °C, MP = -40.5
°C, VP = 8.25 x lO-e mm Hg, WS= 2.69 mg/L BioP = 4, BioA = 1 and BioS = 1 SMILES
0=C(0Cc(ccccl)cl)c(c(ccc2)C(=0)0CCCC)c2, OH = hydroxyl radical; OECD: Organisation for Economic Co-operation
and Development; SIDS = screening information data sets; MITI = Ministry of International Trade and Industry, Japan; BOD
= biochemical oxygen demand; K0c = organic carbon-water partition coefficient
66

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Appendix D REGULATORY HISTORY
The chemical substance, butyl benzyl phthalate, is subject to federal and state laws and regulations in the
United States (TableApx D-l and TableApx D-2). Regulatory actions by other governments, tribes
and international agreements applicable to butyl benzyl phthalate are listed in Table Apx D-3.
D.l Federal Laws and Regulations
Table Apx D-l Federal Laws and Regulations
Maliilcs/Ucgulalions
Description of Authority/Regulation
Description of Regulation
Toxic Substances
Control Act (TSCA)
- Section 6(b)
EPA is directed to identify high-priority
chemical substances for risk evaluation;
and conduct risk evaluations on at least
20 high priority substances no later than
three and one-half years after the date of
enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century
Act.
Butyl benzyl phthalate s one of the 20
chemicals EPA designated as a High-
Priority Substance for risk evaluation
under TSCA (84 FR 71924, December
30, 2019). Designation of butyl benzyl
phthalate as a high-priority substance
constitutes the initiation of the risk
evaluation on the chemical.
Toxic Substances
Control Act (TSCA)
- Section 8(a)
The TSCA Section 8(a) CDR Rule
requires manufacturers (including
importers) to give EPA basic exposure-
related information on the types,
quantities, and uses of chemical
substances produced domestically and
imported into the United States.
Butyl benzyl phthalate manufacturing
(including importing), processing, and
use information is reported under the
CDR rule ( 0816. August 16.
2011).
Toxic Substances
Control Act (TSCA)
- Section 8(b)
EPA must compile, keep current, and
publish a list (the TSCA Inventory) of
each chemical substance manufactured
(including imported) or processed in the
United States.
Butyl benzyl phthalate was on the initial
TSCA Inventory and therefore was not
subject to EPA's new chemicals review
process under TSCA Section 5 (
16309. March 29. 19951
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 risk reports received for butyl
benzyl phthalate (Received: 1992-2009).
One worker exposure submission was
received in 2007. U.S. EPA, ChemView.
(Accessed April 9, 2019).
Toxic Substances
Control Act (TSCA)
- Section 4
Provides EPA with authority to issue
rules, enforceable consent
agreements and orders requiring
manufacturers (including importers) and
processors to test chemical substances
and mixtures.
Ten chemical data submissions from test
rules received for butyl benzyl
phthalate one acute aquatic plant toxicity
studies, five acute toxicity studies, two
chronic aquatic toxicity studies, one
bioaccumulation potential report, one
persistence report. (U.S.
67

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Msiliilcs/Ucgiihilions
Description of Aiithority/Ucgiihilion
Description of Requisition


EPA, ChemView. Accessed April 9,
2019).
Emergency Planning
and Community
Right-To-Know Act
(EPCRA) - Section
313
Requires annual reporting from facilities
in specific industry sectors that employ
10 or more full-time equivalent
employees and that manufacture,
process or otherwise use a TRI-listed
chemical in quantities above threshold
levels. A facility that meets reporting
requirements must submit a reporting
form for each chemical for which it
triggered reporting, providing data
across a variety of categories, including
activities and uses of the chemical,
releases and other waste management
(e.g., quantities recycled, treated,
combusted) and pollution prevention
activities (under Section 6607 of the
Pollution Prevention Act). These data
include on- and off-site data as well as
multimedia data (i.e., air, land and
water).
Butyl benzyl phthalate was on the
original TRI chemical list in 1987 and it
was delisted from the list in calendar year
1994 (40 CFR Part 372). The last
reporting year was 1993.
Clean Water Act
(CWA) - Section
304(a)(1)
Requires EPA to develop and publish
ambient water quality criteria (AWQC)
reflecting the latest scientific knowledge
on the effects on human health that may
be expected from the presence of
pollutants in any body of water.
In 2015, EPA published updated AWQC
for butyl benzyl phthalate, including a
recommendation of 0.1 |ig/L for "Human
Health for the consumption of Water +
Organism" and 0.1 |ig/L for "Human
Health for the consumption of Organism
Only" for states and authorized tribes to
consider when adopting criteria into their
water quality standards. (Docket ID:
EPA-HQ-OW-2014-013 5-0213)
Clean Water Act
(CWA) - Section
301, 304, 306, 307
and 402
Clean Water Act Section 307(a)
establishes a list of toxic pollutants or
combination of pollutants under the
CWA. The statute specifies a list of
families of toxic pollutants also listed in
the Code of Federal Regulations at 40
CFR Part 401.15. The "priority
pollutants" specified by those families
are listed in 40 CFR Part 423 Appendix
A. These are pollutants for which best
available technology effluent limitations
must be established on either a national
basis through rules (Sections 301(b),
Phthalate esters are designated as a toxic
pollutant under Section 307(a)(1) of the
CWA and as such is subject to effluent
limitations. Butyl benzyl phthalate is
listed as a "priority pollutant" in
Appendix A to CFR 40 Part 423 - 126
Priority Pollutants.
Under CWA Section 304, butyl benzyl
phthalate is included in the list of total
toxic organics (TTO) (40 CFR 413.02(i)).
68

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Msiliilcs/Ucgiihilions
Description of Aiithority/Ucgiihilion
Description of Requisition

304(b), 307(b), 306) or on a case-by-
case best professional judgement basis
in NPDES permits, see Section
402(a)(1)(B). EPA identifies the best
available technology that is
economically achievable for that
industry after considering statutorily
prescribed factors and sets regulatory
requirements based on the performance
of that technology.

Resource
Conservation and
Recovery Act
(RCRA) - Section
3001
Directs EPA to develop and promulgate
criteria for identifying the
characteristics of hazardous waste, and
for listing hazardous waste, taking into
account toxicity, persistence, and
degradability in nature, potential for
accumulation in tissue and other related
factors such as flammability,
corrosiveness, and other hazardous
characteristics.
Butyl benzyl phthalate is listed as a
hazardous constituent in Appendix VIII
of Part 261 - Hazardous Constituents
RCRA (40 CFR 261).
Comprehensive
Environmental
Response,
Compensation and
Liability Act
(CERCLA) -
Sections 102(a) and
103
Authorizes EPA to promulgate
regulations designating as hazardous
substances those substances which,
when released into the environment,
may present substantial danger to the
public health or welfare or the
environment.
EPA must also promulgate regulations
establishing the quantity of any
hazardous substance the release of
which must be reported under Section
103.
Section 103 requires persons in charge
of vessels or facilities to report to the
National Response Center if they have
knowledge of a release of a hazardous
substance above the reportable quantity
threshold.
Butyl benzyl phthalate is a hazardous
substance under CERCLA. Releases of
butyl benzyl phthalate in excess of 100
pounds must be reported (40 CFR 302.4).


Superfund
Amendments and
Reauthorization Act
(SARA) -
Requires the Agency to revise the
hazardous ranking system and update
the National Priorities List of hazardous
waste sites, increases state and citizen
involvement in the superfund program
Butyl benzyl phthalate is listed on
SARA, an amendment to CERCLA and
the CERCLA Priority List of Hazardous
Substances. This list includes substances
most commonly found at facilities on the
CERCLA National Priorities List (NPL)
69

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Mat ulcs/Uegulal ions
Description of Authority/Ucgiilalion
Description of Regulation

and provides new enforcement
authorities and settlement tools.
that have been deemed to pose the
greatest threat to public health.
Other Federal Regulations
Consumer Product
Safety Improvement
Act of 2008 (CPSIA)
Under Section 108 of the Consumer
Product Safety Improvement Act of
2008 (CPSIA), CPSC prohibits the
manufacture for sale, offer for sale,
distribution in commerce or importation
of eight phthalates in toys and child care
articles at concentrations greater than
0.1 percent.
The use of butyl benzyl phthalate at
concentrations greater than 0.1 percent is
banned in toys and child care articles (16
CFR Dart 1307V
Federal Hazardous
Materials
Transportation Act
(HMTA)
Section 5103 of the Act directs the
Secretary of Transportation to:
•	Designate material (including an
explosive, radioactive material,
infectious substance, flammable or
combustible liquid, solid or gas, toxic,
oxidizing or corrosive material, and
compressed gas) as hazardous when
the Secretary determines that
transporting the material in commerce
may pose an unreasonable risk to
health and safety or property.
•	Issue regulations for the safe
transportation, including security, of
hazardous material in intrastate,
interstate and foreign commerce.
Butyl benzyl phthalate is listed as a
hazardous material with regard to
transportation and is subject to regulations
prescribing requirements applicable to the
shipment and transportation of listed
hazardous materials. Its reportable quantit;
is 100 lbs (A l.l, Aooendix A.
Table 1)
D.2 State Laws and Regulations
Table Apx D-2 State Laws and Regulations
Stale Actions
Description of Action
State Air Regulations
Allowable Ambient Levels Rhode Island (Air Pollution Regulation No. 22)
700 [j,g/m3 in 24 hours
State Drinking Water
Standards and Guidelines
Florida (Fla. Admin. Code R. Chap. 62-550), Michigan (Mich. Admin.
Code r.299.44 and r.299.49, 2017)
70

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State Actions
Description of Action
State Right-to-Know
Acts
Massachusetts (105 Code Mass. Regs. § 670.000 Appendix A), New Jersey
(8:59 N.J. Admin. Code § 9.1) and Pennsylvania (P.L. 734, No. 159 and 34
Pa. Code § 323).
Chemicals of High
Concern to Children
Several states have adopted reporting laws for chemicals in children's
products containing butyl benzyl phthalate, including Maine (38 MRS A
Chapter 16-D), Minnesota (Toxic Free Kids Act Minn. Stat. 116.9401 to
116.9407), Oregon (Toxic-Free Kids Act, Senate Bill 478, 2015), Vermont
(18 V.S.A § 1776) and Washington State (Wash. Admin. Code 173-334-
130).
Other
California listed butyl benzyl phthalate on Proposition 65 on December 2,
2005 due to developmental toxicity. (Cal Code Regs. Title 27, § 27001).
Butyl benzyl phthalate is listed as a Candidate Chemical under California's
Safer Consumer Products Program (Health and Safety Code § 25252 and
25253).
California issued a Health Hazard Alert for butyl benzyl phthalate (Hazard
Evaluation System and Information Service, 2016).
Butyl benzyl phthalate is on the MA Toxic Use Reduction Act (TURA) list
of 2019 (300 CMR 41.00).
D.3 International Laws and Regulations
Table Apx D-3 Regulatory Actions by other Governments, Tribes, and International Agreements
Country/Tribe/
Organization
Requirements and Restrictions
Canada
Butyl benzyl phthalate is on Canada's National Pollutant Release Inventory
(NPRI). Reportable to NPRI if manufactured, processed or otherwise used
at quantities greater than 10 tons.
European Union
In February 2011, butyl benzyl phthalate was added to Annex XIV of
REACH (Authorisation List) with a sunset date of February 2015.
(European Chemicals Agency (ECHA) database. Accessed April 16, 2019).
Australia
Butyl benzyl phthalate is subject to secondary notifications when importing
or manufacturing the chemical in Australia. Butyl benzyl phthalate was
assessed under Human Health Tier II of the Inventory Multi-Tiered
Assessment and Prioritisation (IMAP) as part of the C4-6 side chain
transitional phthalates. Uses reported include as a plasticiser for polyvinyl
chloride consumer products (including gumboots, toys - secondary
71

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Country/Trilu7
Orgiini/iilion
Requirements sind Restrictions

plaslicizer, play and exercise balls), in adhesiv es, textile printing inks,
automotive refinish, road-marking paints, light industrial, wood coatings
and building products (NICNAS, 2016, Human Health Tier II assessment
for C4-6 side chain transitional phthalates). In addition, butyl benzyl
phthalate was assessed under Environment Tier II of IMAP as part of the
phthalate esters. In 2015, butyl benzyl phthalate was also assessed as a
Priority Existing Chemical (Assessment Report No. 40) (National Industrial
Chemicals Notification and Assessment Scheme (NICNAS). Chemical
inventory. Database accessed April 3, 2019).
Japan
Butyl benzyl phthalate 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
•Air Pollution Control Act
(National Institute of Technology and Evaluation [NITE] Chemical Risk
Information Platform [CHRIP]. Accessed April 11, 2019]).
Austria, Denmark,
Germany, New Zealand,
Poland, Sweden, United
Kingdom
Occupational exposure limits for butyl benzyl phthalate (GESTIS
International limit values for chemical agents (Occupational exposure
limits, OELs) database. [Accessed April 03, 2019]).
72

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Appendix E PROCESS, RELEASE AND OCCUPATIONAL
EXPOSURE INFORMATION
This appendix provides information and data found in preliminary data gathering for butyl benzyl
phthalate.
E.l Process Information
Process-related information potentially relevant to the risk evaluation may include process diagrams,
descriptions and equipment. Such information may inform potential release sources and worker
exposure activities. EPA plans to consider this information in combination with available monitoring
data and estimation methods and models, as appropriate, to quantify occupational exposure and releases
for the various conditions of use in the risk evaluation.
E.l.l Manufacturing (Including Import)
The 2016 CDR reports three facilities that submitted activity data for 2015. Two of these facilities stated
that they imported butyl benzyl phthalate in 2015 and the remaining facility's 2015 manufacture or
import activity is claimed as CBI (U.S. EPA, 2019b). According to 2016 public CDR data, butyl benzyl
phthalate is imported into the United States in liquid and wet solid form (U.S. EPA, 2019b).
E.l.1.1 Domestic Manufacturing
Butyl benzyl phthalate is manufactured through reaction of the monobutyl ester of phthalic acid with
benzyl chloride in solution (PubChem, 2010). The monobutyl ester can be produced through reaction of
phthalic anhydride with n-butyl alcohol, before reaction with benzyl chloride to produce butyl benzyl
phthalate (PubChem, 2010).
E.l.1.2 Import
In general, chemicals may be imported into the United States in bulk via water, air, land, and intermodal
shipments (Tomer and Kane, 2015). These shipments take the form of oceangoing chemical tankers,
railcars, tank trucks, and intermodal tank containers. Butyl benzyl phthalate is shipped in liquid and wet
solid form according to 2016 CDR. Of the two facilities in 2016 CDR that imported butyl benzyl
phthalate in 2015 (excluding the facility for which the importation/manufacturing activity was withheld
or claimed CBI), EPA has identified one site that imported butyl benzyl phthalate directly to other sites
for processing or use (the importing site does not directly handle or store the imported butyl benzyl
phthalate) (U.S. EPA, 2019b). The remaining importation site claimed this activity as CBI.
E.1.2 Processing and Distribution
E.l.2.1 Reactant or Intermediate
Processing as a reactant or intermediate is the use of butyl benzyl phthalate as a feedstock in the
production of another chemical via a chemical reaction in which butyl benzyl phthalate is consumed to
form the product. None of the three sites that reported to 2016 CDR indicated that butyl benzyl phthalate
was processed as a reactant. However, EPA identified that butyl benzyl phthalate is used as an
intermediate to produce organic chemicals in the Use Report (SPIN, 2019; NLM, 2015; Synapse, 2009).
Exact operations for the use of butyl benzyl phthalate as a reactant to produce other chemicals are not
known at this time. For using a chemical as a reactant, operations would typically involve unloading the
chemical from transport containers and feeding the chemical into a reaction vessel(s), where the
chemical would react either fully or to a lesser extent. Following completion of the reaction, the
73

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produced substance may be purified further, thus removing unreacted butyl benzyl phthalate (if any
exists).
E.l.2.2 Incorporated into a Formulation, Mixture or Reaction Product
Incorporation into a formulation, mixture or reaction product refers to the process of mixing or blending
of several raw materials to obtain a single product or preparation. Exact process operations involved in
the incorporation of butyl benzyl phthalate into a chemical formulation, mixture, or reaction product are
dependent on the specific manufacturing process or processes involved. In the 2016 CDR, one company
reported use of butyl benzyl phthalate in the custom compounding of purchased resins (U.S. EPA,
2019b). Butyl benzyl phthalate is also used in the formulation of adhesives and sealants, paints and
coatings, ink, toner, and colorant products, among other formulations (U.S. EPA, 2019a; U.S. EPA,
2019b; SPIN, 2019; GoodGuide, 2011; Synapse, 2009). The exact processes used to formulate products
containing butyl benzyl phthalate are not known at this time; however, several ESDs published by the
OECD and Generic Scenarios published by EPA have been identified that provide general process
descriptions for these types of products. EPA plans to further investigate processing uses of butyl benzyl
phthalate during risk evaluation.
E.	1.2.3 Incorporated into an Article
Incorporation into an article typically refers to a process in which a chemical becomes an integral
component of an article (as defined at 40 CFR 704.3) for distribution in commerce. Exact process
operations involved in the incorporation of butyl benzyl phthalate-containing formulations or reaction
products are dependent on the article. Butyl benzyl phthalate may be incorporated into asphalt paving,
roofing, and coating materials; fabric, textile, and leather products; floor coverings; food contact
surfaces; plastic products; rubber products; and transportation equipment (U.S. EPA, 2019a; U.S. EPA,
2019b; FDA, 2018; Auto Alliance, 2019; Synapse, 2009). EPA plans to further investigate processing
uses of butyl benzyl phthalate during risk evaluation.
F. 1.2.4 Repackaging
Repackaging refers to preparation of a chemical substance for distribution into commerce in a different
form, state, or quantity than originally received/stored, where such activities include transferring a
chemical substance form a bulk storage container into smaller containers.
F.	1.2.5 Recycling
In 2016 CDR, three facilities reported that butyl benzyl phthalate was not recycled (U.S. EPA, 2019b).
EPA plans to further investigate the potential for recycling of butyl benzyl phthalate during risk
evaluation.
E.1.3 Uses
E.l.3.1 Adhesives, Sealants, Paints, and Coatings
Butyl benzyl phthalate is used in a variety of adhesive, sealant, paint, and coating products. Specifically,
butyl benzyl phthalate is used in adhesives used in floor sealing and coverings, adhesives and sealants
used in transportation equipment manufacturing, automotive paints and adhesives, lacquers, and
varnishes (U.S. EPA, 2019ab; U.S. EPA, 2019b; American Chemistry Council, 2019; NLM, 2015). The
application procedure depends on the type of adhesive, sealant, paint, or coating formulation and the
type of substrate. The formulation is loaded into the application reservoir or apparatus and applied to the
substrate via brush, spray, roll, dip, curtain, or syringe or bead application. Application may be manual
or automated. After application, the adhesive, sealant, paint, or coating is allowed to dry or cure (OECD,
74

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2015). The drying/curing process may be promoted through the use of heat or radiation (radiation can
include ultraviolet (UV) and electron beam radiation (OECD, 2010).
E.l.3.2 Automotive Products
Butyl benzyl phthalate is used in automotive care products, such as cleaning formulations, paints and
varnishes, car brake adhesives, and power steering fluid (ACC, 2019; NLM, 2015). EPA plans to further
investigate these uses of butyl benzyl phthalate during risk evaluation.
E.l.3.3 Building/Construction Materials Not Covered Elsewhere
Butyl benzyl pthalate is used in building and construction materials not covered elsewhere, including in
caulk, ceramics, and bricklaying (ACC, 2019; NLM, 2015; DeLima Associates, 2011). EPA did not find
additional information on these products. EPA plans to further investigate these uses of butyl benzyl
phthalate during risk evaluation.
E.l.3.4 Ink, Toner, and Colorant Products
Butyl benzyl phthalate is used in coloring agents, dyes, and pigments (NLM, 2015). Butyl benzyl
phthalate is also used in printing ink and toner and was identified in one handstamp product (U.S. EPA,
2019a; U.S. EPA, 2019b; SPIN, 2019; GoodGuide, 2011; Synapse, 2009). Printing inks consist of
colorants (e.g., pigments, dyes and toners) dispersed in a formulation to form a paste, liquid or solid,
which can be applied to a substrate's surface and dried (U.S. EPA, 2010). Industrial printing processes
can be categorized as lithographic, flexographic, gravure, letterpress, screen printing or digital printing.
Commercial printing may involve lithographic, flexographic, gravure and letterpress printing - all of
which involve the transfer of images from printing plates to a substrate. Screen printing requires a mesh
screen to transfer the ink to a substrate, whereas digital printing allows for the transfer of a digital image
directly onto a substrate. Inkjet printing is the most common form of digital printing. It involves the
application of small drops of ink onto a substrate, with direct contact between the ink nozzle and the
substrate (U.S. EPA, 2010).
E.l.3.5 Plastic and Rubber Products
As described in Section E.l.2.3, butyl benzyl phthalate is used to increase the flexibility of plastic and
rubber products, which may be used industrially, commercially, and by consumers. These products are
used in a variety of products, including floor coverings (such as vinyl floor tiles), vinyl wallpaper,
shower curtains, dental impression materials and equipment, toys, and products used in transportation
equipment manufacturing (U.S. EPA, 2019a; U.S. EPA, 2019b; DeLima Associates, 2011; NLM, 2015;
Auto Alliance, 2019; NASA, 2020). Butyl benzyl phthalate is likely entrained in the products; however,
butyl benzyl phthalate may be available for exposure depending on the application of the end use
products, such as if flooring materials are cut prior to installation. EPA plans to further investigate these
uses of butyl benzyl phthalate during risk evaluation.
E.l.3.6 Other Uses
Butyl benzyl phthalate is also used in castings (BJB Enterprises Inc., 2018), hydraulic fracturing (Orem
et al, 2007), and laboratory chemicals (Sigma-Aldrich, 2019; EPA-HQ-QPPT-2018-0504-00191
Laboratory procedures are generally done within a fume hood, on a bench with local exhaust ventilation
or under general ventilation. EPA plans to further investigate the uses of butyl benzyl phthalate during
risk evaluation.
E.1.4 Disposal
Each of the conditions of use of butyl benzyl phthalate may generate waste streams of the chemical that
are collected and transported to third-party sites for disposal, treatment, or recycling. Industrial sites that
75

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treat or dispose onsite wastes that they themselves generate are assessed in each condition of use
assessment. Similarly, point source discharges of butyl benzyl phthalate to surface water are assessed in
each condition of use assessment (point source discharges are exempt as solid wastes under RCRA).
Wastes of butyl benzyl phthalate that are generated during a condition of use and sent to a third-party
site for treatment, disposal, or recycling may include the following:
•	Wastewater: Butyl benzyl phthalate may be contained in wastewater discharged to POTW or
other, non-public treatment works for treatment. Industrial wastewater containing butyl benzyl
phthalate discharged to a POTW may be subject to EPA or authorized NPDES state pretreatment
programs. The assessment of wastewater discharges to POTWs and non-public treatment works
of butyl benzyl phthalate is included in each of the condition of use assessments.
•	Solid Wastes: Solid wastes are defined under RCRA as any material that is discarded by being:
abandoned; inherently waste-like; a discarded military munition; or recycled in certain ways
(certain instances of the generation and legitimate reclamation of secondary materials are
exempted as solid wastes under RCRA). Solid wastes may subsequently meet RCRA's definition
of hazardous waste by either being listed as a waste at 40 CFR §§ 261.30 to 261.35 or by
meeting waste-like characteristics as defined at 40 CFR §§ 261.20 to 261.24. Solid wastes that
are hazardous wastes are regulated under the more stringent requirements of Subtitle C of
RCRA, whereas non-hazardous solid wastes are regulated under the less stringent requirements
of Subtitle D of RCRA.
Butyl benzyl phthalate is listed as a hazardous constituent in Appendix VIII of Part 261 waste
under RCRA.
•	Wastes Exempted as Solid Wastes under RCRA: Certain conditions of use of butyl benzyl
phthalate may generate wastes of butyl benzyl phthalate that are exempted as solid wastes under
40 CFR § 261.4(a). For example, the generation and legitimate reclamation of hazardous
secondary materials of butyl benzyl phthalate may be exempt as a solid waste.
E.2 Preliminary Occupational Exposure Data
NIOSH HHEs have not been conducted with a focus on butyl benzyl phthalate monitoring and/or
workplace exposure to date. Butyl benzyl phthalate does not have an OSHAIMIS code. As such, OSHA
has not collected monitoring data for this chemical.
76

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Appendix F
SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR INDUSTRIAL
AND COMMERCIAL ACTIVITIES AND USES
Table Apx
-1 Worker and Occupational Non-User Exposure Conceptual Model Supporting Table
l.ili ( \ik-

Sul)i;ili-»nr\
Ri'k'iisi- / l!\|)iisuiv
Sii-n;irio
l!\|)osuiv
l>;ilh\\;i\
I'.\|)hsuiv kllllll-
Ri-i'i-pliir /
I'lipuhiliiin
I'huis hi
k;ilion;ik-
Manufacture
Domestic
Manufacture
Domestic
Manufacture
Manufacture and
Packaging
Liquid
Contact
Dermal
Workers
Yes
2016 CDR references manufacture
in liquid form. Thus, the potential
for exposures to workers exists
during manufacturing.
Solid Contact
Dermal
Workers
No
2016 CDR does not reference
manufacture in solid form.
Vapor
Inhalation
Workers,
ONU
No
Due to PA's vapor pressure (VP)
(VP = 8.25 x 10-6 mm Hg) at room
temperature, potential for vapor
generation is low.
Mist
Inhalation/Dermal
Workers,
ONU
No
Mist generation is not expected
during manufacturing.
Dust
Inhalation/Dermal
Workers,
ONU
No
2016 CDR does not reference
manufacture in solid form.
Liquid/Solid
Contact
Dermal
ONU
No
Exposure is expected to be primarily
restricted to workers who are
directly involved in working with
the chemical. Dermal exposure by
ONU is not expected for this
condition of use as they are not
expected to directly handle the
chemical.
Import
Import
Repackaging of
import containers
Liquid
Contact
Dermal
Workers
Yes
2016 CDR references import in
liquid form. The potential for
exposures to workers exists during
import, but exposure will only occur
in the event the imported material is
repackaged.
Solid Contact
Dermal
Workers
Yes
2016 CDR references import in wet
solid form. The potential for
exposures to workers exists during
import, but exposure will only occur
in the event the imported material is
repackaged.
77

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l.ik ( \ik-
Shim-
C;iU-»iir\
Slll)i;ili-»nr\
Ri'k'iisi- / l!\|)iisuiv
Sii-n;irio
l!\|)osuiv
l>;ilh\\;i\
l!\|)iisiiiv Khuu-
Ri'i'i'pliir /
I'lipilhlliiin
I'hilis hi
K;ilion;ik-




Vapor
Inhalalion
Workers,
ONU
No
])ue to PA's vapor pressure (VP)
(VP = 8.25 x 10-6 mm I Ig) at room
temperature, potential lor vapor
generation is low.
Misl
Inhalation/Dermal
Workers.
ONU
No
Mist generation is not expected
during repackaging of import
containers.
Dust
Inhalation/Dermal
Workers,
ONU
Yes
2016 CDR references wet solid
form, which may create dust
depending on the moisture content.
The potential for dust exposures to
workers and ONUs exists during
import, but exposure will only occur
in the event the imported material is
repackaged.
Liquid/Solid
Contact
Dermal
ONU
No
Exposure is expected to be primarily
restricted to workers who are
directly involved in working with
the chemical. Dermal exposure by
ONU is not expected for this
condition of use as they are not
expected to directly handle the
chemical.
Processing
Incorporated
into
formulation,
mixture or
reaction
product
Filler in: Custom
of purchased
resin
compounding
Plasticizer in:
adhesive
manufacturing;
all other basic
inorganic
chemical
manufacturing;
dental product
manufacturing;
paints and
coatings
manufacturing;
personal care
Processing into
formulations,
mixtures, or
reaction product
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during processing
(incorporation into formulation,
mixture, or reaction product), as
butyl benzyl phthalate may be in
liquid form.
Solid Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during processing
(incorporation into formulation,
mixture, or reaction product), as
butyl benzyl phthalate may be in wet
solid form.
Vapor
Inhalation
Workers,
ONU
Yes
Due to butyl benzyl phthalate's
vapor pressure (VP) (VP = 8.25 x
10-6 mm Hg) at room temperature,
potential for vapor generation is
low. However, some of these
operations may occur at elevated
78

-------
l.ik ( \ili-
C;iU-»iir\
Slll)i;ili-»nr\
Ri'k'iisi- / l!\|)iisuiv
l!\|)osuiv
l!\|)iisiiiv Khuu-
Ri'i'i'pliir /
I'hilis hi
K;ilion;ik-


l>;ilh\\;i\
I'lipilhlliiin



products; printing





temperatures, which increase the


ink





potential for vapor generation.


manufacturing





Mist generation is not expected


Processing aid in:

Mist
Inhalation/Dermal
Workers,
ONU
No
during processing (incorporation
into formulation, mixture, or


petroleum





reaction product).


production





The potential for dust exposures to
workers and ONUs exists during


Laboratory
chemical

Dust
Inhalation/Dermal
Workers,
ONU
Yes
processing as butyl benzyl phthalate
may be in wet solid form, which


manufacturing





may create dust depending on the
moisture content.


Biocide carrier
manufacturing





Exposure is expected to be primarily
restricted to workers who are
directly involved in working with




Liquid/Solid
Contact
Dermal
ONU
No
the chemical. Dermal exposure by
ONU is not expected for this
condition of use as they are not
expected to directly handle the
chemical.

Incorporated
Plasticizers in:
Plastics and Rubber




The potential for exposures to

into articles
asphalt paving,
roofing, and
coating materials
product
manufacturing
(Plastic
Liquid
Contact
Dermal
Workers
Yes
workers exists during incorporation
into articles, as butyl benzyl
phthalate may be in liquid form.


manufacturing;
fabric, textile,
and leather
Converting)
Other article
Solid Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during processing
(incorporation into articles), as butyl


products not
covered
manufacturing




benzyl phthalate may be in solid
form, such as for resins.


elsewhere
manufacturing;





Due to butyl benzyl phthalate's
vapor pressure (VP) (VP = 8.25 x


floor coverings
manufacturing;
food contact

Vapor
Inhalation
Workers,
ONU
Yes
10-6 mm Hg) at room temperature,
potential for vapor generation is
low. However, some of these


surfaces
manufacturing;





operations may occur at elevated
temperatures, which increase the


plastics product





potential for vapor generation.


manufacturing;
rubber product

Mist
Inhalation/Dermal
Workers,
ONU
No
Mist generation is not expected
during incorporation into article.


manufacturing;
textiles, apparel,

Dust
Inhalation/Dermal
Workers,
ONU
Yes
The potential for exposures to
workers exists during processing
79

-------
l.ik ( \ili-
C;iU-»iir\
Slll)i;ili-»nr\
Ri'k'iisi- / l!\|)iisuiv
l!\|)osuiv
I'!\|)hsuiv Khuu-
Ri'i'i'pliir /
I'hilis hi
K;ilion;ik-


P;i 1 hw ;i\
I'lipilhlliiin



and leather
manufacturing;
Transportation





(incorporation into articles), as butyl
benzyl phthalate may be in solid
form, such as for resins.


equipment
manufacturing





Exposure is expected to be primarily
restricted to workers who are
directly involved in working with




Liquid/Solid
Contact
Dermal
ONU
No
the chemical. Dermal exposure by
ONU is not expected for this
condition of use as they are not
expected to directly handle the
chemical.

Repackaging
Repackaging
Repackaging into
large and small
containers
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during repackaging,
as butyl benzyl phthalate may be in
liquid form.




Solid Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during repackaging,
as butyl benzyl phthalate may be
incorporated into products in solid
form.








Due to butyl benzyl phthalate's




Vapor
Inhalation
Workers,
ONU
No
vapor pressure (VP) (VP = 8.25 x
10-6 mm Hg) at room temperature,
potential for vapor generation is
low.




Mist
Inhalation/Dermal
Workers,
ONU
No
Mist generation is not expected
during repackaging.








The potential for dust exposures to
workers and ONUs exists during




Dust
Inhalation/Dermal
Workers,
ONU
Yes
processing (repackaging), as butyl
benzyl phthalate may be
incorporated into products in solid
form.








Exposure is expected to be primarily
restricted to workers who are








directly involved in working with




Liquid/Solid
Contact
Dermal
ONU
No
the chemical. Dermal exposure by
ONU is not expected for this
condition of use as they are not
expected to directly handle the
chemical.
80

-------
l.ili ( \ili-

Slll)i;ili-»nr\
Ri'k'iisi- / l!\|)iisuiv
l!\|)osuiv
l!\|)iisiiiv Khuu-
Ri'i'i'pliir /
I'hilis hi
K;ilion;ik-


l>;ilh\\;i\
I'lipilhlliiin


Recycling
Recycling
Recycling of butyl
benzyl phthalate
and products
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during this use as
liquid formulations may be recycled.



containing butyl
benzyl phthalate
Solid Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during this use as
solid formulations may be recycled.








Due to butyl benzyl phthalate's




Vapor
Inhalation
Workers,
ONU
No
vapor pressure (VP) (VP = 8.25 x
10-6 mm Hg) at room temperature,
potential for vapor generation is
low.




Mist
Inhalation/Dermal
Workers,
ONU
No
Mist generation is not expected
during recycling of liquid wastes.




Dust
Inhalation/Dermal
Workers,
ONU
Yes
Dust generation is possible during
recycling of solid wastes.




Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during this use as







liquid formulations may be recycled.
Industrial/
Adhesives and
Adhesives and
Spray, brush, roll,




These products are in liquid form;
Commercial
Use
sealants;
furnishing
cleaning and
sealants;
furnishing
cleaning and care
dip, and other
forms of
application
Liquid
Contact
Dermal
Workers
Yes
therefore, exposures to workers
exists for butyl benzyl phthalate
used in these products.

care products;
paints and
coatings
products; paints
and coatings

Solid Contact
Dermal
Workers
No
The potential for exposures to solid
butyl benzyl phthalate is not
expected during the use of these
products because they are in liquid
form.








Due to butyl benzyl phthalate's




Vapor
Inhalation
Workers,
ONU
No
vapor pressure (VP) (VP = 8.25 x
10-6 mm Hg) at room temperature,
potential for vapor generation is
low.




Mist
Inhalation/Dermal
Workers,
ONU
Yes
Mist generation is possible during
application of these products.




Dust
Inhalation/Dermal
Workers,
ONU
No
The potential for exposures to solid
butyl benzyl phthalate does not exist
during the use of these products
because they are in liquid form.




Liquid/Solid
Contact
Dermal
ONU
No
Exposure is expected to be primarily
restricted to workers who are







directly involved in working with
81

-------
l.ik ( \ili-
C;iU-»iir\
Slll)i;ili-»nr\
Ri'k'iisi- / l!\|)iisuiv
l!\|)osuiv
l!\|)iisiiiv Khuu-
Ri'i'i'pliir /
I'hilis hi
K;ilion;ik-


l>;ilh\\;i\
I'lipilhlliiin









llie chemical. Dermal exposure by








ONU is not expected lor this








condition of use as tliev are not








expected to directly handle the








chemical.

Automotive
Automotive care
Use of automotive




These products are in liquid form;

care products;
hydraulic
fracturing;
products;
hydraulic
fracturing;
care products
Use in hydraulic
Liquid
Contact
Dermal
Workers
Yes
therefore, exposures to workers
exists for butyl benzyl phthalate
used in these products.

chemical
intermediate;
laboratory use
chemical
intermediate;
laboratory use
fracturing
Use as chemical
intermediate
Solid Contact
Dermal
Workers
No
The potential for exposures to solid
butyl benzyl phthalate is not
expected during the use of these
products because they are in liquid
form.



Use in laboratories




Due to butyl benzyl phthalate's




Vapor
Inhalation
Workers,
ONU
No
vapor pressure (VP) (VP = 8.25 x
10-6 mm Hg) at room temperature,
potential for vapor generation is
low.




Mist
Inhalation/Dermal
Workers,
ONU
No
Mist generation is not expected
during use of these products.




Dust
Inhalation/Dermal
Workers,
ONU
No
The potential for exposures to solid
butyl benzyl phthalate does not exist
during the use of these products
because they are in liquid form.








Exposure is expected to be primarily
restricted to workers who are








directly involved in working with




Liquid/Solid
Contact
Dermal
ONU
No
the chemical. Dermal exposure by
ONU is not expected for this
condition of use as they are not
expected to directly handle the
chemical.

Castings;
building/
construction
materials not
Castings;
building/
construction
materials not
Use of articles
made using butyl
benzyl phthalate
Liquid
Contact
Dermal
Workers
No
The potential for exposures to liquid
butyl benzyl phthalate is not
expected during the use of these
products because they are solid

covered
covered





articles.

elsewhere;
elsewhere; floor





These products may include solid

floor
coverings; plastic

Solid Contact
Dermal
Workers
Yes
articles in which butyl benzyl

covenngs;
and rubber





phthalate is entrained; therefore,
82

-------
l.ili ( \ili-
C;iU-»iir\
Slll)i;ili-»nr\
Ri'k'iisi- / l!\|)iisuiv
l!\|)osuiv
l!\|)iisiiiv Khuu-
Ri'i'i'pliir /
I'hilis hi
K;ilion;ik-


l>;ilh\\;i\
I'lipilhlliiin


plastic and
rubber
products not
covered





butyl benzyl phthalate exposures to
workers is unlikely but may occur if

products not
elsewhere





cutting /sawing / other machining

covered
(transportation





operations occur.

elsewhere
(transportation
equipment
manufacturing,
cast models)
equipment
manufacturing,
cast models)

Vapor
Inhalation
Workers,
ONU
No
Due to butyl benzyl phthalate's
vapor pressure (VP) (VP = 8.25 x
10-6 mm Hg) at room temperature,
potential for vapor generation is
low.




Mist
Inhalation/Dermal
Workers,
ONU
No
Mist generation is not expected
during use of these products.








These products may include solid




Dust
Inhalation/Dermal
Workers,
ONU
Yes
articles in which butyl benzyl
phthalate is entrained; therefore,
butyl benzyl phthalate exposures to
workers and ONUs is unlikely but
may occur if cutting /sawing / other
machining operations occur.








Exposure is expected to be primarily
restricted to workers who are








directly involved in working with




Liquid/Solid
Contact
Dermal
ONU
No
the chemical. Dermal exposure by
ONU is not expected for this
condition of use as they are not
expected to directly handle the
chemical.
Disposal
Disposal
Disposal of butyl
benzyl phthalate
wastes
Worker handling of
wastes
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during this use as
liquid formulations may be
disposed.




Solid Contact
Dermal
Workers
Yes
The potential for exposures to
workers exists during this use as
solid formulations may be disposed








Due to butyl benzyl phthalate's




Vapor
Inhalation
Workers,
ONU
No
vapor pressure (VP) (VP = 8.25 x
10-6 mm Hg) at room temperature,
potential for vapor generation is
low.




Mist
Inhalation/Dermal
Workers,
ONU
No
Mist generation is not expected
during disposal of liquid wastes.
83

-------
l.ik ( \ik-
C;iU-»iir\
Sul)i;ili-»iir\
Kck'iisc / l'.\|)iisuiv
Sii-n;irio
l!\|)osuiv
P;i 1 hw ;i\
l!\|)iisiiiv Rhiiu-
Ri'i'i'pliir /
I'lipilhlliiin
Philis hi
k;ili(ili;ik-




Dust
Inhalation/Dermal
Workers,
ONU
Yes
Dust generation is possible during
disposal of solid wastes.
Liquid/Solid
Contact
Dermal
ONU
No
Exposure is expected to be primarily
restricted to workers who are
directly involved in working with
the chemical. Dermal exposure by
ONU is not expected for this
condition of use as they are not
expected to directly handle the
chemical.
84

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Appendix G SUPPORTING INFORMATION — CONCEPTUAL MODEL FOR CONSUMER
ACTIVITIES AND USES
Table Apx G-l Consumer Exposure Conceptual Model Supporting Table
Life Cu'le
Slii»c

Siibciik'jion
Koloiisc from
sou ive
l'l\|)OSIIIV
Kniili'
Km'plur
I'lilllS In
l.\;ilu;ik'
K;ilinn;ik'



Direct contact








through handling
of articles
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use, EPA plans to evaluate



containing
chemical



dermal exposure.


Fabric, Textile,
Direct contact





Consumer
Use
Furnishing,
Cleaning,
Treatment/Care
Products
and Leather
Products not
Covered
Elsewhere
(Article)
through
mouthing of
articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this
condition of use, EPA plans to evaluate
exposure.



Long-term
emission/mass-

Dermal,
Consumers,
Bystanders

Dermal, oral and inhalation exposure



transfer,
Dust
Inhalation,
Yes
from this condition of use may occur.



Abrasion,
Transfer to Dust

Oral

EPA plans to evaluate exposure.



Direct contact








through handling
of articles
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use. EPA plans to evaluate
Consumer
Use
Packaging,
Plastic and
Rubber Products
containing
chemical



exposure.
Paper, Plastic,
not Covered
Direct contact





Hobby Products
Elsewhere
(Article)
through
mouthing of
articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this
condition of use. EPA plans to evaluate
exposure.
85

-------
Life Cu'le
Slii»c

Siibciik'jion
Koloiisc from
sou ive
l'l\|)OSIIIV
Kniili'
Km'plur
I'lilllS In
l.\;ilu;ik'
K;ilinn;ik'



Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure
from this condition of use may occur.
EPA plans to evaluate exposure.



Direct contact
through handling
of articles
containing
chemical
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use. EPA plans to evaluate
exposure.
Consumer
Use
Packaging,
Paper, Plastic,
Hobby Products
Toys,
Playground, and
Sporting
Equipment
(Article)
Direct contact
through
mouthing of
articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this
condition of use. EPA plans to evaluate
exposure.



Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure
from this condition of use may occur.
EPA plans to evaluate exposure.



Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure
from this condition of use may occur.
EPA plans to evaluate exposure.
Consumer
Use
Construction,
Paint, Electrical,
and Metal
Products
Adhesives and
Sealants
(Product)
Direct contact
through
application or
use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical.



Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible; EPA plans to
evaluate exposure.
86

-------
Life Cu'le
Slii»c

Siibciik'jion
Koloiisc from
sou ive
l'l\|)OSIIIV
Kniili'
Km'plur
I'lilllS In
l.\;ilu;ik'
K;ilinn;ik'



Direct contact
through
application or
use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation
and dermal exposures may occur. EPA
plans to evaluate exposure.



Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure
from this condition of use may occur.
EPA plans to evaluate exposure.
Consumer
Automotive,
Fuel, Agriculture,
Automotive Care
Products
(Product)
Direct contact
through
application or
use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical. EPA
plans to evaluate exposure.
Use
Outdoor Use
Products
Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible; inhalation
exposure from this condition of use may
occur. EPA plans to evaluate exposure.



Direct contact
through
application or
use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation
and dermal exposures would be
expected. EPA plans to evaluate
exposure.



Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure
from this condition of use may occur.
EPA plans to evaluate exposure.
Consumer
Use
Packaging,
Paper, Plastic,
Hobby Products
Arts, Crafts, and
Hobby Materials
(Product)
Direct contact
through
application or
use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical. EPA
plans to evaluate exposure.



Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible; inhalation
exposure from this condition of use may
occur. EPA plans to evaluate exposure.
87

-------
Life Cu'le
Slii»c

Siibciik'jion
Koloiisc from
sou ive
l'l\|)OSIIIV
Kniili'
Km'plur
I'lilllS In
l.\;ilu;ik'
K;ilinn;ik'



Direct contact
through
application or
use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation
and dermal exposures would be
expected. EPA plans to evaluate
exposure.



Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure
from this condition of use may occur.
EPA plans to evaluate exposure.
Consumer
Furnishing,
Cleaning,
Cleaning and
Furnishing Care
Direct contact
through
application or
use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical. EPA
plans to evaluate exposure.
Use
Treatment/Care
Products
Products
(Product)
Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible; EPA plans to
evaluate exposure.



Direct contact
through
application or
use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation
and dermal exposures would be expected
and EPA plans to evaluate exposure.



Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure
from this condition of use may occur.
EPA plans to evaluate exposure.
Consumer
Use
Furnishing,
Cleaning,
Treatment/Care
Products
Floor Coverings
(Product)
Direct contact
through
application or
use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical. EPA
plans to evaluate exposure.



Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible; EPA plans to
evaluate exposure.
88

-------
Life Cu'le
Slii»c

Siibciik'jion
Koloiisc from
sou ive
l'l\|)OSIIIV
Kniili'
Km'plur
I'lilllS In
l.\;ilu;ik'
K;ilinn;ik'



Direct contact
through
application or
use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation
and dermal exposures would be expected
and EPA plans to evaluate exposure.



Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure
from this condition of use may occur.
EPA plans to evaluate exposure.
Consumer
Packaging,
Paper, Plastic,
Hobby Products
Ink, Toner and
Colorant
Direct contact
through
application or
use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical. EPA
plans to evaluate exposure.
Use
Products
(Product)
Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible; EPA plans to
evaluate exposure.



Direct contact
through
application or
use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation
and dermal exposures would be expected
and EPA plans to evaluate exposure.



Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure
from this condition of use may occur.
EPA plans to evaluate exposure.
Consumer
Use
Construction,
Paint, Electrical,
and Metal
Products
Paints and
Coatings
(Product)
Direct contact
through
application or
use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical. EPA
plans to evaluate exposure.



Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible; EPA plans to
evaluate exposure.
89

-------
Life Cu'le
Slii»c

Siibciik'jion
Koloiisc from
sou ive
l'l\|)OSIIIV
Kniili'
Km'plur
I'lilllS In
l.\;ilu;ik'
K;ilinn;ik'



Direct contact
through
application or
use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation
and dermal exposures would be expected
and EPA plans to evaluate exposure.



Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dust generation is possible during the
handling of solid waste. EPA plans to
evaluate exposure.
Consumer
Handling of
Disposal and
Waste
Wastewater,
Liquid wastes
and solid wastes
Wastewater,
Liquid wastes
and solid wastes
Direct contact
through handling
or disposal of
products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in handling and disposal of the
chemical. EPA plans to evaluate
exposure.



Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible; inhalation
exposure from this condition of use may
occur. EPA plans to evaluate exposure.



Direct contact
through
application or
use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
No
Mist generation is not expected during
handling or disposal
90

-------
Appendix H SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES
Table Apx H-l Environmental Exposure Conceptual Model Supporting Table
l.il'o (Acle
S(;i»e
CsiU'Sion
Release
l'l\|)UMIIV
P;Kln\;i\ /
Modiii
l'l\|)OMIIV
Ron (cs
Receptor /
Population
PlilllS lo
r.\;ilu;ile4
Riilioiiiile
All
Emissions to
Air
Emissions to Air
Near facility
ambient air
concentrations
Inhalation
General
Population
Yes
Butyl benzyl phthalate air and
deposition to nearby bodies of
water and soil are expected
exposure pathways, not under
the jurisdiction of other EPA
regulations.
Indirect
deposition to
nearby bodies
of water and
soil catchments
Oral
Dermal
General
Population
Yes
TBD
Aquatic and
Terrestrial
Receptors
Yes
Hazardous and
Municipal Waste
Incinerator
Near facility
ambient air
concentrations/
Indirect
deposition to
nearby bodies
of water and
soil catchments
Inhalation
General
Population
No
EPA docs not have release
information about this pathway,
however, butyl benzyl phthalate
is considered a hazardous
constituent.
TBD
Aquatic and
Terrestrial
Species
Wastewater
or Liquid
Wastes
Industrial pre-
treatment and
wastewater
treatment, or POTW
Direct release
into surface
water and
indirect
partitioning to
sediment
TBD
Aquatic and
Terrestrial
Receptors
Yes
EPA has developed Ambient
Water Quality Criteria for
protection of human health for
butyl benzyl phthalate.
Oral
Dermal
General
Population
No
4 The exposure pathways, exposure routes and hazards EPA plans to consider are subject to change in the final scope, in light of comments received on this draft scope
and other reasonably available information. EPA continues to consider whether and how other EPA-administered statutes and any associated regulatory programs address
the presence of butyl benzyl phthalate in exposure pathways falling under the jurisdiction of these EPA statutes.
91

-------
l.il'o ( \ck'
S(;i»o
CsiU'Sion
Kcloiisc
r.\|NINlM\'
PillllWil.t /
Modiii
l'l\|)OMIIV
Ron (cs
Km'plor /
Population
I'lilllS (o
Kiilioiiiik-



Drinking Water
via Surface or
Ground Water
Oral
Dermal and
Inhalation
(e.g.
showering)
General
Population
Yes
Release of butyl benzyl phthalate
into surface water and indirect
partitioning to drinking water is
an expected exposure pathway.
Biosolids:
application to
soil and/or
migration to
groundwater
and/or surface
water
Oral (e.g.
ingestion of
soil)
Inhalation
General
Population
Yes
EPA plans to analyze the
pathway from biosolids to the
general population and terrestrial
species.

TBD
Aquatic and
Terrestrial
receptors
Yes


Underground
injection
Migration to
groundwater,
potential
surface/drinking
water
Oral
Dermal
Inhalation
General
Population
No
EPA docs not have butyl benzyl
phthalate release information for
this pathway since 1992. Butyl
benzyl phthalate is a hazardous
constituent and underground
injection to hazardous waste
wells is under the jurisdiction of
SDWA and RCRA.
Aquatic and
Terrestrial
Species
TBD

Disposal
Solid and
Liquid
Wastes
Hazardous,
Municipal landfill
and other land
disposal
Lca.cha.tc to
soil, ground
water and/or
mitigation to
surface water
Oral
Dermal
General
Population
No
EPA docs not have release
information about this pathway,
however, butyl benzyl phthalate
is considered a hazardous
constituent..
92

-------