EPA
EPA Document# EPA-740-D-20-016
April 2020
United States	Office of Chemical Safety and
Environmental Protection Agency	Pollution Prevention
Draft Scope of the Risk Evaluation for
Dibutyl Phthalate
(1,2-Benzenedicarboxylic acid, 1,2-dibutyl ester)
CASRN 84-74-2
CHq
HaC
V
April 2020

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TABLE OF CONTENTS
ACKNOWLEDGEMENTS	5
ABBREVIATIONS AND ACRONYMS	6
EXECUTIVE SUMMARY	9
1	INTRODUCTION	12
2	SCOPE OF 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 Results for 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	19
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	23
2.3	Exposures	25
2.3.1	Physical and Chemical (P-Chem) Properties	25
2.3.2	Environmental Fate and Transport	25
2.3.3	Releases to the Environment	25
2.3.4	Environmental Exposures	27
2.3.5	Occupational Exposures	27
2.3.6	Consumer Exposures	28
2.3.7	General Population Exposures	29
2.4	Hazards (Effects)	30
2.4.1	Environmental Hazards	30
2.4.2	Human Health Hazards	30
2.5	Potentially Exposed or Susceptible Subpopulations	30
2.6	C onceptual Model s	31
2.6.1	Conceptual Model for Industrial and Commercial Activities and Uses	31
2.6.2	Conceptual Model for Consumer Activities and Uses	33
2.6.3	Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards (Regulatory Overlay)	35
2.6.3.1	Ambient Air Pathway	37
2.6.3.2	Ambient Water Pathway	37
2.6.3.3	Disposal and Soil Pathways	38
2.6.4	Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards	39
2.7	Analysis Plan	41
2.7.1	P-Chem Properties and Environmental Fate	41
2.7.2	Exposure	41
2.7.2.1	Environmental Releases	42
2.7.2.2	Environmental Exposures	44
2.7.2.3	Occupational Exposures	45
2.7.2.4	Consumer Exposures	46
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2.7.2.5 General Population	48
2.7.3	Hazards (Effects)	50
2.7.3.1	Environmental Hazards	50
2.7.3.2	Human Health Hazards	51
2.7.4	Summary of Risk Approaches for Characterization	53
2.8 Peer Review	54
REFERENCES	55
APPENDICES	61
Appendix A LIST OF GRAY LITERATURE SOURCES	61
Appendix B PHYSICAL AND CHEMICAL PROPERTIES OF DIBUTYL PHTHALATE	64
Appendix C ENVIRONMENTAL FATE AND TRANSPORT PROPERTIES	66
Appendix D REGULATORY HISTORY	68
D.l Federal Laws and Regulations														...............68
D.2 State Laws and Regulations															73
D.3	International Laws and Regulations..........									...........................74
Appendix E PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION.. 78
E.l	Process Information.................											..78
E. 1.1 Manufacture (Including Import)	78
E. 1.1.1 Domestic Manufacturing	78
E.l. 1.2 Import	78
E. 1.2 Processing and Distribution	78
E. 1.2.1 Reactant or Intermediate	78
E. 1.2.2 Incorporated into a Formulation, Mixture or Reaction Product	79
E. 1.2.3 Incorporated into an Article	79
E. 1.2.1 Repackaging	79
E.l.2.2 Recycling	79
E.l.3 Uses	79
E.l.3.1 Adhesives, Sealants, Paints, and Coatings	79
E.l.3.2 Building/Construction Materials Not Covered Elsewhere	80
E.l.3.3 Cleaning and Furnishings Care Products	80
E. 1.3.4 Ink, Toner, and Colorant Products	80
E.l.3.5 Plastic and Rubber Products	80
E.l.3.6 Other Uses	81
E.l.4 Disposal	81
E.2 Preliminary Occupational Exposure Data														82
Appendix F SUPPORTING INFORMATION FOR OCCUPATIONAL EXPOSURE
CONCEPTUAL MODEL	84
Appendix G SUPPORTING INFORMATION FOR CONSUMER, GENERAL POPULATION
AND ENVIRONMENTAL EXPOSURE CONCEPTUAL MODEL	94
Appendix H SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES	100
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LIST OF TABLES
Table 2-1 Results of Title Screening of Submissions to EPA under Various Sections of TSCA	19
Table 2-2 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation	20
Table 2-3 Summary of Dibutyl Phthalate TRI Production-related Waste Managed in 2018	26
Table 2-4 Summary of Releases of Dibutyl Phthalate to the Environment During 2018	26
Table 2-5 Categories and Sources of Environmental Release Data	42
Table 2-6 Potential Sources of Occupational Exposure Data	45
LIST OF FIGURES
Figure 2-1 Gray Literature Search Results for Dibutyl Phthalate	13
Figure 2-2 Peer-reviewed Literature - Physical and Chemical Properties for Dibutyl Phthalate	14
Figure 2-3 Peer-reviewed Literature - Fate and Transport Search Results for Dibutyl Phthalate	15
Figure 2-4 Peer-reviewed Literature - Engineering Search Results for Dibutyl Phthalate	16
Figure 2-5 Peer-reviewed Literature - Exposure Search Results for Dibutyl Phthalate	17
Figure 2-6 Peer-reviewed Literature - Hazard Search Results for Dibutyl Phthalate	18
Figure 2-7 Dibutyl Phthalate Life Cycle Diagram	24
Figure 2-8 Dibutyl Phthalate Conceptual Model for Industrial and Commercial Activities and Uses:
Worker and Occupational Non-User Exposures and Hazards	32
Figure 2-9 Dibutyl Phthalate Conceptual Model for Consumer Activities and Uses: Consumer Exposures
and Hazards	34
Figure 2-10 Dibutyl Phthalate Conceptual Model for Environmental Releases and Wastes:
Environmental and General Population Exposures and Hazards (Regulatory Overlay) ..36
Figure 2-11 Dibutyl Phthalate Conceptual Model for Environmental Releases and Wastes:
Environmental and General Population Exposures and Hazards	40
LIST OF APPENDIX TABLES
TableApx A-l List of Gray Literature Sources that Yielded Results for Dibutyl Phthalate	61
TableApx B-l Physical and Chemical Properties of Dibutyl Phthalate	64
TableApx C-l Environmental Fate Characteristics of Dibutyl Phthalate	66
Table_Apx D-l Federal Laws and Regulations	68
Table_Apx D-2 State Laws and Regulations	73
Table Apx D-3 Regulatory Actions by other Governments, Tribes, and International Agreements	74
Table Apx E-l Summary of NIOSH HHEs with Monitoring for Dibutyl Phthalate	82
Table Apx E-2 Summary of Industry Sectors with Dibutyl Phthalate Monitoring Samples Available
from OSHA Inspections (2010 and 2019)	83
Table Apx F-l Worker and Occupational Non-User Exposure Conceptual Model Supporting Table. 84
Table Apx G-l Consumer Exposure Conceptual Model Supporting Table	94
Table Apx H-l General Population and Environmental Exposure Conceptual Model	100
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ACKNOWLEDGEMENTS
This report was developed by the United States Environmental Protection Agency (U.S. EPA), Office of
Chemical Safety and Pollution Prevention (OCSPP), Office of Pollution Prevention and Toxics (OPPT).
Acknowledgements
The OPPT Assessment Team gratefully acknowledges participation or input from intra-agency
reviewers that included multiple offices within EPA, inter-agency reviewers that included multiple
federal agencies, and assistance from EPA contractors GDIT (Contract No. HHSN316201200013W),
ERG (Contract No. EP-W-12-006), Versar (Contract No. EP-W-17-006), ICF (Contract
No.68HERC19D0003), Abt Associates (Contract No. EP-W-16-009) and SRC (Contract No.
68HERH19F0213). EPA also acknowledges the contributions of technical experts from EPA's Office of
Research and Development.
Docket
Supporting information can be found in public docket: Docket ID: EPA-HQ-OPPT-2018-0503.
Disclaimer
Reference herein to any specific commercial products, process or service by trade name, trademark,
manufacturer or otherwise does not constitute or imply its endorsement, recommendation or favoring by
the United States Government.
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ABBREVIATIONS AND ACRONYMS
ACGIH
American Conference of Governmental Industrial Hygienists
ADME
Absorption, Distribution, Metabolism, and Excretion
AT SDR
Agency for Toxic Substances and Disease Registry
BAF
Bioaccumulation Factor
BP
Boiling Point
BCF
Bioconcentration Factor
BMF
Biomagnification factor
BOD
Biochemical oxygen demand
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
CPSIA
Consumer Product Safety Improvement Act
CSCL
Chemical Substances Control Law
CWA
Clean Water Act
DMR
Discharge Monitoring Report
ECx
Effective Concentration
ECHA
European Chemicals Agency
EC
Engineering Controls
EPA
Environmental Protection Agency
EPCRA
Emergency Planning and Community Right-to-Know Act
ERG
Eastern Research Group
ESD
Emission Scenario Document
EU
European Union
FFDCA
Federal Food, Drug and Cosmetic Act
FR
Federal Register
FYI
For Your Information
GACT
Generally Available Control Technology
GDIT
General Dynamics Information Technology
GESTIS
International Occupational Exposure Limit Database
GS
Generic Scenario
HAP
Hazardous Air Pollutant
Hg
Mercury
HHE
Health Hazard Evaluation
HMTA
Hazardous Materials Transportation Act
ICF
ICF is a global consulting services company
IDLH
Immediately Dangerous to Life and Health
IECCU
Indoor Environmental Concentrations in Buildings with Conditioned and Unconditioned

Zones
IMAP
Inventory Multi-Tiered Assessment and Prioritisation (Australia)

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ISHA
Koc
Kow
LCx
LOAEL
LOEC
MACT
MITI
MOA
MP
NAICS
NESHAP
NICNAS
NIOSH
NITE
NOAEL
NOEC
NPDES
NPRI
OCSPP
OECD
OEL
ONU
OPPT
OSHA
P-chem
PBPK
PBT
PEC
PECO
PEL
PESS
POD
POTW
PPE
PVC
PVDC
PVA
RCRA
REACH
REL
RQ
SDS
SDWA
SRC
STEL
SVOC
TIAB
Industrial Safety and Health Act
Organic Carbon: Water Partition Coefficient
Octanol: Water Partition Coefficient
Lethal Concentration
Lowest Observed Adverse Effect Level
Lowest Observed Effect Concentration
Maximum Achievable Control Technology
Ministry of International Trade and Industry
Mode of Action
Melting point
North American Industry Classification System
National Emission Standards for Hazardous Air Pollutants
National Industrial Chemicals Notification and Assessment Scheme (Australia)
National Institute for Occupational Safety and Health
National Institute of Technology and Evaluation
No Observed Adverse Effect Level
No Observed Effect Concentration
National Pollutant Discharge Elimination System
National Pollutant Release Inventory
Office of Chemical Safety and Pollution Prevention
Organisation for Economic Co-operation and Development
Occupational Exposure Limit
Occupational Non-User
Office of Pollution Prevention and Toxics
Occupational Safety and Health Administration
Phy si cal -chemi cal
Physiologically Based Pharmacokinetic
Persistent, Bioaccumulative, Toxic
Priority Existing Chemical
Population, Exposure, Comparator and Outcome
Permissible Exposure Limit
Potentially Exposed or Susceptible Populations
Point of Departure
Publicly Owned Treatment Works
Personal Protective Equipment
Polyvinyl chloride
Polyvinylidene chloride
Polyvinyl acetate
Resource Conservation and Recovery Act
Registration, Evaluation, Authorisation and Restriction of Chemicals (European Union)
Recommended Exposure Limit
Risk Quotient
Safety Data Sheet
Safe Drinking Water Act
SRC Inc., formerly Syracuse Research Corporation
Short-term Exposure Limit
Semi-volatile Organic Compound
Title and Abstract
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TBD
To be determined
TMF
Trophic Magnification Factors
TRI
Toxics Release Inventory
TSCA
Toxic Substances Control Act
TURA
Toxics Use Reduction Act (Massachusetts)
TWA
Time-weighted average
USGS
United States Geological Survey
VOC
Volatile Organic Compound
VP
Vapor Pressure
WHO
World Health Organization
WS
Water Solubility

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EXECUTIVE SUMMARY
In December 2019, EPA designated dibutyl phthalate (CASRN 84-74-2) as a high-priority substance for
risk evaluation following the prioritization process required by Section 6(b) of the Toxic Substances
Control Act (TSCA) and implementing regulations (40 CFR Part 702) (Docket ID: EPA-HQ-OPPT-
2.018-0503). The first step of the risk evaluation process is the development of the scope document and
this document fulfills the TSCA regulatory requirement to issue a draft scope document as described in
40 CFR 702	The draft scope for dibutyl 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. Dibutyl phthalate, is a colorless to faint yellow, oily liquid with a total production
volume in the United States between 1 million and 10 million pounds.
Reasonably Available Information. EPA leveraged the data and information sources already described
in the document supporting the High-Priority Substance designation to inform the development of this
draft scope document. Furthermore, 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 plans to use 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 plans to apply 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 dibutyl phthalate.
Conditions of Use. EPA plans to evaluate manufacturing, including importing; processing; distribution
in commerce; industrial, commercial and consumer uses; and disposal of dibutyl phthalate in the risk
evaluation. Dibutyl phthalate is manufactured within, as well as imported into, the United States.
Dibutyl phthalate is used in the processing and incorporation into formulations for solvents, plasticizers
Dibutyl phthalate also has several commercial and consumer uses, including explosives, floor coatings,
paints, adhesives, cleaning and furniture products, among others. EPA identified these conditions of use
from information reported to EPA through Chemical Data Reporting (CDR) and Toxics Release
Inventory (TRI), published literature, and consultation with stakeholders for both uses currently in
production and uses whose production may have ceased. Section 2.2 provides details about the
conditions of use within and outside the scope of the risk evaluation. In addition, EPA plans to analyze
distribution in commerce and disposal as part of the risk evaluation.
Conceptual Model. The conceptual models for dibutyl 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. EPA proposes to focus the risk evaluation for
dibutyl phthalate on the following exposures, hazards, and receptors with the understanding that updates
may be made in the final scope document after consideration of public comments and completion of the
systematic review data collection phase.
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	Exposures (Pathways and Routes), Receptors and PESS. EPA plans to analyze both human and
environmental exposures resulting from the conditions of use of dibutyl phthalate that EPA plans
to consider in the risk evaluation. Exposures for dibutyl phthalate are discussed in Section 2.3.
EPA identified environmental monitoring data reporting the presence of dibutyl phthalate in air,
surface water and groundwater, sediment, sewage sludge, waste effluents and biomonitoring
samples (U.S. EPA, 2019a). Dibutyl phthalate is subject to reporting to EPA's Toxics Release
Inventory (TRI) and EPA plans to use TRI information as reasonably available information to
inform dibutyl phthalate's environmental release assessment. For the 2018 reporting year, 61
facilities reported to EPA releases of dibutyl phthalate to air, water, and via land disposal.
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 dibutyl 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
dibutyl phthalate within the scope of the risk evaluation.
Preliminarily, EPA plans to evaluate the following human and environmental exposure
pathways, routes, receptors and PESS in the scope of the risk evaluation. However, EPA plans to
consider comments received on this draft scope and other reasonably available information when
finalizing this scope document, and to adjust the exposure pathways, exposure routes and
hazards included in the scope document as needed.
-	Occupational exposures associated with 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 dibutyl phthalate (Section 2.2.1).
-	Consumer and bystander exposures associated with consumer conditions of use: EPA
plans to evaluate oral, inhalation and dermal exposure to dibutyl phthalate when
consumers and bystanders are exposed via the use and/or handling of consumer products
and articles in the following conditions of use: Adhesives and Sealants; Arts, Crafts, and
Hobby Materials; Building/Construction Materials not Covered Elsewhere; Cleaning and
Furnishing Care Products; Electrical and Electronic Products; Fabric, Textile, and
Leather Products not Covered Elsewhere; Floor Coverings; Furniture and Furnishings not
Covered Elsewhere; Paints and Coatings; Plastic and Rubber Products not Covered
Elsewhere; and Toys, Playground, and Sporting Equipment.
-	General population exposures: EPA plans to evaluate exposure to dibutyl phthalate via
ingestion of drinking water.
-	Receptors and PESS: EPA plans to include 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 dibutyl phthalate for
aquatic and terrestrial receptors.
	Hazards. Hazards for dibutyl 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 dibutyl phthalate as part of the prioritization
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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.
EPA plans to use systematic review methods to evaluate the epidemiological and toxicological
literature for dibutyl phthalate. Relevant mechanistic evidence will also be considered, if
available, to inform the interpretation of findings related to potential human health effects and
the dose-repose assessment. EPA plans to evaluate all of the potential human health hazards for
dibutyl phthalate identified in Section 2.4.2. The broad health effect categories identified in the
prioritization document include reproductive and developmental; immunological; nervous
system; genotoxicity; carcinogenicity; adsorption, distribution, metabolism, and excretion
(ADME); and irritation effects.
Analysis Plan. The analysis plan for dibutyl phthalate is presented in Section 2.7. The analysis plan
outlines the general science approaches that EPA plans to use for the various evidence streams (i.e.,
chemistry, fate, release and engineering, exposure, hazard) supporting the risk evaluation. The analysis
plan is based on EPA's knowledge of dibutyl 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
dibutyl 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 dibutyl phthalate will be peer reviewed. Peer review will be
conducted in accordance with relevant and applicable methods for chemical risk evaluations, including
using EPA's Peer Review Handbook 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 dibutyl
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. Dibutyl 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 r dibutyl 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 (p-chem) 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
into useful categories or tags to facilitate the sorting of information through the systematic review
process. The search and screening process was conducted based on EPA's general expectations for the
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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planning, execution and assessment activities outlined in the Application of Systematic Review in TSCA
Risk Evaluations document (U.S. EPA, 2018a). EPA plans to publish supplemental documentation on
the systematic review methods supporting the dibutyl 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 up 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 dibutyl
phthalate upon publication of the supplemental documentation of those methods.
2.1.1 Search of Gray Literature
EPA surveyed the gray literature2 and identified 137 search results relevant to EPA's risk assessment
needs for dibutyl phthalate. Appendix A lists the gray literature sources that yielded 137 discrete data or
information sources relevant to dibutyl 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 reasonably available
information through systematic review methods and public comments, and the reported numbers in
Figure 2-1 may change.
Gray Literature Tags by Discipline
37/137
Phvsical.Chcmieal
Human. Health. Hazard
24/137
Exposure
15/137
Environmental. I Iazard
Engineering
0	25	50	75	100
Percent Tagged (%)
Figure 2-1 Gray Literature Search Results for Dibutyl 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 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 phthalic anhydride. 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 refer 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.
Boiling Point
Melting Point
240
12
Retrieved for Full-text
Review
Total for TIAB:
P-Chem
Water Soiublity
log KOW
Henry's Law Constant
Siiwi^
Vapor Pressure
Included for Data
Extraction and Data
Evaluation
Vapor Density
7
Density
Viscosity
Dielectric Constant
^	U
Refractive Index
Supplemental Information
Figure 2-2 Peer-reviewed Literature - Physical and Chemical Properties for Dibutyl Phthalate
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Bioconcentration,
Biomagnification, etc.
98
Biodegradation

Hydrolysis
1476
TSCA Fate DBP (2020)
Included
\v1068 )
Excluded
236
Supplemental

Photolysis
85
Sorption
^48J
Volatilization
Wastewater Treatment
[28j
Other
Figure 2-3 Peer-reviewed Literature - Fate and Transport Search Results for Dibutyl Phthalate
Click here for interactive Health Assessment Workplace Collaborative (I-IAWC) Diagram.
15

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General Facility Estimate
Included
Environmental Release
Occupational Exposure
TSCA Engineering DBP
(2020)
Excluded
0
Supplemental
Figure 2-4 Peer-reviewed Literature - Engineering Search Results for Dibutyl Phthalate
Click here for interactive HAWC Diagram.
16

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Include
TSCA Exposure DBP (2020)
Exclude

indoor air
@
soil
sediment
@
biosolids/sludge

surface water
Q
drinking water

aquatic species
[12;
terrestrial species
Q
epidemiological/human
biomonit^ing study
consumer uses and/or
products

dietary

ambient air
Supplemental	9round water

foreian Ian
foreign language
Figure 2-5 Peer-reviewed Literature - Exposure Search Results for Dibutyl Phthalate
Click here for interactive HAWC Diagram.
17

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Retrieved for Full-text
Review
<161}
Human

Animal

Plant
Human Health Model

Ecotoxicological Model
TSCA Hazard DBP (2020)
Exclusion

Supplemental Material

a Mechanistic

ADME/TK/PBPK

Mixture

Case Study or Case Series

No Original Data

Conference Abstract

Susceptible Population

Non-English Record

Field Study

Agent to Induce Allergenic
Response

PECO-Relevant Isomer
Study
Figure 2-6 Peer-reviewed Literature - Hazard Search Results for Dibutyl Phthalate
Click here for interactive HAWC Diagram.
2.1.3 Search Results for TSCA Submissions
Table 2-1 presents the results of screening the titles of data sources and reports submitted to EPA under
various sections of TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century
Act. EPA screened a total of 152 submissions using inclusion/ exclusion criteria specific to individual
disciplines (see Table 2-1 for the list of disciplines). The details about the criteria are not part of this
document but will be provided in a supplemental document that EPA anticipates releasing prior to the
finalization of the scope document. EPA identified 118 submissions that met the inclusion criteria in
these statements and identified 28 submissions with supplemental data. EPA excluded 6 submissions
because the reports were identified as one of the following:
	Submission on a different chemical
	Ranking of chemicals for proposed evaluation
	Letter of notification containing no data
18

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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
10
0
Environmental Fate and Transport
7
0
Environmental and General Population Exposure
39
0
Occupational Exposure/Release Information
9
0
Environmental Hazard
40
2
Human Health Hazard
25
28
2.2 Conditions of Use
As described in the Proposed Designation of Dibutyl Phthalate (CASRN i	> 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 dibutyl phthalate, including:
published literature, company websites, and government and commercial trade databases and
publications. To identify formulated products containing dibutyl 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. SDSs were cross-checked with company websites to make
sure that each product SDS was current. In addition, and when applicable, EPA incorporated
communications with companies, industry groups, environmental organizations, and public comments to
supplement the use information.
After gathering reasonably available information related to the manufacture, processing, distribution in
commerce, use, and disposal of dibutyl phthalate, EPA identified those categories or subcategories of
use activities for dibutyl 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.
Also, EPA identified and described the categories and subcategories of conditions of use that EPA plans
to include in the scope of the risk evaluation (Section 2.2.1; Table 2-2). The conditions of use that EPA
plans to include in the scope are those reflected in the life cycle diagrams and conceptual models.
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.
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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Table 2-2 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
l.ife-Cvcle Stage"
Category
Subcategory
Reference
Manufacturing
Domestic manufacturing
Domestic manufacturing
0
19}
Import
Import
0
19}
Processing
Processing as a reactant
Intermediates in all other basic
organic chemical
manufacturing
U.S.EPA. (20
111

Plasticizers in wholesale and
retail trade
l' S 1-0191
Processing -
incorporating into
formulation, mixture, or
reaction product
Solvents (which become part
of product formulation or
mixture) in all other chemical
product and preparation
manufacturing
019);
NLM (2015) 5926108;
Ullmann's 201 la;
Synapse Information
Resources 2009
Intermediates in asphalt
paving, roofing, and coating
materials manufacturing
019)
Adhesives and sealant
chemicals in construction
019);
NLM (2015) 5926108
Plasticizers in paint and
coating manufacturing
019);
NLM (2015) 5926108;
GoodGuide (2011)
Intermediates in petrochemical
manufacturing
019)
Plasticizers in plastic material
and resin manufacturing
019);
NLM (2015) 5926108
Plasticizers in plastic product
manufacturing
019;)
NLM (2015) 5926108
Functional fluids (closed
systems) in printing and related
support activities
019)
Intermediates in rubber product
manufacturing
019);
NLM (2015) 5926108
Plasticizers in soap, cleaning
compound, and toilet
preparation manufacturing
019)
Solvents in soap, cleaning
compound, and toilet
preparation manufacturing
019)
20

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l.ilc-Cvck' Singe"
(ilU'<>l\Y
Subc:iU'or\
Uclcmicc


Plasticizers in textiles, apparel,
and leather manufacturing
019);
NLM (2015) 5926108
Processing -
incorporating into
articles
Plasticizers in adhesive
manufacturing
019);
NLM (2015) 5926108
Plasticizers in plastics product
manufacturing
U.S.EPA. (2
Plasticizers in rubber product
manufacturing
' vi I \
Repackaging
Laboratory chemicals in
wholesale and retail trade
019)
Plasticizers in wholesale and
retail trade

Recycling
Recycling

Distribution in
Commerce
Distribution in
commerce


Industrial Uses
Non-incorporative
activities
Solvent in Huntsman's maleic
anhydride manufacturing
technology
019)
Solvent
NLM (2015) 5926108;
Ullmann's 201 la;
Synapse Information
Resources 2009
Commercial Uses
Adhesives and sealants
Adhesives and sealants
' v J l \
Cleaning and furnishing
care products
Cleaning and furnishing care
products
019);
NLM (2015) 5926108;
GoodGuide (2011)
Explosive materials
Explosive materials
019);
NLM (2015) 5926108;
Kirk-Othmer (2018);
Synapse Information
Resources 2009
Floor coverings
Floor coverings
i v j j \
Furniture and
furnishings not covered
elsewhere
Furniture and furnishings not
covered elsewhere
' v J l \
Ink, toner, and colorant
products
Ink, toner, and colorant
products
019);
NLM (2015) 5926108
Paints and coatings
Paints and coatings
019);
21

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l.ilc-Cvck' Singe"
(ilU'<>l\Y
S ii hc:i lego i^-
Uclcmicc



NLM (2015) 5926108;
GoodGuide (2011);
Ullmann's (201 lb)
Personal care products
Personal care products
i
Plastic and rubber
products not covered
elsewhere
Plastic and rubber products not
covered elsewhere
U.S.EPA. (2019);
NLM (2015) 5926108
Miscellaneous uses
Laboratory supply
i: s i'P-\ t:o
19}
Consumer Uses
Adhesives and sealants
Adhesives and sealants
0
19}
Arts, crafts and hobby
materials
Arts, crafts and hobby
materials
0
19):
NLM (2015) 5926108
Cleaning and furnishing
care products
Cleaning and furnishing care
products
019);
NLM (2015) 5926108;
GoodGuide (2011)
Fabric, textile, and
leather products not
covered elsewhere
Fabric, textile, and leather
products not covered elsewhere
019)
Floor coverings
Floor coverings
l ^} i \ ..uhn
Furniture and
furnishings not covered
elsewhere
Furniture and furnishings not
covered elsewhere
019)
Paints and coatings
Paints and coatings
019):
NLM (2015) 5926108;
GoodGuide (2011);
Ullmann's (201 lb)
Plastic and rubber
products not covered
elsewhere
Plastic and rubber products not
covered elsewhere
019):
NLM (2015) 5926108
Toys, playground and
sporting equipment
Toys, playground and sporting
equipment
019)
Disposal
Disposal


a) Life Cycle Stage Use Definitions (40 CFR  711.3)
-	"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.
22

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2.2.2	Activities Excluded from the Scope of the Risk Evaluation
As explained in the final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic
Substances Control Act, TSCA Section 6(b)(4)(D) requires EPA to identify the hazards, exposures,
conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to
consider in a risk evaluation, suggesting that EPA may exclude certain activities that it determines to be
conditions of use on a case-by-case basis (82 FR 33726, 33729; July 20, 2017). As a result, EPA does
not plan to 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 is aware of the use of dibutyl phthalate in cosmetics, primarily nail polish, which meet the
definition of cosmetics under Section 201 of the Federal Food, Drug and Cosmetics Act, 21 U.S.C. 
321, and are therefore outside the scope of 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. Uses of dibutyl phthalate in explosive materials in articles, or
components of articles subject to Section 4181 of the Internal Revenue Code of 1954, e.g., ammunition,
are similarly outside the scope of the definition of "chemical substance" TSCA  3(2)(B)(v) and are not
being considered as a "condition of use." 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
Aggregate production volume of dibutyl phthalate in 2015, as reported to EPA during the 2016 CDR
reporting period, was between 1 million and 10 million pounds (U.S. EPA,2017). EPA also uses pre-
2015 CDR production volume information, as detailed in the Proposed Designation of Dibutyl Phthalate
fCASRN	's a Hish-Priority Substance for Risk Evaluation (U.S. EPA,2019a) and will include
future production volume information as it becomes available to support the environmental release
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 EPA plans to consider in
the risk evaluation for the various life cycle stages as presented in Section 2.2.1. This section provides a
brief overview of the industrial, commercial and consumer use categories included in the life cycle
diagram. Appendix E contains more detailed descriptions (e.g., process descriptions, worker activities,
process flow diagrams) for each manufacturing, processing, distribution in commerce, use and disposal
category.
The information in the life cycle diagram is grouped according to the CDR processing codes and use
categories (including functional use codes for industrial uses and product categories for industrial,
commercial and consumer uses). The production volume of dibutyl phthalate in 2015 is included in the
lifecycle diagram, as reported to EPA during the 2016 CDR reporting period, as an aggregate range
between 1 billion and 5 billion pounds (reference).
23

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MFG/IMPORT
Manufacture
(Including Imported)
1M-10M lbs
PROCESSING
	
Processing sis Reactant
(Inlennediale in: All other basic organic chemical
manufacturing; asphalt paving, roofing, and coating
materials manufacturing; petrochemical manufacturing;
rubber product manufacturing
Plasticizer in: wholesale and retail trade)
Incorporation into Formulation. Mixture, or Reaction
Product
(Solvents in: All other chemical product and preparation
manufacturing; Soap, cleaning compound, and toilet
preparation manufacturing:
Adhesive and sealant chemicals in construction:
Plasticizers in: Paint and coaling manufacturing; Plastics
material and resin manufacturing; Plastic product
manufacturing; Soap, cleaning compound, and toilet
preparation manufacturing; Textiles, apparel, and leather
manufacturing;
Functional fluids (closed systems) in: Printing and related
support activities)
Incorporation into Article
(Plasticizers in: Adhesives manufacturing; Plastics product
manufacturing: Rubber product manufacturing)
Repackaging
-K>
INDUSTRIAL, COMMERCIAL, CONSUMER USES RELEASES AND WASTE DISPOSAL
		
Adhesives and sealants i.
Arts, crafts, and hobbv materials 2
Cleaning and furnishings care products 1.2
Fabric,textile,and leather products not covered elsewhere 2
Floor coverings 1
Furniture and furnishings not covered elsewhere 1,2
Inks, toner, and colorant products 1
Paints and coatings 1.2
Plastic and rubber products uot covered elsewhere 1,2
Miscellaneous uses 1,2
e.g.. Solvent in non-incorporative activities; Laboratory supply; Explosive
materials; Toys, playground, and sporting equipment: ...
Disposal
Recycling
See Conceptual Model for
Environmental Releases and
Wastes
Manufacture
(including import)
Processing
Uses
1.	Industrial and/or Commercial
2.	Consumer
Figure 2-7 Dibutyl 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.
24

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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 dibutyl 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 potentially exposed or
susceptible subpopulations, and environmental receptors. EPA will take into account, where relevant,
the duration, intensity (concentration), frequency and number of exposures in characterizing exposures
to dibutyl phthalate.
2.3.1	Physical and Chemical (P-Chem) 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 p-chem properties described in the
Proposed Designation of Dibutyl Phthalate (CASRN 84-74-2) as a High-Priority Substance for Risk
Evaluation (U.S. EPA, 2019a) to support the development of the risk evaluation for dibutyl phthalate
(Appendix B). The values for the p-chem properties 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 dibutyl phthalate. EPA plans to use the environmental fate characteristics described in the
Proposed Designation of Dibutyl Phthalate (CASRN 84-74-2) as a Hish-Priority Substance for Risk
Evaluation (U.S. EPA, 2019a) to support the development of the risk evaluation for dibutyl phthalate
(0). The values for the environmental fate properties 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.
A source of information that EPA plans to consider in evaluating exposure are data reported to the
Toxics Release Inventory (TRI) program. EPA's TRI database contains information on chemical waste
management activities that are reported to EPA by industrial and federal facilities, including quantities
released into the environment (i.e., to air, water, and disposed of to land), treated, burned for energy,
recycled, or transferred off-site to other facilities for these purposes.
Under the Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA)
dibutyl phthalate is a TRI-reportable substance effective January 1, 1987 (40 CFR 372.65). For TRI
reporting,4 facilities in covered sectors in the United States are required to disclose release and other
waste management activity quantities of dibutyl phthalate under the CASRN 84-74-2 if they
manufacture (including import) or process more than 25,000 pounds or otherwise use more than 10,000
pounds of the chemical in a given year by July 1 of the following year.
4 For TRI reporting criteria see https://www.epa.gOY/toxics-release-iiiventorv-tri-program/basics-tri-reporling
25

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Table 2-3 provides production-related waste management data for dibutyl phthalate reported by facilities
to the TRI program for reporting year 2018.5 As shown in the table, 61 facilities reported a total of
nearly 1.5 million pounds of dibutyl phthalate production-related waste managed in 2018. Of this total,
808,417 pounds were treated (primarily on site) and accounted for slightly more than half of the total
quantity of the chemical managed as waste during 2018. Quantities released or otherwise disposed of to
the environment (351,282 pounds) and used for energy recovery (313,219 pounds) accounted for most
of the remainder of the total waste quantity managed. A small portion (less than 1%) of the total quantity
of dibutyl phthalate managed as waste was recycled off site.
Table 2-3 Summary of Dibutyl Phthalate TRI Production-related Waste Managed in 2011
Year
Number
of
l-'acilities
Recycled
(lbs)
Recovered
for
Knergv
(lbs)"
Treated
(lbs)
Released"1"
(lbs)
Total
Product ion
Related Waste
(lbs)

2018
61
11,096
313,219
808,417
351,282
1,484,014
Data source: 2018 TRI Data (Updated November 2019)
3 Terminology used in these columns may not match the more detailed data element names used in the TRI public data and analysis access points.
b Does not include releases due to one-time event not associated with production such as remedial actions or earthquakes.
c Counts all releases including release quantities transferred and release quantities disposed of by a receiving facility reporting to TRI.
Table 2-4 provides a summary of the quantities of dibutyl phthalate reported as released to the
environment during 2018.2 The vast majority (approximately 92%) of dibutyl phthalate released to the
environment was disposed of to land, totaling 306,655 pounds. Of this amount, "all other land disposal"
accounted for nearly 64%, which was comprised of off-site disposal to landfills (146,062 pounds) other
than RCRA Subtitle C landfills, or by other on-site land disposal methods such as placement in waste
piles, spills, or leaks (49,441 pounds). The remaining 36% of total land disposal included disposal to on-
site RCRA Subtitle C landfills and disposal to on-site Class I underground injection wells. There were
zero pounds of dibutyl phthalate reported as released to water via surface water discharges, and a total of
23,850 pounds were released to air as fugitive and stack emissions.
Table 2-4 Summary of Releases of Dibutyl Phthalate to the Environment During 2018
Year

Air Releases

Land Disposal


Year
Nil in her
ol'
l-'aeilities
Slack Aii-
Releases
(lbs)
l"iiiii(i\e
Aii-
Releases
(ll)S)
Water
Releases
llllS)
(lass 1
I nder-
li round
Injection
tills)
RCRA
Subtitle
<
Landfills
(ll)S)
All other
Land
Disposal''
(ll)S)
Other
Releases '
llllS)
Total
Releases 1,1
llllS)
2018
61
16,095
7,754
0
53,330
57,822
195,503
1,261
331,766
23,850
306,655
Data source: 2018 TRI Data (Updated November 2019)
* Terminology used in these columns may not match the more detailed data element names used in the TRI public data and analysis access points.
b These release quantities include releases due to one-time events not associated with production such as remedial actions or earthquakes.
c Counts release quantities once at final disposition, accounting for transfers to other TRI reporting facilities that ultimately dispose of the chemical waste.
5 Reporting year 2018 is the most recent TRI data available. Data presented in Table 2-3 were queried using TRI Explorer
and uses the 2018 National Analysis data set (released to the public in November 2019). This dataset includes revisions for
the years 1988 to 2018 processed by EPA.
26

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The total production-related waste managed quantity shown in Table 2-3 does not include any quantities
reported as catastrophic or one-time releases. It does include quantities transferred off site to receiving
facilities for release or disposal and these same quantities are included in the aggregate as on-site
releases by the receiving facilities. This is referred to as "double counting", because the quantities are
counted twice. That is, when a facility transfers a quantity of a chemical off site for disposal to another
facility, the facility reports the quantity as transferred off site for disposal and, if the receiving facilities
are subject to the TRI reporting requirements, they would report these same quantities as disposed of on
site, and these same quantities would be included in the total release aggregate. This is referred to as
"double counting" because the quantities are counted twice. This is done because total production-
related waste values in the TRI database considers all instances of where and how the waste is managed
(first as a quantity sent off site for disposal and next as a quantity disposed of on-site), and reflects both
the off-site transfer and the on-site disposal quantities, as represented in Table 2-3. However, the TRI
program recognizes that this is the same quantity of the chemical and therefore included it only once in
the total release aggregation in Table 2-4. As a result, the total release quantities shown in the two tables
differ slightly.
EPA plans to review these data in conducting the exposure assessment component of the risk evaluation
for dibutyl phthalate.
2.3.4	Environmental Exposures
The manufacturing, processing, distribution, use and disposal of dibutyl 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 reasonably available information on environmental
exposures in biota to inform the development of the environmental exposure assessment for dibutyl
phthalate.
Monitoring data were identified in EPA's data search for dibutyl phthalate and can be used in the
exposure assessment. Relevant and reliable monitoring studies provide(s) information that can be used
in an exposure assessment. Monitoring studies that measure environmental concentrations or
concentrations of chemical substances in biota provide evidence of exposure. Monitoring data shows
that dibutyl phthalate has been detected in air, surface water and groundwater, sediment, biota, sewage
sludge and waste effluents (Environment Canada. 1994; ECB. 2004; ML) I JO J J, i . I' ^ i' 0; U.S.
Fi'A :00/; I S \ \' v 2018b; ICES. 2 v> t , I % % i *, \ \ \ /\L, I ^ n t'>VU; USGS. i 991 e;
If). Environmental biomonitoring data were identified in EPA's data search for dibutyl
phthalate (MDI 2002; ICES 2018; USGS 1991e). 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 (manufacturing, processing, and industrial/commercial uses) described in Section
2.2.1. In addition, EPA plan to analyze exposure to ONUs, workers, who do not directly handle the
chemical but perform work in an area where the chemical is present, depending on reasonably available
information. EPA also expects to consider the effect(s) that engineering controls (EC) and/or personal
protective equipment (PPE) have on occupational exposure levels as part of the draft risk evaluation.
Worker activities associated with the conditions of use within the scope of the risk evaluation for dibutyl
phthalate will be analyzed, including, but not limited to:
27

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	Unloading and transferring dibutyl phthalate to and from storage containers to process vessels;
	Handling, transporting and disposing of waste containing dibutyl phthalate;
	Cleaning and maintaining equipment;
	Sampling chemicals, formulations or products containing dibutyl phthalate for quality control;
	Repackaging chemicals, formulations or products containing dibutyl phthalate.
Dibutyl phthalate is a liquid at room temperature and has a vapor pressure of 2.01 x 10"5 mm Hg at 25 C
(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
dibutyl phthalate is applied via spray or roll application methods or is handled as a dry powder or at
elevated temperatures.
Dibutyl phthalate has an Occupational Safety and Health Administration (OSHA) permissible exposure
limit (PEL) (OS 09). The PEL is 5 milligrams per cubic meter (mg/m3) over an 8-hour workday,
time weighted average (TWA). National Institute for Occupational Safety and Health (NIOSH) has set
the Recommended Exposure Limit (REL) at 5 mg/m3 TWA and the Immediately Dangerous to Life or
Health Concentration (1DLH) at 4000 mg/m3 (NIOSH. 2005). The American Conference of
Governmental Industrial Hygienists (ACGIH) set the threshold limit value (TLV) at 5 mg/m3 TWA.
Based on the conditions of use, EPA plans to analyze worker exposure to liquids and/or solids via the
dermal route. EPA does not plan to analyze dermal exposure for ONUs because they do not directly
handle dibutyl 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 dibutyl phthalate.
2.3.6 Consumer Exposures
CDR reporting and conversations with industry indicate the presence of dibutyl phthalate in a number of
consumer products and articles including: Adhesives and Sealants; Arts, Crafts, and Hobby Materials;
Building/Construction Materials not Covered Elsewhere; Cleaning and Furnishing Care Products;
Electrical and Electronic Products; Fabric, Textile, and Leather Products not Covered Elsewhere; Floor
Coverings; Furniture and Furnishings not Covered Elsewhere; Paints and Coatings; Plastic and Rubber
Products not Covered Elsewhere; and Toys, Playground, and Sporting Equipment (See Section 2.6.2 and
Figure 2-9). These uses can result in exposures to consumers and bystanders (non-product users that are
incidentally exposed to the product).
Based on reasonably available known consumer conditions of use, inhalation of dibutyl phthalate is
possible through either inhalation of vapor/mist during product usage or indoor air/dust. Oral exposure
of dibutyl phthalate is possible through either ingestion through product use via transfer from hand to
mouth or via through mouthing of articles containing dibutyl phthalate. Dermal exposure may occur via
contact with vapor or mist deposition onto the skin, via direct liquid contact during use, or direct dermal
28

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contact of articles containing dibutyl 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 dibutyl phthalate.
2.3,7 General Population Exposures
Releases of dibutyl phthalate from certain conditions of use, such as manufacturing, processing, or
disposal activities, may result in general population exposures. The general population may be exposed
to dibutyl phthalate from contaminated air, water, and some foods (ATSDR. 2001; CPSC. 2010). Air is
likely the main source of exposure for the general population, but some exposure may come from
consumption of dairy products, fish, and seafood (ATSDR, 2001). The major source of dietary dibutyl
phthalate intake is from consumption of fish (ECB, 2004). Monitoring data shows that dibutyl phthalate
has been detected in air, surface water and groundwater, sediment, biota, sewage sludge and waste
effluents (Environment Canada. 1994; ECB. 2004; MP I 2002; I S ! v l'^0; I . _00"; I S
EPA. 2018b; ICES. 20i8; IJSGS. 199la; IJSGS.. 1991c; USGS. 199Id; USGS. 199le; IJSGS. 199if).
EPA plans to review the reasonably available information for the presence of dibutyl phthalate in the
environmental media relevant to general population exposure.
Environmental and human biomonitoring data were identified in EPA's data search for dibutyl phthalate
(Mill -002; ICES 2018; US* SS i'j9 !:>). The general population's daily exposure to dibutyl phthalate is
estimated to be less than 10 jag/kg/d (CPSC. 2010). Biomonitoring studies measuring dibutyl phthalate
from the urine of children, school teachers, and parents indicate that the primary metabolite for dibutyl
phthalate was higher in the children when compared with the adults (CPSC. 2010). Dibutyl phthalate has
also been detected in human breastmilk (ECB. 2004). Modeling for estimated exposures in women,
infants, toddlers, and children is also available (CPSC. 2014) as are models using the NHANES
2005/2006 exposure estimates (CPSC. 2015). EPA plans to review reasonably available human
biomonitoring data in the risk evaluation.
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2.4 Hazards (Effects)
2.4.1	Environmental Hazards
As described in the Proposed Designation of Dibutyl Phthalate (CASRN 84-74-2) 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 dibutyl
phthalate. EPA considers all the potential environmental hazards for dibutyl 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 dibutyl phthalate. If necessary, EPA plans to update the list of
potential hazards in the final scope document of dibutyl 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 Dibutyl Phthalate (CASRN 84-74-2) 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 dibutyl
phthalate. EPA evaluated all of the potential human health hazards for dibutyl phthalate identified
during prioritization. The health effect categories identified during prioritization included reproductive
toxicity, developmental toxicity, neurotoxicity, genetic toxicity, dermal sensitization, respiratory
sensitization, toxicokinetics, and irritation/corrosion, epidemiology or biomonitoring findings and
ADME. 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 dibutyl 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 United States general population (U.S. EPA. 201 la).
During the Prioritization process, EPA identified the following potentially exposed or susceptible
subpopulations based on CDR information and studies reporting developmental and reproductive
effects: children, women of reproductive age (e.g., 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 data to ascertain whether
some human receptor groups may be exposed via exposure pathways that may be distinct to a particular
subpopulation or life stage (e.g., children's crawling, mouthing or hand-to-mouth behaviors) and
whether some human receptor groups may have higher exposure via identified pathways of exposure
due to unique characteristics (e.g., activities, duration or location of exposure) when compared with the
30

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general population (U.S. EPA. 2006a). Likewise, EPA plans to evaluate reasonably available human
health hazard information to ascertain whether some human receptor groups may have greater
susceptibility than the general population to the chemical's hazard(s).
2.6 Conceptual Models
In this section, EPA presents the conceptual models describing the identified exposures (pathways and
routes), receptors and hazards associated with the conditions of use of dibutyl 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 dibutyl phthalate that EPA plans to include in the risk evaluation. There is potential
for exposures to workers and/or ONU's 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
, an initial determination was made as to whether or not EPA plans to assess each combination of
exposure pathway, route, and receptor will be analyzed in the risk evaluation. The supporting rationale
are presented in Appendix F.
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INDUSTRIAL AND COMMERCIAL
ACTIVITIES / USES
EXPOSURE PATHWAY	EXPOSURE ROUTE	RECEPTORS	HAZARDS
Pf Liquid'
('Solid Contact
Dermal
Processing
-As i 'xrt r -"t
-I ic>npoiaTi"!i into formulation, mixture,
article
Yixv Nhsi Dii1-
Adhesives and sealants
Fugitive Emissions
Cleaning and furnishings care
products
Fabric, textile, and leather products
not co\ ercd elsewhere
Floor coverings
Furniture and furnishings not covered
elsewhere
Inks, toner, and colorant products
Paints and coatings
Plastic and rubber products not
covered elsewhere
Miscellaneous uses
Waste Handling.
Treatment, and
Disposal
??; Liquid Hi)
Figure 2-8 Dibutyl 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 dibutyl
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 dibutyl phthalate. EPA expects that consumers
may be exposed through use of products or articles containing dibutyl 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 evaluate pathways and routes of exposure that may occur during the
varied identified consumer activities and uses. The supporting rationale for consumer pathways
considered for dibutyl phthalate are included in Appendix G.
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CONSUMER ACTIVITIES &
USES
EXP0SI ?RE
PATHWAY
EXPOSURE
ROUTE
RECEPTORS
kRIR LL
U\ ll< M' l, > uVi M
>M t mcici! K
Hu'iiai
P ui it i! iv Pi Jacis
i 1  (
v klM lOli 1 -1 1
J i-'f sr.:
^< !fd
11\ una- \ miHvnujg
* tqm\m
rROUl ( F
k3>

A till
Wastejs IS
! .Ml. itK' A ''cease
el
Faisals arid Coatings
v.o i^iin v't i! <>e<{
1> m. i!,1U
Figure 2-9 Dibutyl 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 dibutyl phthalate.
34

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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 dibutyl 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 dibutyl 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 dibutyl 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 2.6.3.3.
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RELEASES AND WASTES FROM
INDUSTRIAL/COMMERCIAL/	EXPOSURE PATHWAYS	EXPOSURE	RECEPTORS	HAZARDS
CONSUMER USES	ROUTES
CWA-AWQC
Industrial Pre-
Treatment or
Industrial WWT
~ Water. Sediment
Indirect discharge
Fish Ingestion-
Wastewater or
Liquid Wastes
RCRA-HazList
Oral
Underground
Injection
Drinking
Water
Hazards Potentially
Associated with
Acute and'or Chronic
Exposures
Land
Disposal
General
Population
Dermal
Soil
Solid Wastes
Hazardous and
Municipal Waste
Incinerators
CAA-HAP
Liquid Wastes
Inhalation
Fugitive Emissions
Off-site Waste
Transfer
Air
Terrestrial
Species
Emissions to Air 	
Figure 2-10 Dibutyl 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 receptors from releases and wastes from industrial, commercial and
consumer uses of dibutyl phthalate showing the regulatory laws that adequately assess and manage 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 form 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.
36

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2.6.3.1	Ambient Air Pathway
The Clean Air Act (CAA) contains a list of hazardous air pollutants (HAP) and provides EPA with the
authority to add to that list pollutants that present, or may present, a threat of adverse human health
effects or adverse environmental effects. For stationary source categories emitting HAP, the CAA
requires issuance of technology-based standards and, if necessary, additions or revisions to address
developments in practices, processes, and control technologies, and to ensure the standards adequately
protect public health and the environment. The CAA thereby provides EPA with comprehensive
authority to regulate emissions to ambient air of any hazardous air pollutant.
Dibutyl phthalate is a HAP. EPA has issued a number of technology-based standards for source
categories that emit dibutyl phthalate to ambient air and, as appropriate, has reviewed, or is in the
process of reviewing remaining risks.
Emission pathways to ambient air from commercial and industrial stationary sources and associated
inhalation exposure of the general population or terrestrial species in this TSCA evaluation from
stationary source releases of dibutyl phthalate to ambient air are covered under the jurisdiction of the
CAA. EPA's Office of Air and Radiation and Office of Pollution Prevention and Toxics will continue to
work together to provide an understanding and analysis of the CAA regulatory analytical processes and
to exchange information related to toxicity and occurrence data on chemicals undergoing risk evaluation
under TSCA.
2.6.3.2	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 dibutyl phthalate which are
available for possible adoption into state water quality standards and are available for possible use by
National Pollutant Discharge Elimination System (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 dibutyl 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 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 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 dibutyl phthalate, so there are no national recommended criteria for this use available for
37

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adoption into state water quality standards and available for use in NPDES permits. EPA may issue
CWA Section 304(a) aquatic life criteria for dibutyl phthalate in the future if it is identified as a priority
under the CWA.
2.6.3.3 Disposal and Soil Pathways
Dibutyl phthalate is included on the list of hazardous wastes pursuant to RCRA 3001 (40 CFR 
261.33) as a listed waste on the U069 list. The general standard in RCRA Section 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 SDWA).
Emissions to ambient air from municipal and industrial waste incineration and energy recovery units that
form combustion by-products from incineration treatment of dibutyl phthalate wastes may be subject to
regulations, as would dibutyl phthalate burned for energy recovery.
TRI reporting in 2018 indicated 53,330 pounds released to underground injection to a Class I wells.
Environmental disposal of dibutyl phthalate injected into Class I hazardous well types fall under the
jurisdiction of RCRA and SDWA and disposal of dibutyl phthalate via underground injection is not
likely to result in environmental and general population exposures.
EPA has identified releases to land that go to RCRA Subtitle C hazardous waste landfills in the risk
evaluation. Based on 2018 reporting, TRI land disposal of dibutyl phthalate includes Subtitle C landfills
(57,822 pounds identified in Table 2-3) and 195,503 pounds released to "other landfills" both on-site
and off-site. Dibutyl phthalate is present in commercial and consumer products that 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.
Dibutyl phthalate is present in commercial and consumer products that may be disposed of in Municipal
Solid Waste (MSW) landfills. On-site releases RCRA Subtitle D municipal solid waste landfills leading
to exposures of the general population (including susceptible populations) or terrestrial species from
such releases may occur based on current TRI releases for dibutyl phthalate. While permitted and
38

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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 dibutyl 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 dibutyl 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 dibutyl 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, that may lead to
exposure to aquatic and terrestrial receptors, and to the general population via drinking water. The
supporting basis for environmental pathways considered for dibutyl phthalate are included in Appendix
H.
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RELEASES AND W ASTES FROM
INDUSTRIAL / COMMERCIAL /
CONSUMER USES
EXPOSURE PATHWAYS
EXPOSURE
ROUTES
RECEPTORS
HAZARDS
Wastewater or
Liquid Wastes
Industrial Pre-
Trealment or
Industrial WWT


1
Indirect discharge
*
POTW



 Water, Sediment
Biosolids^^
Land
Disposal
Aquatic
Species
Drinking
Water
Soil	~
Ground
Water
CAA
RCRA
SDWA
CWA
Dermal
General
Population
Inhalation
Hazards Potentially
Associated with
Acute and/or Chronic
Exposures
I errcstna
Species
Figure 2-11 Dibutyl 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 dibutyl 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).
40

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2.7 Analysis Plan
The analysis plan is based on EPA's knowledge of dibutyl 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 potentially
exposed or susceptible subpopulations 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 reasonably available, EPA may update its analysis plan in the final scope document.
2.7.1	P-Chem Properties and Environmental Fate
EPA plans to analyze the p-chem properties and environmental fate and transport of dibutyl phthalate as
follows:
1)	Review reasonably available measured or estimated p-chem and environmental fate
endpoint data collected using systematic review procedures and, where reasonably
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 (0), some of
which appeared in the Proposed Designation of Dibutyl Phthalate (CASRN S	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.
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 dibutyl 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-the-scientific-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, surface water, sediment, soil, aquatic biota, and
terrestrial biota associated with exposure to dibutyl phthalate. EPA has not yet determined the exposure
41

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levels in these media or how they may be used in the risk evaluation. Exposure scenarios are 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 reasonably
available monitoring data and modeling approaches.
2.7.2.1 Environmental Releases
EPA plans to analyze releases to environmental media as follows:
1) Review reasonably available published literature and other reasonably available
information on processes and activities associated with the conditions of use to analyze the
types of releases and wastes generated.
EPA has reviewed some key data sources containing information on processes and activities
resulting in releases, and the information found is described in Appendix E. EPA plans to
continue to review data sources 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 2-5 below:
Table 2-5 Categories and Sources of Environmental Release Data	
U.S. EPA TRI Data	
U.S. EPA Generic Scenarios	
OECD Emission Scenario Documents	
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 has reviewed key release data sources including the Toxics Release Inventory (TRI), and
the data from this source is summarized in Section 2.3.3. EPA plans to continue to review
relevant data sources during risk evaluation. EPA plans to match identified data to applicable
conditions of use and identify data gaps where no data are found for particular conditions of use.
EPA plans to 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 reasonably available,
EPA may use a variety of methods including release estimation approaches and assumptions in
the Chemical Screening Tool for Occupational Exposures and Releases Ch em STEER (U.S. EPA.
2013).
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 dibutyl phthalate.
4)
Review reasonably available data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation.
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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
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 Formulations, the 2011 ESP on. Coating Application via Spray-Painting in. the
Automotive Refinishing Industry, the 2.011 ESP on. Chemical Industry, the 2 1) on
Radiation Curable Coating. Inks and Adhesives. the 2015 ESP on the Use of Adhesives. and the
2i D on Plastic Additives may be useful to assess potential releases. EPA plans to critically
review these generic scenarios and ESDs 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-an.d-fate-un.der-tsca#fate.
OECD Emission Scenario Documents are available at the following:
http://www.oecd.org/chemicalsafety/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 ESDs 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 dibutyl phthalate and polymer products and formulations containing
dibutyl 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.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation that
EPA plans to publish prior to finalizing the scope document. The data integration strategy will be
designed to be fit-for-purpose in which EPA plans to use systematic review methods to assemble
the relevant data, evaluate the data for quality and relevance, including strengths and limitations,
followed by synthesis and integration of the evidence.
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2.7.2.2 Environmental Exposures
EPA plans to analyze the following in developing its environmental exposure assessment of dibutyl
phthalate:
1)	Review reasonably available environmental and biological monitoring data for all media
relevant to environmental exposure.
For dibutyl phthalate, environmental media which will be analyzed 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 reasonably 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 will include the
following inputs: direct release into water, sediment, or soil, indirect release into 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 dibutyl 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 dibutyl 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 reasonably 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 reasonably available, and
characterize exposed aquatic and terrestrial populations.
Weight of the scientific evidence of environmental occurrence data and modeled
estimates.
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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:
1)	Review reasonably available exposure monitoring data for specific condition(s) of use.
EPA plans to review exposure data including workplace monitoring data collected by
government agencies such as OSHA and NIOSH, and monitoring data found in published
literature. These workplace monitoring data include personal exposure monitoring data (direct
exposures) and area monitoring data (indirect exposures).
EPA has preliminarily reviewed reasonably available monitoring data collected by OSHA and
NIOSH and will match these data to applicable conditions of use. EPA has also identified
additional data sources that may contain relevant monitoring data for the various conditions of
use. EPA plans to review these sources (identified in Table 2-6) and extract relevant data for
consideration and analysis during risk evaluation.
OSHA has established a PEL of 5 mg/m3, 8-hour TWA. The NIOSH REL for dibutyl phthalate is
also 5 mg/m3. EPA plans to consider the influence of these regulatory limits and recommended
exposure guidelines on occupational exposures in the occupational exposure assessment.
Table 2-6 Potential Sources of Occupational Exposure Data	
U.S. OSHA Chemical Exposure Health Data (CEHD) program data	
U.S. NIOSH Health Hazard Evaluation (HHE) Program reports	
2)	Review reasonably available exposure data for surrogate chemicals that have uses,
volatility and chemical and physical properties similar to dibutyl 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 dibutyl phthalate may serve as surrogates for dibutyl
phthalate.
3)	For conditions of use where data are limited or not reasonably 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 2 D on the Use of Adhesives and the 2009 ESP on
Plastic Additives, the are some of the ESDs and GS's that EPA may use to estimate occupational
exposures. EPA plans 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.
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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 or other government agencies, or reasonably 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 ONU's.
5)	Consider and incorporate applicable EC and/or PPE into exposure scenarios.
EPA plans to review potentially relevant data sources on EC 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 EC, using reasonably available
information on available control technologies and control effectiveness. For example, EPA may
assess worker exposure in industrial use scenarios before and after implementation of local
exhaust ventilation.
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 Table Apx F-l, EPA has grouped the scenarios into
representative release/exposure scenarios. EPA was not able to identify 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/grouping of occupational exposure scenarios based on factors (e.g., process
equipment and handling, magnitude of production volume used, and exposure/release sources)
corresponding to conditions of use as additional information is identified during risk evaluation.
7)	Evaluate the weight of the scientific evidence of occupational exposure data, which may
include qualitative and quantitative sources of information.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation that
EPA plans to publish prior to finalizing the scope document. EPA plans to rely on the weight of
the scientific evidence when evaluating and integrating occupational data. The data integration
strategy will be designed to be fit-for-purpose in which EPA plans to use systematic review
methods to assemble the relevant data, evaluate the data for quality and relevance, including
strengths and limitations, followed by synthesis and integration of the evidence.
2.7.2.4 Consumer Exposures
EPA plans to analyze both consumers using a consumer product and bystanders associated with the
consumer using the product as follows:
1) Group each condition of use to consumer exposure assessment scenario(s).
EPA plans to refine and finalize exposure scenarios for consumers by considering combinations
of sources (ongoing consumer uses), exposure pathways including routes, and exposed
populations.
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For dibutyl 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 reasonably available
data.
Indoor exposure pathways expected to be relatively higher include inhalation of vapors from
indoor air during dibutyl 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 reasonably available.
3)	Review existing indoor exposure models that may be applicable in estimating indoor air.
Indoor exposure models that estimate emission and migration of semi-volatile organic
compounds (SVOCs) into the indoor environment are reasonably available. These models
generally consider mass transfer as informed by the gas-phase mass transfer coefficient, the
solid-phase diffusion coefficient, and the material-air partition coefficient. These properties vary
based on p-chem properties and properties of the material. The OPPT's Indoor Environmental
Concentrations in Buildings with Conditioned and Unconditioned Zones (IECCU) model and
other similar models can be used to estimate indoor air and dust exposures from indoor sources.
4)	Review reasonably available empirical data that may be used in developing, adapting or
applying exposure models to a particular risk evaluation scenario. For example, existing
models developed for a chemical assessment may be applicable to another chemical
assessment if model parameter data are reasonably available.
To the extent other organizations have already modeled a dibutyl 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 dibutyl 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
dibutyl phthalate in specific media (e.g., indoor air).
The availability of dibutyl 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 potentially exposed or susceptible subpopulations need to
be further refined.
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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 dibutyl 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 reasonably 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 reasonably available.
Review reasonably available information on releases to determine how modeled
estimates of concentrations near industrial point sources compare with reasonably
available monitoring data.
Review reasonably available population- or subpopulation-specific exposure factors and
activity patterns to determine if potentially exposed or susceptible subpopulations need
be further defined.
Evaluate the weight of the scientific evidence of general population exposure data.
Map or group each condition of use to general population exposure assessment
scenario(s).
EPA plans to evaluate a variety of data types to determine which types are most appropriate
when quantifying exposure scenarios. Environmental monitoring data, biomonitoring data,
modeled estimates, experimental data, epidemiological data, and survey-based data can all be
used to quantify exposure scenarios. In an effort to associate exposure estimates with sources of
exposure and/or conditions of use, EPA plans to consider source apportionment across exposure
scenarios during risk evaluation. EPA anticipates that there will be a wide range in the relative
exposure potential of the exposure scenarios identified in Appendix F. Source apportionment
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characterizes the relative contribution of any of the following: a use/source toward a total media
concentration, a media concentration toward a total exposure route, or an exposure route toward
a total external or internal dose. This consideration may be qualitative, semi-quantitative, or
quantitative, and is dependent upon reasonably available data and approaches. For example, EPA
may consider the co-location of TSCA industrial facilities with reasonably available monitoring
data or modeled estimates. EPA may compare modeled estimates for discrete outdoor and indoor
sources/uses that apply to unique receptor groups.
After refining and finalizing exposure scenarios, EPA plans to quantify concentrations and/or
doses for these scenarios. The number of scenarios will depend on how combinations of uses,
exposure pathways, and receptors are characterized. The number of scenarios is also dependent
upon the reasonably available data and approaches to quantify scenarios. When quantifying
exposure scenarios, EPA plans to use a tiered approach. First-tier analysis is based on data that is
reasonably available without a significant number of additional inputs or assumptions, and may
be qualitative, semi-quantitative, or quantitative. The results of first tier analyses inform whether
scenarios require more refined analysis. Refined analyses will be iterative and require careful
consideration of variability and uncertainty. Should data become reasonably 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 reasonably available, review existing
exposure models that may be applicable in estimating exposure levels.
For dibutyl phthalate, media where exposure models will be considered for general population
exposure include models that estimate, surface water concentrations, groundwater
concentrations, sediment concentrations, soil concentrations, and uptake from aquatic and
terrestrial environments into edible aquatic and terrestrial organisms.
3)	Review reasonably available exposure modeled estimates. For example, existing models
developed for a previous dibutyl phthalate chemical assessment may be applicable to
EPA's assessment. In addition, another chemical's assessment may also be applicable if
model parameter data are reasonably available.
To the extent other organizations have already modeled dibutyl 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 reasonably 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 reasonably available
monitoring data.
The expected releases from industrial facilities are changing over time. Any modeled
concentrations based on recent release estimates will be carefully compared with reasonably
available monitoring data to determine representativeness.
5)	Review reasonably available information about population- or subpopulation-specific
exposure factors and activity patterns to determine if potentially exposed or susceptible
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subpopulations need to be further defined (e.g., early life and/or puberty as a potential
critical window of exposure).
For dibutyl phthalate, exposure scenarios that involve potentially exposed or susceptible
subpopulations 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 dibutyl 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 dibutyl phthalate to aquatic and/or terrestrial organisms,
including plants, invertebrates (e.g., insects, arachnids, mollusks, crustaceans, etc.), and
vertebrates (e.g., mammals, birds, amphibians, fish, reptiles, etc.) across exposure durations and
conditions if potential environmental hazards are identified through public comments and the
results of the systematic search and screening of the literature. Additional types of environmental
hazard information will also be considered (i.e., analogue and read-across data) when
characterizing the potential hazards of dibutyl 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.
Relative to appropriate exposure durations, suitable environmental hazard data will be reviewed;
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, etc.) may be derived
and used to further understand the hazard characteristics of dibutyl phthalate to aquatic and/or
terrestrial species. Identified environmental hazard thresholds may be used to derived
concentrations of concern (COC), based on endpoints determined to be detrimental to
environmental populations.
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3)	Evaluate the weight of the scientific evidence of environmental hazard data.
During risk evaluation, EPA plans to evaluate and integrate the environmental hazard evidence
identified in the literature inventory using the methods described in the systematic review
documentation that EPA plans to publish prior to finalizing the scope document.
4)	Consider the route(s) of exposure, based on reasonably available monitoring and modeling
data and other reasonably available approaches to integrate exposure and hazard
assessments.
EPA plans to consider the aquatic (e.g., water and sediment exposures) and terrestrial pathways
in the dibutyl phthalate conceptual model. These organisms may be exposed to dibutyl phthalate
via a number of environmental pathways (i.e., surface water, sediment, soil, air).
5)	Conduct an environmental risk characterization of dibutyl phthalate.
EPA plans to conduct a risk characterization of dibutyl phthalate to determine whether there are
risks to the aquatic and/or terrestrial environments from the measured and/or predicted
concentrations of dibutyl phthalate in environmental media (i.e., water, sediment, soil). The data
for environmental monitoring and toxicity will be used in this risk assessment to determine
whether exposure to dibutyl phthalate poses risk for adverse effects in aquatic and/or terrestrial
organisms. Environmental risk will be characterized by calculating risk quotients (RQs) (
EPA. 1998; Bamtfaouse et at.. 1982). The RQs will be derived from hazard benchmarks.
6)	Consider a Persistent, Bioaccumulative, and Toxic (PBT) Assessment of dibutyl phthalate.
EPA plans to consider the persistence, bioaccumulation, and toxic (PBT) potential of dibutyl
phthalate after reviewing relevant p-chem properties and exposure pathways. EPA plans to
assess the reasonably available studies identified in the systematic review process relating to
bioaccumulation and bioconcentration (BAF/BCF) of dibutyl 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 dibutyl 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 dibutyl phthalate. EPA plans to publish the systematic review documentation prior
to finalizing the scope document.
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.
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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.
2012a. 2<' n h, *I). Dose-response analyses may be used if the data meet data quality criteria
and if additional information on the identified hazard endpoints are not reasonably 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 dibutyl 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 (U.S. EPA. 2005).
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 dibutyl
phthalate hazard(s). Susceptibility of particular human receptor groups to dibutyl 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 dibutyl 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-
response relationships in the range of the observed data consistent with EPA's Benchmark Dose
Technical Guidance Document. Where dose-response modeling is not feasible, NOAELs or
LOAELs will be identified. Non-quantitative data will also be evaluated for contribution to
weight of the scientific evidence or for evaluation of qualitative endpoints that are not
appropriate for dose-response assessment.
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EPA plans to evaluate whether the reasonably 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 (2011), and inhalation PODs may be adjusted by exposure duration and chemical
properties in accordance with U.S. EPA. (1994).
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 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 dibutyl
phthalate, which could be important for worker, consumer, and general population risk analysis.
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 reasonably 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.	00). As defined in EPA's Risk Characterization Policy, "the
risk characterization integrates information from the preceding components of the risk evaluation and
synthesizes an overall conclusion about risk that is complete, informative and useful for decision
makers." Risk characterization is considered to be a conscious and deliberate process to bring all
important considerations about risk, not only the likelihood of the risk but also the strengths and
limitations of the assessment, and a description of how others have assessed the risk into an integrated
picture.
The level of information contained in each risk characterization varies according to the type of
assessment for which the characterization is written. Regardless of the level of complexity or
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information, the risk characterization for TSCA risk evaluations will be prepared in a manner that is
transparent, clear, consistent, and reasonable (	XX)) 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
obligations under TSCA Section 26; for example, by identifying and assessing uncertainty and
variability in each step of the risk evaluation, discussing considerations of data quality such as the
reliability, relevance and whether the methods utilized were reasonable and consistent, explaining any
assumptions used, and discussing information generated from independent peer review.
EPA will also be guided by EPA's Information Quality Guidelines ( 2002) as it provides guidance
for presenting risk information. Consistent with those guidelines, EPA plans to identify in the risk
characterization the following: (1) Each population addressed by an estimate of applicable risk effects;
(2) The expected risk or central estimate of risk for the potentially exposed or susceptible
subpopulations affected; (3) Each appropriate upper-bound or lower-bound estimate of risk; (4) Each
significant uncertainty identified in the process of the assessment of risk effects and the studies that
would assist in 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 Risk Evaluation Rule, the purpose of peer review
is for the independent review of the science underlying the risk assessment. 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 dibutyl phthalate will be peer reviewed.
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ATSDR (Agency for Toxic Substances and Disease Registry). (2001). Toxicological profile for di-b-
butyl phthalate. Atlanta, GA: U.S. Department of Health and Human Services, Public Health Service,
Agency for Toxic Substances and Disease Registry. https://www.atsdr.cdc.gov/ToxProfiles/cp 135.pdf
Barnthouse, LW;DeAngelis, DL;Gardner, RH;0'Neill, RV;Suter, GW;Vaughan, DS. (1982).
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inadvertent ingestion of hazardous substances at work? Annals of Occupational Hygiene 50 693-704.
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Bethesda, MD: U.S. Consumer Product Safety Commission, Directorate for Hazard Identification and
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ECB (European Chemicals Bureau). (2004). European Union risk assessment report: Dibutyl phthalate
(DBP). Luxembourg: European Union, European Chemicals Bureau, Institute for Health and Consumer
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Releases of Dibutyl Phthalate (DBP) as well as Information on Potential Alternatives to Its Use.
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Ellington, JJ; Floyd, TL. (1996). Octanol/water partition coefficients for eight phthalate esters.
(EPA600S96006). Cincinnati, OH: National Exposure Research Laboratory.
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84-74-2. HERO ID: 5926413
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Howard, PH; Banerjee, S; Robillard, KH. (1985). Measurement of water solubilities octanol-water
partition coefficients and vapor pressures of commercial phthalate esters. Environmental Toxicology and
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from http://www.ices.dk/marine-data/data-portals/Pages/DOME.aspx
Ishak, H; Stephan, J; Karam, R; Goutaudier, C; Mokbel, I; Saliba, C; Saab, J. (2016). Aqueous
solubility, vapor pressure and octanol-water partition coefficient of two phthalate isomers dibutyl
phthalate and di-isobutyl phthalate contaminants of recycled food packages. Fluid Phase Equilibria 427:
362-370. http://dx.doi.cnt K> KM5/i.fluid :0i- 0/ OlK HERO ID: 3475635
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John Wiley & Sons, Inc (Ed.), doi: 10.1002/0471238961.0524161212091404.a01.pub3
Mackay, D; Shiu, WY; Ma, KC; Lee, SC. (2006). Dibutyl phthalate. In Handbook of physical-chemical
properties and environmental fate for organic chemicals. Boca Raton, FL: CRC press.
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Retrieved from http://ctdbase.org
National Library of Medicine (NLM). (2015). PubChem: Hazardous Substance Data Bank: Dibutyl
phthalate, 84-74-2. https://pubchem.ncbi.nlm.nih.gov/compound/3026#source=H.SDB. HERO ID:
5926108
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Service Registry Numbers (CAS No.). NIOSH Pocket Guide to Chemical Hazards.
https://www.cdc.gov/niosh/npg/npgdcas.html
NIOSH (National Institute for Occupational Safety and Health). (2010). NIOSH Pocket Guide to
Chemical Hazards (pp. 184). Cincinnati, Ohio: U.S. Department of Health and Human Services, Centers
for Disease Control & Prevention, https://www.cdc.gov/niosh/npg/
NIOSH. (2017). Cured-In-Place Pipe (CIPP): Inhalation and Dermal Exposure Risks Associated with
Sanitary Sewer. Storm Sewer, and Drinking Water Pipe Repairs. NIOSH Science Blog.
)gs. cdc.gov/niosh~science~blog/2017/09/26/cipp/
NITE (National Institute of Technology and Evaluation). (2019). Japan CHEmicals Collaborative
Knowledge database (J-CHECK). CASRN: 84-74-2. Available online at
https://www.nite. go.ip/chem/icheck/detail.action?cno=84-74-2&mno=3~1303&request local e=en
NLM (National Institutes of Health, National Library of Medicine). (2015). PubChem: Hazardous
Substance Data Bank: Dibutyl phthalate, 84-74-2. Available online at
://pubchem.ncbi.nlm.nih.eov/compound/3026#source=HSDB
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and Adhesives. http://www.oecd-
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ilibrarv.org/docserver/download/9	df?expires=1497031714&id=id&accname=guest&checksu
m=ESB 188BBD13C6D7100D39B8643ABA.020. HERO ID 3840003.
OECD. (2015). Emission Scenario Document on Use of
Adhesives. http://www.oecd.org/officialdocuments/publicdisplavdocumentpdf/?cote=ENV/JM/MONO(
2015 )4& docl an guage=
OECD (Organisation for Economic Co-operation and Development). (2019). Emission Scenario
Documents. http://www.oecd.ore/chemicalsafetv/risk-assessm.ent/em.issionscenariodocuments.htm.
O'Neil, MJ. (2013). Dibutyl phthalate. In MJ O'Neill; PE Heckelman; PH Dobbelaar; KJ Roman; CM
Kenney; LS Karaffa (Eds.), The Merck index (15th ed., pp. 550). Cambridge, UK: Royal Society of
Chemistry.
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https://www.osha.eov/dsg/annotated-pels/tablez-l.html
RSC (Royal Society of Chemistry). (2019). ChemSpider: Dibutyl phthalate. Available online at
http://www.chem.spider.com/Chem.ical-Staictitre. 13837319.html HERO ID: 5926136
Rumble, J. (2018). Dibutyl phthalate CRC Handbook of Chemistry and Physics (99 ed., pp. 3-16). Boca
Raton, FL: CRC Press. Taylor & Francis Group.
Staples, CA; Peterson, DR; Parkerton, TF; Adams, WJ. (1997). The environmental fate of phthalate
esters: A literature review. Chemosphere 35: 667-749.
Synapse Information Resources. (2009). Specialty Chemicals Source Book. Fourth Edition. Volume 1.
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). (1989). Hydrolysis rate constants for enhancing
property-reactivity relationships. (PB 89-220479). Athens, GA: U.S. Environmental Protection Agency.
Office of Research and Development.
U.S. EPA (U.S. Environmental Protection Agency). (1990). EPA Ambient Monitoring Technology
Information Center (AMTIC): Air toxics data [Database], Retrieved from
https://www3. epa. eov/ttnamti 1 /toxdat.html
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.
57

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https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=71993&CFID=51174829&CFTOKEN=2500631
7. HERO ID: 6488
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[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). (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
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). (2006a). A framework for assessing health risk of
environmental exposures to children (pp. 1-145). (EPA/600/R-05/093F). Washington, DC: U.S.
Environmental Protection Agency, Office of Research and Development, National Center for
Environmental Assessment. http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=l58363. HERO ID:
194567
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(EPA DMR) [Database], Retrieved from fattps://cfpub.epa.gov/dm.r/
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Use of Printing Inks. Available to download at: https://www.epa.gov/tsca-screening-tools/chem.steer-
chemical-screening-tool-exposures-and-environmental-releases
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[EPA Report], (EPA/600/R-090/052F). Washington, DC.
http://cfpub.epa.gov/n.cea/cfm/recordisplav.cfm.?deid=2.36252.. HERO ID: 786546
U.S. EPA. (U.S. Environmental Protection Agency). (201 lb). Recommended Use of Body Weight 3/4 as
the Default Method in Derivation of the Oral Reference Dose. (EPA/100/R-l 1/0001). Washington, DC:
U.S. Environmental Protection Agency, Risk Assessment Forum. February.
https://www.epa.gov/sites/prodiiction/files/2013-09/dociiments/recommended-iise-of-bw34.pdfIIERO
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). (2012). Estimation Programs Interface Suite for
Microsoft Windows, v 4.11 [Computer Program], Washington, DC. Retrieved from
https://www.epa.gov/tsca-screening-tools/epi-siiitetm-estimation-program-interfac
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U.S. EPA (U.S. Environmental Protection Agency). (2013). ChemSTEER User Guide Chemical
Screening Tool for Exposures and Environmental
Releases, https://www.epa.gov/sites/production/files/2015-05/documents/user guide.pdf
U.S. EPA (U.S. Environmental Protection Agency) (2017). Chemical Data Reporting (2012 and 2016
Public CDR database). Washington, DC. U.S. Environmental Protection Agency, Office of Pollution
Prevention and Toxics. Retrieved from ChemView: June 2019. https://www.epa.gov/chem.ical-data-
reporting
U.S. EPA (Environmental Protection Agency). (2018a). Application of Systematic Review
in TSCA Risk Evaluations document (EPA Document# 740-P-18-
001). https://nepis. epa.eov/Exe/ZyPDF.cgi?Dockev=P 100UP8H.txt
U.S. EPA (U.S. Environmental Protection Agency). (2018b). Great Lakes Environmental Database
(GLENDA) [Database], Retrieved from https://www.epa.gov/great-lakes- monitoring/great-lakes-fish-
monitoring-surveillance-program-data
U.S. EPA (U.S. Environmental Protection Agency). (2019a). Proposed designation of Dibutyl Phthalate
(CASRN 84-74-2) as a high-priority substance for risk evaluation. U.S. Environmental Protection
Agency, Office of Chemical Safety and Pollution Prevention.
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. Retrieved: April 25, 2019. http://www.epa.gov/cdr/
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.
Ullmann's. (2011a). Ethanol. Wiley-VCH Verlag GmbH& Co. KGaA. Weinheim, Germany.

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USGS (U.S. Geological Survey). (1991e). USGS Monitoring Data: National Water Quality Monitoring
Council - Soil [Database], Retrieved from
https://www.waterqualitydata.us/portal/#sampleMedia=Soil&mimeType=csv
USGS (U.S. Geological Survey). (1991f). USGS Monitoring Data: National Water Quality Monitoring
Council - Surface Water [Database], Retrieved from
https://www.waterqualitydata.us/portal/#siteType=Aggregate%20surface-water-
use&sampleMedia=Water&mimeType=csv
USGS (U.S. Geological Survey). (1991g). USGS monitoring data: national water quality monitoring
council - tissue [Database], USGS (U.S. Geological Survey).
https://www.waterqualitvdata.us/portal/#sampleMedia=Tissue&mimeType=csv. HERO ID: 6296273
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APPENDICES
Appendix A LIST OF GRAY LITERATURE SOURCES
Table Apx A-l List of Gray Literature Sources that Yielded Results for Dibutyl Phthalate
Source/
Aencv
Source Nitme
Source Type
Source CsHefiorv
ATSDR
ATSDR Tox Profile Updates and
Addendums
Other US
Agency
Resources
Assessment or Related
Document
ATSDR
ATSDR Toxicological Profiles (original
publication)
Other US
Agency
Resources
Assessment or Related
Document
Australian
Government,
Department
of Health
NICNAS Assessments (human health. Tier
I. II or III)
International
Resources
Assessment or Related
Document
CAL EPA
Technical Support Documents for
regulations: Cancer Potency Information
Other US
Agency
Resources
Assessment or Related
Document
CAL EPA
Technical Support Documents for
regulations: Proposition 65, Cancer
Other US
Agency
Resources
Assessment or Related
Document
CALEPA
Technical Support Documents for
regulations: Drinking Water Public Health
Goals
Other US
Agency
Resources
Assessment or Related
Document
CDC
CDC Biomonitoring Tables
Other US
Agency
Resources
Database
ECHA
European Union Risk Assessment Report
International
Resources
Assessment or Related
Document
Env Canada
Chemicals at a Glance (fact sheets)
International
Resources
Assessment or Related
Document
EPA
Office of Water: STORET and WQX
US EPA
Resources
Database
EPA
Office of Air: AQS, Annual
US EPA
Resources
Database
EPA
TSCA Hazard Characterizations
US EPA
Resources
Assessment or Related
Document
61

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Source/
Agency
Source Vime
Source Type
Source CsHefiorv
EPA
Included in 201 1 NATA
US EPA
Resources
Assessment or Related
Document
EPA
Office of Air: National Emissions Inventory
(NEI) - National Emissions Inventory (NEI)
Data (2014, 2011,2008)
US EPA
Resources
Database
EPA
EPA: AP-42
US EPA
Resources
Regulatory Document
or List
EPA
TRI: Envirofacts Toxics Release Inventory
2017 Updated Dataset
US EPA
Resources
Database
EPA
Chemical Data Reporting (2012 and 2016
non-CBI CDR database)
US EPA
Resources
Database
EPA
Chemical Data Reporting (2012 and 2016
CBI CDR database)
US EPA
Resources
Database
EPA
EPA Discharge Monitoring Report Data
US EPA
Resources
Database
EPA
Office of Air: CFRs and Dockets
US EPA
Resources
Regulatory Document
or List
KOECT
Kirk-Othmer Encyclopedia of Chemical
Technology Journal Article
Other Resource
Encyclopedia
NIOSH
CDC NIOSH - Occupational Health
Guideline Documents
Other US
Agency
Resources
Assessment or Related
Document
NIOSH
CDC NIOSH - Pocket Guide
Other US
Agency
Resources
Database
NIOSH
CDC NIOSH - Health Hazard Evaluations
(HHEs)
Other US
Agency
Resources
Assessment or Related
Document
NIOSH
CDC NIOSH - Publications and Products
Other US
Agency
Resources
Assessment or Related
Document
NLM
National Library of Medicine's HazMap
Other US
Agency
Resources
Database
NLM
National Library of Medicine's PubChem
Other US
Agency
Resources
Database
62

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Source/
Agency
Source Vime
Source Type
Source CsHefiorv
NTP
Technical Reports
Other US
Agency
Resources
Assessment or Related
Document
NTP
Additional NTP Reports
Other US
Agency
Resources
Assessment or Related
Document
OECD
OECD Emission Scenario Documents
International
Resources
Assessment or Related
Document
OECD
OECD: General Site
International
Resources
General Search
OSHA
OSHA Chemical Exposure Health Data
Other US
Agency
Resources
Database
OSHA
U.S. OSHA Chemical Exposure Health
Data (CEHD) program data | ERG|
Other US
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
63

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Appendix B PHYSICAL AND CHEMICAL PROPERTIES OF
DIBUTYL PHTHALATE
This appendix provides p-chem information and data found in preliminary data gathering for dibutyl
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 Dibutyl Phthalate (CASRN 84-74-2) as a High-
Priority Substance for Risk Evaluation (U.S. EPA, 2019a) and may be updated as EPA collects
additional information through systematic review methods. All p-chem property values that were
extracted and evaluated as of March 2020 are presented in the supplemental file Data Extraction and
Data Evaluation Tables for Physical Chemical Property Studies (EPA-HQ-OPPT-2018-0503).
Table Apx B-l Physical and Chemical Properties of Dibutyl Phthalate
Properly or Kmlpoinl
Value"
Reference
Data Quality
Kill in
Molecular formula
C16H22O4
NA
NA
Molecular weight
278.35 g/mol
NA
NA
Physical state
Oily liquid
O'Neil, 2013
High
Physical properties
Colorless to faint
yellow, oily liquid,
slight aromatic odor
NLM, 2015
High
Melting point
-35C
Rumble, 2018
High
Boiling point
340C
O'Neil, 2013
High
Density
1.0459- 1.0465 g/cm3 at
20C
NLM, 2015
High
Vapor pressure
2.01 xlO"5 mm Hg at
25C
NLM, 2015
High
Vapor density
9.58 (air = 1)
NLM, 2015
High
Water solubility
11.2 mg/L at 25C
Howard, 1985
High
Log Octanol/water partition
coefficient (Log Kow)
4.53 at 298.15 K
Ishak, 2016
High
Henry's Law constant
1.81 x 10"6 atm-nrVmol at
25C
NLM, 2015
High
64

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Propcrlv or Kmlpoinl
\ Slllll"1
UeferciKT
Dsilsi Qusililv
K;i( in
Flash point
157.2222C
RSC, 2019
High
Auto flammability
Not available


Viscosity
20.3 cP at 20C
NLM, 2015
High
Refractive index
1.4900
NLM, 2015
High
Dielectric constant
6.36
Elsevier, 2019
High
a Measured unless otherwise noted.
NA = Not applicable
65

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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 dibutyl phthalate.
Table Apx C-l Environmental Fate Characteristics of Dibutyl Phthalate
Properly or Kuripoinl
Value"
Reference
Direct Photodegradation
ti/2 = 3 hours
Mackay (2006) citing Jin
(1999)
Indirect Photodegradation
ti/2 = 18.4 hours with reaction with *OH
radical
Mackay (2006) citing Howard
(1989)
Hydrolysis
ti/2 = approximately 22 years
AT SDR (2001) citing U.S
EPA (1989)
Biodegradation (Aerobic)
Water: 69% by BOD, 100% by UV-VIS,
100%) by GC after 2 weeks at a
concentration of 100 ppm unspecified
method (most likely Japanese MITI)
NITE (2019)

Soil: ti/2 = 1.8-53 days reported by
multiple sources in Mackay et al., 2006
Mackay (2006)

3 days by microorganisms isolated from
soil or wastewater; 11-53 days depending
on pH, soil type, etc.; <5 days in garden
soil; 48-552 hours based on unacclimated
aerobic soil grab sample data; 1.8 days at
30 degrees in garden soil; 6.7 days in soil;
11.2 days in soil; 15.8 days in soil


Sediment: ti/2 = 1.0-23 days reported by
multiple sources in Mackay et al., 2006
Mackay (2006)
Biodegradation (Anaerobic)
Water: ti/2 = 1.19-27.2 days reported by
multiple sources in Mackay et al., 2006
Mackay (2006)

Soil: ti/2 = 1-20 days reported by multiple
sources in Mackay et al., 2006
Mackay (2006)

Sediment: ti/2 = 7-30 days reported by
multiple sources in Mackay et al., 2016
Mackay (2006)
Wastewater Treatment
56%o total removal (0.52%> by
biodegradation, 55% by sludge
adsorption, and 0.04%> by volatilization to
air; estimated)13
U.S. EPA (2012)
66

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Properly or Kndpoinl
\ 111 lie.*"
UcfcrciKT
Bioconcentration Factor
3.1-21.2 and 5.2-176 attest substance
concentrations of 0.05 and 0.015 ppm,
respectively (Cyprinus carpio)
NITE (2019)
Accumulation of 1,2 benzenedicarboxylic
acid, 1,2-dibutyl ester in the aquatic and
terrestrial food chain is limited by
biotransformation, which progressively
increases with trophic level
ATSDR (2001) citing Staples
(1997)
Soil Organic Carbon:Water
Partition Coefficient (Log
Koc)
2.17 (marine sediment/seawater);
0.3010-1.60 (clay and seawater);
4.54 (calculated, sediment-water);
3.14 (soil)
Mackay (2006)
aMeasured unless otherwise noted; bEPI SuiteTMphysical property inputs: Log Kow= 4.50, BP = 340 C, MP = -35 C, VP =
2.01 x 10"5 mm Hg, WS = 11.2 mg/L, Henry's Law Constant = 1.81 x 10 6 atm-m3/mol, SMILES:
0=C(0CCCC)c(c(cccl)C(=0)0CCCC)cl; OH = hydroxyl radical; GC = gas chromatography; MITI = Ministry of
International Trade and Industry, Japan; BOD = biochemical oxygen demand; Koc = organic carbon-water partitioning
coefficient
67

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Appendix D REGULATORY HISTORY
The chemical substance, dibutyl 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 Dibutyl Phthalate are listed in Table Apx D-3.
D.l Federal Laws and Regulations
Table Apx D-l Federal Laws and Regulations
Mat ulcs/Uegulal ions
Description of Aiilhorilv/Uegulalion
Description of Regulation
EPA Regulations
Toxic Substances Control
Act (TSCA) - Section
6(b)
EPA is directed to identify high-priority
chemical substances for risk evaluation; and
conduct risk evaluations on at least 20 high
priority substances no later than three and
one-half years after the date of enactment of
the Frank R. Lautenberg Chemical Safety
for the 21st Century Act.
Dibutyl phthalate is one of the
20 chemicals EPA designated as
a High-Priority Substance for
risk evaluation under TSCA (84
FR 71924. December 30. 2019V
Designation of dibutyl phthalate
as high-priority substance
constitutes the initiation of the
risk evaluation on the chemical.
Toxic Substances Control
Act (TSCA) - Section
8(a)
The TSCA Section 8(a) CDR Rule requires
manufacturers (including importers) to give
EPA basic exposure-related information on
the types, quantities and uses of chemical
substances produced domestically and
imported into the United States.
Dibutyl phthalate manufacturing
(including importing),
processing and use information
is reported under the CDR rule
( 16, 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.
Dibutyl phthalate was on the
initial TSCA Inventory and
therefore was not subject to
EPA's new chemicals review
process under TSCA Section 5
( 09, March 29, 1995).
Toxic Substances Control
Act (TSCA) - Section
8(e)
Manufacturers (including importers),
processors, and distributors must
immediately notify EPA if they obtain
information that supports the conclusion
that a chemical substance or mixture
presents a substantial risk of injury to health
or the environment.
Seven substantial risk reports
received for dibutyl phthalate
(1996 -2010) (U.S. EPA,
ChemView. Accessed April 8,
2019).
Toxic Substances Control
Act (TSCA) - Section 4
Provides EPA with authority to issue rules
and orders requiring manufacturers
In 1989, EPA entered an
Enforceable Consent Agreement
68

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Slsiliik's/Ucgiihilions
Description of Aiilhorily/Ucgiihilion
Description ol' Ucgnhilion

(including importers) and processors to test
chemical substances and mixtures.
under TSCA Section 4 with six
companies to perform certain
chemical fate and environmental
effects on certain Alkyl
Phthalates (54FR618).
12 chemical data submissions
from test rules received for
dibutyl phthalate: one acute
aquatic plant toxicity, eight
acute aquatic toxicity, two
chronic aquatic toxicity and one
vapor pressure.
(U.S. EPA, ChemView. Listings
undated. Accessed April 8,
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).
Dibutyl phthalate is a listed
substance subject to reporting
requirements under 40 CFR
372.65 effective as of January
01, 1987.
Clean Air Act (CAA) -
Section 112(b)
Defines the original list of 189 hazardous
air pollutants (HAPs). Under 112(c) of the
CAA, EPA must identify and list source
categories that emit HAP and then set
emission standards for those listed source
categories under CAA Section 112(d). CAA
Section 112(b)(3)(A) specifies that any
person may petition the Administrator to
modify the list of HAP by adding or
deleting a substance. Since 1990, EPA has
Dibutyl phthalate is listed as a
HAP (42 U.S. Code Section
7412).
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Slsiliik's/Ucgiihilions
Description of Aiilhorily/Ucgiihilion
Dcscriplion ol' Ucgiihilion

removed two pollutants from the original
list leaving 187 at present.

Clean Air Act (CAA) -
Section 112(d)
Directs EPA to establish, by rule,
NESHAPs for each category or subcategory
of listed major sources and area sources of
HAPs (listed pursuant to Section 112(c)).
For major sources, the standards must
require the maximum degree of emission
reduction that EPA determines is
achievable by each particular source
category. This is generally referred to as
maximum achievable control technology
(MACT). For area sources, the standards
must require generally achievable control
technology (GACT) though may require
MACT.
EPA has established NESHAPs
for a number of source
categories that emit dibutyl
phthalate to air. (See
https ://www. epa. gov/ stationarv-
sources-air-Dollution/national-
emission-standards-hazardous-
air-Dollutants-neshao-9)
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 dibutyl phthalate,
including a recommendation of
20 |ig/L for "Human Health for
the consumption of Water +
Organism" and 30 |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 5-0242)
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 statue
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), 304(b), 307(b), 306) or on a case-
Dibutyl phthalate is designated
as a toxic pollutant under
Section 307(a)(1) of the CWA
and as such is subject to effluent
limitations.
Under CWA Section 304,
dibutyl phthalate is included in
the list of total toxic organics
(TTO) (40 CFR 413.02(i)).
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Slsiliik's/Ucgiihilions
Description of Aiilhorily/Ucgiihilion
Description ol' Ucgnhilion

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.

Clean Water Act
(CWA) - Section 311(b)
(2)(A) and 501(a) of the
Federal Water Pollution
Control Act.
Requires EPA to develop, promulgate, and
revise as may be appropriate, regulations
designating as hazardous substances, other
than oil, which, when discharged present an
imminent and substantial danger to the
public health or welfare, including, but not
limited to, fish, shellfish, wildlife,
shorelines, and beaches.
Dibutyl phthalate is a designated
hazardous substance in
accordance with Section
311(b)(2)(A) of the Federal
Water Pollution Control Act.
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.
Dibutyl phthalate is included on
the list of hazardous wastes
pursuant to RCRA 3001. RCRA
Hazardous Waste Code: U069.
(40 CFR 261.33)
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.
Dibutyl phthalate is a hazardous
substance under CERCLA.
Releases of dibutyl phthalate in
excess of 10 pounds must be
reported (40 CFR 302.4).
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Mat ulcs/Uegulal ions
Description of AiilhorilY/Ucgulalion
Description of Regulation
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 and
provides new enforcement authorities and
settlement tools.
Dibutyl 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) that have been
deemed to pose the greatest
threat to public health.
Other Federal Regulations
Federal Food, Drug, and
Cosmetic Act (FFDCA)
Provides the FDA with authority to oversee
the safety of food, drugs and cosmetics.
Dibutyl phthalate is listed as
an optional substance to be
used in: adhesives to be used
as components of articles
intended for use in packaging,
transporting, or holding food
(21 CFR  175.105); the base
sheet and coating of
cellophane, alone or in
combination with other
phthalates where total
phthalates do not exceed 5
percent (21 CFR  177.1200).
The FDA has reviewed
phthalates in cosmetic
products but does not restrict
their use.
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: di-
ethylhexyl phthalate, dibutyl phthalate,
butyl benzyl phthalate, di-isononyl
phthalate, di-isobutyl phthalate, di-n-pentyl
phthalate, di-n-hexyl phthalate and
dicyclohexyl phthalate.
The use of dibutyl phthalate at
concentrations greater than 0.1
percent is banned in toys and
child care articles (16 CFR
part 1307).
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Stat ulcs/Uegulal ions
Description of AiilhorilY/Ucgulalion
Description of Regulation
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.
Dibulyl phlhalale 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 (70
FR 34381. June 14 2005V
49 CFR part 172.101 Appendix
A
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: New Hampshire (Env-A 1400: Regulated Toxic
Air Pollutants). Rhode Island (Air Pollution Regulation No. 22)
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), Minnesota (Minn R. Chap. 4720).
State PELs
California (PEL of 5 ppm and no STEL) (Cal Code Regs. Title 8,  5155)
Hawaii (PEL-TWA of 5 mg/m3 and PEL-STEL of 10 mg/m3) (Hawaii
Administrative Rules Section 12-60-50).
State Right-to-
Know Acts
Massachusetts (105 Code Mass. Regs.  670.000 Appendix A), New Jersey
(N.J.A.C. 7:1G) 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 dibutyl phthalate, including Maine (38 MRS A Chapter
16-D), Oregon (Toxic-Free Kids Act, Senate Bill 478, 2015), Vermont (18
V.S.A  1776) and Washington State (Wash. Admin. Code 173-334-130).
Volatile Organic
Compound (VOC)
California regulations may set VOC limits for consumer products and/or ban
the sale of certain consumer products as an ingredient and/or impurity.
California (Title 17, California Code of Regulations, Division 3, Chapter 1,
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Sliiic Actions
Description of Action
Regulations for
Consumer Products
Subchapter 8.5, Articles 1, 2, 3 and 4). Under the Aerosol Coating Products
Regulation, a Maximum Incremental Reactivity value has been established
for dibutyl phthalate (Subchapter 8.6, Article 1,  94700).
Other
California listed dibutyl phthalate on Proposition 65 in 2005 due to
developmental toxicity, female and male reproductive toxicity. (Cal Code
Regs. Title 27, 27001).
Dibutyl 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 dibutyl phthalate (Hazard
Evaluation System and Information Service, 2016).
dibutyl phthalate dibutyl 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/
Organization
Requirements and Restrictions
Canada
Dibutyl phthalate is on the Domestic Substances List (Government of
Canada. Managing substances in the environment. Substances search.
Database accessed April 10, 2019).
Other regulations include:
	Canada's National Pollutant Release Inventory (NPRI). Canada Gazette
Part II, Vol. 128, No. 9, May 04 1994, SOR/94-311
	Dibutyl phthalate did not meet the criteria under subsection 73(1) of the
Canadian Environmental Protection Act, 1999 (CEPA).
European Union
Dibutyl phthalate is registered for use in the EU. (European Chemicals
Agency (ECHA) database. Accessed April 10, 2019.)
In 2008, dibutyl phthalate was listed on the Candidate list as a Substance
of Very High Concern (SVHC) under regulation (EC) No 1907/2006 -
REACH (Registration, Evaluation, Authorization and Restriction of
Chemicals due to its reproductive toxicity (category IB).
In 2012, dibutyl phthalate was added to Annex XIV of REACH
(Authorisation List) with a sunset date of December 21, 2015. After the
sunset date, only persons with approved authorization applications may
continue to use the chemical (European Chemicals Agency (ECHA)
database. The exempted category of use is: uses in the immediate
packaging of medicinal products covered under Regulation (EC) No
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Country/
Orgsiniziilion
Requirements sinri Restrictions

726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC. Accessed
April 10, 2019).
Applications for authorizations to use, including in propellants, electronics
manufacture and closed manufacturing processes:
Under Annex XVII to REACH, dibutyl phthalate:
1.	shall not be used as substances or in mixtures, individually or in any
combination of the phthalates listed in column 1 of this entry, in a
concentration equal to or greater than 0,1 % by weight of the plasticized
material, in toys and childcare articles
2.	shall not be placed on the market in toys or childcare articles,
individually or in any combination of the first three phthalates listed in
column 1 of this entry, in a concentration equal to or greater than 0,1 % by
weight of the plasticized material.
In addition, di-isobutyl phthalate shall not be placed on the market after 7
July 2020 in toys or childcare articles, individually or in any combination
with the first three phthalates listed in column 1 of this entry, in a
concentration equal to or greater than 0,1 % by weight of the plasticized
material.
3.	Shall not be placed on the market after 7 July 2020 in articles,
individually or in any combination of the phthalates listed in column 1 of
this entry, in a concentration equal to or greater than 0,1 % by weight of
the plasticized material in the article.
4.	Paragraph 3 shall not apply to:
(a)	articles exclusively for industrial or agricultural use, or for use
exclusively in the open air, provided that no plasticized material comes
into contact with human mucous membranes or into prolonged contact
with human skin;
(b)	aircraft, placed on the market before 7 January 2024, or articles,
whenever placed on the market, for use exclusively in the maintenance or
repair of those aircraft, where those articles are essential for the safety and
airworthiness of the aircraft;
(c)	motor vehicles within the scope of Directive 2007/46/EC, placed on
the market before 7 January 2024, or articles, whenever placed on the
market, for use exclusively in the maintenance or repair of those vehicles,
where the vehicles cannot function as intended
without those articles;
(d)	articles placed on the market before 7 July 2020;
(e)	measuring devices for laboratory use, or parts thereof;
(f)	materials and articles intended to come into contact with food within
the scope of Regulation (EC) No 1935/2004 or Commission Regulation
(EU)No 10/20111;
(g)	medical devices within the scope of Directives 90/385/EEC,
93/42/EEC or 98/79/EC, or parts thereof;
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Country/
Orgsiniziilion
Requirements sinri Restrictions

(h)	electrical and electronic equipment within the scope of Directive
2011/65/EU;
(i)	the immediate packaging of medicinal products within the scope of
Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive
2001/83/EC;
(j) toys and childcare articles covered by paragraphs 1 or 2.
5. For the purposes of paragraphs 1, 2, 3 and 4(a),
(a) 'plasticized material' means any of the following homogeneous
materials:
-	polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyvinyl
acetate (PVA), polyurethanes,
-	any other polymer (including, inter alia, polymer foams and rubber
material) except silicone rubber and natural latex coatings,
-	surface coatings, non-slip coatings, finishes, decals, printed designs,
-	adhesives, sealants, paints and inks.
European Commission Directive (EU) 2015/863 of 31 March 2015
amended Annex II to Directive 2011/65/EU, to restrict dibutyl phthalate at
0.1% or greater so that:
-	The restriction of dibutyl phthalate shall apply to medical devices,
including in vitro medical devices, and monitoring and control
instruments, including industrial monitoring and control instruments, from
22 July 2021.
-	The restriction of dibutyl phthalate shall not apply to cables or spare
parts for the repair, the reuse, the updating of functionalities or upgrading
of capacity of EEE placed on the market before 22 July 2019, and of
medical devices, including in vitro medical devices, and monitoring and
control instruments, including industrial monitoring and control
instruments, placed on the market before 22 July 2021.
-	The restriction of dibutyl phthalate shall not apply to toys which are
already subject to the restriction of di-ethylhexyl phthalate, butyl benzyl
phthalate and dibutyl phthalate through entry 51 of Annex XVII to
Regulation (EC) No 1907/2006.
Dibutyl phthalate is subject to the Restriction of Hazardous Substances
Directive (RoHS), EU/2015/863, which restricts the use of hazardous
substances at more than 0.1% by weight at the 'homogeneous material'
level in electrical and electronic equipment, beginning July 22, 2019.
(European Commission RoHS).
Australia
Dibutyl phthalate was assessed under Human Health and Environment
(Phthalate esters) Tier II of the Inventory Multi-Tiered Assessment and
Prioritisation (IMAP). Dibutyl phthalate has been listed and assessed as a
Priority Existing Chemical (PEC/36, November 2013).
NICNAS found no reports of the phthalate being manufactured as a raw
material in Australia. Dibutyl phthalate is imported into Australia mainly
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Country/
Orgsiniziilion
Requirements sinri Restrictions

as a component of finished products or mixtures and also as a raw material
for local formulation and processing. There are currently no restrictions on
the manufacture, import or use of dibutyl phthalate in Australia.
Dibutyl phthalate is listed in the Safe Work Australia List of Designated
Hazardous Substances contained in the Hazardous Substances Information
System (HSIS) as a Reproductive Toxicant Category 2 (requiring it to be
labelled with the risk phrase [R61]May cause harm to the unborn child);
and Reproductive Toxicant Category 3 (requiring the risk phrase [R62]
Possible risk of impaired fertility). Data accessed April 10, 2019:
Japan
Dibutyl 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
	Industrial Safety and Health Act (ISHA)
	Air Pollution Control Law
(National Institute of Technology and Evaluation [NITE] Chemical Risk
Information Platform [CHRIP], Accessed April 10, 2019
World Health
Organization (WHO)
Established a tolerable daily intake of 66 |ig dibutyl phthalate/kg body
weight based on a LOAEL of 66 mg/kg body weight per day for
developmental and reproductive toxicity in rats from a continuous
breeding study, incorporating an uncertainty factor of 1,000. (WHO
Environmental Health Criteria 189, 1997)
Australia, Austria,
Belgium, Canada,
Denmark, European
Union, France,
Germany, Ireland,
Japan, Latvia, New
Zealand, People's
Republic of China,
Poland, Singapore,
South Korea, Spain,
Sweden, Switzerland,
United Kingdom
Occupational exposure limits for dibutyl phthalate (GESTIS International
limit values for chemical agents (Occupational exposure limits, OELs)
database. Accessed April 12, 2019).
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Appendix E PROCESS, RELEASE AND OCCUPATIONAL
EXPOSURE INFORMATION
This appendix provides information and data found in preliminary data gathering for Dibutyl 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 Manufacture (Including Import)
The 2016 CDR reports 21 facilities that submitted activity data for 2015. 11 of these facilities stated that
they imported dibutyl phthalate in 2015, one stated that they manufactured dibutyl phthalate in 2015,
and the remaining nine facilities' 2015 manufacture or import activity is withheld or claimed as CBI
(U.S. EPA,2019). According to 2016 public CDR data, dibutyl phthalate is both domestically
manufactured in and imported into the United States in liquid form (U.S. EPA,2019).
E.l.1.1 Domestic Manufacturing
Dibutyl phthalate is manufactured through the esterification of the carboxyl groups of dibutyl phthalate
with n-butyl alcohol in the presence of sulfuric acid as a catalyst (ECHA, 2009). After the esterification
reaction, excess alcohol is recovered and dibutyl phthalate is purified through distillation or activated
charcoal (ECHA, 2009).
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. Dibutyl phthalate is shipped in liquid form
according to 2016 CDR. Of the 11 facilities in 2016 CDR that imported dibutyl phthalate in 2015
(excluding the facilities for which the importation/manufacturing activity was withheld or claimed CBI),
EPA has identified two sites that imported dibutyl phthalate directly to their sites for on-site processing
or use and nine sites that imported dibutyl phthalate directly to other sites for processing or use (the
importing site does not directly handle or store the imported dibutyl phthalate) (U.S. EPA,2019).
E.1.2 Processing and Distribution
E.l.2.1 Reactant or Intermediate
Processing as a reactant or intermediate is the use of dibutyl phthalate as a feedstock in the production of
another chemical via a chemical reaction in which dibutyl phthalate is consumed to form the product.
Two companies that reported to 2016 CDR indicated that dibutyl phthalate was processed as a reactant
in the production of other chemicals. Dibutyl phthalate is used as an intermediate to produce plastics and
rubber products, adhesives, paints and coatings, and asphalt products (U.S. EPA,2019).
Exact operations for the use of dibutyl 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
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chemical would react either fully or to a lesser extent. Following completion of the reaction, the
produced substance may be purified further, thus removing unreacted dibutyl 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 dibutyl phthalate into a chemical formulation, mixture, or reaction product are
dependent on the specific manufacturing process or processes involved. Companies reported to 2016
CDR that dibutyl phthalate is used as a plasticizer in the formulation of paint and coating, plastic
material and resin, plastic products, soap, cleaning compound, and toilet preparation manufacturing
(U.S. EPA,2019; NLM, 2015). Dibutyl phthalate is used as a functional fluid in printing activities and a
solvent in other chemical manufacturing (U.S. EPA,2019; NLM, 2015; Ullman's, 201 la; Synapse,
2009). Dibutyl phthalate is also used in the formulation of ink, toner, and colorant products, among other
formulations (NLM, 2015). The exact processes used to formulate products containing dibutyl 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 dibutyl 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 dibutyl phthalate-containing formulations or reaction
products are dependent on the article. Three companies reported to 2016 CDR that dibutyl phthalate is
used as a plasticizer in the production of plastic products and one company reported the use of dibutyl
phthalate as a plasticizer in rubber products (U.S. EPA, 2019). Dibutyl phthalate may also be used as a
plasticizer in ceramic and in textiles and apparel (NLM, 2015). EPA plans to further investigate
processing uses of dibutyl phthalate during risk evaluation.
E. 1.2.1 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.
E.l.2.2 Recycling
In 2016 CDR, two facilities reported that dibutyl phthalate was recycled (i.e., recycled, remanufactured,
reprocessed, or reused). Thirteen facilities reported that this chemical was not recycled (U.S.
EPA,2019). According to 2018 TRI, a small portion (less than 1%) of the total quantity of dibutyl
phthalate managed as waste was recycled off site.
E.1.3 Uses
E.l.3.1 Adhesives, Sealants, Paints, and Coatings
Dibutyl phthalate is used in a variety of adhesive, sealant, paint, and coating products. Specifically,
dibutyl phthalate is used in adhesives and sealants used in food packaging and labels, wallpaper, floor
sealing and coating, poly(vinyl acetate) coatings, lacquers, varnishes, paints, and coatings used in the
building and construction industry (U.S. EPA,2019; NLM, 2015; GoodGuide, 2011; Ullmann's, 2011b).
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
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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,
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 Building/Construction Materials Not Covered Elsewhere
Dibutyl phthalate is used in building and construction materials not covered elsewhere, including in
caulking materials (GoodGuide, 2011) and in asphalt paving, roofing, and coating materials (U.S.
EPA,2019). EPA did not find additional information on these products. EPA plans to further investigate
these uses of dibutyl phthalate during risk evaluation.
In addition, dibutyl phthalate is an additive in polyester, vinyl ester, or epoxy resin cured-in-place pipe
(CIPP) (NIOSH, 2017). CIPP is used for in-place repairs to pipes such as water mains. Workers repair
pipes in place by first inserting a resin-impregnated liner in the damaged pipe, then forcing steam, hot
water, or ultraviolet light across the liner to cure the resin (NIOSH, 2017).
E.l.3.3 Cleaning and Furnishings Care Products
Dibutyl phthalate may be present in cleaning and furnishing care products, such as glass window
cleaning formulations, carpet and floor cleaners, spot removers, and shoe care products (U.S. EPA,2019;
NLM, 2015; GoodGuide, 2011). Once formulated, cleaning solutions containing dibutyl phthalate can
be applied to substrates using a variety of application methods, including roller application, brushing,
dipping, pouring, spraying and wiping. Application may be automated or manual, depending on the
cleaning product and the industry. Consumer cleaning solutions are likely to be applied manually,
whereas professional cleaning processes are often automated. The applied cleaning solution is then
removed from the substrate, along with the contaminants, and discarded as waste.
E.l.3.4 Ink, Toner, and Colorant Products
Dibutyl phthalate is used in ink, toner, and colorant products, including coloring agents, printing inks,
digital inks, and inks and toners used in the electronics industry (U.S. EPA,2019; NLM, 2015). 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 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, dibutyl phthalate is used in the production of plastic and rubber
products, which may be used industrially, commercially, and by consumers. These products are used in
a variety of products, including building and construction materials, flooring materials, and furniture and
furnishings (U.S. EPA,2019; NLM, 2015). Dibutyl phthalate is likely entrained in the products;
however, dibutyl phthalate may be available for exposure depending on the application of the end use
products, such as if building and construction materials are cut prior to installation. EPA plans to further
investigate these uses of dibutyl phthalate during risk evaluation.
80

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E.l.3.6 Other Uses
Dibutyl phthalate is used as a solvent in Huntsman's maleic anhydride manufacturing technology (U.S.
EPA,2019) and in explosives and propel 1 ants (Akhavan, 2018; NLM, 2015; Synapse, 2009). Dibutyl
phthalate is also used as a laboratory chemical (non-incorporative) (U.S. EPA,2019; NLM, 2015;
Ullman's, 201 la; Synapse, 2009). Laboratory procedures are generally done within a fume hood, on a
bench with local exhaust ventilation or under general ventilation.
EPA plans to evaluate these uses of dibutyl phthalate during risk evaluation.
E.1.4 Disposal
Each of the conditions of use of dibutyl 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
treat or dispose onsite wastes that they themselves generate are assessed in each condition of use
assessment. Similarly, point source discharges of dibutyl phthalate to surface water are assessed in each
condition of use assessment (point source discharges are exempt as solid wastes under RCRA). Wastes
of dibutyl 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: Dibutyl phthalate may be contained in wastewater discharged to POTW or other,
non-public treatment works for treatment. Industrial wastewater containing dibutyl 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 dibutyl 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.
Dibutyl phthalate is a U-listed hazardous waste under code U069 under RCRA; therefore,
discarded, unused pure and commercial grades of dibutyl phthalate are regulated as a hazardous
waste under RCRA (40 CFR  261.33(f)).
	Wastes Exempted as Solid Wastes under RCRA: Certain conditions of use of dibutyl phthalate
may generate wastes of dibutyl 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 dibutyl phthalate may be exempt as a solid waste.
According to 2018 TRI, the vast majority (approximately 92%) of dibutyl phthalate released to the
environment was disposed of to land, totaling 306,655 pounds. Of this amount, "all other land disposal"
accounted for nearly 64%, which comprised off-site disposal to landfills (146,062 pounds) other than
RCRA Subtitle C landfills, or by other on-site land disposal methods such as placement in waste piles,
spills, or leaks (49,441 pounds). The remaining 36% of total land disposal included disposal to on-site
81

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RCRA Subtitle C landfills and disposal to on-site Class I underground injection wells. There were zero
pounds of dibutyl phthalate reported as released to water via surface water discharges, and a total of
23,850 pounds were released to air as fugitive and stack emissions.
E.2 Preliminary Occupational Exposure Data
EPA presents below an example of occupational exposure-related information obtained from
preliminary data gathering. EPA plans to consider this information and data in combination with other
data and methods for use in the risk evaluation.
TableApx E-l summarizes NIOSH Health Hazard Evaluations identified during EPA's preliminary
data gathering.
Table Apx E-l Summary of NIOSH HHEs with Monitoring for Dibutyl Phthalate
Year of
Publication
Report Number
Facility Description
1998
HETA 97-0214-2689
Hydraulic Door Closer Manufacture - Application
of Paints and Coatings
1987
MHETA 86-191-1836
Highway Sign Fabrication and Silkscreening
1986
HETA 85-060-1670
Xerox Copying (High School Media Center)
1982
HETA 81-275-1122
Carbonless Paper Handling (Administrative) -
General Telephone Company
1982
HETA 81-277-1089
Cartridge Ammunition Manufacture
1981
HE 80-094-840
Automobile Manufacture and Assembly
1977
HE 76-92-363
Acrylic Furniture Manufacture
a Table includes HHEs identified to date
Table Apx E-2 summarizes OSHA CEHD identified during EPA's preliminary data gathering.
82

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TableApx E-2 Summary of Industry Sectors with Dibutyl Phthalate Monitoring Samples
NAICS
NAICS Description
Number of
Data Points
312113
Ice Manufacturing
2
313320
Fabric Coating Mills
3
325611
Soap and Other Detergent
Manufacturing
2
333131
Mining Machinery and Equipment
Manufacturing
2
337920
Blind and Shade Manufacturing
2
811490
Other Personal and Household Goods
Repair and Maintenance
1
812112
Beauty Salons
1
928110
National Security
2
83

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Appendix F
SUPPORTING INFORMATION FOR OCCUPATIONAL EXPOSURE
CONCEPTUAL MODEL
Table Apx F-l Worker and Occupational Non-User Exposure Conceptual Model Supporting Table

Manufacture
Domestic
Manufacture
Import
Domestic
Manufacture
Import
Manufacture and
Packaging
Repackaging of
import containers
 .	. i:\imsuIV RmiU  .
|	I *i i|iiil.il ! hi
Liquid
Contact
Solid
Contact
Vapor
Mist
Dust
Liquid/Solid
Contact
Liquid
Contact
Dermal
Dermal
Inhalation
Inhalation/Dermal
Inhalation/Dermal
Dermal
Dermal
Workers
Workers
Workers,
ONU
Workers,
ONU
Workers,
ONU
ONU
Workers
Yes
No
No
No
No
No
Yes
2016 CDR references
manufacture in liquid form.
Thus, the potential for
exposures to workers exists
during manufacturing.
2016 CDR does not include
information on manufacture
in solid form. Thus, the
potential for exposures to
workers does not exist
during manufacturing.	
Due to dibutyl phthalate's
vapor pressure (VP) (VP =
2.01 x 10-5 mm Hg) at
room temperature, potential
for vapor generation is low.
Mist generation is not
expected during
manufacturing.
2016 CDR references
manufacture in liquid form.
Thus, the potential for dust
exposures to workers does
not exist during
manufacturing.
Exposure is expected to be
primarily restricted to
workers who are directly
involved in working with
the chemical. ONUs are not
expected to come in direct
contact with the chemicals.
2016 CDR references
import in liquid form. Thus,
84

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the potential for exposures
to workers exists during
manufacturing.
Solid
Contact
Dermal
Workers
No
2016 CDR does not include
information on import in
solid form. Thus, the
potential for exposures to
workers does not exist
during manufacturing.
Vapor
Inhalation
Workers,
ONU
No
Due to dibutyl phthalate's
vapor pressure (VP) (VP =
2.01 x 10-5 mm Hg) at
room temperature, potential
for vapor generation is low.
Mist
Inhalation/Dermal
Workers,
ONU
No
Mist generation is not
expected during importing.
Dust
Inhalation/Dermal
Workers,
ONU
No
2016 CDR references
import in liquid form. Thus,
the potential for dust
exposures to workers does
not exist during
manufacturing.
Liquid/Solid
Contact
Dermal
ONU
No
Exposure is expected to be
primarily restricted to
workers who are directly
involved in working with
the chemical. ONUs are not
expected to come in direct
contact with the chemicals.
Processing
Processing as a
Reactant
Intermediate in: all
other basic organic
chemical
manufacturing;
Plasticizers in
wholesale and retail
trade
Processing as a
reactant
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures
to workers exists during
processing as a reactant, as
dibutyl phthalate is in
liquid form.
Solid
Contact
Dermal
Workers
No
The potential for exposures
to workers does not exist
during processing as a
reactant, as dibutyl
phthalate is in liquid form.
Vapor
Inhalation
Workers,
ONU
Yes
Due to dibutyl phthalate's
vapor pressure (VP) (VP =
85

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2.01 x 10-5 mm Hg) at
room temperature, potential
for vapor generation is low.
However, some of these
operations may occur at
elevated temperatures,
which increase the potential
for vapor generation.
Mist
Inhalation/Dermal
Workers,
ONU
No
Mist generation is not
expected during processing
as a reactant.
Dust
Inhalation/Dermal
Workers,
ONU
No
The potential for exposures
to workers does not exist
during processing as a
reactant, as dibutyl
phthalate is 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
the chemical. ONUs are not
expected to come in direct
contact with the chemicals.
Incorporated
into
formulation,
mixture or
reaction product
Solvents (which
become part of
product formulation
or mixture) in: all
other chemical
product and
preparation
manufacturing; soap,
cleaning compound,
and toilet
preparation
manufacturing
Intermediates: in
asphalt paving,
roofing, and coating
materials
manufacturing;
Processing into
formulations,
mixtures, or reaction
product
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures
to workers exists during
incorporation into
formulation, mixture or
reaction product, as dibutyl
phthalate is 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
dibutyl phthalate may be in
solid form, such as for
compounded resins.
Vapor
Inhalation
Workers,
ONU
Yes
Due to dibutyl phthalate's
vapor pressure (VP) (VP =
2.01 x 10-5 mm Hg) at
room temperature, potential
86

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petrochemical
manufacturing;





for vapor generation is low.
However, some of these


rubber product
manufacturing





operations may occur at
elevated temperatures,
which increase the potential


Adhesives and





for vapor generation.


sealant chemicals in:





Mist generation is not


construction
Plasticizers in: paint

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


and coating





reaction product.


manufacturing;
plastic material and





The potential for exposures
to workers exists during


resin manufacturing;
plastic product
manufacturing; soap,

Dust
Inhalation/Dermal
Workers,
ONU
Yes
processing (incorporation
into formulation, mixture,
or reaction product), as


cleaning compound,
and toilet





dibutyl phthalate may be in
solid form, such as for


preparation





compounded resins.


manufacturing;








textiles, apparel, and
leather
manufacturing

Liquid/Solid
Contact
Dermal
ONU
No
Exposure is expected to be
primarily restricted to
workers who are directly
involved in working with


Functional fluids




the chemical. ONUs are not


(closed systems) in:
printing and related





expected to come in direct
contact with the chemicals.


support activities







Incorporated
Plasticizers in:
Plastics and Rubber




The potential for exposures

into articles
adhesive
manufacturing;
plastics product
manufacturing;
product manufacturing
(Plastic Converting)
Other article
Liquid
Contact
Dermal
Workers
Yes
to workers exists during
incorporation into articles,
as dibutyl phthalate may be
in liquid form.


rubber product
manufacturing
manufacturing




The potential for exposures
to workers exists during




Solid
Contact
Dermal
Workers
Yes
processing (incorporation
into articles), as dibutyl
phthalate may be in solid
form, such as for resins.




Vapor
Inhalation
Workers,
ONU
Yes
Due to dibutyl phthalate's
vapor pressure (VP) (VP =
87

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2.01 x 10-5 mm Hg) at
room temperature, potential
for vapor generation is low.
However, some of these
operations may occur at
elevated temperatures,
which increase the potential
for vapor generation.
Mst
Inhalation/Dermal
Workers,
ONU
No
Mist generation is not
expected during
incorporation into article.
Dust
Inhalation/Dermal
Workers,
ONU
Yes
The potential for exposures
to workers exists during
processing (incorporation
into articles), as dibutyl
phthalate may be in solid
form, such as for resins.
Liquid/Solid
Contact
Dermal
ONU
No
Exposure is expected to be
primarily restricted to
workers who are directly
involved in working with
the chemical. ONUs are not
expected to come in direct
contact with the chemicals.
Repackaging
Repackaging
Repackaging into large
and small containers
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures
to workers exists during
processing (repackaging),
as dibutyl phthalate is in
liquid form.
Solid
Contact
Dermal
Workers
Yes
The potential for exposures
to workers exists during
processing (repackaging),
as dibutyl phthalate may be
incorporated into products
in solid form.
Vapor
Inhalation
Workers,
ONU
No
Due to dibutyl phthalate's
vapor pressure (VP) (VP =
2.01 x 10-5 mm Hg) at
room temperature, potential
for vapor generation is low.
88

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Mist
Inhalation/Dermal
Workers,
ONU
No
Mist generation is not
expected during
repackaging.
Dust
Inhalation/Dermal
Workers,
ONU
Yes
The potential for dust
exposures to workers and
ONUs exists during
processing (repackaging),
as dibutyl phthalate may be
incorporated into products
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. ONUs are not
expected to come in direct
contact with the chemicals.
Recycling
Recycling
Recycling of dibutyl
phthalate and products
containing dibutyl
phthalate
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures
to workers exists during
this use as liquid
formulations may be
recycled.
Solid
Contact
Dermal
Workers
Yes
The potential for exposures
to workers exists during
this use as solid
formulations may be
recycled.
Vapor
Inhalation
Workers,
ONU
No
Due to dibutyl phthalate's
vapor pressure (VP) (VP =
2.01 x 10-5 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/Solid
Contact
Dermal
ONU
No
Exposure is expected to be
primarily restricted to
workers who are directly
89

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involved in working with








the chemical. ONUs are not








expected to come in direct








contact with the chemicals.
Industrial/
Adhesives and
Adhesives and
Spray, brush, roll, dip,




These products are in liquid
Commercial Use
sealants;
sealants; cleaning
and other forms of
Liquid
Contact



form; therefore, exposures

cleaning and
furnishings care
and furnishings care
products; paints and
application
Dermal
Workers
Yes
to workers exists for
dibutyl phthalate used in

products; paints
coatings;





these products.

and coatings;


Solid
Contact
Dermal
Workers
No
The potential for exposures
to solid dibutyl phthalate is
not expected during the use







of these products because
they are in liquid form.








Due to dibutyl phthalate's




Vapor
Inhalation
Workers,
ONU
No
vapor pressure (VP) (VP =
2.01 x 10-5 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,
No
The potential for exposures
to solid dibutyl phthalate
does not exist during the




ONU
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







the chemical. ONUs are not
expected to come in direct
contact with the chemicals.

Non-
Non-incorporative
Use of solvents




These products are in liquid

incorporative
solvent use; Ink,
solvent use; Ink,
toner, and colorant
containing dibutyl
phthalate in non-
Liquid
Contact
Dermal
Workers
Yes
form; therefore, exposures
to workers exists for

toner, and
colorant
products; laboratory
supplies
incorporative activities



dibutyl phthalate used in
these products.
90

-------
l.ili- C>ik' Sl;ic
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products;
laboratory
supplies

Use of ink, toner, and
colorant products (e.g.,
printing)
Use in laboratories
Solid
Contact
Dermal
Workers
No
The potential for exposures
to solid dibutyl phthalate is
not expected during the use
of these products because
they are in liquid form.








Due to dibutyl phthalate's




Vapor
Inhalation
Workers,
ONU
No
vapor pressure (VP) (VP =
2.01 x 10-5 mm Fig) at







room temperature, potential
for vapor generation is low.






Workers,
ONU

Mist generation is not




Mist
Inhalation/Dermal
No
expected during use of
these products.




Dust
Inhalation/Dermal
Workers,
No
The potential for exposures
to solid dibutyl phthalate
does not exist during the




ONU
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







the chemical. ONUs are not
expected to come in direct
contact with the chemicals.

Explosive
materials; Floor
coverings;
furniture and
Explosive materials;
Floor coverings;
furniture and
furnishings not
Use of articles made
using dibutyl phthalate
Liquid
Contact
Dermal
Workers
No
The potential for exposures
to liquid dibutyl phthalate
is not expected during the
use of these products

furnishings not
covered elsewhere;





because they are solid

covered
Personal care





articles.

elsewhere;
Personal care
products; plastic and
rubber products not





These products may
include solid articles in

products; plastic
and rubber
covered elsewhere

Solid
Contact



which dibutyl phthalate is
entrained; therefore, dibutyl

products not
covered
elsewhere


Dermal
Workers
Yes
phthalate exposures to
workers is unlikely but may
occur if cutting /sawing /
other machining operations
occur.
91

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Due to dibutyl phthalate's








vapor pressure (VP) (VP =
2.01 x 10-5 mm Hg) at








room temperature, potential




Vapor
Inhalation
Workers,
ONU
Yes
for vapor generation is low.
However, these products
may be used such that
vapors are generated (e.g.,
at high temperatures, in
cured-in-place pipe)






Workers,
ONU

Mist generation is not




Mst
Inhalation/Dermal
No
expected during use of







these products.








These products may
include solid articles in








which dibutyl phthalate is
entrained; therefore, dibutyl




Dust
Inhalation/Dermal
Workers,
ONU
Yes
phthalate exposures to
workers and ONUs is
unlikely but may occur if
cutting /sawing / other
machining operations
occur.




Liquid/Solid
Contact
Dermal
ONU
No
Exposure is expected to be
primarily restricted to
workers who are directly
involved in working with







the chemical. ONUs are not
expected to come in direct
contact with the chemicals.
Disposal
Disposal
Disposal of dibutyl
Worker handling of




The potential for exposures


phthalate wastes
wastes
Liquid
Contact
Dermal
Workers
Yes
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
92

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Vapor
Inhalation
Workers,
ONU
No
Due to dibutyl phthalate's
vapor pressure (VP) (VP =
2.01 x 10-5 mm Hg) at
room temperature, potential
for vapor generation is low.
Mist
Inhalation/Dennal
Workers,
ONU
No
Mist generation is not
expected during disposal of
liquid wastes.
Dust
Inhalation/Dennal
Workers,
ONU
Yes
Dust generation is possible
during disposal of solid
wastes.
Liquid/Solid
Contact
Dennal
ONU
No
Exposure is expected to be
primarily restricted to
workers who are directly
involved in working with
the chemical. ONUs are not
expected to come in direct
contact with the chemicals.
93

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Appendix G SUPPORTING INFORMATION FOR CONSUMER, GENERAL POPULATION
AND ENVIRONMENTAL EXPOSURE CONCEPTUAL MODEL
Table Apx G-l Consumer Exposure Conceptual Model Supporting Table
Life Cu'le
Sliic

Siibciik'jion
Koloiisc from
SOII IVl'
l'l\|)OSIIIV
Kniili'
Km'plur
I'lilllS In
l.\;ilu;ik'
Kiilimiiik'



Direct contact








through handling
of articles
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use.



containing
chemical




Construction,
Building/
Construction
Direct contact
through





Consumer
Use
Paint, Electrical,
and Metal
Products
Materials Not
Covered
Elsewhere
(Article)
mouthing of
articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this
condition of use.



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



Transfer to Dust








Direct contact








through handling
of articles
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use.



containing
chemical






Direct contact






Construction,
Electrical and
through





Consumer
Use
Paint, Electrical,
and Metal
Products
Electronic
Products
(Article)
mouthing of
articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this
condition of use.



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



Transfer to Dust





94

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Life Cu'le
Sliic

Siibciik'jion
Koloiisc from
SOII IVl'
l'l\|)OSIIIV
Kniili'
Km'plur
I'lilllS In
l.\;ilu;ik'
Kiilimiiik'



Direct contact








through handling
of articles
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use.



containing
chemical






Direct contact





Consumer
Use
Furnishing,
Cleaning,
Treatment/Care
Products
Floor Coverings
(Article)
through
mouthing of
articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this
condition of use.



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



Transfer to Dust








Direct contact








through handling
of articles
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use.



containing
chemical





Furniture and
Furnishings not
Covered
Elsewhere
(Article)
Direct contact





Consumer
Use
Furnishing,
Cleaning,
Treatment/Care
through
mouthing of
articles
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this
condition of use.

Productss
containing
chemical








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



Transfer to Dust







Plastic and
Direct contact





Consumer
Use
Packaging,
Paper, Plastic,
Hobby Products
Rubber Products
not Covered
Elsewhere
(Article)
through handling
of articles
containing
chemical
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use.
95

-------
Life Cu'le
Sliic

Siibciik'jion
Koloiisc from
SOII IVl'
l'l\|)OSIIIV
Kniili'
Km'plur
I'lilllS In
l.\;ilu;ik'
Kiilimiiik'



Direct contact








through
mouthing of
articles
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this
condition of use.



containing
chemical








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



Transfer to Dust








Direct contact








through handling
of articles
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use.



containing
chemical



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.



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



Transfer to Dust





Consumer
Use
Construction,
Paint, Electrical,
and Metal
Products
Adhesives and
Sealants
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.
(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.
96

-------
Life Cu'le
Sliic

Siibciik'jion
Koloiisc from
SOII IVl'
l'l\|)OSIIIV
Kniili'
Km'plur
I'lilllS In
l.\;ilu;ik'
Kiilimiiik'



Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible.



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.



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.
Consumer
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.
Use
Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible.



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.
Consumer
Use
Furnishing,
Cleaning,
Treatment/Care
Products
Cleaning and
Furnishing Care
Products
(Product)
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.
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.
97

-------
Life Cu'le
Sliic

Siibciik'jion
Koloiisc from
SOII IVl'
l'l\|)OSIIIV
Kniili'
Km'plur
I'lilllS In
l.\;ilu;ik'
Kiilimiiik'



Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible.



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.



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.
Consumer
Furnishing,
Cleaning,
Fabric, Textile
and Leather
Products not
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.
Use
Treatment/Care
Products
Covered
Elsewhere
(Product)
Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible.



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.
Consumer
Use
Construction,
Paint, Electrical,
and Metal
Products
Paints and
Coatings
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.
(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.
98

-------
Life Cu'le
Sliic

Siibciik'jion
Koloiisc from
SOII IVl'
l'l\|)OSIIIV
Kniili'
Km'plur
I'lilllS In
l.\;ilu;ik'
Kiilimiiik'



Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible.



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.



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
Consumer
Handling of
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.
Disposal and
Waste
Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible.



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.
99

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Appendix H SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES
Table Apx H-l General Population and Environmental Exposure Conceptual Model
l.il'o ( \ck'
S(;ie

Kck'sisi*
r.\|)ONIMY
I\i(Iin;i\ /
Modiii
l'l\|)UMIIV
Koii les
Km'plor /
Population
I'lilllS lo
I.Milunk'1'
Kiilioiiiik-
All
1 Emissions lo
\ll
1 Emissions lo \ 11"
Near I'acilils
anihieni air
concentrations
Inhalation
General
I'opiilalion
\n
Dihnisl plulialale is a II \l' lieciiiise
sialioiiaiA sonive releases of dihni> 1
plillialale to anihieni air are under I lie
liirisdieliiiii ol ilie ( \ \
1 nd i reel
deposition lo
iiearln bodies
of ualer and
soil catchments
(>ral
Dermal
(icneral
I'opiilalion
\n
II !l)
\qnalic and
1 circsiiial
Receptors
\o
Wastewater
or Liquid
Wastes
Industrial pre-
treatment and
wastewater
treatment, or POTW
Direct release
into surface
water and
indirect
partitioning to
sediment
TBD
Aqualic and
Terrestrial
Receptors
Y cs
1 :P \ has de\ eloped \nihieni W ater
Oiialils ( riieria lor protection ol human
health loi'dibiilv 1 phthalate
Oral
Dermal
General
Population
VI .
Drinking Water
via Surface or
Ground Water
Oral
Dermal and
Inhalation
(e.g.
showering)
General
Population
Yes
Release of dibutyl phthalate into surface
water and indirect partitioning to drinking
water is an expected exposure pathway.
Biosolids:
application to
soil and/or
migration to
groundwater
Oral (e.g.
ingestion of
soil)
Inhalation
General
Population
Yes
EPA plans to analyze the pathway from
biosolids to the general population,
aquatic and terrestrial species.
6 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 dibutyl phthalate in exposure pathways falling under the jurisdiction of these EPA statutes.
100

-------
l.il'o ( \ck'
S(;io
C;iU'iin
Kck'sisi*
I'1\|)osiiiv
Pillliw il> /
Modiii
l'l\|)UMIIV
Koii les
Km'plor /
Population
PlilllS lo
I.Milunk'1'
Kiilioiiiik-



and/or surface
water
TBD
Aquatic and
Terrestrial
receptors
Yes

U nderground
injection
Migration to
groundwater,
potential
surface/drinking
water
Oral
Dermal
Inhalation
General
Population
No
Dibutyl phthalalc is released lo Class I
Underground Injection Wells which are
covered by RCRA. and SDWA.
Aquatic and
Terrestrial
Species
TBD

Disposal
Solid and
Liquid
Wastes
Municipal landfill
and other land
disposal
Lcachatc to
soil, ground
water and/or
mitigation to
surface water
Oral
Dermal
General
Population
No
Dibutyl phthalalc is included on the list of
hazardous wastes pursuant lo RCRA 3001
(40 CFR 261.33).
TBD
Aquatic and
Terrestrial
Receptors
101

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