EPA Document# EPA-740-R1-7015
May 2018
United States Office of Chemical Safety and
Environmental Protection Agency Pollution Prevention
Problem Formulation of the Risk Evaluation for
N-Methylpyrrolidone
(2-Pyrrolidinone, 1-Methyl-)
CASRN: 872-50-4
May 2018
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 6
ABBREVIATIONS 7
EXECUTIVE SUMMARY 9
1 INTRODUCTION 11
1.1 Regul atory Hi story 12
1.2 Assessment History 13
1.3 Data and Information Collection 14
1.4 Data Screening During Problem Formulation 15
2 PROBLEM FORMULATION 16
2.1 Physical-Chemical Properties 16
2.2 Conditions of Use 17
2.2.1 Data and Information Sources 17
2.2.2 Identification of Conditions of Use 17
2.2.2.1 Categories and Subcategories Determined Not to be Conditions of Use or Otherwise
Excluded During Problem Formulation 18
2.2.2.2 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 18
2.2.2.3 Overview of Conditions of Use and Life Cycle Diagram 26
2.3 Exposures 29
2.3.1 Fate and Transport 29
2.3.2 Releases to the Environment 31
2.3.3 Presence in the Environment and Biota 32
2.3.4 Environmental Exposures 33
2.3.5 Human Exposures 34
2.3.5.1 Occupational Exposures 34
2.3.5.2 Consumer Exposures 35
2.3.5.3 General Population Exposures 36
2.3.5.4 Potentially Exposed or Susceptible Subpopulations 37
2.4 Hazards (Effects) 38
2.4.1 Environmental Hazards 38
2.4.2 Human Health Hazards 40
2.4.2.1 Non-Cancer Hazards 40
2.4.2.2 Genotoxicity and Cancer Hazards 41
2.4.2.3 Potentially Exposed or Susceptible Subpopulations 41
2.5 C onceptual Model s 41
2.5.1 Conceptual Model for Industrial and Commercial Activities and Uses: Potential Exposures
and Hazards 42
2.5.2 Conceptual Model for Consumer Activities and Uses: Potential Exposures and Hazards.... 45
2.5.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards 47
2.5.3.1 Pathways That EPA Expects to Include in Risk Evaluation but Not Further Analyze .. 47
2.5.3.2 Pathways that EPA Does Not Plan to Include in the Risk Evaluation 49
2.6 Analysis Plan 53
2.6.1 Exposure 53
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2.6.1.1 Environmental Releases 53
2.6.1.2 Environmental Fate 55
2.6.1.3 Environmental Exposures 56
2.6.1.4 Occupational Exposures 56
2.6.1.5 Consumer Exposures 57
2.6.1.6 General Population Exposures 59
2.6.2 Hazards (Effects) 59
2.6.2.1 Environmental Hazards 59
2.6.2.2 Human Health Hazards 59
2.6.3 Risk Characterization 60
REFERENCES 62
APPENDICES 69
Appendix A REGULATORY HISTORY 69
A.l Federal Laws and Regulations 69
A.2 State Laws and Regulations .....73
A.3 International Laws and Regulations .74
Appendix B PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION .. 76
B. 1 Process Information.. ........76
B. 1.1 Manufacture (Including Import) 76
B. 1.1.1 Domestic Manufacturing 76
B.l.1.2 Import 77
B.1.2 Processing 77
B. 1.2.1 Reactant/Intermediate 77
B. 1.2.2 Incorporation into Formulation, Mixture, or Reaction Product 77
B. 1.2.3 Incorporation into Article 78
B. 1.2.4 Repackaging 78
B. 1.2.5 Recycling 78
B.1.3 Uses 78
B.1.3.1 Paints and Coatings 78
B. 1.3.2 Solvents for Cleaning and Degreasing 79
B. 1.3.3 Ink, Toner and C ol orant Products 79
B. 1.3.4 Processing Aids Specific to Petroleum Production 80
B.1.3.5 Adhesives and Sealants 80
B. 1.3.6 Other Uses 81
B.1.4 Disposal 81
B.2 Occupational Exposure Data.. .81
B.3 Sources Containing Potentially Relevant Data or Information 83
Appendix C SURFACE WATER ANALYSIS OF NMP RELEASES 91
Appendix D SUPPORTING TABLE FOR INDUSTRIAL AND COMMERCIAL ACTIVITIES
AND USES CONCEPTUAL MODEL 93
Appendix E SUPPORTING TABLE FOR CONSUMER ACTIVITES AND USES
CONCEPTUAL MODEL 106
Appendix F SUPPORTING TABLE FOR ENVIRONMENTAL RELEASES AND WASTES
CONCEPTUAL MODEL 126
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Appendix G INCLUSION AND EXCLUSION CRITERIA FOR FULL TEXT SCREENING 128
G. 1 Inclusion Criteria for Data Sources Reporting Environmental Fate Data... 128
G.2 Inclusion Criteria for Data Sources Reporting Releases and Occupational Exposure Data .....129
G.3 Inclusion Criteria for Data Sources Reporting Exposure Data on Consumers and Ecological
Receptors ...............132
G.4 Inclusion Criteria for Data Sources Reporting Human Health Hazards 134
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LIST OF TABLES
Table 1-1. Assessment History ofNMP 13
Table 2-1. Physical-Chemical Properties ofNMP 16
Table 2-2. Categories and Subcategories Determined Not to be Conditions of Use or Otherwise
Excluded During Problem Formulation 18
Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 18
Table 2-4. Production Volume ofNMP in CDR Reporting Period (2012 to 2015) a 26
Table 2-5. Environmental Fate Characteristics ofNMP 30
Table 2-6. Summary ofNMP TRI Production-Related Waste Managed in 2015 (lbs) 31
Table 2-7. Summary ofNMP TRI Releases to the Environment in 2015 (lbs) 31
Table 2-8. Ecological Hazard Characterization ofNMP 39
LIST OF FIGURES
Figure 2-1. NMP Life Cycle Diagram 28
Figure 2-2. NMP Conceptual Model for Industrial and Commercial Activities and Uses: Potential
Exposures and Hazards 44
Figure 2-3. NMP Conceptual Model for Consumer Activities and Uses: Potential Exposures and
Hazards 46
Figure 2-4. NMP Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards 52
LIST OF APPENDIX TABLES
Table_Apx A-l. Federal Laws and Regulations 69
Table_Apx A-2. State Laws and Regulations 73
Table_Apx A-3. Regulatory Actions by Other Governments and Tribes 74
TableApx B-l. Mapping of Scenarios to Industry Sectors with NMP Personal Monitoring Air Samples
Obtained from OSHA Inspections Conducted Between 2012 and 2016 82
Table Apx B-2. Mapping of Scenarios to Industry Sectors with NMP Area Monitoring Air Samples
Obtained from OSHA Inspections Conducted Between 2012 and 2016 82
Table_Apx B-3. Summary of NIOSH HHE NMP Data 82
Table Apx B-4. Potentially Relevant Data Sources for Information Related to Process Description 84
Table_Apx B-5. Measured or Estimated Release Data 86
Table Apx B-6. Personal Exposure Monitoring and Area Monitoring Data 88
Table Apx B-7. Engineering Controls and Personal Protective Equipment 89
Table_Apx C-l. Estimated NMP Surface Water Concentrations 91
Table Apx D-l. Worker Exposure Conceptual Model Supporting Table (Note that rows shaded in gray
are excluded from the scope of this risk evaluation) 93
Table Apx E-l. Supporting Table for Consumer Activities and Uses Conceptual Model 106
Table Apx F-l. Supporting Table for Environmental Releases and Wastes Conceptual Model 126
LIST OF APPENDIX FIGURES
Figure_Apx B-l. NMP Manufacturing Under Adiabatic Conditions 76
Figure Apx B-2. NMP Manufacturing Using Gamma-Butyrolactone (GBL) and Monomethylamine
(MMA) 77
Figure_Apx C-l. Estimated Surface Water Concentration for 12-Day NMP Discharge 92
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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 and/or input from Intra-agency
reviewers that included multiple offices within EPA, Inter-agency reviewers that included multiple
Federal agencies, and assistance from EPA contractors GDIT (Contract No. CIO-SP3,
HHSN316201200013W), ERG (Contract No. EP-W-12-006), Versar (Contract No. EP-W-17-006), ICF
(Contract No. EPC14001) and SRC (Contract No. EP-W-12-003).
Docket
Supporting information can be found in the public docket: EPA-HQ-QPPT-2016-0743
Disclaimer
Reference herein to any specific commercial products, process or service by trade name, trademark,
manufacturer or otherwise does not constitute or imply its endorsement, recommendation or favoring by
the United States Government.
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ABBREVIATIONS
°c
Degrees Celsius
AIHA
American Industrial Hygiene Association
atm
Atmosphere(s)
AT SDR
Agency for Toxic Substances and Disease Registry
BAF
Bioaccumulation Factor
BCF
Bioconcentration Factor
CAA
Clean Air Act
CASRN
Chemical Abstracts Service Registry Number
CBI
Confidential Business Information
CCL
Contaminant Candidate List
CDR
Chemical Data Reporting
CEHD
Chemical Exposure Health Data
CEM
Consumer Exposure Model
CFR
Code of Federal Regulations
ChV
Chronic Value
cm3
Cubic Centimeter(s)
coc
Concentration of Concern
CSCL
Chemical Substances Control Law
DMR
Discharge Monitoring Report
DTSC
Department of Toxic Substances Control
EC
European Commission
ECso
Effective Concentration with 50% immobilized test organisms
ECHA
European Chemicals Agency
EPA
Environmental Protection Agency
EPCRA
Emergency Planning and Community Right-to-Know Act
ESD
Emission Scenario Document
EU
European Union
FDA
Food and Drug Administration
FFDCA
Federal Food, Drug and Cosmetic Act
GBL
Gamma-Butyrolactone
GS
Generic Scenarios
HESIS
Hazard Evaluation System and Information Service
HHE
Health Hazard Evaluation
HPV
High Production Volume
Hr
Hour
IMAP
Inventory Multi-Tiered Assessment and Prioritisation
IRIS
Integrated Risk Information System
kg
Kilogram(s)
L
Liter(s)
LOAEL
Lowest Observed Adverse Effect Level
LOEC
Lowest Observed Effect Concentration
lb
Pound(s)
LC50
Lethal Concentration of 50% test organisms
LOEC
Lowest Observed Effect Concentration
Log Koc
Logarithmic Soil Organic Carbon:Water Partition Coefficient
Log Kow
Logarithmic Octanol:Water Partition Coefficient
3
m
Cubic Meter(s)
MADL
Maximum Allowable Dose Level
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mg
Milligram(s)
NOAEL
No Observed Adverse Effect Level
NOEC
No Observed Effect Concentration
ONU
Occupational Non-User
Hg
Microgram(s)
MMA
Monomethylamine
mmHg
Millimeter(s) of Mercury
mPas
Millipascal(s)-Second
MITI
Ministry of International Trade and Industry
SDS
Safety Data Sheet
MSW
Municipal Solid Waste
NAICS
North American Industry Classification System
NESHAP
National Emission Standards for Hazardous Air Pollutants
NICNAS
National Industrial Chemicals Notification and Assessment Scheme
NIOSH
National Institute for Occupational Safety and Health
NITE
National Institute of Technology and Evaluation
NMP
N-Methy lpy rroli done
NSPS
New Source Performance Standards
NWQMC
National Water Quality Monitoring Council
OCSPP
Office of Chemical Safety and Pollution Prevention
OECD
Organisation for Economic Cooperation and Development
OEHHA
Office of Environmental Health Hazard Assessment
OEL
Occupational Exposure Limits
OPPT
Office of Pollution Prevention and Toxics
OSHA
Occupational Safety and Health Administration
PBZ
Personal Breathing Zone
PDE
Permissible Daily Exposure
PDM
Probabilistic Dilution Model
PECO
Populations, Exposures, Comparisons, Outcomes
PEL
Permissible Exposure Limit
POD
Point of Departure
POTW
Publicly Owned Treatment Works
PPE
Personal Protective Equipment
ppm
Part(s) per Million
PSD
Particle Size Distribution
RCRA
Resource Conservation and Recovery Act
REACH
Registration, Evaluation, Authorisation and Restriction of Chemicals
SDWA
Safe Drinking Water Act
SIDS
Screening Information Data Set
SNAP
Significant New Alternatives Policy
STORET
STOrage and RETrieval
SVHC
Substance of Very High Concern
TRI
Toxics Release Inventory
TSCA
Toxic Substances Control Act
TWA
Time-Weighted Average
USGS
United States Geological Survey
VOC
Volatile Organic Compound
WEEL
Workplace Environmental Exposure Level
Yr
Years(s)
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EXECUTIVE SUMMARY
TSCA § 6(b)(4) requires the U.S. Environmental Protection Agency (EPA) to establish a risk evaluation
process. In performing risk evaluations for existing chemicals, EPA is directed to "determine whether a
chemical substance presents an unreasonable risk of injury to health or the environment, without
consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed
or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator under the
conditions of use." In December of 2016, EPA published a list of 10 chemical substances that are the
subject of the Agency's initial chemical risk evaluations ( 7), as required by TSCA §
6(b)(2)(A). N-methylpyrrolidone (NMP) was one of these chemicals.
TSCA § 6(b)(4)(D) requires that EPA publish the scope of the risk evaluation to be conducted, including
the hazards, exposures, conditions of use and potentially exposed or susceptible subpopulations that the
Administrator expects to consider. In June 2017, EPA published the Scope of the Risk Evaluation for
NMP (EPA-HO-OPPT-201.6-0743) As explained in the scope document, because there was insufficient
time for EPA to provide an opportunity for comment on a draft of the scope, as EPA intends to do for
future scope documents, EPA is publishing and taking public comment on the problem formulation
document to refine the current scope, as an additional interim step prior to publication of the draft risk
evaluation for NMP. Comments received on this problem formulation document will inform
development of the draft risk evaluation.
This problem formulation document refines the conditions of use and exposures presented in the scope
of the risk evaluation for NMP and presents refinements to the conceptual models and analysis plan that
describe how EPA expects to evaluate risks.
N-methylpyrrolidone, also called N-methyl-2-pyrrolidone, or l-methyl-2-pyrrolidone, is a high
production volume (HPV) chemical that is widely used during the manufacture and production of
polymers, pharmaceuticals, agrichemicals and petroleum products (U.S. EPA. 2015). For the purposes
of this problem formulation, "NMP" refers to N-methylpyrrolidone (CASRN 872-50-4). NMP is subject
to federal and state regulations and reporting requirements. In terms of federal regulation, NMP has been
a reportable Toxics Release Inventory (TRI) chemical under Section 313 of the Emergency Planning and
Community Right-to-Know Act (EPCRA) since 1995. NMP is also reported under the Toxic Substances
Control Act's Chemical Data Reporting (CDR) Rule. NMP is subject to Clean Air Act (CAA) Section
111 Performance Standards for New Stationary Sources of Air Pollution for volatile organic carbon
(VOC) emissions from synthetic organic chemical manufacturing industry distillation operations and
reactor processes. NMP also is listed under the CAA's National Volatile Organic Compound Emission
Standards for Aerosol Coatings. NMP is identified on both the Third (2009) and Fourth (2016)
Contaminant Candidate Lists under the Safe Drinking Water Act (SDWA).
Information on domestic manufacture, processing and use of NMP is available to EPA through its
Chemical Data Reporting (CDR) Rule, issued under TSCA. In 2015, more than 160 million pounds of
NMP was reported to be manufactured (including imported) in the U.S. According to a recent EPA
market report, the primary uses for NMP include petrochemical processing, engineering plastic coatings,
electronics, pharmaceutical and agrichemical manufacturing and solvent cleaning (EPA-HQ-OPPT-
201.6-0743).
This document presents the potential exposures that may result from NMP conditions of use considered
under the scope of the risk evaluation. Exposures may occur to workers and occupational non-users (i.e.,
workers who do not directly handle NMP but perform work in an area where it is used), consumers and
bystanders (i.e., non-users who are incidentally exposed to NMP as a result of consumer product use)
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and members of the general population. Workers and occupational non-users may be exposed to NMP
during various conditions of use (e.g., manufacturing, processing and industrial/commercial uses).
General population exposures may result from industrial and/or commercial uses; industrial releases to
air, water or land and other conditions of use. EPA expects the highest exposures to NMP will generally
involve workers in industrial and commercial settings; however, NMP occurs in numerous consumer
products and can therefore, result in exposures outside the occupational setting. For NMP, EPA
considers workers, occupational non-users, consumers, bystanders, and certain other groups of
individuals who may experience greater exposures than the general population to be potentially exposed
or susceptible subpopulations. During risk evaluation, EPA expects to further analyze inhalation
exposures to NMP vapor and mist (for workers, occupational non-users, consumers and bystanders).
EPA also expects to analyze dermal exposures from direct contact with NMP-containing liquids (for
workers and consumers) and indirect exposure from vapor-through-skin contact (for workers,
occupational non-users, consumers and bystanders).
NMP has been the subject of numerous assessments with various hazards identified following oral,
dermal and inhalation exposure. Reproductive/developmental effects were identified as sensitive
endpoints for evaluating human health risks in the previous assessment of NMP use in paint and coating
removal (U.S. EPA. 2015). EPA expects to evaluate all potential hazards for NMP, using the previous
analysis as a starting point for identifying key and supporting studies and including any information
found in recent literature. The relevant studies will be evaluated using the data quality criteria provided
in the Application of Systematic Review in TSCA Risk Evaluations document ( ).
Previously identified human health hazards include irritation and adverse effects on hepatic, renal,
immune, reproductive/developmental and central nervous systems. If additional hazard concerns are
identified during systematic review of the literature, these effects will also be considered. Risks will be
evaluated based on the specific hazards and exposure scenarios identified.
The revised conceptual models presented in this problem formulation identify conditions of use;
exposure pathways (e.g., media); exposure routes (e.g., inhalation, dermal, oral); potentially exposed or
susceptible subpopulations; and hazards EPA expects to consider during risk evaluation. The initial
conceptual models provided in the scope document were revised during problem formulation based on
evaluation of reasonably available information for physical and chemical properties, fate, exposures,
hazards, and conditions of use and based upon consideration of other statutory and regulatory
authorities. In each problem formulation document for the first 10 chemical substances, EPA also
refined the activities, hazards, and exposure pathways that will be included in and excluded from the risk
evaluation.
EPA's overall objectives are to conduct timely, relevant, high-quality and scientifically credible risk
evaluations within the statutory deadlines and to evaluate the conditions of use that raise the greatest
potential for risk 82 FR 33726. 33728 (July 20, 2017).
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1 INTRODUCTION
This document presents for comment the problem formulation of the risk evaluation to be conducted for
NMP under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The Frank R.
Lautenberg Chemical Safety for the 21st Century Act amended the Toxic Substances Control Act
(TSCA), the Nation's primary chemicals management law, on June 22, 2016. The new law includes
statutory requirements and deadlines for actions related to conducting risk evaluations of existing
chemicals.
In December of 2016, EPA published a list of 10 chemical substances that are the subject of the
Agency's initial chemical risk evaluations ( ), as required by TSCA § 6(b)(2)(A). These 10
chemical substances were drawn from the 2014 update of EPA's TSCA Work Plan for Chemical
Assessments, a list of chemicals that EPA identified in 2012 and updated in 2014 (currently totaling 90
chemicals) for further assessment under TSCA. EPA's designation of the first 10 chemical substances
constituted the initiation of the risk evaluation process for each of these chemical substances, pursuant to
the requirements of TSCA § 6(b)(4).
TSCA § 6(b)(4)(D) requires that EPA publish the scope of the risk evaluation to be conducted, including
the hazards, exposures, conditions of use and potentially exposed or susceptible subpopulations that the
Administrator expects to consider, within 6 months after the initiation of a risk evaluation. The scope
documents for all first 10 chemical substances were issued on June 22, 2017. The first 10 problem
formulation documents are a refinement of what was presented in the first 10 scope documents. TSCA §
6(b)(4)(D) does not distinguish between scoping and problem formulation, and requires EPA to issue
scope documents that include information about the chemical substance, including the hazards,
exposures, conditions of use, and the potentially exposed or susceptible subpopulations that the
Administrator expects to consider in the risk evaluation. In the future, EPA expects scoping and problem
formulation to be completed prior to the issuance of scope documents and intends to issue scope
documents that include problem formulation.
As explained in the scope document, because there was insufficient time for EPA to provide an
opportunity for comment on a draft of the scope, as EPA intends to do for future scope documents, EPA
is publishing and taking public comment on a problem formulation document to refine the current scope,
as an additional interim step prior to publication of the draft risk evaluation for NMP. Comments
received on this problem formulation document will inform development of the draft risk evaluation.
The Agency defines problem formulation as the analytical phase of the risk assessment in which "the
purpose for the assessment is articulated, the problem is defined and a plan for analyzing and
characterizing risk is determined" [see Section 2.2 of the Framework for Human Health Risk Assessment
to Inform Decision Makings (U.S. EPA. 2014)1. The outcome of problem formulation includes the
conceptual model(s) and an analysis plan. The conceptual model describes the linkages between
stressors and adverse human health effects, including the stressor(s), exposure pathway(s), exposed life
stage(s) and population(s) and endpoint(s) that will be addressed during risk evaluation (U.S. EPA.
2014). The analysis plan follows the development of the conceptual model(s) and is intended to describe
the approach for conducting the risk evaluation, including its design, methods, key inputs and intended
outputs as described in EPA's Human Health Risk Assessment Frame work (U.S. EPA. 2.014). The
problem formulation documents refine the initial conceptual models and analysis plans that were
provided in the scope documents.
EPA identified exposure pathways that are covered under the jurisdiction of regulatory programs and
associated analytical processes carried out under other EPA-administered environmental statutes -
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namely, the Safe Drinking Water Act (SDWA), and the Resource Conservation and Recovery Act
(RCRA) - which EPA does not expect to include in the risk evaluation. As a general matter, EPA
believes certain programs under other Federal environmental laws adequately assess and effectively
manage the risks for those covered exposure pathways. To use Agency resources efficiently under the
TSCA program, to avoid duplicating efforts taken pursuant to other Agency programs, to maximize
scientific and analytical efforts and to meet the three-year statutory deadline, EPA is planning to
exercise its discretion under TSCA 6(b)(4)(D) to focus its analytical efforts on exposures that are likely
to present the greatest concern and consequently merit a risk evaluation under TSCA, by excluding, on a
case-by-case basis, certain exposure pathways that fall under the jurisdiction of other EPA-administered
statutes.1 EPA does not expect to include any such excluded pathways in the risk evaluation. The
provisions of various EPA environmental statutes and their implementing regulations represent the
judgement of Congress and the Administrator, respectively, as to the degree of health and environmental
risk reduction that is sufficient under various environmental statutes.
EPA also identified any conditions of use, hazards, or exposure pathways which were included in the
scope document and that EPA expects to include in the risk evaluation but which EPA does not expect
to further analyze during risk evaluation. EPA expects to be able to reach conclusions about specific
conditions of use, hazards or exposure pathways without further analysis and therefore expects to
conduct no further analysis on those conditions of use, hazards or exposure pathways in order to focus
the Agency's resources on more extensive or quantitative analyses. Each risk evaluation will be "fit-for-
purpose," meaning not all conditions of use will warrant the same level of evaluation and the Agency
may be able to reach some conclusions without comprehensive or quantitative risk evaluations. 82 PR
4 33734, 33739 (July 20, 2017).
EPA received comments on the published scope document for NMP and has considered the comments
specific to NMP in this problem formulation document. EPA is soliciting public comment on this
problem formulation document and when the draft risk evaluation is issued, the Agency intends to
respond to comments that are submitted. In its draft risk evaluation, EPA may revise the conclusions and
approaches contained in this problem formulation, including the conditions of use and pathways covered
and the conceptual models and analysis plan, based on comments received.
1.1 Regulatory History
EPA conducted a search of existing laws and regulations and assessments pertaining to NMP. EPA
compiled information available from federal, state, international and other government sources, as cited
in Appendix A. EPA evaluated and considered the impact of existing laws and regulations (e.g.,
regulations on landfill disposal, design, and operations) during problem formulation to determine what,
if any further analysis might be necessary as part of the risk evaluation. Additional consideration of the
nexus between these existing regulations and TSCA conditions of use may be necessary as specific
exposure scenarios are developed during the analysis phase of the risk evaluation.
Federal Laws and Regulations
NMP is subject to federal statutes or regulations other than TSCA, that are implemented by other offices
within EPA and/or other federal agencies/departments. A summary of federal laws, regulations and
implementing authorities is provided in Appendix A.l.
1 As explained in the final rule for chemical risk evaluation procedures, "EPA may, on a case-by case basis, exclude certain
activities that EPA has determined to be conditions of use in order to focus its analytical efforts on those exposures that are
likely to present the greatest concern, and consequently merit an unreasonable risk determination." 82 FR 33726, 33728 (July
20, 2017).
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State Laws and Regulations
NMP is subject to state statutes or regulations implemented by state agencies or departments. A
summary of state laws, regulations and implementing authorities is provided in Appendix A.2.
Laws and Regulations in Other Countries and International Treaties or Agreements
NMP is subject to statutes or regulations in countries other than the United States and/or international
treaties and/or agreements. A summary of these laws, regulations, treaties and/or agreements is provided
in Appendix A. 3.
1.2 Assessment History
EPA has identified assessments conducted by other EPA Programs and other organizations (see Table
1-1). Depending on the source, these assessments may include information on conditions of use,
hazards, exposures and potentially exposed or susceptible subpopulations. Table 1-1 shows the
assessments that have been conducted. EPA found no additional assessments beyond those listed.
In addition to using this information, EPA intends to conduct a full review of the relevant
data/information collected in the initial comprehensive search [see NMP (CASRN872-50-4)
Bibliography: Supplemental File for the TSCA Scope Document, {\\\ 1 !i t- • i' If * II i )]
following the literature search and screening strategies documented in the Strategy for Conducting
Literature Searches for NMP: Supplemental File for the TSCA Scope Document, EPA-HQ-OPP'T-!
0743). This will ensure that EPA considers all data/information that has been made available since these
assessments were conducted.
Table 1-1. Assessment History of NMP
Authoring Organization
Assessment
EPA Assessments
U.S. EPA, Office of Pollution Prevention and Toxics
(OPPT)
TSCA. Work Plan Chemical Risk Assessment
N-Methylpyrrolidone: Paint Stripping Use
CASRN 872-50-4 U.S. EPA (2015)
U.S. EPA, OPPT
Re-assessment of Pesticide Inert Ingredient
Exemption under the Food Quality Protection
Act U.S. EPA. (2006a)
Other U.S.-Based Organizations
California Office of Environmental Health Hazard
Assessment (OEHHA)
< reposition 65 Maximum Allowable Dose
Level for Reproductive Toxicity OEHHA
(2003)
International
National Industrial Chemicals Notification and
Assessment Scheme (NICNAS), Australian
Government
Human Health Tier III assessment NICNAS
c
Government of Canada, Environment Canada,
Health Canada
Draft Screening Assessment of Risks to Human
and Ecological Recepti
European Commission (EC), Scientific Committee on
Occupational Exposure Limits (OELs)
Evaluation of Occupational Exposure Limits for
NMP EC (2016)
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Authoring Organization
Assessment
Organisation for Economic Co-operation and
Development (OECD), Cooperative Chemicals
Assessment Program
NMP: SIDS Initial Assessment Profile
OECD (2007)
World Health Organization (WHO) International
Programme on Chemical Safety (IPCS)
Concise International Chemical Assessment
Document 35 N-METHYLPYRROLIDONE
WHO (2
Danish Ministry of the Environment
Environmental Protection Agency
Survey of .N liliestyrelsen
(Danish EPA. 2 )
1.3 Data and Information Collection
EPA/OPPT generally applies a systematic review process and workflow that includes: (1) data
collection; (2) data evaluation; and (3) integration of the scientific data used in risk evaluations
developed under TSCA. Scientific analysis is often iterative in nature as new knowledge is obtained.
Hence, EPA/OPPT expects multiple refinements regarding data collection will occur during the process
of risk evaluation. Additional information that may be considered, and was not part of the initial
comprehensive bibliographies will be documented in the Draft Risk Evaluation for NMP.
Data Collection: Data Search
EPA/OPPT conducted chemical-specific searches for information on: physical-chemical properties;
environmental fate and transport; conditions of use; environmental and human exposures; and ecological
and human health hazards, including potentially exposed or susceptible subpopulations.
EPA/OPPT designed its initial data search to be broad enough to capture a comprehensive set of sources
containing data and/or information potentially relevant to the risk evaluation. For most disciplines, the
search was not limited by date and was conducted on a wide range of data sources, including but not
limited to: peer-reviewed and gray literature (e.g., publicly-available industry reports, trade association
resources, government reports). When available, EPA/OPPT relied on the search strategies from recent
assessments to identify relevant references and supplemented these searches to identify relevant
information published after the end date of the previous search to capture more recent literature. Strategy
for Conducting Literature Searches for NMP: Supplemental File for the TSCA Scope Document (EPA-
HQ-OPPT-^ ) provides details about the data sources and search terms used in the literature
search.
Data Collection: Data Screening
Following the data search, references were screened and categorized using selection criteria outlined in
the Strategy for Conducting Literature Searches for NMP: Supplemental File for the TSCA Scope
Document (EPA-HQ-QPPT-20116 0743). Titles and abstracts were screened against the criteria as a first
step with the goal of identifying a smaller subset of the relevant data to move forward into the
subsequent data extraction and data evaluation steps. Prior to full-text review, EPA/OPPT anticipates
refinements to the screening strategies, as informed by an evaluation of the performance of the initial
title/abstract screening and categorization process.
The categorization scheme (or tagging structure) used for data screening varies by scientific discipline
(i.e., physical-chemical properties; environmental fate and transport; chemical use/conditions of use
information; environmental and human exposures, including potentially exposed or susceptible
Page 14 of 135
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subpopulations identified by virtue of greater exposure; human health hazards, including potentially
exposed or susceptible subpopulations identified by virtue of greater susceptibility; and ecological
hazards). However, within each data set, there are two broad categories or data tags: (1) on-topic
references or (2) off-topic references. On-topic references are those that may contain data and/or
information relevant to the risk evaluation. Off-topic references are those that do not appear to contain
data or information relevant to the risk evaluation. The Strategy for Conducting Literature Searches for
NMP: Supplemental File for the TSCA Scope Document (EP A-HQ-QPPT-2016-0743) discusses the
inclusion and exclusion criteria that EPA/OPPT used to categorize references as on-topic or off-topic.
Additional data screening using sub-categories (or sub-tags) was also performed to facilitate further
sorting of data/information. For example, identifying references by source type (e.g., published peer-
reviewed journal article, government report); data type (e.g., primary data, review article); human health
hazard (e.g., liver toxicity, reproductive toxicity); or chemical-specific and use-specific data or
information. These sub-categories are described in the Strategy for Conducting Literature Searches for
NMP: Supplemental File for the TSCA Scope Document (EP A-H.Q-QPP'T-2016-0743) and will be used
to organize the different streams of data during the stages of data evaluation and data integration steps of
systematic review.
Results of the initial search and categorization results can be found in the NMP (CASRN 872-50-4)
Bibliography: Supplemental File for the TSCA Scope Document, (I V * 111 » II I'll '.0 16-0743). This
document provides a comprehensive list (bibliography) of the sources of data identified by the initial
search and categorization for on-topic and off-topic references. Because systematic review is an iterative
process, EPA/OPPT expects that some references may move from on-topic to off-topic categories, and
vice versa. Moreover, targeted supplemental searches may also be conducted to address specific needs
for the analysis phase (e.g., to locate specific data needed for modeling); hence, additional on-topic
references not initially identified in the initial search may be identified as the systematic review process
proceeds.
1.4 Data Screening During Problem Formulation
EPA/OPPT is in the process of completing the full text screening of the on-topic references identified in
the NMP (CASRN 872-50-4) Bibliography: Supplemental File for the TSCA Scope Document, (EPA-
HQ-OPPT-^ ). The screening process and criteria at the full-text level is described in the
Application of Systematic Review in TSCA Risk Evaluations document (U.S. EP \ JO 18). Appendix G
provides the inclusion and exclusion criteria applied at the full text screening. The eligibility criteria are
guided by the analytical considerations in the revised conceptual models and analysis plan, as discussed
in the problem formulation document. Thus, it is expected that the number of data/information sources
entering evaluation is reduced to those that are relevant to address the technical approach and issues
described in the analysis plan of this document.
Following the screening process, the quality of the included data/information sources will be assessed
using the evaluation strategies described in the Application of Systematic Review in TSCA Risk
Evaluations (U.S. EPA. 2018).
Page 15 of 135
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2 PROBLEM FORMULATION
As required by TSCA, the scope of the risk evaluation identifies the conditions of use, hazards,
exposures and potentially exposed or susceptible subpopulations the Administrator expects to consider.
To communicate and visually convey the relationships between these components, EPA included in the
scope document a life cycle diagram and conceptual models that describe the potential relationships
between NMP and human and ecological receptors. During problem formulation, EPA revised the
conceptual models based on further data gathering and analysis as presented in this document. An
updated analysis plan is also included which identifies, to the extent feasible, the approaches and
methods that EPA may use to assess exposures, effects (hazards) and risks associated with the
conditions of use identified for NMP.
2.1 Physical-Chemical Properties
Physical-chemical properties influence the environmental behavior and the toxic properties of a
chemical, thereby informing the potential conditions of use, exposure pathways, routes and hazards that
EPA intends to consider. During problem formulation, EPA considered the measured or estimated
physical-chemical properties set forth in Table 2-1. The value reported for vapor pressure was updated
(0.345 mmHg) to reflect information obtained from a primary source, which is considered more
defensible than the original value (0.19 mmHg) taken from a secondary source.
Table 2-1. Physical-Chemical Properties of NMP
Property
Value a
Reference
Molecular formula
C5H9ON
Molecular weight
99.1 g/mole
O'Neil et al. (2.006)
Physical form
Colorless to yellow liquid; amine odor
O'Neil et al. (2006)
Melting point
-25°C
Ashf '94)
Boiling point
202°C
O'Neil et al. (2006)
Density
1.03 at 25°C
O'Neil et al. (2006)
Vapor pressure
0.345 mmHg at 25°C
Daubert and Banner (1989)
Vapor density
3.4 (air = 1)
Z)
Water solubility
1,000 g/L at 25°C
O'Neil et al. (2006)
Octanol:water partition
coefficient (log Kow)
- 0.38 at 25°C
Sasaki et al. (1988)
Henry's Law constant
3.2 x 10"9 atm mVmole
>012b)
Flash point
95°C (open cup)
Riddick et al < !,}N6)
Autoflammability
Not available
Viscosity
1.65 mPa-sat25°C
O'Neil et al. (2006)
Refractive index
Not applicable
Dielectric constant
Not applicable
"Measured unless otherwise noted.
-------
2.2 Conditions of Use
TSCA § 3(4) defines the conditions of use as "the circumstances, as determined by the Administrator,
under which a chemical substance is intended, known, or reasonably foreseen to be manufactured,
processed, distributed in commerce, used, or disposed of."
2.2.1 Data and Information Sources
In the scope documents, EPA identified, based on reasonably available information, the conditions of
use for the subject chemicals. EPA searched available data sources (e.g., Use and Market Profile for
NMP, 'P'T-201.6-0743). Based on this search, EPA published a preliminary list of
information and sources related to chemical conditions of use (see Preliminary Information on
Manufacturing, Processing, Distribution, Use, and Disposal: NMP, EP A-HQ-OPPT-2016-0743-0003)
prior to a February 2017 public meeting on scoping efforts convened to solicit comment and input from
the public. EPA also convened meetings with companies, industry groups, chemical users and other
stakeholders to aid in identifying conditions of use and verifying conditions of use identified by EPA.
The information and input received from the public and stakeholder meetings was incorporated into this
problem formulation document to the extent appropriate, as indicated in Table 2-3. Thus, EPA believes
the identified manufacturing, processing, distribution, use and disposal activities constitute the intended,
known, and reasonably foreseen activities associated with the subject chemical, based on reasonably
available information.
2.2.2 Identification of Conditions of Use
To determine the current conditions of use of NMP and conversely, activities that do not qualify as
conditions of use, EPA conducted extensive research and outreach. This included EPA's review of
published literature and online databases including the most recent data available from EPA's Chemical
Data Reporting program (CDR) and Safety Data Sheets (SDSs). EPA also conducted online research by
reviewing company websites of potential manufacturers, importers, distributors, retailers, or other users
of NMP and queried government and commercial trade databases. EPA also received comments on the
Scope of the Risk Evaluation for NMP (EPA-HQ-CX that were used to determine the
conditions of use. In addition, EPA convened meetings with companies, industry groups, chemical users,
states, environmental groups, and other stakeholders to aid in identifying and verifying the conditions of
use identified by EPA. Those meetings included a February 14, 2017 public meeting with such entities
CEPA-HO-OPP'
EPA has removed from the problem formulation any conditions of use that EPA does not plan to include
in the risk evaluation - for example because EPA has insufficient information to find certain activities
are circumstances under which the chemical is actually "intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used or disposed of." EPA has also identified any
conditions of use that EPA does not expect to include in the risk evaluation. As explained in the final
rule for Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act,
TSCA section 6(b)(4)(D) requires EPA to identify "the hazards, exposures, conditions of use, and the
potentially exposed or susceptible subpopulations that the Administrator expects to consider" in a risk
evaluation, suggesting that EPA may exclude specific activities that EPA has determined to be
conditions of use on a case-by-case basis. (82 FR 33736, 33729; July 20, 2017). For example, EPA may
exclude conditions of use that the Agency has sufficient basis to conclude would present only de
minimis exposures or otherwise insignificant risks (such as use in a closed system that effectively
precludes exposure, or use as an intermediate).
Page 17 of 135
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The activities that EPA no longer believes are conditions of use or that were otherwise excluded during
problem formulation are described in Section 2.2.2.1. The conditions of use included in the scope of the
risk evaluation are summarized in Section 2.2.2.2
2.2.2.1 Categories and Subcategories Determined Not to be Conditions of Use or
Otherwise Excluded During Problem Formulation
Based on the foregoing research and outreach, EPA does not have reason to believe that any conditions
of use identified in the NMP Scope document should be excluded from the risk evaluation.
Table 2-2. Categories and Subcategories Determined Not to be Conditions of Use or Otherwise
Excluded During Problem Formulation
l.il'e Cycle Stage
Category 11
Subcategory h
References
No activities were
excluded from risk
evaluation.
2.2.2.2 Categories and Subcategories of Conditions of Use Included in the Scope of
the Risk Evaluation
For NMP, EPA has conducted public outreach and literature searches to collect information about
NMP's conditions of use and has reviewed reasonably available information obtained by EPA
concerning activities associated with NMP. Based on this research and outreach, EPA does not have
reason to believe that any conditions of use identified in the NMP scope should be excluded from risk
evaluation. Therefore, all NMP conditions of use will be included in the risk evaluation.
NMP is widely used in the manufacture and production of electronics, petroleum products,
pharmaceuticals, polymers and other specialty chemicals. It also has numerous applications in paints,
coatings, and adhesives as well as products that facilitate their removal.
Table 2-3 summarizes each life cycle stage and the corresponding categories and subcategories of
conditions of use for NMP that EPA expects to consider during risk evaluation. Using the 2016 CDR
(U.S. EPA. 2016b). EPA identified industrial processing or use activities, industrial function categories
and commercial and consumer use product categories. EPA identified the subcategories by
supplementing CDR data with other published literature and information obtained through stakeholder
consultations. For risk evaluations, EPA intends to consider each life cycle stage (with corresponding
use categories and subcategories) and assess the potential sources of release and related exposures
associated with that life cycle stage.
Beyond the uses identified in the Scope of the Risk Evaluation for NMP ( EPA-1H
EPA has received no additional information identifying additional current conditions of use for NMP
from public comment and stakeholder meetings.
Table 2-3. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
l.ile Cycle
Stage
Category "
Subcategory h
References
Manufacture
Domestic
Manufacture
Domestic Manufacture
2.016b)
Page 18 of 135
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1 .ile Cycle
S(si«c
CsiU'gorv 11
Siihc:iU'«or\ h
UofomuTs
Import
Import
Processing
Processing as a
reactant or
intermediate
Intermediate in Plastic Material
and Resin Manufacturing and in
Pharmaceutical and Medicine
Manufacturing
U.S. EPA. (2.016b).
Public comments EPA-HO-
OPPT-2016-0743-0010. EP A-
HO-nfl * o i -0015.
EPA-HO-QPH -_Vi 0 IP
0017
Other
2.016b)
Incorporated into
formulation,
mixture or reaction
product
Adhesives and sealant chemicals
in Adhesive Manufacturing
2016b). Market
profile EPA-HO-OPPT-2016-
0743, Public comments EPA-
HO-OPI -0007.
EP A-HO-OPPT-2016-0743 -
0009. EP A-HO-OPPT-2016-
0 -C< 001 1
Anti-adhesive agents in Printing
and Related Support Activities
U.S. EPA. (2.016b). Market
profile EP A-HO-OPPT-2016-
0743
Paint additives and coating
additives not described by other
codes in Paint and Coating
Manufacturing; and Print Ink
Manufacturing
2016b). Market
profile PPT-2016-
0743, Public comments EPA-
HO-OPI -0007.
EP A-HO-OPPT-2016-0743 -
0009. EP A-HO-OPPT-2016-
Plating agents and surface
treating agents in Fabricated
Metal Product Manufacturing
2.016b)
Processing
Incorporated into
formulation,
mixture or reaction
product
Processing aids, not otherwise
listed in Plastic Material and
Resin Manufacturing
2016b).
Public comments EPA-HO-
OPP'l' :0 k--0 '4.'. 00t\ I PA
HO-nn \ _*m o s.-oor.
EP A-HO-OPPT-2016-0743 -
0o , \ 1 \ 'H'lM •
0743-0038
Page 19 of 135
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1 .ile Cycle
S(si«c
(si logon 11
Siihc:iU'«or\ h
UofomuTs
Sol\ cuts (lor cleaning or
degreasing) in Non-Metallic
Mineral Product Manufacturing;
Machinery Manufacturing;
Plastic Material and Resin
Manufacturing; Primary Metal
Manufacturing; Soap, Cleaning
Compound and Toilet
Preparation Manufacturing;
Transportation Equipment
Manufacturing; All Other
Chemical Product and
Preparation Manufacturing;
Printing and Related Support
Activities; Services; Wholesale
and Retail Trade
. Market
profile EPA-HO-OPPT-2016-
0743, Public comments EPA-
HO-OPFI-.01 1 -0010.
EPA-HO-OPPT-2016-0743 -
001 1. H> \ Ut M WT-2016-
K ^ . U \ 110-0PPT-
3028
Solvents (which become part of
product formulation or mixture)
in Electrical Equipment,
Appliance and Component
Manufacturing; Other
Manufacturing; Paint and
Coating Manufacturing; Print Ink
Manufacturing; Soap, Cleaning
Compound and Toilet
Preparation Manufacturing;
Transportation Equipment
Manufacturing; All Other
Chemical Product and
Preparation Manufacturing;
Printing and Related Support
Activities; Wholesale and Retail
Trade
>016b). Market
profile EPA-HO-OPPT-2016-
0743, Public comments EPA-
HO-OPI -0007.
EPA-HO-OPPT-2016-0743 -
0009. EPA-HO-OPPT-2016-
0743-0010. EP A-HO-OPPT-
.or imi s, a \
OPPT-2016-0743-0019. EP A-
HO~( -0024.
EPA-HO-0]vri -:oi o
!. ip \ n'PT-2016-
0/ L'< 0034
Processing
Incorporated into
formulation,
mixture or reaction
product
Surface active agents in Soap,
Cleaning Compound and Toilet
Preparation Manufacturing
>016b). Market
profile EPA-HO-OPPT-2016-
0743
Other uses in Oil and Gas
Drilling, Extraction and Support
Activities; Plastic Material and
Resin Manufacturing; Services
U.S. EPA (2016b). Market
profile EPA-HO-OPPT-2016-
0743, Public comment EPA-
HO-OPPT-2016-0743-001 o
Page 20 of 135
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l-ifc Cycle
Slsige
(si lego rv 11
SuhcsiU'gorv h
UofomuTs
Incorporated into
article
1 .iihi'icanls and lubricant
additives in Machinery
Manufacturing
. Market
profile EPA-HO-OPPT-2016-
0743
Paint additives and coating
additives not described by other
codes in Transportation
Equipment Manufacturing
2.016b)
Solvents (which become part of
product formulation or mixture),
including in Textiles, Apparel
and Leather Manufacturing
U.S. EPA. (2016b).
Market profile T-
"in."- ! , Public comment
EPA-HO-OPPT-2016-0743 -
Other, including in Plastic
Product Manufacturing
JO 16b). Market
profile EPA-HO-OPPT-2016-
0743; EPA-HO-OF
67
Repackaging
Wholesale and Retail Trade
Ml 6b)
Recycling
Recycling
JO 17b). U.S. EPA
(2016b), Public comments
EPA-HO-OPPT-2016-0743 -
ooi , n» \ uo ovv\ •
Distribution
in commerce
Distribution
Distribution in Commerce
2017b). U.S. EPA
(2016b); Use document EPA-
HO-OPI -0003
Industrial
commercial
and
consumer
Paints and coatings
Paint and coating removers
2016b). Market
profile EPA-HO-OPPT-2016-
0743, Public comments EPA-
HO-OPPT-: -0008.
use
EPA-HO-OPPT-2016-0743 -
0010. EPA-HO-OP
o i . ooi i, h * v M I»T-
0018. EPA-HO-
Ol-IM A«t 0 I.; 0023. EPA-
HO-< -0025.
EPA-HO-OPPT-2016-0743 -
Adhesive removers
Market profile T-
11II • ¦ 111 4 , Public comments
EPA-HO-OPPT-2016-0743 -
Page 21 of 135
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l-ifc Cycle
Slsige
(si lego rv 11
SuhcsiU'gorv h
UofomuTs
0743-0018
Lacquers, stains, varnishes,
primers and floor finishes
Market profile T-
1111 >¦> -¦1 ! , Public comments
EP A-HO-OPPT-2016-0743 -
0018. EP A-HO-OPPT-2016-
<< i r \ uo «*ri» \
0035
Powder coatings (surface
preparation)
Market profile T-
2016-0743. Public comments
PPT-2016-0743-
0016
Paint additives and
coating additives
not described by
other codes
Paint additives and
coating additives
not described by
other codes
Use in Computer and Electronic
Product Manufacturing,
Construction, Fabricated Metal
Product Manufacturing,
Machinery Manufacturing, Other
Manufacturing, Paint and
Coating Manufacturing, Primary
Metal Manufacturing,
Transportation Equipment
Manufacturing, Wholesale and
Retail Trade
>016b).
Public comments EPA-HO-
OPPT-2' 3006. EPA-
-0007.
EP A-HO-OPPT-2016-0743 -
0009. EPA-HO-OP
0:11 001 \,tV\ orPT-
0 1 , n \
< M j 1 1 ^V|\ I J \
HO-nn \ 0 1 .-0011'.
EP A-HO-OPPT-2016-0743 -
0023. EPA-HO-OP
u s « i, \ . M PT-
0027. EPA-HO-
Ol-IM A«t 0 1; 0031. EPA-
HO-< -0032.
EP A-HO-OPPT-2016-0743 -
00, . < r \ OPPT-2016-
<< -H fM36.EPA-H'^ '1 PT-
0063; EPA-HO-
OPPT-2016-0743-0064
Industrial
commercial
and
consumer
use
Solvents (for
cleaning or
degreasing)
Use in Electrical Equipment,
Appliance and Component
Manufacturing.
Public comments EPA-HO-
OPP' 3006. EPA-
HO-OPPT-2016-0743-0007.
EP A-HO-OPPT-2016-0743 -
0009. EPA-HO-OP
<< -H i'm; ,!l' \ do «*ri» \
:vi
OPPT-2016-0743-0027
Ink, toner and
colorant products
Printer ink
2.016b). Use
document. EPA-HO-O
Page 22 of 135
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l-ifc Cycle
Slsige
(si lego rv 11
SuhcsiU'gorv h
UofomuTs
Processing aids,
specific to
petroleum
production
Processing aids,
specific to
petroleum
production
. Public
comments EPA-HO-OPPT-
6. EPA-HO-
< M j 1 j'LiV' 1 016b). Market
profile EPA-HO-OPP'T-2016-
0743, Public comment EPA-
HO-OPPT-201 * 07 IJ -001S
Petrochemical Manufacturing
>016b).
Public comment, EPA-HO-
OPP'r :oic-o -00.*. i
Adhesives and
sealants
Adhesives and sealant chemicals
including binding agents
>016b). Market
profile EPA-HO-OPPT-2016-
0743, Public comments EPA-
HO-OPI -0006.
EPA-HO-OPPT-2016-0743 -
0743-00* < . U' \ i-M OVV\
o i r \
< M j 1 1 ^Vl 1, I j \
HO-'
0016EPA-H
o ^ oo! , M \ orPT-
2016-0743 -001 SEP A-HO-
< M j 1 1 I J \
HO-OPPT-2016-0743 -0023
Industrial
commercial
and
consumer
use
Adhesives and
sealants
Single component glues and
adhesives, including lubricant
adhesives
JO 16b). Market
profile EPA-HO-OPPT-2016-
0743. Public comments EPA-
ho-opp i _vi • ^ n.oot i.
epa-ho-o:
0018. EPA-HO-OP
o i, oo \ ; i ^ U0 v M PT-
0036
Two-component glues and
adhesives, including some resins
U.S. EPA (2016b). Market
profile EPA-HO-OPP'T-2016-
0743, Public comments EPA-
HO-OPI I -.01 1 -001 1.
EPA-HO-OPPT-2016-0743 -
0016. EPA-HO-OPPT-2016-
0/ L'< 00IS,
Page 23 of 135
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1 .ile Cycle
S(si«c
CsiU'gorv 11
Siihc:iU'«or\ h
UofomuTs
Soldering niiilciials
Market profile
2 , Public comments
EP A-HO-OPPT-2016-0743 -
0023
Other uses
Anti-freeze and de-icing products
>016b)
Automotive care products
1016b). Public
comment,
epa-ho-o:
Lubricants and greases
>016b)
Metal products not
covered elsewhere
>016b).
Public comment,
EP A-HO-OPPT-2016-0743 -
0027. EPA-HO-OP
07 sj 0028 Public comment,
EP A-HO-OPPT-2016-0743 -
0027. EP A-HO-OPPT-2016-
0 -C< 002.8
Laboratory chemicals
U.S. EPA (2016b).
Public comments EPA-HO-
OPPT-2016-0743-0007. EP A-
HO-< -0009
Industrial
commercial
and
consumer
use
Other uses
Lithium ion batteries
Market profile T-
, Public comment
EP A-HO-OPPT-2016-0743 -
0005
Cleaning and furniture care
products, including wood
cleaners, gasket removers
Market profile T-
2 , Public comment
EP A-HO-OPPT-2016-0743 -
0025. EPA-HO-OP
Other uses in Oil and Gas
Drilling, Extraction and Support
Activitiesc
>016b).
Lubricant and lubricant additives,
including hydrophilic coatings
Market profile T-
2016-0743
Fertilizer and other agricultural
chemical manufacturing -
processing aids and solvents
>016b).
Public comment EPA-HO-
OPPT-2mj-o 1 ^vk<. 5 J \
HO-OPPT-2016-0743 -003 6
Page 24 of 135
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1 .ile Cycle
S(si«c
CsiU'gorv 11
Siihc:iU'«or\ h
UofomuTs
Pharmaceutical and Medicine
Manufacturing - functional fluids
(closed systems)
Public comment
EP A-HG-GPPT-2016-0743 -
003 I
Wood preservatives
Market profile I-
2016-0743. Public comment
PPT-2016-0743-
0023
Disposal
Disposal
Industrial pre-treatment
>017b)
Industrial wastewater treatment
Publicly owned treatment works
(POTW)
Ml 7b)
Underground injection
Ml 7b).
Public comment EPA-HO-
OPPT-21
Landfill (municipal, hazardous or
other land disposal)
Emissions to air
Incinerators (municipal and
hazardous waste)
a These categories of conditions of use appear in the life cycle diagram, reflect CDR codes and broadly represent NMP
conditions of use in industrial and/or commercial settings.
b These subcategories reflect more specific uses of NMP.
0 Industrial use added to reflect the use of NMP in products in the Oil and Gas Drilling, Extraction This addition to the risk
evaluation will help ensure that EPA determines whether NMP presents an unreasonable risk "under the conditions of use,"
TSCA 6(b)(4)(A).
Although the NMP Scope Document indicated that uses assessed in the 2015 risk assessment would not
be re-evaluated (EPA-HQ-OPPT 2016-0743). EPA has decided to include these conditions of use in the
risk evaluation as described in this problem formulation. EPA is including these conditions of use so that
they are part of EPA's determination of whether NMP may present an unreasonable risk "under the
conditions of use," TSCA 6(b)(4)(A). EPA has concluded that the Agency's assessment of the potential
risks from this widely used chemical will be more robust if the risks from these conditions of use are
evaluated by applying the standards and guidance provided under amended TSCA. This includes
ensuring the evaluation is consistent with the scientific standards in Section 26 of TSCA, the Procedures
for Chemical Risk Evaluation under the Amended Toxic Substances Control Act (40 CFR Part 702) and
EPA's supplemental document, Application of Systematic Review in TSCA Risk Evaluations (
2018). EPA also expects to consider other available hazard and exposure data to ensure that all
reasonably available information is taken into consideration. It is important to note that conducting these
evaluations does not preclude EPA from finalizing the proposed NMP regulation (K ).
Page 25 of 135
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2.2.2.3 Overview of Conditions of Use and Life Cycle Diagram
The life cycle diagram provided in Figure 2-1 depicts the conditions of use that are considered within
the scope of the risk evaluation during various life cycle stages including manufacturing, processing,
distribution, use (industrial, commercial, and consumer) and disposal. Additions or changes to
conditions of use based on additional information gathered or analyzed during problem formulation are
described further in Sections 2.2.2.1 and 2.2.2.2. The information is grouped according to Chemical
Data Reporting (CDR) processing codes and use categories (including functional use codes for industrial
uses and product categories for industrial, commercial and consumer uses), in combination with other
data sources (e.g., published literature and consultation with stakeholders), to provide an overview of
conditions of use. EPA notes that some subcategories of use may be grouped under multiple CDR
categories.
Use categories include the following: "industrial use" means use at a site at which one or more
chemicals or mixtures are manufactured (including imported) or processed. "Commercial use" means
the use of a chemical or a mixture containing a chemical (including as part of an article) in a commercial
enterprise providing saleable goods or services. "Consumer use" means the use of a chemical or a
mixture containing a chemical (including as part of an article, such as furniture or clothing) when sold to
or made available to consumers for their use (U.S. EPA. 2016b).
To understand conditions of use relative to one another and the associated exposure potential under
those conditions of use, the life cycle diagram includes the production volume associated with each
stage of the life cycle, as reported during the 2016 CDR reporting period (U.S. EPA. 2016b). when the
volume was not claimed confidential business information (CBI).
The 2016 CDR reporting data for NMP are provided in Table 2-4 from EPA's CDR database. This
information has not changed from that provided in the scope document.
Table 2-4. Production Volume of NMP in
CDR Reporting Period (2012 to 2015
a
Reporting Year
2012
2013
2014
2015
Total Aggregate
Production Volume (lbs)
164,311,844
168,187,596
171,095,221
160,818,058
" The CDR data for the 2016 rcDortinu period is available via ChemView dittos://itrva.eDa.eov/chemviewN) ("U.S. EPA.
20.1.6b). Because of an ongoing CBI substantiation process required by amended TSCA, the CDR data available in the scope
document is more specific than currently in ChemView.
Descriptions of the industrial, commercial and consumer use categories identified from the 2016 CDR
(U.S. EPA. 2016b) and included in the life cycle diagram are summarized below. The descriptions
provide a brief overview of the use category; Appendix B contains more detailed descriptions (e.g.,
process descriptions, worker activities, process flow diagrams, equipment illustrations) for each
manufacture, processing, use and disposal category. The descriptions provided below are primarily
based on the corresponding industrial function category and/or commercial and consumer product
category descriptions from the 2016 CDR and can be found in EPA's Instructions for Reporting 2016
ISC A Chemical Data Reporting (U.S. EPA. 2016a).
The "Paints and Coatings" category encompasses chemical substances contained in products that are
used in a variety of coatings including paints, glazes, grouts, hydrophilic coatings, stains and wood
preservatives. Removers of paints and coatings also fall into this category. Products in this category
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have applications in industrial, commercial and consumer settings and are available in both liquid and
aerosol formulations.
The "Solvents for Cleaning and Degreasing" category encompasses various chemical substances used
to dissolve oil, grease and similar materials from a variety of substrates including metal surfaces,
glassware and textiles. This category includes industrial, commercial and consumer uses of NMP for
cleaning electrical equipment, gaskets, leather and other textiles, as well as a variety of other substrates.
This category also includes chemical substances used as solvents during the production of electronic
products and lithium ion batteries. Most NMP formulations in this category are liquid, but aerosol
cleaning formulations are also available.
The "Ink, Toner and Colorant Products" category encompasses chemical substances that are
contained in products used for printer inks and toners. Specifically, NMP can be found as a component
of ink thinners, weather resistant markers for polyurethane tags and inks used in 3D printers. NMP is
also found in inks used within industrial, commercial and consumer settings, and is typically formulated
as a liquid.
The "Processing Aids, Specific to Petroleum Production" category encompasses chemical substances
which are used to aid in the production of petrochemical, plastic and rubber products. This category is
primarily industrial, and formulations are liquid.
The "Adhesives and Sealants" category encompasses chemical substances contained in adhesive and
sealant products used to fasten other materials together. NMP is used as an adhesive or sealant for a
wide variety of products including: pressure-sensitive adhesives, polyurethane curatives, floor sealants
and sealants for automotive parts. These products have industrial, commercial and consumer
applications and can be found in liquid, solid and aerosol formulations.
The "Other uses" category covers a wide variety of products containing NMP, including automotive
care products, deicers as well as NMP use in laboratory settings. EPA notes that some of the uses
identified for NMP may be considered critical to national security. These uses and their importance to
national security will be considered during the risk evaluation, and as part of any resulting regulatory
actions the Agency may deem necessary to protect human health and the environment.
Figure 2-1 depicts the life cycle diagram of NMP, from manufacturing to the point of disposal.
Activities related to distribution (e.g., loading, unloading) will be considered throughout the NMP life
cycle, rather than using a single distribution scenario.
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MFG/IMPORT
PROCESSING
Manufacturing
(Includes Import)
(161 million lbs)
Processing as
Reactant/lntermediate
(Volume CBI)
e.g., high-temperature polymers
Incorporated into
Formulation, Mixture, or
Reaction Products
(> 3.08 million lbs)
e.g., paints, cleaners, adhesives
Incorporated into Article
(> 170,000 lbs)
e.g., machinery, plastics,textiles
Repackaging
(Volume CBI)
e.g., wholesaleand retail trade
Recycling
e.g., recovered and
reclaimed solvents
INDUSTRIAL, COMMERCIAL, CONSUMER USES 3
~
RELEASES and WASTE DISPOSAL
Paints and Coatings
(>728,000 lbs)
e.g., paint removal
Solvents for Cleaning and
Degreasing
(>521,000 lbs)
e.g., photoresist removal/cleaner,
sealant remover, cleaner, aerosol
foaming cleaner
Ink, Toner and Colorant products
(181,000 lbs)
e.g., printer ink
Processing Aids, Specific to
Petroleum Production
(>3,080 lbs)
Adhesives and Sealants
(> 1,760 lbs)
e.g., adhesive, automotive seam sealer
Other Uses
e.g., laboratory chemicals; fabric, textile
and leather products; arts, crafts and
hobby materials; toys, playground and
sporti ng goods/eq u i pment
Disposal
See Figure 2-4 for Environmental Releases and
Wastes
Manufacturing(includes import)
Processing
Uses. At the scope level of detail in the life
cycle diagram, we are not distinguishing
between industria l/commere ial/consumer
uses.The differences between these uses
will be further investigated and defined
during risk evaluation.
Figure 2-1. NMP Life Cycle Diagram
The life cycle diagram depicts the conditi ons of use that are within the scope of the risk evaluation during various life cycle stages including
manufacturing, processing, distribution, use and disposal. The production volumes shown are for reporting year 2015 from the 2016 CDR
reporting period ( J.S. EPA. 2016b). Activities related to distribution (e.g., loading, unloading) will be considered throughout the NMP life
cycle, rather than using a single distribution scenario.
a See Table 2-3 for additional uses not mentioned specifically in this diagram.
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2.3 Exposures
For TSCA exposure assessments, EPA expects to evaluate exposures and releases to the environment
resulting from the conditions of use applicable to NMP. Post-release pathways and routes will be
described to characterize the relationship or connection between the conditions of use for NMP and the
exposure to receptors, including potentially exposed or susceptible subpopulations and ecological
receptors. EPA will take into account, where relevant, the duration, intensity (concentration), and
frequency of exposures in characterizing exposures to NMP.
2.3.1 Fate and Transport
Environmental fate includes both transport and transformation processes. Environmental transport is the
movement of the chemical within and between environmental media. Transformation occurs through the
degradation or reaction of the chemical with other species in the environment. Hence, knowledge of the
environmental fate of the chemical informs the determination of the specific exposure pathways and
potential human and ecological receptors EPA expects to consider during risk evaluation. Table 2-5
provides environmental fate data that EPA identified and considered in developing the scope for NMP.
This information has not changed from that provided in the scope document.
During problem formulation, fate data including information pertaining to volatilization during
wastewater treatment, volatilization from lakes and rivers, biodegradation rates and the organic
carbon:water partition coefficient (log Koc) were used when considering changes to the conceptual
models. Model results and basic principles were used to support the fate data while relevant literature is
evaluated via the systematic review process.
EPI Suite™ modules were used to predict volatilization of NMP from wastewater treatment plants,
lakes, and rivers ( 012b). The EPI Suite™ module that estimates chemical removal in
sewage treatment plants ("STP" module) was run using default settings to evaluate the potential for
NMP to biodegrade, volatilize to air or adsorb to sludge during wastewater treatment. The STP module,
using BIOWIN predictions for biodegradation rates, estimates that most (> 90%) of the NMP releases to
wastewater will be removed by biodegradation. BIOWIN model predictions further indicate negligible
(< 1%) removal of NMP via adsorption to sludge or volatilization to air.
The EPI Suite™ module that estimates volatilization from lakes and rivers ("Volatilization" module)
was run using default settings to evaluate the potential for NMP to volatilize from surface water. The
input parameters required for estimating the volatilization (evaporation) rate of an organic chemical
from a water body are water depth, wind speed and current velocity of a river or lake. The model results
indicate that volatilization from surface water is unlikely to be a significant removal pathway for NMP
(U.S. EPA. 2012b). Aerobic biodegradation is expected to be the primary removal pathway for NMP in
many surface water environments based on measured data (see Table 2-5).
Experimental data and EPISuite™ model predictions indicate that NMP will degrade in aerobic
environments ( 2012b); however, the BIOWIN module within EPISuite™ that estimates
anaerobic biodegradation potential (BIOWIN 7) predicts that NMP will not rapidly biodegrade under
anaerobic conditions. These model predictions are consistent with previous NMP assessments (OECD.
2.007; WHO. 20m. * ^ \ 98b).
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Table 2-5. Environmental Fate Characteristics of NMP
Property or Endpoint
Value a
Reference
Direct photo-degradation
Not available
Indirect photo-degradation
5.8 hours (estimated for atmospheric degradation)
U.S. EPA a
Hydrolysis half-life
Does not undergo hydrolysis
U.S. EPA a
Biodegradation
99% (duration not indicated) (aerobic in water,
coupled-units)
50% in < 12 days (aerobic in soil)
95% removal in 2 weeks (aerobic in static die-
away system test, sewage sludge inoculum, OECD
301A)
95% in 7 days (SCAS, OECD 303A)
U.S. EPA (1998b)
73%) in 28 days (aerobic in water, Modified
Ministry of International Trade and Industry
(MITI), OECD 301C)
91-97%) in 28 days (aerobic, Sturm, OECD 301B)
98%o in 4 days (aerobic in water and sludge, Zahn-
Wellens, OECD 302B)
88%o in 30 days (closed-bottle test, OECD 301D)
99% in 19 days (modified screening, OECD 301E)
I S f-T\L>0tS
Bioconcentration factor
(BCF)
3.16 (estimated)
! ? ; f. \
Bioaccumulation factor
(BAF)
0.9 (estimated)
U.S. EPA (2.012b)
Soil organic carbon/water
partition coefficient
(log Koc)
0.9 (estimated)
I S t-T \ « 2012b)
a Measured unless otherwise noted.
NMP does not persist in the environment. Upon release into the atmosphere, it is expected to biodegrade
via reaction with photo-chemically produced hydroxyl radicals in ambient air. The half-life for this
reaction is approximately 5.8 hours, assuming a hydroxyl radical concentration of 1.5 x 106 hydroxyl
radicals/cm3 air and a 12-hour day ( 015). NMP is hygroscopic and can dissolve in water
droplets. Atmospheric releases may be removed via condensation, wet deposition or further reaction
with hydroxyl radicals.
Although neat (pure) NMP is slightly volatile, volatilization from water and moist soils is not likely
based on its Henry's Law constant (3.2 x 10"9 atm mVmole). NMP is not expected to adsorb to
suspended solids or sediment upon release to water due to its estimated soil organic carbon/water
partition coefficient (log Koc = 0.9). NMP exhibits high mobility in soil; hence, environmental releases
are expected to migrate from soil to ground water (U.S. EPA. 2.012b).
NMP exhibits low potential for bioaccumulation in the environment. Measured bioconcentration studies
for NMP were not presented in EPA's previous evaluation of risks associated with NMP use in paint and
coating removal (U.S. EPA. 2.015); however, based on the estimated BAF and BCF values (0.9 and 3.16,
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respectively), NMP is not expected to bioaccumulate or bioconcentrate in aquatic organisms (U.S. EPA.
2012b. 1999); OECD, 2007, 3809443}.
2.3.2 Releases to the Environment
Releases to the environment from conditions of use (e.g., industrial and commercial processes,
commercial or consumer uses resulting in down-the-drain releases) are one component of potential
exposure and may be derived from reported data that are obtained through direct measurement,
calculations based on empirical data and/or assumptions and models.
A source of information EPA expects to consider for evaluating exposures are data reported under the
Toxics Release Inventory (TRI) program. Under the Emergency Planning and Community Right-to-
Know Act (EPCRA) Section 313, NMP is a TRI-reportable substance effective January 1, 1995. During
problem formulation EPA further analyzed the TRI data and examined the definitions of elements in the
TRI data to determine the level of confidence that a release would result from specific types of disposal
to land (e.g., RCRA Subtitle C hazardous landfill and Class I underground Injection wells) and
incineration. EPA also examined how NMP is treated at industrial facilities.
Table 2-6 provides production-related waste management data (also referred to as waste managed) for
NMP reported by industrial facilities to the TRI program for 2015. Table 2-7 provides more detailed
information on the actual quantities of NMP released to air and water or disposed of on land.
Table 2-6. Summary of NMP TRI Production-Related Waste Managed in 2015 (lbs)
Number of
Facilities
Recycling
Energy
Recovery
Treatment
Releases a'b'c
Total Production
Related Waste
386
47,453,751
7,603,919
14,944,336
8,807,902
78,819,909
Data source: 2015 TRI Data (undated March 2017) (U.S. EPA. 2017b).
a 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 a one-time event not associated with production such as remedial actions or earthquakes.
0 Counts all releases including release quantities transferred and those disposed of by a receiving facility reporting to TRI.
In 2015, 386 facilities reported a total of 78.8 million pounds of NMP waste managed. Of this total, over
47.5 million pounds of NMP were recycled; 34 TRI facilities reported recycling NMP on-site and 85
facilities reported distribution of NMP off-site for recycling, representing approximately 60% of the
total waste managed. In addition, approximately 7.6 million pounds of NMP was used for energy
recovery; 14.9 million pounds were treated and 8.8 million pounds were released to the environment.
Table 2-7. Summary of NMP TRI Releases to the Environment in 2015 (lbs
Number
of
Facilities
Air Releases
Water
Releases
Land Disposal
Other
Releases b
Total
Releases c
Stack
Air
Releases
Fugitive
Air
Releases
Class I
Under-
ground
Injection
RCRAa
Subtitle C
Landfills
All other
Land
Disposalb
Subtotal
884,851
542,101
3,625,939
93,217
2,719,441
Total
386
1,426,952
14,092
6,438,597
28,099
8,108,070
Data source: 2015 TRI Data (undated March 2017) (U.S. EPA. 2017b).
a RCRA (Resource Conservation and Recovery Act)
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Number
of
Facilities
Air Releases
Water
Releases
Land Disposal
Other
Releases b
Total
Releases c
Stack
Air
Releases
Fugitive
Air
Releases
Class I
Under-
ground
Injection
RCRAa
Subtitle C
Landfills
All other
Land
Disposalb
b Terminology used in these columns may not match the more detailed data element names used in the TRI public data and
analysis access points.
0 These release quantities do include releases due to one-time events not associated with production such as remedial actions
or earthquakes.
Roughly 79% (~ 6.4 million pounds) of the environmental releases reported for NMP in 2015 were to
land, 18% (~ 1.4 million pounds) were to air (stack and fugitive emissions), and 0.2% (-14,000 pounds)
were discharged to water (Table 2-7). The stack releases reported to TRI represent the total amount of
NMP air releases from stacks, confined vents, ducts, pipes or other confined air streams. Many facilities
reported stack air releases from NMP destruction via incineration, including hazardous waste facilities
and facilities that perform other industrial activities (i.e., federal, state or municipal). These estimates
likely represent decomposition products, as NMP destruction via incineration is highly efficient.
Most of the on-site land disposal reported for NMP in 2015 was to Class I underground injection wells
(~ 3.6 million pounds). Only 13 pounds went to on-site landfills other than RCRA Subtitle C Landfills
and other land disposal. No NMP was reported as disposed on-site in Class II-V underground injection
wells, on-site land treatment, or on-site surface impoundments. Most off-site releases (~ 2.7 million
pounds) went to landfills other than RCRA Subtitle C Landfills. Other release amounts were reported as
transfers to RCRA Subtitle C Landfills (~ 93,217 pounds), other land disposal types (~ 25,648 pounds)
and off-site land treatment (- 330 pounds).
While the production-related waste managed shown in Table 2-6 excludes any quantities reported as
catastrophic or one-time releases (TRI Section 8 data), release quantities shown in Table 2-7 include
both production-related and non-routine quantities (TRI Section 5 and 6 data). As a result, release
quantities may differ slightly and may further reflect differences in TRI calculation methods for reported
release range estimates (U.S. EPA 2016c).
EPA is aware of additional sources of information for NMP release data, such as assessments from other
countries, and the Discharge Monitoring Report (DMR) Pollutant Loading Tool, which provides
additional information on releases to surface water. For example, the 2011 European Chemicals Agency
(ECHA) Dossier on the identification of NMP as a substance of very high concern includes a
compilation of the conditions of use for NMP, along with some discussion of potential sources of
environmental release information. The DMR loading tool calculates pollutant loadings from permit and
DMR data from EPA's Integrated Compliance Information System for the National Pollutant Discharge
Elimination System. The limited DMR data available for NMP will be further analyzed during risk
evaluation.
2.3.3 Presence in the Environment and Biota
Monitoring studies or a collection of relevant and reliable monitoring studies provide(s) information that
can be used in an exposure assessment. Monitoring studies that measure environmental concentrations
or concentrations of chemical substances in biota provide evidence of exposure. Limited environmental
monitoring data were identified in EPA's data search for NMP.
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EPA has developed an electronic STOrage and RETrieval system for water quality monitoring data
known as STORET, which maps monitoring sites and allows for download of sampling data of surface
water monitoring sites (U.S. EPA. 2012c). In addition, the Water Quality Portal, a cooperative service
sponsored by the U.S. Geological Survey (USGS), EPA and the National Water Quality Monitoring
Council (NWQMC. 2017) provide both STORET data and surface water and ground water monitoring
data from USGS. An initial search within the STORET system listed NMP as a sampled parameter, but
did not include any site-specific information for NMP (NWQMC. ).
NMP has been detected in industrial landfill leachate (Danish EPA. 2015). Although it is not currently
subject to any proposed or promulgated water regulations, NMP has been detected in wastewater (WHO.
2001) and is included on EPA's Drinking Water Contaminant Candidate Lists (CCL) 3 and 4 because it
is a suspected contaminant in public water systems that may require regulation under the Safe Drinking
Water Act (SDWA) (74 FR 51850, October 8, 2009 and 81 FR 81099 November 16, 2016).
The Air Quality System contains air pollution monitoring data collected by EPA, as well as state, local
and tribal agencies. A preliminary search of this database revealed that NMP is not a pollutant included
in national, state or tribal ambient air monitoring programs.
According to the Environment Canada and Health Canada Draft Screening Assessment, NMP has been
monitored in indoor air samples in Canada. NMP air concentrations associated with carpet and rubber-
based flooring were reported in a Canadian study on indoor air releases from building materials and
furnishings. NMP also was detected in air and dust samples collected from homes during a field study in
Quebec (EC/HC. 2017).
2.3.4 Environmental Exposures
The manufacturing, processing, distribution, use and disposal of NMP can result in releases to the
environment. In this section, EPA presents exposures to aquatic and terrestrial organisms.
Aquatic Exposures
EPA did not identify water monitoring data for NMP during its review of the national surface water
monitoring database. The 2015 TRI data on direct and indirect environmental releases were used to
estimate NMP concentrations in surface water. Direct releases represent environmental releases of NMP
that are discharged directly from a facility into a receiving water body (after treatment), whereas indirect
releases represent discharges to surface water that occur following treatment at a municipal wastewater
facility.
To capture "high-end" surface water concentrations, EPA compiled the release data for six facilities that
reported the largest NMP direct water releases. This represented > 99% of the total volume of NMP
reported as a direct discharge to surface water during the 2015 TRI reporting period. Since there were
many more facilities reporting indirect releases of NMP to surface water, seven of the facilities reporting
the largest indirect water releases (representing ~ 11% of the total number of facilities reporting indirect
discharges) were compiled. The volume of NMP released from these facilities encompassed more than
68%) of the total volume of NMP reported as an indirect discharge to surface water (see Appendix C).
For problem formulation, EPA used release data reported in the 2015 TRI to predict surface water
concentrations near the associated reporting facilities. To examine whether (near-facility) surface water
concentrations may present a risk concern for aquatic organisms, EPA employed a first-tier screening
approach, utilizing readily-available data, modeling tools and conservative assumptions.
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EPA's Probabilistic Dilution Model (PDM) was used to estimate site-specific surface water
concentrations based on the 2015 TRI data for "on-site" NMP releases to surface waters (
2.007). The reported TRI releases were based on available information including monitoring data,
emission factors, mass balance and/or other engineering calculations. The PDM also incorporates
wastewater treatment removal efficiency. For this analysis, wastewater treatment removal efficiency was
conservatively assumed to be 0%, as the reported NMP water releases were assumed to account for
wastewater treatment a priori. Further, as the total days of release were not reported in these sources,
EPA assumed a range of possible release days (i.e., 12 and 250 days/year) for facilities directly
discharging NMP to surface water and 250 days/year for indirect discharges from wastewater treatment
plants or Publicly Owned Treatment Works (POTWs) receiving indirect discharges of NMP).
The "high-end" surface water concentrations (i.e., those obtained assuming a low stream flow for the
receiving water body) from all PDM runs ranged from 224 |ig/L to 0.00005 |ig/L, for the acute (i.e.,
assumed fewer than 20 days of environmental releases per year) and chronic exposure scenario (i.e.,
more than 20 days of environmental releases per year assumed), respectively. The maximum acute
scenario concentration was 224 |ig/L and the maximum chronic scenario concentration was 11 |ig/L. For
a full table of results, see Table Apx C-l in Appendix C.
Terrestrial Exposures
Terrestrial populations living near industrial and commercial facilities that use NMP may be exposed via
multiple routes. EPA did not identify monitoring data for NMP releases to the environment; however,
the 2015 TRI data indicate that most of the reported releases were landfilled or injected underground.
2.3.5 Human Exposures
In this section EPA presents information on occupational, consumer and general population exposures.
Subpopulations within these exposed groups, including potentially exposed or susceptible
subpopulations, are also presented.
2.3.5.1 Occupational Exposures
Exposure pathways and exposure routes are listed below for worker activities under the various
conditions of use (industrial or commercial) described in Section 2.2. In addition, exposures to
occupational non-users (i.e., individuals who do not directly handle NMP, but perform work in an area
where it is present) are also listed. Engineering controls and/or personal protective equipment may
impact occupational exposure levels.
In the previous risk assessment ( .015). EPA assessed dermal and inhalation exposures
associated with occupational use of NMP in paint and coating removal. These uses and exposure
pathways will be further considered during risk evaluation.
Workers and occupational non-users may be exposed to NMP when performing activities associated
with the conditions of use described in Section 2.2 including, but not limited to:
• Unloading and transferring NMP to and from storage containers to process vessels;
• Using NMP in process equipment (e.g., applying photoresists during silicon wafer production);
• Applying formulations and products containing NMP onto substrates (e.g., applying adhesives,
sealants and NMP-containing products that facilitate their removal);
• Cleaning and maintaining equipment;
• Sampling chemical formulations or products containing NMP for quality control
• Repackaging chemical formulations or products containing NMP
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• Handling, transporting and disposing wastes containing NMP;
• Performing other work activities in or near areas where NMP is used.
Key Data
Key data that inform occupational exposure assessment include the Occupational Safety and Health
Administration (OSHA) Chemical Exposure Health Data (CEHD) and National Institute for
Occupational Safety and Health (NIOSH) Health Hazard Evaluation (HHE) program data. OSHA data
are workplace monitoring data from OSHA inspections. OSHA data can be obtained through CEHD
https://www.osha.eov/openeov/healthsamples.html. TableApx B-land TableApx B-2 in Appendix B
provide a summary of the monitoring data available for NMP (air samples obtained from OSHA
inspections conducted between 2011 and 2016). NIOSH HHEs are conducted at the request of
employees, union officials, or employers and help inform potential hazards at the workplace. HHEs can
be downloaded at https://www.cdc.eov/niosh/hhe/. Table Apx B-3 provides a summary of the NMP air
monitoring data obtained from NIOSH HHEs. EPA will review these data and evaluate their utility
during risk evaluation.
There is a potential for dermal and inhalation exposures to NMP in the workplace (including contact
with liquid, aerosol mist and vapor forms of NMP). OSHA has not established regulatory exposure
limits for NMP. The only recommended exposure limit identified for NMP is a non-regulatory limit
established by the American Industrial Hygiene Association (AIHA): a workplace environmental
exposure level (WEEL) of 10 ppm as an 8-hour (hr) time weighted average (TWA), with the addition of
a cautionary note addressing concerns for skin contact. Additional information can be obtained at
https://ww.tCTa.ore/OARS/WEEL.html.
Dermal
Based on the occupational exposure scenarios identified in Table 2-3, EPA expects a potential for
worker exposure via skin contact with NMP (liquid, vapor, mist or dust). Because NMP is readily
absorbed through the skin, dermal exposures can significantly impact body burden. Dermal exposure is
therefore expected to be an important pathway for workers and occupational non-users (i.e., vapor-
through-skin exposure).
Inhalation
Although NMP has a relatively low vapor pressure, some conditions of use identified in Table 2-3 may
present a concern for inhalation exposure to workers and occupational non-users, particularly those that
involve vaporization or spray application. Exposures can also occur from NMP (i.e., vapor, mist, dust)
that deposits in the upper respiratory tract. Because NMP is expected to be rapidly absorbed at the point
of contact, materials deposited in the upper airway will be considered as an inhalation exposure.
2.3.5.2 Consumer Exposures
NMP can be found in consumer products and/or commercial products that are readily available for
purchase at common retailers CEPA-HQ-QPPTSections 3 and 4 and Table 2-3) and
can therefore result in exposures to consumers and bystanders (non-users who are incidentally exposed
to NMP as a result of consumer product use).
In the previous risk assessment CIJ.S. EPA. 2015). EPA investigated dermal and inhalation exposures
from consumer use of NMP-containing products during paint and coating removal. EPA modeled
exposures to consumers and bystanders using a variety of indoor exposure scenarios that varied specific
input parameters including (but not limited to) the product formulation (NMP weight fraction), method
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of application (i.e., brush vs. spray), and duration of use (U.S. EPA. 2015). The conditions of use
assessed in the previous NMP assessment will be further considered during risk evaluation.
Dermal
EPA expects dermal exposure to be a significant route of exposure for consumers and bystanders.
Dermal exposure to consumers may occur from direct contact with NMP-containing liquids or from
deposition onto skin (e.g., vapor, mist or dust). Direct skin contact with NMP-containing liquids could
be concurrent with vapor-through-skin exposures for some conditions of use, particularly those that
involve heating or spray application. The frequency/duration and extent of exposure (i.e., surface area of
exposed skin) are expected to significantly impact body burden. Bystanders are not expected to have
direct contact with NMP-containing liquids, but may be exposed via skin deposition.
Inhalation
Although NMP has a low vapor pressure, there is potential for inhalation exposure to consumers and
bystanders during heating or spray application of products that contain NMP. Exposures to consumers
and bystanders may also occur through ingestion of airborne materials that deposit in the upper
respiratory tract. EPA assumes these exposures are absorbed via inhalation.
Oral
There is potential for oral exposure to consumers from contact with NMP-containing products via hand-
to-mouth activity. Mouthing behaviors may also be an important consideration, especially for children.
The frequency and duration of these activities and the NMP content in related products can significantly
impact exposure potential. During risk evaluation. EPA expects to further analyze oral exposures to
consumers that may result from incidental ingestion of NMP during use of formulations, products or
other articles that contain NMP (e.g., children's toys, arts and crafts kits, games, bedding, textiles, and
kitchen ware).
EPA's previous assessment of NMP use in paint and coating removal did not include an evaluation of
oral exposure to consumers, which may have resulted in an underestimation of the total exposure
potential for this population. During problem formulation, EPA reviewed publicly available consumer
product data (e.g., the Centers for Disease Control Household Database and the Chemical and Product
Categories database). Based on the use categories listed in Table 2-3, a table of preliminary exposure
scenarios was developed to map the associated conditions of use and exposure pathways identified for
NMP (see Appendix Table Apx E-l. Supporting Table for Consumer Activities and Uses Conceptual
Model).
2.3.5.3 General Population Exposures
Wastewater/liquid wastes, solid wastes or air emissions of NMP could result in potential pathways for
oral, dermal or inhalation exposure to the general population
Oral
Oral exposure to NMP is expected to be a relevant route of exposure for the general population.
Individuals may be exposed to NMP levels that occur in drinking water and/or well water. EPA was
unable to locate monitoring data for NMP levels in the ambient environment; however, wet deposition
from air could be a significant (air-to-ground) removal pathway. NMP exhibits high mobility in soil;
environmental releases are ultimately expected to migrate to water.
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Dermal
General population exposure to NMP may occur through dermal contact with NMP concentrations in
drinking water and/or well water during bathing, or from public recreation in impacted waterways.
Inhalation
Inhalation is expected to be a relevant route of exposure for the general population due to the propensity
for NMP air releases from ongoing commercial and industrial activities. Limited information was
identified for air emissions resulting from NMP use in industrial operations.
2.3.5.4 Potentially Exposed or Susceptible Subpopulations
TSCA requires the determination of whether a chemical substance presents an unreasonable risk to "a
potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation" by EPA.
TSCA § 3(12) states that "the term 'potentially exposed or susceptible subpopulation' means a group of
individuals within the general population identified by the Administrator who, due to either greater
susceptibility or greater exposure, may be at greater risk than the general population of adverse health
effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women,
workers, or the elderly." General population is "the total of individuals inhabiting an area or making up a
whole group" and refers here to the U.S. general population ( 011).
As part of problem formulation, EPA identified potentially exposed or susceptible subpopulations for
further analysis during the development and refinement of the conceptual models, exposure scenarios
and analysis plan. In this section, EPA addresses the potentially exposed or susceptible subpopulations
identified as relevant based on greater exposure. EPA will address the subpopulations identified as
relevant based on greater susceptibility in the hazard section.
EPA identifies the following as potentially exposed or susceptible subpopulations that EPA expects to
consider in the risk evaluation due to their greater exposure:
• Workers and occupational non-users;
• Consumers and bystanders associated with consumer use. NMP has been identified in products
available to consumers; however, only some individuals within the general population may use
these products. Therefore, those who do use these products represent a potentially exposed or
susceptible subpopulation due to greater exposure.
• Other groups of individuals within the general population who may experience greater
exposures due to their proximity to conditions of use identified in Section 2.2 that result in
releases to the environment and subsequent exposures (e.g., individuals who live or work near
manufacturing, processing, use or disposal sites).
In developing exposure scenarios, EPA will analyze available data to ascertain whether some human
receptor groups may be exposed via pathways that may be distinct to a particular subpopulation or life
stage and whether some human receptor groups may have higher exposure via identified pathways of
exposure due to unique characteristics (e.g., activities, duration or location of exposure) when compared
with the general population ( ,006b).
In summary, in the risk evaluation for NMP, EPA expects to analyze the following potentially exposed
groups of human receptors: workers, occupational non-users, consumers, bystanders associated with
consumer use and other groups of individuals within the general population who may experience greater
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exposure. EPA may also identify additional potentially exposed or susceptible subpopulations that will
be considered based on greater exposure.
2.4 Hazards (Effects)
For scoping, EPA conducted comprehensive searches for data on hazards of NMP, as described in the
Strategy for Conducting Literature Searches for NMP: Supplemental File for the TSCA Scope Document
EPA-HQ-Ol 0743). Based on initial screening, EPA expects to analyze the hazards of NMP
identified in this problem formulation document. However, when conducting the risk evaluation, the
relevance of each hazard within the context of a specific exposure scenario will be judged for
appropriateness. For example, hazards that occur only as a result of chronic exposures may not be
applicable to acute exposure scenarios. Thus it is unlikely that all identified hazards will be considered
for every exposure scenario.
2.4.1 Environmental Hazards
EPA identified the following sources of environmental hazard data for NMP:
1, o \ .01 ), (Danish < \ * ), EC/HC (201?) and Ecological Hazard Literature Search
Results in the NMP (CASRN 872-50-4) Bibliography: Supplemental File for the TSCA Scope Document
(EPA-HQ-QPP'T-2016-0743). Only the on-topic references listed in the Ecological Hazard Literature
Search Results were considered as potentially relevant data/information sources for the risk evaluation.
Inclusion criteria were used to screen the results of the ECOTOX literature search (as explained in the
Strategy for Conducting Literature Searches for NMP: Supplemental Document to the TSCA Scope
document, CASRN872-50-4). Data from the screened literature are summarized below (Table 2-8) as
ranges (min-max). EPA expects to review these data/information sources during risk evaluation using
the data quality review evaluation metrics and the rating criteria described in the Application of
Systematic Review in TSCA Risk Evaluations ( 018).
Acute Toxicity to Aquatic Organisms
The acute 96-hour LCso values reported for fish range from >500 mg/L Rainbow trout (Oncorhynchus
mykiss) to 4,030 mg/L for Orfe (Leuciscus idus). Four acute toxicity studies with aquatic invertebrates
have been identified; two used the water flea and two studies used grass shrimp as the test species. The
48-hr ECso for water fleas ranged from 1.23 to 4,897 mg/L, whereas the reported 48-hr EC50 for grass
shrimp ranged from > 299 to 1,107 mg/L. For green algae, the 72-hr EC50 values ranged from > 500 to
600.5 mg/L.
Chronic Toxicity to Aquatic Invertebrates
Chronic aquatic toxicity data are available for NMP. From a 21-day study with Daphnia magna, the
chronic toxicity value was calculated as 17.68 mg/L based on reproduction (using the NOEC value of
12.5 mg/L and the LOEC value of 25 mg/L).
Toxicity to Sediment and Terrestrial Organisms
EPA did not identify data on NMP hazards to sediment invertebrates, or terrestrial organisms including
soil invertebrates; however, based on the physical-chemical and fate properties of NMP, accumulation in
these environmental compartments is unlikely (see Section 2.3.1). NMP exposure to soil- or sediment-
dwelling organisms is not expected to be significant; therefore, hazards to these organisms will not be
analyzed further during risk evaluation (see Section 2.3.4).
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Table 2-8. Ecological Hazard Characterization of N1V
IP
Duration
Test organism
Endpoint
Hazard
value*
Units
Effect Endpoint
Reference
Aquatic Organisms
Acute
Fish
LC50
>500-4030
mg/L
Mortality
(BASF. 1983) as cited in
OECD (2009b): (BASF.
1986) as cited in OECD
(2009b)
Aquatic
invertebrates
ECso
1.23 -4897
mg/L
Immobilization
Lan et al. (2004); GAF
(1979) as cited in OECD
(2009b)
Algae
ECso
>500-
600.5
mg/L
Growth
(ECHA. 2014b)
Acute COC
0.246 mg/L
Chronic
Fish
ChV
-
mg/L
Aquatic
invertebrates
NOEC
LOEC
ChV
12.5
25
17.68
mg/L
Reproduction
BASF AG (2001) as cited
in OECD (2009b)
Algae
ChV
125
(NOEC)
mg/L
(ECHA. 2014b)
Chronic COC
1.768 mg/L
Terrestrial Organisms
Acute
Avian
LD50 25°°-
5000
mg/kg-
bw
Mortality
HazeltonLab (1980) as
cited in OECD (2009b)
Values in the tables are presented as reported by the study authors; - = endpoint not addressed
Concentrations of Concern
The screening-level acute and chronic concentrations of concern (COCs) for NMP were derived based
on the lowest or most toxic ecological toxicity values (e.g., L/EC50). The information below describes
how the acute and chronic COC's were calculated for environmental toxicity of NMP using assessment
factors.
The application of assessment factors is based on established EPA/OPPT methods (U.S. EPA. 2013.
2012d) and were used in this hazard assessment to calculate lower bound effect levels (referred to as the
concentration of concern; COC) that would likely encompass more sensitive species not specifically
represented by the available experimental data. Also, assessment factors are included in the COC
calculation to account for differences in inter- and intraspecies variability, as well as laboratory-to-field
variability. It should be noted that these assessment factors are dependent upon the availability of
datasets that can be used to characterize relative sensitivities across multiple species within a given taxa
or species group, but are often standardized in risk assessments conducted under TSCA, since the data
available for most industrial chemicals is limited.
The concentrations of concern for each endpoint were derived based on the ecological hazard data for
NMP. The information below describes how the acute and chronic COCs were calculated for aquatic
toxicity.
The acute COC is derived by dividing the aquatic invertebrates 48-hr EC50 of 1.23 mg/L (the lowest
acute value in the dataset) by an assessment factor of 5:
• Lowest acute value for 48-hr aquatic invertebrates EC50 (1.23 mg/L)/5 = 0.246 mg/L (246 |ig/L)
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The acute COC of 246 |ig/L, derived from the experimental aquatic invertebrate endpoint, is used as a
conservative hazard level for NMP in this problem formulation.
The chronic COC was determined based on the lowest chronic toxicity value divided by an assessment
factor of 10:
• Lowest chronic value for (21-day) Daphnia = 17.68 mg/L/10 = 1.768 mg/L (1,768 |ig/L)
The chronic COC of 1,768 |ig/L, derived from the experimental aquatic invertebrate endpoint, is used as
the lower bound hazard level for NMP in this problem formulation.
2.4.2 Human Health Hazards
EPA recently published a risk assessment on NMP use in paint and coating removal, hence many of the
hazards of NMP exposure have been compiled and reviewed ( 2015). EPA relied heavily on
this comprehensive review in preparing the current problem formulation document. Numerous human
health hazards have been identified for NMP including adverse effects on hepatic, renal, immune,
reproductive/developmental and central nervous systems (RIVM. 2013; OECD. 2007; WHO. 2001).
EPA expects to use the previous review as a starting point for identifying both key and supporting
studies that will be used to inform hazard characterization, including dose-response analysis. The
relevant studies will be evaluated using the data quality criteria in the Application of Systematic Review
in TSCA Risk Evaluations document (U.S. EPA. 2018). EPA also expects to consider studies that have
been published since this review, as identified in the literature search conducted by the Agency (NMP
(CASRN 872-50-4) Bibliography: Supplemental File for the TSCA Scope Document, EPA-HQ-OPPT-
2 ). Based on reasonably available information, the following sections briefly describe the
potential hazards that may be associated with NMP exposure.
2.4.2.1 Non-Cancer Hazards
Irritation and Sensitization
NMP is a skin, eye and possible respiratory irritant. Although the available sensitization data have
significant limitations, there are multiple studies of NMP in humans with no reports of sensitization
following NMP exposure (RIVM. 2013).
Acute Toxicity
The acute toxicity of NMP is expected to be low based on results from laboratory animal studies
including oral, dermal, inhalation, intraperitoneal and intravenous routes of exposure in rats and mice
(RIVM. 2013; OECD. 2007; WHO. 2001).
Systemic Effects
Systemic effects observed following oral repeated-dose toxicity testing include body weight reductions,
alterations in hematology and clinical chemistry parameters, liver and kidney toxicity, neurotoxicity and
thymic atrophy. More severe effects have been noted following whole-body inhalation exposure (which
includes dermal and oral uptake), including bone marrow hypoplasia, testicular effects, necrosis of
lymphoid tissue (observed in the thymus, spleen and lymph nodes) and mortality ( d, 2013; OECD.
2007; WHO. 2001).
Reproductive/Developmental Toxicity
A continuum of biologically relevant reproductive/developmental effects have been reported following
NMP exposure (e.g., decreased fetal and pup body weight, delayed ossification, skeletal malformations
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and increased fetal and pup mortality). EPA previously identified reproductive/developmental effects as
sensitive endpoints for evaluating the human health risks associated with NMP exposure U.S. EPA.
Q
2.4.2.2 Genotoxicity and Cancer Hazards
NMP is not mutagenic, based on results from bacterial and mammalian in vitro tests and in vivo systems
and is not considered to be carcinogenic (RIVM. 2013; OECD. 2007; WHO. 20011
Unless new information indicates otherwise, EPA does not expect to conduct additional in-depth
analysis of genotoxicity and cancer hazards during risk evaluation.
2.4.2.3 Potentially Exposed or Susceptible Subpopulations
TSCA requires that the determination of whether a chemical substance presents an unreasonable risk
include consideration of unreasonable risk to "a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation" by EPA. TSCA § 3(12) states that "the term 'potentially
exposed or susceptible subpopulation' means a group of individuals within the general population
identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at
greater risk than the general population of adverse health effects from exposure to a chemical substance
or mixture, such as infants, children, pregnant women, workers, or the elderly." In developing the hazard
assessment, EPA will analyze available data to ascertain whether some human receptor groups may have
greater susceptibility than the general population to the chemical's hazard(s). In the previous risk
assessment ( ), EPA identified young children and pregnant women as potentially
susceptible subpopulations.
2.5 Conceptual Models
EPA risk assessment guidance (I \ 1" \ Jo 14, r 98c). defines problem formulation as the part of the
risk assessment framework that identifies the major factors to be considered in the assessment. It draws
from the regulatory, decision-making and policy context of the assessment and informs the assessment's
technical approach.
A conceptual model describes the actual or predicted relationships between the chemical substance and
receptors, either human or environmental. These conceptual models are integrated depictions of the
conditions of use, exposures (pathways and routes), hazards and receptors. The initial conceptual models
describing the scope of the assessment for NMP, have been refined during problem formulation. The
changes to the conceptual models in this problem formulation are described along with the rationales.
In this section EPA outlines those pathways that will be included and further analyzed in the risk
evaluation; will be included but will not be further analyzed in risk evaluation; and will not be included
in the TSCA risk evaluation; and the underlying rationale for these decisions.
EPA determined as part of problem formulation that it is not necessary to conduct further analysis on
certain exposure pathways that were identified in the NMP Scope Document (EPA-HQ-OPPT 2016-
0743) and that remain in the risk evaluation. Each risk evaluation will be "fit-for-purpose," meaning not
all conditions of use will warrant the same level of evaluation and the Agency may be able to reach
some conclusions without extensive or quantitative risk evaluations 8^ 3, 33734, 33739 (July
20, 2017).
As part of this problem formulation, EPA identified exposure pathways under regulatory programs of
other environmental statutes, administered by EPA, which adequately assess and effectively manage
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exposures and for which long-standing regulatory and analytical processes already exist, i.e., the Safe
Drinking Water Act (SDWA) and the Resource Conservation and Recovery Act (RCRA). OPPT worked
closely with the offices within EPA that administer and implement the regulatory programs under these
statutes. In some cases, EPA has determined that chemicals present in various media pathways (i.e., air,
water, land) fall under the jurisdiction of existing regulatory programs and associated analytical
processes carried out under other EPA-administered statutes and have been assessed and effectively
managed under those programs. EPA believes the TSCA risk evaluation should generally focus on those
exposure pathways associated with TSCA conditions of use that are not adequately assessed and
effectively managed under the regulatory regimes discussed above because these pathways are likely to
represent the greatest areas of risk concern. As a result, EPA does not expect to include in the risk
evaluation certain exposure pathways identified in the NMP scope document.
2.5.1 Conceptual Model for Industrial and Commercial Activities and Uses: Potential
Exposures and Hazards
The revised conceptual model (Figure 2-2) describes the pathways of exposure from industrial and
commercial activities and uses of NMP that EPA expects to include in the risk evaluation. There is a
potential for inhalation and dermal exposure to workers during manufacturing, processing, use and
disposal of NMP. Inhalation and vapor-through-skin exposures are also possible for occupational non-
users, particularly with conditions of use that involve heating or spray application.
Dermal exposure is expected to be a major route of concern in occupational settings; however, there is a
potential for inhalation exposure with some conditions of use that involve heating or spray application.
EPA expects to evaluate dermal and inhalation risks to workers and occupational non-users exposed
during manufacturing, processing, distribution, use and disposal of NMP.
Inhalation
EPA's previous assessment of NMP use in paint and coating removal identified inhalation as a route of
concern for occupational exposure 115). NMP is well absorbed from the respiratory tract
( sson andPaulsson. 1997). but has a low vapor pressure which effectively limits inhalation
potential. Lung uptake is directly related to the NMP air concentration and duration of exposure. EPA
expects that inhalation exposure may be significant for some conditions of use identified in Table 2-3,
particularly those that involve heating or spray application. Incidental ingestion of inhaled NMP
(vapor/mist/dust) will be considered as an inhalation exposure. EPA expects to further analyze
inhalation exposures to workers and occupational non-users during risk evaluation.
Dermal
EPA's previous assessment identified dermal contact as a major route of concern for NMP
Q For workers, dermal exposures would be concurrent with inhalation exposures and NMP is well
absorbed; therefore, dermal contact (e.g., liquid, vapor, mist, dust) is expected to significantly impact
body burden (Bader et at.. 2008; Keener et ai. 2007). Because occupational non-users would not handle
NMP directly, EPA does not expect to further analyze dermal exposure via liquid contact. During risk
evaluation, EPA expects to further analyze dermal exposures to workers from skin contact with NMP
(e.g., liquid, vapor, mist, dust) and vapor-through-skin contact in occupational non-users.
The Occupational Safety and Health Administration (OSHA) has not established regulatory exposure
limits for NMP. The only recommended exposure limit identified is a non-regulatory limit established
by the AIHA: a workplace environmental exposure level (WEEL) of 10 ppm as an 8-hr time weighted
average (TWA), with the addition of a cautionary note addressing concerns for skin contact (AIHA..
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2011). EPA expects to further analyze dermal exposure to workers and occupational non-users during
risk evaluation.
Waste Handling, Treatment and Disposal
Figure 2-2 shows that waste handling, treatment and disposal is expected to lead to the same exposure
pathways as other industrial and commercial activities and uses. The path leading from "Waste
Handling, Treatment and Disposal" to "Hazards Potentially Associated with Acute and/or Chronic
Exposures" was re-routed to accurately reflect the expected exposure pathway, route and receptors
associated with the conditions of use identified for NMP.
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INDUSTRIAL AND COMMERCIAL
ACTIVITIES / USES
EXPOSURE PATHWAY
EXPOSURE ROUTE
RECEPTORSe
HAZARDS
Manufacturing
Processing:
As reactant/
intermediate
Incorporated into
formulation, mixture, or
reaction product
Incorporated into article
Repackaging
Recycling
Pa i nts a nd Coati ngs
e.g., pa i nt remova Ia
Solvents for CI ea ni ng a nd
Degreasing
Inks,Toner and Colorant
Products
Processing Aids, Specific to
Petroleum Production
Adhes ives a nd Sea I a nts
Other Usesb
^ Liquid Contact
^ Vapor/Mist/Dust
Outdoor Airc
(See Figure 2-4 for
Emissions to Air)
^ Dermal
^ lnhalationd ^
Workers
Occupational
Non-Users
Hazards Potentially Associated with
Acute and/or Chronic Exposures
See Section 2.4.2
KEY:
GrayText: Sources/Media/Receptors that will
not be further analyzed
^ Pathways that will be further analyzed
—~ Pathways that will not be further
analyzed
Waste Handling,
Treatment and Disposal
j_ w Wastewater , Liquid Wastes, Solid Wastes
(See Figure 2-4)
Figure 2-2. NMP Conceptual Model for Industrial and Commercial Activities and Uses: Potential Exposures and Hazards
The exposure pathways, exposure routes and hazards to human receptors from industrial and commercial activities and uses of NMP.
a U.S. EPA (2015) assessed NMP use in paint removal; these uses will be considered during risk evaluation to ensure previous assessments are in aligmnent with the
Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act (40 CFR Part 702).
b Some products are used in both commercial and consumer applications. Additional uses of NMP are included in Table 2-3.
0 Emissions to outdoor air include stack emissions and fugitive emissions such as fugitive equipment leaks from valves, pump seals, flanges, compressors, sampling
connections and open-ended lines; evaporative losses from surface impoundment and spills; and releases from building ventilation systems.
dOral exposure via incidental ingestion of inhaled vapor/mist/dust will be considered as an inhalation exposure.
e Receptors include potentially exposed or susceptible subpopulations.
f When data and information are available to support the analysis, EPA expects to consider the effect that engineering controls and/or personal protective equipment have
on occupational exposure levels.
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2.5.2 Conceptual Model for Consumer Activities and Uses: Potential Exposures and
Hazards
The revised conceptual model (Figure 2-3) illustrates the pathways of exposure resulting from NMP
consumer uses that EPA expects to evaluate. In the (U.S. EPA. 2015) risk assessment, dermal and
inhalation exposures were assessed as the most likely exposure routes; however, there is a potential for
oral exposure under some conditions of use. It should be noted that consumers may purchase and use
products primarily intended for commercial use.
Inhalation
As mentioned above, EPA/OPPT's 2015 assessment of NMP use in paint stripping identified inhalation
as a route of concern I v l/p \ \ JO 15). EPA expects inhalation exposure to be significant for some
conditions of use identified in Table 2-3, particularly those that involve heating or spray application.
Incidental ingestion of inhaled NMP (vapor/mist/dust) will be considered as an inhalation exposure.
EPA expects to further analyze inhalation exposures to consumers and bystanders during risk evaluation.
Dermal
There is a potential for dermal exposure from use of consumer products that contain NMP. Dermal
exposure may occur from vapor or mist deposition onto skin, or from direct contact with NMP liquid
during use. Dermal exposure to liquid NMP could be concurrent with vapor-through-skin exposures for
some conditions of use, particularly those that involve heating or spray application of products with a
high NMP weight fraction. Bystanders will not have dermal contact with liquid NMP, but could have
vapor-through-skin uptake.
Consumers and bystanders can have skin contact with NMP vapor concurrently with inhalation
exposures. As noted for workers (see Section 2.5.1), lung uptake is impacted by the NMP weight
fraction in liquid, the NMP vapor concentration in air and the duration and extent of dermal contact (i.e.,
surface area of exposed skin) with liquid and vapor forms of NMP. EPA expects to further analyze
dermal exposure to consumers via direct contact with NMP-containing liquids and vapor-through-skin
exposure to consumers and bystanders.
Oral
There is a potential for oral exposure to consumers from contact with NMP-containing products via
hand-to-mouth activity. Mouthing behaviors may also be an important consideration, especially for
children. The frequency and duration of these activities, as well as the NMP content in related products
can impact exposure potential. EPA expects to further analyze consumer oral exposures that may result
from hand-to-mouth activity and mouthing behaviors during use of formulations, products or other
articles that contain NMP (e.g., toys, textiles).
Disposal
There is a potential for consumer exposure via oral, dermal and inhalation routes during disposal of
NMP-containing products. Individuals may be exposed via contact with liquid or vapor forms of NMP
when products are discarded. During risk evaluation, EPA expects to further analyze consumer
exposures associated with the disposal of consumer products that contain NMP.
For each condition of use identified in Table 2-3, a determination was made as to whether each unique
combination of exposure pathway, route, and receptor would be further analyzed during risk evaluation.
The results of that analysis along with the supporting rationale are presented in Appendix C and
Appendix E.
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CONSUMER ACTIVITIES / USES EXPOSURE PATHWAY
EXPOSURE ROUTE
RECEPTORS e
HAZARDS
Consumers
Bystanders
Consumers
Bystanders
! w Wastewater; Liquid Wastes, Solid Wastes
(See Figure 2-4)
Oral
Oral
Liquid Contact
Vapor/Mist/Dust
Liquid Contact
Vapor/Mist/Dust
Dermal
Dermal
Inhalationd
lnhalationd
Adhesives and Sealants
nk, Toner, and Colorant Products
e.g., printer ink
Paints and Coatings
e.g., paint removal
Solvents for Cleaning and
Degreasing
Consumer Handlingand Disposal
of Wastec
Other Uses b
e.g., arts,crafts and hobby
materia Is; articles
Hazards Potentially Associated
with Acute and/or Chronic
Exposures:
See Section 2.4.2
KEY:
GrayText: Sources/Media/Receptors that will notbe
further analyzed
^ Pathways that will be further analyzed
Pathways that will notbe further analyzed
Figure 2-3. NMP Conceptual Model for Consumer Activities and Uses: Potential Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human receptors from consumer activities and uses of
NMP.
a U.S. EPA (2015) assessed NMP use in paint and coating removal; these uses will be considered during risk evaluation to ensure previous assessments are in aligmnent
with the Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act (40 CFR Part 702).
b Some products are used in both commercial and consumer applications; additional uses of NMP are included in Table 2-3.
0 Consumers may also be exposed while handling municipal wastes; however, the pathway is uncertain.
d Oral exposure via incidental ingestion of inhaled vapor/mist/dust will be considered as an inhalation exposure.
e Receptors include potentially exposed or susceptible subpopulations.
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2.5.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures
and Hazards
The revised conceptual model (Figure 2-4) illustrates the exposure pathways anticipated for humans and
other ecological receptors from environmental releases and waste streams associated with industrial and
commercial use of NMP that EPA expects to include in the risk evaluation. The exposure pathways that
EPA expects to include but not further analyze in the risk evaluation are described in Section 2.5.3.1 and
shown in the conceptual model.
2.5.3.1 Pathways That EPA Expects to Include in Risk Evaluation but Not Further
Analyze
EPA does not expect to further analyze environmental exposures to NMP.
Ambient Water Pathways
EPA does not plan to further analyze exposures to humans or ecological receptors including fish, aquatic
invertebrates and algae from NMP releases to ambient surface water. Based on 2015 TRI reporting, an
estimated 14,092 pounds of NMP was released to surface water from industrial and commercial sources
(U.S. EPA.! ). Although NMP exhibits high water solubility, it is not expected to persist in surface
waters because it readily biodegrades under aerobic conditions.
Environmental monitoring data were not identified for NMP; however, based on the estimated exposure
concentrations (described in Section 2.3.4), and available ecological hazard information (summarized in
Section 2.4.1), EPA does not plan to further analyze risks to aquatic organisms from NMP releases to
surface water. A first-tier exposure analysis predicted surface water concentrations as high as 224 |ig/L
and 11 |ig/L for the acute and chronic exposure scenarios, respectively based on reported TRI releases
(summarized in Section 2.4.1). These values do not exceed the acute and chronic COCs for aquatic
organisms (246 |ig/L and 1,768 |ig/L, respectively) indicating a low risk concern. This finding is
supported by a recent ecological risk classification completed by Environment and Climate Change
Canada which identified a low risk concern for NMP (ECCC. 2016).
EPA does not plan to further analyze exposures to humans that may result from NMP releases to
ambient surface water. A first-tier analysis used to estimate NMP surface water concentrations based on
the highest water releases reported in the 2015 TRI database showed that NMP levels in well water
could be as high as 0.07 mg/kg/day. In the previous NMP risk assessment ( 015). EPA
identified a point of departure (POD) for chronic exposure in humans (48 mg/kg/day), which when
compared to the estimated exposure concentration, resulted in a margin of exposure (MOE) that
exceeded the benchmark MOE (675 versus 30, respectively). EPA also estimated oral and dermal
exposure to NMP during showering/bathing. The calculated MOE, based on aggregate estimates of oral,
inhalation and dermal exposure (338), exceeded the benchmark MOE (30), indicating a low risk
concern.
Sediment Pathway
EPA does not plan to further analyze exposures to sediment-dwelling organisms during risk evaluation,
as NMP is unlikely to accumulate in sediment. NMP is not expected to adsorb to sediment due to its
water solubility (> 1000 g/L) and low partitioning to organic matter (log Koc = 0.9). This is supported by
EPISUITE fugacity model predictions which indicate limited partitioning to sediment (< 1%). No
ecotoxicity studies were identified for sediment-dwelling organisms; however, the available hazard data
indicate a low concern for NMP toxicity to plants and aquatic organisms. Because NMP toxicity to
sediment-dwelling invertebrates is expected to be comparable to that of aquatic invertebrates and NMP
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is unlikely to accumulate in sediment, a low risk concern is expected for this environmental
compartment.
Land-Applied Biosolids Pathway
EPA does not plan to further analyze other land releases during risk evaluation, including those that may
result from land application of biosolids. NMP exhibits high water solubility (1000 g/L) and limited
potential for adsorption to organic matter (estimated log Koc = 0.9); therefore, land releases will
ultimately partition to the aqueous phase (i.e., biosolids associated waste water and soil pore water) upon
release into the environment. Because NMP readily biodegrades in environments with active microbial
populations, NMP residues that remain following waste water treatment are not expected to persist.
NMP concentrations in biosolids-associated water are expected to decrease, primarily via aerobic
degradation, during transport, processing (including dewatering), handling, and land application of
biosolids (which may include spraying).
Migration of NMP between ground water and surface water has not been documented, but may be
mitigated by abiotic and biotic degradation in the water column. Overall, the NMP concentrations in
surface water resulting from land application of biosolids are expected to be much less than those
associated with direct release of wastewater treatment plant effluents to surface water. EPA's
conservative assessment of this exposure scenario predicted NMP surface water concentrations that are
well below the hazard benchmarks identified for humans and aquatic organisms (see Appendix C);
therefore, this exposure pathway is not expected to present a risk concern.
Ambient Air Pathways
EPA does not plan to further analyze NMP air releases or associated exposures to terrestrial wildlife, as
inhalation exposure and bioaccumulation potential are expected to be low (BCF = 3.16, BAF = 0.9; see
Section 2.4). Negligible volatilization of NMP is expected from moist soil and wastewater. Because
NMP exhibits low volatility and readily biodegrades under aerobic conditions ( £015). the
concentrations in ambient air are unlikely to reach levels that would present a risk concern for terrestrial
organisms. This conclusion is supported by the ecological risk classification derived for NMP by
Environment and Climate Change Canada, which identified a low ecological risk concern for NMP
(ECCC. 2016V
EPA does not plan to further analyze human exposures that may result from inhalation of outdoor air
containing NMP released from industrial and commercial facilities. A first-tier screening analysis was
used to estimate the potential (near field) exposure to populations located downwind of facilities
reporting the highest NMP air releases based on 2015 TRI data. Using EPA's SCREEN3 Model and the
highest reported stack emissions, the estimated NMP concentration in ambient air was approximately
0.41 mg/m3.
In the previous NMP assessment, EPA used data on NMP-induced decreases in fetal body weight as the
basis for risk estimation. Benchmark dose modeling of internal dose estimates based on physiologically-
based pharmacokinetic modelling was used to determine a POD (48 mg/kg/day) for estimating risks
associated with chronic exposure in humans ( 05). This POD was converted to an
inhalation dose (based on a total dose of 3,840 mg/day, and 80 kg bodyweight). EPA's EFAST model
uses a default breathing rate of 0.61 m3/hour over a 24-hour period (14.6 m3/day). Hence the inhalation
POD is: (3,840 mg/day)/(14.6 m3/day) = 263 mg/m3 (24-hour TWA). EPA also expects to consider
studies that have been published since this assessment, as identified in the literature search conducted by
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the Agency (NMP (CASRN 872-50-4) Bibliography: Supplemental File for the TSCA Scope Document,
EPA-HO-QPPT 2016-0743Y
During problem formulation, EPA assessed the risks associated with chronic NMP exposure by
comparing the estimated concentration of NMP in ambient air (0.41 mg/m3) to the POD for inhalation
exposure (263 mg/m3). This resulted in a margin of exposure (MOE) that exceeded the benchmark MOE
(641 versus 30, respectively) indicating a low risk concern.
EPA acknowledges the possibility that NMP releases to ambient air may be wet deposited to soil and
surface water; however, aerobic degradation and atmospheric dispersion are expected to limit the NMP
air concentrations available to organisms that inhabit these compartments. As such, NMP air removal
via wet deposition (from air to water or soil) is not expected to result in significant accumulation in these
environmental compartments. This conclusion is supported by EPA's conservative assessment of NMP
concentrations in air and surface water; the Tier 1 exposure estimates for these media do not indicate a
concern for humans or other ecological receptors. The exposure pathways associated with NMP releases
to ambient air will not be further analyzed during risk evaluation.
2.5.3.2 Pathways that EPA Does Not Plan to Include in the Risk Evaluation
Exposures to receptors (i.e., general population, terrestrial species) may occur from industrial and/or
commercial uses, industrial releases to air, water or land, and other conditions of use. As described in
Section 2.5, EPA does not expect to include in the risk evaluation pathways under programs of other
environmental statutes, administered by EPA, which adequately assess and effectively manage
exposures and for which long-standing regulatory and analytical processes already exist. These
pathways are described below.
Drinking Water Pathway
EPA has regular analytical processes to identify and evaluate drinking water contaminants of potential
regulatory concern for public water systems under the Safe Drinking Water Act (SDWA).
The Contaminant Candidate List (CCL) is a list of unregulated contaminants that are known or
anticipated to occur in public water systems and that may require regulation. EPA must publish a CCL
and make Regulatory Determinations to regulate at least five CCL contaminants every 5 years. To
regulate a contaminant, EPA must conclude the contaminant may have adverse health effects, occurs or
is substantially likely to occur in public water systems at a level of concern and that regulation, in the
sole judgement of the Administrator, presents a meaningful opportunity for health risk reduction.
NMP is listed on EPA's fourth CCL. NMP is on the CCL because EPA's Office of Water concluded that
based on occurrence and health information the chemical is known or anticipated to occur in public
water systems and may require regulation. Based on TRI information, the Agency concluded that NMP
may occur in public water systems. Once contaminants have been placed on the CCL, EPA identifies if
there are any additional data needs, including gaps in occurrence data for evaluation under Regulatory
Determination; if sufficient occurrence data is lacking, the contaminant may be considered for
monitoring under the Unregulated Contaminant Monitoring Rule. Hence, because the drinking water
exposure pathway for NMP is being addressed under the regular analytical processes used to identify
and evaluate drinking water contaminants of potential regulatory concern for public water systems under
SDWA, EPA does not expect to include this pathway in the risk evaluation for NMP under TSCA.
EPA's Office of Water and Office of Pollution Prevention and Toxics will continue to work together
providing understanding and analysis of the SDWA regulatory analytical processes for public water
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systems and to exchange information related to toxicity and occurrence data on chemicals undergoing
risk evaluation under TSCA.
Disposal Pathways
The general standard in RCRA section 3004(a) for the technical criteria that govern the management
(treatment, storage, and disposal) of hazardous waste (i.e., Subtitle C) are those "necessary to protect
human health and the environment," RCRA 3004(a). The regulatory criteria for identifying
"characteristic" hazardous wastes and for "listing" a waste as hazardous also relate solely to the
potential risks to human health or the environment. 40 C.F.R. §§ 261.11, 261.21-261.24. RCRA
statutory criteria for identifying hazardous wastes require EPA to "tak[e] into account toxicity,
persistence, and degradability in nature, potential for accumulation in tissue, and other related factors
such as flammability, corrosiveness, and other hazardous characteristics." Subtitle C controls cover not
only hazardous wastes that are landfilled, but also hazardous wastes that are incinerated (subject to joint
control under RCRA Subtitle C and the Clean Air Act (CAA) hazardous waste combustion maximum
achievable control technology) or injected underground into Class I hazardous waste wells (subject to
joint control under Subtitle C and SDWA).
EPA does not expect to include emissions to ambient air from municipal and industrial waste
incineration and energy recovery units in the risk evaluation, as they are regulated under section 129 of
the Clean Air Act. CAA section 129 requires EPA to review and, if necessary, add provisions to ensure
the standards adequately protect public health and the environment. Thus, combustion by-products from
incineration treatment of NMP wastes (approximately 6 million lbs) would be subject to these
regulations, as would NMP burned for energy recovery (7.6 million lbs).
EPA does not expect to consider on-site NMP land releases that are disposed via underground injection
in the risk evaluation. Most of the on-site land disposal reported for NMP in the 2015 TRI was to Class I
underground injection wells (approximately 3.6 million pounds), with no reported environmental
releases via underground injection to Class II-VI wells (U.S. EPA. 2017b). Environmental disposal of
NMP via injection into Class I wells is managed and prevented from further environmental releases by
RCRA and SDWA regulations. Therefore, disposal of NMP via underground injection is not likely to
result in environmental and general population exposures.
EPA does not plan to consider on-site land releases that go to RCRA Subtitle C hazardous waste
landfills during risk evaluation. Based on the 2015 TRI data, approximately 93,217 pounds of NMP
were transferred to RCRA Subtitle C landfills; smaller amounts (approximately 25,648 pounds) were
characterized as "other" land disposal and off-site land treatment (approximately 330 pounds) (U.S.
EPA. 2017b). Design standards for Subtitle C landfills require double liner, double leachate collection
and removal systems, leak detection system, run on, runoff, and wind dispersal controls, and a
construction quality assurance program. They are also subject to closure and post-closure care
requirements including installing and maintaining a final cover, continuing operation of the leachate
collection and removal system until leachate is no longer detected, maintaining and monitoring the leak
detection and groundwater monitoring system. Bulk liquids may not be disposed in Subtitle C landfills.
Subtitle C landfill operators are required to implement an analysis and testing program to ensure
adequate knowledge of waste being managed and to train personnel on routine and emergency
operations at the facility. Hazardous waste being disposed in Subtitle C landfills must also meet RCRA
waste treatment standards before disposal. Given these controls, general population exposure to NMP
from Subtitle C landfill leachate is not expected to be a significant exposure pathway.
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EPA does not expect to include releases to land from RCRA Subtitle D municipal solid waste (MSW)
landfills or exposures to the general population or terrestrial species from such releases in the risk
evaluation. While permitted and managed by individual states, MSW landfills are required by federal
regulations to implement some of the same requirements as Subtitle C landfills. MSW landfills 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, as well as providing financial assurance for funding of any needed corrective actions.
MSW landfills have been designed to allow for the small amounts of hazardous waste generated by
households and very small quantity waste generators (< 220 pounds per month). Bulk liquids, such as
free solvent, may not be disposed of in MSW landfills.
EPA does not expect to consider on-site releases to land from industrial non-hazardous waste and
construction/demolition waste landfills in the NMP risk evaluation. Industrial non-hazardous and
construction/demolition waste landfills are primarily regulated under state regulatory programs. States
must also implement limited federal regulatory requirements for siting, groundwater monitoring and
corrective action and a prohibition on open dumping and disposal of bulk liquids. States may also
establish additional requirements such as for liners, post-closure and financial assurance, but are not
required to do so. Therefore, EPA does not expect to include this exposure pathway in the risk
evaluation.
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RELEASES AND WASTES FROM
INDUSTRIAL / COMMERCIAL / CONSUMER USES
EXPOSURE PATHWAY EXPOSURE ROUTE
RECEPTORS c
HAZARDS
Indirect discharge
^ r Waste 3 ransport
POTW
Wastewater or
Liquid Wastes'
Recycling, Other
Treatment b
Off-site Waste
Transfer
Underground
Injection
Liquid Wastes
Solid Wastes
Industrial Pre-
Treatment or
Industrial WWT
Incinerators
(Municipals
Hazardous Waste)
Municipal,
Hazardous Landfill
or Other Land
Disposal
KEY:
GrayText: Sources/Media/Receptors that will not be
further analyzed
~ Pathwaysthat will be further analyzed
Pathways that will not be further analyzed
Figure 2-4. NMP Conceptual Model for Environmental Releases and Wastes: Potential Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human and environmental receptors from environmental releases and wastes of
NMP.
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 (i.e., down the drain). Drinking water will undergo further treatment in drinking water
treatment plant. Ground water may also be a source of drinking water.
b Additional releases may occur from recycling and other waste treatment.
0 Volatilization from or liquid contact with drinking/tap water in the home during showering, bathing and washing represents another potential exposure pathway.
d Presence of mist is unlikely; inhalation and oral exposure are expected to be negligible.
e Receptors include potentially exposed or susceptible subpopulations.
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2.6 Analysis Plan
The analysis plan presented in this problem formulation is a refinement of the initial analysis plan
published in the Scope of the Risk Evaluation for NMP ( 17a).
The analysis plan outlined here is based on the conditions of use identified for NMP, as described in
Section 2.2 of this problem formulation. EPA is implementing systematic review approaches to identify,
select, assess, integrate and summarize the findings of studies supporting the TSCA risk evaluation. The
analytical approaches and considerations in the analysis plan are used to frame the scope of the
systematic review activities for this assessment. The supplemental document, Application of Systematic
Review in TSCA Risk Evaluations (U.S. EPA. 2018). provides additional information about criteria and
methods that have been and will be applied to the first 10 chemical risk evaluations.
While EPA has conducted a search for reasonably available information from public sources as
described in the Scope of the Risk Evaluation for NMP (U.S. EPA. 2017a). EPA encourages submission
of additional existing data, such as full study reports or workplace monitoring from industry sources,
that may be relevant for refining conditions of use, exposures, hazards and potentially exposed or
susceptible subpopulations during the risk evaluation. EPA will continue to consider new information
submitted by the public.
During risk evaluation, EPA will rely on the comprehensive literature results [NMP (CASRN872-50-4)
Bibliography: Supplemental File for the TSCA Scope Document, EP A-HQ-QPP' V -1' >'> I o - >'>' -1. ¦ ]. or
supplemental literature searches to address specific questions. Further, EPA may consider any relevant
CBI in the risk evaluation in a manner that protects the confidentiality of the information from public
disclosure. The analysis plan is based on EPA's knowledge of NMP to date, which includes partial, but
not complete review of identified literature. If additional data or approaches become available, EPA may
refine its analysis plan based on this information.
2.6.1 Exposure
Based on their physical-chemical properties, expected sources, and transport and transformation within
the outdoor and indoor environment chemical substances are more likely to be present in some media
and less likely to be present in others. Media-specific levels will vary based on the chemical substance
of interest. For most chemical substances, level(s) can be characterized through a combination of
available monitoring data and modeling approaches.
2.6.1.1 Environmental Releases
EPA expects to consider and analyze releases to relevant environmental media as follows:
1) Review reasonably available published literature or information on processes and activities
associated with NMP conditions of use to evaluate the types of releases and wastes generated.
EPA has reviewed some key data sources containing information on processes and activities
resulting in releases. EPA will continue to review potentially relevant data sources identified in
Appendix B during risk evaluation.
2) Review reasonably available chemical-specific release data, including measured or estimated
release data (e.g., data collected under the TRI program). EPA has reviewed key data sources
including TRI; this data is summarized in Section 2.3.2 above. EPA will continue to review
relevant data sources during risk evaluation. EPA will match identified data to applicable
conditions of use and identify data gaps where no data are found for specific conditions of use.
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EPA will attempt to address data gaps identified as described in steps 3 and 4 below by
considering potential surrogate data and models.
Review measured or estimated release data for surrogate chemicals that have similar uses,
volatility, and physical-chemical properties. Data for solvents that are used in the same types of
applications may be considered as surrogate data for NMP. Perchloroethylene,
dimethylformamide and NMP are used in paints, coatings, adhesives, sealants, and cleaning
formulations. In addition, NMP is sometimes used as a replacement for methylene chloride in
some paint removal use applications. EPA will review the literature sources identified and if
surrogate data are found, EPA will match these data to applicable conditions of use to determine
their suitability for filling data gaps. EPA will evaluate the utility of surrogate data to fill data
gaps where uses of NMP and other solvents align. If surrogate data are used, EPA normally
converts air concentrations using the ratio of the vapor pressures of the two chemicals.
Understand and consider regulatory limits that may inform estimation of environmental releases.
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 will further consider relevant regulatory requirements in estimating releases during risk
evaluation. While NMP is not a hazardous air pollutant regulated under the Clean Air Act, some
related rules may provide relevant information on sectors that use NMP. For example, the
National Emission Standards for Hazardous Air Pollutants (NESHAP) for Paint Stripping and
Miscellaneous Surface Coating Operations (40 CFR Part 63, Subpart HHHHHH) may provide
useful information on industry sectors that use solvents (including NMP) for paint removal and
surface coating applications.
Review and determine the applicability of the Organisation for Economic Cooperation and
Development (OECD) Emission Scenario Documents (ESD) and EPA Generic Scenarios to
estimation of environmental releases. Potentially relevant OECD ESDs and EPA Generic
Scenarios (GS) have been identified that correspond to some conditions of use. For example, the
ESD on Industrial Use of Adhesives for Substrate Bonding, the ESD on the Coating Industry
(paints, lacquers and varnishes), and the GS on Application of Agricultural Pesticides are some
of the ESDs and GSs that EPA may use to assess potential releases. EPA will need to critically
review the GSs and ESDs to determine their applicability to the conditions of use assessed. EPA
was not able to identify ESDs or GSs corresponding to several conditions of use, including the
manufacture and import of NMP, use of NMP in soldering materials and use of NMP in
petrochemical purifications. EPA will perform additional targeted research to understand those
conditions of use which may inform identification of release scenarios. EPA may also need to
perform targeted research for applicable models and associated parameters that EPA may use to
estimate releases for specific conditions of use. If ESDs and GSs are not available to fill data
gaps, other methods may be considered, including existing emission factors, such as those from
EPA AP-42, to estimate environmental releases of NMP to air from various conditions of use.
Map or group condition(s) of use to release assessment scenario(s). EPA has identified release
scenarios and mapped them to some conditions of use. For example, some scenario groupings
include Contractor Adhesive Removal and Industrial Spray Application of Lacquers, Paints, and
Coatings. EPA grouped similar conditions of use (based on factors including process equipment
and handling, release sources and usage rates of NMP and formulations containing NMP, or
professional judgement) into scenario groupings but may further refine these groupings as
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additional information becomes available during risk evaluation. EPA was not able to identify
release scenarios corresponding to several conditions of use due to a lack of general knowledge
of those conditions of use. EPA will perform additional targeted research to understand those
uses which may inform identification of release scenarios.
Evaluate the weight of evidence for environmental release data. The data integration strategy will
be designed to be fit-for-purpose in which EPA will use systematic review methods to assemble
the relevant data, evaluate the data for quality and relevance, including strengths and limitations,
followed by synthesis and integration of the evidence.
2.6.1.2 Environmental Fate
EPA expects to consider and analyze fate and transport in environmental media as follows:
1) Review reasonably available measured or estimated environmental fate endpoint data collected
through the literature search.
A general overview of persistence and bioaccumulation was presented in the TSCA Work Plan
Chemical Risk Assessment of N-Methylpyrrolidone: Paint Removal Use CASRN 872-50-4 (U.S.
EPA. 2015). Key environmental fate characteristics were included in the Scope of the Risk
Evaluation for N-Methylpyrrolidone (U.S. EPA. 2.017a) and in previous assessments of NMP,
including those conducted by EPA's Office of Pesticide Programs (U.S. EPA. 2015). US
California Office of Environmental Health Hazard Assessment (OEHHA. 2003). Australia
Department of Health, National Industrial Chemicals Notification and Assessment Scheme
(Australian Government Department of Health. 2016). Environment Canada, Health Canada
(EC/HC. 2017). and European Commission, Scientific Committee on Occupational Exposure
Limits (EC. 2016). These information sources will be used as a starting point for the
environmental fate assessment. Other sources that will be consulted include those that are
identified through the systematic review process. Studies will be evaluated using the evaluation
strategies laid out in the supplemental document, Application of Systematic Review in TSCA Risk
Evaluations (U.S. EPA... 2018).
If measured values are not available (this will be determined during systematic review), chemical
properties will be estimated using EPI Suite, SPARC and other chemical parameter estimation
models. Estimated fate properties will be reviewed for applicability and quality.
2) Using measured environmental fate data and/or environmental fate modeling, determine the
influence of environmental fate endpoints (e.g., persistence, bioaccumulation, partitioning,
transport) on pathways and routes of exposure for human and environmental receptors.
Measured fate data including atmospheric photolysis rates, hydrolysis, and aerobic and anaerobic
biodegradation rates, along with physical-chemical properties and models such as the EPI
Suite™ STP model (which estimates removal during wastewater treatment due to adsorption to
sludge and volatilization to air), will be used to characterize the movement of NMP within and
among environmental media and the persistence of NMP within specific media.
3) Evaluate the weight of the evidence of environmental fate data.
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2.6.1.3 Environmental Exposures
EPA does not plan to further analyze environmental exposures to NMP, based on the rationale described
in Section 2.3.4.
2.6.1.4 Occupational Exposures
EPA expects to consider and analyze exposures to workers and occupational non-users as follows:
1) Review reasonably available exposure monitoring data for specific condition(s) of use. Exposure
data to be reviewed may include workplace monitoring data collected by government agencies
such as OSHA and the National Institute of Occupational Safety and Health (NIOSH), and
monitoring data found in published literature. These workplace monitoring data may include
personal exposure monitoring data and area monitoring data (e.g., stationary sampling). Data,
information, and studies will be evaluated using the evaluation strategies laid out in the
Application of Systematic Review in TSCA Risk Evaluations document (U.S. EPA. 2018). EPA
has reviewed available monitoring data collected by OSHA (see the summary in Appendix
2.6.3B.2) 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 will review the sources identified in Appendix B and extract relevant data for
consideration and analysis during risk evaluation. Data gaps will be identified where no data are
found for specific conditions of use. EPA will attempt to address data gaps identified as
described in steps 2 and 3 below. Where possible, job descriptions may be useful in
distinguishing exposures to different subpopulations within a specific condition of use.
2) Review reasonably available exposure data for surrogate chemicals that have uses, volatility and
physical-chemical properties that are comparable to NMP. EPA will 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. For several uses (e.g., use as solvent), EPA believes that
dimethylformamide may share the same or similar conditions of use and may be considered as a
surrogate for NMP.
3) For conditions of use where data are limited or not available, review existing exposure models
that may be applicable in estimating exposure levels. Models may be generic, broadly applicable
models or may be specific to conditions of use (e.g., some OECD Emission Scenario Documents
(ESDs) and U.S. EPA Generic Scenarios (GSs) may be identified as potentially mapping to some
conditions of use). EPA has identified potentially relevant OECD ESDs and EPA GSs that
correspond to some conditions of use. For example, the ESD on Industrial Use of Adhesives for
Substrate Bonding, the ESD on Metal Finishing and the GS on the Manufacture and Use of
Printing Inks are some of the ESDs and GSs that EPA may use to estimate occupational
exposures. EPA will need to critically review these scenarios to determine their applicability to
the conditions of use identified for NMP. EPA was not able to identify ESDs or GSs
corresponding to several conditions of use, including recycling of NMP and solvent mixtures
containing NMP, processing and formulation of NMP into industrial, commercial and consumer
products, use of NMP in paints and coatings, and use of NMP in petrochemical purifications.
EPA will perform additional targeted research to understand those conditions of use, which may
inform identification of exposure scenarios. EPA may also need to perform targeted research to
identify applicable models that EPA may use to estimate exposures for specific conditions of
use. If any models are identified as applicable, EPA will search for appropriate model parameter
data (as described in step 4 below). If parameter data can be located or assumed, exposure
estimates generated from these models may be used for potentially filling data gaps.
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4) Review reasonably available information that may be used in developing, adapting or applying
exposure models to the risk evaluation. This step will be performed after Steps 2 and 3 above.
Based on information developed from Steps 2 and 3, EPA will 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 previously assessed dermal and
inhalation exposure to workers and occupational non-users during NMP use in paint and graffiti
removal (U.S. EPA. 2015). Inputs to the PBPK model were developed from air monitoring data
and dermal parameter data and assumptions for workers. EPA will utilize results from the
previous assessment during risk evaluation. EPA may develop models for other conditions of
use, where appropriate.
5) Consider and incorporate applicable engineering controls and/or personal protective equipment
into exposure scenarios. EPA will review potentially relevant data sources on engineering
controls and personal protective equipment as identified in Table Apx B-7 and determine their
applicability for incorporation into specific exposure scenarios during risk evaluation. OSHA has
not established any occupational exposure limits for NMP; however, AIHA has adopted a
recommended workplace environmental exposure level (WEEL) of 10 ppm based on a time-
weighted average (TWA) over an 8-hour workday. EPA will consider the influence of the
recommended exposure guidelines in its occupational exposure assessment.
6) Map or group each condition of use to occupational exposure assessment scenario(s). EPA has
identified occupational exposure scenarios and mapped them to conditions of use. For example,
one scenario grouping is the Industrial Spray Application of Lacquers, Paints, and Coatings,
where products containing NMP are applied to substrates via spraying methods in an industrial
setting. EPA grouped similar conditions of use (e.g., based on factors including process
equipment and handling, usage rates and NMP content of product formulations, exposure/release
sources, or professional judgement) into scenario groupings but may further refine these
groupings as additional information is identified during risk evaluation. EPA was not able to
identify occupational exposure scenarios corresponding to several conditions of use due to a lack
of general understanding of those conditions of use. For example, EPA has not identified
information related to exposure during the use of NMP in petrochemical purifications. EPA will
perform targeted research to understand those uses which may inform identification and
refinement of occupational exposure scenarios.
7) Evaluate the weight of evidence of occupational exposure data. The data integration strategy will
be designed to be "fit-for-purpose". EPA will use systematic review methods to assemble the
relevant data and evaluate data quality, including strengths and limitations, followed by synthesis
and integration of the evidence.
2.6.1.5 Consumer Exposures
EPA expects to consider and analyze exposures to consumers as follows:
1) Refine and finalize exposure scenarios for consumers by considering unique combinations of
sources (consumer uses), exposure pathways, exposure settings, exposed populations and
exposure routes. For NMP, the following are noteworthy considerations in constructing exposure
scenarios for consumers:
• reasonably available data sources, including those that provide information on NMP content
in manufactured, processed, used, or recycled consumer products and articles, including
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temporal trends associated with such data; an example of an information source with product
information (e.g., NMP content) is the CDC Household Products Database.
• information characterizing use patterns for consumer products that contain NMP including
how the product is used, the amount of product used, the frequency and duration of use and
specific characteristics regarding the room in which the product is used;
• the exposure setting and route of exposure for potentially exposed populations, including
susceptible subpopulations that may be exposed via consumer product use, including those
who use commercial products that contain higher concentrations of NMP, or those who may
use NMP-containing products more frequently;
• information characterizing the potential for NMP release from products and articles into the
indoor environment through diffusion from materials to air, physical abrasion, or direct
transfer to dust;
• EPA will map products according to their NMP content, use patterns and exposure routes,
including potentially exposed or susceptible subpopulations to develop exposure scenarios.
Evaluate consumer exposures to products and articles containing NMP. The 2015 NMP Risk
Assessment for Paint Removal Use provides an in-depth characterization of paint removal
products, including the NMP content, use patterns and associated exposures that may occur via
their use. During risk evaluation, EPA will consider these paint removal uses along with other
consumer uses to conduct a first-tier exposure analysis. The results of this analysis will then be
used to determine which consumer use scenarios may need a more refined exposure assessment.
In addition to the comparison of consumer exposure scenarios to each other, the associated
exposure estimates for each scenario will also be compared to the hazard benchmarks identified
for dermal and inhalation exposure. Based on the results of this evaluation, EPA may consider a
subset of consumer use scenarios for a more extensive analysis.
Evaluate the indoor exposure pathways based on available data. Indoor exposures are likely to be
higher than outdoor exposures and may include a potential for oral, dermal and inhalation
contact. Data sources associated with these pathways have not been comprehensively evaluated;
however, quantitative comparisons across exposure pathways will be considered during risk
evaluation.
Review existing consumer exposure models that may be applicable in estimating indoor air
concentrations (near field and far field) for the user and in estimating dermal exposure to
consumer users. Determine the applicability of the identified models for use in a quantitative
exposure assessment.
Review reasonably available consumer product-specific sources to determine how exposure
estimates compare with each other and with indoor monitoring data on NMP levels in dust or
indoor air. EPA will review the available empirical data for use in developing, adapting or
applying exposure models such as the Consumer Exposure Model (CEM) to the risk evaluation.
The CEM parameters used in EPA's 2015 assessment of NMP use in paint removal and will be
reviewed to determine if they can be used to evaluate other NMP use scenarios.
Review reasonably available population- or subpopulation-specific exposure factors and activity
patterns to determine if EPA's identification of potentially exposed or susceptible subpopulations
need to be further refined. Possible considerations include:
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• the characteristics of the user of the consumer product and the bystander(s) in the room,
including for example, women of child bearing age and children.
• subpopulations who may have greater exposure due to the magnitude, frequency or
duration of exposure as applicable to specific consumer products.
7) Evaluate the weight of evidence available for consumer exposure estimates based on different
approaches.
2.6.1.6 General Population Exposures
EPA does not expect to include general population exposures in the risk evaluation for NMP. EPA has
determined that the existing regulatory programs and associated analytical processes adequately assess
and effectively manage the risks of NMP that may be present in various media pathways (e.g., air, water,
land) for the general population. For these cases, EPA believes that the TSCA risk evaluation should
focus not on those exposure pathways, but rather on exposure pathways associated with TSCA
conditions of use that are not subject to those regulatory processes, because the latter pathways are likely
to represent the greatest areas of concern to EPA.
2.6.2 Hazards (Effects)
2.6.2.1 Environmental Hazards
EPA's conservative screening analysis demonstrated a low risk concern for NMP based on currently
available information (e.g., physical-chemical properties, fate characteristics and TRI-reported
environmental releases). EPA does not expect to further analyze environmental hazards.
2.6.2.2 Human Health Hazards
EPA expects to consider and analyze human health hazards as follows:
1) Review reasonably available human health hazard data, including data from alternative test
methods as needed (e.g., computational toxicology and bioinformatics; high-throughput
screening methods; data on categories and read-across; in vitro studies; systems biology).
Human health studies will be evaluated using the evaluation strategies laid out in the
supplemental document, Application of Systematic Review in TSCA Risk Evaluations (U.S. EPA.
2018). Human and animal data will be identified and included as described in the inclusion and
exclusion criteria in Appendix G. EPA expects to prioritize the evaluation of mechanistic
evidence. Specifically, EPA does not plan to evaluate mechanistic studies unless needed to
clarify questions about associations between NMP and health effects and its relevance to
humans. The Applications of Systematic Review in TSCA Risk Evaluations document describes
the process of how studies will be evaluated using specific data evaluation criteria and a
predetermined approach. Study results will be extracted and presented in evidence tables by
hazard endpoint. EPA expects to evaluate relevant studies identified in the TSCA Work Plan
Chemical Risk Assessment on NMP use in Paint Stripping \ H < r \ {2015). In addition, EPA
intends to review studies that were captured in the comprehensive literature search conducted by
the Agency for NMP \NMP (CASRN 872-50-4) Bibliography: Supplemental File for the TSCA
Scope Document, (EPA-HQ-QPPT-2016-0743)1. and supplemental literature searches to address
specific questions. Further, EPA will consider any relevant CBI in a manner that protects the
confidentiality of the information from public disclosure.
2) When evaluating available data, determine whether specific individual groups may have greater
susceptibility to NMP hazard(s) than the general population.
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3) Conduct hazard identification (the qualitative process of identifying human health hazard
endpoints) and dose-response assessment (the quantitative relationship between hazard and
exposure) for all identified human health hazard endpoints.
Human health hazards from acute and chronic exposures will be identified by evaluating the
human and animal data that meet the data quality criteria described in Application of Systematic
Review in TSCA Risk Evaluations ( ). Studies meeting data quality criteria will be
grouped by routes of exposure relevant to humans.
4) Dose-response assessment will be performed in accordance with EPA guidance (U.S. EPA.
2012a). Dose-response analyses performed to support the TSCA Work Plan Chemical Risk
Assessment on NMP use in Paint Stripping U.S. EPA. (2015) may be used if the data meet data
quality criteria and if additional information on the identified hazard endpoints or additional
hazard endpoints would not alter this analysis.
5) Derive POD and conduct benchmark dose modeling when feasible based on the available data.
Hazard data will be evaluated to determine the type of dose-response modeling that is applicable,
if updates are needed. When modeling is feasible, a set of dose-response models that are
consistent with a variety of underlying biological processes will be applied to empirically model
the dose-response relationships within the range of the observed data consistent with EPA's
Benchmark Dose Technical Guidance Document. When dose-response modeling is not feasible,
NOAEL or LOAEL values will be identified.
6) Consider the route(s) of exposure (oral, inhalation, dermal), available exposure data and
modeling approaches to integrate exposure and hazard assessment.
7) Evaluate the weight of evidence based on human health hazard data.
EPA will rely on the weight of scientific evidence when evaluating and integrating human health
hazard data. The strategy will be designed to be "fit-for-purpose". EPA will use systematic
review methods to assemble the relevant data, evaluate for quality and relevance, including
strengths and limitations, followed by synthesis and integration of the evidence.
2.6.3 Risk Characterization
Risk characterization is an integral component of the risk assessment process for both ecological and
human health risks. EPA will derive the risk characterization in accordance with EPA's Risk
Characterization Handbook (U.S. EPA. 2000). As defined in EPA's Risk Characterization Policy, "the
risk characterization integrates information from the preceding components of the risk evaluation and
synthesizes an overall conclusion about risk that is complete, informative and useful for decision
makers." Risk characterization is considered to be a conscious and deliberate process to bring all
important considerations about risk, not only the likelihood of risk but also the strengths and limitations
of the assessment and a description of how others have assessed the risk into an integrated picture.
Risk characterization at EPA assumes different levels of complexity depending on the nature of the risk
being characterized. The level of information contained in each risk characterization varies according to
the type of assessment for which the characterization is written. Regardless of the level of complexity or
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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 ( 00). EPA will also present information in this
section consistent with approaches described in the Procedures for Chemical Risk Evaluation Under the
Amended Toxic Substances Control Act ( 26). For instance, in the risk characterization
summary, EPA will further carry out the obligations under TSCA section 26; for example, by
identifying and assessing uncertainty and variability in each step of the risk evaluation, discussing
considerations of data quality such as the reliability, relevance and whether the methods utilized were
reasonable and consistent, explaining any assumptions used, and discussing information generated from
independent peer review. EPA will also be guided by EPA's Information Quality Guidelines (
2002) which provide guidance for presenting risk information. Consistent with those guidelines, in the
risk characterization, EPA will identify: (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.
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(WQX) [database] [Database], Washington, DC. Retrieved from http://www.epa.gov/storet/
(U.S. Environmental Protection Agency). (2012d). Sustainable futures P2 framework manual
[EPA Report], (EPA-748-B12-001). Washington DC. http://www.epa.gov/sustainable-
futures/ sustainable-futures-p2-framework-manual.
(U.S. Environmental Protection Agency). (2013). Interpretive assistance document for
assessment of discrete organic chemicals. Sustainable futures summary assessment [EPA
Report], Washington, DC. http://www.epa.gov/sites/production/files/2Q15~Q5/docurnents/05-
iad discretes iune^ if.
(U.S. Environmental Protection Agency). (2014). Framework for Human Health Risk
Assessment to Inform Decision Making. (EPA/100/R-14/001). Washington, DC: Environmental
Protection Agency, Office of the Science Advisor.
https://www.epa.gOv/sites/prodiiction./files/2014 1J j!«_>cuments/hhra-framework-final-201J |If.
(U.S. Environmental Protection Agency). (2015). TSCA work plan chemical risk assessment.
N-Methylpyrrolidone: Paint stripper use (CASRN: 872-50-4). In Office of Chemical Safety and
Pollution Prevention. (740-R1-5002). Washington, DC.
https://www.epa.gOv/sites/production./files/2.015-l 1/documents/nn nal.pdf.
(U.S. Environmental Protection Agency). (2016a). Instructions for reporting 2016 TSCA
chemical data reporting. Washington, DC: Office of Pollution Prevention and Toxics.
reporting.
(2016b). Public database 2016 chemical data reporting (May 2017 release). Washington, DC:
US Environmental Protection Agency, Office of Pollution Prevention and Toxics. Retrieved
from https://www.epa.gov/chem.ical-data-reporting
(2016c). Toxic release inventory: N-methyl-2-pyrrolidone [Database],
LJ5 EPA (U.S. Environmental Protection Agency). (2017a). Scope of the risk evaluation for N-
Methylpyrrolidone (2-Pyrrolidinone, 1-Methyl-). CASRN: 872-50-4 [EPA Report], (EPA-740-
Rl-7005). https://www.epa.gov/sites/production/files/201 Oo/documents/nmp scow
[•
(2017b). Toxics Release Inventory (TRI). Retrieved from https://www.epa.gov/toxics-
release-inventory-tri-program/tri-data-and-tools
(U.S. Environmental Protection Agency). (2018). Application of systematic review in TSCA
risk evaluations: DRAFT Version 1.0. (740P18001). Washington, D.C.: U.S. Environmental
Protection Agency, Office of Chemical Safety and Pollution Prevention.
White. PL; Bardok (2004). Paint and finish removers.
WHO (World Health Organization). (2001). Concise International Chemical Assessment Document 35:
N-Methyl-2-Pyrrolidone. Geneva, Switzerland.
http://www.inchem.org/documents/cicads/cicads/cicad35.htm.
Xiaofei. E; Wadj _)_,_Nozakt _ i Mivauchi. H; Tanaka. S; Seki. Y; Koizumi. A. (2000). A linear
pharmacokinetic model predicts usefulness of N-methyl-2-pyrrolidone (NMP) in plasma or urine
as a biomarker for biological monitoring for NMP exposure. J Occup Health. 42(6): 321-327.
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APPENDICES
Appendix A REGULATORY HISTORY
A.l Federal Laws and Regulations
Table Apx A-l. Federal Laws and Regulations
Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
EPA Regulations
Toxic Substances
Control Act (TSCA)
- Section 6(a)
Provides EPA with the authority to prohibit
or limit the manufacture (including import),
processing, distribution in commerce, use or
disposal of a chemical if EPA evaluates the
risk and concludes that the chemical presents
an unreasonable risk to human health or the
environment.
Proposed rule (82 FR 7464)
regulating NMP uses in paint
and coating removal
Toxic Substances
Control Act (TSCA)
- Section 6(b)
Directs EPA to promulgate regulations to
establish processes for prioritizing chemicals
and conducting risk evaluations on priority
chemicals. In the meantime, EPA is directed
to identify and begin risk evaluations on
10 chemical substances drawn from the 2014
update of the TSCA Work Plan for Chemical
Assessments.
NMP is on the initial list of
chemicals to be evaluated for
unreasonable risk under TSCA
(81 FR 91927, December 19,
2016)
Toxic Substances
Control Act (TSCA)
- Section8(a)
The TSCA section 8(a) Chemical Data
Reporting (CDR) Rule requires
manufacturers (including importers) to give
EPA basic exposure-related information on
the types, quantities and uses of chemical
substances produced domestically and
imported into the US.
NMP manufacturing, importing,
processing and use information
is reported under the Chemical
Data Reporting (CDR) rule (76
FR 50816, August 16, 2011).
Toxic Substances
Control Act (TSCA)
- Section8(b)
EPA must compile, keep current and publish
a list (the TSCA Inventory) of each chemical
substance manufactured, processed, or
imported in the United States.
NMP was on the initial TSCA
Inventory and therefore was not
subject to EPA's new chemicals
review process (60 FR 16309,
March 29, 1995).
Toxic Substances
Control Act (TSCA)
- Section 8(e)
Manufacturers (including importers),
processors and distributors must immediately
notify EPA if they obtain information that
supports the conclusion that a chemical
substance or mixture presents a substantial
risk of injury to health or the environment.
Seven notifications of substantial
risk (Section 8(e)) received
(2007-2010) (US EPA,
ChemView. Accessed April 13,
2017).
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
Toxic Substances
Control Act (TSCA)
- Section 4
Provides EPA with authority to issue rules
and orders requiring manufacturers
(including importers) and processors to test
chemical substances and mixtures.
Six submissions from a test rule
(Section 4) received in the mid-
1990s. (US EPA, ChemView.
Accessed April 13, 2017).
Emergency Planning
and Community
Right-To-Know Act
(EPCRA) - Section
313
Requires annual reporting from facilities in
specific industry sectors that employ 10 or
more full time equivalent employees and that
manufacture, process, or otherwise use a
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). This data includes
on-site and off-site data as well as
multimedia data (i.e., air, land and water).
NMP is a listed substance
subject to reporting requirements
under 40 CFR 372.65 effective
as of January 1, 1995.
Federal Food, Drug
and Cosmetic Act
(FFDCA) - Section
408
FFDCA governs the allowable residues of
pesticides in food. Section 408 of the
FFDCA provides EPA with the authority to
set tolerances (rules that establish maximum
allowable residue limits), or exemptions
from the requirement of a tolerance, for all
residues of a pesticide (including both active
and inert ingredients) that are in or on food.
Prior to issuing a tolerance or exemption
from tolerance, EPA must determine that the
tolerance or exemption is "safe." Sections
408(b) and (c) of the FFDCA define "safe"
to mean the Agency has a reasonable
certainty that no harm will result from
aggregate exposures to the pesticide residue,
including all dietary exposure and all other
exposure (e.g., non-occupational exposures)
for which there is reliable information.
Pesticide tolerances or exemptions from
tolerance that do not meet the FFDCA safety
standard are subject to revocation. In the
absence of a tolerance or an exemption from
tolerance, a food containing a pesticide
residue is considered adulterated and may
not be distributed in interstate commerce.
NMP is currently approved for
use as a solvent and co-solvent
inert ingredient in pesticide
formulations for both food and
non-food uses and is exempt
from the requirements of a
tolerance limit (40 CFR Part
180.920).
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
Clean Air Act (CAA)
- Section 111 (b)
Requires EPA to establish new source
performance standards (NSPS) for any
category of new or modified stationary
sources that EPA determines causes, or
contributes significantly to, air pollution
which may reasonably be anticipated to
endanger public health or welfare. The
standards are based on the degree of
emission limitation achievable through the
application of the best system of emission
reduction which (considering the cost of
achieving reductions and non-air quality
health and environmental impacts and energy
requirements) EPA determines has been
adequately demonstrated.
NMP is subject to Clean Air Act
Section 111 Standards of
Performance for New Stationary
Sources of Air Pollutants for
VOC emissions from synthetic
organic chemical manufacturing
industry distillation operations
(40 CFR Part 60, subpart NNN)
and reactor processes (40 CFR
Part 60, Subpart RRR).
Clean Air Act (CAA)
- Section 183(e)
Section 183(e) requires EPA to list the
categories of consumer and commercial
products that account for at least 80 percent
of all VOC emissions in areas that violate the
National Ambient Air Quality Standards for
ozone and to issue standards for these
categories that require "best available
controls." In lieu of regulations, EPA may
issue control techniques guidelines if the
guidelines are determined to be substantially
as effective as regulations.
NMP is listed under the National
Volatile Organic Compound
Emission Standards for Aerosol
Coatings (40 CFR part 59,
subpart E).
Clean Air Act (CAA)
- Section 612
Under Section 612 of the Clean Air Act
(CAA), EPA's Significant New Alternatives
Policy (SNAP) program reviews substitutes
for ozone depleting substances within a
comparative risk framework. EPA publishes
lists of acceptable and unacceptable
alternatives. A determination that an
alternative is unacceptable, or acceptable
only with conditions, is made through
rulemaking.
Under EPA's SNAP program,
EPA listed NMP as an
acceptable substitute for
"straight organic solvent
cleaning (with terpenes, C620
petroleum hydrocarbons,
oxygenated organic solvents
such as ketones, esters, alcohols,
etc.)" for metals, electronics and
precision cleaning and
"Oxygenated organic solvents
(esters, ethers, alcohols,
ketones)" for aerosol solvents
(59 FR, March 18, 1994).
Safe Drinking Water
Act (SDWA) -
Section 1412 (b)
Every 5 years, EPA must publish a list of
contaminants (1) that are currently
unregulated, (2) that are known or
anticipated to occur in public water systems,
NMP was identified on both the
Third (2009) and Fourth (2016)
Contaminant Candidate Lists (74
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
and (3) which might require regulations
under SDWA. EPA must also determine
whether to regulate at least five contaminants
from the list every 5 years.
FR 51850, October 8, 2009) (81
FR 81099 November 17, 2016).
Other Federal Regulations
Occupational Safety
and Health Act
(OSHA)
Requires employers to provide their workers
with a place of employment free from
recognized hazards to safety and health, such
as exposure to toxic chemicals, excessive
noise levels, mechanical dangers, heat or
cold stress, or unsanitary conditions.
Under the Act, OSHA can issue occupational
safety and health standards including such
provisions as Permissible Exposure Limits
(PELs), exposure monitoring, engineering
and administrative control measures and
respiratory protection.
OSHA has not established a PEL
for NMP, though OSHA
identifies potential symptoms
and health effects associated
with NMP including eye
irritation, severe skin irritation
with chronic exposure and
reproductive hazards including
possible fetal toxicity.
Federal Food, Drug
and Cosmetic Act
(FFDCA)
Provides the U.S Food and Drug
Administration (FDA) with authority to
oversee the safety of food, drugs and
cosmetics.
Food and Drug Administration
identifies NMP as an "Indirect
Additive Used in Food Contact
Substances" specifically as:
1) an adjuvant substance in the
preparation of slimicides (21
CFR 176.300),
2) an adjuvant substance in the
production of polysulfone resin
authorized for use as articles
intended for use in contact with
food (21 CFR 177.1655) and
3) a residual solvent in
polyetherone sulfone resins
authorized as articles for
repeated use in contact with food
(21 CFR 177.2440).
FDA also identifies NMP as a
Class 2 solvent, namely a solvent
that "should be limited in
pharmaceutical products because
of their inherent toxicity."
FDA established a Permissible
Daily Exposure (PDE) for NMP
of 5.3 mg/day with a
concentration limit of 530 ppm.
FDA's Center for Veterinary
Medicine developed a method in
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Statutes/Regulations
Description of Authority/Regulation
Description of Regulation
2011 for detection of the
residues of NMP in edible
tissues of cattle (21 CFR
500.1410)
A.2 State Laws and Regulations
Table Apx A-2. State Laws and Regulations
State Actions
Description of Action
State Air Regulations
New Hampshire (Env-A 1400: Regulated Toxic Air Pollutants) lists NMP
as a regulated toxic air pollutant.
Vermont (Vermont Air Pollution Control Regulations, 5261) lists NMP as
a hazardous air contaminant.
Chemicals of Concern to
Children
Several states have adopted reporting laws for chemicals in children's
products that include NMP including Oregon (OAR 333-016-2000),
Vermont (18 V.S.A. sections 1771 to 1779) and Washington state (WAC
173-334-130). Minnesota has listed NMP as a chemical of concern to
children (Minnesota Statutes 116.9401 to 116.9407).
State Permissible
Exposure Limits
California PEL is 1 ppm as an 8hr-time-weighted average (TWA), along
with a skin notation (Cal Code Regs, title 8, section 5155).
State Right-to-Know Acts
Massachusetts (454 CMR 21.00), New Jersey (42 N.J.R. 1709(a)) and
Pennsylvania (Chapter 323. Hazardous Substance List).
Other
In California, NMP is listed on Proposition 65 (Cal. Code Regs, title 27,
section 27001) due to reproductive toxicity. California OEHHA lists a
Maximum Allowable Dose Level (MADL) for inhalation exposure =
3,200 |ig/day MADL for dermal exposure = 17,000 |ig/day.
The California Department of Toxic Substances Control (DTSC) Safer
Consumer Products Program lists NMP as a Candidate Chemical for
development toxicity and reproductive toxicity. In addition, DTSC is
moving to address paint strippers containing NMP and specifically
cautioned against replacing Methylene Chloride with NMP. California is
considering a separate rule on NMP.
California Department of Public Health's Hazard Evaluation System and
Information Service (HESIS) issued a Health Hazard Advisory on NMP in
2006 and updated the Advisory in June 2014. The Advisory is aimed at
workers and employers at sites where NMP is used.
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A.3 International Laws and Regulations
Table Apx A-3. Regulatory Actions by Other Governments and Tribes
Country/Organization
Requirements and Restrictions
European Union
In 2011, NMP 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).
In March 2017, NMP was included in the public consultation of chemicals
recommended for inclusion in Annex XIV of the European Chemicals
Agency (ECHA) under Annex (Authorisation list) of regulation (EC) No
1907/2006 - REACH (Registration, Evaluation, Authorization and
Restriction of Chemicals).
In 2013, the Netherlands submitted a proposal under REACH to restrict
manufacturing and all industrial and professional uses of NMP where
workers' exposure exceeds a level specified in the restriction (European
Chemicals Agency (ECHA) database. Accessed April 18, 2017).
On April 18, 2018, the European Union added NMP to REACH Annex
XVII, the restricted substances list. The action specifies three conditions of
restriction. The conditions are: 1) NMP shall not be placed on the market
as a substance on its own or in mixtures in concentrations greater than
0.3% after May 9, 2020, unless manufacturers, importers and downstream
users have included chemical safety reports and safety data sheets with
Derived No-Effect Levels (DNELs) relating to workers' exposures of 14.4
mg/m3 for exposure by inhalation and 4.8 mg/kg/day for dermal exposure;
2) NMP shall not be manufactured, or used, as a substance on its own or in
mixtures in a concentration equal to or greater than 0.3% after May 9, 2020
unless manufacturers and downstream users take the appropriate risk
management measures and provide the appropriate operational conditions
to ensure that exposure of workers is below the DNELs specified above:
and 3) the restrictions above shall apply from May 9, 2024 to placing on
the market for use, or use, as a solvent or reactant in the process of coating
wires.
Australia
NMP was assessed under Human Health Tier III of the Inventory Multi-
tiered Assessment and Prioritisation (IMAP) (National Industrial
Chemicals Notification and Assessment Scheme, NICNAS, 2017, Human
Health Tier III assessment for 2-Pyrrolidinone, lmethyl-. Accessed April,
18 2017).
Japan
NMP 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)
• Industrial Safety and Health Act
(National Institute of Technology and Evaluation (NITE) Chemical Risk
Information Platform (CHIRP). Accessed April 18, 2017).
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Country/Organization
Requirements and Restrictions
European Union and
Australia, Austria,
Belgium, Canada
(Ontario), Denmark,
Finland, France,
Germany, Ireland, Italy,
Latvia, New Zealand,
Poland, Spain, Sweden,
Switzerland, The
Netherlands, Turkey and
the United Kingdom.
Occupational exposure limits for NMP (GESTIS International limit values
for chemical agents (Occupational exposure limits, OELs) database.
Accessed April 18, 2017).
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Appendix B PROCESS, RELEASE AND OCCUPATIONAL
EXPOSURE INFORMATION
This appendix provides information and data found during preliminary data gathering for NMP.
B.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 for consideration. Note that the processing information below is representative of
NMP, but not inclusive of all uses. EPA will consider this information and data in combination with
other data and methods for use in the risk evaluation.
B.l.l Manufacture (Including Import)
According to 2016 public CDR data, NMP is both domestically manufactured in and imported into the
United States ( 2016b).
B.l.1.1 Domestic Manufacturing
NMP can be manufactured using different methods. One method involves reaction of butyrolactone with
an excess of pure or aqueous methyl amine in a high pressure tube (Harreus et at... 2011). This reaction is
shown in Figure_Apx B-l and is taken from (Anderson and Liu. 2000). This exothermic reaction takes
place under adiabatic conditions, and produces a reaction product containing NMP that is subsequently
distilled to purify the NMP produced. This method of manufacturing results in a 97% yield of NMP
(Barrens et at.. ).
CNHCH3 *" f I •+* ff;J0
n vr>
€1%
FigureApx B-l. NMP Manufacturing Under Adiabatic Conditions
Another process for manufacturing NMP involves reacting gamma-butyrolactone (GBL) and
monomethylamine (MM A), as shown in Figure Apx B-2 (Johnson Matthev Process Technologies.
2017). This reaction is non-catalyzed and takes place in two stages. The first stage produces a long-chain
amide that is cyclized, then dehydrated to form NMP during the second stage of the reaction. The
reaction product which contains NMP is then distilled to purify the NMP.
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x'iT ° + H»0
Mi*
n«methy)»2>pyrroiick>ne water
(NMP)
FigureApx B-2. NMP Manufacturing Using Gamma-Butyrolactone (GBL) and
Monomethylamine (MMA)
NMP is also manufactured from maleic anhydride in an integrated production process at a Mitsubishi
plant in Japan (Mitsubishi Chemical. 2017).
B.l.1.2 Import
Typical import activities for NMP include storage in warehouses prior to distribution for further
processing and use and quality control sampling.
Transfers of NMP are generally done with steel piping, as rubber hose is not suitable for handling. NMP
may be transported in tank cars, tank trailers or drums. Shipping containers normally consist of unlined
steel (Anderson and Liu. 2000).
B.1.2 Processing
B. 1.2.1 Reactant/Intermediate
The exact process operations involved during the use of NMP as a chemical intermediate are dependent
on the final product that is being synthesized. For NMP use as a chemical intermediate, operations
would typically involve unloading NMP from transport containers and feeding it into reaction vessel(s),
where the NMP would either react fully or to a lesser extent. Following completion of the reaction, the
produced substance may or may not be purified further, thus removing unreacted NMP (if present). The
reacted NMP is assumed to be destroyed and therefore is not expected to be released to the environment
or to present a potential for worker exposure.
B.l.2.2 Incorporation into Formulation, Mixture, or Reaction Product
NMP is incorporated into formulations for a wide range of products, including cleaning products, paints,
coatings, adhesives, sealants, inks and toners (ECUA. 2011). Formulation processes for these products
typically involve similar operations. First, the components of the product formulation are unloaded from
transport containers, either directly into the mixing equipment or into an intermediate storage vessel.
Transfer from transport containers may be manual or automated, through the use of a pumping system.
An automated dispenser may be used to feed components into the mixing vessel to ensure that precise
amounts are added at the proper time during the mixing process. Once in the mixing vessel, the
components are then mixed in either a batch or continuous system. Evaporative losses of NMP and other
volatile components will depend on whether a closed or open system is used during the mixing process
(OECD. 2010aY
Depending on the specific product, the formulation may be further processed through filtering. Once the
formulation is completed, it is sampled for quality purposes. The final formulation is then filled into
containers, either through manual dispensing from transfer lines or through utilization of an automatic
system. Automatic filling systems are generally used for the filling of smaller containers that are
• butyroiactone MMA
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intended for consumer and commercial applications, whereas manual filling is done for larger containers
(e.g., tank trucks, totes, drums) which are typically used in an industrial setting (« ).
B.l.2.3 Incorporation into Article
EPA defines articles as manufactured items that are formed to a specific shape or design during
manufacture and for which the end use is dependent in whole or in part upon their shape or design. The
exact process operations involved in the incorporation of NMP are dependent on the 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. The exact process
operations involved in the incorporation of NMP-containing formulations or reaction products are
dependent on the article. EPA identified the following processing activities that incorporate NMP and
NMP formulations or reaction products into articles.
B.l.2.4 Repackaging
Typical repackaging operations involve transferring of NMP into appropriately sized containers to meet
customer demands/needs.
B.l.2.5 Recycling
NMP is used as an extractive solvent for effective removal of various compounds by petrochemical and
other industries (ECHA. 2011). In this capacity, NMP absorbs the compound being extracted and can be
regenerated and recycled for reuse; this is described in further detail in the Petrochemical Processing
Aid section.
B.1.3 Uses
In this document, EPA has grouped uses based on CDR categories and identified examples within these
categories as subcategories of use. Note that some subcategories may be grouped under multiple CDR
subcategories. These differences will be further investigated and refined during risk evaluation.
B.l.3.1 Paints and Coatings
The physical-chemical properties of NMP make it miscible in water and many hydrocarbon solvents,
allowing NMP to be used in a diverse range of paint and coating applications (ECHA.. 2011). The
components of the paint or coating are formulated as discussed in the previous section. Note that many
paint and coating formulations are filtered to remove any undesired solids (such as gel, pigment or filler
agglomerates) (OECD. 2010a) prior to packaging into transport containers.
Containers of formulated paints and coating products are then sent to the customer for application,
where they may be diluted and mixed prior to application ( ). Application techniques
include brushing, rolling, spraying, printing, dipping and curtain coating, and may be manual or
automated. Once applied to the substrate, the paint or coating is allowed to dry or "cure" during this
time, the NMP in the coating evaporates completely (ECHA.. 2011). The drying/curing process may be
promoted through the use of heat or radiation (radiation can include ultraviolet and electron beam
radiation), but this more common for waterborne coatings (OECD. 2010a). Due to its evaporation
potential, NMP is not assumed to be present in articles after the drying/curing process is complete
(ECHA. ).
NMP is used for paint removal in a variety of industries, such as the automotive, aircraft, construction
and refinishing industries. Application methods include manual or automated, with techniques such as
spraying, brushing, pouring, wiping and rolling. Additional details on this use of NMP can be found in
the previous risk assessment which evaluated the use of NMP in paint and coating removal (U.S. EPA.
2015).
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B.l.3.2 Solvents for Cleaning and Decreasing
NMP is used in a variety of cleaning products, because of its high solvating power for plastics, resins,
oil and grease (ECHA.. ). NMP is used in industrial cleaners and degreasers, graffiti-removing
products and consumer cleaning products. NMP is also used in the electronics industry as a solvent
carrier in photoresist formulations, and for removal of excess photoresist from silicon wafers (ECHA.
201 n.
Once formulated, cleaning solutions containing NMP can be applied to substrates using a variety of
application methods, including roller application, brushing, dipping, pouring, spraying and wiping. NMP
application may be automated or manual, depending on the cleaning product. Consumer cleaning
solutions are likely to be applied manually, whereas industrial cleaning processes are often automated.
The applied cleaning solution is then removed from the substrate, along with the contaminants, and
discarded as waste.
Degreasing operations are used to remove dirt, grease and surface contaminants from the substrate.
NMP is reportedly used as a solvent in degreasing tanks in the aerospace industry (ECHA. 2011).
Industrial degreasing operations can involve batch or continuous processes; actual operation can include
vapor-phase and/or liquid-phase degreasing (e.g., cold cleaning) (U.S. EPA. 2016b).
Photoresist formulations containing solvents, such as NMP, are applied using a dispensing apparatus
that applies small amounts of photoresist formulations to wafers, which are then spun at a high speed to
uniformly coat their surface. The excess photoresist that is spun off of the wafer is then disposed of as
waste. The coated wafers are subsequently baked to evaporate the carrier solvent, exposed to form an
image and then baked again to ensure that trace amounts of solvent are evaporated (OE( ).
Wafers are then developed to dissolve unwanted portions of the photoresist and etched to remove
unwanted areas of silicon substrate or deposited film before the residual photoresist is removed. Wet
removal processes involve submersion of wafers in a bath solution containing chemicals such as
solvents, acids or bases, to dissolve the photoresist. The waste bath containing the dissolved photoresist
is collected, and potentially treated, prior to disposal (OECD. 2010b).
B.l.3.3 Ink, Toner and Colorant Products
Printing inks are comprised 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 (OECD. 2010c). In
addition to colorants, ink formulations contain several types of substances including solvents such as
NMP, binders, thinners, dispersing agents and drying agents. During product formulation, colorants are
generally added after all of the other components have been combined and mixed. Dispersion usually
involves a milling process, to break up and evenly distribute the colorant throughout the formulation.
Transport containers for inks and toners can vary widely depending on the intended end use of the
product formulation. Consumer products are packaged into smaller containers, such as cartridges for
printing or writing inks, whereas product formulations intended for industrial printing operations are
generally packaged into larger (e.g., 1-5-gallon) containers (OECD. 2010c).
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
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between the ink nozzle and the substrate. Consumer printing is generally limited to digital inkjet
printing; however, consumers also use inks that are pre-loaded into a pen prior to distribution in
commerce (ECHA. 2011).
B.l.3.4 Processing Aids Specific to Petroleum Production
NMP is used as a petrochemical processing aid in a variety of applications including extraction of
aromatic hydrocarbons from lube oils; separation and recovery of aromatic hydrocarbons from mixed
hydrocarbon feedstocks; recovery of acetylenes, olefins and diolefins; removal of sulfur compounds
from natural gas and refinery gases; and dehydration of natural gas (Anderson and Liu. 2.000).
Extractive distillation involves distillation in the presence of a solvent (or mixture of solvents) which
acts as a separating agent, displaying both a selectivity for, and the capacity to solubilize components in
a mixture to be separated (Doherty and Knapp. 2004). Solvents interact differently with the components
of the mixture to be separated, thereby altering their relative volatility and allowing them to be
separated. Solvent are added near the top of the extractive distillation column, while the mixture to be
separated is added at a second feed point further down the column. The component with the higher
volatility in the presence of a solvent is distilled overhead as the distillate and components with lower
volatility are removed with the solvent in the column bottoms. The solvent is then separated from other
components of the mixture, generally through distillation in a second column, and then recycled back to
the extractive distillation column (Doherty and Knapp. 2004).
NMP is used both for the extraction of unwanted aromatics from lube oils and the recovery of
hydrocarbons from feedstocks, via extractive distillation (ECHA..; ). NMP is favorable for the
extractive distillation of hydrocarbons because hydrocarbons are highly soluble in NMP, and the use of
NMP for extraction does not lead to the formation of azeotropes. NMP also has high resistance to heat
and chemicals (Stevens et at.. 2.007).
Other uses of NMP in petrochemical processing involve first using NMP to absorb specific compounds,
then separating the NMP from the absorbed compounds, similar to the extractive distillation process
(Anderson and Liu. 2000). Examples of absorptive processes include NMP use in the recovery of
acetylenes, olefins and diolefins; removal of sulfur compounds from natural and refinery gases; and the
dehydration of natural gas.
Absorption using a solvent, such as NMP, generally involves two towers, an absorption tower and a
removal tower. The mixture to be separated and the solvent are first introduced into the absorption
tower. Here the solvent absorbs the miscible compound and this heavier stream leaves in the bottoms of
the column. The solvent mixture is then sent to another column where the absorbed compound is
recovered from the solvent. The solvent may undergo further processes, such as scrubbing, to be fully
regenerated before being recycled back into the absorption column (Gannon and Schaffer. 2003).
(Information specific to the use of NMP for hydraulic fracturing operations was not identified.)
B.l.3.5 Adhesives and Sealants
NMP is used as a component in the formulation of solvent-based adhesives and sealants (OECD.
2.009a). Once the adhesive or sealant is received by the user, it may be diluted or mixed prior to
application (OE 15). The adhesive formulation is then loaded into the application reservoir or
apparatus and applied to the substrate via spray, roll, curtain, syringe or bead application which may be
manual or automated. After application, the adhesive or sealant is allowed to dry, usually at ambient
temperature. During this time the solvent completely evaporates and a bond is formed between the
Page 80 of 135
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substrates. In some instances, heat is applied to the substrate to promote the drying or curing of the
adhesive or sealant (OECD. 2015).
B.l.3.6 Other Uses
A number of other uses have been identified for NMP, including laboratory use for various research and
cleaning purposes. These activities typically occur within a fume hood, on a bench with local exhaust
ventilation, or under conditions that include general ventilation (ECUA. 2011).
Lithium Ion Battery Manufacturing
NMP use as a solvent for electrode preparation and in electrolyte formulations used for lithium ion
battery manufacturing is growing (Daniel. 2008). Electrolyte formulations usually include a lithium salt
dissolved in a solvent-based solution (Kamienski. 2004). The electrolyte is formulated separately, then
filled into the assembled cell, which consists of the electrode structures. Once the electrolyte solution is
added, the battery is sealed.
Pharmaceuticals
NMP is increasingly being used as a solvent and extraction medium for the manufacture and formulation
of pharmaceuticals (EC 311).
Reaction Medium
in industry, NMP is often used as a reaction medium for polymerization reactions, because many
polymers are soluble in NMP (Anderson and Liu. 2000). Specific polymers that are soluble in NMP
include polyvinyl acetate, polyvinyl fluoride, polystyrene, nylon, polyimides, polyesters, acrylics,
polycarbonates and synthetic elastomers. Depending on the intended product, once the polymer is
synthesized in the NMP-containing reaction medium, it may be isolated and precipitated. However,
some polymer-based resin and coating formulations, such as polyurethane dispersions, will include
NMP in the final formulation (6 PI. 2017). Additional uses of NMP as a reaction medium have not been
identified.
Textiles and Clothing
NMP has been found in textiles; however, EPA has not identified information specific to the use of
NMP in the textile industry.
B.1.4 Disposal
NMP is not designated as a hazardous substance under federal regulations thus, there are no federal
regulations determining how NMP and NMP-containing products may be disposed. However, three
states, Massachusetts, New Jersey and Pennsylvania have designated NMP as a hazardous substance,
thereby regulating NMP disposal. EPA has not identified other specific NMP disposal information.
B.2 Occupational Exposure Data
EPA presents herein some examples of occupational exposure-related information for NMP obtained
from preliminary data gathering. EPA expects to consider this information in combination with other
readily available data and methods for use in risk evaluation.
TableApx B-l and TableApx B-2 show mappings of release and worker exposure scenarios to
industry sectors with available OSHA monitoring data obtained from OSHA inspections between 2002
and 2016 for personal monitoring data and area monitoring data, respectively. EPA attempted to group
industry sectors, designated by North American Industry Classification System (NAICS) code,
Page 81 of 135
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according to possible release/exposure scenarios, but there is a great degree of uncertainty where and
how NMP may be used in these industries. The industry sectors in TableApx B-l and TableApx B-2
were extracted from the OSHA CEHD (OSHA. ).
EPA also found some NIOSH HHE data since 2000 that are summarized and included in Table Apx
B-3.
Table Apx B-l. Mapping of Scenarios to Industry Sectors with NMP Personal Monitoring Air
Samples Obtained from OSHA Inspections Conducted Between 2012 ant
2016
Possible Release/Exposure Scenario
NAICS
NAICS Description
Paint stripping; Adhesive removal by contractors; Roll/curtain, spray, or
manual application of lacquers, stains, varnishes, and primers
811420
Reupholstery and Furniture
Repair
Aerosol degreasing; Wipe cleaning; Spray, manual (brushing), or dip
application of metal finishing products;
333249
Other Industrial Machinery
Manufacturing
Unknown - this establishment is an OSHA facility
923110
Administration of Education
Programs
11 Samples are not 8-hr TWA. Results include non-detects (below limit of quantification) and exclude blank samples.
Table Apx B-2. Mapping of Scenarios to Industry Sectors with NMP Area Monitoring Air
Samples Obtained from OSHA Inspections Conducted Between 2012 and 2016
Possible Release/Exposure Scenario
NAICS
NAICS Description
Paint stripping; Adhesive removal by contractors; Roll/curtain, spray, or manual
application of lacquers, stains, varnishes, and primers
811420
Re-upholstery and
Furniture Repair
Samples are not 8-hr TWA. Results include non-detects (below limit of quantification) and exclude blank samples.
Table Apx B-3. Summary of NIOSH HHE NMP Data
Exposure/Release
Scenario
Facility
Description
Number of
Exposure
Samples
Minimum of
Exposure
Values (ppm)
Maximum of
Exposure
Values (ppm)
Comments
Sou rcc
Paint and coating
removal
Floor refinishing
7 (PBZ)
13 (Area)
1.4 (PBZ)
2.2 (Area)
5.2 (PBZ)
9.3 (Area)
Samples are a mix of
full-shift and short-term
exposures.
Kiefer
Spray application of
paints, coatings, and
adhesives
Spray
application of
paints onto
automotive seals
48 (PBZ)
20 (Area)
0.01 (PBZ)
0.01 (Area)
1.27 (PBZ)
25.0 (Area)
Individual data points
not provided. Source
only includes range and
average of exposure
values by job function.
NIOSH
PBZ - Personal Breathing Zone
Page 82 of 135
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B.3 Sources Containing Potentially Relevant Data or Information
Some sources of information and data related to releases and worker exposure were found during the
Systematic review literature search. Sources of data or information identified in the Analysis Plan
Sections 2.6.1.1 (releases) and 2.6.1.3 (occupational exposures) are shown in the four tables below. The
data sources identified are based on preliminary results to date of the full-text screening step of the
systematic review process. Further screening and quality evaluation are on-going. These sources will be
reviewed to determine the utility of the data and information in the Risk Evaluation.
Page 83 of 135
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Table Apx B-4. Potentially Relevant Data Sources for Information Related to Process Description
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sea lamprey pesticide application. Cincinnati, OH.
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NICNAS (1997). Full public report: Polymer in byk-410.
NICNAS (1997)
NICNAS (2001). Full public report: Polymer in primal binder u-51.
NICNAS (2001)
NICNAS (1998). Full public report: Copolymer in foraperle 321.
NIC I)
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TURI (1996). N-methyl pyrrolidone: Chemical profile. Lowell, MA, The Toxics Use Reduction Institute.
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U.S. EPA (1998). Cleaner technologies substitutes assessment for professional fabricare processes: Appendix F:
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BASF (1993). Modification of a vapor degreasing machine for immersion cleaning use N-methylpyrrolidone.
Parsippany, NJ.
BASF (1993)
BASF (1998). N-methylpyrrolidone(NMP): Biodegradability. Parsippany, NJ.
8)
ERG (2000). Preferred and alternative methods for estimating air emissions from paint and ink manufacturing
facilities. Durham, NC, Emission Inventory Improvement Program.
ERG (2000)
Technikon LLC (2001). Core box cleaner study: Evaporative emission study of specialty systems' solvent FC-47-G1.
McClellan, CA, Casting Emission Reduction Program.
Technikon. LLC
(2.001)
EC (2004). Effectiveness of vapour retardants in reducing risks to human health from paint strippers containing
dichloromethane. Brussels, Belgium.
EC (2004a)
ERM (2017). Life cycle assessment of used oil management. London, UK.
ERM (2
Table Apx B-5. Measured or Estimated Release Data
Bibliography
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Kim, B. R., et al. (2000). "Henry's law constants for paint solvents and their implications on volatile organic
compound emissions from automotive painting." Water Environment Research 72(1): 65-74.
Kim et al. (2000)
OECD (2009). Emission scenario document on adhesive formulation. Paris, France.
OECD (2009a)
OECD (2017). Emission Scenario Document (ESD) on the use of textile dyes.
OECD (2015). Emission scenario document on use of adhesives. Paris, France.
OECD (2010). Emission Scenario Document on Formulation of Radiation Curable Coatings, Inks and Adhesives.
Series on Emission Scenario Documents No. 21. Paris, OECD Environmental Health and Safetv Publications.
OEC
OECD (2010). Emission Scenario Document on Photoresist Use in Semiconductor Manufacturing. Series on
Emission Scenario Documents No. 9. Paris, OECD Environmental Health and Safetv Publications.
I
OECD (2010). Scoping Document for Emission Scenario Document on Manufacturing and Use of Printing Inks,
OECD Environmental Health and Safety Publications.
OEC
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OECD (2011). EMISSION SCENARIO DOCUMENT ON RADIATION CURABLE COATING, INKS AND
ADHESIVES. Series on Emission Scenario Documents No. 27. Paris, OECD Environmental Health and Safety
Publications.
(2016). Toxic release inventory: N-methyl-2-pyrrolidone.
U.S. EPA. (2016c)
(2017). Hazardous substances data bank: l-Methyl-2-pyrrolidinone. Rockville, MD, U.S. National Library of
Medicine.
HSDB (
ATSDR (2015). Health consultation: Review of air quality data: Intel Corporation - New Mexico facility: Rio
Rancho, Sandoval County, New Mexico: EPA facility ID: NMD000609339, Part 2. Atlanta, GA, U.S. Department of
Health and Human Services.
ATSDR (2015)
NICNAS (1997). Full public report: Polymer in byk-410.
NIC 7)
NICNAS (2001). Full public report: Polymer in primal binder u-51.
NICNAS (2001)
NICNAS (1998). Full public report: Copolymer in foraperle 321.
NIC S)
BASF (1993). Modification of a vapor degreasing machine for immersion cleaning use N-methylpyrrolidone.
Parsippany, NJ.
3}
ERG (2000). Preferred and alternative methods for estimating air emissions from paint and ink manufacturing
facilities. Durham, NC, Emission Inventory Improvement Program.
000)
MO DNR (2001). State of Missouri toxics release inventory: Summary report: 1999 data. Jefferson City, MO,
Technical Assistance Office.
I [R (2001)
Technikon LLC (2001). Core box cleaner study: Evaporative emission study of specialty systems' solvent FC-47-G1.
McClellan, CA, Casting Emission Reduction Program.
Technikon. LLC
(2001)
Chemistry Industry Association of Canada (2017). All substances emissions for 2012 and projections for 2015.
Ottawa, Canada.
Chemistry Industry
Association of
Canada(2017b)
Chemistry Industry Association of Canada (2017). All substances emissions for 2011 and projections for 2014.
Ottawa, Canada.
Chemistry Industry
Association of
Canada
Page 87 of 135
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Table Apx B-6. Personal Exposure Monitoring and Area Monitoring Data
Bibliography
url
Nishimura, S., et al. (2009). "A cross-sectional observation of effect of exposure to N-methyl-2-pyrrolidone (NMP) on
workers' health." Industrial Health 47(4): 355-362.
Nishimura et al.
(2.009)
Haufroid, V., et al. (2014). "Biological monitoring and health effects of low-level exposure to N-methyl-2-
Dvrrolidone: a cross-sectional studv." International Archives of Occupational and Environmental Health 87(6): 663-
674.
Haufroid et al.
(2014)
Solomon, G. M., et al. (1996). "Stillbirth after occupational exposure to N-methyl-2-pyrrolidone: A case report and
review of the literature." Journal of Occupational and Environmental Medicine 38(7): 705-713.
Solomon, et al.
Bader, M., et al. (2006). "Ambient monitoring and biomonitoring of workers exposed to N-methyl-2-pyrrolidone in an
industrial facility." International Archives of Occupational and Environmental Health 79(5): 357-364.
Bader et al. (2C
Xiaofei, E., et al. (2000). "A linear pharmacokinetic model predicts usefulness of N-methyl-2-pyrrolidone (NMP) in
plasma or urine as a biomarker for biological monitoring for NMP exposure." Journal of Occupational Health 42(6):
321-327.
Xiaofei et al.
(2000)
NICNAS (2013). Human health Tier II assessment for 2-pyrrolidinone, 1-methyl, CAS Number 872-50-4. N. I. C. N.
Department of Health and S. Assessment.
NICNAS C
RIVM (2013). Annex XV Restriction Report: Proposal for a Restriction. RIVM, Bureau REACH. The Netherlands,
National Institute for Public Health and the Environment (RIVM).
Rl\
WHO (2001). Concise International Chemical Assessment Document 35: N-Methyl-2-Pyrrolidone. Geneva,
Switzerland.
WHO (2001)
ECHA (2014). Background document to the opinion on the annex XV dossier proposing restrictions on l-methyl-2-
pyrrolidone (NMP). Helsinki, Finland.
ECU \ *:0i ki)
NIOSH (2014). International chemical safety cards (ICDC): N-methyl-2-pyrrolidone. Atlanta, GA.
NIOSH (2014b)
OSHA (2017). Sampling and analytical methods: N-methyl-2-pyrrolidinone. Washington, DC, U.S. Department of
Labor, Occupational Safety and Health Administration.
OS!
BASF (1993). Modification of a vapor degreasing machine for immersion cleaning use N-methylpyrrolidone.
Parsippany, NJ.
>F (1993)
Page 88 of 135
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OEHHA (2007). Occupational health hazard risk assessment project for California: Identification of chemicals of
concern, possible risk assessment methods, and examples of health protective occupational air concentrations.
Sacramento, CA.
007)
EC (2007). Recommendation from the scientific committee on occupational exposure limits for n-methyl-2-
pyrrolidone. Brussels, Belgium.
EC (2007b)
EU (2007). Impact assessment of potential restrictions on the marketing and use of dichloromethane in paint strippers.
Revised final report-Annexes. Brussels, Belgium, European Commission, Directorate-General Enterprise and
Industry.
EC (2007a)
EC (2004). Effectiveness of vapour retardants in reducing risks to human health from paint strippers containing
dichloromethane. Brussels, Belgium.
;2004b)
IF A (2010). MEGA evaluations for the preparation of REACH exposure scenarios for N-methyl-2-pyrrolidone
(vapor). Institute for Occupational Safety and Health of the German Social Accident Insurance (IF A). July, 2010.
http://www.dguv.de/medien/ifa/en/fac/reach/mega_auswertungen/n_methyl_2_pyrrolidon_en.pdf
Table Apx B-7. Engineering Controls and Personal Protective Equipment
Bibliography
url
Nishimura, S., et al. (2009). "A cross-sectional observation of effect of exposure to N-methyl-2-pyrrolidone (NMP) on
workers' health." Industrial Health 47(4): 355-362.
Nishimur
a et al.
(2009)
Bader, M., et al. (2006). "Ambient monitoring and biomonitoring of workers exposed to N-methyl-2-pyrrolidone in an
industrial facility." International Archives of Occupational and Environmental Health 79(5): 357-364.
Bader et
al. (2006)
Meier, S., et al. (2013). "Biomonitoring of exposure to N-methvl-2-pvrrolidone in workers of the automobile industry." Annals
of Occupational Hygiene 57(6): 766-773.
Meier et
NICNAS (2013). Human health Tier II assessment for 2-pyrrolidinone, 1-methyl, CAS Number 872-50-4. N. I. C. N.
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NICNAS
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pyrrolidone (NMP). Helsinki, Finland.
IA
(2014a)
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OECD (2015). Emission scenario document on use of adhesives. Paris, France.
OECD
OECD (2010). Emission Scenario Document on Formulation of Radiation Curable Coatings, Inks and Adhesives. Series on
Emission Scenario Documents No. 21. Paris, OECD Environmental Health and Safetv Publications.
OECD
f 2010a)
OECD (2010). Emission Scenario Document on Photoresist Use in Semiconductor Manufacturing. Series on Emission
Scenario Documents No. 9. Paris, OECD Environmental Health and Safetv Publications.
OECD
(2010b)
OECD (2011). EMISSION SCENARIO DOCUMENT ON RADIATION CURABLE COATING, INKS AND ADHESIVES.
Series on Emission Scenario Documents No. 27. Paris, OECD Environmental Health and Safetv Publications.
OECD
White, D. L. and J. A. Bardole (2004). Paint and finish removers.
White and
Bardole
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(2017). PubChem: 1-Methyl-2-pyrrolidinone. Washington, DC, National Institute of Health, U.S. National Library of
Medicine, National Center for Biotechnology Information.
NOB I
(2017). Hazardous substances databank: l-Methyl-2-pyrrolidinone. Rockville, MD, U.S. National Library of Medicine.
HSDB
i
NIOSH (2014). Health hazard evaluation report no. HHE-2011-0099-3211, evaluation of employee exposures during sea
lamprey pesticide application. Cincinnati, OH.
NIOSH
(2.014a)
NIOSH (2014). International chemical safety cards (ICDC): N-methyl-2-pyrrolidone. Atlanta, GA.
NIOSH
NICNAS (1997). Full public report: Polymer in byk-410.
NICNAS
NICNAS (2001). Full public report: Polymer in primal binder u-51.
NICNAS
(2.001)
NICNAS (1998). Full public report: Copolymer in foraperle 321.
NICNAS
>8)
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HESIS
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Page 90 of 135
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Appendix C SURFACE WATER ANALYSIS OF NMP RELEASES
This appendix provides an analysis of surface water concentrations based on reported surface water
releases of NMP.
EPA considered several scenarios to estimate NMP concentrations in surface water resulting from
industrial discharges. Using 2015 TRI available data and EPA's first-tier, Probabilistic Dilution Model
(PDM) within the EPA Exposure and Fate Assessment Screening Tool (E-FAST), facilities with the
largest releases of NMP were modeled for 12 days of release, and 250 days of release. The 12-day
release scenario represents an acute scenario in which periodic maintenance and cleaning activities
result in periodic releases. The 250-day scenario represents a chronic scenario in which operations
consist of fairly constant discharges of NMP. Six facilities had reported direct discharges of NMP to
surface waters and seven facilities reported indirect discharges, that is discharges sent to a municipal
treatment facility also known as a public-owned treatment works (POTW) for treatment and discharge
into surface waters. The single day release was considered the most conservative scenario since the
NMP surface water concentrations were highest (see Table_Apx C-l).
Table Apx C-l. Estimated NMP Surface Water Concentrations
Top Facility Discharges (2015)
State
Direct TRI
Pounds
(Ibs/yr)
Indirect
TRI
Pounds
(Ibs/yr)
PDM; input loadings
(kg/site/day)
PDM; stream NMP
concentrations
Facility Location
12 day
scenario
250 day
scenario
12 day (ug/L)
250 day (ug/L)
WILMINGTON
NC
8,987
0
339.71
16.31
224.00
10.75
RICHMOND
VA
4,602
0
173.96
8.35
119.70
5.75
ESSEX JUNCTION
VT
451
0
17.05
0.82
44.49
2.14
BRADFORD
PA
26.83
0
1.01
0.05
8.49
0.4
FORT WAYNE
IN
22.1
0
0.84
0.04
5.56
0.27
WYANDOTTE
Ml
2
21.52
0.08
0.00
0.0011
0.0000538
WESTBOROUGH
MA
8,048
304.21
14.60
69.03
WILMINGTON
MA
42,682
1613.38
77.44
4.79
PENSACOLA
FL
12,384
468.12
22.47
467.92
SAINT LOUIS
MO
12,001
453.64
21.77
50.86
ALOHA
OR
13,600
514.08
24.68
39.91
HILLSBORO
OR
40,800
1542.24
74.03
119.72
EPA then compared the surface water concentrations with the aquatic organism acute and chronic COCs
estimated during problem formulation, 246 ppb and 1,768 ppb, respectively.
Page 91 of 135
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FigureApx C-l. Estimated Surface Water Concentration for 12-Day NMP Discharge
12 Day NMP Discharge Scenario
_ 300
1 250
C
o
+s 200
ra
£ 150
u
c
u 100
S 50
on
a. o
Acute COC = 246 ug/L
1
^ -4*" oV- ^ ^
J" J"
& >¦
Facilities Reporting NMP Surface Water Discharges iriTRI
Figure Apx C-2. Estimated Surface Water Concentration for 250 Day NMP Discharge
250 Day Discharge Scenario
< lsoo
&D
3. lsoo
o 140D Chronic COC = 1.7&S u.g/L
ra 1200
Facilities Reporting NMP Surface Water Discharges inTRi
For all modeled NMP release scenarios, none of the facility discharges resulted in an exceedance of the
acute or chronic levels of concern identified for ecological receptors.
Page 92 of 135
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Appendix D SUPPORTING TABLE FOR INDUSTRIAL AND COMMERCIAL
ACTIVITIES AND USES CONCEPTUAL MODEL
TableApx D-l. Worker Exposure Conceptual Model Supporting Table (Note that rows shaded in gray are excluded from the scope
of this risk evaluation)
Life Cycle
Stage
Category
Sii besitegorv
Release /
l.xposu re
Seena rio
Fx posure
Pathway
Fxposu re Route
Receptor /
Population
Fu rtlier
Analysis
Rationale for Further Analysis /
110 Further Analysis
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway. The number of
sites manufacturing NMP is
limited per CDR (11 sites).
EPA will further evaluate vapor
generation potential, as inhalation
Vapor
Inhalation
Workers,
ONU
Yes
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
NMP is well absorbed following
Manufacture
Domestic
Manufacture
Domestic Manufacture
Manufacture of
NMP
Vapor
Dermal
Workers,
ONU
Yes
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure (U.S. EPA, 2015).
Vapor-through-skin is a pathway
of concern.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
Mist/
Dust
Dermal/Inhalation
Workers,
ONU
No
Generation of mist and dust
containing NMP is not expected
during this operation.
Page 93 of 135
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Life ( vole
Stage
Category
Sii bcntegoiy
Release /
Fxposu re
Soena rio
Fxposure
Pathway
Fxposure Route
Receptor /
Population
Further
Analysis
Rationale for Further Analysis /
110 Further Analysis
Liquid
Contact
Dermal
Workers
Yes
Exposure expected only in the
event the imported material is
repackaged into different sized
containers. Exposure frequency
may be low. However, the number
of workers potentially exposed
may be high per CDR (13
submissions reporting <10
workers, 1 submission reporting
10 to 25 workers, 5 submissions
reporting 50 to 100 workers, 1
submission reporting 100 to 500
workers, and 9 submissions
claiming CBI or NKRA for
number of workers).
Manufacture
Import
Import
Repackaging of
import
containers
Vapor
Inhalation
Workers,
ONU
Yes
Exposure expected only in the
event the imported material is
repackaged into different sized
containers. EPA will further
evaluate vapor generation
potential, as inhalation exposures
are expected to be limited for
certain conditions of use due to the
low volatility of NMP (VP =
0.345 mmHg).
Vapor
Dermal
Workers,
ONU
Yes
Exposure expected only in the
event the imported material is
repackaged into different sized
containers. NMP is well absorbed
following dermal exposures and
dermal absorption including NMP
from the vapor phase typically
contributes significantly to human
exposure (IIS. EPA, 2015Y
Vapor-through-skin is a pathway
of concern.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
Mist/
Dust
Dermal/Inhalation
Workers,
ONU
No
Generation of mist and dust
containing NMP is not expected
during this operation.
Page 94 of 135
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Life ( vole
Stage
Category
Sii bcntegoiy
Release /
Fxposu re
Soena rio
Fxposure
Pathway
Fxposu re Route
Receptor /
Population
Further
Analysis
Rationale for Further Analysis /
no Further Analysis
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway. The number of
workers potentially exposed may
be high per CDR (1 submission
reporting 500 to 1,000 workers
and 1 submission reporting NKRA
for number of workers).
Processing as a
reactant or
intermediate
Vapor
Inhalation
Workers,
ONU
Yes
EPA will further evaluate vapor
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
Processing
Pharmaceutical and Medicine
Manufacturing; Other
Chemical Manufacturing
manufacturing;
Chemical
Manufacturing
Vapor
Dermal
Workers,
ONU
Yes
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure (IIS. EPA, 2015).
Vapor-through-skin is a pathway
of concern.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
Mist/
Dust
Dermal/Inhalation
Workers,
ONU
No
Generation of mist and dust
containing NMP is not expected
during this operation.
Adhesives and sealant
chemicals in Adhesive
Manufacturing; Anti-
adhesive agents in Printing
and Related Support
Activities; Paint additives
and coating additives not
Formulation of
adhesives;
Formulation of
chemical
mixtures;
Formulation of
paints, and
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway. The number of
workers potentially exposed may
be high per CDR (34 submissions
reporting number of workers
ranging from <10 to 500 to 1,000
workers).
Processing
Incorporated
into
formulation,
mixture or
reaction product
described by other codes in
Paint and Coating
Manufacturing; Print Ink
Manufacturing; Plating
agents and surface treating
agents in Fabricated Metal
coatings;
Formulation of
printing inks;
Formulation of
metal finishing
chemicals;
Vapor
Inhalation
Workers,
ONU
Yes
EPA will further evaluate vapor
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
Product Manufacturing;
Solvents (for cleaning or
degreasing) in Non-Metallic
Mineral Product
Manufacturing, Machinery
Manufacturing, Plastic
Formulation of
cleaning and
degreasing
products;
Formulation of
cleaning fluids;
Vapor
Dermal
Workers,
ONU
Yes
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure (U.S. EPA, 2015).
Page 95 of 135
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Life ( vole
Stage
Category
Sii bcntegoiy
Material and Resin
Manufacturing, Primary
Metal Manufacturing, Soap,
Cleaning Compound and
Toilet Preparation
Manufacturing,
Transportation Equipment
Manufacturing, All Other
Chemical Product and
Preparation Manufacturing,
Printing and Related Support
Activities, Services,
Wholesale and Retail Trade;
Solvents (which become part
of product formulation or
mixture) in Electrical
Equipment, Appliance and
Component Manufacturing,
Other Manufacturing, Paint
and Coating Manufacturing,
Print Ink Manufacturing,
Soap, Cleaning Compound
and Toilet Preparation
Manufacturing,
Transportation Equipment
Manufacturing, All Other
Chemical Product and
Preparation Manufacturing,
Printing and Related Support
Activities, Wholesale and
Retail Trade; Surface active
agents in Soap, Cleaning
Compound and Toilet
Preparation Manufacturing;
Other uses in Oil and Gas
Drilling, Extraction and
Support Activities.
Release /
Fxposu re
Soena rio
Formulation of
petrochemical
products
Fxposure
Pathway
Fxposu re Route
Receptor /
Population
Further
Analysis
Rationale for Further Analysis /
no Further Analysis
Vapor-through-skin is a pathway
of concern.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
Mist/
Dust
Dermal/Inhalation
Workers,
ONU
No
Generation of mist mid dust
containing NMP is not expected
during this operation.
Processing
Incorporated
into
formulation,
mixture or
reaction product
Solvents (which become part
of product formulation or
mixture) in Other
Manufacturing, All Other
Chemical Product and
Preparation Manufacturing.
Formulation of
granular
agricultural
products
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway. The number of
workers potentially exposed may
be high per CDR (34 submissions
reporting number of workers
ranging from <10 to 500 to 1,000
workers).
Vapor
Inhalation
Workers,
ONU
Yes
EPA will further evaluate vapor
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
Page 96 of 135
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Life ( vole
Stage
Category
Sii bcntegoiy
Release /
Fxposu re
Soena rio
Fxposure
Pathway
Fxposu re Route
Receptor /
Population
Further
Analysis
Rationale for Further Analysis /
no Further Analysis
use due to the low volatility of
NMP (VP = 0.345 mmHg).
Dust
Inhalation
Workers,
ONU
Yes
Dust formation is possible during
manufacturing of solid products.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
Vapor
Dermal
Workers,
ONU
Yes
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure fU.S. EPA, 2015Y
Vapor-through-skin is a pathway
of concern.
Mist
Dermal/Inhalation
Workers,
ONU
No
Mist generation not expected
during this operation.
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway.
Lubricants and lubricant
additives in Machinery
Formulation of
lubricants;
Formulation of
Paints and
Coatings;
Formulation of
textile finishing
chemicals
Vapor
Inhalation
Workers,
ONU
Yes
EPA will further evaluate vapor
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
Processing
Incorporated
into article
Manufacturing; Paint
additives and coating
additives not described by
other codes in Transportation
Equipment Manufacturing;
Solvents (which become part
of product formulation or
mixture), including in
Vapor
Dermal
Workers,
ONU
Yes
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure (U.S. EPA, 2015).
Vapor-through-skin is a pathway
of concern.
Textiles, Apparel and Leather
Manufacturing
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
Mist/
Dust
Dermal/Inhalation
Workers,
ONU
No
Generation of mist and dust
containing NMP is not expected
during this operation.
Processing
Incorporated
into article
Other, including in Plastic
Product Manufacturing
Plastics
compounding
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway.
Page 97 of 135
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Life ( vole
Stage
Category
Sii bcntegoiy
Release /
Fxposu re
Soena rio
Fxposure
Pathway
Fxposure Route
Receptor /
Population
Further
Analysis
Rationale for Further Analysis /
110 Further Analysis
and Plastics
EPA will further evaluate vapor
converting
Vapor
Inhalation
Workers,
ONU
Yes
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
Dust
Inhalation
Workers,
ONU
Yes
Dust formation is possible during
plastic processing activities.
Dermal exposure is expected to be
Liquid
Contact
Dermal
ONU
No
primarily to workers directly
involved in working with the
chemical.
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
Vapor
Dermal
Workers,
ONU
Yes
the vapor phase typically
contributes significantly to human
exposure (U.S. EPA, 2015Y
Vapor-through-skin is a pathway
of concern.
Mist
Dermal/Inhalation
Workers,
ONU
No
Mist generation not expected
during this operation.
Liquid
Contact
Dermal
Workers
Yes
Low ranking - screening-level
analysis will be done
Vapor
Inhalation
Workers,
ONU
Yes
Low ranking - screening-level
analysis will be done
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
Processing
Repackaging
Wholesale and Retail Trade
Repackaging
into large and
small containers
Vapor
Dermal
Workers,
ONU
Yes
the vapor phase typically
contributes significantly to human
exposure ("U.S. EPA, 2015).
Vapor-through-skin is a pathway
of concern.
Dermal exposure is expected to be
Liquid
Contact
Dermal
ONU
No
primarily to workers directly
involved in working with the
chemical.
Mist/
Dust
Workers,
ONU
Generation of mist and dust
Dermal/Inhalation
No
containing NMP is not expected
during this operation.
Processing
Recycling
Recycling
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway.
Page 98 of 135
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Life Cycle
Stiige
Category
Sii bcntegoiy
Release /
Fxposu re
Seeiiii rio
Fxposure
l\ithwsiy
Fxposu ro Route
Receptor /
Population
Further
Analysis
Riitioiiiile for Further Ansilvsis /
110 Further Analysis
Vapor
Inhalation
Workers,
ONU
Yes
EPA will further evaluate vapor
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
Recycling of
process solvents
containing NMP
Vapor
Dermal
Workers,
ONU
Yes
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure fU.S. EPA, 2015).
Vapor-through-skin is a pathway
of concern.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
Mist/
Dust
Dermal/Inhalation
Workers,
ONU
No
Generation of mist and dust
containing NMP is not expected
during this operation.
Distribution
Distribution
Distribution
Distribution of
bulk shipments
of NMP;
Distribution of
formulated
products
Liquid
Contact,
Vapor /
Dust
Dermal/
Inhalation
Workers,
ONU
No
Low priority for assessment.
Exposure will only occur in the
event of spills.
Industrial,
commercial,
Paints and
coatings; Paint
additives and
coating
Adhesive and paint and
coating removers; Lacquers,
stains, varnishes, primers and
floor finishes; Powder
coatings (surface
preparation); Paint and
Coating Use in Computer and
Adhesive and
paint and
coating removal
by contractors;
Roll/curtain
application and
spray
application of
paints, coatings,
adhesives, and
sealants and
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway. The number of
workers potentially exposed may
be high per CDR (16 submissions
reporting the number of workers
ranging from <10 workers to
>10,000 workers).
and
consumer
use
additives not
described by
other codes;
Adhesives and
sealants
Electronic Product
Manufacturing, Construction,
Fabricated Metal Product
Manufacturing, Machinery
Manufacturing, Other
Manufacturing, Paint and
Vapor
Inhalation
Workers,
ONU
Yes
EPA will further evaluate vapor
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
Coating Manufacturing,
Primary Metal
Mist
Inhalation
Workers,
ONU
Yes
Mist generation is expected to
occur during this operation.
Page 99 of 135
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Life Cycle
Stage
Category
Sii beiitegoiy
Relesise /
Fxposu re
Scensi rio
Fxposure
Psithwsiy
Fxposure Route
Receptor /
Population
Further
Analysis
Riitioiiiile for Further Analysis /
110 Further Analysis
Manufacturing,
Transportation Equipment
Manufacturing, Wholesale
and Retail Trade; Adhesives
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
and sealant chemicals
including binding agents;
Single component glues and
adhesives, including
lubricant adhesives; Two-
component glues and
adhesives, including some
resins
Vapor
Dermal
Workers,
ONU
Yes
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure (IIS. EPA. 2015V
Vapor-through-skin is a pathway
of concern.
Dust
Dermal/Inhalation
Workers,
ONU
No
Generation of dust containing
NMP is not expected during this
operation.
Lacquers, stains, varnishes,
primers and floor finishes;
Powder coatings (surface
preparation); Paint and
Coating Use in Computer and
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway. The number of
workers potentially exposed may
be high per CDR (16 submissions
reporting the number of workers
ranging from <10 workers to
>10,000 workers).
Industrial,
Paints and
coatings; Paint
additives and
Electronic Product
Manufacturing, Construction,
Fabricated Metal Product
Manufacturing, Machinery
Manufacturing, Other
Manufacturing, Paint and
Manual
(roller/brush)
application and
Vapor
Inhalation
Workers,
ONU
Yes
EPA will further evaluate vapor
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
commercial,
and
consumer
use
coating
additives not
described by
other codes;
Adhesives and
sealants
Coating Manufacturing,
Primary Metal
Manufacturing,
Transportation Equipment
Manufacturing, Wholesale
and Retail Trade; Adhesives
and sealant chemicals
including binding agents;
syringe/bead
application of
paints, coatings,
adhesives, and
sealants and
removers
Vapor
Dermal
Workers,
ONU
Yes
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure (U.S. EPA. 2015).
Vapor-through-skin is a pathway
of concern.
Single component glues and
adhesives, including
lubricant adhesives; Two-
component glues and
adhesives, including some
resins
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
Mist/
Dust
Dermal/Inhalation
Workers,
ONU
No
Generation of mist and dust
containing NMP is not expected
during this operation.
Industrial,
commercial,
Aerosol
degreasing
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway.
Page 100 of 135
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Life ( vole
Stage
Category
Sii bcntegoiy
Release /
Fxposu re
Soena rio
Fx posure
Pathway
Fxposure Route
Receptor /
Population
Further
Analysis
Rationale for Further Analysis /
110 Further Analysis
and
consumer
use
Vapor
Inhalation
Workers,
ONU
Yes
EPA will further evaluate vapor
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
Mist
Inhalation
Workers,
ONU
Yes
Mist generation is expected to
occur during this operation.
Solvents (for
cleaning or
degreasing)
Use in Electrical Equipment,
Appliance and Component
Manufacturing
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
Vapor
Dermal
Workers,
ONU
Yes
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure (U.S. EPA, 2015Y
Vapor-through-skin is a pathway
of concern.
Dust
Dermal/Inhalation
Workers,
ONU
No
Generation of dust containing
NMP is not expected during this
operation.
Page 101 of 135
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Life ( vole
Stage
Category
Sii bcntegoiy
Release /
Fxposu re
Soena rio
Fx posure
Pathway
Fxposu re Route
Receptor /
Population
Further
Analysis
Rationale for Further Analysis /
no Further Analysis
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway.
Vapor
Inhalation
Workers,
ONU
Yes
EPA will further evaluate vapor
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
Industrial,
commercial,
and
consumer
use
Solvents (for
cleaning or
degreasing)
Use in Electrical Equipment,
Appliance and Component
Manufacturing
Wipe cleaning
Vapor
Dermal
Workers,
ONU
Yes
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure (IIS. EPA, 2015).
Vapor-through-skin is a pathway
of concern.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
Mist/
Dust
Dermal/Inhalation
Workers,
ONU
No
Generation of mist and dust
containing NMP is not expected
during this operation.
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway. The number of
workers is limited per CDR (1
submission reporting <10 workers
and 1 submission reporting 100 to
500 workers).
Industrial,
commercial,
and
consumer
use
Ink, toner and
colorant
products
Printer ink
Industrial /
commercial
printing
Vapor
Inhalation
Workers,
ONU
Yes
EPA will further evaluate vapor
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
Vapor
Dermal
Workers,
ONU
Yes
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure (U.S. EPA, 2015).
Vapor-through-skin is a pathway
of concern.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
Page 102 of 135
-------
Life ( vole
Stage
Category
Sii bcntegoiy
Release /
Fxposu re
Soena rio
Fxposure
Pathway
Fxposu re Route
Receptor /
Population
Further
Analysis
Rationale for Further Analysis /
no Further Analysis
Mist/
Dust
Dermal/Inhalation
Workers,
ONU
No
Generation of mist and dust
containing NMP is not expected
during this operation.
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway. The number of
workers potentially exposed is
limited per CDR (1 submission
reporting 50 to 100 workers and 2
submissions reporting NKRA for
number of workers).
Industrial,
Processing aids,
specific to
petroleum
production
Oil and gas
extraction;
Petrochemical
purifications
Vapor
Inhalation
Workers,
ONU
Yes
EPA will further evaluate vapor
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
commercial,
and
consumer
use
Petrochemical Manufacturing
Vapor
Dermal
Workers,
ONU
Yes
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure fU.S. EPA, 2015).
Vapor-through-skin is a pathway
of concern.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
Mist/
Dust
Dermal/Inhalation
Workers,
ONU
No
Generation of mist and dust
containing NMP is not expected
during this operation.
Industrial,
commercial,
and
Adhesives and
sealants
Soldering materials
Industrial and
commercial
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway. The number of
workers potenitally exposed is
limited per CDR (1 submission
reporting 50 to 100 workers and 2
submissions reporting NKRA for
number of workers).
consumer
use
soldering
Vapor
Inhalation
Workers,
ONU
Yes
EPA will further evaluate vapor
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
Page 103 of 135
-------
Life ( vole
Stage
Category
Sii bcntegoiy
Release /
Fxposu re
Soena rio
Fxposure
Pathway
Fxposu re Route
Receptor /
Population
Further
Analysis
Rationale for Further Analysis /
no Further Analysis
Vapor
Dermal
Workers,
ONU
Yes
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure fU.S. EPA, 2015).
Vapor-through-skin is a pathway
of concern.
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
Mist/
Dust
Dermal/Inhalation
Workers,
ONU
Yes
EPA will further evaluate to
determine if mist and dust
generation is applicable.
Commercial
automotive
servicing,
including
application of
lubricants;
Manual
(brushing) and
dip application
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway. However, the
potential for exposure is unknown
where NMP is incorporated into
articles.
Industrial,
commercial,
and
consumer
use
anti-freeze and de-icing
products; automotive care
products; lubricants and
greases; Lubricant and
lubricant additives, including
hydrophilic coatings; Metal
products not covered
elsewhere; Laboratory
chemicals; Lithium ion
batteries; Cleaning and
furniture care products,
including wood cleaners,
gasket removers;
Pharmaceutical and Medicine
Vapor
Inhalation
Workers,
ONU
Yes
EPA will further evaluate vapor
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
Other uses
finishing
products;
Laboratory use;
Industrial
battery use;
Wipe cleaning;
Pharmaceutical
chemical
Vapor
Dermal
Workers,
ONU
Yes
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure (IIS. EPA. 2015V
Vapor-through-skin is a pathway
of concern.
Manufacturing - functional
fluids (closed systems);
Wood preservatives
extractions;
Manual
(paste/brush)
application of
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
wood
preservatives
Mist/
Dust
Dermal/Inhalation
Workers,
ONU
No
Generation of mist and dust
containing NMP is not expected
during this operation.
Industrial,
commercial,
Other uses
Other aerosol uses, e.g. metal
products not covered
Spray
application of
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway.
Page 104 of 135
-------
Life ( vole
Stage
Category
Sii bcntegoiy
Release /
Fxposu re
Soena rio
Fxposure
Pathway
Fxposu re Route
Receptor /
Population
Further
Analysis
Rationale for Further Analysis /
no Further Analysis
and
consumer
use
elsewhere; Cleaning and
furniture care products,
including wood cleaners,
gasket removers; Fertilizer
and other agricultural
chemical manufacturing -
metal finishing
products;
Spray/aerosol
application of
cleaning
products;
Vapor
Inhalation
Workers,
ONU
Yes
EPA will further evaluate vapor
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
processing aids and solvents
Commercial
fertilizer
Mist
Inhalation
Workers,
ONU
Yes
Mist generation is expected to
occur during this operation.
application
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
Vapor
Dermal
Workers,
ONU
Yes
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure (U.S. EPA, 2015Y
Vapor-through-skin is a pathway
of concern.
Dust
Dermal/Inhalation
Workers,
ONU
No
Chemical is not expected to be in
solid form.
Liquid
Contact
Dermal
Workers
Yes
Dermal exposure is expected to be
a primary pathway. Frequency of
exposure and the potential for
dermal immersion needs to be
evaluated.
Waste
Handling,
Treatment and
Disposal
Worker handling
Vapor
Inhalation
Workers,
ONU
Yes
EPA will further evaluate vapor
generation potential, as inhalation
exposures are expected to be
limited for certain conditions of
use due to the low volatility of
NMP (VP = 0.345 mmHg).
Disposal
Disposal of NMP wastes
and disposal of
waste
Liquid
Contact
Dermal
ONU
No
Dermal exposure is expected to be
primarily to workers directly
involved in working with the
chemical.
Vapor
Dermal
Workers,
ONU
Yes
NMP is well absorbed following
dermal exposures and dermal
absorption including NMP from
the vapor phase typically
contributes significantly to human
exposure (IIS. EPA, 2015Y
Vapor-through-skin is a pathway
of concern.
Page 105 of 135
-------
Appendix E SUPPORTING TABLE FOR CONSUMER ACTIVITES AND USES
CONCEPTUAL MODEL
Table Apx
C-l. Supporting Table for Consumer Activities and
Jses Concepi
tual Model
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Consumer
Use
Paints and
Coatings
Paint and
coating
removers
Evaporation
from surface
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Consumer
Use
Paints and
Coatings
Paint and
coating
removers
Spray
Application
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Page 106 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Consumer
Use
Paints and
Coatings
Paint and
coating
removers
Spray
Application
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Consumer
Use
Paints and
Coatings
Adhesive
Evaporation
from surface
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Page 107 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Consumer
Use
Paints and
Coatings
Adhesive
removers
Spray
Application
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Lacquers,
stains,
varnishes,
primers and
floor finishes
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Consumer
Use
Paints and
Coatings
Evaporation
from surface
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Page 108 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Vapor/Mist
Inhalation
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Lacquers,
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Consumer
Use
Paints and
Coatings
stains,
varnishes,
primers and
floor finishes
Spray
Application
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Page 109 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Consumer
Use
Paint
additives
and coating
additives
Construction;
Wholesale and
Retail Trade
Evaporation
from surface
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Consumer
Use
Paint
additives
and coating
additives
Construction;
Wholesale and
Retail Trade
Spray
Application
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Page 110 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Consumer
Use
Solvents (for
cleaning and
degreasing)
Use in
Electrical
Equipment,
Appliance and
Component
Manufacturing
Evaporation
from surface
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Page 111 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Consumer
Use
Solvents (for
cleaning and
degreasing)
Use in
Electrical
Equipment,
Appliance and
Component
Spray
Application
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Manufacturing
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Consumer
Use
Ink, toner
and colorant
products
Printer ink
Evaporation
from surface
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Page 112 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Consumer
Use
Ink, toner
and colorant
products
Inks in writing
equipement
Evaporation
from surface
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Page 113 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Consumer
Use
Adhesives
and sealants
Adhesives and
sealant
chemicals
including
binding agents
Evaporation
from surface
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Consumer
Use
Adhesives
and sealants
Adhesives and
sealant
chemicals
including
binding agents
Spray
Application
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Page 114 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Consumer
Use
Adhesives
and sealants
Single
component
glues and
adhesives,
including
lubricant
adhesives
Evaporation
from surface
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Consumer
Use
Adhesives
and sealants
Single
component
glues and
Spray
Application
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Page 115 of 135
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Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
adhesives,
including
lubricant
adhesives
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Consumer
Adhesives
Two-
component
glues and
Evaporation
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Use
and sealants
adhesives,
including some
resins
from surface
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Page 116 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Consumer
Use
Adhesives
and sealants
Soldering
materials
Evaporation
from surface
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Consumer
Use
Other uses
Automotive
care products
Evaporation
from surface
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Page 117 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Consumer
Use
Other uses
Automotive
care products
Spray
Application
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Page 118 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Consumer
Use
Other uses
Lubricants and
greases
Evaporation
from surface
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Consumer
Other uses
Lubricants and
Spray
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Use
greases
Application
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
Page 119 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
NMP contamination of hands resulting from near-
Liquid contact
Oral
Bystanders
Yes
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Consumer
Use
Other uses
Cleaning and
furniture care
products,
including wood
cleaners,
Evaporation
from surface
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
gasket
removers
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
NMP contamination of hands resulting from near-
Liquid contact
Oral
Bystanders
Yes
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Consumer
Use
Other uses
Cleaning and
furniture care
products,
Spray
Application
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Page 120 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
including wood
cleaners,
gasket
removers
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Lubricant and
lubricant
additives,
including
hydrophilic
coatings
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Consumer
Use
Other uses
Evaporation
from surface
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Page 121 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Consumer
Use
Other uses
Lubricant and
lubricant
additives,
including
hydrophilic
coatings
Spray
Application
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Consumer
Use
Other uses
Wood
preservatives
Evaporation
from surface
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Page 122 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Consumer
Use
Other uses
Wood
preservatives
Spray
Application
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Page 123 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Consumer
Use
Other uses
Arts and
Crafts, Hobby
Materials
Evaporation
from surface
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Liquid contact
Dermal
Consumers
Yes
Dermal exposure is expected to be a primary pathway
since NMP is well absorbed following dermal
exposures.
Consumer
Use
Other uses
Arts and
Crafts, Hobby
Materials
Spray
Application
Vapor through
skin
Dermal
Consumers/
Bystanders
Yes
NMP is well absorbed following dermal exposures
and dermal absorption including NMP from the vapor
phase typically contributes significantly to human
exposure (U.S. EPA, 2015a). Vapor-through-skin is a
pathway of concern.
Liquid contact
Oral
Consumers
Yes
NMP contamination of hands resulting from product
use may result in consumer exposure to NMP via
ingestion. NMP exposure via oral route is expected to
be low.
Page 124 of 135
-------
Life Cycle
Stage
Category
Subcategory
Release /
Exposure
Scenario
Exposure
Pathway
Exposure
Routes
Receptor
Proposed for
Further
Analysis
Rationale for Further Analysis/ No Further Analysis
Vapor/Mist
Inhalation
Consumers/
Bystanders
Yes
EPA will further evaluate vapor generation potential,
as inhalation exposures are expected to be limited for
certain conditions of use due to the low volatility of
NMP (VP = 0.345 mmHg).
Liquid contact
Dermal
Bystanders
No
Bystanders are not expected to have direct contact
with liquids containing NMP
Liquid contact
Oral
Bystanders
Yes
NMP contamination of hands resulting from near-
field use may result in consumer exposure to NMP
via ingestion. NMP exposure via oral route is
expected to be unlikely for bystanders.
Consumer
Use
Other uses
Articles
Children's soft
toys, blankets,
etc
Liquid contact
Dermal
Consumers
(Children)
Yes
Residual NMP in article could be source of dermal
exposure. NMP is well absorbed following dermal
exposures.
Liquid contact
Oral
(mouthing)
Consumers
(Children)
Yes
Residual NMP in article could be source of exposure
due to children's mouthing behavior.
Page 125 of 135
-------
Appendix F SUPPORTING TABLE FOR ENVIRONMENTAL RELEASES AND WASTES
CONCEPTUAL MODEL
Table Apx F-l. Supporting Table for Environmental Releases and Wastes Conceptual JV
Life Cycle
Stajjc
Release
Exposure Pathway/
Media
Exposure
Routes
Receptor/
Population
Further
Analysis?
Rationale for Further Analysis/ No Further
Analysis
Disposal
.Industrial wastewater
treatment operations
Direct release into
surface water
Surface water
Aquatic Species
No
Conservative Tier 1 screening indicates low risk
concern for aquatic organisms (see section 2.3.4)
Terrestrial Species
No
Conservative Tier 1 screening indicates low
concentrations of NMP in surface water.
Ingestion of water is not expected to be a
significant route of NMP exposure for terrestrial
organisms.
Industrial wastewater
treatment, operations
Direct release into
surface water and
indirect partitioning to
sediment
Sediment
Aquatic Species
No
NMP has low sorption to soil, sludge, and
sediment (log Koc = 0.9) and will instead stay in
the associated aqueous phases due to high water
solubility (1.000 g/L).
Terrestrial Species
No
Disposal
Induslrial prc-l.rcat.mcnl.
then transfer to Publicly
Owned Treatment Works
(POTW)
Direct release into
surface water
Surface water
Aquatic Species
No
Conservative Tier 1 screening indicates low risk
concern for aquatic organisms (see section 2.3.4)
Terrestrial Species
No
NMP exposure via ingestion of water and
inhalation of air arc expected to present a low risk
concern for terrestrial organisms.
Disposal
I ndusl rial prc-l.rcal.mcnl.
then transfer to Publicly
Owned Treatment Works
(POTW)
Direct release into
surface water and
indirect partitioning to
sediment
Sediment
Aquatic Species
No
NMP has low sorption to soil, sludge, and
sediment (log Koc = 0.9) and will instead stay in
the associated aqueous phases (solubilitv = 1.000
g/L).
Disposal
Industrial prc-l.rcal.mcnl.
then transfer to Publicly
Owned Treatment Works
(POTW)
Direct release into
surface water and
indirect partitioning to
sediment
Sediment
Terrestrial Species
No
Based on physical-chemical properties (log Koc =
0.9). NMP is not expected to partition to soil,
sludge, and sediment. NMP is expected to remain
in the aqueous phase (water solubilitv = 1.000
g/L).
odel
Page 126 of 135
-------
Life Cycle
Stajjc
Release
Exposure Pathway/
Media
Exposure
Routes
Receptor/
Population
Further
Analysis?
Rationale for Further Analysis/ No Further
Analysis
Disposal
Biosolids and land
Migration from
biosolids via soil
deposition
Soil
Terrestrial Species
No
Due to NMP's physical-chemical properties, (log
Koc = 0.9. and water solubility = 1.000 g/L).
NMP is not expected to partition to soil: aerobic
biodegradation and mobility in soil arc expected
to limit accumulation in this environmental
compartment.
disposal to soil
Groundwater -
Ingestion
General
Population: Adults
and children living
near facilities
No
Conservative Tier 1 screening indicates low
concentrations of NMP in surface water. NMP
releases from land applicat ion of biosolids arc
expected to be much less than those associated
with direct release of wastewater treatment plant
effluents to surface water.
All
Emissions to Air
Near facility ambient
air concentrations
Inhalation
General
Population: Adults
and children living
near facilities
No
Conservative Tier 1 screening indicates low risk
concern to general population (sec section
2.5.3.1)
Indirect deposition to
nearby bodies of water
and soil catchments
Soil
Terrestrial Species
No
NMP is not expected to remain in soil for long
periods of time due to aerobic biodegradation and
migration to groundwater due to the log Koc (0.9)
and water solubility (1.000 g/L).
Page 127 of 135
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Appendix G INCLUSION AND EXCLUSION CRITERIA FOR
FULL TEXT SCREENING
Appendix G contains the eligibility criteria for various data streams informing the TSCA risk evaluation:
environmental fate; engineering and occupational exposure; exposure to consumers; and human health
hazard. The criteria are applied to the on-topic references that were identified following title and abstract
screening of the comprehensive search results published on June 22, 2017.
Systematic reviews typically describe the study eligibility criteria in the form of PECO statements or a
modified framework. PECO stands for Population, Exposure, Comparator and Outcome and the approach is
used to formulate explicit and detailed criteria about those characteristics in the publication that should be
present in order to be eligible for inclusion in the review. EPA/OPPT adopted the PECO approach to guide
the inclusion/exclusion decisions during full text screening.
Inclusion and exclusion criteria were also used during the title and abstract screening, and documentation
about the criteria can be found in the Strategy for Conducting Literature Searches document published in
June 2017 along with each of the TSCA Scope documents. The list of on-topic references resulting from
the title and abstract screening is undergoing full text screening using the criteria in the PECO statements.
The overall objective of the screening process is to select the most relevant evidence for the TSCA risk
evaluation. As a general rule, EPA is excluding non-English data/information sources and will translate on
a case by case basis.
The inclusion and exclusion criteria for ecotoxicological data have been documented in the ECOTOX
SOPs. The criteria can be found at https://cfpub.epa.eov/ecotox/help.cfm?helptabs=tab4) and in the
Sir ale gy for Conducting Literature Searches document published along with each of the TSCA Scope
documents.
G.l Inclusion Criteria for Data Sources Reporting Environmental Fate
Data
EPA/OPPT developed a generic PESO statement to guide the full text screening of environmental fate data
sources. PESO stands for Pathways and Processes, Exposure, Setting or Scenario, and Outcomes.
Subsequent versions of the PESO statement may be produced throughout the process of screening and
evaluating data for the chemicals undergoing TSCA risk evaluation. Studies that comply with the inclusion
criteria in the PESO statement are eligible for inclusion, considered for evaluation, and possibly included in
the environmental fate assessment. On the other hand, data sources are excluded if they do not meet the
criteria in the PESO statement.
Assessors seek information on various chemical-specific fate endpoints and associated fate processes,
environmental media and exposure pathways as part of the process of developing the environmental fate
assessment.
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G.2 Inclusion Criteria for Data Sources Reporting Releases and
Occupational Exposure Data
EPA/OPPT developed a generic RESO statement to guide the full text screening of releases and
occupational exposure literature (TableApx Gl). RESO stands for Receptors, Exposure, Setting or
Scenario, and Outcomes. Subsequent versions of the RESO statement may be produced throughout the
process of screening and evaluating data for the chemicals undergoing TSCA risk evaluation. Studies
that comply with the inclusion criteria specified in the RESO statement will be eligible for inclusion,
considered for evaluation, and possibly included in the environmental release and occupational exposure
assessments, while those that do not meet these criteria will be excluded.
The RESO statement should be used along with the engineering, release and occupational exposure data
needs table (Table Apx G2) when screening the literature.
Since full text screening commenced right after the publication of the TSCA Scope document, the
criteria for engineering and occupational exposure data were set to be broad to capture relevant
information that would support the risk evaluation. Thus, the inclusion and exclusion criteria for full text
screening do not reflect the refinements to the conceptual model and analysis plan resulting from
problem formulation. As part of the iterative process, EPA is in the process of refining the results of the
full text screening to incorporate the changes in information/data needs to support the risk evaluation.
Table Apx G-l. Inclusion Criteria for Data Sources Reporting Release and Occupational
Exposure Data
RESO Element
Evidence
• Humans:
Workers, including occupational non-users
Receptors
Please refer to the conceptual models for more information about the ecological and human
receptors included in the TSCA risk evaluation.
Exposure
• Worker exposure to and relevant occupational environmental releases of the chemical
substance of interest
o Dermal and inhalation exposure routes (as indicated in the conceptual model)
Please refer to the conceptual models for more information about the routes and media/pathways
included in the TSCA risk evaluation.
Setting or
Scenario
• Any occupational setting or scenario resulting in worker exposure and environmental releases
(includes all manufacturing, processing, use, disposal indicated in Table Apx G below.
Outcomes
• Quantitative estimates* of worker exposures and of relevant environmental releases from
occupational settings
• General information and data related and relevant to the occupational estimates
* Metrics (e.g., mg/kg/day or mg/m3 for worker exposures, kg/site/day for releases) are determined by
toxicologists for worker exposures and by exposure assessors for releases; also, the Engineering, Release, and
Occupational Exposure Data Needs (Table Apx G2) provides a list of related and relevant general information.
TSCA=Toxic Substances Control Act
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TableApx G-2. Engineering, Environmental Release and Occupational Data Necessary to Develop
the Environmental Release and Occupational Exposure Assessments
Objective
Determined
during Scoping
Type of Data
General
Engineering
Assessment (may
apply for either
or both
Occupational
Exposures and /
or Environmental
Releases)
1. Description of the life cycle of the chemical(s) of interest, from manufacture to end-of-life (e.g., each
manufacturing, processing, or use step), and material flow between the industrial and commercial life cycle
stages. {Tags: Life cycle description, Life cycle diagram} a
2. The total annual U.S. volume (lb/yr or kg/yr) of the chemical(s) of interest manufactured, imported,
processed, and used; and the share of total annual manufacturing and import volume that is processed or
used in each life cycle step. {Tags: Production volume, Import volume, Use volume, Percent PV}a
3. Description of processes, equipment, unit operations, and material flows and frequencies (lb/site-day or
kg/site-day and days/yr; lb/site-batch and batches/yr) of the chemical(s) of interest during each industrial/
commercial life cycle step. Note: if available, include weight fractions of the chemical of interest and
material flows of all associated primary chemicals (especially water). {Tags: Process description, Process
material flow rate, Annual operating days, Annual batches, Weight fractions (for each of above,
manufacture, import, processing, use)}11
4. Basic chemical properties relevant for assessing exposures and releases, e.g., molecular weight, normal
boiling point, melting point, physical form, and room temperature vapor pressure. {Tags: Molecular
weight, Boiling point, Melting point, Physical form, Vapor pressure, Water solubility}a
5. Number of sites that manufacture, process, or use the chemical(s) of interest for each industrial/
commercial life cycle step and site location. {Tags: Numbers of sites (manufacture, import, processing,
use), Site locations}a
Occupational
Exposures
6. Description of worker activities with exposure potential during the manufacture, processing, or use of the
chemical(s) of interest in each industrial/commercial life cycle stage. {Tags: Worker activities
(manufacture, import, processing, use)}a
7. Potential routes of exposure (e.g., inhalation, dermal). {Tags: Routes of exposure (manufacture, import,
processing, use)}a
8. Physical form of the chemical(s) of interest for each exposure route (e.g., liquid, vapor, mist) and activity.
{Tags: Physical form during worker activities (manufacture, import, processing, use)}a
9. Breathing zone (personal sample) measurements of occupational exposures to the chemical(s) of interest,
measured as time-weighted average (TWA), short-term exposures, or peak exposures in each occupational
life cycle stage (or in a workplace scenario similar to an occupational life cycle stage). {Tags: PBZ
measurements (manufacture, import, processing, use)}a
10. Area or stationary measurements of airborne concentrations of the chemical(s) of interest in each
occupational setting and life cycle stage (or in a workplace scenario similar to the life cycle stage of
interest). {Tags: Area measurements (manufacture, import, processing, use)}a
11. For solids, bulk and dust particle size distribution (PSD) data. {Tags: PSD measurements (manufacture,
import, processing, use)}a
12. Dermal exposure data. {Tags: Dermal measurements (manufacture, import, processing, use)}
Data needs associated with mathematical modeling (will be determined on a case-by-case basis). {Tags:
Worker exposure modeling data needs (manufacture, import, processing, use)}a
13. Exposure duration (hrs/day). {Tags: Worker exposure durations (manufacture, import, processing, use)}a
14. Exposure frequency (days/yr). {Tags: Worker exposure frequencies (manufacture, import, processing,
use)}a
15. Number of workers who potentially handle or have exposure to the chemical(s) of interest in each life
cycle stage. {Tags: Numbers of workers exposed (manufacture, import, processing, use)}a
16. Personal protective equipment (PPE) types employed by industries within the scope. {Tags: Worker PPE
(manufacture, import, processing, use)}a
17. Engineering controls employed to reduce occupational exposures in each occupational life cycle stage (or
in a workplace scenario similar to the life cycle stage of interest), and associated data or estimates of
exposure reductions. {Tags: Engineering controls (manufacture, import, processing, use), Engineering
control effectiveness data}a
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Environmental
Releases (to
relevant
environmental
media)
18. Description of sources of potential environmental releases, including cleaning of residues from process
equipment and transport containers involved during the manufacture, processing, or use of the chemical(s)
of interest in each life cycle stage. {Tags: Release sources (manufacture, import, processing, use)}a
19. Estimated mass (lb or kg) of the chemical(s) of interest released from industrial and commercial sites to
each environmental medium (water) and treatment and disposal methods (POTW), including releases per
site and aggregated over all sites (annual release rates, daily release rates) {Tags: Release rates
(manufacture, import, processing, use)}a
20. Release or emission factors. {Tags: Emission factors (manufacture, import, processing, use)}a
21. Number of release days per year. {Tags: Release frequencies (manufacture, import, processing, use)}a
22. Data needs associated with mathematical modeling (will be determined on a case-by-case basis). {Tags:
Release modeling data needs (manufacture, import, processing, use)}a
23. Waste treatment methods and pollution control devices employed by the industries within scope and
associated data on release/emission reductions. {Tags: Treatment/ emission controls (manufacture, import,
processing, use), Treatment/ emission controls removal/ effectiveness data}a
Notes:
" These are the tags included in the full text screening form. The screener makes a selection from these specific tags, which
describe more specific types of data or information.
Abbreviations:
hr = Hour
kg = Kilogram(s)
lb = Pound(s)
yr = Year
P V = Production volume
PBZ = Personal breathing zone
POTW = Publicly owned treatment works
PPE = Personal protective equipment
PSD = Particle size distribution
TWA = Time-weighted average
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G.3 Inclusion Criteria for Data Sources Reporting Exposure Data on
Consumers and Ecological Receptors
EPA/OPPT developed PECO statements to guide the full text screening of exposure data/information for
human (i.e., consumers, potentially exposed or susceptible subpopulations) and ecological receptors.
Subsequent versions of the PECO statements may be produced throughout the process of screening and
evaluating data for the chemicals undergoing TSCA risk evaluation. Studies that comply with the
inclusion criteria in the PECO statement are eligible for inclusion, considered for evaluation, and
possibly included in the exposure assessment. On the other hand, data sources are excluded if they do
not meet the criteria in the PECO statement. The NMP-specific PECO is provided in TableApx G1 thru
TableApx G4.
Since full text screening commenced right after the publication of the TSCA Scope document, the
criteria for exposure data were set to be broad to capture relevant information that would support the risk
evaluation. Thus, the inclusion and exclusion criteria for full text screening do not reflect the
refinements to the conceptual model and analysis plan resulting from problem formulation. As part of
the iterative process, EPA is in the process of refining the results of the full text screening to incorporate
the changes in information/data needs to support the risk evaluation.
Table Apx G-3. Inclusion Criteria for the Data Sources Reporting N-Methylpyrrolidone
Exposure Data on Consumers and Ecological Receptors
PECO Element
Evidence
Population
Human: Consumers (i.e., individuals who use a product directlv) and
bystanders (i.e., those individuals who happen to be in close proximity during
use of NMP-containing products), including, susceptible populations (e.g.,
lifestages, preexisting conditions, genetic factors), such as infants, children,
pregnant women, women of child bearing age; do-it-yourself (DIY) or high-end
consumers.
Ecological: Aauatic and terrestrial biota (organisms and plants).
Exposure
Expected Primary Exposure Sources, Pathways, Routes
Sources: Consumer uses in the home producing releases of NMP to air and
dermal contact; industrial and commercial activities that generate releases to
surface water; NMP remaining primarily in aqueous media of biosolids after
wastewater treatment.
Pathways: Indoor/outdoor air and dermal contact with NMP in consumer
products (e.g., liquid contact), vapor/mist/dust, dust; biosolids application to
soil.
Routes: oral (dust or bv mouthing), inhalation (vapor/mist), dermal (liauid
contact); dermal (vapor to skin).
Comparator
Human: Consider media-specific background exposure scenarios and
use/source-specific exposure scenarios as well as which receptors are and are
not reasonably exposed across the projected exposure scenarios.
(Scenario)
Ecological: Aauatic and terrestrial species exposure via contact with or
ingestion of surface water; terrestrial species exposure via contact with soil.
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PECO Element
Evidence
Outcomes for
Exposure
Concentration or
Dose
Human: Acute, subchronic, and/or chronic external exposure dose estimates
(mg/kg/day); acute, subchronic, and/or chronic air concentration estimates
(mg/m3 or mg/L). Both external potential dose and internal dose based on
biomonitoring and reverse dosimetry mg/kg/day will be considered.
Ecological: A range of ecological receptors will be considered using surface
water concentrations, sediment concentrations, and soil concentrations.
Abbreviations:
NMP = N-Methylpyrrolidone
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G.4 Inclusion Criteria for Data Sources Reporting Human Health
Hazards
EPA/O PPT developed chemical-spedtic PECO statements TableApx G1 thru TableApx G4) to guide
the full text screening of the human health hazard literature. Subsequent versions of the PECOs may be
produced throughout the process of screening and evaluating data for the chemicals undergoing TSCA
risk evaluation. Studies that comply with the criteria specified in the PECO statement will be eligible for
inclusion, considered for evaluation, and possibly included in the human health hazard assessment,
while those that do not meet these criteria will be excluded according to the exclusion criteria.
In general, the PECO statements were based on (1) information accompanying the TSCA Scope
document, and (2) preliminary review of the health effects literature from authoritative sources cited in
the TSCA Scope documents. When applicable, these authoritative sources (e.g., IRIS assessments,
EPA/OPPT's Work Plan problem formulations or risk assessments) will serve as starting points to
identify PECO-relevant studies.
Table Apx G-4. Inclusion Criteria for Data Sources Reporting Human Health Hazards Related to
N-Methylpyrrolidone (NMP) a
IM'.CO
T. lemon I
l'.\ idence Siiviim
I'iipoi's/l-'oiiluivs Included
P;ipers/I"e;i lures r.xcluded
Population b
Human
• Any population
• All lifestages
• Study designs:
o Controlled exposure, cohort, case-control,
cross-sectional, case-crossover
o Case studies and case series that are related
to deaths from acute exposure
• Case studies and case series for all
endDoints other than death from acute
exposure
Animal
• All non-human whole-organism mammalian
species
• All lifestages
• Non-mammalian species
Exposure
Human
• Exposure based on administered dose or
concentration ofNMP, biomonitoring data (e.g.,
urine, blood or other specimens), environmental
or occupational-setting monitoring data (e.g.,
air, water levels), job title or residence
• Primary metabolites of interest as identified in
biomonitoring studies (5-hydroxy-N-methyl-2-
pyrrolidone (5-HNMP) and 2-hydroxy-N-
methylsuccinimide (2-HMSI))
• Exposure identified as or vresumed to be from
oral, dermal, inhalation routes
• Any number of exposure groups
• Quantitative, semi-quantitative or qualitative
estimates of exposure
• Exposures to multiple chemicals/mixtures only
if NMP or related metabolites were
independently measured and analyzed
• Route of exposure not by inhalation,
oral or dermal type (e.g.,
intraperitoneal, injection)
• Multiple chemical/mixture exposures
with no independent measurement of or
exposure to NMP (or related
metabolite)
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IM'.CO
r.k-iiK'iii
l.\ idence Sdviiin
P
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